cyrilzakka/clinical-trials huggingface dataset:
Quantitative EEG Assessment of Cue-Induced Changes in Brain Activity in Alcohol Use Disorders

Exposure to alcohol related cues, such as the sight of alcoholic drinks, may induce craving for alcohol in drinkers. In this study, the effects of exposure to (1) the pictures of alcoholic drinks and (2) the imagining of a scene related to drinking on activity in the frontal region of the brain in heavy social drinkers will be determined. This study is being conducted to develop the methods needed to allow for the detection of cue-induced changes in drinkers using the EEG. The objective of this pilot study is to establish procedures for detecting alcohol-related cue-elicited changes in EEG activity in heavy drinkers.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged 21 to 70.
2. History of heavy drinking: Defined as at least 8 occasions in the past month that individual had at least 5 drinks (males) or 4 drinks (females) in one sitting.
3. The subject must currently not be in treatment for any alcohol use disorder
4. Subject must be able to comprehend and perform study related information and tasks in English and have a willingness to complete study procedures.
5. Subject must be able to provide written informed consent, at time of consent BAC has to be 0.00%.
6. The subject must have the ability to read/speak English

Exclusion Criteria:

1. Severe impairment of sight, smell, or hearing that would result in a significant alteration in the response to alcohol related cues.
2. Currently on a medication used to treat alcoholism or is known to alter EEG activity or responsiveness to cue presentation including acamprosate, anticonvulsants, anticholinergics, antipsychotics, benzodiazepine receptor agonists, beta adrenergic receptor antagonists, and naltrexone.
3. History of any neurological or psychiatric disorder that would result in abnormal EEG activity such as severe brain trauma, seizure disorders, stroke or that would severly alter response to the cue presentation such as schizophrenia or any other psychotic or severe mood disorder.
4. CIWA-AR score of 8 or higher or any history indicating that the subject is at risk for experiencing severe alcohol withdrawal symptoms if her or his drinking is discontinued for any period of time.
5. The subject must not be pregnant. -
Safety and Efficacy of S-8184 in Second Line Treatment of Stage III or IV Ovarian Cancer

Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients with stage III or IV platinum resistant ovarian cancer or primary peritoneal carcinoma.

The goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of S-8184 in this patient population.

Eligibility Criteria:
Inclusion Criteria:

Histologic diagnosis of ovarian cancer or primary peritoneal carcinoma

Stage III or IV disease

One and only one prior cytotoxic chemotherapy regimen which must have included a platinum agent

Platinum resistant disease, defined as documented progression within six months of completion of first line therapy

Adult (18 years of age or older) patients

Adequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3)

Serum creatinine less than 2.0 mg/dL

Total bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values

ECOG performance status of 0 - 2

Bidimensional measurable or clinically evaluable disease

Patients who have signed an IRB / Ethics Committee approved informed consent

Life expectancy at least 12 weeks

Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery)

Patient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.)

Exclusion Criteria:

Patients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel)

Females who are pregnant or lactating

Patients with peripheral neuropathy NCI-CTC grade 2 or greater

Patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry

Patients who have had an investigational agent within 4 weeks of study entry

Patients receiving concurrent anticonvulsants known to induce P450 isoenzymes
A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.

The study will include a screening period of up to 5 weeks. The primary endpoint will be at Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed approximately 4 weeks after end of treatment.

Eligibility Criteria:
Inclusion Criteria

* Have a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening.
* Have had stable body weight (±5%) during the 90 days preceding screening.
* Have been diagnosed with Type 2 Diabetes (T2D).
* Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day.

Exclusion Criteria:

* Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
* Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening.
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
* Have a prior or planned surgical treatment for obesity.
* Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening.
* Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<45 milliliter/min (mL/min)/1.73 m².
* Have any of the following cardiovascular (CV) conditions within 2 months prior to screening.

  * acute myocardial infarction.
  * cerebrovascular accident (stroke).
  * unstable angina .
  * hospitalization due to congestive heart failure, or
  * coronary artery revascularization.
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.
* Have a history of chronic or acute pancreatitis.
Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 Diabetes

The goal of this interventional study is to test whether sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce the effects of high dietary sodium intake in patients with type 2 diabetes.

Participants will undergo a dietary intervention consisting of a week of high-sodium diet, followed by a week of low-sodium diet. At the end of each week the patients will undergo:

* 24-h ambulatory blood pressure measurement;
* 24-h urine collection;
* bioimpedance analysis for body composition determination;
* blood and urine tests.

The study will compare patients treated with SGLT2i and patients not treated with SGLT2i to test whether the treatment reduces the effects of high sodium intake on blood pressure, body composition and biochemical variables.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years;
* both males and females;
* type 2 diabetes.

Exclusion Criteria:

* type 1 diabetes;
* insulin treatment;
* uncontrolled hypertension (SBP \> 160 mmHg and/or DBP \>95 mmHg);
* pregnancy;
* other acute or chronic conditions influencing blood pressure and glucose metabolism.
Carb Counting Vs. Simplified Qualitative Meal-Size Estimation

The goal of this study is to compare qualitative meal-size estimation to accurate carb counting in adolescents with Type One Diabetes using all available AID (Automated Insulin Delivery) systems. We will compare glucose control parameters and patient related outcome measures between the groups. 120 children and adolescents with type 1 Diabetes who begin using AID system will be randomly assigned to one of two groups: simplified qualitative meal size estimation or accurate carb counting. The study will last 6 months, with an additional optional follow up points at 12 and 24 months.

In the first visit all patients will receive nutrition guidance from the dietitian. In the accurate carb counting group, participants will use precise carb counting to manage their meals. In the simplified qualitative meal-size estimation group, participants will use a simplified meal announcement based on three presets for each meal, small, medium, or large, which will be personalized based on the dietitian's assessment. During the study, the dietitian will evaluate the insulin-to-carb ratio and meal estimation at least once in the first two weeks.

Follow-up visits will be scheduled at 4-6 weeks, 3, and 6 months after the study's initiation. At each visit participants will upload their data from their AID systems. Evaluation of their diabetes control will be made and an assessment regarding the carbohydrates calculation method. Digital questionnaires assessing diabetes distress, disordered eating behaviors, dietary regimen, and eating patterns will be provided at the beginning of the study and after 6 months, with an additional optional follow-up points that will be held at 12 and 24 months after the study's initiation.


Eligibility Criteria:
Inclusion Criteria:

1. T1D- diagnosed
2. Age 6-18 years
3. Treated with insulin (multiple daily injections or pump) and intending to initiate treatment with AID systems

Exclusion Criteria:

1. Non-T1D
2. Unstable medical conditions (other than diabetes) that may impact weight or diabetes management (as severe psychiatric disorders, various syndromes)
3. Use of medications that may impact weight or diabetes management (as use of steroids for an extended period of time. use of GLP-1)
4. Inability to understand the information, material and questionnaires of the study -
Development of Self-administrable Psychological Intervention Programs Supported by New Technologies as a Treatment for Patients With Functional Digestive Disorders.

Disorders of gut-brain interaction (DGBI) are produced by disturbances in the interplay between the gut and the central nervous system. Several psychological factors like anxiety, depression and altered coping are over-represented in these disorders. Recent surveys have shown that DGBI affect up to 40 % of the general population.

Psychological interventions like cognitive behavioral therapy and hypnosis have been shown to be beneficial for managing these disorders. However, access to psychological interventions is very limited due to lack of resources to treat these very frequent conditions.

OBJECTIVE: To determine the effects of psychological interventions using specifically developed therapeutic programs based on virtual reality, for telematic use at home, on symptoms severity, comorbidities, visceral sensitivity and intestinal dysbiosis in patients with DGBI.

METHODOLOGY: After development of a program of psycho-education on DGBI using interactive immersion by means of virtual reality (VR) a randomized clinical trial will be developed. Consecutive patients will be randomized 1:1 to active treatment or placebo. In each patient in the active treatment group a session of psychoeducation using specifically developed VR-video leaded by a gastroenterologists, will be followed by telematic weekly group sessions of psycho-education leaded by a psychologist. During the 6 weeks of the treatment period patients will be instructed to perform self-administrable sessions of psychotherapy at home (by means VR). Patients in the placebo group willl take a placebo capsule daily.

OUTCOME MEASURES. In all patients, severity of symptoms (primary outcome), QoL, somatic and psychological comorbidities (using specific questionnaires), visceral sensitivity (by means of a barostat) and microbiota analysis, will be performed before and at the end of the treatment period. Symptom severity will be assess also in follow-up phone calls at 3 and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* BMI (Body Mass Index) between 18.5-24.99, with variations of up to 15%.
* Ability to understand instructions and follow protocol.
* Access to internet network from usual residence.

Exclusion Criteria:

* Previous history of abdominal surgery with the exception of appendectomy and herniorrhaphy.
* Abuse of alcohol, tobacco or narcotics.
* Medical evidence of organic gastrointestinal pathology, hepatopathy, endocrinopathy, heart disease or contagious disease, as well as major psychiatric disorder.
Application of Health Empowerment Theory to Enhance Health Empowerment Levels and Self-Health Management Ability Among Older Migrants: A Randomized Controlled Trial

This study aimed to evaluate the effectiveness of a theory-based health self-management program in empowering older migrants to manage their health. This study used a single-blind, randomized controlled trial design. A comparison was conducted between the experimental and control groups in terms of pre-test and post-test levels of health empowerment and health self-management abilities.


Eligibility Criteria:
Inclusion Criteria:

* (1) age 60 years or older; (2) residing in thelocal area for a minimum of six months; (3) agreement to participate in the study and willingness tosign the informed consent form; and (4) possessing a clear sense of autonomy and the ability tounderstand and engage with the content of the study intervention activities.

Exclusion Criteria:

* (1) absencefrom two consecutive lectures or group activities without prior notification and (2) voluntary withdrawal from the study at the participant's request.
Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)

The purpose of this pilot study is to investigate the relationship between attention and emotional function post-Traumatic Brain Injury (TBI) in an effort to better understand the cognitive mechanisms of emotional processing in patients with TBI, and explore novel treatment strategies to improve emotional regulation using with transcranial direct current stimulation (tDCS) to modulate activity in the dysfunctional prefrontal-limbic circuits.

Thirty (30) individuals status post TBI with complaints of emotional dysfunction 6 months post-brain injury and Fifteen (15) healthy controls will participate in the study. The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30-45 minutes for 6 weeks as described below. The control group will receive sham-tDCS 20 minutes and computerized cognitive training for 30-45 minutes twice a week for 6 weeks (12 training sessions). The sham group will not receive real tDCS after completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Brain Injury at least 6 months prior
* Family or self-identification of cognitive or emotional difficulties
* Unchanged and stabilized medical treatment in the three weeks prior to the screening

Exclusion Criteria:

* Any social or medical problem that precludes completion of the protocol.
* Presence of focal motor deficits in the upper extremities.
* Comorbid psychiatric disease such as schizophrenia, or active substance abusers (except nicotine).
* History of craniectomy, active infection, or seizure activity beyond 1 week post-TBI.
* Complicating medical problems such as uncontrolled hypertension, diabetes with signs of neuropathy, and previous neurological illness such as head trauma, prior stroke, epilepsy or demyelinating disease, implanted neuromodulatory or electronic device, metal in head
* Pregnancy
Practicability and Acceptability of Stylomax® in Children

Primary objective:

to evaluate the practicability and acceptability of STYLOMAX®, a new injection device for MAXOMAT®, in children, for 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Children over 3 years of age with growth hormone deficiency, requiring treatment with MAXOMAT® according to the criteria of the MA.

Exclusion Criteria:

* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug

CP-945,598 is eliminated following extensive metabolism. For some drugs, decreased renal (kidney) function can affect their elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety and tolerability of CP-945,598 in patients with severe renal impairment and healthy control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Normal Subjects: 1.Healthy. 2.Matched for age (± 5 yrs), weight (± 10 kg), and gender ratio (± 2 subjects per gender).
* Subjects with Renal Disease: 1. Severe impairment (Creatinine clearance \<30 mL/min) 2. Stable renal disease:no change in the last 30 days. 3. Stable dose of medication and/or treatment. 4. Reasonably well-controlled type 1 and type 2 diabetics

Exclusion Criteria:

* All subjects: Non-prescribed use of drugs of abuse/ recreational drugs; recent treatment with experimental drugs or herbal experiments; EKG and blood pressure parameters falling outside of protocol-specified limits; history of regular alcohol or tobacco use exceeding protocol-specified limits
* Normal subjects: Medically important health conditions; recent use of prescription or non-prescription medications.
* Subjects with renal disease: Subjects requiring dialysis; certain chronic medical conditions; patients who have received renal transplant; severe and/or poorly controlled diabetes; Treatment with protocol-specified drugs that may alter the way the body absorbs or processes CP-945,598.
The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products

Single-center open-label multiple dose randomized two period cross-over study to examine Advanced Glycation End Product (AGE) levels in human subjects pre and post empagliflozin administration.

Single-center open-label multiple dose randomized two period cross-over study.

The North-Shore Long Island Jewish Institutional Review Board will be used to approve our study protocol.

All patients will give written informed consent and comply with the Helsinki agreement and good clinical practices guidelines.

Treatment Plan:

Eligible patients will be randomized to receive linagliptin 5mg daily or empagliflozin 25mg daily for 30 days followed by a 30 day washout period and crossover. All pre-existing diabetic medications will continue unchanged.

Fasting blood carboxymethyl lysine (CML), methylglyoxal (MG), vascular cell adhesion molecule (VCAM), tumor necrosis factor (TNF) alpha, 8-isoprostane, and routine chemistries and urinary CML, MG, and creatinine will be measured at baseline, after 30 days, 60 days and 90 days.

AGE levels will be measured by Elisa.

Eligibility Criteria:
Inclusion Criteria:

* T2DM
* Age ≥ 18
* glomerular filtration rate ≥ 30 ml/min/1.73 m2 body-surface area
* A1C ≥ 7% any higher limit
* SLGT-2 inhibitor naïve
* On stable doses of current medications for at least 3 months.

Exclusion Criteria:

* Indication of liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 2 x upper limit of normal during screening or run-in phase
* Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
* Contraindications to background therapy according to the local label
* Any uncontrolled endocrine disorder except type 2 diabetes
* Pre-menopausal women (last menstruation ≤1 year prior to informed consent) who were nursing, pregnant, or of child-bearing potential and were not practicing an acceptable method of birth control, or did not plan to continue using this method throughout the study, or did not agree to submit to periodic pregnancy testing during the trial

  o Acceptable methods of birth control include tubal ligation, transdermal patch, intrauterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method, vasectomy of partner
* Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
* Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial involving an investigational drug and/or follow-up
Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting

Subjects-currently in outpatient mental health care--will participate in 2 psychotherapy sessions, one with oxytocin spray and one with placebo spray. Sessions will be videotaped, and cortisol and heart rate will be measured. We hypothesize that oxytocin will have positive benefits on nonverbal behavior in the therapy session, as well as have positive effects on subjective anxiety, cortisol and heart rate.


Eligibility Criteria:
Inclusion Criteria:

* in current mental health treatment
* male 18-65

Exclusion Criteria:

* diagnosis of schizophrenia or psychosis
* diagnosis of autism or Aspergers disorder
* active substance use disorder
* at moderate or high risk of self-harm
A Study of 68Ga-PSMA-11 PET Scans in People With Brain Tumors

The purpose of this study is to find out whether 68Ga-PSMA-11 PET/CT is effective in assessing tumor uptake (tumor activity seen in cancerous tissue) in participants with high-grade glioma/HGG or brain metastases.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign (or their legally acceptable representative (LAR) must sign) a written informed consent document
* Adults ≥ 18 years old
* Suspicion for or histologically or cytologically confirmed and previously treated HGG or brain metastases from a primary extracranial malignancy
* Lesion size ≥ 1 cm (for the lesion to be biopsied)
* ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
* Planned to undergo biopsy/resection of brain lesion

Exclusion Criteria:

* Inability to undergo a PET scan (e.g., claustrophobia or noncompatible implant in case PET/MR is performed)
* Pregnant or nursing female. All women of childbearing potential must have a documented negative serum or urine pregnancy test \<1 week before study.
* Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients with severe allergy to both iodinated and gadolinium contrast.