cyrilzakka/clinical-trials huggingface dataset:
Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose \[up to BTDS 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief and tolerability.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed all visits of the double-blind phase on study drug, and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase.
* For subjects entering the extension, 4 electrocardiograms (ECGs) are required at entry if none were collected prior to randomization while on BTDS 20. NOTE: Subjects with any 1 QT data corrected for heart rate using the Fridericia formula (QTcF) interval ≥ 500 milliseconds (msec) would be discontinued from the extension phase

Exclusion Criteria:

* Subjects requiring long-acting opioid analgesics \[once- or twice-daily dosing with a every (q) 24 hours (h) or q12h drug\] or transdermal fentanyl during the extension phase should be discontinued from the study.
Transcranial Direct Current Stimulation Augmented Exposure and Response Prevention for Obsessive-Compulsive Disorder

This study is investigating whether combining noninvasive brain stimulation with behavior therapy can help to improve outcomes for obsessive-compulsive disorder (OCD). Exposure and response prevention (ERP) -- a specific type of behavior therapy -- is a first line treatment for OCD. This study will test whether a form of noninvasive brain stimulation called transcranial direct current stimulation (tDCS), can help ERP work better.


Eligibility Criteria:
Inclusion Criteria:

* Current primary OCD diagnosis and current Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score of ≥16
* 18-65 years of age
* Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent
* Right-handed
* No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry. Psychiatric medications will be limited to the following: serotonin reuptake inhibitors (SRI; including clomipramine), combination antidepressants (including bupropion and serotonin-norepinephrine reuptake inhibitors), buspirone, benzodiazepines, and/or stimulants
* Naive to tDCS

Exclusion Criteria:

* Active substance use disorder
* Lifetime diagnosis of psychotic or bipolar mood disorder
* Previous minimally adequate trial of ERP (e.g., at least 16 sessions including both therapist and self-directed exposure and response prevention)
* Therapy outside the study protocol which has evidence for efficacy with OCD during the study intervention period
* Active suicidal or homicidal ideation
* Organic brain disease or injury
* Any health problems that would interfere with study participation, including contraindications to tDCS (e.g., skin condition, mental implant in skull)
* Women who are pregnant or breastfeeding. All women participants of child-bearing age are required to have a negative pregnancy test prior to treatment, and must use medically acceptable birth control during study participation. Medically acceptable birth control includes: established oral, injected, implanted, or vaginal ring hormonal contraception, an intrauterine device (IUD), two barrier contraception methods (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), or having a vasectomized partner
* Use of anticonvulsant medications (including depakote, gabapentin, tegretol, dilantin, lamictal) and/or glutamate-acting agents (including n-acetylcysteine, riluzole, amantadine, memantine).
Study on Single-cell Regulons Atlas of Pancreatic Ductal Adenocarcinoma

The first purpose of this study is to reveal the gene regulatory network of pancreatic cancer by analyzing single-cell transcriptome sequencing data and to draw a pancreatic cancer regulator map. In addition, bulk transcriptome sequencing data are combined to construct and verify the genetic prognostic model of pancreatic cancer regulators, providing clinical tools for accurate prognostic stratification and personalized treatment of pancreatic cancer patients. The second purpose of this study is to explore the molecular mechanism by which the key oncogene in the gene prognostic model promotes pancreatic cancer advance. New ideas and scientific basis are provided for finding potential molecular targets for the treatment of pancreatic cancer. Thus, the investigators included a Tissue Microarray (TMA)-based cohort of 68 PDAC patient tissue samples. TMA was obtained from OUTDO BIOTECH (Shanghai, China). The study was approved by the institutional review board, and ethics document number is YB M-05-01.


Eligibility Criteria:
Inclusion Criteria:

* Pancreatic ductal adenocarcinoma
* With post-operative paraffin specimens

Exclusion Criteria:

* Other types of pancreatic cancer other than pancreatic ductal adenocarcinoma
* Without post-operative paraffin specimens or less than 20% of the paraffin sections contain cancerous tissue
Preoperative Volume Substitution in Elective Surgery Patients

Preoperative fasting can evoke a hypovolemia which may cause a hemodynamic instability during introduction of anesthesia.

The purpose of this study is to test the hypothesis that a defined preoperative volume substitution compared to standard procedure will result in a reduced incidence of hemodynamic instabilities during introduction of anesthesia in elective surgery patients.

The preoperative fasting period often lasts longer than 2 hours as recommended by various national and international anesthetic guidelines. Thus, hypovolemia is more often then anticipated. In awake patients this condition is often masked. Introduction of anesthesia often leads to an unmasking of hypovolemia with a consecutive hemodynamic instability.

Aim of the study is to test the hypothesis that a preoperative volume substitution (8 ml/kg RingerAcetate Solution in 15 min. prior to introduction of anesthesia) reduces possible hemodynamic instabilities during initiation of anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* thyreoid, parathyroid or gallbladder surgery
* general anesthesia

Exclusion Criteria:

* coronary artery disease
* congestive heart disease (≥ New York Heart Association (NYHA) 2)
* insulin dependent diabetes mellitus
* renal insufficiency (creatinine \> 2,0 mg/dl)
* cerebrovascular disease
* severe hypertension (≥ antihypertensive drugs)
Phase I Combination Ixabepilone + Cisplatin

The purpose of this study is to determine the highest dose of ixabepilone that can be given safely with cisplatin without causing severe or life-threatening side effects and for some patients with non-small cell lung cancer, the effects (good or bad) on your cancer will also be studied


Eligibility Criteria:
Escalation Phase Subjects: Primary solid tumor not curable by local measures such as surgery, radiation

Inclusion Criteria:

* Men and women age ≥ 18

Exclusion:

* More than 2 prior chemotherapy containing regimens for metastatic disease
* No prior exposure to cisplatin or ixabepilone

Expansion Phase Subjects: Advanced Non-small cell lung cancer

Inclusion Criteria:

* Men and women age ≥ 18

Exclusion:

* No prior chemotherapy-containing regimen for metastatic disease
* No prior exposure to cisplatin or ixabepilone
Efficacy of a Web-based Sexual Violence Risk Reduction Program for Female College Students

This study evaluates the efficacy of a web-based program for female college freshmen ("RealConsent") in reducing their risk of sexual violence victimization. Half the participants will receive RealConsent-F and half will receive an attention-placebo control ("Stress and Mood Management").

Sexual assault of college women is a serious and complex public health problem: one in five college women report being sexually assaulted. The purpose of this study is to conduct a randomized controlled trial study with 750 female college students from three universities to test the efficacy of RealConsent, a sexual violence risk reduction program for college women, compared to an attention-placebo control. RealConsent is a multi-media 3-hour program based on social cognitive theory and alcohol myopia theory. The primary outcome will be self-reported sexual violence victimization and the secondary outcomes will be alcohol and dating protective- and risk-related behaviors and resistance strategies. The investigators expect that women in the treatment group will report less sexual violence victimization than women in the control group. Expected outcomes are demonstrated feasibility and efficacy of a technologically novel risk reduction program for female college students.

Eligibility Criteria:
Inclusion Criteria:

* female, aged 18-20 years, full-time freshmen, matriculated at Georgia State University, Emory University, or University of Georgia, and single (i.e., not in a committed dating relationship).

Exclusion Criteria:

* other education levels, married, and/or graduate status
Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)

STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP).

STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP) by promoting:

1. counseling and referral to primary care, during OB visits, via electronic health record (EHR)-based clinical decision support (CDS)
2. dysglycemia testing for women with prior GDM, prompted via CDS during both OB and primary care visits
3. dissemination of understandable information on future risk and the need for ongoing evaluation generated automatically via the EHR and printed for patients with after-visit summaries (AVS)
4. motivational messaging and reminders supporting transitions of care delivered directly to patients via short message service (SMS) text messages
5. individualized outreach and support for those who need additional help arranging a primary care visit

We will utilize a stepped wedge design to achieve the study's specific aims, which are to:

Aim 1 Test the effectiveness of STEP-UP, compared with usual care, to improve patient: 1) knowledge of reproductive risks associated with T2DM and recommended self-care activities; 2) engage in self-care behaviors, including diet, physical activity, adherence to diabetes medications, and use of folic acid and most or moderately effective contraception, when indicated; and 3) clinical measures, including hemoglobin A1c, blood pressure, and LDL cholesterol.

Aim 2 Investigate the heterogeneity of STEP-UP intervention effects by patients' race, ethnicity, and language.

Aim 3 Assess the reach, adoption, implementation, maintenance and costs of STEP-UP components.

Eligibility Criteria:
Inclusion Criteria:

* Delivered during an accrual period,
* Had a chart diagnosis during their index pregnancy of GDM and/or HDP,
* Attended at least 1 prenatal care visit at a study site in the 6 months prior to delivery,
* Speak English or Spanish,
* Age 18 or older
MIND Diet and Cognitive Function in Middle-aged and Older Adults

A 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years.

Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet and Cognitive Decline in Middle-aged and Elderly People is a 12-month cluster-randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet education on the rate of cognitive change and several other secondary outcomes in 1200 adults aged 40-69 years. The proposed MIND diet for this study is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet-dementia field and Chinese Dietary Guidelines 2022. Specifically, the proposed MIND diet education will emphasize the consumption of whole grains, dark green leafy vegetables, dark red/yellow vegetables, other vegetables, berries and citrus, poultry, fish and seafood, beans and legumes, nuts, olive and seed oils, and green tea, and restrict red and processed meats, animal fat, fried foods, and sweets and pastries. The trial will employ a cluster randomization design comparing the effects on cognitive change of the MIND intervention diet education among 1200 adults aged 40-69 years. Secondary outcomes will include dietary behavior changes, health status changes, etc. The proposed study is sited at Taian, Shandong, China.

Eligibility Criteria:
Inclusion Criteria:

* Normal chewing function, able to eat hard foods such as nuts.
* Willing to participate and sign an informed consent form.
* Able to understand research procedures and adhere to them throughout the entire study period.

Exclusion Criteria:

* Participation in or have participated in other clinical trial studies within the past year.
* Medication to treat Alzheimer's or Parkinson's disease.
* Diagnosis of severe chronic diseases, such as cancer.
PK Driven Prophylaxis for Hemophilia A

The purpose of this study is to evaluate the implementation of pharmacokinetic (PK) driven prophylaxis in current clinical practice

Starting from 3 pharmacokinetic (PK) points, data are entered in the PK calculator device, and treatment dose is adjusted following the results of PK values obtained and clinical bleeding data

Eligibility Criteria:
Inclusion Criteria:

* Male Patient
* Severe or moderately severe haemophilia A (FVIII = 2 %), preventively treated (processing) by ADVATE for at least 6 months,
* At last 6 years old,
* An informed consent must be signed by the patient or his legal representative for the patients minor.
* Affiliated to a national insurance scheme

Exclusion Criteria:

* Previous or actual treatment with FVIII inhibitors \> 0,6 UB at the selection
* Induction of immune tolerance
* Planned orthopedic surgery for the 18 next months
* Any other haemostatic pathology
* Any treatment interacting on the haemostasis
* Patient under guardianship
* Patient participating in another biomedical research
Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents With Cannabis Use Disorder

This project seeks to learn more about the effects of cannabis use on the endocannabinoid system and endogenous opioid systems in adolescents to address a fundamental gap in knowledge and identify biomarkers that may help distinguish youth who relapse from youth who remain sober.

Learning the effects of cannabis use on the endocannabinoid system and endogenous opioid systems in adolescents addresses a fundamental gap in knowledge and may identify biomarkers that help distinguish youth who relapse from youth who remain sober.

The specific aims of the project are to:

1. Measure endocannabinoid (eCB) and endogenous opioid (endorphin) levels in the blood of adolescents who use cannabis regularly and adolescents who never use cannabis. We expect eCB and endorphin levels to differ significantly in adolescents who use cannabis regularly compared to adolescents who do not.
2. Characterize circulating eCB and endorphin levels at baseline, during abstinence, and after natural resumption of cannabis use.
3. Collect data to evaluate cannabis craving and to test for association of craving with eCB and endorphin levels in adolescents who use cannabis regularly. We expect that larger changes in eCB and endorphin levels will be associated with higher craving scores.

Eligibility Criteria:
Inclusion Criteria:

1. 14 to 25 years of age.
2. Use cannabis at least twice a week for the past month.

Exclusion Criteria:

1. Refusal of valid written consent,
2. Current psychosis,
3. Obvious intoxication,
4. Current risk of suicide,
5. Violence sufficiently great to interfere with evaluation or to endanger evaluators,
6. Obvious intellectual deficiency as noted during the informed consent process, or inability of patient or family to comply with the study protocol.
7. Use of other illicit drugs in the past 90 days by self-report or detected by urine drug test.
8. Use of opioid medications for medical or recreational purposes currently or within the past 90 days.
9. Does not have access to an Internet connected devise or cannot use Zoom.
RCT of Russian IDU Peer Network HIV Prevention Intervention - 1

The purpose of this study is to conduct a randomized controlled trial to assess the efficacy of a peer-educator intervention focused on injection drug users and their drug and sexual networks. We expect that participants who receive the intervention will demonstrate a reduction in the rate of HIV infection and HIV risk behaviors and members of their risk network will also demonstrate reductions in risk behaviors compared to those in the control group.

Intravenous drug use (IDU) is driving the HIV epidemic in Russia; over 90% of all HIV-1 infections have occurred within communities of IDUs. In St. Petersburg (population 5 million), the prevalence of HIV infection in IDUs (estimated population 100,000) leapt from 4% in 1999 to 12% in 2000. At present there are an estimated 5-7 million IDUs, a four-fold increase since the end of the Soviet Union. In St. Petersburg, there has been a three-fold increase in regular IDUs and a nine-fold increase in teenage IDUs during the past five years.

The intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Providing peer educator training to IDUs may efficiently cultivate sustainable protective behavioral norms related to injection and sexual risk among the IDU educators' social networks. Prior studies have demonstrated that peer educator programs can realize such normative changes, and it is hypothesized in this study that these normative changes will be reflected in significant reductions in the rates of HIV transmission among the peer educators and the members of their social networks.

Comparison condition: Informed by the Centers for Disease Control model of best practice" standard of care of HIV testing and counseling, participants in the comparison condition will receive risk reduction education and motivational counseling to reduce their risk behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Of legal age to independently provide written informed consent for research
* Report having injected drugs at least 12 times in the last three months
* HIV seronegative (ELISA confirmed)
* Willing and able to recruit at least three HIV risk network members who are eligible for study participation

Exclusion Criteria:

* Prior or concurrent enrollment in the last 6 months in another HIV behavioral or biomedical prevention study
* Psychological disturbance or cognitive impairment that appears to limit the ability to understand study procedures, as determined by clinic staff
* Any other condition that, in the opinion of the investigator, would make participation in the study unsafe, or otherwise interfere with the study objectives
Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care

Burns represent one of the most severe and dreaded traumas. Burned and traumatized tissue is known as eschar. The dead eschar, if not removed, often becomes heavily contaminated and is the source of local and/or systemic infection or sepsis. The local inflammation and infection destroy healthy surrounding tissues and extends the original damage. In order to prevent these complications, and in order to minimize the risk of infection, it is imperative to evaluate the burn and remove all of the offending eschar at the earliest possible opportunity. This removal of dead tissue is termed "debridement".

The most direct debridement method for eschar removal is surgery. Traditional, conservative non-surgical debridement is a lengthy process which often involves many complications.

The objective of this study is to evaluate the safety and enzymatic debriding efficacy of Debrase Gel Dressing (DGD) in hospitalized patients with deep partial thickness and/or full thickness thermal burns and to compare DGD to standard of care (SOC).

Completed study.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females between 4 years to 55 years of age,
2. Thermal burns caused by fire/flame, scalds or contact,
3. Deep partial thickness (mixed deep dermal) and/or full thickness (3°) burn wounds ≥ 5% and ≤ 30% Total Body Surface Area (TBSA); all these wounds must receive study treatment,
4. At least one wound of ≥ 2% TBSA deep partial thickness and/or full thickness burn,
5. Total burn wounds ≤ 30% TBSA,
6. Signed written informed consent.

Exclusion Criteria:

1. Deep partial thickness and/or full thickness facial burn wounds, \> 0.5% TBSA; study treatment of facial burns is not allowed,
2. Study treatment of perineal and/or genital burns (A patient with these wounds may be enrolled but the wounds may not be designated as target wounds),
3. Circumferential anterior/posterior trunk full thickness fire/flame burns, \> 15% TBSA, (Circumferential is defined as encircling ≥ 80% of the trunk circumference.)
4. Pre-enrollment escharotomy,
5. Heavily contaminated burns or pre-existing infections,
6. Signs that may indicate smoke inhalation,
7. General condition of patient would contraindicate surgery,
8. Pregnant women (positive pregnancy test) or nursing mothers,
9. Poorly controlled diabetes mellitus (HbA1c\>9%),
10. Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases),
11. Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins),
12. Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or neoplastic disease),