cyrilzakka/clinical-trials huggingface dataset:
Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Liver Transplantation Surgery

The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for liver transplantation surgery.


Eligibility Criteria:
Inclusion Criteria:

* Liver disease undergoing Liver transplantation

Exclusion Criteria:

-
Lung Cancer Early Molecular Assessment Trial

The investigators hypothesize that an early molecular profiling, that includes both tissue and blood-bases analysis, for all NSCLC patients, including stage I-III, will increase diagnostic efficiency. When molecular profiles are available at an earlier stage of disease, more patients will benefit from personalized therapy once needed. This will result in both a better quality of life and outcome.

In this prospective multicentre trial tumours of all patients presenting with NSCLC will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing. A minimal molecular profiling is depicted but other targets will be included in due time. The study is divided in two parts. In the first part participating centres will have a run-in period of half a year in which molecular profiling is performed as is currently standard of care. This period will be used to measure the impact of increased awareness on the diagnostic process. During the second part of the study a comprehensive upfront profiling according to local standards will take place for all NSCLC patients. Liquid (blood) biopsies will be included in order to increase the diagnostic yield for those patients where tissue biopsies are not adequate. Patients will be treated according to standard of care, or included in clinical studies where appropriate. Re-biopsies (both tissue and liquid) will be advocated at the time of establishing disease progression/disseminated disease, and personalized therapy will be initiated according to the existing data from the molecular profiling.

Eligibility Criteria:
Inclusion Criteria:

* Suspicion of lung carcinoma or established NSCLC but awaiting start of definitive treatment
* Written informed consent to undergo diagnostic procedure and molecular analysis of the disease.

Exclusion Criteria:

* Not motivated to receive any treatment at any point in time. Patients who consider undergoing treatment in the future are eligible.
COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics

In some clinical forms of COVID-19, an uncontrolled hyper-inflammatory reaction known as a "cytokine storm" appears abruptly, around day 7, and is associated with rapid respiratory deterioration, requiring hospitalization in an intensive care unit (ICU).

At present, although risk factors for this severe form have been described, there are no validated criteria for determining which individual patients will develop this aggravation.

The study of respiratory sounds (amplitude, frequency, ...) has made it possible in other respiratory pathologies (e.g., chronic obstructive pulmonary disease) to predict exacerbations several days in advance.

Having a predictive respiratory pattern for worsening in COVID-19 would make it possible to anticipate the need for intensive care hospital beds, by means of a tool easily available on a mobile phone.


Eligibility Criteria:
Inclusion Criteria:

* French speaking
* Affiliated to a social security system
* Owning a mobile phone capable of accessing the COVOICE application

Exclusion Criteria:

* Incapable adults
* People deprived of their liberty
* People under administrative or judicial supervision
* Patients intubated or hospitalized in intensive care unit
Evaluation of Efficiency for Three Different Aligning Archwires During Initial Orthodontic Leveling

The present prospective clinical study was directed to evaluate the efficiency of three different aligning archwires during initial orthodontic leveling.

The present prospective clinical study was directed to evaluate efficiency of three different aligning arch wires during initial orthodontic leveling.

The sample of present study included 30 patients, 15 females and 15 males; with a mean age was 17.81 ± 1.96 years. They were randomly allocated into three equal groups, according to the type of the aligning arch wire as follows:

1. Group A: in which 10 patients, with a mean age was 17.27 ± 1.95 years, were treated with conventional singlestrand NiTi arch wires.
2. Group B: in which 10 patients, with a mean age was 17.33 ± 2.42 years, were treated with Niobium-titanium-tantalum-Zirconium (Gummetal) arch wires.
3. Group C: in which 10 patients, with a mean age was 18.70 ± 1.49 years, were treated with multistrand NiTi arch wires.

Mandibular orthodontic study models were taken every 4 weeks and laser scanned to obtain 3D digital models during the 3 months observation period of the study. The changes in LII were determined at every 4 weeks observation intervals. Moreover, the changes in inter-canine, inter-1st premolar and inter-molar widths before and after three months were evaluated and compared among the three groups of aligning arch wires.

Data were collected and statistically analyzed via Statistical Package for Social Science (SPSS, version 23). One Way ANOVA and Kruskall-Wallis tests were used to assess the difference among the three studied groups and paired t-test was used to assess the difference and percent of changes within each group before and after three months observation period.

Eligibility Criteria:
Inclusion criteria:

* An age range from 15 to 20 years
* All permanent teeth have erupted (3rd molar not included)
* Angle class I malocclusion with normal facial proportions.
* Moderate crowding in the lower dental arch that required treatment with fixed appliance using the non-extraction approach.
* Good oral hygiene with healthy periodontium, good general health without any systematic disease that could affect the treatment.

Exclusion Criteria:

* Severe crowding that requires an extraction approach.
* A blocked-out tooth that prevent the easy placement of the bracket at the initial bonding appointment.
* Poor oral hygiene or periodontal compromised teeth.
* Relevant medical history and/or regular medication that contraindicates and/or interferes with orthodontic treatment.
* Craniofacial anomalies or previous history of trauma, bruxism, or parafunction.
* Previous orthodontic treatment.
Effect of a Six-week Integrated Attention Training Program on the Cognitive Functions of Older Adults With Co-occurring Anxiety Symptoms and Subjective Cognitive Complaints

The goal of this single-blind randomized control trial is to compare a 6-week Integrated Attention Training Program (IATP) and health education in older people with co-occurrence of anxiety symptoms and subjective cognitive decline (SCC).

The study aims to answer if a 6-week Integrated Attention Training Program (IATP) will improve cognitive, anxiety, and level of pro-inflammatory biomarkers in this high-risk group.

Older adults with co-occurring anxiety and SCC will be recruited to participate in a 6-week single-blind randomized controlled trial. IATP group (Intervention group) will undergo attention and functional training. Control group will receive health education.

Investigators will compare the IATP with health education to see if cognitive function, anxiety symptoms, and level of pro-inflammatory biomarkers in comparison to health education will improved after intervention and over 24 weeks.

This is a 2-armed randomized control trial. For both groups, participants will attend a 45-minute training twice a week for consecutive 6 weeks in a group of 6 people. IATP group (I) will begin with 5 minutes of warm up to give instructions, followed by 5 minutes of breathing exercises, 5 minutes of body scanning, 10 minutes of dual-task training, 15 minutes of functional training, and 5 minutes of performance appraisal under guidance of an intervention instructor. Control group (C) will receive 12 sessions of health education on managing chronic diseases or conditions commonly found in old age during the intervention period.

Assessments will take place at baseline (T0), immediately after intervention (T1) and after 24-week (T2).

Measurement will include a battery of cognitive assessments, Hamilton Anxiety Scale (HAM-A), and a questionnaire on sociodemographic characteristics (age, sex, educational level, and socioeconomic status), physical and mental health statuses, and lifestyle patterns (smoking, drinking, and leisure activities in the past one month). In addition, a 15ml blood sample will be collected from each consenting participant by a phlebotomist for an inflammatory assay analysis at T0. Follow-up assessments and blood collections will be arranged at 6th (T1) and 24th (T2) week.

Linear mixed effects models will analyze the changes on anxiety and cognitive performance from baseline to endpoints. All the analyses will be based on Intention-to-treat principle.

Eligibility Criteria:
Inclusion Criteria:

1. Older adults aged 60 to 90 years;
2. No Major Neurocognitive Disorders
3. Presence of anxiety symptoms
4. Presence of Subjective Cognitive Complaints

Exclusion Criteria:

1. Clinical dementia
2. History of major depression
3. Presence of major neurological deficit
4. Presence of severe visual impairment; or
5. Currently on any psychotropic or other medications known to affect cognition; or
6. Participation in other cognitive trainings or interventions 6 months prior to this study or during the study period.
Effect of Exercise Training in Autonomic Modulation in Breast Cancer Patients

The aim of this study is to evaluate the effect of exercise training in the autonomic nervous system activity in breast cancer patients, who underwent doxorubicin medication.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients at stages 1, 2 and 3;
* Sedentary;
* Currently at treatment;
* 4-6 months after surgery

Exclusion Criteria:

* Musculoskeletal injuries or disorders;
* Mental illnesses
* Stage 4 (Metastasis)
* Enrolled in other exercise program
Evaluating the Effects of EHRs, P4P and Medical Home Redesign in the Hudson Valley

The investigators will conduct a longitudinal cohort study with concurrent controls. The investigators will include all primary care physicians in the Hudson Valley including family practitioners, internists, and pediatricians. The purpose of this study is to determine the effects of implementing electronic health records (EHRs), pay-for-performance incentives for physicians (P4P), and Medical Home redesign on health care quality, cost and patient experience in the Hudson Valley.

The Hudson Valley is implementing several innovative programs to potentially improve quality and reduce the cost of health care delivered. First the Taconic Health Information Network and Communities Regional Health Information Organization (THINC RHIO) is facilitating diffusion of EHRs in office practices in the Hudson Valley. Second, THINC RHIO is also offering a strategic approach to pay-for-performance. Third, an additional component of the THINC P4P project will be an added financial incentive for private practice physicians who implement and reach Level II of Physician Practice Connections® - Patient Centered Medical Home (PCMH)™, NCQA's new national recognition system for physician practices. Our study will seek to determine the effect of each of these initiatives on health care quality and cost of care in the Hudson Valley. We will also measure the patient experience before and after implementation of the Medical Home.

Eligibility Criteria:
Inclusion Criteria:

* Primary care physicians working in the offices practices in the Hudson Valley, and who are members of the Taconic IPA.

Exclusion Criteria:

* Physicians who opt out from the study.
Analysis of Proinflammatory Factors in the Synovial Fluid In Patients With Rotator Cuff Disease

Role of proinflammatory factors in Patients with Rotator Cuff Disease

Objective:

To measure the levels of various cytokines and metalloproteases in patients with rotator cuff disease, and control group and to determine the correlations among them.

We hypothesize that cytokines and MMP's level will be significantly higher in patients with RC pathology than in control group and will be related to the time frame since injury (i.e. - higher levels as close to the injury). In addition we will examine possible relation of those levels to the pain curve by using Visual Analogue Scale.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation.
2. Patients between age 18-65 scheduled for a surgery in a Shoulder unit
3. Patients suffering from Rotator Cuff Disease
4. Patients suffering from any noninflammatory shoulder condition which requires surgical intervention

Exclusion Criteria:

1. Revision rotator cuff repair
2. Recurrent shoulder surgery
3. Psychiatric illness
4. Inflammatory condition.
5. Current use of anti-inflammatory drugs.
6. Previous or current shoulder infection.
Seminal TEX101 as a Predictor of Recovery of Spermatogenesis in Azoospermic Men With Palpable Varicocele

The aim of the study is to assess if seminal TEX 101 can predict the restoration of spermatogenesis and appearance of sperms in the ejaculate after micro-surgical varicocelectomy among azoospermic patients.

Male patients (40) cases attending the outpatient clinic of Andrology at KASR EL-AINI university hospitals, all patients presented with azoospermia, age:18-43 years, complaining mainly of infertility or accidently discovered azoospermia during premarital check-up or chronic testicular pain caused by longstanding varicocele. Infertile Non Obstructive Azoospermia (NOA) (n=40) subjected to varicocelectomy and patients evaluated 3 months after varicocelectomy by semen analysis, then according to results population divided into 2 groups: Group A (Responders): Patients with positive semen analysis for

sperms 3 months after varicocelectomy.

Group B (Non Responders): Patients with no sperms in semen analysis

in 3 and/or 6 months after varicocelectomy.

Method of Estimation of human TEX101 in semen:

A 1 ml collected semen samples were centrifuged for 20 minutes at 1000xg at 4 o C, then supernatant of each sample was collected for estimation of TEX101. The human TEX101 (Testis expressed 101) was assayed by commercially available ELISA kit supplied by Wuhan Fine Biotech Co., Ltd. China.

Principle of the procedure:

This kit was based on sandwich enzyme-linked immune-sorbent assay technique. Anti- TEX101 antibody was pre-coated onto 96-well plate. The biotin conjugated antibody was used as detection antibodies. The standards, test samples and biotin conjugated detection antibody were added to the wells subsequently, and washed with wash buffer.

HRP-Streptavidin was added and unbound conjugates were washed away with wash buffer. TMB substrates were used to visualize HRP enzymatic reaction. TMB was catalyzed by HRP to produce a blue color product that changed into yellow after adding acidic stop solution. The intensity of yellow is proportional to the target amount of sample captured in plate.

Eligibility Criteria:
Inclusion Criteria:

* Azoospermia in at least 2 separate semen analyses
* Palpable varicocele

Exclusion Criteria:

* Obstructive azoospermia
* Abnormal Karyotype
* Previous chemotherapy, radiotherapy and or diagnosed maligancy.
* previous testicular of inguinal surgeries.
* secondary azoospermia
Comparison of Insulin Detemir With Insulin Glargine in Type 2 Diabetes

This trial is conducted in the United States of America (USA). The purpose of this study is to determine if the use of insulin detemir in combination with insulin aspart is safe and at least as effective as insulin glargine in combination with insulin aspart for the control of blood glucose in patients with Type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes for more than 12 months
* Currently treated with glucose lowering tablets or insulin
* HbA1c: 7.0-12.0%
Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer

This research is being done to see how effective high-dose rate endorectal brachytherapy (HDRBT) is in treating cancer of the lowest part of the bowel (rectum). In this study we want to try to decrease side effects and shorten the course of radiation treatment for patients with cancer of their rectum by using a high-dose rate endorectal brachytherapy (HDRBT). This is a different form of radiation than what is normally given (CRT). With HDRBT, the radiation is given through an applicator placed into the bowel next to the tumor. The radiation is directed at the tumor and a small area around it.

This study is a pilot study open to patients with clinical stage T2N1 or T3N0-1 resectable rectal cancer. The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer. This study assumes that the rate of pathological response to HDRBT will be similar to historical controls (conventional neoadjuvant chemoradiation). All patients will receive postoperative standard 5-fluorouracil (FU) based chemotherapy (at the discretion of the medical oncologist). The clinical response will be assessed with endoscopic/ultrasound, pelvic MRI and fluorodeoxyglucose (FDG)-positron emission tomography (PET)/CT. In addition, tissue and serum will be collected to evaluate for biological predictors of response to therapy. The endpoints of this study include adverse events (gastrointestinal toxicity), quality of life as measured by the quality of life questionnaire (QLQ)-C30, and tumor regression/response.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed adenocarcinoma of the rectum
* Able to undergo local staging of the rectal tumor performed by MRI and/or endoscopic ultrasonography (EUS) demonstrating a T2N1 or T3N0-1 tumor
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Participants are willing to undergo initial therapy and if needed subsequent therapy prior to resection at Johns Hopkins Medical Institutions
* English as a primary language in order to complete the quality of life questionnaires

Exclusion Criteria:

* Patients with tumors \>12 cm from the anal verge.
* Near obstructing or bulky tumors which will not allow application of the endorectal probe
* Patients with distant metastatic disease
* Any pelvic lymph nodes outside of the mesorectum (iliac or inguinal)
* Prior history of radiation therapy to the pelvis
* Prior history of chemotherapy for rectal cancer
* Active connective tissue disease such as scleroderma or Crohn's disease
A Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3617 Capsule in Patients With Advanced Malignant Tumors

TQB3617 is a bromodomain and extra-terminal (BET) inhibitor that can competitively bind to bromodomains (BRDs) with Acetylated lysine(Kac) and block or partially block the role of KAc in subsequent gene transcription and regulation of chromatin structure, thereby playing an anti-tumor role.


Eligibility Criteria:
Inclusion Criteria:

* Aged: ≥18 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Life expectancy ≥ 3 months.
* Patients with advanced malignancy tumor who have failed standard treatment or are unable to receive standard treatment or have no effective treatment.
* Female and male subjects should agree to use an adequate method of contraception starting with signing informed consent form (ICF) through 180 days after the last dose of study. The women of reproductive age who blood/urine results were positivetherapy before the first study drug is administered within less than 7 days.

Exclusion Criteria:

* Patients has had or is currently having other malignant tumors within 3 years.
* Patients have multiple factors that affect their oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction).
* The patient had unmitigated toxic reactions due to any prior treatment.
* Patients underwent major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to the start of study treatment.
* Patients have long - term unhealed wounds or fractures.
* Patients were taking Cytochrome P450 3A4, Cytochrome P450 3A5, Cytochrome P450 2A6, Cytochrome P450 2D6 (CYP3A4, CYP3A5, CYP2A6,CYP2D6) inhibitors or inducers before oral medication.
* Patients who, in the investigator's judgment, have a comorbidity that seriously endangers patient safety or interferes with study completion, or who are considered unsuitable for inclusion for other reasons.
Ambulatory Urodynamic Evaluation of Sacral Neuromodulation for Non-Obstructive Urinary Retention

Ambulatory Urodynamic measurement on patients with diminished or absent bladder contractility before and after trial with Sacral Neuromodulation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diminished or absent bladder contraction

Exclusion Criteria:

* Prior Neuromodulation therapy
Dietary Protein in the Very-low-birth-weight Infant

In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula.

Babies will be fed the assigned formula between the time they achieve full enteral feeds and hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and compared between groups. Feeding tolerance, protein-energy status and body composition between the study groups will also be analysed.

After discharge, babies will be fed a post-discharge preterm infant formula (PDF) between hospital discharge and 3 m corrected age.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \<32 w, determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof
* Birth weight ≤1500 g
* Tolerating an enteral intake of ≥100 ml/kg/d for ≥ 24 h
* Subject is anticipated to receive the study formula for ≥ 3 consecutive weeks after FEF have been achieved
* In infants fed human milk, formula is anticipated to provide 50% or more of total energy intake, calculated on a weekly basis and based on the assumption that human milk has an energy density of 67 kcal/dl
* Written informed consent has been obtained from the legal representative

Exclusion Criteria:

* Cardiac failure requiring fluid restriction with diuretic therapy for ≥ 3 consecutive days
* Peri-/intra-ventricular haemorrhage (grade 3-4) determined using cranial ultrasonography
* Renal disease: by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased BUN and creatinine
* Sepsis: defined by symptoms requiring antibiotic therapy and confirmed by a positive blood culture
* Necrotizing Enterocolitis: defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3)
* Hepatic dysfunction: defined by jaundice (direct bilirubin \>1.0 mg/dl) which is associated with one or more abnormal liver function tests (AST, ALT or GGT)
* Lung disease, severe enough to require steroid therapy.
* Small size for gestational age (SGA) - body weight ≤ 5th percentile for that gestational age.
* Participation in another clinical trial that may affect outcomes of this study