cyrilzakka/clinical-trials huggingface dataset:
Mobile Cognitive Behavioral Therapy for Medical and Graduate Students

The study aims to assess and compare clinician-delivered cognitive behavior therapy (CBT) supplemented with "MAYA", a mobile cognitive behavioral therapy app program to clinician-delivered cognitive behavioral therapy alone. The experimental group will be asked to use the mobile application at least two times per week for six weeks, for at least 20 minutes on each of the two days in addition to the clinician-delivered CBT. Participants will complete a weekly self-report assessment battery designed to assess anxiety and mood symptoms. The investigators think that clinician-delivered CBT supplemented with "MAYA" will improve more effective at improving symptoms of anxiety and depression than clinician-delivered CBT alone.

Growing evidence suggests a need for anxiety and depression treatments that can be disseminated easily to young adults. Many do not seek out treatment for reasons including lack of availability and high cost. There is a growing need for accessible, affordable, research-supported treatments designed to increase the practice of skills and therefore improve treatment outcomes. Graduate students use mobile devices frequently; thus, mobile app-based interventions may be particularly appealing to individuals in this age range with anxiety or depression who are unable to access more traditional psychotherapy administered in person by a therapist.

The study aims to compare the efficacy and feasibility of clinician-delivered cognitive behavior therapy supplemented with the mobile app program to clinician- delivered cognitive behavioral therapy alone. Young adults with anxiety and/or depression will be randomized to clinician-delivered CBT (active control group) or to the clinician CBT + mobile app (intervention group). In the active control group, participants will participate in weekly clinician-delivered Cognitive Behavior Therapy. In the intervention group, participants will participate in weekly clinician-delivered Cognitive Behavior Therapy and use a mobile application for at least 20 minutes two times per week for six weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40 years.
* Clinically significant anxiety (as determined by a score of 10 or greater on the GAD-7) or clinically significant depression (as determined by a score of 10 or greater on the PHQ-9).
* Current graduate student at Weill Cornell Medicine.
* Access to an Apple iPhone

Exclusion Criteria:

* Lifetime diagnosis of a bipolar or psychotic disorder.
* Intent or plan to attempt suicide.
Effect of a Single Colecalciferol Dose on Insulin Resistance

A Prospective Double-Blinded, Placebo Controlled, Randomized Trial comparing a single dose of Vitamin D (Colecalciferol) 300.00UI to placebo on patients with insulin resistance. Primary Outcome: Blood glucose and homeostasis model assessment for insulin resistance (HOMA-R) after 90 days. Study hypothesis: Vitamin D treatment may improve insulin resistance and decrease glucose level, since there is an association between hypovitaminosis D and increased insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Fasten Blood Glucose \> 100 mg/dL and \< 126 mg/dL
* Age \> 18 years

Exclusion Criteria:

* Diabetes Mellitus
* Use of metformin
* Vitamin D Use
* Hypercalcemia
* Chronic Hepatitis
* HIV
Registry HBOT in DFU

Overview of available data to assess the benefits of HBOT to DFU patients

10 year retrospective registry to measure outcomes regarding major amputations, mortality, hospital admissions in patients with a diabetic foot ulcer with peripheral ischaemia. Two groups will be compared: complementary HBOT and a control group.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus
* Meggitt-Wagner classification grade 2-4, existing \> 4 weeks
* Complete 1 year follow-up

Exclusion Criteria:

* Chronic Obstructive Pulmonary Disease (COPD) GOLD IV
* Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within the last 3 months
* Metastasized malignancy
* Left ventricular ejection fraction (EF) \<20% or external pacemaker
* Recent thoracic or middle ear surgery
* Severe epilepsy
* Uncontrollable high fever
* Pregnancy
Cereset for Caregivers

In this single arm, open label study, investigators will evaluate the feasibility of using the Cereset (formerly known as HIRREM - high-resolution relational, resonance-based electroencephalic mirroring) intervention for a stressed population confronting an acute burden on their lives - caregivers of newly diagnosed high-grade glioma patients. The Cereset intervention is a closed-loop acoustic stimulation intervention that has been studied in patients with PTSD, insomnia, postural orthostatic tachycardia, and military veterans.

Primary Objective:

• To determine the feasibility of completing the prescribed Cereset Research Office intervention for trial participants in this single arm, open label study.

Secondary Objectives

* To assess the tolerability of the intervention
* To assess changes in trial participant wellbeing and quality of life.
* To assess changes in physiological response at pre-intervention and post-intervention time points.

Exploratory Objectives

* To assess the utilization of Cereset Research Wearable (portable, limited scope wearable device) after the CRO intervention.
* To assess the participant acceptability of the Cereset Research Intervention.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Identified as caregiver by patient with glioma as defined as the primary, non-professional, non-paid person who provides the majority of emotional financial and/or physical support. There will only be one trial participant allowed per patient/caregiver dyad.
* The trial participant must be caring for a patient who is:
* ≥18 years of age
* Has a histologically confirmed malignancy that is a high grade glioma which includes (astrocytoma, oligodendroglioma, glioblastoma, ependymoma).
* Any World Health Organization (WHO) grade gliomas
* Trial participant is able to understand and the willingness to sign an IRB-approved informed consent document.
* Trial participant is able to sit in a chair for 90 minutes.

Exclusion Criteria:

* Trial participant is a heavy alcohol user per the Substance Abuse and Mental Health Services Administration.

  * Heavy alcohol use is defined as binge drinking on 5 or more days in the past month.
  * Binge drinking is defined as 4 drinks for women and 5 drinks for men on the same occasion.
* Trial participant has severe hearing impairment defined as word discrimination at \<50% with or without the use of hearing aids.
* Trial participant's weight is greater than or equal to 400 pounds at time of enrollment (chair limit).
* Prior trial participant use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, neurofeedback, biofeedback, or deep brain stimulation (DBS) within one month before enrollment.
* Trial participant has previously used HIRREM, or Cereset.
* Trial participant has a known seizure disorder requiring ongoing anti-epileptics prescribed specifically for seizure disorder.
* Trial participant states he or she will not be able to abstain from daily use of alcohol or recreational drugs during the intervention period.
Three Different Oxygenation Strategies in Bronchoscopy Procedures Under Sedation

The purpose of study aims to determine which of the three different oxygenation strategies, including nasal cannula, modified nasopharyngeal cannula, and HFNO groups, is safer in patients undergoing bronchoscopy under sedation.

The patients will be evaluated in the anesthesia polyclinic before the procedure, routine preparation will be made, and written informed consent will be obtained. After being informed about the study and potential risks, all patients who gave written informed consent will be enrolled in the study by recording their demographic information after determining whether they are eligible to participate in the study. In addition, STOP-BANG and FRAIL fragility questionnaires will be administered to the patients. Which oxygenation method should be used which patient will be left to the decision of the Anesthesiologist; The oxygenation tools used in the bronchoscopy unit are nasal cannula, modified nasopharyngeal cannula, and HFNO. When the patients are taken to the procedure room, anesthesia management will be applied by the standard working order of the anesthesia clinic. In addition to non-invasive arterial blood pressure monitoring, 5-channel ECG and pulse oximetry, and standard hemodynamic monitoring, Bispectral Index (BIS) monitoring will be performed. During the process, oxygen saturation will be continuously monitored and the lowest value will be recorded. Interventions made in cases of low oxygen saturation will also be recorded. At the end of the procedure, the patient will be taken to the recovery unit after waking up.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing bronchoscopy

Exclusion Criteria:

* Do not have the ability to read, understand and sign the consent form
* Pregnancy
* Contraindications to anesthetic drugs
* Hemodynamically unstable patients
* Having a peripheral vascular disease
* Intubated patients
* Patients with tracheostomy
A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* rheumatoid arthritis \>=6 months duration;
* DAS28\>=3.2;
* inadequate response to prior treatment with a stable dose (\>=8 weeks) of DMARD therapy.

Exclusion Criteria:

* rheumatic autoimmune disease other than rheumatoid arthritis;
* history of or current inflammatory joint disease other than rheumatoid arthritis;
* unsuccessful treatment with an anti-TNF agent;
* previous/concurrent treatment with any cell-depleting therapies.
Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis

This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, with chronic HCV genotype 1 infection
* Documentation as treatment-experienced having received pegylated interferon (Peg-IFN) + RBV ≥ 4 weeks of duration without an additional agent in the regimen without achieving sustained viral response (SVR)
* Presence of compensated cirrhosis
* Screening laboratory values within defined thresholds
* Must use specific contraceptive methods if female of childbearing potential or sexually active male
* Not pregnant or a nursing female

Exclusion Criteria:

* Co-infection with HIV or hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
A Study to Compare the Safety and Drug Levels in Blood When Using Various Forms of GSK189075 Given to Healthy Subjects

The purpose of this research study is to look at concentrations of GSK189075 in blood when different long and short acting forms of the drug are taken by mouth. The results will help to decide whether a long-acting form of GSK189075 can be made. The effects of the drug on the body and safety will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Are a healthy, non-smoking adult, 18 to 55 years old.
* Are not overly thin or overly heavy for your height.
* Are a female who is unable to have children, or is willing to use birth control throughout the study.
* Are willing and able to follow all study-related instructions provided by the site staff. - Are willing to provide signed consent.

Exclusion Criteria:

* Are a pregnant or a nursing female.
* Have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
* Have had certain infections within 4 weeks before the expected the first dose of study drug.
* Have HIV or hepatitis, or have alcohol in your system at the screening visit.
* Have a history of alcohol abuse.
* Have been in another research study in the last month or have taken certain medications in the 2 weeks before study drug would be taken.
* Have laboratory tests that are outside the normal range.
A Modified Method for Blind Bedside Placement of Post-pyloric Feeding Tube.

To compare efficacy and safety of a new modified post-pyloric feeding tube bedside catheterization with Corpak 10-10-10 protocol and electromagnetic guided catheterization for treatment of patients with dysphagia and at high-risk of aspiration pneumonia. We conducted a single-center, single-blinded, and randomized controlled clinical trial. A total of 63 patients were treated with the non-gravity type CORFLO gastrointestinal feeding tube between 2017.1 and 2019.1 using different procedures: in the M group, patients underwent modified post-pyloric feeding tube bedside placement; in C group, patients underwent conventional Corpak protocol; in EM group, patients received standard electromagnetic guided tube placement.


Eligibility Criteria:
Inclusion Criteria:

* All patients had dysphagia that could not be alleviated within 48 hours
* High-risk status with aspiration pneumonia, including consciousness disorder caused by various diseases, severe dementia, bed rest, gastroesophageal reflux, hiccup, gastric retention, achalasia of pyloric.
* Can't receive nasogastric tube feeding.

Exclusion Criteria:

* The previous history of upper abdominal surgery.
* Gastroduodenal ulcer and esophagogastric varices;
* Severe sinusitis and nasal bone fracture;
* Patients with recent gastrointestinal bleeding, intestinal obstruction, ischemic bowel disease, and epistaxis;
* Patients with electromagnetically-guided catheterization should additionally exclude implantable cardiac defibrillator, implantable cardiac pacemaker or diaphragm pacemaker.
Developing an Integrated System Approach for the Management of Hypertension: A Pilot Study

Hypertension has become a public health concern worldwide due to its significant contribution to the global health burden and its role as a prominent risk factor for the development of a number of chronic diseases such as Cardiovascular diseases (CVD), the leading cause of mortality in Pakistan and Worldwide. According to WHO, about 7.5 million deaths worldwide is attributable to hypertension i.e. about 12.8% of the total of all deaths. This accounts for 57 million disability adjusted life years (DALYS) or 3.7% of total DALYS.

Studies suggest that hypertension is among the top five most common presenting complaints to private general practice clinics. Therefore, primary care physicians/Family physicians are the first line service providers and; thus it is important to manage hypertensive patients early, through lifestyle and treatment interventions that may prevent the complications such as development of CVDs etc.

To the best of authors' knowledge limited evidence is available from Pakistan on management of hypertension through an integrated approach. Therefore, the aim of the trial is to develop a health delivery system that effectively manages hypertension at primary care level.

Hypothesis: The development of an integrated management approach will be effective in managing hypertension at all levels among hypertensive patients.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 40 years or over visiting the selected IMS centre with known hypertension or with consistently elevated BP on two separate visits (mean of last two of three measurements of systolic pressure ≥140 mm Hg or mean diastolic pressure ≥90 mm Hg) or already receiving treatment will be eligible for inclusion in the study.

Exclusion Criteria:

* Those patients who require intensive care unit or coronary care unit admissions, or are diagnosed to have cognitive impairment, are agitated due to severe pain, non-resident of Karachi, or having language barrier will be excluded from the study.
* A screening form will be designed for the collection of the above mentioned information. The rationale of excluding all the participants with above mentioned condition is that the participants having these health concerns will either not be able to respond to our questionnaire or their presence may confound our results.
Effect of Whey Protein Supplementation and Resistance Exercise on Muscle Parameters in Older Adults

This research study is looking at the effects of a whey protein nutritional supplement on changes in muscle mass, strength and physical function in response to a 6 month program of strength training exercise.


Eligibility Criteria:
Inclusion Criteria:

* Male and Females 70-85 yrs
* Community dwelling
* Short Physical Performance Battery score \< 10
* BMI = 21-32.5

Exclusion Criteria:

* Acute or terminal illness
* Mini Mental State Exam \< 23
* Myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure
* Upper or lower extremity fracture in previous 6 months
* Uncontrolled hypertension (\>150/90 mm Hg).
* Neuromuscular diseases and drugs which affect neuromuscular function.
* Hormone replacement therapy
* eGFR \<30 mL/min/1.73m2
* Types I and II Diabetes Mellitus
* Dietary protein intake \< 0.8 g.kg-1.day-1
* Disorders of nutrient absorption
* Milk, or whey allergy
* Sulfa drugs and allergy to PABA-containing sunscreens
Pelvic Inclination Measurement by Navigated Ultrasound

Prospective, multicenter, non-randomized study.

Primary endpoint : to confirm the proper functioning of the device in vivo by analyzing intra and interobserver reproducibility of repeated measurements on healthy controls.

Secondary endpoint : to describe the values of pelvic inclination while standing, sitting and lying in patients with severe hip osteoarthritis before and after total hip arthroplasty

After signing the inform consent form:

For the first endpoint (, 3 healthy volunteers of different morphotypes will have one consultation comprising :

* a medical examination
* 10 measurements of pelvic inclination in sitting position, 10 measurements of pelvic inclination in supine position and 10 measurements of pelvic inclination in standing position, each realized per three different operators. These measurements will be carried out with navigated ultrasound.

For the secondary endpoint, 30 patients awaiting for a hip replacement surgical intervention will realized one consultation the day before the intervention, and one consultation at 2 months after surgery, each comprising :

* a medical examination
* 3 measurements of pelvic inclination (1 standing, 1 sitting and 1 supine). These measurements will be carried out with navigated ultrasound.


Eligibility Criteria:
Inclusion Criteria:

For primary endpoint

* No medical or surgical history
* Major healthy voluntary topic with

  * Body Mass Index (BMI) \<20 for a subject
  * 24 \<BMI \<26 for a subject
  * BMI\> 30 for a subject
* Subject having signed an informed consent

For the secondary endpoint

* Adult patient requiring total hip arthroplasty for severe hip osteoarthritis
* Patient having signed an informed consent

Exclusion Criteria:

* Minor subject
* Resumption of total hip prosthesis
* Subject who can not express their consent to research
* Presence of medical or surgical history for healthy volunteers
A Study of Chinese Adults With Lymphoma

The main aim of this study is to improve methods of clinical testing and therapy for lymphoma participants.

This study will involve collecting information about participants from past medical records.

This is an observational, non-interventional, retrospective study to evaluate staining and interpretation concordance of CD30 expression detected by 9 immunohistochemistry (IHC) assays and VENTANA CD30 IHC assay in Chinese lymphoma participants.

This study will enroll approximately 1000 participants. The data will be collected via chart review in the electronic case report forms (eCRFs). All the participants will be assigned to a single observational cohort:

• Participants With Malignant Lymphoma

This multi-center trial will be conducted in China. The overall duration of the study will be approximately 21 months.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with diagnosis of cHL, ALCL, MF-LCT, DLBCL, PMBL, ENKTCL, PTCL-NOS, AITL and PCCD30+TCLPD.
2. Participants with available FFPE samples archived within 3 years.
3. Whose tissue slides of FFPE samples were previously IHC stained, their CD30 expression showed as well-localized positive stain and investigator deemed appropriate for evaluation.

Exclusion Criteria:

1. Sample is not sufficient for CD30 testing.
2. Incomplete sample information including key demographic characteristic, clinicopathological parameters and previous CD30 testing results.
A Registry Study of Biomarkers in Heart Failure

The registry study aims to discover the prognostic value of bio-markers in heart failure

The purpose of this study is to investigate the prognostic value of biomarkers in Heart Failure.Patients with confirmed diagnosis of heart failure are enrolled.The primary outcome is all-cause mortality based on the death certificates. The secondary outcome is readmission for heart failure and all-cause mortality/readmission for heart failure according to the patients' medical records.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years at the time of admission to the hospital
* With symptoms of new-onset or worsening heart failure
* Received or is eligible to receive a principal hospital discharge diagnosis of HF
* With signs and syndromes as follows: dyspnea at rest or with minimal exertion (dyspnea, orthopnea, or edema)；Rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography.
* Patients who received packed red blood cells, whole blood, or platelets less than 10 days before the blood sample was taken;

Exclusion Criteria:

* Have objective evidence of cardiac dysfunction documented either by plasma concentrations of BNP and/or N-terminal pro-brain natriuretic peptide (NT-proBNP) \<35 pg/mL or \<125 pg/ml, respectively
* Current known inability to follow instructions or comply with follow-up procedures.
* Eligible patients without informed consent form
INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle Arthroplasty in patients having a calcaneal stem.

The primary objective of this study is to determine the radiographic outcomes of patients who have received TAA with the calcaneal stem. Due to the fixation of the stem in the calcaneus, talar component position, osteolysis and bone quality are of interest to the FDA. Specifically, subsidence and/or migration of the talar component, osteolysis as a measure of wear, and bone quality of the talus, cuboid and navicular are to be evaluated in this study. Therefore, the radiographic outcomes of this study aim to assess these parameters

Eligibility Criteria:
Inclusion Criteria:

Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.

Exclusion Criteria:

Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.