cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper

The purpose of this study is to investigate whether or not marijuana blunts will produce comparable plasma THC levels as marijuana joints and if blunts will produce larger cardiovascular and subjective effects.

There has been a rapid increase in marijuana use during the 1990s, with the most recent generation often smoking marijuana in the form of 'blunts' as opposed to more traditional routes such as in pipes or in cigarette paper. A blunt is made by removing the tobacco from a cigar and replacing it with marijuana (Golub and Johnson, 1999). The cigar wrapper contains tobacco and nicotine, which may interact with the cardiovascular and subjective effects of the marijuana to produce a different set of effects and risks than cigarette paper. Anecdotally, marijuana smokers report that blunts are more potent than joints, yet there have been no controlled studies addressing whether blunts enhance the subjective-effects and health-related consequences of marijuana use. We are proposing to do a within-subject, placebo-controlled study directly comparing the cardiovascular, subjective and pharmacokinetic effects of marijuana smoked in blunts compared to identical quantities of marijuana smoked in cigarette paper. Research volunteers will be current blunt smokers. Each will participate in six, 4-hour outpatient sessions. After baseline data have been collected (heart rate, blood pressure, mood scales, exhaled carbon monoxide, plasma THC and nicotine levels), participants will take 3 puffs, 5 seconds in duration, from a NIDA marijuana cigarette containing 0.0, 1.8 and 3.6% THC or from a blunt containing an equivalent quantity and strength of marijuana. Participants will be blind to the type of marijuana cigarette smoked. We will measure plasma THC and nicotine, subjective mood ratings, and heart rate and blood pressure repeatedly over the course of 180 minutes following smoking. This study is the first controlled investigation of the consequences of this new method of marijuana smoking; the data obtained may be useful in guiding future development of marijuana pharmacotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Current blunt marijuana use (minimum of twice/week) drug screen
* 21-45 years of age
* Practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD)

Exclusion Criteria:

* Current, repeated illicit drug use(excluding marijuana)
* Heavy cigarette use (\> 10 cigarettes/day)
* Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension)
* Laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP \> 140/90; hematocrit \< 34 for women, \< 36 for men)
* Significant adverse reaction to marijuana
* Current parole or probation
* Pregnancy or current lactation
* History of significant violent behavior
* Major current Axis I psychopathology(e.g., mood disorder with functional impairment or suicide risk, anxiety disorder, schizophrenia)
* History of heart disease
* Current use of any over-the-counter or prescription
The Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction

The primary objective of the PERI-STEMI trial is to assess whether sacubitril-valsartan is more effective in preventing adverse LV remodeling for patients with ST-elevation myocardial infarction (STEMI) than enalapril.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 - 75 years old
* First-time ST-segment elevation myocardial infarction based on the newest ESC guidelines
* Timely primary percutaneous coronary intervention within 12 hours from onset
* Written informed consent acquired

Exclusion Criteria:

* Known history of or persistent clinical chronic heart failure prior to randomization
* Previous use of ARNI, or intolerance or contraindications to study drugs including ARNI or ACEI
* History of significant chronic coronary obstruction and adverse ventricular remodeling
* History of any cardiomyopathy, valvular heart disease, congenital heart disease, stent or CABG, or planned open-heart surgery within 3 months
* History of hepatic impairment or history of cirrhosis with evidence of portal hypertension
* History of chronic renal dysfunction, or eGFR \< 30 ml/min/1.73 m2
* History of malignancy and with a life span less than one year
* Patients with a known history of angioedema related to previous ACEIs/ARB therapy.
* With contraindication to MRI examination (pacemaker and claustrophobia) or cannot finish breath-holding when lying on the examination bed
* Pregnancy or nursing women
Sirolimus Versus Anti-Vascular Endothelial Growth Factor (antiVEGF) for Wet AMD

Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous AntiVEGF treatment.

Forty subjects will be randomized to receive intravitreal Sirolimus or standard of care treatment in a 1:1 ratio. Over the course of the six month trial plus a 6 month optional extension, subjects will be evaluated monthly. Treatment with Sirolimus will be given at baseline, month 2 and month 4 with sham injections given at months 1, 3 and 5. For subjects in the extension Sirolimus will also be given at months 6, 8 and 10 with sham at month 7, 9, and 11. Subjects in the standard of care group will receive anti-VEGF injections or sham monthly. Retreatment criteria will be based upon continued subretinal edema, intraretinal edema or active chorioretinal neovascularization (CNV)

Eligibility Criteria:
Inclusion Criteria:

* best corrected visual acuity of 5-65, inclusive, in study eye
* presence of choroid neovascularization secondary to AMD
* persistent edema despite at least 3 previous intravitreal anti-VEGF injections in the past 5 months

Exclusion Criteria:

* greater than 100 micron decrease in central subfield thickness on Optical Coherence Topography (OCT) since last standard of care visit
* history of major ophthalmic surgery in the study eye in the past 3 months
* history of significant ocular disease or condition other than exudative AMD that may confound results
Biomarker-s of Abusive Head Trauma by Proteomics

The aim of our study is to highlight biomarker-s of Abusive Head Trauma by proteomics analyses on the serum of child victims of abuse.


Eligibility Criteria:
Inclusion Criteria:

* Age : 0-2 y.o
* Medical consultation for malaise, seizure (without fever), loss of consciousness, traumatic bain injury, or cranioplasty
* Blood test during medical care
* Accepted informed consent

Exclusion Criteria:

* Refused informed consent
* For control groups : medical history of child abuse
* For AHT group : rare metabolic disease (Menkes, etc..)
Optimum Menstrual Cycle Time for Endometrioma Excision

This study evaluates the optimum day of menstrual period for the excision of endometriomas to minimize the damage of surgery to normal ovarian tissue. Patients will be grouped as follicular, ovulatory and luteal according to menstrual days. Ovarian damage will be evaluated with both pathologic examination and anti-mullerian hormone levels before and after the surgery.

Endometriosis is a common gynecologic disease seen in about 10% of women in reproductive age. The most common site of endometriosis is overt. Cystic formation of ovarian endometriosis is called endometrioma (chocolate cyst). Definitive treatment of endometriomas is excision by laparoscopy. The disadvantage of this surgery is the removal of some of the normal ovarian follicles within cystectomy material. This procedure can damage the ovarian reserves with the treatment of endometriomas, which are already the cause of infertility, and lead to the conditions such as infertility or early menopause. It has been understood that the ovarian reserves of the patients who underwent endometrioma cystectomy with the decrease of the Anti-Mullerian Hormone values, which is an over reserve parameter.

Eligibility Criteria:
Inclusion Criteria:

* 4 to 10 cm unilateral ovarian endometrioma
* having clinically indication of laparoscopic ovarian endometrioma excision

Exclusion Criteria:

* prior gynecologic surgery
* prior abdominal surgery
* additional operation in the same session
* having the diagnosis of premature ovarian failure or ovarian insufficiency
* having any diagnosis of malignancy
* having diagnosis of a non-gynecologic chronicle disease
Effect of Feedings on Caffeine in Premature Infants

Almost all infants born \<29 weeks gestational age develop apnea of prematurity and are treated with caffeine. Type of diet and disease states may be significant contributors of variability in caffeine metabolism and pharmacokinetics (PK) in this population. This prospective, observational, open-label, opportunistic PK study will compare the population PK of caffeine between infants fed formula and infants fed exclusively breast milk; compare the activities of caffeine metabolizing enzymes between infants fed formula and infants fed exclusively breast milk; and determine the effect of hypoxia, hypotension, and infection on caffeine PK and metabolism in premature infants.

This study will use a consecutive patient sampling approach. All eligible participants admitted at each site will be approached. Caffeine and feedings will be administered per standard of care. Manipulations of caffeine dosing or feeding regimens will not be a part of this protocol. To minimize the amount of blood sampling, the investigators will use a sparse sampling methodology. Urine will be collected for analysis of caffeine and caffeine metabolite concentrations. Caffeine pharmacokinetics will be described by population pharmacokinetic analysis. Urinary concentrations of caffeine and its metabolites will be used to calculate metabolic ratios as markers of enzyme activity.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from parent(s) or legal guardian(s)
* \<29 weeks birth gestational age
* Postnatal age ≤15 days
* Receiving caffeine (intravenous or oral) per standard of care for prevention or treatment of apnea of prematurity

Exclusion Criteria:

* Known major congenital or chromosomal anomaly
Rituximab and Gemcitabine for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Rituximab has been demonstrated to sensitize drug-resistant NHL cells to the cytotoxic actions of several chemotherapy agents by enhancing sensitivity of tumor cells to chemotherapy-induced apoptosis. Gemcitabine, a nucleoside analog that is used in several other malignancies, has shown very promising activity in patients with refractory Hodgkin's disease and low-grade NHL. The combination of rituximab and gemcitabine may have synergistic cytotoxic action in patients with relapsed or refractory DLBCL and possibly lead to improved response rates and demonstrable clinical benefit.

This trial will investigate the efficacy the combination of rituximab and gemcitabine in treating patients with relapsed or refractory DLBCL.

OUTLINE: This is a multi-center study.

* Rituximab 375 mg/m2 day 1 of 21 day cycle
* Gemcitabine 1000 mg/m2 days 1 and 8 of 21 day cycle

Subgroup 1. Relapsed after responding to first line chemotherapy, who are not candidates for salvage high-dose chemotherapy.

Subgroup 2. Failure to achieve a complete response or relapsed after responding to salvage chemotherapy (any number of salvage regimens allowed), who are not candidates for high-dose chemotherapy.

Subgroup 3. Refractory to first line chemotherapy and/or 1 (one) salvage chemotherapy regimen.

Subgroup 4. Progression after high-dose chemotherapy. Patients with progressive disease within 3 months of high-dose chemotherapy are not allowed.

Performance Status: ECOG performance status 0, 1, 2

Life expectancy: Not specified

Hematopoietic:·

* ANC ≥ 1,000/mm3·
* Platelets ≥ 100,000/mm3

Hepatic:·

* Total bilirubin ≤ 2.0 x ULN·
* ALT and AST ≤ 3 x ULN unless lymphoma involves the liver on CT scan then AST and ALT can be \< 5 x ULN

Renal:·

* Serum creatinine ≤ 2.0 mg/dl (except for patients on dialysis)

Cardiovascular:·

* Not specified

Pulmonary:·

* Not specified

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven DLBCL which meet the criteria of any of the 4 subgroups
* Transformed DLBCL from a previous indolent NHL which meet the criteria of any of the 4 subgroups and have received at least one standard chemotherapy regimen for aggressive NHL or a biopsy upon progression of disease has been obtained to confirm the presence of DLBCL. The concomitant presence of a component of low grade lymphoma will NOT exclude participation
* Measurable disease per Standardized Response Criteria for Non-Hodgkin's Lymphoma
* Prior gemcitabine therapy is allowed.
* Negative pregnancy test

Exclusion Criteria:

* No history of life-threatening reactions to rituximab.
* No history of gemcitabine intolerance; prior gemcitabine therapy is allowed.
* No history of malignancy in the last 5 years (basal cell carcinoma of the skin excluded).
* No central nervous system or cerebrospinal fluid involvement
* No other investigational drugs received within 30 days prior to being registered for protocol therapy.
* No active infections.
* No current breastfeeding
Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.

The objective of the study is to assess the efficacy and safety of SAR97276A in severe malaria in pediatric patients. Before treating pediatric patients with severe malaria, the efficacy and safety of SAR97276A will be first tested in adult patients, then in pediatric patients, with uncomplicated malaria.

The safety and the concentration of SAR97276A in blood and plasma will be assessed in adult and pediatric patients.

The treatment will be administered by intramuscular or intravenous route depending on the cohort. The treatment will be administered as single dose or 3-day repeated dose. The patients will be hospitalized for 3 days and followed up to 28 days following study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with uncomplicated malaria will be enrolled in cohort 1
* Pediatric patients with uncomplicated malaria will be enrolled in cohort 2
* Pediatric patients with severe malaria will be enrolled in cohort 3
* Plasmodium falciparum malaria confirmed in blood smear
* Fever within the last 24 hours.

Exclusion Criteria:

* Treatment with an antimalarial agent within 72h of screening
* Severe concomitant disease
* Pregnant or breast-feeding women
* Women of child bearing potential not protected by an effective method of birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Microdystrophin Gene Transfer Study in Adolescents and Children With DMD

This is a controlled, open-label, single-ascending dose study to evaluate the safety, tolerability and efficacy of SGT-001 in adolescents and children with Duchenne muscular dystrophy (DMD). Participants will receive a single intravenous (IV) infusion of SGT-001 and will be followed for approximately 5 years.

The protocol was amended to drop the control arm after 4 participants were dosed. Participants currently enrolling are assigned to active treatment. Control participants enrolled under original protocol will continue through the study per the original protocol.


Eligibility Criteria:
Inclusion Criteria:

* Established clinical diagnosis of DMD and documented dystrophin gene mutation predictive of DMD phenotype
* Confirmed absence of dystrophin as determined by muscle biopsy (ambulatory participants)
* Anti-AAV9 antibodies below protocol-specified thresholds
* Stable cardiac and pulmonary function
* Adolescents: non-ambulatory by protocol-specified criteria
* Children: ambulatory by protocol-specified criteria
* Stable daily dose (or equivalent) of oral corticosteroids ≥ 12 weeks

Exclusion Criteria:

* Prior or ongoing medical condition or physical examination, ECG or laboratory findings that could adversely affect participant safety, compromise completion of treatment and follow-up, or impair assessment of study results
* Abnormal liver function
* Abnormal renal function
* Clinically significant coagulation abnormalities
* Impaired cardiovascular function based on cardiac MRI or ECHO
* Impaired respiratory function based on FVC % predicted or need for daytime ventilatory support
* Significant spinal deformity or presence of spinal rods
* Body mass index ≥ 95th percentile for age
* Exposure to another investigational drug within 3 months or 5 half-lives prior to screening
* Exposure to drugs affecting dystrophin or utrophin expression within 6 months prior to screening

Additional inclusion/exclusion criteria may apply.
A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients

The primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertraline/placebo over a 12-week treatment period. The secondary objectives of the study are a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial) and after discontinuation, b) to compare physical health outcomes, medical services utilization, and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone, and c) to assess whether early co-administration of sertraline/ alprazolam XR will result in greater maintenance of treatment response than sertraline/placebo over the three months following the 12 week acute treatment program.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will include men and women over the age of eighteen;
* the ability to give written informed consent;
* current principal or co-principal psychiatric diagnosis of panic disorder with or without agoraphobia based on DSM-IV criteria (American Psychiatric Association, 1994);
* willing to use an effective means of contraception;
* free of psychoactive medications for at least 2 weeks prior to study enrollment;
* not actively be suicidal.

Exclusion Criteria:

* actively suicidal;
* medical conditions for which either sertraline or alprazolam XR would be contraindicated;
* recent six month history of substance or alcohol abuse;
* history or presence of psychotic or bipolar disorder;
* women who are pregnant or breastfeeding;
* history or presence of a seizure disorder or a known history of more than one childhood febrile seizure;
* presence of a personality disorder severe enough to compromise the investigator's ability to evaluate the efficacy and safety of the study medication;
* concomitant therapy with other psychotropic medication(s);
* clinically significant abnormality during physical examination, vital signs, EKG, urine drug screen, or laboratory tests at the screen visit.
Open Label Extension Study of AMX0035 in Patients With ALS

This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the Centaur study.

The Centaur Open Label Extension Study (CENTAUR-OLE) is designed to provide longer term access to AMX0035 for patients with ALS who participated in the CENTAUR study. The study will assess longer term safety and therapeutic potential of AMX0035.

Eligibility Criteria:
Inclusion Criteria:

1. Completion of all visits in the randomized, double blind AMX0035 study. Subjects that receive tracheostomy or PAV during the course of the main study will still be followed as ITT until the week 24 visit before enrollment in the OLE.
2. Must enroll in the OLE within 28 days of the Week 24 visit of the main study.
3. Signed informed consent to enter the open label extension phase.

Exclusion Criteria:

1. Discontinued study drug prematurely in the double-blind phase of the study for reasons other than tracheostomy or PAV.
2. Exposure to or anticipated requirement for any disallowed medication listed below.
3. Any ongoing adverse events that in the opinion of the Site Investigator are clear contraindications to the study drug.
4. Unstable cardiac or other life-threatening disease emergent during the randomized, double blind study
5. Any major medical condition that in the opinion of the Site Investigator would interfere with the study and place the subject at increased risk.
Relative Bioavailability Study of Nirmatrelvir/Ritonavir Oral Powder Relative to the Commercial Tablets and Estimation of the Effect of Food on Bioavailability of the Nirmatrelvir/Ritonavir Oral Powder in Healthy Participants.

The purpose of this study is to estimate the relative bioavailability (rBA) of nirmatrelvir/ritonavir oral powder in 3 different food vehicles relative to the Paxlovid® tablets under fasted condition in healthy adult participants, and to estimate the effect of food on the rBA of the nirmatrelvir/ritonavir oral powder formulation. The study will also assess the safety, tolerability, and palatability of nirmatrelvir/ritonavir oral powder in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), laboratory tests, vital signs and standard 12 lead ECGs.
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion Criteria:

* Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White syndrome).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antibody (HCVAb). Hepatitis B vaccination is allowed.
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
* Participant who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period.
* A positive urine drug test.