cyrilzakka/clinical-trials huggingface dataset:
The Healthy Kids+ Initiative: Promoting Active Living Through Healthy Choices

The study will test the effectiveness and examine the sustained effects of weekly programming on enhancing (1) lifestyle behaviors (physical activity, dietary intake, use of technology, amount of sleep), (2) self-efficacy, (3) self-esteem, and (4) readiness to change among children ages 8-11 years.

The purpose of this study is to implement and evaluate the Healthy Kids+ initiative -- a community-engaged research project - through an existing after-school program in Las Cruces, NM. The Healthy Kids+ initiative will encourage daily lifestyle behaviors (5 or more servings of fruits and vegetables, 2 hours or less of recreational screen time, 1 hour of physical activity, 0 sugary drinks, 10 hours of sleep) that impact childhood obesity. This research project will integrate lessons and activities designed to help kids incorporate changes into their lives to enhance their health and wellness. Overall, it is expected that children participating in the Healthy Kids+ initiative, three times per week, will demonstrate significant changes in improving lifestyle behaviors and maintaining both cognitive and affective changes.Healthy Kids+ will be integrated into the 21st Century afterschool program to provide children at the school sites with relevant PA and health related programming throughout the year. The proposed study will include a repeated-measures research design. A power analysis revealed that for a moderate effect size (f = .25, Cohen, 1988), with five percent type I error and 80% power, three follow up time points, and within subject's correlation of 0.5, we will need to recruit at a minimum 100 total participants. However, our potential participant pool is much larger, and thus we plan on over recruiting (N = 200) to mitigate lost data from attrition rates. The Healthy Kids+ program will be implemented three times a week for 30 weeks. A midyear assessment will be conducted 15-weeks into the program. Participants will then take part in a post assessment at the completion of the 30-week program. The primary quantitative outcome measures include levels of lifestyle behaviors (PA, healthy eating habits, screen time, sleep). The outcome measures will also include self-efficacy, self-esteem, and the level of readiness to change relevant to aforementioned lifestyle behaviors.

Based on Healthy Kids+, we revised and partnered with Fred Hutchinson Cancer Center to expand this trial. For this follow up project, we will recruit 30 children total at NMSU. For this follow up project, we will use accelerometer to objectively measure physical activity and sleep, as well as validated surveys measures for dietary intake and related health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 8-11 years enrolled in the after-school program at the selected sites.

Exclusion Criteria:

* Children not enrolled in the after-school program at the selected sites.
A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will receive 1 of 2 doses of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a difference between GWP42003-P and placebo in their effect on seizure frequency.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant has a well-documented clinical history of epilepsy.
* Participant has a clinical diagnosis of Tuberous Sclerosis Complex (TSC) according to the criteria agreed by the 2012 International TSC Consensus Conference.
* All medications or interventions for epilepsy (including ketogenic diet and any neurostimulation devices for epilepsy) must have been stable for 1 month prior to screening and the participant is willing to maintain a stable regimen throughout the trial.

Key Exclusion Criteria:

* Participant has a history of pseudo-seizures.
* Participant has clinically significant unstable medical conditions other than epilepsy.
* Participant has an illness in the 4 weeks prior to screening or randomization, other than epilepsy, which in the opinion of the investigator could affect seizure frequency.
* Participant has undergone general anesthetic in the 4 weeks prior to screening or randomization.
* Participant has undergone surgery for epilepsy in the 6 months prior to screening.
* Participant is being considered for epilepsy surgery or any procedure involving general anesthesia.
* Participant has been taking felbamate for less than 1 year prior to screening.
* Participant is taking an oral mTOR inhibitor.
* Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP), such as sesame oil.
* Participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month or at screening.
* Participant is currently using or has in the past used recreational or medicinal cannabis, or cannabinoid-based medications, within the 3 months prior to screening and is unwilling to abstain for the duration for the study.
* Participant has tumor growth which, in the opinion of the Investigator, could affect the primary endpoint.
* Participant has significantly impaired hepatic function at the screening or randomization visit
* Participant has received an IMP within the 12 weeks prior to the screening visit.
Conventional Bronchoscopy Plus Rose Versus Electromagnetic Navigation (EMN) Plus Rose in Small Peripheral Lesions

The aim of this study is to evaluate if Electromagnetic navigation (ENB) in combination with rapid on site evaluation (ROSE) can improve diagnostic accuracy in those patients who fail to be diagnosed with conventional fluoroscopic assisted bronchoscopy (FBS) in combination with ROSE.


Eligibility Criteria:
Inclusion Criteria:

* presence of small peripheral lung lesions (\< 3 cm) in patient suitable for surgical procedure

Exclusion Criteria:

* patient with metastatic disease
* patients unfit for surgical procedure
A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users

This study will evaluate the abuse potential of ALKS 5461.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg
* Be a current recreational opioid user who has used opioids for non-therapeutic purposes (ie for psychoactive effects) at least 10 times in their lifetime
* Agree to use an approved method of contraception for the duration of the study unless surgically sterile or postmenopausal
* Be willing and able to abide by all study requirements and restrictions
* Additional criteria may apply

Exclusion Criteria:

* Have evidence of drug or alcohol dependence within the past 2 years
* Have a positive drug screen for opioids, amphetamines, cocaine, or benzodiazepines upon admission to the clinic
* Have a history of severe allergic reaction (including anaphylaxis) to any food, medication, or bee sting
* Be currently pregnant, breastfeeding, or planning to become pregnant during the study
* Currently have or have a history of allergy or hypersensitivity to opioid agonists, opioid antagonists or related drugs (eg, oxycodone, morphine, naltrexone, and naloxone)
* Have a positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
* Have donated or lost more than 500 mL whole blood
* Additional criteria may apply.
The Acute Effect Of Different Kinesiological Tape

This study aims to compare the acute effects of different kinesiology tapes on pain, functional performance and trunk endurance in young adults with chronic low back pain. Seventy young adults with chronic low back pain between the ages of 18-40 were included in our study. The individuals included in our study were divided into two groups by a simple randomization method. Star-shaped kinesiology taping was applied to the 1st group, and I-shaped kinesiology taping was applied to the 2nd group. The demographic and physical characteristics of the individuals who agreed to participate in the study were recorded. Visual Analogue Scale (VAS) to evaluate pain before taping, immediately after taping and 4 days after taping, Oswestry low back pain disability scale (OLBPDS) to assess disability level, Lumbar Flexion Repeat Speed Test, Sit-and-Stand Test to evaluate functional performance in both groups. Biering Sorenson Test was applied to evaluate the forward bending test with weight and trunk endurance.

Star-shaped kinesiology taping was applied to the 1st group, and I-shaped kinesiology taping was applied to the 2nd group. The demographic and physical characteristics of the individuals who agreed to participate in the study were recorded. Visual Analogue Scale (VAS) to evaluate pain before taping, immediately after taping and 4 days after taping, Oswestry low back pain disability scale (OLBPDS) to assess disability level, Lumbar Flexion Repeat Speed Test, Sit-and-Stand Test to evaluate functional performance in both groups. Biering Sorenson Test was applied to evaluate the forward bending test with weight and trunk endurance.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-40 who accept participating in the research,
* low back pain for at least 3 months,
* have no perception problems
* can cope well,
* individuals who regularly come to the controls and evaluations of the physical therapy program.

Exclusion Criteria:

* undergone spinal surgery,
* have complain of low back pain due to inflammatory, tumoral, metabolic cause, orthopedic (pes planus, genu varum, genu valgum, scoliosis, etc.) or neurological (Multiple Sclerosis, Stroke, etc.) problems that prevent treatment, spine or lower back pain.
* have extremity surgery,
* have another musculoskeletal disorder affecting the lower extremity,
* pregnancy
Application of hUC-MSCs in Treating Acute Lung Injury: a Single Center Prospective Clinical Research

The patients suffered from acute lung ininjury (200\<PaO2/FiO2 ≤ 300) will be divided into two groups: MSCs-treated group: patients are treated by intravenous injection of hUC-MSCs suspention ; control group: patients were treated with vehicle(Albumin) . The standard Therapies of acute lung injury were the same in both groups. In the following-up days, all the patients were monitored by the same items to evaluate the therapeutic effects.


Eligibility Criteria:
Inclusion Criteria:

* 1.≤ 3 days (72h)
* 2.Age ≥18 years, ≤65 years
* 3.200\<PaO2/FiO2 ≤ 300
* 4.Chest X-ray/chest CT : infiltrates of both lungs
* 5.Need assisted ventilation (ventilation or high flow oxygen therapy)
* 6.No left heart failure, pulmonary edema
* 7.Agree to participate and signe an informed consent

Exclusion Criteria:

* 1.Life expectancy \<3 months due to non-respiratory failure
* 2.Patients receiving extracorporeal membrane oxygenation support therapy(ECMO),high frequency oscillatory ventilation
* 3.History of HIV, malignant tumors, or impaired immune function
* 4.Patients accepted major surgery in the past 14 days (such as tumor removal, thoracotomy, heart surgery, abdominal surgery, intracranial surgery, or surgery for more than 3 hours, etc.)
* 5.Pregnancy
* 6.Have a serious concomitant disease
* 7.Unable to follow-up
* 8.History of severe allergic reactions or allergy to saline and serum
* 9.Already participated in another clinical study within 12 weeks
* 10.Pulmonary edema caused by other underlying diseases
A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients

This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the study if medically appropriate.

This is a Phase I study of the combination tamoxifen and 9-cis-Retinoic acid in patients with breast cancer. The primary objective of the study is; 1) to determine the maximum tolerated dose of 9-cis-Retinoic acid in combination with Tamoxifen and to determine the overall and dose limiting toxicities. Other objectives are: 2) to determine the effect of Tamoxifen on the pharmacokinetics of 9-cis-Retinoic acid; 3) to evaluate the anti-tumor activity of this combination therapy within the context of a phase I study; 4) and to determine the expression of surrogate biomarkers of breast carcinogenesis before and after treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

All patients must have histologically documented diagnosis of Stage III, or IV breast carcinoma.

Patients with stage III that has completed chemotherapy: Estrogen receptor (ER) or progesterone receptor (PR) positive tumor required if premenopausal. Either ER/PR-positive or -negative tumor allowed if postmenopausal and have received prior chemotherapy.

Patients may have stage IV with ER/PR-positive or -negative tumor.

No CNS metastases, pseudotumor cereri, or seizures.

PRIOR/CONCURRENT THERAPY:

Patients who have ecovered from the toxic effects of prior therapy will be eligible.

Patients with prior tamoxifen will be allowed to participate. At least 3 weeks must have elapsed since the last dose of chemotherapy.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Sex: Men and women.

Menopausal status: Any status.

Patients must have a performance status of ECOG 0-2.

Patients must have Hematopoietic criteria of:

ANC at least 1,500/mm(3).

Platelet count at least 90,000/mm(3).

Patients must have Hepatic criteria of:

In the absence of tumor involvement:

Bilirubin no greater than twice normal;

SGOT no greater than twice normal;

Alkaline phosphate no greater than twice normal;

Fasting triglycerides less than 3 times normal.

Patients must have Renal criteria of:

Serum creatinine no greater than 1.5 mg/dL OR;

Creatinine clearance at least 60 mL/min.

Other:

No allergy to study medications.

No nonmalignant systemic disease that would preclude therapy.

No second malignancy within 5 years except: Curatively treated basal cell skin carcinoma. Cervical carcinoma in situ.

Pregnant women will be excluded.

Negative pregnancy test required within 7 days prior to entry.

Adequate contraception required for 4 weeks prior to, during, and for 1 year after study.

Patients must give informed consent.

Patients who are poor medical or psychiatric risks will be eligible.
Indirect Pulp Capping With Resin Modified Glass Ionomer

In deep carious lesions, presenting risk of pulp exposition, a treatment option is the partial caries removal of carious tissue followed by provisional restoration, while this approach is called indirect pulp capping. The aim of this double-blinding controlled randomized clinical trial is to evaluate the success of indirect pulp capping using only resin-modified glass ionomer, while the additional layer of calcium hydroxide was used as control. The sample of 112 molars and/or premolars (n=56), presenting deep carious lesions, from patients with age between 15 and 30 years treated in dental clinic at Department of Dentistry of Federal University of Sergipe. The selected carious lesions must be reached 2/3 of dentin, observed in bite-wing radiography, without pulp involving and/or other factor that to compromise the evaluation. After detailed anamneses, the selected teeth will be radiographed e all carious tissue from surrounding walls will be removed. At the floor of cavity, the carious tissue will be partially removed using hand dentin excavators, remaining the caries-affected dentin and avoiding the pulp exposition. The removed carious tissue from the floor of cavity will be evaluated for presence of Lactobacilos e Estreptococos Mutans, while the remaining dentin will be evaluated for consistency, colour and humidity. Randomly, the cavity will be provisionally restored with: Control - dress and cement of calcium hydroxide followed resin-modified glass ionomer; or Experimental - only resin-modified glass ionomer. The distance between the base of restoration and the pulp cavity cap will be measured by bitw-wing radiography. The patients will be re-evaluated after 15 days, while the teeth with compromised pulp vitality will be excluded from the study. The remaining patients will be evaluated after 6 months. The distance between the base of restoration and the pulp cavity cap will be measured again, followed by provisional restoration removal. The remaining caries-affected dentin from floor of cavity will be fully removed and a bacteriological evaluation performed. The consistency, colour and humidity of this tissue will be evaluated too. Finally, the permanent restorations will performed.


Eligibility Criteria:
Inclusion Criteria:

* Molars and pre-molars presenting carious lesions involving 2/3 inner of dentin tissue.

Exclusion Criteria:

* Teeth presenting signs of irreversible pulpits or necrose, cervical lesion and/or root exposition, or with carious lesion reaching the pulp.
Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors

The purpose of this study is to determine if High-dose 111In-Pentetreotide known as NeuroendoMedix®, is an effective treatment for Neuroendocrine Tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have received first line standard chemotherapy and/or radiation therapy for neuroendocrine malignancy in the past and failed the therapy.
* Patients must have evidence of residual multifocal active tumor.
* All patients must sign an informed consent indicating the awareness of the investigational nature of the studies involved.
* All patients must have a Karnofsky performance status of at least 60.
* Patients must be greater than 18 years of age.
* Patients must have measurable and/or followable disease based on either clinical or radiologic exam.
* Sensitivity to Indium-111 pentetreotide or any of its components is an absolute contraindication to participation in this trial.
* An absolute contraindication is pregnancy as evidenced by the clinical condition, a positive pregnancy test (Beta type Human chorionic gonadotropin (β-HCG) or pelvic ultrasound).
* If patients have received prior radionuclide therapy of the same product, there must be documented response to that therapy and/or residual active stable disease.

Exclusion Criteria:

* Karnofsky performance status of 50 or less.
* Patients who are unable to give informed consent.
* Patients under 18 years of age. There will be no upper age discrimination.
* Patients who are pregnant or those potentially pregnant subjects not willing to practice effective contraceptive techniques during the study period.
* Patients with renal insufficiency as defined by a calculated creatinine clearance (based on age, weight and serum creatinine) of 39.9 ml/min or less.
A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC) medication is safe and effective in participants with chronic hepatitis B virus infection (cHBV).

This is a Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Participants with cHBV.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female between ages 18 and 70 years
* Virologically-suppressed (defined as HBV DNA ≤limit of quantitation (LOQ) for at least 6 months before screening on SOC NUC therapy
* HBeAg-positive or HBeAg-negative at screening
* In good general health except for cHBV

Key Exclusion Criteria:

* Co-infection with HIV, hepatitis C virus (HCV), hepatitis E virus (HEV) or hepatitis D virus (HDV)
* History or evidence of hepatic decompensation (including gastrointestinal bleeding or esophageal varices) at any time prior to or at time of screening
* Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the Investigator or the Sponsor makes the participant unsuitable for the study
* Previous treatment with an investigational agent for HBV other than ABI-H0731 in the last 6 months before screening
* History of hepatocellular carcinoma (HCC)
* Females who are lactating or pregnant or wish to become pregnant are excluded from the study
* Exclusionary laboratory parameters at screening include:

  * Platelet count \<100,000/mm3
  * Albumin \<lower limit of normal (LLN)
  * Direct bilirubin \>1.2×upper limit of normal (ULN)
  * Alanine aminotransferase (ALT) \>5×ULN at screening
  * International Normalized Ratio (INR) \>1.5×ULN
  * Glomerular filtration rate (GFR) \<60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Quality Assessment in Acute Stroke Care

The purpose of the study is to evaluate the quality of care on a 16 bed stroke unit by using a new developed clinical pathway.


Eligibility Criteria:
Inclusion Criteria:

* admission to the stroke unit of the university hospital in Muenster, Germany
* acute ischemic stroke or transient ischemic attack

Exclusion Criteria:

* intracerebral haemorrhage
* neurological symptoms due to other pathology than acute ischemic stroke or transient ischemic attack
* intraarterial thrombolysis
* necessity of artificial ventilation
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes

Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms, such as famciclovir and aciclovir.

This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with famciclovir (125 mg) versus aciclovir (200 mg) in patients with active recurrent genital herpes.

STUDY DESIGN

* Open-label, prospective, parallel group, intent to treat trial
* Experiment duration: 5 days
* 2 visits (days 1, and 5)
* Reduction of symptoms
* Adverse events evaluation

Eligibility Criteria:
Inclusion criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Patients with clinical diagnosis of recurrent genital herpes;
3. Score symptoms higher than 4;
4. Negative pregnant urine test.

Exclusion criteria:

1. Pregnancy or risk of pregnancy.
2. Lactation
3. Any pathology or past medical condition that can interfere with this protocol.
4. Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study);
5. Patients with immunodeficiency and/or immunosuppressive disease;
6. Hypersensitivity to components of the formula;
7. Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.