cyrilzakka/clinical-trials huggingface dataset:
Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit

In the context of postoperative hypertension in the intensive care units, or after resusitation of hypertensive patients, intravenous antihypertensive drugs are often used. Among those drugs, Nicardipine is an effective drug, but with side effects such as inhibition of pulmonary vasoconstriction. Only preclinical studies have investigated the pathophysiology of this mechanism, and no clinical study have proven its clinical relevance.

The aim of this study is to establish the incidence of Nicardipine induced hypoxemia and to compare it to another antihypertensive agent, Urapidil.

Prospective observational study in 4 intensive care units in one general hospital and one university hospital.

Once Nicardipine or Urapidil infusion is started, data collection of respiratory related information such as type of ventilation, arterial partial pressure of oxygen, blood pressure, cardiac frequency.

Statistical analysis for two qualitative variables: Group (Nicardipine or Urapidil) and occurrence or worsening of hypoxemia. Secondary outcoumes analysed such as maximal drop of blood pressure, evolution of the PaO2/FiO2 ratio, length of hospital stay, duration of mechanical ventilation in the ventilated patients.

Analysis for different subgroups : Patients with known atelectasis, postoperative of cardiac surgery, neuro-intensive care.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* With acute arterial systolic hypertension over 140mmHg
* Requiring intravenous administration of one of the two following drugs : Urapidil or Nicardipine

Exclusion Criteria:

* Patient ventilated Under Nitrogen Monoxyde
* Contraindication to Nicardipine or Urapidil
* Refusal of the patient or his relatives
* Patient treated for pulmonary hypertension
Relationship Between Microbiota and Prognosis of Hepatocellular Carcinoma(HCC) After Systemic Treatments

By tracking the short-term and long-term results of HCC patients treated with systemic therapies,the difference of microbiota between responded patients and non-responded patients was analyzed, and the correlation between gut and oral microbiota and short-term and long-term results was explored, so as to improve people's awareness of microbiota and pay attention to its prevention and treatment.

The investigators consecutively admit patients the questionnaire and collect the fecal. And by tracking the short-term and long-term outcomes of HCC patients treated with systemic therapies,the difference of gut microbiota between responded patients and non-responded patients is analyzed, and the correlation between gut and oral microbiota and short-term and long-term results is explored.Adverse events (AE) are recorded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 4.0).Tumor response is mainly evaluated by experienced hepatologists using radiological method within 4-12 weeks after treatments according to the RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST).Overall survival (OS) and Progression-free survival (PFS) are recorded.

Eligibility Criteria:
Inclusion Criteria:

* clinically or pathologically diagnosed HCC
* didn't receive prior anti-tumor treatments
* didn't receive prior antibiotics
* Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-1
* Child-Pugh score of ≤7
* complete clinical and follow-up information.

Exclusion Criteria:

* combined with other malignancies
* receive surgical treatment
* lost follow-up
* Child-Pugh score of\>7
* uncompleted clinical and follow-up information
* overall survival less than 1 month
* receive prior antibiotics
Open Nipple Sparing Mastectomy (NSM)

This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively

This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively

Eligibility Criteria:
Inclusion Criteria:

All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval

Exclusion Criteria:

-
Comparison of Metformin and Pioglitazone in Regulating Menstrual Irregularities and Hyperandrogenism

To compare metformin with pioglitazone in improving menstrual irregularities and hyperandrogenism in women with PCOS so that an alternate and better treatment option will be available for hyperinsulinemia in pcos patients.

This study will be a prospective, randomized, open label, multicentre study. It will be carried out in outpatients department of Obstetrics and gynecology, at the Dow university of Hospital and mamji hospital Karachi.

The study period will be of 6 months. Polycystic ovarian syndrome PCOS constitute most common endocrinopathy present in 4-7% women of reproductive age. Rotterdam criteria, diagnosis of PCOS require two of the three features: oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries by u/s and the absence of other endocrine conditions such as hypothyroidism, cushing syndrome, congenital adrenal hyperplasia, or hyperprolactinemia.

Insulin resistance and hyperinsulinemia may play a key role in pathogenesis of this syndrome by deregulating LH secretion at central level and increased stimulation of cytochrome p450 in ovary, hyperinsulinemia also decreases the circulating concentration of SHBG and contribute to greater concentration of free androgens in blood, cut off of insulin level for insulin resistance in Pakistani population is 9.25U/ml. On basis of evidence, Insulin sensitizing agents has been recently proposed as a useful treatment option in women with pcos, which by reducing insulin resistance and hyperinsulinemia, reduce the insulin driven ovarian and adrenal hyperandrogenism usually restoring normal LH and FSH secretion and ovulatory cycles.

Eligibility Criteria:
Inclusion Criteria:

1. women of age 18-40 with primary or secondary infertility.
2. Polycystic ovarian syndrome daignosed using rotterdam criteria.
3. Not taken any medication before for PCOS.

Exclusion Criteria:

1. Women having type 1 or type 2 diabetes mellitus.
2. Abnormal kidney or liver function.
3. Hypertension or heart disease.
4. Gonadotrophin induction or ovarian drilling before will not be included in this study.
Suprapatellar Nailing of Tibial Shaft Fractures

To investigate the functional outcomes and prevalence and severity of knee pain for patients undergoing suprapatellar nailing of tibial shaft fractures.

Suprapatellar nailing...

Participants will be followed for 10 years prospectively. Follow up visits will occur at 2 weeks, 6weeks, 3 months, 6 months, 12 months, 3 years, 5 years, 7 years and 10 years.

Interim analysis will be done at 1, 3, 5, and 7 years with final analysis occuring at 10 years.

Primary and secondary endpoints in patients undergoing suprapatellar nailing of tibial shaft fractures are:

1. To evaluate the long term presence of knee pain
2. To evaluate the long term functional outcomes

Eligibility Criteria:
Inclusion Criteria:

* Isolated, unilateral tibial shaft fractures
* Orthopaedic Trauma Association (OTA) classification of 42 and may extend to 43A or 43B
* age 18-65, including pregnant women
* open or closed fractures
* able to sign consent
* english speaking

Exclusion Criteria:

* compartment syndrome
* other lower extremity injuries that will affect functional outcomes
* problems maintaining follow up (homeless, not willing to return for follow up)
* pathological fractures
* prisoners
* previous retained hardware in the injured leg
* injuries requiring vascular repair
Adequacy of the New Pediatric Isoniazid/Rifampin/Pyrazinamide (HRZ) Tablet

Lack of quality-assured pediatric formulations of the first-line antituberculosis (anti-TB) drugs is barrier to optimized tuberculosis (TB) treatment outcome in children. In 2010 and subsequently modified in 2014, the World Health Organization (WHO) recommended increased dosages of the first-line anti-TB drugs for children, but there were no child-friendly fixed-dose combination (FDC) formulations based on the guidelines. A large proportion of children treated with the new guidelines using old formulations did not achieve the desired rifampin peak concentration (Cmax) \> 8 mg/L and pyrazinamide Cmax \> 35 mg/L. The TB Alliance and the WHO led the development of a new child-appropriate isoniazid/rifampin/pyrazinamide (HRZ) and isoniazid/rifampin (HR) FDC formulation in line with current WHO recommended dosing guidelines. The new formulations dissolve quickly in liquid, have palatable fruit flavors, and are expected to improved daily adherence but no studies have evaluated the pharmacokinetics (PK) of the FDC formulation in children. The study team hypothesize that the new dispersible HRZ FDC tablet, dosed according to current WHO weight-band dosing recommendations will result in better PK parameters for each drug component than that achieved by the old formulation.

This study will evaluate the PK of the new pediatric HRZ FDC tablet in Ghanaian children with TB with and without HIV coinfection. The new HRZ FDC dispersible tablet was designed to be child-friendly and to achieve recommended dosages for each weight-band. The formulation has been rolled out in Africa without PK studies in the target population to verify that the tablets achieves adequate drug concentrations. The current study will evaluate the adequacy of the formulation by examining the PK of the component drugs as well as the effect of HIV coinfection. The direct PK data will be used in a population PK model and stimulations to define optimal weight-band dosages and proportions of the components of the pediatric FDC tablets.

Eligibility Criteria:
Inclusion Criteria:

* Children with active TB with or without HIV coinfection. Active TB diagnosis defined by clinical criteria consistent with active TB and/or a positive AFB smear.
* Available for follow-up until completion of TB treatment and/or achievement of a study endpoint like discontinuation of therapy, and/or pharmacokinetic sampling.

Exclusion Criteria:

* Children with concurrent conditions other than HIV, have acute hepatitis within 30 days of study entry, persistent vomiting, and diarrhea will be excluded from the study.
* Unable to obtain informed signed consent from parent(s) or legal guardian.
* Have AIDS-related opportunistic infections other than TB, history of or proven acute hepatitis within 30 days of study entry, persistent vomiting, or diarrhea.
* Hemoglobin \< 6 g/dl, white blood cells \< 2500/mm3, serum creatinine \> 1.5 mg/dl, aspartate transaminase (AST) and alanine transaminase (ALT) \> 2 times upper limit of normal.
A Trial of Three Types of Enemas Used to Treat Functional Constipation in Children

Functional constipation is extremely common in children and is defined as painful, hard stools or firm stools for twice or less per week. Functional constipation accounts for 3% of general pediatric visits and up to 25% of pediatric gastroenterology visits. Constipation and fecal impaction can lead to a range of symptoms including decreased appetite, vomiting, and abdominal pain frequently resulting in Emergency Department (ED) presentation. In contrast to the outpatient setting where diet and oral medications work well to relieve symptoms related to functional constipation, ED management requires an approach with quicker results. For immediate relief of symptoms, disimpaction via enema use may be better than polyethylene glycol (PEG) 3350 for children. However, the type of enema to be used is not well studied. Currently, any patient presenting to the ED with a presumed diagnosis of abdominal pain due to functional constipation receives an oral dose of PEG and one of the following three types of enemas (based on the ED treating attending's discretion): phosphate or Fleets enema, normal saline enema, or mineral oil enema. There is no evidence in the literature that demonstrates any difference in the effectiveness of each of these enemas. The investigators propose a randomized control trial of the three types of pediatric enemas readily used in our ED to determine the best approach. There will be three arms within this study: a) PEG plus phosphate enema b) PEG plus normal saline enema and c) PEG plus mineral oil enema. The physicians enrolling patients will not be the treating physicians. The four principal investigators (blinded to the type of enema being used), following appropriate informed consent, will obtain pain scores (Faces Pain Scale - Revised) pre- and post-administration of each of the three treatments listed above in order to determine the best enema to use in children 4-12 years of age. Other outcomes to be analyzed will include the patient's weight pre- and post-administration of the enema, satisfaction ratings on a visual analog scale from the treating physician (who will also be blinded), and parental surveys on the day of administration and 3-5 days following discharge. Data analysis for pain scores will be completed with repeated measures anova. Categorical values will be compared using Chi Square analysis and continuous variables will be compared using parametric statistics.


Eligibility Criteria:
Inclusion Criteria:

* Age 4-12 years
* Receiving enema in ED for presumed constipation

Exclusion Criteria:

* Critically ill patient
* Any history of renal insufficiency, renal disease, or elevated creatinine
* Any history of intestinal anatomic abnormality (i.e. anal stenosis, anal surgery, bowel obstruction, hirschprung's disease)
* An inability to self-report pain
* Presence of gastrostomy or jejunostomy tube
* Any history of gastrointestinal dysmotility
* Inability to read or speak English or Spanish
Action of Amantadine on Post-Stroke Aphasic Patients

The objective of the study is to test the action of the amantadine, as DOPA-agonist, in a double blind cross-over trial, amantadine / placebo, on the verbal fluency of chronic post stroke aphasic patients.

In France, there are around 30000 aphasic patients. The actual taking care of these patients after stroke includes the treatment of acute stage in stroke unit, followed by rehabilitation program. However, most non fluent aphasic patients remain chronically handicapped despite of intensive logopedic training.

The objective of this clinical project is to test the action of pharmacologic agents on verbal fluency of aphasic patients victims of cerebral infarctions. Only a few studies have been done with various pharmacologic agents, and although the results were not clearly conclusive, they were sufficiently positive for suggesting to launch a well controlled randomized cross-over study.

Then the objective of study is to test the action of the amantadine, as DOPA-agonist, in a double blind cross-over trial, amantadine / placebo, on the verbal fluency of chronic post stroke aphasic patients.

Eligibility Criteria:
Inclusion Criteria:

* RANKIN \< 3
* \> 18 years and \< 75
* francophone
* within cognitive deficit known before stroke
* stroke, single in sylvian artery area
* aphasia " non fluent " following a stroke
* stroke \> six month
* stable treatment

Exclusion Criteria:

* RANKIN \> 3
* non francophone
* do not read nor write
* many stroke - against indication
* participated in another clinical trial
* deaf or blind
* intercurrent disease
* new treatment (\< 2 months) cognitive
* pregnant or lactating
Validation of a Home-screening Test for Lactose Intolerance

The hypothesis underlying this study is that whilst there is no home-screening test for lactose intolerance, this test would have significant value as lactose tolerance tests and breath hydrogen tests are expensive and time consuming. Therefore, it would be highly beneficial to validate a simple home-screening test.

This study will validate a simple home-screening test that uses lactose and not milk.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed lactose intolerance as demonstrated by a lactose tolerance test
* Diagnosed as not having lactose intolerance as demonstrated by a lactose tolerance test

Exclusion Criteria:

* Pregnant
* Breastfeeding
* Unwillingness to comply with study outline
Predictive Value of Intraoperative Indocyanine Green Clearance Test After Partially Blood Flow Blocking in Postoperative Liver Reserve

Predictive value of intraoperative indocyanine green clearance measurement during selective hepatic vascular trial clamping on remnant liver function after anatomic liver resection.

In this study, we will prospectively and consecutively enroll patients undergoing hemi-hepatectomy or lateral segmentectomy. ICG clearance measurements will be performed both preoperatively and intraoperatively under partial blood blocking of resecting segments. This study will use PHLF, C-D grade, MELD grade and postoperative hospital stay to evaluate and compare the potential of these measurements to predict postoperative liver function. Accordingly, we are supposed to demonstrate the sensitivity and specificity of intraoperative ICG clearance measurement in detecting postoperative liver failure. Furthermore, cut-off values would be defined to identify high, medium or low risk patients.

Eligibility Criteria:
Inclusion Criteria:

* (a) patients scheduled to undergo major anatomic liver resection according to clinical assessment, (b) patients'expectation of life longer than 3 months, and (c) age between 18 to 80 years old.

Exclusion Criteria:

* (a) patients could not tolerate liver surgery according to preoperative tests, (b) with no need for major liver resection according to intraoperative assessment, (c) had any contraindications to liver surgery, or (d) ICG metabolic disorder.
An Open-label Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term

To demonstrate the efficacy of controlled-release dinoprostone vaginal insert (DVI) for cervical ripening success (either Bishop Score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert administration.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at term (≥37 weeks 0 day and \< 41 weeks 0 day of gestation) at the Baseline visit
* Candidate for pharmacologic induction of labour
* Singleton pregnancy with live infant in vertex presentation
* Baseline BS ≤ 4 at the Baseline visit
* Parity ≤ 3 (parity is defined as one or more births live or stillbirths after 22 weeks 0 day gestation)
* Written informed consent

Exclusion Criteria:

* Women in active labour
* Presence of uterine or cervical scar including scar from previous caesarean section, and previous cone biopsy of the cervix and loop electrosurgical excision procedure (LEEP)
* Uterine abnormality e.g. bicornuate uterus
* Administration of oxytocin, any cervical ripening or labour inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to IMP administration. Magnesium sulfate is permitted if prescribed as treatment for preeclampsia or pregnancy induced hypertension
* Presence of the following conditions/symptoms:

Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 110 mmHg. Platelets \< 100,000/µL. Increased liver function tests (2x upper limits of normal range). Severe, persistent right upper quadrant/epigastric pain. Progressive renal insufficiency: Creatinine \> 1.1 mg/dL, Doubling of creatinine in the absence of other renal disease. Pulmonary edema. New onset cerebral or visual disturbances.

* Suspected or confirmed cephalopelvic disproportion and/or fetal malpresentation
* Diagnosed congenital abnormalities, not including polydactyly
* Suspected or confirmed intrauterine growth retardation (≤ mean 1.5 SD of normal estimated fetal weight for dates)
* Any evidence of fetal compromise at Baseline visit (e.g., non-reassuring fetal heart rate pattern, meconium staining, history of non-reassuring fetal status or abnormal umbilical artery Doppler wave form)
* Intake of medication with aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) at V2
* Ruptured membranes ≥ 48 hours prior to IMP administration
* Suspected clinical chorioamnionitis
* Current pelvic inflammatory disease, unless adequate prior treatment has been instituted
* Fever (axillary temperature ≥ 38.0°C) at the Baseline visit
* Any condition in which vaginal delivery is contraindicated (e.g., placenta previa or any unexplained vaginal bleeding at any time after 24 weeks 0 day during this pregnancy)
* Known or suspected allergy to, dinoprostone, other prostaglandins or any constituent of IMP
* Any condition urgently requiring delivery
* History of asthma or glaucoma
* Unable to comply with the protocol
* Any other medical condition which in the judgement of the investigators would impair participation in the trial
PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)

The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 3 to 6 months of age with bronchiolitis.


Eligibility Criteria:
Inclusion Criteria :

* Active bronchiolitis or a history of bronchiolitis and asthma-like symptoms

Exclusion Criteria :

* A history of any significant illness that will pose additional risk to the patient
Effects of Sage Extracts on Cognitive Function During Aerobic Exercise

Extracts of sage have been reported to interact with central nervous system (CNS) mechanisms relevant to cognitive performance but, to date, no trial has clearly demonstrated the possible effects in healthy individuals in fatiguing conditions. The current study investigates the effects of this supplementation in healthy males and females versus placebo on cognition, heart rate and perceived exertion, during a fatiguing cycling exercise.

Healthy males and females will be tested in fresh and fatiguing conditions to mimic individuals at the beginning or during a competition where cognitive function are important for decision making for example. Tests will be conducted during the warm-up (fresh), during fatiguing situations (during two consecutive 10-minutes pedaling exercises) and during recovery. Tests will include a reverse digit memory test (from 3 to 7 digits), a stroop test, a simple reaction time test. Moreover, heart rate and rating of perceived exertion will be quantified.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index lower than 27 and waist size lower than 94 cm
* physical activity higher than 3 hours a week
* written informed consent

Exclusion Criteria:

* more than 12 hours training a week
* asthmatic, smokers or under medicinal drugs
* dietary supplement, sports drink, special dietary food or functional food, of any kind, liable or presented as liable to enhance physical performances
Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia

Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.

Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C).

Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).

Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)

Eligibility Criteria:
Inclusion Criteria:

* With an Eckardt symptom score ≥ 4
* The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy)
* Informed patient consent was obtained

Exclusion Criteria:

* Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk
* Pseudoachalasia
* Megaesophagus (diameter of \> 7 cm)