cyrilzakka/clinical-trials huggingface dataset:
Innovative Approaches for Minor Consent: Consent 2.0

The purpose of this study is to examine how the consent process affects the acceptability of participation in biomedical HIV prevention trials, from the perspective of behaviorally high-risk minors and the parents of minor adolescents.

Potential participants will be recruited from clinical settings and HIV testing centers. If interested in participation, they will take a short Computer Assisted Self-Interview (CASI) screening survey to determine eligibility. Those eligible will take part in the one-day study visit at that time or will provide contact information to set up the study visit at a later date.

All study participants will attend a one-day study visit at their respective study site. Upon arrival, participants will complete a CASI that collects demographic, social, behavioral, and attitudinal measures. Next, participants will take part in a simulated consent process for two hypothetical trials modeled after ATN 113 and HPTN 077. Study procedures differ for adolescents and parents, so each group is described separately below:

Adolescent Participants: For each hypothetical trial, research staff will lead the participant through a simulated consent process consistent with their randomized consent condition. Then, the participant will complete a CASI assessing Willingness to Participate (WTP) and will work with research staff to complete the University of San Diego (UCSD) Brief Assessment of Capacity to Consent (UBACC).

Parent Participants: For each hypothetical trial, research staff will review the informed consent forms with the parent. The parent will complete a CASI with three vignettes that describe each of the three possible consent conditions. Parents will rate the acceptability of each vignette. Then, the participant will work with research staff to complete the UCSD Brief Assessment of Capacity to Consent (UBACC). Finally, the participant will answer a series of questions via CASI.

A subset of 6-8 adolescents and 6-8 parents per study site will complete a debriefing interview assessing adolescent and parent perspectives on the various consent conditions in greater depth, and to better understand the role of study features, family, and adolescent characteristics in willingness to participate/willingness to support the hypothetical research studies.

Eligibility Criteria:
Note: Age limits apply to adolescent participants and to the adolescent children of parent participants.

Adolescent Inclusion Criteria

* Age 14-17 inclusive
* Able to read and speak English
* HIV status is negative or unknown
* Engaged in high-risk sexual activity in the last six months

Adolescent Exclusion Criteria

* Child of a parent already enrolled in the study

Parent Inclusion Criteria

* Able to read and speak English
* Parent or guardian of an adolescent who is between ages 14-17
* The parent/guardian's adolescent's HIV status is either negative or unknown

Parent Exclusion Criteria

* Parent of a child already enrolled in the study
Embody Insertional Achilles Tendinopathy

The primary objective of this study is to evaluate the long-term effects on ankle/Achilles tendon pain after repair of insertional Achilles tendinopathy (IAT) augmented with TAPESTRY Biointegrative Implant.

This study is a prospective case series of patients who have had insertional Achilles tendinopathy repair augmented with the Tapestry Biointegrative Implant. The primary aim of the study is to describe patient reported pain 12 months after surgical repair with Tapestry. The secondary aims are to assess the proportion of study subjects that experience treatment-related adverse events post-surgery, treatment related serious adverse events resulting in second surgical intervention, quality of life and other patient reported outcomes at all follow up timepoints post-surgery, and tissue thickness measured with MRI at 6 months post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult, 21 years and older;
* Insertional Achilles tendonitis requiring surgery that has failed at least 2 weeks of conservative management, which consist of:

  1. Shoe modification; or
  2. Nonsteroidal anti-inflammatory drugs; or
  3. Physical Therapy with/without modalities.
* Chronic Achilles tendon pain lasting longer than 3 months;
* MRI of the ankle within 30 days prior to the study surgery;
* Ability and willingness to comply with prescribed post-operative rehabilitation program;
* Ability and willingness to comply with follow-up regimen;
* Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures; and
* Ability to read, understand, and complete subject-reported outcomes in English.

Exclusion Criteria:

* History of Achilles tendon rupture;
* Previous Achilles tendon surgery on the index ankle;
* Genetic collagen disease, hypersensitivity, or objection to using bovine-derived materials;
* History of auto-immune or immunodeficiency disorders;
* History of chronic inflammatory disorders;
* Oral steroid use in last 2 months or injectable steroid use in last 4 weeks;
* History of heavy smoking (\> 1 pack per day) within last 6 months;
* Hypersensitivity to poly(D,L-lactide) materials;
* Metal implants, fillings, shrapnel, and/or screws;
* Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study;
* Currently involved in any injury litigation or worker's compensation claims relating to the index ankle;
* Enrolled, or plans to enroll, in another clinical trial during this studythat would affect the outcomes of this study; or
* History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation.
Randomized, Placebo-controlled Trial of an AMPAkine in Major Depressive Disorder

The purpose of this study is to test a candidate drug, Org 24448,in a phase II clinical trial in adult patients with moderately treatment-resistant unipolar major depressive disorder.

Major depressive disorder (MDD) is a common, severe, chronic and often life-threatening illness. Major depression contributes to significant morbidity and mortality. Available pharmacotherapies for major depression are suboptimal in terms of speed of onset, efficacy, and tolerability. Current medications for severe, chronic mood disorders are not based on pathophysiological models of illness, but rather are variation of monoaminergic-based therapies. Org 24448 represents a new treatment approach for depression, by potentiating the AMPA receptor subfamily of ionotropic glutamate receptors. This drug has been shown to have antidepressant features in preclinical models, as well as cognitive-enhancing qualities.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of MDD
* Have not responded to an adequate trial of one antidepressant in the current episode or have not completed antidepressant trials due to intolerance to ≤3 antidepressant medications in the current or a previous episode

Exclusion Criteria:

* Presence of psychotic features, OCD, drug or alcohol dependency with the preceding 3 months
The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol

POT-GFR-PK is a single dose pharmacokinetic study oral tetrahydrocannabinol (THC) and cannabidiol (CBD) in healthy adult controls and individuals with chronic kidney disease including those treated with in-center hemodialysis.

Adults aged greater than 25 years including 6 with eGFR\>60ml/min/1.73m2, 6 eGFR 30-59ml/min/1.73m2, 6 eGFR \<30ml/min/1.73m2 (CKD Epidemiology Collaboration equation) and 6 receiving in-center hemodialysis at least 2x weekly via a tunnelled catheter will receive THC 0.1mg/kg and CBD 2mg/kg by mouth in the form of MediPharm Labs-001 (MPL-001) (50mg CBD/2mg THC per 1mL). In healthy controls and participants with chronic kidney disease, blood samples will be collected at t=0, 1, 2, 3, 3.5 and 4 hours post THC/CBD administration. In participants receiving in-center hemodialysis, blood samples will be collected at t=0, 1, 2, 3, 3.5 and 4 hours post THC/CBD administration and during hemodialysis at t=0, 60, 120, 180 minutes and 15 minutes prior to the end of hemodialysis (at a reduced pump speed with blood flow 50-100ml/min) and 60 minutes post-hemodialysis. A 24 hour urine will be collected in all participants except those receiving hemodialysis without any residual urine output. Dialysate samples will be collected at 1,2,3 hours during hemodialysis and at the end of hemodialysis. Blood samples will also be collected at 24 and 48 hours. Plasma, urine and dialysis cannabinoids (THC, CBD and their metabolites) will be quantified using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry.

Eligibility Criteria:
Inclusion Criteria:

1. adult age\>25 years
2. estimated glomerular filtration rate (eGFR)\>60ml/min/1.73m2 or eGFR\<60ml/min/1.73m2 by the CKD Epidemiology Collaboration equation including in-center hemodialysis at least 2x weekly for a minimum of 3 hours per treatment via a tunnelled catheter treated \>90 days
3. agree to take the medication as directed in the study
4. provides informed consent

Exclusion Criteria:

1. body mass index \<20 or \>35kg/m2
2. physical dependence on any drug other than caffeine or nicotine
3. history of clinically significant adverse event associated with cannabis intoxication
4. history of psychosis or mania or any active major psychiatric disorder
5. recent (within 30 days) use of any cannabinoid (natural or synthetic) identified by self-report or urine drug screen for cannabinoids
6. taking any medication with known interactions with THC or CBD via cytochrome P450 (CYP) CYP2C9, CYP2C19 and CYP4A6 or CYP2D4 (e.g. anti-epileptic drugs, calcineurin inhibitors, anti-fungal)
7. evidence of liver dysfunction (ALT less than 3 times upper limit of normal, bilirubin below upper limit of normal, international normalized ratio\<1.5)
8. pregnant or breastfeeding women
9. change in ideal body weight or dry weight in the last 4 weeks
10. intradialytic hypotension (systolic blood pressure\<90mmHg) requiring an intervention in the previous 4 weeks
A Study to Assess the Validation and Mapping of the Suicide Ideation and Behavior Assessment

The main purpose of this cross-sectional study is to generate data to support the psychometric properties of the Suicide Ideation and Behavior Assessment Tool (SIBAT) and validate its use in participants at imminent risk of suicide.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be able to speak, read, and write English sufficiently well to complete consent process and self-administer study questionnaires
* Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of the interviews and, when applicable, the videotaping required for the study and are willing to participate in the study. Adolescents (minors) who in the judgment of the investigator are capable of understanding the nature of the study can be enrolled only after obtaining consent of a legally acceptable representative. Assent must be obtained from any participating adolescents (minors)
* Each participant or legally acceptable representative must check a separate box on the consent form if he or she agrees to have interviews video-recorded. Participants who do not consent to video recording will only be administered the SIBAT

Exclusion Criteria:

- Participant has any clinically relevant physical or mental conditions including, but not limited to vision problems, physical disability, severe mental illness, or cognitive impairment (such as from acute intoxication or dementia) which, in the opinion of the investigator, would interfere with ability to complete the study interviews
ICG Fluorescence Guided Lymph Node Mapping for Determination of Bowel Resection Margins in Colon Cancer

The study is aimed at investigating feasibility of defining colon resection margins for colon cancer with ICG by comparing lymphatic distribution of subserosally injected dye with actual spread of lymphatic metastases reported by pathologists after specimen examination

In this study 2.5 mg/ml indocyanine green solution is injected subserosally into colonic wall near the tumour in 4 points (1 ml each). The fluorescence is assessed before specimen removal (at least 30 min after injection) and its mesenteric distribution is marked by surgeon on the specimen. Proximal and distal colonic resection margins are chosen to be at least 10 cm long and to include the whole area of fluorescence. After removal, lymphatic node groups according JSCCR are also marked on fresh specimen. During pathological examination each lymph node is assessed not only for presence of metastases but also for its exact location in relation to margins of indocyanine distribution.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed adenocarcinoma of colon (caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid)
2. TNM T1-4a N0-2 M0-1
3. Clinical indications to colonic resection
4. ECOG - 0-2
5. Signed informed consent.

Exclusion Criteria:

1. Medical or psychiatric reasons interfering with patient's decision to participate in the study.
2. Pregnancy or breastfeeding.
3. Medical conditions contraindicating surgical procedure.
4. Acute bowel obstruction, bleeding or perforation.
5. Hypersensitivity to indocyanine green, sodium iodide or iodine
6. Hyperthyroidism or autonomic thyroid adenomas
7. Kidney failure of any aetiology
8. Hepatic failure of any aetiology
9. Poorly tolerated indocyanine injection in the past.
Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy

Patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity.

More than 700.000 open abdominal surgeries (laparotomies) are performed each year in Germany (2). A major surgical complication after laparotomy is abdominal fascia dehiscence which might appear either as early (burst abdomen with evisceration) or as late complication (incisional hernia). These patients usually undergo surgery for secondary fascial closure associated with markedly increased morbidity (3) including high recurrence rates (up to 45%) (4). The applied surgical strategy of abdominal wall closure (i.e. the combination of suture technique and material) is of high relevance for prevention of fascia dehiscence and, moreover, constitutes the main factor directly controllable by the surgeon. While several randomized controlled trials (RCT) (3; 5-8) as well as meta-analyses (9-12) exist that address the issue of optimal fascia closure in elective laparotomies, there is no RCT dealing exclusively with the emergency setting. As a result abdominal fascia closure is performed according to the surgeon's individual preference rather than according to evidence-based data. Therefore, the present RCT is designed to compare the most established strategies (continuous slowly absorbable sutures and interrupted rapidly absorbable sutures) for abdominal wall closure in order to determine differences between both strategies after midline incisions.

Eligibility Criteria:
Inclusion Criteria:

1. Preoperative Inclusion criteria:

   * Age equal or greater than 18 years
   * Expected survival time more than 12 months
   * Patients undergoing primary and emergency midline laparotomy (patients with prior laparoscopy (not colon resections) or minor abdominal operation (e.g. appendectomy, cholecystectomy, hysterectomy, sectio) may be included into the trial)
   * Suspected septic abdominal focus (e.g. perforated stomach ulcer, perforated diverticulitis)
   * Informed consent
2. Intraoperative inclusion criteria before closure:

   * Successful source control
   * Abdominal lavage

Exclusion Criteria:

1. Preoperative exclusion criteria:

   * Participation in another intervention-trial with interference of intervention and outcome of this study
2. Intraoperative exclusion criteria before closure:

   * Planned re-laparotomy
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison to ezetimibe 10 mg daily after 24 weeks of treatment in Asia in participants with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

* To evaluate the effect of alirocumab 75 mg in comparison with ezetimibe 10 mg on LDL-C after 12 weeks of treatment.
* To evaluate the effect of alirocumab on other lipid parameters: e.g., apolipoprotein B (Apo B), non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein a (Lp\[a\]), HDL-C, triglycerides (TG), apolipoprotein A-1 (Apo A-1).
* To evaluate the safety and tolerability of alirocumab.
* To evaluate the development of anti-alirocumab antibodies.
* To evaluate the pharmacokinetics (PK) of alirocumab.

The maximum study duration was 35 weeks per participant, which included a screening period of up to 3 weeks, a 24-week randomized treatment period, and an 8-week post-treatment follow-up period.

Eligibility Criteria:
Inclusion criteria:

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at a stable dose for at least 4 weeks prior to the screening visit (Week -3).

Exclusion criteria:

* Participants without established CHD or CHD risk equivalents.
* LDL-C \<70 mg/dL (\<1.81 mmol/L) at the screening visit (Week -3) in participants with history of documented CV disease.
* LDL-C \<100 mg/dL (\<2.59 mmol/L) at the screening visit (Week -3) in participants without history of documented CV disease.
* Change in statin dose or dose regimen from screening to randomization.
* Currently taking a statin other than atorvastatin, rosuvastatin, or simvastatin.
* Atorvastatin, rosuvastatin, or simvastatin was not taken daily or not taken at a registered dose.
* Daily doses above atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg.
* Use of cholesterol absorption inhibitor (ie, ezetimibe), omega-3 fatty acid (at doses ≥1000 mg daily), nicotinic acid, fibrates, bile acid-binding sequestrant, or red yeast rice products in the past 4 weeks prior to screening visit (Week -3).
* Fasting serum triglycerides \>400 mg/dL (\>4.52 mmol/L) at the screening period.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with non-myeloid malignancy
* At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
* Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization
* Adequate serum folate and vitamin B12
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Of legal age at the time written informed consent is obtained

Exclusion Criteria:

* Known history of seizure disorder
* Known primary hematologic disorder causing anemia other than non-myeloid malignancies
* Unstable/uncontrolled cardiac condition
* Clinically significant inflammatory disease
* Other diagnoses not related to the cancer which can cause anemia
* Inadequate renal and liver function
* Iron deficiency
* Known positive test for HIV infection
* Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
* Received more than 2 red blood cell (RBC) transfusions within 4 weeks of randomization; or any RBC transfusion within 14 days before randomization; or any planned RBC transfusion between randomization and study day 1
* Received any erythropoietic therapy within 4 weeks of study day 1 or any planned erythropoietic therapy between randomization and study day 1
* Other investigational procedures
* Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s)
* Pregnant or breast feeding
* Not using adequate contraceptive precautions
* Previously randomized into this study
* Known hypersensitivity to any products to be administered
* Concerns for subject's compliance
InterStim Prospective Database

The study is to collect information from patient charts and patient questionnaires to evaluate the effects of nerve stimulation therapy on urinary dysfunction.

Men and women with urinary incontinence (leakage of urine), frequency, and bladder pain experience embarrassment, inconvenience, and a significant negative impact on their quality of life. Although traditional treatments such as medications, diet modification, and bladder training provide relief for some people, others do not experience improvement with these treatments. Recently, mechanical devices much like a heart pacemaker have been developed to stimulate the nerves (sacral and pudendal) responsible for controlling bladder function. During a two stage operation, a permanent electrical wire is implanted in the lower back and connected to a mechanical box (stimulator) implanted under the patients skin in the hip area.

Participants will be asked to complete a set of questionnaires (Intake Form, Urinary Incontinence Treatment Network (UITN) Sexual Activity Questionnaire, Interstitial Cystitis Symptom Index and Problem Index, voiding diary) within 60 days prior to the procedure. Preoperative clinical information such as primary diagnosis, history of failed therapies, and medical history will be collected from the physician office record, and operative information will be collected from the inpatient hospital record. After the two stage operation (3, 6, and 12 months, then yearly thereafter as long as the device is in place) participants will be sent questionnaires. Upon completion and return to the study site

Eligibility Criteria:
Inclusion Criteria:

* All patients at least 18 years of age scheduled for sacral nerve stimulator implantation at William Beaumont Hospital, Royal Oak, Michigan who give informed consent to participate in the project.

Exclusion Criteria:

* None