linjc16/ctgov huggingface dataset:
Detection of Latent Tuberculosis in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the performance of the tuberculin skin test, used for more than 50 years as a diagnostic tool for latent tuberculosis infection, with 2 blood tests which have recently become commercially available (Interferon-gamma release assays) in a population of immunosuppressed individuals with chronic renal failure undergoing long term hemodialysis

Detailed Description
-----------------
This prospective study includes all adults aged over 18 years of age who accept to be included in the study and provided written informed consent. All patients are under long term hemodialysis for chronic renal failure. They are subjected to a questionnaire including history of contacts with tuberculosis (TB), prior treatment for TB, history of prior tuberculin skin testing, history of BCG vaccination, country of origin, trips or prolonged stays in high incidence areas, smoking history, and medications. All patients will have a chest X-ray, and simultaneous testing with the tuberculin skin test according to the Mantoux technique, and with the T-SPOT. TB and QuantiFERON Gold in tube Interferon-gamma release assays. The study analysis agreement between tests, detection of prior TB and presumptive latent tuberculosis infection, based on these items.

Official Title
-----------------
Interferon-Gamma Release Assays (IGRA) Versus Tuberculin Skin Testing for Detection of Latent Tuberculosis Infection (TB) in Chronic Hemodialysis Patients

Conditions
-----------------
Chronic Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged over 18 Under hemodialysis for > 3 months End stage renal failure Exclusion Criteria: Refusal to participate Prior tuberculin skin test > 15 mm or any adverse reaction to tuberculin skin test

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemodialysis<br>Patients under chronic hemodialysis for chronic end stage renal failure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative performance of tuberculin skin test and interferon gamma release assays for detecting latent tuberculosis infection |  | cross-sectionnal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between tuberculin skin test and interferon gamma release assays as well as agreement between interferon gamma release assays |  | cross-sectionnal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis, end stage renal failure, tuberculosis, latent tuberculosis infection, Patients under hemodialysis for end stage renal failure
Bronchoalveolar Immune Response Determination

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish if cells present in lung tissue during extrinsic allergic alveolitis (EAA) are able to elicit an immune response against specific antigens. The hypothesis is: cells in BAL lavage fluid from patients with EAA will be responsive to specific antigens and this response can be measured using ELISPOT.

Detailed Description
-----------------
Subjects suffering from extrinsic allergic alveolitis caused by pigeons will undergo a broncho alveolar lavage. Cells obtained from this BAL will be used for ELISPOT technique with pigeon specific antigens

Official Title
-----------------
Study to Determine the Immune Response From Broncho-alveolar Cells Against Pigeon Specific Antigens

Conditions
-----------------
Extrinsic Allergic Alveolitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspicion of pigeon induced extrinsic alveolitis Exclusion Criteria: use of oral steroids unable to give informed consent age below 18

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-EAA, pigeon<br>subject with BAL because of diseases not suspected to be EAA | |
| EAA, pigeon<br>Bird fanciers with a typical clinical presentation suspected for pigeon induced EAA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ELISPOT response in cells obtained from broncho-alveolar lavage | All elispots will be performed the same day, the end point will be available the next day | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elispot response in cells from blood | ELispots will be performed the same day as blood collection, results will be available the next day | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pigeon, bird fancier, extrinsic allergic alveolitis, BAL, broncho-alveolar lavage, elispot, antigen
Official Record of Patients Diagnosed With Lymphangioleiomyomatosis (LAM)

Study Overview
=================
Brief Summary
-----------------
Pulmonary lymphoangioleiomyomatosis (LAM) is a rare destructive lung disease typically affecting women of childbearing age. Currently, there is no effective therapy for the disease and the prognosis is poor. In order to better study this disease, the National Heart, Lung, and Blood Institute (NHLBI) has developed a registry to keep an official record of patients diagnosed with LAM. This research project will collect data from 6 health care centers as well as outside physicians. Researchers hope to provide valuable information about the rate of lung destruction and quality of life in patients with LAM. Patients participating in this study will be followed for 5 years. Tissue collected from these patients may contribute to the development of future studies on the disease processes of LAM.

Detailed Description
-----------------
LAM is a rare disease that predominantly affects women of child-bearing age. To study in more detail this rare disease, this multi-center project will establish a registry of persons with LAM. By combining data from 6 centers and outside physicians, this study may yield valuable information regarding the rate of decline in pulmonary function and quality of life in individuals with LAM. These patients will be followed over a five-year period. Tissue collected from study participants may facilitate future studies into the molecular basis of LAM.

Official Title
-----------------
Lymphangioleiomyomatosis (LAM) Registry

Conditions
-----------------
Leiomyomatosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Informed consent must be obtained from the patient. Patients must be female. Patients must be age 18 or older. Patients with prevalent and incident cases are eligible. Patients with the presence or absence of underlying diagnosis or evidence of Tuberous Sclerosis Complex (TSC) are eligible. Patients must have a diagnosis of LAM confirmed by any of the following criteria: Lung biopsy (transbronchial, surgical, transthoracic) judged to be diagnostic by the Tissue Core pathologists; OR Biopsy of lymph node or other mass judged to be diagnostic by the Tissue Core pathologists; OR High resolution CT scan of the chest which is judged to be diagnostic of LAM with a high degree of certainty by all three of the expert radiologists making up the Imaging Core. Patients may be enrolled in other protocols.
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
-----------------
Progesterone, Pulmonary Function Tests, Pneumothorax, Oopherectomy, High Resolution CT, Tuberous Sclerosis Complex, Lymphangioleiomyomatosis (LAM)
Comparison of Two Insertion Technique of I-gel

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of rotational technique in the insertion of i-gel

Detailed Description
-----------------
The i-gel is one of the 2nd generation supraglottic airways. The rotational technique is known to increase the success rate of insertion of other supraglottic airways. The investigators try to evaluate the efficacy of rotational technique in the insertion of i-gel.

Official Title
-----------------
Comparison of Two Insertion Technique of I-gel: Standard Versus 90-degree Rotation

Conditions
-----------------
Prostate Cancer, Prostate Tumor, Bladder Cancer, Bladder Tumor

Intervention / Treatment
-----------------
* Procedure: Rotational technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients scheduled for general anesthesia(transurethral resection of bladder tumor or transurethral resection of the prostate) using i-gelTM Exclusion Criteria: History of recent postoperative sore throat History of difficult airway Mouth opening < 2.5 cm Emergency operation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>i-gel will be inserted without rotation | |
| Experimental: Rotation<br>Rotational technique applied | Procedure: Rotational technique<br>* 90 degree rotation<br>* Other names: 90 degree rotation technique;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of insertion | check oropharyngeal leakage at pressure 12 cmH2O | up to 30 min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative sore throat | severe/moderate/minimal/none | up to 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
success
Blood Pressure Lowering Effects of Amosartan Regarding Proviso iN Patients With High Blood Pressure

Study Overview
=================
Brief Summary
-----------------
Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension

Detailed Description
-----------------
After taking Amozatan (AMS, amlodipine / rozanthin combination) in patients with essential hypertension, the percentage of patients who reached the mean systolic target blood pressure was evaluated

Official Title
-----------------
Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients With Hypertension: Prospective, Multicenter, Observational Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Amosartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine or rosartan monotherapy In patients with stage 2 hypertension (SBP 160-179 mmHg), patients requiring a combination therapy to reach the target blood pressure Patients who were changed to amosartan while using other hypertensive agents Exclusion Criteria: Patients with hypersensitivity to dihydropyridine derivatives of amosartan Women who are pregnant or who may be pregnant and breastfeeding Patients with severe hepatic dysfunction Patients with severe aortic stenosis Patients at risk of shock Patients participating in other clinical studies

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: Amosartan|amosartan is a combination of amlodipine, which is a calcium channel blocker (CCB), and rozatan, an angiotensin II receptor antagonist (ARB), and is an antihypertensive agent|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with essential hypertension evaluated the mean blood pressure after taking amosartan. | Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension | 6 month |
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin

Study Overview
=================
Brief Summary
-----------------
This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients undergoing hemodialysis.

Detailed Description
-----------------
Visits during the expanded access program will consist of a Baseline Visit to confirm eligibility and an End of Treatment visit. Patients will receive IV difelikefalin at a dose of 0.5 mcg/kg after each dialysis session, generally 3 times per week. The End of Treatment visit will be defined as the first dialysis visit following the last dose of IV difelikefalin under the intermediate-size patient population expanded access protocol.

Official Title
-----------------
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin

Conditions
-----------------
Uremic Pruritus

Intervention / Treatment
-----------------
* Drug: Difelikefalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Adults ≥ 18 years old; Has end-stage renal disease (ESRD) and is currently receiving in-center hemodialysis; Has moderate-to-severe pruritus attributed to ESRD which is significantly impacting the patient's quality of life; Has no comparable or satisfactory alternative therapy for the treatment of moderate-to-severe pruritus, as determined by the sponsor-investigator. Key Exclusion Criteria: Has severe hepatic impairment (Child-Pugh class C), as the influence of severe hepatic impairment on the pharmacokinetics of difelikefalin has not been evaluated; Is pregnant or nursing; Has been exposed to any other investigational medication in the past 60 days; Present any other reason which may lead to an unfavorable risk-benefit ratio for treatment with difelikefalin, as determined by the sponsor-investigator; Has a known or suspected allergy to difelikefalin or any component of the investigational product.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Difelikefalin|IV Difelikefalin 0.5 mcg/kg administered after each dialysis session (3 times/week)|

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
-----------------
Hemodialysis, Pruritus, Uremic Pruritus, Dialysis, CR845, Difelikefalin, Chronic Itch, CKD, CKD-associated pruritus, CKD-aP, ESRD (end stage renal disease), Itch, Itching, KALM, Chronic Kidney Disease, Kidney failure, chronic, Kidney dysfunction, Generalized pruritus, Expanded access, Compassionate use
Comparison of Two Oral Appliances in the Treatment of Sleep Apnea Syndrome

Study Overview
=================
Brief Summary
-----------------
Monocentric comparative group study comparing the efficacy and short-term tolerance of a propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be equally effective and tolerated.

Official Title
-----------------
Comparison of a Retention Type and Propulsion Type Oral Appliance in the Treatment of Obstructive Sleep Apnea

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

Intervention / Treatment
-----------------
* Device: Herbst (propulsion type oral appliance)
* Device: Retention type appliance (ORM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sufficient teeth to allow wearing of the device Mild to severe OSAS Ability to answer the questionnaires No concomitant CPAP treatment BMI inferior to 32 kg/m2 Exclusion Criteria: Important dental or parodontal disease Central sleep apnea Jaw opening limitations Temporo-mandibular joint dysfunction Major gag reflex precluding the long-term use of the device Major or unstable cardiovascular or pulmonary disease

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propulsion type appliance (Herbst)<br> | Device: Herbst (propulsion type oral appliance)<br>* Oral appliance<br>|
| Active Comparator: Retention type appliance (ORM)<br>Retention type appliance | Device: Retention type appliance (ORM)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography) |  | 12 months |
Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy

Study Overview
=================
Brief Summary
-----------------
A prospective observational study on italian women undergoing ulipristal acetate (uPa) therapy for symptomatic myomas and its impact on symptomatology and moreover on myomas architecture. We also evaluate changes in the endometrial pattern of selected women.

Official Title
-----------------
Long-term Observation of Symptomatic Women With Uterine Fibroids Who Have Been Treated With Ulipristal Acetate: Findings on Symptomatology, Morphological Structure, Endometrial Patterns

Conditions
-----------------
Myoma, Uterine Bleeding, Dysfunctional, Uterine Bleeding Heavy, Dysmenorrhea, Endometrium Hyperplasia

Intervention / Treatment
-----------------
* Diagnostic Test: Transvaginal ultrasonographic examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: number of myomas from 1 to 4 heavy menstrual bleeding conservative treatment request Exclusion Criteria: concurrent endometrial pathology post-menopausal status hepatic pathology endocrine or metabolic disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ulipristal acetate based therapy<br>Fertile women under ulipristal acetate treatment | Diagnostic Test: Transvaginal ultrasonographic examination<br>* Evaluation of endometrial thickness; myoma size and volume<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysmenhorrea (VAS score) |  | 12 months | 
| Endometrial thickess (mm) |  | 12 months | 
| Myoma's diameter (mm) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate (LBR) | Live birth rate if women conceived spontaneously or through ARTs after treatment | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ulipristal acetate, myoma, leiomyoma, endometrial patterns, symptomatology
Immunmodulation in Patients With HHT

Study Overview
=================
Brief Summary
-----------------
Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder. Literature suggests that HHT is often associated with higher frequency of infectious diseases. The purpose of this study is to evaluate a variety of immunologic parameters in the blood serum of HHT patients in comparison to probands.

Detailed Description
-----------------
Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and visceral arteriovenous malformations. Literature and the investigators' observation suggest that HHT is often associated with higher frequency of infectious diseases. This might be a hint for a immunocompromised situation. The purpose of this study is to evaluate a variety of immunologic parameters in the blood serum of HHT patients in comparison to probands.

Official Title
-----------------
Immunmodulation in Patients With HHT

Conditions
-----------------
Hereditary Haemorrhagic Telangiectasia (HHT)

Intervention / Treatment
-----------------
* Other: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 or over, HHT Exclusion Criteria: Unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients with HHT<br>blood sample of patients with HHT | Other: blood sample<br>* none, only laboratory tests on blood serum<br>|
| probands<br>blood sample of healthy controls | Other: blood sample<br>* none, only laboratory tests on blood serum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amounts of leucocytes in patients with HHT |  | November 2016 - December 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in distribution of leucocytes in patients with HHT |  | November 2016 - December 2018 |