cyrilzakka/clinical-trials huggingface dataset:
Functional Predictive Value of Collective Outcome Measure(s) Status Post Total Hip/Knee Arthroplasty

Researchers are trying to assess a predictive value or correlation of outcome measures results on subjects following a total knee or total hip arthroplasty in order to better predict the time frame taken to achieve certain functional milestones that are pertinent to subject population.

Subjects will undergo testing for a normal physical therapy clinical assessment that is standard of care for anyone who has a total hip or total knee surgery. Researchers will be using the data obtained from standard therapy care and see if correlations exist from that data and the time taken to complete specific functional tasks.

Eligibility Criteria:
Inclusion Criteria:

* Patient's 18 years or older
* Patients who recently underwent a primary total hip or total knee arthroplasty
* Patient who recently underwent a total hip or total knee revision

Exclusion Criteria:

* Patients who lack the ability to provide informed consent
* Patients with previous total joint replacement within the last 6 months
* Patients with complications following surgery such as DVT/PE/Infection
Follow-up of Recovery Condition in Survivors of Acute Respiratory Distress Syndrome

Hope to realize the recovery condition of ARDS survivors in Taiwan. It would be helpful not only to design the proper rehabilitation program but also to be a useful reference for the poor recovery patients to take hospice care if indicated.

This study will enroll the participant met the diagnostic criteria of ARDS. The basic data, clinical manifestations, laboratory data and outcomes of participants will be recorded.

And the investigator will also follow up the pulse oximeter, peak expiratory flow rate, six-minute walk test and health-related quality of life measures with SF-36 in 3, 6 and 12 months after the participants were discharged from the ICU. Through this study, the investigator hope to realize the recovery condition of ARDS survivors in Taiwan.

It would be helpful not only to design the proper rehabilitation program but also to be a useful reference for the poor recovery patients to take hospice care if indicated.

Eligibility Criteria:
Inclusion Criteria:

* ARDS patients

Exclusion Criteria:

* NA
Sacral Neuromodulation in Children and Adolescents

The purpose of this study is to assess the efficacy of neuromodulation for treatment of chronic constipation and fecal incontinence in pediatric patients and to evaluate the differences between the invasive vs. non-invasive approach.

Patients are selected according to the eligibility requirements. After obtaining informed consent off-label use and potential risks of sacral neuromodulation, all included patients and next of kin give written informed consent to the study.

At baseline, patients are randomized to one of the two predefined subgroups: either invasive sacral neuromodulation or non-invasive sacral neuromodulation. Clinical symptoms and outcome variables are compared regarding the beginning of non-invasive sacral neuromodulation or the implantation of the tined lead electrode. Patients are closely monitored within 6 months. Treatment success is evaluated in routine clinical check-ups (week 4/8/12 and 24) and via specialized questionnaires and bowel movement diaries. Quality of life is evaluated at baseline and after 12 and 24 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* age between 2-17 years
* informed consent
* chronic constipation according to the ROME IV criteria for more than 3 months with or without encopresis/soiling despite underlying diseases such as slow-transit constipation, rectal evacuation disorders or Hirschsprung's disease.
* refractory to conventional treatment in an appropriate weight-adapted application (training for bowel movements, lifestyle changes, pelvic floor training, pharmacological options)
* in cases of Hirschsprung's disease: diagnosis confirmed histologically by rectal biopsies and in case of resection of an aganglionic segement: period between surgery and SNM at least 1 year
* in cases of anorectal malformation or mechanical obstruction: post-surgical status: period between surgery and SNM at least 1 year

Exclusion Criteria:

* metabolic, inflammatory, and hormonal causes for chronic constipation
* toxic megacolon or further emergencies, which must be treated surgically
* sacral fractures or substantial differences in the sacral anatomy
* inflammatory bowel disorders
* rectal prolapse
* neuronal malignancies under medical and radiation therapy
* seizures
Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR

This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus single antiplatelet therapy (SAPT) in patients after TAVR. Patients who accept successful TAVR will be randomized to receive either the OAC group (Vitamin-K antagonists) or the SAPT group (aspirin) for 6 months on a 1:1 ratio. After that, patients from both groups will be treated with single antiplatelet therapy (aspirin). All patients will be followed for 1 year to test the difference between net clinical benefits and bioprosthetic valve thrombosis diagnosed by 4D-CT.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-85 years old with severe aortic stenosis;
* Successful TAVR via femoral artery approach (VARC 3 device success criteria);
* Implantation of self-expanding bioprosthetic valve;
* Be willing to give informed consent.

Exclusion Criteria:

* Patients with anticoagulant indications, such as atrial fibrillation, intracardiac thrombosis, deep vein thrombosis, pulmonary embolism, history of mechanical valve implantation;
* Patients needed double antiplatelet therapy, such as acute myocardial infarction within one year, coronary stent implantation within 6 months, peripheral artery stent implantation within 3 months;
* Patients who received concomitant TAVR and percutaneous coronary intervention;
* Patients with peptic ulcers or active bleeding or history of cerebral hemorrhage
* Patients with ischemic stroke or TIA within 6 months;
* Patients with left ventricular ejection fraction \< 30% or pulmonary hypertension (\>70mmHg) before discharge;
* Patients intolerant or allergic to aspirin or Vitamin-K antagonists (warfarin);
* Patients with evaluated glomerular filtration rate \<15ml/min/m2 (Cockcroft formula) or on dialysis;
* Patients with poor compliance, unable to complete the study and follow-up as required;
* Patients' life expectancy less than 1 year;
* Patients who already participated in other clinical trials (within the last 30 days).
Vitamin D Supplementation to Obese Chinese Males

Hypothesis: Oral Supplementation of Vitamin D can Reduce Hypersecretion of Parathyroid Hormone and Insulin Resistance in Obese Chinese Males.

Protocol: Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) or eight weeks to the obese males compared with the normal-weight males. Index measures were conducted at baseline and endpoint.


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) ≥ 28kg/m2 or 18.5 ≤ BMI \< 24 (kg/m2)
* non vegetarian Han Chinese and did not smoke, drink, nor take vitamin D supplements for \> 2 y
* fasting serum glucose \< 7.0 mmol/L
* serum glucose of 2 hr after 75 g oral glucose loading \< 11.1 mmol/L
* normal functioning of liver and kidney evaluated by alkaline phosphatase, aspartate aminotransferase, creatinine, and uric acid

Exclusion Criteria:

* not match the above inclusion criteria
* diagnosed as having any organic diseases were excluded
Genetic and Environmental Characteristics of Primary Pulmonary Hypertension

The goal of this study is to identify the modifying genes and environmental features that regulate the clinical expression of mutations in bone morphogenetic protein receptor 2 (BMPR2); to develop the understanding of how BMPR2 mutations result in disease; and to identify the undiscovered genetic mutations that cause primary pulmonary hypertension (PPH).

BACKGROUND:

PPH is a progressive disease that causes obstruction of the smallest arteries in the lungs, which often leads to heart failure. It threatens the lives of thousands of individuals. PPH affects both genders at any age, although females are affected twice as often as males. In a recent important advance, mutations in BMPR2 were associated with both familial and sporadic PPH. Because only 20% of people with a BMPR2 mutation ever develop PPH, other genes or modifying biologic events must contribute to the clinical development of the disease. PPH was recently renamed Idiopathic Pulmonary Arterial Hypertension or Familial Pulmonary Arterial Hypertension.

DESIGN NARRATIVE:

This study will utilize a database and specimen bank developed from 100 families affected by PPH across the United States. In families with genetic mutations not yet identified, changes in the BMPR2 gene will be studied, including in the promoter and intronic regions, and chance recombination events that could confirm another locus near 2q33 will be examined. New methods will look for modifier genes in large families with known mutations; examine kindreds for mitochondrial DNA haplotypes; and test candidate genes, including NOS-1, NOS-3, and the serotonin transporter. This study will determine the functional mechanisms by which variations found in the BMPR2 alleles alter BMP signal transduction by defining the biochemical effects of the mutant proteins on signaling pathways. In addition, the study will examine the perceived risks and benefits of clinical genetic testing and counseling in individuals from families at high risk for PPH and will determine how this new information might be most helpful to these individuals and their families.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PPH, or family members of individuals diagnosed with PPH, for inclusion in the database and specimen bank
CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation

The goal of thisobservational study is to systematically assess the presence and distribution of CMR-defined inflammation and fibrosis in clinically stable HT recipients with DSA detected during active screening for AMR surveillance. The main outcome is to study the prevalence of fibrosis, edema and of altered T1 mapping values in patients with DSA and the prevalence of patients with DSA among all the enrolled patients

This is a multicentric prospective study with experimental sample collection. Therapy and procedures will be performed according to clinical practice and current guidelines. Caring physicians will be blinded to the results of study specific assays, which will not be used to change standard cynical decision making. Patients will be enrolled in the study at the time of the DSA assay performed in the context of standard surveillance (yearly monitoring for anti-HLA antibodies is recommended by current guidelines and is part of routine clinical practice). At study entry patients will receive blood sampling to assay dd-cfDNA (centralized laboratory) and T-reg populations (local laboratory). Clinical characteristics, medical history, and results of standard laboratory tests will be collected at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years

  * Post heart transplantation follow-up between 1 and 15 y
  * Ambulatory clinical stable
  * Left ventricular ejection fraction (LVEF) \> 40% (as assessed by complete cardiac ultrasound within 3 months before the enrolment)

Exclusion Criteria:

* Unplanned hospitalization for cardiovascular causes in the previous three months

  * Biopsy-proven cellular (2R or greater) or AMR (pAMR\> 1 ) in the previous 3 months
  * Any contraindication to CMR
  * Known pregnancy
Topical Application of AS101 for the Treatment of Atopic Dermatitis

Atopic Dermatitis is a chronic non contagious disease that causes itchy, inflamed skin. The purpose of this study is to evaluate the safety and efficacy of topical AS101 ointment for the treatment of Atopic dermatitis.

Atopic dermatitis (AD) is the most common chronic inflammatory skin disease, affecting 10-20% of children and 2% of adults worldwide. The mechanism of AD is still not completely understood, but the disorder appears to result from the complex interaction between immunological responses, various susceptability genes, defects in skin barrier function, host and environmental factors and infectious agents. AS101 is a non toxic potent immunomodulator that has been shown to have beneficial effects in diverse pre clinical and clinical studies. Recently, AS101 has shown efficacy and safety in the treatment of mild to moderate Psoriasis which shares with AD a related immunological mechanism along with the AS101 ability to decrease the level of interleukins known to be involved ith the pathogenesis of AD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Atopic Dermatitis for at least 6 months prior to enrollment.
* Diseased Body surface area (BSA) ≤ 20%.
* Male and Female ≥ 18.
* Adequate general health.
* Signed Informed consent form by the patient or his/her legal guardian.
* Patient must be able and willing to comply with all protocol requirements.

Exclusion Criteria:

* Patient who is unable to provide fully informed consent.
* Pregnant of breast-feeding females.
* Concomitant dermatologic or medical condition(s) which may interfere with the patient's response evaluation.
* Evidence of an infection in the targeted zones.
* Known sensitivity to any of the drug component.
* Immunocompromised patients.
* Concomitant medications such as:

  * Topical corticosteroid within 2 weeks prior to Day 1 visit;
  * Systemic steroids and immunosuppressants within 1 month prior to Day 1 visit; \*Systemic anti-histamines and antibiotics within 2 weeks prior to Day 1 visit; \*Phototherapy within 4 weeks prior to Day 1 visit;
  * Anticipated exaggerated exposure to sunlight during the whole treatment period and 4 weeks prior to Day 1 visit.
Patient Reported Outcomes by Patients With Metastatic Renal Cell Carcinoma

The purpose of PRORECECA is to test whether adding weekly active patient-reported outcomes to the treatment of patients with metastatic renal cell carcinoma can improve patient-reported physical function.

PRORECECA is a two-armed randomized controlled trial for patients with metastatic renal cell carcinoma initiating 1st or 2nd line of standard therapy.

Patients will be randomized to either receiving questions from Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) with a specifically developed alert-algorithm and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) or receiving standard procedure regarding side effect registration and handling.

The hypothesis is that weekly active patient-reported outcomes in the intervention group can improve physical function 30% compared to the group who receive standard care and standard handling of side effects.

A total of 174 patients will be included with 87 patients in each arm.

Primary endpoint is physical function reported by the patient after 3 months of treatment. The patients will assess their physical function by completing the EORTC QLQ-C30.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with metastatic renal cell carcinoma
2. Age ≥ 18 years
3. Starting 1st or 2nd line treatment at enrolment
4. Performance status (PS) ≤ 2
5. Able to read Danish
6. No serious cognitive impairment
7. Patient has given written informed consent

Exclusion Criteria:

1. No smart phone
2. Patient participating in other interventional studies. This is only relevant for studies that might interfere with the intervention. Cases of doubt will be settled by the protocol committee.
3. Persons deprived of liberty or under guardianship or curators
4. Dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial
5. Earlier participation in PRORECECA (e.g. when changing from 1st to 2nd line of treatment)
Pathology Analysis of OPMD Patient Myotomies

The study aims to characterize the effect of OPMD mutation on muscle function. Muscle samples will be received from oculopharyngeal muscular dystrophy (OPMD) patients who undergo cricopharyngeal muscle-cutting surgery, as part of their routine healthcare and treatment.


Eligibility Criteria:
Inclusion Criteria:

* OPMD patients both male and female.
* OPMD patients between the ages 18-70 years.
* OPMD patients who are referred to the cricopharyngeal muscle-cutting surgery as part of their usual treatment.

Exclusion Criteria:

• OPMD patients not referred to the cricopharyngeal muscle-cutting surgery as part of their usual treatment.
Contingency Management to Promote Smoking Cessation

Many hospitals and outpatient clinics often refer people who smoke to quitlines and provide prescriptions for smoking cessation medications, but patients rarely fully engage in counseling or use their cessation medications. This is a single-arm, open-label pilot study to provide feasibility metrics for a text-based contingency management (CM) intervention to increase engagement in smoking cessation treatment. All participants (N=20) will be referred to a state quitline and will receive a prescription for medication plus 12 weeks of a text-based CM intervention to increase engagement in quitline calls and varenicline utilization. The engagement of participants in quitline counseling will be tracked for 6 weeks and medication utilization for 12 weeks post-enrollment. The investigators will use mixed-methods to collect implementation and acceptability data to inform changes to the text-based contingency management (CM) intervention.

Novel approaches are needed to engage people who smoke in treatment in a way that increases their odds of quitting. Contingency management (CM) interventions provide financial incentives to participants contingent on objective evidence of behavior change and are effective in enhancing medication adherence and treatment engagement for numerous health conditions, including tobacco dependence treatment. Critical gaps, however, remain in our knowledge regarding how best to deploy CM.

The goal of this study is to evaluate the acceptability and feasibility of combined CM for engaging patients in smoking cessation treatment. Participants (N=20) will receive "CounsCM" for engaging in five quitline calls and "MedCM" for utilizing varenicline over twelve weeks. CM payments will be automated and dispensed on a daily basis using a reloadable debit card. The investigators will use surveys and structured interviews to understand strengths, weaknesses, and areas for improvement.

Eligibility Criteria:
Inclusion Criteria:

* Smoked in the past 30 days
* Smoke at least 1 cigarette per day when they smoke
* ≥ 18 years old
* Kansas resident
* Speak/read English
* Access to a mobile phone
* Mobile phone receives text messages
* No varenicline contraindications (no acute renal impairment)
* Insurance coverage for varenicline
* Have no significant co-morbidity (i.e., life-threatening illness, communication barriers or altered mental status)
* Cognitively able to participate
* Physically able to participate
* Not pregnant/breastfeeding

Exclusion Criteria:

* Medically ineligible for varenicline
* Patient on smoking cessation medication within 2 weeks of admission date
* Patient already talked to quitline in the past 2 weeks.
* Patients participating in other quit smoking program or research study
This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding

The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure.

The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.


Eligibility Criteria:
Inclusion criteria:

* ≥ 18 years at screening.
* Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
* Currently taking dabigatran etexilate
* They meet the following criteria:

  * Group A: Overt bleeding judged by the physician to require a reversal agent. OR
  * Group B: A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.

Exclusion criteria:

Group A:

* Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care.
* Patients with no clinical signs of bleeding.
* Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

Group B:

* A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
* Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
Performance of Junctional Tourniquets in Normal Human Volunteers

Normal human adult volunteers wereused to investigate the performance of medical devices intended to stop junctional bleeding on the battlefield.

Four FDA-cleared junctional tourniquets (Combat Ready Clamp (CRoC), Abdominal Aortic and Junctional Tourniquet (AAJT), Junctional Emergency Treatment Tool (JETT), and SAM Junctional Tourniquet (SJT)) wereassessed in a laboratory on healthy human volunteers. Lower extremity pulses were measured in 10 volunteers before and after junctional tourniquet application aimed at stopping the distal pulse assessed by Doppler auscultation. Tourniquets were applied in a randomized fashion, with 5 min rest periods between each application. Each tourniquet was applied to each subject, such that the subjects acted as their own controls.

Eligibility Criteria:
Inclusion Criteria:

* Adult human volunteers who are recruited, screened, and consent to participate
* Ages at least 18 years old to no more than 60 years old (\<61) on the date of consent
* Male or female
* A worker for the US Military or US Government (active duty military, civilian employees, contractors)

Exclusion Criteria:

* Active-duty military subjects without their supervisor's permission to participate
* Detainees or prisoners
* Evidence of major disease of an artery (e.g., artery or vein surgery, atherosclerotic disease diagnosis, stroke, peripheral vascular disease or dysfunction such as Reynaud's phenomenon, migraine headaches, or cardiovascular disease \[uncontrolled hypertension, heart attack, or arrhythmias\]), active abdominal, inguinal, gluteal, or thigh disease, major deformity, or hernias
* Pregnancy
* Contracted employees to the US Military or US Government without contractual permission to participate in the research