cyrilzakka/clinical-trials huggingface dataset:
Building Long-term Academic Success Through Ongoing Fun Fitness Program

The purpose of the research study is to investigate if daily motor activities, including fitness activities, gross motor skills, fine motor skills, and motor coordination activities result in physiological, cognitive, and behavioral benefits to children at Odyssey Academy. The study will compare students' performance after intervention by comparing an intervention period to a standard care period, and comparing intervention students to students engaged in standard school activities in the area of academic performance.

The objective of this study is to track if daily participation in motor lab activities for school age children improves their academic performance. Academic performance is associated with motor skills, coordination, and executive function. Our objectives are to determine if daily participation in motor lab activities changes these skills, to better understand these relationships, track outcomes of children participating in motor lab intervention compared to non-intervention and children receiving standard level of care in the school, and to be able to follow the intervention students over time.

The specific aims of the study are:

1. To investigate whether gross motor skills, fine motor skills, and physical fitness, predict executive function skills.
2. To determine the relationship between these variables and academic performance.
3. To examine the relationship between participation in motor lab activities and measures of change in fitness, gross motor skills, fine motor skills, executive function, and academic performance.
4. To evaluate if participation in daily motor lab activities predicts fitness level, gross motor skills, fine motor skills, executive function, and academic success at the end of the school year and in the next school year.

Eligibility Criteria:
Inclusion Criteria:

* students in grades kindergarten through fourth grade,
* students below grade level in reading
* in Odyssey Academy's reading program

Exclusion Criteria:

* students that are not part of the specialized reading program at Odyssey Academy
* are unwilling to participate in the motor lab intervention
* lack conversational ability in the use of the English language.
Multiomic Signatures of Microbial Metabolites Following Prebiotic Fiber Supplementation

The investigators propose a comprehensive, multiomic study that will integrate longitudinal data associating changes in specific gut bacteria and host in response to prebiotic fiber supplementation. These data will guide the development of an integrative biological signature relating bacterial-derived metabolites with biological outcome in the host. The open sharing of data generated by the proposed research represents a significant public resource that will support and accelerate future novel studies.

Phenolics-rich prebiotic fiber has been correlated with a number of positive health outcomes, however their bioavailability is typically low. A large portion the gut microbiota metabolize these fibers releasing a range of phenolic acids, which are believed to be principle bioactive components driving reduction in disease risk. Despite this, little evidence exists linking specific gut bacteria with the metabolites they produce and the downstream biological effects that these compounds exert. With this study, the investigators propose to assemble a cohort of healthy individuals that will receive prebiotic supplementation, during comprehensive, longitudinal characterization of the microbiota and host changes with clinical markers and multiple omics assays. These multiomic data will then be integrated, generating unique biological signatures that define the role that microbial metabolites from specific bacteria play in host biological activity. To validate the biological function of these microbial metabolites, gnobiotic mice will be inoculated with the microbial strains identified. The newly identified metabolites will also be synthesized in vitro to demonstrate their structure, biological properties and applications. Through this study the investigators expect to gain a detailed and clear understanding of the physiological changes, at the mechanistic level, that occur in the microbiome and host in response to dietary supplementation with prebiotic fiber.

Eligibility Criteria:
Inclusion Criteria:

- good general health

Exclusion Criteria:

* Chronic inflammatory conditions
* Major organ disease
* Heavy alcohol use
* Pregnancy/lactation
* Use of medication known to affect carbohydrate or lipid metabolism
* Active eating disorder
Effect of External Heat on a Transdermal Granisetron Patch in Pharmacokinetics (PK) of Healthy Subjects

The purpose of this study is to determine the effect of heat applied to a granisetron transdermal patch in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects aged ≥ 18 and ≤ 45 years at screening. Subjects must demonstrate understanding of the purposes and risks of the study and agree to follow the restrictions and schedule of study procedures, as evidenced by voluntary written informed consent (signed and dated) obtained before taking part in any trial-related activities.

Exclusion Criteria:

* Any current or previous disease, disorder, allergy or condition (including recent unexplained weight loss) that could affect the study conduct or laboratory assessments, or that presents undue risk from the study medication or procedures. Hypersensitivity to adhesive plasters or surgical tape.
* Any physical examination or screening investigation result that indicates the subject is unfit for the study.
* Scarring on upper arms, including extensive tattoos making skin reactions unevaluable.
* A positive virology test, urine test for drugs of abuse, or pregnancy test result (females of childbearing potential only).
* Recent use of prescribed or over-the-counter medication that, in the opinion of the Investigator or the Sponsor, will interfere with the study procedures or compromise safety.
* Received an investigational drug within 3 months (90 days) preceding patch application.
* Loss of ≥ 400 mL of blood (e.g. been a blood donor) within the past 3 months.
* Average weekly alcohol consumption of greater than 21 units (males) or 14 units (females), or habitually smokes ≥ 5 cigarettes or equivalent tobacco per day within the 6 months before patch application. Subjects may not smoke while confined to the study site. Subjects must not consume alcohol, or xanthine-containing foods or drinks within 48 hours prior to dosing until discharge.
* Lactating female subjects, and female subjects of childbearing potential who are not willing to use an acceptable form of contraception from the screening visit, during the study and for 90 days after the study.
* Employee of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members of the employees or the Investigator.
A Study of LY3502970 in Healthy Participants

The main purposes of this study are to determine:

* The safety of LY3502970 and any side effects that might be associated with it.
* How much LY3502970 gets into the bloodstream and how long it takes the body to get rid of it.

This study has 5 parts (A, B, C, D, and E). Parts A and D involve a single dose of LY3502970 and will last about 15 days. Part B and E involve multiple doses of LY3502970 and will last about 4 weeks. Part C involves two single doses of LY3502970 and will last about 29 days. Each participant will enroll in only one part. Screening must be completed within 28 days before study start. This study is for research purposes only, and is not intended to treat any medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females, as determined by medical history
* Have safety laboratory results within normal reference ranges

Exclusion Criteria:

* Have known allergies to LY3502970, glucagon-like peptide-1 (GLP-1) analogs, related compounds
* Abnormal electrocardiogram (ECG) at screening
* Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.
The Pivotal Study of RapidPulseTM Aspiration System

The goal of this clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 8 hours of symptom onset or last seen normal. Subjects will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participation in the trial is for 90 days.

The purpose of this prospective, open label clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System as frontline approach in the treatment of large vessel occlusions in patients experiencing Acute Ischemic Stroke within 8 hours of symptom onset or last seen normal. The target sample size for this clinical trial is 170 subjects enrolled in up to 30 sites globally. The maximum number of subjects that may be enrolled is 340. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge (whichever comes first). The final study visit will occur approximately 90 days after the index event. The primary effectiveness endpoint is the proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by modified treatment in cerebral infarction score (mTICI) ≥ 2c after the first pass as assessed by an independent Imaging Core Lab. The primary safety endpoint is the proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy as assessed by a central events committee (CEC).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years
* Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6
* Able to be treated within 8 hours of symptom onset or last known normal (LKN)
* Able to be treated within 120 minutes from the time of the qualifying baseline CT/MR image
* Pre-morbid Modified Rankin Scale (mRS) score 0-1
* Angiographic confirmation of large vessel occlusion (LVO) in the anterior (intracranial ICA or MCA M1 or M2 segments) or posterior circulation (vertebral or basilar arteries) as confirmed by digital subtraction angiography (DSA) irrespective of IV thrombolysis administration
* Candidate to receive treatment with ADAPT technique (Direct Aspiration First-Pass Technique)

Exclusion Criteria:

* Intracranial Hemorrhage (ICH)
* Alberta Stroke Program Early CT Score (ASPECTS) \<6
* Intracranial Atherosclerotic Disease (ICAD)
* Multiple or tandem occlusions
* Life expectancy less than 6 months
Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age

This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-659, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects with F/F or F/MF genotypes.

The study was discontinued after completion of Part A due to Sponsor's discretion.


Eligibility Criteria:
Key Inclusion Criteria:

* Homozygous or heterozygous for F508del mutation (F/F or F/MF genotypes)
* Forced expiratory volume in 1 second (FEV1) value ≥40% of predicted mean for age, sex, and height.

Key Exclusion Criteria:

* Clinically significant cirrhosis with or without portal hypertension
* Lung infection with organisms associated with a more rapid decline in pulmonary status.
* Solid organ or hematological transplantation.

Other protocol defined Inclusion/Exclusion criteria may apply.
Three Measures for the Prevention of Carious Lesions in Preschool Children

Analysis different measures preventive effect on carious Lesions incidence and oral microecological system change of preschool children

Different caries prevention trials including fluoride vanish, IgY-passive immunotherapy and probiotics lasting 24 months were conducted with a total of 500 children aged 24 to 54 months of age in Lin'an, Zhejiang, China. The trials were cluster- domized .After obtaining parent´s informed consent, preschool children were clinical examinated according to ICDAS-Ⅱ and microbiological tested of saliva at baseline, 1m, 6m, 12m, 18m and 24m. To find the differences of caries incidence and oral microecology change in four groups, dmfs will be assessed and saliva will be analysed in experiment.

Eligibility Criteria:
Inclusion Criteria:

* preschool children in good general health
* At least 18 deciduous teeth

Exclusion Criteria:

* With major systemic disease or on long-term medication
* Not cooperative and refuse dental treatment
* With a history of extra fluoride supplement
* Take antibiotics for nearly 8 weeks
Comparison of Laryngeal Masks in Urethral Cystoscopic Surgery Operations: a Prospective Randomized Clinical Study

The use of Laryngeal masks are increased.This study aimed to compare lma pro seal and baska -mask in urethral retrograde sistoscopy operations.

The use of Laryngeal masks are increased. Aimed to compare lma pro seal and baska -mask in urologic retrograde sistoscopy operations. ASA 1-2 80 subjects who is undergoing elective URS operations were enrolled in this prospective randomized clinical study. The demographic and airway characteristics of patients preoperatively and lam insertion times, nasogastric insertion times number of intubation attempts, fiberoptic grades from the lam, expired tidal volume, oropharyngeal leak pressures, peak and mean airway pressures preoperatively, minor complications like sore throat, hoarseness, dysphagia were recorded at the postoperative care unit.

Eligibility Criteria:
Inclusion Criteria:18-65 years of age

* undergoing elective urs operations
* bmı\<35
* ASA I-II

Exclusion Criteria:\<18 years of age

* bmı\>35
* ASA III-IV
Pemetrexed Plus a Comparator Versus a Combination of 2 Comparators in First-Line Treatment of Colorectal Cancer

In this study, patients will receive either pemetrexed plus irinotecan or 5-fluorouracil (5-FU), leucovorin, and irinotecan.

The purposes of this study are to determine:

* How pemetrexed plus irinotecan compares with 5-FU, leucovorin, and irinotecan in terms of efficacy.
* The safety of pemetrexed plus irinotecan and any side effects that might be associated with it as compared with 5-FU, leucovorin, and irinotecan.
* Whether pemetrexed can help patients with colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

The patient must have:

* Histologic or cytologic diagnosis of adenocarcinoma of the colon or rectum.
* Performance status of 0 to 2 on the ECOG Performance Status Scale.
* Standard postoperative adjuvant radiation therapy for rectal cancer is allowed.
* Locally advanced or metastatic disease.
* Must be 18 years of age.

Exclusion Criteria:

The patient must not have:

* Received prior chemotherapy for advanced disease. Prior adjuvant therapy, including 5-FU, is allowed if it has been more than 12 months since the last treatment.
* Received prior treatment with irinotecan in the adjuvant setting.
* Are unable to take vitamin B12 or folic acid.
* Are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs, or COX-2 inhibitors for a 5-day period.
* Have a second primary malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG)

Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.

Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma
* Male or female at least 18 years of age and able to provide written informed consent
* Mean IOP (at baseline visit after washout of any medications) must be 22 mm Hg and no greater than 38 mm Hg
* Likely to be available and willing to attend follow-up visits

Exclusion Criteria:

* Angle closure glaucoma
* Secondary glaucomas
* Prior glaucoma procedures
* Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease
Auto-inoculation of a Wart in Multiple Viral Warts

This study is being conducted to see effectiveness of auto-inoculation of a wart in multiple viral warts. Patients with recurrent, multiple warts of all types, are being recruited for the study. A wart is excised, minced and then inoculated in a subcutaneous pocket made on the volar aspect of forearm. Patients are to be reviewed after every 4 weeks to note any reduction in number warts.

A single arm, Phase 1, Clinical Study

Eligibility Criteria:
Inclusion Criteria:

* Individuals having 5 or warts
* Individuals having any types of warts

Exclusion Criteria:

* Individuals using any other treatment for warts
The PK/PD Study of Multiple Dose of SHR3824 in Healthy Volunteers

SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in healthy subjects.


Eligibility Criteria:
Inclusion criteria:

* Chinese male and female subjects aged 18 to 45 years.
* BMI:18 -25 kg/m2.
* Healthy according to medical history, physical examination findings, 12-lead ECG findings, and clinical laboratory evaluations.

Exclusion criteria:

* History of or current clinically significant medical illness as determined by the Investigator.
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose.
* Pregnancy or breastfeeding . Significant acute or chronic medical illness, including renal impairment, or recent surgery.
* Donation of blood or plasma within the 4 weeks prior to the start of the study or acceptance of blood transfusion within 8 weeks.
Role of Vascular Endothelial Growth Factor (VEGF) in Acute Lung Injury/Adult Respiratory Distress Syndrome (ARDS)

Understanding the role VEGF plays in ARDS consequently provides an ideal opportunity to discover new therapies for ARDS.

In previous lab experiments, we observed evidence of pulmonary edema following alveolar epithelial overexpression of VEGF, suggesting a potential role for VEGF in ARDS. In addition, we found that preventing VEGF from reaching its target receptor(s) by overexpressing a soluble form of a VEGF receptor protein prevents edema formation.

These observations heighten the plausibility of VEGF playing an important role in the development of increased pulmonary capillary permeability during acute lung injury. Understanding this role VEGF plays in ARDS consequently provides an ideal opportunity to discover new therapies for ARDS.

Eligibility Criteria:
Inclusion Criteria:

1. Patients that meet the American-European Consensus Conference criteria for ARDS \[(1) Widespread pulmonary infiltrates; (2) Pulmonary capillary wedge pressure 18 mmHg; (3) PaOz/FiO; ratio 200; (4) compatible history\], or acute lung injury \[same as ARDS, but PaOz/FiOz ratio 300\], or are at increased risk for developing acute lung injury because of sepsis, pancreatitis, trauma, acid aspiration, radiation or chemotherapy-induced lung toxicity, and near drowning. Pulmonary edema is divided into two broad categories: hydrostatic or cardiogenic and increased-permeability or noncardiogenic edema12. Since ARDS is noncardiogenic in origin, patients with pulmonary edema due to congestive heart failure will serve as a control group.
2. Inpatients that are endotracheally intubated.
3. Patients that are able to provide informed consent or informed consent is granted by a family member or legal health care proxy.
4. Males or females that are 18 years or older.

Exclusion Criteria:

- Individuals who are too hypoxemic for bronchoscopy to be performed safely. Patients requiring V\\0z \> 0.7 and/or PEEP 15 will be excluded.

2. If the patient will be unable to tolerate bronchoscopy because of severe

acidosis, tension pneumothorax, active bronchospasm, hemodynamically significant cardiac arrhythmia, or intractable shock as defined as the inability to maintain a mean arterial pressure 60 mmHg or severe uncorrectable bleeding diathesis (tendency) or as otherwise determined by the pulmonary physician.

3. Females who are pregnant will not be accepted into the study. 4. Patients with recent (48 hours) acute myocardial infraction will not be accepted into the study.

5. Patients with a history of adverse reactions to lidocaine will be not be accepted into the study. 6. Patients who lack capacity to give informed consent due to acute panic attack, "intensive care unit" psychosis or other psychologic dysfunction.
Longterm-Evaluation of Vitelene® Against Standard

The purpose of this randomised prospective multicenter longterm study is to evaluate the survival rate of the implant, wear and periprosthetic osteolysis of highly cross-linked polyethylene with and without addition of Vitamin E (UHMWPE-XE vs. UHMWPE-X) in Total Hip Arthroplasty.


Eligibility Criteria:
Inclusion:

* Minimum age: 18 years
* Maximum age: 75 years
* Indication of cementless THA
* Approval of study participation and treatment according to study protocol
* Physical and mental willingness of adhering to clinical and radiological follow up

Exclusion:

* Patient is not able to join follow up
* Increased risk of anaesthesia according to the "American Society of Anesthesiology": ASA IV
* Tumor disease
* Alcohol and drug dependency
* Permanent cortisone therapy
* Clinical relevant infections
* Pregnancy and planned pregnancy
* Previous interventions like adjustment-osteotomy, treatment of fractures or THA on affected side
* Acute fractures of the affected hip joint
* Patients with bone quality, which doesn´t allow a cementless treatment
* Requirements of clinical relevant deformities (condition after preoperation or bone fracture, leg length discrepancy \> 30 mm, Offset-reduction about \> 30 mm)
* Small acetabular treatments with 28 mm heads
* Treatments without using ceramic heads
* Treatments which require neck prolonging components