cyrilzakka/clinical-trials huggingface dataset:
Medication Adherence and Outcomes Among Patients in United States With HIV

With support from the NIH, this pilot study will assess the feasibility of using wireless devices and financial incentives to motivate medication adherence among HIV-positive adults in the U.S., focusing on those with non-suppressed viral loads.

While daily lotteries using wireless devices may have great potential for improving adherence to ART regimens, substantial questions exist as to whether it is: 1) possible to achieve high rates of uptake for a pilot offering wireless devices to high-risk populations; 2) achieve high rates of sustained engagement.

The goal of this study is to explore the feasibility of using wireless devices and financial incentives to motivate medication adherence among high-risk HIV positive patients. By partnering with the Drexel Partnership Comprehensive Care Clinic at Drexel University, the investigators will be able to identify such patients using clinic patient data, use clinic and physician communication channels to enroll them, and maintain high levels of ongoing participation through the use of incentives. The aim is to improve antiretroviral medication adherence among high-risk HIV positive patients by providing patients with a AdhereTech device (electronic pill bottle), daily adherence notifications tracked by the Way to Health platform, as well as daily lotteries and financial incentives. Upon completion, this study will answer questions important to the feasibility of conducting well-powered randomized controlled trials to improve adherence among HIV patients within the U.S. who have sub-optimal adherence.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HIV, established in 2017 or earlier
* Patients at least 18 years of age or older
* Currently prescribed first or second line ART medications
* Non-suppressed viral loads, with two consecutive non-suppressed viral loads (VL\>400 copies/ml) for the past two lab readings.

Exclusion Criteria:

* Pregnant
* Prescribed Maraviroc or Fuzeon
* More than 5 additional medications
* Diagnosed with insulin dependent diabetes
* Unable to provide consent
* Non-English speaker
* Cognitive impairment, per PI discretion
* Does not have stable residence
Pilot Study to Evaluate Efficacy of Botanical Extracts as Protein Amplifier for Skeletal Muscle Strength & Growth.

Sponsor proposes ingredients that when added to daily whey supplementation, can lead to increased muscle strength, improves sleep quality and reduction in fatigue level.

The present study is a randomized, blinded, placebo-controlled, pilot study. Approximately 40 males aged between ≥ 20 and ≤ 35 years, will be screened. Each trial arm will have at least 5 completed after accounting for dropout/withdrawal rate of 20%. The treatment duration for all the study participants will be 28 to 56 days (Day 56 is only applicable for participants with less than 10% increase in weight leg pressed for 1 RM on Day 28. All participants in arm 1 of study will have their end of study visit on Day 28).Sponsor proposes ingredients that when added to daily whey supplementation, can lead to increased muscle strength, improves sleep quality and reduction in fatigue level.

Eligibility Criteria:
Inclusion Criteria:

1. Males aged 20 - 35 years with active lifestyle moderate physical activity level as per International Physical Activity Questionnaire.
2. Recreationally active but not participating in resistance type training on regular basis.
3. Body mass index (BMI) 22 - 29.9 kg/ m2
4. Participants with an Insomnia Severity Index score ≥7 and ≤14
5. Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs. prior to the exercise lab visit.
6. Fasting Glucose ≤ 110 mg/ dl
7. Systolic Blood Pressure ≤ 129 mm Hg and Diastolic Blood Pressure ≤ 89 mm Hg
8. TSH (thyroid stimulating hormone) ≥0.4 and ≤ 4.9 mIU/L

Exclusion Criteria:

1. Engaged in structured weight training during the previous 12 months prior to screening.
2. Presence of chronic disease.
3. Changes in body weight more than 4.5 kg (10 pounds) in the past three months.
4. Participants with uncontrolled hypertension.
5. Participants who are diagnosed with Type II Diabetes Mellitus.
6. History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders.
7. Allergy to whey or herbal ingredients.
8. Participants who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put them at unacceptable risk for participation in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
9. Participants who have been part of a clinical trial within 90 days prior to the screening.
10. Participants who have used whey or other supplemental proteins anytime in last 3 months
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

The purpose of this study is to evaluate the application of Negative Atrioventricular Hysteresis (NAVH) to improve electrical synchrony in Cardiac Resynchronization Therapy (CRT) patients.


Eligibility Criteria:
Inclusion Criteria:

* Implanted with a functioning SJM Quadripolar CRT Pacing System
* QRS duration \> 140 ms
* Left bundle branch block documented
* Ability to provide informed consent for study participation
* Willing to comply with the study evaluation requirements
* At least 18 years of age

Exclusion Criteria:

* CRT Pacing System implanted less than 1 week at time of enrollment
* CRT Pacing System implanted more than 24 months at time of enrollment
* CRT Pacing System implanted more than 90 days at time of enrollment AND intrinsic QRS duration is shorter than pre-implant intrinsic QRS duration by more than 10 ms
* Resting ventricular rate \>100 bpm
* Intrinsic PR interval \> 300 ms
* Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
* A recent myocardial infarction, ablation, drug intoxication, electrolyte imbalance, or any condition within the last 90 days that would be contraindicated for CRT programming changes in the opinion of the investigator
* Women who are pregnant or who plan to become pregnant during the study
Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer

To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or rezvilutamide in combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).


Eligibility Criteria:
Main Inclusion Criteria:

1. Age ≥ 40 years, male.
2. Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.
3. pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);
4. Patients with PSA \< 0.1ng/ml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;
5. Biochemical recurrence (two consecutive rises in PSA with absolute values \> 0.2ng/ml, the time interval ≥ 2 weeks apart ) and no local recurrence or distant metastatic lesions on conventional imaging (bone scan and CT/MRI scan);
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
7. Estimated life expectancy \>10 year;
8. Adequate laboratory parameters

   * Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L
   * Platelet count (PLT) ≥ 100 x 10\^9/L
   * Haemoglobin (Hb) ≥ 90 g/L
   * Serum creatinine (Cr) ≤ 1.5 x upper limit of normal(ULN) or creatinine clearance \> 50 ml/min.
   * Total bilirubin (TBIL) ≤ 1.5 x ULN.
   * Glutamic oxaloacetic transaminase (AST/SGOT) or glutamic alanine transaminase (ALT/SGPT) levels ≤ 2.5 x ULN.
   * International normalised ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5 x ULN .
   * Left ventricular ejection fraction (LVEF) ≥ 50%.
9. Patients able to comply with the protocol. Arm 1 subjects are proposed to receive salvage radiation therapy, while arm 2 subjects are not suitable for or refuse radiation therapy.
10. Signed informed consent.

Main Exclusion Criteria:

1. Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .
2. Postoperative biochemical recurrence with PSA \> 2 ng/ml.
3. Postoperative pathology containing neuro-endocrine differentiation or small cell features.
4. Prior malignancy other than prostate cancer in the past three years.
5. History of any of the following:

   * Seizure or known condition that may pre-dispose to seizure
   * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to entry.
   * Active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis)
6. Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.
Zinc Deficiency Treatment in Celiac Disease: Supplementation Versus Diet

Micronutrient deficiencies are common amongst celiac disease (CeD) patients due to consumption of a restrictive and nutritionally unbalanced gluten-free diet (GFD) in addition to slow intestinal villi healing. Preliminary data of 221 patients attending our Celiac Disease Clinic at McMaster University show that 64% of patients on a GFD have nutrient deficiencies with zinc (Zn) deficiency affecting 48% of treated CeD patients. Dietary supplements are prescribed to treat Zn deficiency and it is unclear whether Zn levels can be restored with optimizing Zn in diet. This project will evaluate the the feasibility of dietary therapy to treat Zn deficiency in CeD in comparison to supplementation. Additional objectives of this pilot study, are to assess the efficacy of Zn optimized GFD compared to Zn supplements in 1) normalizing plasma Zn levels and 2) improving CeD gastrointestinal and extra-intestinal symptoms at 3 and 6 month. Subjects will be recruited from McMaster Celiac clinic. This randomized controlled trial aims to recruit 50 CeD participants with two treatment groups; zinc optimized diet (guided by dietitian to achieve target of 11 mg/day for females and 14 mg /day for males) or zinc oral supplementation (25 mg zinc gluconate tablet/day; 7 mg elemental Zn) with a total study a total study period of 6 months and 4 visits. To be included in the study the investigators require celiac diagnosed patients confirmed through CeD serology and duodenal biopsies adhering to a GFD \> 6 months and plasma Zn ≤9.3 µmol/L. Questionnaires will be used to assess presentation of symptoms, dietary adherence, quality of life, depression and anxiety. The trial would be considered to be feasible if the enrolment fraction (i.e., number of enrolled patients /number of eligible patients) is 60% or above.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CeD based on specific CeD serology (elevated anti-tissue transglutaminase IgA, deaminated gliadin peptides-Immunoglobulin G or anti-endomysial antibodies IgA) and confirmed by duodenal biopsies showing villous atrophy (Marsh 3a or greater);
* Adopting a gluten-free diet for at least 6 months;
* Untreated Zn deficiency (Zn plasma levels ≤9.3 µmol/L)

Exclusion Criteria:

* Are already on a Zn optimized diet;
* Treatment with Zn supplements or multivitamins containing \>11 mg of Zn in the last month;
* Prior allergic reaction to Zn supplements;
* Treatment with antibiotics or probiotics supplements in the last 30 days;
* Pregnancy or lactation
* Current infection in the last 30 days;
* Intestinal obstruction, short gut (remnant bowel \<180 cm), or any serious illness considered by the investigator that will interfere with the study procedure or results. Data including medication and supplementation will be recorded in case report form and Zn content added to total Zn in the analysis.
* Untreated pancreatic insufficiency (fecal elastase \<200).
Learning by Repetitive Viewing of Peer Modeling Patient Education Videos by Adults With Down Syndrome

The learning of appropriate hand washing technique through repetitive watching of a video depicting an adult with DS washing his hands will be studied.

This study is a next step in evaluating the use of videos depicting a person with DS demonstrating hand washing. The initial study demonstrated improvement in hand washing technique with a verbal explanation of hand washing technique using an Illinois Department of Public Health handout and viewing one of the handwashing videos one time. The study demonstrated a statistical significant difference between learning by viewing the handout and a video of an adult with DS washing his hands vs just viewing the handout.viewing a handout Likely due to small sample size, the study did not demonstrate statistical significance between watching the video of a person with DS washing his hands vs watching the other videos but the trend for the best improvement in handwashing technique was for the group viewing another person with DS demonstrating the handwashing. The hypothesis of this study is that repeated viewing of a video and practicing hand washing will lead to even greater improvement in hand washing technique.

Eligibility Criteria:
Inclusion criteria

Individuals with:

* DS aged 18 and older
* The ability to use a checklist or to be taught how to use a checklist
* The ability to use a tablet or to be taught how to use a tablet
* Access to an Internet connection

Exclusion criteria

Individuals who:

* Are not yet adults
* Are unwilling to consent and/or assent
* Are unable or unwilling to return the ADSC for the 1 month and 2 months follow up visits
* sensitivity to soap
The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis

The combination of dietary protein ingestion and resistance exercise are essential to increase muscle protein synthesis. The vast majority of studies assessing protein intake following resistance exercise in young adults has been conducted exclusively in men or in studies where both men and women are assessed. The increase in muscle mass is thought to be impacted by sex hormones that fluctuate across different phases of the menstrual cycle. However, the effect of menstrual cycle phase on muscle protein synthesis following exercise is not known.


Eligibility Criteria:
Inclusion Criteria:

* Female, aged 18-40 years
* BMI between 18 and 30 kg/m2
* Recreationally active
* Regular menstrual cycle

Exclusion Criteria:

* Smoking or use of tobacco containing products
* Irregular menstrual cycle
* Currently on any form of hormonal contraception
* Post-menopausal
* Pregnant or breastfeeding
* Diagnosed metabolic/pulmonary/musculoskeletal illness
* Diagnosed cardiovascular disease or hypertension
* Use of medications that may impact protein metabolism or are anti-inflammatory
* Gastrointestinal disorders
* Allergy to pomegranate or amino acids
* Injuries that would impact ability to complete study
Investigation About Advance Directives

Advance directives are again in the heart of debate since the Leonetti-Claeys's law . These pieces of legislation allow everyone to decide by advance their wishes of the end of life.However, it does not seem that to legislate on a subject is enough to apply the text of law. High authority of health suggest that medical and paramedical staff have to participate to the elaboration of the questionnaire and the redaction of advance directives.

So the aim is that ,before asking patient about their knowledge on these advance directive, to evaluate if the staff knows about the law .


Eligibility Criteria:
Inclusion Criteria:

* nurse
* doctors
* paramedical staff

Exclusion Criteria:

* refusing participation
Tackling 30-day Readmissions in Patients With Cirrhosis: The SALTYFOOD Trial

The purpose of this study is to determine the feasibility of a home meal delivery program for patients with cirrhosis and ascites and to determine the effectiveness of a salt-restricted (2 gram sodium) meal delivery program in reducing the need for therapeutic paracenteses and/or all-cause re-admissions for these patients. Many patients with cirrhosis don't have enough nutrients in the body and are frail and these meals may help them maintain a good diet and lead to improved quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years or older of age
* Clinical diagnosis of cirrhosis with ascites. Diagnosis of cirrhosis will be based upon:

  1. liver biopsy, OR
  2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
  3. 2 of the following 4 criteria: i. Ultrasound (US), computerized axial tomography (CT) or Magnetic Resonance Imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites) ii. Fibroscan liver stiffness score \>13 kPa iii. Laboratory testing: Aspartate Aminotransferase (AST)/platelet ratio index (APRI) \>2.0 iv. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
* 3) At least one of the following: Any cause hospitalization within 90 days OR outpatient therapeutic paracentesis within 30 days

Exclusion Criteria:

* Language barriers that cannot be surmounted with in-person interpreters
* Estimated life expectancy \< 3 months
* Pregnancy (self-reported)
* Unable or unwilling to provide consent
* History of liver transplant
* Planned discharge to nursing facility
* Anuria or serum creatinine \> 2.0 mg/dL
* Uncontrolled hepatic encephalopathy
The Effect of Video-based Multimedia Information Before Amniocentesis on Pain, Anxiety and Pregnancy Outcomes

The goal of this clinical trial is to assess the effect of video-based multimedia information before amniocentesis on pain, anxiety and pregnancy outcomes

Amniocentesis is the most commonly used invasive prenatal diagnostic test. This study aimed to investigate the effect of video-based multimedia information (MMI) on the anxiety and pain levels of patients undergoing amniocentesis.

All consecutive women aged 18-45 years scheduled for amniocentesis were included in this prospective randomized controlled study. Subjects were assigned to receive video-based MMI or traditional written information (controls). Anxiety levels were assessed at the first admission using the State and Trait Anxiety Inventory-State (STAI-S). After MMI and written information, STAI-S was repeated before the procedure. A standard amniocentesis procedure was performed on all patients by the same perinatology physicians. After amniocentesis, a Likert scale was used to evaluate the ease of the procedure and patient satisfaction, and a visual analog scale was used to evaluate pain. Pregnancy results and amniocentesis results were noted

Eligibility Criteria:
Inclusion Criteria:

* All consecutive women aged 18-45 years scheduled for amniocentesis

Exclusion Criteria:

-
Vaccine Therapy in Treating Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with resected or locally advanced unresectable pancreatic cancer.

OBJECTIVES: I. Determine the safety and toxicity of vaccination with MUC-1 antigen and immunologic adjuvant SB AS-2 in patients with resected or locally advanced unresectable pancreatic cancer. II. Determine the maximum tolerated dose and/or recommended phase II dose of MUC-1 antigen in this patient population. III. Determine the qualitative and quantitative tumor response to this treatment in these patients. IV. Determine the disease-free survival in resected patients, progression-free survival in locally advanced unresectable patients, and overall survival in all patients receiving this treatment.

OUTLINE: This is a dose escalation study of MUC-1 antigen. Patients receive vaccination with MUC-1 antigen and immunologic adjuvant SB AS-2 intramuscularly on day 1. Treatment repeats every 3 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 year after the last vaccination, patients without recurrent disease may receive booster vaccines annually. Cohorts of 4 to 8 patients receive escalating doses of MUC-1 antigen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 2 of 8 patients experience dose-limiting toxicity. Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed resected or locally advanced unresectable pancreatic cancer No metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 4 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double barrier contraception 1 week before, during, and for at least 2 weeks after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent glucocorticosteroids Radiotherapy: No prior radiotherapy Surgery: At least 3 weeks since prior resection of pancreatic cancer Other: No concurrent non-steroidal anti-inflammatory drugs (NSAIDs)
Effects Of Dry Needling On Sternocleidomastoid Muscle For Pain And Disability In Migraine

To determine the effects, sequel of dry needling in migraine by resolving MTrPs in sternocleidomastoid muscle.

To determine the possession of dry needling technique to mitigate the frequency, intensity and duration of headache.

To determine the effectiveness of dry needling in the disability hindrance in migraine patients.

This is a randomized control study of 60 volunteers with migraine induced by myofacial triggers in sternocleidomastoid muscle. The migraine will be diagnosed by the neurologist and for the evaluation of trigger points and muscle thickness ultrasound will be done. After the diagnostic procedure and complete history evaluation from the selected population 30 subjects will be subjected to dry needling group and 30 others will be kept in the placebo group. All the participants will receive six sessions at the myofascial trigger point area there should be the gap of at least 48 hours between two sessions. As for the assessment details, such as the frequency, intensity and duration of the headaches; the consumption of drugs; the thickness of SCM muscles; the pain pressure threshold and the cervical range motions will be recorded before, immediately following the response, and at the 1-month follow-up

Eligibility Criteria:
Inclusion Criteria:

* Submitted with a headache diagnosis by a neurologist.
* Presence of active Trigger points in the Sternocleidomastoid muscle reproducing the symptoms of migraine.
* Active trigger points will be identified if "there is muscle sensitivity that has been activated by pressure and reproduces the patient's referred pain and headache."
* A jump sign the characteristic behavioral response to compression on a trigger point, will be produced.

Exclusion Criteria:

* background of neck trauma
* cervical radiculopathy
* History of head/shoulder surgery
* Diagnosis of other unusual headaches/migraines
* Phobia of pricking
* pregnancy