cyrilzakka/clinical-trials huggingface dataset:
Exercise & Overweight Children's Cognition

This research focuses on overweight, sedentary children whose health, cognition, and academic performance are therefore at risk, and who may be particularly responsive to exercise interventions.

This study will determine whether regular exercise per se (i.e. compared to attention control, or placebo, condition) benefits children's cognition and achievement, and will provide insight into neural mechanisms. A substudy will examine exercise-induced changes in brain structure.

Provision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic by persuading policymakers, schools and communities that time spent in physical activity enhances, rather than detracts from, learning.

An ancillary study adding cardiometabolic outcome measures was added (R01HL087923-02S1, http://projectreporter.nih.gov/project_info_description.cfm?aid=7880457\&icde=20104167)

Eligibility Criteria:
Inclusion Criteria:

* 8-11 years of age
* Overweight or obese (BMI-for-age \>= 85th percentile)
* Able to participate in exercise testing and intervention

Exclusion Criteria:

* Medical condition or medications that would interfere with measurements
* Participation in weight control or formal exercise program outside physical education that meets more than 1 day/week
* T-score \> 75 on the BRIEF Behavior Regulation scale to avoid program disruption
Evaluation of Halitosis After Treatment With Photodynamic Therapy

Halitosis is the term used to define an unpleasant odor emanating from the mouth. Some lung diseases, such as bronchiectasis, are among the extra-oral causes of this condition. However, no studies have evaluated the reasons and treatment of halitosis in the population of adults with bronchiectasis. Methods and analysis: A randomized, controlled trial is proposed. Halitosis will be evaluated based on the measurement of volatile sulfur compounds (VSC) using gas chromatography. The participants (n=40) with halitosis and bronchiectasis will be randomized into two groups: G1-treatment with photodynamic therapy (n = 20) or G2-cleaning of the tongue with a tongue scraper (n = 20). After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria P. gingivalis and T. denticola. If the halitosis persists, the participants will receive periodontal treatment. The evaluation of halitosis and the microbiological analysis will be repeated. If the halitosis is solved, the participants will return after three months for an additional evaluation. This protocol will determine the effectiveness of phototherapy regarding the reduction of halitosis in healthy older adults and those with bronchiectasis.

A single-center, randomized, controlled, single-blind clinical trial was designed in accordance with the criteria recommended for interventional trials in the SPIRIT Statement. The project for the proposed study received approval from the Human Research Ethics Committee o fNove de Julho University(certificate number: 1057901).

Selection of individuals - characterization of sample - Two groups will be composed of adults in treatment at the dental clinic of Nove de Julho University. After verbal and written explanations of the study, those who agree to participate will sign a statement of informed consent approved by the Human Research Ethics Committee of Nove de Julho University. The study will be conducted in compliance with the precepts stipulated in the Declaration of Helsinki (revised in Fortaleza, Brazil, 2013).

Eligibility Criteria:
Inclusion Criteria:

* every age in both genders
* With diagnosis of bronchiectasis (experimental group)
* Patients clinically stable (compensated) (control group)
* Have more than 10 teeth
* Do not have any changes in the anatomy of the back of the tongue (geographical or fissured tongue)
* With positive halitosis, SH2 level \>112 ppb

Exclusion Criteria:

* Smokers or ex-smokers for less than 5 years
* Patients diagnosed with cystic fibrosis
* Patients with hypersensitivity to the photosensitizer
The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation

This study aimed to investigate the relationship between administration of probiotics and improvement in quality of life in women with functional constipation.


Eligibility Criteria:
Inclusion Criteria:

* Being declared healthy based on initial examination and the Structured Interview Questionnaire (SIQ)
* Having the symptoms and signs of functional constipation refer to ROME IV
* Able to communicate well
* Able to consume 1 bottle of fermented milk each day for three weeks
* Not using antibiotic no later than one week before supplementation

Exclusion Criteria:

* Diagnosed with functional bowel disorder
* Using anesthesia at least 4 weeks before treatment
* Having a serious pathological disorder (carcinoma)
* During healing phase of acute gastrointestinal disorders at least 4 weeks before treatment
* Having severe heart disease
* Taking chronic medications such as antidepressants or analgesics
Effects of Recursive Self-feedback on Speech Production in Aphasia

The goal of this clinical trial is to test the effects of recursive self-feedback procedures on spontaneous speech production in stroke survivors with impaired speech production (aphasia). The main question it aims to answer is:

• To what extent can stroke survivors with aphasia use their self-feedback alone to improve their spontaneous speech production?

Participants will be engaged in the following activities:

* They will perform language and cognitive tasks.
* Afterwards, they will receive treatments using tablets and headphones at no cost to them.
* The experimental treatments (recursive self-feedback procedures) entails responding to prompts, listening to playbacks of their speech response and attempt to minimize/correct the errors in the next attempt. This process will be repeated multiple times per prompt.
* The experimental treatments are two: an adaptive version that adapts the complexity of the treatment prompt and a non-adaptive version that does not adapt task complexity.
* Researchers will compare the experimental treatments to see if both have similar effects on improving spontaneous speech production.


Eligibility Criteria:
Inclusion Criteria:

* 6 months post left hemisphere stroke
* Aphasia due to left hemisphere stroke
* Dominant English speaker

Exclusion Criteria:

* Speech-language deficits due to neurological insults such as Parkinson's disease, neurodegenerative conditions etc.
* Uncorrected sensory impairments.
* Language comprehension impairment.
* Severe cognitive impairment.
Pharmacokinetic and Pharmacodynamic Profiles of Aliskiren in Japanese Patients With Mild to Moderate Essential Hypertension

This study will evaluate the pharmacokinetic profile, the effect of rennin inhibition and the relationship among pharmacokinetics, renin-angiotensin system (RAS) biomarkers, and blood pressure lowering effects of oral doses of SPP100 in Japanese patients with mild to moderate essential hypertension. Safety will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients with mild to moderate essential hypertension aged 20 to 80 years
* Blood pressure: Mean (based on 3 recordings at 1-2 minute intervals) sitting diastolic blood pressure values on 14 days or 3 days before the treatment should meet the following criteria:

  * 14 days before treatment: ≥ 90 mmHg and \< 110 mmHg
  * 3 days before treatment: ≥ 95 mmHg and \< 110 mmHg
  * The difference in mean sitting diastolic blood pressure between 14 days and 3 days before the treatment is within 10 mmHg
* Body weight no less than 50 kg

Exclusion Criteria:

* Patients with mean (based on 3 recordings at 1-2 minute intervals) systolic blood pressure ≥ 180 mmHg and/or mean diastolic blood pressure ≥ 110 mmHg at Day -28, Day -14 and Day -3.
* Patients with or suspected of having secondary hypertension
* Patients suspected of having malignant hypertension

Other protocol-defined inclusion/exclusion criteria may apply
Senofilcon A Lenses in Moderate to Severe Dry Eye Disease

A clinical trial using Senofilcon A daily lenses in the treatment of moderate to severe dry eye. This a comparison between signs and symptoms prior to and during treatment.

32 patients with moderate to severe dry eye will be enrolled in this short-term proof of concept study to determine the efficacy in using soft lenses made of Senofilcon A in reducing signs and symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of moderate to severe dry eye associated with either Graft-versus-host disease (GVHD), Sjogren syndrome, idiopathic dry eyes, or minimal limbal cell deficiency
* A baseline Schirmer tear test (1) of less than 5 mm at 5 minutes without anesthesia
* Have a visual analog score for comfort of 50 or less (scale of 1-100, with 100 meaning perfect ocular comfort and 1 meaning severe ocular pain)
* Ability or the resources to insert and remove the study lenses
* An OSDI score greater than 42
* A willingness to sign an informed consent

Exclusion Criteria:

* No dry eyes or mild dry eyes
* A baseline Schirmer tear test (1) of greater than 5 mm of wetting at 5 minutes
* Dry eye comfort score of greater than 50 on a visual analog scale
* Unable to insert or remove the study lenses (or have a family member do so)
* Have an OSDI score less than 42
* Has been diagnosed with neurotrophic keratopathy in either eye
* Unwilling to enroll in the study, and unwilling to provide signed informed consent to participate in the study
Sit Less, Interact and Move More (SLIMM) 2 Study

* Prolonged sitting (sedentary behavior) is a risk factor for decreased kidney function, obesity, diabetes and mortality. Prolonged sitting is associated with decreased kidney function and increased risk of diabetes, heart disease and death.
* In a previous pilot study funded by NIH, it was shown that a Sit Less, Interact and Move More (SLIMM) intervention targeting sedentary behavior in people with kidney disease was able to decrease prolonged sitting but that effect was not sustained.
* Therefore, the researchers are currently conducting a follow-up study named Sit Less, Interact and Move More (SLIMM) 2.
* This NIH funded study is conducted at the University of Utah and Stanford University.
* The purpose of this study is to see if guided resistance training (to improve muscle strength) and semaglutide (FDA approved diabetes and weight loss medication that might also improve physical function) can boost adherence to the SLIMM Intervention and reduce sedentary behavior.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Glomerular Filtration Rate (eGFR) 20 to \<60 mL/min/1.73m\^2
* Able to perform resistance training
* Access to compatible "smartphone" or device (i.e., Android, Kindle or Apple with internet connectivity or mobile network), desktop or laptop

Exclusion Criteria:

* Type 1 Diabetes
* History of gastroparesis or paralytic ileus
* At baseline, if sedentary time is 25 min/hr or less, measured by accelerometer
* Potential contraindications to semaglutide such as a history of pancreatitis, and a family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma.
* Previous bariatric surgery
* Medical condition likely to limit survival to less than 1 year
* Anticipated start of dialysis or kidney transplantation within 6 months
* Any factors judged by the investigator or study team to likely limit adherence to interventions
* Vulnerable populations- pregnant or incarcerated
* Enrolled in interventional trials using drugs or devices
* Not able to undergo informed consent
* Recent hospitalizations or major interventional procedures done within the past 60 days
* Known or suspected hypersensitivity to tegaderm
* Use of any GLP-1 receptor agonist within 30 days prior to screening
* Presently classified as being in New York Heart Association (NYHA) Class IV Heart Failure
* Daytime use of supplemental oxygen (i.e., prescribed a stationary or portable oxygen system)
* Presence of metastatic cancer
* Current use of mobility aid(s)
* Living in the same household of a participant already enrolled in the study
CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).

Clinical trial for the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL

To evaluate the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in Adult patients with newly diagnosed high-risk and Ph- B-ALL in this prospective, single arm study.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 and ≤65 years old
2. Newly diagnosed and high risk B-ALL according to the 2022 WHO classification
3. The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-;
4. Anticipated survival time more than 12 weeks;
5. Those who voluntarily participated in this trial and provided informed consent.

Exclusion Criteria:

1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
5. Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus
6. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
7. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
8. Other uncontrolled diseases that were not suitable for this trial;
9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
The Natural History of Human Stingray Injuries

Stingray injuries can be a hazard shared by many types of beachgoers. Stingrays often lie in the sand and when stepped on by the unsuspecting beachgoer their tail snaps foreword, resulting in a barbed stinger injecting venom into the victim. Little exists in the current literature on the natural history of stingray injuries. Most of the existing literature looks at the incidence of stings, and to a certain extent the demographic of people who seek care. To our knowledge no study has attempted to collect a more inclusive population of those people who are stung and follow them prospectively to determine the incidence of medical intervention, infection, etc.

This study aims to describe and quantify the natural history of stingray injuries and to better understand their time course and medical requirements. The study setting will be Seal Beach, which reports some of the greatest number of annual stingray injuries for any single beach on the pacific coast. Participants will be identified by the Seal Beach lifeguards who are believed to treat the majority of stingray injuries suffered at the beach. Eligible persons will be consented for participation over the phone by research personnel. If enrolled in the study they will receive a phone call by research personnel one week and one month after the injury that will collect information about the symptoms they have experienced and the medical interventions they have received, if any. This study is strictly observational in nature and will not involve any interventions on the part of study personnel or alter the manner in which or types of medical assessments or treatments.


Eligibility Criteria:
Inclusion Criteria:

* People at Seal Beach, California
* People identified by Life guard personnel as being stung by a stingray at Seal Beach
* Adults or
* Children whose parent or guardian are present at the time of the injury

Exclusion Criteria:

* People who have previously been enrolled in the study
* People who the lifeguard believes were stung or bit by a marine organism other than a stingray or a terrestrial organism
Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy

The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and 50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. This study was conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of T2DM in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy
* HbA1c in the range of 7.0-10.0%
* Body mass index in the range of 20-35 kg/m\^2

Exclusion Criteria:

* Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
* Significant heart diseases Other protocol-defined inclusion/exclusion criteria may apply
Pulmonary Vein Antrum Isolation (PVAI) Plus Scar Homogenization and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation

This study aims to examine the long-term success rate of catheter ablation in non-paroxysmal atrial fibrillation patients using different ablation strategies such as : (i) pulmonary vein antrum isolation (PVAI) + isolation of left atrial posterior wall, (ii) PVAI plus scar homogenization, (iii) PVAI plus isolation of posterior wall plus ablation of non-PV triggers \[ PVAI: Pulmonary Vein Antrum Isolation

Non-PV triggers: Triggers arising from sites other than pulmonary veins\]

Back ground: Pulmonary vein antrum isolation (PVAI) as a lone procedure, is known to have limited success rate in terms of long-term recurrence-free survival in non-paroxysmal atrial fibrillation (NPAF) and additional ablations isolating extra-PV triggers seem to improve the outcome (1). The extra-PV triggers include triggers from other sites such as left atrial posterior wall, superior vena cava, interatrial septum, crista terminalis, left atrial appendage and coronary sinus (1, 2). These are known to be independent predictors of late AF recurrence following catheter ablation (3, 4, and 5). Earlier studies have demonstrated better ablation outcome in NPAF when non-PV triggers sites were isolated along with PVAI (5, 6). Moreover, Verma et al had reported high (57%) recurrence rate post-index procedure in AF patients with pre-existent scar (7). However, published data are conflicting regarding the benefits of additional substrate guided ablation (scar homogenization) compared to conventional PVAI alone strategy (8). Also, limited data is available showing a comparison of the lasting efficacy of the above three procedures when used in different combinations.

Hypothesis: The combined ablation strategy including PVAI, scar homogenization and ablation of extra-PV triggers has the highest likelihood of maintaining long-term sinus rhythm in patients with NPAF.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Patients undergoing first catheter ablation for drug-refractory Persistent (PerAF) or long-standing persistent AF (LSPAF)
3. Ability to understand and provide signed informed consent

Exclusion Criteria:

1. Previous catheter ablation or MAZE procedure in left atrium
2. Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc
Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection

Groin incisions in vascular surgery have complications in up to 30% of cases at 30 days, resulting in reductions in patient quality of life and increased costs. Prior attempts at reducing this complication rate have been largely unsuccessful. The purpose of this study is to determine the feasibility of routine Vialize use for vascular surgeries involving a groin incision and to determine the rates of surgical site infection/dehiscence in such patients receiving subcutaneous Vialize.


Eligibility Criteria:
Inclusion Criteria:

* The study population will consist of patients undergoing vascular procedures with groin incisions. Patients must be at least 18- years-old and able to complete baseline measurements. All subjects will be compensated. Patients undergoing treatment for peripheral arterial disease (e.g., femoropopliteal bypass), aneurysm disease (e.g., aortofemoral bypass), end-stage kidney disease (e.g., loop thigh graft), and miscellaneous procedures (e.g., femoral exposure for delivery of device) will be eligible.

Exclusion Criteria:

* Patients undergoing use of negative pressure wound therapy (e.g., Prevena) and local antibiotic placement (e.g., vancomycin powder) will be excluded. Additionally, organ-transplant recipients will be excluded.
Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma

This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine I 131 Tositumomab more broadly available to patients. Secondary endpoints will be to obtain additional safety and efficacy information for this treatment regimen. Post study drug administration follow-ups will continue for up to ten years. These will include blood-work and adverse event assessments for 13 weeks post dosing, patient response evaluations at Week 13, Months 6, 12, 18, 24, and Long-Term Follow-ups every 6 months until the elapse of 5 years from the dosimetric dose and then annually thereafter through year 10. Thyroid function will be monitored annually during Long-term follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of low- grade NHL or transformed low-grade NHL (tumor must be CD 20 positive).
* Prior treatment with at least one chemotherapy regimen and have relapsed or progressed, or failed to achieve an objective response on last chemotherapy regimen.
* Karnofsky performance status of at least 60% and anticipated survival of at least 3 months.
* Absolute granulocyte of \>/= 1,500/mm3.
* Platelet count of \>/= 100,000/mm3, and not require sustained support of hematopoietic cytokines, or transfusion of blood products.
* Adequate renal function (i.e., \<1.5x Upper Limit of Normal), and hepatic transaminases (AST \<5 times ULN).
* Signed IRB/IEC-approved informed consent.

Exclusion Criteria:

* Patients with a mean of \>25% of the intratrabecular marrow space involved with lymphoma.
* Patients who received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosurea compounds) or who exhibit persistent clinical evidence of toxicity.
* Patients who have undergone stem cell or bone marrow transplant, active obstructive hydronephrosis, active infection, New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.
* Known HIV infection.
* Pregnant or nursing patients.
* Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer, in-situ cervical cancer, or cancer for which the patient has been disease-free for 5 years.
* Patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with more than 3500 cGy.
* Patients who received prior radioimmunotherapy, known brain or leptomeningeal metastases, HAMA positivity.
* Patients who are receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.