cyrilzakka/clinical-trials huggingface dataset:
LSD Treatment for Persons With Alcohol Use Disorder

Alcohol use causes more overall harm than any other drug and is the seventh leading risk factor for both deaths and disability-adjusted life years. Alcohol use disorders (AUD) are among the most common and undertreated mental disorders in developed countries. Pharmacological and psychotherapeutic treatments only show limited efficacy and around 60% of the patients relapse in the short-term after withdrawal.

Lysergic acid diethylamide (LSD) was investigated in numerous clinical trials during the 1950s and 1960s. Specifically, the use of LSD in the treatment of AUD was investigated extensively. A pooled analysis of six historical clinical trials demonstrated, that a single dose of LSD significantly reduced alcohol use at three and six months after LSD administration. However, these trials are limited by several factors, including the use of diagnostic standards that are no longer not up to date, single, high-dose treatment regimes, missing biological assessment for alcohol use, and no consequent assessment of blinding.

Therefore, the present study aims to evaluate the safety and efficacy of LSD for the treatment of AUD and addresses the shortcomings of previous studies. The trial has a double-blind, active placebo-controlled, randomized, parallel design and will be conducted in specialized treatment centers for addictive disorders in Switzerland. The study will include 126 patients after withdrawal treatment and will primarily assess the efficacy of LSD for the treatment of AUD. Patients will be treated using a 1:1 allocation. Each arm will last 20 weeks and will comprise nine study visits without drug administration and two study days involving LSD or active placebo administration. In the first session, patients in the treatment group will receive a dose of 150 µg LSD, followed by another 150 µg or 250 µg LSD in the second session, which will take place approximately 4 weeks after the first session.

The primary outcome is the mean of percent heavy drinking days after administration of two doses of LSD at 3 months follow-up. Additionally, the study will assess neurobiological mechanisms of action and several other measures.


Eligibility Criteria:
Key inclusion criteria:

* age ≥ 25 years
* moderate to severe AUD
* completion of a qualified detoxification for AUD within 30 days prior to screening
* a minimum of 4 heavy drinking days within the last 30 days before detoxification
* intention to stop or decrease drinking

Key exclusion criteria:

* significant alcohol withdrawal symptoms at screening
* participating or starting in any formal treatment for AUD until completion of visit 9
* cognitive impairment
* borderline personality disorder
* current post-traumatic stress disorder
* current suicidality or history of a serious suicide attempt
* significant prodromal symptoms
* history of a diagnosis of a psychotic or bipolar disorder in subjects or first-degree relatives
* pregnancy or breast-feeding
* lack of safe contraception are exclusion criterion for women only
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population

The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51 vaccination in a pediatric population from endemic regions.

Open-label, randomized, active controlled Phase 3 study in children aged ≥ 2 months to \< 18 years. Subjects aged ≥ 2 months to \< 12 months were randomized in a 2:1 ratio to receive IC51 (0.25 ml dose) or Prevnar® as a safety comparator. Children aged ≥ 12 months to \< 3 years and ≥ 12 years to \< 18 years were randomized in a 3:1 ratio to receive IC51 (0.25 ml dose \< 3 years, 0.5 ml ≥ 12 years) or HAVRIX®720 as safety comparator.

For subjects aged ≥ 3 years to \< 12 years, a dose finding run-in phase was performed. A total of 200 subjects were randomized 1:1 to receive either the 0.25 ml or the 0.5 ml dose of IC51, and the appropriate dose was determined based on an interim analysis. After this run-in phase, 300 further children in this age group were randomized 2:1 to receive either 0.5 ml of IC51 or HAVRIX®720.

Immunogenicity was be studied in a subgroup of 30 children aged ≥ 2 months to \< 12 months; 125 children aged ≥ 12 months to \< 3 years and 140 children ≥ 12 years to \< 18 years. For the age group of ≥ 3 to \< 12 years immunogenicity was assessed in the 200 children enrolled during the dose-finding run-in phase.

Eligibility Criteria:
Inclusion Criteria:

* Male or female healthy children and adolescents aged \> 2 months to \< 18 years at the time of first vaccination.
* Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
* Female subjects: either no childbearing potential or negative pregnancy test, for females after menarche willingness to practice a reliable method of contraception.

Exclusion Criteria:

* Clinical manifestation of Japanese Encephalitis
* History of Flavivirus vaccination (including any investigational vaccines)
* History of vaccination with HAVRIX®720 and/or Prevnar®
* History of immunodeficiency or immunosuppressive therapy
* Known HIV, HBV or HCV infection
* History of hypersensitivity reactions to other vaccines
* Acute febrile infection at each visit during which the subject receives a vaccination
* Active or passive immunization within 2 weeks prior to the first IC51 vaccination and up to the second IC51 vaccination.
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
* Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
* A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment

Exclusion Criteria:

* Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams \[mg\] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (\>=) 20 mg of dexamethasone within 14 days before randomization
* Had plasmapheresis within 28 days of randomization
* Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
* Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
* Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
* Myeloma Frailty Index of \>=2 with the exception of participants who have a score of 2 based on age alone
A Couples-based Approach for Increasing Physical Activity Among Adults With Type 2 Diabetes

In a 6-week experimental design, up to 90 adult couples in which one partner has Type 2 Diabetes (T2D) will be randomly assigned to either the collaborative implementation intentions (Collaborative IIs), the Individual Implementation Intentions (Individual IIs) condition, or the control condition. As this is a pilot study, randomization for the experimental groups vs the control groups will occur at a 2:1 ratio. Thus, the experimental conditions will contain up to 36 participants and the control condition will contain up to 18 participants. Adults with T2D who are living with a romantic partner, not meeting current physical activity guidelines but able and willing to begin a new physical activity (PA) routine and their partners will be assessed at baseline, 3 weeks and 6 weeks after the experimental manipulation. Partners will report on their own investment in the patient's goal and patients will report on their own PA self-efficacy. Patient's PA will be measured through self-report, partner report and accelerometers for a week prior to each survey assessment. These specific aims are planned:

AIM 1: Determine whether collaborative IIs for patient's PA lead to a greater increase in partner investment in partners of adults with T2D than do individual IIs or control.

AIM 2: Determine whether collaborative IIs for patient's PA lead to a greater increase in patient PA self-efficacy in adults with T2D than do individual IIs or control.

AIM 3: Determine whether collaborative IIs for patient's PA lead to a greater increase in patient PA in adults with T2D than do individual IIs or control.


Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age
* Able to read and understand English
* Does not meet physical activity guidelines (\< 150 minutes of moderate-vigorous exercise per week) for the last 3 months\* (only required of one partner)
* Diagnosed with Type 2 Diabetes\* (only required of one partner)
* Married or living with a romantic partner

Exclusion Criteria:

* Medical or physical contraindications to participate in physical activity
Inflammatory Response as a Prognostic Factor of Recurrence of Atrial Fibrillation After Ablation

The aim of this study is to evaluate inflammatory response as a prognostic factor of atrial fibrillation recurrency after ablation. Inflammatory response will be assessed by double measurement of C-reactive protein, fibroblast growth factor 2 (FGF2), matrix metallopeptidase 8 (MMP8) and body temperature. Dynamics of change of troponin I will be measured additionally.

After ablation each patient will be monitored with ECG telemonitoring system for 7 days.


Eligibility Criteria:
Inclusion Criteria:

* signed consent;
* criteria for ablation of atrial fibrillation.

Exclusion Criteria:

* previous pulmonary veins isolation;
* ablation other than pulmonary veins isolation during the procedure;
* atrial fibrillation at the beginning of ablation procedure;
* usage of 'single shot' devices.
Massage Therapy in Treating Patients With Cancer Pain

RATIONALE: Massage therapy may help lessen pain caused by cancer.

PURPOSE: This randomized phase II trial is studying how well massage therapy works in treating patients with cancer pain.

OBJECTIVES:

* Determine whether the effects of massage therapy in patients with cancer pain are sufficiently promising to warrant a definitive trial.
* Determine the feasibility of a definitive trial.

OUTLINE: This is a randomized, controlled, pilot study. Patients are stratified according to in-patient status (yes vs no) and first baseline pain score ≥ 7 (yes vs no). Patients are randomized to 1 of 3 treatment arms.

* Arm I (massage therapy): Patients receive a light touch ("Reiki") massage over 45 minutes.
* Arm II (volunteer visit control): Patients receive a 45-minute visit from a trained volunteer who will be available to sit quietly or talk with the patient to discuss issues of concern, as desired by the patient. Volunteers will not touch the patient except to pat their shoulder or briefly hold their hand.
* Arm III (quiet time control): Patients receive 45 minutes of quiet time. Pain and mood are assessed at baseline, immediately after treatment, at 6 hours and 24 hours after treatment, and then daily for the next 5 days after treatment.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of cancer
* Baseline pain score ≥ 2 on a 0-10 rating scale where 0 = no pain
* Pain syndrome must be the result of cancer and/or cancer treatment

  * No postoperative or other acute procedural pain

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Concurrent pharmacologic pain therapy allowed
Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient

The purpose of study is to assess the efficacy of add-on estrogen pretreatment in GnRH antagonist protocol on oocyte retrieval as compared with GnRH antagonist protocol for patients with poor ovarian response Add-on estrogen pretreatment protocol is superior to none pretreatment GnRH antagonist protocol for the number of oocytes retrieval

Women of advanced maternal age seeking ART treatment are characterized as poor ovarian responders in the process of ovarian simulation. Poor response to ovarian stimulation causes high cycle cancellation rate and extremely low pregnancy rate.

More attention has been paid to the potential interest of steroid pretreatments in GnRH antagonist cycles; not only for scheduling the GnRH antagonist cycles, but also for synchronizing the follicular growth which may result in more oocytes retrieved. But available clinical results are controversial.

Previous studies have shown that utilizing the natural negative feedback of the hypothalamus-pituitary-ovary axis induced by estradiol valerate pretreatment effectively prevented inter-cycle increases in follicle-stimulating hormone, improved follicle synchronization, and resulted in a more coordinated follicular development, leading to the recovery of more mature oocytes. However none of the randomized controlled studies compared estradiol valerate pretreatment or not on treatment outcomes, ongoing pregnancy rate, directly on poor response patients using estradiol valerate pretreatment in GnRH antagonist protocol.

Eligibility Criteria:
Inclusion Criteria:Bologna criteria

* At least two of the following three features must be present:

  1. Advanced maternal age (≥40 years) or any other risk factor for POR
  2. A previous POR (≤3 oocytes with a conventional stimulation protocol)
  3. An abnormal ovarian reserve test (i.e. antral follicle count \< 5-7 follicles or AMH\< 0.5 - 1.1 ng/mL)

Exclusion Criteria:

1. Age ≥45 years,
2. Patients who conducted PGD/PGS, and donor egg cycles were excluded.
3. Presence of unilateral ovary absence
4. Abnormal uterine deformity or structure.
5. Spontaneous abortion patients with three or more (including biochemical pregnancy abortion)
6. With other endocrine disease, ovulation disorders such as adrenal cortex function or thyroid dysfunction
7. Have assisted reproductive technology contraindications or pregnancy contraindication of patients
Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes

We hypothesize that insulin glulisine is non-inferior to currently proven rapid-acting insulin lispro when used in a basal/bolus regimen to treat hyperglycemia in patients with gestational diabetes mellitus.

To date, only two rapid-acting insulin analogs have been shown to be safe and effective for the treatment of diabetes during pregnancy: insulin aspart and insulin lispro.

The pharmacokinetics and pharmacodynamics of insulin glulisine are unique and insulin glulisine may be the best rapid-acting analog for the treatment of post-prandial hyperglycemia. We believe that insulin glulisine should be evaluated in women with gestational diabetes for its potential efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent to participate in clinical trial
* Pregnant and 20-30 weeks gestation
* Diagnosed with gestational diabetes
* Failed diet therapy (failed lifestyle modification will be defined as 10% or greater SMBG values above pre-meal \<90mg/dL and post prandial \< 120mg/dL
* Eat at least 2 meals per day

Exclusion Criteria:

* Pregnant women \<18 years old
* Blood pressure \> 140/80 mmHg
* A1C equal to or greater than 6.5% at time of enrollment
* Pre-pregnancy BMI \> 40Kg/m squared
* Evidence of any fetal anomaly on any fetal ultrasound
* Currently using hypoglycemic agent
* Refusal to use insulin before meals
* Inability to understand instructions or to consent to participate
* Pregnant women with history of T1DM or T2DM
* Clinical judgment by investigator that patient is inappropriate for clinical trial or has a metabolic disorder that could interfere with results
Evaluation of the SARC-F Score as a Screening Tool for Undernutrition in a Geriatric Population

To study the relationship between sarcopenia and undernutrition in adult patients over 70 years of age, and at the same time to define a threshold value for the predictive SARC-F score of undernutrition.

Hypothesis : the SARC-F score is correlated with malnutrition defined according to the following HAS criteria :

Moderate denutrition Severe denutrition

The geriatric population is a population at risk, given the frequent and numerous comorbidities present. Undernutrition is one of these, which is frequently associated with sarcopenia, that is, a decrease in muscle strength. Its screening must be early to avoid complications (osteoporosis, fractures, infections ...) and given the cost it generates for society. However, the detection of undernutrition can sometimes be time-consuming and its criteria in default, such as in the presence of edema or obesity, for example. There is a score, the SARC-F, which allows to detect sarcopenia from a result greater than or equal to 4, but which does not allow direct detection of undernutrition.

The primary objective is to evaluate the SARC-F score as a screening tool for undernutrition in a geriatric population, secondary objectives being to find a threshold value at this score, and also to estimate a prevalence of undernutrition in this population.

It will be a cross-sectional exploratory study to evaluate a diagnostic tool, the SARC-F score, with comparison between cases and controls.

The study will be conducted in a single center, a geriatric short-stay service. Participation in the study will be offered to any patient admitted to the geriatric ward, those who meet the inclusion criteria and do not have exclusion criteria will have to complete the SARC-F questionnaire during their stay, and to do the handgrip test and impedancemetry performed by a third party. Biological data (albumin, pre-albumin and C-Reactive Protein) and anthropometric data will be collected and analyzed to determine if the patient is malnourished or not, and the results of SARC-F will be compared between these 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* 70 years and over
* living at home or in nursing homes in Puy-de-Dôme
* sent in short geriatric stay at the Grand Pré clinic by their general practioner, an emergency department or an EHPAD

Exclusion Criteria:

* refusal to participate in the study
* severe dementia preventing answering SARC-F questions
* no fluency in the French language
* patient with a pacemaker (contraindication of the use of impedancemetry)
Obesity and Caries in Young South Asian Children: A Common Risk Factor Approach

The CHALO ("Child Health Action to Lower Oral Caries and Obesity") -- from an Urdu word meaning "Let's go!"-is a multi-level strategy to reduce pediatric obesity and dental caries risk in South Asian (SA) children. Obesity and caries are the two most prominent health disparities of early childhood. Both caries and obesity: a) disproportionately impact low-income children of color, b) share common risk behaviors, i.e., feeding practices, and c) can most effectively be reduced or prevented prevention in infancy and early childhood. SA immigrant children are at high risk for both. CHALO includes both a randomized controlled trial (RCT) aimed at reducing risk behavior, and a Knowledge Translation project to raise awareness in SA lay and professional communities regarding child health risks.

CHALO builds upon the team's prior research re: cariogenic (R34-DE-022282) and obesogenic behaviors (10, 14, 15). CHALO's intervention components-- home visits, phone support, and "patient navigation" to dental visits-- proved to be feasible and acceptable. In the pilot R34, there were promising behavioral change on all measures. CHALO builds on this work, with the addition of: a) sippy cups as an intervention target, b) an iPad-based dietary recall tool, "MySmileBuddy," c) caries and obesity data, and; d) increased intervention contacts- consistent with recent child obesity and caries interventions (16, 17).

An RCT (Aim 1) will enroll 360 mothers of children 4-6 month olds from New York City (n=3) and New Jersey (n=2) pediatric practices in SAPPHIRE ("SA Practice Partnership for Health Improvement and Research"). The Community Health Worker intervention includes: a) home visits with mothers/families (n=6 visits over one year) and follow up telephone support; b) patient navigation to make/keep timely dental visits (2x by 18 months). The Knowledge Translation component (Aim 2) will raise awareness of child health risks in SA communities and among professionals who provide their care. The campaign will include both traditional and social media components and will be evaluated using multiple metrics.

Eligibility Criteria:
Inclusion Criteria:

* Age: Child is \< 6 months of age at time of recruitment
* Insurance: Child is enrolled in either Medicaid or CHIP
* Nativity- Mother was born in India, Pakistan, or Bangladesh)
* Language- Mother speaks standard Bengali, English or Hindi/Urdu
* Agency- Mother is index child's primary caretaker.

Exclusion Criteria:

* Inability to provide informed consent per RA judgment
* Plans to travel for \> 1 month during follow-up, and
* child health condition barring participation (per pediatrician review of recruitment lists).