cyrilzakka/clinical-trials huggingface dataset:
To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets

To demonstrate the relative bioavailability of Desipramine Hydrochloride tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Granisetron 1 mg Tablets Under Fasting Conditions

The objective of this study is to evaluate the comparative bioavailability between granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets (Roche, USA), after a single-dose in health subjects under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking, male and female subjects, 18 years of age or older.
* BMI ≥ 19 and ≤ 30.
* No significant diseases or clinically significant findings in a physical examination.
* No clinically significant abnormal laboratory values.
* No clinically significant findings in the 12-lead electrocardiogram (ECG).
* No clinically significant findings from the vital signs measurement.
* Be informed of the nature of the study and given written consent prior to receiving any study procedure.

Negative for:

* HIV.
* Hepatitis B surface antigen and Hepatitis C antibody.
* Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
* Urine cotinine test.
* Serum HCG consistent with pregnancy (females only).

Females who participate in this study are:

* unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy) OR
* willing to remain abstinent \[not engage in sexual intercourse\] OR
* willing to use an effective method of double-barrier birth control \[partner using condom and female using diaphragm, contraceptive sponge, spermicide or IUD\]
* Females who participate in this study are not pregnant and/or non-lactating.

Exclusion Criteria:

* Known history or presence of any clinically significant medical condition.
* Known or suspected carcinoma.
* On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
* Participated in another clinical trial or received an investigational product within 30 days prior to drug administration.
* Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500 mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation).
* Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing OR females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
* Requirement of any non-topical medication (prescription and/or over-the-counter) on a routine basis.
* Difficulty fasting or consuming the standard meals.
* Do not tolerate venipuncture.
* Unable to read or sign the ICF.

Known history or presence of:

* Hypersensitivity or idiosyncratic reaction to granisetron hydrochloride and/or any other drug substances with similar activity.
* Alcoholism within the last 12 months.
* Drug dependence and/or substance abuse.
* Use of tobacco or nicotine-containing products, within the last 6 months.
Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors

The purpose of this study is to determine whether the combination of Ulocuplumab and Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer.

* Intervention model: Single group for Stage 1 DLT, then Parallel
* Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* SCLC or PAC that is advanced or has spread to other parts of the body
* Treated with at least one other chemotherapy that did not work or where cancer relapsed
* Minimal limitations on activities of daily living as measured by Eastern Cooperative Oncology Group (ECOG) score of 0-1

Exclusion Criteria:

* Patients with cancer that spread to the brain
* Active, known or suspected autoimmune disease
* Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
Increasing the Variety of Vegetables and Fruits Served to Preschool Children at a Snack

Intake of vegetables and fruits in preschool children is less than recommended amounts. Although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. The purpose of this study was to test whether increasing the variety of vegetables and fruits served to preschool children affected the amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would increase both the amount selected and the amount eaten.


Eligibility Criteria:
Inclusion Criteria:

* attenders at the relevant child care center

Exclusion Criteria:

* allergy or sensitivity to any test food
Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study

This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 to 55 years old
* Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
* Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
* Body Mass Index (BMI) 18 to 32 kg/m2
* Willing and able to give informed consent
* Additional inclusion criteria apply

Exclusion Criteria:

* Planning to conceive a child during the study or within 2 months after the last dose of study drug
* Is positive for hepatitis A, B or C, and/or HIV
* Has clinically significant abnormalities in baseline laboratory evaluations
* Subject has a clinically significant abnormal electrocardiogram (ECG)
* Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device)
* Additional exclusion criteria apply
Effects of Almond Consumption on the Human Gastrointestinal Microbiota and Metabolic Health

The proposed work will investigate the effect of almond consumption as a snack on human gastrointestinal microbiota and on metabolic health.

This study is a randomized, controlled, investigator-blinded, parallel arm design with two treatment conditions. There will be a phone screening, in person pre-intervention testing, a one-week baseline period devoid of all nuts and seeds followed by a 12-week intervention period, and a post-testing appointment. Participants will be randomized to consume almonds or isocaloric snack for 12 weeks. Participants will provide stool samples during baseline testing and during the 12th week of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Males \& Females
* 30-60 years of age
* BMI 25-34.9 kg/m\^2
* Ability to drop off fecal sample within 15 minutes of defecation

Exclusion Criteria:

* Physician diagnosed metabolic or gastrointestinal diseases
* Fasting blood glucose \>126 mg/dL
* Blood pressure \>160/100 mm Hg
* Anemia
* Elevation in serum transaminases (i.e. \>3 times the upper limit of normal)
* Evidence of liver disease, including primary biliary cirrhosis or gallbladder disease, constipation
* Currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin, or medications known to impact bowel function.
* Pregnant, breastfeeding or postmenopausal
* Smoker, tobacco use
* Allergic to nuts
* Consume \> 2 alcoholic beverages/day
* Abuse drugs
* Have had \> 5% weight change in the past month or \> 10% change in the past year
* Have taken antibiotics during the previous 2 months
* Unable to consume the experimental treatments (almonds or pretzels)
* Bariatric surgery
* Gallbladder removal
* Allergic to lidocaine or other topical anesthetics
Intraarticular Corticosteroid Therapy in Perthes Disease.

Legg-Calve-Perthes disease (LCP) represents the loss of blood flow to the head of the femur, resulting in significant hip pain and potential long term disability. This study represents a single center, randomized, prospective, controlled study comparing the treatment of LCP with an intraarticular corticosteroid (triamcinolone hexacetonide) injection with traditional nonoperative treatment.

Legg-Calve-Perthes disease (LCP) represents the loss of blood flow to the head of the femur, resulting in significant hip pain and potential long term disability. The cause of LCP is still unknown, but tends to occur predominantly in boys from ages 4-12. For the majority of those affected, observation and symptomatic treatment with oral antiinflammatories, such as ibuprofen, is indicated. This study represents a single center, randomized, prospective, controlled study comparing the treatment of LCP with an intraarticular corticosteroid (triamcinolone hexacetonide) injection with traditional nonoperative treatment. The investigators will test for improved outcomes by measuring functional outcomes (PODCI and ASKp questionnaires, StepWatch activity monitor), hip range of motion and visual-analog pain scales. The investigators hypothesize that injections of corticosteroids (potent, injectable antiinflammatories) will result in improved overall function through decreased pain and increased hip range of motion in this patient population.Additional biological research will be performed. There is no human information on the inflammatory response that occurs in the hip joint of children with Perthes disease, and there are no true animal models of Perthes disease. To better understand the pathobiology of Perthes disease, the collection of joint fluid from both hips may provide insight into the treatment of a disease for which we currently have no explanation of cause, and consequently no therapies

Eligibility Criteria:
Inclusion Criteria:

* age of 4 to 12 years
* diagnosed with Idiopathic osteonecrosis of the femoral head
* symptoms less than 12 months old.

Exclusion Criteria:

* Symptoms for more than 12 months
* Previous treatment other than anti-inflammatories, crutches or bed rest
* Subjects more than 8 years old or have a hand bone age greater than 6 years old and lateral pillar B or B/C disease.
* Bilateral hip disease
* Personal or family history of problems with general anesthesia
* Prior steroid treatment
* Previous diagnosis of:

  * Asthma
  * Identifiable rheumatologic condition
  * Metabolic Diseases (including but not limited to Gaucher's disease or congenital hypothyroidism)
  * Sickle cell disease
  * Known pain syndrome
  * Hip sepsis
  * Prior malignancy (solid organ or bone marrow transplant)
  * Blood Clotting disorder
Xylitol Chewable Tablets Versus Xylitol Chewing Gum in Geriatric Bedridden Patients

This study will be conducted to evaluate the effectiveness of using dissolving Xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients in increasing salivary pH and decreasing bacterial count in both saliva and interdental plaque.

This study will be conducted to evaluate the value of using dissolving Xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients ,as an alternative to tooth brushing and mouth rinsing, in increasing salivary pH and decreasing bacterial count in both saliva and interdental plaque.plaque and salivary sampling will be taken in certain time ,at baseline T0, then after 5minutes T1, then at 15 days T3. Salivary pH will be measured by using pH meter and streptococcus mutans bacterial count will be calculated through culture in mitis salivarius bacitracin

Eligibility Criteria:
Inclusion Criteria:

1. Age range above 65 years old
2. Bedridden patients
3. Males or females
4. Concious patients
5. Co-operative patients approving to participate in the trial.
6. Subjects who signed informed consent

Exclusion Criteria:

1. Individuals had taken antibiotics during the last four weeks or anticipated doing so during the study
2. Subjects who wore removable prosthesis
3. Patients with systemic diseases that have any oral manifestations
4. History of Smoking
5. Allergy to any of chewing gum or tablets ingredients
6. Evidence of tempromandibular joint disorders
7. Presence of intraoral infections
8. Currently using any mouth rinse
Clinical Treatment of Refractory Breast Cancer Based on Organoid Drug Sensitivity Results

This study aims to enroll refractory breast cancer patients. Patient-derived organoid will be established, and drug sensitivity test will be conducted to intervene in the selection of clinical treatment plans. Efficacy evaluation and prognosis analysis will also be conducted. It is hoped that this study will provide a basis for the development of personalized treatment plans.

Forty patients with refractory breast cancer who met the inclusion criteria were enrolled in the study after signing an informed consent form. Tumor samples were obtained through clinical puncture, and qualified samples were subjected to organoid modeling. Perform drug sensitivity test on the established breast cancer organoids. The drugs used are all that have been marketed and applied in clinical practice. According to the results of organoid drug sensitivity analysis, the patient received a treatment plan with relatively sensitive drugs. Follow up prognostic data and relevant clinical information of enrolled patients, conduct statistical analysis on the consistency between drug sensitivity test results and patient treatment response, and evaluate the clinical effectiveness of treatment plans guided by organoid drug sensitivity results.

Eligibility Criteria:
Inclusion Criteria:

1. Female, aged ≥ 18 years and ≤ 75 years old;
2. Breast cancer confirmed by histology or cytology;
3. One of the following two conditions shall be met: a) Operable breast cancer: Recurrent progression during adjuvant therapy; or the time from initial treatment to the onset of disease progression is less than or equal to 2 years; b) Non-operable breast cancer: patients who have changed two line treatment plans within 6 months;
4. Being able to obtain sufficient fresh tissue specimens for organoid establishment through puncture;
5. Expected survival time ≥ 3 months;
6. The patient voluntarily joined this study and signed an informed consent form (ICF), with good compliance and cooperation in follow-up.

Exclusion Criteria:

1. Pregnant and lactating women;
2. Patients who have clinically significant (i.e. active) heart disease (such as congestive heart failure, symptomatic coronary artery disease, arrhythmia, etc.) or myocardial infarction within the past 12 months;
3. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
4. The researchers believe that patients are not suitable for inclusion.
Design and Piloting of a Complex Intervention to Support Breastfeeding Self-efficacy (CRIAA Program)

The aim of the study is to design and pilot the effect of a complex intervention to support mothers' breastfeeding self-efficacy and professional self-efficacy to support breastfeeding families, considering breastfeeding as a health promoting behavior. Specific objectives are the evaluation of feasibility and acceptability of the intervention, and estimate the preliminary effect on maternal and professional self-efficacy.

Breastfeeding is the optimal feeding during early childhood. However, the prevalence of exclusive breastfeeding is not as expected. The evidence of effectiveness of interventions designed to support breastfeeding is not conclusive. Breastfeeding is a complex experience, influenced by numerous factors, as self-efficacy, that require interdisciplinary approaches.The aim of the study is to design and pilot the effect of a complex intervention to support mothers' breastfeeding self-efficacy and professional self-efficacy to support breastfeeding families, considering breastfeeding as a health promoting behavior. The project will be done in two stages a) design of the intervention and b) experimental pilot trial with control and intervention groups, for evaluation of feasibility, acceptability of the intervention and preliminary estimate of its effect on maternal and professional self-efficacy. The project will be carry out in two public outpatient clinics (Centro de Salud Familiar Alberto Hurtado y Centro de Salud Familiar Juan Pablo II) in Santiago, Chile. Participants will be breastfeeding women and their partner/family member; and health professionals who provide care to mother and child. Intervention group will receive a breastfeeding workshop during the third trimester of pregnancy and on-line breastfeeding support during the first 6 months postpartum. Health professionals will be train to deliver the intervention.Control group will receive the standard care as provided in the outpatient clinic.

Eligibility Criteria:
Inclusion Criteria:

* Being in physiological pregnancy in the third trimester
* Speak Spanish
* Give informed consent

Exclusion Criteria:

* Pathology during pregnancy that entails difficulties for breastfeeding
* Multiple pregnancy
* Breastfeeding especial situations (cleft lip and palate, congenital heart disease and newborn's hospitalization)
* Preterm birth (at \<37 weeks gestation)
Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients

The purpose of this study is to evaluate the safety and efficacy of a system combining continuous glucose measurement with a computer-based algorithm for insulin delivery in patients undergoing elective cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* elective cardiac surgery

Exclusion Criteria:

* insulin allergy
* mental incapacity
* language barrier
VitamIn and oXygen Interventions and Cardiovascular Events

This study examines the risks and benefits of antioxidants and normal versus high inspiratory oxygen fraction during anaesthesia.

Adult patients with risk factors for developing postoperative cardiac complications will be enrolled in the study. The patients will be randomised to receiving antioxidants or placebo perioperatively and 30% or 80% inspiratory oxygen concentration during anaesthesia and 2 hours postoperatively. The primary outcome is MINS (myocardial injury after non-cardiac surgery). The antioxidants are ascorbic acid (vitamin C) 3 grams intravenously preoperatively and N-acetylcysteine 100 milligrams/kilogram body weight intravenous infusion for 4 hours, starting at the same time as anaesthesia.

The study is a long-term follow-up study of the risk of mortality, MI and readmissions performed at 1 year after inclusion of the last patient. Two other follow-up studies are planned: One investigation of ischaemic troponin elevations defined as peak troponin levels above the internationally defined thresholds without extracardiac causes; another investigating the intervention effects in the subgroup of patients undergoing vascular surgery with specific emphasis on episodes of intraoperative hypotension within the following thresholds: MAP below 70 mmHg, 65 mmHg, 60 mmHg and 55 mmHg.

Eligibility Criteria:
Inclusion criteria:

All of the listed criteria (1.-4.) must be met.

1. Age 45 years or above
2. Elective or acute surgery in general anaesthesia
3. Scheduled for abdominal, orthopaedic, or vascular surgery with expected surgery duration of one hour or more.
4. Fulfil any 1 of the following 5 criteria:

   1. - History of coronary artery disease including angina
   2. - History of stroke
   3. - Undergoing vascular surgery
   4. - History of peripheral arterial disease
   5. - Any 2 of the following 8 criteria: i. Acute surgery ii. Current or previous daily smoking iii. History of hypertension iv. Diabetes mellitus requiring medical treatment v. History of transient cerebral ischemia vi. Plasma creatinine \>175 µM vii. Age 70 years or above viii. History of congestive heart failure

Exclusion criteria:

1. Surgery within 30 days prior to operation
2. Arterial oxygen saturation below 90% without oxygen supplementation
3. Inability to give informed consent
4. Drug allergy towards any of the drugs involved in the trial
5. Previous treatment with bleomycin
6. Pregnancy
Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy

To assess the feasibility and success of endoscopic ultrasound (EUS) directed biliary stone removal without use of fluoroscopy. Success for this study will be defined as the successful removal of all stones from the bile duct without the use of fluoroscopy. Fluoroscopy will only be used at the end of a presumed successful procedure to confirm that all stones are removed.


Eligibility Criteria:
Inclusion Criteria:

* Patients able to give informed consent
* Patients referred to IES for the endoscopic evaluation and treatment of suspected bile duct stones

Exclusion Criteria:

* Patients with \>3 bile duct stones or with any stone \>12mm on EUS
* Patients with no bile duct stones on EUS
* Patients with altered biliary anatomy (periampullary diverticulum, anomalous pancreatibiliary junction, altered surgical anatomy)
* Patients who are pregnant or breast-feeding
Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial

The purpose of this study is to evaluate the efficacy and safety of electroacupuncture （EA） for simple female stress urinary incontinence.

Stress urinary incontinence (SUI) is a common disease of female. The inconvenience caused by SUI affects the patients' quality of life and health seriously. To date, there has not specific therapy on SUI. Former research showed acupuncture may work for SUI. This multi-center randomized controlled clinical trial of acupuncture for simple female stress urinary incontinence is designed to confirm the efficacy and safety of EA. This project is conducted by Chinese researchers, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for simple female stress urinary incontinence.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnosis of Simple female stress urinary incontinence
* 40-75 years old
* Volunteered to join this research and signed the informed consent

Exclusion Criteria:

* urge urinary incontinence, mixed urinary incontinence, overflow urinary incontinence, etc
* After operation for urinary incontinence or pelvic floor operation
* Edeoptosis≥Degree 2
* Symptomatic urinary tract infection
* RUV\>30ml
* Qmax\<20ml/s
* Constrained movement of walking, stairs climbing, running
* Patients with continuous treatment for stress urinary incontinence or medicine for bladder function
* With serious cardiovascular, cerebral, liver, kidney, or psychiatric disease, diabetes, MSA, Injury of cauda equine, myeleterosis.
* During pregnancy or lactation period
* With cardiac pacemaker, Metal allergy or severe needle phobia