cyrilzakka/clinical-trials huggingface dataset:
Comparing Basic Life Support Performance With Serious Game Based Module and Simulation Based Hands on Training

The aim of this study is creating this platform and investigating whether performance evaluation of BLS trainings would be more objective compared to conventional OSCE (Objective Structured Clinical Examination) exams, if these evaluations were carried out with the platform which is combining OSCE scoring criteria with sensor data retrieved from the simulator's sensors.

The participants of this study consisted of 25 volunteers among Acibadem Mehmet Ali Aydinlar University students without prior knowledge of basic life support protocol. 11 Participants (44.0%) were male, 14 (56.0%) were female. The participants were informed about the study and signed consent forms before participating the study. After a brief introduction of the serious gaming module, the participants were asked to choose the self-test mode of the serious game module. The participants' number of attempts was not limited. Following serious game based training, the hands-on training module combining OSCE scoring criteria with sensor data retrieved from the simulator's sensors was used for hands-on performance evaluation. After familiarization with the system using self-training mode, the participants were asked to proceed the BLS Hands-on training app with the simulator under the supervision of the educator. The simulation sessions were also recorded in order to use these recordings for conventional OSCE (Objective Structured Clinical Examination) performance evaluation. Conventional OSCE score of each participant was obtained by watching the recorded sessions of BLS trainings.Spearman's rho correlation test was used for calculating the correlation between serious gaming, hands on training module with including sensor data from the simulator and OSCE scores.

Eligibility Criteria:
Inclusion Criteria:

* Having no prior Basic Life Support Training

Exclusion Criteria:

* Having prior Basic Life Support Training
Prophylactic Transfer of Leukemia-reactive T Cells After Allogeneic Transplantation

Efforts to decrease the risk of GvHD by depleting T cells from the graft in CML patients have been complicated by an increased incidence of leukemia-relapse. Newer protocols using CD34+ selected hematopoietic cells from matched-sibling donors and subsequent infusion of T cells in incremental doses to treat or avoid relapse of disease seem to be more promising. In this study, we try to further optimize this approach by the prophylactic infusion of cytotoxic T cells activated ex-vivo against leukemia-associated/specific antigens using peptide-pulsed dendritic cells.

The conditioning protocol contains:

Total Body Irradiation 8-12 Gy (4-6 x 2 Gy, a 2 x/die) day -9 to-7 Thiotepa 10 mg/kg (2 x 5 mg/kg) day -5 Fludarabine 200 mg/m2 (5 x 40 mg/m2) day -6 to-2 ATG Fresenius 25 mg/kg (5 x 5 mg/kg) day -6 to-2 Cyclosporine A 1 mg/kg Day -10 to-3

on day 0 CD34+ cells after immunomagnetic selection are infused. \> 4 x 10e6/kg CD34 cells/kg are required.

On days 28, 56 and 112 after transplantation, cytotoxic T cells generated in-vitro are infused in patients who do not have signs of acute GvHD.

Regular follow-up compromises immune monitoring including Tetramer analyses of Peptide-reactive T cells

Eligibility Criteria:
Inclusion Criteria:

* age 18-60
* Ph+ CML
* HLA A0201, 0301, 1101, B0801
* BCR-ABL b3a2 positive
* no significant comorbidities
* resistance or intolerance of imatinib

Exclusion Criteria:

* HIV positive
* blast crisis
Variability of Pentacam-derived Back Elevation Measurements in Keratoconus and Cross-linked Corneas

Primary objective of this study was to assess the intrasession, intersession and interobserver variability of the Pentacam-derived posterior corneal elevation measurements in keratoconus eyes and eyes that underwent Corneal Collagen Cross-liknking (CxL) treatment due to progressive keratoconus.

The Pentacam Classic (Oculus Optikgerate GmbH, Heidelberg, Germany, software version 1.14r04) was used for the sake of the study.Two study groups were formed: 1) Keratoconus group (KC) included patients with progressive keratoconus and 2) Collagen-Cross-linking group (CXL) included keratoconus patients that had been treated with uneventful CXL at least on year prior to their enrollment in the study.

Three consecutive scans were obtained by two experienced operators. The same procedure was repeated within two weeks for the assessment of intersession variability. In all cases acceptable maps had at least 10.0mm of corneal coverage.All back elevation points were codified in order to facilitate statistical processing of data. Further to single point analysis, three additional parameters were evaluated: a) zone 4 parameter (z4) which derived by the analysis of all points at the central 4.0mm diameter zone, b) zone 8 parameter (z8) which derived by the analysis of all points at the central 8.0mm diameter zone, and, c) highest elevation point parameter (HEP), which derived by the analysis of the highest elevation points for all participants. Reproducibility of measurements was evaluated by means of intraclass correlation coefficients (ICC). Three different ICC types were calculated: a) intrasession ICC for both operators (ICC1 \& ICC2), b) interobserver ICC, and, c) intersession ICC. Moreover, Bland-Altman plots were used to evaluate the level of agreement between the two operators.

Eligibility Criteria:
Inclusion Criteria:

* Progressive keratoconus (Keratoconus group)
* Corneal collagen cross linking (CxL) treatment at least one year prior to enrollment (CxL group)

Exclusion Criteria:

* Glaucoma
* Suspicion of glaucoma
* history of herpetic keratitis
* corneal scarring
* severe eye dryness
* pregnancy or nursing
* current corneal infection
* underlying autoimmune disease
RObotic PArtial Nephrectomy National Study

The purpose of the study is to set up the larger prospective study on robotic partial nephrectomy, to describe the characteristics of patients operated for kidney cancer by this surgical procedure and also to determine the modalities of hemostasis in this procedure.

The primary objective of the study is to describe the characteristics of patients operated for kidney cancer by a robotic partial nephrectomy in France (recruiting centers, patient profile, tumor characteristics).

Secondary Objective(s):

1. To describe the surgical techniques and operative development.
2. To assess the modalities of haemostasis, during robotic partial nephrectomy.
3. To assess peri-operative morbidity in robotic partial nephrectomy and post-operative complications.
4. To assess the outcome of renal function after a robotic partial nephrectomy. This study is a national, multicenter, prospective, cohort.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years old at the time of screening
* Subject has been diagnosed with renal tumor(s)
* Subject will undergo a robot assisted partial nephrectomy
* Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria: None
Study of VX-770 and Rifampin in Healthy Male Subjects

The objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770.

This is a single-center, nonrandomized, open-label, 2-period, 1-sequence crossover study to investigate the safety, tolerability and pharmacokinetics of VX 770 when administered alone or with rifampin.

All enrolled subjects will receive the same treatments and undergo the same procedures. In Period 1, subjects will receive a single dose of VX 770 on Day 1. In Period 2, subjects will receive a daily dose of rifampin on Days 1 through 10 and a single dose of VX 770 on Day 6.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be male and between 18 and 55 years of age
* Subject must have a body mass index (BMI) from 18 to 30 kg/m2

Exclusion Criteria:

* History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject
* Subjects who have active tuberculosis, human immunodeficiency virus, hepatitis C, or active hepatitis B
Towards a Post-exposition Pharmacological Prophylaxis for Post-traumatic Stress Disorder

In this study, we investigate the role that deep sleep plays in the prevention of posttraumatic stress disorder after someone has been exposed to a trauma by boosting deep sleep with two drug conditions compared to placebo condition. Each volunteer in the study goes through all three conditions. The quantity of intrusive memories of the trauma will be compared between the three conditions.

The present study seeks to investigate the potential to pharmacologically modulate slow-wave sleep in the acute aftermath of an experimentally-induced trauma in the interest of developing a secondary prevention of posttraumatic stress disorder. The effects of a GABAergic compound will be compared with that of a noradrenergic compound. Memory, sleep and stress-related immune response factors will be quantified and compared across drug conditions.

Eligibility Criteria:
Inclusion Criteria:

* Speaks and understands German
* BMI 18.5 -\< 25
* Non-smoker status
* Habitual 5 or fewer alcoholic beverages / week
* Habitual 3 or fewer caffeinated beverages / day
* Habitual average sleep duration 7-9 h / night
* Normal or corrected-to-normal vision
* Insomnia Severity Index score between 8-14

Exclusion Criteria:

* Travel across 3 or more time zones within 3 months of study start
* Habitual napping
* Extreme chronotype, determined by Morningness-Eveningness Questionnaire
* History of or presence of a trauma- or stressor-related disorder
* History of or presence of neurological disorder, psychiatric disorder or head injury
* History of or presence of a sleep disorder
* History of or presence of cardiovascular disorder
* Use of illicit drugs
* Atypical preference for excessively violent portrayals
* Faints at the site of blood or brutality
* Has participated in a study \< 30 days or a study such as this (i.e., experimental trauma) at all.
VALIDATE Valsartan and Supportive Measures - Impact on Drug Adherence of Treated Hypertensive Patients

The purpose of this study is to assess the impact of supportive measures on the drug adherence of patients with essential hypertension


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \>= 18 years
* Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).
* Patients with mild essential hypertension: Systolic blood pressure ≥ 140 mmHg and \< 170 and/or diastolic blood pressure ≥ 90 mmHg and \< 105 mmHg"

Exclusion Criteria:

* Moderate and severe hypertension
* Pregnant or nursing women
* A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Other protocol-defined inclusion/exclusion criteria may apply
Color Doppler and Mri Diffusion in Major Salivary Gland Masses

This study intend to evaluate the combined value of ADC and COLOR DOPPLER in differentiating benign and malignant salivary gland tumors in comparison to histopathological findings and its use in preoperative prediction of benign and malignant masses.

the study aim to achieve preoperative differentiation between benign and malignant masses of the major salivary glands using the ADC values and Color Doppler values (PSV - PI - RI)

Eligibility Criteria:
Inclusion Criteria:

1- patients must be 18 of age or older. 2= patients must have a suspicious swelling in major salivary glands.

Exclusion Criteria:

1. Patients with history of metal plates or screws or artificial joints.
2. Patients who have phobia of indoor places.
3. Patients with contraindication to MRI like intra-cerebral aneurysmal clips, cardiac pacemaker, and metallic foreign body at region of examination.
Clinical, Biological and NMR Outcome Measures Study for Hereditary Inclusion Body Myopathy Due to Mutation of UDP-N-acetylglucosamine 2-epimerase/N-acetylmannosamine Kinase Gene (GNE)

The objective of the study is to identify the best clinical and biological outcome measures for further therapeutics approaches.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age.
* Must be willing and able to provide consent.
* Must have a genetic diagnosis of HIBM, GNE myopathy, Quadriceps Sparing Myopathy (QSM), Inclusion Body Myopathy Type 2, distal myopathy with rimmed vacuoles (DMRV), or Nonaka disease.
* Must be willing and able to comply with all study requirements.
* Affiliated to or a beneficiary of a social security category
* Must take part in the HIBM-PMP UX001-CL401 study

Exclusion Criteria:

* Received ManNAc therapy or other similar substance
* Any unrelated, comorbid disease or condition that, in the view of the investigator, would interfere with study participation or would affect safety.
* Patients with specific contraindication to MRI (i.e. metallic foreign body, claustrophobia...) will be allowed to participate, but MRI will not be performed.
* Pregnant women.
Long Pulse Versus Short Pulse Laser Dusting for Renal Stones

The purpose of this research study is to compare how well two treatments work for removing kidney stones. The two study groups include ureteroscopy with long/short pulse lithotripsy to remove kidney stones. Both of these options are considered standard of care and are used currently in surgery.

This study will compare two types of laser lithotripsy to see the pulse duration to determine which settings are more effective. This is a randomized control trial with subjects randomized to either long pulse or a short pulse group. Those subjects with a single kidney/ureter stone measuring up to 20 mm will be eligible for the study. The procedures will be performed using the standard of care instruments and techniques but the pulse type setting in surgery will be constant. Some Holmium laser devices provide the option to modulate the pulse duration. A longer laser pulse duration (700 μs or 1500 μs) as compared to a traditional pulse duration (300 μs or 350 μs) has been demonstrated in vitro studies to provide effective stone disintegration while reducing laser fiber tip degradation and stone retropulsion. Both the long and the short setting can dust the stone and currently we alternate in each procedure from one setting to the other and it is unclear which setting is more effective. No changes to operative technique will be performed for subjects in the study vs regular patients undergoing the same procedure. All subjects will be seen one week to one month after surgery for stent removal and follow up.

Eligibility Criteria:
Inclusion Criteria:

* Kidney/ureter single stone between up to 2 cm
* Age over 18 years
* Two kidneys

Exclusion Criteria:

* Solitary Kidney
* Age under 18
* Pregnancy
The Pediatric Development Clinic Study

Many preterm, low birth weight and other high-risk infants are surviving the early neonatal period. However, upon discharge from the neonatal units, this at-risk population has little support for their health, nutrition and development in the community. To address this emerging need, Partners In Health in collaboration with the Ministry of Health and UNICEF, has created a pediatric developmental clinic (PDC) to follow the high-risk infants after discharge from hospitals and health centers.

Neonatal health and improving neonatal mortality has become one of the top priorities globally. In Rwanda, hospital care has advanced significantly with the development of national neonatal care guidelines and widespread provider training. As advances in technology and resuscitation become more commonly available, many preterm, low birth weight and other high-risk infants are surviving the early neonatal period. However, upon discharge from the neonatal units, this at-risk population has little support for their health, nutrition and development in the community. To address this emerging need, Partners In Health in collaboration with the Ministry of Health and UNICEF, has created a pediatric developmental clinic (PDC) to follow the high-risk infants after discharge from hospitals and health centers. Prior to implementation, a community-based descriptive study assessing the baseline medical, nutritional and developmental needs of low-birth weight and preterm infants who are the target population of the pediatric development clinic was conducted (Baseline Phase One). Subsequently, after 1-2 years of implementation an evaluation of clinical, nutritional and developmental outcomes of children followed in PDC will be conducted in comparison with the baseline study outcomes (Post-PDC Phase Two). Ongoing research on PDC implementation will focus on research on patient and provider experiences, overall clinic processes, cost-effectiveness, expansion of the PDC model, decentralization to health centers, and longer term outcomes of children enrolled in the PDC to further help refine the PDC model (Post-PDC Phase Three)

Eligibility Criteria:
Inclusion Criteria:

* All under-five children meeting PDC referral criteria as described in the study population description will be enrolled in PDC.

Exclusion Criteria:

* Patients who do not meet referral criterial for PDC or who are over age 5 years.
In Our Study We Compare Results of Two Oncoplastic Breast Surgery (short Scar Reduction Mammoplasty and Wise Pattern Reduction Mammoplasty) As Surgical Treatment of Breast Cancer

in our study we compare results of two oncoplastic breast surgery (short scar reduction mammoplasty and wise pattern reduction mammoplasty) as surgical treatment of breast cancer


Eligibility Criteria:
Inclusion Criteria:

1. Female patients with ages ranging from 25 to 75 years.
2. Patients with operable breast cancer (Stage I, II and IIIa).
3. Patients with moderate to large /ptotic breasts.

Exclusion Criteria:

1. Patients with a contraindication to breast conservative surgery:

   1. Multi-centric disease that can't be incorporated by local excision through a single incision that achieves adequate safety margin and satisfactory cosmetic results.
   2. inflammatory carcinoma.
   3. Contraindications to postoperative radiation e.g. pregnancy, pre-existing lung disease with reduced diffusing capacity and pulmonary TB.
   4. diffuse suspicious malignant micro-calcification on mammography.
   5. inability to attain negative surgical margins.
   6. cardiomyopathy
   7. connective tissue disorders with significant vasculitis.
2. Previous chest wall or breast radiation.
3. Patients' refusal participation.
Correlation Between Depression Scores and Serum NF-ĸB/NLRP3 Axis, Biotinidase, and HMGB After Treatment With Isotretinoin in Patients With Acne Vulgaris

Acne is a chronic inflammatory disease of the pilosebaceous unit resulting from androgen-induced increased sebum production, altered keratinization, inflammation, and bacterial colonization of hair follicles on the face, neck, chest, and back by, Cutibacterium acnes. Although all age groups can be affected, it is primarily a disease of adolescence. Treatment selection is based on disease severity, patient preference, and tolerability. Isotretinoin is drug of chioce used for moderate and severe acne. Isotretinoin results in a significant reduction in sebum production, influences comedogenesis, lowers surface and ductal c. acnes and has anti-inflammatory properties. Biotin deficiency may be caused by insufficient dietary uptake of biotin, drug- vitamin interactions and increased biotin catabolism during pregnancy and in smokers. Biotin deficiency can also be precipitated by decreased activities of biotinidase, which plays a central role in the intestinal absorption of biotin


Eligibility Criteria:
Inclusion Criteria:

Age of 19 to 35 years. Body mass index (BMI) of 18.5 to 23 kg/m2. Acne vulgaris (global acne scoring more than 18)

Exclusion Criteria:

Use of oral steroids, oral contraceptives, oral vitamin A derivatives, antibiotics, or herbal medicines that may affect the test results during the last 4 weeks.

Alcohol drinking within the last week. Smoking. Pregnancy or lactation. Judgement that physical or mental testing is not appropriate for the clinical trial.

Participation in other clinical trials that may affect this t
The GLOWING Study: Growing Life, Optimizing Wellness 2

This study will help us learn more about how maternal health can influence child health.

This study follows people who are healthy and less than 36 weeks pregnant to see how the mother's health can impact their child's growth and development. Up to 300 people including the mother and their future child will be a part of this study. The study will follow the child until they are two years of age.

Eligibility Criteria:
Inclusion Criteria:

* Pre-pregnancy BMI 18.5-45
* Singleton pregnancy
* at least 18 years of age
* conceived without assisted fertility treatments

Exclusion Criteria:

* Preexisting medical conditions (e.g. DM, GDM, CRF, HTN, pre-eclampsia or eclampsia, malignancies, seizure disorder, lupus, serious psychiatric disorders)
* sexually transmitted diseases
* medications during pregnancy known to influence fetal growth
* smoking, alcohol drinking or drug use during pregnancy
Anorexia Nervosa and Its Effects on Brain Function, Body Metabolism and Their Interaction in Adolescents

The aim of the research project is to investigate the neurological, physiological and behavioral underpinnings associated with the development of anorexia nervosa in adolescents. The goal of the project is to enable new ways to both predict the course of the disease and to influence this process.

The aim of the project is to enable new ways to both predict and influence the course of anorexia nervosa. This is a three-year follow-up study in which we investigate the neurological and physiological factors underpinnings of anorexia nervosa with structural and functional magnetic resonance imaging (fMRI). In addition to this, a variety of methods is used, such as physiological measurements and questionnaire data, as well as investigation of intestinal microbiota associated with anorexia nervosa. Altogether 100 girls aged 13-17 will be recruited for the study: 50 patients with anorexia nervosa and 50 healthy controls. The participants are monitored annually and the fMRI scan is repeated at the last visit. Additionally, 40 participants (20 patients and 20 healthy controls) will participate in a cardiac sub-study. In this, the participants will also have an MRI scan and ultrasound examination of the heart.

Eligibility Criteria:
Inclusion criteria for anorexia nervosa patients:

* Female sex
* Age 13-17 years
* Body mass index \< 17.5 kg/m2
* Currently fulfilling modified Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis criteria for anorexia nervosa with or without amenorrhea
* Anorexia nervosa diagnosed within 2 yers

Inclusion criteria for healthy controls:

* Female sex
* Age 13-17 years
* Body mass index 18,5-25 kg/m2
* No lifetime history of obesity (Body mass index ≥ 30) or eating disorders

Exclusion criteria:

* Any chronic illness or medication that could affect glucose metabolism or neurotransmission
* Any other current mental disorder (excluding anorexia nervosa for the patient participants)
* Severe previous mental disorder (excluding anorexia nervosa for the patient participants)
* Smoking of tobacco, snuffing, or use of narcotics
* Abusive use of alcohol