linjc16/ctgov huggingface dataset:
Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving Tacrolimus

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant patients.

Official Title
-----------------
Open-label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium in Patients With Stable Renal Transplant Receiving Tacrolimus

Conditions
-----------------
Prevention of Acute Rejection After Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Enteric-coated mycophenolate sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First or second (single or double) deceased or living donor kidney/kidney-pancreas transplant received at least six months previously; Immunosuppressive therapy with tacrolimus and mycophenolate mofetil (MMF); Exclusion Criteria: Subjects expected to discontinue tacrolimus therapy; Patients with thrombocytopenia (<75,000/mm3), an absolute neutrophil count of <1,500/mm3 and/or leukopenia (<2,500/mm3), or anemia (hemoglobin <6 g/dl) at baseline; Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia >2.5 mg/dL) or worsening renal function in the previous two months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enteric-coated mycophenolate sodium|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy proven acute rejection |  |  | 
| Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms) |  |  | 
| Quality of life related to GI symptoms (GIQLI scale) |  |  | 
| Full blood count |  |  | 
| Gastrointestinal Adverse Events (check-list) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium, tacrolimus.
An Observational Study on the Natural Course of Chronic Pancreatitis

Study Overview
=================
Brief Summary
-----------------
To explore the impact on genetic and environmental factors for clinical manifestation, and the progression of chronic pancreatitis, including development of pancreatic insufficiency and other complications.

Detailed Description
-----------------
The present study was an observational study aimed to explore the impact of genetic factors (rare pathogenic variants of CP) and environmental factors(smoking and alcohol assumption) on the clinical manifestation and progression of CP. The observation items included the pain patterns, incidence of complications of CP, pancreatic cancer and death.

Official Title
-----------------
The Impact of Genetic and Environmental Factors on the Progression of Chronic Pancreatitis：An Observational Study

Conditions
-----------------
Chronic Pancreatitis, Genetic Mutation, Smoking, Tobacco, Drinking, Alcohol

Intervention / Treatment
-----------------
* Behavioral: smoking and alcohol assumption
* Diagnostic Test: genetic sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a diagnosis of chronic pancreatitis agree to join the study and provide informed consent Exclusion Criteria: autoimmune pancreatitis pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis the follow-up time less than 2 years patients presenting with diabetes and/or steatorrhea at onset of CP.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: smoking and alcohol assumption|documenting the change of smoking and drinking status during the follow-up period|
|Diagnostic Test: genetic sequencing|sequencing the susceptibility genes for CP, including serine protease inhibitor Kazal type 1, cationic trypsinogen, cystic fibrosis transmembrane conductance regulator, chymotrypsin C, etc.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Number of Patients Developing Pancreatic Insufficiency | The primary endpoint was the number of patients developing pancreatic insufficiency, categorised as 1) diabetes and steatorrhea, 2) diabetes only, or 3) steatorrhea only. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | all-cause death | 20 years |
Polymorphisms in Inflammatory Cytokines Genes in Subjects With Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnea is a common sleep disorder. It is known to be related with increased body mass, abdominal obesity, insulin resistance and hypertension. It is currently believed to be a feature of the metabolic syndrome. Other features of the metabolic syndrome-such as insulin resistace were found related to inflammation and inflammatory cytokines. Several polymorphisms in the genes that encode interleukin 6,inteleukin 10 and TNF-alpha have significant influence on the amounts of cytokine production. we thus hypothesize that polymorphisms related to increased pruduction are more common in subjects with OSA than in matched controls

Detailed Description
-----------------
Patients attending a sleep apnea clinic for evluation will be recruited. Patients found positive for OSA will be compared to the patients with a negative study for OSA for the prevalence of polymorphisms in genes of inflammatory cytokines and cytokine levels

Official Title
-----------------
A Cross Sectional Study of Patients With Obstructive Sleep Apnea for Polymorphisms in Genes of Inflammatory Cytokines.

Conditions
-----------------
Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients attending the sleep apnea clinic for evaluation Exclusion Criteria: patients known to have inflammatory conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OSA inflammatory cytokines, metabolic syndrome
Determine the Incidence of Long QT Amongst a Large Cohort of Subjects Diagnosed With Unilateral or Bilateral Sensorineural Hearing Loss.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the true incidence of long QT (LQT) amongst a large cohort of subjects diagnosed with unilateral (right/left) or bilateral sensorineural hearing loss.

Detailed Description
-----------------
The purpose of this study is to determine the true incidence of long QT (LQT) amongst a large cohort of subjects diagnosed with unilateral (right/left) or bilateral sensorineural hearing loss. The goal of this study is to answer the following questions: What is the incidence of an abnormal ECG (QTc > 450 msec) in neonates greater than a week of age with either unilateral or bilateral Sensorineural hearing loss? What percentage of neonates greater than one week of age with either bilateral or unilateral sensorineural hearing loss and an abnormal ECG have an identifiable genetic mutation? What is the incidence of an abnormal genetic mutation consistent with long QT regardless of the ECG in neonates with bilateral sensorineural hearing loss?

Official Title
-----------------
Long QT & Hearing Loss Prospective Study Registry

Conditions
-----------------
Sensorineural Hearing Loss, Long QT Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All newborns who demonstrate a refer in one or both ears on a routine newborn hearing screen Documentation of informed consent Inborn Ability to perform an ABR (auditory brainstem response screen technology) screening test No major anomalies Subjects' parents willing to provide follow-up data on their child Exclusion Criteria: Newborns with a syndromic cause of hearing loss Parents unwilling to provide follow-up data Major congenital anomalies Major medical problem or conditions. (i.e., hypoxic ischemic encephalopathy (HIE), persistent pulmonary hypertension neonate (PPHN), meconium aspiration, etc.) Congenital cytomegalovirus (CMV)

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 90 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of an abnormal ECG (QTc > 450) in neonates greater than a week of age with either unilateral or bilateral sensorineural hearing loss | ECG results to determine QTc length | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In neonates > 1 week of age with either bilateral or unilateral sensorineural hearing loss and an abnormal ECG, percentage have an identifiable genetic mutation | Audiology diagnostic results | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sensorineural hearing loss, Long QT Syndrome
Isomil Post Marketing Observational Study

Study Overview
=================
Brief Summary
-----------------
The use of soy-isolate protein based formula for infants with cow's milk protein intolerance is common in Indonesia, however, there has not been any systematic collection of clinical data to determine the formula's gastrointestinal tolerance, and the parent's perceptions regarding the formula.

Official Title
-----------------
A Prospective, Open-label, Post-marketing Observational Study to Document the Use of Soy-based Infant Formula With Low Chain Polyunsaturates (LCP) in Infants With Symptoms Suggestive to Cow's Milk Allergy

Conditions
-----------------
Cow's Milk Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants of 6 - 12 months of age full term infants birth weight more than 2500 grams infants developed symptoms suggestive adverse reactions to cow's milk protein in the investigator's clinical judgements subject is prescribed a soy-based infant formula by physician Exclusion Criteria: established/suspected hypersensitivity fo soy presence of adverse reactions to cow's milk caused by coincidental infections or other systemic disease history of blood group incompatibility, premature delivery, HIV infections, major congenital abnormalities, systemic diseases presence of severe gastrointestinal disorder subject is participating in any interventional clinical study

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Isomil Advance with LCP<br>4 spoonful of Isomil Advance with LCP in 240 mL of water, 4 times a day | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent's acceptance in the feeding of a soy-based infant formula with LCP in infants with symptoms suggestive adverse reactions to cow milk protein |  | 4-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of infants with gastrointestinal adverse events |  | 4-week | 
| percentage of infants with adverse events |  | 4-week |
Serological Identification of Celiac Disease in Kids

Study Overview
=================
Brief Summary
-----------------
The investigators aim to examine the feasibility of incorporating serological celiac disease (CD) screening into general pediatric outpatient clinics in Sweden and through structured monitoring examine the effects of diagnosing and treating screening-detected CD. Screening will be tailored to general pediatric outpatient clinics in the Gothenburg metropolitan area with the goal to screen 1000 children over four months. Screening for CD will be carried out by measuring tissue transglutaminase autoantibodies (TGA) in blood. Children who are persistently TGA positive will be enrolled into a 6-12-month follow-up protocol responsible for diagnosing CD, installation of gluten-free diet and to assess their short-term impact upon the child's wellbeing. Other components to assess include (I) the feasibility to incorporate CD screening into busy pediatric practices; (II) parental/child interest in, and satisfaction with, participating in a CD screening program and (III) identifying key considerations for a possible scaled-up, broad-based, CD screening.

Official Title
-----------------
Serological Identification of Celiac Disease in Kids (Swedish: Screening för Celiaki på Barnmottagning)

Conditions
-----------------
Celiac Disease in Children, Pediatric Disorder, Health, Subjective, Growth Delay

Intervention / Treatment
-----------------
* Diagnostic Test: tissue transglutaminase autoantibodies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 2-17 years old Patient at pediatric outpatient clinics in Gothenburg metro area Parental and adolescent consent to screening Exclusion Criteria for serological screening: Established celiac disease diagnosis Type 1 diabetes

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: tissue transglutaminase autoantibodies|celiac disease-specific autoantibodies|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants diagnosed with celiac disease | Celiac disease diagnosed according to European pediatric (ESPGHAN) guidelines | Assessed after 6-12 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants identified with celiac disease autoimmunity | Celiac disease autoimmunity defined by having two consecutive positive tests for tissue transglutaminase (TTG) autoantibodies | Assessed after performed two tests of TTG (apprx. 1-2 months after enrollment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screening
Non Invasive Diagnostic of Endometrial Receptivity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine a lipidomic profile on the endometrial fluid, that can predict endometrial receptivity.

Official Title
-----------------
A Non Invasive Diagnostic of Endometrial Receptivity Based on Lipidomic Profile on Endometrial Fluid.

Conditions
-----------------
Endometrial Receptivity Failure

Intervention / Treatment
-----------------
* Other: Lipid identification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oocyte donors undergoing controlled ovarian stimulation Regular menstrual cycles no abnormal karyotype generally healthy BMI 19-29 Kg/m2 (both inclusive) 18 to 35 years old. Exclusion criteria: -patients diagnosed with endometriosis and/or endometritis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipids<br> | Other: Lipid identification<br>* The lipids are identified using Mass Spectrometry<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of lipids in the endometrial fluid as a diagnostic factor. |  | 1 year |
The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients

Study Overview
=================
Brief Summary
-----------------
Vitiligo is a relatively common acquired disorder of pigmentation characterized by the development of well-defined white macules on the skin. Biopsies of lesional skin reveal a loss of epidermal melanocytes. Lesions may occur in a localized or generalized distribution and may coalesce into large, depigmented areas. Given the contrast between the white areas and normal skin, the disease is most disfiguring in darker skin types and has a profound impact on the quality of life of both children and adults . Patients with vitiligo often experience stigmatization, social isolation, and low self-esteem. The therapys include topical steroids, topical immunosuppresant, systemic steroids, phototherapy, and surgery. The aim of this study is to investigate the effect of phototherpy and accupuncture combined therapy for vitiligo patients.

Official Title
-----------------
The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients

Conditions
-----------------
Brief Description of Focus of Study Instead

Intervention / Treatment
-----------------
* Device: Surrounding needling+ phototherapy
* Device: phototherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Vitiligo Exclusion Criteria: pregnancy immune disorder infection other dermatosis in treating areas

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: needling<br>needling + phototherapy | Device: Surrounding needling+ phototherapy<br>* Surrounding needling+ phototherapy<br>* Other names: phototherapy;|
| Placebo Comparator: phototherapy<br>phototherapy | Device: phototherapy<br>* phototherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| repigmentation | repigmentation amount | 12weeks |
EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This trial examines the role of EUS-FNA (Oesophageal Endoscopic Ultrasound with Fine Needle Aspiration) as an endoscopic technique for the mediastinal staging of patients with lung cancer. Patients will be randomized to either conventional surgical technique or EUS-FNA.

Official Title
-----------------
EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer: A Randomized Trial

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: EUS-FNA
* Procedure: Conventional Surgical Technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with histological or cytological proof of non small cell lung cancer (NSCLC) or with a high clinical suspicion for lung cancer (but without pathologically confirmed diagnosis from the bronchoscopy or CT guided transthoracal biopsies) in whom the next step is normally a diagnostic or therapeutic surgical intervention no distant metastases after routine clinical work up (PET is optional, not mandatory) provision of a written informed consent recent CT-scan of the thorax (<28 days before randomization date) age 18 years or older clinically fit for surgery Exclusion Criteria: proof of small cell lung cancer (SCLC) with CWU (bronchoscopy or CT guided transthoracal punction) stage IV NSCLC patients with a solitary pulmonary nodule (thus without enlarged mediastinal lymph nodes on CT and without mediastinal PET hot spots) : these do not require further mediastinal investigation former therapy (chemotherapy or radiotherapy or surgery) for lung cancer other concomitant malignancies reasons for which the patient is unable to swallow the EUS-instrument (e.g. zenker diverticulum, unexplained esophageal stenosis) uncorrected coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: EUS-FNA|nan|
|Procedure: Conventional Surgical Technique|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of surgical interventions avoided |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of EUS-FNA for mediastinal staging of lung cancer |  |  |