cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Patients With Known or Suspected Heart Disease

In this study researchers will admit and evaluate patients with known or suspected heart disease referred to the Cardiology Branch of the National Heart, Lung, and Blood Institute (NHLBI).

Patients participating in this study will undergo a general medical evaluation, including blood tests, urine, examination, chest x-ray and electrocardiogram (EKG). In addition, patients may be asked to have an echocardiogram (ultrasound scan of the heart) and to perform an exercise stress test.

These tests are designed to assess the types and causes of patient's heart diseases and to determine if they can participate in other, specific research studies.

The principal mission of the NIH is the conduct of research that elucidates biological mechanisms, pathogenesis, and treatment of disease. Patients with known or suspected cardiovascular diseases are referred to NHLBI cardiologists for consideration of participation in clinical research protocols. However, eligibility for participation is often uncertain from referral information or even after an outpatient evaluation. The purpose of this protocol is to permit inpatient evaluation of patients for whom participation in clinical research protocols is under consideration in order to determine protocol eligibility by means of conventional laboratory and cardiovascular testing.

Eligibility Criteria:
* INCLUSION CRITERIA:

The following is a representative list of the types of patient presentations and potential diagnoses eligible for this protocol:

1. Coronary artery disease with angina or inducible myocardial ischemia as determined by noninvasive testing.
2. Cardiomyopathies including congestive phenotypes.
3. Peripheral artery disease with intermittent claudication or limb-threatening ischemia.
4. Renovascular disease with uncontrolled hypertension, intermittent pulmonary edema, or evidence of ischemic nephropathy.
5. Upper extremity peripheral artery disease.
6. Diabetes with heart failure.
7. Pulmonary hypertension.

EXCLUSION CRITERIA:

Pregnancy, for those patients who require catheterization-based diagnostics.

Inability to provide informed consent.
Clinical Experience With a Tensor Fasciae Latae Perforator Flap Based on Septocutaneous Perforators

The purpose of this study is to evaluate the possible harvest of a tensor fasciae latae flap based on septocutaneous perforators.This study should further confirm our data from an anatomical study concerning location, distribution, diameter and differentiation of the perforators.


Eligibility Criteria:
Inclusion Criteria:

* soft tissue defect
* no previous operations in the thigh region

Exclusion Criteria:

* obese patients
A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck

This phase II, open-label, randomized study will evaluate the efficacy and safety of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2 weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation of progressive disease and upon meeting eligibility criteria. Anticipated time on study treatment is until disease progression or intolerable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically confirmed Stage III or IV recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
* Progressive disease on or after first-line platinum-based chemotherapy regimen for R/M SCCHN (maximum of 6 cycles)
* No more than one platinum-based chemotherapy regimen for R/M SCCHN is allowed
* Prior platinum-based treatment as definitive chemo/radiotherapy for locally advanced disease is allowed if completed/terminated \>/= 6 months before the platinum-based regimen for R/M SCCHN
* Consent to provide archival tumor tissue for biomarker testing
* Measurable disease per RECIST v1.1
* ECOG performance status of 0, 1 or 2
* Adequate hematologic, renal and liver function

Exclusion Criteria:

* Nasopharyngeal cancer
* Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members
* This includes but is not limited to cetuximab, panitumumab, erlotinib, geftinib, and lapatinib
* Prior treatment with an EGFR inhibitor is allowed if it was administered as part of definitive therapy for locally advanced disease and completed \>/=1 year before study enrollment
* Leptomeningeal disease as the only manifestation of the current malignancy
* Active infection requiring iv antibiotics
* Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs
* Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; bone fractures)
* History of heart failure or serious cardiac arrhythmia
* History of myocardial infarction within 6 months of Cycle 1, Day 1
* Clinically significant liver disease, including active viral, alcoholic or other hepatitis, cirrhosis, or current alcohol abuse
* HIV infection
* Primary central nervous system (CNS) malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
* Pregnant or lactating women
* Malignancies other than SCCHN within 5 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors

This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.


Eligibility Criteria:
Inclusion Criteria: - Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine the suitability for the trial - Male haemophilia A or B patients with inhibitors aged 18 years or older at the time of signing informed consent - Patients currently in need of treatment with bypassing agents Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Known inherited or acquired bleeding disorder other than haemophilia - Ongoing or planned immune tolerance induction therapy or prophylaxis with FVIII or FIX
Clinical Performance of CAD/CAM Splint Materials

The goal of this clinical study is to compare the performance of computer aided designed and computer aided manufactured (CAD/CAM) occlusal splints with splints produced with conventional methods. The main questions this clinical study aims to answer are:

* Do CAD/CAM splints have the same therapeutic effect as the traditional splints ?
* Do CAD/CAM splints demonstrate better surface wear and fit and lower wear in opposing jaw than traditional splints ?
* Is objective pain evaluation of the patient better with CAD/CAM splints ?

Participants were asked to use the splints for 6 months, 8 hours a day and come for follow-up appointments 3 times during this 6 month period:

* Delivery appointment
* First appointment: one week later after delivery appointment
* Last appointment: 6 months after delivery appointment Researchers compared CAD/CAM groups with traditional group to see the clinical performance of the CAD/CAM groups.

24 patients applying to Istanbul University Faculty of Dentistry Department of Prosthodontics and diagnosed with Diagnostic Criteria/ Temporomandibular Disorders (DC/TMD) protocol were included in the study. The patients were randomly divided into 3 groups (n=8); PEEK group (PEEKG), PMMA group (PMMAG), and control group (CG). Dental stone casts of the upper and the lower jaws of the patients were obtained by condensation type silicone impression material and occlusal splints were fabricated in study groups with digital method (designed and milled, manufactured with CAD/CAM) either from PEEK blocks or PMMA blocks and in control group with traditional vacuum pressing machine and adapted by the clinician at chairside. The patients wore the splints for 6 months. Surface roughness, surface wear, fit of the splints and patient satisfaction as well as therapeutic effect of the splints were examined.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with TMD according to DC/TMD
* Aged between 18 and 65

Exclusion Criteria:

* Patients with removable dentures
* Patients diagnosed with Disc displacement without reduction according to DC/TMD
* Patients receiving medication for psychological disorders
* Patients diagnosed with systemic joint disorders
* Pregnant
* Patients who has received TMD treatment in the last 6 months
Nudging for Behavior Change in School Cafeterias

The main purpose of this research is to look at a school lunchroom intervention that is known to improve fruit, vegetable, and milk consumption and see how it changes in the long run and if it affects the child's behavior permanently. The intervention will include the giving the vegetables descriptive names, moving the fruit to right next to the register and in attractive bowls, and increasing the amount of white milk served by 10%. The main forms of analyzing these results are through food preparation records, lunch sales records, and tray waste records. The first focus of this study is to see if there is a specific point in an intervention when improvement stops and therefore the intervention needs to be updated. This procedure involves looking at five similar middle schools with this same intervention over a 15 week period. The time of intervention implementation will vary by three week intervals, so the first will start the first week of school, the next school will start after three weeks of school, the next will start after six weeks of school, and the next will start after nine weeks of school, and the last will be a control school where there will be no intervention implementation. These intervals will help eliminate bias dealing with the beginning of the year excitement and seasonal effects. Food preparation records and lunch sales records will be collected from the school for the 15 week period. Tray waste will be recorded by having 200 randomly selected trays measured and collected twice a week over the 15 week period. This focus will help schools manage when they need to change their intervention so that improvements will not stop. The second focus of this study is to see if the children's improvement is kept when the intervention has stopped. This procedure will involve looking at a similar school to the other 5 schools. But unlike the other schools, this one will have the first 5 weeks without the intervention, then 5 weeks with the intervention, and then another 5 weeks without the intervention. Food preparation records and lunch sales records will be collected from the school for the 15 week period. Tray waste will be recorded by having 200 randomly selected trays measured and collected twice a week over the 15 week period. This second focus will help identify how effective this intervention is in permanently changing dietary habits.


Eligibility Criteria:
Inclusion Criteria:

* This research focused on food choices of middle school students, grades 6-8, which generally range in ages 11-14. In addition, since we are interested in learning about the types of cafeteria foods children select and what they throw away, we focus on students who receive a school lunch meal.

Exclusion Criteria:

* We exclude students who do not receive a school lunch meal.
Sedation Strategies for Diagnostic Bronchoscopy

Diagnostic bronchoscopy is an invasive procedure performed to diagnose respiratory diseases. But pain has been complained by most of the patients receiving such procedures. Sedation or anesthesia was required by both of the patients and bronchoscopists. Unfortunately, no consensus has been made upon the sedation strategies. Multiple sedation approaches have been applied, such as midazolam and fentanyl, remifentanil and propofol, dexmedetomidine and propofol. The present study was designed to compare these protocols in sedation for diagnostic bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for flexible diagnostic bronchoscopy
* Adult patients aged 18 to 65 years
* American Society of Anesthesiologists (ASA) Physical Status Classification I-II
* BMI 18.5-25kg/m2
* Subjects provide informed consent

Exclusion Criteria:

* Severe airway obstruction
* Coagulation disorder
* Repeat bronchoscopy (more than 3 times)
* Severe liver and renal dysfunction
* Cardiovascular and cerebrovascular diseases
* Pregnancy
* Chronic opioid user
* Drug abusers or addicts
Xpert MTB/Rif, a New Tool for the Diagnosis of Pulmonary Tuberculosis in Two Municipalities in Brazil

Diagnosis of tuberculosis (TB) is a challenge because sputum smear, the most rapid and inexpensive test, often fails to detect the disease, in around 20 to 30% of cases. Culture of sputum yields a correct diagnosis in up to 90% of cases, but results are only available in 4 to 8 weeks, depending on the method. A new test (Xpert MTB/Rif) based on a rapid technique, named polymerase chain reaction (PCR), detects TB in less than 2 hours over 95% of cases, in addition to identification of cases resistant to certain drugs used to treat TB. The test is expensive, but several studies have demonstrated its accuracy, and since most steps are automatized, savings can be expected from human resources work. The aims of our study are (1) to evaluate this tool as a substitute test for sputum smears in routine conditions; (2) evaluate if it is cost-effective, meaning that effectiveness of the test may outweigh the extra cost, and (3) evaluate the acceptability of the test among patients and health care workers.

The main study consisted of a group-randomized pragmatic trial following a stepped-wedge design. The GeneXpert machines will be installed in laboratories of the basic health units in Rio de Janeiro and Manaus, two cities with a high burden of the disease in Brazil. Doctors will prescribe routine tests in the clinics. When sputum specimens arrive in the laboratory, instead of performing smears, the Xpert MTB/Rif will be performed during the intervention period. If positive, a sputum smear will also be performed. The intervention period will be preceded by an observation period during which routine will be kept unchanged, i.e., only smears will be performed. The observation period will serve as a comparator (control). The investigators will then see how many more cases were detected during the intervention period, and in particular, how many smear-negative cases were detected, compared to the observation period.

A total of 35,000 specimens are expected to be tested with the new technology in 14 laboratories. Laboratories, not individuals, will be randomized.

Eligibility Criteria:
Inclusion Criteria:

laboratories -and not subjects - will be randomized. All laboratories will start doing smears, when indicated by randomization, they will switch to Xpert MTB/Rif. There are no inclusion or exclusion criteria for the labs. Sputum specimens from non-diagnostic (follow up) patients, second samples for diagnostic tests, insufficient volume/visible blood specimens will be excluded from the Xpert testing.
A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD

It is estimated that in the United States there are approximately 8 million individuals with moderate to severe chronic kidney disease (CKD), not on dialysis. Volume expansion plays an important role in the pathogenesis of hypertension in patients with CKD. For this pilot study, the investigators hypothesize that administration of chlorthalidone among patients with moderate to severe CKD will improve blood pressure (BP).


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years.
* Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 but ≥20 mL/min/1.73m2.
* Poorly controlled blood pressure by 24-hour ambulatory blood pressure (BP) monitoring.
* Treated hypertension: use of at least one antihypertensive drug. One of the drugs should be either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). If these are contraindicated then use of a beta-blocker is required.

Exclusion Criteria:

* Use of thiazide or thiazide-like drugs in the previous 3 months.
* Use of furosemide in a dose \>200 mg/d.
* Ambulatory BP of either ≥160 systolic or ≥100 mmHg by 24-hour ambulatory BP monitoring.
* Expected to receive renal replacement therapy within the next 3 months.
* Vascular event such as myocardial infarction, heart failure hospitalization, or stroke within 3 months prior to randomization.
* Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives. condoms and diaphragms will be considered reliable).
* Known hypersensitivity to thiazide or sulfa drugs.
* Organ transplant recipient or therapy with immunosuppressive agents. Nasal or inhaled corticosteroids will be permitted.
Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria

Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney transplant recipients could be useful to prevent pyelonephritis in these patients.

Design: Randomized prospective study. Setting: University Hospital with an active kidney transplantation program. Patients: Adult kidney transplant recipients. Interventions: Kidney transplant recipients with asymptomatic bacteriuria will be randomly assigned to be treated with antibiotics or to be followed without antibiotic therapy.

Measurements: Urine cultures will be collected weekly during the first month after transplantation, every 2 weeks until three months after transplantation, every month until 6 months after transplantation and every 3 months until 12 months after transplantation. Urine culture will be as well collected if urinary symptoms appeared.

Primary end points: To determine in both groups: the incidence of pyelonephritis.

Secondary end points: To determine outcomes in both groups (renal function, hospitalization, rejection, graft loss, opportunistic infections and mortality) and infection by multiresistant microorganisms.

Eligibility Criteria:
Inclusion Criteria:

* Patients who receive a transplant allograft during study period

Exclusion Criteria:

* No acceptation of study
Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations

In our study, we aimed to calculate the ideal measurement of the distance of the erector spina muscle to the skin and to find the best ultrasonography image at different thoracic levels (T1-T2, T5-T6, T5-T6, T11-T12) and in other positions (lateral-sitting-pron) to improve the quality of the block in patients who will undergo erector spina plan block.

Our primary goal is to determine which thoracic level the erector spinae muscle is closer to the skin and whether the USG screen image is better. Our secondary goal is to find out in which position the erector spinae muscle is closer to the skin and the USG screen image is better.

1- Abstract Introduction Erector spina plana block can be performed in different positions (sitting-lateral-pron) and at different thoracic levels. In our study, we aimed to calculate the ideal measurement of the distance of the erector spina muscle to the skin and to find the best ultrasonography image at different thoracic levels (T1-T2, T5-T6, T5-T6, T11-T12) and in other positions (lateral-sitting-pron) to improve the quality of the block in patients who will undergo erector spina plan block. Material and Methods A total of 80 patients (40 females and 40 males, ASA I-II) aged 18-65 years were included in the study. The erector spinae muscle was determined at T1-T2, T5-T6, and T11-T12 levels and in lateral, sitting, and prone positions, respectively, with a high frequency 10-15 millihertz linear probe of ultrasound, The distance from the skin to the midline of the ultrasound screen was measured, and the best ultrasound screen image was recorded. Erector spina plan block, distance measurement, different positions, interfascial plan block.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 18-65 years ASA (American Society of Anaesthesiologists) I-II who were to undergo cholecystectomy who were to undergo mastectomy who were to undergo inguinal hernia who were to undergo thoracic surgery

Exclusion Criteria:

Patients in whom peripheral nerve block was contraindicated uncooperative patients disabled patients emergency cases patients with scoliosis pregnant and breastfeeding women patients with trauma incision scars in the measured area ASA III-IV-V group patients
Omacor and Placebo in Carotid Plaque Stability

The purpose of this study is to investigate the effect of intake of Omacor (Omega-3-acid ethyl ester 90) 2g/day on specified parameters related to the stability of carotid plaque in patients awaiting endarterectomy.

There is evidence both from epidemiological studies and large clinical trials that consumption of long-chain Omega-3 polyunsaturated fatty acids (PUFA) found in oily fish and fish oils, protects against cardiovascular disease in Western Populations. The large clinical trial GISSI-Prevention showed radical reductions in Cardiovascular Disease and Sudden Cardiac Death after the intake of Omega-3 PUFA, and statistically significant effects were seen after only a few months of use.

One of the models for explaining this markedly effect hypothesizes that Omega-3 PUFA, with its anti inflammatory effects, might act to stabilize atherosclerotic plaques by decreasing infiltration of inflammatory cells into the plaques and/or by decreasing the activity of these cells once resident in the plaque. A previous clinical study has showed increased incorporation of the Omega-3 fatty acids EPA and DHA in carotid plaque after intake of Omega-3 PUFA. The morphological properties of the plaque was also altered, showing thicker fibrous caps and less inflammation determined by the AHA and modified AHA classification.

These findings are important to confirm. Secondly additional indicators of plaque stability are required to strengthen the hypothesis. Also the mechanisms by which the morphological changes come about need to be identified. The model that is being used assesses structural changes associated with plaque rupture and instability through different important variables.

Comparisons: Double blind comparison of Omacor 2g/day and placebo in patients awaiting endarterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Males of females above 18 years of age
* Patients awaiting carotid endarterectomy
* Written Informed Consent

Exclusion Criteria:

* Patients consuming fish oil or evening primrose oil preparations
* Patients eating \> 2 oily fish meals per week
* Patients requiring operation within 7 days
* Pregnant or breastfeeding
* Patients participating in other clinical studies involving treatment with drug
Efficacy of Acupuncture on Induction of Labor

The purpose of this study is to evaluate the efficacy and safety of acupuncture for the induction of labor in pregnant women at the 40 weeks + 4 days of gestation.

Women at 40+2-40+4 gestational age were allocated to receive acupuncture twice a week or observation in order to observe the efficacy of acupuncture in labour onset.

Eligibility Criteria:
Inclusion Criteria:

* Physiological pregnant women at 40 weeks + 4 days of gestation

Exclusion Criteria:

* Fetal or maternal disease