cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (ASD)

The main purpose of this study is to evaluate safety and tolerability in a subgroup of patients with Autism Spectrum Disorder (ASD). In addition, Pharmacokinetics and Pharmacodynamics, as well as efficacy of STP1 are being explored.

After obtaining written informed consent, those patients who are deemed eligible for the study, will be randomized on Day 1, in a double-blinded manner, in a 3:1ratio to receive either oral STP1 (twice daily) or placebo (twice daily). The total study duration is 6 weeks, including a screening phase of up to 2 weeks, a treatment phase of 2 weeks and a post-treatment follow-up phase of 2 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female individuals, between 18 and 40 years, diagnosed of ASD.
2. Patients will be assessed for specific developmental anthropometric \& anatomical criteria as well as personal and family medical history as assessed by the ASD-Phen1 semi structured interview form.
3. Patients must have a parent or reliable caregiver who can provide information about the pre-natal period and early developmental period, as required by the protocol.
4. Patient and/or parent or legal guardian willing and consenting to participate.
5. Patients with ASD and comorbid seizure disorder should be seizure-free for at least 6 months prior to screening.
6. Before enrolling in the study, subjects must agree to use double-barrier birth control methods if they engage in intercourse.

Key Exclusion Criteria:

1. Patients with an identified genetic cause of ASD in their medical record will be excluded from the study.
2. History of traumatic head injury, cerebrovascular disorder, congestive heart failure, hepatic or renal disease.
3. Thrombocytopenia.
4. Type 1 Diabetes Mellitus or uncontrolled type 2 Diabetes Mellitus, or latent autoimmune diabetes of the adult.
5. A significant risk for suicidal behavior.
6. Initiation of, or a major change in psychological / behavioral intervention within 4 weeks prior to randomization.
7. Patient with any active infection.
8. Systolic blood pressure (SBP) \<80 mmHg or diastolic blood pressure (DBP) \<40 mmHg or a drop in SBP of ≥20 mm Hg, or in DBP of ≥10 mm Hg, during the orthostatic recordings.
9. Clinically relevant electrocardiogram (ECG) abnormalities.
10. Clinically significant abnormal laboratory test.
11. Active clinically significant disease.
12. History of malignancy.
13. Pregnant (confirmed by laboratory testing) or lactating female patient.
Rehabilitation of Working Memory and Brain Plasticity After Traumatic Brain Injury: Plastim-MDTC

The aim of this study is to assess the brain correlates, as assessed with multimodal MRI, of working memory training in patients with severe traumatic brain injury (TBI)

This is a pilot feasibility study. Patients with subacute/chronic (\> 6 months) severe TBI will be included if they suffer from a deficit in working memory. They will receive a specific hierarchical training of working memory (3 sessions per week during three months), according to a previously described methodology.

A multimodal MRI will be performed at neuroSpin center (CEA, Orsay, France) before and after cognitive training, including: structural imaging (T1, FLAIR and diffusion tensor imaging, DTI); functional connectivity at rest; and functional activation during a working memory task (n-back).

Behavioral and imaging changes after training will be analysed individually and compared to a group of healthy controls matched for age, gender and education.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe traumatic brain injury
* 6 months or more after the injury
* working memory deficit on cognitive testing

Exclusion Criteria:

* previous neurological or psychiatric condition
* severe behavioral troubles
* contra-indication to MRI
* pregnancy
Can Alternative Treatment Have an Impact on Cervical Dysplasia?

In this study two questions will be answered:

* can mindfulness meditation help cell-changed on the cervix to disappear?
* can mindfulness meditation lower the psychological distress when women have abnormal cervical cancer screening results?

200 women, who have participated in cervical cancer screening and have mild dysplasia, will be randomized into two groups; an intervention group and a control group. The intervention group will be asked to do mindfulness meditation twice a week listening to instructions from a CD. 200 additional women having normal cervical screening results will also be included in the project.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 23-29 years
* Participated in cervical cancer screening
* Having mild dysplasia and normal screening results

Exclusion Criteria:

* Women who have previously had dysplasia
An Algorithm for Intra-operative Goal-directed Haemodynamic Management in Non-cardiac Surgery

A systematic literature search a goal-directed haemodynamic algorithm was created. The hypothesis of this study was that the goal-directed haemodynamic algorithm is feasible and can improve clinical outcome.

After a systematic literature search a goal-directed haemodynamic algorithm was created. The algorithm was adapted to international standards and consensus was reached through a modified Delphi method at international meetings. The feasibility of using the algorithm for intraoperative haemodynamic management was tested and the resultant clinical data analyzed retrospectively for several types of surgery with the hypothesis that the goal-directed haemodynamic algorithm is feasible in the clinical setting and can improve clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a surgical repair of hip fractures, open right hemicolectomy and extended hemicolectomy, radical tumor debulking in primary ovarian cancer or a pylorus-preserving pancreatic head resection at the Charité - University Medicine Berlin, Campus Virchow Clinic
* 18 years and older

Exclusion Criteria:

* emergency procedures
Randomized Controlled Multi-center Short Course Treatment for Rifampicin Resistant Tuberculosis

This study is a randomized, controlled, multi-center clinical study. The main purpose of this study was to study the efficacy and safety data of total oral short-term therapy as an alternative to injection in the treatment of newly diagnosed RR-TB patients.

A group: 4-6 INH EMB PZA Pto AM Cfz Mfx / 5 EMB PZA Cfz Mfx B group: 4-6 INH EMB PZA Pto LZD Cfz Mfx / 5 EMB PZA Cfz Mfx C group: 4-6 BDQ LZD MFX CS CFZ / 5MFX CS CFZ (INH: Isoniazid, EMB: Ethambutol, PZA: Pyrazinamide, Pto: Prothionamide, AM: Amikacin, Cfz: Clofazimine, Mfx: Moxifloxacin, LZD: Linezolid, BDQ: Bedaquiline, CS: Cycloserine) A group is the control group which includes injectable drugs (AM). B group and C group are the experimental groups which are total oral short-term therapy.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent and accepted follow-up;
* the age is between 18 and 65 years old, both male and female, including inpatients and outpatients;
* no use of anti tuberculosis drugs, or use of anti tuberculosis drugs less than 1 month;
* the results of molecular biology test confirmed rifampicin resistance or MDR-TB patients;
* chest CT examination confirmed pulmonary tuberculosis, pulmonary lesions, or cavity;
* premenopausal women had negative pregnancy urine test and agreed to use high-efficiency contraceptive measures during the study period.

Exclusion Criteria:

* drug sensitivity test or molecular drug sensitivity results show that the drug resistance (except isoniazid) or any component of the drug has a history of allergy, or is taking any drug that is contraindicated to the drug in the short-term treatment program;
* severe renal insufficiency (creatinine clearance rate (CrCl) less than 30 ml / min).
* liver function impairment (ALT and / or AST level 3 times higher than the upper limit of laboratory reference value, if it is temporary increase, it can be included after treatment recovery);
* those who are unable to participate in or comply with the treatment and follow-up;
* Q-T interval \> 450 millisecond;
* have a history of cardiovascular diseases or are suffering from such diseases as heart failure, hypertension (poor blood pressure control), arrhythmia or post myocardial infarction state;
* pregnant or lactating women;
* those who are unable to take oral drugs;
* those who are currently participating in other clinical trials;
* patients with HIV positive or active viral hepatitis.
Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure

The Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure (ENIGMA-HF) study is a pragmatic parallel-arm randomized control trial of a quality improvement (QI) intervention involving email nudges to cardiology clinic managers to schedule appointments specific to guideline directed medical therapy (GDMT) initiation, with the goal of optimizing mineralocorticoid-receptor antagonist (MRA) use by patients with heart failure with reduced ejection fraction (HFrEF) cared for by cardiologists within the University of California, Los Angeles (UCLA) Health System.

Importance: Guideline directed medical therapy (GDMT) is a specific set of 4 medications proven to improve morbidity and mortality for patients with heart failure (HF) with reduced ejection fraction (HFrEF), yet they are underutilized nationally and internationally. Various quality improvement (QI) interventions have had varying degrees of success at increasing GDMT prescription and titration.

Objective: The purpose of the study is to assess whether email nudges to UCLA Health cardiology clinic managers to schedule GDMT-specific appointments can lead to increased utilization of a specific medication within GDMT called a mineralocorticoid-receptor antagonist (MRA). Pertinent secondary objectives will include evaluating whether email nudges specific to MRA would increase utilization of the other medications in GDMT and whether they would increase appointments specific to GDMT.

Design, Setting, and Participants: The basic design is a pragmatic parallel-arm randomized control trial of a QI intervention. The setting is cardiology outpatient clinics at a large university-based single integrated healthcare system (UCLA Health). Participants are outpatients with HFrEF under the care of a UCLA cardiologist, with an ejection fraction on file, and currently not prescribed an MRA.

Hypothesis: The investigators hypothesize that the intervention will lead to an increased utilization of MRA, compared to the control arm.

Eligibility Criteria:
Inclusion Criteria:

* Facility: UCLA Health System
* Patient is 18 years of age or older
* Patient is under the care of a UCLA cardiologist
* Patient has a primary diagnosis of HFrEF
* Patient is not currently prescribed an MRA

Exclusion Criteria:

* Hyperkalemia
* Chronic kidney disease stage 4 or higher
* Pregnant or breastfeeding patients
* Heart transplant or ventricular-assist device patients
* Hospice patients
* Patients without an LVEF on file
* Patients with an EF \>35%
Cocaine Abuse and Attention Deficit Disorder - 3

The purpose of this study is to evaluate cocaine abuse and Attention Deficit Disorder

To evaluate the safety and efficacy of methylphenidate and bupropion in treating individuals with adult Attention Deficit Disorder.

Eligibility Criteria:
Inclusion Criteria:

current adult ADHD current cocaine dependence

Exclusion Criteria:

no current major depression
A Study of Macitentan in Children Below 2 Years of Age

The purpose of this study is to learn what happens to macitentan and its active metabolite (aprocitentan) in the body of children aged between 1 month and 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary arterial hypertension (PAH): 1) including participants with Down syndrome. Diagnosis must have been confirmed by (historical, any time before screening) right heart catheterization mean pulmonary arterial pressure (mPAP) greater than or equal to (\>=) 25 millimeter of mercury (mmHg), pulmonary arterial wedge pressure (PAWP) less than or equal to (=\<)15 mmHg, pulmonary vascular resistance index greater than (\>) 3 Wood units \* meter square (m\^2) where in the absence of pulmonary vein obstruction and/or significant lung disease PAWP can be replaced left atrium pressure or left ventricular end diastolic pressure (in the absence of mitral stenosis) assessed by heart catheterization. a) Idiopathic PAH, or b) Heritable PAH, or c) PAH associated with congenital heart disease: i) Eisenmenger syndrome (Qp/Qs less than (\<) 1.5 and saturation of peripheral oxygen ≤ 90 percent (%) measured by pulse oximetry at room air), or ii) Inoperable open left-to-right shunts (with a Pulmonary vascular resistance \[PVR\] \> 8 WU and Qp/Qs \<2), or iii) Co-incidental shunt (that is, not explaining hemodynamically the presence of PAH), or iv) Post-operative PAH (persisting/recurring/developing ≥ 6 months after repair of shunt), or d) Drug or toxin induced PAH, or e) PAH associated with Human immunodeficiency viruses (HIV)
* World Health Organization Functional Class (WHO FC) I, II, or III
* PAH-specific treatment-naive participants or participants on PAH specific monotherapy or combination of 2 therapies. Use of macitentan before or during screening is allowed
* Body weight of greater than or equal to (\>=) 3.5 kilogram (kg)
* Parent(s) (preferably both if available or as per local requirements) or participant's legally designated representative must sign an informed consent form (ICF) indicating that they understand the purpose of, and procedures required for, the study and is/are willing to allow the child to participate in the study

Exclusion Criteria:

* PAH due to portal hypertension, schistosomiasis, pulmonary veno-occlusive disease and/or pulmonary capillary hemangiomatosis
* Persistent pulmonary hypertension of the newborn
* The following congenital cardiac abnormalities: a) Cyanotic congenital cardiac lesions such as transposition of the great arteries, truncus arteriosus, pulmonary atresia with ventricular septal defect, unless operatively repaired and with no residual shunt. b) Univentricular heart and/or participants with Fontan-palliation
* Pulmonary hypertension due to lung disease
* Known diagnosis of bronchopulmonary dysplasia
Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment

The authors hypothesize that there is a correlation between the percentage of CD4+ T cells expressing CD32a and/or X and the quantity of DNA found in peripheral blood mononuclear cells in patients infected with HIV-1. Also, that there is a correlation between expression of CD32a and/or X and proviral load.


Eligibility Criteria:
Inclusion Criteria:

* Patient infected with aviremic HIV-1 (\<20 copies of HIV-1 RNA/ml plasma) undergoing antiretroviral treatment for at least 2 years
* Patient has known duration of infection and treatment
* Patient has known pretherapeutic CD4+ T cell count and viremia
* Patient has known CD4+ T cell count, residual viremia and CD4/CD8 ratio for previous 2 years
* Patient weighs at least 56kg
* The patient is not opposed to their inclusion in the study
* The patient must be a member or beneficiary of a health insurance plan
* Patient at least 18 years old

Exclusion Criteria:

* Patient has an acute infection
* The subject has already been included in the study or is in a period of exclusion determined by a previous study
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient is pregnant, parturient or breastfeeding
Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus

The aim of this study was to evaluate the effect of propolis or metformin on glycemic control in patients with type 2 diabetes mellitus without pharmacological treatment.

All patients received for 12 weeks propolis, metformin or placebo. Fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, a metabolic profile, areas under the curve of glucose and insulin, insulinogenic index, Stumvoll index, and Matsuda index were measured.

A randomized, double-blind, placebo-controlled clinical trial of three pharmacological groups was carried out, with the participation of 36 patients with type 2 Diabetes Mellitus without pharmacological treatment.

At the beginning and end of the study, fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, and a metabolic profile were measured. Areas under the curve of glucose and insulin, total insulin secretion insulinogenic index), the first phase of insulin secretion (Stumvoll index), and insulin sensitivity (Matsuda index) were calculated.

All patients received for 12 weeks two capsules a day, one before the first bite of breakfast and another before the first bite of dinner. 12 of them took propolis (300 mg), another 12 received metformin (850 mg), and 12 more placebo in the same pharmacological presentation.

This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.

Results are presented as mean and standard deviation. Intra-group differences were evaluated using Kruskal-Wallis and Mann-Whitney U-tests, while inter-group differences were calculated with the Wilcoxon test; p≤0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Patients both sexes
* Age between 30 and 60 years
* Mild to moderate physical activity
* Stable body weight for at least 12 weeks prior to the study
* BMI 25.0 - 34.9 kg/m2
* Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels \>126 mg/dl; or postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose \>200 mg/dl
* Informed consent signed

Exclusion Criteria:

* Women with confirmed or suspected pregnancy
* Women under lactation and/or puerperium
* Previous treatment for glucose
* Fasting glucose ≥250 mg/dL
* Known uncontrolled renal, hepatic, heart or thyroid diseased
* Hypersensibility to ingredients of intervention
* Known allergies to bee stings or their derived products
* Triglycerides ≥500 mg/dL
* Total cholesterol ≥240 mg/dL
The Safety and Efficacy of Fecal Microbiota Transplant (FMT) for Steroid-refractory Graft-versus-host Disease

This clinical study evaluates the safety and efficacy of fecal microbiota transplantation (FMT) in patients with steroid-refractory graft-versus-host disease (GVHD).


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to sign the informed consent form and complete follow-up;
2. Aged 18-65 years, regardless of gender;
3. Patients with refractory GVHD.

Exclusion Criteria:

1. life-threatening or associated with severe non-GvHD complications;
2. Persistent malignant conditions;
3. Patients who have undergone second or multiple hematopoietic stem cell transplants;
4. History of severe allergic reactions;
5. Any condition that the investigator considers unsuitable for inclusion (such as any history, treatment history, or abnormal test data that may confound the study results, interfere with full participation in the study, or harm the patient's interests);
Epithelioid Hemangioma of Bone And Soft Tissue

The controversy surrounding epithelioid hemangioma diagnosis stems from its somewhat aggressive clinical characteristics, including multifocal presentation and occasional lymph node involvement.

The investigators reviewed the clinicopathologic and radiologic characteristics of bone and soft tissue epithelioid hemangioma in patients treated at our institution with available tissue for molecular testing.

The hypothesis is that epithelioid hemangioma may present with multifocal involvement and rare loco-regional lymph node metastasis, but it remains a benign tumor with excellent prognosis.

The investigators retrospectively reviewed patients treated for epithelioid hemangioma of the bone and soft tissue in a single insitution. The purpose of this study is to evaluate the pathological, clinical, and radiological characteristics of epithelioid hemangioma arising within bone and soft tissue, in the first cohort of cases where the definitive diagnosis is supplemented by molecular techniques.

The hypothesis is that the improved knowledge regarding this rare entity can more definitively elucidate the benign biology of epithelioid hemangioma.

Eligibility Criteria:
Inclusion Criteria:

* patients with epithelioid hemangioma of bone and soft tissue in the extremities and pelvis

Exclusion Criteria:

* patients with epithelioid hemangioma of bone and soft tissue in the spine
Couple-focused Intervention for Sun Protection

The goal of this pilot study is to develop and test a couple-based intervention to increase sun protection practices. First, the investigators will develop the intervention website, Sun Safe Partners online. Next, the investigators will gather feedback and preferences for content in a small sample of couples who do not regularly engage in sun protection practices. The investigators will also gather preliminary information regarding the impact of the couple-based intervention.

Aim 1: To develop and evaluate the feasibility of a couple-based sun protection intervention.

Aim 2: To examine the impact of the couple-based sun protection intervention on sun protection practices, individual attitudes, relationship perspective on sun protection, and couples' discussion with each other and their supportive communications about sun protection.

Aim 3: To develop and refine a SunSafe Partners online intervention. This process includes refining existing intervention content drawn from the first phase of this pilot research as well as formative and usability studies to obtain user-generated feedback on additional content and the approach.

Aim 4: To gather pilot data on participation in and evaluations of the Sun Safe partner's intervention from Aim 3.

Arm 1: Web-based intervention called Sun Safe Partners Online

Arm 2: Generic Online Sun Safety Information intervention- 4 links emailed to participants

Eligibility Criteria:
Inclusion Criteria:

1. Both partners age 18-75 years or 19-75 in Nebraska and Alabama given the age of majority in those states;
2. Married or co-habiting with a significant other for at least one year;
3. Partner 1 willing to to provide contact information for their spouse;
4. Partner 1 and spouse respond with never, rarely, sometimes, or often to question " When outdoors in warm weather, how often do participants protect their skin (by staying in the shade or covering your body with protective clothes or 30+ SPF sunscreen)?" Those who respond with always to this question will be excluded.
5. Partner 1 and spouse have an email account and internet access.

Exclusion Criteria:

Partner 1 and spouse/partner have a personal history of skin cancer (non-melanoma or melanoma)

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Study of Blood Samples From Patients With Ewing Sarcoma and Their Relatives

RATIONALE: Studying samples of blood in the laboratory from patients with cancer and their relatives may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples collected from patients with Ewing sarcoma and their relatives.

OBJECTIVES:

* To identify and characterize a genetic susceptibility factor to Ewing's sarcoma by performing a Genome-Wide Association Study with as many as possible Ewing sarcoma patients.

OUTLINE: This is a multicenter study.

Blood samples are collected from patients and their relatives. Blood DNA samples are analyzed for susceptibility genes of Ewing Sarcoma.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients with Ewing sarcoma
* Relatives of Ewing sarcoma patients

PATIENT CHARACTERISTICS:

* Patients with a fusion genes specific of Ewing Sarcoma

PRIOR CONCURRENT THERAPY:

* Not applicable