cyrilzakka/clinical-trials huggingface dataset:
Immunopathology of Polymyalgia Rheumatica on Shoulder Bursae's Biopsies

The work carried out at the Brest University Hospital on serum immunological changes in patients with polymyalgia rheumatica (PMR) (based on clinical protocols TENOR, SEMAPHORE, THEN) made it possible to describe the changes in the distribution of lymphocyte subpopulations and cytokine levels during PPR, before and then under treatment compared to controls.

However, in systemic autoimmune or inflammatory pathologies, serum immunological mechanisms are rarely a reflection of intra-tissue mechanisms.

In the specific case of PMR, there are few data concerning muscular or joint immunological modifications. The investigators now wish to study the immunological modifications occurring at the tissue sites of interest, in particular in the shoulder bursae


Eligibility Criteria:
For everyone :

* Signed consent
* Patients over 50

Inclusion criteria :

For case patients:

* Addressed for PMR (diagnosis OR relapse)
* Score greater than or equal to 4 (without ultrasound criteria) or greater than or equal to 6 (with ultrasound criteria), according to the ACR / EULAR 2012 criteria for polymyalgia rheumatica, and suffering from bilateral scapular pain as well as an increased CRP level .
* Thickening of more than 2mm at least one shoulder bursae in ultrasound
* DAS-PPR\> = 10

For witnesses:

- Shoulder surgery scheduled for mechanical pathology

Exclusion criteria :

For everyone :

* MRI with Gadolinium injection in the previous month- Clinical or paraclinical signs of giant cell arteritis
* Patient under protective measure or unable to consent
* Active cancer
* Active infection

For the cases:

- History of biotherapy treatment

For witnesses:

* History of inflammatory rheumatism
* Active inflammatory rheumatism
Sensory Motor Lateralization as Handwriting Intervention in School-Based OT

Children who attend School-Based Occupational Therapy (SBOT) show mixed dominance and a liable decreased in the structural and functional differentiation between the two hemispheres. The lack of right-left disparity has been found to link to mirror invariance, poor spatial organization, fragmentary reversals, and handwriting difficulty. This study intends to find out, whether, Sensory Motor Lateralization (SML), "With" a rightward bias, profits handwriting more than the conventional (CON) "Without".

10 to 30% of school children suffer handwriting difficulty. Many of them are eventually referred to SBOT for remedial intervention. Among these children, 70% show mixed dominance in their hand and/or leg use, and a likely functional and structural interhemispherical asymmetry reduction. This would make them right-left symmetrical. Learning, thus, may be challenged, because people who are right-left balanced would not have a consistent reference point to process the learning materials regularly in any pre-determined directions. They are, thus, prone to suffer mirror invariance, fragmentary reversal errors, and handwriting difficulty, especially with the fast and accurate construction of asymmetrical letters from memory.

To enhance right-left disparity, dispel mirror invariance, and facilitate the automatized handwriting, SML preferentially belabors one's right eye, ear, hand and leg in therapy, that would greater engage the left hemisphere for its acclaimed vantages over learning. This study investigates, whether SML, wielding such a rightward bias, profits handwriting greater than CON.

Eligibility Criteria:
Inclusion Criteria:

* Any Special or Regular Education students with Individualized Education Plans (IEPs), OT mandates, and handwriting goals.
* Has Intelligence Quotient (IQ) equal to or above 60.
* Ambulatory.
* Proficient in English, and fluent in naming, identifying, and accessing the sequence of letters in the alphabet.
* The students who attend Physical Therapy (PT), Adaptive Physical Education (PE), and any other programs are included, if the programs being provided are skill-, theme-, or task-oriented, not involving any muscle strengthening activities.

Exclusion Criteria:

* All are excluded, if the study candidates have any medical condition(s) that would prohibit them from the full physical participation in school.
Gastric Per Oral Endoscopic Myotomy (G-POEM) in Refractory Gastroparesis

Refractory gastroparesis is a disease characterized by a delayed gastric emptying without a mechanical obstruction. Actual treatments have a limited efficacy and gastric per-oral endoscopic myotomy (G-POEM) is a new treatment that has demonstrated initial promising results in these patients. The investigators aims are to evaluate security and efficacy of this endoscopic treatment in participants with refractory gastroparesis.

Gastroparesis is a chronic, condition characterized by a delayed gastric emptying without a mechanical obstruction. This disease is associated with high morbidity and mortality with a prevalence up to 4% of population. Patients with this disease have a reduced quality of life. The principal etiologies include: post-surgical, diabetes, medications and idiopathic. Symptoms include nausea, vomiting, early satiety, bloating and abdominal pain. Diagnosis is based on the combination of symptoms and studies as gastroscopy that shows retained food in the stomach without a gastric outlet obstruction and confirmed with a gastric emptying scintigraphy. Treatments have limited effect in these patients, including medications, botulinum toxin injection, surgical gastric electrical stimulation, laparoscopic pyloroplasty and stent placement. G-POEM is a new technique based on per-oral endoscopic myotomy treatment in achalasia patients, which has been recently proposed for treatment of patients with refractory gastroparesis with good initial results. The investigators aim is to evaluate the safety and efficacy of this new technique in a group of mexican participants with this disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory gastroparesis based on delayed gastric emptying symptoms: Nausea, retching, vomiting, abdominal pain, early satiety, post-prandial fullness, bloating.
* Refractoriness defines as the presence of symptoms with failure or recurrence after other type of treatment.
* Any etiology: diabetes, post-surgical, idiopathic

Exclusion Criteria:

* Pregnancy
* Portal hypertension
* Gastric malignant condition
* Active prepyloric ulcer
* Mechanical pyloric stenosis
EMA of Substance Use in Homeless Youth

The proposed study will provide critical information on Ecological Momentary Assessment (EMA) design characteristics that promote retention in a vulnerable and under-represented population in research-youth experiencing homelessness. The study will use an EMA app to collect substance use, mood, craving, social surroundings, and trauma measures over a 14-day period in youth age 18-24 (n=40) recruited from Star House, a homeless youth drop-in center. Youth will be randomized in 2x2 factorial design (fixed incentive model vs. prize-based model; random assessment 3x vs. 6x per day).


Eligibility Criteria:
Inclusion Criteria:

* currently homeless, defined as lacking a fixed, regular, and adequate nighttime residence.
* report any of the following past-month frequencies of substance use (NIDA ASSIST screen) used in prior EMA studies: a) heavy episodic or "binge" drinking (≥4 drinks per day for women/≥5 drinks for men) ≥2 days per month ; b) marijuana use ≥2 days per week; or c) any illicit drug use.

Exclusion Criteria:

-
Trial of Posture Correction Girdle for Adolescents With Early Scoliosis

Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads to the three dimensional deformity of the spine. Spine curvature increases in youths as puberty progresses. Generally, only observation is suggested for adolescents with early scoliosis (Cobb's angle ≤ 20°). Rigid brace treatment is too draconian for them due to the high corrective force which nearly constrains all movements. Flexible brace treatment is an alternative option; however, its efficacy is still controversial. Posture correction girdle with a specialized design for teenagers with scoliosis is limited and most part of them can only provide some improvement for bad postures, such as hunchback. A scientific approach should be used to design and develop posture correction girdle as a treatment option for adolescents with early scoliosis.

The design of posture correction girdle will incorporate different mechanisms, such as

1. compression and pulling forces through a close fit of the intimate apparel
2. lumbar flexion by using a supporting belt
3. transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system
4. axial rotation or coupled motion by using a system with uneven straps, and
5. an active mechanism that aims to shift the trunk away from areas of pressure.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AIS
* Cobb's angle 10˚-20˚
* Risser grade ≤ 2
* No prior treatment
* Pre-menarche or post- menarche by no more than 1 year
* Ability to read and understand English or Chinese
* Physical and mental ability to adhere to anisotropic textile braces protocol

Exclusion Criteria:

* Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
* History of previous surgical or orthotic treatment for AIS
* Contraindications for pulmonary and/ or exercise tests
* Psychiatric disorders
* Recent trauma
* Recent traumatic (emotional) event
A Study of Sleeve Gastrectomy Risks and Benefits

This research study is being conducted to collect information to improve the outcomes of patients who have renal failure and are scheduled to have a sleeve gastrectomy.

We will collect information on changes in physical performance, activity, blood pressure and glucose metabolism, body composition, and the quality of life prior to and three months after sleeve gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant candidates with obesity.
* Accepted for sleeve gastrectomy (SG).
* Accepted for kidney transplantation if criteria are met after SG.

Exclusion Criteria:

* Not undergoing sleeve gastrectomy.
* Unable to connect through telehealth technology.
* History of medical non-adherence that can affect adherence to the protocol.
* Any other medical condition that in the opinion of the Principal Investigators warrants exclusion for safety reasons.
Iodine Status in Portuguese Children and the Role of Salt Fortification in School Canteens

It is well known that insufficient iodine intakes impairs the production of thyroid hormones, essential for cognitive development and healthy growth.

Although the World Health Organization (WHO) promotes public health measures for an adequate iodine consumption, it is estimated that one in three school age children remain iodine deficient worldwide. Whereas there is no mandatory iodisation programs in Portugal, young infants are among the most vulnerable to iodine deficiency due to their special requirements.

Therefore, the present study aims to evaluate iodine status in school age Portuguese children (6-12y), compare iodine status in children, cognitive outcomes and thyroid health and monitor the use of iodised salt in school canteens exploring potential implications in children's iodine status.

Iodine is essential for the synthesis of thyroid hormones. Thyroid hormones, especially during periods of increased susceptibility, are crucial for neurodevelopment. Inadequate levels of iodine in the diet may lead to a strong and decisive cognitive impairment which poses a major public health challenge. The World Health Organization prioritized the intake of iodine and recommends the universal enrichment of salt with iodine, so it may reach the general population. In 2013 the Portuguese Department of Education (DGE) issued, as a result of the collaboration with the Portuguese Department of Health (DGS) under the National Program to Promote Healthy Eating a directive introducing the use of iodized salt in school canteens. To ensure the effectiveness and the impact of these policies in Portugal, this project aims to (1) evaluate urinary iodine status in school children (6-12 y), (2) monitor the use of iodized salt in schools, (3) explore potential associations between these parameters. The results of this project will be used to educate food service professionals regarding the use of iodized salt and inform the community about the impact of iodine in health, based on the Norwegian model.

In this study a total of 4800 school aged children will be recruited from approximately 160 schools in the north of Portugal. Parents will be asked to complete the CBCL 6-18, Child Behaviour Checklist and a comprehensive questionnaire which will collect data regarding the child lifestyle and diet. A urine sample will be collected from each participant in school and the Raven's Colored Progressive Matrices will be applied to evaluate children cognitive performance. Anthropometry measurements will be also collected.

Eligibility Criteria:
Inclusion Criteria: School children aged 6 to 12 -

Exclusion Criteria:

-
A Study to Assess the Clinical Outcomes of Surgical Phaco Segmentation Techniques in Patients Undergoing Cataract Surgery

The purpose of this research study is to evaluate the clinical outcomes of different cataract surgical techniques for lens fragmentation in subjects undergoing routine cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits as confirmed by provision of written informed consent.
2. Subjects with a visually significant cataract scheduled to undergo cataract surgery
3. Subjects \> 18 years of age
4. BCVA at baseline not better than 20/40
5. Grade 1+ cataracts

Exclusion Criteria:

1. Subjects not able to complete the informed consent form
2. Subjects \< 18 years of age
3. Polar cataracts
4. Zonular instability
INTERNATIONAL SURVEY ON COMPLEXITY IN LIVER TRANSPLANTATION

The aim of this study is to perform an online survey to assess the perception of international liver transplant surgeons regarding the complexity and surgical difficulty in liver transplantation and to develop a complexity score and classification.


Eligibility Criteria:
Inclusion Criteria:

* surgeons in liver transplantation center
* all countries

Exclusion Criteria:

* none
Vasopressin in the Elderly: Physiological Changes in Neuroendocrine Function and Urinary Secretion in Healthy Aging

Elderly people are at a high risk for disturbances in water homeostasis, with both hypo- and hypernatremia being more common with increasing age. Several changes in the physiology of the ageing body are responsible for this predisposition towards hypo- and hypernatremia, including diminished thirst perception, decreasing kidney function, and altered body composition. In addition, age-related changes in AVP secretion have been suggested, but findings remain inconclusive. Possibly, this controversy is due to measurement challenges of AVP.

Copeptin, a surrogate marker of AVP-release, is more stable and a reliable assay is commercially available. While copeptin stimulation and suppression has been studied in healthy volunteers, no study assessed possible changes in copeptin dynamics occurring with ageing.

Therefore, the aim of this study is to investigate copeptin levels in hypo- and hyperosmolar states in generally healthy elderly adults compared to young controls. The investigators hypothesize that both the suppression and stimulation of copeptin is impaired and that the overall range of variation is diminished with increasing age.

This is a monocentric open-labeled randomized controlled trial conducted at the university hospital Basel. All participants will be scheduled for a copeptin stimulation test using hypertonic saline infusion and a copeptin suppression test using water ingestion. The order of the two study visits will be randomized at study inclusion.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-30 years or ≥ 60 years
* Normonatremia (135-145 mmol/L)
* Plasma osmolality 280-300 mOsm/kg
* BMI ≥18 and ≤ 30 kg/m2

Exclusion Criteria:

* Regular use of medication with effects on water homeostasis (e.g. blood pressure medication, neuroleptics, desmopressin, etc.)
* Any severe disease requiring frequent medical care, except physiotherapy and/or psychotherapy
* Pacemaker or ICD
* History of thrombosis
* Active oncologic disease
* Heart failure
* Liver cirrhosis
* Estimated glomerular filtration rate (eGFR) \< 60 ml/kg/1.73 m2
* Uncontrolled hypertension \>160 mmHg systolic or \>100 mmHg diastolic
* Polydipsia (ingestion of \>3L fluids per day) and polyuria (\>50 ml/kg urine production within 24 hours)
* Pregnancy or breastfeeding
* Participation in a study with investigational drugs within 30 days
* Acute illness
* Inability to follow study procedures
Efficacy/Safety Study to Explore a New Topical Formulation in Atopic Dermatitis

The study shall explore whether treatment of atopic dermatitis is equally effective with Phoenix medical device as compared to standard therapy (Hydrocortisone cream).


Eligibility Criteria:
Inclusion Criteria:

* Male or female Caucasians aged between 18 and 60 years
* Patients with mild atopic dermatitis (AD) presenting a scoring AD (SCORAD) rating below 50
* Skin type I - IV according to Fitzpatrick
* Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and \<= 12) at Baseline
* Acute symptom of pruritus at Baseline

Exclusion Criteria:

* Any other skin disease at the test area that would interfere with the clinical assessment in the opinion of the investigator
* Moles, tattoos, strong pigmentation, or scars at the test area that would interfere with the clinical assessment
* Regular intake of antiphlogistic drugs (for example nonsteroidal anti-inflammatory drugs \[NSAIDs\])
* Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
* UV-therapy or the use of solarium within 30 days before screening as well as during the trial
* Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial
Study to Evaluate the Mass Balance and Biotransformation of [14C]-Fluzoparib in Chinese Patients With Solid Tumor

Study to Evaluate the Mass Balance and Biotransformation of Single Dose \[14C\]-FZPL in Chinese Patients with Solid Tumor


Eligibility Criteria:
Inclusion Criteria:

1. Subjects diagnosed with advanced solid malignancies who are refractory or intolerant to standard therapy or considered to be benefit from the treatment of fluzoparib.
2. ECOG performance status of 0 to 1.
3. Life expectancy of more than 3 months.
4. Signing the informed consent forms.
5. Adequate bone marrow, liver and renal function.
6. Be able to communicate well with the researcher and be able to complete the trial in accordance with the program.

Exclusion Criteria:

1. Subjects who take any drugs that strongly inhibit or induce the CYP450 enzyme 14 days prior to study drug administration；
2. Those who have history of alcohol abuse (it was defined as that the daily alcohol consumption was higher than the following criteria: the weekly alcohol consumption was higher than 14 units of alcohol (1 unit= 360 ml beers/45 ml liquor containing 40% alcohol/150ml grape wine) 6 months prior to screening period, or the alcohol breath test results ≥20 mg/dl during screening period；
3. Subjects who smoked daily \>5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study.
4. Subjects who have history of drug abuse or taking soft drug (i.e., marihuana) 3 months prior to screening period or taking hard drugs (i.e., cocaine, amphetamines, benzodiazepine, etc.); or the results of urine test in drugs were positive.
5. Subjects who were used to drink grapefruit juice or overconsumption of tea, coffee, and the drink with caffeine; and cannot give up them during test.
6. Subjects who need long-term exposure to radiation, or who have been exposed to PET-CT or ECT within 3 months prior to study drug administration or who have participated in the labeling test of radiopharmaceuticals.
7. Subjects who have fertility planning within the range of starting trial - 1 year after finishing trial.
8. Subjects who have excessive bleeding or blood donation (400ml) 3 months prior to screening period, or planned to donate blood 1 month after finishing this trial.
9. Subjects who have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
10. Subjects must not have had prior treatment with PARP inhibitors.
11. Subjects who cannot complete this study because of other reasons, or any factors judged by investigator that the participants cannot meet.
A Study of L-735,524 in HIV-Positive Children and Adolescents

To evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate ( MK-639; Crixivan ) in HIV-seropositive older children and adolescents. To compare the plasma concentration profile after the initial dose with data from a historical group of adults. To obtain preliminary data on antiviral activity of MK-639.

Patients receive MK-639 for 14 and one-third days. Repeat plasma samples are collected up to 8 hours following the first and last dose. Urine samples are collected on days 1 and 5.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV positivity.
* No active opportunistic infection within the past 30 days, other than superficial candidiasis of the oral cavity or vagina.
* Body surface area at least 1.0 sqm.
* Consent of parent or guardian.

Prior Medication:

Allowed:

* Aerosolized pentamidine.
* Topical antifungals.
* TMP / SMX.
* AZT.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Significant hepatic disease including HBsAg or hepatitis C positivity.
* Significant neurologic disease such as loss of intellectual ability, motor deficits, or seizure disorder.
* Significant cardiac disease including dysrhythmia or cardiomyopathy.
* Significant medical condition or laboratory abnormality that may pose additional risk to patient on study or confound the results.
* Has a social situation that may interfere with study participation.

Concurrent Medication:

Excluded:

* Oral contraceptives.

Patients with the following prior conditions are excluded:

* History of serious allergic drug reactions.
* History of significant cardiac disease.
* Participation on another clinical trial within the past 4 weeks.
* Donated blood within the past 4 weeks.

Prior Medication:

Excluded within the past 4 weeks:

* Hematopoietic growth factors.

Excluded within the past 2 weeks:

* Antiretroviral agent other than zidovudine.
* Oral contraceptives.
* Prophylaxis for opportunistic infections, other than aerosolized pentamidine, topical antifungals, and TMP/SMX.
* Any other medication unless approved by Merck clinical monitor. Current illicit drug use.
Study to Evaluate Long-Term Tolerability and Safety of Oral Prucalopride in Chronic Constipation

Objectives: Evaluation of the clinical long-term safety, tolerability, patient satisfaction, pharmacokinetics and pattern of use of oral prucalopride tablets given in doses up to 4 mg once daily to patients with chronic constipation


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant, non-breast-feeding female outpatients of at least 18 years of age
2. Patient had completed the entire treatment period of the PRU-INT-6 study or the PRU-INT-12 study .

Exclusion Criteria:

1. Patients with impaired renal function
2. Patients with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
3. Females of child-bearing potential without adequate contraceptive protection during the study.