cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Implementation of the Phoenix PrEP (Pre-Exposure Prophylaxis) Access Project for Youth Aged 13-24

This study will evaluate the implementation of a PrEP program for youth aged 13-24 in Phoenix, AZ. Numbers of youth who initiate PrEP, how long they continue with PrEP, and the barriers for youth who are trying to initiate and continue taking PrEP will be examined.

This observational study will describe the barriers encountered and the benefits found as youth engage in a PrEP program, the Phoenix PrEP Access Project and as they participate in PrEP provided through standard medical care. This study does not investigate the safety, efficacy or other medical benefits of PrEP, but looks at the issues surrounding youth who are trying to access PrEP.

Eligibility Criteria:
Inclusion Criteria

* sexually active youth aged 13 through 24,
* at risk for contracting HIV,
* Negative for HIV as indicated by Negative Elisa and Western Blot (WB) or Negative 4th Generation test,
* weight greater than 35kg,
* offered PrEP to reduce the risk of contracting HIV.

Exclusion Criteria

* Unknown or Positive HIV status,
* Renal Impairment as indicated by elevated BUN or Creatinine, abnormal urinalysis,
* Active infection with Hepatitis B Virus,
* Taking other medications containing Emtricitabine, Tenofovir or tenofovir alafenamide(TAF) such as Atripla, Complera, Emtriva, Genvoya, Odefsey, Stribild, and Viread taking drugs containing lamivudine,
* taking Hepsera,
* clinical symptoms consistent with acute viral infection within the past month.
Estrogen Diastolic Heart Failure

Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12 weeks to determine if markers of systolic and diastolic function change by echocardiography as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).

This preliminary, feasibility study will randomize 28 peri-menopausal women to either hormone replacement therapy or placebo for 12 weeks. Prior to randomization, each participant will undergo echocardiography, measurements of activity using the Duke Activity Status Index, measurements of quality of life and laboratory data, including b-type natriuretic peptide (BNP) measurements. Following the intervention for 12 weeks, these measurements will all be repeated.

Eligibility Criteria:
Inclusion Criteria:

* 28 healthy recently postmenopausal women with last menstrual bleeding 12 months at study entry. Women with last menstrual bleeding within 12 months at study entry are those who are peri-menopausal and for whom the drug is FDA approved.

Exclusion Criteria:

* History of hysterectomy, oophorectomy or both
* History of heart disease including cardiac transplantation, heart failure, bypass surgery or percutaneous intervention, and valve disease defined as moderate or severe valve regurgitation or stenosis
* History of bone disease including non-traumatic vertebral fractures on radiography
* Uncontrolled chronic disease (including uncontrolled diabetes defined as a hemoglobin A1C \>8, uncontrolled hypertension defined as a systolic blood pressure \>160 mmHg, awaiting organ transplant)
* Previous or current cancer, excluding basal cell carcinoma
* Previous or current thromboembolic disease
* Previous intolerance of Hormone replacement therapy (HRT) or Oral contraception (OC)
* Current or previous use of HRT within the past 3 months
* Current or recent (\<12 months) substance abuse, including tobacco use
* No drug interactions with HRT
* No racial or ethnic groups will be excluded
Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy.

Efficacy Evaluation of Enhanced Bowel Preparation Instructions in Elective Colonoscopy.

This is a prospective, randomized, controlled clinical investigation designed to evaluate the efficacy of enhanced bowel preparation instructions (automated SMS, information website, and pre-recorded phone call) in improving bowel preparation quality in elective colonoscopy.

Subjects from the interventional and control group will receive standard of care bowel preparation instruction.

The interventional group will receive enhanced instructions delivered by automated SMS, information website and pre-recorded phone calls in the 48 hours leading up to the colonoscopy day. The intention is to provide a reminder, to reiterate instruction on clear fluid diet and timing of bowel preparation medication, and to provide additional graphical illustration on the information website.

Subjects in the interventional group must reply "OK" to each automated SMS or press "1" on the keypad at the end of the automated phone call to acknowledge understanding and receipt of instruction. Failure to acknowledge trigger an alert for a booking office staff member to directly call the patient and confirm compliance.

The clinical investigation will be conducted at one hospital in the state of New South Wales, Australia.

Subjects will be randomized to the interventional group (enhanced instruction) versus the control group (standard instruction).

The proceduralist assessing outcome measures at the time of colonoscopy is blinded to the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Elective colonoscopy booking at Griffith Base Hospital.

Exclusion Criteria:

* Emergency colonoscopy
* Patients who are unable to understand bowel preparation instructions in the following languages: English, Italian, Punjabi, Gujarati, Samoan, Mandarin.
Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study

The original RCT trial is designed to compare self-tailored titanium-coated polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of efficacy, safety and cost-effective at 1-year follow-up. This study will follow women in the original RCT study for up to 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment into this study is open only to women that already participated in previous RCT, no new treatment interventions will be given. Recruitment into the previous RCT is closed. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.

The previous study is a randomized trial designed to compare the composite success rate between patients with self-cut mesh procedure and those with mesh-kit procedure. The original RCT study includes a 1-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures. The goal of this long-term follow-up study is to extend the follow-up of women in the previous RCT study up to 10 years from the time of surgery and to compare the success and complication rates of the two surgical treatment groups over this extended time period.

The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 10 years. A supplemental study investigates the long-term success rate and complications of transvaginal mesh procedure in women in both of the study arms.

Eligibility Criteria:
Inclusion Criteria:

* Women enrolled in previous RCT study

Exclusion Criteria:

* Inability to provide informed consent. Informed consent will be obtained prior to each telephone interview and each in-person visit.
* Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.
Multiple Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes

BMS-820132 is an investigational new drug being developed by BMS for treating Type 2 diabetes. The purpose of this study is to test the safety/tolerability (potential side effects) of multiple doses of the investigational new drug, as well as the amount of study drug in the blood and its effects on blood sugar,in subjects with type 2 diabetes.

Study Classification: Safety, Pharmacokinetics/dynamics

Eligibility Criteria:
Inclusion Criteria:

* Males and females of childbearing potential (willing to use an acceptable method of contraception), or females of non-childbearing potential (i.e., post-menopausal or surgically sterile).
* Diagnosis of type 2 diabetes treated with metformin monotherapy (at least 1500 mg/day for at least 6 months) on a stable regimen for at least 2 months.
* Body Mass Index (BMI) of 18.5 to 40 kg/m2.
* Fasting glucose in the range of 125-275 mg/dL.
* Hemoglobin A1c (HbA1c) in the range of 7.0% -11.0%.
* Fasting C-peptide \> 1 ng/mL.

Exclusion Criteria:

* Clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations, and any significant acute or chronic medical illness other than stable and well controlled hypertension, microalbuminuria, dyslipidemia, depression, or hypothyroidism.
* History of diabetic ketoacidosis, hyperosmolar nonketotic syndrome, lactic acidosis, hypoglycemia (i.e., ≥ 1 self-reported episodes of hypoglycemia within the last 3 months or ≥ 2 self-reported episodes of hypoglycemia within the last 6 months), or hypoglycemia unawareness.
* Any major surgery within 4 weeks of study drug administration.
* Any gastrointestinal surgery that could impact upon the absorption of study drug.
* Smoking more than 10 cigarettes per day.
* Recent drug or alcohol abuse.
* Women who are pregnant or breastfeeding.
* Positive urine screen for drugs of abuse.
* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV)-1, -2 antibody.
Effects of O2 and/or CO2 Inhalation on Rest and Exercise Pulmonary Hemodynamic

The aim of this study is to describe the pulmonary hemodynamic evolution at rest and during a short constant load exercise in 4 conditions :

* normoxia
* hypoxia
* hypercapnia
* association hypoxia and hypercapnia


Eligibility Criteria:
Inclusion criteria:

* healthy male
* exercise capacity between 100 and 130 % of theorical values

Exclusion criteria:

* smoker
* headache
* impossibility to perform an exercise test
* no tricuspid regurgitation on the echocardiography
ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder

Amplitude changes of the N1 and the N1/P2 ERP component in response to different tone intensities have been suggested as a correlative of central serotonergic activity. A strong loudness dependence amplitude increase (strong intensity dependence) reflects low serotonergic neurotransmission and vice versa. Many researchers assumed that the brain serotonergic activity could influence treatment response of highly selective serotonin reuptake inhibitors in depression and anxiety disorders. There are a couple of studies reporting associations of N1 amplitude intensity dependence with response to Citalopram (positive correlation) and Reboxetine (negative correlation) treatment in major depressive disorder patients. But so far there have been no reports about associations between ERP N1 and antidepressant response in GAD patients.

So, it would be very interesting to explore the correlations between ERP N1 amplitude change and the Escitalopram treatment responsiveness in GAD patients.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV TR for GAD
* Hamilton Rating Scale for Anxiety (HAMA) \>18
* 18 to 75 years old

Exclusion Criteria:

* Severe medical illness
* Other psychiatric illness
* HAMD \> 18
* High suicidal risk
* pregnancy
Reveal LINQ Registry

The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.

The study is a prospective, non-randomized, observational, multi-center, global study. The study will characterize clinical actions initiated by Reveal LINQ arrhythmia detection and estimate procedure-related acute infection rate. Approximately 1,500 subjects will be implanted with a Reveal LINQ ICM and undergo continuous remote monitoring and be followed prospectively from insertion through 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
* Subject is intended to receive or be treated with the have a Reveal LINQ ICM inserted in the next 30 days.
* Patient enrolled before or on the same date of insertion of the Reveal LINQ ICM
* Subject consent prior to ICM insertion

Exclusion Criteria:

* Subject who is, or is expected to be inaccessible for follow-up
* Subject with exclusion criteria required by local law
* Subject is currently enrolled in or plans to enroll a concurrent study that may confound the results of this study. Co-enrollment in any concurrent drug and/or device clinical study (including registries) requires approval of the study manager or designee.
Efficiency Study of the EUS-FNA Needles With and Without a Side Port in Pancreatic Masses

For diagnosis of pancreatic tumors, endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (EUS-FNA) are well established techniques in clinical practice. We hypothesize that a FNA needle with a side port could improve the diagnostic yield. The aim of this prospective randomized study is to determine whether there is a difference in diagnostic yield in patients with pancreatic masses for evaluation.

For diagnosis of pancreatic tumors, endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (EUS-FNA) are well established techniques in clinical practice. In the case of EUS, an ultrasonic transducer located at the tip of the echoendoscope allows the endoscopist to visualize the wall of gastrointestinal tract as a series of definable layers corresponding to histology, and also enables detailed images of areas outside of the digestive tract. EUS has a significant clinical impact because it allows assessment of submucosal GI lesions, loco-regional staging of gastrointestinal malignancy, tissue diagnosis by EUS-FNA and staging of pancreaticobiliary lesions, non-small-cell lung carcinoma, and mediastinal disease. In prospective trials, EUS-FNA has been clearly established to be an important diagnostic tool with excellent safety profile.

Olympus has recently made commercially available a new 22 gauge FNA needle with a side port at the needle tip to facilitate the process of FNA and increase the diagnostic yield. There have been preliminary unpublished retrospective data that suggested the yield might be raised. However, there are no prospective multicenter randomized controlled studies to ascertain the validity of the assumption. The aim of this prospective randomized study is to determine whether there is a difference in diagnostic yield between EZ-Shot 2 (model: NA-220H-8022) and EZ-Shot 2 with side port (NA-230H-8022) in patients with pancreatic masses for evaluation. We hypothesize that a FNA needle with a side port could improve the diagnostic yield.

Eligibility Criteria:
Inclusion criteria:

1. all patients referred for EUS-FNA of pancreatic masses;
2. informed consent is obtained for performance of EUS-FNA.

Exclusion criteria:

1. presence of active gastrointestinal bleeding
Postoperative Results of Surgical Treatment of Lung Cancer After 30 Days

This is a retrospective, descriptive analysis of (1) 30 day postoperative results of surgery for lung cancer, (2) 30 day outcome predictors - compared to an earlier similar study in the same hospital (St Olav University Hospital, Trondheim, Norway).


Eligibility Criteria:
Inclusion Criteria:

* Lung cancer patients after surgery in 2002-2004 at dept for Heart and Lung Surgery, St.Olavs University Hospital, Trondheim, Norway.

Exclusion Criteria:

* Carcinoid tumor, small-cell lung cancer, lung metastases
Horticultural Practices for Children

The study was conducted with a parallel group randomized controlled experimental design to determine the effect of horticultural practices on internet addiction, social skills and stress levels in children. The children underwent horticultural practices for 6 weeks. Children were given a post-test at the end of the intervention program (week 6), a first follow-up three months after the intervention and a second follow-up six months later.


Eligibility Criteria:
Inclusion Criteria:

* studying in the 6th and 7th grade of secondary school
* volunteering to participate in the research
* consent by the family for participation in the study

Exclusion Criteria:

- the presence of a disease against the materials to be used in horticultural practices (pollen, plant, seed and fertilizer allergy, etc.)
Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients

Sedation and analgesia are fundamental tools for managing critical patients who require mechanical ventilation. However, recent scientific literature highlights that excessive sedation in these patients can increase the duration of mechanical ventilation and extend the overall length of stay in intensive care, as well as expose them to a higher risk of hypotension, venous thrombosis, and nosocomial pneumonia. The titration of sedation and analgesia in intensive care, on the other hand, is currently based primarily on clinical parameters (such as the onset of delirium, asynchronies with the ventilator, for example), which can lead to treatments not proportionate to the patient's needs.

The present study aims to evaluate the application, in an intensive care setting, of the Conox® system, a device already widely used in monitoring the anesthetic plan in the operating room. This tool would allow, through the processing of an EEG trace, the assessment of the level of sedation (qCON) and the probable algic response (qNOX), thus providing valuable information for the fine-tuning of the analgo-sedative plan.


Eligibility Criteria:
Inclusion Criteria:

Age 18-90 years Admission to the ICU for less than 24 hours Expected mechanical ventilation for \>48 hours Ongoing sedation

Exclusion Criteria:

Mechanical ventilation (MV) for less than 48 hours Patient or next of kin refusal to participate BMI \> 35 Cerebrovascular disease Scheduled surgery Neuromuscular disease Presence of craniofacial trauma that prevents the placement of electrodes
Transversus Abdominis Plane (TAP) Block After Kidney Transplantation

Postoperative pain is a major problem in patients who either donate a kidney or undergo kidney transplantation. This pain is commonly treated with opioids, which can cause several side effects, ranging from pruritus, impaired vigilance, and most concerning to severe respiratory depression. This can be aggravated in the recipient by accumulation of opioid metabolites secondary to renal impairment and secretion.

Several studies have shown an opioid sparing effect of a transversus abdominis plane (TAP) block after surgery in the lower abdomen. In the proposed study, we plan to compare the impact of an ultrasound guided single shot transversus abdominis plane (TAP) block versus a ultrasound guided sham block with normal saline (placebo) on postoperative pain scores, postoperative opioid consumption, as well as patient's satisfaction.

The investigators hypothesize, that patients who receive a TAP block will have lower postoperative pain scores, lower postoperative opioid consumption as well as higher satisfaction scores.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years, English speaking, receiving a kidney transplant or donating a kidney as part of standard clinical care

Exclusion Criteria:

* Allergy to local anesthetics or opioids, coagulopathy or dementia. Patients with known history of IV drug abuse and with very high preoperative opioid requirements (defined as \> 120 mg oxycodone/ day, use of methadone or fentanyl patches) will also be excluded from this study.

Coagulopathy will be assessed by the patient's history and physical. Should there be concerns regarding "easy bleeding" or "easy bruising", further workup of the patient's coagulation will be ordered (PT, PTT, INR). Since we perform the TAP block after 3-4 hours of kidney surgery, any patient with coagulopathy will most likely have been canceled prior to surgery. Therefore, we would deem any patient, who was eligible for kidney surgery, eligible for a TAP block at the end of the surgical procedure.
Membrane Blue Versus Infracyanine Green

To compare possible toxicities of membrane blue and infracyanine green in vivo by macular function and peripheral visual field.


Eligibility Criteria:
Inclusion Criteria:

* Macular pucker or macular hole

Exclusion Criteria:

* Any other retinal disease
Multiparametric PET-MRI Integration for a New Approach to Tumor Heterogeneity in Non-Small Cell Lung Cancer (NSCLC): Pilot Study

To estimate the intra and inter-operator reproducibility of multiparametric regional PET-MRI mapping in locally advanced and trace mestastatic non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

1. Locally advanced NSCLC (stages IIB, IIIA or IIIB of the TNM classification 7th edition) or trace metastatic stage IV (\</=5 mestastasis, \</= 3 organ reached)
2. Exclusive therapeutic management by concomitant radio-chemotherapy administered in accordance with international recommendations (dual therapy with platinum salts)
3. Signed consent
4. Patients affiliated with the social security scheme or beneficiary of a similar scheme.

Exclusion Criteria:

1. Minor
2. Pregnant / lactating woman
3. Person deprived of liberty by judicial or administrative decision, adults who are the subject of a legal protection measure or unable to express their consent
4. Previous cancer in the 2 years prior to registration
5. Previousradiotherapy / thoracic surgery
6. Patients under experimental treatment or for whom the administration of an experimental treatment is planned
7. Claustrophobic patients
8. Severe Renal Insufficiency (Clearance MDRD Cockroft \<30ml / min)
9. Uncontrolled diabetes, hyperglycemia\> 1.8g / L
10. Patient with metallic implants not compatible with MRI or any immovable implanted electronic medical device (eg pacemaker, neurostimulator, cochlear implants, etc.)
Adolescent Transition West Africa

This trial will serve as an outcome evaluation of 'Adolescent Transition in West Africa' (ATWA), a school-based program in Mali, Burkina Faso, and Niger for adolescents ages 10-19. The overall objectives of the project are as follows: Impact: Improved sexual and reproductive health and rights of 472,180 adolescents. Outcome 1: Improved sexual and reproductive health and rights and gender equality knowledge, intent, and behaviors among 472,180 adolescents. Outcome 2: 500 health facilities offer quality adolescent responsive SRH services that are used by adolescent girls and boys. To evaluate program impact, an external evaluation will be conducted. A pre/post cross-sectional evaluation design will be used across two evaluation years.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in primary or secondary school
* Participating in community group (Niger only)
* Aged 10 to 19

Exclusion Criteria:

* Not enrolled in school (Mali and Burkina Faso)
* Younger than age 10
* Older than age 19