cyrilzakka/clinical-trials huggingface dataset:
Open Trial of Trauma-focused Psychodynamic Psychotherapy for People Living With HIV and PTSD

People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. This pilot study adapts for PLWH a non-exposure based psychotherapy for PTSD focused on reflecting on one's emotions and relationships and understanding and working through how trauma may have disrupted them. The study team is interested in better understanding the needs of PLWH with PTSD, learning whether PLWH with PTSD find this treatment acceptable and helpful, and beginning to understand the relationship between HIV-related health factors (e.g., inflammation and stress biology) and PTSD, and how these health factors may improve during treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DSM-5 defined PTSD, per the Clinician Administered PTSD Scale \& CAPS-5 total severity score greater than or equal to 25
* HIV diagnosis (by medical records or HIV testing)
* Stable psychiatric/psychotropic medication for \>=2 months and ongoing during treatment

Exclusion Criteria:

* Psychosis
* Bipolar I
* Acute suicidality
* Current substance use disorder
* Organic mental syndrome or intellectual disability
* Unstable non-HIV medical conditions
Impact of FTO Gene Variation on Body Composition, Lipid Profile, Insulin Resistance, Advanced Glycation End-Products and Ghrelin Levels in Response to Hypocaloric, Protein Rich-Diet

Obesity is a widespread disease that basically develops from unhealthy lifestyle and genetics. The Fat-mass and obesity associated (FTO) gene affects appetite and energy intake of the body, thus elevating fat mass and body weight. The single nucleotide polymorphism (SNP) rs9939609 of the FTO gene is a common variant in different ethnic groups, and its A allele is associated with increased body mass and waist circumference. Hence, the carriers of rs9939609 SNP are prone to weight gain if a healthy diet and lifestyle are not maintained. Similarly, high levels of serum cholesterol and triglycerides, while low levels of high-density lipoproteins are observed in carriers of rs9939609 AA genotype. For individuals having FTO rs9939609 A allele, consumption of hypocaloric diets (1500 kcal/day) consisting of high protein foods up to 25-30% of total daily energy intake might help reduce body weight. However, weight loss tends to vary in individuals after consuming the same diet under similar environmental conditions, so it is important to know the effect of different genotypes that might cause this variation. The study aimed to genotype overweight and obese adults for FTO rs9939609 polymorphism and to determine the effect of this polymorphism on body weight, BMI, waist and hip circumferences, lipid profile, insulin sensitivity, ghrelin levels, inflammatory markers and advanced glycation end-products in these individuals after consumption of a hypocaloric, high-protein diet for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 1Overweight (BMI ≥ 25kg/m2) and obese (BMI ≥ 30kg/m2) individuals.
* Both genders.
* Age 18-50 years.

Exclusion Criteria:

* Children, pregnant and lactating women
* Individuals taking medication for weight loss or undergoing any other weight loss dietary intervention.
* Individuals having lost more than 5 pounds in the past three-month period.
* Patients with any psychiatric disorders, heart, liver, kidney disease, diabetes or abnormal thyroid function.
Pregnancy and Childbirth in Women with Thalassemia Yesterday and Today

Recent advances in the management of thalassemia have significantly improved life expectancy and quality of life of patients with this hemoglobinopathy, with a consequent increase in their reproductive potential and desire to have children.Since an initial report of a successful pregnancy in a woman with thalassemia major by Walker in 1969, hundreds of pregnancies have been reported so far, highlighting that women carefully managed in the preconception phase usually carry out a successful gestation and labor, both in case of spontaneous conception and assisted reproductive techniques.


Eligibility Criteria:
Inclusion Criteria:

* Transfusion dependent and nontransfusion- dependent thalassemia
* Pregnancy ended with the birth of a live or dead foetus
* Pregnancy ended in miscarriage or voluntary abortion
* Pregnancy in progress

Exclusion Criteria:

* Other types of anemia
* Pregnancy not initiated despite assisted fertilization practices
* Subjects unwilling to sign informed consent
A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion

The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.

Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.

Eligibility Criteria:
Inclusion Criteria:

* Meet criteria to obtain abortion
* Present with closed cervical os and no vaginal bleeding
* Live fetus at time of presentation for service
* Have no contraindications to study procedures, according to provider
* Be able to consent to procedure, either by reading consent document or by having consent document read to her
* Be willing to follow study procedures

Exclusion Criteria:

* Known previous transmural uterine incision
* Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
* Any contraindications to vaginal delivery
* Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Clinical Trial Comparing Safety and Pharmacokinetics of Standard Antibiotic Therapy, Plus Aurexis® or Placebo, for Treatment of Staphylococcus Aureus Bacteremia (SAB)

Hospitalized patients at least 18 years of age, with Staphylococcus aureus bacteremia (SAB) will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed until Study Day 57. Aurexis is a humanized monoclonal antibody that is designed to combat Staphylococcus aureus.

The purpose of this study is to assess the safety and pharmacokinetics of standard antibiotic therapy, plus Aurexis or Placebo for treatment of (SAB). Additionally, certain tests and measurements will be conducted to preliminarily determine if Aurexis demonstrates any benefit to these patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age ≥ 18 years old
* Informed consent obtained from subject or legal guardian
* Willing to practice reliable birth control measures during the study period
* Diagnosis of SAB, as evidenced by clinical symptoms and one positive blood culture obtained ≤ 72 hours prior to initiation of study drug infusion

Exclusion Criteria:

* Pregnant or nursing females
* Polymicrobial bacteremia
* Diagnosis of septic shock (refer to APPENDIX B)
* Neutropenia (absolute neutrophil count \< 500/mm³)
* Undergoing any type of dialysis or expected to start dialysis within 30 days
* Moribund clinical condition with a high likelihood of death within 72 hours of randomization
* Received an investigational drug within 30 days of study entry
* Considered unlikely to comply with the study procedures or to return for scheduled post-treatment evaluations
A Study Evaluating the Safety and Pharmacokinetics of Aldurazyme® (Laronidase) in MPS I Patients Less Than 5 Years Old

The main objectives of this study are to evaluate the safety and pharmacokinetics (PK) of enzyme replacement therapy with recombinant human alpha-L-iduronidase \[Aldurazyme® (laronidase)\] in mucopolysaccharidosis I (MPS I) patients less than 5 years old. Efficacy measurements will also be evaluated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent is required from the parent(s) or legal guardian(s) prior to any protocol-related procedures being performed. (A separate informed consent will be requested from the parent(s) for their genotyping, which is independent of the inclusion.)
* Be less than 5 years of age at the time of enrollment.
* Have confirmed iduronidase deficiency with a fibroblast or leukocyte alpha-L-iduronidase enzyme activity level of less than 10.0 % of the lower limit of the normal range, or below the detection range of the measuring laboratory.
* Have a clinical diagnosis of MPS I based on genotyping.
* Documentation in his/her medical record that the parent(s) or legal guardian(s) have had counseling or a consultation regarding HSCT in order to assure that the parent(s) or legal guardian(s) are fully informed regarding the risks and benefits of this alternative treatment for patients eligible for the trial and with the severe manifestations of MPS I with neurodegeneration.

Exclusion Criteria:

* The patient is under consideration for or has undergone hematopoietic stem cell transplantation (HSCT).
* The patient has acute hydrocephalus at the time of enrollment.
* The patient has a clinically significant organic disease (with the exception of symptoms relating to MPS I) including: cardiovascular, hepatic, pulmonary, neurologic, or renal disease, other serious intercurrent illness, or extenuating circumstances that, in the opinion of the Investigator, would preclude participation in the trial or potentially decrease survival.
* The patient has received any investigational product within 30 days prior to trial enrollment.
* The patient has known severe hypersensitivity to Aldurazyme® (laronidase) or components of the delivery solution.
18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies

The purpose of this study is to see how a new tracer named 18F-MFBG (Meta Fluorobenzyl Guanidine) behaves in the body after injection, how it spreads to all the organs and how it is removed from the body. We will also study how long 18F-MFBG lasts in the blood after administered. In addition we want to study if 18F-MFBG can show Neuroendocrine tumors on a PET-CT or PET MR scan.


Eligibility Criteria:
Inclusion Criteria:

Phase I:

* Eligible patients include patients with histologically proven Neuroendocrine tumors (paraganglioma, PHEO, or well differentiated NET of the lung or GI system) or NB. Patients who have NB, the diagnosis must be in accordance with the International Criteria, i.e., either histopathology or bone marrow involvement. Patients must be ≥5 years of age and able to undergo PET scan without sedation
* All patients must have MIBG-avid disease and evaluable disease on MIBG scan at the time of enrollment onto the protocol.
* Performance status of ≥60 on Karnofsky scale for patients \>16 years of age and \>60 on Lansky scale for patients \<16 years of age.
* Cardiac, pulmonary, gastrointestinal and neurologic toxicity should all be ≤grade 2.

Expansion Cohort:

* Patients with diagnosis of NB (in accordance with the International Criteria, i.e., either histopathology or bone marrow involvement)
* Patients must be able to undergo PET scan without sedation
* Patients must have prior MIBG-avid disease and evaluable disease on MIBG scan at the time of enrollment onto the protocol.

  * If MIBG scan is available within 4 weeks of MFBG, with no intervening treatment, MIBG scan will not be repeated.
  * If prior MIBG scan is available \>4 weeks of MFBG, MIBG scan will be done within a week (prior or after) of MFBG.
* Performance status of ≥60 on Karnofsky scale for patients \>16 years of age and \>60 on Lansky scale for patients ≤16 years of age.
* Cardiac, pulmonary, gastrointestinal and neurologic toxicity should all be ≤grade 2.
* Patients with positive lesion detection by 18F-MFBG may be eligible for repeat imaging scan, at the discretion of PI or study investigator(s).

Exclusion Criteria:

* Major organ toxicity including cardiac, pulmonary, gastrointestinal and neurologic toxicity more than grade 2.
* Active serious infections not controlled by antibiotics.
* Inability or unwillingness to undergo PET scanning
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Women who are pregnant or breastfeeding.
* Patient has an active malignancy of metastatic potential other than the known NE tumor for the past 3 years.
* Patients should not have received chemotherapy or radiation therapy (localized radiation therapy is allowed to non-evaluable sites) between prior 123I-MIBG scan and 18F-MFBG administration.
* Patients requiring anesthesia, who are not already undergoing anesthesia for standard-of-care procedures.
Effect of Awareness-Based Stress Reducatıon Program Applıed to Parents Wıth A Chıld Wıth Autısm

This research was planned to examine the effect of mindfulness-based stress reduction program applied to parents with autistic children on the level of depression, anxiety, stress and hopelessness.

The program applied to parents with children with autism will be carried out once a week for 60 minutes, for 8 weeks, in 8 sessions in total. The program will be conducted in face-to-face groups. Sessions will be held in a suitable area in the practice area. In each 60-minute session, it is planned to be 20 minutes of narration on the subject of the session, accompanied by a power point presentation, and the remaining 40 minutes of exercise, meditation practices and sharing experiences. In the table indicating the general operation of the sessions within the scope of the research; The purpose, target, teaching method, material place, time, session content and application steps of each session will be given to the participants. Awareness-Based Stress Reduction Program Applied to Parents with Children with Autism will be given to the participants in the first week, including the important points of the program, prepared by the researchers, and expert opinions will be taken.

Eligibility Criteria:
Inclusion Criteria

* Being a parent of a child with autism
* Being literate and able to communicate in Turkish

Exclusion Criteria:

* Having a diagnosed mental and mental health problem
* Having a chronic, mental and mental health problem other than autism in a child with autism
* Having previously participated in a mindfulness-based stress reduction program
* Having another disabled child
Choline Supplementation and Cardiovascular Health

Trimethylamine-N-oxide (TMAO), a metabolite produced by gut microbial metabolism of dietary choline, has recently been causally linked to atherosclerosis in animal models and has been shown to be predictive of cardiovascular disease (CVD) risk in some but not all cohort studies. The relevance of observations in animals to humans is unclear and little information is available on the mechanisms linking TMAO to increased CVD risk. Vascular dysfunction plays a critical role in the initiation and progression of atherothrombotic disease. Whether TMAO impairs vascular function in humans is not known. The purpose of this study is to determine if acute supplementation of dietary choline, which increases TMAO, impairs vascular function.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Healthy
* Non-smoking
* Weight stable for previous 6 months (±2.0 kg)
* BMI \<35 kg/m\^2
* Verbal and written informed consent
* Approved for participation by study medical director (Jose Rivero, M.D.)

Exclusion Criteria:

* Smoking
* Pregnancy
* Obese (BMI\>35 kg/m2)
* Altered dietary patterns within the last month of recruitment
* Unstable heart disease or diabetes
* Untreated high blood pressure or high cholesterol
* Allergies to choline
* Unvaccinated against COVID-19
A New Micrografting Technique for Vitiligo

This study evaluates micrografting using a harvesting and grafting process that has been designed by Momelan Technologies. The overall concept is to harvest several small pieces of skin, each measuring about 1.75 mm in diameter from a normal pigmented area using a commercially available suction blister device, adhere them to a sterile elastomeric substrate and is then place it on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).

Participants with vitiligo patches undergo removal of the epidermis of the affected vitiligo skin with dermabrasion. Several small pieces of pigmented skin (1.75mm) from the patient are taken from another area with the use of a suction blister device. The harvested pigmented skin is adhered to a sterile elastomeric substrate and placed on the previously dermabraded affected area.

Originally the primary outcome was percentage of change in pigmentation with UV photos at 10 weeks in sites undergoing grafts compared to control sites. However, because we were unable to take UV photos, we had to revise our primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 to 80 years old
* Have a diagnosis of stable vitiligo as defined by Vitiligo Disease Activity Score of 0 or 1
* Has 3 comparable vitiliginous areas of trunk or extremities (excluding hands) each measuring at least 3cm×3cm in size, with at least 80% of depigmentation, and anticipated equal sun exposure.
* Have not used any topical therapy to patches or Ultraviolet light therapy for at least 2 weeks (subjects may restart phototherapy at week 10 if desired)
* Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
* Agree to follow and undergo all study-related procedures

Exclusion Criteria:

* Female patients who are breastfeeding, pregnant, or planning to become pregnant
* Patients with a history of hypertrophic scaring or keloids and psoriasis
* Subjects on any dose of coumadin, warfarin, Plavix or at least 325 mg aspirin.
* Concurrent use of immunosuppressive medications such as oral steroids, tacrolimus and other cytotoxic reagents within 2 weeks of grafting)
* Subject who received topical therapy or UV light ( phototherapy)in last 2 weeks
* Patients with a positive HIV status
* Patients withDiabetes Mellitus with a hemoglobin A1C of more than 8.
* Subjects with dermatologic conditions that may Koebnerize such as psoriasis and lichen planus.
* Participation in another interventional study with potential exposure to an investigational drug within past 30 days
Overcoming Resistance to EGFR Neutralization by Combination of Monoclonal Antibodies and Novel Cancer Drugs

The study is aimed at patients with advanced cancer and EGFR mutation. Some molecules recently discovered at the level of tumor tissue can influence the response to anti-EGFR drugs. Among these molecules is NRG1, which binds to the EGFR receptor family.

Unravelling the mechanisms that give cancer cells resistance to such biologics could improve response to therapy and survival. And analyzing tumors during anti-EGFR drug therapy used in clinical practice could allow us to perform analyses on NRG1 and hypothesize a possible strategy to increase survival

Experimental, tissue study. Patients with EGFR receptor amplification/overexpression or activating mutations treated with anti-EGFR cancer therapies will be involved in the study as required in normal clinical practice. Clinical information of the patients, relevant to the conduct of the study, will be collected: age, sex, ethnicity, smoking habit, diagnosis, staging of the tumor, site of any metastases, possible presence of ascites and/or pleural effusion, type of oncological therapy administered, concomitant therapies, radiological re-evaluation of the tumor, response to treatment, survival.

Similarly, peripheral blood, tissue obtained from archival tumor biopsies, ascitic and/or pleural fluid samples (taken, if present, as per clinical practice) will be collected. Primary cell cultures will be derived from tumor biopsies, ascites, and/or pleural effusion for in vitro studies The lymphocyte population will be isolated from the peripheral blood of patients

Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥ 18 years
* patients with advanced cancer characterized by amplification/overexpression or activating mutations of the EGFR receptor.
* patients who are candidates for treatment with TKI and/or mAbs both in the first and second line, according to clinical practice.
* possibility of obtaining all information relating to the clinical history - obtaining written informed consent

Exclusion Criteria:

* Patients who in the opinion of the investigator may not be compliant with the needs of the study
* patients suffering from pathologies (e.g. psychiatric, neurological) that do not allow the obtaining of valid informed consent
High Fidelity Simulation-based Learning Approach in Maternal and Infant Care

Study type: clinical trial - randomized control trial Primary purpose: to explore the effectiveness of high-fidelity simulation (HFS) interventions, specifically scenario-based training with pre-briefing and de-briefing on (1) knowledge and self-efficacy (2) problem solving abilities, (3) the learning experience among nursing students in baby care and breastfeeding, as compared to traditional training.

Primary outcome: breastfeeding self-efficacy scores and knowledge in the intervention compared to the control group Secondary outcome: Simulation Design Scale and Education Practices Questionnaire

Background and Rationale of Study:

Nursing students commonly reported feeling unprepared in maternity and infant care clinical setting or lack competencies. Additionally, nurses are concerned about the clinical reasoning skills of new graduates, which may lead to poor quality of infants or maternal outcomes. Despite this importance, it is difficult to provide more clinical opportunities especially during COVID pandemics. High-fidelity simulation-based learning (HFS) can help to bridge the gap between theory and practice, with manikin citing the similarities to practice in a 'real' situation. By incorporating different scenarios, prebriefing and debriefing into the HFS, students can enhance their learning experience. However, there is a lack of studies specifically examining the use of HFS in baby care and breastfeeding among nursing students. The impact of HFS on learning outcomes, including knowledge and skills, problem solving abilities, and learning experience are unclear.

Eligibility Criteria:
Inclusion Criteria:

* undergraduate nursing students
* newly enrolled obstetric course
* can provide consent for simulation confidentiality
* do not have previous clinical experience or training in obstetrical units

Exclusion Criteria:

• Nil