cyrilzakka/clinical-trials huggingface dataset:
The Effect of Telephone Education on Fear of Movement and Quality of Life in Patients With Lumbar Disc Herniation Surgery.

The aim is to quantify the fear of movement and quality of life of telephone education on lumbar disc herniation surgery.

In the randomized controlled study, patients will be randomized into two categories: experimental and control groups. The experimental group will receive intervention via online information for 6 weeks after discharge. The control group will not be given online training other than standard nursing care. At the end of 6 weeks, the difference between fear of movement and quality of life between the two groups will be examined.

Eligibility Criteria:
Inclusion Criteria:

* being over 18 years old
* knowing how to read and write Turkish
* No hearing or speech impairment
* Having lumbar disc herniation surgery for the first time
* having a personal cell phone
* being discharged 5 days after surgery

Exclusion Criteria:

* being under 18 years old
* being illiterate
* having a hearing and speech disability
* not having a personal cell phone
* staying in the hospital for more than 5 days after surgery
Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation

The optimal antithrombotic treatment for Coronary Heart disease (CHD) patients combined with Atrial Fibrillation (AF) is unresolved at present. Although the European and American guidelines have given a hand for us, there is absence of real-world data on the safety and efficacy of antithrombotic therapy in Asian populations. Only a few clinical trials are available to guide difficult decision on antithrombotic therapy in patients with combined AF and CHD，the investigators highlight the need for the rapid development of clinical trials to close the large gaps in evidence. This research aims to know the real-world use of antithrombotic treatment and clinical prognosis in Coronary Heart Disease patients complicated with Atrial Fibrillation.

1. Our study is an observational, retrospective Study.
2. Key date elements and definition of each variable were in line with the American Heart Association(AHA)/European Society of Cardiology(ECS） recommendation on AF and CHD. To reflect the contemporary antithrombotic management of AF and CHD in the past five years, the following data were collected: basic socio-demographic information, symptoms and signs relating to AF, medical history, results of physical examination and laboratory test.
3. Follow-up time is at least 12 months. The patients will be asked about their medications and clinical outcomes by telephone interview or outpatient clinic. Then we will analyze the relative safety and efficacy of the various antithrombotic regimens.
4. Based on the largest prospective study by Denmark about this issue, we anticipate an 30% incidence of composite outcome in the triple therapy arm. To achieve a precision of 10% with an α=0.05 and the rate of defaulters is 10%. The final estimated sample size was 986.
5. Henan institute of cardiology epidemiology is responsible for design, date quality control and statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chest pain and a significant lesion \>50% angiographically.
2. Patients with a documented AF as confirmed by 12 leads ECG or Holter ECG.

Exclusion Criteria:

1. Rheumatic valvular disease.
2. Contraindications to oral anticoagulation.
3. Combined with other serious diseases with a life expectancy \< 1 year.
Residential Retreat for Veterans and First-responders

The purpose of this study is to determine the potential efficacy and feasibility of a residential retreat program to address PTSD symptoms in Veterans and First-responders

After obtaining written consent, participants will complete their program as they had previously intended. Each wave of the residential retreat program will last 5 days. During the program, participants will complete the study questionnaires. They will complete these questionnaires again 1 month after the completion of the program. As a control, individuals completing the program in the online format will also be asked to provide written consent and will complete the questionnaires during the program and 1-month after its completion.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PTSD, being a military veteran or first-responder, awareness of treating physician about program attendance

Exclusion Criteria:

* None
The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery

The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to Memorial Hermann Medical Center with acute femur fractures that require open surgical approaches for fracture reduction and implant application, including patients with subtrochanteric, high-energy intertrochanteric, periprosthetic, and intra-articular distal femur fractures.

Exclusion Criteria:

* Preoperative use of any anticoagulant
* History of deep venous thrombosis or pulmonary embolus
* Allergy to TXA
* Hepatic dysfunction (AST/ALT \> 60)
* Renal dysfunction (Cr \> 1.5 or GFR \< 30)
* History of cerebrovascular accident in the past 12 months
* Active coronary artery disease (event in the past 12 months)
* Presence of drug-eluting stent
* Color blindness
* Presence of an additional acute injury that could contribute to blood transfusion requirements
Emergency Department, Rapid Assessment for Sexually Transmitted Infection

To evaluate if a rapid urine Nucleic Acid Amplification Testing (NAAT) is non-inferior to the traditional swab NAAT for gonorrhea and chlamydia when performed in the Emergency Department.

All patients presenting to the Emergency Department during the study period who are tested for gonorrhea and chlamydia by the traditional swab NAAT will concurrently have their urine tested for gonorrhea and chlamydia using the Cepheid GeneXpert rapid NAAT. The result of both tests will be compared to determine if the rapid assay is non-inferior to the current traditional NAAT. Both the traditional and Cepheid GeneXpert rapid NAAT are FDA and CDC approved for evaluation of gonorrhea and chlamydia. However, the Cepheid GeneXpert rapid NAAT has not been prospectively validated in the Emergency Department setting. We intend for both the provider obtaining the sample and the technician running the rapid assay sample to be blinded to the result of the traditional NAAT. The Cepheid GeneXpert rapid NAAT will not be used in patient care decisions.

Eligibility Criteria:
Inclusion Criteria:

* Clinical concern for gonorrhea and/or chlamydia infection
* Concurrent testing for gonorrhea and chlamydia using traditional NAAT assay

Exclusion Criteria:

* age \<18 years
Study of the Anti-tumoral Immune Response

This study evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral antigens breast cancer and glioma.


Eligibility Criteria:
Inclusion Criteria:

* Performance status 0,1 or 2
* breast cancer or glioma
* Arm glioma: patients without anti-tumoral treatment
* Arm breast cancer: inclusion before treatment
* Arm breast cancer HER2: patients with current therapy

Exclusion Criteria:

* Psychiatric disease compromising the understanding of the information or the realization of the study
* vulnerable People according to the law (minors, adults under protection, private persons of freedom ...)
* Unaffiliated People to the Social Security
* People being for the period of exclusion from another study
* Life expectancy estimated unless 3 months.
* For patients in Arm glioma: patients having already begun a systematic treatment.
* For patients with a breast cancer: patient already under current therapy
Acupuncture With/Without Self-acupressure for Post-oophorectomy Hot Flashes in BRCA Carriers

Risk-reducing surgery with salpingo-oophorectomy (RRSO) is the standard recommended treatment for all female carriers of BRCA genes 1 and 2. The post-surgical menopause induced is invariably accompanied by hot flashes and other symptoms, which can severely impair quality of life and function. Hormone-replacement therapy (HRT) is the standard conventional treatment for these symptoms, though these drugs do not always provide adequate relief and many patients either cannot receive them due to a diagnosis of breast cancer or hypercoagulable state; or are unwilling to take them due to their concern about the associated increased risk for developing hormone-induced breast cancer.

Acupuncture and acupressure have been researched extensively and shown to be both safe and effective in reducing hot flashes in post-menopausal patients and in those with breast cancer receiving anti-hormonal drugs.

The present study will examine the effectiveness of acupuncture, with/without self-acupressure, on 200 post- RRSO patients who suffer from at least 5 hot flashes per day, including those treated with HRT. All participants will receive 8 weekly treatments with acupuncture, and then randomly assigned to receive (or not) self-administered acupressure, to be performed daily at home. The response to the study interventions will be assessed using daily Hot Flash Scores, the Menopause Specific Quality of Life (MenQoL) and Measure Yourself Concerns and Wellbeing (MYCAW) questionnaires (at baseline; at the end of the 8-week intervention; and at 16 weeks). The safety of the study treatments will be assessed throughout.


Eligibility Criteria:
Inclusion Criteria:

* Female carriers of the BRCA 1 and 2 genes
* age ≥ 25 years
* after risk-reducing salpingo-oophorectomy
* reporting ≥ 5 hot flashes per day

Exclusion Criteria:

* Patients not fulfilling the study inclusion criteria will be excluded from participation
Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity

The primary objective of this study is to evaluate the toxicity profile of GRID therapy using dose levels of 10Gy, 15 Gy and 20Gy in pediatric osteosarcoma of the extremity.

Subjects will receive GRID radiotherapy. GRID radiation therapy is considered a standard radiation therapy method however is not typically used in pediatric osteosarcoma patients. This protocol will evaluate whether or not the use of this therapy will provide benefit to this patient population.

Eligibility Criteria:
Inclusion Criteria:

* History of cytological or histological documentation of non-metastatic extremity osteosarcoma.
* 5-21 years of age.
* Subject is eligible for routine chemotherapy and routine surgery for the treatment of non-metastatic extremity osteosarcoma
* Informed consent is obtained

Exclusion Criteria:

* Females with a positive urine pregnancy test.
* Unable to comply with study procedures
A Study to Assess the Safety and Pharmacokinetics of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Subjects

To evaluate the safety and pharmacokinetics of GV-971 capsules after oral a single or multiple doses of 900 mg, 1200 mg and 1500 mg in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects;
2. Age：≥18 and ≤40 on the date signing informed consent;
3. Body mass index (BMI): 19-26 kg/m2 and the weight ≥50 kg for male and ≥45 kg for female；
4. Subjects are able to understand the study procedures and methods, and willing to strictly comply with the protocol and give written informed consent.

Exclusion Criteria:

1. Subjects may be allergic to GV-971 in the opinion of the investigator;
2. With diseases which could impact on the absorption, distribution, metabolism and excretion (ADME) of study drugs or protocol adherence in the opinion of the investigator (such medical disorder/disease may relate to cardiovascular, liver, kidney, digestive, immune, blood, endocrine, metabolic, cancer, neuropsychiatric,etc );
3. Blood donation of ≥400 mL or severe blood lose and the volume of blood loss ≥400 mL within 12 weeks prior to screening;
4. Participation in any investigational drug or medical instrument study within 3 months prior to screening;
5. Use of any prescription medicine or herbal remedy, over the counter medication or dietary supplements such as vitamin, calcium within 2 weeks prior to screening;
6. Smoking more than 10 cigarettes a day, drugs or alcohol abuse within 6 months prior to screening;
7. Use of heparin, alginic sodium diester , mannose ester within 4 weeks prior to screening；
8. Clinically significant abnormalities in physical examination and laboratory test results or 12-lead ECG, etc. in screening;
9. Clinically significant abnormalities in Chest X-ray or abdominal B-ultrasound examination;
10. Positive seurology screen for Hepatitis B( HBsAg), Hepatitis C(HCV), HIV and USR unheated serum reagin test;
11. Vegetarian or person with dietary restrictions;
12. Subjects able to father a child are unwilling to use highly effective physical form of birth control from the trial period until 3 months after the completion of study;
13. Any other reasons that the subject is not eligible for participation in the study in the opinion of the investigator.
TumorGlow Intraoperative Molecular Imaging (IMI)

This is a Phase 1/2 study in patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment who are considered to be good surgical candidates to evaluate the safety and efficacy of the image-guided surgery using indocyanine green for intramolecular imaging of solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years of age or older.
* Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment.
* Good operative candidate as determined by the treating physician and/or multidisciplinary team.
* Subject capable of giving informed consent.

Exclusion Criteria:

* Subject unable to participate in the consent process.
* Vulnerable population including pregnant women, prisoners, and children.
* History of uncontrolled hypertension (e.g., history of an ER admission for hypertensive crisis or ≥ 3 blood pressure medications)
* Patients with a self-reported history of iodide allergies.
All Children in Focus (ABC) 0-2 Years: A Pilot Study

The goal of this clinical trial is to compare parents tools to handle challenges and strengths as parents. The main questions it aims to answer are:

* Do participating parents feel more confident than non partipating parents?
* Does the program have positive effects on parenting practices, parents´ well-being, and social support?
* Is the programme more effective for some groups of parents ( e.g., gender, socioeconomis status)

Participating parents will attend four 1-hour, manual based sessions followed by a 30-minutes optional coffe break. In addition parents will be asked to do homework assignments between the sessions.

Researchers will compare the intervention group with an equally sized control group that will receive the program later the same year.


Eligibility Criteria:
Inclusion Criteria:

Parents to children aged 0-2 years

Exclusion Criteria:

Non fluent in Swedish language
Predictive Factors of Good Results After Multiligamentar Knee Reconstruction (MLKR)

Multiligamentar knee injury has consequences on knee function (instability, arthritis, life disagreement). Surgical reconstructions have known recent evolutions. The goal of this study is to evaluate functional and clinical results at one year of those new surgical technics. A clinical and functional follow up will be performed before the surgery, then at 6 months and one year.

Patients will also benefit of a Magnetic Resonance Imaging (MRI) and isokinetic evaluations at one year.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne

Exclusion Criteria:

* Refusal
ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

The aim of this study is to determine the ED90 of hyperbaric intrathecal bupivacaine for the super obese population undergoing cesarean section under a combined spinal epidural technique.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) class 2 and 3
* English speaking
* Gestational age \> 36 weeks
* Scheduled for cesarean delivery under combined spinal epidural anesthesia
* 18 years or older
* BMI \> 50 kg/m2

Exclusion Criteria:

* History of past or current intravenous drug or chronic opioid abuse
* Allergy or contraindication to any study medications
* Intrapartum cesarean delivery under epidural anesthesia
* Cesarean delivery under general anesthesia
Compare Remote Patient Management and Standard Care in CRT-D and ICD-patients to Assess the Effect on Heart Failure

This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician (standard arm).


Eligibility Criteria:
Inclusion Criteria:

* Implantation of a market-approved Medtronic Connexus CRT-D- or DR-ICD-device
* Patient consents to study
* Ability to replace follow-ups with CareLink follow-ups
* Ability to attend all follow-ups at study center

Exclusion Criteria:

* Permanent AF
* Less than 18 years of age
* Life expectancy less than 15 months
* Participation in another clinical study
* Pregnancy
Behavioural Economics-based Incentives in Adults With Type 2 Diabetes (BET2)

A randomised control trial of adults with newly diagnosed type 2 diabetes to assess the effectiveness of behavioural economics-based incentives on healthy lifestyle behaviour, using a pragmatic trial approach.

This is a randomised control trial of adults aged 30-70 with newly diagnosed type 2 diabetes within a year in Hong Kong to compare the effectiveness of financial incentives and combined financial and social incentives against a control group receiving standard care. We plan to recruit 261 participants and follow them for 9-months (6-month intervention period and a 3-month post-intervention follow-up period) to assess glycemic control and other health indicators. Participants will be randomly assigned to one of three groups (in ratio 1:1:1): arm A (financial incentives in addition to standard care), arm B (financial and social incentives in addition to standard care), and arm C (control arm receiving standard care). Financial incentives will be framed around loss aversion and the endowment effect. Social incentives will include peer competition, and social support. Financial and social incentives are to encourage increased physical activity and participants will use a pedometer to track activity. Participants are followed for an additional 3-months after the cessation of incentives to assess the sustainability of lifestyle changes.

This trial adopts a pragmatic study design based on the PRECIS-2 tool and RE-AIM frameworks.

Eligibility Criteria:
Inclusion Criteria:

* Chinese adults aged 30-70 years
* Capable of providing informed consent
* Resident in Hong Kong
* Able to communicate in English or Chinese
* Diagnosed with type 2 diabetes within past year
* 6.5% ≤ HbA1c ≤ 9.0%
* Willing to take blood tests
* Access to a phone to track physical activity and receive text messages
* Physically mobile for duration of the trial

Exclusion Criteria:

* Planned surgery in the next 6 months
* Biological impairment or health condition affecting the ability to walk, such as blindness, physical immobility, and paralysis
* Pregnant or breastfeeding
* On insulin for diabetes control
High Clopidogrel Dose Versus Prasugrel and Ticagrelor in High Reactive Stable Patients

Dual antiplatelet therapy with Aspirin and Clopidogrel for at least one year is essential in patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) with drug eluting stent(s) implantation. Interindividual variability in platelet response to Clopidogrel has been reported, with several mechanisms (intrinsic high platelet reactivity \[PR\], variability of the drug metabolism, and various drug interactions) being implicated for high post-Clopidogrel treatment PR. The investigators aim to perform a prospective, single-center, investigator-initiated, randomized, study to compare platelet inhibition by Prasugrel 10 mg/day, Ticagrelor (90 mg twice daily) and high-dose 150 mg/day Clopidogrel in patients with High on-treatment platelet reactivity (HTPR) with standard dose of Clopidogrel. Patients with HTPR (defined as area under curve-AUC ≥ 450 or \> 45 Unit) and with loss-of-function allele CYP2C19\*2 will be enrolled in the study and will be randomized (Day 0) in a 1:1:1 ratio, to either Clopidogrel 150 mg a day or Prasugrel 10 mg a day or Ticagrelor (90 mg twice daily) until Day-15 and-30 post randomization.


Eligibility Criteria:
Inclusion Criteria:

* patients underwent to percutaneous coronary intervention (PCI)
* clopidogrel resistance after Platelet reactivity blood test

Exclusion Criteria:

* history of bleeding diathesis
* chronic oral anticoagulation treatment
* contraindications to antiplatelet therapy
* PCI or coronary artery bypass grafting (CABG) \< 3 months
* hemodynamic instability
* platelet count \< 100,000/μl
* hematocrit \< 30%
* creatinine clearance \< 25 ml/min
* Patients with a history of stroke
* contraindication for prasugrel administration
* patients weighing \< 60 kg
* \> 75 years of age.