cyrilzakka/clinical-trials huggingface dataset:
Metabolomics Characterization of Biomarkers of ASCVD and Prediction Model

1. Describe the risk factors and metabonomics characteristics of atherosclerotic cardiovascular disease in Chinese patients.
2. Establish accurate prediction model of atherosclerotic heart disease.

According to the Chinese cardiovascular disease report released in 2017, cardiovascular disease death is the leading cause of death of urban and rural residents, so cardiovascular disease risk assessment is particularly important. The development of cardiovascular risk assessment model was dated from Framingham Heart Study which first proposed the concept of risk factors, and then adjusted the model several times. In 2016, the China-PAR evaluated the cardiovascular disease risk of Chinese population. However, the application of metabolomics in coronary heart disease is a rapidly developing field and also a new field .

Therefore, the aim of this study was to

1.Describe the risk factors of atherosclerotic cardiovascular disease and the characteristics of metabolomics in Chinese population.

2. Establish an accurate prediction model of atherosclerotic heart disease. Research plan：

1. 1869 risk-stratified people were recruited.
2. Plasma samples were collected incluing disease status and other potential influencing factors.
3. Through the high-throughput detection of body metabolites, combined with multivariate statistical analysis, the metabolic markers with significant difference in different risk levels were screened for risk prediction.
4. All recruited people underwent coronary angiography.
5. The distribution of age and gender in each group should be matched and balanced as far as possible.

Eligibility Criteria:
Inclusion Criteria:

1. The age of the population is 18 or more than 18 years old.
2. According to China PAR equations, Chinese guidelines and consensus on cardiovascular risk assessment and management，it is considered as healthy, low, medium, high and extremely high risk group.
3. The subjects read and fully understood the patient's instructions and signed the informed consent

Exclusion Criteria:

1. Refused to sign informed consent.
2. ACS is caused by surgery, trauma, or other diseases.
3. Age less than 18 years old.
4. Pregnant women.
5. In the past 3 months, the patients were treated with trauma surgery.
6. There are aortic dissection, pulmonary embolism, pneumonia, pericarditis, myocarditis, stress cardiomyopathy.
7. Severe heart failure.
8. Liver and kidney failure.
9. Blood borne infectious diseases: including HIV / AIDS, hepatitis B, hepatitis C, etc.
10. Patients with a history of malignancies, autoimmune diseases, severe infectious diseases and trauma.
11. Any condition (such as travel, speech disorder, mental disorder) that the researcher believes can significantly limit the completion of the patient's follow-up.
Effectiveness of Bobath/Halliwick on Children With Cerebral Palsy

Investigation of the effectiveness of water based therapy on children with Cerebral Palsy (CP)

The purpose of this randomized controlled trial was:

To examine the effectiveness of the Halliwick concept intervention in water approach for people with motor deficiency and, more specifically, for children with diagnosed cerebral palsy.

In a second phase, to compare the contribution of water intervention to the child's motor development against just Bobath physiotherapeutic intervention, in terms of the milestones of gross motor skills of the children over time.

The aim of the research is to determine the contribution of the Halliwick Concept- Hydrotherapeutic Intervention approach in the psychomotor development in children with cerebral palsy and to explore its contribution to a comprehensive therapeutic approach for these children. It is a fact that, in recent years, parallel therapeutic approaches have gained ground, which, in combination with the physiotherapeutic treatment, contributes to the enhancement of therapeutic effects in early and follow-up intervention for children with cerebral palsy.

The study resulted from the fact that there is not such a large-scale study in Greece. Also, there are few published studies in the world, trying to evaluate the therapeutic benefit of the Halliwick Concept as an hydro-therapeutic approach.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Cerebral Palsy
* Not have some type of surgery or botulinum toxin infusion in the last year.
* The children with cognitive limitations were selected, in order to be able to execute elementary commands.
* Attending treatment program by the same therapist, either on water, or on land.

Exclusion Criteria:

* Children with autism
* Children who had some scheduled surgery or botulinum toxin injection.
* Children with severe vision problems
* Children who could not follow the verbal instructions or reproduce a test reproduction.
* Children who were absent from the treatment program either in the water or on land for over a week
Abiomed Impella RT-DAQ - Observational Study

Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition

The objective of this study is to develop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module, which can replace invasive hemodynamic monitoring in the future.

Eligibility Criteria:
Inclusion Criteria:

1. Ongoing or planned intensive care management with Impella support
2. Presence or planned placement of a cardiac output measurement

   1. Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement)
   2. Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods

Exclusion Criteria:

1. Age \< 18 years
2. Pregnancy
3. Anticipated support duration \<24 h
miRNA and Myokines in Patients With PAH

The overall objective of this study is to fulfill the Pilot study (miRNA and Myokines Acutely-expressed During Exercise) goal to Investigate the excretion of skeletal muscle-derived miRNA and myokines in patients with pulmonary arterial hypertension during acute exercise that are biologically active and modulate skeletal muscle function during exercise.

Pulmonary arterial hypertension (PAH), is characterized by the proliferation of endothelial and smooth muscle cells within the precapillary pulmonary vasculature, if untreated results in increased pulmonary vascular resistance and death. The hallmark perivascular infiltrates in PAH contain inflammatory macrophages and lymphocytes resulting in endothelial dysfunction and involves the dysregulation of distinct inflammatory mechanisms. Idiopathic PAH (iPAH) and scleroderma-associated PAH (SSc-PAH), are related by similar clinical and pathophysiologic features. Patients with PAH experience a central cardiovascular limitation to exercise. Despite effective treatment with pulmonary vasodilators, many resting PAH (rPAH) patients continue to experience exercise intolerance. PAH is increasingly acknowledged as a systemic disease, beyond abnormalities of the pulmonary vasculature. Although other contributions to exercise intolerance in PAH exist, skeletal muscle dysfunction significantly impacts exercise tolerance. The molecular mechanisms behind skeletal muscle dysfunction in PAH remain unclear. Provocative testing with invasive cardiopulmonary exercise testing challenges the cardio-pulmonary-vascular and skeletal muscle systems and elicits a cascade of physiologic events not measurable at rest. Myokines are circulating mediators released from skeletal muscle in an endocrine-like fashion in disease and health influencing many factors but not limited to systemic inflammation, immunity and endothelial function. Myokines have not been well described in PAH. Preliminary data indicate that myokines play important, yet still undescribed, roles in this disease. MicroRNAs (miRNAs) are small non-coding RNA molecules, which negatively regulate gene expression via repressing translation and degrading messenger RNAs through sequence-specific binding. There is a growing literature regarding the biological activity of extracellular miRNAs in PAH and in aerobic exercise. miR-126 has been implicated in skeletal muscle dysfunction in PAH, while miR-133 is skeletal muscle-specific but unlike miR-126 it is not yet implicated in skeletal muscle dysfunction in PAH.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a RHC/iCPET procedure at the UPMC Presbyterian Hospital Catheterization Lab.
* 18 years of age or older
* Able to read and understand the informed consent.
* Subjects who have signed the iCPET registry consent.

Exclusion Criteria:

* Pregnant women
* people under 18
* Who are unable to read and understand the informed consent.
* Subjects prescribed anticoagulant therapy
Comparison of PENG Block and FICB in Hip Fracture Patients

Fascia iliaca compartment block (FICB) has been considered the block of choice for patients with hip fracture. However, pericapsular nerve group (PENG) block, one of the relatively newly-developed blocks, could be also used for analgesia in patients with hip fracture. Since PENG block could block the accessory obturator nerve, PENG block might have greater analgesic effects compared to FICB theoretically. However, the comparison of these two blocks in patients with hip fracture has not performed in clinical setting. Thus, we aimed to compare the analgesic effect of PENG block and FICB.


Eligibility Criteria:
Inclusion Criteria:

* ASA PS 1-4
* age: ≥19
* baseline pain score (associated with hip fracture): ≥4

Exclusion Criteria:

* patients who do not agree to participate in this study
* patients with uncontrolled hypertension, hyperthyroidism, severe dementia
* allergic to ropivacaine
* contraindicated to spinal anesthesia due to coagulopathy, severe aortic stenosis/mitral stenosis, or active infection on lumbar region
* patients who are considered ineligible with any other reason by investigators
Assessment of Whole Gut Transit Time Using the SmartPill Capsule

Our null hypothesis states that the two techniques (Sitzmarks radioopaque markers and SmartPill) are equivalent and is demonstrated if the study population shows a correlation of 0.7 or higher.

The purpose of the study is to measure total gastrointestinal transit time using SmartPill GI Monitoring System with pH.p Capsule and compare the transit time determined by capsule transit to the conventional radioopaque marker technique.

Both techniques are simultaneously applied in normal and constipated adult populations.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between ages of 18-80 years of age with functional constipation that fulfills the Rome II definition of functional constipation
* Bowel movement frequency of \< 3 times per week but at least once per two weeks.
* Constipation symptoms for at least 1 year duration.
* Constipation, not abdominal pain, as the primary symptom.
* Ability to stop fiber, laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to the study and during the 5 day study period.
* Ability to stop proton pump inhibitors 7 days prior to the study and H2RAs for 3 days prior to the study.

Exclusion Criteria:

* Previous history of bezoars.
* Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
* Any abdominal surgery within the past 3 months
* Known or history of inflammatory bowel disease
* History of diverticulitis, diverticular stricture, and other intestinal strictures
* Tobacco use within eight hours prior to capsule ingestion and during the initial 8 hour recording on Day 0 or the Ingestion visit.
* Alcohol use within eight hours prior to capsule ingestion and throughout the entire monitoring period (5 days).
* BMI \> 38
* Allergies to components of the SmartBar (Appendix IX).
* Females of childbearing age who are not practicing birth control and/or are pregnant or lactating. (A urine pregnancy test will be performed on female subjects prior to capsule ingestion).
* Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
* Use of medical devices such as pacemakers, infusion pumps, or insulin pumps.
* Any contraindication to use of Fleets Enema or balloon expulsion test.
* Uncontrolled diabetes with a hemoglobin A1C greater than 10.
Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART

The study will be two parallel group, triple blinded randomized controlled clinical trial that based on CONSORT (consolidated standards of reporting trials) guideline .The selected participants according to inclusion and exclusion criteria will be randomly allocated in two groups using (Research Randomizer Program) .

Blinding All participants don't know the type of received restorative material (ACTIVA Kids or High -viscosity GI restorative material) and the outcome will be evaluated by a examiner other than operator who doesn't know the type of received restorative material also.

Study setting The study will be performed at pediatric Department and Dental Public Health Department of Faculty of Dentistry, Ain Shams University, and at the institute of Graduate Studies and Research, Ain Shams University.

Sample size: 60 participants Recruitment/Setting The all participants of this study have been selected after complete clinical examination has been done with full medical and dental history , history of medications and history of hospitalization. In patients who receive dental treatment as an usual care in clinics of Pediatric Dentistry and Dental Public Health Department at faculty of dentistry, Ain-Shams University.

Informed consent designed to include all data about dental procedures in this study and clear more details about time consuming in the procedure and follow up visits, used materials and adverse event of this procedure . All participants have the wright to withdraw from this study at any time .The consent will be assigned from each patient by the patient's parents or guardians after explanation of the study.

The full mouth rehabilitation will be performed by postgraduate student registered at the master Degree at the Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry, Ain- Shams University All subjects receive instructions on oral health, particularly in relation to oral hygiene and sugar consumption

Eligibility Criteria:
Inclusion Criteria:

1. Children aged from 4 to 8 years old, in good general health
2. Children classified as class 3 or 4 based on Frankel et al. classification. (26)
3. The children have at least one primary molar with class I carious lesion.
4. Asymptomatic teeth (without spontaneous pain)

Exclusion Criteria:

1. Medically compromised patient
2. Presence of pulp exposure, pain, mobility
3. Presence of swelling, abscess or fistula near the tooth
4. Not accessible carious lesion to hand instruments
SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects

Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126

A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects

Eligibility Criteria:
PART 1 \& 2 (Healthy Volunteers)

Inclusion Criteria:

* Healthy male subjects and female subjects of NOCBP.
* Between 18 and 55 years of age (Part 1) and 30 and 55 years of age (Part 2), inclusive.
* A body mass index of between 18.0 and 32.0 kg/m2, inclusive.
* Contraception requirements for male \& female subjects.

Exclusion Criteria:

* Known hypersensitivity or allergy to AMT-126 or excipient contained in the drug formulation.
* Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
* Presence, or history of clinically significant disease which requires treatment, as judged by the investigator.
* Evidence of current SARS-CoV-2 or COVID infection.
* Women of child-bearing potential.
Answering Questions About Vitamin D Supplementation and Sun Exposure in Patients Who Have Undergone Surgery for Stage IB, Stage II, or Stage IIIA Melanoma

RATIONALE: Gathering information about vitamin D supplementation and sun exposure in patients with melanoma may help doctors learn more about the disease and find what may affect cancer relapse.

PURPOSE: This clinical trial is studying vitamin D supplementation and sun exposure in patients who have undergone surgery for stage IB, stage II, or stage IIIA melanoma.

OBJECTIVES:

* To examine the findings of the pilot study, that vitamin D supplementation in combination with vitamin D receptor (VDR) polymorphisms protects from late relapse (after 3 years) in patients who have had melanoma.
* To investigate the effects of vitamin D supplement dosage in reducing the risk of late relapse.
* To examine if vitamin D supplementation in combination with particular VDR polymorphisms protects from early relapse (before 3 years).
* To examine if serum levels of vitamin D correlate with risk of relapse in groups of patients with different VDR polymorphisms.
* To examine the effect of vitamin supplementation and VDR status on time to relapse and survival in these patients.
* To examine other factors that may affect risk of relapse by assembling a tissue (genomic DNA and serum) resource.
* To investigate the effect of exposure to incidental drugs, such as statins, on risk of relapse in these patients.

OUTLINE: Patients are stratified according to disease relapse in the past 5 years (yes vs no).

Patients are asked to complete a food frequency questionnaire focusing on vitamin D and the following area: supplementation of diet with vitamins/fish oil and duration of use; sun exposure and sunscreen-use per decade prior to and after diagnosis. Patients are also asked to provide a blood sample for serum and DNA analysis. Consenting patients are also tagged with the Office of National Statistics to allow passive follow up.

Stored tissue from the patient's primary melanoma may be used to corroborate research findings using immunohistochemistry or studies of gene expression, polymorphism, or mutation.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with melanoma
* Must meet either of the following conditions:

  * Resected stage IB, II, or IIIA disease that has relapsed as either stage III or IV disease (cases)

    * First loco regional and/or visceral relapse (with/without sentinel node biopsy)

      * No more than 3 months since first relapse
  * Resected stage IB, II, or IIIA disease that has not relapsed for ≥ 5 years (controls)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)

Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Weight ≥ 35 kg
* Previous cholangiographic evidence of PSC by magnetic resonance cholangiopancreatography (MRCP) or direct cholangiography or liver biopsy findings
* Serum GGT ≥ 2 × upper limit of normal (ULN)
* On a stable UDCA treatment regimen for ≥ 8 weeks

Exclusion Criteria:

* Secondary sclerosing cholangitis
* Percutaneous or endoscopically-placed biliary drain or stent
* History of cholangiocarcinoma or clinical suspicion of new dominant stricture within 1 year
* Ascending cholangitis requiring intravenous antibiotic therapy within 60 days prior to Screening
* Concomitant overlap syndrome with primary biliary cholangitis (PBC)
* Significant hepatic decompensation
* Alternative causes of chronic liver disease
* Hospitalization for colitis within 30 days prior to Screening
* Serum creatinine \> 1.2 x ULN
* Hemoglobin \< 10 g/dL
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
General vs Spinal Anesthesia for Total Joint Arthroplasty-Anterior Approach: A Single-Institution Observational Study

The study compares the effects of various anesthetic techniques on anterior approach total hip arthroplasty results retrospectively

Under general (GA) or spinal anesthesia (SA), total hip arthroplasty using the anterior approach (THA-A) can be safely performed. The best method is not sufficiently described in the literature currently in existence.This observational study was carried out at a single facility with consecutive enrollment of patients getting primary THA-A. The investigators compared the difference in complication rates, intraoperative blood loss, length of hospital stay, and duration of surgery, acetabular and femoral component orientation and stem subsidence.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent direct anterior approach primary total hip arthroplasty with general anesthesia
* patients who underwent direct anterior approach primary total hip arthroplasty with spinal anesthesia

Exclusion Criteria:

* patients who underwent revision total hip arthroplasty
* patients who underwent total hip arthroplasty with approaches other than direct anterior approach
* patients who underwent primary total hip arthroplasty due to hip fractures
STREAMER : STent Restenosis And MEdicaments Release

It is a pilot study to evaluate the feasibility and the efficiency of local delivery of paclitaxel after stenting of long femoropopliteal arterial lesions TASC C and D before the realization of a large randomized multicentric study. Patients concerned are in critical ischemia.


Eligibility Criteria:
Inclusion Criteria:

* patients with critical ischemia of a lower limb with ankle pressure \< 50 mmHg
* lesions TASC C and D of the superficial femoral or popliteal artery

Exclusion Criteria:

* patient allergic to paclitaxel
* patient with a cancer, a neutropenia, with immunosuppressor medicament or chemotherapy
* patient with contraindication to take 2 anti-aggregants platelets
Next Generation Rocklatan

The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

During Stage 1, approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms: 3 different concentrations of AR-17043, placebo comparator, or netarsudil 0.02% (Rhopressa®) for a treatment duration of 7 days.

During Stage 2, approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms: low and high concentrations of PG043 (AR-17043/latanoprost 0.005%), AR-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (Rocklatan®) for a treatment duration of 28 days.

Eligibility Criteria:
Stage 1 Key Inclusion Criteria;

* Diagnosis of OAG or OHT in both eyes.
* High unmedicated IOP measurements in the study eye as specified in the protocol.
* Corrected visual acuity equal to or better than +1.0 logMAR (Snellen equivalent equal to or better than 20/200) in the study eye.
* Other protocol-specified inclusion criteria may apply.

Stage 2 Key Inclusion Criteria:

* Diagnosis of OAG or OHT in both eyes.
* High unmedicated IOP measurements in the study eye as specified in the protocol.
* Corrected visual acuity equal to or better than +0.7 logMAR (Snellen equivalent equal to or better than 20/100) in the study eye.
* Other protocol-specified inclusion criteria may apply.

Stage 1 and Stage 2 Key Exclusion Criteria:

* Current use of more than 2 ocular hypotensive medications within 30 days (either eye).
* Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening.
* Glaucoma other than OAG.
* Previous glaucoma surgery.
* Any abnormality preventing reliable measurements.
* Unable to demonstrate proper eyedrop instillation.
* Other protocol-specified exclusion criteria may apply.