linjc16/ctgov huggingface dataset:
Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test whether vaccinations with CYT003-QbG10 can improve allergy symptoms in patients with house dust mite allergy. The active treatment will be compared against placebo.

Official Title
-----------------
Double-blind, Placebo-controlled Dose-finding Study With CYT003-QbG10 in Adult Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy

Conditions
-----------------
Rhinoconjunctivitis, Allergies

Intervention / Treatment
-----------------
* Drug: CYT003-QbG10
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens Further criteria as defined in the study protocol Exclusion Criteria: Clinically manifested seasonal allergy/-ies which is/are expected to interfere with the patient's study treatment schedule and/or assessments Clinically relevant perennial allergy/-ies other than house dust mites allergy Contraindication to any study test or procedure Further criteria as defined in the study protocol

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: 1<br> | Drug: CYT003-QbG10<br>* subcutaneous injection<br>|
| Experimental: 2<br> | Drug: CYT003-QbG10<br>* subcutaneous injection<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhinoconjunctivitis symptom and medication scores |  | Pre- / Post-Treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rhinoconjunctivitis due to house dust mite allergy
New Protocol in Unexplained Infertility

Study Overview
=================
Brief Summary
-----------------
The new protocol ANTIUI provides good results regarding ovulation and pregnancy rates in patients with unexplained infertility

Detailed Description
-----------------
Patients with unexplained infertility has normal investigations regarding hormonal, structural data. Semen is normal but no pregnancy occurs. Before trying ICSI, we could help these patients with ANTIUI

Official Title
-----------------
A Higher Ovulation and Pregnancy Rates in Patients With Unexplained Infertility After Application of ANTIUI Protocol: A Randomized Multicenter Controlled Study

Conditions
-----------------
Unexplained Infertility

Intervention / Treatment
-----------------
* Drug: Gonadotropin
* Drug: Standard protocol in IUI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unexplained infertility Duration less than 5 years Good ovarian reserve AMH> 1.1 Normal patent tubes No previous trials of IUI with the same protocol Exclusion Criteria: Age > 35 years Duration of infertility> 5 years Abnormal semen Hypoplastic tubes prior failed ICSI

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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
Interventional Model Description: 2 parallel groups each is receiving different intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Will receive ANTIUI protocol | Drug: Gonadotropin<br>* Giving patients gonadotropins and antagonist cetrotide<br>|
| Active Comparator: Control group<br>Will receive standard protocol in IUI and unexplained infertility | Drug: Standard protocol in IUI<br>* Giving patients gonadotropins without antagonist cetrotide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation | Disappearance of mature follicle | 6 months | 
| Pregnancy | Number of pregnant cases | 6 months |
Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major

Study Overview
=================
Brief Summary
-----------------
Patient with thalassemia major have many endocrine diseases, such as hypopituitarism, hypothyroidism, hypoparathyroidis, osteoporosis, and etc.. These problems may be due to anemia itself or related to iron deposition. This study aimed to investigate the endocrine aspect of thalassemia major patients in Taiwan in order to introduce early intervention or treatment in the future.

Official Title
-----------------
Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major

Conditions
-----------------
Thalassemia Major

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Thalassemia major Patients of 20-85 years old Exclusion Criteria: Patients younger than 20 years old. Patients older than 85 years old. Patients who are pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Abnormal bone mineral density rate | abnormal bone mineral density is defined as T-score < -1 SD in menopause women or men older than 50 years old, or Z score < -2 SD in premenopausal women or men not older than 50 year old. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abnormal thyroid function rate | abnormal thyroid function is defined as abnormal free thyroxine or abnormal thyrotropin. Normal range of free thyroxine is 0.6-1.75 ng/dl. normal range of thyrotropin is 0.1-4.5 mU/l. | 10 years | 
| abnormal pituitary function rate | abnormal pituitary function is defined as any of the abnormality in serum adrenocorticotropin (pg/l), IGF-1 (ng/ml). thyrotropin (mU/l), FSH (U/l), LH (U/l) | 10 years |
Risk Factors Predicting Prognosis and Outcome of Elderly Patients With Isolated Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
Although several prognostic models have been developed to predict outcome for patients with severe traumatic brain injury (TBI), currently no study describes the impact of respiratory failure during Emergency Department treatment on mortality in a population of elderly patients. The purpose of the present study was to evaluate factors predicting poor outcome with special emphasis on the impact of respiratory failure on mortality in elderly patients with isolated severe TBI. All elderly patients (age ≥ 65 years) with isolated severe head injury, admitted to this Level I trauma center, during a period of 16 years (from January 1992 to December 2008) were identified from the trauma registry. Stepwise logistic regression analysis was used to identify risk factors for a poor prognosis and outcome. The logistic regression found the following variables influencing the mortality: respiratory failure (p<0.0005; OR: 9.369), pupillary response (p<0.0212, OR: 3.393) and ISS score (p<0.0001, OR:1.179). A significant (p<0.0001) increased risk of death was also found for patients with a midline shift >15 mm. The present study predicts a strong correlation between respiratory failure, pathological pupillary response, a higher ISS and substantial midline shift with poor outcomes in elderly patients sustaining an isolated severe TBI.

Official Title
-----------------
Risk Factors Predicting Prognosis and Outcome of Elderly Patients With Isolated Traumatic Brain Injury

Conditions
-----------------
Brain Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
The inclusion criteria for this study were: patients aged 65 years and older and acute severe TBI defined by an Abbreviated Injury Scale (AIS-head) score of ≥ 3 for the head region. Exclusion criteria for this study were as followed: oral intubation prior to ED-admission; no details of the time of injury (e.g. chronic subdural hematomas) and any concomitant injuries. Patients who received oral intubation prior to ED-admission were excluded due to the high variability of indications other than respiratory failure or secondary neurological decline (e.g. intubation required for aspiration protection) that may not be necessarily related to TBI induced secondary respiratory failure.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Emergency Department Management | Interventions, Critical Care Procedures, Blood units, e.g. that were done within the first 3 hours after trauma within the emergency trauma room | 16 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Outcome Scale |  | 16 years |
Molecular Analysis and Treatment Options of Thymic Malignancies

Study Overview
=================
Brief Summary
-----------------
Thymic malignancies are the most common tumors of the anterior mediastinum, though surgery and radiation often effectively treat thymic carcinomas, a minority continue to progress and eventually lead to death. Therefore, there is an unmet need for more effective therapies for thymic malignancies. Considering the role of molecular alterations has yet to be defined in the treatment of thymoma and thymic malignancies, there is an urgent recognition that molecular alterations in the thymic malignancies are important to predict response and survival for novel targeted therapies. In summary, identification of genetic alterations in thymic malignancies is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with thymic malignancies to further the characterization of molecular alterations and develop (novel) treatments based on the detection.

Official Title
-----------------
Molecular Landscape Analysis and Treatment Options for Thymic Epithelial Tumors

Conditions
-----------------
Thymic Epithelial Tumor, Thymic Carcinoma, Thymic Cancer

Intervention / Treatment
-----------------
* Drug: Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven diagnosis of thymic malignancies 18 years of age or older Ability to understand and the willingness to sign a written informed consent document

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Chemotherapy|different treatments based on the molecular analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Collect detailed clinical information on patients with thymic malignancies via the electronic medical records | 20 years | 
| Disease control rate (DCR) | Collect detailed clinical information on patients with thymic malignancies via the electronic medical records | 20 years | 
| Progression-free survival (PFS) | Collect detailed clinical information on patients with thymic malignancies via the electronic medical records | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Collect detailed clinical information on patients with thymic malignancies via the electronic medical records | 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thymic malignancy, thymoma, chemotherapy, targeted therapy, immunotherapy, molecular landscape
Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate bronchoalveolar lavage fluid and serum obtained from pediatric patients with storage disorders prior to allogeneic hematopoietic stem cell transplantation (HSCT) for the presence of proinflammatory cytokines and for the production of nitric oxide by alveolar macrophages to identify possible risk factors for pulmonary complications. II. Investigate the underlying mechanism for the development of significant pulmonary complications in these patients during HSCT. III. Evaluate bronchoalveolar lavage fluid and serum obtained from these same patients at the time a pulmonary complication develops post-HSCT, or at 60 days post-HSCT if there has been no pulmonary complications.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo bronchoscopy with bronchoalveolar lavage (BAL) prior to allogeneic hematopoietic stem cell transplantation (HSCT). ELISA assays for cytokines are performed. Patients are followed post-HSCT for the development of transplant related pulmonary complications. A repeat bronchoscopy with BAL is performed at the time pulmonary complications develop or at day 60 post-HSCT if no complications develop. Cytokine assays are repeated.

Conditions
-----------------
I Cell Disease, Fucosidosis, Globoid Cell Leukodystrophy, Adrenoleukodystrophy, Mannosidosis, Niemann-Pick Disease, Pulmonary Complications, Mucopolysaccharidosis I, Mucopolysaccharidosis VI, Metachromatic Leukodystrophy, Gaucher's Disease, Wolman Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnosis of an inborn error of metabolism eligible for allogeneic hematopoietic stem cell transplantation on protocol UMN-MT-1995-01

Ages Eligible for Study
-----------------
Minimum Age: 0 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
-----------------
I cell disease, Gaucher's disease, Niemann-Pick disease, Wolman disease, adrenoleukodystrophy, disease-related problem/condition, fucosidosis, genetic diseases and dysmorphic syndromes, globoid cell leukodystrophy, inborn errors of metabolism, mannosidosis, metachromatic leukodystrophy, mucopolysaccharidosis, mucopolysaccharidosis I, mucopolysaccharidosis VI, oncologic disorders, pulmonary complications, rare disease, sphingolipidoses
KOrean Borderline Ovarian Tumor (KOBOT) Registry

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to collect data on Korean patients with borderline ovarian tumors.

Detailed Description
-----------------
The researchers retrospectively collected data on Korean patients with borderline ovarian tumors (BOTs) diagnosed, treated, and followed between November 1994 and February 2015 at institutions where placed in the Republic of Korea. And the researchers prospectively will collect data on all Korean patients with BOTs at institutions where placed in the Republic of Korea since March, 2015. If patients agree to participate in this KOBOT registry, patient's data (such as age, body mass index, preoperative findings, laboratory findings, radiologic findings, operative findings, pathologic findings, postoperative findings) will be collected in a research database. The research database will be updated, every 6 month, to include data on patient's disease outcome and follow-up care. Although most data will be collected form the medical record, patient may agin be contacted so that researchers can collection some data if it is not in the medical record.

Official Title
-----------------
Establishing the Registry of Korean Patients With Borderline Ovarian Tumors

Conditions
-----------------
Ovarian Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with borderline ovarian tumors (BOTs) diagnosed, treated, and followed between November 1994 and February 2015 at institutions where placed in the Republic of Korea. All patients undergoing gynecologic surgery for BOTs at institutions where placed in the Republic of Korea since March, 2015 Exclusion Criteria: Patients who did not receive primary treatment or follow-up for at least 6 months at each institution were excluded from analysis
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Recurrence-free survival |  | up to 100 months |
Assessment of the the ETView Double-lumen Tube

Study Overview
=================
Brief Summary
-----------------
The double tube ETView is particularly innovative as it includes an integrated optical fiber to visualize the carena. This study aims to verify if if its use avoids the requirement of a fibreoptic bronchoscopy.

Official Title
-----------------
Assessment of the the ETView Double-lumen Tube

Conditions
-----------------
Tracheal Intubation

Intervention / Treatment
-----------------
* Device: ETView Double-Lumen Tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective thoracic surgery with anticipated use of a DLT Exclusion Criteria: left pneumonectomy or left lobectomy requiring an anastomosis on the left main bronchus proximal left bronchial lesion anatomical abnormality of the bronchial tree suspicion of difficult mask ventilation or intubation

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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EtView<br>Use of ETVew double-lumen tube | Device: ETView Double-Lumen Tube<br>* Tracheal intubation is performed using a ETView Double-Lumen Tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of insertion | Rate of insertion, defined as successful placement of airway device in correct position without help of fibreoptic bronchoscopy | 300 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use evaluated by the anesthesiologist | Evaluation using a score (1 = easy to use, 2 = not so easy, 3 = difficult) | 3 hours | 
| Quality of lung collapse | Evaluation using a score (1 = atelectatic lung, 2 = lung well isolated but not atelectatic, 3 = failure of lung isolation) | 3 hours | 
| Rate of misplacement occurring after patients removal from dorsal to lateral position |  | 1 hour | 
| Rate of misplacement, occurring during surgery |  | 3 hours | 
| Rate of requirement to a conventional double lumen tube | ETView Double-Lumen Tube is not well positioned. It is withdrawn and replaced by a conventional double lumen tube | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients, Undergoing, Elective, Thoracic, Surgery
Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2

Study Overview
=================
Brief Summary
-----------------
Edible parts of the artichoke plant (Cynara cardunculus, Cynara scolymus) are traditionally known in folk-medicine for lipid lowering and choleretic effects. Furthermore, antidiabetic effects are described. In the past year's research attributed health promoting effects to the main active compounds chlorogenic acid, luteolin and apigenin. Present literature indicates potential antidiabetic effects by different mechanisms like downregulation of gluconeogenesis, increased GLP-1 secretion and modification of insulin signalling. Up to now only few human clinical trials provide insufficient data to conclude the therapeutic potential of cynara scolymus extract in the treatment of type 2 diabetes. The primary objective is to evaluate the antidiabetic effect and the mechanisms of glucose lowering by a 12-week treatment with a highly-standardized extract of cynara scolymus in subjects with diabetes mellitus type 2 compared to placebo.

Official Title
-----------------
Cynara Scolymus Extract for Treatment of Diabetes Mellitus Type 2, a Pilot Clinical Trial Clinical Study Protocol

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

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Cynara Scolymus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥18 years old. Diagnosis of diabetes mellitus type 2 ≥ 90 days prior to screening HbA1c-level between 6.5-9% Body mass index of ≥ 28 kg/m2 Stable daily dose (for at least 30 days) of 1-3 oral antidiabetic drug (metformin, sulfonylurea, SGLT-2 inhibitor, thiazolidinedione or DPP-IV-inhibitor) Exclusion Criteria: Subjects with diabetes mellitus type 1 or history of ketoacidosis, Uncontrolled diabetes, defined as fasting plasma glucose ≥20mmol/l or recurrent hypoglycemia (defined as capillary glucose values ≤3.5mmol/l) Use of insulin or GLP-1-receptor agonists Women wanting to become pregnant Pregnant or breast-feeding women Known hepatic disorder Severe renal insufficiency (GFR ≤30ml/min) History of inflammatory bowel disease History of gastric bypass or gastric sleeve surgery Anticoagulation with vitamin K-antagonists

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 3x2 capsules / day<br>|
| Experimental: Cynara Scolymus<br> | Drug: Cynara Scolymus<br>* 3x2 capsules / day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbA1c-level from baseline to week 12 |  | 12 weeks |