linjc16/ctgov huggingface dataset:
Evaluation of Antithrombin Deficiency in Patients of Intensive Care Unit Placed on Extracorporeal Membrane Oxygenation

Study Overview
=================
Brief Summary
-----------------
Prospective, monocentric, non-interventional study in patients placed on extracorporeal membrane oxygenation (ECMO)

Detailed Description
-----------------
Our hypothesis is that ECMO initiation is responsible for a severe decrease of antithrombin level in a high proportion of patients who develop heparin resistance.

Official Title
-----------------
Evaluation of Antithrombin Deficiency in Patients of Intensive Care Unit Placed on Extracorporeal Membrane Oxygenation

Conditions
-----------------
Severe Cardiac Insufficiency

Intervention / Treatment
-----------------
* Biological: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any ICU patient of receiving veno-arterial extracorporeal membrane oxygenation Patients who have not expressed opposition to participate Exclusion Criteria: Arterial thrombosis or progressive venous thrombosis Contraindication to heparin Constitutional deficiency in antithrombin Patient refusal Minor patient Protected major (safeguard justice, trusteeship and guardianship) and persons deprived of liberty

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 |
| --- | --- |
| Extracorporeal membrane oxygenation<br> | Biological: Blood sample<br>* Blood sample collection from a peripheral catheter at ECMO initiation (H0), then 2h, 6h, 12h, 24h and daily from day 2 to day 7 or at ECMO discontinuation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study antithrombin level from during the first 24h after ECMO initiation | Blood sample at ECMO initiation (H0), then 2h, 6h, 12h, 24h and daily from day 2 to day 7 or at ECMO discontinuation | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study antithrombin level 24h after initialization of ECMO | Blood sample at 24h | Hour 24 | 
| To study the prevalence of antithrombin (AT) deficiency (≤70%) at each time point (from H0 to day 7) | Blood sample | Day 7 | 
| To study relationship between antithrombin level and heparin resistance | Blood sample | Day 7 | 
| To study relationship between antithrombin level and thrombin generation test | Blood sample | Day 7 | 
| To study clinical factors associated with AT deficiency | Blood sample | Day 7 | 
| To describe clinical evolution of patients according to initial AT level | Blood sample | Hour 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extracorporeal membrane oxygenation
Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Official Title
-----------------
Named Patient Use Program to Provide Abemaciclib for the Treatment of Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Abemaciclib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hormone receptor positive metastatic breast cancer for whom there is reasonable expectation that abemaciclib may provide clinical benefit and who are suitable to receive abemaciclib.

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: Abemaciclib|Administered orally.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of Latent Tuberculosis Infection (LTBI) by High Resolution Scanner

Study Overview
=================
Brief Summary
-----------------
It is traditionally considered that someone with a positive tuberculin skin test (TST) (and/or positive result in Cell Interferon-Gamma Release Assay (TIGRA), depending on the different countries' guidelines) is infected but not ill when the absence of lesions is demonstrated in a thorax X-Ray assay. Even though, the experiences described in literature using cows and pigs as animal models for the study of LTBI demonstrate the presence of this kind of lesion in the animals, even too small to be detected by X-Ray assay, which would suggest they also could happen in human LTBI. Nowadays, the High Resolution Scanners (HR TC) offer the possibility of detecting any lesion approximately 1 mm in diameter, so the investigators plan to use this technique to screen people already infected by M. tuberculosis (but not ill, following the Diagnosis Standard Guidelines). Additional pathological analysis of resected and post-mortem tissues will provide lesion-based profiles of humans infected with tuberculosis.

Detailed Description
-----------------
It is traditionally considered that the development of LTBI is due to the M. tuberculosis ability to develop a dormancy state within well-structured lesions (granulomas), which can remain in the lung of the host even for life. The investigators have developed a new original hypothesis based on scientific evidence that takes into account the idea that a lesion cannot be held forever, because the host tends to remove any lesion in order to rebuild the original parenchyma, in a healing process. Even if M. tuberculosis can remain in a dormant/non-replicating state for a long period, this is an important but not sufficient factor to explain the LTBI. The Dynamic Hypothesis tries to explain the existence of LTBI in spite of the healing process that could remove it by a constant reinfection of the host's tissue.

Official Title
-----------------
Study of Latent Tuberculosis Infection (LTBI) by High Resolution Scanner

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with TST+ (plus positive TIGRA result, if possible) and normal thorax X-ray assay (normal as absence of any detectable lesion) Exclusion Criteria: Active TB Any medical condition or illness that could compromise the volunteer's health if entering the project

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?
-----------------
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
-----------------
Latent Tuberculosis Infection, High Resolution Scanners, Dynamic Hypothesis of Latent Tuberculosis Infection
Luteal Supplementation With Rec-LH After GnRH-agonist Triggering in In Vitro (IVF)

Study Overview
=================
Brief Summary
-----------------
Our aim is to access whether we can achieve equivalent pregnancy rates by the addition of six doses of luteal support with recLH after agonist triggering for IVF cycles in the absence of OHSS.

Detailed Description
-----------------
Whether pregnancy outcome after GnRH-agonist triggering could be improved by adding luteal recLH support plus progesterone, compared to that observed after ovulation triggering with HCG in GnRH antagonist stimulated cycles.

Official Title
-----------------
A Phase IV Study on the Effect of Luteal Supplementation With Rec-LH on the Pregnancy Rate After Ovulation Triggering With GnRH-agonist Instead of HCG in IVF Protocol;Proof of Concept

Conditions
-----------------
Pregnancy, Pregnancy Loss

Intervention / Treatment
-----------------
* Drug: 300IU rec-LH
* Drug: progesterone 600mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: < 36years, single blastocystET, FSH < 12 Exclusion Criteria: endometriosis, 3 and 4, pco, frozen sperm

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 36 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: HCG for ovulation triggering and luteal progesterone<br>conventional triggering with HCG and conventional luteal support with progesterone | Drug: progesterone 600mg<br>* luteal support<br>|
| Experimental: Agonist triggering and rec-LH luteal support plus progesterone<br>new method of triggering with GnRH-agonist and proof of concept intervention with novel way of luteal support with rec-LH plus the usual co-treatment with progesterone | Drug: 300IU rec-LH<br>* luteal alternate doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy occurrence, pregnancy loss |  | 14 days after OPU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hormone levels, OHSS, endometrium |  | 14 days after oocyte pick up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy
Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of Ofev Capsules under the real world setting in patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype (PF-ILD).

Official Title
-----------------
Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan

Conditions
-----------------
Lung Diseases, Interstitial

Intervention / Treatment
-----------------
* Drug: Nintedanib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in Japan with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included. Exclusion Criteria: Diagnosis of Idiopathic Pulmonary Fibrosis Patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype due to systemic scleroderma as the underlying disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients newly initiating Nintedanib<br> | Drug: Nintedanib<br>* Capsules<br>* Other names: Ofev;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions (ADRs) |  | up to 104 weeks |
The Effects of Cervical Stabilization Exercises on Pulmonary Functions and Respiratory Muscle Strength

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the effects of stabilization exercises on pulmonary functions and respiratory muscle strength. 42 participants with neck pain enrolled the study.

Detailed Description
-----------------
This study aims to assess the effects of stabilization exercises on pulmonary functions and respiratory muscle strength. 42 participants with neck pain enrolled the study. Participants were divided into two groups, stabilization group (n=21) and the control group (n=21). The participants underwent a total of 24 sessions of treatment thrice a week for eight weeks under the supervision of a physiotherapist.

Official Title
-----------------
The Effects of Cervical Stabilization Exercises on Pulmonary Functions and Respiratory Muscle Strength in Patients With Neck Pain

Conditions
-----------------
Neck Pain

Intervention / Treatment
-----------------
* Other: cervical stabilization exercises
* Other: conventional exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neck pain longer than 3 months patients between ages of 18 and 55 Exclusion Criteria: patients with neurologic symptoms patients with chronic pulmonary disease previous surgery on cervical region

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Other: the stabilization group<br>the stabilization group performed cervical stabilization exercises in lying, sitting, standing and on a swisball 3times a week during 8 weeks. | Other: cervical stabilization exercises<br>* cervical stabilization exercises<br>|
| Other: the control group<br>the control group performed conventional exercises including neck isometric, isotonic and posture exercises 3 times a week during 8 weeks. | Other: conventional exercises<br>* conventional exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary functions | pulmonary functions were measured with spirometric tests by two experienced physical therapists. | 8 weeks | 
| respiratory muscle strength | respiratory muscle strength was measured using mouth pressure device by two experienced physical therapists. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neck pain, pulmonary function test, respiratory muscle strength, cervical stabilization exercises
Analysis of Immune Responses to HIV Vaccines

Study Overview
=================
Brief Summary
-----------------
This study will evaluate a test designed to measure immune system responses to HIV and HIV vaccines.

Detailed Description
-----------------
Assays for HIV-specific human CD4 and CD8 T cell immunity are needed in order to evaluate the immune response to HIV vaccines. Such assays should be robust, reproducible, and amenable to high throughput analysis of clinical specimens. Cytokine flow cytometry (CFC) assays can reliably and specifically detect human CD4 and CD8 T cell responses to AIDS-related opportunistic infections, including those caused by cytomegalovirus, Mycobacterium tuberculosis, the Mycobacterium avium complex, cryptococcus, and human papillomavirus. The purpose of this study is to devise and evaluate a similar CFC assay for the detection and quantitation of CD4 and CD8 T cell responses against HIV. This study will evaluate a Gag-IFNg CFC assay by comparing the results of this assay with results from other assays of immune phenotype and function in long-term nonprogressors, untreated patients with progressive HIV disease, and recipients of candidate HIV vaccines. The study will also examine HIV-specific immune responses in HIV infected individuals who appear to exhibit significant immune protection from HIV disease. Participants in this study will be drawn from other studies currently underway. As a part of those studies, participants will have regular blood tests. Blood samples from those studies will be used in this study. No participants will be directly enrolled in this study.

Official Title
-----------------
Flow Cytometry Study of T Cell Responses to HIV Vaccines

Conditions
-----------------
Acquired Immunodeficiency Syndrome, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Blood samples from 5 cohorts of HIV infected individuals and 2 cohorts of HIV uninfected individuals will be evaluated. Varying stages of HIV disease are represented in these cohorts, including: Individuals who have been exposed but who have not seroconverted Individuals who have recently seroconverted HAART-treated patients who receive immune modulators such as IL-2 and therapeutic immunization HAART-treated patients who undergo structured treatment interruptions HAART-treated patients who have durable suppression of viremia HAART-treated patients who experience incomplete suppression of viremia HAART-treated patients followed with careful drug adherence monitoring Long-term nonprogressors Untreated progressors
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Seronegativity, HIV Preventive Vaccine, HIV Therapeutic Vaccine
Natural History Study of Choroideremia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the rate of progression of all stages of choroideremia using a variety of assessments performed in the clinic including visual field measures, specialized photography of the eye and participant-reported visual problems

Official Title
-----------------
A Multicenter Prospective Observational Natural History Study in Patients With Choroideremia

Conditions
-----------------
Choroideremia

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (Primary Cohort): Healthy individuals (at least 14 years) with choroideremia (20/200 or better vision) willing to participate in an observational study and meeting the eligibility criteria. Inclusion Criteria (Expansion Cohort): Healthy individuals (at least 18 years) with choroideremia (20/200 or better vision in both eyes) willing to participate in an observational study and meeting the eligibility criteria. Exclusion Criteria (Primary and Expansion Cohort): Prior therapy with an AAV vector-based treatment Pre-existing eye conditions that would: (1) preclude future planned treatment in a therapeutic intent clinical trial (i.e. intravitreal injection), (2) interfere with the interpretation of study endpoints, and/ or put patient at risk for surgical complications Complicating systemic diseases that would preclude future enrollment in a therapeutic intent clinical trial Any other condition that would not allow the potential subject to complete follow-up examinations during the course of the study and, in the opinion of the investigator, makes the potential subject unsuitable for the study.

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Cohort<br>No intervention | Other: Observation<br> <br> |
| Expansion Cohort<br>No intervention | Other: Observation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of progression of disease | A variety of psychophysical, anatomical and image-based endpoints | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinal degeneration, eye, REP-1 gene
A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma

Study Overview
=================
Brief Summary
-----------------
To evaluate the response rate of cetuximab plus irinotecan combination therapy in subjects with EGFR-detectable metastatic colorectal carcinoma who have documented progressive disease to irinotecan-based chemotherapy and who have failed (progressive disease or intolerance) previous oxaliplatin-based and fluoropyrimidine-based chemotherapies.

Official Title
-----------------
A Multi-center, Open Label, Non-randomized, Phase II Study to Assess the Activity and Safety of Cetuximab Plus Irinotecan in Subjects With EGFR-detectable Metastatic Colorectal Carcinoma

Conditions
-----------------
Colorectal Carcinoma

Intervention / Treatment
-----------------
* Drug: Cetuximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must have surgically unresectable metastatic colorectal carcinoma. The subjects who have received and failed Ilinotecan, oxaliplatin and fluoropyrimidine-based chemotherapy ECOG PS 0-2 Exclusion Criteria: Subjects with symptomatic cerebral metastasis

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response according to the RECIST criteria accessed every 6 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression, duration of achieved response, and the disease control rate will be accessed in all patients who received Cetuximab. The worst toxicity grades per patients will be tabulated for adverse events and laboratory measurements. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFR-detectable metastatic colorectal carcinoma with documented progressive disease to irinotecan-based chemotherapy and failure