cyrilzakka/clinical-trials huggingface dataset:
Healthy Marriage and Responsible Fatherhood Grant Program With Phoenix House of New York

The purpose of this study is to provide a process and outcome evaluation of the HMRF grant-funded Connections program. Phoenix Houses of New York, Inc. has been given a new grant to continue and refine its successful Connections program which equips single and coupled participants with significant substance use disorders (SUD) with the skills and knowledge needed to (1) create and/or sustain healthy relationships/marriages, (2) equip participants with the skills and knowledge to raise children in a functional and healthy environment, (3) improve their financial stability, job readiness and employability to improve economic self-sufficiency and responsibility, and (4) reduce relationship stress and strain on interactions between co-parents.

The process evaluation will focus on:

* Documenting project implementations and determining efficient replication methods for effective program components,
* Monitoring completion of overall program goals and objectives, and
* Allow for quality improvement during the five year grant cycle.

The outcome evaluation which focuses on participant level impact will ask the following:

* Does participation in evidence-based relationship education improve healthy relationship skills for single or coupled enrollees?
* Does participation in partner education and support classes improve co-parenting relationship?
* Do participants have better attitudes toward their ability to manage money (i.e. savings, paying bills) after workshops in financial literacy and other money management services?
* Do participants have improved attitudes on their own employability after workshops targeted at job readiness?
* Does participation in job readiness preparation translate into improved employment prospects or readiness factors? (Readiness factors may include increased family assets and economic status.)
* Does participation in family care management sessions improve marriage/relationship, child and family well-being?
* Does participation in parenting education improve parenting skills and attitudes toward parenting? Does participation in parenting education improve commitment to parenting and children?

Eligibility Criteria:
Inclusion Criteria:

* Adult Phoenix House clients who are enrolled in Connections evidence-based interventions

Exclusion Criteria:

* Inability to provide informed consent
Casodex/Zoladex Biomarkers in Localised Prostate Cancer

To evaluate anti-androgen (bicalutamide) induced biological and molecular changes in prostate comparison to chemical castration induced (goserelin) ones


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed localised prostate biopsy specimen that contains sufficient tumour for evaluation of cell proliferation and apoptosis markers
2. Patients who are scheduled for radical prostatectomy with curative intents
Atrial Fibrillation/Sinus Rhythm Before and After Cardioversion

This study´s aim is to collect scientific data about patients with atrial inflammation by two principles of sensors measuring congestive heart failure.


Eligibility Criteria:
Inclusion Criteria:

* patients with atrial fibrillation and planned cardioversion
* male and female patients aged at least 18 years
* patients being able to understand and to follow the study staff´s instructions
* signed informed consent

Exclusion Criteria:

* persons being hosted in an institution by administrative order or court injunction
* pregnancy or breast feeding
* persons not being able to consent
* persons with implanted electronic devices
* material incompatiblity
* acute or chronic inflammation of the external or middle ear canal
* abnormal anatomic ear canal (congenital or pathological)
* persons in a dependent relationship to the investigator or employment contract
The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects

A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects

This is the first time HEC88473 will be administered to humans. The aim of this study is to obtain safety, tolerability, PK, PD, and immunogenicity data of HEC88473 SC administration as single and multiple ascending doses in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females, of any race, between 18 and 60 years of age, inclusive, at screening.
2. Body weight ≥ 50 kg, and body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening.
3. In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at screening as assessed by the investigator (or designee).
4. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
3. History of alcoholism or drug/chemical abuse within 2 years prior to the first dosing.
4. Alcohol consumption of \> 21 units per week for males and \> 14 units per week for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
5. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening and/or check-in.
6. Immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to the first dosing or planned vaccination during the course of the study.
7. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to the first dosing.
8. Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to first dosing, unless deemed acceptable by the investigator (or designee).
Surgical Treatment Of Complex Regional Pain Syndrome Type II (CRPS II)

The purpose of this study is to investigated and evaluated the effectiveness of a new surgical technique for the treatment of severe chronic pain stages (Complex Regional Pain Syndrome Type II).

For 140 years the treatment of Complex Regional Pain Syndromes Type II (CRPS II) has been an unsolved problem. Recent findings in animal models assume that CRPS Type II is maintained by a coupling of newly sprouted sympathetic and sensible fibres. Therapeutic approaches have included conventional pain medication, physical therapy, sympathetic blocks, transcutaneous or spinal cord stimulation, injections or infusion therapies and sympathectomy. Alone or in combination these therapies often yielded unfavorable results. The majority of physicians dealing with CRPS patients are convinced that a surgical treatment of the affected extremity only exacerbates the symptoms, especially its hallmark excruciating pain.

Patients with a CRPS Type II at the upper or the lower limb will be included in the study after ineffective pain therapy for more than 6 months. The most proximal region of pain associated with CRPS can be localized and 2% Lidocain will be injected into that area. If the sympathetic, deep, burning pain can be blocked repeatedly with these injections, the subcutaneous veins in the previously determined area will be surgically removed. This operation should lead to the permanent resolution of symptoms.

A visual analogue scale (VAS), the Nottingham Health Profile (NHP), thermography and physical examinations will be used to evaluate the outcome of the operation.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from CRPS Type II after after ineffective pain therapy for more than 6 months.

Exclusion Criteria:

* Ineffective testinfiltration with an local anesthetic Pregnancy
The Impact of Swallowing Intervention for Elderly Community Dwellers

The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-20 minutes each.

The investigators have designed a simple and user-friendly swallowing rehabilitation training method called "systematic simple swallowing training" based on commonly used swallowing training techniques in the department of rehabilitation medicine and the prevalent pathological causes of swallowing disorders in the elderly. It has shown promising preliminary efficacy. The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-20 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* Age over 60 years old.
* No hospitalization within the past six months.
* With clear consciousness and able to cooperate with questionnaires and training.
* The elderly people who voluntarily participate and agree to adhere until the end of the study.
* early dysphagia.

Exclusion Criteria:

* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Physical disability.
* Difficulty in mobility.
* Simultaneously receiving other therapies that might influence this study.
* Individuals with a gastrostomy.
* Abnormalities of the oral, pharyngeal, or esophageal structures.
Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis: Phase III Clinical Trial

Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients with knee Osteoarthritis


Eligibility Criteria:
Inclusion Criteria:

* Adult males and females aged 20 to 75 years
* Kellgren-Lawrence (KL) grade 1 to 3
* Individuals who voluntarily decide to participate in the study and provide written informed consent form
* Individuals who can understand and follow instructions and can participate in the study during the entire study period

Exclusion Criteria:

* Individuals who have clear secondary osteoarthritis caused by inflammatory, infectious, metabolic arthritis, or other conditions such as rheumatoid arthritis, rather than primary knee osteoarthritis as determined by the investigator
* Individuals with other factors that could potentially affect the assessment of this clinical study due to pain caused by osteoarthritis or other conditions in the hip joint
* Individuals who have undergone knee joint arthroplasty
* Individuals who have undergone open knee surgery (ligament reconstruction, osteotomy) within 3 years prior to the screening visit
AG & IM in CA Stomach Protocol

This is a multi-center prospective case control study aiming to compare different methods of risk stratification models in predicting the risk of gastric cancer development.

The case control study would compare which type of assessment (Endoscopic / histological) is more accurate in predicting the risk of gastric cancer development.

The risk factor assessment would be based on the following criteria.

Endoscopic assessment:

1. Atrophic gastritis, based on Kimura Takemoto Classification
2. Kyoto classification of gastritis
3. Intestinal metaplasia, based on Endoscopic Mapping and Grading of Intestinal Metaplasia (EGGIM) Histological assessment (Based on random biopsies)

1. Operative Links on Gastritis Assessment 2. Operative Links on Gastric Intestinal Metaplasia

Eligibility Criteria:
Two groups of patients would be recruited in this case control study.

1. Gastric neoplasia group Patients with newly diagnosed or history of cancer of stomach or gastric high grade dysplasia.
2. Control group Patients with no prior history of gastric dysplasia or cancer

Inclusion criteria:

1. Age 40 or above
2. Undergo elective upper gastrointestinal endoscopy

Exclusion criteria:

1. Patients with history of gastrectomy
2. Patients with severe thrombocytopenia (Platelet count \<50) or coagulopathy (INR \> 1.5 or on anticoagulation)
3. Contraindication to upper gastrointestinal endoscopy
4. Allergy towards sedative agents (Midazolam / Diazepam) or local anaesthetic spray (Lignocaine)
5. Patients who cannot give informed consent
A Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section

The objective of this study was to determine if blunt needle use during cesarean section closure protects against glove perforation and percutaneous injury to the surgeon and surgical assistant. A secondary objective was to determine physician satisfaction with blunt needles during the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Pregnant
* Undergoing a cesarean section

Exclusion Criteria:

* Under age 18
* Non-English speaking
Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration

This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. The primary purpose of this study is to compare the overall safety and efficacy between the leadless pacemaker and left bundle area pacing.

This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. This study is designed to compare the safety and effectiveness of two types of pacemaker treatments: leadless pacemakers and left bundle area pacing. Patients who's heart rhythm indicate a degree of heart block that slows the heart beat and decreases the amount of blood the heart is pumping to the rest of the body will be identified by physicians to participate. This study seeks to improve our understanding of heart rhythm disorders to allow us to provide the best treatment for our patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18
2. Planned for permanent pacemaker implantation for AV node disease (first, second or third degree)
3. Preserved ejection fraction \> 50%
4. Preserved sinus node function
5. Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
6. Life expectancy \> 1 year
7. Female subject of childbearing potential is not pregnant, not breast feeding, does not plan to be pregnant during the course of the study, and agrees to use a highly effective contraceptive method (i.e. IUD, birth control, vasectomized partner, sexual abstinence, etc.) during the course of the study.
8. Subject has been informed of the nature of the study, agrees to its provision and has provided written informed consent, approved by the IRB

Exclusion Criteria:

1. Sinus node dysfunction, anticipating atrial pacing or atrial fibrillation
2. Anatomical restriction for either MICRA or transvenous pacing such as

   1. Access vein occlusion or thrombosis
   2. previous radiation therapy at insertion site
   3. inferior vena cava filter
3. Endstage renal disease (ESRD)/on dialysis
4. Dementia (inability to give consent)
5. Moderate to Severe Tricuspid valve regurgitation
6. Moderate to Severe Mitral valve regurgitation
7. History of mitral or tricuspid valve surgery
8. Preexisting implanted pacemaker or ICD or lead
9. Subject is allergic to titanium
10. Life expectancy \< 1 year
11. Recurrent or high risk of infections
12. Active malignancy requiring systemic chemotherapy or local chest radiation
13. Subject has myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit
14. CABG, valve surgery or PCI within the last 3 months
15. Other major cardiac surgery within the last 6 months
16. Persistent and permanent atrial fibrillation diagnosed by a healthcare provider
17. NYHA class 3 or 4 Heart Failure
Development of Melt Organic Baking Fat for Reducing Child Obesity

The purpose of this study is to compare the effects of a cooking oil on metabolic rate, appetite, and metabolic risk markers.

The overall objectives of this study are to determine whether a Melt Organic baking blend can alter energy balance towards a negative energy balance by enhancing thermic effect of food and improving feelings of satiety relative to a control, corn oil, in overweight and obese adolescents.

This study will employ a 2-arm, double-blind, randomized, crossover design. Each arm will consist of one test day and will differ in the type of oil incorporated in the test breakfast: test blend 3.2 or corn oil. Oil sequence will be randomized. Each test day will follow the same protocol and will be separated by at least two weeks for boys or 4 weeks for girls to ensure that testing occurs during the same phase of their menstrual cycle for each test day.

Participants will arrive at the testing center after an overnight 12-h fast. Upon arrival, body weight will be taken and a catheter will be inserted in an antecubital vein. The participant will then rest for 30 minutes, after which resting metabolic rate (RMR) will be measured using an indirect calorimetry cart. RMR will be measured over a 45-min period. At the end of the RMR measurement, a fasting blood sample will be obtained, and the participant will be given a standard breakfast (containing 20 g of fat from either test blend 3.2 or corn oil) to consume over a 10-min period. The fat in the breakfast will be provided in test muffins. The test breakfast will provide 35% of the participant's daily energy requirements, estimated using the Schofield equation. The muffin will provide 450 kcal and the rest of the energy will be provided in the form of fat free yogurt, up to 140 kcal, and applesauce.

Following breakfast, postprandial energy expenditure will be assessed every hour using the indirect calorimetry cart. At each hour of this 5-h period, participants will fill out a visual analog scale to assess their feelings of appetite and satiety and will perform a computer task assessing prospective food intake. Immediately after breakfast, and at 30, 45, 60, 120, and 180 minutes after breakfast, a blood sample will be drawn from the catheter for metabolite and hormone measurements.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) equal to or greater than 85th percentile for age and sex
* Weight stable (+/- 2.5 kg) for at least 3 months prior to screening

Exclusion Criteria:

* Any endocrine disorder, including type 1 diabetes
* Weight loss attempted in past 3 months
* Currently using medication (prescription or over-the-counter) that could impact study outcomes
* Asthma
* Anemia
* Diagnosis of psychoses, bipolar disorder, major depression, severe personality disorder; history of suicidal tendencies
* Use of (current or in the past 4 weeks) any investigational medications or devices
* Allergy/sensitivity to wheat, milk, eggs, nuts
Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool

The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a prediabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to prediabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation.

Patient activation, which incorporates elements of self-efficacy and readiness to change, is particularly important in managing conditions like pre-diabetes, where the mainstay of treatment is behavioral lifestyle change and self-management. Unfortunately, Primary Care Physicians (PCPs) often do not have adequate training on how to promote patient activation. Traditionally, patient decision aids are used in shared decision-making to help elicit patient preferences and guide treatment options. However, the guides primarily focus on reviewing treatment options rather than increasing patient activation, which is key to successful and efficient behavioral counseling. The Patient Activation Measure (PAM) is a widely used and validated patient-reported outcome measure for assessing patient activation. Studies have demonstrated that using PAM to tailor care to a patient's activation level decreased health service utilization while improving clinical outcomes like blood pressure and self-management behaviors.

The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a pre-diabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to pre-diabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation.

Eligibility Criteria:
Inclusion Criteria:

* prediabetes
* patient at Johns Hopkins General Internal Medicine clinic at Green Spring Station
* MyChart account

Exclusion Criteria:

* history of diabetes
* non-English speaker
* severe intellectual disability or psychiatric comorbidities