cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese

A phase 2 study to assess the efficacy of NA-931 alone or in addition to Tirzepatide to assess efficacy and safety in overweight or obese men and women

This Phase 2 study investigates if NA-931 in addition to Tirzepatide can demonstrate synergic effects by enhancing efficacy and reducing adverse events including preserve/increase muscle mass in the presence of weight and/or fat mass loss.

Eligibility Criteria:
Inclusion Criteria:

* A written informed consent must be obtained before any study-related assessments are performed.
* Men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria:

  * Two negative pregnancy tests (at screening and at randomization, prior to dosing)
  * Use of intrauterine device, from at least 3 months before the baseline visit through at least 4 months after the last dose of NA-931/placebo oral, and an additional contraceptive (barrier) method from screening through at least 4 months after the last dose of NA-931/placebo oral.
* Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia)
* Stable body weight (± 5 kg) within 90 days of screening, and body weight \<150 kg
* Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight
* Able to communicate well with the Investigator, comply with the study requirements and adhere to the diet and activity programs for the study duration

Exclusion Criteria:

* • History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to Tirzepatide (Zepbound® or Mounjaro®)

  * Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer, or longer if required by local regulations
  * Treatment with any medication for the indication of obesity within the past 30 days before screening
  * Diagnosis of diabetes requiring current use of any antidiabetic drug or HbA1c ≥ 6.5% Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic drug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impaired glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet and exercise) is not an exclusion.
  * Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV). History of hepatitis A or hepatitis C successfully treated is not exclusionary. Active COVID-19 infection.
  * Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation, or plasma donation (\> 250 mL) within 14 days prior to the first dose
  * Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol
Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.

The rhizarthrosis, or the degenerative osteoarthritis of the trapezo-metacarpal joint, is a frequent degenerative osteoarthritis.

The treatment associates not pharmacological measures, such as resting relative of the joint, the orthosis of rest, glazing and pharmacological measures such analgesic, anti-inflammatory not steroidal per bones or premises, even infiltrations cortisone or by hyaluronic acid.

No study has, for the moment, tested the interest of the combination of cortisone and hyaluronic acid in rhizarthrosis. In view of the current publications, we propose to carry out a study on two arms, with corticosteroids in reference arm; the experimental arm is the combination of hyaluronic acid and cortisone.


Eligibility Criteria:
Inclusion Criteria:

* Adults, ≥ 40 years
* Pain located at the root of the thumb (near the wrist) and awakened by direct pressure and movement
* Pain resistant to well-conducted medical treatment, with analgesics, NSAIDs, icing with pain (analog visual scale) ≥ 4 for more than 3 months
* Radiological findings (kapandji face + profile incidence) typical of rhizarthrosis, stage II or III of Eaton and Litter, with at least 2 of the following 5 radiological elements observed on the trapeziometacarpal joint:

  * marginal osteophyte
  * pinching of the joint space
  * sclerosis of the subchondral space
  * subchondral kyst
  * absence of osteopenia
* Patient with the ability to understand the protocol and signed informed consent
* Patient receiving social security

Exclusion Criteria:

* Known allergy to any of the products (corticosteroids or hyaluronic acid) including its excipients (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol)
* Change of analgesic treatment within 4 weeks before inclusion.
* Patients with symptomatic bilateral rhizarthrosis
* Scaphoid-trapezial arthrosis
* Local or general infection
* Severe coagulation disorders, ongoing anticoagulant therapy
* severe and / or uncontrolled hypertension
* Earlier local surgery
* Associated inflammatory rheumatism
* Tendinopathy of De Quervain, thumb to jump associated
* Infiltrations earlier than 6 months
* Diabetes imbalanced
* Live vaccines
* Severe water and / or sodium retention (hypernatremia), particularly in cases of heart failure, decompensated liver failure (edema and ascites failure)
* Pregnant or lactating women
* Immunocompromised or hemodialysis patients
* Patients under guardianship, trusteeship, or deprived of liberty
* Patients participating in another clinical research protocol involving a drug or medical device
* Patients unable to follow the protocol, according to the judgment of the investigator
Risk Factors and Outcomes of Immune-Mediated Encephalitis Following Exposure to Nivolumab

A case series analysis of encephalitis events reported to the Sponsor for patients treated with nivolumab to assess the risk factors and outcomes of immune-mediated encephalitis.


Eligibility Criteria:
Inclusion Criteria:

* Moderate, severe, life-threatening or fatal encephalitis events occurring in patients treated with nivolumab and reported to the Sponsor

Exclusion Criteria:

* Encephalitis cases identified through literature reviews and not reported to the Sponsor
* Encephalitis cases identified from company-sponsored observational studies with secondary data collection
* Spontaneous reports not submitted directly to the Sponsor

Other protocol-defined inclusion/exclusion criteria apply
Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD

The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world clinical setting in Japan.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed ADPKD
* total kidney volume of 750 or more

Exclusion Criteria:

-
Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension

This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients ≥ 18 years of age
* Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and \< 200 mmHg at Visit 2

Exclusion Criteria:

* Mild to moderate hypertension
* Pregnant or nursing (lactating) women
* Women of child-bearing potential
* Previous or current diagnosis of heart failure New York Heart Association(NYHA) Class II-IV.
* Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1.
* Uncontrolled Type 1 or Type 2 diabetes mellitus
* Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
* History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
* Patients on a combination of 3 or more antihypertensive medications

Other protocol-defined inclusion/exclusion criteria may apply
Methylphenidate and Parkinson's Disease

The purpose of this trial is to determine if methylphenidate (MPD), a drug marketed in the U.S. to treat hyperactivity and narcolepsy, added to levodopa, will increase the beneficial effects of levodopa without bothersome side effects in people with Parkinson's disease (PD).

Parkinson's disease (PD) is a common disorder caused by the loss of dopamine-producing brain cells. The disorder is generally treated with levodopa combined with carbidopa. Nerve cells use levodopa to make dopamine. Carbidopa delays the conversion of levodopa into dopamine until it reaches the brain. Motor fluctuations (the wearing off effects of levodopa characterized by sometimes rapid changes between uncontrolled and normal movements) are a common, and often difficult to manage, source of disability in people with PD.

In this trial researchers will study the effects of methylphenidate (MPD), also known as Ritalin-a drug marketed in the U.S. to treat hyperactivity and narcolepsy-on carbidopa/levodopa and other antiparkinson medications taken orally by individuals with Parkinson's disease who experience motor fluctuations when they take levodopa. The overall goal of this project is to develop better symptomatic therapies for PD.

After 2 screening visits to the treatment clinic to evaluate the wearing "on" and "off" effects of levodopa, eligible participants will be scheduled for 3 admissions to the General Clinical Research Center at Oregon Health \& Science University during which they randomly will receive the study drug, MPD, or placebo, along with their usual carbidopa/levodopa therapy and/or other antiparkinson medications. Also, participants will have their parkinsonism (tremor, rigidity, postural instability, and bradykinesia) rated and blood pressure and pulse measured at regular intervals.

Duration of the study for participants is about 3 weeks and includes 2 outpatient clinic visits (for screening) and 3 inpatient clinic visits (with overnight stays).

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PD treated with levodopa and experiencing motor fluctuations
* At least 21 years of age
* Male or female.

Exclusion Criteria:

* Cardiovascular disease, psychosis, extreme anxiety, dementia and other unstable medical conditions.
A Study Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro

Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins.


Eligibility Criteria:
Inclusion Criteria:

1. Established diagnosis of type 1 diabetes for not less than 5 years
2. HbA1c values of not more than 9%
3. Age: 19 to 70 years
4. Sex: Male or Female
5. Body Mass Index: 18 - 28 kg/m2
6. Informed consent must be obtained in writing for all volunteers.

Exclusion Criteria:

1. Type 2 Diabetes mellitus.
2. History of hypersensitivity to any of the components in the study medication.
3. History of severe or multiple allergies.
4. Treatment with any other investigational drug in the last 1 month before study entry.
5. Treatment with any concomitant medication that in the judgment of the investigator. would interfere with the study results.
6. Progressive disease likely to prove fatal (e.g. malignancies).
7. Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
8. Having a significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the investigator.
9. Blood donation within the last 30 days.
10. A women who is lactating.
11. Pregnant women or women intending to become pregnant during the study.
12. A sexually active woman of childbearing age not actively practicing birth control by using a medically accepted device or therapy.
13. Positive Serology for HIV, Hepatitis B or Hepatitis C.
14. Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the investigator.
15. A lack of compliance or other reasons which, in the opinion of the investigator, prevent the participation of the subject in the study.
This Study Will Examine the Effects of GSK256066 to Protect Mild Steroid-naive Asthmatics Against an Antigen Challenge

This will be a single centre, randomised, double-blind, placebo-controlled, 2-period crossover study to investigate the effect of treatment with repeat inhaled doses of GSK256066 on bronchial hyper-reactivity to adenosine monophosphate.


Eligibility Criteria:
Inclusion: (All must Apply)

* Males and females aged 18 to 55 years inclusive.
* Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation.
* Pre-bronchodilator FEV1 \>75% of predicted at screening.
* Documented sensitivity to AMP with a provocative concentration of AMP resulting in a 20% fall in FEV1 (PC20 AMP) of \<80 mg/ml at the screening visit.
* Demonstrate stable bronchoconstriction in response to inhaled AMP at the run-in visit. 'Stable bronchoconstriction' is a term to define a population of asthmatics who have a repeatable and reproducible response to a challenge agent that induces bronchoconstriction. The run-in PC20 needs to be within 1.25DD of the screening PC20.
* Non-smoking status as verified by urinary cotinine levels below 300 ng/mL cotinine at the screening visit. This can include ex-smokers who have given up smoking for \>6 months and have less than a 5 pack-year smoking history.
* Able and willing to give written informed consent to take part in the study.
* Available to complete all study measurements.

Exclusion:

* Pregnant or nursing females.
* Past or present disease, which as judged by the investigator, may affect the outcome of this study.
* Subject has known history of hypertension or is hypertensive at screening.
* Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
* History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.
* Unable to abstain from prescription medication, other than short acting inhaled beta-agonists and paracetamol for the treatment of minor ailments eg headache from 48h before the first dose until the follow-up visit.
* The subject has participated in a clinical trial during the previous 3 months.
* History of blood donation (450 mL) within 2 months of starting the clinical study.
* The subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female.
* The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen or HIV antibodies.
* The subject has positive drugs of abuse test.
* Subjects weighing less than 50kg are to be excluded from participating in the study.
Effects of Dual-transcranial Direct Current Stimulation During Physical Therapy in Sub-acute Stroke

The aim of the present study is to evaluate the possible effect of using dual-tDCS applied during conventional physical therapy on lower limb function in stroke patients.

Recently dual-tDCS applied before the conventional physical therapy show positive effect of lower limb performance. However to explore the time during which dual-tDCS can be combined with physical therapy to maximize motor performance is required. Results from the present study with be compared with our previous study that used dual-tDCS applied before physical therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age range 18-75 years.
2. First ever-ischemic lesion in the territory of middle cerebral artery or anterior cerebral artery. CT scan/MRI result is thus required.
3. Sub acute phase of stroke (less than 6 months)
4. Able to sit-to-stand and stand-to-sit independently
5. Able to walk without physical assistance at least 6 m
6. Free of any neurological antecedent, unstable medical conditions or condition that may increase the risk of stimulation such as epilepsy

Exclusion Criteria:

1. Pre-stroke disability
2. Pregnant
3. Be unable to understand the instruction
4. No clear neurological antecedent history or psychiatric disorder
5. Excessive pain in any joint of the paretic limb (numerical pain rating score \> 7)
6. Presence of intracranial metal implantation, cochlea implant, or cardiac pacemaker
7. Subjects are participating in the other protocol or receiving alternative treatment such as acupuncture
Effect of Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist (NAVA) in Chronic Obstructive Pulmonary Disease (COPD) Patients

The investigators' aim is to study the effect of pressure support ventilation at two levels of PEEP and Pressure Support versus neurally adjusted ventilatory assist (NAVA) in COPD patients.

In this study, two levels of pressure support and PEEP during pressure support ventilation are compared with neurally adjusted ventilatory assist (NAVA) in COPD patients by measuring respiratory mechanics, intrinsic PEEP, work of breathing and patient's level of comfort.

Eligibility Criteria:
Inclusion Criteria:

* Stable COPD patients during non invasive mechanical ventilation

Exclusion Criteria:

* Haemodynamic instability
* Coma
Evaluation of Perioperative Lung Ultrasound Scores in Laparoscopic Pediatric Surgeries

Laparoscopic surgeries require carbon-dioxide into the abdomen which may occasionally lead to atelectasis. The extent of this atelectasis is not well documented in peri-operative period although it has been extensively researched in critical care set up. In this study, it is aimed to observe the ultrasonographic condition of lungs in laparoscopic pediatric surgeries. The hypothesis was the Lung Ultrasound Scores would worsen in those surgeries by the end of the operation. Aged between 1-18 years pediatric patients who are scheduled for laparoscopic surgeries will be included in the study to observe the changes in the lung visuals throughout the operation. For that, after safe endotracheal intubation first ultrasonography will be performed for the first (T1) time, and the second ultrasonography will be performed once the surgery is finished and before extubation (T2). Lastly, the third evaluation will be performed after 30 minutes in post anesthesia care unit (T3). Lung Ultrasound Score (LUS) is calculated as follows: Both hemi-thoraxes are divided into 6 different zones, and depending on the number of B-lines, which happens due to aeration loss in lung tissue, every zone is scored. If there is no B-line, it is zero points. If the B-lines in the visual lower than 4, the area is scored as 1 point. The areas with B-lines more than 3 is scored as 2 points. Furthermore, if there is any disruption on the pleural face, then the area is scored as 3 points. Accordingly, the worst case scenario refers 36 points, meaning the less the points the better the lung aeration.

Primary outcome is defined as T2 LUS which will show the actual condition of at the end of the surgery. For that, T1 scores and T2 scores will be compared. The secondary outcomes include T3 LUS, (T3-T1)LUS, intraoperative hemodynamics, length of stay in Post Anesthesia Care Unite, postoperative aldrete scores for discharging to ward, and intraoperative ventilation variables.


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic pediatric surgeries
* Aged between 1-18 years

Exclusion Criteria:

* Patients with Constitutional lung diseases
* Patients with Heart failure
* Patients with pulmonary hypertension
Evaluation of a Biofeedback-assisted Meditation Program as a Stress Management Tool for Hospital Nurses

The purpose of this study is to assess a novel meditation program which is biofeedback reinforced (Healing Rhythms™) as a means to improving stress management in a population of nurses practicing in the hospital setting.

Stress is a common problem with significant ramifications for health. This is especially true in the workplace and particularly true for nurses practicing in a hospital environment. A number of factors (e.g. an aging population, the obesity epidemic, patients presenting with multi-system diseases, etc.) have dramatically increased the demands on hospital nurses in the past decade. This increased stress has potential ramifications at a personal level (e.g. increased risk of ill health) as well as an institutional (e.g. higher staff turnover). Meditation has been shown to be an effective tool for stress management. A self-directed, computer-guided meditation training program that can be pursued independently may be particularly useful for hospital nurses where scheduling challenges may preclude the use of scheduled classes. Healing Rhythms™ is a computer program that teaches meditation and uses biofeedback (heart rate variability and galvanic skin response) to reinforce the training.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years of age
* Subjects that have given consent to participate
* Subjects that have access to a home computer

Exclusion Criteria:

* Subjects who are currently engaged in a routine meditative practice
Outcome Assessment in Patients Treated With Hyperbaric Oxygen Using OxyVu Tissue Oxygenation Monitoring System

The objective is to define patient eligibility for hyperbaric oxygen therapy and to evaluate wound healing progression using a new hyperspectral imaging technology.

The purpose of this clinical study is to define patient eligibility for hyperbaric oxygen therapy (HBOT) and to evaluate wound healing progression during HBOT using a new hyperspectral imaging technology (OxyVu).

Eligibility Criteria:
Inclusion criteria:

* 18 - 85 years of age
* Patients with wounds that meet the criteria for hyperbaric oxygen therapy (e.g. problem wound, diabetic foot ulcer, necrotizing soft tissue infections)
* Compromised Flap or Grafts.

Exclusion criteria:

* Patients with poor cardiac output (EF \< 20%)
* Patients with severe obstructive pulmonary disease who don't qualify for HBOT
* Patients with untreated asthma who don't qualify for HBOT
* Patients utilizing supplemental oxygen and those on ventilators
* Patients on life support medications (pressors)