cyrilzakka/clinical-trials huggingface dataset:
Postoperative Hypoxia and Body Position

The study aims at investigate whether the oxygen partial pressure is improved in the prone position postoperative after abdominal surgery. Included are 50 adults operated with abdominal surgery. The Intervention is turning from supine to prone position and then back to supine position while measuring whether an improvement occurs in oxygen saturation and oxygen partial pressure, or not.

Postoperative hypoxia complicates 30% - 50% of abdominal surgeries. The cause of postoperative restrictive lung function and hypoxia is unknown. Previous studies report that oxygen partial pressure decreases by an average of 2 kPa after abdominal surgery, while carbon dioxide partial pressure is unchanged and vital capacity decreases by 35%. Patients are operated and treated in the post anesthesia care unit in the supine position. The study aims at investigate whether the oxygen partial pressure is improved in the prone position postoperative after abdominal surgery or not.

Inclusion: 50 adults operated with abdominal surgery. Exclusion: Esophageal surgery, Abdominal vessel surgery. Decline participation. Intervention: turning from supine to prone position and then back to supine position again.

Primary outcome: Change in oxygen saturation and oxygen partial pressure. Secondary outcome: Change in carbondioxide partial pressure Procedures: Partial blood gas is taken before surgery. On the day of surgery or the day after: starting in supine position with continuous measurements of oxygen saturation from pulse oximetry, transcutaneous carbon-dioxide partial pressure and blood gas. Then turning to prone position and then back to supine position.

Eligibility Criteria:
Inclusion Criteria:

* Being operated within 2 in the abdomen because of upper gastrointestinal surgery, colorectal surgery, urological surgery or emergency surgery
* Must be able to turn from supine position to prone position in the bed

Exclusion Criteria:

* Esophageal surgery, Abdominal vessel surgery.
* Decline participation.
Ataxia and Exercise Disease Using MRI and Gait Analysis

The first aim is to show balance training improves DCD individual's ability to compensate for their activity limitations, but does not impact disease progression.

The second aim is to demonstrate aerobic exercise improves balance and gait in DCD persons by affecting brain processes and slowing cerebellar atrophy.

Individuals with degenerative cerebellar disease (DCD) exhibit gradual loss of coordination resulting in impaired balance, gait deviations, and severe, progressive disability. With no available disease-modifying medications, balance training is the primary treatment option to improve motor skills and functional performance. There is no evidence, however, that balance training impacts DCD at the tissue level.

Aerobic training, on the other hand, may modify DCD progression as evident from animal data. Compared to sedentary controls, aerobically trained DCD rats have enhanced lifespan, motor function, and cerebellar Purkinje cell survival. Numerous animal studies also document that aerobic training has a direct, favorable effect on the brain that includes production of neurotrophic hormones, enhancement of neuroplasticity mechanisms, and protection from neurotoxins.

The effects of aerobic training in humans with DCD are relatively unknown, despite these encouraging animal data. A single study to date has evaluated the benefits of aerobic exercise on DCD in humans, and this was a secondary outcome of the study. Although participants performed limited aerobic training during the study, modest functional benefits were still detected.

The main objective of this project will be to compare the benefits of aerobic versus balance training in DCD. We hypothesize that both aerobic and balance training will improve function in DCD subjects, but that the mechanisms in which these improvements occur differ. 1) Balance training improves DCD individual's ability to compensate for their activity limitations, but does not impact disease progression. 2) Aerobic exercise improves balance and gait in DCD persons by affecting brain processes and slowing cerebellar atrophy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with spinocerebellar ataxia
* Cerebellar atrophy on MRI
* Prevalence of ataxia on clinical exam
* Ability to safely ride a stationary exercise bike

Exclusion Criteria:

* Other neurologic conditions
* Heart disease
* Cognitive impairment
* Medical instability
Plasma, Urine and Tear Omics Changes in Different Diets

The study plans to start in July 2021, and it is expected that 20 healthy people (aged 18-70 years old, BMI 18.5-40kg/m2) will carry out a 5-week intervention and follow-up. Participants will be enrolled in the group through the screening and plan to take regular diet, OGTT, high-fat diet, low-calorie diet and ketogenic diet within 5 weeks. The proteomics and metabolomics indicators of tear, plasma, and urine specimens will be measured at 5 time points at baseline, 30 minutes, 1 hour, 2 hours, and 3 hours for each diet. The correlation of proteomics and metabolomics indicators with classic laboratory parameters (BMI, HDL, LDL, cholesterol, triglyceride levels, and insulin resistance (HOMA-IR)) will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy individuals aged 20-70 years, with a body mass index (BMI) of 18.5-40 kg/m².
2. No known chronic medical conditions.
3. Willingness to comply with study requirements and adhere to the intervention protocol.

Exclusion Criteria:

1. Presence of significant medical conditions or chronic diseases.
2. Diagnosis of diabetes mellitus or prediabetes.
3. Triglyceride level ≥4 mmol/L.
4. Blood pressure ≥160/100 mmHg or presence of malignant hypertension.
5. History of an eating disorder.
6. Previous bariatric surgery.
7. Severe gastrointestinal diseases.
8. History of diarrhea within the past two weeks.
9. Special dietary requirements or known food allergies.
10. Pregnancy or breastfeeding.
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.

In this study, the investigators propose that persistent disseminated tumor cells (DTC) present after systemic therapy represent a unique subpopulation of all DTC, are predictors of a poor response to systemic therapy and correlate with poor clinical outcome. The investigators hypothesize that systemic therapy-resistant DTC can be identified by their expression of a unique constellation of tumor marker proteins which may be similar to those expressed by breast cancer stem cells. In this research, the investigators' specific aims are : 1) to characterize tumor markers expressed by DTC which are present after systemic therapy, 2) to compare the expression of these markers to that on DTC detected prior to systemic therapy, 3) to correlate expression of the defined tumor markers on DTC with clinical outcome of breast cancer patients to identify those markers that are predictive of disease recurrence, 4) to utilize biomarkers identified in Specific Aims 1 and 2 to isolate purified DTC for further molecular analysis.

Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed with clinical stage II, III, or IV breast cancer
* Planning to undergo neoadjuvant or adjuvant systemic therapy; patients who have already completed neoadjuvant systemic therapy are also eligible
* Must be \>= 18 years of age
* If female, must not be pregnant
* Must not have Hepatitis B, C, or HIV
* Must be willing and able to sign informed consent document
Comparison of Three Motor-cognitive Training Programs

Understanding how to delay age-related physical and mental declines is an issue for aging research. It has been shown that isolated aerobic, coordination and cognitive training improve brain functions and cognitive performances. Moreover, the combination of them leads to greater effects. Different combination modalities are possible: training programs demanding cognitive resources within the activity performed in a natural environment like Nordic Walking (or Tai chi, Dance...); or as in a conceptually-grounded circuit training where training components are systematically combined and their intensity controlled. The aim of this study is to compare three training programs: a Nordic walking one (NW), and two conceptual grounded, circuits training (CT-c; CT-fit). CT-c implemented by dual-task (DT) exercises, while CT-fit characterized by cognitive charge embodied in the movements through the use of technology. An improvement in physical, motor, and cognitive functions is expected by all three groups. However, our primary hypothesis is that the CT-fit will impact executive functions more.

45 healthy independent living community dwellers participants aged 65 to 80 will be recruited. Participants will be included after a general medical examination (geriatric screening and cycle-ergometer maximal effort test). The main exclusion criteria are signs of cognitive impairment, (MMSE \<26/30), and physical impairments. Participants will be randomly divided into the 3 groups (NW, CT-c, CT-fit): The training program will last 8 weeks, 1 hour 3 times a week. Pre and post-tests will include cognitive assessment (MoCA; TMT; Stroop task, Happy Neuron™ working memory test, Rey Complex Figure copy task and dual-task capacities through the DT-OTMT); motor fitness assessment (Bipedal upright standing, Unipedal balance test, walking speed and size of the base of support, Timed Up \& Go, Chair sit and reach test and Four square stepping test) and physical assessment (10 m incremental shuttle walking test, maximal handgrip force, 30s chair rise stand).

Improving cognitive functions by adding new technology embodied in a systematically combined training (exergame), would result to be the best solution to optimize training for aging people.


Eligibility Criteria:
Inclusion Criteria:

* Considered apt for moderate physical activity practice (validated by a maximal VO2 cycle-ergometer test by a cardiologist)
* Sedentary or moderately active (objectified by the categories obtained at the IPAQ)
* Cognitively healthy (objectified by a score at the MMSE of 26 and above)

Exclusion Criteria:

* Colorblindness
* Uncorrected earing and/or visual impairment
* Presence of a known psychiatric or neurologic condition
* Under psychotropic treatment or beta-blockers
Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II

The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as an autologous bone-regenerating graft in the reconstruction of deficient bone in two clinical indications:

1. Long and short bone extra-articular comminuted fracture
2. Long and short bones extra and intra articular defect /Gap or non-union, incapable of self-regeneration

Primary Endpoint:

Safety: to establish that the transplantation of BonoFill-II into bone defect/gap is safe under the following conditions:

* No treatment-related appearance of heterotrophic bone ossification
* No excessive bone formation at the transplantation sites
* No abnormalities in the treated sites

Efficacy: to establish that the transplantation of BonoFill-II into bone defect/gap is effective under the following conditions:

Bone continuity rate, measured radiographically by CT at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Long and short bones extra articular comminuted fracture or
* Long and short bones extra and intra articular defect/gap or non union, incapable of self-regeneration

Exclusion Criteria:

* Age is under 18 or above 80
* A simple fracture manageable by one definitive treatment
* Pregnant or lactating women
* Patients with active infection anywhere in the body except in the injured bone site that is in question and needs osteogenic treatment.
* Subjects with recorded medical history diseases such as heart diseases, renal failure.
* Subject treated currently with systemic steroids.
* Subjects with known autoimmune diseases, such as Addison's disease, Celiac disease - sprue (gluten-sensitive enteropathy), Dermatomyositis, Graves disease, Hashimoto's thyroiditis, Multiple sclerosis, Myasthenia gravis, Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome, Systemic lupus erythematosus.
* Subjects diagnosed with osteoporosis
* Subjects that have a known scar healing problem (keloid formation).
* Subjects treated with Bisphosphonate drugs
* Oncology patients in treatment
* Subjects who received chemotherapy or radiotherapy treatment in the past
* Subjects participating in another clinical trial 30 days prior to and during the study period.
* Drug addicts and psychiatric patients patients incapable of giving consent.
* Subjects with a known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation.
* Subjects with any known allergy for local/general anesthesia.
* Positive serology for either HIV, hepatitis B or hepatitis C.
* Abnormal clinically significant laboratory test and findings, as per the investigator's judgment.
Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears

Extension Study of Protocol RC-001- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection into Partial Thickness Rotator Cuff Tears. Purpose is to investigate the Long- term safety and efficacy of autologous stem cells in patients with partial thickness rotator cuff tears versus a steroid treatment.

The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space.

The ADRC mixture is generated from the Transpose® RT System, a point-of-care solution for extraction of an autologous regenerative cell mixture from the adipose tissue after a same-day limited liposuction procedure. A pilot clinical study was recently completed using an injection of ADRC compared to a corticosteroid injection for treatment of PTRCTs. Results support the initiation of a pivotal study to study the same.

Eligibility Criteria:
Inclusion Criteria:

* Patient completed participation in RC-001 (NCT02918136) study
* Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial.

Exclusion Criteria:

* none
Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing

Medicare is requesting outcome data on patients who received Prolaris testing and were prescribed active surveillance (AS). In order to ensure appropriate patient care, it is important to understand how this added prognostic information influences the selection and durability of AS and corresponding clinical outcomes. To address this knowledge gap, this study will evaluate how frequently men with low disease-specific mortality (DSM) risk based on Prolaris CCR score and who meet NCCN low-risk criteria initially select AS (AS selection). This study also will assess how long Prolaris-tested men who initially select AS remain on this course before proceeding to definitive treatment (AS durability), and whether AS duration impacts biochemical recurrence (BCR) and metastasis risk in these men. This retrospective, observational and multi-site study will combine patient CCR scores with longitudinal clinical data to address these questions.

This is a multicenter, retrospective, observational study in men diagnosed with localized PrCa who had Prolaris testing prior to the treatment decision. The study will collect demographic, clinical, pathologic, and Prolaris test data from medical records and Myriad's Prolaris database.

The primary objective of this study is to evaluate the rate of BCR or metastasis, whichever occurs first, among Prolaris-tested men who were at low risk of DSM (≤3.2%), who also met NCCN low-risk criteria, and who were initially treated with AS.

The secondary objectives of the study are to evaluate the frequency of AS selection among all men who had low DSM risk, as determined by Prolaris testing and AS durability among Prolaris-tested men with low DSM risk who selected and initiated this treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with localized PrCa at participating sites between January 1, 2013 and August 1, 2017.
* Have undergone Prolaris testing and have a CCR score with estimated DSM risk ≤3.2%.
* Have NCCN low-risk disease2.

Exclusion Criteria:

* Received any therapy other than 5α-reductase inhibitor (5-ARI) prior to diagnostic biopsy.
* Over 80 years of age at diagnosis.
* History of hypogonadism at the time of diagnosis.
* Co-occurring malignancy, excluding non-melanoma skin cancer.
* Enrolled in another investigational study.
Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery

Patients with diabetes have poorer cardiac surgery outcomes compared with non-diabetics. Proper blood glucose management is critical to reduce the morbidity and mortality for diabetic patients after cardiac surgery.

SGLT2 inhibitors including dapagliflozin as a new diabetes drug can reduce heart failure hospitalization rates and overall cardiovascular mortality in patients with cardiovascular disease.

This study is to assess the impact of one year of treatment of SGLT2 inhibitors on cardiac function, postoperative complications and long-term cardiovascular mortality in diabetic patients undergoing cardiac surgery.

The investigators use echocardiography to evaluated cardiac function in diabetic patients during perioperative cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old at index date.
2. Diagnosis of Type 2 Diabetes.
3. Scheduled for cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy).
4. eGFR ≥ 60 ml/min/1.73 m2.
5. Patients who agree to receive treatment with SGLT2 inhibitors.
6. Patients must be on current stable hemodynamic profile , without dehydration.

Exclusion Criteria:

1. Diagnosis of Type 1 Diabetes.
2. eGFR \< 60 ml/min/1.73 m2.
3. Unstable or rapidly progressive renal disease.
4. Hypersensitivity to dapagliflozin or any excipients.
5. Severe hepatic disease.
6. Patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days.
7. Any other reason considered by a study physician to be inappropriate for inclusion.
Bifeprunox in the Treatment of Schizophrenia

Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia
* understand nature of study
* able to be managed in out-patient setting for long-term bifeprunox treatment

Exclusion Criteria:

* current primary diagnosis other than schizophrenia
* suicide risk
* diagnosis or history of substance abuse
* uncontrolled hypertension
A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol;
2. Aged ≥ 50 years at screening;

   Study Eye:
3. Diagnosis of nAMD as determined by the PI;
4. Active CNV lesions secondary to age-related macular degeneration (AMD);
5. Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment

Exclusion Criteria:

1. Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline;
2. Retinal pigment epithelial tear in the study eye at screening;
3. Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;
4. Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;
5. History of retinal detachment or active retinal detachment in the study eye;
6. Any prior gene therapy.
Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis

Children with cystic fibrosis require increased caloric intake to maintain appropriate growth, an important determinant of long-term outcomes. This study seeks to determine the feasibility of using a novel therapeutic food to promote weight gain and growth in children with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Cystic Fibrosis diagnosed by sweat test or genetic testing.
* Exocrine Pancreatic Insufficiency and receiving pancreatic enzyme replacement therapy
* BMI or weight for age of less than the 50th percentile

Exclusion Criteria:

* Cystic fibrosis related diabetes mellitus
* Cystic fibrosis related liver disease.
* Anaphylactic or other allergy to peanut, cow's milk, oat flour or other RUTF ingredients.
* Patients who are status-post lung or liver transplantation
* Currently receiving enteral supplemental nutrition through gastrostomy or nasogastric tube.
A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants

This is a Phase I, open-label, non-randomized, parallel-group, single-dose study in healthy adult male participants. The aim is to investigate the relative bioavailability (rBA) of NXT007 among subcutaneous (SC) injection sites (abdomen, upper arm, and thigh) and the absolute bioavailability (aBA) of SC NXT007 administration. In addition, the pharmacodynamic, safety, tolerability, and immunogenicity of a single dose of NXT007 following SC or intravenous (IV) administration are assessed.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy as determined by medical evaluation that includes medical history, physical examination, vital signs, laboratory tests, and 12-lead ECG
* Body mass index (BMI) within the range of 18.5 to 30.0 kg/m\^2
* Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm

Exclusion Criteria:

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immunological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data
* History of allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies; or known hypersensitivity to any constituent of the product
* Clinically relevant medical history and/or family history or signs of thromboembolic disease such as deep vein thrombosis
* FVIII activity ≥120 International Units per decilitre (IU/dL) at screening
* Clinically significant abnormality on electrocardiogram (ECG) at screening such as QTcF after 10-minute supine rest \>450 milliseconds (ms); marked resting bradycardia (mean heart rate \<40 beats per minute \[bpm\]); marked resting tachycardia (mean heart rate \>100 bpm); or any other clinically significant ECG abnormality
* Supine systolic blood pressure at screening ≥140 millimetres of mercury (mm Hg) or \<90 mm Hg or supine diastolic blood pressure at screening ≥90 mm Hg or \<40 mm Hg
* Clinically significant abnormality on protein C activity (chromogenic assay), activated protein C resistance test, protein S free antigen, and/or antithrombin III activity levels
* Poor peripheral venous access
* Any other reason that, in the judgment of the investigator, would render the participants unsuitable for study participation