cyrilzakka/clinical-trials huggingface dataset:
Effects of Portrayals of Successful Treatment and Role Fulfillment on Mental Illness Stigma

This study aims to measure levels of mental illness stigma based on successful treatment and societal role fulfillment of the individual portrayed with mental illness.

This study aims to measure levels of mental illness stigma based on successful treatment and societal role fulfillment of the individual portrayed with mental illness. This study utilizes eight vignettes portraying two different mental illnesses (depression and schizophrenia), with one vignette giving no details about role fulfillment or treatment, another giving no details about role fulfillment but successful treatment, another giving details on role fulfillment but no treatment, and last giving details on both role fulfillment and successful treatment.

Eligibility Criteria:
Inclusion Criteria:

* All adults who consider Buyende District their primary residence and who are capable of providing consent

Exclusion Criteria:

* Minors younger than 18 years of age
* Persons who do not consider Buyende District their primary place of residence
Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction

Acute coronary syndromes (ACS) are still associated with high morbidity and mortality, despite several improvements in their management. This may indicate that important pathogenic mechanisms contribute to both stable and unstable atherosclerotic disease mechanisms.

Based upon previous research, the investigators believe that providing a block in the damaging inflammatory loop though short term inhibition of Interleukin-6 receptor signalling, could be an attractive therapeutic target in ACS; and of particular interest in patients with non-ST elevation myocardial infarction (NSTEMI), a disease often characterized by widespread coronary inflammation with multiple unstable plaques.

The investigators hypothesize that a single administration of the anti-Interleukin 6 receptor antagonist Tocilizumab, in patients with NSTEMI, may interrupt the self-perpetuating inflammatory loops which could improve plaque stability, with potential secondary beneficial effects on myocardial damage.

This will be investigated in a randomized, double blind, placebo-controlled study, including a total of 120 patients.


Eligibility Criteria:
Inclusion Criteria:

* NSTEMI (ESC Type 1)
* Age 18-80 years
* Troponin T \>/= 30 ng/ml
* Informed consent to participation

Exclusion Criteria:

* STEMI
* Known cardiac disease, except coronary disease (cardiomyopathy, heart failure with known EF \< 45%, severe valvular heart disease attending regular follow-up, recent PCI/ACB (\< 3 months))
* Hemodynamic and/or respiratory instability
* Cardiac arrest in acute phase
* Concurrent condition affecting/potentially affecting CRP (infection, malignancy, autoimmune disease)
* Recent major surgery (\< 3 months)
* Recent/concurrent immunosuppressant treatment (\< 2 weeks, except NSAIDs)
* Severe renal failure (eGFR \< 30 ml/min)
* Pregnancy
* Contraindications to any study investigations and/or medication.
* Expected non-adherence to study protocol
National Gilles De La Tourette Study Group

Tourette syndrome is rare. In France, about 3000 patients have a severe form of the disease. The aim of this study is to collect clinical characteristics in 200 patients with Tourette syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Tourette syndrome

Exclusion Criteria:

* severe cognitive disorders
Single Dose of 9-cis-retinoic Acid in Hepatic Patients

To test whether patients with hepatic insufficiency can tolerate one oral dose of 9-cis-retinoic acid and to test whether the metabolism of retinoic acid is altered.


Eligibility Criteria:
Inclusion Criteria:

1. Have biopsy verified hepatic insufficiency
2. Medically stable.
3. Ultra sonic examination of lever within the past 3 months
4. No pregnancy documented in women. use of anticonception during study and 1 month after

Exclusion criteria:

1. Odd blood counts and samples not related to hepatic disease
2. encephalopathy (\> grad II)
3. concomitant treatment with pharmaca that is metabolized by CYP3A4 in the liver.
4. Cardiac disease
5. Kidney disease
6. Epilepsia
7. Stroke
8. Esophagal bleeding
9. Severe ascites
10. HIV-positivity
11. Psychiatric disorder
12. Cancer
13. pregnancy or lactating women.
Latino Youth Agricultural Study

This project implements and evaluates a promotora-based intervention targeted at adolescent farm workers. The goal of the project is to determine the effectiveness of each intervention in promoting increased knowledge and practice of pesticide safety behaviors.

This project implements and evaluates a promotora-based intervention targeted at adolescent farm workers. The intervention will be delivered to two different treatment groups: 1) adolescent only, adolescents receive the adapted adolescent version of La Familia Sana program and 2) family enhanced, adolescent and mother both receive the La Familia Sana program. In addition, there will be a control group where adolescent farmworkers will not be exposed to any pesticide safety program. Our project will:

1. Determine if a promotora-based intervention targeting pesticide safety in the workplace is effective in increasing knowledge about safety behaviors among Latino adolescents engaged in farm work.
2. Delineate variation by group among adolescents' knowledge about safety behaviors.
3. Delineate variation in adolescents' pesticide safety behaviors and neurological outcomes after intervention between all groups.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent self-identifies as Latino, Hispanic, or of Latin American heritage
* Adolescent is between the ages of 12-21
* Adolescent has been engaged (paid or unpaid) in farm work for at least 10 hours in he last 30 days
* Adolescent has a parent living with them

Exclusion Criteria:

* Refusal of youth to provide assent or parent to provide consent
Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes

This trial is conducted in Europe.

A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in children between 6 and 21 years with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Current intensified insulin treatment
* Injection of insulin Semilente®MC at bedtime for at least 6 weeks
* BMI maximum 32 kg/m\^2
* HbA1c \> 5.5 % and \< 12.0 %

Exclusion Criteria:

* Current treatment with premixed insulin(s)
* Impaired hepatic or renal function
* Recurrent major hypoglycaemia
Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment

The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function.


Eligibility Criteria:
Inclusion Criteria:

* Stable congestive heart failure
* Impaired renal function
* Taking oral loop diuretic

Exclusion Criteria:

* Acutely decompensated (unstable) and end stage heart failure
* Diuretics other than loop diuretics
* Pregnant or nursing
* Inability to follow instructions
* Participation in another clinical trial within past 30 days
Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke

This interventional study evaluates the effects of an overground propulsion neuroprosthesis that delivers adaptive neurostimulation assistance to the paretic plantarflexors and dorsiflexors of people post-stroke. Individuals with chronic post-stroke hemiparesis will walk with and without the neuroprosthesis overground and on a treadmill. The goal of the study is to understand how adaptive neurostimulation delivered by the neuroprosthesis affects clinical and biomechanical measures of walking function in order to guide future rehabilitation approaches for restoring walking ability after stroke.

This interventional study evaluates the effects of an overground propulsion neuroprosthesis that delivers adaptive neurostimulation assistance to the paretic plantarflexors and dorsiflexors of people post-stroke. Individuals with chronic post-stroke hemiparesis will walk with and without the neuroprosthesis overground and on a treadmill. The goal of the study is to understand how adaptive neurostimulation delivered by the neuroprosthesis affects clinical and biomechanical measures of walking function in order to guide future rehabilitation approaches for restoring walking ability after stroke.

Ten individuals with chronic post-stroke hemiparesis will complete a single session of walking with and without the neuroprosthesis. Study evaluations will be conducted both before and after the session, without the neuroprosthesis active, and during the neuroprosthesis-supported walking.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a stroke event occurring at least 6 months ago
* Observable gait deficits
* Independent ambulation for at least 30 meters (using an assistive device as needed but without a rigid brace or ankle foot orthosis)
* Passive ankle dorsiflexion range of motion to neutral with the knee extended
* Ability to follow a 3-step command
* Resting heart rate between 40-100 bpm
* Resting blood pressure between 90/60 and 170/90 mmHg
* NIH Stroke Scale Question 1b score \> 1 and Question 1c score \> 0
* HIPAA Authorization to allow communication with healthcare provider
* Medical clearance by a physician

Exclusion Criteria:

* Severe aphasia or inability to communicate with investigators
* Neglect or hemianopia
* Serious comorbidities that may interfere with ability to participate in the research (e.g. musculoskeletal, cardiovascular, pulmonary)
* Pacemakers or similar electrical implants that could be affected by electrical stimulation
* Metal implants directly under the stimulation sites
* Pressure ulcers or skin wounds located near human-device interface sites
* More than 2 unexplained falls in the previous month
A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

The purpose of the study is to demonstrate the bioequivalence of the proposed commercial neratinib tablet formulation (240 mg strength x 1) to the reference Phase 3 tablet formulation (40 mg tablet strength x 6) under fed and fasted conditions in healthy subjects.

The study will be an open label, randomized, 4 period, 4 treatment, 4 sequence (Williams design), cross over.

Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Healthy male and/or female of non-childbearing potential subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
Safety and Efficacy Study of Depelestat in Acute Respiratory Distress Syndrome (ARDS) Patients

The study is aimed to assess safety of Depelestat treatment, as well as efficacy on prevention and treatment of alveolar inflammation in early pulmonary fibrosis in patients suffering from persistent Acute Respiratory Distress Syndrome.

This is a multicenter, randomised, double-blind, parallel groups, placebo-controlled, 1 week treatment of Depelestat, in patients suffering from persistent ARDS.

Patients admitted in the intensive care unit presenting ARDS criteria persistent for 12 hours to 24 hours, will be randomly assigned to the treatment by Depelestat or placebo, after a pre-treatment period as short as possible with a maximum of 48 hours since ARDS criteria are met. During the pre-treatment period, the informed consent will be obtained from the legally authorized relative of the patient, and pre-treatment biological and functional examinations will be performed, particularly blood samples and BAL for biological parameters measurement, and ventilatory mechanics, for assessment of static compliance of the respiratory system.

After the pre-treatment period, the patient will receive treatment by Depelestat or placebo during 7 days, or until extubation of the patient if this occurs before 7 days of treatment. During this treatment period, the patient will be submitted to a daily measurement of static compliance of the respiratory system, as long as the patient adaptation to 24 hours after mechanical ventilation allows the procedure, and at 96 initiation of treatment, to a blood sampling and a bronchoalveolar lavage for several biological parameters assessment.

On the first and last day of administration, blood will be also collected for pharmacokinetic evaluation.

During the post-treatment period, the patient will be submitted, at 48 h ± 24 h after the end of treatment, to a blood sampling and a BAL (this BAL is not performed when contraindication criteria are present, if the patient is already extubated, and in case of planed extubation during the subsequent 24 hours) for several biological parameters assessment, and a daily measurement of static compliance as long as the patient adaptation to mechanical ventilation allows the procedure. Patients already extubated will not be submitted to BAL nor to static compliance measurements.

After the end of the treatment, patients will be followed daily for 28 days after the diagnostic of ARDS, or until death whichever occurred first.

The duration of the study for each survivor patient will be 28 days. Survivors to day 28 will be contacted monthly to assess survival and fill in a QOL questionnaire on days 60 and 90.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from persistent ARDS as defined by the American and European Consensus Conference on ARDS, 1994

Exclusion Criteria:

* ARDS secondary to traumatism
* Pulmonary emphysema on pulmonary fibrosis
* Lung pneumocystosis
* Bronchopleural fistula
* Systemic corticosteroid treatment for more than 2 weeks before inclusion
* Severe organ disease excepted renal
Effect of Cannula Size on Oxygen Saturation During Nasal High Flow Therapy in Newborns

Treatment with nasal high flow therapy (NHF) is an increasingly popular method of respiratory support in newborns.

Safe and effective use of NHF requires selection of an appropriate nasal prong-to-nares ratio because leak can influence the delivered pressure.

To the best of our knowledge, this is the first study to investigate the effect of using different NHF cannula size on peripheral oxygen saturation in newborns with respiratory distress.

NHF will be applied at 8 L/min using the AIRVO 2 through smaller and larger Optiflow nasal cannula. The study will have a randomized crossover design. The larger or smaller cannula size will be applied as the first intervention during each experiment. During each experiment, if the larger cannula is applied first, then the smaller cannula will be applied second and if the smaller cannula is applied first, then the larger cannula will be applied second. Each experiment will last for 1.5 hour.

* During baseline, supplemental oxygen will be added during NHF therapy to keep SpO2 in normal ranges (90%-94%). When the SpO2 has stabilized then the level of supplemental oxygen will be set for the entire experiment unless there is a significant change in SpO2 as determined by the attending consultant.
* There will be three consecutive 30-min periods of recording during each experiment and each experiment will last approximately 1.5 hour.
* Ventilation will be assessed by Respiratory Inductance Plethysmography (Respitrace) and transcutaneous carbon dioxide and oxygen.
* Recordings will be made using ADInstruments Powerlab and Labchart software with video recording of the patient.
* Routine measurement of heart rate, respiratory rate and oxygen saturations will be performed as per standard neonatal practice.

The researcher is an experienced neonatal consultant who will be directly observing the baby throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Term and near term newborns with respiratory distress receiving treatment with NHF
2. ≤ 48 hours old
3. FiO2 ≥ 0,4
4. Written parental informed consent

Exclusion Criteria:

1. Infants who are clinically unstable and unsuitable for non-invasive respiratory support as judged by consultant clinician (meet nHF failure criteria).
2. Known major upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly
3. A parent has not given written informed consent to their baby's participation.
4. Prior intubation and/or surfactant administration
5. Known or suspected hypoxic ischemic encephalopathy
A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have Type 2 Diabetes
* Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol), as determined by the central laboratory at screening.
* Have been on stable diabetes treatment with metformin ≥1500 milligram (mg)/day during the 90 days prior to screening and maintained through randomization.
* Are of stable body weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment

Exclusion Criteria:

* Have Type 1 Diabetes
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema, for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors.
* Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
* Have a New York Heart Association functional classification IV congestive heart failure.
* Have an estimated glomerular filtration rate (eGFR) \<45 milliliter/minute (mL/min)/1.73 square meter (m²) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory at screening.
* Have a serum calcitonin level of ≥35 nanogram/Liter (ng/L), as determined by the central laboratory at screening.
* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)

Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): A Pilot Study.

The clinical study is designed as single center, prospective, non-randomized and non-blinded clinical study. Since the surgical procedure is independent of the population a single center study is applied. A double-blind study is not possible considering the implantation procedure with the surgeon always knowing if the device is set. Therefore, the study is designed to be non-randomized and non-blinded as a pilot trial.

To reduce bias and other influences of single surgeon skills a principal investigator and one investigator are part of the clinical study. Further, subjects with previous treatments such as Pillar implant or previous airway surgery other than nasal, adenoid, tonsil or UPPP are excluded from the clinical study. A double-blind study is not possible considering the implantation procedure with the surgeon always knowing if the device is set. Therefore, the study is designed to be non-randomized and non-blinded as a pilot trial.

Eligibility Criteria:
Inclusion Criteria:

* • Socially disturbing snoring and obstructive sleep apnea syndrome with AHI≥10/h

  * Predominantly retropalatal obstructions established either by:
  * Drug-induced sedation nasendoscopy
  * or ApneaGraph ≥60% (optional)
  * or successful application of the Velumount palatal device (optional)
  * Findings for predominantly retropalatal obstructions in ENT-examination:
  * No tonsils or tonsils grade I
  * Normal finding of larynx and tongue base, no omega-shaped epiglottis
  * No lingual tonsil hypertrophy
  * ASA (American Society of Anaesthesiology, 1963) classes I or II
  * Body mass index (BMI) \< 30 kg/m2
  * Age \> 18 yrs
  * Fix bed partner
  * Ability to read and understand the patient's information

Exclusion Criteria:

* • Previous Pillar implants

  * Medartis palatinal implant (from previous phase I study)
  * Previous airway surgery other than nasal, adenoid, tonsil or UPPP
  * Presence of other sleep disorders
  * Psychiatric disorders
  * Neurological disorders (e.g. Cerebrovascular injury)
  * Dysmorphia of the cranial skeleton
  * Pregnancy or breastfeeding
  * Known hypersensitivity to nitinol
  * Participation in another clinical study
  * Recurrent tonsillitis with prescription of antibiotics during the last 2 years (≥3x/year)
  * Omega-shaped epiglottis
  * Lingual tonsil hypertrophy
  * Kinking of the internal carotid artery
Cardiovascular Risk and Chronic Obstructive Pulmonary Disease

The principal objective of the study is to measure parameters of inflammation, oxidative stress, and vascular, respiratory, and peripheral muscle function parameters, and identify parameters indicative of evolving cardiovascular risk (CVR) in COPD patients, using multivariate analysis.

Reduced lung function is a major risk factor for cardiovascular mortality (CV), regardless of age, sex and history of smoking. Similarly, CV events are known causes of mortality in patients with chronic obstructive pulmonary disease (COPD). The investigators propose to determine the parameters influencing the evolution of CV risk in a cohort of COPD patients followed over 5 years. For this the investigators will study the role of inflammation, oxidative stress, and vascular, respiratory and peripheral muscle function parameters.

In order to study a sufficient number of patients the investigators propose to group data from two cohorts: a first cohort of 121 COPD patients that already exists (currently closed to inclusions but still undergoing follow-up (NCT00404430)) and a new cohort of 150, decompensated or not, COPD patients.

This study is of major scientific interest and will enable to obtain extremely important information to better understand COPD.

Eligibility Criteria:
Inclusion Criteria:

For patients with stable COPD:

* Men or women aged 18 to 85
* FEV1/FVC \< 70% or proven BPCO
* Patients who have given their free and informed consent in writing

For patients with decompensated COPD:

* Men or women aged 18 to 85
* FEV1/FVC \< 70% or proven BPCO
* At the time of acute respiratory failure (ARF), when admitted to hospital:

  * Respiratory rate \> 25 cycles per minute
  * PaCO2 \> 45 mmHg
  * blood pH \< 7.35
* When included in the study:

  * pH \> 7.33 at the end of ARF, 2 days in a row, or 3 to 7 days post-D1 decompensation (admission to the hospital)
  * Fever \< 38.5°C
* Patients who have given their free and informed consent in writing

Exclusion Criteria:

* Obvious evolving infection or CRP \> 100 mg/L
* Cardiac decompensation considered the main cause of decompensation or chronic heart failure with LVEF \< 45%
* Evolving neoplasia
* On antioxidants: N-acetyl-cysteine, selenium, vit. C, vit. E
* Pregnant or nursing women
* Patients under tutorship or curatorship
* Patients participating in a drug clinical research study
* Patients not affiliated to the French social security system (or equivalent)
* Patients deprived of liberty or hospitalized without consent.