cyrilzakka/clinical-trials huggingface dataset:
PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons

A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.

A prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.

Eligibility Criteria:
Inclusion Criteria:

Clinical inclusion criteria

1. Age above 18 years and consentable
2. Angiographically proven coronary artery disease
3. Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve
4. Written informed consent

Angiographic inclusion criteria

1. De-novo lesion in a native coronary artery
2. Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation
3. Luminal diameter reduction of 50-100% by visual estimation
4. Severe calcification of the target lesion (for definition see appendix)

Exclusion Criteria:

Clinical exclusion criteria

1. Myocardial infarction (within 1 week)
2. Decompensated heart failure
3. Limited long term prognosis due to other conditions

Angiographic exclusion criteria

1. Target lesion is in a coronary artery bypass graft
2. Target lesion is an in-stent restenosis
3. Target vessel thrombus
Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting

This study aims to prove that at a dose of 1 mg Haloperidol possesses a high success rate in controlling established postoperative nausea and vomiting (PONV) in the first 24 hours following administration similar to the standard of care ondansetron 4 mg.

Patients undergoing surgery under general anesthesia may experience several complications in their postoperative period. Nausea and vomiting are some of the more common of these complications. Several medications can be used for prevention of these specific complications, but treatment remains more cost-efficient.

Haloperidol is anti-psychotic which, at low doses, can prevent the occurrence of nausea and vomiting. Its usefulness for prophylaxis has been demonstrated in several studies. However, its use for treating established postoperative nausea and vomiting (PONV) has not been properly studied.

In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, investigators will enroll 120 patients, and compare the effect of a dose of 1 mg Haloperidol versus Ondansetron 4 mg and document the varying degrees of success in treating nausea and vomiting as well as possible side effects.

Investigators expect to observe that Haloperidol is as effective as treatment with Ondansetron.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80
* ASA class I, II, and III
* undergoing elective surgery under general anesthesia

Exclusion Criteria:

* Patients with history of arrhythmias, QTc prolongation or allergies to the study drugs will be excluded from the study.
Pinverin Application Trial to Reduce Bowel Uptake of FDG (Fluorodeoxyglucose)

1. Background

   1. PET/CT (positron emission tomography/computed tomography) using FDG (fluorodeoxyglucose) is widely used for evaluation of cancer patients.
   2. Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT.
   3. There is no widely-accepted method to reduce the bowel FDG uptake.
2. Purpose

   1. To know whether pinverin (pinaverium bromide) application during PET/CT can reduce bowel uptake of FDG.
   2. Pinverin is a calcium-channel blocker that ameliorates the bowel contraction.
   3. Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel contraction during PET/CT acquisition.
3. Method

   1. Intervention versus control: administration of single tablet of pinverin (50mg) perorally versus simple water (\~100mL).
   2. Timing of administration: At the time of FDG injection. PET/CT images will be acquired 1hr post FDG injection.
4. Primary outcome

   1. SUV (standardized uptake value) difference between pinverin administered patient group versus control group.
   2. SUV (standardized uptake value) is calculated as: (decay corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi)


Eligibility Criteria:
Inclusion Criteria:

* Any cancer patients
* Candidate of positron emission tomography/computed tomography

Exclusion Criteria:

* Diabetes mellitus
* Inflammatory bowel disease
* Irritable bowel syndrome
* Peritoneal carcinomatosis
* Peritonitis
* Abdominal pain
* Diarrhea
* Medical test requiring bowel preparation within 1 month
* History of abdominal surgery
* Symptom or sign of colitis
* Pregnancy or lactation
* Hypersensitivity to pinaverium bromide
* Lactate intolerance
* Anit-depressant medication
Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children

Evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention for school-aged children with type 1 diabetes and their caregivers in a pilot randomized trial. The primary outcome is improvements in child sleep, and secondary outcomes include glycemic control (HbA1c, % in range), improvements in parent sleep, parental distress, and child behavior problems.


Eligibility Criteria:
Inclusion Criteria:

* child between 5-9 years of age
* child have been diagnosed with type 1 diabetes for at least 12 months
* caregiver lives with child
* caregiver can read/speak English

Exclusion Criteria:

* child has other major health problems or sleep disorders other than insufficient sleep or insomnia
* participating in other intervention studies
Safety and Efficacy of Autologous Adipose-Derived Stem Cell Transplantation in Patients With Type 1 Diabetes

The purpose of this study is to determine whether intravenous administration of autologous adipose stem cells is safe and beneficial in patients with type 1 diabetes.

Diabetes Mellitus is of large epidemic proportions worldwide. It is proliferating at such a fast rate that new novel drugs and other therapeutic approaches are required. The purpose of this Phase I/II study is to determine whether the intravenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe and efficacious in patients with Type 1 Diabetes Mellitus. Patients will be observed over 12 months following the procedure, with 2 weeks, 1 month and tri-monthly diagnostics and life style questionaires.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Type I diabetes for at least 2 years
* Insulin-dependent

Exclusion Criteria:

* Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent CVA or acute renal failure.
Transgender Observational Performance

The study will evaluate the sports capabilities of transgender women mainly in terms of muscular strength and aerobic capacity (VO2max). The control group will be composed of cisgender women and cisgender men with the same levels of physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a transgender woman by the DSM-V or ICD10.
* Gonadectomized and non-gonadectomized
* Initiation of androgen blockade and/or estrogen use after 12 years of age.
* Age range 18 to 50 years old.
* BMI: 18.0 to 34.9 kg/m2.
* Well-trained individuals (IPAQ very active)

Exclusion Criteria:

* Current or previous morbidities that could interfere with strength or aerobic tests.
* Chronic illnesses and/or chronic medication use.
* Musculoskeletal limitations.
Diaphragmatic Ultrasound Associated With RSBI Predict Weaning Issue: the Rapid Shallow Diaphragmatic Index (RSDI)

The Rapid Shallow Breathing Index (RSBI) is the ratio between respiratory rate (RR) and tidal volume (VT). It is routinely used to predict mechanical ventilation weaning outcome in ICU patients. However RSBI doesn't reflect the muscular contribution of diaphragm or accessory muscles in generating tidal volume. Actually, diaphragmatic dysfunction can even delay weaning process, because accessory muscles are more fatigable than the diaphragm.

Hence, the investigators hypothesized that diaphragmatic displacement (DD) could be associated with RSBI in a new index named Rapid Shallow Diaphragmatic Index (RSDI) such as: RSDI = RSBI/DD.

The aim of this study is to compare the ability of the RSDI versus the traditional RSBI to predict weaning success in ready-to-wean patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Mechanically ventilated patient \> 24 hours
* Weaning ventilator phase (PEEP \< 9 cmH2O and Support \< 15 cm H2O)
* Ventilated via tracheostomy tube patient can be included on removal day of the cannula
* Patient's agreement to participate

Exclusion Criteria:

* Moribund patient
* Decision to forgo life sustaining therapy patient
* Patient with ventilation via tracheostomy tube before admission to ICU
* BMI \> 45
Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer

The purpose of this study is to collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Patients with advanced non-small cell lung cancer (NSCLC).
* Patients who have received one previous chemotherapy for NSCLC.
* Full recovery from previous chemotherapy.
* Presence of either measurable or non-measurable disease by radiologic study or physical examination.
* At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient).
* At least 24 hours since prior radiotherapy providing that marked bone marrow suppression is NOT expected. Patients who have received radiotherapy must have recovered from any reversible side effects (e.g. nausea and vomiting).
* Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion Criteria:

* Symptoms of brain metastasis (cancer spreading to the brain), requiring treatment with steroids.
* Active infection.
* Severe medical problems other than the diagnosis of NSCLC, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
* Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.
* Use of investigational drug within 30 days prior to the first dose of study medication.
* Women who are pregnant or lactating.
* Patients of child-bearing potential refusing to practice adequate birth control methods.
* Patients with conditions which might alter absorption of an oral drug.
Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating

The aim of the present study was to specifically screen obese diabetic adolescent female individuals for BED, checking the variants of the GR gene (rs56149945; rs41423247) amongst identified individuals, and this led to assessing the impact of binge eating disorders on glycaemic control in obese diabetic adolescent females in Pakistan, South Asia.

Challenges in eating for diabetic adolescents can be categorized as eating disorders (ED) and disordered eating symptoms (DES). Binge-eating disorder (BED) is defined as recurrent episodes of binge eating at least once a week over a three-month time period and it is accompanied by feeling the lack of control and marked distress over one's eating behaviour. The aim of the present study was to specifically screen obese diabetic adolescent female individuals for BED, checking the variants of the GR gene (rs56149945; rs41423247) amongst identified individuals, and this led to assessing the impact of binge eating disorders on glycaemic control in obese diabetic adolescent females in Pakistan, South Asia.

Eligibility Criteria:
Inclusion Criteria:

* Unmarried females diagnosed with Type 2 diabetes \> 12 months
* Age 10-19 years
* Obesity class I and II (based on BMI range of 30 - 40).

Exclusion Criteria:

* Presence of psychosis, major psychiatric or neurocognitive disorder
* Substance use
* Untreated attention-deficit hyperactivity disorder
* Use of psychopharmacological medications or psychotherapy
* Class III obesity
The Effect of Independent Obstetric Operating Room on Decision-to-delivery Interval for Emergency Cesarean Section

The study is to investigate whether the establishing independent obstetric operating centre can shorten the decision-to-delivery interval and improve delivery outcomes of emergency cesarean section.

The newest define of decision-to-delivery interval (DDI) is the interval between the time at which the senior obstetrician makes the decision that a caesarean section is required and the time at which the fetus (or first fetus in the case of multiples) is delivered. The recommended DDI by the American College of Obstetricians and Gynecologists and the Royal College of Obstetricians and Gynecologists is within 30 minutes. The 30 minutes rule is also used to measure the overall performance of an obstetric unit in our country. Lower rate of DDI over 30 minutes will improve the outcome of neonatal outcomes.

Affiliated Foshan Maternity \& Child Healthcare Hospital is a tertiary care hospital in south of our country. Obstetric operations in this hospital are used to perform in a big general operating center, which is shared by all departments of the hospital. In December 23, 2020, a new wing of the hospital opened in response to the growing number of patients. In the new wing, an independent obstetric operating center was established to provide health care for obstetric operating. The original and new obstetric units were built according to the same standard. The medical staff shifts between original and new obstetric units every three months. Six months after the new wing of hospital opened, we set off a randomized and controlled trial (RCT). The RCT is aimed to investigate whether the independent obstetric operating center can shorten the DDI, decrease the rate of DDI over 30 minutes and improve neonatal outcomes.

Women who are over 18 years old, meet the conditions of vaginal delivery and decided to give birth vaginally by doctor and patient will be random distributed to original or new obstetric unit from July 1, 2021 to June 30,2022. Women need ECS in original obstetric unit will be send to the general operating center (named standard group), those need ECS in the new wing will be send to the obstetric operating center (named new group). DDI and other related variables of those who need ECS will be recorded. Data of a total of 60 ECS in each group will be collected and analyzed at last. Women who with missing data should be excluded.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old, meet the conditions of vaginal delivery, decided to give birth vaginally

Exclusion Criteria:

* with missing data
Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects.

This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.


Eligibility Criteria:
Inclusion Criteria:

Healthy males between the ages of 18 and 55 years. Body Mass Index of 18 to 30 kg/m2, and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

Smoking in excess of the equivalent of 5 cigarettes per day. Treatment with an experimental drug within 30 days or sildenafil, vardenafil, tadalfil within 4 days before first study dose.

Develop blood pressure lowering or experience dizziness, lightheadedness when going from the laying down position to standing position.
Effects of 14-days of HMB-free Acid on Changes in Muscle During 4-days of Survival Training

Sustained high-intensity activity, such as survival training with little nourishment available, can result in a loss of muscle performance. This study will examine the effects of a nutritional supplement to maintain muscle and muscle performance during this period.

Sustained high intensity activity that is often accompanied by sleep and nutrient deprivation is a common characteristic of survival training. Survival training is a requirement in the preparation of pilots, where they learn evasion and survival skills that they may need to avoid capture in a situation in which they have bailed from their plane. The physiological stresses associated with the nature of these operations often results in significant decrements in lean body mass, muscle size and muscle endurance and power. During a sudden evacuation from the aircraft the pilot only takes a small survival bag. There is a limit to what can possibly be put in this bag. However, the ability to provide a dietary supplement specifically targeting muscle may provide an important resource for maintaining muscle mass and performance. Thus, the purpose of this study is to determine the efficacy of 14 days of HMB-FA ingestion on maintaining muscle architecture and muscle performance during 4-days of survival training. In addition, anabolic and catabolic markers of stress, inflammation and muscle damage will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 27 Years of age
* Soldier members of Special Operations
* Healthy as assessed by the Unit's Medical Officers
* Subject provides written and dated informed consent to participate

Exclusion Criteria:

* A history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders
* Use of medications that may affect the study outcomes
* Use of nutritional supplements (such as protein drinks, creatine, HMB and vitamins) in the 3 months prior to the start of the study
* Subject is currently participating in another clinical trial or has received an investigational product within thirty days prior to screening/enrollment
The Safety of a Novel Acellular Dermal Template as Treatment for Burns and Scars

In this study the safety and feasibility of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. We expect this treatment to be safe, and to provide better outcome regarding scar quality.

Using dermal substitutes in combination with a split-thickness skin graft (STSG) is a well acknowledged therapy in burns and reconstructive surgery. Nevertheless, the ideal substitute is not available yet. We therefore want to investigate the use of an acellular dermal template (Novomaix), in combination with STSG, to treat these defects. Adult patients with acute (burn) wounds (group 1) and scars (group 2) will be included in this study. This phase I study aims to investigate the safety and feasibility of the use of this dermal matrix, with regard to graft take, epithelialisation and complications after transplantation. Moreover, scar quality will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years

  1. with acute burns/trauma wounds that require skin grafting (group 1) OR
  2. with scar problems requiring surgical treatment (group 2)
* Full thickness skin defects of 50 cm2 or more, but \<50% TBSA
* Skin defects must be configured in such a way that two areas of 25 cm2 can be grafted
* Informed consent by the patient

Exclusion Criteria:

* Patients with infected wounds
* Pregnant or breast feeding females
* Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, diabetes, collagenoses, cancer)
* Known allergy against porcine collagen or elastin
* Patients who are expected (according to the responsible medical doctor) to be noncompliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
* Previous enrolment of the patient into the current study
12 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With Metformin

The purpose of this Phase 2a study is to evaluate the efficacy, safety and tolerability, of multiple parallel doses of PF-00734200 following oral administration to adult human subjects with T2DM who currently are on a stable dose of metformin.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes
* Hb1AC \>7%-11% inclusive
* Male and females 18-70; females must be post-menopausal
* On a stable dose of metformin hydrochloride

Exclusion Criteria:

* Medical history of stroke, unstable angina, heart attack within one year of enrollment, and alcohol dependency or recent drug abuse.
* Women of childbearing potential, pregnant or nursing
* Evidence of diabetic complications with significant end-organ damage
Total Laparoscopic Hysterectomy vs Minilap Hysterectomy

The objective of this study is to compare the perioperative outcomes between mini-lap hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications.

A prospective randomized open-label study was conducted. Women \>18 years of age undergoing TLH because of benign indications were recruited. Patients were randomized for either TLH (Group I, 40 cases) or minilap hysterectomy (Group II, 40 cases) through 4-5cm abdominal Pfannenstiel incision.

Inclusion criteria were mobile uterus with benign lesion and with a size up to 12 weeks gestation. Exclusion criteria adopted were patients with enlarged uterus \< 12 weeks, suspected malignancy and large adnexal masses (\>5cm). Peri-operative outcomes were compared.

Written informed consent was obtained from all the patients and the Departmental Ethical Committee approved the study. Patients from OB/GYN Mansoura University Hospital were enrolled. All the operations were performed by at least one of the consultants included as authors in this study.

Eligibility Criteria:
Inclusion Criteria:

* Mobile uterus.
* Uterine size up to 12 weeks gestation.
* Benign lesions.

Exclusion Criteria:

* Enlarged uterus \> 12 weeks gestation.
* Suspected malignancy.
* Large adnexal masses.
Effects of Hip Abductor and External Rotator Strength Training in Patients With Patellofemoral Pain Syndrome

The first purpose was to compare the difference between leg press exercise(LPE) and additional hip abductor and external rotator muscle strength training to leg press exercise(LPE+HAE) in muscle strength, hip kinematics during step down, pain severity and function for patients diagnosed with patellofemoral pain syndrome. The second one was to discover the relationship between the change in muscle strength performance and the difference of hip joint kinematics post treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patellofemoral pain syndrome ( Bilateral or unilateral)
* Special tests: crepitus during compression test, patellar grind test (Clarke's sign), pain during compression test, palpation ( at least 2 )
* Below 50 years old
* Pain :after long sitting, up/down stair, squat, kneeling, running \& jumping ( at least 2 )
* Pain duration at least 1 month
* At least 1 item of PSS score more than 3 cm

Exclusion Criteria:

* Knee operation
* Central or peripheral neurological deficits
* Obvious knee joint or lower extremity malalignment
* People involved in competitive sports
* PSS sub-scale pain experienced last week more than 8cm
* Have been taking anti-inflammatory drugs , received anti-inflammatory injection or received other therapy for past 3 months