cyrilzakka/clinical-trials huggingface dataset:
Use of a Peptide-based Formula in an Adult Population

The study is designed to observe the use of a peptide-based oral nutrition supplement in adults with chronic malabsorption or maldigestion who require supplemental nutrition as assessed by a clinician.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age.
* Subject has chronic malabsorption or maldigestion.
* Subject requires supplemental nutrition as assessed by a clinician.
* Subject agrees to consume 2 servings of the study product a day for at least 16 consecutive days during Treatment period.

Exclusion Criteria:

* Subject is currently taking or has taken antibiotics within 2 weeks prior to enrollment in the study.
* Subject has current active malignant disease or was treated within the last 6 months for cancer.
* Subject has a history of diabetes mellitus.
* Subject is pregnant as demonstrated by a urine pregnancy test.
* Subject has severe auto immune disease and is on immuno-modulating therapy.
* Subject has a history of allergy to any of the ingredients in the study product.
* Subject has active HIV.
* Subject has a known aversion to flavor of product being tested.
* Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption.
* Subject has an obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product.
* Subject is taking part in another non-Sponsor approved clinical trial.
Trial on Vascular Inflammation in Atopic Dermatitis

A total of 30 subjects with moderate to severe atopic dermatitis. Thirty subjects without AD matched for sex, age and coronary artery disease risk factor with the AD subjects will also be included. All subjects will undergo the following imaging procedures: a 18FDG-PET to quantify vascular inflammation in the ascending aorta and carotids and a MDCT to calculate the Agatston score. Skin and blood biomarkers will also be assessed.


Eligibility Criteria:
Main inclusion Criteria:

* Men or women
* 18 years of age or older at time of consent.
* For AD subjects only: Confirmed clinical diagnosis of active AD according to Hanifin and Rajka criteria, BSA, EASI and IGA.
* For AD subjects only: Diagnosis of atopic dermatitis for at least 5 years.
* Women of childbearing potential is willing to use effective contraceptive method.
* Women of childbearing potential must have a negative urine pregnancy test.

Main exclusion Criteria:

* Has known cardiovascular arterial disease, a pacemaker, psoriasis, uncontrolled diabetes.
* Presence of an unstable co-morbidity that could have an effect on vascular inflammation.
* Heart rate restriction for patients with asthma or COPD.
* Use of any topical medication for atopic dermatitis on the site to be biopsied.
* Use of systemic treatments for atopic dermatitis.
* Use of phototherapy, tanning booth or other ultraviolet light sources.
* Use of biologics.
* Use of experimental medications.
L-Citrulline in Patients With Post-Polio Syndrome

The purpose of the study is to show that the intake of L-citrulline improves muscle function in patients with Post-Polio Syndrome (PPS).

This is a single center, randomized, double-blind, placebo controlled study. The study medication consists of L-citrulline, respectively placebo given orally; 5 g L-citrulline or placebo will be given three times daily. The duration of the study is 48 weeks and comprehends one screening and four study visits.

Additionally, in order to investigate whether PPS is associated with an atrophy of spinal cord gray and potentially also white matter as well as motor cortex atrophy, it is planned to offer all trial participants an additional optional spinal cord/brain MRI investigation and a MRI at week 48 and a follow-up one year later together with a clinical and physiotherapy assessment during extension phase. We don't expect Citrulline to affect the spinal cord gray or white and gray matter.

Eligibility Criteria:
Inclusion Criteria:

* Prior paralytic poliomyelitis with evidence of motor neuron loss
* A period of partial or complete functional recovery after acute paralytic Poliomyelitis
* Slowly progressive and persistent new muscle weakness or decreased endurance, with or without generalized fatigue, muscle atrophy, or muscle and joint pain. Symptoms that persist for at least a year
* Exclusion of other neuromuscular, medical and skeletal abnormalities as causes of symptoms
* Patients older than 18 years at time of Screening
* ambulant
* ability to walk 150m in the 6 min. Walking distance (6MWD)
* females of childbearing potential willing to use contraceptive during the study

Exclusion Criteria:

* Previous (3 months or less) or concomitant participation in any other therapeutic trial
* Use of L-citrulline or L-arginine within the last 3 months
* Known individual hypersensitivity to L-citrulline
* Known or suspected malignancy
* Other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of investigator
* Pregnant or breast-feeding women
* Severe renal failure (calculated glomerular filtration rate (GFR) \< 30 ml/min)
Short-term Postural Training for Older Adults

Generalization refers to skill transfer under various working spaces following motor practice. The extent of generalization effect links causal to in-depth recognition of error properties during motor practice. Idiom says "imperfect practice makes perfect". It could be beneficial for the elderly to gain superior capacity of balance transfer skill under the short-term productive failure learning environments. In contrast to traditional visual feedback that uses error avoidance training to optimize target balance task, the present 3-year proposal is to propose three potential neuro-cognitive strategies to improve motor skill transfer following stabilometer training. The strategies are expected to enhance opportunities of error experience and motor exploration via modified visual feedback, underlying facilitations of attentional resource and error-related neural networks. In the first year, the neuro-cognitive strategy for balance practice is progressive augmentation of visual error size to improve balance skill transfer. In the second year, the neuro-cognitive strategy for balance practice is visual feedback with virtual uncertainness of motor goal. In the third year, the neuro-cognitive strategy for balance practice is stroboscopic vision. EEG and central of pressure will be processed with non-linear approaches. Graph theory will characterize EEG functional connectivity and brain network efficiency regarding to brain mechanisms for practice-related leaning transfer. Trajectories of central of pressure will be analyzed with stabilogram diffusion analysis to reveal behavior mechanisms for practice-related variations in feedback and feedforward process for error corrections.


Eligibility Criteria:
Inclusion Criteria:

* Age above 60 years old healthy older adults without a history of falls.
* Able to understand and give informed consent.
* The Mini-Mental State Examination test score above 25-30.
* Lower limb muscle strength is evaluated as G grade
* The corrected visual acuity was within the normal range.

Exclusion Criteria:

* Any known history of mental illness
* Any neuromuscular or degenerative neurological disease(ex:stroke、SCI、TBI...etc)
* Any known history of cerebral cerebellar disease or intracranial metal implants.
* Weak of hearing or wearing a hearing aid
Mitigating Adverse Sexual and Reproductive Health Outcomes Among Young Adolescents

This study evaluates the effectiveness of comprehensive sexuality education (CSE) among young adolescents (10-14 years) in schools. A total of 33 schools will participate in the trial with 15 intervention arm that will receive CSE education and 18 in the control arm, Intervention will go on for one year

The International Technical Guidance on Sexuality Education (ITGSE) defines CSE as "an age-appropriate, culturally relevant approach to teaching about sexuality and relationships by providing scientifically accurate, realistic, non-judgmental information and CSE improves sexual and reproductive health outcomes of young people by delaying sexual debut, promoting condom use and increasing sexual health knowledge, however, most of these outcomes have been reported in older adolescents and there is limited evidence for effectiveness of CSE among young adolescents

The study aims at improving adolescent sexual and reproductive health of young adolescents through CSE that is led by interdisciplinary university students' team in an environment where no consistent or regulated sexual and reproductive health education program currently exists

Eligibility Criteria:
Inclusion Criteria:

* adolescent 10-14 years in primary school
* Adolescent in primary 5 or 6 of education in Uganda
* Written consent/assent to participate

Exclusion Criteria:

* Below 10 years or above 14 years at baseline
* No consent obtained
Statistical Learning As a Novel Intervention for Cortical Blindness

This project aims to develop a novel visual training paradigm for use in visually-intact participants and those sufferings from stroke-induced visual impairments. Our task design is built upon theories of statistical learning to reduce the overall training burden while still producing profound improvements to visual abilities. Efficacy will be first established in visually-intact controls before testing in stroke survivors to assess the feasibility of this form of learning in the damaged visual system.


Eligibility Criteria:
Cortically Blind participants

Inclusion criteria:

* Between 21 and 75 years of age
* Residents of the United States or Canada
* Have successfully completed previous enrollment in Dr. Huxlin study (IRB #5966 or #75)
* Exhibit unilateral stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained within the specified age range of 21 - 75 years (verified by MRI and/or CT scans)
* Reliable visual field defects in both eyes (homonymous defects) as measured by Humphrey visual fields. This deficit must be large enough to enclose a 5-deg diameter visual stimulus.
* Able to fixate on visual targets reliably for 1000ms within 1-deg of visual angle.
* Willing, able, and competent to provide their own informed consent
* Normal cognitive abilities and be able to understand written and oral instructions in English

Exclusion criteria:

* Past or present ocular disease interfering with visual acuity
* Best corrected visual acuity (BCVA) worse than 20/40 in either eye
* Sustained documented or suspected damage to the dorsal Lateral Geniculate Nucleus
* Presence of diffuse whole brain degenerative processes
* History of traumatic brain injury
* Any other brain damage deemed by study staff to potentially interfere with training ability or outcome measures
* Documented history of drug/alcohol abuse
* Currently taking neuroactive medications which would impact training, as determined by PI
* Cognitive or seizure disorders
* One-sided attentional neglect
* Those who lack the competence or are otherwise unable to perform the visual training exercises as directed.

Control participants

Inclusion criteria:

* Between 21 and 75 years of age
* No history of neurological disorder.
* Competent and responsible, as determined by the screening interview

Exclusion criteria:

* Any damage to the visual system
* Those who are suffering from an active disease process involving their nervous system.
* Presence of cognitive or seizure disorders
* Best corrected visual acuity worse than 20/40 in either eye
* Presence of visual field loss from ocular disease or disorder
The Effect of Preoperative Warming on Postoperative Hypothermia

36 patients American society of anesthesiology (ASA) physical status I,II and III undergoing general anesthesia for elective transurethral resection of the prostate (TUR-P) surgery will be included in the study. Patients will be randomized into two groups; first group(control group) and second group (forced-air warming). Resistive heating will start when patients are transferred to the operating room table; forced-air warming will start before preoperative 30 minute.

The primary aim of this study was to compare the effect of prewarming on perioperative hypothermia in elderly patients undergoing TURP under general anesthesia. In addition, we aimed to evaluate the effects of prewarming on hemodynamic variables, PACU output time, tremor, patient comfort and satisfaction. The investigators plan to enroll 36 patients in 2 groups. Body temperature will be measured at the core temperature, hemodynamic variables. Shivering will be graded by visual inspection. Thermal discomfort scale, patient satisfaction will be evaluated. The investigators hypothesize will decrease the forced air prewarming incidence of perioperative hypothermia.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50-85 years undergoing general anesthesia for TURP surgery
* ASA physical status I and III patients
* Body mass index between 15 and 36 kg/m2
* General anesthesia time is 30-90 minutes

Exclusion Criteria:

* without written consent,
* inadequate Turkish comprehension,
* known impaired thermoregulation or thyroid disorders,
* severe hypertension (systolic blood pressure \[SBP\]\>180 mmHg or diastolic blood pressure \[DBP\] \> 110 mmHg in the operating suite admission),
* an angiotensin-converting enzyme inhibitor/angiotensin II receptor antagonist on the day of surgery,
* secondary hypertension (e.g., renal artery stenosis, pheochromocytoma, Cushing's syndrome),
* vascular disease,
* poor cutaneous perfusion,
* serious skin lesions
* baseline temperature ≥37.5°C (degrees centigrade)
D-Serine Treatment of Negative Symptoms and Cognitive Deficits in Schizophrenia

This study is based on the hypothesis that by increasing N-methyl-D-aspartic acid (NMDA) receptor function in the brain and thereby increasing the capacity of the brain to both form new connections and strengthen existing connections, schizophrenic patients may derive both greater and sustained benefit from cognitive retraining.

Patients with schizophrenia or schizoaffective disorder who are currently receiving antipsychotic medication will be randomly assigned in a double-blind manner to receive either D-serine (30 mg/kg) or placebo in addition to cognitive rehabilitation or a non-interactive placebo for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder

Exclusion

* Pregnant or lactating
Development of Clinical and Biological Database in Colorectal Cancer

Creation of circulating cancer cell-lines and caracterisation of these cell-lines which will be collected before any treatment in patients with metastatic colon adenocarcinoma

In the light of literature data, it becomes crucial to develop models for studying the functionality of CTCs. In this context, xenograft models in nude mice have recently been described9,10. Establishing cell lines to allow CTC amplification to have enough material to work is an attractive approach. Some recent studies have demonstrated the feasibility of establishing such tools in breast or prostate cancer, 11, 12 but no studies have been done for colorectal cancer. Thus on the basis of the hypothesis that circulating tumor cells could be, or at least contain, cancerous stem cells, we propose to isolate them under conditions that promote their survival in order to characterize them in the particular context of colorectal cancer.

If CTCs consist at least in part of CSCs, they should survive in an environment favorable to the culture of these cells. It is for this reason that purified CTCs will be seeded in plaques that prevent cell adhesion and in a serum-free medium but including growth factors (M12) under hypoxia conditions to approximate their original context. The ability of these cells to form spheres will be observed under these conditions.

In this context, the team of the Institute of Functional Genomics of Montpellier are the first, to have developed and characterized three lines of CTC from blood samples of patients with metastatic colon cancer (Grillet F. and al; submitted for publication). In addition to the characterization of these rare cells and the decryption of some of the mechanisms involved in tumor dissemination, this tool is very valuable for the clinic. Indeed, it could help the establishment of personalized medicine to test quickly (less than 3 weeks) on the CTC of the patient, the effectiveness of conventional treatments but also new drugs included in clinical protocols. For the basic research part, this line will help us to characterize these cells because the number is no longer a limiting factor, the main objective now being to obtain more lines from a blood sample from patients with different profiles by optimizing cell culture conditions.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years
* Histological evidence of metastatic colorectal cancer
* Naïve patients receiving chemotherapy at the metastatic stage or who have received adjuvant chemotherapy for more than 6 months
* Obtain signed informed consent prior to any specific preselection procedure.

Exclusion Criteria:

* History of Chemotherapy Treatment and / or Targeted Therapy for Metastatic Colorectal Cancer
* Breastfeeding or pregnant woman
* Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons
* Any severe or unstable medical, psychiatric or other condition that may interfere with the patient's safety, consent or compliance with the study protocol
* Patient not benefiting from a social security scheme
Piloting a Mobile Game for Behavioral Therapy

The following study aims to understand the feasibility of the mobile app and game, GuessWhat, to deliver behavioral therapy to children with autism. The GuessWhat app is a charades style game that engages parent and child in fluid social interaction where the parent must guess what the child is acting out based on the prompt shown on the phone screen. Participants will use their own personal phone to download the study app. The app will walk participants through a variety of charades style games. The interactive games will be video recorded and all data are transferred securely to the Wall Lab for analysis. This study is enrolling parents of children with ASD who are at least 18 years of age and have a child between 3-12 years old. Parents are asked to complete questionnaires before and after playing the GuessWhat game with their child 3-4 times per week for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Parent who is at least 18 years old of child with autism.
* Child with autism is between 3 and 12 years old at time of baseline data collection.

Exclusion Criteria:

* Parent is not able to read or speak English
* Parent does not have an Android or iOs smartphone compatible with GuessWhat App
Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care in Turkey

In this observational study, it is aimed to investigate the mortality and morbidity rates of hospital-acquired blood stream infections that are treated in intensive care units (ICU). The effects of properties of the micro-organism such as type and antimicrobial resistance on the infection and its outcomes will be mainly explored. In addition, the impact of antibiotic options and other treatment modalities on survival of patients will be investigated. Twenty-seven different ICUs from Turkey will be included in this study.

Blood stream infection (BSI) is defined as the identification of a culprit pathogen in the blood culture sample of a participant. As such, and once contaminants are excluded, BSI is the only cause of sepsis where the presence of an infection and the pathogen are known with certainty. This makes BSI the perfect model of infection to study the effects of the micro-organism on the participant, and the effects of the antibiotics and other treatments on survival. There is an increasing trend in antimicrobial resistance rates among microorganisms that are associated with nosocomial infections treated in ICU. However, infectious diseases physicians from Turkey do not know contemporary epidemiological data of hospital-acquired BSI treated in ICU in Turkey.

This study 'Epidemiology and Determinants of Outcomes of Hospital-Acquired Blood Stream Infections in the Intensive Care in Turkey' is a multi-center prospective observational cohort study that will include patients with hospital-acquired blood stream infections (HA-BSI) treated in ICUs in Turkey. This study will present unknown current epidemiology of HA-BSI in Turkey. Furthermore, It will provide very important data about 28-day mortality rates of HA-BSI treated in ICU. The primary outcomes of this study can be accounted as following: (i)determinants of outcomes of HA-BSI, (ii) the effects of the source of infection on outcomes, (iii) the effects of microorganism on these outcomes, (iv) the effects of antimicrobial therapy and of source control on investigated outcomes. In this study, participant specific and organizational factors will be explored and the determinants of management of HA-BSI in ICUs will be described.

There will be no intervention in this study. The data of participants will be obtained from hospital database and recorded into electronic case report forms anonymously.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 Years.
* Hospital Acquired Bloodstream Infection (HA-BSI).
* Treated in the ICU.
* ICU acquired OR Hospital acquired prior to ICU admission

Exclusion Criteria:

* Patients that had a positive blood culture in the hospital and transferred to ICU for a different reason than specific treatment of the causes or consequences of HA-BSI.
* Previous inclusion in the study.
* HA-BSI is defined as a positive blood culture (BC) sampled after 48 hours following hospital admission.
The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta

Osteogenesis imperfecta (OI) is an inherited disease of the connective tissue. Symptoms are fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. The aim of the present study is to investigate the effect of treatment of adult OI patients with bisphosphonate (zoledronic acid), parathyroid hormone (PTH) or placebo on bone mass, fracture risk and quality of life.

The investigators will therefore conduct a double blind, placebo controlled trial, taking genotype and previous antiresorptive therapy into account.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of osteogenesis imperfecta
* BMD\<-1.0 or

Exclusion Criteria:

* creatinine clearance \<30mL/min
* treatment with glucocorticoids \> 5mg daily during the last 3 months
* metabolic bone disease or vitamin d deficiency
* liver or kidney disease
* contradictions to zoledronic acid or teriparatide
* increased baseline risk of osteosarcoma