cyrilzakka/clinical-trials huggingface dataset:
The Acute Effect of Boxing on Balance, Neuropsychological, and Visual Functions

Prior research has investigated the effect of repetitive head trauma as it relates to physiological and psychological function. Boxing is one particular sport which predisposes athletes to a large amount of head impacts. We plan to assess the effects of a boxing tournament on balance, neuropsychological, and visual functions.

This is a prospective, repeated measures cohort study, which is able to make within-subject (pre and post boxing tournament) comparisons on measures of physiologic and behavioral function.

We plan to enroll boxing athletes who are participating in a boxing tournament. Each individual will be assessed on the following tests: balance (dynamic and static balance), vestibular-ocular motor function, neuropsychological function, and symptoms. Additionally, each boxing match will be video recorded and the total number of head impacts they sustain will be documented.

* In order to prospectively assess how a boxing tournament affects balance, neuropsychological, and visual functions from pre-tournament assessments to post-tournament assessments (Specific Aim 1), we plan to test all athletes before competition at the Pan-American games begins (pre-test) and after they have been eliminated from the tournament (post-test).
* In order to measure the associations between the number of head blows sustained during a boxing tournament with balance, neuropsychological, visual, and symptom deficits, we will also use a video camera to record each match and count the total number of hits to the head.

Eligibility Criteria:
Inclusion Criteria:

1. Participation in boxing at a pre-specified tournament
2. Medically cleared to participate in the tournament, as determined by the attending medical staff

Exclusion Criteria:

1. Any pre-existing neurological disorder, including but not limited to stroke, intracranial hemorrhage, any movement disorder, and cerebral palsy.
2. Any currently active psychiatric condition, including specifically major depression, bipolar disorder or schizophrenia. A history of a psychiatric condition but no ongoing psychiatric episode (e.g. not currently undergoing treatment for a major depressive episode) would not be an exclusion.
3. Any unstable medical condition
NAtural Course and Prognosis of PFIC and Effect of Biliary Diversion

The natural course of PFIC syndromes and the effect of diversion techniques, have so far not been characterized in a rigorous manner within a larger population of patients. In fact, the clinical or biochemical parameters which most directly define and/or predict the success of reduced enterohepatic circulation (either by surgical diversion or medically) are still unclear.

The present project aims to:

1. Define the natural course of disease in patients with genetically defined FIC1 deficiency (PFIC1), BSEP deficiency (PFIC2), MDR3 deficiency (PFIC3) and other subtypes of the PFIC disease family (including e.g. Myo5B deficiency, TJP2 deficiency, a.o.), with respect to relevant biochemical and clinical parameters (and if available, histological). Included will be patients homozygous for a known, disease-causing mutation, patients compound homozygous for two disease-causing mutations or heterozygous for one disease-causing mutation in combination with the corresponding clinical phenotype .
2. Define the change in the natural course of disease in response to biliary diversion surgery and or liver transplantation, based on short- and long(er)-term changes in biochemical (if available, histological) and clinical parameters, including outcome measures. Follow up after transplantation will be limited, follow up after surgical biliary diversion will be as long as possible.
3. Assessment of biochemical variables as possible surrogate endpoints for clinical hard endpoints. If possible this allows for identification of low-risk to high-risk patients early during follow-up.
4. If patient numbers permit, to establish genotype-phenotype relationships for the most common genetic mutations causing the indicated diseases.

Based on this project it is anticipated that the investigators are able:

* to characterize the variation in natural course of disease (whether or not genotype dependent) to allow clinicians to rationally select a target population for assessing the effect of medical intervention, rather than surgical biliary diversion);
* to identify and qualify one or more biomarkers that independently predict either improved or poor clinical outcomes of surgical biliary diversion;
* to investigate if the identified biomarker(s) can be used as surrogate end point(s) for assessing and predicting outcomes with novel interventional strategies.


Eligibility Criteria:
Inclusion Criteria:

Clinical suspicion for FIC1-, BSEP- or MDR3-deficiency or of any other subtype of the PFIC family
Indomethacin Versus Placebo in Women With Preterm Premature Rupture of Membranes (PPROM)

The purpose of this study is to determine if the short term use of indomethacin will reduce the number of women delivering within 48 hours when given to women with preterm premature rupture of membranes (PPROM) between 24- 32 weeks of gestation. We hypothesize that indomethacin's anti-inflammatory and tocolytic action will reduce the number of women delivering within 48 hours when given to women with PPROM between 24-32 weeks of gestation.

Preterm premature rupture of membranes (PPROM) is defined as rupture of the chorioamniotic membranes before the onset of labor prior to 37 weeks of gestation. The etiology of PPROM is not well understood but likely to be multifactorial. Although the underlying mechanism of PPROM is unknown, some speculate it is the human's inflammatory response to bacterial infection with the subsequent production of prostaglandins which weaken the fetal membranes. Therefore, the use of indomethacin, a prostaglandin inhibitor, may decrease prostaglandin synthesis leading to less uterine irritability and prevention of weakened membranes.

This is a double blind randomized controlled trial comparing indomethacin to placebo in women with PPROM between the gestational ages of 24-32 weeks. Women between the gestational age of 24 to 32 weeks with premature rupture of membranes and not in active labor will be eligible for this clinical trial. After informed consent, patients will be randomized to either indomethacin or placebo. Maternal and neonatal outcomes will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 24 0/7 - 31 5/7 weeks by LMP or ultrasound
* Documentation of rupture by demonstrating pooling or 2/3 diagnostic tests (pooling, ferning and nitrazine positivity)

Exclusion Criteria:

* Membrane rupture greater than 72 hours
* Persistent labor characterized by regular painful contractions with cervical change and/or cervix visually greater than 5 cm
* Chorioamnionitis defined by having 2 or more of the following: maternal temperature \> 100.4, persistent fetal tachycardia (\>170bpm), maternal tachycardia (\>110bpm) in the absence of other likely cause, uterine tenderness.
* Non-reassuring fetal heart rate tracing or biophysical testing
* Vaginal hemorrhage
* Lethal fetal anomalies
* Intrauterine fetal demise
* Maternal conditions which precludes expectant management
* Fetal condition which precludes expectant management
* Maternal allergy to indomethacin
* Maternal active gastritis
* Multiple gestations
* HIV with viral load \>1000
* HSV with active herpetic lesions
* Cervical cerclage
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers

The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care, as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.


Eligibility Criteria:
Inclusion Criteria:

1. Diabetes mellitus.
2. Male or female at least 18 years old.
3. Subject must agree to adhere to all protocol procedures and return for all scheduled visits, and must be willing and able to provide written informed consent.
4. Subject is to be treated on an outpatient basis.
5. Full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli with a surface area ≥ 1 cm2 after the wound has undergone appropriate debridement.
6. Localized mild infection of the ulcer.
7. The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.
8. Subject must have plain radiographs taken within 2 days prior to entry showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot.

Exclusion Criteria:

1. IDSA-defined moderate infection.
2. IDSA-defined severe infection.
3. Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
4. \> 1 infected foot ulcer.
5. Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.
6. Subject has received a systemic antibiotic within 48 hours prior to Screening.
7. Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
8. Bone or joint involvement is suspected based on clinical examination or plain X-ray.
9. Clinically significant peripheral arterial disease requiring vascular intervention.
10. Subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period, or is unable to safely monitor the infection status at home.
Efficacy of Adding Patellar Mobilization to Hip and Knee Exercises in Patients With Patellofemoral Pain Syndrome

Patellofemoral pain syndrome is a common source of anterior knee pain. The causes of PFPS may be multifactorial such as biomechanical disorders, muscle weakness which affect the dynamic stability of lower limb and alter patellar tracking in trochlear groove. Moreover, the syndrome associated with muscular tightness of iliotibial band, gastrocnemius, soleus, hamstring and quadriceps. Strengthening and stretching exercises are effective in improving patient's symptoms. However, they do not sufficient in correction of kinematic changes associated with PFPS. Patellar mobilization is effective in improving patient'symptoms in cases with PFPS. However, studies that conducted patellar mobilization were either low quality studies or no study combined patellar mobilization with hip and knee exercises.

Therefore, APTA guidelines recommended for conducting high quality study to investigate the effect of adding patellar mobilization to exercise therapy to support the definite recommendation delivered to therapists.

this is interventional study in which patients will receive stretching and strengthening exercises in control group. in addition, experimental group will receive the same exercises of control group in addition to patellar mobilization, retinacula release and deep friction message.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranging between 18 and 35 years
2. Tenderness of medial and lateral borders of patella
3. Retropatellar pain
4. Duration of symptoms of patellofemoral pain syndrome is greater than 4 weeks
5. Positive patellar compression test
6. Pain intensity is more than 3 at visual analogue scale
7. Had a history of insidious onset
8. Had anterior knee pain during 2 or more of provocative activities that include stair ascent or descent, kneeling, prolonged sitting, or squatting

Exclusion Criteria:

1. Previous patellar realignment surgery or patellar fracture
2. Had a history of traumatic patellar dislocation
3. Had a history of previous knee surgery
4. Had any form of inflammatory arthritis that include osteoarthritis or rheumatoid arthritis
5. Had a history of knee menisci, ligaments, bursae, or synovial plica syndrome dysfunction
6. Taking corticosteroids or nonsteroidal anti-inflammatory medication
7. Inability to attend treatment program to the end of sessions
Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death

The purpose of this study is to determine whether ICD(Implantable Cardioverter Defibrillator) implantation on the top of optimal medical therapy in patients with variant angina manifesting as aborted sudden cardiac death reduces the incidence of the death from any cause compared with optimal medical therapy alone.

All participants will be monitored over a span of five years and the time point of the year of last subject last visit. The term "year of last subject last visit" refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patients experienced successfully resuscitated cardiac arrest due to documented ventricular fibrillation or sustained rapid ventricular tachycardia
* Diagnosed as variant angina, defined by spontaneous coronary spasm with ST elevation (≥0.1mV) in the coronary angiogram and/or documented coronary spasm on ergonovine provocation coronary angiography

Exclusion Criteria:

* Significant (\>50%) coronary artery stenosis on coronary angiography
* Organic heart disease known to be associated with sudden cardiac arrest.

  * Heart failure with reduced ejection fraction (Left Ventricular Ejection Fraction \< 35%)
  * Presence of LV akinesia or aneurysm
  * Hypertrophic cardiomyopathy
  * Arrhythmogenic right ventricular dysplasia
* Chronic Heart Failure New York Heart Association functional class III or IV
* prior history of atrial or ventricular arrhythmia requiring class I or III antiarrhythmic drugs (flecainide, propafenone, amiodarone, sotalol and dronedarone)
* Prior catheter ablation for ventricular arrhythmia
* Primary cardiac electrical diseases (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia)
* Prior pacemaker or Implantable Cardioverter Defibrillator
* 2nd or 3rd degree AV block not related to coronary ischemia, requiring permanent pacemaker
* Patients with poor neurologic outcome (defined as cerebral performance category scale ≥3)
* Life expectancy \<2 years
* Psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up
Medtronic PSR TDD PMCF

The purpose of this study is to provide continuing evaluation and reporting of safety and performance of the SynchroMed II Infusion System within its intended use. Data will support post-market surveillance obligations.

This study was originally posted under NCT01524276 and now posted alone to adapt to new ISO regulation.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive or be treated with an eligible Medtronic product
* Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment
* The indication for implant meets approved indications
* The patient can reasonably be expected to remain fully on label for a 48-month time period after implant

Exclusion Criteria:

* Patient who is, or will be, inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
* There is no indication at enrollment (e.g., medical conditions, anticipated relocation, etc.) that the patient will be unable to complete 48 months of follow-up after implant
A Trial of SHR-7367 in Subjects With Advanced Solid Tumors

This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
2. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;
3. Histopathologically or cytologically documented advanced or metastatic malignancies;
4. At least 1 measurable lesion conforming to RECIST 1.1 criteria;
5. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
6. Female and male patients of reproductive potential must agree to use highly effective contraception.

Exclusion Criteria:

1. Any immunostimulants administered within 4 weeks;
2. Systemic anti-tumor therapy within 4 weeks;
3. Any investigational cancer therapy administered within 4 weeks;
4. Surgical procedures requiring general anesthesia within 4 weeks;
5. History of autoimmune diseases;
6. History of immunodeficiency;
7. Severe infections within 2 weeks prior to the first study treatment;
8. Clinically significant cardiovascular condition;
9. Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;
10. Known history of serious allergic reactions to the investigational product or its main ingredients.
Intraoperative Analysis of the Central Retina in ERF

Changes in the retinal anatomy that occur in epiretinal fibrosis have not been sufficiently studied. It is possible that epiretinal fibrosis leads not only to traction dislocation of the macula, but also to ILM anatomical disorders.

Purpose: to study anatomical changes in the Central retina in epiretinal fibrosis.

Surgical treatment: standard vitrectomy 25-27G; ERM amd ILM stainig by Membrane Blue Dual; epiretinal membrane removal, ILM peeling if the divulsion of ILM was detected.

Expected results: improving the quality of epiretinal fibrosis surgery by obtaining a more detailed picture of the pathological process

Eligibility Criteria:
Inclusion Criteria:

* BCVA \< 0,6;

Exclusion Criteria:.

* secondary ERM, glaucoma, diabetic retinopathy, high myopia, BCVA\>0,6
Development of a Sign-Out Tool to Improve Handoffs in Care

The purpose of this grant is to fund the research necessary to fully understand the impact of this sign-out tool on clinician workflow, quality of sign-out, and continuity of care. This information will inform exactly how Partners will move ahead with tools to improve handoffs in care (i.e., whether the prototype will be adapted further, adopted Partners wide, or abandoned in favor of other solutions). The investigators hypothesize that a web-based handoff tool improves provider satisfaction, the quality of written sign-outs, and measures of continuity of care compared with current handoff tools.

This study will attempt to answer the following questions:

1. What are the specific needs for clinical content among various clinical personnel (nurses, residents, and attendings) on different services at two different hospitals (MGH, BWH)?
2. How can IT support sign-out that facilitates interdisciplinary communication and yet preserves user-specific content among different clinical personnel?
3. Can a sign-out tool currently deployed at MGH be transferred to BWH using existing IT services and a minimum amount of local IS effort?
4. What will be the future needs of this tool so that it can fully access data from MetaVision once it is deployed?
5. How should the tool be further improved such that it optimizes user adoption, provider satisfaction and workflow, the quality of sign-out, and continuity of care?
6. Is it feasible for a future, refined version of this tool to be adopted across Partners acute care hospitals?

The study design is an observational, before-after pilot study. A multi-disciplinary steering committee and working group will be assembled to determine requirements and guide design in conjunction with HPM leadership, research staff, a Partners IS analyst, and MGH LCS personnel. The intervention will then be implemented on two services. Before and during implementation, several outcomes will be measured, including provider satisfaction and workflow, continuity of care, and quality of sign-out.

Deliverables will include the following:

1. Clinical and functional specifications for a new web-based sign-out tool
2. A prototype of the sign-out tool tested on 2 active clinical services, one each at MGH and BWH
3. A report of the impact of the tool on clinical care
4. Lessons learned regarding design and implementation that can be applied to more broad-based efforts
5. An update to the Sign-out White Paper with recommendations for action based on the results of this study The lessons learned will be applicable not only to Partners, but to other institutions (nationwide and worldwide) wishing to improve patient safety during handoffs in care.

Eligibility Criteria:
Inclusion Criteria:

* All nurses, residents, PAs, and attendings on the two study services

Exclusion Criteria:

* Clinical staff not on study services within study period
HPV Prevalence in 16-20 Year Old Males

In Quebec, 18 birth cohorts of girls were vaccinated against HPV (aged 9 to 29 years in 2020). With an observed vaccination coverage of \>80% an important herd effect might be expected. This study aim is to measure the HPV types prevalence in unvaccinated sexually active boys aged 16 to 20 years.

An HPV immunization program is in place in Quebec since 2008. By 2020 18 birth cohorts of girls were eligible for vaccination. Vaccine uptake with at least one dose of vaccine was \>80%. With such a high vaccine uptake an important herd immunity might be expected. The main objective of this study is to measure the prevalence of different HPV types in unvaccinated sexually active boys aged 16 to 20 years. This is a cross sectional study which includes one visit for all participants. Self sampling technic is used. During this phase of the study a total of 681 boys will be recruited. An additional phase of the study will be conducted at the condition that the prevalence of HPV6/11/16/18/31/33/45/52 and 58 in unvaccinated boys will be at least 8.65%. The second phase of the study if conducted will measure the prevalence of the same HPV types in 681 vaccinated boys of the same age.

Eligibility Criteria:
Inclusion Criteria:

* unvaccinated against HPV
* sexually active

Exclusion Criteria:

* received an HPV vaccine
* non sexually active