cyrilzakka/clinical-trials huggingface dataset:
Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients

DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing fifteen HIV antigens that assemble to HIV-like particles. These particles are safe; replication, integration and reverse transcription deficient. DermaVir is targeted to Langerhans cells by topical administration with DermaPrep. Langerhans cells with DermaVir migrate to lymph nodes and induce HIV-specific T cells that can kill HIV-infected cells.

GIEU006 is a Phase II randomized, placebo-controlled, dose-finding, double-blinded, multicenter study to assess the safety, tolerability, immunogenicity, and preliminary antiretroviral activity of DermaVir in antiretroviral therapy naïve adults with HIV-infection.

Patients were randomized into one of the following 6 arms:

* Arm 1: Low dose DermaVir (0.2 mg DNA in 2 DermaPrep patches, n=9)
* Arm 2: Low dose Placebo (2 DermaPrep patches, n=3)
* Arm 3: Medium dose DermaVir (0.4 mg DNA in 4 DermaPrep patches, n=9)
* Arm 4: Medium dose Placebo (4 DermaPrep patches, n=3)
* Arm 5: High dose DermaVir (0.8 mg DNA in 8 DermaPrep patches, n=9)
* Arm 6: High dose Placebo (8 DermaPrep patches, n=3) DermaPrep Patch size: 80 cm2. DermaVir Standard Unit per patch is 0.1 mg DNA = 0.8 mL of DermaVir nanomedicine.

The patch sites for immunization are preferably the left or right upper back and left or right upper ventral thigh. The same skin sites should be used for all immunizations.

Immunization schedule (Days): 0, 42, 84, and 126.

The total DermaVir dose:

* Low dose: 0.8 mg DNA
* Medium dose: 1.6 mg DNA
* High Dose: 3.2 mg DNA

DermaVir immunizations were administered over an 18-week period Primary endpoint: 24 weeks Safety follow up: 234 weeks

Eligibility Criteria:
Main inclusion Criteria:

* HIV antibody positive
* Plasma HIV RNA value ≥5,000 copies/mL and ≤ 150,000 c/mL
* Antiretroviral therapy naïve
* Documented CD4+ T-cell count at screening ≥400 cells/mm3

Main exclusion Criteria:

* No skin disease
* No tattoos, or changes in pigmentation at the selected skin immunization sites
* No acute or chronic illness (e.g Hepatitis C)
* No chronic autoimmune diseases
* No treatment with any immune modulating agents
Tourniquet in Total Knee Replacement Short and Long Duration: A Comparative Study

Total knee arthroplasty (TKA) is an effective treatment in severe osteoarthritis. We aim to compare the advantages and disadvantages related to the duration of tourniquet application in TKA surgeries.

Total knee arthroplasty (TKA) is considered an effective method in relieving pain and regaining function in severe osteoarthritis patients; however, it is associated with increased blood loss risk which can increase the need for blood transfusion. Tourniquet use during surgery is controversial as it provides a clear visualization which decreases the blood loss and ensures proper cementation which makes it used frequently during TKA. However, its use is associated with complications like nerve palsy, thigh pain, swelling, joint stiffness, wound complications, subcutaneous fat necrosis, vascular injury, deep venous thrombosis (DVT), and prolonged duration of quadriceps recovery.

The proper duration of tourniquet application is also controversial as it affects TKA postoperative outcomes as increasing tourniquet application duration can aggravate the complications risk because of the increased tissue exposure to ischemia. Therefore, minimization of the tourniquet application duration is important which makes researchers investigate if tourniquet application during the cementation process only in TKA could decrease the complications and fasten the recovery.

Limited tourniquet application during TKA decreased swelling and joint pain while it was not associated with blood loss, recovery, or operation time. While applying a tourniquet only in cementation could reduce blood loss, fasten the recovery period, and reduce pain after TKA surgery.

However, decreasing tourniquet application to be only during cementation was associated with increased blood transfusion risk which indicated that this approach was impractical if there was not any improvement in recovery. Therefore, a balance should exist between the increased blood loss and blood transfusion risk during cementation tourniquet application. Therefore, the application time of a tourniquet during cementation in TKA is controversial and no meta-analysis compared using a tourniquet only to the long tourniquet use in TKA surgeries.

Therefore, randomized controlled trials (RCTs) are needed to compare which strategy is better which made us perform this study to compare both strategies regarding pain, Oxford Knee Score (OKS), hospital stay, pain, Knee Society Score (KSS), blood loss, and range of motion (ROM).

Eligibility Criteria:
Inclusion Criteria:

* We included symptomatic grade IV knee primary osteoarthritis cases who were candidates for TKA surgery

Exclusion Criteria:

* we excluded patients with a history of post-infection or traumatic osteoarthritis, knee deformity, hematological diseases, currant infection focus, immune-suppression, or inflammatory arthritis.
Intervention on Development and Growth at Children in Poverty

Children in extreme poverty lack adequate care and face increased health risks. The earlier poverty strikes in the developmental process, the more deleterious and long-lasting its effects. There is, however, growing evidence that early interventions can prevent the negative consequences. Such interventions are effective, particularly when they are of high quality, organized at home and parents are involved. Recently, baseline assessment of developmental and nutritional status of SOS children and children in extreme poverty in Jimma region of South-West Ethiopia revealed that these children have developmental problems in language, motor, social-emotional skills and nutritional status. The impact of play-oriented stimulation activities integrated into the existing SOS basic program, on developmental outcomes, has never been investigated in this context. The main objective of the study is, therefore, to evaluate the impact of play-oriented stimulation integrated into the basic SOS program on the developmental outcomes of children living with foster families. This was done by comparing the intervention children with their age-matched children (control), not receiving the stimulation package. It was hypothesized that this package would significantly improve the developmental skills of these children.


Eligibility Criteria:
Inclusion Criteria:

* Children who were selected by the SOS children's village as lacking parental care and receive basic services;
* Children living in Jimma town;
* Children from 3 months to 59 months of age.

Exclusion Criteria:

* Children with observable physical disabilities which hinders mobility;
* Children with severe mental retardation;
* Children with discernable hearing and visual impairments.
A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)

The objectives of this study are to evaluate the safety, efficacy, and dose-response relationship of IW-3718 administered orally to participants who have GERD and continue to experience GERD symptoms while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).


Eligibility Criteria:
Inclusion Criteria:

* Patient is an ambulatory, community-dwelling male or nonpregnant female and is at least 18 years old at the Screening Visit. Lactating females must agree not to breastfeed.
* Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) on ≥ 4 days per week during the 8 weeks before the Screening Visit while taking standard QD PPI therapy.

Exclusion Criteria:

* Patient may not meet any of the excluded conditions specified in the protocol
* Patient has any alarm symptoms including but not limited to GI bleeding, anemia, vomiting, dysphagia, or unexpected weight loss any time during the Screening or Pretreatment Periods
* Patient has a history of clinically significant hypersensitivity or allergies to any of the excipients contained in the study medication (active or placebo).

NOTE: Additional inclusion/exclusion criteria may apply.
Modafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia

The purpose of this study is to test the effect of modafinil on the negative symptoms, such as blunted affect and social withdrawal, of schizophrenic patients and to determine modafinil's effect on excessive daytime sleepiness. A secondary purpose of the study is to examine the effect of modafinil on cognitive functioning of schizophrenic patients.

Twenty six male patients with schizophrenia (twelve with Excessive Daytime Sleepiness and twelve without) will be enrolled at the San Diego Veterans Affairs Medical Center. Modafinil has been shown to increase alertness in individuals who are pathologically sleepy (Study C1538a/301/NAIUS).

Subjects will be randomized in a 1:1 ratio, stratified by excessive daytime sleepiness (value of \>=9 on the Epworth Sleepiness Scale). Subjects will receive either modafinil or placebo, supplied by the sponsor. The study drug will be taken by mouth once daily in the morning. The titration schedule will be as follows:

1. The beginning does will be 50mg for 2 weeks
2. The study medication will be increased to 100mg at the week 2 study visit
3. The study medication will be increased to 200mg at the week 4 study visit and will continue for the remaining 4 weeks of the study. If subjects are unable to tolerate dosage increases, the dose will be decreased to the previous level.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able to communicate and give voluntary informed consent
* Subjects must be of the male gender
* Between the ages of 18 to 65 years.
* A diagnosis of Schizophrenia or Schizoaffective disorder as determined by DSM-IV criteria.
* Not conservatorized
* A negative symptom score on the PANSS of \>= 20 and an MMSE score of \>24
* No clinical evidence of a current unstable medical illness
* No current clinical evidence or past history of cerebral neurological impairment (including strokes, tumors or trauma leading to loss of consciousness)
* No history of drug or alcohol dependence in the past 2 years
* No evidence of drug or alcohol abuse in the past year, as determined by the DSM-IV criteria.
* No diagnosis of Narcolepsy as determined by DSM-IV criteria
* Must have an approved contact person for the duration of the study
* May be on a stable dose of SSRI for depressive symptoms
* No history of aggression
* No uncontrolled hypertension, as defined below (subjects cannot have any of the following):

  1. a new diagnosis of hypertension, or
  2. a change in antihypertensive medications in the past 30 days, or
  3. acute hypertension (systolic\>160mmHg, diastolic\>100mmHg)
* Maybe on a stable dose of a benzodiazepine
* The following medications will not be allowed during the study- methylphenidate, amphetamines, pemoline, zolpidem, MAO inhibitors, anticoagulant, TCA's, or barbiturates.
* Be on a stable does of an atypical neuroleptic
* May be on a stable does of an anticonvulsant for mood stabilization

Exclusion Criteria:

* Subjects cannot be female.
Single and Multiple-Ascending Dose Study of CRN04894 in Healthy Volunteers

A Phase 1, first-in-human, double-blind, randomized, placebo-controlled study to evaluate the safety of CRN04894 in healthy volunteers as well as the relationship between exposure and pharmacodynamic (PD) parameters.


Eligibility Criteria:
Inclusion Criteria:

* Females must be either postmenopausal or surgically sterile; or using stable and permitted highly effective method of contraception - use of oral hormonal contraceptives are not allowed during the study
* Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential
* ACTH-stimulated serum cortisol high-dose ACTH stimulation test conducted at Screening

Exclusion Criteria:

* Use of topical, nasal, inhaled, or oral corticosteroids.
* Use of any investigational drug within the past 60 days.
* Have a medically significant illness within 30 days prior to screening.
* Use of prohibited prescribed or nonprescribed medications and/or nonmedications/alternative medicinal products.
* Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
* Unstable psychological disorder ≤1 year prior to Screening.
Readiness for Behavior Change After a Heart Attack

The purpose of this study is to test if an early appointment (within 10 days) when compared to a standard appointment (5 weeks) will affect attendance at the Cardiac Rehabilitation orientation and subsequent enrollment into cardiac rehabilitation.

Cardiac Rehabilitation is central to full recovery after a myocardial infarction or a cardiac stenting procedure. Yet, this therapy is underutilized across the nation. Henry Ford currently enrolls about 42% of eligible patients. In addition, it currently takes, on average, 42 +/-26 days from hospital discharge to enrollment in rehabilitation. During this delay, there is strong tendency to return to prior habits (sedentary lifestyle, smoking, poor nutrition, etc.) that led to the myocardial infarction in the first place. This delay is both 1) unnecessary and 2) probably harmful to the patients' readiness to make changes.

The investigators seek to perform a randomized controlled trial of early (7-10 days) vs standard referral (5-6 weeks) to cardiac rehabilitation. In addition, the investigators will examine the patients' readiness to change through the first 3 months of the post-hospitalization period and correlate that to their behavior and enrollment in cardiac rehabilitation. Assessment of readiness to change will be accomplished by serial survey's, which will be administered at discharge, 2 weeks, 5 weeks, and 13 weeks after discharge.

Patients will consent to take the survey and be observed in a clinical study. However, in order to avoid the Hawthorne Effect, patients they will not initially be aware of the primary hypothesis, as the investigators strongly believe this will affect the main behavior they are trying to measure. Full patient disclosure will occur at the end of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Stable Angina
* Myocardial infarction
* Percutaneous coronary intervention
* willingness to participate and consent for medical record review
* willingness to complete survey's

Exclusion Criteria:

* Recent illicit drug use
* Unstable psychiatric condition
* Moderate or severe dementia
* Inability to follow-up
* Leaving system with plans to enroll in cardiac rehabilitation out-of-system
* Inability to exercise (amputee, severe claudication)
* Unstable medical condition that would prevent regular exercise training
* Uncorrected severe aortic stenosis or severe mitral stenosis
* Referring physician feels that exercise is contra-indicated due to safety or other patient specific factors
* CABG, LVAD, or Heart Transplant
Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis

The purpose of this study is to determine the safety and tolerability of single doses of SBI-087 in subjects with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit.
* Must meet criteria for rheumatoid arthritis with functional class I to III.
* Diagnosis of rheumatoid arthritis more than 6 months before study day 1 and rheumatoid arthritis onset after 16 years of age

Exclusion Criteria:

* Any significant health problems other than rheumatoid arthritis.
* Treatment of greater than 10 mg of prednisone per day.
* Treatment with cyclophosphamide.
Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy

patients who had failed previous H. pylori eradication on standard triple therapy were randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d) (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were performed with 13C urea breath test (UBT) or invasive tests (Giemsa histology, CLO test, and culture). In patients who maintained continuous H. pylori negativity for the first year after eradication therapy, H. pylori status was assessed every year. For the evaluation of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or intestinal metaplasia were analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Patients were considered persistent H. pylori infection if 13C-urea breath test (UBT) or invasive H. pylori test (Giemsa histology, CLO test, culture) were positive despite PPI-based triple therapy.

Exclusion Criteria:

* Patients were excluded from the study if they had a history of renal or hepatic impairment, previous gastric surgery, pregnancy or lactation, therapy with steroids or non-steroidal anti-inflammatory drugs, or therapy with a proton pump inhibitor (PPI) or antibiotics within four weeks of entry.
A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529

This phase I study is to assess the mass balance recovery after a single oral dose of \[14C\]-AK0529 in healthy male subjects.

This is a single centre, single-dose, non-randomised, open label study. The primary objectives of this study are to assess the mass balance recovery and provide biosamples for metabolite profiling and structural identification after a single oral dose of \[14C\]-AK0529 in healthy male subjects. 7 subjects will be recruited to receive a single oral administration of a solution containing 300 mg AK0529. The total duration of the study will be approximately 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Aged between 30 and 55 years of age, inclusive
* Body mass index of 18.0 to 35.0 kg/m2, inclusive, or, if outside the range, considered not clinically significant by the investigator and the medical monitor
* Must be willing and able to communicate and participate in the whole study
* Must have regular daily bowel movements
* Must provide written informed consent
* Must agree to use an adequate method of contraception

Exclusion Criteria:

* Subjects who have received any IMP in a clinical research study within the previous 3 months
* Subjects who are study site or sponsor employees, or immediate family members of a study site or sponsor employee
* Subjects who have previously been enrolled in this study
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption \>21 units per week
* Current smokers and those who have smoked within the last 12 months
* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
* Radiation exposure. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
* Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
* Abnormal liver function as assessed by clinical chemistry
* Positive drugs of abuse test result
* Positive HBsAg, HCV Ab or HIV results
* Evidence of renal impairment at screening
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, neurological, dermatological or GI disease, or psychiatric disorder, as judged by the investigator
* Any abnormality of ECG parameters
* Any abnormality of cardiac rhythm or history thereof
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed, unless it is active at screening or admission
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal or any other 'alternative' remedies in the 14 days before IMP administration
* Failure to satisfy the investigator of fitness to participate for any other reason
The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients

Critically ill patients are at risk of or suffering from one or more key organs or organ system failure. This study will measure the effect of traditional Chinese medicine(TCM) interventions on critically ill patients admitted to the intensive care unit (ICU).

The goal of this clinical trial is to learn if traditional Chinese medicine(TCM) is effective for prevention and treatment of organ failure in ICU patients. Patients in this group will receive intervention for 2 weeks.

A multi-center non-randomized real word data study, will include 3 groups: intervention group (TCM)(n=70), control group and historical control group (admitted to the same ICU in the period of 01.2019 to 12.2023).

Main outcomes include sequential organ failure assessment (SOFA) score, ICU length of stay, hospital length of stay, number of days of respirator uses and western medicine medication used study follow up will be 2 weeks.

Critically ill patients are at risk of or suffering from one or more key organs or organ system failure. This study will measure the effect of traditional Chinese medicine(TCM) interventions on critically ill patients admitted to the intensive care unit (ICU).

A multi center non-randomized real word data study, will include 3 groups: intervention group (n=70), control group (patients recruited enrolled to the ICU during the study period) and historical control group (admitted to the same ICU in the period of 01.2019 to 12.2023). The intervention group will receive traditional Chinese herbal medicine and/or acupuncture and/or low level laser applied on acupuncture points depending on TCM doctor decision and patient TCM diagnosis. Intervention period will be 2 weeks.

Main outcomes include sequential organ failure assessment (SOFA) score, ICU length of stay, hospital length of stay, number of days of respirator uses and western medicine medication used study follow up will be 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 and above
* Surgical ICU patients
* The use of Chinese medicine must be approved by the attending physician in the surgical intensive care unit

Exclusion criteria:

* Patients' family members refuse TCM intervention
Gravity Versus Pump Infusion of Distending Media for Hysteroscopic Myomectomy

To compare the perioperative outcome between the gravity versus pump infusion groups in women who received hysteroscopic myomectomy


Eligibility Criteria:
Inclusion Criteria:

* \>20 years old women
* women who received hysteroscopic myomectomy