cyrilzakka/clinical-trials huggingface dataset:
CVD Risk Reduction Trial

The purpose of this study is to provide lifestyle counselling for protective health behavior (exercise, diet, smoking cessation) to small groups (6-8 subjects) via teleconference. The sample includes individuals at elevated risk for cardiovascular disease (CVD) as well as individuals with established CVD. Our hypothesis is that telephone-based lifestyle counselling will (1) significantly increase protective lifestyle behavior (diet, exercise, smoke-free living) and (2) significantly reduce CVD risk factors at 6-month follow-up.

COHRT was a 2 parallel-group randomized controlled trial that was designed to assess the efficacy of a community outreach strategy for cardiovascular disease (CVD) risk reduction among individuals at elevated risk for CV events. Randomization was stratified for diagnosis of CHD, type 1 or 2 diabetes, sex, and clinical depression, and blocked within our northern, rural, and urban recruitment sites. A 2X3 mixed factorial design was utilized: 2 Groups (Usual Care, UC/Lifestyle Counselling,LC) X 3 Intervals (Baseline, post-treatment, 6-month follow-up). All subjects received personal CVD risk factor feedback and standardized handouts on heart healthy lifestyle change. The LC group received 6 weekly 1-hour sessions of lifestyle counseling that was provided via teleconference in small groups (4-8 persons). Group facilitators were trained in a manualized protocol of motivational interviewing that was designed for CVD risk reduction through lifestyle change. Weekly supervision was also provided. We hypothesized that the LC group (vs. UC) would significantly increase protective health behavior (exercise, diet, smoke-free living) at post-treatment and 6-month follow-up. The secondary hypothesis was that LC would significantly reduce (1) CVD risk factors, (SBP, DBP, total cholesterol, LDL cholesterol), (2) 10-year absolute risk among subjects without CVD, and (3) significantly increase quality of life as measured by symptoms of depression, psychological stress, and social support.

Eligibility Criteria:
Inclusion Criteria:

* 35 to 74 years of age,
* Diagnosis of CVD or Type 1 or 2 diabetes, or
* ≥2 of the following CVD risk factors:

  * Confirmed diagnosis of hypertension,
  * Dyslipidemia,
  * Males aged ≥55 years/females aged ≥60 years,
  * Family history of CHD or stroke;
  * Current smoker, or
  * BMI ≥ 27.

Exclusion Criteria:

* Diagnosis of clinically significant cardiac complications (e.g. arrhythmia, unstable angina) or a congenital cardiac condition;
* Major psychiatric illness (e.g. psychosis), history of alcohol or drug dependence within the previous year, or residence in a non-private setting.
A Snapshot Audit of Traumatic Pelvic Ring Injuries

Multicenter, snapshot cohort studies or audits have the ability to gather large patient numbers in short time periods from many healthcare systems with different resources or practices of care concerning one specific surgical condition. This type of studies allows exploration of differences in patient populations and management across the sampled cohort to identify areas of practice variability that may result in apparent differences in outcome. As such, whilst not providing true evidence of efficacy or the impact of a single variable on overall outcome, these studies can be hypothesis-generating and identify areas warranting further study in future randomized controlled trials (1). Snapshots also shed light on the real world practice, rather than the presumed or guideline suggested patient care (2).

Traumatic Pelvic Ring Injuries (TPRI) represent a broad spectrum of trauma-associated pathologies with a distinct bimodal age distribution in patients admitted through the Emergency Departments of all acute care hospitals. In younger patients, this type of injury is often associated with high-energy trauma, hemodynamic instability, high mortality and morbidity rates (3-6). In the elderly population, pelvic fractures result from low energy trauma mechanisms (e.g. ground level fall) and can affect the long-term independency and life quality of geriatric patients (7).

There is substantial variation in the management of pelvic ring injuries among pelvic trauma surgeons; these variations include but are not limited to the timing of definitive fixation, the indications and protocols of conservative treatment, and the appropriate osteosynthesis of the anterior and/or posterior pelvic fractures (8).

This 'ESTES snapshot audit' -a prospective observational cohort study- has a dual purpose. Firstly, as an epidemiological study, it aims to report the burden of injury in specific hospitals, distributed widely throughout Europe. Secondly, this study aims to demonstrate current strategies for both, younger (after high-energy trauma) and geriatric patients (after low-energy trauma) employed to assess and treat these patients. These twin aims will serve to provide a 'snapshot' of current medical practice, but will also be hypothesis-generating while providing a rich source of patient-level data to allow further analysis of particular clinical questions. The acquired study data can be subsequently evaluated and compared to patient data of established pelvic trauma registries across Europe.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years of age) admitted for traumatic pelvic ring injuries (AO/FFP-Classification).

Exclusion Criteria:

* Concomitant acetabular fractures
Cerebral Palsy Upper Extremity Orthotic Device

Upper extremity therapies for children with cerebral palsy (CP) have been validated for improving function in higher functioning patients. Those who function at the lowest end of the scale, on the Manual Ability Classification System scale (MACS) III-V, comprise 34-54% of the population, but as yet have no evidence-based interventions specific to their needs. Lower functioning children often retain some voluntary control of the elbow in spite of limited finger motion. A dynamic splint, or exoskeleton, could utilize the tenodesis effect from elbow motion to drive finger release while retaining flexor tone for grasp, potentially creating a portable, home-based therapeutic tool. The purpose of this study is to assess the effectiveness of an upper extremity orthotic device in improving the upper extremity function of children with cerebral palsy who have limited use of their hands.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of cerebral palsy, age 4-17 years, moderate-severe hand disability as graded by the Manual Ability Classification System, active movement of the elbow, ability to follow commands and participate in goal-making and repetitive tasks

Exclusion Criteria:

* mild or extremely severe hand disability, Botox or orthopaedic surgery within the past 6 months, severe contractures, lack of voluntary arm motion, unable to follow commands due to severe cognitive impairment
Bioequivalence Study of CJ-30060 in Healthy Volunteers

To compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor® 10mg in healthy volunteers.

The purpose of this study is to compare the pharmacokinetics and safety after a single dose administration of CJ-30060 and Exforge® 5/160mg, Crestor® 10mg in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 20 to 45 years at screening
* BMI: 18\~29.9kg/㎡
* Body weight ≥50kg
* Subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding

Exclusion Criteria:

* Subjects who had a medical history of severe cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological or neuropsychological disease
* Subjects who have symptoms of an acute disease within 28days before first administration
* Subjects who have clinically significant active, chronic disease
* Subjects who fall under the criteria below in laboratory test

  * AST/ALT \> UNL (upper normal limit) × 2
  * Total bilirubin \> UNL × 1.5
  * CrCL \< 50mL/min
  * CPK \> UNL × 2.5
* Subjects with clinically significant low blood pressure at screening test(systolic blood presure is less than 100mmHg or diastolic blood pressure is less than 60mmHg)
* Subjects with any positive reaction in HBsAg, anti-HCV Ab, anti HIV Ab, VDRL tests
Feasibility and Efficacy of Physical Literacy Screening Integration Into Pediatric Clinical Settings

The proposed research will be the first study to investigate the feasibility of incorporating physical literacy screening into primary care clinical settings, while determining the efficacy of integration on physical literacy. To investigate aim 1, feasibility, the research team will provide all children ages 6-11 presenting for well-child care by the participating pediatricians with physical literacy screening (PAVSPED) at point of entry for care. The child will complete the 5 yes/no screen and answers will be provided to the pediatrician for acknowledgement. To investigate aim 2, efficacy, participants will be randomized into a control group (standard of care) or an intervention group (patient education). The intervention group will receive the patient education document with their questionnaire, randomization will occur by the study team prior to subject visits. The patient education will be designed to address and investigate the four domains of physical literacy including, knowledge and understanding, motivation and confidence, daily behavior, and physical competence, (i.e., referral based training/PT (passive), self-motivated/directed exercise choice (speaks to child ownership/motivation), simple play outside 60 minutes/day (middle)). All participants will receive a 6-month follow-up email with the same 6 questions to assess if responses changed between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* • Children 6-11 years presenting for an annual well-child appointment at Longwood Pediatrics

Exclusion Criteria:

* • Children with physical handicaps or other significant health problems that would preclude physical activity involvement.
CCB Safety Study in Treatment of Hypertension of ADPKD

This study examines the safety and efficacy of calcium channel blocker (CCB) in the treatment of hypertension of Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients. Angiotensin receptor blocker (ARB) was shown to have kidney protecting effects in patients with renal diseases including ADPKD, glomerulonephritis and diabetic nephropathy. In case whose blood pressure is not normalized by ARB alone, CCB is selected additionally. Recent research suggests genetic calcium channel disorder is responsible for the progression of ADPKD. It is not examined clinically if CCB treatment has any harmful effect to patients with ADPKD. This study examines the safety of Cilnidipine (CCB) in the ADPKD patients whose blood pressure is not controlled under 130/85 mmHg by Candesartan (ARB) alone.


Eligibility Criteria:
Inclusion Criteria:

* ADPKD patients.
* Blood pressure measured at out-patient setting is above 130/85 mmHg.
* Age between 20 and 60 years old.
* Plasma creatinine less than 2.0mg in man and 1.5mg in woman.
* Patients give informed consent.

Exclusion Criteria:

* Patients with severe cardiovascular and hepatic disorders.
* Patients with complications of central nervous vascular disorders.
* Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods.
* Patients currently engaging in other experimental protocol.
* Patients with intracranial aneurysma.
* Patients who must use diuretics.
* Allergic patients to Candesartan or Cilnidipine.
* Patients whose hypertension is not controlled by medication of this protocol.
Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism

To determine whether iron deficiency anemia can be an indication for the treatment of subclinical hypothyroidism.

51 Patients presented to our university outpatient internal medicine clinic who are found to have iron deficiency anemia coexisting with subclinical hypothyroidism have been included in this study. Patients were randomly assigned to oral iron or oral iron plus levothyroxin therapy. The physician and the patients did not know who received oral iron only or oral iron plus levothyroxine treatment. Hematologic parameters as well as serum iron, ferritin and iron binding capacity were being measured at the beginning and 3 months after treatment in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis and laboratory confirmation of iron deficiency anemia and subclinical hypothyroidism
* Must be able to swallow tablets

Exclusion Criteria:

* Multifactorial anemia or anemia due to other reasons
* Iron deficiency anemia requiring urgent intervention- cardiac ischemia, severe anemia, GI or GU losses due to malignancy and or acute/subacute big loses by respiratory, Gİ, GU, etc. system
* Prior thyroid disorder and/or treatment history
* Presence of any other co-morbid disease like renal insufficiency/ failure, coronary heart disease, hypertension, diabetes mellitus, any endocrine system disease other than subclinical hypothyroidism
Haemostasis and Tranexamic Acid in Caesarean Delivery

The aim of the study is to evaluate haemostasis and fibrinolysis in peripartum of caesarean delivery and the effect of tranexamic acid (TXA) given in prevention of post-partum haemorrhage (PPH).

Post-partum haemorrhage (PPH) remains a leading cause of maternal morbidity and mortality. Haemostasis and fibrinolysis are activated in peripartum. Fibrinolysis is decreased during pregnancy, is quickly activated after childbirth and can be overactivated in case of PPH. Tranexamic acid (TXA), an antifibrinolytic drug, has been proven to efficiently decrease bleeding and death in PPH. Its place in prevention of PPH after caesarean section remains to be established. The aim of the study protocol TRAAP2 is to conduct a large multicentre randomized, double blind placebo-controlled trial to adequately assess the impact of TXA for preventing PPH following a caesarean section. Peripartum is also a period of increased thrombo-embolic risk. TXA has never been proven to increase thromboembolic events. Nevertheless, it seems important to reserve TXA for women with activated fibrinolysis.

The aim of the ancillary biologic study BIO-TRAAP is thus to explore haemostasis and fibrinolysis in peripartum, to determine which women will in the future benefit from TXA. Fibrinolysis will be studied by clot lysis time by Global Fibrinolytic Capacity test on the Lysis Timer (GFC/LT), t-PA, PAI-1, PAI-2, euglobulin clot lysis time, plasminogen, plasmin-anti-plasmin complex, thrombin-anti-thrombin complex, fibrin degradation products (FDP).

Eligibility Criteria:
Inclusion Criteria:

* patient randomized into TRAAP2 study (NCT03431805):

  * adult women admitted for a planned caesarean delivery,
  * at term ≥ 34 weeks,
  * haemoglobin level at the last blood sample \>9g/dl,
  * blood Formula numbering within 7 days before caesarean delivery, informed signed consent)
* informed signed consent for BIO-TRAAP

Exclusion Criteria:

* patient not included into TRAAP2 study:

  * previous thrombotic event or pre-existing pro-thrombotic disease,
  * epileptic state or history of seizures,
  * presence of any chronic or active cardiovascular disease outside hypertension,
  * any chronic or active renal disease including renal, chronic or acute insufficiency (glomerular flow \<90mL / min), and chronic or active liver disease at risk thrombotic or haemorrhagic,
  * autoimmune disease,
  * sickle cell disease,
  * placenta praevia,
  * placenta accreta/increta/percreta,
  * abruption placentae,
  * eclampsia,
  * HELLP syndrome,
  * in utero fetal death,
  * administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery,
  * general anaesthesia,
  * hypersensitivity to tranexamic acid or concentrated hydrochloric acid, instrumental extraction failure,
  * multiple pregnancy with genital delivery of the first twin and caesarean delivery for the second or at third trimester,
  * poor understanding of the French language
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)

The primary features of schizophrenia and schizoaffective disorder are characterized by positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving or maintaining productive employment. Asenapine is an investigational drug that may help to correct the above characteristics of schizophrenia by altering the inbalance of brain hormones such as dopamine and serotonin. This is a 12-month trial that will test the efficacy and safety of asenapine using an active comparator (olanzapine) in the treatment of patients with schizophrenia. Patients who complete the 12-month trial will have the option of continuing on drug until the treatment code for the 12-month trial is unblinded.


Eligibility Criteria:
Inclusion Criteria:

* Subject with schizophrenia or schizoaffective disorder. Subject must sign a written informed consent.

Exclusion Criteria:

* Have an uncontrolled, unstable, clinically significant medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
Tempus Sculptor Study: Small Cell Lung Cancer (SCLC) Observational Study

The study is a non-interventional evaluation of participants with SCLC who will receive diagnostic and (where possible) post-progression tumor tissue profiling, alongside plasma ctDNA biomarker profiling in addition to their standard of care therapy and disease surveillance.


Eligibility Criteria:
The following are the inclusion criteria. Participants are eligible to be included in this study only if all the following criteria apply. The participant has/is:

* Histologically confirmed small cell lung cancer diagnosis
* Diagnosis made with excisional or core needle biopsy specimen (fine needle aspirate may be permitted with approval from the PI)
* Subjects must submit fresh or archived FFPE tumor sample to the central laboratory
* ECOG performance status of 0-2 at time of enrollment
* Planned extensive stage first-line therapy of etoposide plus carboplatin plus PD-L1 inhibitor (atezolizumab or durvalumab)
* Extensive stage disease at time of diagnosis
* Willing and able to provide informed consent
* Radiotherapy is permitted as long as there is measurable disease outside of the radiotherapy port

Participants will be excluded from the study if any of the following criteria apply. The participant has/is:

* History of prior systemic treatment of SCLC
* Prior diagnosis of non-small cell lung cancer is excluded if the cancer is diagnosed \< 3 years prior to study entry. Additionally, the participant must be off all therapy for the NSCLC at the time of study entry.
* Mixed small cell and non-small cell histology
* Suspected metastatic cancer from other sites (i.e., those without a known or suspected lung primary diagnosis)
* Not willing to have additional blood samples collected
Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)

The purpose of this postmarketing surveillance study is to collect an extensive body of data in a large patient population in every day life to investigate the safety and efficacy of NOXAFIL® (posaconazole) in the treatment of invasive fungal disease.

Data regarding demographics, underlying disease, prior fungal infection, prior antifungal medication, invasive fungal infection signs \& symptoms, concomitant medication, posaconazole use, tolerability, safety and therapy outcome will be collected on abstracted electronic Case Report Forms.

This surveillance study was originally limited to subjects receiving posaconazole as salvage antifungal therapy as indicated. A subgroup of subjects at risk for invasive fungal infection was included for prophylactic treatment following the enlargement of the marketing authorization for NOXAFIL® (posaconazole) during the course of the study. These participants only contributed data for the assessment of safety.

Eligibility Criteria:
Inclusion Criteria:

Adult subjects with:

* Invasive aspergillosis refractory to, or intolerant of, amphotericin B or itraconazole,
* Fusariosis refractory to, or intolerant of, amphotericin B,
* Chromoblastomycosis and mycetoma refractory to, or intolerant of, itraconazole,
* Coccidiomycosis refractory to, or intolerant of, amphotericin B, itraconazole or fluconazole.
* Subjects receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk for developing invasive fungal infections.
* Hematopoietic stem-cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for Graft-versus-host disease and who are at high risk for developing invasive fungal infections.

Exclusion Criteria:

* Comedication of the participant with ergotamine, dihydroergotamine, terfenadine, astemizole, cisapride, pimozide, halofantrine, or chinidine.
Pregnancy Outcomes on Advanced Maternal Age

A prospective observational study of pregnancy outcomes at advanced maternal age among primigravida which include maternal ,fetal, obstetric and perinatal outcomes

The investigator will have 2 groups of primigravida , the first group will be presented by 50 women aged 35 y or more and the second group will be presented by 50 women aged 20 y to 34 y The first group will be also divided into 2 subgroups : group (1A ) aged 35 y to 40 y and group (1B) aged above 40 y The investigator will compare the outcomes between the two group , also comparing the outcomes between women with spontaneous pregnancy and those using ART ( Assisted Reproductive Technology ) The participants will undergo routine investigations at the first antenatal visit and a monthly ultrasound examination until delivery The participants will be screened for gestational diabetes mellitus using oral glucose tolerance test between 24 :34 weeks of pregnancy The participants will be screened for gestational hypertension after 20 weeks of pregnancy Obstetric outcomes will be recorded regarding pregnancy induced hypertension, gestational diabetes mellitus , anemia, antepartum hemorrhage, obstetric shock and intrapartum hemorrhage Maternal outcomes will be recorded regarding mode of delivery ,time of delivery ,preterm labor ,obstructed labor and prolonged labor Fetal outcomes will be recorded regarding congenital malformation ,intra uterine growth retardation ,intra uterine fetal death and still birth Perinatal outcomes will be recorded regarded birth weight ,birth asphyxia , neonatal hypoglycemia ,hyperbilirubinemia and ICU admission

Eligibility Criteria:
Inclusion Criteria:

* all primigravida women aged 20 to 34 years in control group and aged 35years or more in case group who seeking for antenatal care in mansoura university hospital and who accept study protocol

Exclusion Criteria:

* multipara
* women aged less than 20 years
* women with any medical disorder ( anti phospholipid syndrome , chronic hypertension ,Diabetes, autoimmune disease and thrombosis embolic disease )