cyrilzakka/clinical-trials huggingface dataset:
Syphilis Response to Higher Penicillin Dosage: The 2.4 Versus 7.2 Study

Syphilis remains a significant health problem worldwide, with an estimated 10.6 million new cases per year. Due to shared transmission route and risk factors, co-infection with syphilis and Human Immunodeficiency Virus (HIV) is not uncommon. Several studies have evaluated the response to syphilis treatment in HIV-infected patients. They support the claim that patients with HIV have a slower decrease in syphilis antibody titers, and that they may progress to neurosyphilis in earlier stages.

The Center for Disease Control and Prevention's Sexually Transmitted Disease Treatment Guidelines has advocated treating HIV-infected patients who have primary, secondary syphilis or early latent syphilis with the same doses of penicillin as for HIV-uninfected patients (single dose of 2.4 million units of benzathine penicillin G). The investigators designed a randomized controlled trial in order to compare the efficacy of three- versus single-dosed regimens of intramuscular benzathine penicillin G (BPG) for the treatment of early syphilis in HIV-infected patients.

The investigators conducted a prospective, randomized, open label study at three clinical sites including Thomas Street Health Center and North West Clinic (Harris Health System), and the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas. After obtaining written informed consent, the investigators randomly assigned patients to either a single intramuscular injection of 2.4 million units of BPG (standard therapy) or three doses (enhanced therapy) of intramuscular BPG administered weekly (a total of 7.2 million units).

Patients were eligible for inclusion in the study if they were 18 years of age or older and had a diagnosis of HIV. The diagnosis of syphilis was made based on a positive Rapid Plasma Reagin (RPR) and treponema pallidum particle agglutination tests. Patients with primary, secondary and early latent syphilis were included.

Exclusion criteria were history of penicillin allergy, diagnosis of late latent syphilis, neurosyphilis, and antibiotic use with significant activity against Treponema pallidum within the preceding two weeks.

Follow-up period was 12 months. Serum samples were obtained at initial visit and follow-up visits every 3 months for serological testing for syphilis. Treatment success was defined as a decrease in RPR titer of \>= 2 dilutions (4-fold) from the initial RPR titer during the follow-up period.

Both intention-to-treat and per-protocol analyses were performed

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HIV by ELISA and confirmed by Western blot
* Positive Rapid Plasma Reagin and treponema pallidum particle agglutination tests

Exclusion Criteria:

* History of penicillin allergy
* Diagnosis of late latent syphilis
* Diagnosis of neurosyphilis
* Antibiotic use with significant activity against Treponema pallidum within the preceding two weeks
Mycophenolic Acid Pharmacokinetics and Pharmacogenomics in Lupus Nephritis

This study investigate mycophenic acid (MPA) pharmacokinetics and pharmacogenomics and their impact on the clinical outcomes in lupus nephritis (LN) patients. Lupus nephritis patients (both active or inactive) will be recruited. MPA levels will be checked at 1, 2, 4, 8, 10, 12 hrs after MMF administration by an enzymatic assay upon recruitment, then at 6-months' intervals and also when clinically significant events occurred. The MPA levels will be correlated with clinical parameters and outcomes. Pharmacogenomics studies will also be carried out and correlated with MPA exposure and clinical outcomes.

This study investigate mycophenic acid (MPA) pharmacokinetics and pharmacogenomics and their impact on the clinical outcomes in lupus nephritis (LN) patients. Lupus nephritis patients (both active or inactive) will be recruited. MPA levels will be checked at 1, 2, 4, 8, 10, 12 hrs after MMF administration by an enzymatic assay upon recruitment, then at 6-months' intervals and also when clinically significant events occurred. The MPA levels will be correlated with clinical parameters and outcomes. For active patients, the MPA levels will be correlated with treatment response (CR or PR) and side effects. For patients in remission, the MPA levels will be correlated with drug tolerability and relapse. Pharmacogenomics studies will also be carried out and correlated with MPA exposure and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with recent active LN (biopsy-proven Class III/IV+/-V LN according to the ISN/RPS 2003 classifications within 3 months, with proteinuria \>0.5 g/day and/or active urinary sediments) who receive corticosteroids and MMF (1g bd for 6 months) as induction treatment.
2. LN patients in remission (defined as proteinuria \<0.5 g/day with inactive urinary sediment, prednisolone \<10 mg/day) and on stable MMF maintenance (dose unchanged within the previous 3 months).

Exclusion Criteria:

1. Patients who receive enteric-coated mycophenolic acid (myfortic).
2. Patients who receive concomitant calcineurin inhibitors (e.g. cyclosporine or tacrolimus) other than corticosteroids and MMF.
3. Patients who receive concomitant medications which affect the MPA pharmacokinetics such as cholestyramine, acyclovir, and rifampicin.
4. Patients who are pregnant or lactating.
5. Patients with gastric emptying disorders
6. Patients with hepatic or biliary diseases
Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk

An observational, Other Designs (OD) post-marketing, multicenter study, which will obtain retrospective data from male patients diagnosed with invasive breast cancer between 2000 and 2019 in the medical oncology departments of hospitals that are associated with Spanish Breast Cancer Research Group (GEICAM) (using information obtained from patient medical histories).

One of the objectives of this project is to ensure representativeness of the cases referred to. Accordingly, participating sites agree to enroll in the study male patients who were diagnosed with breast cancer in the period between 2000 and 2019.

Eligibility Criteria:
Inclusion Criteria:

* Male patients diagnosed with primary invasive breast carcinoma between the years 2000-2019, and who have been treated and/or followed up in the Medical Oncology Departments of participating sites.
* The enrollment of patients who died is allowed.

Exclusion Criteria:

* Male patients who do not wish to participate in the study for any reason.
Distal Nerve Electrical Stimulation for Neuromuscular Reinnervation

During the process of nerve microsurgical reconstruction, 30 minutes of electrical stimulation is applied to the distal end of the damaged nerve to assess its potential benefits for nerve regeneration, functional recovery, slowing down the degeneration at the neuromuscular junction, and preventing muscle atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and older
* Acute peripheral nerve rupture between the elbow and wrist
* Acute rupture of the median or ulnar nerve
* Patients who have signed a valid written consent for surgery and trials

Exclusion Criteria:

* History of injury or other causes leading to muscle and joint dysfunction in the affected area
* Patients with radial nerve damage
* Diabetes
* History of arrhythmia
* Stroke
* Multiple sclerosis
* Hereditary peripheral neuropathy
* Amyotrophic lateral sclerosis (ALS)
* Patients with a pacemaker
* Presence of local infection at the wound site
* Pregnant or breastfeeding women
* Patients deemed unsuitable for enrollment by a physician
A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Participants

The primary purpose of this study is to assess the palatability and compare acceptability of brensocatib oral solutions.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18.0 and 32.0 kilogram per meter square (kg/m\^2), inclusive, and a body weight of ≥50 kilograms (kg) at screening.
* In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs measurements, clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable), and physical examination at screening and/or Day 1, as assessed by the investigator (or designee).
* Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.

Exclusion Criteria:

* Positive hepatitis panel and/or positive human immunodeficiency virus test.
* The participant has a mouth pathology including, but not limited to, pain, ulcer, edema, mucosal erosion, and/or (dental) abscesses, or receives treatment for oral pathologies or oral treatment for any disease.
* The participant is unable to taste and smell normally, to his/her own opinion, at any time throughout the study duration Participants who have an impaired sense of taste and/or smell due to any conditions like common cold or sinusitis are not eligible to take part or continue the study.
* Administration of a vaccine in the past 14 days prior to Day 1.
* Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 60 days or 5 half-lives of that drug prior to Day 1, whichever is longer.
* History of alcoholism or drug/chemical abuse within 2 years prior to Day 1.
* Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
* Poor peripheral venous access.

Note: Other inclusion/exclusion criteria may apply.
Effect of Oral Water in Healthy Volunteers on Cardiac Output, Regional Flow and Microcirculation in Healthy Volunteers

Human digestive system physiologically ensures the absorption of oral water and hydration of the human body. Water is quickly absorbed by the digestive tract with a peak between 15 and 20 minutes. It has demonstrated that oral water remains the best hydration solution that have an effect on plasma volume expansion and cardiovascular system during exercise. While the cardiovascular effect of fluid expansion by saline serum is well known (venous return, preload and cardiac output), effect of oral water varies in the literature depending on the physiological state of the patient and the clinical state. Thus, the investigators aim to investigate oral water effects on fluid responsiveness, regional blood flow and microcirculatory changes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer subject between 18 and 30 years old
* patient with a regular sinus rhythm
* Echogenic subject.
* Fasting of solid and liquid since 8 h
* Subject in regular sinus rhythm.
* Written consent signed.

Exclusion Criteria:

* Any known cardiac, renal or endocrine pathology.
* Arrhythmia rhythm disorder by atrial fibrillation
* Pregnant or nursing woman.
* Pathology versus indicating Nacl administration.
* Person under tutors or curators or deprived of liberty.
* Person not affiliated to a social security scheme.
Precision Exercise Therapeutics (PET-pilot)

The aim of this randomized cross-over study is to collect information for the design of a precision exercise therapy cohort that will predict what modality of physical activity a physically inactive individual with overweight should perform to increase insulin sensitivity given their unique biology, environment, and context.

This pilot study is needed prior to launching precision therapeutics programs, with the purpose to decrease the risk of research waste, increase the reliability of the experimental tests and estimate adequate sample size.

25 participants will be recruited to undergo three sets of experiments. An experiment consists of one exercise bout followed by an assessment of whole-body insulin sensitivity (measured from a oral glucose tolerance test) 1 and 2 days following the completion of the exercise bout yielding 19 study days of 3 hours each across 7 weeks, including the baseline measurement. The exercise modalities include 1) continuous aerobic exercise, 2) high intensity exercise and 3) resistance exercise training. A set consists of test-retest of the same experiment.

The objectives of this pilot study are

1. to assess the longevity of the increased whole-body insulin sensitivity in the days following different exercise modalities
2. To estimate the intra-individual differences of different exercise modalities on whole-body insulin sensitivity the days following the last exercise bout
3. To assess the fidelity of the test- and exercise protocols

Eligibility Criteria:
Inclusion Criteria:

* BMI\>25
* Age\> 40 years
* Inactivity, defined as \< 1,5 hours of structured physical activity pr. week at moderate intensity and cycling \< 30 minutes/5 km pr. day at moderate intensity (moderate intensity = out of breath but able to speak)

Exclusion Criteria:

* • HbA1c\>53 mmol/mol

  * Uncontrolled hypertension
  * Uncontrolled hyperlipidemia,
  * Known hyperthyroid disease
  * Endocrine disorders causing obesity
  * Known autoimmune disease
  * Unstable cardiovascular disease
  * Glucose lowering medications except for low dose metformin (=\<1000 mg/day)
  * Current treatment with anti-inflammatory medication, unless pain killers without prescription
  * No participation in other research intervention studies
  * Pregnancy/considering pregnancy within the study period
  * Conditions countering exercise
Efficacy of a Dedicated Therapeutic Education Program in Patients at High Cardiovascular Risk

A dedicated therapeutic education program is an essential tool in the management of hypertension as well as in the control of other cardiovascular risk factors. The purpose of this study is therefore to evaluate the effect of such a therapeutic education program in general practice patients at high cardiovascular risk.

Current guidelines for the prevention of cardiovascular disease recognize the major interest of an optimal control of all cardiovascular risk factors. It includes high blood pressure reduction, dietetic measures (weight loss - control of dyslipidemia and diabetes - regular physical activity), smoking cessation, stress management, ... In that way, some authors suggest that it is essential for patients at high risk to have knowledge about their own pathology, medication, and to better understand the real benefit of specific lifestyle behaviors and the importance of blood pressure and glycaemia surveillance ... The aim of this randomized controlled trial is to evaluate the efficacy of a dedicated therapeutic education program to control blood pressure and other cardiovascular risk factors in general practice patients at high cardiovascular risk.

250 patients are being enrolled. All patients will receive standard care but only 125 patients (randomized 1 to 1) will receive a structured therapeutic education program.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman of more than 18 years with a health insurance policy
* General practice patients who are agree to participate of the program of patient's therapeutic education in Lille (59) or Arras (62)
* Written informed consent must be obtained prior to performing any study-specific procedures
* Patient at high cardiovascular risk (Patient with a high blood pressure and 3 cardiovascular risk factors and/or Patient with cardiovascular disease)

Exclusion Criteria:

* Patient unwilling to take part to the therapeutic education program or to the study
* Patient not suitable to participate in the therapeutic education program
* Patient with dementia
* Anticipated survival (due to comorbidities) of less than one year from baseline
* Patient with current addiction or current alcohol / drug abuse
* Patient with known plans to move to another area of the country
* Unable to obtain written informed consent
* Patient who are pregnant or lactating
* Person without liberty by administrative or judiciary decision
Reconstruction of the Anterior Cruciate Ligament of the Knee Joint, by the Method of Stabilization of the Screw With a Bioabsorbable Method, With or Without the Use of Autogenous Spongiform Bone Grafts.

Clinical and comparative evaluation of the results of autograft healing of the tendon of the semitendinus muscle in the tibial canal, after reconstruction of the anterior cruciate ligament of the knee joint, by the method of stabilization of the screw with a bioabsorbable method, with or without the use of autogenous spongiform bone grafts.

Assessment of the results of autograft healing of the tendon of the semitendinus muscle in the tibial canal, after the reconstruction of the anterior cruciate ligament (ACL) of the knee joint using the arthroscopic technique, with the method of tibial stabilization with a bioabsorbable screw (Arthrex) with the use of autogenous transplantation of spongy bone, drilling of the tibial canal inserted into the tibial canal prior to insertion of the screw. The detailed objectives are: comparison of the treatment results - healing and reconstruction of the autograft of the semitendinus tendon in the tibial canal of the knee joint, obtained in the study groups using two methods:

A- stabilization of the tibial attachment with a bioabsorbable screw (Arthrex) with simultaneous application to the tibial canal of autogenous cancellous bone grafts taken during the drilling of this canal and

B- stabilization of the tibial insertion with a bioabsorbable screw (Arthrex) without simultaneous application of autogenous cancellous bone grafts to the tibial canal.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years;
* Surgery for ACL damage to the knee joint;
* Arthroscopic surgery;
* No prior knee surgical interventions;
* No additional pathologies in this anatomical area;
* Informed consent of the patient to participate in the study.

Exclusion Criteria:

* Age under 18 or over 65;
* Previous surgical interventions in the examined anatomical area;
* Additional pathologies in this area identified as part of preoperative diagnostics;
* Damage to the second knee joint;
* Failure to comply with the rigor of the same rehabilitation treatment protocol.
Safety, Pharmacokinetics, and Pharmacodynamics of Ruzasvir (MK-8408) in Participants With Hepatitis C Infection (MK-8408-003)

This is a 3-part study of Ruzasvir (MK-8408) for participants with hepatitis C infection. Successive participants will be enrolled as dose levels are evaluated to find the maximum safe and well tolerated dose of Ruzasvir. Part I will be for participants with hepatitis C virus (HCV) genotype 3 (GT3) and will run first: Part II will be for participants with HCV genotype 1a (GT1a), and Part III will be for participants with HCV genotype 2b (GT2b). Parts II and III may run concurrently. The primary study hypothesis is that a safe and tolerable dose of Ruzasvir that reduces viral load will be found to support further clinical investigation.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \>=18 to\<=37 kg/m\^2
* In general good health, except for HCV infection
* Clinical diagnosis of chronic HCV infection exclusively GT3 (Panels A-D) or exclusively GT1a (Panels E-F), or exclusively GT2b (Panels G-H).
* Must agree to follow the smoking restrictions defined by the CRU
* Must agree to use an acceptable method of contraception during the study and for 90 days after the last dose of ruzasvir

Exclusion Criteria:

* Clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases
* History of clinically significant hepatic disease, Gilbert's disease or biliary tract disease
* History of cancer (malignancy) with the exception of adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, or successfully-treated malignancies ≥10 years prior to screening
* History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
* Positive for hepatitis B or human immunodeficiency virus (HIV)
* Major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to screening
* Participated in another investigational trial within 4 weeks prior to the screening visit
* QTc interval \>=470 msec (for males) or \>= 480 msec (for females)
* Unable to refrain from or anticipates use of any medication (prescription and/or non-prescription) or herbal remedies beginning approximately 2 weeks prior to first study drug dose, throughout the trial until the post-trial visit
* Consumes \>2 glasses of alcoholic beverages per day
* Regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 12 months
* Evidence or history of chronic hepatitis not caused by HCV
* Previous treatment with other HCV NS5A inhibitors such as MK-8742, daclatasvir, or MK-8325
* Treatment with other HCV therapies such as the HCV protease
* Evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score \>=3)
Attention Bias Modification Treatment for Anxious Youth

The purpose of this project is to study the feasibility and efficacy of attention bias modification treatment (ABMT) in a randomized-controlled sample of anxious youth.

The purpose of this study is to determine whether or not ABMT computer-based interventions can be used successfully to help reduce anxiety disorder symptoms in children ages 7 to 17. ABMT is different from most other treatments for anxiety because it is not medication or talk therapy. ABMT is a computerized attention training program designed to change how we direct our attention. The purpose of ABMT is to set in place attentional patterns that do not lead to excessive anxiety. Research has shown that it may be highly effective in reducing anxiety. The Intervention will be composed of your child engaging in 6 brief weekly ABMT sessions. The sessions seem like a repetitive computer game.

This study is appropriate for children who may have symptoms of an anxiety disorder, like Generalized Anxiety Disorder, Separation anxiety Disorder, Social Anxiety Disorder, Specific Phobia, or Obsessive-Compulsive Disorder." Children who appear eligible for the study may attend a diagnostic evaluation and assessment if they meet study criteria.

If a child is eligible for the study, he or she will be randomly assigned to either get an "active" form of the computer program or a "placebo" or inactive form of the computer program. The child will come to six weekly appointments at our clinic that are quite brief, about a half hour. Then the child will have an evaluation after the last of the six appointments to see if the computer intervention was helpful in reducing his or her anxiety. We'd then wait a month and then have a final evaluation to see if the child's anxiety has changed over that period of time.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis on Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual-IV Child and Parent versions of Separation Anxiety Disorder, Social Phobia, Specific Phobia, Obsessive-Compulsive Disorder, or Generalized Anxiety Disorder
* Age 7 to 17

Exclusion Criteria:

* Posttraumatic stress disorder or primary diagnosis of major depressive disorder
* Seizure disorder
* Current treatment with psychotropic medication
* Multiple chronic learning disabilities and/or conduct problems