cyrilzakka/clinical-trials huggingface dataset:
Reducing Cardiovascular Risk of African Americans

Diseases such as hypertension and stroke affect mid-life and older African Americans at higher rates than Whites, negatively affecting health status of this group. This project determine the effectiveness of a faith-based health intervention for mid-life and older African Americans using community-based participatory research approaches.

Mid-life and older African Americans (AAs), a population that is increasing in number, have high rates of cardiovascular-related morbidity and mortality in relation to Whites. For this population, dietary and physical activity behaviors are related to the incidence of cardiovascular disease (CVD). Few tested health promotion interventions tailored for mid-life and older AAs are available yet churches have been shown to be an effective environment for AA health programs. Thus, the overall goal of this project is to reduce CVD risk factors in mid-life and older AAs through implementing and evaluating a church-based health intervention. Using the Transtheoretical Model of Behavior Change (TTM) and Socio-ecological theory (SE), the objectives of this project were to: 1) determine the effectiveness of a church-based intervention in relation to dietary behaviors (food choice, dietary quality), habitual physical activity) and CVD clinical risk factors of mid-life and older African Americans by increasing consumption of fruits, vegetables and calcium-rich foods; decreasing consumption of fat, sugar and sodium; increasing habitual physical activity; and improving selected clinical outcomes (blood pressure, body weight, glucose, among others); 2) identify the differential influence of program components of the intervention; 3) examine variables that might mediate the process of goal achievement; and 4) determine variables that are related to stage of change progression in goal achievement. Midlife and older AAs (n=221) from six churches, three treatment and three comparison, in North Florida were randomly selected from the churches, stratifying by age and gender. The intervention, Health for Hearts United, was developed using a community-based participatory approach and included literature-based conceptual elements of awareness building, clinical learning and efficacy development. Instruments included a food and lifestyle habits questionnaire (food frequency, NCI fruit and vegetable screener, NCI fat screener, physical activity items, TTM items, background characteristics, among others). Clinical data, including 24 hour recall, were collected from a subsample of participants (n=104). Data were collected at four points: Baseline, 6 ,18 and 24 month. The project was guided by research and community advisory committees.

Eligibility Criteria:
Inclusion Criteria:

* 45 years of age or older
* African American
* member and regular attender of church (at least twice a month)
* resident of Gadsden and Leon counties in North Florida.

Exclusion Criteria:

* Under 45 years of age
* not African American
* not a member and regular attender of church
* not a resident of Gadsden and Leon counties in North Florida.
Assessment by the CANS Score Versus Anthropometry and Impact on Early Neonatal Morbidities

Assessment of malnutrition within 48 hours of birth through anthropometric indices as Weight, Length and Head circumference, Proportionality indices as MAC/HC ratio, Ponderal index and Body mass index, Clinical assessment of nutritional status (CANS) score. Detection of early neonatal morbidities within the first week of life including Hypoglycemia ,Polycythemia, Respiratory Distress Syndrome, Neonatal sepsis, Hyperbilirubinemia and Feeding intolerance

Within the 1st 48 hours of birth, all live born, singleton neonates with gestational ages between 28-40 weeks will be included in the study after obtaining an informed consent from their legal guardians.

Assessment of malnutrition within 48 hours of birth:

1. Anthropometric indices:

   Weight (using the infant weighing scale). Length (using the infant measuring board). Head circumference (using non-metallic non-stretchable tape).
2. Proportionality indices:

   MAC/HC ratio (Calculation for each infant and value will be plotted on and compared with a standard curve). Ponderal index Body mass index
3. Clinical assessment of nutritional status (CANS) score:

A total score \<25 is considered as fetal malnutrition. 3. Detection of early neonatal morbidities within the first week of life (for those who will require NICU admission):

1. Hypoglycemia (Random blood sugar)
2. Polycythemia (Hematocrit level)
3. Respiratory Distress Syndrome
4. Neonatal sepsis (Clinically, Laboratory: CBC with diff., CRP, C/S)
5. Hyperbilirubinemia (Serum bilirubin level, Need of phototherapy or exchange transfusion)
6. Feeding intolerance (Abdominal distension with prominent intestinal loops, Gastric residue more than 3ml/kg before feeding at least 2 times/ day)

Eligibility Criteria:
Inclusion Criteria:

Neonates of both genders. Gestational age between 28-40 weeks. Singleton pregnancies.

Exclusion Criteria:

Presence of congenital anomalies. Infants of diabetic mothers
Evaluation of the Pharmacokinetics and Safety of Inaxaplin in Participants With Mild or Moderate Hepatic Impairment

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of Inaxaplin (IXP) in participants with mild or moderate hepatic impairment and in matched healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Cohorts 1 and 3: Participants with Hepatic Impairment

  * Cohort 1 (mild impairment): defined as a Child-Pugh total score of 5 to 6 (Child-Pugh Class A)
  * Cohort 3 (moderate impairment): defined as a Child-Pugh total score of 7 to 9 (Child-Pugh Class B)
* Cohorts 2 and 4: Healthy Participants

  * Participants will be matched during screening to participants with mild (Cohort 1) or moderate (Cohort 3) hepatic impairment according to each of the following parameters: age (± 10 years); sex; and BMI (± 15%)

Key Exclusion Criteria:

* Cohorts 1 and 3: Participants with Hepatic Impairment

  * Acute febrile illness within 14 days and/or acute illness within 5 days before first dose of study drug
  * Participants who smoke
* Cohorts 2 and 4: Healthy Participants

  * Acute febrile illness within 14 days and/or acute illness within 5 days before first dose of study drug
  * Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply
Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems

The Phoenix Post-Approval Registry is a prospective, multi-center, single arm registry sponsored by Volcano Corporation to evaluate the short and long term performance and clinical outcomes of the Phoenix Atherectomy System.

The Phoenix Post-Approval Registry is an prospective, multi-center, single arm registry, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Phoenix Atherectomy System. The study includes consecutive patients treated with the Phoenix Atherectomy System in a post-market (commercial device use) setting. Patients will be followed under real-world conditions for up to 12 months after the index procedure.

All patients with a planned endovascular revascularization procedure receiving treatment with the Phoenix Atherectomy System as all or part of their PAD treatment strategy may be included. Written informed consent must be obtained from each patient prior to enrollment in the study. Enrolled patients will undergo PAD treatment that includes Phoenix atherectomy, according to institutional or local standard of care. Data collection will include medical record review of procedures performed according to standard of care.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is ≥18 years of age.
2. Patient understands the research nature of the study and is willing and capable of providing written informed consent.
3. Scheduled for and receives treatment with the Phoenix Atherectomy System as all or part of their PAD treatment.
4. Meets Phoenix Atherectomy System catheter Instruction for Use (IFU) criteria.

Exclusion Criteria:

* Patients who have ANY of the following exclusion criteria are NOT eligible for the study:

  1. Patients unwilling or unable to comply with the protocol including 12-month follow-up for patients with CLI at baseline.
  2. Patient is participating in another device or drug clinical trial that interferes with this protocol follow up schedule.
Cross Bracing Protocol With And Without Dynamic Neuromuscular Stabilization Training in Athletes

ACL Injury is a severe injury for athletes, which frequently results in functional limits and a higher likelihood of re-injury. Although bracing regimens are frequently used in rehabilitation, their ability to restore functional movements after an ACL Injury is still uncertain. Dynamic neuromuscular stabilization (DNS) training, which targets the core and proprioception, has emerged as a viable method for enhancing motor control and decreasing knee instability. The objective of this study is to examine the synergistic impact of cross bracing and DNS training on the functional movements of athletes who have recently experienced an ACL Injury .

A randomized controlled trial will be conducted to study the effects of different interventions on athletes with acute ACL Injury. The participants will be divided into two groups: (A= control group) Cross bracing with conservative treatment, (B= Treatment group) Cross bracing + DNS training with conservative treatment. Both groups will engage in targeted exercises that aim to activate the core, improve proprioception, and enhance movement patterns. The participants' functional movements will be assessed at the beginning of the study and 6 weeks later using established questionnaire such as International Knee Documentation Committee (IKDC) score - assesses knee function and symptoms, Landing error scoring system (LESS), Y Balance (YB), Functional movement screening (FMS) Statistical analysis will be performed to compare the functional performance and neuromuscular parameters between the groups in order to determine the most effective intervention for restoring movement quality after ACL Injury .

The study's emphasis on cross bracing protocol and DNS training is warranted due to the necessity of investigating non-invasive and conservative therapy methods that have the ability to improve functional movements in athletes with ACL Injury . Cross bracing is frequently employed to offer external reinforcement and enhance stability to the knee joint subsequent to an ACL damage, whereas DNS training concentrates on reconditioning the neuromuscular system to enhance movement patterns and motor control. The study seeks to provide significant insights into the most effective rehabilitation regimens for athletes with acute ACL Injury by evaluating the effects of two therapies. The ultimate goal is to enhance their functional results and long-term sports performance.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female
* Age: 18-30 years.
* Mentally and verbally capable of participating in the study.
* Positive Lachman Test
* Diagnosis of acute ACL Injury with grade 1 and 2 through MRI or arthroscopy.

Exclusion Criteria:

* Inflammatory disease, rheumatoid arthritis, spondyloarthropathy or active malignancy.
* Neurological disorder or systemic disease.
* Previous surgery on the affected knee.
* Meniscal tear or articular cartilage damage requiring surgical repair
Comparison of Remineralisation Efficacy of MI PASTE Plus® and REMIN PRO® for White Spot Lesions in Primary Teeth

The present study aimed to compare the remineralisation capacity of white spot enamel lesions between two commercially available tooth pastes (Remin Pro and MI PASTE PLUS), applied at home twice a day on the anterior upper primary teeth by the patient and parents.

Objective: To evaluate and compare the clinical efficacy of Remin Pro® and MI Paste Plus® for the remineralisation of white spot lesions (WSL) on the enamel of primary teeth.

Methods: The selected design for this study was a randomised double-blind clinical trial based on CONSORT guidelines. Patients with at least one upper anterior primary tooth with a WSL on the enamel surface, with units of fluorescence (UF) ranged from 11-20 (evaluated with DIAGNOdent) were included in the study. Patients were randomly assigned to receive either the twice-daily at-home topical application of Remin Pro® or MI Paste Plus® (both as experimental pastes) or Colgate Total® (as control paste). The degree of remineralisation was quantified by the change in the number of UF from the baseline evaluation and at days 10 and 21. The difference between groups was statistically evaluated using ANCOVA and ANOVA techniques.

Eligibility Criteria:
Inclusion Criteria:

* Young paediatric patients with at least one upper anterior primary tooth exhibiting one or several WSL on the smooth enamel surface.
* Attending the Paediatric Dentistry Postgraduate Program's Clinic
* Enamel lesions with units of fluorescence (UF) ranging from 11-20 as determined by DIAGNOdent
* Signed Informed Consent

Exclusion Criteria:

* History of hypersensitivity to any of the compounds of the pastes
* Enamel hypoplasia
* Compromising systemic diseases
The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight Loss

The incidence of Gall Stones after Bariatric surgery and its association with weight loss

Gallstone (GS) formation is common in obese patients, particularly during rapid weight loss.This study aimed to determine the incidence of GS in patients underwent bariatric surgery (BS) and the influence of weight loss on GS formation.

Eligibility Criteria:
Inclusion Criteria:

* (BMI) ≥35kg/m2 with one or more obesity-related comorbidities
* a BMI \> 40 kg/m2 without coexisting medical problems

Exclusion Criteria:

-a conrtaindication for bariatric surgery
Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge

The purpose of this study is to explore the activity of UR-63325 in a model of allergic rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise healthy.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent to participate (prior to any study-related procedures being performed) as shown by a signature on the volunteer consent form and to be able to adhere to the study restrictions and examination schedule
* Subjects with confirmed history of seasonal allergic rhinitis to grass pollen (by direct questioning of presence of positive skin prick test to pollen and History of Symptoms of allergic rhinitis) within the previous two years
* Positive skin prick test to timothy grass pollen (wheal difference with negative control ≥ 3 mm) at screening
* Subjects with positive response to screening nasal challenge with increasing doses of timothy grass pollen (Symptoms worsening with respect to the response to the diluent challenge of ≥4 points in the total nasal symptom score \[TNSS\]) within one hour after last nasal allergen challenge
* Screening and baseline FEV1 \>80% predicted and FEV1/FVC \> 70% predicted

Exclusion Criteria:

* Symptoms of allergic rhinitis within 2 weeks prior to screening
* Upper respiratory infection or sinusitis within 14 days of screening and also within 14 days of study start in each of the two periods
* Structural nasal abnormalities or nasal polyps on examination, a history of nose bleeding or recent nasal surgery
* History of asthma or asthmatic symptoms or other respiratory disease other than rhinitis within the last 2 years or FEV1\<80% of predicted at screening or baseline
Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery

The primary objective of this clinical investigation is to determine whether post-arthroscopic treatment with 10 ml of 0.5% sodium hyaluronate (VISCOSEAL® SYRINGE) can relief pain, improve mobility and promote joint recovery, compared to the standard arthroscopy procedure alone, in patients undergoing arthroscopic procedure.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 18 and 75 years of age.
* Good general health condition.
* Signed written informed consent.
* Patients with necessity for arthroscopic meniscal surgery.
* Ensured compliance of subject over the whole study period.

Exclusion Criteria:

* Concomitant or previous participation in a clinical investigation within the last 3 months prior to study inclusion.
* Knee joint arthroscopy in study relevant joint within 6 months prior to study inclusion.
* Patients with known hypersensitivity to the investigational device (i.e. active compound and excipients) or any component or procedure used in the study.
* Contraindication for the use of the investigational product or for the scheduled arthroscopy, used anesthesia and post-surgical treatment.
* Concomitant disease of sufficient severity (e.g. uncontrolled diabetes mellitus, carcinoma, etc.), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study.
* Concomitant disease of sufficient severity at study relevant joint (e.g. known or suspected infection, peripheral neuropathy or presence of hemarthros).
* List of concomitant medications not allowed which interfere with the functional assessments of this study.
* Use of medication contraindicated for arthroscopic surgery.
* Intra-articular treatment with a sodium hyaluronate-based product within the last 6 months or use of corticosteroid containing substance within the last 3 months at study relevant joint.
* Recent history of drug and/or alcohol abuse (within the last 6 months) or patients with severe mental illness or suicidal tendency.
* Pregnant or lactating females.
* Participants of childbearing age (pre-menopausal) who do not accept the use of methods of birth control with pearl index ≤ 1% (i.e. oral contraceptives, vaginal ring, hormone-releasing Intrauterine Device (IUD), implants, depot syringes, hormone patch, double barrier method, tubal ligation, vasectomised partner,...) during the treatment period and the first 4 weeks of follow-up period.
* Subjects having a high probability of non-compliance to the study procedures according to investigator's judgement (like illiteracy, insufficient knowledge of local language).
* Kellgren III-IV on study relevant side (confirmed by X-ray).
Enhancing Father's Ability to Support Their Preschool Child

This study focuses on the development of the Fathers Supporting Success in Preschoolers (FSSP) Program, which combines evidence-based parenting interventions with Dialogic Reading to engage fathers in and improve parenting and child behavior.


Eligibility Criteria:
Inclusion Criteria:

* Male Guardian
* Child enrolled in partnering Head Start site

Exclusion Criteria:

* Mental Health issues that prohibit involvement in group-based prevention study (e.g., psychosis)
Study of Mocetinostat in Patients With Urothelial Carcinoma Having Inactivating Alterations of Specific Genes

Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. This study is a Phase 2 trial evaluating the efficacy of mocetinostat in patients that have advanced urothelial carcinoma that has specific changes in tumor genes. Patients must have previously received treatment with chemotherapy that included a "platinum-containing agent" such as cisplatin. The study will enroll in stages, with 15 patients in the first stage. More patients will be added to the study if enough patients having beneficial responses are observed. Mocetinostat will be administered using oral capsules three times each week (eg, Monday, Wednesday and Friday). The study is designed to evaluate whether the number of patients responding to treatment is substantially higher than would be expected with other available treatments.

To be eligible for this study, patient tumor testing must demonstrate a genetic alteration resulting in the loss of function of the Histone Acetyltransferase (HAT) family genes, CREBBP and/or EP300, including gene deletions or selected inactivating mutations. If testing has not already been performed, the study will provide for the testing.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of urothelial carcinoma
* Metastatic or locally advanced disease
* Prior chemotherapy that included a platinum agent
* Test results showing genetic change in tumor gene for CREBBP and/or EP300
* At least one tumor that can be measured

Exclusion Criteria:

* Uncontrolled tumor in the brain
* Impaired heart function
Evaluation of Autogenous Tooth- Derived Graft With Bovine Bone For Surgical Repair of Unilateral Alveolar Cleft

The aim of this study is evaluation of autogenous tooth-derived graft combined with bovine bone for surgical repair of unilateral alveolar cleft .

Decalcified dentin graft is thought to be a good graft material that can substitute existing autogenous bone graft materials. It can be easily and readily available, with minimal risk of infection, minimal donor site morbidity as no vital bone is sacrificed, it can be easily shaped to fit into the bony defect and it can be used as block or in powder forms, the hypothesis is to evaluate the biological and the physical properties of both and autogenous tooth derived graft and bovine bone to increase the quality and density of newly formed bone in alveolar cleft grafting

Criteria of patient selection:

Inclusion Criteria:

Patients with unilateral alveolar clefts requiring repair. patients free from any systemic disease that may affect normal healing of bone. patients in an age 7y up to 14 y. patients have teeth to be sacrificed, as primary teeth, carious teeth, malposed teeth, supernumerary tooth\& non functional tooth in the study group.

Exclusion criteria:

Bilateral alveolar clefts. Immunocompromized patients. Syndromic patients. Patients have good full set of teeth, cannot be sacrified in study group The patients grouping with unilateral alveolar cleft will be classified into two equal groups according to the grafting material used for alveolar cleft repair.

Study Group:

This will include 8 patients with unilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone .

Control Group:

This will include 8 patients in whom alveolar cleft will be repaired using bovine bone .

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral alveolar clefts requiring repair.
* patients free from any systemic disease that may affect normal healing of bone.
* patients in an age 7y up to 14 y.
* patients have teeth to be sacrificed, as primary teeth, carious teeth, malposed teeth, supernumerary tooth\& non functional tooth in the study group.

Exclusion Criteria:

* Bilateral alveolar clefts.
* Immunocompromized patients.
* Syndromic patients.
* Patients have good full set of teeth, cannot be sacrified in study group