cyrilzakka/clinical-trials huggingface dataset:
Timing and Dosage of Acute Intermittent Hypoxia in Persons With SCI

This study will utilize short duration and mild levels of reduced oxygen (hypoxia) to induce spinal plasticity while evaluating the appropriate timing schedule for this intervention, as well as, the effects of superimposing sessions of a therapy, in individuals with chronic incomplete SCI. Our aim is to establish the time-course of outcome improvement and decay following a single session or multiple sessions of AIH therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Spinal cord lesion at level of C3 to T1
2. Individuals with a history of incomplete spinal cord injury, classified as ASIA C or D
3. Individuals must be at least 6 months status post injury
4. Individuals must be between the ages of 18-70 years inclusive, male or female
5. Spinal cord injury must be secondary to a non-progressive etiology
6. Individuals must be medically stable.
7. Able to comply with protocol/study requirements
8. Not currently (\>2 weeks) taking any medications for spasticity management.

Exclusion Criteria:

1. Recent change in the use of narcotic, anti-inflammatory or pain medication
2. Unstable medical conditions or any other clinical observation that may affect the candidate's performance, health, safety or the ability to participate in the study, as determined by the treating therapist
3. History of sleep apnea
4. Active participation in another movement research study or therapy program
5. Anti-spasticity drug injection less than 3 months, prior to beginning treatment
6. Musculoskeletal pain that interferes with participation in study
7. Women who are currently, may be or planning on becoming pregnant
HCV Care Pathway in Ile-de-France

The main objective of this research is to evaluate a care pathway adapted to different category populations at risk of being infected with the hepatitis C virus in order to improve both the diagnosis turnaround times and the access to treatment. The aim is to allow a quick and effective access to diagnosis and treatment of HCV by strengthening the city hospital networks, access to early consultations and coordination of medical social actors.

The current estimation of infected persons with chronic hepatitis C in France is over 200 ,000. It appears that prevention, screening, care management, medical and social care of patients can be significantly improved especially among the most vulnerable populations. Indeed, these new HCV infections are mediated by drug-using people, prisoners, migrants, men who have sex with men (MSM) and who are supported too late and without real access to treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and more
* Positive Hepatitis C virus
* Patient having expressed a non-objection to participate in this research

Exclusion Criteria: None
Mesothelioma Avastin Plus Pemetrexed-cisplatin Study

Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.

A phase II trial associating the reference chemotherapy (pemetrexed plus cisplatin) with bevacizumab is needed to ensure that no specific toxicity is induced by this association, and that this triplet have interesting activity. As pleural mesothélioma is a rare tumor, a phase III trial, using the survival data from the phase II part study, will be able to include a sufficient number of patients, in a reasonable period of time, to answer the question of efficacy of the anti-angiogenic triplet, providing the efficacy outcomes could be considered as favorable, at the end of the phase II part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Malignant, histologically proved, non resectable pleural Mesothelioma
* In case of pleural effusion, a talc pleurodesis, although not recommended, is allowed in accordance with current local practice, at the time of diagnostic thorascopy, with inclusion CT scan performed after pleurodesis.
* ECOG Performance status 0-2
* Mesothelioma with only pleural effusion without uni- or bidimensionally measurable disease will be eligible (adapted RECIST criteria)
* At least 18 years of age, less than 76 years of age
* Radiation therapy of thoracocentis tract (3 x 7Gy) performed before beginning medical study treatment, and the interval between thoracoscopic procedure and radiation will not exceed 28 days

Exclusion Criteria:

* Prior chemotherapy
* Brain metastasis
* History of cerebral vascular accident (CVA) or transient ischemic attack
Correlation Between Sleep Quality , Physical Fitness and Body Mass Index

It is estimated that 10-13% of adults suffer from chronic insomnia. Short sleep duration is linked to obesity, type 2 diabetes, high blood pressure, and cardiovascular diseases. Feeling tired during the day predicts poor sleep quality (SQ), while wakefulness is linked to better SQ. Previous studies have also reported a relationship between short sleep duration and increased Body Mass Index (BMI), and a high correlation between increased BMI and decreased SQ, with more frequent awakenings. Moreover, there is a connection between sleep disorders and weight gain. The study is significant because it aims to uncover the relationships between sleep quality, physical fitness, and body mass index (BMI) in physical therapy students, offering insights crucial for improving their health and academic performance. By identifying how these factors interact, the study can inform targeted interventions to enhance student well-being, clinical competence, and long-term health. Additionally, the findings can guide educational programs to support healthier lifestyles and enable students to serve as effective role models for their future patients, thereby contributing to overall healthcare quality.


Eligibility Criteria:
Inclusion Criteria:

* Student of both gender with age that ranges from 18 to 25 years old.
* Must be actively enrolled in an accredited physical therapy program.
* Open to students from any year of study within the physical therapy program.

Exclusion Criteria:

* Diagnosed with sleep disorders such as insomnia, sleep apnea, or narcolepsy.
* Chronic physical conditions like cardiovascular, respiratory, neurological, or musculoskeletal disorders.
* Metabolic or endocrine disorders such as diabetes or thyroid disorders.
Sleep Disorders in Patients With Suspected Lung Cancer Before and After Thoracic Surgery

The main aim of this study is to prospectively evaluate the occurrence of sleep disorders in patients undergoing thoracic surgery due to the preliminary diagnosis of lung cancer. Secondary aims include anxiety, depressive mood and functional outcomes before and 3 months after the intervention.

Cancer surgery is one of the traumas that affect human life, starting from diagnostic procedures, along with the recovery process. Although 5-year survival in lung cancer has increased to 60%, there is a general prejudice that lung cancer has a poor prognosis. A preliminary diagnosis of a such condition has consequently a negative effect on the mood and sleep patterns of the patients, starting already from the beginning of the diagnostic procedures. In our study, we want to evaluate the occurrence of sleep disorders, anxiety, depressive mood and functional outcomes before and 3 months after the surgical intervention. This would also help us to better identify the patients in need for professional support for sleep disorders as well as psychiatric conditions, and thus, a better management of patients with lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo lung resection with a pre-diagnosis of lung cancer
* Being literate or having the physical strength to answer questions.

Exclusion Criteria:

* The patient has a chronic disease such as dementia or treatment-resistant schizophrenia in which reality assessment is impaired.
* Patients who have received chemotherapy and / or radiotherapy due to their previous disease.
Detecting Postoperative Recurrence in Crohn's Disease

Up to ¾ of patients who have been diagnosed with Crohn's disease (CD) will have to undergo bowel resection during their lifetime despite modern medical therapies. Unfortunately, disease recurrence is common and endoscopic detection of recurring inflammation precedes clinical relapse. Endoscopic investigation is therefore recommended to manage these patients.

This multi center, prospective study compares the conventional endoscopic method, ileo-colonoscopy to a new technique, i.e., colonic capsule endoscopy (CCE). CCE enables investigation of the small bowel and the large intestines by using a double-sided video camera with about 10 hours acquisition time.

This study aims to evaluate the performance of CCE to detect postoperative recurrence of CD and detection rate of colonic and anastomotic recurrence is compared to ileo-colonoscopy. Proximal (small bowel) lesions are additionally recorded and impact on clinical management of the findings is accounted for. Moreover, safety aspects and influence of the findings on progress of the disease are monitored. All consecutive patients who are operated for CD in any of the participating study centers are eligible. Included are patients with segmental small bowel, ileocecal or segmental colonic resection.

In some cases capsule retention has been reported at an average of 2-3% with CD patients at elevated risk. Therefore, patency capsule is performed before application of the video CCE to exclude bowel obstruction.

Sample size estimation results in n = 70, requiring each 140 capsule endoscopes and 140 patency capsules for performance of postoperative screening (ca 4-8 weeks postoperatively) and detection of postoperative recurrence (ca 4-8 months postoperatively).


Eligibility Criteria:
Inclusion Criteria:

* Segmental bowel resection for Crohn's disease

  * Ileocecal resection
  * Small bowel resection
  * Segmental colonic resection
* Informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Intestinal obstruction as suspected by anamnesis or clinical/technical investigation
* Dysphagia or ileus
* Non-passage of the intact 'Agile Patency Capsule' within 72 hours
* Pregnancy
Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema

To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.

Primary Objective: To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.

Secondary Objective:To investigate ranibizumab's additional benefit on visual improvement, facilitation of surgery and postoperative outcomes in PDR-DME patients receiving vitrectomy.

Study design: This study is a prospective, randomized, single-blinded, blank-controlled, multi-center clinical trial that requires vitrectomy for PDR-DME patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years old;
2. Type I or II diabetes mellitus, clinically diagnosed as diabetic macular edema
3. Diagnosed as proliferative diabetic retinopathy and pas plana vitrectomy (PPV) is required to undergo due to non-absorbent vitreous hemorrhage (VH), fibrovascular proliferation with vitreoretinal adhesions or tractional retinal detachment (TRD); or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation; as well as other indications of PPV at the investigator's discretion
4. Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Exclusion Criteria:

1. Pregnancy or lactation;
2. History of stroke, peripheral vascular disease, angina or myocardial infarction within six months
3. Intraocular treatment with corticosteroids, anti-vascular endothelium growth factor or intraocular surgery within 45 days preceding baseline;
4. Clinically confirmed intraocular pressure (IOP) \>=21 mmHg, uncontrolled glaucoma or iris neovascularization in either eye
Written Genetic Counseling and Mutation Analysis of BRCA1 and BRCA2 to Patients With Breast Cancer

The overall purpose of the study is to evaluate a method for offering mutation analysis of BRCA1 and BRCA2 to all patients with newly diagnosed breast cancer, regardless of age at diagnosis and family history. Information about the study as well as pre-test genetic counseling will primarily be given in a written way. In addition to that, if a study participant wishes to, she can also receive pre-test telephone genetic counseling.

Study population:

All patients with newly diagnosed breast cancer in southern Sweden are offered inclusion in the SCAN-B study at the time of diagnosis pre-surgery. If they consent to that, a part of the tumor is sent to a lab in Lund, Sweden, for research purposes (RNA sequencing etc.). Patients that are included in the SCAN-B study are eligible for inclusion in BRCAsearch, see inclusion and exclusion criteria.

Study procedure (summary):

1. An envelope with written information is given to the patient at the visit to the surgeon the week after surgery. This envelope contains a written genetic counseling, information about the study, an informed consent form, psychosocial questionnaires and our contact information (telephone, e-mail). The patient can contact a genetic counselor for pre-test telephone genetic counseling if she wishes to.
2. BRCA1 and BRCA2 are analyzed by full sequencing.
3. Non-carriers are informed about the test result with a letter. Mutation carriers and VUS (variants of uncertain significance) are telephoned and given a time for an appointment at the Department of Clinical Genetics within a week.
4. Psychosocial self-reported questionnaires (HAD scale, EORTC QLQ-C30, EORTC QLQ-BR23) are delivered at 3 times: At invitation to the study, one month after information about test result, and one year after information about test result.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is included in the SCAN-B study.
2. The patient is recently diagnosed with an invasive breast cancer or a ductal cancer in situ.
3. The patient has signed an informed consent form.

Exclusion Criteria:

1. The patient is unable to understand the written information in Swedish.
2. The patient's psychological state, due to chronic och temporary reasons, is such that one could suspect that information about the study or genetic testing could be substantially detrimental to the psychological well-beeing.
A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation


Eligibility Criteria:
Inclusion Criteria:

* Completed study drug treatment in a parent study i.e.VX17-445-102 (NCT03525444) and VX17-445-103 (NCT03525548); or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study.

Exclusion Criteria:

* History of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator.
* Current participation in an investigational drug trial (other than a parent study)

Other protocol defined Inclusion/Exclusion criteria may apply.
Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?

The aim of the study is to evaluate the effect of experimental (vegetarian) diet compared to conventional diet with similar caloric restriction on insulin resistance, body weight and body composition in type 2 diabetic patients after 3 month diet program and additional 3 month diet program combined with intensive exercise.

Hypothesis: Greater improvement in insulin resistance, greater weight loss without compromising the body composition (subjects will lose fat preferentially to lean body mass) and differences in the fatty tissue metabolism will be found in the experimental (vegetarian) group compared to the control (conventional diet) group despite the similar advise on caloric restriction in both diets. The differences between the two groups will increase after an intensive physical exercise program.

Open randomized study. Individuals with type 2 diabetes (n=60) will be recruited through newspaper advertisements and through advertisements in the hospital. They will be randomly assigned to a low-fat vegetarian diet or a diet following the guidelines of the Study Group on Diabetes and Nutrition of the European Association for the Study of Diabetes (DNSG) (21) with similar caloric restriction (-500 kcal/d). The participants will be followed for 12 weeks and then for another 12 weeks with the addition of intensive physical exercise. All meals during the 6 months will be provided.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals with type 2 diabetes as defined by the criteria of the American Diabetes Association and recognized by WHO, Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (19,20)
2. Concurrent T2 DM therapy: The use of oral hypoglycemic medication stable for the last 3 months
3. HbA1c ≥ 4 and ≤ 9.0 % (IFCC) \~ ≥ 6.0 and ≤ 11 % (DCCT)
4. Men and women who are 30 to 70 years of age
5. Body Mass Index (kg/m2) between 25 and 53
6. Informed Consent: a signed and dated written consent obtained from the subject before any procedures are performed
7. Willing to change dietary habits and to follow the prescribed diet and exercise program

Exclusion Criteria:

1. Current alcohol or drug abuse
2. Pregnancy, lactating
3. Unstable medical status
4. Diagnosis of Type 1 diabetes mellitus
5. Significant weight gain or loss (defined as ≥ 10% of total body weight) within the past 3 months prior to screening.
6. Pacemaker or metal in the body.
Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition

This study is being implemented to identify the role of prophylactic use of ethanol lock in adult patients on home parenteral nutrition (HPN). Central catheter related blood stream infection is a major complication in patients on HPN. The investigators hypothesize that the prophylactic use of ELT will decrease the number of catheter related blood stream infections compared to the control group. The investigators further hypothesize that with the introduction of prophylactic ELT, the number of infections will decrease.

Catheter-related bloodstream infection (CRBSI) is a serious complication for home parenteral nutrition (HPN) patients causing morbidity, mortality, and prolonged hospitalization. CRBSIs may also result in the need for central venous catheter (CVC) removal and replacement. Current literature supports the use of antibiotics locks in patients with repeated CRBSI. There is a growing concern about the increased risk of microbial resistance with the long term use antibiotic locks. Ethanol lock therapy (ELT) has broad spectrum coverage and includes gram negative bacteria, gram positive bacteria, atypical bacteria, and fungi. Compared with antibiotic and other solution locks, which have limitations, ELT has excellent broad-spectrum bactericidal and fungicidal killing action and poses no problems with development of resistance over time. There is a lack of a randomized controlled study to characterize the role of ELT in adult patients on HPN.

Eligibility Criteria:
Inclusion Criteria:

* Newly started on Home parenteral Nutrition and anticipated duration \>3 months.
* Not previously on Home Parenteral Nutrition.
* Providing consent.
* Patients with non-medicare insurance.
* Patients with medicare insurance and a supplementary insurance.
* Patients with single lumen Hickman® catheters.
* No known alcohol addiction.

Exclusion Criteria:

* Failure to provide consent
* Patients with medicare insurance and no other supplemental private insurance
* Patients with a catheter type other than a single lumen Hickman®
* Patients who are on HPN for less than three months
* Pregnant patients
* Patients who have previous proven addiction and dependence to alcohol.
* Patients lacking capacity to provide consent
* Patients who are not be managed by HPN team at investigator's institution
Sarcopenia and Multimodal Rehabilitation on the Prognosis of Rectal Cancer Patients Receiving CCRT

Investigators use clinical trial to explore the role of sarcopenia and multimodal rehabilitation in prognosis of rectal cancer patients receiving concurrent chemoradiotherapy.

The impact of sarcopenia and the effect of multimodal rehabilitation will be evaluated in the rectal cancer patients receiving pre-operative concurrent chemoradiotherapy. This is a randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* age\>20
* rectal cancer patients receiving concurrent chemoradiotherapy
* agree to join the trial and sign the informed consent form

Exclusion Criteria:

* unstable vital sign
* unable to excise
* not suitable after evaluation by Principal Investigator
Gene Expression Profiles to Categorize Wilms Tumors

This laboratory study is using gene expression profiling to identify different categories of Wilms tumors. Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

OBJECTIVES:

I. Identify new molecular categories of Wilms tumor (WT) based on the gene expression profiles of samples from patients with this disease.

II. Develop a classifying system (classifier) that will predict a defined number of clinically relevant categories based on expression of an established set of genes.

III. Confirm and test the classifier with further analysis of the genes by several different methodologies, using additional patient samples that are outside of the case/cohort but which possess the clinically or scientifically relevant parameter.

IV. Validate the use of the classifier to predict defined groups within a second set of samples (for which investigators are blinded to the clinical and biological data) by subsequent comparison with true incidence of pertinent markers.

OUTLINE:

Three hundred tumor specimens are analyzed for genetic expression profiles using Affymetrix assays. Specific genes are identified as classifiers and analyzed using tissue arrays. An additional 300 specimens are examined for gene expression and categorized according to the classifiers.

Eligibility Criteria:
Inclusion Criteria:

* Specimens from patients previously enrolled as "On Study" or "Followed Biology Only" on protocol NWTSG-5 (COG-Q9401)

  * Study follow-up data for disease status available
* National Wilms Tumor Study Group/Children's Oncology Group pathology review showing "favorable" histology
* Sufficient biology samples available without using biology bank reserves