cyrilzakka/clinical-trials huggingface dataset:
Using Transcriptional Assessment of Immune Response to Assess Immunosuppression After Liver Transplantation

To develop a prospective quantitative liver allograft monitoring protocol and retrospectively validate the use of Phenotypic personalized medicine (PPM) in immunosuppression dosing in liver transplant recipients.

The investigators have developed a computational approach, Phenotypic Personalized Medicine (PPM), to utilize empiric clinical data to construct patient-specific visual maps that represent each individual's phenotypic response to drug treatment. Because this process does not require a priori knowledge of disease mechanism, it can effectively personalize drug dosing for any disease despite frequent changes to treatment regimens or patient physiology and genetics. In a pilot randomized controlled trial and its follow-up larger trial, the investigators have shown that transplant patients prospectively dosed with PPM-determined tacrolimus doses had improved drug trough-level management compared with standard of care physician-determined tacrolimus doses.

The ultimate objective in this project is to improve graft and patient outcomes in solid organ transplant recipients by using PPM to optimize immunosuppression dosing. The investigators hypothesize that existing and clinically validated quantifiable markers of immune state and allograft injury are clinically useful measures that can be employed with PPM as actionable analytical inputs for a dynamic optimization of patient-specific immunosuppression. The investigators will test this hypothesis by developing a prospective quantitative liver allograft monitoring protocol and validate the use of PPM in immunosuppression dosing in liver transplant recipients.

This study constitutes the first step in developing and then validating a personalized immunosuppression platform. The mechanism-independent nature of PPM ensures that it will be adaptive and actionable so that it can be applied to diverse sets of patients. The scalability of PPM also ensures that it can be deployed at a scale that can be applied widely to patients receiving care regardless of location.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* At least one-month post-transplant
* Recipient of a liver transplant alone or a simultaneous liver-kidney transplant

Exclusion Criteria:

* Unwilling to provide informed consent
* Recipient of a previous bone marrow or stem cell transplant
* Pregnant
* Unlikely to be able to comply with the study requirements, as determined by the PI
Effects of Exercises on Physical Performance

Aim: The aim of the study was to investigate the effects of thrower's ten exercises on the upper extremity performance in healthy sedentary individuals.

Method: 36 healthy sedentary men and women aged 18-35 years will be included in the study. Subjects will be divided into two groups: exercise and control. The exercise group will be given Thrower's Ten training sessions 3 times a week over an 8-week period. Before and after the study, the subjects were tested for dynamic balance on the upper extremity with the Upper Limp Y balance test and for explosive power with the medicine ball throw test. Moreover, the strength of the shoulder rotator muscles was measured with an isokinetic dynamometer at a speed of 60º/sec.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women and men aged 18-35 years

Exclusion Criteria:

* Individuals with any neurological, orthopedic, cardiovascular, psychological problems,
* individuals who have a musculoskeletal injury in the last 1 year,
* individuals who doing regular physical activity/sport in the last 6 months
Admission of Adult-onset Still Disease Patients in the ICU

Since its first description in 1971, diagnosing adult-onset Still's disease (AOSD), a rare multisystemic disorder considered as a multigenic autoinflammatory syndrome, remains challenging. Rarely, AOSD may present severe systemic manifestations and require intensive care. The main purpose of the Stil ICU study is to make the first description of the epidemiology of critically ill AOSD patients. The investigators will use a retrospective cohort study design with dual recruitment strategies: (1) via the AOSD referral centres network and (2) via a French academic medical ICU network.


Eligibility Criteria:
Inclusion Criteria:

* AOSD (history of newly diagnosed)
* ICU admission between January 2001 and June 2017

Exclusion Criteria:

* adults under protection
* admission in step-down unit
Ameliorating Attention Problems in Children With Sickle Cell Disease (SCD)

The purpose of this study is to assess whether methylphenidate is effective in enhancing the cognitive performance of children with the HbSS or HbSC genotype of SCD who have sustained neurological complications on laboratory-based measures of sustained attention, reaction time, and executive functions, and indirectly, verbal short-term and long-term memory.

Sickle cell disease (SCD) is a group of autosomal recessive disorders, affecting an estimated 1 in 400 African American newborns annually. The pathophysiology of this group of disorders involves the production of abnormal hemoglobin (HbS), which causes red blood cells to assume a rigid, sickled shape upon release of oxygen, thereby reducing their viability in circulation. Consequently, chronic anemia and system-wide ischemia result in acute painful episodes, organ system failure, and neurological complications. Among the most debilitating effects of SCD are neurological complications. Despite the mounting evidence for structural and functional involvement of the frontal systems in pediatric SCD, there have been no clinical trials designed to manage the cognitive and behavioral sequelae associated with pediatric SCD.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent can be obtained from parent or care-giver and Assent can be obtained from the child
* Children with sickle cell disease (HbSS or HbSC)
* Age range from 6 to 16 years inclusive
* English is the child's primary language
* T-score greater than or equal to 63 on either the Conners' Parent Rating Scale - Revised or the Conners' Teacher Rating

Exclusion Criteria:

* History of glaucoma for which methylphenidate is contraindicated
* Child or immediate family member has a history of a tic disorder or Tourette's syndrome
* Child is currently receiving antidepressant, anxiolytic, antipsychotic, or stimulant drug therapy
* Family history of substance abuse disorder due to potential for abuse of stimulants by caregivers or other family members
* Recent history of uncontrolled seizures (may be on anticonvulsants, provided seizures are under "reasonable" control and that the patient and family understand the risk of altered seizure control and potential interference with maintaining therapeutic levels of anticonvulsants)
* Hypothyroidism
* Symptoms of affective and mood disorders
* Previously diagnosed with ADHD prior to the onset of neurological complications (e.g., stroke or silent infarct) as documented in the medical record or caregiver report.
* Mental retardation (FSIQ \< 70 on WASI)
Intervention for Male STDs in India

The specific aim of this study is to complete an ongoing randomized controlled trial of the efficacy of behavioral intervention compared to STI treatment/HIV counseling alone in decreasing risk behavior and incident HIV/STI infections in Mumbai, India.

India has the second highest number of HIV infections of any country in the world, and the epidemic continues unabated. This trial is focused on high risk men attending public STI clinics. A proposed 2 and a half year study, this trial will utilize the continuation of a randomized controlled trial of a behavioral intervention compared to HIV C\&T and STI treatment alone targeting HIV uninfected male STI patients. The specific aims are to complete the current behavioral intervention trial and to expand the current investigations to include: the evaluation of men who have sex with men as well as women and evaluate the use of alcohol to the entire sample of recruited men. STI patients will be recruited from three sites and if randomized will agree to a 12 month participation commitment. Strategies employed in both arms of the trial are simple and the fundamental components of an HIV prevention strategy. By demonstrating their effectiveness in India the hope is to encourage the public health leadership to adopt them and continue to change drug treatment availability.

Eligibility Criteria:
Inclusion Criteria:

1. Males, over 16 years of age
2. Hindu or Marathi speakers
3. Have no plan to move permanently out of Mumbia in the following 12 months
4. have a symptom of an STI or have had a sexual exposure in the past 6 months. A sexual exposure is defined as having sex with a commercial sex worker (FSW), having unprotected sex with anyone, male or female, or if the patient came to the clinic seeking an HIV test.
5. Patients will be required to provide an address that can be located by a tracer.

Exclusion Criteria:

1. HIV positive subjects.
Prevention and Early Detection of Cervical Cancer Through Self-Administered Screening

This study examines prevention and early detection of cervical cancer through self-administration screening of patients in Western Uganda. The cervix is the opening of the uterus or womb, which is the organ that supports babies before they are born. There are simple tests that let doctors know whether or not patients have cells that may become cancer. Some of the tests determine whether patients have an increased risk for cervical disease, but they do not actually confirm that they have it: these are called "screening" tests. This study may help researchers determine how to best deliver cervical cancer prevention services using the HPV test.

PRIMARY OBJECTIVES:

I. To establish the acceptance and correlates of self-collected human papillomavirus (HPV)-ribonucleic acid (RNA) testing among women in the rural Ugandan community as well as the incidence and determinants of successful completion of the cervical cancer screening cascade from self-collected HPV testing to receipt of results.

II. To ascertain the frequency and determinants of successful acquisition of treatment among women who have HPV detected on self-collected swabs in rural Uganda.

III. To derive population-based estimates of the prevalence of high-risk HPV and cervical intraepithelial neoplasia (CIN) detected through community-based screening employing self-collected HPV RNA testing in rural Uganda.

OUTLINE:

Patients receive a specimen kit for collection of HPV samples. Patients complete questionnaire before and after collection HPV samples. Patients may also participate in an interview about general ideas in improving the screening and treatment process. Patients with positive results, undergo treatment for cervical cancer.

Eligibility Criteria:
Inclusion Criteria:

* Women in the three Ugandan districts (Kiboga, Kyankwanzi and Hoima) who access screening during the community health campaigns
* Age 25-49 years
* Resident in the study district
* Provision of informed consent

Exclusion Criteria:

* Clinical signs and symptoms of cancer of the cervix
Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopy

Quality assurance of the laboratory examinations. Prospective non-interventional study with ThinPrep slides collected during the German Co-Screening Program and routinely sent to the lab to prospectively evaluate the clinical performance of the Hologic Genius Digital Cytology (DC) system vs. the liquid-based cytology (LBC) manual microscopic approach

The cause of cervical cancer is a persistent infection with high-risk types of human papillomavirus (HPV). Cytology has been the gold standard for cervical screening since the introduction of routine screening with the Pap test in the 1950s due to its effect on mortality in regions with screening programs. Since that time, there have been several technological advances (LBC, Imaging) to improve and automate cervical cytology, resulting in increased disease detection and efficiency. The Hologic's Genius Digital Diagnostics System is a CE-IVD (CE-marked in vitro diagnostic device) marked digital cytology platform. For quality assurance and to prospectively evaluate the Hologic Genius Digital Cytology (DC) system in the lab, selected routinely screened and already archived slides will be additionally reviewed with the liquid-based cytology (LBC) manual microscopic approach. Only anonymized results will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* LBC ThinPrep® samples are collected by gynaecologists and sent routinely to cytology laboratory Zotz \& Klimas as part of the German Cervical cancer screening program.
Comparing Fixed-bearing Versus Mobile-bearing Prosthesis in Total Knee Arthroplasty: A Prospective Randomized Trial

The purpose of this study is to determine which prosthesis is better in total knee arthroplasty

Theoretical advantages of mobile-bearing devices led surgeons to use these prostheses instead of fixed-bearing devices as traditional implants. This study was designed to compare Fixed-bearing versus Mobile-bearing Prosthesis in Total Knee Arthroplasty through a five-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with expected primary total knee arthroplasty

Exclusion Criteria:

* Mediolateral instability
* Infective arthritis
* Severe deformity
* Revision
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure

The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram \[mg\] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram \[mg/kg\]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.

Part A: This part includes a 12-day Initial PK, PD, and Safety Assessment Period. Participants in Part A will not participate in Part B. Randomization in Part B of this study will begin once the cumulative data from the Initial PK, PD, and Safety Assessment Period in Part A are deemed acceptable by the Independent Data Monitoring Committee. Part A of the study will consist of an up to 21-day Screening Period, a 12-day Initial PK, PD, and Safety Assessment Period, a 12-month Open-Label Treatment Period, and a 30-day Follow-Up phone contact. Part B: Participants will be randomly assigned to two treatment groups and randomization ratio will be 2:1 for rivaroxaban and ASA. ASA will be used as control. There will be an up to a 21-day Screening Period, a 12 month Open-Label Treatment Period and a 30-day Follow-Up phone contact.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be considered to be clinically stable by the investigator and able to tolerate oral or enteral administration of a suspension formulation and oral/enteral feedings
* Satisfactory initial post-Fontan transthoracic echocardiographic Screening as defined in the Post-Fontan Echocardiographic Examination Research Protocol
* Parent/legally acceptable representative must sign an informed consent form (ICF) and child assent will also be provided, if applicable, according to local requirements

Exclusion Criteria:

* Evidence of thrombosis, including those that are asymptomatic confirmed by post-Fontan procedure transthoracic echocardiogram, or other imaging techniques, during the Screening period of the study
* History of gastrointestinal disease or surgery associated with clinically relevant impaired absorption
* History of or signs/symptoms suggestive of protein-losing enteropathy
* Active bleeding or high risk for bleeding contraindicating antiplatelet or anticoagulant therapy, including a history of intracranial bleeding
* Platelet count less than (\<)50\*10\^9/Liters (L) at Screening
* Estimated glomerular filtration rate (eGFR) \<30 milliliters per minute per 1.73 meter square (mL/min/1.73m\^2)
* Known clinically significant liver disease
Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy

This study investigates the potential for temporally-interfering electric field stimulation (TIEFS) to treat epilepsy. In this case series within and between subjects design, the impact of TIEFS on epilepsy biomarkers was studied in patients with medial temporal lobe epilepsy.

Secondary analyses examine the underlying physiological effects of TIEF on local brain activity and brain networks.

Participants Patients with drug-resistant focal epilepsy and a clinical diagnosis of medial temporal epilepsy undergoing invasive intracranial electrophysiology studies will be consented in accord with institutional review boards at Emory University, Saint-Anne University Hospital, and the Institute of Neurosurgery and Neurointervention, Semmelweis University. The determination of medial temporal epilepsy is based on clinical semiology, EEG, PET, MRI, and invasive electrophysiology. Across all centers, patients underwent the stimulation protocols 6 to 10 days post-implantation after patient-specific electric field modeling to determine TIEFS electrode placement.

Patients then undergo two sessions of TIEFS on separate days, one sham (aligned carriers), and one active (with an offset in frequency between the carriers to provide a lower-frequency modulation envelope at the anatomical target.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing invasive intracranial EEG studies

Exclusion Criteria:

* None
Impact of an Oral Health Intervention

This pilot study will assess the effectiveness of an original oral health education program on affecting the behaviors of patients diagnosed with eating disorders.


Eligibility Criteria:
Inclusion Criteria:

* Patient of the UNC Center for Excellence for Eating Disorders inpatient unit or outpatient clinic.
* Diagnosis of anorexia nervosa or bulimia nervosa
* Aged 13-50 years
* English-speaking

Exclusion Criteria:

* Decisionally impaired (i.e., Incapable of providing informed consent in the opinion of the primary care provider in UNC Center for Excellence for Eating Disorders)
* Involuntarily committed to the inpatient service of the UNC Department of Psychiatry
Randomized Clinical Trial on Transanal Irrigation

Objective The primary objective is to demonstrate superiority of the Peristeen cone catheter compared to standard of care.

The secondary objective is to investigate quality of life and different benefits and aspects of treatment and satisfaction with the Peristeen cone catheter.

Design of the investigation This is a randomised, open-label, parallel investigation comparing the Peristeen cone catheter with standard of care in subjects with major LARS (LARS score ≥ 30). Each subject will be enrolled for a study duration of 12 weeks. Subjects will be randomized to the treatments stratified by neo-adjuvant radiotherapy.

The comparator in this study will be current standard of care for patients with LARS which is conservative bowel management. This is defined as: Supportive therapy according to the individual treatment protocols available at each participating site.

Primary endpoint and secondary endpoints

Primary endpoint:

• LARS score, obtained from the LARS score questionnaire\*

Secondary endpoints:

* Number of subjects with Major LARS\*
* FIQL Score - scale 1, Modified American Society for Colorectal Surgeons Questionnaire\*
* FIQL Score - scale 2, Modified American Society for Colorectal Surgeons Questionnaire\*
* FIQL Score - scale 3, Modified American Society for Colorectal Surgeons Questionnaire\*
* FIQL Score - scale 4, Modified American Society for Colorectal Surgeons Questionnaire\*
* EQ-5D-5L - utility score\*
* EQ-5D-5L - VAS score (scale 0-10 cm)\*
* Satisfaction with treatment (scale 0-10 cm)\*
* Number of adverse events\* \*All endpoints are measured per subject at study completion


Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age and have full legal Capacity
2. Have given written informed consent
3. Be mental and physical capable to perform transanal irrigation with cone catheter
4. Have a LARS score ≥ 30 after rectal resection
5. Be treated according to individual treatment protocol for conservatory bowel management at participating site
6. Have proof of complete healing of the anastomosis by endoscopy or radiology before stoma closure
7. At least 3-months from last surgery in colorectum
8. Be evaluated to be suitable for transanal Irrigation procedure with a cone catheter by endoscopy, defecography or comparable procedure

Exclusion Criteria:

1. Active/recurrent colorectal cancer
2. Leaking anastomosis
3. Known anal or colorectal stenosis
4. Within 4 weeks of endoscopic polypectomy
5. Ischaemic colitis
6. Acute inflammatory bowel disease
7. Acute diverticulitis
8. Current or planned pregnancy
The Relationship Between Functional Constipation and Sacroiliac Joint Dysfunction

The purpose of this study; to compare individuals with and without chronic constipation in terms of sacroiliac joint dysfunction and to examine the relationship between chronic constipation and sacroiliac joint.

Constipation is a heterogeneous, polysymptomatic and multifactorial disease. Many symptoms are used to define the term constipation, such as hard stool, excessive straining, few bowel movements, use of digital maneuvers during defecation, abdominal bloating, and a feeling of inadequate evacuation.

Chronic constipation is seen in approximately 14% of the world. It is seen on average 2 times more in women.

Visceral and somatic neural control of defecation is provided by the Sacral 2-4 segments of the spinal cord. It is in neural relationship with the sacroiliac joint and pelvic floor muscles, which also provide innervation from the same segments. These visceral and somatic structures can affect each other through viscerosomatic and somatovisceral reflexes. This means that an afferent input from the rectum can reflect on and around the sacroiliac joint.

Based on this connection, we think that primary chronic constipation without an organic cause may be associated with sacroiliac joint dysfunction. In the literature review, no study examining this relationship was found.

This study is planned to evaluate individuals with and without chronic constipation in terms of sacroiliac joint dysfunction and to examine the relationship between chronic constipation and sacroiliac joint.

Eligibility Criteria:
Inclusion Criteria (for functional constipation group):

* Voluntary participation in the research
* Fulfill the diagnostic criteria for functional constipation (Rome IV)
* Being women
* Not using laxatives for at least the last 4 weeks

Inclusion Criteria (for control group):

* Voluntary participation in the research
* Being women
* Not having functional constipation

Exclusion Criteria:

* Having cooperation problems
* Being pregnant
* Being breast-feeding
* Taking medication for depression, hypertension, sleep disorders, and pain
* Having parkinson, stroke, spinal cord injury, multiple sclerosis, hypothyroidism, Diabetes Mellitus, cerebral Palsy, thyroid problems, cancer, presence of tumor, presence of hernia, endometriosis, neuropathy, myopathy, scleroderma, inflammatory bowel diseases (Crohn, gastrointestinal tuberculosis, celiac, colon diverticulum, colonoscopy), cognitive impairment
* Having neurological or metabolic or malignant disorders
* Having a history of open abdominal surgery
* Having a history of pelvic and abdominal radiotherapy