linjc16/ctgov huggingface dataset:
Expanded Access Protocol for Patients With Eosinophilic Esophagitis

Study Overview
=================
Brief Summary
-----------------
This expanded access program is an open-label, single-arm design where consenting patients may participate up until APT-1011 is commercially available in the relevant regions or the protocol is terminated by the Sponsor.

Detailed Description
-----------------
Patients will receive a 120-day supply of APT-1011 and will attend scheduled clinic visits every 4 months. Telephone visits will be performed as needed. At each clinic visit (or additional telephone visit), adverse events (AEs) and concomitant medications will be collected. The Global EoE score will be collected at clinic visits.

Official Title
-----------------
APT-1011 (Fluticasone ODT) Expanded Access Protocol for Patients With Eosinophilic Esophagitis

Conditions
-----------------
Eosinophilic Esophagitis

Intervention / Treatment
-----------------
* Drug: APT-1011 3 mg HS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥12 years of age at the time of informed consent Signed ICF and willing and able to adhere to all procedures; signed assent form and parent/guardian ICF must also be collected for adolescents Confirmed medical history of EoE Adult and adolescent patients who are unable or ineligible to enroll in an APT-1011 clinical study or have failed available treatment options Willing and able to adhere to the treatment regimen and visit schedule Exclusion Criteria: Have known contraindication, hypersensitivity, or intolerance to corticosteroids Have signs and symptoms of adrenal suppression or hypercorticism Use of potent CYP3A4 inhibitors (e.g., ritonavir and ketoconazole) are prohibited Have current alcohol or drug abuse in the opinion of the Investigator Female patients who are pregnant, breastfeeding, or planning to become pregnant while participating in the program Female patients of child-bearing potential who are unable to comply with adequate contraception use during the program

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: APT-1011 3 mg HS|APT-1011 is an orally disintegrating tablet that includes fluticasone propionate as its active ingredient.|

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
-----------------
APT-1011, Esophagitis, Eosinophilic Esophagitis, Esophageal Diseases, Gastrointestinal Diseases, Gastroenteritis, Eosinophilia, Leukocyte Disorders, Hematologic Diseases, Hypersensitivity, Immediate, Hypersensitivity, Immune System Diseases, Fluticasone, Anti-Inflammatory Agents, Bronchodilator Agents, Autonomic Agents, Peripheral Nervous System Agents, Anti-Asthmatic Agents, Respiratory System Agents, Anti-Allergic Agents
Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection

Study Overview
=================
Brief Summary
-----------------
Proton pump inhibitors (PPIs) are mainly metabolized in the liver by CYP2C19, one of the cytochrome P450 isoenzymes, which shows a genetic polymorphism associated with enzyme activities. The most essential role of a PPI in H. pylori eradication therapy is to make antibiotics more stable and bioavailable in the stomach by raising intragastric pH to neutral levels. Most patients who have failed in the eradication of H. pylori infection by triple therapy with a PPI, amoxicillin (AMPC) and clarithromycin (CAM) at standard doses have extensive metabolizer (EM) genotypes of CYP2C19 and/or are infected with CAM-resistant strains of H. pylori. Four-times daily dosing of a PPI could achieve complete gastric acid inhibition. Dual therapy with 4-times daily dosing of a PPI and AMPC could yield sufficient re-eradication rates in patients with EM genotype of CYP2C19. Metronidazole (MNZ)-based re-eradication therapy, such as triple PPI/AMPC/MNZ therapy, also achieved high eradication rates and has been recommended as the second line therapy in Japan. But carcinogenic actions of MNZ have been unclear. The purpose of this study is to compare the re-eradication rates of H. pylori infection by the dual high-dose PPI/AMPC therapy and triple PPI/AMPC/MNZ therapy, and to validate the efficacies of these re-eradication regimens as second line eradication therapies.

Official Title
-----------------
Dual Therapy With High-Dose of Rabeprazole and Amoxicilline Versus Triple Therapy With Rabeprazole, Amoxicilline and Metronidazole as the Second Line Therapy for the Cure of H. Pylori Infection

Conditions
-----------------
Helicobacter Infections, Gastritis, Gastric Ulcer, Duodenal Ulcer

Intervention / Treatment
-----------------
* Drug: rabeprazole, amoxicillin, clarithromycin, metronidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with H. pylori infection Exclusion Criteria: Patients without H. pylori infection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rabeprazole, amoxicillin, clarithromycin, metronidazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Which treatment yields the higher re-eradication rate of H. pylori infection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
H. pylori infection
C-Control: Efficacy and Safety of Therapy With Rosuvastatin in Statin-Naive and in Statin-Switched Patients

Study Overview
=================
Brief Summary
-----------------
The study explores efficacy and safety of the lipid-lowering therapy with CRESTOR in statin-naive patients and in patients with previously unsuccessful statin therapy. This study was designed to investigate the dynamic of the lipid parameters and therapy tolerability during 8-10 weeks treatment with CRESTOR

Official Title
-----------------
C-Control: Efficacy and Safety of Therapy With Rosuvastatin in Statin-Naive and in Statin-Switched Patients

Conditions
-----------------
Hypercholesteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hypercholesteremia who was never treated with statins before Patient with hypercholesteremia who was treated with a statin (other then rosuvastatin) but because of its adverse effects/insufficient action was switched to therapy with CRESTOR Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pt with hypercholesteremia<br>Patients treated with CRESTOR because of hypercholesteremia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-Cholesterin, HDL-Cholesterin, Triglycerides, Total Cholesterin |  | 3 visits within 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of CRESTOR-therapy |  | 3 visits within 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperlipidemia, Rosuvastatin, Efficacy, tolerability, CRESTOR therapy
A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy

Study Overview
=================
Brief Summary
-----------------
This randomized controlled study is designed to test the non inferiority of no attachment of posterior mesh compared to fixation of posterior mesh to the vagina in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity and rate of recurrence.

Official Title
-----------------
A Novel Approach to Posterior Mesh Fixation in Laparoscopic Sacral Colpopexy: a Randomized Control Trial

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Procedure: laparoscopic sacral colpopexy with posterior mesh no attachment
* Procedure: laparoscopic sacral colpopexy with posterior mesh attachment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence Exclusion Criteria: Age > 75 years Severe cardiovascular or respiratory disease Pregnancy

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

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: posterior mesh no attachment<br>laparoscopic sacral colpopexy with no fixation of posterior mesh | Procedure: laparoscopic sacral colpopexy with posterior mesh no attachment<br>* pelvic organ prolapse correction with laparoscopic sacralcolpopexy with no attachement of posterior mesh<br>|
| Active Comparator: posterior mesh attachment<br>laparoscopic sacral colpopexy with fixation of posterior mesh by suture | Procedure: laparoscopic sacral colpopexy with posterior mesh attachment<br>* pelvic organ prolapse correction with laparoscopic sacralcolpopexy with the attachement of posterior mesh to vagina<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correction of pelvic organ prolapse | number of women with correction of prolapse mesured in S POP-Q stage during FU visit | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of recurrence | number of women with de novo anterior or posterior or central prolapse | 1 year | 
| long term outcomes | number of women with nicturia, dysuria, obstructed defecation , urinary incontinence, pelvic pain | 1 year |
Study of Changes of Lymphocyte Subsets in Chemotherapy Course of Patients With Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the changes of lymphocyte subsets in chemotherapy course of patients with non-small cell lung cancer

Detailed Description
-----------------
patients with primary non-small cell lung cancer who received first chemotherapy in Beijing Chaoyang Hospital affiliated to Capital Medical University were collected, and the percentage of lymphocyte subsets at 9 time points before, during, and after chemotherapy was detected by flow cytometry method.We will investigate the changes of patients' lymphocyte subsets in chemotherapy courses. The correlation of the percentage of lymphocyte subsets and age, gender, pathological type, clinical stage, surgery or not, clinical efficacy assessment will be further analyzed.

Official Title
-----------------
Study of Changes of Lymphocyte Subsets in Chemotherapy Course of Patients With Non-small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Each Period Non-small Cell Lung Cancer, Which Was Confirmed by Histopathology. patients has only lung cancer . Functional Status Score (PS) ≧ 70. The first time for chemotherapy . A Written Informed Consent. Exclusion Criteria: Merging other tumors. HAve autoimmune diseases. AIDS

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of patients' lymphocyte subsets in chemotherapy courses. |  | up to cycle 4 day 9 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non- small cell lung cancer;, lymphocyte subsets
Attitudes of General Practitioners in Lorraine Towards Prediabetes

Study Overview
=================
Brief Summary
-----------------
Screening for the risk factors of type 2 diabetes is a part of the primary prevention approach. Pre-diabetes is one of the modifiable risk factors; however, it remains under-diagnosed. Our aim was to analyse the attitudes of general practitioners in Lorraine towards prediabetes

Official Title
-----------------
Attitudes of General Practitioners in Lorraine Towards Prediabetes

Conditions
-----------------
PreDiabetes

Intervention / Treatment
-----------------
* Other: online anonymous exploratory study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General practitioner Practice in Lorraine Installed or substitute Exclusively private practice or mixed activity Exclusion Criteria: Retired physicians General practitioners working exclusively in hospital
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: online anonymous exploratory study|online self-administered questionnary|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the attitudes by general practitioners towards pre-diabetes | answers to self-administered questionnary | 4 months |
Effects of Miglitol on Daily Plasma Glucose in type2 Diabetes Treated With Insulin

Study Overview
=================
Brief Summary
-----------------
In this study, the effect of miglitol on daily plasma glucose will be evaluated in type 2 diabetic patients treated with insulin.

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: miglitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type2 diabetes postprandial plasma glucose levels ≧180mg/dl Exclusion Criteria: type1 diabetes AST(GOT) or ALT(GPT) ≧100IU/l creatinine ≧2.0mg/dl

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: miglitol|nan|

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
-----------------
alpha-glucosidase inhibitor,Insulin
Adult-onset Generalized Morphea

Study Overview
=================
Brief Summary
-----------------
This study aimed to describe the demographical and clinical characteristics of a retrospective cohort of adult-onset GM and to investigate whether these findings differ between patients with an isomorphic and a symmetric pattern of lesion distribution.

Official Title
-----------------
Adult-onset Generalized Morphea : A Retrospective Multicenter Study

Conditions
-----------------
Generalized Morphea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of onset ≥ 18 years Patients with generalized morphea as defined by criteria established by Laxer and Zulian (4 or more morpheaform plaques larger than 3 centimeters that show tendency to confluence and involve at least 2 different anatomic sites) Availability of good-quality clinical photographs Patient who, after being informed, has not expressed his or her opposition to the re-use of his or her data for the purposes of this research Exclusion Criteria: Patients with linear morphea who met criteria for generalized morphea Patient's opposition to participate

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective study of generalized morphea in adult patients consulted in dermatology departments |  | Files analyzed retrospectily from January 1st, 2019 to September 30, 2019 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morphea, Generalized Morphea, Localized Scleroderma
Cell Culture of Glioma Specimens for in Vitro Preclinical Studies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to culture primary human brain tumor cells with the specific aims of: Develop primary cultures from human brain tumor surgical specimens Determine the genetic and molecular fingerprints of brain tumors that may have prognostic significance Delineate the mechanisms underlying oncogenesis of brain tumors. Perform in vitro assays with brain tumor derived primary cultures to assess the efficacy of novel therapeutic agents.

Official Title
-----------------
Primary Cell Culture of Surgical Glioma Specimens for Invitro Preclinical Studies

Conditions
-----------------
Brain Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older undergoing surgical resection for glioma Exclusion Criteria: Under 18 years of age

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
Clinical Observation of Integrated Chinese Medicine With Western Medicine for the Reduction of Chemotherapy-induced Hematologic Toxicity

Study Overview
=================
Brief Summary
-----------------
We conducted an observational study to investigate the effectiveness and safety of Integrated Chinese Medicine With Western Medicine for bone marrow suppression induced by chemotherapy in patients with cancer. The TCM constitution and pulse diagnosis was also observed in the study.

Detailed Description
-----------------
Patients with cancer under chemotherapy and integrated Western and Chinese medicine were enrolled in this observational study. The assessment of radial pressure pulse (RPP) was performed before and after chemotherapy. The correlation between the spectral energy (SE0-10 Hz, SE10-50 Hz, and SE13-50 Hz) of the RPP at six diagnosis positions and the blood cell counts before and after chemotherapy were analyzed.

Official Title
-----------------
Clinical Observation of Integrated Chinese Medicine With Western Medicine for the Reduction of Chemotherapy-induced Hematologic Toxicity

Conditions
-----------------
Myelosuppression

Intervention / Treatment
-----------------
* Procedure: Chemotherapy and Integrated Chinese Medicine With Western Medicine for cancer treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cancer diagnosed through pathological histology Patients with cancer under chemotherapy and Integrated Chinese Medicine With Western Medicine Patients with an Eastern Cooperative Oncology Group Performance score of 0-2 Patients having normal liver and kidney functions and electrocardiography and eligible for chemotherapy with normal bone marrow hematopoietic function Patients who were voluntarily involved in this study Exclusion Criteria: Cases that did not meet the inclusion criteria Patients who could not cooperate with pulse diagnosis Patients with underlying diseases such as chronic obstructive pulmonary disease, cardiac failure, chronic renal failure, cirrhosis, etc. Patients with severe infection Patients with severe cachexia

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Chemotherapy and Integrated Chinese Medicine With Western Medicine for cancer treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy-induced Hematologic Toxicity | the blood cell count before and after chemotherapy was collected for measurement of severity of myelosuppression | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traditional Chinese Medicine; radial pulse assessment; sphygmography; pulse diagnosis; myelosuppression; cancer