cyrilzakka/clinical-trials huggingface dataset:
Effect of Adaptive Sports After Acquired Physical Disability

This study is a cross-sectional trial which aims to evaluate the effect of practicing a physical activity on different domains of the ICF among individuals with an acquired physical disability. Two different groups of individuals with a spinal cord injury will be enrolled: one composed of subjects who manage to reach the WHO's recommendations regarding physical activity, and the other of subjects who do not.

The present study will recruit participants based on a set of defined eligibility criteria, in adaptive sports clubs teams and in groups or associations of individuals with an acquired, and permanent, physical disability. Based on the presence or absence of a regular physical activity practice undertaken by the subjects who give their consent to participate in the study, they will be divided into two groups: one where individuals regularly practice a physical activity, and one where they do not.

A set of defined outcome measures (detailed in the "Outcome Measures"section) will be assessed in both groups.

The outcomes measures will be analysed statistically, using SPSS software. Depending on the nature of the variables (qualitative or quantitative), different tests will be performed. Normality will also be verified and will determine which statistical analysis will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed non-progressive spinal cord injury
* dependent on wheelchair for mobility
* more than 6 months since diagnosis of spinal injury
* able to understand and speak french

Exclusion Criteria:

* medical contra-indication to the testing
* cognitive deficiency which limits communication
Clinical Outcomes of Sutured Versus Sutureless Conjunctival Autograft in Primary Pterygium Excision

The goal of this study is to find out if a certain technique in pterygium excision surgery ,using no sutures, is better than the technique mostly used ,which uses sutures.

Investigators aim to find out whether the no sutures technique provides better efficiency and patient satisfaction than the traditional approach. They predict that if this study provides evidence of the advantages of this technique over the one used, surgeons would be encouraged to use it instead. Because not only would the patient benefit, the surgeon also may save operative time and effort used in the technique which uses sutures.

This study is a comparative interventional study, in which patients are assigned into two groups comparable in age, gender, and general condition. The first group consists of patients with primary pterygium who will undergo surgery in a traditional approach in which the pterygium is surgically removed and after which a conjuctival graft is placed on the exposed sclera and sutured to the surrounding conjuctiva; in comparison, patients of the second group undergo pterygium excision in a similar matter initially.But the conjuctival graft is placed on the exposed sclera without suturing it to the nearby conjuctiva; instead, the graft remains in place using the patient's autologous blood. Fresh blood is left under the graft, while the surgeon merely compresses the graft for a few minutes. The aim of this study is to reach a conclusion as to which technique is more beneficial, to the patient and surgeon.

Patients included in this study must have primary pterygium, no known hematological condition, and full consent to the study. Surgery time is recorded to compare the effect of avoiding sutures on the surgeon's speed. After that, Patients are followed up in documented certain intervals post-operative, to assess graft displacement, signs of inflammation, signs of bleeding under graft, and patients' overall discomfort and satisfaction.

Finally, the two groups are compared with all factors taken into consideration. The ultimate target is to document evidence of the efficiency of the sutureless technique and endorse its application by Ophthalmologists elsewhere.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18-60 years old.
* Patients diagnosed with primary Pterygium (Grades 1-4)

Exclusion Criteria:

* Patients unable to offer viable consent
* Patients with other significant ocular surface diseases, bleeding disorders, or systemic conditions affecting wound healing.)
* Recurrent pterygium
* Combined ocular surgery
Stent Implantation of Polyurethane Expandable Valve, by Catheter, in Patients With Pulmonary Valve Dysfunction

Prospective Study, Single Arm to evaluate the safety and efficacy of polyurethane expandable valve implantation in the pulmonary position, in 5 patients over 18 years of age, with pulmonary valve dysfunction and moderate to severe impairment of Right Ventricular function. During throughout the study, safety parameters related to valve operation will be evaluated (patient's Functional Class), in addition to the occurrence of Serious Adverse Events. After the procedure, the patient must be hospitalized in the Intensive Care Unit until the complete hemodynamic stabilization and normalization of lung function and in good general condition (2 to 3 days of stay) and then transferred to the ward (2 to 3 days and stay) before hospital discharge. A formal Statistical Analysis Plan (SAP) will be developed and finalized before closing the database. Full details of data presentations and analysis will be provided in SAP.

Additional statistical analyses, other than those described in this section, may be performed if deemed appropriate and included in SAP. Any deviations from the final analysis plan or what is presented in the protocol will be discussed in the final study report. No formal inferential statistics will be applied to the data collected in the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older;
* Pulmonary valve dysfunction and moderate to severe impairment of Right Ventricle function;
* Functional Class II to IV New York Heart Association (NYHA) classification of heart failure.

Exclusion Criteria:

* Impairment of cardiovascular function;
* Neurological impairment;
* Syndromes without prognosis or survival of less than 1 year;
* Carriers of infection undergoing medical treatment;
* Patients undergoing artificial life support;
* Known hypersensitivity to aspirin or heparin;
* Positive urine or serum test for pregnancy in female patients of reproductive age.
Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing

The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters. The investigators will be testing how the pressure measurements recorded with this device compare to the gold standard measurement of urodynamics.

For patients with neurogenic bladder, regular monitoring of bladder pressure and capacity is a critical component of maintaining renal and urinary health. This monitoring is currently done by in-office urodynamics testing (UDS). This testing is done intermittently, leaving open the possibility of worsening of bladder function and renal deterioration between testing sessions.

This study utilizes a novel pressure monitoring device which is portable and hooks to the end of a standard urinary catheter. The investigators will be investigating if this device can achieve similar pressure measurements as UDS. The investigators hope is that this device will provide similar measurements to UDS, and can be developed as a home bladder-pressure monitoring tool.

This study will enroll children with neurogenic bladder who are currently undergoing UDS as part of their regular care. The measurements will be taken as part of the standard UDS protocol (with insertion of the UDS catheter) and will then be compared to the values obtained with UDS testing.

Eligibility Criteria:
Inclusion Criteria:

* must have diagnosed neurogenic bladder
* undergoing urodynamics testing as part of routine clinical care

Exclusion Criteria:

-None
Apomorphine Nasal Powder in the Treatment of Parkinson's Disease "Off" Periods.

To determine the safety and tolerability of repeated dosing with Apomorphine Nasal Powder in subjects with Parkinson's Disease.


Eligibility Criteria:
Inclusion Criteria:

* 1 year history of Parkinson's Disease; stable PD medications for 4 weeks; at least one documented "off" period per day

Exclusion Criteria:

* hypersensitivity to apomorphine; participation in a clinical trial in the last 12 weeks; pregnant or lactating females
Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women with HIV in South Africa: Part 2

The investigators will conduct the formative work that is necessary to develop a novel, multi-level intervention (inclusive of patient- and provider-level components), which will increase awareness of and modify the complex, intersecting factors that contribute to cervical cancer development among cisgender women with HIV (WWH). In Aim 1a, the investigators will explore the multi-level barriers and facilitators to follow-up appointment attendance among WWH who have had a recent high-risk abnormal Pap smear in the past six months, via qualitative interviews with WWH who have either attended at least one follow-up visit (n\<10) or have not yet attended a follow-up visit (n\<10). In Aim 1b, the investigators will explore provider awareness of the HIV-cervical cancer relationship and perspectives on barriers to retention in care via qualitative interviews (n\<8). For Aim 2, The study team will leverage the Aim 1 data, develop a patient-level intervention (1-2 sessions) and a provider toolkit, with the goal of increasing retention in care among WWH who are at heightened risk for cervical cancer. The study team will seek feedback on the manual and the toolkit from providers and from a community advisory board. In Aim 3a, the investigators will test the feasibility and acceptability of the intervention in a pilot randomized control trial (RCT) (n\<60). The study team will also assess (1) changes in self-efficacy to attend cervical cancer-related healthcare appointments pre-post intervention, (2) the proportion of women who attend a follow-up appointment, and, of those participants, (3) the proportion of women who complete the next phase of treatment. In Aim 3b, the investigators will explore the feasibility of intervention implementation in the clinic and acceptability of the provider-level intervention components in qualitative interviews with providers, clinic staff, the interventionalists, and other key stakeholders (n\<10).


Eligibility Criteria:
Inclusion Criteria:

* Having a cervix
* Aged 18+
* Living with HIV
* Recent high-risk abnormal Pap results within the last month (if needed, we may increase the range by up to 6 months to ensure that we meet our targets).

Exclusion Criteria:

* Younger than 18 years old
* HIV-negative
* No cervix/history of hysterectomy
* Recent normal or low-risk abnormal Pap results
* Unable to provide informed consent or assent in English or isiZulu and/or have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.
High-dose Opioid Versus Opioid-sparing Anaesthesia in Cardiac Surgery

BACKGROUND In cardiac surgery, high-dose opioid contributes to adverse events associated with poor postoperative outcomes. There is growing evidence that nerve block-based multi-modal anesthesia protocols may reduce intraoperative opioid consumption without compromising analgesia management and consequently improve patient's early postoperative recovery.

OBJECTIVE To determine whether opioid-sparing anaesthesia based on ultrasound-guided nerve block could improve early postoperative recovery after cardiac surgery.

DESIGN A randomised controlled trial. SETTING A tertiary hospital. PATIENTS Eighty patients aged 45 to 70 years undergoing cardiac surgery were enrolled. Key exclusion criteria included contraindication to interventions or drugs and a history of chronic pain or chronic opioid use.

INTERVENTIONS Eligible patients were randomised at a 1:1 ratio to receive either opioid-sparing anaesthesia based on ultrasound-guided nerve block (intervention group) or opioid-based anaesthesia (control group).

MAIN OUTCOME MEASURES The primary outcome was the global score of the 15-item Quality of Recovery (QoR-15) questionnaire at 24h after surgery. Secondary outcomes included QoR-15 at 72h after surgery, postoperative pain score, the incidence of postoperative adverse events and chronic pain. Other outcomes included endotracheal intubation duration, length of hospitalization, and hospital costs.


Eligibility Criteria:
Inclusion Criteria:

Male or female adult patients aged 45 to 70 years, awaiting elective cardiac surgery, and American Society of Anaesthesiologists physical status classes II or III were eligible.

Exclusion Criteria:

contraindications to punctual or local anesthetic drugs, a history of chronic pain or chronic opioid use, and an inability to communicate or refuse to enroll.
Dexamethasone in Lower Third Molar Surgery

The aim of this randomized double-blind cross over clinical trial is to investigate effectiveness of different routes of applications (intramuscular and submucous at the site of surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of life after lower third molar surgery.


Eligibility Criteria:
Inclusion Criteria:

* Healthy patients (ASA I)
* Bilateral symmetrically impacted lower third molars according to Pel-Gregory's and Winter's classification

Exclusion Criteria:

* Heavy tobacco smokers
* Drug and / or alcohol abusers
A Clinical Trial to Assess the Effects of a Mouthwash Containing Chlorine Dioxide on Oral Malodor

A mouthwash containing chlorine dioxide would be effective to reduce oral malodor.

A randomized, double blind, crossover, placebo-controlled clinical trial was conducted among 15 healthy male volunteers, who were divided into 2 groups: experimental or control group. In the first test phase, the subjects in the experimental group were instructed to rinse with the mouthwash containing ClO2 and those in the control group with the placebo mouthwash without ClO2. In the second test phase after one week washout period, same procedure was conducted with the opposite mouthwashes. Oral malodor was evaluated at before rinsing, right after rinsing and follows up every 30 minutes till 4 hours with OM, and the concentrations of hydrogen sulfide (H2S), methyl mercaptan (CH3SH) and dimethyl sulfide ((CH3)2S) which are the main volatile sulfur compounds (VSCs) of human oral malodor were evaluated with GC.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of oral malodor
* Rinsing the mouthwash

Exclusion Criteria:

* oral malodor caused by foods
Noom Coach for Bariatric Surgery

The prevalence of overweight in America is a national public health crisis. As more people consider bariatric surgery for the treatment of severe obesity, it is imperative to identify factors influencing surgical outcomes. Technology, particularly the Noom Coach platform, offers a unique opportunity to improve standard interventions utilized in bariatric surgery programs. This study plans to test the efficacy of the Noom Coach platform on patients' adherence behaviors and psychosocial factors compared to standard care.

Overweight and obesity have reached epidemic proportions in the United States. Few behavioral treatments are effective for overweight, and bariatric surgery is consequently an increasingly important option. Although these procedures produce significantly more weight change than psychosocial treatments, post-operative weight losses vary widely, about 20% of patients clearly experience suboptimal weight loss, and a notable subset of these patients demonstrate substantial weight regain. Further, 20-30% report persistence of disturbed eating, depression or anxiety, or impaired health related quality of life. Adherence, or "the extent to which a person's behavior coincides with medical or health advice," contributes to variable weight and psychosocial outcomes, as well as failure to follow dietary guidelines, each of which negatively impacts weight loss.

The present study, utilizing "Noom Coach for Bariatric Health", offers a unique opportunity to overcome obstacles to providing empirically supported treatments and to improve standard interventions utilized in bariatric surgery programs; however, rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. The project will therefore test a combined smartphone app and health coaching system to improve adherence and behavioral outcomes for patients receiving bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in: the Mount Sinai Bariatric Surgery Program and planning to receive a bariatric procedure.
* Between the ages of 18 and 60 at entry to the study.
* Speak English.

Exclusion Criteria:

* Clinically significant cognitive limitations or history of developmental disability.
* History of neurological disorder or injury.
* Current/lifetime Diagnostic and Statistical Manual of Mental Disorders (DSM-5) serious psychiatric disorder, such as bipolar disorder, schizophrenia, or psychotic disorder.
* Acute suicide risk.
* Current DSM-5 alcohol or substance use disorder.
* Pregnancy.
Comparison of Lysine Clonixinate, Ketorolac and Metamizole Sodium in Scorpion Stings

The cases of scorpion stings are matters of medical importance, where Mexico is considered as one of the main countries of such public health problem.

The states with the highest incidence of cases in 2018 were Jalisco with 47370 bite reports, Guerrero with 40672 cases and Guanajuato with 40331, according to the national epidemiological surveillance system.

Due to the high affinity on ion channels, where a cystine inhibitor BmP01, it is directed to the nociceptive ion channel TRPV1 to produce pain.Pain has been reported to occur in approximately 97% of patients They are seen in the emergency room.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of pain by scorpion stings
* Patients\> 18 years old
* Clinical diagnosis of scorpion sting poisoning grade I, II and III.
* Chronic degenerative diseases (renal failure, hypertension, liver damage)

Exclusion Criteria:

* Patients who reject the continuation of medical treatment
* Patients who are transferred to a unit of second level of care.
* Patients with pharmacological treatment prior
3D US Guided Femoral Artery Access for TAVI

Rationale: Bleeding and vascular complications of the femoral artery still account for significant morbidity and mortality in transcatheter aortic valve implantation procedures. Although steadily declining over the past years through smaller diameter devices and use of ultrasound, major complications still occur in 3-4 % of patients. Femoral access is often obtained using 2D US guidance already. New 3D US probes can aid in increasing anatomical awareness. This can improve first pass success during procedures. Furthermore, for new closure devices, entering the artery at a straight angle at precisely 12 o'clock probably reduces complications. Therefore, the investigators hypothesize improved real time needle guidance using three dimensional ultrasound can decrease procedure related complications.


Eligibility Criteria:
Inclusion Criteria:

* Adult age (\>18 years)
* Scheduled to undergo elective transcatheter aortic valve implantation with percutaneous access through the femoral artery
* Written Informed consent

Exclusion Criteria:

* Unable to obtain informed consent
* Vascular access via alternative approach (radial/subclavian) or surgical cutdown
Evaluation of the Implementation and Effectiveness of IPP-HPV

The purpose of the proposed pilot study is to assess the implementation of IPP-HPV immunization at Yale New Haven Hospital (YNHH) and to identify potential barriers to and facilitators of this intervention to optimize its feasibility and effectiveness. It is imperative that innovative interventions be developed to achieve comprehensive utilization of this highly effective vaccine to reduce rates of HPV infection, lower rates of cervical and other HPV associated cancers, and address cancer disparities.

Administration of the HPV vaccine during the inpatient postpartum hospital stay has the potential to be an innovative intervention to improve HPV immunization rates. Following onset of pregnancy, the postpartum period becomes the next available opportunity to immunize with the HPV vaccine, which is safe in breastfeeding women. The benefits of such an intervention include a focus on women engaged with the health care system who are often highly motivated to invest in their personal health.

Specific Aims Aim 1: To evaluate receptivity and concerns of postpartum women with receiving the HPV vaccine during the inpatient postpartum admission as part of the Inpatient Postpartum HPV Immunization Quality Improvement Program (IPP-HPV).

Aim 2: To evaluate receptivity and concerns of healthcare providers with inpatient postpartum HPV immunization as part of IPP-HPV and to identify facilitators of and barriers to its implementation.

Aim 3: To assess the uptake and effectiveness of a Pilot Quality Improvement Program to increase HPV vaccine uptake (IPP-HPV) for Yale New Haven Hospital (YNHH) Women's Center and Center for Women's Health and Midwifery (CWHM) postpartum patients ≤ 26 years of age who deliver at YNHH York Street Campus (YSC) or Saint Raphael Campus (SRC).

Eligibility Criteria:
Inclusion Criteria:

* Women participating in the IPP-HPV Quality Improvement Program:
* Postpartum YNHH Women's Center and CWHM patients
* ≤ 26 years at time of delivery who deliver at YNHH YSC or SRC
* Have not already received 3 doses of the HPV vaccine at time of delivery
* Fluent in English or Spanish
* Able and willing to provide consent

AND

* Yale New Haven Hospital (YNHH) Women's Center and Center for Women's Health and Midwifery (CWHM) postpartum patients
* ≤ 26 years of age
* Delivered at YNHH York Street Campus (YSC) or Saint Raphael Campus (SRC) in the first year of the IPP-HPV program or in the one year preceding implementation of the program

OR

* YNHH inpatient postpartum nurses or Women's Center outpatient postpartum nurses or inpatient or outpatient obstetric providers affiliated with the Women's Center or Center for Women's Health and Midwifery
* Able and willing to provide consent

Exclusion Criteria:

-
Foot Orthoses and Elderly Women With Osteoporosis

The objective of this study was to determine if foot orthoses are effective in improving balance, pain and disability in elderly women with osteoporosis.

Aging has been associated with balance impairment. The use of foot orthoses has been shown to be a feasible strategy for improving postural control.The objective of this study was to determine if foot orthoses (with metatarsal pad and medial arch support) are effective as an adjuvant treatment to improve balance, foot pain and disability in elderly women with osteoporosis. Another purpose was to verify if social demographic and clinical factors such as age, race, education, marital status, age of menopause, use of drugs related to balance dysfunction, visual or hearing complaints, body mass index, previous fractures and number of falls may influence the results.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of osteoporosis

Exclusion Criteria:

* reduced tactile and thermal foot sensibility
* compromised skin integrity of the lower limbs
* autoimmune rheumatic diseases
* vestibular symptoms
* central nervous system pathologies
* peripheral neuropathy
* use of insoles in the last month
* lower limb prostheses
* previous history of foot surgery
* amputation of the lower limbs
* inability to attend the necessary reevaluations and/or to follow instructions and procedures of the research protocol