cyrilzakka/clinical-trials huggingface dataset:
"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"

This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.


Eligibility Criteria:
Major Inclusion Criteria:

1. Male or female between 18 and 75 years of age, inclusive
2. Diagnosis of OSA according to ICSD-3 criteria
3. Body mass index from 18 to \<45 kg/m2
4. Consent to use a medically acceptable method of contraception
5. Willing and able to provide written informed consent

Major Exclusion Criteria:

1. Female subjects who are pregnant, nursing, or lactating.
2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
4. History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy or safety assessments or the ability of the subject to complete the trial per the judgment of the principal investigator
5. History of bariatric surgery within the past year or a history of any gastric bypass procedure
6. Presence or history of significant cardiovascular disease
7. Use of any over the counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
8. Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
9. Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
10. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression

The Johns Hopkins Department of Psychiatry is conducting a research study to examine the effectiveness of riluzole in treating the depressed phase of bipolar disorder. This outpatient treatment study of medication or placebo will last 9-12 weeks. The study includes medical and psychiatric evaluations as well as time-limited medication treatment at no cost, and you will be compensated for your participation.

The study will last 8 to 12 weeks and requires weekly visits. Participants will come to Johns Hopkins for a screening visit during which they will talk with a psychiatrist, answer questions about their mood and symptoms, have their blood drawn and have a brief physical exam. If they meet criteria for the study, any antidepressant medication that they are taking will be tapered and stopped before beginning study medications. Participation in the study includes free study medication, labs, and testing plus reimbursement for transportation. Participants will also be paid and after the study referred back to their treating psychiatrist with treatment recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-75
* Diagnosed with Bipolar I or II disorder and currently depressed
* Tried at least one antidepressant during the current episode of depression
* Currently taking either lithium, depakote, or tegretol
* Currently in outpatient treatment with a psychiatrist

Exclusion Criteria:

* Current psychotic symptoms
* Women who are pregnant or nursing
* Any serious, uncontrolled medical illness
* History of liver problems
* Current or past blood diseases
* Current drug or alcohol abuse
* Currently receiving Electroconvulsive Shock Therapy (ECT)
* Judged to be at serious suicidal risk
Study of Changes and Characteristics of Genes in Patients With Pancreatic Cancer for Better Treatment Selection

Researchers are looking for better ways of understanding and treating pancreatic cancer. The purpose of this study is to see how useful it is to look for changes and characteristics in your genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour. These characteristics may be useful in choosing treatments for patients in the future. Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with advanced pancreatic ductal adenocarcinomas and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histological or radiological diagnosis of locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with borderline resectable disease are not eligible.
* Patient must have a tumor lesion that is amenable to a core needle biopsy.
* Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
* Patients must be fit enough to safely undergo a tumor biopsy.
* Age 18 years or older.
* Eastern Cooperative Group (ECOG) performance status of 1 or less.
* Life expectancy of greater than 90 days.
* Patients must have normal organ and marrow function
* Patients must undergo systemic treatment with m-FOLFIRINOX or nab-paclitaxel as a first line standard systemic palliative treatment or combination treatment with m-FOLFIRINOX or nab-paclitaxel with or without other investigational agents within a clinical trial as a first line palliative treatment.
* Ability to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patients with one or more contraindications to tumor biopsy.
* Patients who have prior systemic treatment (chemotherapy or any other anti-cancer agent) in advanced setting.
* Patients who are currently on anti-cancer treatment including chemotherapy.
* Patients with known brain metastases.
* Patients with advanced PDAC who are going to be treated with gemcitabine monotherapy in advanced setting.
* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
The Effect of Amlodipine and Lisinopril on Retinal Autoregulation in Type 1 Diabetes

The purpose of this study is to compare the effect of two antihypertensive drugs on retinal vessel diameter in young type 1 diabetics. The retinal vessel analyzer (RVA) was used to investigate how the drugs affected vessel diameter, when the subjects were exposed to an increase in blood pressure, induced by isometric muscle contraction and when they were stimulated by flickering light.

Diabetes is a leading cause of blindness in the western part of the world. Diabetic patients develop diabetic retinopathy which can progress to blindness. Diabetic retinopathy is associated with an increase of blood flow in the retinal vessels, ischaemia in the periphery and macular oedema. It has been shown in previous trials, that the pressure and metabolic autoregulation is disturbed in patients with diabetes, and it is believed to contribute to the development of diabetic retinopathy.

In healthy subjects the retinal arterioles will contract during an increase in blood pressure, but trials have shown that this response is impaired in diabetics. When the retina is exposed to flickering lights, the metabolism increase and the arterioles in healthy subjects dilates. In diabetics this dilation is impaired. In this trial we want to investigate if an ACE-inhibitor (lisinopril) or calcium channel blocker (amlodipine) influence this response in subjects exposed to increased blood pressure vs increased retinal metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* 18-35 years of age
* Simplex retinopathy at last screening (Less than 10 retinal haemorrhages at the nearest ordinary screening examination)
* normotensive (BP not above 160 mmHg systolic or 100 mmHg diastolic)

Exclusion Criteria:

* Pregnancy
* Systolic Bloodpressure above 160 mmHg
* Diastolic bloodpressure above 100 mmHg
* Retinopathy grade higher than simplex retinopathy
* Prior retinal laser photocoagulation
Cardiac Effects of Spiolto®/Respimat® in Patients With Congestive Heart Failure and COPD

The aim of this study is to evaluate the pulmonary and cardiac effects of the LABA / LAMA combination Tiotropium / Olodaterol therapy in patients suffering from both congestive heart failure and chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
* Symptomatic with regard to dyspnea (NYHA II-III, mMRC Dyspnea score \> 1)
* Diagnosis of COPD (FEV1/FVC ratio \<70%, FEV1 \< 80%)
* Patients with hyperinflation at rest defined as Residual Volume (RV) \> 135 % predicted
* Diagnosis of moderate symptomatic ischaemic Congestive heart failure (LVEF \> 35 -45%)
* Stability of CHF during the preceding 3 months (no hospitalization due to CHF, stable CHF medication)
* Male or female aged \> 18 years
* Written informed consent prior to study participation
* The subject is willing and able to follow the procedures outlined in the protocol

Exclusion Criteria:

* Lack of informed consent
* Pregnant and lactating females
* Acute moderate-severe exacerbation of COPD, acute respiratory failure (pH \< 7,35 and/ or respiratory rate \> 30/min within 3 months prior to inclusion)
* Unstable heart failure or planned change in medication (hospitalization due to CHF within 3 months prior to inclusion), any angina pectoris
* Not symptomatic
* Patient has been committed to an institution by legal or regulatory order
* Participation in a parallel interventional clinical trial
* Any COPD maintenance therapy before start of randomization
* History or diagnosis of Asthma
* LVEF \<35 % or ICD or pacemaker
* Myocardial infarction 6 months prior inclusion
* History of life-threatening arrhythmias (e.g. NSVT or ventricular tachycardia, aFib, AV-Block, pacemaker treatment etc.)
* History of diagnosis of Thyrotoxicosis
* Chronic kidney disease with an crea-clearance ≤30 ml/min
* History of significant alcohol or drug abuse, as judged by the Investigator
* Fibrotic lung disease (e.g. IPF, ILD)
* Contraindications for MRT (e.g. pacemaker, defibrillator, ferromagnetic metal implants, tattoos, claustrophobia, etc. according to MRI checklist used in the clinical routine)
Pediatric Acute Respiratory Distress Syndrome Asia Study

Mortality rates in children with pediatric acute respiratory distress syndrome (PARDS) are higher in Asia compared to other regions. In adults with acute respiratory distress syndrome, the only therapy that improves mortality rates is a lung protective ventilation strategy. The pediatric ventilation recommendations are extrapolated from evidence in adults, including ventilation with low tidal volume, low peak/plateau pressures and high-end expiratory pressure. A recent retrospective study of ventilation practices in Asia showed varying practices with regards to pulmonary and non-pulmonary therapies, including ventilation. This study aims to determine the prevalence and outcomes of PARDS in the Pediatric Acute and Critical Care Medicine Asian Network (PACCMAN). This study will also determine the use of pulmonary (mechanical ventilation, steroids, neuromuscular blockade, surfactant, pulmonary vasodilators, prone positioning) and non-pulmonary (nutrition, sedation, fluid management, transfusion) PARDS therapies. To achieve this aim, a prospective observational study which involves systematic screening of all pediatric intensive care unit (PICU) admissions and collection of pertinent clinical data will be conducted. Recruitment will be consecutive and follow up will continue to intensive care discharge.

The overall objective of this study is to prospectively determine the epidemiology of children with PARDS and describe its management in Asia. The first specific aim is to determine the prevalence of PARDS among PICU admissions. This will be achieved by establishing a systematic manner of screening patients and including them in this study. The second specific aim is to describe the use of pulmonary and non-pulmonary therapies in PARDS. This study will utilize an established dataset to extract pertinent and analyzable clinical data.The third specific aim is to determine the outcome of patients with PARDS. These outcomes will include functional data, PICU mortality, ventilator duration and length of stay data. This is a two-part study - the first part to establish the baseline prevalence and ventilator management strategies, the second part will include the implementation of an evidence based ventilation protocol as part of routine care. The same screening process, eligibility criteria and data collection will apply throughout the two parts. We aim to obtain data for approximately 2years prior to and 2years subsequent to the implementation of the ventilator protocol.

Eligibility Criteria:
Inclusion Criteria:

* Satisfies the Pediatric Acute Lung Injury Consensus Conference (PALICC) criteria for PARDS

Exclusion Criteria:

* Premature neonates with a corrected age of less than 33 weeks and perinatal lung disease
* High flow nasal cannula
Brain Response to an Intervention Using Guided, At-Home Technology for the Mind

The objective of this study is to assess the effectiveness of two digital programs for providing mental stimulation, improving cognition, and inducing changes in brain structure and function.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 25-80 years of age.
* Ability to understand and speak English, follow written and verbal instructions (English), and give informed consent (English), as assessed by study staff.
* Ability to comply with all the testing and study requirements, including the ability to independently use a video conferencing tool and the ability to independently use a computer to access the web.
* Ability to independently complete a daily, online intervention and outcome assessments using a web browser compatible with the intervention and assessment software on a reliable, internet-connected laptop or desktop computer.

Exclusion Criteria:

* Current, controlled (requiring treatment) or uncontrolled psychiatric diagnosis, including but not limited to posttraumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, attention-deficit/hyperactivity disorder, or other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments.
* Current, controlled (requiring treatment) or uncontrolled neurological diagnosis, including but not limited to Alzheimer's Disease, other dementias, mild cognitive impairment, Huntington's Disease, Parkinson's Disease, multiple sclerosis, stroke, epilepsy, aphasia, or other condition that in the opinion of the Investigator may confound study data/assessments.
* Any other medical condition in the last 90 days that in the opinion of the Investigator may confound study data/assessments.
* Has been under the care of a caretaker or has not been living independently in the last 90 days.
* In the last three years has used any of the following for more than two weeks continuously: Online courses, Online brain training programs
* Known sensitivity (such as headaches, dizziness, nausea) to bright, stimulating video displays.
* History of seizures (excluding febrile seizures), or significant motor or vocal tics, including but not limited to Tourette's Disorder and photo-sensitive epilepsy.
* Visual acuity that cannot be corrected that prevents or negatively impacts computer activity.
* Has participated in a clinical trial within 90 days prior to screening.
* Pregnancy or planning to become pregnant.

Additional Exclusion Criteria for Cohort B only:

* Unwillingness or inability to comply with imaging safety protocols.
* Metal implants or exposure to shrapnel.
* Left-handed or ambidextrous.
Multicenter Randomized Trial of 68Ga-PSMA-11 PET/CT Based SRT After Radical Prostatectomy

This phase III trial studies how well Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT) works in diagnosing participants with prostate cancer that has come back after surgery. 68Ga-PSMA-11 are taken up by cancer cells. Diagnostic procedures, such as PET/CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread. Giving 68Ga-PSMA-11 with PET/CT may help doctors plan better for salvage radiation therapy in participants with recurrent prostate cancer.

PRIMARY OBJECTIVE:

I. Success rate of salvage radiation therapy (SRT) measured as biochemical progression-free survival after initiation of SRT.

SECONDARY OBJECTIVES:

I. Sub-group analysis of the primary endpoint (success rate of SRT) within the subgroup with baseline PSA ≥ 0.5 ng/ml II. 5-year biochemical progression-free survival rate (from date of randomization).

III. Metastasis free survival. IV. Initiation of additional salvage therapy after completion of SRT. V. Change in initial treatment intent.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive standard of care SRT.

ARM II: Participants receive 68Ga-PSMA-11 intravenously (IV) and 50-100 minutes later undergo whole-body (skull base to mid-thighs) PET/CT. Participants then undergo SRT per the discretion of the treating radiation oncologist.

After conclusion of PET/CT, participants are followed up periodically for up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Histopathology proven prostate cancer.
* Planned SRT for recurrence after primary prostatectomy.
* Prostate-specific antigen (PSA) \>= 0.1 ng/ml at time of enrollment.
* Willingness to undergo radiotherapy.
* Treating radiation oncologist intends to incorporate 68Ga-PSMA-11 PET/CT findings into the radiotherapy plan if patient undergoes 68Ga-PSMA-11 PET/CT.

Exclusion Criteria:

* Extra-pelvic metastasis on any imaging or biopsy.
* Androgen deprivation therapy (ADT) within 3 months before 68Ga-PSMA-11 PET/CT.
* Contraindications to radiotherapy (including active inflammatory bowel disease).
* Concurrent systemic therapy for prostate cancer with investigational agents.
Prophylactic Omentopexy During Laparoscopic Insertion of Peritoneal Dialysis Catheter

The purpose of this study is to compare function of the peritoneal dialysis catheter in two groups of patients with and without prophylactic omentopexy that was performed during laparoscopic insertion of peritoneal catheters.

Peritoneal dialysis is a know and accepted treatment in patients with end stage renal diseases. The is a safe, easy and cheap treatment modality in these patients. After introduction and development of laparoscopic procedures for insertion of peritoneal dialysis catheters, some prophylactic surgical techniques have been proposed as measures to reduce catheter malfunction. Omentopexy is among these techniques. The purpose of this study is to compare function of the peritoneal dialysis catheter (including inflow and outflow failure) in two groups of patients with and without prophylactic omentopexy that was performed during laparoscopic insertion of peritoneal catheters.

Eligibility Criteria:
Inclusion Criteria:

• End-stage renal failure in need of prolonged dialysis referred for insertion of peritoneal dialysis catheter

Exclusion Criteria:

* Contraindications to laparoscopic surgery
* Coagulative disorder
* Death of participant due to other reasons before usage of peritoneal catheter
Mindfulness Practice vs Strength Training on Pain, Kinesiophobia and Function Among Sprinters

The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive the strength training only. Group B will receive the mindfulness-exercise in addition to the strength training protocol.

The objective of the study is to determine the effects of mindfulness practice with strength training on pain, kinesiophobia and function among sprinters with patellofemoral syndrome. The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive the strength training only. Group B will receive the mindfulness-exercise in addition to the strength training protocol. Usual pain, pain during stepping, and pain during running will be assessed using visual analog scales. Functional limitations of the knee will be assessed using the Knee Outcome Survey. Fear of movement, pain catastrophizing, and coping strategies will be measured via the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, and the Coping Strategies Questionnaire, respectively. For strength training we will use Muscle-strengthening Exercise Questionnaire Short Form (MSEQ). These outcomes will be assessed at baseline and after 6 weeks

The data will be analyzed by SPSS, version 25. Statistical significance is P=0.05.

Eligibility Criteria:
Inclusion Criteria:

* Males and Female between the ages of 18 and 40 years, Report running ≥2 times per week for \>45 minutes or a minimum weekly running distance of 10 km, Present a history of insidious onset of signs and symptoms of PFP in 1 or both knees that was unrelated to trauma for at least 3 months before assessment, score \<85/100 on the Activities of Daily Living Scale and Sports related of the Knee Outcome Survey (KOS-ADLS)

Exclusion Criteria:

* Intra-articular condition, Coexisting lower limb injury, History of patellar dislocation or knee surgery, Osgood-Schlatter or Sinding- Larsen-Johansson syndrome
The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy

This study is designed to identify the minimal effective tested dose of fruit extract consumed with a bread which provides a reduction in venous post-prandial blood glucose compared to a reference bread.


Eligibility Criteria:
Inclusion criteria:

* Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
* Apparently healthy males and females: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
* Fasting blood glucose value of subjects ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening.

Exclusion criteria:

* Use of antibiotics within 3 months before day 1; use of any other medication except paracetamol, within 14 days before day 1.
* Blood donation in the past 3 months and/or during the study.
* Reported intense sporting activities \> 10 h/week.
* Consumption of \> 14 units (female subjects) and \> 21 units (male subjects) alcoholic drinks in a typical week.
* Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
* If female, is pregnant (or has been pregnant during the last \< 3 months) or will be planning pregnancy during the study period.
* If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period.
* Dislike, known allergy or intolerance to test products or other food products provided during the study.