linjc16/ctgov huggingface dataset:
Superomedial Pedicle Versus Inferior Pedicle Techniques in Wise Pattern Reduction Mammaplasty :A Comparison Study

Study Overview
=================
Brief Summary
-----------------
A comparison study between superomedial and Inferior pedicle techniques in wise pattern reduction mammaplasty

Detailed Description
-----------------
To compare complications of both techniques in wise pattern reduction mammaplasty and to correlate between complications and patient mediated factors

Official Title
-----------------
Superomedial Pedicle Versus Inferior Pedicle Techniques in Wise Pattern Reduction Mammaplasty :A Comparison Study

Conditions
-----------------
To Compare Complications of Both Techniques in Wise Pattern Reduction Mammaplasty and to Correlate Between Complications and Patient Mediated Factors

Intervention / Treatment
-----------------
* Procedure: Reduction mammaplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: previous extensive breast surgery Breast cancer
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wise pattern reduction mammaplasty using Inferior pedicle<br>Wise pattern reduction mammaplasty using Inferior pedicle | Procedure: Reduction mammaplasty<br>* Breast reduction surgery<br>* Other names: Superomedial pedicle versus Inferior pedicle techniques in wise pattern reduction mammaplasty;|
| Active Comparator: Wise pattern reduction mammaplasty using superomedial pedicle<br> | Procedure: Reduction mammaplasty<br>* Breast reduction surgery<br>* Other names: Superomedial pedicle versus Inferior pedicle techniques in wise pattern reduction mammaplasty;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare complications of both techniques including nipple areola complex necrosis | Complications include NAC necrosis and other minor complications including wound dehiscence and seroma or hematoma | 30 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate between complications and patient mediated factors | Patient mediated factors including age, BMI, preoperative hb, suprasternal notch to nipple distance | 30 days postoperative |
Representation of the Bladder Innervation Using Diffusion Tensor Imaging Fiber Tracking With MRI - a Pilot Study

Study Overview
=================
Brief Summary
-----------------
The exact innervation of the bladder and the changes after a spinal cord injury have been not yet been illustrated. Diffusion tensor imaging with magnetic resonance imaging is a new technique which can be used to visualize single nerve fibers, and thus represent the neural supply of a region in vivo. There are studies in which both the sacral plexus and the lumbar nerve roots have been represented using diffusion tensor imaging. However, there is no study concerning the innervation of the bladder. The investigators are therefore using diffusion tensor imaging with magnetic resonance imaging to represent the bladder innervation of individuals with neurogenic lower urinary tract dysfunction and individuals with normal bladder function.

Conditions
-----------------
Spinal Cord Injury, Neurogenic Lower Urinary Tract Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neurogenic lower urinary trat dysfunction normal bladder function Exclusion Criteria: no signed informed consent contraindications for MRI (pace maker, implanted metal, claustrophobia) upper or lower urinary tract surgeries pregnancy (anamnestic)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control<br>individuals with normal bladder function | |
| neurogenic bladder<br>individuals suffering from neurogenic lower urinary tract dysfunction | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bladder innervation quality | bladder innervation is illustrated using diffusion tensor imaging fiber tracking with magnetic resonance imaging | day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diffusion tensor imaging fiber tracking, magnetic resonance Imaging, spinal cord injury, neurogenic lower urinary tract dysfunction
A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)

Official Title
-----------------
A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Adalimumab (D2E7)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Diagnosis of Crohn's disease CDAI score at baseline of between 220 and 450 Normal laboratory parameters Willing and able to give informed consent Exclusion: Diagnosis of ulcerative colitis Women cannot be pregnant or breastfeeding No previous use of infliximab or other anti-TNF antagonists No previous history of tuberculosis or listeria infection No previous history of cancer other than successfully treated skin cancer

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Adalimumab (D2E7)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of the induction of clinical remission |  |  | 
| (achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4. |  |  |
A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Official Title
-----------------
A Randomised, Single-centre, Double-blind, Parallelgroup, Multiple Dose Trial Comparing the Within-subject Variability of SIBA and Insulin Glargine With Respect to Pharmacodynamic Response at Steady State Conditions in Subjects With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin degludec
* Drug: insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18-65 years (both inclusive) Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index 18.0-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDeg<br> | Drug: insulin degludec<br>* The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days<br>|
| Experimental: IGlar<br> | Drug: insulin glargine<br>* The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the glucose infusion rate curve during one dosing interval at steady state |  | 0-24 hours (derived on treatment days 6, 9 and 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the NN1250 concentration-time curve during one dosing interval at steady state |  | 0-24 hours (derived on treatment days 6, 9 and 12) |
Natural History of Wilson Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of the registry/repository is to provide a mechanism to store data and specimens to support the conduct of future research about Wilson disease (WD). The overall aim is to determine the optimal testing for diagnosis and parameters for monitoring treatment of WD that will aid product utilization and development.

Detailed Description
-----------------
There are three aims outlined as part of this research study. Aim 1 is to study the natural history of a carefully characterized cohort of patients with WD followed longitudinally at Centers of Excellence for WD in the United States and in the United Kingdom. Aim 2 seeks to evaluate parameters for diagnosis and treatment monitoring for patients on chelation therapy and zinc treatment for their WD. Data gathered in Specific aim 1 will be used for analyzing the components of the diagnostic scores for patients. Aim 3 is intended to determine whether a composite index or a biomarker can be used as surrogate marker for treatment monitoring for current patients on therapy that can be used for future patient treatment trials.

Official Title
-----------------
Natural History of Wilson Disease: Registry for Patients With Wilson Disease

Conditions
-----------------
Wilson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known diagnosis of WD Able and willing to provide informed consent for adults (Parental/guardian permission (informed consent) and if appropriate, child assent for participants <18 (or per local Institutional Review Board (IRB) regulation) Exclusion Criteria: Diagnosis of WD has been excluded Unwilling to provide informed consent or assent
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 |
| --- | --- | --- |
| Create registry for Wilson disease | This outcome is a binary 'yes/no' outcome as to whether or not this study can successfully create a repository with the intent to store data and specimens to support the conduct of future research on Wilson disease. | 5 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wilson Disease
Prevalence of Gastroesophageal Reflux During Childhood and Teenage Years in France

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess prevalence of gastrooesophageal reflux during childhood and teenage years in France and to describe patients'symptoms and gastrooesophageal reflux management

Official Title
-----------------
Prevalence of Gastroesophageal Reflux During Childhood and Teenage Years in France

Conditions
-----------------
Gastroesophageal Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children from 0 to 17years old seen in consultation Exclusion Criteria:

Ages Eligible for Study
-----------------
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>children from 0 to 17 years old | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess prevalence of gastrooesophageal reflux during childhood and teenage years in France, particularly 0-1 year-old prevalence and 1-11 year-old prevalence |  | At the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| describe patients'symptoms and gastrooesophageal reflux management |  | At the end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastroesophageal reflux, prevalence, childhood, France
Registry Study on Primary Ciliary Dyskinesia in Chinese Children

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, prospective cohort study of patients diagnosed with primary ciliary dyskinesia, the clinical information of recruited patients, including clinical manifestations, lung function, chest imaging, quality of life and other indicators, will be followed for 10 years.

Detailed Description
-----------------
All new cases of primary ciliary dyskinesia which was confirmed or diagnosed at each center from the beginning of the study are made the investigation of the clinical manifestations and specific tests by the standard diagnostic process.Then all the patients' following clinical data will be followed for 10 years (once per six month): clinical manifestations, lung function, chest imaging (once per year), quality of life and other indicators.

Official Title
-----------------
Registry Study on Primary Ciliary Dyskinesia in Chinese children-a Multicenter, Prospective Cohort Study

Conditions
-----------------
Primary Ciliary Dyskinesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A included patient must be coincident with all the following items: Age 0 18 years old Any organ system symptoms consistent with PCD and being conform to the clinical diagnostic standard of Katergener syndrome or being coincident with at least two following specific tests: Abnormal ciliary beat frequency or movement by the high speed photography microscope Abnormal ciliary structure through the electronic microscopy The nasal NO decreased significantly The target gene mutation found The clinical diagnostic criteria of the Katergener syndrome: ① bronchial expansion; ② sinusitis or nasal polyps; ③ transposition of viscera and (or) dextrocardia. If all the typical clinical manifestations but only 1 specific test with positive results, can also be included in the registration of suspected PCD cases Consent to provide the related clinical specimen to the certain hospital The guardians of the patients fully understand the purpose of the study, volunteer their children to participate in this study, and sign informed consent. Exclusion Criteria: Subject will be excluded if she or he has one of the following: It is unable to provide complete medical records or the current condition can not accept the diagnosis process She or he cannot agree to participate in the study.

Ages Eligible for Study
-----------------
Maximum Age: 18 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 |
| --- | --- | --- |
| Change from baseline in lung function on the spirometry | forced expiratory volume at one second (FEV1) in Liter | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children
Cannabidiol Treatment of Cognitive Dysfunction in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study is a six-week, randomized, placebo-controlled, fixed dose trial comparing cannabidiol Vs. placebo added to a stable dose of antipsychotic medications in patients diagnosed with schizophrenia.

Official Title
-----------------
Cannabinoid Receptor Antagonist Treatment of Cognitive Dysfunction in Schizophrenia

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Drug: Cannabidiol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia or Schizoaffective disorder (DSM-IV SCID-confirmed), Exclusion Criteria: Women who are pregnant, nursing or unwilling to use appropriate birth control measures during study participation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabidiol<br> | Drug: Cannabidiol<br>* Active Cannabidiol daily over 6 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Short Term Memory | Verbal short term memory is measured through the Hopkins Verbal Learning Test. Each trial has a max total score of 12 (range of 0-12), and the max total score for all three trials is 36 (range of 0-36). However, the data listed below is reported in the form of a t-score, with a higher score representing better verbal learning. These t-score values are normalizing the scores to populations, comparing them to a representative sample, with a mean of 50. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Cognition as Measured on the MATRICS Battery | Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) is intended to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. A higher score indicates better cognition (i.e. speed of processing, attention, verbal and non-verbal working memory, visual learning, reasoning, problem solving, and social cognition). The below scores are t-score values, which are normalized scores to the population and comparing the scores to a representative sample. | 6 weeks |
A Trial Assessing The Long Term Safety And Tolerability Of [S,S]-Reboxetine In Patients With Post-Shingles Pain.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic pain following shingles. This is the extension study of Protocol A6061026.

Official Title
-----------------
An Open-Label Extension Trial Assessing The Safety And Tolerability Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN).

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: [S,S]-Reboxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have met the patient selection criteria for the preceding double-blind Protocol A6061026 and have completed the 16-week trial. Patients at screening must have a score of >/=40mm on the pain visual analogue scale. Exclusion Criteria: Serious adverse event during the preceding double-blind Protocol A6061026 that was determined to be related to the trial medication by the Investigator. Patient treatment compliance was less than 80% in the preceding double-blind Protocol A6061026.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: s, s reboxetine<br> | Drug: [S,S]-Reboxetine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs |  |  | 
| Physical examination |  |  | 
| 12-lead ECG |  |  | 
| Hematology/Biochemistry |  |  | 
| Adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual Analogue Scale |  |  | 
| Patient Global Impression of Change |  |  |