cyrilzakka/clinical-trials huggingface dataset:
Positive Connections: COPA2

This study proposes to assess the impact of a provider-based intervention to enhance re-engagement and improve retention, adherence, persistence and viral load among challenging patients in Argentina

Motivational Interviewing (MI) has primarily been utilized as a counseling strategy by therapists to counter addiction and improve lifestyle behaviors.

This application proposes to train physicians to utilize MI to promote re-engagement in HIV care and to sustain retention and adherence. The study will increase the reach of the original pilot study and increase its generalizability, expanding the patient population to a wide variety of public and private clinic and hospital patients, including transgender women, drug users, men who have sex with men (MSM), and heterosexual men and women.

Eligibility Criteria:
Inclusion Criteria:

* HIV seropositive
* At least 18 years of age (there will be no upper age range)
* "Challenging" HIV-infected patients, defined as 1) diagnosed for \> 6 months and having detectable viral load \> 500 copies/mL at last assessment following 6 months of ART prescription, AND 2) not retained in care, i.e., 3 missed pharmacy pick-ups in the last 6 consecutive months, or not attending a physician visit in the last 12 months or more

Exclusion Criteria:

* Participants with delirium and/or psychosis will be excluded.

There are no exclusions based on literacy as all materials will be administered using an audio computer assisted self-interview system (ACASI) supervised by assessors.
Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A

The study is to investigate the safety, tolerability, and pharmacokinetics (the determination of the concentration of the administered drug in blood over time) of recombinant Factor VIII Fc fusion protein (rFVIIIFc) in previously-treated subjects with severe hemophilia A.


Eligibility Criteria:
Inclusion Criteria:

1. Male and 12 years of age and older and weigh at least 40 kg
2. Diagnosed with severe hemophilia A (baseline Factor VIII level less than 1%)
3. History of at least 100 exposure days to any Factor VIII product

Exclusion Criteria:

1. History of Factor VIII inhibitors
2. Kidney or liver dysfunction
3. Diagnosed with another coagulation defect other than hemophilia A
Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 and \<= 65 years
* ITP diagnosed at least 6 months prior to study entry by history, physical exam, blood count and blood smear
* Baseline platelet count of \<= 20 x 10 to the 9th/L determined prior to administration of the study drug on the day of the first infusion
* No IVIG treatment for ITP during the two weeks prior to the first infusion of the study drug
* For females of child bearing potential, use of adequate birth control measures during study participation
* Written informed consent

Exclusion Criteria:

* Serum values of ALT, AST, alkaline phosphatase, and total bilirubin exceeding 2.5 times the upper limit of normal at screening
* Renal dysfunction defined as serum creatinine greater than or equal to 2 mg/dL at screening
* Underlying other autoimmune or lymphoproliferative disorder
* Uncontrolled hypertension
* Cardiac insufficiency NYHA III and IV, coronary heart disease (CHD) NYHA III and IV
* Malignancy or history of malignancy
* Documented selective IgA deficiency (\<= 10 mg/dL)
* Treatment with another investigational drug in the four weeks prior to study entry or current treatment with another investigational product
* History of severe adverse reactions to blood and/or blood products
* Pregnancy or lactation
* Positivity for HIV, or HCV antibodies, or HBsAg
* History of unresponsiveness to IVIG defined as a peak increment in platelet count \<= 20,000/µL coincident with the last IVIG treatment course prior to study entry
Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms

Evaluation of clinical, therapeutic and prognostic relevance of new experimental results as well as optimization of therapeutic models and development of a new algorithm for therapeutic plan and therapy in patients with uterine neoplasm


Eligibility Criteria:
Inclusion Criteria:

* Confirmed uterine malignancy ( cervical cancer, endometrial cancer, sarcoma)
* If operable: surgical primary therapy: laparoscopic/robot-assisted or open radical gyneco-oncological surgery
* Written consent
* Willingness and ability to participate in all study-specific procedures
* Age ≥ 18 years

Exclusion Criteria:

* Severe and acute general disease in the last 4 weeks
* Acute or chronic psychiatric disorders
* Other factors questioning study participation (e.g. acute psychosocial stress, insufficient understanding of nature and consequences of the study, inadequate skills of the German language)
Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients

The aim of this study is to evaluate the prokinetic effect of metoclopramide on gastric emptying in critically ill mechanically ventilated patients .

More than 50% of patients in ICU have gastric dysmotility, which leads to slow gastric emptying(GE) and high gastric residual volume (GRV) and is associated with increased mortality in these patients

Eligibility Criteria:
Inclusion Criteria:

1. Patients' age 20 - 60 years.
2. Either gender.
3. Mechanically ventilated head trauma patients.
4. Patients receiving enteral feeding via nasogastric tube.

Exclusion Criteria:

1. Patients with contraindications to enteral feeding.
2. Patients with extrapyramidal manifestations.
3. Patients with known allergy to metoclopramide.
4. Patients with seizures.
5. Patients with renal or hepatic diseases.
Obesity, Sarcopenic, Risk of Falls in Spanish Postmenopausal Women

To analyze the effects of a Pilates exercise program on obesity, sarcopenic, risk of falls and health in Spanish postmenopausal women.

This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.

The study will define two groups:

* A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
* An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.

Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.

Eligibility Criteria:
Inclusion Criteria:

* No menstrual activity for at least 12 months.
* Present obesity and / or sarcopenic.
* Do not participate in a weight loss program.
* Be able to understand the instructions, programs and protocols of this project.

Exclusion Criteria:

* Contraindications for conducting physical tests.
* Diseases that limit the static and dynamic balance and physical activity. -
* Central or peripheral vestibular or nerve alterations.
PMCF Study of MOTIVATION HIP System in THA

This is a retrospective and prospective, multi-center, post-market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the study device system.

The objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available MOTIVATION HIP Total Hip System used in primary total hip arthroplasty (THA).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years old, inclusive.
* Had a primary unilateral or bilateral (simultaneous or staged) THA based on physical exam and medical history, including diagnosis of severe hip pain and disability.
* Had received MOTIVATION HIPTM Total Hip System per the approved indications for use for the THA.
* No history of previous prosthetic replacement device of any type, including surface replacement arthroplasty, endoprosthesis, etc. of the affected hip joint(s) beside investigational product.
* Willing and able to provide written informed consent by signing and dating the EC approved informed consent form.
* Willing and able to complete scheduled follow-up evaluations..

Exclusion Criteria:

* The patient is:

  * A prisoner
  * Mentally incompetent or unable to understand what participation in the study entails
  * A known alcohol or drug abuser
  * Anticipated to be non-compliant

    * Has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure or complications in postoperative care.
    * Has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
    * Has a diagnosed systemic disease that could affect his/her safety or the study outcome.
    * Known to be pregnant.
    * Has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.
    * Insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e., osteoporosis), cancer, and radiation.
    * Osteoradionecrosis in the affected hip joint.
    * Known sensitivity or allergic reaction to one or more of the implanted materials.
    * Known local bone tumors and/or cysts in the operative hip.
    * Body Mass Index (BMI) \> 40.
Study of Dr. Pyke's Supplement for Stream (S4S) in Men With Prostatism and ED

This is the first clinical trial of Dr. Pyke's Supplement for Stream (S4S), a proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3, to investigate its effects on prostatism and erections, and its tolerability, when taken daily and twice-daily for 2 weeks.

This is a 2-week clinical trial of Dr. Pyke's Supplement for Stream (S4S), a proprietary combination of Panax ginseng extract, L-citrullline, beta-sitosterol and vitamin D3, investigating its lower urinary tract effects, sexual effects, and tolerability in two dose regimens-daily for a week and twice daily for a week--in men who have Lower Urinary Tract Symptoms (LUTS) and may have erectile dysfunction (ED). No clinic visits are required. Subjects will be consented, screened, supplied with S4S, and tested via the Internet. Subset analyses will evaluate effects in three populations: men with at least moderate lower urinary tract symptoms (LUTS), according to standard score cutoff; men with at least moderate Erectile Dysfunction (ED, according to standard score cutoff; and all men dissatisfied with their urinary function and meeting minimal criteria for inclusion.

Eligibility Criteria:
Inclusion Criteria:

Inclusion requirements for all subjects

1. Men at least 40 years of age
2. Screening IPSS QoL must be 4-6:

   If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Delighted (0), Pleased (1), Mostly Satisfied (2), Mixed (3), Mostly Dissatisfied (4), Unhappy (5), Terrible (6)
3. Gives informed consent for study and is willing to take the treatments and complete the scheduled evaluations
4. Willing to buy S4S for $30, with the understanding that a rebate of $30 or a coupon for $30 off the cost of a second 30-dose supply of S4S will be offered if the subject completes the electronic questionnaires at the end of the treatment

Required for target efficacy subset

Meets criterion for at least moderate ED: IIEF-5 (erectile function) score \<13 - or:

Meets criterion for at least moderate Lower urinary tract symptoms (LUTS): IPSS score at least 20

Exclusion Criteria:

1. Known allergy or sensitivity to ginseng, L-citrulline, canola oil or soybean oil.
2. Current severe side effects from any drug
3. Using medication(s) for angina pectoris, LUTS, or ED and has not consulted personal physician on advisability of participating in this study.
4. Women
Special Drug Use Surveillance for Entresto Tablets

This is a single arm, multicenter, observational study in Japanese chronic heart failure patients.

This study is a special drug use surveillance to evaluate the safety and efficacy of Entresto Tablets (hereafter called Entresto) clinically administered in Japanese patients for the newly approved indication of "chronic heart failure" and to be conducted as one of the RMP-specified additional pharmacovigilance activities.

Eligibility Criteria:
Inclusion Criteria:

* Patients must provide written consent to cooperate in this study before the start of Entresto
* Patients using Entresto for the first time for the following indication Indication: chronic heart failure patients on standard of care for chronic heart failure

Exclusion Criteria:

* Patients with a history of treatment with a drug containing the same ingredient (investigational drug or post-marketing clinical study drug) as Entresto
* The following patients for whom Entresto is contraindicated in the package insert Patients with a history of hypersensitivity to any of the Entresto ingredients Patients with a history of angioedema (angiotensin II receptor blockers or angiotensin converting enzyme inhibitors-induced angioedema, hereditary angioedema, acquired angioedema, idiopathic angioedema etc.) Diabetic patients on aliskiren fumarate Patients with severe hepatic impairment (Child-Pugh class C) Pregnant or possibly pregnant women
Feasibility Study: Ulthera® System for the Treatment of Axillary Hyperhidrosis

Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at 7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days post-treatment #2.

Subjects will be randomized to one of two study groups:

* Group A: Split body treatment. Ultherapy to one axilla, Sham treatment to the other axilla.
* Group B: Bilateral Ultherapy treatments, with a pre-treatment subcutaneous lidocaine injection administered to one axillary side.

Hyperhidrosis Disease Severity Scale (HDSS), gravimetric test and starch iodine test will be obtained at all study visits. Patient satisfaction questionnaires will also be obtained at 30, 60 and 90 days post-treatment #2.

Eligibility Criteria:
Inclusion Criteria:

* Male and female, ages 18-75
* Subject is in good health
* Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies
* At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.)
* HDSS score of 3 or 4.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.

Exclusion Criteria:

* Dermal disorder including infection at anticipated treatment sites in either axilla.
* Previous botulinum toxin treatment of the axilla in the past year.
* Expected use of botulinum toxin for the treatment of any other disease during the study period.
* Known allergy to starch powder or iodine.
* Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria.
* Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery.
* Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period.
Medium Dose of Cytarabine and Mitoxantrone

By observation of the inpatients in shenzhen people's hospital,research the curative effect of the two chemotherapy schemes on AML-High dose of cytarabine and HAM.

The patients of AML in shenzhen people's hospital were randomly divided into two therapy groups.One group was treated by High dose of cytarabine ,and the other was HAM.Evaluate the two chemotherapy schemes by bone marrow suppression time and patient survival time.

Eligibility Criteria:
Inclusion Criteria:

people diagnosed as AML

Exclusion Criteria:

* acute promyeloytic leukemia
Comparison of Three Knee Replacements

The present randomized controlled trial is designed to compare one novel total knee replacement (TKR) design and two conventional TKR designs in terms of functional outcome. 80 patients will be randomized in each of the three arms (240 altogether).

The study will compare the short-term functional outcome (at 2 years) of TKR performed with a novel TKR design (Persona , Zimmer, Warsaw, IN, USA) against TKRs performed with two conventional designs (PFC, DePuy, Warsaw, IN, USA and Nexgen, Zimmer, Warsaw, IN, USA).

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing total knee replacement surgery for primary osteoarthritis
* no previous open major surgery in the joint ( e.g. osteotomy)
* unilateral operative treatment, with no plans for surgical treatment of the contralateral knee in the near future
* patients living in the local hospital district (Pirkanmaa Hospital District)
* Kellgren-Lawrence grade 3-4 knee osteoarthritis in plain radiographs

Exclusion Criteria:

* Unwilling to provide informed consent
* \> 15 degrees varus or valgus, or \>15 degree fixed flexion deformity
* predominantly patellofemoral osteoarthritis
* Physical, emotional or neurological conditions that would compromise the patient´s compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson, MS, etc.)
Investigating Neuronal and Peripheral Markers of Brain Heart Interaction in Healthy Participants Under Stress

This study seeks to investigate which regions of the brain are relevant in the regulation of cardiac control and how the interplay between HRV and those regions change during different physiological states (stress versus relaxation). In order to achieve this, we will use functional magnetic resonance imaging (fMRI) during an experimental task consisting of deep breathing and a psychosocial stress task (Montreal Imaging Stress Task).

Heart rate variability (HRV) is an important indicator of an organism's ability to adapt and regulate autonomic cardiac function. High heart rate variability is an indicator of good adaptability to physical and mental demands, while decreased HRV is associated with increased vulnerability to psychological and physical stressors. Previous studies have shown that the central autonomic network, composed of several regions of the brain such as the amygdala and prefrontal cortex, play an important role in regulating heart rate variability. However, the exact neural correlates and underlying neural mechanisms involved in autonomic cardiac control are still a subject of investigation. Furthermore, the dynamic connectivity between heart rate variability and the central autonomic network under changing physiological circumstances remains largely unexplored. This study seeks to investigate which regions of the brain are especially relevant in the regulation of cardiac control and how the interplay between HRV and those regions change during different physiological states (stress versus relaxation). In order to achieve this, we will use functional magnetic resonance imaging (fMRI) during an experimental task consisting of deep breathing and a psychosocial stress task (Montreal Imaging Stress Task). This paradigm will allow assessing the dynamic interplay between the heart and the brain. 30 healthy participants will be recruited, in addition to fMRI scanning participants will perform a psychometric test battery. A better understanding of these psychobiological mechanisms is a fundamental requirement for a better understanding of the autonomic regulation of HRV and the development of improved treatment strategies for disorders characterized by an impaired autonomic system and reduced HRV.

Eligibility Criteria:
Inclusion Criteria:

1. Over age of 18 years.
2. Right-handedness.
3. Normal or corrected-to-normal vision.

Exclusion Criteria:

1. History of head injury or surgery
2. History of neurological disorder
3. Severe psychiatric comorbidity (psychosis, bipolar disorder, substance abuse)
4. Smoking
5. Borderline personality disorder
6. Current psychotropic medication
7. Inability to undergo fMRI scan (e.g. metallic implants, claustrophobia, pacemakers)
8. Pregnancy
ATHENA: Natural History of Disease Study in Alport Syndrome Patients

There is limited published clinical data about the natural history of renal disease in Alport syndrome. The RG012-01 study will collect data to characterize the progression of renal dysfunction in Alport syndrome patients.

Patients with a confirmed diagnosis of Alport syndrome who have qualifying GFR will be considered for enrollment. The sequential sampling of subjects' urine and/or blood will allow an assessment of the rate of change of established clinical endpoints, such as GFR and/or the rate of change of other renal biomarkers (proteinuria and β-2 microglobulin) in subjects whose renal function is steadily declining. The identification of surrogate markers that track the decline of renal function and could correlate with time to end-stage renal disease (ESRD) is a key goal of the natural history study.

This is a natural history study, designed to collect data from patients with Alport syndrome with qualifying GFR. Assessments and blood and urine sample collection will be performed at Baseline and every 12 weeks thereafter, for up to 120 weeks. Scheduling of clinic visits will take in to consideration the timing of Standard of Care (SOC) visits. Alternative arrangements may be made to enable subjects to schedule a home nurse visit for study procedures instead of certain clinic visits. Remaining blood and urine aliquots will be stored and may be used in the future for the discovery, analysis, verification and/or validation of other biomarkers or test for renal disease. The samples will be kept for up to five years. Each sample will be identified only by it's barcode number and will not be individually identifiable.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and comply with the requirements of the study and willing and able to provide written informed consent; pediatric subjects must be able to provide assent;
* Age 12-65 years of age;
* Confirmed diagnosis of Alport syndrome (clinical, histopathologic and/or genetic diagnosis of Alport syndrome);
* eGFR 45-90 ml/min/1.73 m2, within 30 days of enrollment.

Exclusion Criteria:

* Use of investigational drugs at the time of enrollment, or within 30 days, or 5 half-lives of enrollment, whichever is longer;
* Ongoing chronic hemodialysis therapy and/or renal transplant recipient.
A Study To Investigate The Safety, Tolerability And Blood Levels Of GSK598809

GSK598809 is being developed to facilitate overcoming an addiction to nicotine and to help people stop smoking. This study will investigate if GSK598809 is safe and tolerated in people who smoke and will also look at blood levels of GSK598809 and nicotine.


Eligibility Criteria:
Inclusion criteria:

* Healthy adult male smoker between the ages of 18 and 50 years
* Body weight greater than 50kg and BMI between 18.5-29.9 kg/m2.
* No abnormalities on the medical, psychiatric or laboratory evaluation
* Smoke on average more than 20 but less that 40 cigarettes per day for the past year and not tried to give up in the 3 months before the study.

Exclusion criteria:

* History of psychiatric disorder or sleep disorder.
* Receiving treatment for smoking cessation.
* Use tobacco products other than cigarettes.