cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess New Formulations of TEV-56286

The primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy adult participants.

The secondary objective is to evaluate the safety and tolerability of TEV-56286.

The planned duration for each participant is approximately 70 days which includes a 45 day screening period.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 kg/m2 to 32.0 kg/m2 (inclusive)
* Females of childbearing potential agree to take appropriate measures to prevent pregnancy during the study
* Males who do not have a documented vasectomy or are not congenitally sterile must agree to abstinence or use of barrier method with spermicide with female partner. Male participant who is having sexual intercourse with a woman of childbearing potential who is not currently pregnant will be advised of her requirement to use an additional highly effective contraceptive method
* NOTE - Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Participation in another clinical trial simultaneously
* Females who are lactating, breastfeeding, or intends to become pregnant over the course of the study
* History of alcohol, drug or any other substance, abuse, addiction or dependence in the last 12 months (except for caffeine)
* Major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of IMP, or surgery scheduled during the study or follow-up period
* Donated blood or blood products (eg, white blood cells \[WBCs\], platelets, etc.) within the 60 days before screening, or has donated blood or blood products at least twice within the 6 months before screening, or has donated plasma within 7 days of the screening visit or has received blood or blood products in the 6 weeks before screening
* Personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope, or previous personal treatment for high blood pressure
* NOTE - Additional criteria apply, please contact the investigator for more information
Optimizing Electroconvulsive Therapy for Depression

This study will evaluate the effectiveness of electroconvulsive therapy (ECT) administered with medication for the treatment of a major depressive episode (unipolar or bipolar) and will compare two types of ECT.

This study addresses 2 issues in the optimization of ECT in patients with major depression: whether patients treated with ECT should receive concurrent treatment with antidepressant medications, and the relative efficacy and side effects of high dosage right unilateral (RUL) ECT compared to low dosage bilateral (BL) ECT.

This study has 2 phases. In Phase I, patients are randomized to receive nortriptyline, venlafaxine (Effexor), or placebo while they simultaneously receive either high dosage RUL ECT or low dosage BL ECT. Patients have an electrocardiogram (EKG), a chest x-ray, medical and neurological examinations, and blood tests. Memory function is assessed before and after ECT. Whenever feasible, patients are withdrawn from all prior psychotropic medication before the start of ECT. ECT is administered 3 times per week to inpatients and twice a week to outpatients. Patients continue ECT until they are asymptomatic or until there is a plateau in improvement over 2 treatments.

Patients who respond to ECT enter Phase II and add lithium to either nortriptyline or venlafaxine within 1-3 days of the last ECT. Clinical and side effect evaluations and blood level determinations are conducted weekly for the first month, every 2 weeks until Week 12, and every 4 weeks for the remaining 12 weeks. Following any indication of relapse, patients are monitored more intensively and are re-evaluated within 1 week. The neurocognitive battery is readministered to all patients at 2 and 6 months after the acute ECT course, regardless of ECT clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Major depressive episode (unipolar or bipolar)
* Pre-ECT score of 20 or higher on Hamilton Rating Scale for Depression
* Able to withdraw psychotropic drugs (up to 3 mg/day lorazepam allowed)
* ECT indicated

Exclusion Criteria:

* Schizophrenia, schizoaffective disorder, or other psychosis
* Amnestic disorder, dementia, or delirium
* Pregnancy
* Epilepsy
* Current alcohol or substance abuse or dependence
* CNS disease or brain injury not associated with psychotropic drug exposure
* ECT in the past 6 months
* Medical contraindication for treatment with either nortriptyline or venlafaxine, including allergy to amitriptyline, nortriptyline, or venlafaxine; narrow angle glaucoma; sinus node disease; bundle branch disease; myocardial infarction; coronary artery bypass or angioplasty; or angina
* Type I antiarrhythmic medication
* Supine blood pressure \>= 170 mmHg systolic or \>= 105 mmHg diastolic at 3 readings over 2 days
Development of a Marker of Adherence for Tracking Consumption of Nutrient Supplements

The purpose of this study is to determine whether selected adherence markers can be used to track daily or intermittent consumption of nutrient supplements.

The investigators will assess whether urinary concentrations of selected adherence markers can be used to distinguish between daily or intermittent consumption of lipid-based nutrient supplements.

Eligibility Criteria:
Inclusion Criteria:

* non-pregnant, non-lactating women

Exclusion Criteria:

* BMI \<18.5kg/m2 or \>25.0 kg/m2
* Diagnosis of chronic disease
* Use of medication that can affect gastrointestinal mobility
* Consumption of more than 7 alcoholic drinks per week
* Smoking
* Unwillingness to refrain from consuming dietary sources of the marker compound(s) 3 days prior to, and during the 12 day urine collection period
* Unwillingness to adhere to the study protocol
* Peanut allergy
* Cow milk allergy
* Soy allergy
* Almond allergy
* Allergy to adherence markers
* Pregnancy
Glucagon-Like Peptide-1 (GLP-1) Suppression of Alpha Cell Secretion in Type 2 Diabetes Mellitus (T2DM)

The incretin hormone glucagon-like peptide-1 (GLP-1) has known insulinotrophic and glucagonostatic properties. However, inpatients with type 2 diabetes mellitus (T2DM)it is shown, that the beta cell sensitivity towards GLP-1 is decreased, when comparing to healthy controls. Further, these patients have decreased GLP-1 response to a meal.

The aim of this study is to elucidate if the diabetic hyperglucagonemia, seen in these patients both during fasting and in a postprandial condition, is coursed by a decreased sensitivity to GLP-1 in the diabetic alpha cell.

Ten T2DM patients and ten matched healthy control subjects will be examined on two separate days. Day 1: increasing GLP-1 infusions and Day 2: saline. During both days plasma glucose (PG) will be clamped at fasting level (FPG).

Patients with T2DM will be submitted til a Day 3, here PG will be normalized over-night by an adjustable insulin infusion, on the following day the GLP-1 infusion of Day 1 will be repeated.

The hypothesis is that these patients have decreased alpha cell sensitivity to GLP-1 as is the case with the beta cell sensitivity. This decreased sensitivity, the investigators speculate, contributes the defect suppression og glucagon and thereby to the increased PG levels seen in T2DM. Further the investigators will elucidate if this sensitivity can be increased by normalizing the diabetic PG to a normal FPG level.


Eligibility Criteria:
Inclusion Criteria:

* T2DM according to WHO criteria
* Written consent
* Age \> 18 years

Exclusion Criteria:

* Kidney or hepatic disease
* Treatment with insulin or glitazone
Ability of a Cat Food to Reduce Respiratory Symptoms in Cat Allergic Patients

Cat allergy is the most common animal allergy, affecting approximately 1 in 5 adults worldwide. The prevalence of allergy to furry animals is increasing, and cat allergy is a major risk factor for the development of asthma and rhinitis.

Fel-d1 is the major feline allergen, to which 95% of cat allergic people react. All cats produce Fel-d1 regardless of breed, age, coat type, sex or weight. Fel-d1 is contained primarily in the saliva and sebum of cats.

This allergy manifests itself as allergic rhinitis (AR) (sneezing, cold, coughing, conjunctivitis with watering and itching), severe asthma, and irritation and swelling of the skin when scratched.

A new approach to managing cat allergies is to neutralize the allergens at the source by feeding domestic cats a diet containing anti-Fel-d1 IgY antibodies. The purpose of this pilot study is to determine whether feeding domestic cats a food containing an egg product with anti-Fel d1 IgY (PRO PLAN® LIVECLEAT®) induces a reduction of allergic symptoms in their owners.


Eligibility Criteria:
Inclusion Criteria:

* Uncontrolled allergic rhinitis (with or without treatment)
* Persistent allergic rhinitis with worsening of symptoms upon exposure to cats
* Presence of one or two cats in the household, whose diet consists mainly of dry kibble
* Agreement of the patient to change the food of the cat(s) and to feed it exclusively with the test kibbles during the study.
* Diagnosis of cat allergy defined by a positive prick test to standardized cat allergen or cat-specific IgE.
* Absence of allergy to pollens emitted in the region during the 4 months following the inclusion date, confirmed by a negative skin test.
* Person owning an android and/or IOS smartphone and having the possibility to connect to the internet (via phone subscription or WIFI connection),
* Person who agrees to install the MASK-air application (medical device) on his personal smartphone,
* Person having read and understood the information note and having signed their participation agreement before any specific procedure of the study.

Exclusion Criteria:

* Person planning to be away from the cat(s) for more than one week/month in the 4 months following the inclusion visit
* Patient who has had a new cat in the home for less than one month
* Patient in regular contact with other animals to which they are allergic
* Patient with uncontrolled asthma
* Patient receiving immunotherapy for cat allergies
* Patient participating or having participated in an allergic rhinitis study within the last 30 days or 5 half-lives of study medication
* Person who has difficulty understanding or reading the information
* Person declaring to be under guardianship, curatorship or safeguard of justice.
Effect of Nano-Bio Fusion Gel on Palatal Wound Healing After Free Gingival Graft Harvest.

The main aim of soft tissue grafts is to treat mucogingival defects such as exposed root surfaces or augment gingival tissue dimensions. In single or multiple root coverage procedures, autogenous grafts are considered to be the gold standard. where the palate is considered to be the most frequent site for graft harvesting, this procedure is accompanied with complications such as postoperative pain and bleeding. Despite all materials used in the literature, no proven golden standard exits. This study will compare the effect of Nano-Bio Fusion gingival gel versus natural healing with stent as a palatal dressing in the management of wound healing and pain.

In the literature, there are many modalities proposed in an attempt to decrease such complications such as the use of PRF, non-eugenol dressing Coe-pack, medicinal plant extract, hyaluronic acid. Despite all, no proven gold standard exits.

Nano- Bio Fusion gel is a highly functional paste containing (nano vitamin C, nano vitamin E and propolis extract) that was used before as an adjunct to scaling and root planning in the management of chronic periodontitis.

Owing to its natural composition, Vitamin C enhances the synthesis, maturation, secretion and degradation of collagen. Also, propolis extract is mainly composed of flavonoids possessing antimicrobial, anti-inflammatory and now recognized as owning regenerative capacities.

Whereas vitamin E acts as an antioxidant, free radical scavenger, facilitate angiogenesis and epithelialization. Thus, Nano Bio Fusion gel could be tested as a palatal wound dressing aiming to enhance postoperative wound healing and wound re-epithelization.

Palatal Stent will be used in the control group which was previously used in several studies. The choice of the stent was to confirm that any observed effect will be due to the gel only as stent will be used in both groups. Follow up will be over month.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy/controlled patients scheduled for various periodontal or peri-implant plastic surgeries, requiring palatal free gingival graft harvesting, either epithelialized or de-epithelialized.
* Compliant Patients
* Good Oral Hygiene

Exclusion Criteria:

* Uncontrolled systemic diseases
* Pregnancy or lactating females
* Patients with severe gagging reflex
* Patients unwilling to sign an informed consent
Individual Patient Exposure and Response in Pediatric Lupus

The purpose of this research study is to see if an electronic pill bottle cap can help children and teens with systemic lupus better remember to take their medicine. It will also gather information on the best dose of hydroxychloroquine (Plaquenil®) for children and teens. Participants in this study will continue to take their usual medication as prescribed by their doctors. Participants will receive an electronic pill bottle cap, a smartphone, and a Fitbit. Over 6 months, a nurse will visit each participant 4 times to ask questions about symptoms, draw blood, and take a urine sample. After the study, participants will be able to keep the electronic pill bottle cap and Fitbit, but will return the smartphone.

This is an exploratory Phase 2, single site, open-label, direct-to-family, adherence and exposure-response study of hydroxychloroquine (HCQ) in pediatric systemic lupus. The study will measure a participant's adherence to HCQ self-administration using an electronic pill bottle cap that records date/time of bottle opening and provides participants with a reminder when a dosage is due and/or missed. All participants will be provided with the electronic pill bottle cap to use with their regular HCQ prescription at the start of the study. For the first 2 weeks of the trial, the electronic notifications will be disabled to determine a baseline measure of adherence. Within 1 day after Visit 2, the electronic notifications will be turned on for all participants, resulting in a series of alerts (via electronic pill bottle cap alerts and smartphone push notifications, text message, and/or automated phone calls). Participants will continue to receive notifications via the electronic pill bottle cap through Visit 4. Throughout the study, participants will undergo a series of blood draws and urinalysis collections, and be asked to complete various questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent form and assent, when necessary
2. Age 5-17.5 years at consent
3. Enrolled in the CARRA Registry with a diagnosis of systemic lupus erythematosus as documented in the CARRA Registry
4. Receiving hydroxychloroquine as standard of care for ≥ 3 months
5. Participant and Caregiver primary language of English
6. Willing and able to comply with study procedures, at the discretion of the study principal investigator
7. Access to internet

Exclusion Criteria:

There are no pre-defined exclusion criterion for this trial.
Phase I Study of Kukoamine B Mesilate in Healthy Volunteers

The purpose of this study is to assess safety, tolerance and pharmacokinetics of a single intravenous injection Kukoamine B Mesilate in health volunteer


Eligibility Criteria:
Inclusion Criteria:

* Gender: male or female, each sex ratio does not exceed 2/3;
* 18-45 years (including upper and lower limit), the general situation is good;
* Body mass index (BMI) in 19-28 (including upper and lower limit of the range), BW ≥ 50kg (female) and 60kg (male);
* Nearly half of the year, no child care program and agreed to take effective measures to contraception during the study period, women of childbearing age blood pregnancy test was negative;
* Subjects to fully understand the purpose, properties, method and reactions may occur of test drug trials.Voluntarily signed the informed consents, and agreed to abide by the requirements of clinical protocols.

Exclusion Criteria:

* Primary disease in important organs;
* Mental or physical disability;
* Familial hereditary disease;
* Screening supine blood pressure (after 5 minutes of rest) systolic or diastolic blood pressure greater than 90\~140mmHg, beyond the scope of 50\~90mmHg, Or pulse (HR) beyond 50bpm\~100bpm
* Abnormal results of any clinically meaningful physical examination, vital signs, ECG or clinical laboratory;
* History of immunodeficiency diseases, including HIV antibody positive;
* Detection of antibody positive, hepatitis B surface antigen or antibody to hepatitis C / syphilis positive;
* Alcohol and drug abusers;
* Smoking and drinking are (drinking 14 units of alcohol per week: 1 unit = beer 285 ml, or liquor 25 ml, or wine 1 cup. numbers of daily smoking ≥ 5) and / or not smoking and drinking in the test period;
* Any discharge period may affect the study drug, or in the past 3 months participated in any drug clinical trials;
* Before entering the group 4 weeks using any prescription drugs before entering the group, or use of any non prescription drugs within 2 weeks (vitamins, herbal tonics, food additives), or into the group within 2 weeks before taking effect of drug metabolizing enzymes in food, such as grapefruit or grapefruit drink. Can the use of acetaminophen, but must record report in CRF;
* The last 3 months had a history of blood donation or significant blood loss (more than 400ml);
* There are drugs, the clinical significance of the history of food allergy and atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known drug to test drugs or similar drug allergy test;
* Lactating women, pregnant women or unable to take effective contraceptive measures;
* Researchers believe that the other is not suitable to take the test factors participants.
Impact of Home Zinc Treatment for Acute Diarrhea in Children

Background. Zinc deficiency is common in Africa. It has been shown in Asia that zinc as treatment for diarrhea can shorten the course of episodes of diarrhea, as well as prevent future episodes. The use of zinc at home to treat diarrhea in an African setting, where malaria, HIV and malnutrition are common, has not been well-studied.

Objective. To evaluate if zinc treatment for diarrhea given at home in Kenyan children will decrease the community prevalence of diarrhea more than zinc given only in the clinic Work planned. We propose to do a community-randomized intervention study of 10 days of dispersible zinc tablets given in the home, in addition to ORS, to treat diarrhea in children under-5 years of age living in a rural part of Bondo District. The comparison group will be children who receive zinc and ORS in the clinic only. The primary outcome will be a comparison of the prevalence of diarrhea in home zinc versus nonhome zinc villages. Secondary outcomes will be the incidence of repeat episodes of diarrhea, the duration of diarrheal illness, the prevalence of acute respiratory infection, and the effect of malaria infection on treatment with zinc. Thirty-three villages (approximately 1300 children) will be enrolled and children will be followed for 1 year.

Significance of results. If this study shows zinc given at home to be effective, this might be considered by the Kenyan MOH as an essential component of the treatment of diarrhea in children at the community level.


Eligibility Criteria:
Inclusion Criteria:

* All children 2 to 59 months of age in households within 33 selected villages

Exclusion Criteria:

* Children under 2 months of age will not be eligible for enrollment, until they reach 2 months of age as the role of zinc has not been well-studied in neonates. Children of parents who do not give written informed consent for their participation will not be enrolled.
Personalized Prediction Strategy for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

This is a 3 year longitudinal study to establish a personalized prediction and prevention system for acute exacerbation of chronic obstructive pulmonary disease（AECOPD). Data will be collected which contained with clinical, pathophysiology, etiology and immunology information of chronic obstructive pulmonary disease(COPD) patients and analyzed by data mining combined with Internet technology.


Eligibility Criteria:
Inclusion Criteria:

* Patients was diagnosed as COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines older than 40 years old.

  * A signed and dated written informed consent is obtained prior to participation.
  * Able to comply with the requirements of the protocol and be available for study visits over 3 years.

Exclusion Criteria:

* A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:

  * Known respiratory disorders, or disorders identified at screening/visit 1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)
  * Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and Lupus)
  * Known to be severely alpha-1-antitrypsin deficient
  * Has experienced a moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) within the last 4 weeks
  * Having undergone lung surgery (e.g. lung reduction, lung transplant)
  * Have cancer or have had cancer in the 5 years prior to study entry
  * Having received a blood transfusion in the 4 weeks prior to study start
  * Inability to walk
  * Taking part in a blinded drug study
  * Having therapy with systemic corticosteroids at inclusion.
Differences in Brain Activity in the Application of Upper Limb Exercise Tasks Through Virtual Reality

This study aims to find out the difference in brain activity when performing upper limb exercise tasks through virtual reality-based MOTOCOG equipment for chronic stroke patients.

This study aims to find out the difference in brain activity when performing upper limb exercise tasks through virtual reality-based MOTOCOG equipment for chronic stroke patients. All participants will participate in tasks for upper limb exercise conducted for 26 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 to 80 years
* FMA Upper scores more than 25 and less than 58
* Patients whose lesions do not include stimulation regions
* Patients with stroke with more than 6 months of onset
* K-MMSE scores more than 24
* patients who can Grasp \& release

Exclusion Criteria:

* Difficult to communicate due to severe language impairment.
* Accompanied by an existing serious neurogenic disease
* Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder