cyrilzakka/clinical-trials huggingface dataset:
Acetylcholinesterase Inhibitor in Anorexia Nervosa: Multicenter, Double-Blind, Placebo-Controlled Trial

The goal of this clinical trial is to learn if the daily take of donepezil can treat adult patient suffering from anorexia nervosa. The main question it aims to answer is : do daily donepezil intake permit weight gain and reduction of food restriction rituals ? The treatment is a capsule comprising a drug limiting the degradation of a neurotransmitter called acetylcholine. This treatment has long been used to treat certain cognitive disorders. Researchers will compare two drug dosage and a look-alike capsule that contains no drug to see if the dose has an impact on the effect. Participants will take one capsule per day for three months will have regular hospital visits for cognitive and metabolic tests.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Presence of the 3 DSM-V criteria for Anorexia Nervosa
* Restrictive subtype of Anorexia Nervosa according to DSM-5
* Body Mass Index between 15 and 18.5 kg/m²
* Aged 18 to 65 years
* Resting heart rate \&gt; or = 40 bpm
* Use of a highly effective contraceptive method
* Affiliation or entitlement to a Health Insurance scheme
* Prior free, informed, and written consent

Exclusion Criteria:

* Presence of one or more somatic criteria for hospitalization according to french HAS 2010 guidelines
* Past diagnosis of anorexia nervosa with binge-eating/purging type
* Past diagnosis of bulimia nervosa
* Past diagnosis of binge-eating disorder
* Associated diagnosis of schizophrenia and/or persistent delusional disorder and/or bipolar disorder
* History of asthma or obstructive bronchopulmonary disease
* History of peptic ulcer disease or concurrent treatment with non-steroidal anti-inflammatory drugs
* History of epileptic disorders
* Renal insufficiency (glomerular filtration rate less than 60 mL/min according to the MDRD formula)
* Hepatic insufficiency or transaminase levels greater than 5 times the normal upper limit
* Conductance disorder characterized by electrocardiogram
* QTc according to Bazett's formula greater than 480 ms on electrocardiogram
* Current or recent (within three weeks prior to inclusion) psychotropic treatment (including antidepressants, to avoid interaction/potentiation in this population)
* Treatment involving the following cytochromes: P450, P3A4, P2D6
* Known hypersensitivity to donepezil hydrochloride, piperidine derivatives, or any excipients of the investigational drug
* Pregnant or breastfeeding woman
* Person under legal protection measures
* Person under guardianship measures
The Effect of Dates and Castor Oil on the Initiation of Spontaneous Labor in Primigravida Parturients

Finding a natural and efficient method to improve the chance of entering spontaneous labor beyond 39 weeks of gestation will address both the medical necessity and the will of many parturients to avoid medical interventions.

In this study we aim to evaluate the effect of dates and castor oil on the initiation of spontaneous labor in primigravida parturients.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who come to the obstetrical emergency department for normal check up between 39+4 and 40+2 weeks of gestation
* Primipara
* Bishop cervical score below 5
* Low risk pregnancy
* Singleton pregnancy
* Vertex presentation
* Women who haven't consumed dates over once a week in month prior the checkup and haven't consumed castor oil prior to enrollment.

Exclusion Criteria:

* Any medical indication for labor induction
* Regular contractions
* Premature rupture of membranes
* Women who consumed dates over once a week in month prior the checkup or consumed castor oil prior to enrollment.
Using Smartphones in the Neonatal Intensive Care Unit

The goal of this research is to develop and pilot the NICU-2-Home service, a health information technology (IT) concept centered on a smart phone app. NICU-2-Home will provide support to parents of very low birth weight (VLBW) infants as they transition from the NICU to their homes and eventually establish a medical home with the infant's pediatrician. Once the app is developed, we will conduct a feasibility study with randomization to pilot test the ability of NICU-2-Home app to (a) improve parent's self-efficacy and confidence in caring for their VLBW infant, (b) decrease parental stress, and (c) enhance involvement with their VLBW infants compared to controls.

After 2-3 months in the Neonatal Intensive Care Unit (NICU), mothers and fathers of Very Low Birth Weight (VLBW) infants face discharge home with trepidation. Having a VLBW infant that has survived to discharge, these parents now must perform a myriad of health care tasks once at home, yet parents often feel ill-prepared, uninformed, and unskilled to provide this care. The goal of this exploratory research is to develop and pilot the NICU-2-Home service, a health information technology (IT) concept centered on the smart phone that will be created with researchers at Motorola. NICU-2-Home will provide support to parents of VLBW infants as they transition from the NICU to their homes and eventually establish a medical home with the infant's pediatrician. Phase 1 of this research uses qualitative methods and an iterative process to design the NICU-2-Home content service that will support parents as they transition to home from the NICU through interviews with the major stakeholders: parents, neonatal physicians, neonatal staff, and community pediatricians. Phase 2 evaluates NICU-2-Home as parents are transitioning to home and includes a feasibility study with randomization to pilot test the ability of NICU-2-Home to (a) improve parent's self-efficacy and confidence in caring for their VLBW infant, (b) decrease parental stress, and (c) enhance involvement with their VLBW infants compared to controls.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Older than 18 years old
* Have at least one VLBW infant who survived to discharge and transitioned to home

Exclusion Criteria:

- N/A
Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).

The main purpose of the trial is to prove the therapeutic value of the product and enable an effective and safe dosage schedule to be recommended

The objective of this study is to determine the biologic activity of a Glycyphagus domesticus allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

The skin testing procedure, based on the Nordic Guidelines is the reference method for the biological calibration of in-House Reference Preparations (IHRP). The method is not intended for routine testing of allergen extracts. The use of this procedure is the basis for the definition of biological activity units: "the activity of an allergen extract is 10,000 Biological Units (BU) per ml (10 HEP per ml), when the extract provokes an specific skin reaction in the median sensitive patient with a wheal of the same size as a wheal provoked by a positive reference solution consisting of histamine 54.3 mmol/l (for example histamine dihydrochloride 10 mg/ml), when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are clinically allergic and cutaneously reactive to the allergen concerned".

Eligibility Criteria:
Subject inclusion criteria:

1. A documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to Glycyphagus domesticus.
2. Positive skin prick test with an available preparation of the same allergen extract (a wheal major diameter of at least 3 mm) and/or a positive test for specific IgE.
3. Mean of the areas of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 7 mm2.
4. Age ≥ 18 years and ≤ 50 years
5. Subject can be male or female
6. Subject must be capable of providing written informed consent

Subject exclusion criteria:

1. Subjects should not be excluded due to low or high sensitivity to Glycyphagus domesticus.
2. Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested.
3. Use of drugs that may interfere with the skin reactions.
4. Pregnancy, dermographism, atopic dermatitis (locally at the test site), urticaria.
5. Any disease which prohibits the use of adrenaline (hyperthyroidism, arterial hypertension, cardiopathy, etc.)
6. Lack of cooperation which may interfere with the study, or subjects with severe psychiatric, psychological or neurological disorders.
Urinary Biomarkers of Renal Injury in Inflammatory Bowel Disease

The study aims to early detection of renal injury in patients diagnosed to have inflammatory bowel disease with normal kidney function test focusing on glomerular filtration barrier injury and tubular injury and it's relation to disease activity so precautions could be taken properly to prevent further renal injury later on .

Inflammatory bowel disease (IBD) is a chronic and relapsing inflammatory condition of the gastrointestinal tract. Crohn's disease and ulcerative colitis are the two principal types of IBD. The prevalence of IBD has been increasing worldwide . Extraintestinal manifestations of IBD are common, occurring in 6% to 47% of patients involving nearly every organ system .

Renal and urinary system involvement are common in IBD patients with incidence varying from 4% to 23% and is greater in patients with more severe and long-standing disease. Apart from secondary complications, such as nephrolithiasis, hydronephrosis and amyloidosis, other disorders have also been reported. Membranous glomerulonephritis, rapidly progressive glomerulonephritis, mesangiocapillary glomerulonephritis, IgA nephropathy, thin basement membrane disease and kidney granuloma found to be connected with IBD. In addition, non-specific morphological changes in the glomeruli of patients with IBD, like podocyte effacement and mesangial deposition of immunoglobulin and complement have been well documented. Cases of interstitial nephritis reported to be attributed to the nephrotoxic effect of aminosalicylates which used in IBD treatment.

Alpha one microglobulin is a relatively small protein that undergoes glomerular filtration followed by reabsorption and catabolism in the proximal tubules. Increased urinary α1-microglobulin concentration therefore provides an index of proximal tubule dysfunction .

Glomerular filtration barrier related protein changes have not been closely investigated in IBD patients . Nephrin is podocyte-associated protein that play key roles in maintaining the structural and functional integrity of the kidney's filtration barrier. The shedding of nephrin reflects compromisation of podocytes' functional and structural integrity.

Eligibility Criteria:
Inclusion Criteria:

- Patients diagnosed to have inflammatory bowel disease (ulcerative colitis or chron's disease )with age more than 18 years and normal kidney function test

Exclusion Criteria:

Patients known to have renal disease due to other causes . Diabetic patients . Hypertensive patients
Clinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars

This study will be conducted to evaluate the performance; in terms of retention and caries inhibition; of the newly introduced bioactive resin based pits and fissure sealant versus conventional resin based pits and fissure sealant in caries susceptible fissures in posterior molars in patients at risk of caries. Evaluation will be done by visual tactile examination \& VistaCAM.

In the investigator's study the comparator material will be BioCoat® by Premier® ; new bioactive resin pits and fissures sealant featuring SmartCap™ Technology. SmartCap™ Technology utilizes patented semi-permeable resin microcapsules. In BioCoat, the rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, which diffuse in and out of the sealant. Greater fluoride uptake in the presence of calcium and phosphate ions is assumed.

With limited evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it was found beneficial to evaluate the newly introduced material using a randomized controlled trial to test the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as conventional resin based pits and fissure sealant in susceptible fissures.

Eligibility Criteria:
Inclusion Criteria of participants:

* Patients with bilateral caries susceptible fissures in molars showing no signs of caries.
* 19 - 40 years.
* Males or Females.
* Co-operative patients approving to participate in the trial.

Exclusion criteria of participants:

* Patients younger than 19 years old or older than 40 years old.
* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Allergic history concerning methacrylate.
* Rampant caries.
* Heavy smoking.
* Xerostomia.
* Lack of compliance.
* Evidence of severe bruxism, clenching, or tempromandibular joint disorders.
Congenital or Idiopathic Complete Right Bundle Branch Block: Physiological Significance and Molecular Characterization

This study is to determine 1) the incidence of altered right bundle conduction, including CRBBB, IRBBB or rsR' pattern in the Taipei city based on the school survey databank from 1999 to 2002, 2) the associated cardiac lesions, 3) clinical presentations relevant to the altered right bundle conduction, 4) the association with QTc prolongation and dispersion and HRV from a 5-minutes recording. Finally, molecular characterization for those with CRBBB or Brugada pattern EKG, especially those with positive family history will be studied.

The EKG pattern and medical records from the school survey from 1999 to 2002 in Taipei city will be reviewed, and the basic data of those with CRBBB, IRBBB and rsR' pattern will be recorded. Interview will be made and the echocardiographic measurements will be performed to identify associated cardiac defects. EKG parameters and QT, QTc, QT dispersion, QTc dispersion and HRV parameters will be obtained from a semi-automated system. Time domain and frequency domain measures will be calculated and expressed as SDNN, triangular index, SDNN index, total power, low frequency power and high frequency power. Mutational analysis and DNA sequencing will be conducted in those with CRBBB or Brugada pattern EKG, especially those with positive family history.

Based on these data, the clinical significance of altered bundle branch conduction identified from a school survey may be defined. For those with isolated CRBBB or IRBBB, the adjunctive value of HRV and QT parameters will determined the high risk group, and 24 hour Holter recording and Treadmill exercise test will then perform in these patients to define association with ventricular arrhythmia.

Eligibility Criteria:
Inclusion Criteria:

* ECG showed right bundle branch block

Exclusion Criteria:

* can't tolerate Treadmill ECG study
ProsTIC Registry of Men Treated With PSMA Theranostics

This is a descriptive, observational, prospective, open-ended, registry utilising electronic data capture to collect information on the outcomes of men treated with prostate specific-membrane antigen (PSMA) theranostics.

The aim of the registry is to collect data of men with pre-treated metastatic castration-resistant prostate cancer (mCRPC) receiving Lutetium 177 (177Lu)-PSMA outside of a clinical trial to assess "real world" anti-tumour utility. The primary objective is to assess prostate specific antigen (PSA) response rate to 177Lu-PSMA in men with mCRPC.

Patients with mCRPC who have have progression or intolerance on a novel anti-androgen targeted agent (abiraterone and/or enzalutamide and/or apalutamide) will be eligible for the study.

The investigators intend to evaluate the safety of 177Lu-PSMA, in addition to determining patient PSA progression-free survival (PFS), objective radiographic response rates and overall survival (OS). Health-related quality of life (QoL) and pain will also be observed. Additional objectives are to identify biomarkers and assess the relationship between PSMA and F-fluorodeoxyglucose (FDG) Positron Emission Tomography-Computed Tomography (PET/CT) parameters associated with clinical outcomes.

Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of mCRPC
2. Progression or intolerance on a novel anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide or darolutamide)
3. Prior therapy with at least one taxane cytotoxic (these agents may have been received upfront for metastatic hormone-sensitive prostate cancer) or the patient is symptomatic and assessed as unfit for chemotherapy
4. Referred to nuclear medicine and being considered for Lu-PSMA therapy according to institutional procedure guidelines
The Clinical Efficacy of Hip Protection Orthosis for the Protection of Hip Dislocation

Single Blinded, Randomized-control tiral, Multicenter clinical trial


Eligibility Criteria:
Inclusion Criteria:

* GMFCE level IV or V in the Cerebral palsy
* age from 1 to 10

Exclusion Criteria:

* History of hip joint surgery
* Botulinum toxin injection to hip muscle past 3 months or expected in our study duration
Trial of Myopia Prevention Using +3D Lenses

The purpose of this study is to assess whether a short-term imposed myopic defocus is effective in preventing the development and progression of juvenile-onset myopia in Chinese children.

1. To determine if +3D lenses wearing for half an hour everyday prevents the development and progression of myopia in school children.
2. To identify ocular parameters and risk factors at baseline associated with development and progression of myopia.

Eligibility Criteria:
Inclusion Criteria:

* All children in the selected class are enrolled

Exclusion Criteria:

* Hyperopia \> +2.0 D
* High myopia \> -6.0 D
* Astigmatism\> 1.5 D
* Anisometropia \> 1.5 D
* Strabismus and amblyopia
* Any ocular, systemic, or neurodevelopmental conditions that could influence refractive development
* Chronic medication use that might affect myopia progression or visual acuity
* Already receiving other treatment for progressing myopia
Bone Properties in Hypoparathyroidism: Effects of PTH

Whereas much information is known about the properties of bone in primary hyperparathyroidism, a disorder of parathyroid hormone (PTH) excess, virtually nothing is known about the skeleton in hypoparathyroidism, a disorder in which PTH is absent. The purpose of this research project is to test the hypothesis that the skeleton in hypoparathyroidism is abnormal in its metabolic, densitometric, geometric, biomechanical and microarchitectural features. We will also test the hypothesis that the skeleton is dependent upon PTH for normal structure and function. Using non-invasive approaches as well as direct analysis of bone itself, the human hypoparathyroid skeleton will be thoroughly characterized. With each patient serving as his/her own control, we will determine how, to what extent, and in what ways the administration of PTH restores skeletal dynamics and structure to the hypoparathyroid skeleton. In this way, we will identify those structural and dynamic elements of the skeleton that are influenced by or dependent upon PTH. Methods to be utilized include dual energy X-ray absorptiometry, quantitative central and peripheral computed tomography, geometry and size quantification, histomorphometry by standard and microCT methods, finite element analysis, biochemical bone markers, quantitative back scattered electron imaging, and Fourier Transform Infrared Spectroscopy. This research project will extend our knowledge of the skeletal effects of PTH to its deficient range and thus complete our understanding of PTH action on bone gained by our many years of studying PTH overexpression in primary hyperparathyroidism. This investigation may also provide insight into the means by which PTH helps to restore the skeleton when it is used to treat osteoporosis.

A detailed description of the methods used in this study include the following: direct analysis of bone itself. skeletal dynamics and structure such as dual energy X-ray absorptiometry, quantitative central and peripheral computed tomography, geometry and size quantification, histomorphometry by standard and microCT methods, finite element analysis, biochemical bone markers, quantitative back scattered electron imaging, and Fourier Transform Infrared Spectroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Hypoparathyroidism

Exclusion Criteria:

* Bisphosphonate use
Impact of Sleep Disordered Breathing in Older Adults

To test the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression.

BACKGROUND:

The health impact of disordered breathing during sleep among middle-aged and older men and women in the general population had not been well studied, and the need for treating relatively mild degrees of sleep-disordered breathing was unknown in 1994. The study was the first population study which examined the effect of sleep-disordered breathing on these health outcomes. The study sought to establish the prevalence of clinically important sleep-disordered breathing among middle-aged and older men and women and to provide quantitative data to serve as the basis for selecting patients for screening and deciding which patients might benefit from therapeutic intervention.

DESIGN NARRATIVE:

The study evaluated the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression. The study used the Veterans Administration Normative Aging Study (NAS) population, which consisted of approximately 1,700 community-dwelling-men who returned for examination every three years. Respiratory function was assessed during sleep among these men and their wives using a validated method for home sleep monitoring. Blood pressure, health-related quality of life, and depression score were also assessed in the home. The potential associations of sleep-disordered breathing with hypertension, impaired health-related quality of life, and depression were evaluated, and the possibility that these relationships differed between men and women was examined.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria