cyrilzakka/clinical-trials huggingface dataset:
Brief Video Interventions for Depression

In this study, we test brief video interventions for those with elevated depressive symptoms. We randomize participants to one of three conditions. (1) An entrée condition involving in-depth coverage a set of cognitive behavioral therapy (CBT) skills. (2) A sampler condition which introduces three sets of CBT skills. (3) A control condition involving no skills. Among those in the entrée condition, participants are further randomized to one of three CBT skills. We plan on two sets of primary comparisons. First, we will compare the effects of each form of video intervention (i.e., entrée and sampler) to the control condition. Second, we will compare the entrée and sampler conditions. We will recruit participants from Amazon's Mechanical Turk program (MTurk). In the intervention conditions, participants will be asked to watch several videos and practice skills using worksheets. They will also be asked to practice skills introduced in the videos in the week following the intervention. In the control condition, participants will not watch videos. One week after the intervention, all participants will respond to a follow-up assessment.

Access to the study will be provided via the MTurk website. Study measures and interventions will be provided via Qualtrics. To determine eligibility, participants will be asked to fill out a pre-screening measure of depressive symptoms, the Personal Health Questionnaire-9 (PHQ-9). Those who score 10 or higher will be eligible. After consenting to participate, participants will fill out baseline measures, be randomly assigned to a condition, participate in any condition related procedures, and then respond to a follow-up assessment one week later.

Each brief intervention consists of watching a series of videos. After each video, participants in the intervention conditions will be prompted to answer a series of questions to practice the skills explained in the videos. For the entrée and sampler conditions, watching all videos and filling out any worksheets that are part of the initial intervention is expected to take approximately 30 minutes.

Participants in the entrée and sampler conditions will be asked to work on a coping skills worksheet over the next seven days (estimated to involve about 10 minutes of work). Participants will receive an email seven days after participating in the brief intervention, asking them to take part in the following portion of the study. Before beginning the follow-up activity, participants in the intervention conditions will be asked to upload the coping skills worksheet they worked on. All participants will be asked to respond to follow-up assessment measures at this point.

Eligibility Criteria:
Inclusion Criteria:

* Score above 10 on the Patient Health Questionnaire-9
* Are 18 years of age or older
Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin.

Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design

Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design:

Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of phenytoin (PHT) in last phases;

Group B: Pre-treatment with PHT, treatment with PHT and ascending doses of ESL in last phases

Eligibility Criteria:
Inclusion Criteria:

* Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer
* Non-black male aged of at least 18 years but not older than 45 years with a body mass index (BMI) greater than or equal to 19 and below 30 kg/m2
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance (laboratory tests are presented in section 6.1.1.3)
* Healthy according to the medical history, laboratory results and physical examination
* Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day, and an ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day 1 of this study

Exclusion Criteria:

* Significant history of hypersensitivity to phenytoin, eslicarbazepine, oxcarbazepine, carbamazepine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
* Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
* History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
* Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
* Presence of significant heart disease or disorder according to ECG
* Presence or history of significant central nervous system disorder like convulsion or depression
* Hemoglobin count below 135 g/L (at screening)
* Use of valproic acid in the previous 7 days prior to Day 1 of the study.
* Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
* Any clinically significant illness in the previous 28 days before day 1 of this study
* Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids,phenytoin and rifampin), in the previous 28 days before Day 1 of this study.
Occupational Therapy Fatigue Management-Based Intervention for Metastatic Renal Cell Carcinoma

This clinical trial studies the effects of occupational therapy fatigue management in patients with renal cell cancer that has spread to other places in the body (metastatic). Many patients diagnosed with cancer experience cancer-related fatigue. These patients that are also on immunotherapy can experience added distressing fatigue that impacts their daily lives. Occupational therapy uses a client-centered and holistic approach to work collaboratively with patients to assess fatigue and develop strategies to manage each individual's specific needs. Fatigue-based management is a fundamental component of occupational therapy rehabilitation regimens. This trial may help patients address and reduce their fatigue.

PRIMARY OBJECTIVE:

I. To determine if an occupational therapy (OT)-based intervention can reduce cancer-related fatigue by 10 percent as measured by the brief fatigue inventory (BFI) tool, in patients undergoing immunotherapy for metastatic renal cell carcinoma.

SECONDARY OBJECTIVES:

I. To determine if an OT-based intervention can improve pain ratings. II. To determine if an OT-based intervention can improve indices of depression. III. To determine if an OT-based intervention can improve indices of anxiety. IV. To determine if an OT-based intervention can maintain a reduced level of fatigue beyond the period of intervention.

OUTLINE:

Patients participate in OT sessions weekly for 3 weeks over 30 minutes each. Patients also complete questionnaires to assess anxiety, depression, fatigue and pain at baseline, 5 and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over.
* Sufficiently fluent in English.
* Cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC).
* Evidence of metastatic disease.
* Clinician assessed prognosis of greater than or equal to six months.
* Patients who are undergoing immunotherapy treatment (with a checkpoint inhibitor) for advanced kidney cancer who have grade 1 or 2 fatigue based on physician assessment at the time of study entry.
* Willing and independently able to provide consent.
An Observational Study to Investigate the Efficacy, Safety, Tolerability and the Effect on Quality of Life of Telmisartan (Micardis) and Telmisartan With HCTZ (Micardis Plus) in Patients With Hypertension

An observational study to investigate the efficacy, safety, tolerability and the effect on quality of life of Telmisartan (Micardis) and Telmisartan with HCTZ (Micardis Plus) in patients with hypertension


Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written/verbal informed consent in accordance with GCP (Good Clinical Practice) and local legislation
2. Patients aged 18 \~ under 80
3. Hypertension as described below:

   * Newly diagnosed patients with hypertension
   * Patients with current antihypertensive therapy

Exclusion Criteria:

1. Female subjects who are breastfeeding, pregnant or who plan to be pregnant during the study
2. Known or suspected secondary hypertension(e.g. pheochromocytoma)
3. Patients who have been treated with telmisartan prior to the acquisition of informed consent (including verbal informed consent)
TAP Blocks vs. IV Lidocaine for Kidney Transplants

This study will compare continuous intravenous lidocaine against single-injection transversus abdominis plane (TAP) block as a modality for postoperative analgesia in kidney transplant surgery.

This study is a non-inferiority trial designed to assess the analgesic efficacy of an intravenous (IV) lidocaine infusion against single-injection transversus abdominis plane (TAP) block in patients undergoing kidney transplant surgery. The investigators propose a study of 124 subjects randomized into two groups. The control group will receive a TAP block. The study group will receive a continuous IV lidocaine infusion. The investigators hypothesize that there will be no statistically significant difference in postoperative opioid consumption between the two groups in the first 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipient
* \>18 years old
* Consent to participate

Exclusion Criteria:

* \<18 years old
* Refusal to participate
* Chronic opioid use
* Seizure disorder
* Allergy to local anesthestics
* Severe hepatic disease
Quality of Life 1y and 2 y After VV-ECMO for COVID-19

This study aims to investigate the quality of life and the outcome after veno-venous extracoporeal membrane oxygenation (ECMO) support fir severe acute respiratory syndrome (ARDS) in COVID-19 patients.

The investigators follow our COVID-19 patients supported by ECMO, we make phone calls or real-life visits to pthe patients to score the quality of life, by using the SF-36. The SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality , social functioning , role emotional , and mental health.

The participants are contacted 3 months, 6months, 1year and 2 years after the ECMO support started for evaluation of the SF-36.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PCR-confirmed COVID-19 infection AND
* Acute Respiratory Distress Syndrome who require veno-venous ECMO therapy.

Exclusion Criteria:

* None
Restoring the Beneficial Effects of Enterohepatic Bile Salt Signalling by Chyme Reinfusion in Patients With a Double Enterostomy

Multicentre prospective human experimental study to determine the effect of chyme reinfusion in patients with a double enterostomy on plasma levels of Fibroblast Growth Factor (FGF19)

Patients supported by chyme reinfusion will be followed for 3 days pre chyme reinfusion and for 7 weeks during chyme reinfusion. Three days prior chyme reinfusion, baseline characteristics will be determined, an ileal biopsy, blood, chyme and urine will be collected. Furthermore, blood, chyme, faeces and urine will be collected at the first day of chime reinfusion. These materials will be collected again at week 1, 3, 5 and 7 weeks after initiation of chyme reinfusion. A second ileal biopsy will be performed at week 3.

Eligibility Criteria:
Inclusion Criteria:

* Age equal or above 18 years old
* Temporary double enterostomy treated by chyme reinfusion as a routine primary care
* Downstream bowel of at least 25 cm of healthy small bowel, accessible by a stoma, and suitable for chyme reinfusion and ileal biopsy
* In case of enterocutaneous fistula, diagnosis of fistula origin and localization confirmed by additional medical imaging (computerized tomography/fistulography)
* Written informed consent.

Exclusion Criteria:

* Patients with a mental disability
* Pregnancy or lactation
* Hepatocellular carcinoma
* Blood coagulation disorders
* Shock of any cause
* Patients subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Monovision for the Treatment of Diplopia

PURPOSE:

The purpose of this study is to quantitatively assess the efficacy of monovision correction in the treatment of acquired small angle binocular diplopia in adult patients.

METHOD:

Twenty patients with symptomatic diplopia were enrolled in a prospective treatment trial. All had stable deviations of 10 prism diopters or less for over three months. Each received monovision spectacles and/ or contact lenses with distance correction in the dominant eye. Half received a +3.00 diopter (D) add and the others received +2.50 D. The validated and standardized Diplopia Questionnaire and Amblyopia and Strabismus Questionnaire (ASQE) were used to quantify the efficacy of monovision correction for diplopia by measuring the functional impact on vision-specific quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Strabismic Deviation less than 12 Prism Diopters

Exclusion Criteria:

* Inability to sign informed consent
Evaluating the Need for the Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation

To determine clinically significant difference in results obtained from cataract surgery using IA. One eye will receive aphakic measurements only and the fellow eye will receive aphakic and then pseudophakic measurements when implanting a toric IOL.

To determine if there is a clinically significant difference in the results obtained for the toric IOL implantation when using IA to measure the aphakic eye only and when using IA to measure the aphakic eye and then the pseudophakic eye, with toric IOL implantation.

Eligibility Criteria:
Inclusion Criteria:

* willing and able to understand and sign an informed consent
* willing and able to attend all study visits
* presenting for uncomplicated bilateral cataract surgery and have an interest in a toric iol
* have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error)
* have visually significant cataracts
* have regular corneal astigmatism of 1.0D to 5.0D in both eyes with a difference between eyes of 1.0D or less
* have potential post operative acuity of 20/25 or better

Exclusion Criteria:

* corneal pathology
* amblyopia
* prior corneal refractive surgery or other refractive surgery
* previous anterior or posterior chamber surgery that the investigator feels may compromise visual outcomes
* Diabetic retinopathy if the investigator feels this will compromise visual outcomes
* macular degeneration
* history of retinal detachment
* irregular astigmatism or keratoconus
* strabismus
* if in the surgeon's opinion the subject is not an appropriate candidate for iol implantation
* subjects who have an acute or chronic disease or illness that would confound the results of this investigation
Biomarkers of Oat Product Intake: The BiOAT Marker Study

The aim of this project is to evaluate avenanthramides and avenacosides and their metabolites as specific biomarkers of oat product intake in humans. Biomarkers will be evaluated after i) a single dose through a single meal based on a solid and a liquid oat-based product (pharmacokinetic study) ii) week-long consumption at three different intake levels (dose-response). The study will be carried out as a two-way cross-over design with two different oat products, liquid or solid, where each product is provided 3 times per day during 5 days per product. A wash-out period of 8 days where participants consume their habitual diet is implemented. The first day of study meal intervention includes postprandial measurements during 8 hours.


Eligibility Criteria:
Inclusion Criteria:

* Females and males
* Age 18-80 years
* Body mass index (BMI) 18.5-30 kg/m2
* Fasting glucose ≤ 6.1 mmol/l
* Low density lipoprotein (LDL) Cholesterol ≤ 5.30 mmol/L
* Triglycerides ≤ 2.60 mmol/L
* Signed informed consent

Exclusion Criteria:

* Food allergies or intolerances preventing consumption of any products included in the study.
* Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.
* Pregnant, lactating or planning a pregnancy during the study period.
* Antibiotic use for the last 3 months.
* Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.
* History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)
* Previous major gastrointestinal surgery
* Have type I diabetes
* Thyroid disorder
The Effect of Virtual Reality-Based Disaster Education Given to Nursing Students on Disaster Preparedness

It is thought that, as a result of the virtual reality-based disaster training given to nursing students, the psychological preparedness of nursing students who will work before, during and after the disaster will increase in disaster preparedness and disaster threat. It is thought that this research will lead to the development of school-based interventions at other universities in similar situations.

The purpose of this research is to increase the level of psychological preparation and awareness of disaster preparedness and disaster threat through virtual reality-based disaster education given to nursing students.


Eligibility Criteria:
Inclusion Criteria:

* Being a 3rd and 4th year nursing student at the relevant universities where the study will be conducted,
* Not having taken the disaster management course before,
* Not having any health problems related to vision and hearing,
* Not wearing glasses to be able to use virtual reality (VR) glasses

Exclusion Criteria:

* Having any problems with vision or hearing
* Using glasses
Pyridostigmine and Its Effects on Autonomic Modulation in Diabetic Patients

The purpose of the study is to determine if pyridostigmine bromide improves heart rate variability of type 2 diabetes mellitus subjects with cardiovascular autonomic neuropathy.

The reduced heart rate variability is associated with increased risk of death in patients with diabetes mellitus. Cholinesterase inhibition with pyridostigmine bromide increases heart rate variability in normal individuals and congestive heart failure subjects but its effects on patients with diabetes mellitus is unknown. Based on those evidences, we will test if the short-term administration of pyridostigmine bromide increases heart rate variability in patients with diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus

Exclusion Criteria:

* myocardial infarction
* acute ischemic syndromes
* second or third degree atrioventricular block
* active alcoholism
* thyroid dysfunction
* chronic obstructive pulmonary disease
* history of intolerance to pyridostigmine.
Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients

This study evaluates the efficacy of erythropoietin in refractory autoimmune encephalitis. Ten patients will receive 100 IU/kg of erythropoietin 3 times a week for 12 weeks.

Erythropoietin can improve the refractory autoimmune encephalitis. Erythropoietin has tissue-protective effect via activation of Janus kinase (JAK)-2, signal transducer and activator of transcription (STAT)-5 pathway and NF-kappa B pathway. The activation of JAK-2 and STAT-5 promote hemoglobin synthesis and facilitate cell cycle progression. Also, NF-kappa B pathway inhibition regulates pro-inflammatory cytokine production.

We expect that erythropoietin may lead to improve the symptoms and outcome of autoimmune encephalitis.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed autoimmune encephalitis
* Ineffective 1st line treatment (e.g. steroid IV, IVIg) and 2nd line treatment (e.g. Rituximab or cyclophosphamide)

Exclusion Criteria:

* Hemoglobin \> 12g/dL
* Hematochrit \>36%
* Thrombocytosis \> 750K
* AST or ALT \> 120
* HIV (+)
* Allergic reaction upon erythropoietin
* Uncontrolled hypertension
* mRS before the autoimmune encephalitis \> 3
* Breast feeding or pregnancy
* History of ischemic stroke or pulmonary thrombosis
* Refuse to be enrolled
GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver

The primary objective is to determine the galactose single point (GSP) cutoff values to discriminate subjects with different hepatic function. The secondary objective is to analyze the correlations between GSP and other hepatic function assessment methods among this trial subjects.

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease, including the potential for progression to nonalcoholic steatohepatitis (NASH), followed by fibrosis and ultimately cirrhosis. The gold standard to evaluate fibrosis in patients with NAFLD is liver biopsy. The investigators aimed to evaluate the clinical utility of using the galactose single point (GSP) test which recommended by the US FDA to quantitatively measure liver function in patients with NAFLD.

Eligibility Criteria:
Inclusion Criteria:

Subject must fulfill all of the following criteria to be eligible for the study:

1. Male or female with age between 20-80.
2. Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.

Exclusion Criteria:

Any of the following criteria will disqualify the subject from participation:

1. History of serious allergic reaction to galactose and have galactosemia.
2. History of receiving total gastrectomy, subtotal gastrectomy, celiac disease, or small intestinal resection.
3. History of diabetes mellitus.
4. Subjects are children or handicapped people.
5. Subjects with any other reasons considered by the investigator not in the condition to enter into the trial.
Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs. History of allergic or adverse response to buprenorphine hydrochloride or any comparable or similar product.