cyrilzakka/clinical-trials huggingface dataset:
BIBR 277 Capsule in Patients With Essential Hypertension

The efficacy and safety of Telmisartan capsule in patients with essential hypertension were evaluated in comparison with Enalapril Maleate in the double blind trial.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 25 years of age
* Patient is either male or female
* Outpatient. Change to inpatient is not allowed during the study period
* Blood pressure is measured 3 times or more during the 4-week observation period; the last 2 measurements in the sitting position (intervals between measurements must be less than 4 weeks) are stabilized for both of systolic pressure (within +/- 30 mmHg) and diastolic pressure within +/- 15 mmHg) with the mean exceeding 160 mmHg for systolic and 95 mmHG for diastolic pressure

Exclusion Criteria:

* Patient has severe hypertension (the last 2 measurements in the observation period exceed 120 mmHg in terms of diastolic blood pressure)
* Patient has secondary or malignant hypertension
* Patient has a history of severe cardiac failure, unstable angina, or myocardial infarction within previous six months
* Patient has atrioventricular conduction disturbance, atrial fibrillation or severe arrhythmia
* Patient has any symptoms of cerebrovascular disorder
* Patient has serious hepatic dysfunction (either GOT (glutamic-oxaloacetic transaminase) or GPT (glutamic-pyruvic transaminase) exceeds 100 U)
* Patient has renal dysfunction (serum creatinin ≥ 2.1 mg/dl)
* Patient has uncontrolled diabetic (either of the following tests exceeds the specified standards: fasting blood glucose exceeding 151 mg/dl or HbA1c exceeding 8%)
* Patient has a history of drug sensitivity to ACE (angiotensin converting enzyme) inhibitors and angiotensin II receptor antagonists
* Patient has a history of angioedema due to ACE inhibitors
* Patient has hyperkalemia (K exceeding 5.5 mEq/l)
* Patient has received enalapril just before the start of observation period
* Patient has received treatment with any other investigational drug(s) within three months of the start of observation period
* Patients is pregnant, breast-feeding, or possible pregnant, or wants to be pregnant during the study period
* Patient has any other condition that the investigator or subinvestigator feels would be inappropriate for the study participation
Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)

The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria
* Willingness of subject to follow all study procedures
* Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight

Exclusion Criteria:

* Pregnancy and breast-feeding
* Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
* Clinically manifested immunosuppressive disorder or known history of malignant disease
* History of relevant drug and/or food allergies
Maternal Periodontal Status and Cytokines in Preeclampsia

Background: The purpose of this study is to examine the relationship between maternal preeclampsia and periodontal parameters and the correlation of these two disorders with maternal gingival crevicular fluid levels (GCF) of interleukin (IL)-35, interleukin-37 and interleukin-6. The investigators also investigated their relation to the severity of preeclampsia.

Methods: 82 preeclamptic women were recruited to the study (29 healthy pregnant women, 30 mild preeclamptic patient, 23 severe preeclamptic patient ). The clinical periodontal parameters and GCF samples were collected in the first day of puerperium.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 45 years
* 25 and 40 weeks of gestation.
* Healthy pregnants, mild and severe preeclampsia

Exclusion Criteria:

* Patients with accompanying diseases
* multiple gestations
* congenital abnormalities were excluded from the study.
A Trial to Compare Surgery With Sorafenib for Hepatic Celluler Cancer With Portal Vein Tumor Thrombosis

According to the guidelines recommended, only a few new targeted therapy drugs treatment, such as Sorafenib, is proper. It's 3 year survival rate is only 8% or so. According to our previous study, patients with hepatic carcinoma without portal vein tumor thrombus backbone and the contralateral tumor thrombus applyed tumor excision, along with tumor thrombus, the 3 year survival rate can reach 39.9%, the 5-year survival rate can reach 22.7%, curative effect is obviously better.


Eligibility Criteria:
Inclusion Criteria:

* 1. Clinical diagnosis of Hepatic cellular Carcinoma. 2. Patients with Portal Vein Tumor Thrombus (PVTT) of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI.

  3. Patients with a solitary tumor or multiple tumor which are resectable. 4. Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis.

  5. Patients without surgical contraindication. 6. Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) \< 10% before treatment.

  7. Laboratory examination: haemoglobin (Hb)\>100g/L, white blood cell (WBC) \> 3000/mL, PLT \> 8×10\*10/L before treatment.

  8. Patients without severe esophagealgastric varices before treatment. 9. Patients with HBV，HBV DNA≤100, 000 copy/mL. 10. All of the patients has written consent for this research.

Exclusion Criteria:

* 1.Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis.

  2.Patients with surgical contraindication. 3.Patients with Child C grade liver function before treatment. 4.Patients with other malignancy. 5.Patients treated with hepatic resection or TACE before this treatment. 6.Patients with severe esophagealgastric varices or refractory ascites or coagulation dysfunction before treatment.
Genetics of Obsessive-Compulsive Disorder

The purpose of this study is to identify genes that affect susceptibility to obsessive-compulsive disorder (OCD). By identifying genes that increase or decrease the risk of OCD, researchers can better understand how the condition develops and ultimately improve treatment for people with OCD.

OCD is a severe, familial condition that affects approximately 2% of the population. The way OCD is inherited is not clearly understood, but researchers believe it is complex and involves multiple genes. This study will detect and localize genes that increase or decrease susceptibility to OCD. The data collected from this study will be combined with data from other research studies to determine gene linkage and association.

Obsessive-compulsive disorder (OCD) is a severe, heritable condition with a lifetime prevalence of about two percent of the population. The mode of inheritance is poorly understood but is likely complex, involving multiple loci of small to major effect. Since 1995, the NIMH-IRP has been active in a multi-center family study of OCD, led by Dr. Gerald Nestadt of Johns Hopkins University, which was approved via a competitive NIMH extramural application (MH 502140). An expanded consortium of sites (including new sites at Brown and Harvard Universities) anticipates adding 300 new affected sib-pair families over the next three years. This sample will be used for linkage and association analyses. Data will be shared within this consortium of investigators studying OCD, and will eventually be combined with data obtained from a second consortium.

Eligibility Criteria:
* INCLUSION CRITERIA:

Must have a diagnosis of obsessive-compulsive disorder, or be a family member (usually a parent or sibling) of someone with obsessive-compulsive disorder.

Certain disorders are considered part of OCD "spectrum" disorders and often include family members with OCD. These include Tourette's Syndrome, other individuals with tics, and Trichotillomania (severe hair pulling), and other forms of repetitive behaviors.

Persons with primary behavioral difficulties who do not fit with the current definitions of "OCD and OCD spectrum disorders" may not be eligible. These include compulsive shopping, gambling, or compulsive sexual behaviors.
Dose Effects of SCF on Calcium Metabolism and GI Microflora in Adolescents

Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in rats and in adolescent boys and girls.

The growing knowledge of non-digestible oligosaccharide (NDO)-related health benefits has led to the identification of other fermentable carbohydrates which may improve bone balance and bone health parameters. One such carbohydrate is the corn derivative, soluble corn fiber (SCF). Already known for its association with improved intestinal health and influence on colonic microflora content, we have been studying the effects of SCF on calcium absorption and bone health. First we found that soluble corn fiber (SCF) greatly enhanced calcium utilization and bone properties in a growing rat model. Results from this study demonstrated that SCF was capable of increasing bone mineral content, density and bone strength parameters in 4-week old, male rats. Our study in adolescent boys and girls showed a 12% increase in calcium absorption after consuming 12 g SCF for 21 days compared to a control period in a crossover design using a controlled feeding metabolic balance approach. Given these profound changes on calcium absorption and in bone, a logical next step is to study a dose-response effect of SCF on calcium absorption, bone turnover, and gut microflora in free-living adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescent Caucasian girls between the ages of 12-14. This population has been chosen because they exhibit higher risk for osteoporosis later in life.

Exclusion Criteria:

* Habitual dietary patterns including less than 550 and greater than 1500 mg Ca per day. This represents the 5th and 95th percentile of usual intake of girls 9-13 y in the US.
* History of smoking, alcohol use, illegal or non-prescription drug use
* History of disordered calcium or bone metabolism e.g. Paget's disease, hyper or hypo-calcemia
* History of gastrointestinal diseases (Crohn's, celiac, inflammatory bowel disease)
* History of diseases that affect kidney or liver function.
* Body Mass Index (BMI) less than 5th percentile for age or greater than the 90th percentile for age
* Having a broken bone within the last 6 months.
* Regular consumption of foods or supplements containing prebiotics or probiotics
* History of pregnancy or use of contraceptives
Chronic Knee Pain Study

Specific Aims: 1) To examine differences between AA and white patients with knee OA in willingness to consider knee joint replacement. 2) To examine the relationship between socio-cultural factors and patient willingness to consider joint replacement. 3) To examine how demographic, socio-cultural, and clinical factors mediate the relationship between race and patient willingness. 4) To examine the relationship between patient willingness and referral to orthopedic care for knee OA (secondary aim).

Experimental design/Methodology: A cross-sectional survey study design will be used to examine socio-cultural and clinical factors that may vary by race/ethnicity and may be determinants of willingness to consider joint replacement as a treatment option. Patients with symptomatic and radiographic knee OA from the primary care clinics will be surveyed. Only individuals with knee OA of sufficient severity that would be considered candidates for joint replacement will be included. Analytic strategies include ordinal logistic regression, path analysis, and regression trees.

Subject population: The study sample will consist of approximately 133 African American and 419 white patients with OA of the knee in a primary care setting.


Eligibility Criteria:
Inclusion Criteria:

* over age 50
* chronic knee pain
* radiographic evidence of knee OA

Exclusion Criteria:

* previous joint replacement
* inflammatory arthritis
Penetrating Abdominal Injuries From the Battle of Mosul

The battle of Mosul was characterized by the use of improvised explosive devices, human shields and suicide bombers in an urban setting. It is unclear whether this type of warfare cause more extensive abdominal injuries to civilians than combatants. All patients admitted with penetrating abdominal injury subjected to an exploratory laparotomy at Emergency Hospital, Erbil, between October 17, 2016 and July 16, 2017 will be included. Differences in demographics, injury mechanism, time since injury, clinical status on arrival, intraoperative findings, postoperative complications and outcome will be studied.

Study Rationale The battle of Mosul was characterized by the use of improvised explosive devices, human shields and suicide bombers in an urban setting. It is unclear whether this type of warfare cause more extensive abdominal injuries to civilians than combatants. Understanding of the correlation between the severity of abdominal injuries, type of warfare and population affected is of importance when planning for surgical care in a conflict setting.

Aim To assess whether civilians obtain more extensive abdominal injuries than combatants in an urban battle characterized by the use of indiscriminate weapons.

Study Design An observational retrospective cohort study with longitudinal data collection.

All patients admitted with penetrating abdominal injury subjected to an exploratory laparotomy at Emergency Hospital, Erbil, between October 17, 2016 and July 16, 2017 will be included. Differences in demographics, injury mechanism, time since injury, clinical status on arrival, intraoperative findings, postoperative complications and outcome will be analysed.

Primary Objective Differences in injury mechanism, organs injured, surgical treatment given, postoperative complications and outcome between civilians and combatants.

Secondary Objectives Differences in surgical treatment given, postoperative complications and outcome between patients with prior surgical treatment of their injury and patients without prior surgical treatment.

Differences in surgical treatment given, postoperative complications and outcome between patients who receive surgical treatment less than 24 hours from injury and patients who receive surgical treatment more than 24 hours from injury will be analysed.

Statistical methods Differences between groups will be analysed using t-test and regression models.

Eligibility Criteria:
Inclusion Criteria (all must be fulfilled):

* Penetrating abdominal injury
* Subjected to an exploratory laparotomy at Emergency Hospital, Erbil, Iraq
* Between October 17, 2016 and July 16, 2017

Exclusion Criteria (all must be fulfilled):

* Patients who received treatment several times will only be counted as one patient
* Between October 17, 2016 and July 16, 2017
Reason for Prescribing Rice Infant Formula

The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest.

The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest. Secondary objectives are to describe the modalities of feeding before, during and after consuming the RIF, to describe the growth of children who have consumed a RIF for at least 1 month, on the basis of anthropometric data collected during the first year of life. As a second intention, this study also aims to monitor the evolution of child's digestive and allergic symptoms, if any, and the sociodemographic characteristics of the infant's family.

Eligibility Criteria:
Inclusion Criteria:

* Child aged between 6 and 36 months,
* Child who has already consumed a RIF for at least one month, or still consuming a RIF, or who will benefit from taking a RIF, according to the pediatrician,
* Legal representatives (parents/guardians) deemed capable of following the requirements of the protocol and have given their consent orally.

Exclusion Criteria:

* Child with a clinically relevant and significant abnormality in the medical history or on physical examination;
* Child who has been hospitalized in a neonatology unit (due to prematurity, malformation or neonatal pathology), or born with a low birth weight (≤ 2,500 g);
* For children not diversified at the time of starting RIF: mixed feeding with RIF and breast milk and/or infant formula based on cow's milk;
* Child born to minor parent(s);
* Infant or infant's family unable to comply with study protocol or procedures, in the judgment of the investigator;
* Participation in any other clinical trial prior to inclusion;
* Refusal of the Parents / legal representatives of the child, or who do not master the French language well enough to understand the information letter.
Measuring the Impact of Integrating Maternal and Newborn HIV Testing With Childhood Immunization Services

This randomized evaluation measured the impact of two levels of support for the integration of infant and postpartum maternal HIV testing with routine immunization services in Southern Zambia on the number of postpartum maternal HIV tests, infant HIV tests, and 1st dose diphtheria, pertussis, and tetanus (DPT1) vaccines.

This evaluation assessed two levels of support for the integration of early infant and maternal HIV testing with existing routine immunization services in rural health facilities in Southern Zambia with the aim of determining whether infant and postpartum maternal HIV testing rates would increase without harming immunization uptake. The evaluation randomized 60 health facilities to one of three study arms: 1) Control (status quo); 2) Simple Intervention; and 3) Comprehensive Intervention. The Simple Intervention included restocking of HIV test kits and reminding health facilities of existing HIV testing guidelines by government health officials. The Comprehensive Intervention included the Simple Intervention components, as well as community sensitization, hands-on operational support to integrate services and improve patient flow, and opt-out HIV testing for mothers and infants according to existing guidelines. The change in the average number of monthly HIV tests and immunizations (DPT1) between the intervention period and baseline were compared between treatment and control facilities.

Eligibility Criteria:
Note that this evaluation used administrative data - no participants were enrolled for the main part of this study. Participants were enrolled for the qualitative portions of the study.

Inclusion Criteria:

* Mothers who had an infant within the past 18 months during the intervention period (Oct 2013 - Mar 2014)
* Infants who were at least six weeks of age and under six months of age during the intervention period (Oct 2013 - Mar 2014)
* Qualitative activities included facility staff and mothers and caregivers whose infants were due for their 6 week immunization during the intervention period.

Exclusion Criteria:

* Mothers who did not have an infant within the past 18 months during the intervention period
* Infants who were less than six weeks of age during the intervention period or greater than six months of age throughout out the intervention period.
* Adults who were not mothers or caregivers with an infant due for his/her 6 week immunization during the intervention period were excluded from the qualitative activities.
EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events

EDUCATE is a prospective, multi-center study designed to collect real-world safety and clinical outcomes in subjects receiving one or more Endeavor Zotarolimus-Eluting Stents and either clopidogrel and aspirin or prasugrel and aspirin as part of a dual antiplatelet therapy (DAPT) drug regimen.

To provide clinical information on rates of late and very late stent thrombosis after Endeavor Drug-eluting Stent (DES)placement in an all comers population with a broad range of bleeding and thrombosis risk. EDUCATE will further analyze the current practice of clinicians regarding temporary cessation of antiplatelet therapy and its association with clinical outcomes. In addition, patients included in this broad Endeavor registry will also be contributed to the DAPT native study population for analysis of 12 vs 30 months duration of dual antiplatelet therapy.

Eligibility Criteria:
ENROLLMENT INCLUSION CRITERIA

* Patient is older than 18 years.
* The patient or patient's legal representative has consented to participate and has authorized the collection and release of his medical information by signing the "Subject Informed Consent Form".
* Patients undergoing percutaneous intervention with Endeavor stent deployment (or has within 24 hours).
* The patient is willing and able to cooperate with study procedures and required follow up visits.

ENROLLMENT EXCLUSION CRITERIA

* Index procedure stent placement with stent diameter \< 2.5 mm or \> 3.5 mm.
* Pregnant women.
* Current medical condition with a life expectancy of less than 3 years.
* The patient is currently participating in another investigational device or drug study that clinically interferes with the EDUCATE Study. The patient may only be enrolled in the EDUCATE Study once.
* Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use.
* Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
* Patients treated with any stent other than the Endeavor stent during the index procedure.

RANDOMIZATION INCLUSION CRITERIA AT 12 MONTHS

* Subject is "12 Month Clear".
* Subjects without known contraindication to dual antiplatelet therapy for at least 18 months after randomization.

RANDOMIZATION EXCLUSION CRITERIA AT 12 MONTHS

* Pregnant women.
* Subject switched thienopyridine type or dose within 6 months prior to randomization.
* Planned surgery necessitating discontinuation of antiplatelet therapy within the 18 months following randomization.
* Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization.
* Planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization.
* Current medical condition with a life expectancy of less than 3 years.
* Subjects on warfarin or similar anticoagulant therapy.