cyrilzakka/clinical-trials huggingface dataset:
Bright Light Therapy During Residential Alcohol Withdrawal

This is a randomized controlled trial assessing the effectiveness of light therapy versus placebo in patients undergoing alcohol withdrawal.

All eligible patients will be offered and explained the study by a psychiatrist/addictologist during the consultation (or teleconsultation) to schedule a 14-day hospitalization for alcohol withdrawal (maximum 3 months before hospitalization). Patients will be randomized centrally to one of the following two treatment conditions (blind maintained by a nurse independent of the assessment), on day D0 of inpatient treatment for withdrawal (standardized withdrawal over 14 days with hydration, vitamin B1, benzodiazepines in gradual decrease before stopping and according to signs of withdrawal):

1. Active light therapy (10,000 Lux).
2. Placebo light therapy (with filter \<10 Lux). Every morning in the room (patient in a single room), at 8 am, for 30 min, for the entire duration of withdrawal, i.e. 13 days (start on D1) and stopped on D14.

No change in usual care apart from this intervention.

After checking the inclusion and non-inclusion criteria and obtaining consent, patients will be randomized (ratio 1:1) between the groups with active light therapy or placebo, by connecting to a randomization website (REDCap software) using a randomization list prepared in advance, balanced by block of randomly variable size

Eligibility Criteria:
Inclusion Criteria:

* Patients must be aged from 18 to 65 years old and have a diagnosis of Alcohol Use Disorder
* Patients must be intreated for alcohol withdrawal, for at least two weeks
* Patients must report heavy drinking episodes in the past month
* Patients must be able to understand medical information and consent to the treatment
* Patients must be considering a goal of abstinence from alcohol

Exclusion Criteria:

* Ophthalmic pathology (cataract, macular degeneration, glaucoma, retinitis pigmentosa) and diseases affecting the retina (retinopathy, diabetes, herpes, etc.)
* Subjects who have already received light therapy in the last 6 months
* Lactating of pregnant women
* Psychiatric comorbidity requiring an intreatment, or risk of manic episode (subjects with depressive or anxious symptoms compatible with an out-treatment can be included)
* Substance Use Disorder other than alcohol and/or tobacco
* Severe cognitive impairment (MOCA \< 10)
* Patients being under legal protection measure
rhGH Therapy on Hepatic Drug Metabolism

The purpose of the study is to understand the effect of rhGH therapy on hepatic drug metabolism in children with idiopathic growth hormone deficiency.

Growth Hormone (GH) deficiency is a prominent cause of short stature, affecting approximately 14,000 children in the US. Although a single study has demonstrated reduces CYP1A2 activity following Gh replacement therapy, the effect of GH on the most abundant phase 1 biotransformation pathways (e.g. CYP2D6 and CYP3A4) remain largely uncharacterized. This information gap exists largely due to the lack of sufficiently safe, specific and non-invasive methods appropriate for the longitudinal evaluation of enzyme activity in young children. We can overcome these problems by employing validated phenotyping methods using caffeine, a commonly ingested dietary substance and dextromethorphan, a safe, non-sedating over the counter anti-tussive agent. Application of these methods will permit us to identify, characterize and describe the isoform-specific effects of rhGH on major phase 1 hepatic drug biotransformation pathways, thereby addressing this information gap with minimal risk to children.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 4 to 14 years with a height less than the 5th percentile for age and sex or having a decelerated across two major percentiles (5th, 10th, 25th, 50th, 90th, and 95th) on standard pediatric growth curves, poor growth velocity (less than 5 centimeters/year), radiographic evidence of delayed bone age (i.e. greater than 1 SD below the mean for chronological age) and a documented diagnosis of idiopathic growth hormone deficiency \[as determined by failure to raise serum GH concentrations 10 microgram/Liter following provocative testing with two growth hormone secretagogues(e.g. insulin, arginine, or clonidine)\].
* All subjects will be prepubertal, as determined by Tanner staging.

Exclusion Criteria:

* Children receiving medications known to induce or inhibit hepatic CYP1A2, NAT-2, XO, CYP2D6 or CYP3A4 activity.
* Subjects with a history of smoking (including exposure to second hand smoke \> 8 hours per day) or illicit drug use.
* Subjects with a history of hepatic, renal, cardiac or thyroid disorders. Presence of hepatic, renal, cardiac or thyroid disease will be established based on clinical history and results of recent laboratory tests conducted as part of the routine medical evaluation of children who are being considered for rhGH therapy.
* Children experiencing fever or acute viral illness
* Children who have a history of a hypersensitivity reaction to dextromethorphan or caffeine
* Children who have received prior treatment with rhGH
* Children who are receiving corticosteroids or thyroid hormone
Investigation of Low-intensity Focused Ultrasound Pressure

Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI.

Study aims to determine safety and efficacy of variable pressures of low-intensity focused ultrasound using an electrical stimulation to create a somatosensory evoked potential and record eeg and fMRI outcome measures. A primary safety study will be conducted prior to 'full scale' data collection.

Eligibility Criteria:
Inclusion Criteria:

Understand and speak English

Exclusion Criteria:

1. Claustrophobia (scanning environment may be uncomfortable).
2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
3. Contraindications to CT: pregnancy
4. Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
5. History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
6. History of head injury resulting in loss of consciousness for \>10 minutes.
7. History of alcohol or drug dependence (through self-report).
Ocular Pulse Amplitude And Choroidal Laser Doppler Flowmetry

This study intends to investigate the relationship between choroidal blood flow and ocular pulse amplitude (OPA).

One eye is randomly selected in 18 healthy subjects. OPA is assessed with Dynamic Contour Tonometry. Submacular choroidal blood flow is measured with Laser Doppler Flowmetry. During both examinations the systemic blood pressure is continuously recorded with Finometer. An average systolic and diastolic LDF parameter flow during 30 seconds are determined and the pulsatility index is calculated according to the formula (LDFsys-LDFdia)/LDFdia. An association of OPA with the LDF pulsatility index, systemic blood pressure values and mean intraocular pressure will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects should present no history of ocular diseases, of current topical medication, or of drug or alcohol abuse. Furthermore, a best corrected visual acuity above 20/25 in both eyes, lack of pathological findings upon a slit-lamp examination and dilated direct fundoscopy, and an IOP \< 21 mmHg in both eyes will be required.

Exclusion Criteria:

* History of chronic or recurrent severe inflammatory eye disease such as scleritis or uveitis.
* History of ocular trauma or intraocular surgery. History of infection or inflammation within the past 3 months.
* History and clinical evidence for other retinal disease such as age-related degeneration, or diabetic retinopathy.
Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns

This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM).

This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM). A comparison will be made between burn wounds treated with BTM and the institution's standard of care (SOC).

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent directly or via legal representative prior to any clinical study procedures being performed
2. Willing to comply with all study procedures and expects to be available for the duration of the study
3. Male and females ≥ 18 years of age and ≤ 75 years of age
4. Patients with deep dermal or full thickness burns between 3% and 60%, inclusive, of their total body surface area (TBSA).

   Types of burns include the following:
   * Scalding including from hot water, cooking oil, grease
   * Flame
   * Flash
   * Contact
5. Subjects who have staged surgical procedures planned e.g., one procedure to excise the burn injury and a later procedure to prepare the wound bed and apply an autologous skin graft.
6. The minimum total area across all lesions to have NovoSorb® BTM applied is 3% TBSA
7. Females, who are non-pregnant, naturally postmenopausal, or who agree to use effective contraceptive methods throughout the course of the study.

Exclusion Criteria:

1. Has a known hypersensitivity to polyurethane
2. Only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn/crush, i.e., road rash
3. Multiple traumas, i.e., significant traumatic injury to a solid organ in addition to skin
4. Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy
5. Presence of a medical condition that might interfere with treatment evaluation; or require a change in therapy including but not limited to, significant immune deficiency, or skin or vascular diseases in the area of the wound
6. For females - has known or suspected pregnancy, planned pregnancy, or during lactation
7. Has exposure to any other investigational agent within the last 6 months
8. Has exposure to any other treatment/device that will interfere with NovoSorb® BTM integration
9. Anticipated inability to perform wound care and follow-up procedures
10. Anticipates of a level of non-compliance
11. The use of off-label treatments for full-thickness / deep-dermal burns is not permitted
12. Clinical signs of wound infection at areas to be potentially treated using NovoSorb® BTM that in the opinion of the investigator may compromise safety and study objectives
13. The use of NovoSorb® BTM on the face and in the perineum area is not permitted
Maternal Smoking During Pregnancy and Female Fetal Testosterone Levels

* The investigators hope their study will answer the question of whether or not fetal testosterone levels are increased in female newborns exposed to nicotine as a result of maternal smoking during pregnancy. Secondarily they plan to also evaluate maternal cotinine and testosterone levels and newborn anogenital distance, second digit to fourth digit (2D:4D) finger length ratio, newborn length and birth weight.
* The investigators hope by performing this study, they will help to uncover the effect of tobacco exposure in utero on human female fetal testosterone levels, thus improving the counseling for tobacco use in pregnancy.

Epidemiological studies and laboratory research performed on animal models have revealed that the effects of maternal smoking during pregnancy go beyond the perinatal period due to the effect of nicotine on increasing fetal testosterone levels. This is of great concern as an increase fetal testosterone has been linked to impaired reproductive development and infertility in both male and female offspring, early onset of menarche in females, shorter body height, increased BMI, shortened anogenital distance and low second digit to fourth digit finger length ratio. Additionally elevated fetal testosterone levels have been associated with development of psychosocial disorders such as Autism, ADHD, antisocial behavior, conduct disorder, adult criminal behavior, and sensation seeking behavior.

Although there have been a few animal studies that have investigated the effects of maternal nicotine exposure on fetal testosterone levels with review of the epidemiologic literature on subsequent adverse implications, no known human studies have been performed to further investigate the relationship between maternal smoking during pregnancy and female fetal testosterone levels.

Eligibility Criteria:
Inclusion Criteria:

* Women, \>/= 18 years old
* Current singleton pregnancy
* Recruited prior to 3rd trimester lab visit
* Known female fetus confirmed by Ultrasound, typically performed 18 to 22 weeks, or later gestational age (GA)
* Self reported smoker (of at least ½ pack per day) or non-smoker documented in electronic chart.
* Eligibility will not be limited by desired mode of delivery

Exclusion Criteria:

* Patients who successfully quit smoking at \<14 weeks gestation and who have not resumed smoking during the pregnancy will be excluded from the case/control arm of study.
* Patients considered light smokers, who self report smoking less than ½ pack per day.
* Patients with Polycystic Ovarian Syndrome
Delayed Cord Clamping in Premature Infants

Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of premature infants. However this procedure is not standard due to concerns that the premature infant will get too cold. In this study the investigators look at using a plastic covering and a chemical warmer to keep the small premature baby warm while waiting 30-60 seconds to clamp the umbilical cord.

Enrolled premature infants will be compared to age matched historical controls that did not receive delayed cord clamping but were placed under a warmer immediately after birth. Outcomes to be analyzed include initial body temperature, hematocrit at birth and 24 hours of age, number of red blood cell transfusions during hospital stay, umbilical cord gas, first blood gas following delivery, blood pressure data in the first 24 hours, fluid bolus and inotrope requirement in the first 24 hours, incidence of intraventricular hemorrhage and late-onset sepsis, peak bilirubin level, length of phototherapy, and Apgar scores.

Eligibility Criteria:
Inclusion Criteria:

* premature infants at 24-28 completed weeks gestation at the time of delivery
* informed consent obtained from parents prior to delivery

Exclusion Criteria:

* multiple gestation (twins, triplets, etc)
* prolonged fetal bradycardia
* placental abruption or previa
* maternal illness
* major congenital anomalies
* maternal fever in labor
* fetal illness (e.g. isoimmune hemolysis)
Association of PeRiODontal Disease and gUt Microbiome With Coronary artEry Disease (PRODUCE Study)

The purpose of this study is to explore the relationship between periodontal disease and coronary artery disease through changes in the gut microbiome. In addition, the investigators aim to find possible periodontal pathogens that have association with cardiovascular disease.

The previous studies have reported the associations among cardiovascular disease, periodontitis, and gut microbiome dysbiosis. However, there is a lack of evidences about the axis of association from oral-gut-cardiovascular disease. The investigators hypothesized that periodontal disease might induce dysbiosis of gut microbiome and dysbiosis might have a role in cardiovascular disease (as called "oro-gut-vascular axis"). The investigators aim to prove this hypothesis through this case-control, cross-sectional study.

Eligibility Criteria:
Inclusion Criteria:

-Patients aged from 19 to 80 years who underwent invasive coronary angiography for clinical necessity, with informed consent

Exclusion Criteria:

* Patients with prosthetic valve
* pregnancy
* active malignancy
* active autoimmune disease
* active inflammatory bowel disease
* chronic kidney disease (eGFR\<30, or on dialysis)
* Active liver disease or liver cirrhosis
* consistent use of probiotics
* prior gastrointestinal surgery within 1 year
Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation

RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against normal tissues. Methotrexate and cyclosporine may prevent this from happening.

PURPOSE: Phase III trial to study the effectiveness of treatment with methotrexate and cyclosporine after bone marrow transplantation to provide protection against acute graft-versus-host disease.

OBJECTIVES: I. Determine the efficacy of a combination of methotrexate and cyclosporine, administered after grafting, to prevent the development of acute graft versus host disease (GVHD) in patients undergoing allogeneic bone marrow transplantation.

OUTLINE: Patients receive methotrexate IV on days 1,3,6, and 11. Patients also receive cyclosporine IV twice a day until the patient is eating, then it is administered orally twice a day. Cyclosporine begins on day -1 and continues until day 180. The dose is reduced beginning on day 50.

PROJECTED ACCRUAL: Accrual will continue until further notice.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Ongoing bone marrow transplantation from HLA-matched siblings or HLA non-identical family members or unrelated donor

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not severely limited by disease other than leukemia Hematopoietic: Not specified Hepatic: No severe hepatic disease Renal: No history of hemorrhagic cystitis No renal disease Cardiovascular No symptomatic cardiac disease Other: No contraindication to the use of cyclosporine or methotrexate

PRIOR CONCURRENT THERAPY: No concurrent experimental treatment on other GVHD prophylaxis studies
School Nurse Intervention and After School Exercise Program for Overweight Teens

Adolescent overweight and obesity have increased dramatically in the past several decades. High schools are well-positioned to deliver weight loss treatment to overweight and obese adolescents, as they have the facilities and staff to deliver a physical activity program, school nurses with the skills to provide counseling, and are easily accessible by adolescents. This exploratory study will test the feasibility and ability of a school-based intervention, consisting of school nurse counseling and a school-based exercise program, to reduce BMI and improve dietary quality, physical activity, and sedentary behaviors in overweight and obese adolescents. If effective, this could prove to be a cost-effective and relatively easy intervention to disseminate widely for significant public health impact.


Eligibility Criteria:
Inclusion Criteria:

* enrolled in grades 9 - 12
* BMI \> 85th percentile for age/sex
* able to understand and participate in the study
* able and willing to provide informed assent (adolescent) and consent (parent)
* English-speaking with at least one English-speaking parent

Exclusion Criteria:

* planning to move out of the area within the next 8 months
* medical condition that precludes adherence to study dietary recommendations (e.g., pregnancy, Crohn's disease, ulcerative colitis)
* diagnosis of a serious psychiatric illness (e.g., psychiatric hospitalization, eating disorder, suicidal) within the past 5 years
* genetic or endocrine causes of obesity (e.g., pradi Willi, Cushing's Syndrome)
* developmental delay that would prevent participation in the intervention or measurements
* prescribed medications associated with weight gain (e.g.,oral steroids)
* morbidly obese, defined as weighing \> 300 pounds
Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. Riluzole may help slow the growth of tumor cells.

PURPOSE: This phase I trial is studying riluzole in women with stage I, stage II, or stage IIIA breast cancer.

OBJECTIVES:

Primary

* To evaluate the effects of glutamate receptor blockade with riluzole on cellular pathways important in the genesis and progression of disease in women with stage I-IIIA breast cancer by examining components of the mGluR1 signaling pathway in the pre- and post-treatment tumor samples to determine if glutamate blockade affects signaling through this pathway.

Secondary

* To determine whether treatment with riluzole affects the proliferation and apoptosis in a manner suggesting a potential for therapeutic effectiveness.
* To determine whether treatment with riluzole causes objectively measurable tumor shrinkage.

OUTLINE: Patients receive oral riluzole twice daily on days -14 to 0. Approximately 12 hours after completion of riluzole therapy patients undergo standard surgery (i.e., partial or total mastectomy) along with sentinel lymph node biopsy (for patients with node-negative disease) or full axillary dissection (for patients with node-positive disease) on day 0.

Patients undergo 3-dimensional image assessment at pre- and post-treatment by Computerized Ultrasound Risk Evaluation (C.U.R.E.).

Patients undergo core needle biopsy at baseline and during surgery for biomarker analysis (e.g., mGluR1) by IHC, western blotting, and RT-PCR. Blood samples are collected for GRM1 polymorphism analysis.

After completion of study treatment, patients are followed every 6 months for 1 year and then according to standard-of-care thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of adenocarcinoma of the breast

  * Stage I (T1c)-IIIA disease meeting the following criteria:

    * Large enough (\> 1 cm) to undergo additional multiple core needle biopsies preoperatively
    * Surgically resectable for cure or palliation without first requiring neoadjuvant chemotherapy
* Patients who have previously been treated for breast cancer, but are judged to have developed a new primary cancer, rather than a recurrence, are eligible

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* ANC ≥ 1,000/mm³
* Platelet count ≥ 50,000/mm³
* Liver function tests ≤ 3 times upper limit of normal (ULN)
* Total bilirubin ≤ 2 times ULN
* Creatinine ≤ 1.5 mg/dL
* INR ≤ 25% normal limits
* Not pregnant or nursing
* No known history of HIV or AIDS
* No known history of hepatitis B or C
* No history of vertigo or Ménière's type of disorder
* No history of allergic reaction to riluzole or similar compounds

PRIOR CONCURRENT THERAPY:

* No prior estrogen blockers, chemotherapy, radiotherapy, biological therapy, or surgery for the treatment of breast cancer