cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)

This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.


Eligibility Criteria:
Inclusion criteria

* Participants with essential hypertension:

  * who are on single drug therapy
  * who are newly diagnosed and not yet taking any drug therapy, or have not had any drug therapy for at least 2 weeks prior to entering study
  * who have blood pressure readings of 90mmHg ≤ MSDBP \< 110mmHg and 140mmHg ≤ MSSBP \<180mmHg after 2 weeks wash-out for patients on single agent.
* Randomization (Visit 3)

  * After dosing of amlodipine 5mg for 6 weeks, blood pressure readings are:

    * 90mmHg ≤ MSDBP \< 110mmHg and 140mmHg ≤ MSSBP \< 180mmHg.

Exclusion criteria

* Participant with MSDBP ≥ 110mmHg or MSSBP ≥ 180mmHg.
* Participant currently taking ≥ 2 antihypertensive medications (note: fixed-dose combination medicine should be counted as the number of active ingredients).
* Participant with known secondary hypertension of any etiology.
* Participant with malignant hypertension or current evidence of impending or active malignant hypertension, including headache, papilledema, cardiac ischemia, or pulmonary congestion precipitated by elevated blood pressure.
* Participant with known intolerance, contraindication or hypersensitivity to any component of dihydropyridines, angiotensin II receptor blockers.
* Participant showing positive in pregnancy test, lactating woman, or woman who intends to get pregnant during the study period.
Development, Implementation and Initiation of Normative Database Quantitative Ultra High Field MRI Paramaters

The Centre for Magnetic Resonance in Biology and Medicine (CRMBM, UMR-CNRS 7339 AMU) obtained funding for a whole body NMR imaging at 7. It is the only MRI at 7T installed in a hospital in France (only two 7T MRI in France) and therefore a unique opportunity to develop new diagnostic approaches.

The purpose of this study is to develop, implement and validate new MRI quantitative parameters derived from ultra high field MRI in order to characterize non-invasively with an unprecedented resolution and sensitivity, anatomy as well as certain physiological, hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart in healthy subjects

The key is that the goal of our projects is not only producing images of better quality than using a 3T scanner but also making images differently, by highlighting new contrasts and features of theses organs in order to improve the diagnosis and prognosis of neurological, psychiatric, cardiovascular and rheumatologic diseases.

Eligibility Criteria:
Inclusion Criteria:

* People not presenting contraindications to the MRI (pacemaker, agitation, metallic brightness, claustrophobia etc.)
* People having no intra-physical object potentially conductive.
* People having no affection after detailed interrogation

Exclusion Criteria:

* People staying in a sanitary or social establishment
* People in emergency situation
* People not wishing to be informed about anomalies in the MRI
* Pregnancy
Effectiveness of Insoles Provided to Patients With Diabetes. A Longitudinal Randomized Controlled Study in Gothenburg

Introduction: Insoles and shoes are frequently prescribed to prevent foot ulcers in patients at risk of diabetes. A combination of neuropathy and foot deformities raises the risk from 1% to between 4-7% according to the Swedish National Board of Health and Welfare, Guidelines Diabetes Care 2010. Preventative care, which includes foot care, annual inspection of the feet, education and prescription of insoles in combination with well fitting shoes are supposed to decrease the risk of ulcers and prevent amputation. Further research is, however, needed to evaluate the effectiveness of these commonly prescribed insoles. The aim of this study is to compare three different types of insoles with respect to pressure distribution. Every 6 months follow-up is assessed until 24 months is reached.

Patients included in the study were randomized into 3 different groups. Group number 1 and 2 got custom made insoles out of EVA (Ethyl Vinyl Acetate) with different hardness 35 and 55 shore respectively. Group nr 3 got prefabricated insole with support of the medial arch and in the forefoot. The top layer was covered with a 2 mm cushioned material, 25 shore, made out of microcellular urethane. All patients were recommended to wear good walking shoes with a semi rigid outer sole and stable heel counter. One and the same technician made the casting and fabricated the insoles as well as delivered the devices. Deliverance occured 2-3 weeks after the first visit.

At deliverance base line measurement was assessed.

Eligibility Criteria:
Inclusion criteria:

* First time visitor to Dept of Prosthetics \& Orthotics
* Diabetes
* Age \> 18 year
* Be able to walk independently
* Be able to read and understand Swedish

Exclusion Criteria:

* Ulcers
Clinical Evaluation of the Levita Robotic Platform

The purpose of this study is to evaluate the safety and feasibility of the Levita Robotic Platform (LRP) used with the Levita Magnetic Surgical System (MSS)

Prospective, multi-center, single-arm, open label study designed to assess the safety and feasibility of the use of the Levita Robotic Platform with the Levita Magnetic Surgical System in laparoscopic procedures.

Eligibility Criteria:
Inclusion Criteria:

* • Subject is at least 18 years of age

  * Subject is scheduled to undergo elective laparoscopic procedure
  * Subject signs a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures

Exclusion Criteria:

* • Subjects with pacemakers, defibrillators, or other electromedical implants

  * Subjects with ferromagnetic implants
  * Subjects with significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
  * Subjects with a clinical history of impaired coagulation confirmed by abnormal blood tests
  * Subject has an anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
  * Subject is pregnant or wishes to become pregnant during the length of study participation
  * Subject is not likely to comply with the follow-up evaluation schedule
  * Subject is participating in a clinical trial of another investigational drug or device
Ultrasound in Muscle Biopsy

The objective of the proposed study is to evaluate the clinical utility of muscle ultrasonography for improving the diagnostic yield and safety of core muscle biopsy. Our facility currently uses core (needle) biopsy to obtain muscle samples in patients 18 years old or older. Currently, there is no imaging tool used to guide the actual biopsy. As muscle biopsy is an invasive and potentially painful procedure, improving the diagnostic yield of this test is important.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive subjects scheduled for a biopsy at our EMG laboratory will be asked if they would like to participate until a total of 40 participants are obtained.

Exclusion Criteria:

* Age under 18 years.
* Inability to provide consent for participation.
The Impact of Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients

The aim of the study is to identify the diagnostic value of the focused assessed echocardiography in septic patients undergoing urgent abdominal surgery due to peritonitis. The investigators expect that the incidence of hemodynamic instability will be reduced and the survival of the patients will be improved.

Often sepsis remains undiagnosed at the very beginning because of the concentration to the surgical pathology in perioperative period. This results in unacceptably high mortality. The investigators hypothesize that extended hemodynamic monitoring by focused transthoracic echocardiography will personalize early fluid resuscitation which will improve patient's outcome.

The goals of the investigators study are:

* To conduct two-group randomized controlled clinical trial to compare patient management based on standard monitoring and extended hemodynamic monitoring by focused transthoracic echocardiography in patients undergoing urgent abdominal surgery due to peritonitis.
* To demonstrate that patient management based on extended hemodynamic monitoring by focused echocardiography results in improved survival, reduced incidence of hemodynamic instability during perioperative period.
* To compare an amount of administrated of intravenous fluids in both groups.

The investigators hypothesize that focused echocardiography monitoring will result in more administrated intravenous fluids during perioperative period.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old.
* Patients undergoing urgent abdominal surgery due to diffuse peritonitis.
* SOFA score \>2.
* Patients who sign an agreement to participate in the study.

Exclusion Criteria:

* Younger than 18 years old.
* Known pregnancy.
* Unconscious patients or those who do not agree to participate in the study.
* Contraindication to central venous or arterial catheterization.
* Patients who were already treated in ICU because of sepsis or septic shock before this surgery.
* Known chronic renal failure.
* Re-laparotomy.
* Peritonitis due to acute mesenteric ischaemia, thrombosis or trauma.
* Dying patients.
Access to Nutritional Services and the Effect on Maternal Weight Gain

The purpose of this study is to evaluate the effect of access to nutrition services on pregnancy outcomes in the obese urban population. There are many studies that have shown that obesity has a negative impact on pregnancy. However, currently there are only a few small studies that specifically look at ease of access to nutrition services in an obese urban population and the effect this has on maternal weight gain and pregnancy outcomes. This study will compare two groups of pregnant women with a BMI of 30 or greater. The investigators hypothesize that access to nutritional services will lead to decreased weight gain during pregnancy and improved pregnancy outcomes.

The purpose of this study is to evaluate the effect of access to nutrition services on pregnancy outcomes in the obese urban population. Approximately one fourth of women in the United States are overweight and nearly one third are considered to be obese. Pregnancy places obese women at increased risk for several adverse events in the antepartum, intrapartum, and postpartum period. There are many studies that have shown that obesity in pregnancy has a negative impact on pregnancy. However, currently there are few studies in the United States that specifically look at ease of access to nutrition services in an obese urban population and the effect this has on pregnancy outcomes. This study will be a randomized controlled study that will compare two groups of pregnant women with a BMI of 30 or greater one of which has access to nutritional services along with routine prenatal care while the other gets only routine prenatal care. The investigators hypothesize that the obese parturient who has access to nutritional services will have decreased weight gain during pregnancy and ultimately have improved pregnancy outcomes. This will help to guide future care for the obese parturient in the urban population who may have limited access to services.

Eligibility Criteria:
Inclusion Criteria:

* primigravid women
* age 19-40yrs
* less than or equal to 18 weeks gestation at time of enrollment
* body mass index (BMI) greater than or equal to 30

Exclusion Criteria:

* multiparous women
* less than 19 yrs of age or older than 40
* greater than 18 weeks gestation at time of enrollment
* body mass index (BMI) less than 30
* any significant past medical history including hypertension, diabetes, renal disease, coagulopathy
* past surgical history of gastric bypass/weight loss surgery
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty

The main aim of the present study was to evaluate the therapeutic potential and safety of transarterial infusion of granulocyte colony stimulating factor (G-CSF) mobilized cluster of differentiation (CD) 133(+) cells when combined with percutaneous transluminal angioplasty (PTA) in treatment of below the knee (BTK) peripheral arterial disease (PAD) in diabetic patients.

CD133+ cell, a bone marrow derived subpopulation of adult hematopoietic progenitor cells, confers high proliferative, vasculogenic and regenerative capacity in vitro and in vivo. thereby suggesting that CD133+ cells may induce vasculogenesis, improve limb perfusion, prevent tissue loss and restore ambulatory function in patients with critical limb ischemia. Although several small, randomized trials have been conducted so far demonstrating safety of autologous cells of bone marrow origin for the treatment, the reported benefits were found to be variable. A meta-analysis of autologous bone marrow derived cell therapy for critical limb ischemia trials suggested that application of autologous stem cell transplantation in curing limb ischemic patients does not have obviously effectiveness in the improvement of ankle brachial pressure (ABI) of the limb ischemic patients. But it can dramatically reduce the rate of amputation.

Therefore, in the present study, the investigators aim to evaluate the therapeutic potential and safety of transarterial infusion of g-csf-mobilized CD 133(+) cells when combined with PTA in treatment of below the knee PAD in diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age range: 18-75 years , Gender: Both
2. Patients with below the knee limb ischemia with diabetes.
3. Rutherford class 2-6.
4. Target lesions with a diameter reduction of at least 50% and have an occlusion of longer than 4 cm on angiography.
5. Have no previous history of any stem cell therapy \[infusion of CD133 endothelial progenitor cell (EPC)\].

Written informed consent signed by the patients or representatives. -

Exclusion Criteria:

1. Previous bypass surgery or stent placement at the ipsilateral lower limb
2. History of intolerance to antiplatelet therapy, heparin, or contrast media.
3. Presence of any of the following conditions:

   1. severe liver disease (such as ascites, esophageal varices, liver transplantation);
   2. hemodynamic instability;
   3. Severely impaired renal function (serum creatinine level \> 2.5 mg/dL).
   4. Receiving immunosuppressive therapy;
   5. History of decompensated heart failure (New York Heart Association class III or IV and level) or myocardial infarction, or heart bypass surgery;
   6. Bleeding diathesis;
   7. Active systemic bacterial infection;
   8. Acute thrombophlebitis or deep vein thrombosis of the target limb; 4) Pregnant or lactating women, or women of child bearing age unable or unwilling to use effective contraception during the study period; 5) Expected survival time of less than 24 months -
Activity Restriction for Women With Arrested Preterm Labor

to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.

Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors.

Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs that can slow or stop labor contractions in the attempt to delay births preceded by PTL. Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In most of these women, PTL stops, but as their risk of PTB remains high, some have advocated use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance tocolytic agent has been shown to be beneficial in preventing PTB.

Some authors have also advocated the use of activity restriction in women with arrested PTL to reduce the risk of PTB. Activity restriction is defined as the following forms of activity restriction: pelvic rest and prohibition of sexual activity, reduction of work and/or non work activity. So far, the benefit of activity restriction in women with arrested PTL is still subject of debate and no Randomized Controlled Trial (RCT) has been undertaken.

Thus, the aim of this trial is to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.

Eligibility Criteria:
Inclusion Criteria:

* singleton gestations;
* arrested PTL;
* TVU CL \< 25 mm;
* 18 years to 50 years.

Exclusion Criteria:

* multiple gestations;
* symptoms of PTL (not arrested PTL);
* TVU CL ≥ 25mm;
* premature rupture of amnion and chorion membranes (PROM) at the time of randomization;
* cerclage in situ at the time of randomization;
* pessary in situ at the time of randomization;
* vaginal bleeding at the time of randomization;
* women who are unconscious, severly ill, mentally handicapped;
* women under the age of 18 years or over the age of 50 years.
Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers

The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged between 18 and 45 years, inclusive.
* Body mass index (BMI) between 19 and 30 kg/m2, inclusive.
* Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
* Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
* Clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
* Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
* Non-smokers or who smoke ≤ 10 cigarettes or equivalent per day.
* Able and willing to give written informed consent.
* (If female) Not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device.
* (If female) Negative urine pregnancy test at screening and admission to each treatment period.

Exclusion Criteria:

* Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
* Clinically relevant surgical history.
* History of relevant atopy or drug hypersensitivity.
* History of alcoholism or drug abuse.
* Consumed more than 14 units of alcohol a week.
* Significant infection or known inflammatory process at screening or admission to each treatment period.
* Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
* Used medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion.
* Used any investigational drug or participated in any clinical trial within 6 months prior to screening.
* Participated in more than 2 clinical trials within the 12 months prior to screening.
* Donated or received any blood or blood products within the 3 months prior to screening.
* Vegetarians, vegans or with medical dietary restrictions.
* Could not communicate reliably with the investigator.
* Unlikely to co-operate with the requirements of the study.
* Unwilling or unable to give written informed consent.
* (If female) Pregnant or breast-feeding.
* (If female) Of childbearing potential and she did not use an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives.
Safety, Tolerability and Pharmacokinetics of Increasing Repeated Doses of BIIF 1149 BS in Healthy Male Volunteers

The objective of the present study was to obtain information about the safety and tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary pharmacokinetics data (steady state and accumulation factor)


Eligibility Criteria:
Inclusion Criteria:

* Participants should be healthy males
* Age range from 21 to 50 years
* Within +- 20% of their normal weight (Broca-Index)
* In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study
* Each subject will have his medical history taken and will receive a complete medical examination (incl. demographics, medical history, check of inclusion/exclusion criteria, physical examination, vital signs, 12-lead Electrocardiogram (ECG)
* Haematopoietic, hepatic and renal function test will be carried out in the laboratory
* The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance

Exclusion Criteria:

* Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (\>= 24 hours) within ten half-lives of the respective drug before enrolment in the study
* Use of any other drugs which might influence the results of the trial during the week previous to the start of the study
* Participation in another study with an investigational drug within the last two months preceding this study
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 40g/day)
* Drug abuse
* Blood donation (\>= 100 ml) within the last 4 weeks
* Excessive physical activities (e.g. competitive sports) within the last week before the study