cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Safety and Efficacy of Tradipitant vs. Placebo in Idiopathic and Diabetic Gastroparesis

To investigate the safety and efficacy of tradipitant versus placebo in relieving nausea and other symptoms of gastroparesis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with gastroparesis
* Demonstrated delayed gastric emptying
* Presence of moderate to severe nausea
* Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

Exclusion Criteria:

* Another active disorder or treatment which could explain or contribute to symptoms of gastroparesis
* A positive test for drugs of abuse at the screening or evaluation visits;
* Exposure to any investigational medication in the past 60 days
* Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year
Progressive Strength in Hand Osteoarthritis

Background: Hand osteoarthritis (OA) is highly prevalent, affecting 55-70% of the population over 55 years with an age-related progressive increase. The OA of interphalangeal (IF) and carpometacarpal joints may have varying degrees of deformity associated with pain, decreased of grip and pinch strength, decreased range of motion and functional impairment. Systematic reviews and meta-analyzes have shown the beneficial effect of exercise for lower limb OA, however for hand OA exercise is still used based on recommendations based on clinical experience and low quality studies, not allowing a conclusion about the effects of exercise in pain, function and strength in hand OA patients.

Objective: assess the effectiveness of progressive resistance strength training program on pain, function and strength in hand OA patients.

Methods: diagnostic of hand OA according to American College of Rheumatology of at least 1year, age over 50 years, both genders, pain in IF joints between 3-8 cm on a 10-cm numerical pain scale (NPS). Sixty patients who meet the eligibility criteria were randomized into exercise group (EG) and control group (CG). Both groups performed a session regarding joint protection and energy conservation before randomization. The EG performed a progressive resistance strength training program for intrinsic muscles of the hand for 12 weeks. The outcome measures were NPS; Australian/Canadian (AUSCAN) Hand Osteoarthritis Index and Cochin Hand Functional Scale for hand function; grip and pinch strengthening using the Hydraulic Hand Dynamometer and a pinch gauge dynamometer and satisfaction with the treatment using a Likert scale. A blinded evaluator performed the evaluations at baseline, 6 and 12 weeks after treatment baseline.


Eligibility Criteria:
Inclusion Criteria:

* diagnostic of hand OA according to american college of rheumatology of at least 1year;
* age over 50 years;
* both genders;
* pain in interphalangeal joints between 3-8 cm on a 10-cm numerical pain scale

Exclusion Criteria:

* other joint disease in hands;
* other rheumatic systemic disease;
* surgery in hands or writs;
* exercise or joint injection in hands in the previous 3 months;
* disability to perform the exercises.
Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor

This is a preliminary randomised controlled trial comparing the use of pre-operative 3D models to select an intrasaccular flow disruptor for endovascular aneurysm cure.

Patients will be randomised 3:1 either in the intervention or control group. Intervention consists of using the pre-operative Digital Subtraction Angiography (DSA) to create a 3D plastic model. This model is used to test different sizes of device. At the end of this pre-operative test a single device is recommended for the real procedure. The control group will use the current method for size selection (measurement of mean width and minimum height) on DSA.

Eligibility Criteria:
Inclusion Criteria:

* Intracranial aneurysm, suitable for a treatment by Woven Endobridge (WEB) device after multidisciplinary team decision
* Consent form signed
* The patient benefits from health insurance

Exclusion Criteria:

* Legal incapacity
* Women at risk of pregnancy
Caregiver-aided Powered Wheelchair Skills

There has been only minimal research on wheelchair skills by the caregivers of manual or powered wheelchair. There are no published data on the extent to which caregivers can enhance the mobility of powered wheelchair users. The primary objective of this study is to test the hypothesis that caregivers enhance the wheelchair skills capacity, confidence and performance of the powered wheelchair users to whom they provide assistance. Our secondary objective is to add to the literature on the measurement properties of the wheelchair skills test (questionnaire and capability version) for powered wheelchair users and their caregivers.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* able to communicate in English and/or French (depending upon the site)
* live within 50 km of the research centre
* be willing to participate (as evidenced by completion of the assessment)
* be able to set a scheduled time for the study visit when both the caregiver and wheelchair user will be present and provide informed consent

Caregivers:

* must be an unpaid caregiver (e.g. a family member or friend)
* spend an average total of at least 2 hours per week with the powered wheelchair user that includes powered wheelchair mobility.

Wheelchair user:

* must have his/her own powered wheelchair
* use the powered wheelchair for at least 6 hours per week
* have a caregiver who spends an average total of at least 2 hours per week with the powered wheelchair user that includes powered wheelchair mobility.

Exclusion Criteria:

* have unstable medical conditions (e.g. angina, seizures) that might make the use of a powered wheelchair dangerous
* emotional problems (e.g. severe anxiety, depression) that might make participation unsafe or unpleasant
Research on Intraoperative Hypothermia Risk Prediction Model and Temperature Management Strategy for Elderly Patients During Surgery Based on Dynamic Incremental Training

With the support of partial dual temperature monitoring (comparing the specific difference between standardized axillary temperature monitoring and esophageal temperature), this trial is divided into the following three parts:

1. Multi center observational study: Establish and validate a dynamic incremental training intraoperative hypothermia prediction model - Intelligent Care for the Elderly (ICE) - Intraoperative hypothermia warning system, and provide ICE Offline for use by healthcare professionals and ICE Online for further model updates when needed for clinical or research purposes.
2. Multi center non randomized controlled clinical trial: Conduct a multi center stratified temperature management clinical trial based on ICE Offline after dynamic incremental training to verify the clinical and economic benefits of the model and active warming.
3. Pre and post comparative study: Collect data before ICE application and compare it with data after ICE promotion.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients (aged 60 and above) undergoing non cardiac elective surgery under general anesthesia;
* Surgical duration ≥ 30 minutes;
* Normal preoperative bleeding and clotting time
* American society of Aneshesiologists physical status classification system:Ⅰ～Ⅳ

Exclusion Criteria:

* Mental illness
* Cirrhosis
* Existence or potential central hyperthermia
* Metabolic thermoregulatory abnormalities
* History of malignant hyperthermia or family history
* Extensive skin burns or injuries
* Seriously infect
* Long term use of nonsteroidal anti-inflammatory drugs
* Expected difficult airway
* Researchers believe that individuals who are not suitable to participate in clinical trial
* Refusal to sign informed consent form
* Withdraw informed consent form
* Severe bleeding or shock during perioperative period.
Oral Care of Intubated Intensive Care Patient

The aim of the research was to examine the effect of oral care bundle application on oral health, salivary pH (power of hydrogen), dry mouth and ventilator associated pneumonia in intubated patients compared to standard oral care.

Maintaining the integrity of the oral mucosa in intensive care unit patients is very important due to its close relationship with systemic health, disease risk and self-image, as well as comfort and nutrition. Serious problems develop in patients who have no or insufficient saliva movement or production, are unconscious, or have an artificial airway. Oral health problems, which begin with the deterioration of the saliva flow and content of intubated patients, lead to much more risky and costly situations that end in ventilator associated pneumonia. In the literature, it is seen that oral care practices performed in accordance with protocols increase the risk of complications and that bundle care practices used in different care areas increase the performance of care.In this randomized controlled study, people who were aged between 18 and 70, had received mechanical ventilation support, were intubated orally and in the first 24 hours of intubation, and had a stable hemodynamic status were included in the study.

Eligibility Criteria:
Inclusion Criteria:

* mechanical ventilation support,
* orally intubation
* in the first 24 hours of intubation,
* stable hemodynamic status

Exclusion Criteria:

* pneumonia
* Sjögren's Syndrome,
* radiotherapy and/or chemotherapy,
* oral care contraindications,
* head and neck trauma,
* platelet count below 50 thousand,
* could not be positioned appropriately,
* agitation
A Study to Evaluate the Use of Memantine In Combination With Anti-HIV Drugs to Treat AIDS Dementia Complex (ADC)

The purpose of this study is to determine the safety and effectiveness of memantine, an experimental drug, in improving AIDS dementia complex (ADC).

The symptoms of ADC can be improved with zidovudine (ZDV). However, ZDV therapy has been associated with significant toxicities, and the effectiveness of ZDV seems to decrease during the second and third years of therapy. The effectiveness of other antiretroviral drugs as treatment for ADC is not known, so it is important to explore alternative therapies.

The signs and symptoms of the AIDS Dementia Complex can be alleviated by zidovudine (ZDV). However, ZDV therapy has been associated with significant toxicities, particularly bone marrow suppression. The efficacy of ZDV appears to decrease during the second and third years of therapy. It is not known whether this reflects cumulative toxicity. In addition, the efficacy of other antiretroviral agents remains uncertain. Hence, adjunctive therapy for cognitive and motor symptoms of AIDS is important.

Patients will be randomized to one of the following 2 arms:

Arm 1 receives memantine plus concurrent antiretroviral therapy; Arm 2 receives placebo plus concurrent antiretroviral therapy. The initial dose of memantine is increased each week for the next 3 weeks, unless a maximum tolerated dose is reached. Following a 16-week evaluation period there is a 4-week washout prior to re-assessment. After the washout period, all patients, including those formerly randomized to the placebo arm, are given the opportunity to receive an open-label, 12-week administration of memantine. \[AS PER AMENDMENT 4/6/99: The open-label phase is extended by 48 weeks to a total of 60 weeks of therapy. Patients who did not receive the initial 12 weeks of open-label treatment are eligible still for the 48-week open-label treatment phase.\]

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV positive.
* Have been diagnosed with AIDS dementia complex (ADC).
* Have an estimated IQ of at least 70 (before the onset of ADC) or the ability to read at a 6th grade level.
* Have impaired mental skills.
* Are age18 or older.

Exclusion Criteria

You will not be eligible for this study if you:

* Have a history of a neurologic disease unrelated to HIV infection.
* Have a history of chronic seizures or head injuries.
* Have a history of central nervous system infections.
* Have certain cancers.
* Have any psychiatric illness.
* Have an active AIDS-defining opportunistic infection.
* Are pregnant or breast-feeding.
Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter

The purpose of this investigation is to characterize the safety and performance of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology in clinical use.

This is a prospective, single-arm, multicenter, non-randomized study. Up to 3 sites in up to 3 countries will enroll up to 30 subjects in total. The study is designed to characterize the safety and performance of the bronchoscopic ablation procedure using the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology.

The primary objective of this prospective, single-arm, multicenter, non-randomized study is to characterize the safety of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology device in subjects undergoing lung ablation procedures.

The primary endpoint is the composite rate of adverse events related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.

The following secondary endpoints will be evaluated:

* Composite rate of serious adverse events related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology through 1-month follow-up.
* Composite rate of all adverse events related to the procedure or study devices through 1-month follow-up.
* Composite rate of all serious adverse events related to the procedure or study devices through 1-month follow-up.
* Patient satisfaction and pain (Bronchoscopic Ablation Patient Pain and Satisfaction Survey)
* Quality of life (EQ-5D Scale)
* Technical success
* Technique efficacy

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years of age
2. Subject has provided informed consent
3. Subject is able and willing to comply with the study follow-up schedule
4. Subject has a definitive diagnosis of cancer in the lung
5. Target nodule is ≤ 30mm in maximum diameter
6. There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure
7. Subject is a candidate for an elective electromagnetic navigation bronchoscopy (ENB) procedure
8. Subject is a candidate for an elective lung ablation procedure according to standard of care and product Instructions for Use
9. Subject is not a candidate for lung surgery or refuses lung surgery
10. Subject is not a candidate for stereotactic body radiation therapy (SBRT) or refuses SBRT

Exclusion Criteria:

1. Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or trachea
2. Patients currently diagnosed with Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage IV emphysema
3. Female subjects who are pregnant or nursing as determined by standard site practices
4. Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
5. The investigator determines that participation in the study may jeopardize the safety or welfare of the subject
Healing of Punch Graft Wounds. Comparative Study Between MariGen and Oasis: a Non-inferiority Study

The objective is to determine, if healing of punch biopsy wounds treated with the fish skin derived MariGen Wound dressing is non-inferior to healing with wounds treated with pig intestines derived Oasis Sheet wound dressing. Secondary endpoints are: Incidence of erythema, Pain, Infection, Quantitative measurements of autoantibodies at baseline and 4 weeks after start of treatment


Eligibility Criteria:
Inclusion Criteria:

* \>18 yrs
* Healthy individual
* Signature of informed consent

Exclusion Criteria:

* Autoimmune disease
* Immunosuppressive treatment
* Use of addictive drugs
* Excessive use of alcohol
* Known fish allergy
* Known allergy to proteins with porcine origin
* Peripheral vascular disease
* Pregnant women
* Persons receiving anticoagulation therapy or systemic corticosteroids will be excluded.
A Bioequivalence Study of L04TD2 Compared to Administration of L04RD1 in Healthy Volunteers

This is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD2 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* A subject aged 19 to less than 65 years at the time of the screening visit
* A subject with a body weight of 55kg or higher and a body mass index (BMI) of 18.0 kg/m2 to 29.9 kg/m2, inclusive
* A subject considered appropriate to participate in the study according to the results of lab tests such as the hematological test, blood chemistry test, serum test, urinalysis, etc. and ECG set and conducted by the principal investigator (or a delegated study physician) according to the characteristics of the investigational product
* A subject who agreed to exclude the possibility of pregnancy by having themselves, their spouses, or partners use medically appropriate contraceptive methods and not to provide sperm or egg from the first dose to 7 days after the last dose of IP administration
* A subject who voluntarily signed the informed consent form after listening to and understanding sufficient explanation on the purpose, content of this clinical study, the characteristics of the investigational product, expected adverse events, etc.

Exclusion Criteria:

* A subject who has clinically significant diseases in the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and genitourinary system, mental and nervous system, musculoskeletal system, immune system, otolaryngeal system, skin system, and ophthalmic system or has had the diseases
* A subject who had gastrointestinal surgery (excluding simple appendectomy or hernia surgery) which may affect the absorption of drugs or have gastrointestinal diseases
* A subject who took drugs that induce and inhibit drug metabolizing enzymes such as barbiturates within one month from the first administration date or drugs that might affect this clinical study within 10 days from the first administration date (subjects may participate depending on the pharmacodynamics and pharmacokinetics such as the interactions with the investigational product, half-life, etc.)
* A subject who participated in another clinical study or bioequivalence study where they were administered the investigational product within 6 months prior to the first dose of the investigational drug
* A subject considered by the principal investigator (or a delegated study physician) as inappropriate to participate in this clinical study due to reasons other than the above inclusion and exclusion criteria
Pilot Study on the Value of Bedside Pleuropulmonary Ultrasound in Patients With Sickle Cell Disease Presenting With Vaso-occlusive Crisis

Describe the proportion of patients with major sickle cell syndrome in vaso-occlusive crisis presenting at least one pleuropulmonary ultrasound abnormality during one of the ultrasounds performed at D0, between D2 and D5 during hospitalization and at D-1 of discharge.

We hypothesize that pleuropulmonary ultrasound will make it possible to detect the serious complications associated with vaso-occlusive crises in patients with major sickle cell syndrome earlier and more reliably, in departments where ultrasound tools are still underdeveloped, while avoiding the need for more conventional radiology examinations that cause radiation in multi-hospitalized patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient agreeing to participate in the study
* Patient with sickle-cell disease consulted to the emergency department or hospitalized in a conventional internal medicine department for a clinical picture of severe vaso-occlusive crisis (CVO) requiring hospitalization.
* Hospitalization in the internal medicine department
* Possible re-inclusion in the event of a subsequent episode of severe CVO

Exclusion Criteria:

* Subject under guardianship or subject deprived of freedom.
* Primary acute chest syndrom (not following a crisis)
* Pulmonary pathologies interfering with pleuro-pulmonary echo analysis: pneumonectomy, pulmonary fibrosis.
Optimized Therapy in Severe Traumatic Brain Injured Patients

Severe traumatic brain injury is associated with life-threatening and incapacitating secondary injury.

Contemporary therapeutic interventions are aimed at preventing and treating secondary damage. In this context, improved cerebral metabolism is an important target in modern neurointensive care.

The main hypothesis is that continuous intravenous infusion of glutamyl-alanyl dipeptide restores disturbed brain metabolism following severe traumatic brain injury.

Patients suffering from severe traumatic brain injury and requiring multimodal neuromonitoring during pharmacological coma will receive alanyl-glutamine dipeptide (Dipeptiven) as part of standard clinical nutrition.

In two groups of patients the influence of different duration of infusion (group 1: 24 hours; group 2: 5 days) will be investigated. For this, pharmacokinetic and pharmacodynamic parameters in plasma and brain are determined.

Increased plasma glutamine and alanine in arterial and jugular venous plasma and in cerebral microdialysates are to reflect efficacy of Dipeptiven infusion.

Plasma glutamate levels as well as changes in cerebral glutamate, lactate, lactate/pyruvate ratio, intracranial pressure, bispectral index electroencephalography will be measured to exclude potential adverse effects

Eligibility Criteria:
Inclusion Criteria:

* severe traumatic brain injury
* prolonged pharmacologic coma
* multimodal neuromonitoring (microdialysis, ptiO2)
* enteral nutrition

Exclusion Criteria:

* patients anticipated to decease within 48 hours
* abdominal injury
* mass transfusion
* renal impairment
* hepatic impairment
* barbiturate coma
* parenteral nutrition
* weight below 50 kg
* weight above 100 kg
Soap Versus Normal Salin Plus Povidone-iodine in Ununion Wound

Comparison of the effect of water and soap irrigation with Povidone-iodine And normal salin treatment of patients with ununion laparatomy or episiotomy wound ( a pilot study)

IN Comparison of the effect of water and soap irrigation with Povidone-iodine And normal salin treatment of patients with ununion laparatomy or episiotomy wound ( a pilot study), We use soap in one group and Povidone-iodine And normal salin in other group for irrigation of ununion laparatomy or episiotomy wound.it's require the patients in Povidone-iodine And normal salin group be at hospital till wound be able to closed.

Eligibility Criteria:
Inclusion Criteria:

* all the women coming to Shariati hospital or Gynecologist's office with complain of ununion wound of laparatomy or episiotomy enroll to this study

Exclusion Criteria:

* patients not satisfacted to participant in the study exclude of it