cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study to Investigate the Efficacy of Partially Absorbable Mesh in Patients With Pelvic Organ Prolapsed

The purpose of this study is to evaluate the efficacy, recurrence, postoperative complications of partially absorbable mesh(Seratom®PA) in patients with pelvic organ prolapse.

Patients with pelvic organ prolapse are administrated partially absorbable mesh(Seratom®PA). It is performed pelvic organ prolapse quantification(POP-Q) examination, quality of life(QOL) questionnaire complications at postop 2week, 12week, 24week.

Eligibility Criteria:
Inclusion Criteria:

1. Woman who aged 41 years or older
2. Subjects who have symptomatic pelvic organ prolapse quantification(POP-Q) stage II \& cystocele or higher requiring surgical repair
3. Subjects who desires vaginal reconstructive surgery
4. Subjects who have uterus \< 12 weeks size
5. Subjects who are able to complete study questionnaires and assessment
6. Subjects who are available for 6 months follow-up

Exclusion Criteria:

1. Subjects who have medical contractions, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use, or a compromised immune system
2. Subjects who have received anticoagulation therapy
3. Subjects who are on current intermittent catheterization
4. Subjects whose BMI is over 30kg/m2
5. Subjects who have uncontrolled diabetes
6. Subjects who are on any medication which could result in compromised immune response, such as immune modulators
7. Subjects who are currently pregnant or intends to become pregnant during the study period or \<12 months post-partum
8. Subjects who have received other laparoscopic or abdominal or pelvic surgery in the past 1 months
9. Subjects who need for concomitant surgery requiring an abdominal incision
10. Subjects who have had a prior prolapse implant procedure (i.e. IVS tunneler, Perigee, Apogee, graft augmented repair, etc)

    * Note: previous traditional repairs are allowed.
11. Subjects who have had radiation therapy to the pelvic area
12. Subjects who have pelvic cancer or have had pelvic cancer within the past 12 months or have had on cytostatic medication within the past 12 months
13. Subjects who have a shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys.)
14. Subjects who have a known neurologic or medical condition affecting bladder function (e.g. Multiple Sclerosis, spinal cord injury)
15. Subjects who have a known hypersensitivity to the graft material(s)
Medication Development in Alcoholism: Investigating Glucocorticoid Antagonists

The primary hypotheses under test are that alcohol dependent subjects treated with mifepristone will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers, 18-65 years of age
* Meets Diagnostic and Statistical Manual of Mental Disorders Fourth Addition (DSM-IV) criteria for current alcohol dependence
* Subjects will not be seeking treatment because the medication studies are not treatment trials
* Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session
* Negative Breath Alcohol Concentration (BAC) and a Clinical Institute Withdrawal Assessment-Alcohol (CIWA-A) score of \< 8 at screening and time of lab session to eliminate acute alcohol or withdrawal effects on dependent measures
* Subjects must be able to complete and understand questionnaires and study procedures in English and sign an informed consent

Exclusion Criteria:

* Significant medical disorders that will increase potential risk or interfere with study participation as determined by the Study Physician
* Female subjects with childbearing potential who are pregnant, nursing, or refuse to use double barrier (non-hormonal) methods of birth control for the duration of the study and one month thereafter
* Meets DSM-IV criteria for a major Axis I disorder including mood or anxiety disorders or substance dependence disorders other than alcohol or nicotine dependence
* History of allergy or hypersensitivity to the study drugs or the ingredients
* Treatment within the month prior to screening with 1.) an investigational drug or vaccine; 2.) drugs that may influence study outcomes, e.g., disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), anticonvulsants, antidepressants.
* In need of or currently taking any psychoactive medications.
Walk to School and Physical Activity

The purpose of the proposed study is to determine the effect of walking to school for one week on total physical activity and patterns of physical activity in third, fourth and fifth grade students.

Increasing children's physical activity has become an important public health concern. Active transportation (walking and bicycling) is one aspect of children's physical activity that has received little attention but may provide a means of increasing children's activity levels. Traveling to school is a common activity for most children in the United States. Due to this regularity, active transportation to school provides a possible way to incorporate an increase in children's moderate-to-vigorous physical activity into a routine activity.

Several "walk to school" programs have been implemented but it is not known if the physical activity levels of children walking to school are greater than those that get chauffeured or bused. Theoretically, moderate intensity activity should be greater in the walkers compared to others. This difference should be in proportion to the duration of the walk to and from school; determined by how far the child lives from the school. However, more activity in the morning may have an impact on activity levels later in the day. Therefore, differences in daily activity patterns in addition to total activity need to be considered.

Comparison(s): Following a baseline week, the physical activity of students randomized to a Walk to School group will be compared to those randomized to a Control group, who will continue to be driven to school.

Eligibility Criteria:
Inclusion Criteria:

* 3rd, 4th, or 5th grade at participating school

Exclusion Criteria:

* Currently walking or bicycling to school at least 4 times per week
* Physical or mental disability that would prevent walking to school under adult supervision.
Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit

This study is based on the hypothesis that access to smoking cessation treatment (SCT) reimbursement may significantly increase the number of successful quitters in a population of smokers motivated to quit by: 1) increasing the use of SCTs in quit attempts, and 2) by improving subject adherence to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Daily smokers (10 cigarettes per day or more);
* Smokers motivated to make a quit attempt within the next 14 days;
* Potential subjects must be outpatients;
* A subject must have a stable mental and physical medical condition (as per investigator's judgment).

Exclusion Criteria:

* A subject currently eligible for smoking cessation treatment (SCT) reimbursement, whether from a public or a private drug insurance;
* A subject with an unknown drug insurance status;
* A subject living in a household where there is someone already recruited in the study;
* A subject with an unfilled SCT prescription issued within the past three months or with an unused SCT product;
* A subject with a life-threatening illness (ie, known or suspected cancer or other disease with a life expectancy of less than one year).
Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mg

The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with asthma since at least 6 months prior to first visit
* Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit
* At least one asthma exacerbation more than one but less than twelve months prior to first visit

Exclusion Criteria:

* Respiratory infection affecting asthma within 30 days before first visit
* Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit
* Any significant disease or disorder that may jeopardize the safety of the patient

Additional inclusion and exclusion criteria will be evaluated by the Investigator.
Asian Registry of the BioFreedom Stent for STEMI Patients

The BioFreedom BA9 (Stainless Steel) Drug Coated Stent is an approved stent that is already commercially available in Europe and Asia. The purpose of this registry is to assess the safety and efficacy of the BioFreedom stent for treatment of a specific group of patients; patients with a myocardial infarction (STEMI). The objective is to capture patients' outcomes and antithrombotic strategies data using one or several BioFreedom Stents in the routine treatment of these STEMI patients.

The purpose of this registry is to assess the safety and efficacy of the BioFreedom stent for treatment of STEMI patients. The objective is to capture patients' outcomes and antithrombotic strategies data using one or several BioFreedom Stents in the routine treatment of STEMI patients. This will be a fully observational post market registry designed to enroll 1000 STEMI patients at about 20 centers in up to 8 Asian countries where the BioFreedom BA9 (SS) DCS is available for clinical use.

The primary endpoint is LTF, which is a composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization.

The investigators expect event rates of the composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization to be 4.3% at one year as observed in the COMFORTABLE AMI study. Assuming a one-sided type I error (α) of 0.025, and a non-inferiority margin of 1.9%, a cohort of 1000 patients will have more than 80% power to conclude non-inferiority. The complete data analysis will be described in a Statistical Analysis Plan (SAP) that will be finalized and signed before the one year database lock.

Primary and secondary endpoint related events will be adjudicated by independent adjudicators. The study will be monitored per a monitoring plan, data will be collected in an electronic data capture system.

All enrolled patients will be followed up at 1, 4 and 12 months to collect information on their current status, review of cardiac medication taken and any adverse events that they have experienced.

Both CERC and Biosensors will follow company SOP's which are GCP and ISO 14155:2011 compliant.

Eligibility Criteria:
Inclusion Criteria:

1. STEMI patients treated with one or several BioFreedom stent(s) within 12h of symptom onset
2. Patients who agree to comply with the follow up requirements.
3. Patients with a life expectancy of \> 1 year at time of consent.
4. Patients eligible to receive dual anti platelet therapy (DAPT). The establishment of the DAPT regimen is at the physician's discretion.

Exclusion Criteria:

1. Patients in cardiogenic shock
2. Any out of hospital cardiac arrest
3. Glasgow score \< 15
4. Patients unable or unwilling to give documented informed consent
5. Patients with any PCI 6 months prior to the baseline procedure
6. Patients taking part in another interventional trial which has not completed follow-up for the primary endpoint
7. Patient has received an additional stent different from a BioFreedomBA9 (SS) DCS stent during the index procedure.
8. Pregnant or breastfeeding women
Prone Positioning in Neurologically Deceased Potential Organ Donors to Improve Donor Lung Function and Lung Transplant Recipient Outcomes

The purpose of this study is to determine the practicality of performing a future, large-scale study. The future study will look at the effect of mechanical ventilation in neurologically deceased (brain-dead) lung donors who are positioned to lay flat on their stomach (prone position), compared to donors who are positioned to lay flat on their back (supine position). The study will also look at the potential impact of prone positioning of the donor on transplant recipients of the study organs.

The investigators are doing this study because the investigators want to increase the availability of donor lungs for lung transplant. Lung transplant is a life-saving treatment for individuals with lung disease, but there are not enough donated lungs to meet demand. Researchers are looking for better ways of preventing donated lungs from becoming unsuitable for transplant. Because of this, the goal of our study is to test whether prone positioning in neurologically deceased (brain-dead) lung donors can improve donor lung function and decrease complications, potentially increasing the number of donor lungs that can be used for transplant.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Neurological determination of death at time of study entry
3. Consent to organ donation
4. Eligible for organ donation as confirmed by Trillium Gift of Life Network Coordinator

Exclusion Criteria:

1. Open chest or abdominal wounds on the ventral body surface
2. Absolute contraindication to lung transplantation on initial eligibility screening:

   * Infection i. Positive HIV, HbsAg, Human T-lymphotropic virus-I/II test results ii. Positive West Nile Virus (WNV PCR) test results iii. Rabies diagnosis or within the last 6 months bitten by an animal proven to have rabies iv. Active endocarditis v. Active encephalitis or meningitis of unknown etiology vi. Active disseminated tuberculosis vii. Viral hemorrhagic fever including Ebola or known exposure to person with Ebola viii. COVID-19 presumptive or confirmed positive in the last 14 days
   * Malignancy i. Donors with active cancer (donors receiving chemotherapy or radiation therapy or palliative cancer care within the last 5 years); excluding skin and primary brain tumors and prostate cancers.

ii. Donors with a history of the following malignancies:

* Lung Cancer
* Choriocarcinoma
* Breast Cancer
* Colon Cancer within the last 10 years iii. Donors with active or past history of melanoma o Clinician decision that prone position is contraindicated
Community Trial to Enhance Organ Donation

The purpose of this study is to determine the effect of a 5-minute video intervention regarding organ donation and transplantation on increasing the number of organ donor cards signed in Northeastern Ohio Bureau of Motor Vehicles (OBMV) branches and on willingness to donate organs while living. The investigators hypothesize that persons in the intervention group will sign more donor cards and be more willing to donate organs while living than persons in the control group.

We propose a community-based randomized controlled trial involving 450 intervention and 450 control patrons visiting Ohio Bureau of Motor Vehicle branches (OBMV) to obtain a driver's license. Interventions patrons will watch a 5-minute video prior to entering the OBMV. Study personnel will interview intervention and control patrons after they leave the OBMV to determine whether they signed an organ donor card. We will also determine the effect of the video intervention on willingness to donate organs while living.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Applying for driver's license, driver's permit or state id

Exclusion Criteria:

* Non-English speaking
* Persons who have already signed donor card
Botulinum for Chronic Exertional Compartment Syndrome

We will investigate the feasibility of a simple outpatient one time injection regimen for the treatment of Chronic Exertional Compartment Syndrome (CECS). We think botulinum toxin injections will be a potentially cost-effective, low-risk alternative to surgery in reducing pain and returning patients to full activity.

The study will be a prospective cohort pilot study designed to compare Active Duty patients, 18 years of age or older, with Chronic Exertional Compartment Syndrome (CECS) undergoing two different treatment interventions. The first arm will be patients receiving investigational botulinum toxin injections. The second arm will be patients who undergo the standard of care surgical fasciotomy. Both arms will be evaluated for pain relief with the universal pain scale and lower extremity functional index (LEFI) surveys at pre-treatment and again at one, three, and six months post-treatment. Clinical data that will be analyzed for research purposes in both groups include age, sex, height, weight, body mass index, time to diagnosis, minutes of exercise prior to onset of symptoms, minutes of rest before relief of symptoms, LEFI and pain on the Universal Pain Assessment Tool.

Eligibility Criteria:
Inclusion Criteria:

* Adult ages 18-65
* Active duty military
* Unable to run 1.5 miles without producing symptoms, including aching, burning, numbness, tingling, or weakness in the affected limb
* Failed conservative treatment over a period of 2 months, including trial of rest, NSAIDs, icing, and stretching routine
* Meets standard of care clinical diagnostic intramuscular compartment pressure criteria for CECS, based on standardized IMP needle testing. See below for testing protocol and criteria.

Exclusion Criteria:

* Prior Botulinum toxin injections into the affected limb
* Prior compartment release of the affected limb
* Pregnant or becomes pregnant during the study
* Standard of care clinical exams indicating other more likely causes of leg pain
Local Control With Reduced-dose Radiotherapy for High-Risk Neuroblastoma

The purpose of this study is to give 12T a smaller dose of radiation in order to decrease these late side effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of neuroblastoma (International Classification of Disease for Oncology \[ICD-O\] morphology 9500/3) confirmed by MSKCC pathologic review
* Patients must have high-risk neuroblastoma as defined by the COG Risk Stratification Schema

  o Patients with International agreement on staging (INSS) stage 4 are eligible with the following:
* MYCN amplification, regardless of age or additional biologic features
* Age \>18 months, regardless of biologic features OR
* Age 1-18 months, with any of the 3 following unfavorable biologic OR features: MYCN amplification, unfavorable pathology, and/or DNA index = 1

  o Patients with INSS stage 3 are eligible with the following:
* MYCN amplification, regardless of age or additional biologic features OR
* Age \> 18 months with unfavorable pathology, regardless of MYCN status

  o Patients with INSS stage 2a or 2b are eligible with the following:
* MYCN amplification, regardless of age or additional biologic features

  o Patients with INSS stage 4s are eligible with the following:
* MYCN amplification, regardless of additional biologic features Patients must have undergone chemotherapy and surgery for high-risk neuroblastoma prior to enrollment on trial.
* Age at time of enrollment of ≥1 month and ≤18 years
* Female patients of childbearing potential must have a negative pregnancy test within 14 days of radiation start.
* Female patients who are lactating must agree to stop breast-feeding.
* Sexually active patients of childbearing potential must agree to use effective contraception.

Exclusion Criteria:

* Patients with gross residual tumor after surgical resection
* Patients who have received prior radiotherapy at or adjacent to the primary tumor bed
* Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
Operant Conditioning of Sensory Brain Responses to Reduce Phantom Limb Pain in People With Limb Amputation

The study will investigate the application of a non-pharmacological operant conditioning approach to reduce phantom limb pain (PLP). PLP afflicts 60-90% people who have lost a limb. It can last for years and lead to drug dependence, job loss, and poor quality of life. Current non-pharmacological interventions are encouraging but limited, and their efficacy remains unclear. Limb amputation is known to lead to abnormal sensorimotor reorganization in the brain. Multiple studies have shown that PLP severity is correlated with the extent of this reorganization. The current study will train participants via realtime feedback of brain responses to promote more normal sensorimotor response, with the goal to reduce phantom limb pain.

The study will be recruiting people who have had a limb amputation (traumatic or atraumatic) and are experiencing chronic phantom limb pain (PLP). Participants will be asked to be seated during the study session. Non-painful peripheral stimulation will be applied to elicit a brain response. Electrodes will be placed on the scalp to record these electrical brain responses during the study session. Visual feedback based on the response will be provided in pseudo realtime. The study will involve three 1-hour sessions per week for 8-9 weeks, followed by 2 follow-up sessions at 3 and 6 months after the last session. Assessments of pain intensity and quality, and neurophysiological sensorimotor response, will be performed before the first session, after the last session, and at follow-up sessions. Additional electroencephalography (EEG) based assessments will also be performed as exploratory measures, to assess inter- and intra- hemispheric functional connectivity and sensorimotor responses associated with amputation and operant conditioning training.

Eligibility Criteria:
Inclusion Criteria:

* An upper (or lower limb) amputation more than 6 months ago, that has produced a moderate to severe hand/arm (or foot/leg) phantom limb pain,
* Male or female age 18 years or older,
* Medical clearance to participate,
* Reasonable expectation that ongoing medications, if any, will be maintained without change for at least 4 months from the start of the study,
* Able to provide informed consent and to understand the study instructions,
* Able to participate in the specific study procedures.

Exclusion Criteria:

* Presence of other medically unstable and/or infectious condition (e.g., uncontrolled diabetes with recent weight loss, diabetic coma, frequent insulin reactions),
* A cardiac condition (e.g., history of myocardial infarction or congestive heart failure),
* Cognitive and/or attention difficulties affecting participant's ability to follow study directions,
* Known skin disorders or damaged skin at the anticipated at the scalp for EEG recording (e.g., unhealed wounds, broken skin).
* Metal implants above the chest
High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy

The purpose of this study is to determine the efficacy and safety of nasal high flow oxygen therapy during diagnostic bronchoscopy.

Hypoxemia is frequently seen during diagnostic bronchoscopy. Nasal prong or other existing oxygen supply methods are often difficult to maintain adequate oxygenation during bronchoscopy. In particular, bronchoscopy to patients already showing hypoxemia can be dangerous even though applying conventional oxygen therapy. Thus, we want to elucidate the usefulness of nasal high flow oxygen therapy to hypoxemic patients undergoing diagnostic bronchoscopy.

Eligibility Criteria:
Inclusion Criteria: 1 or 2

1. PaO2 \< 60 mmHg on ABGA or SpO2 \< 90 % in room air AND SpO2 ≥ 95% or PaO2 ≥ 75mmHg in low flow oxygen therapy
2. Planning to diagnostic bronchoscopic procedure (e.g. bronchial washing, BAL, bronchoscopic biopsy, EBUS-TBNA etc.)

Exclusion Criteria:

1. patients who did not agree to provide information
2. patients requiring for emergent intubation
3. patients can not wear or be already applied high flow nasal oxygen therapy
4. patients with unstable vital sign(e.g. severe hypotension, uncontrolled arrhythmia, etc.)
5. patients with multiple organ failures
6. patients with plan to therapeutic bronchoscopic procedure(e.g. intervention)