cyrilzakka/clinical-trials huggingface dataset:
Comparing Exergaming and Usual Care Physical Therapy in Nursing Home Residents

The objective of this clinical trial is to compare the effects of exergaming and usual care physical therapy on physical function in older adults residing in nursing homes.

This trial seeks to answer the following key questions:

* Does physical function differ between interventions after treatment?
* How do these interventions impact enjoyment of therapy?
* Are there differences in adherence or perceived exertion between the interventions?

A single-blind, randomized controlled trial will be conducted to compare exergaming and usual care interventions. Participants will be recruited from nursing homes in the province of Toledo, and the study will follow the CONSORT guidelines for clinical, crossover, and parallel trials.

Two experimental groups will be tested, with interventions performed three days per week for six weeks, each session lasting approximately 30 minutes. The exergaming group will play seven video games from the Party Fowl app, while the usual care group will continue their standard exercise routine.

Outcome measures will be assessed at baseline, post-intervention (6 weeks), and at a 3-month follow-up to evaluate the middle-term effects of both interventions.

Eligibility Criteria:
Inclusion Criteria:

* subjects over 60 years of age
* score equal to or greater than 20 on the Mini Mental cognitive test
* Subjects that present the ability to stand without the use of technical aids or with the technical assistance of a device used for walking.

Exclusion Criteria:

* severe visual impairment
* medical contraindication for physical activity
* pathology or problem that could prevent the test from being carried out.
Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease

In this single-center, randomized controlled trial, patients (4-8 months) with CHD were randomly assigned to either a recovery group (home-based rehab exercise periodically) supervised by cellphone APP or to a control group. Left ventricular ejection fractions (LVEF), the rate of increase in heart rate (rHRI), and the rate of recovery heart rate (rHRR) were measured for representing cardiopulmonary capacity. The Alberta test and Neuro-intelligence Scale were used to evaluate their motor developmental outcomes. This study verified the feasibility of this rehab method and indicated that 6-month home-based exercise training can improve cardiopulmonary endurance and motor developmental level in infant CHD patients.


Eligibility Criteria:
Inclusion Criteria:

* CHD infants (aged 4-8 months) with atrial septum defect (ASD) or ventricular septum defect (VSD)

Exclusion Criteria:

* chromosomal abnormalities; family history of mental retardation; small for gestational age and prematurity; history of perinatal asphyxia and hyperbilirubinemia; history of central nervous system disease or imaging suggestive of brain dysplasia
Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection

This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG monitor.


Eligibility Criteria:
Inclusion Criteria:

* The subject is 18 to 80 years of age.
* Subject can read and communicate in English.
* Subject's cardiac rhythm shall be Normal Sinus Rhythm or Atrial Fibrillation (Afib). This determination will be made using FDA cleared 3-lead ECG which will label subject's cardiac rhythm as such.

Exclusion Criteria:

* Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.
* Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of Subjects With Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)

A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of ADX-629 in Subjects with Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female, between 18 to 65 years of age (inclusive) at Screening Visit.
* Subjects must give their signed and dated written informed consent (in English) to participate prior to commencing any study-related activities and must be willing to comply with study procedures, study restrictions, study protocol, and return for the required assessments.
* Female subjects of either non-childbearing potential or of child-bearing potential who commit to consistent and correct use of at least one highly effective or two effective forms of contraception starting at least 4 weeks prior to the Screening Visit and for at least 30 days post last dose of study drug.
* Generally healthy subjects with mild controlled asthma for 2 years at Screening Visit according to the Global Initiative for Asthma criteria.

Exclusion Criteria:

* History and presence of clinically significant cardiovascular, renal, neurologic, hepatologic, endocrinologic, gastrointestinal, genitourinary, autoimmune, hematological, or metabolic disease other than asthma, which in the opinion of Investigator may either put the subject at risk or influence the results during the study.
* Positive skin prick test to other perennial allergens (i.e., mold, dog with ≥ 3 mm wheal compared to negative control). Subjects with seasonal allergy symptoms that occur or are anticipated to occur during the study should result in subject exclusion or rescheduling until the subject is out of the allergy season.
* Any relevant pulmonary disease within 1 year prior to dosing at the discretion of the investigator.
* Recent hospitalization with asthma in the last 6 months or any other medical condition that the Investigator deems incompatible with participation in the trial.
Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries

This is a double-arm randomized control trial evaluating the impact of preoperative opioid-free analgesia on time to trial of void in ambulatory urogynecologic surgeries. The investigators hypothesize that receipt of acetaminophen, celecoxib and gabapentin preoperatively versus acetaminophen alone will reduce the time to trial of void in patients undergoing same-day minor urogynecologic procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. All female patients over 18 years of age from the Northwell Health urogynecology offices in Bay Shore, Syosset, and Huntington, NY who are undergoing transvaginal minor urogynecologic surgery (midurethral sling, periurethral bulking injections, anterior repair, posterior repair, and perineorrhaphy) at South Shore Surgery Center
4. In good general health as evidenced by medical history
5. Ability to take oral medication and be willing to adhere to the study intervention
6. Patients may be English or Spanish-speaking and must be able to provide informed consent

Exclusion Criteria:

1. Pregnancy or lactation
2. Younger than age 18
3. Known allergic reactions to acetaminophen, celecoxib or gabapentin or any components within the medication formulation
4. Patients with Myasthenia Gravis, renal disease with CrCl \< 50, seizure disorder, substance use disorder, anaphylaxis and angioedema to gabapentin, Drug reaction with Eosinophilia and Systemic Symptoms (DRESS), driving impairment, increased seizures suicidal behavior and respiratory depression.
5. Patients with a , history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDS or DRESS, history of gastric bypass surgery, heart failure, active GI ulcer, active GI bleeding, inflammatory bowel disease, cerebrovascular bleeding, liver impairment/hepatic disease, hyperkalemia.
6. Patients with compromised renal function who are notable to receive NSAIDs
7. Patients with significant cardiovascular disease, such as patients with heart failure
8. Patient with recent evidence of worsening fluid retention
9. Both non-English and non-Spanish speaking patients
10. Urogynecologic surgeries for apical repair (sacrocolpopexy, uterosacral ligament suspension, sacrospinous ligament suspension, colpocleisis)
11. Current use of illicit substances (cocaine, non-prescription opioids, marijuana)
12. Current use of gabapentin as home medication
Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia

Duloxetine is FDA approved as pharmacological treatment for Fibromyalgia. The use of SSRIs has been endorsed by the 2013 Canadian guidelines. The data available for Escitalopram as a treatment modality for Fibromyalgia is limited, however small trials have demonstrated its efficacy. No head to head comparisons between escitalopram and duloxetine have been undertaken. We aim to conduct a single blind, randomized control trial to assess the comparative efficacy of duloxetine vs escitalopram in drug naive patients with newly diagnosed Fibromyalgia.

180 drug naive patients with newly diagnosed fibromyalga according to the modified ACR 2016 criteria shall be enrolled by consecutive sampling after taking written informed consent. Baseline severity of fibromyalgia shall be assessed via the Revised Fibromyalgia Impact Questionnaire (FIQ-R). They shall be randomized via cluster randomization into two groups. The first group shall receive Duloxetine 30mg, will be increased to 60mg after one week. The second group shall receive Escitalopram 10mg to be increased to 20mg after one week. Patients shall be followed at 0,2,4,8 and 12 weeks. At each visit, any subjective change in symptoms shall be noted and the FIQ-R shall be re administered. At the end of the trial, the overall change in the FIQ-R from baseline shall be assessed and the difference between both groups will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Drug Naive patients
* Newly diagnosed with FIbromyalgia according to Modified ACR 2016 criteria

Exclusion Criteria:

* Concomitant depression/bipolar disorder or any other documented psychiatric illness
* Autoimmune disorders (SLE, RA)
* Peripheral Neuropathic pain due to any cause
* Uncontrolled hypertension
* Impaired renal or hepatic functions (on Lab assay)
* Chronic infections (e.g.Tuberculosis)
Characteristics and Clinical Outcomes of Peritoneal Dialysis Patients

Peritoneal dialysis patients worldwide account for about 11% of the global dialysis population. The global annual growth rate of peritoneal dialysis is estimated to be 8%, which is listed as the preferred method of renal replacement therapy in most countries. Although peritoneal dialysis has been widely used, due to complications such as peritoneal dialysis related infection, peritoneal ultrafiltration failure and EPS, the failure rate of peritoneal dialysis technology is high, and the 3-year technical survival rate is only 64%. Therefore, this study intends to explore clinical strategies for maintaining the long-term peritoneal dialysis by analyzing the clinical characteristics of patients , as well as the differences of risk factors affecting the survival rate of peritoneal dialysis technology at different time stages of peritoneal dialysis treatment.


Eligibility Criteria:
Inclusion Criteria:

* ESRD patients
* The first time of peritoneal dialysis

Exclusion Criteria:

* Age \<18 years at start of PD
* Transfer or follow-up loss
* Previous transplantation or HD history
* Incomplete clinical data
Multicenter Study of Family Nursing to Treat Heart Failure

The purpose of this study is to determine whether Family Focused Nursing are effective in the treatment of heart failure outpatients with respect to health-related quality of life.

Quality of life is impaired among patients with heart failure and their next of kin compared to other patients with chronic diseases. Besides, there are still a number of patients who misunderstand or have difficulties remembering the counseling they are provided during the course of illness. International guidelines recommend that the patient's relatives are involved in patient education as well as the treatment. Family interventions might contribute to improvement in quality of life, enhanced illness-management and delayed readmission and mortality among patients with heart failure. However, up till today, only two observational studies have investigated the effect of family intervention on outcomes of treatment for heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Referred to follow-up nursing treatment in nurse-led heart failure clinic
* Diagnosed chronic heart failure, based on systolic dysfunction (left ventricular ejection fraction (LVEF) ≤40%)
* New York Heart Association (NYHA) classification II-IV symptoms
* Signed informed consent

Exclusion Criteria:

* Patients not understanding or talking danish
* In terminal phase of another serious illness such as i.e. cancer with expected lifetime less than 6 months
* Patients not giving informed consent
A Study of Immunotherapy With TIL (Tumor Infiltrating Lymphocytes) in Combination With Intra-tumoral Injections of Interferon Gamma-adenovirus (Ad-IFNg) in Patients With Stage IIIc or Stage IV Metastatic Melanoma (AJCC)(Protocol TIL-Ad-INFg)

The main objective of this study is to evaluate the clinical and biologic toxicity of cell therapy by adoptive transfer of TIL in combination with intra-tumoral injections of Ad-INFg.


Eligibility Criteria:
Pre-Inclusion Criteria:

* Male or female patients ≥ 18 and ≤ 75 years of age
* Patients must have signed informed consent
* A negative pregnancy test for women with childbearing potential
* Patients with stage IIIc/IV metastatic melanoma (AJCC 6th edition) with nodal relapse, in transit metastasis, unresectable cutaneous metastases, visceral metastases except bone and brain metastases
* Presence of at least one lesion accessible for intra-tumoral injections of Ad-IFNg
* A negative brain scan, eliminating any brain metastases
* ECOG performance status of 0-2
* Adequate bone-marrow reserve, renal function and hepatic function as assessed by standard laboratory criteria
* Subjects affiliated to an appropriate social security system

Inclusion Criteria:

* Negative viral serology (HIV ½, p24 Ag, HTLV 1 / 2, B and C hepatitis)

Exclusion Criteria:

* For female : the patient is pregnant or lactating or not using contraception and proved by a negative pregnancy test
* Positive viral serology for HIV ½, p24 Ag, HTLV 1 / 2 or B and C hepatitis
* History or current manifestations of severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, serious rhythm disorders or ECG signs of previous myocardial infarction)
* Any serious illness, acute or chronic, e.g. active infection requiring antibiotics, bleeding disorders or any other condition that requires concomitant medications not allowed during this study
* Presence of a second active cancer except in situ cervical cancer or skin carcinoma
* Intercurrent disease requiring a corticosteroid treatment or a treatment with interferon-α
* Any autoimmune disease including active diabetes mellitus or immunodeficiency. Vitiligo in not an exclusion criteria
* Uncontrolled thyroid dysfunction
* Concurrently participation in a biomedical research (drug or radiotherapy) within the month preceding inclusion
* Metastatic lymph node stage alone with an indication of lymphadenectomy
* Brain or bone metastases discovered by radiological examination during the inclusion assessment
* Surgically resectable metastases
* Ocular melanoma
* More than one line of chemotherapy for treatment of melanoma
* Chemotherapy, immunotherapy or radiotherapy within 4 weeks before baseline (6 weeks for nitroso-ureas and mitomycin C)
* Contraindication for the use of vasopressor agents
* Treatment with molecules in pre-marketing development or whose development is finished less than 4 weeks
A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers

To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs).

Healing percentages

Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥ 18 years of age
* Ankle-brachial index (ABI) \> 0.80
* Study wound 2-64 cm2 surface area
* Wound does not exhibit a greater than 50% reduction in surface area during the screening period

Exclusion Criteria:

* Suspected or confirmed signs/symptoms of wound infection
* Hypersensitivity to bovine collagen
* Body Mass Index (BMI) ≥ 45
Driving Pressure Limited Ventilation During Video-assisted Thoracoscopic Lobectomy

This study aims to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients undergoing one-lung ventilation during Video-assisted thoracoscopic lobectomy.

• More recently, the so-called lung-protective intraoperative ventilation strategies have been advocated to prevent lung injury. Such strategies aim at minimizing lung hyperinflation as well as cycling collapse and reopening of lung units, through the use of low tidal volumes (VTs) and positive end-expiratory pressure (PEEP). However, despite huge improvements in surgical and anesthesia techniques and management. It is surprising that, so far, mortality and pulmonary complication rates were not reduced over time .Recently, several investigations suggest an association between high driving pressure (the difference between the plateau pressure and the level of PEEP) and outcome for patients with acute respiratory distress syndrome. It is uncertain whether a similar association exists for high driving pressure during surgery and the occurrence of postoperative pulmonary complications. In this issue, Ary S Neto and colleagues report an individual patient data meta-analysis further investigating the risk of mechanical ventilation in healthy individuals during general anesthesia .After both a multivariate and mediation analysis, the driving pressure, but not the tidal volume or the positive end-expiratory pressure applied, seemed to be the only parameter that was associated with the development of postoperative pulmonary complications. This randomized controlled trial is aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation.

Eligibility Criteria:
Inclusion Criteria:

1. Adults greater than or equal to 18 years
2. ARISCAT（Assess Respiratory Risk in Surgical Patients in Catalonia）≥26 points
3. Patients undergoing video-assisted thoracoscopic lobectomy

Exclusion Criteria:

1. The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4
2. Emergency surgery
3. Pulmonary hypertension
4. Forced vital capacity or forced expiratory volume in 1 sec \< 70% of the predicted values
5. Coagulation disorder
6. Pulmonary or extrapulmonary infections
7. History of treatment with steroid in 3 months before surgery
8. History of recurrent pneumothorax
9. History of lung resection surgery
10. History of mechanical ventilation in 2 weeks
11. Body Mass Index\[≥35 kg／m2 \]
12. Patient who is contraindicated with application of positive end expiratory pressure
OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS

This study is undertaken to compare the effects of treatment with commonly used OCP containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and they will be correlated with changes in hormonal parameters post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with PCOS according to the Rotterdam criteria

Exclusion Criteria:

* Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
* Medical or surgical treatment of PCOS during the previous 3 months
* Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone
* Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months)
* Inability to understand the proposal of the study precluding effective informed consent
Anterior Shoulder Dislocation

To compare and validate the two clinical algorithms

Clinical Decision rules have safely and successfully allowed clinicians to reduce the total number of radiographs ordered, while detecting patients with important pathology or injuries. The Ottawa Ankle and Knee Rules were developed from a series of studies, and have successfully reduced the number of radiographs ordered by physicians without missing serious ankle fractures (1-4). Likewise, the NEXUS group developed a clinical decision rule for the selection of blunt trauma patients who are appropriate for imaging, based on clinical features (5).

Drs. Hendey and Emond have separately developed similar algorithms for selective radiography in patients with a suspected shoulder dislocation (6-10). The goal of the current study is to compare and validate the two clinical algorithms.

Both approaches examine clinical features that are readily accessible to the physician at the time of ED evaluation. In the pre-reduction assessment, both algorithms included the mechanism of injury and whether the patient had experienced a previous shoulder dislocation. Hendey additionally assessed whether the physician was clinically confident of the dislocation (8). Emond additionally included the age of the patient, and the presence or absence of humeral ecchymosis (9). In the post-reduction assessment, both algorithms emphasize the importance of clinical certainty of reduction, as well as the presence of a fracture dislocation.

Eligibility Criteria:
Inclusion Criteria:

* adult patients 18 years and older
* patient with a suspected acute anterior shoulder dislocation

Exclusion Criteria:

* patients under 18 years of age
* prisoners
AIDA 2000 Guidelines

Prospective use of RT-PCR for PML/RARa might be used to guide a total tehrapy approach in APL, including refined diagnosis, front-line treatment, assessment of response and anticipated salvage therapy for patients who undergo molecular relapse.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 1 years and \< 61 years
* Morphologic diagnosis of APL
* PS \<= 3
* Presence in leukemic cells at diagnosis of t(15;17), and/or PML/RARa rearrangement by RT-PCR. T
* The presence of additional cytogenetic lesions is not considered an exclusion criterion
* Serum creatinine \<=2.5 mg/dL
* Serum bilirubin, alkaline phosphatase, or GOT/ASAT \<= 3 times the upper normal limit
* Negative pregnancy test
* Written informed consent

Exclusion Criteria:

* Age \>= 61 years
* Prior antileukemic chemotherapy for APL
* Absence of PML-RARa rearrangement after successful RNA extraction and amplification of control gene
* Prior antileikemic chemotherapy for APL
* Presence of a concomitant malignant neoplasm, except basal cell carcinoma Concurrent treatment with cytotoxic chemotherapy or radiotherapy
* Oteher progressive malignant disease. However, secondary acute promyelocytic leukemia following "cured" Hodgkin's disease or otehr cured malignancies may be included, as well as secondary leukemias following other exposure to alkylating agents or radiation for other reasons