cyrilzakka/clinical-trials huggingface dataset:
Granisetron 1 mg Tablets, Non-fasting

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 fed 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.
Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term

Induction of labour with vaginal misoprostol, in women with premature rupture of membranes at term, results in significant shortening of induction to delivery time in comparison to vaginal PGE2 gel induction.


Eligibility Criteria:
Inclusion Criteria:

* Premature rupture of membranes at 37 or more weeks
* Single live fetus in cephalic presentation

Exclusion Criteria:

* Women in labour
* Women with contraindication of induction of labour
* Women with previous caesarean section or uterine surgery
Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE)

To compare the feasibility and surgical outcomes between complete salpingectomy and standard postpartum tubal ligation (partial salpingectomy) at the time of cesarean delivery in women with undesired future fertility. as a possible ovarian cancer risk-reducing procedure.

All pregnant women receiving prenatal care within the UAB Health System, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat) will be approached about the study. Patients will be randomized to receive either the standard tubal ligation practice at our institution (modified Pomeroy procedure or Parkland) or a complete salpingectomy. The objective of this trial is to evaluate if a complete salpingectomy can be performed safely and comparable to a standard postpartum tubal ligation.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women \> 25 years receiving prenatal care within the UAB Health System, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat)
* Informed consent obtained

Exclusion Criteria:

* Inability to obtain informed consent
* Fetal death or anomalies
* Preterm delivery \< 36 weeks gestation
* Immune-compromising disease
* Chronic steroid use
* Chronic prophylactic or therapeutic anti-coagulation
* Patients no followed in our regional health system
* Known BRCA mutation carrier status
* Age \< 25 years
The Optimal Treatment Duration for Inspiratory Muscle Strengthening Exercises in Stroke Patients

The first aim of this study is if there is any difference between 4 or 8 weeks of inspiratory muscle training ( IMT ) exercises groups and control groups in stroke survivors. The secondary aims of this study is if there is any difference in walking capacity (in 8th, 12th, 24th weeks) and pulmonary complications (pneumonia incidences) in long term follow-ups (6 months) in these aforementioned groups

Stroke is one of the leading causes of death and disability. It is not only because of loss of extremity motions but also loss of inspiratory muscle strength. In this study we aimed to determine the optimum duration for inspiratory muscle training exercises for stroke survivors since there is not enough data about it in the literature.

The study will include at least 54 patients in total and 18 in each groups ( two intervention and one control) . The patients will be evaluated for angina, chronic obstructive pulmonary disease, congestive heart disease; in these conditions the patients will be excluded from the study. Also in first examinations we will evaluate the maximal inspiratory pressure (MIP) of patients, of them the ones with MIP measurements above 80 mmH2O will also be excluded since it is the expected value in normal people.

After admission and randomizing the patients, baseline measurements of MIP, 6-minutes walking test will be done. In intervention groups the patients will get 30 minutes of inspiratory muscle training exercises ( 15 minutes of two session each day) with threshold IMT device every weekday. And in control group, the patients will get sham intervention for 8 weeks. The MIP and 6-minutes walking test will be done in 8th,12th and 24th weeks. And also in 24th week we will record the pneumonia incidence if occured.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic/ hemorrhagic stroke
* Stroke duration\> 3 months
* Age\> 18 years old
* Baseline maximal inspiratory pressure below 80 cmH2O

Exclusion Criteria:

* Cognitive deficiency
* Facial paralysis
* Chronic obstructive pulmonary disease
* Congestive heart disease
* Myocardial infarction in last three months
* Angina pectoris
A High Protein Diet and Weight Maintenance

An investigation into long term weight maintenance using a high protein or high carbohydrate diet, after a large and rapid weight loss.


Eligibility Criteria:
Inclusion Criteria:

* healthy men and women with a BMI \>27kg/m2 with co-morbities or BMI \>30kg/m2

Exclusion Criteria:

* people with Type II diabetes or other endocrine disorders, women who were pregnant or breastfeeding or planning to become pregnant
The Staying Well Study: An Open Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depression

Pregnant women with histories of depression are at high risk of depressive relapse during the perinatal period, and options for relapse prevention are limited. Mindfulness-based cognitive therapy (MBCT) has strong evidence among general populations but has not been studied among at risk pregnant women.

This study is the first phase of a multi-phase project adapting MBCT for perinatal women (MBCT-PD). It is being conducted in a collaboration between the University of Colorado, Emory University, and Kaiser Permanente at Colorado and Georgia.

Mindfulness-based cognitive therapy (MBCT) represents one of the most important recent developments in the effort to prevent recurrent depression. Explicitly designed to modify core underlying vulnerability factors among recovered individuals with histories of depression, MBCT may have high applicability to the prevention of perinatal depression (PD).

During this phase of the project the investigators will employ an iterative process to develop, within routine obstetric clinical settings, the MBCT-PD program across a two-center open trial of pregnant women at high risk of perinatal depression. During this phase, the investigators will modify the standard MBCT approach to be sensitive and specific to women at high risk of perinatal depressive relapse or recurrence based on previous history of depression and will address the following aims:

* Specific Aim 1: To examine the feasibility of MBCT-PD with respect to identification and enrollment of women at-risk of perinatal depression based on a history of depression.
* Specific Aim 2: To examine the engagement of women with the MBCT-PD approach with respect to retention, completion of daily practice assignments, and satisfaction
* Specific Aim 3: To examine the clinical outcomes including change in depression symptom levels and rates of relapse/recurrence over the course of the intervention and through a 6-month postpartum follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant up to 32 weeks gestation
* Meeting criteria for prior depression
* Failure to meet criteria for a diagnosis of MDD in the last two months
* Available for group intervention scheduled meetings

Exclusion Criteria:

* Presence of schizophrenia or schizoaffective disorder
* Presence of bipolar disorder or current psychosis
* Presence of organic mental disorder or pervasive developmental delay
* Presence of current eating disorder
* Presence of current substance abuse or dependence
* Presence of antisocial, borderline, or schizotypal personality disorder
* Presence of imminent suicide or homicide risk
* Presence of any other axis I or II disorders that necessitate priority treatment not provided by the study protocol
* Women with any medical conditions that would preclude participation, including high-risk pregnancy
Nurse-led Follow-up Care for Head and Neck Cancer Patients

The purpose of this study is to conduct an early evaluation of a nurse-led follow up intervention added to the usual medically oriented follow up care. Besides evaluating the feasibility and acceptability to patients, the effect on psychosocial adjustment and quality of life of patients is determined.

Background: After treatment for cancer, follow-up surveillance is regarded important. In head and neck cancer patients however, increasing research evidence shows that at least the goal of detecting recurrence of cancer during routine control visits in an asymptomatic stage is not achieved. Other goals of follow-up such as management of treatment complications and helping patients and families cope and adjust remain important and ask for an accurate, effective but tailored and sensitive approach. Increasingly, nurses are mentioned as care providers best suited to perform this task.

Aim: The purpose of this study is to conduct an early evaluation of a nurse-led follow up intervention added to the usual medically oriented follow up care. Besides evaluating the feasibility and acceptability to patients, the effect on psychosocial adjustment and quality of life of patients is determined.

Methods and design: A quasi-experimental prospective design is used. Two groups of patients are enrolled consecutively (n=160) and patient data are collected at baseline (T0), at 6(T1) and at 12(T2) months respectively. The duration of the intervention is defined to the first year of follow up. Participating nurses are trained prior to the recruitment of the intervention group and receive supervision and individual coaching during the entire duration of the intervention phase.

Outcome measures: Primary outcome, psychosocial adjustment to illness. Secondary outcomes, health related quality of life, psychosocial problems, and usage of care.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a primary head and neck tumour
* Absence of other cancers diagnosed
* Treatment with curative intent, all treatment modalities
* Treatment and 12 month follow-up planned in Radboud University Nijmegen Medical Centre
* Able to speak, write and understand Dutch
* Cognitively able to give informed consent

Exclusion Criteria:

* Actual psychiatric disease
* Actual alcohol addiction
* Known life expectancy of \< 6 months
Non-Contrast Magnetic Resonance Angiography Assessment of Patients Referred for Transcatheter Aortic Valve Implantation

The overall objective of this proposal is to examine the feasibility and accuracy of non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals referred for transcatheter aortic valve implantation (TAVI).


Eligibility Criteria:
Inclusion Criteria:

* Adults with severe aortic stenosis referred for possible transcatheter aortic valve implantation with clinically indicated computed tomography imaging

Exclusion Criteria:

* Inability or unwillingness to consent
* Inability to complete magnetic resonance imaging (MRI) study
* Contraindication to MRI
* Participation in another research study
* Non-diagnostic computed tomography scan
Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction

This is a multi-center, prospective, randomized, controlled study. The patients with STEMI who were to undergo PPCI were divided into PCSK9 inhibitor group (n=80) and conventional treatment group (n=80) using the interactive web response system (IWRS), at a 1:1 ratio. In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months; the control group received conventional treatment. Cardiac Magnetic Resonance Imaging (MRI) were used to measure myocardial salvage index at 1 week after operation as primary endpoints. Eject fraction at 6 months after operation will also be measured by MRI as secondary endpoints. Serum TnI/T，CKMB levels were detected q8h for three times and and LDL-C levels were detected at 1 month, 3 months and 6 months after operation. Blood inflammation indicators were detected before and 1 week after the operation, and 6 months after the operation.


Eligibility Criteria:
Inclusion Criteria:

1. The age is greater than 18 years old and less than or equal to 80 years old.
2. Patients who are clinically diagnosed with STEMI onset within 24 hours and who are planning to undergo PPCI .
3. Signed informed consent.

Exclusion Criteria:

1. Patients who are allergic to PCSK9 inhibitors.
2. Multivessel disease planned for selective intervention within half a year.
3. Patients who have previously undergone revascularization.
4. Pregnant women or women who plan to become pregnant in the next 2 years.
5. Patients whose life expectancy is less than 1 year.
6. Severe liver or kidney dysfunction (ALT\>5 times ULA, eGFR\<15ml/min/1.73m2)
7. Known active malignant tumor diseases.
8. Patients considered by the investigator to be unsuitable to participate in this study.
An Evaluation of the Daytime Use of an Investigational Lubricant Eye Drop

The purpose of this study is to describe the subjective assessments of an investigational lubricant eye drop.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of dry eye
* Current use of Refresh Liquigel, GenTeal Gel Drops or Refresh Celluvisc at least twice daily

Exclusion Criteria:

* Must not have worn contact lenses within 7 days preceding enrollment
* Must not have had punctal plugs inserted within 30 days preceding enrollment
Application of Photogrammetry for Manual Skills Training in Undergrad Physiotherapy Students

Education research shows that healthcare professional training can be made more efficient and effective with the integration of simulation technology. Despite the relevance of this technology in the training of medical students, evidence on its effectiveness in physiotherapy manual skills training is limited.

To compare the effectiveness of real-object three dimensional (3D) produced by Photogrammetry versus two dimensional (2D) images for the introduction of manual therapy skills to undergraduate physiotherapy students, with a blended learning activity.

Using a randomised controlled trial design, first-year students enrolled in a 4-year bachelor with honours physiotherapy degree, participated in a 2-hour blended learning session. Three manual assessment techniques were presented - cervical compression, distraction and flexion-rotation tests. The techniques were demonstrated through two sets of learning materials with either real-object rotatable 3D images using Close-range Photogrammetry (experimental group) or traditional 2D computer images (control group). Students were examined after the training using an objective structured clinical evaluation (OSCE) procedure. The OSCE required the participants to demonstrate the three techniques learnt with the assessment criteria as therapist's position and skills, patient's position and overall management of the physical examination. The score of the standardized 9 item-practical performance test, with a maximum score of 54, was used as the primary outcome measure for analyses.

Eligibility Criteria:
Inclusion Criteria:

Physiotherapy students with no experience in spinal assessment

Exclusion Criteria:

People with unfavourable experience or responses to 360-degree video or VR/AR videos
Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

Hypertension is a major risk factor for stroke and cardiovascular mortality. Catheter- based renal denervation causes substantial and sustained blood- pressure reduction in patients with resistant hypertension.

The purpose of RENSYMPIS is to study the effects of renal denervation on:

1. Cardiovascular function
2. Metabolic factors
3. Inflammatory and endocrine factors
4. Coagulation
5. Sleep


Eligibility Criteria:
Inclusion Criteria:

* Resistant Hypertension (systolic blood pressure \>160mmHg and 3 or more antihypertensive agents in use)
* Age 30- 69 years
* Written informed consent

Exclusion Criteria:

* Secondary hypertension
* Pseudohypertension
* Pregnancy
* Renal insufficiency (GFR \<45ml/min)
* Clinically significant stenotic valvular disease
* Oral anticoagulation
* CCS III-IV symptoms or CABG/PCI in previous 6 months
* Prior stroke
* Contrast agent allergy
* inappropriate renal artery anatomy (\< 4mm diameter, \< 20mm length)
To Evaluate Real-world Safety, Effectiveness and Appropriate Use of Micatrio® Combination Tablets Treatment in Patients With Hypertension

Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension

Non-interventional study based on newly collected data. The study will consist of a baseline visit and follow-up visits at Week 4, 8, 12, 24, 36 and 52 for patients who have newly initiated Micatrio® Combination Tablets. The patients will be followed up until discontinuation of Micatrio® Combination Tablets treatment or the end of study.

All patients administrated Micatrio® Combination Tablets after the launch at the sites contracted with the sponsor will be registered.

Eligibility Criteria:
Inclusion criteria:

* Patients who are prescribed with Micatrio® Combination Tablets by the discretion of investigators based on the Japanese package insert
* Patients who have never been treated with Micatrio® Combination Tablets before enrolment

Exclusion criteria:

Patients who are participating/planned to participate in a clinical trial
Bioavailability From Chickpea Meals in Ileostomists?

The matrix of a food can significantly affect how well humans can absorb and use nutrients. Plants like fruits, vegetables, nuts, grains, and legumes have cell walls that form a network around their cells. These cell walls are a barrier for the digestive system to break down completely, which can make it harder to digest the food and get energy from it. This study will explore how the integrity of plant cell walls affects how well humans can absorb macronutrients (protein, fat and carbohydrates) and beneficial compounds e.g. phytochemicals. The study will compare two chickpea meals that have similar nutrients and energy content but differ in the amount of intact plant cell walls e.g. chickpea salad meal (INTACT diet) and chickpea burger meal (BROKEN diet).

The energy content of food can be in principle calculated by multiplying the content of each energy-yielding substrate by the corresponding heat of combustion. However, only part of this energy yielding substrates is converted to energy because of their incomplete digestion and absorption in the gastrointestinal tract. The structural composition of foods, known as the food matrix, significantly affects nutrient bioavailability. One such structural feature is the integrity of plant tissues characterised by the interconnected, continuous network of cell walls which surround and protect plant cells. When cellular integrity is retained, macronutrients are naturally "encapsulated" within cell walls which effectively reduces the rate and the extent of their digestibility by 6-7% compared to a diet poor in plant-based foods. This study aims to investigate the effect of plant tissue integrity on the total energy excretion of a diet, bioavailability of macronutrients and bioactive compounds, and on plasma levels of glucose, essential amino acids and triglycerides. The investigators will do this by comparing two diets which have (approximately) the same composition in macronutrients and energy but different levels of plant tissues integrity, namely a diet rich in intact plant tissues (INTACT diet), and a diet poor in such intact plant tissues (BROKEN diet). The investigators will use an ileostomy model to be able to determine the difference in energy excretion at the level of the terminal ileum.

Eligibility Criteria:
Inclusion Criteria:

* Previously had an ileostomy
* ≥1.5-years post-operative
* Aged 18-60 years
* Males and females (not currently pregnant/lactating)
* Non-smokers
* Not allergic to nuts and celery

Exclusion Criteria:

* Never had an ileostomy
* \<1.5-year post-operative
* Not aged 18-60 years
* Pregnant/lactating female
* Smokers
* Allergic to nuts and celery