cyrilzakka/clinical-trials huggingface dataset:
Cultural Modification of an Evidence Based Healthy Lifestyle Intervention for People Post Stroke Who Identify as Hispanic/Latino

The purpose of this trial is to examine weight loss for Hispanic/Latino people with stroke (CVA) who take part in a healthy lifestyle program that has been culturally modified for Hispanic/Latino people

Weight gain greatly increases the risk of chronic diseases such as diabetes, metabolic syndrome, pulmonary and heart disease. The Group Lifestyle Balance (GLB) intervention is a 12-month, evidence-based weight-loss program that has been used extensively with the general population and with people after CVA, however, it is not adapted to be linguistically and culturally appropriate for Latino persons post stroke. We will modified the program to meet the needs of Latino people with a CVA (GLB-CVA Latino).

Aims:

1. : To create a modification of the CDC-recognized, evidence-based GLB-CVA to be culturally appropriate to meet the unique needs of people who identify as Hispanic/Latino, available in English and Spanish languages, using a Community-Based Participatory Research approach and AB of key stakeholders (patients, caregivers, clinicians, researchers).
2. : Conduct a single-arm trial to describe the effect of participation in the GLB-CVA Latino on primary and secondary outcomes for 24 individuals who identify as Hispanic/Latino (12 English speakers and 12 Spanish speakers) at 3, 6, and 12 months from baseline.
3. : Evaluate the participant compliance (feasibility) and fidelity (adherence to the DPP GLB content) with the GLB-CVA Latino intervention.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥25
* Identify as Hispanic or Latino
* 18-85 years of age
* All types of stroke
* Medically able to participate in a weight-loss program
* Physical Activity Readiness Questionnaire +
* ≥12 months post first stroke

Exclusion Criteria:

* Contraindications for physical activity
* Low Cognitive Function
* Residing in hospital, acute rehab, SNF
* Not fluent in English or Spanish
* Pre-existing eating disorder
* Pregnancy
Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old

The purpose of the study is:

* To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old.
* To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.

Atropine is an effective treatment of moderate amblyopia. Reduction of the plus sphere for the sound eye is an accepted method of enhancing and possibly accelerating the treatment effect. Demonstrating additional value of the plano lens in terms of speed of improvement will shorten the treatment period, possibly improving child and parental compliance, leading to improved overall outcomes for patients with amblyopia. If the plano lens leads to greater improvement, then there will be less permanent visual impairment in patients with a history of amblyopia. It also is important to determine if the use of a plano lens in conjunction with atropine has a deleterious effect on the sound eye, and if yes, how often this occurs.

Little is known about the pharmacologic treatment of severe amblyopia. This study will provide important prospectively determined outcome data at little additional expense.

In a study conducted by the Pediatric Eye Disease Investigator Group, A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia, the use of weekend atropine for moderate amblyopia was as effective as daily treatment. Intermittent atropine use (such as using it only on the weekends) has the theoretical potential benefit of the sound eye having some time each week during which cycloplegia is only partial. It is possible that allowing some loss of the cycloplegic effect over the course of each week may be safer for the sound eye.

The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimes for the 18 week primary treatment period are: 1) Atropine 1% once each weekend day in the sound eye and 2) Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 3 to less than 7 years old with amblyopia associated with strabismus, anisometropia, or both.
* Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference \> 3 logMAR lines.
* Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.

Exclusion Criteria:

* Atropine treatment within 6 months of enrollment and other amblyopia treatment of any type (other than normal spectacle lenses) used within one month of enrollment
* No myopia in amblyopic eye
rhTPO in Critical Patients With Thrombocytopenia

The primary objectives of this study are to assess the impact of rhTPO on mortality among severe sepsis patients with thrombocytopenia, as well as changes of platelet counts and platelet transfusion rates.

Thrombocytopenia is prevalent among critical patients who is admitted to intensive care unit. Researches have shown that thrombocytopenia is associated with mortality among those patients. Currently, no standard therapy exist for critical patients with Thrombocytopenia. In 2012 SSC guideline, platelet transfusion is induced for thrombocytopenia in critical patients for reducing the risk of bleeding. However, indication for platelet transfusion is relatively strict. No early intervention could be done according to this guideline. Previous studies have shown that recombinant human thrombopoietin can reduce severe sepsis with low platelet 28-day mortality in patients with hyperlipidemia, effectively improve peripheral platelet number, reducing the probability of platelet transfusion.The primary objectives of this study are to assess the impact of rhTPO on mortality among severe sepsis patients with thrombocytopenia, as well as changes of platelet counts and platelet transfusion rates.

Eligibility Criteria:
Inclusion Criteria:

* Patients would be include if Diagnosed as sepsis according to ACCP/CCM criteria Platelet counts is less than 50×109/L for 2 continues days Patient or legally authorized representative able to provide informed consent

Exclusion Criteria:

* Subject has had a splenectomy for any reason Subject has an active malignancy who is now under chemotherapy Subject has a known history of bone marrow stem cell disorder Subject is receiving other investigational agents or procedures Subject is currently enrolled in, or has completed within the last 30 days, another investigational device or drug study Subject is pregnant or breast feeding Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally acceptable representative Subject has any kind of disorder that compromises the ability of the subject to comply with study procedures Subject is less than 18 years or more than 85 years of age History of bone marrow, lung, liver, pancreas, or small-bowel transplantation Acute pancreatitis with no established source of infection
Assessment of Vertigo and Dizziness in Individuals Following COVID-19

This cross-sectional study aimed to assess the prevalence of dizziness/vertigo in individuals following COVID-19 and to investigate potential risk factors associated with these symptoms. A total of 296 patients aged 20-66 years who had recovered from COVID-19 were evaluated at Istanbul Physical Medicine and Rehabilitation Training and Research Hospital between June 1, 2021, and December 31, 2021. Clinical and demographic data, including COVID-19 history, comorbidities, and symptom characteristics, were collected. Dizziness-related disability was assessed using the Dizziness Handicap Inventory (DHI), while balance performance was evaluated with the Berg Balance Scale (BBS).


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 20-66 years.
* History of confirmed COVID-19 infection.
* Ability to speak and understand Turkish.
* Willingness to provide verbal and written informed consent.

Exclusion Criteria:

* Pre-existing vertigo or balance disorders (e.g., benign paroxysmal positional vertigo, Ménière's disease, vestibular migraine, vestibular neuritis).
* Inner ear diseases or vestibular dysfunction.
* Neurological disorders affecting balance (e.g., multiple sclerosis, Parkinson's disease, history of stroke, epilepsy).
* Psychiatric conditions that could cause dizziness (e.g., anxiety, panic attacks, depression).
* History of head or neck trauma in the past six months.
* Moderate to severe visual impairment.
* Chronic alcohol or substance use.
* Use of ototoxic medications.
* Severe cardiovascular diseases (e.g., orthostatic hypotension, advanced heart failure, severe arrhythmias).
* Pregnant or breastfeeding women.
* Acute infection other than COVID-19 in the past three months.
* Severe COVID-19 requiring hospitalization
Resynchronization Surgery Combined Unified Efficacy

The purpose of the study is to compare survivability and efficacy of the patients with severe ischemic heart failure after coronary artery bypass grafting alone and coronary artery bypass grafting with single-step implantation of CRT system (CABG alone vs CABG + CRT )


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age 18-80
* History of ischemic heart failure and indications for CABG
* LVEF less than 35% estimated by echocardiography measured within 3 months of study entry
* NYHA and CCS (angina) II-IV functional class
* Signs of dyssynchrony (at least one of the following three): QRS \> 120 ms or dyssynchrony based on Doppler-methods (Tissue Tracking and TSI methods) or CARE HF criteria: Aortic pre-ejection delay \>140ms, Interventricular mechanical delay \>40 ms, Delayed activation of postero-lateral LV wall

Exclusion Criteria:

* Failure to provide informed consent.
* Previous cardiac surgery
* Non-cardiac illness with a life expectancy of less than 3 year
* Non-cardiac illness imposing substantial operative mortality
* Previous heart, kidney, liver, or lung transplantation
* Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device
* Successful coronary revascularization (СABG or PCI) within 12 months of study enrollment
* Chronic atrial fibrillation
Phase I/II Study of Neoadjuvant Chemoradiotherapy With S-1/ Oxaliplatin in Patients With Gastric Cancer: Randomized Phase II Study of S-1/RT vs. S-1/Oxaliplatin/RT

To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years

  * Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma ③ Localized gastric cancer of clinical stage (T2N(+), T3/T4)

    * ECOG performance status of 0 to 1 ⑤ Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 50mL/min ⑥ Written informed consent form

Exclusion Criteria:

* T1 (regardless of N stage), T2N0

  * M1 ③ Peritoneal seeding ④ Uncontrolled medical condition
Antimicrobial Coated Sutures in Paediatric Surgery

The purpose of this study is to determine if suture material coated by antimicrobial agent triclosan would decrease the incidence of surgical site infections (SSIs) in paediatric surgery compared to ordinary sutures.

1500 children (age form 4 weeks to 18 years) coming for general pediatric surgery to the Oulu University Hospital are randomised to have sutures coated with triclosan (Vicryl Plus, Monocryl Plus) or ordinary sutures. The occurrence of SSIs is monitored by email questionnaires to the parents on days 10 and 30. The diagnosis of SSIs are made along CDC criteria.

We have now (spring 2014) recruited almost 1500 patients to the study. When reviewing the recruited material, we found out that the study suture material has been used in 83% of the recruited patients. The reasons for this have been clinical issue during the operation where melting suture material may not have been needed at all.

We have decided to prolong recruiting so that we would gather the calculated sample size of 1500 of patient with study suture material. This will take 12-18 months (probably till autumn 2015).

Eligibility Criteria:
Inclusion Criteria:

* any general surgery during childhood where melting sutures will be used

Exclusion Criteria:

* wound infection as a cause for surgery
Treatment of Erosive Digital Osteoarthritis by Transcutaneous Auricular Nerve Stimulation

Erosive hand osteoarthritis (EHOA) is a subtype of had osteoarthritis characterized by inflammation and pain, with subsequent burden. Few symptomatic treatments are available in EHOA, while this population with EHOA has frequently comorbidities.

Stimulation of the vagus nerve (VN), belonging to parasympathetic system, dampens pro-inflammatory cytokines production by splenic macrophages, through to the binding of acetylcholine neurotransmitter to α7nicotinic receptor on macrophages: this is the cholinergic anti-inflammatory pathway (CAP). Beyond its anti-inflammatory effects, VNS is analgesic in chronic pain disorders (headache, fibromyalgia). Beside implantable devices, VNS may be performed using transcutaneous stimulation of the ascendant auricular branch of the VN (tVNS) at the left ear localized on the cymba conchae tVNS is well-tolerated therapy avoiding invasive neurosurgery.

The investigator do the hypothesis that auricular tVNS using a transcutaneous electrical nerve stimulation (TENS) device could be a novel, simple and well-tolerated analgesic and anti-inflammatory treatment of symptomatic EHOA.

In symptomatic and inflammatory EHOA patients, we will apply tNVNS using device from Schwa-Medico (TENSeco2 + auricular electrode + conductive gel) 25 Hz stimulation will be applied, intensity escalated up to 15 mA or below if tingling sensation.

tVNS will be performed 1 hour daily for 1 month and we will assess EHOA symptoms (pain and function) at 1 month (end of the study)

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years
* Symptomatic HOA (1990 American College of Rheumatology criteria)
* EHOA according to hand radiographs with ≥1 erosive digital joints of proximal or distal interphalangeal joint (phases "E" or "R" of Verbruggen-Veys score)
* Visual Analogic Scale (VAS) for hand pain ≥ 40/100 at inclusion

  -≥1 interphalangeal joints symptomatic ≥ 3 months despite analgesics or non-steroidal anti-inflammatory drugs (NSAIDs) (or contraindicated)
* ≥1 symptomatic interphalangeal joint with clinical palpable synovitis at inclusion
* Informed written consent

Exclusion Criteria:

* Isolated thumb-base OA (ie, rhizarthrosis)
* Hand osteoarthritis secondary to other known causes (eg gout, psoriatic arthritis)
* Psoriasis
* Current skin disease of the ear
* Ear canal not adapted to apply the auricular electrode
* History of severe cardiac disease (coronary artery disease, rhythm disturbance, heart failure, valvulopathy)
* Conduction or rhythm disturbances on electrocardiogram
* Symptomatic orthostatic hypotension or vasovagal syncope history
* History of vagotomy
* Pregnancy
* Fibromyalgia
* Use of other electrically active medical devices (eg pacemaker)
* Documented sleep apnea
* Use of corticosteroid (oral, intramuscular, intra-articular or intravenous), immunosuppressive agents, hyaluronic acid injection in interphalangeal joint within the last 3 months
* Hand surgery planned during the study period
* Pregnancy or breastfeeding if applicable
* Oral NSAIDs consumption during the last 48 hours before inclusion
Food Insecurity in Oncology

This trial will examine the feasibility and preliminary effectiveness of providing unconditional cash transfers to food insecure female breast and gynecologic cancer patients.

Approximately one-third of cancer survivors report food insecurity, characterized by limited access to adequate food for active, healthy living because of a lack of money and other resources. Unconditional cash transfers offer direct monetary assistance that can be used to meet immediate food or other financial needs and may positively impact health care resource utilization and health-related quality of life.

In this delayed intervention trial, 44 female breast and gynecologic cancer patients experiencing food insecurity will be randomized in a 1:1 ratio to receive unconditional cash transfers (UCT) for 3 months or an equivalent one-time UCT at the end of the study.

Quantitative surveys will be administered at baseline and after 3-months. Survey measures will include questions about health care resource utilization, health-related quality of life, food security, hospitalization use, emergency department use, and mental health. The main objective for this pilot trial is to assess feasibility. The investigators will measure whether the investigators can: recruit 44 food insecure participants meeting the eligibility criteria over a 3-month recruitment window and describe the barriers and facilitators of the recruitment process. The investigators will also monitor retention and survey completion. At the end of the 3 month follow-up period, all participants will complete a semi-structured exit interview.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of female breast (ICD-10 C50), ovarian (ICD-10 C56), endometrial (ICD-10 C54), cervical (ICD-10 C53), vulvar cancer (ICD-10 C51)
* Diagnosed within 24-months of identification
* Stage I-III
* Completed initial course of cancer directed therapy (surgery, radiation, chemotherapy).
* Age ≥18
* Able to speak English or Spanish
* Food insecure

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
Weight Loss and Exercise in Physically Limited Obese Elderly Subjects

The overall purpose of this research is to determine the effect of weight loss and physical training on quality of life, physical function, metabolism, bone strength, body fat and muscle mass.

Obesity causes serious medical complications and impairs quality of life. Moreover, in elderly persons, obesity can lead to frailty because of decreased strength, joint function, balance and mobility associated with aging. The primary objective of this study is to evaluate the effect of weight loss and physical training on physical function, body composition, metabolism and quality of life in frail, obese elderly men and women. Subjects are randomized to either control or 10% weight loss plus physical training.

Eligibility Criteria:
Inclusion Criteria:

* Obese (BMI 30 or greater) elderly (age 65 years or older) Frailty

Exclusion Criteria:

* Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results. Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 yr, current use of bone acting drugs.
Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma

This was a randomized, placebo-controlled, double-blind, six-sequence, three-period cross-over study in asthma patients. The study consisted of a 14-day screening period, followed by a 14-day run-in period, and a treatment epoch which consists of three treatment periods, with a minimum duration of 14 days each followed (for the 2 first treatment periods) by a wash-out period. The duration of each treatment period may be extended up to a duration of 18 days if needed for operational reasons. The third treatment period was followed by a Study Completion evaluation at 1-7 days following the last dose. The treatment periods were separated by wash-out periods of 14 to 21 days duration.


Eligibility Criteria:
Inclusion Criteria:

Patients with a documented physician diagnosis of asthma and who additionally meet the following criteria:

* Patients receiving daily treatment with an inhaled corticosteroid at a low or medium daily dose
* On a stable regimen for at least 4 weeks prior to screening.
* Pre-bronchodilator FEV1 ≥ 60 % and \< 100% of the predicted normal value for the patient during screening.
* Patients who demonstrate an increase in FEV1 of ≥ 12 % and ≥ 200 mL after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Screening. All patients must perform a reversibility test at Screening.
* At screening, and baseline (day 1 pre-dose time) of the first treatment period, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position and again in the standing position as outlined in the SOM. Sitting and standing vital signs should be within the following ranges:
* oral body temperature between 35.0-37.5 °C
* systolic blood pressure, 90-159 mmHg
* diastolic blood pressure, 50-99 mmHg
* pulse rate, 40-90 bpm
* Hypertensive patients must have been on stable antihypertensive therapy for at least 4 weeks prior to screening to be included in the trial.
* Patients must weigh at least 50 kg at screening to participate in the study, and must have a body mass index (BMI) within the range of 18 to 40 kg/m2.

Exclusion Criteria:

* Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the drugs of a similar class
* Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 1 year of Screening.
* Patients who have had previous intubation for a severe asthma ttack/exacerbation.
* Patients with a history of clinically relevant bronchoconstriction upon repeated forced expiratory maneuvers.
* History of paradoxical bronchospasm in response to inhaled medicines.
* Patients who during the run-in period prior to randomization require the use of ≥12 puffs / 24 hours of rescue medication for 48 hours (over two consecutive days) or who have a decline in PEF from the reference PEFof ≥ 30% for 6 consecutive scheduled PEF readings
* Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers).