linjc16/ctgov huggingface dataset:
Anakinra in Myositis

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients with treatment-resistant inflammatory myopathies. Patients and methods: Fifteen patients with refractory polymyositis (PM), dermatomyositis (DM), or inclusion body myositis (IBM) were treated with 100 mg anakinra subcutaneously per day during 12 months. Outcome measures included myositis disease activity score with improvement defined according to The International Myositis Assessment and Clinical Studies Group (IMACS) and for muscle performance the functional index of myositis (FI). In addition repeat muscle biopsies were performed

Official Title
-----------------
Anakinra in Patients With Refractory Idiopathic Inflammatory Myopathies

Conditions
-----------------
Polymyositis, Dermatomyositis, Inclusion Body Myositis

Intervention / Treatment
-----------------
* Drug: Anakinra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 18 to 80 years with diagnosis of PM, DM or IBM based Peter and Bohan's and Grigg's criteria. All patients had to be capable of giving informed consent. Other inclusion criteria were muscle strength and/or function reduced at least 20 % below predicted values as measured by functional index (FI) [45-47] and failure to respond to treatment with high-dose glucocorticoids (0.75 mg/kg/day for at least one month) in combination with azathioprine and/or methotrexate for at least two months. - Exclusion Criteria: serious infections such as hepatitis, pneumonia, pyelonephritis in the previous 3 months; history of opportunistic infections such as tuberculosis, drug resistant atypical mycobacterium, active pneumocystis carinii, active cytomegalovirus infection; documented HIV infection; alcoholism, alcoholic liver disease or other chronic liver disease; chest x-ray suggestive of active tuberculosis; and pregnant, nursing mothers or patients with planned pregnancy within one and a half years of enrolment. -

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Impact of Switching to NNRTI-based Therapy on the Quality of Life of HIV-infected Patients With Virological Suppression

Study Overview
=================
Brief Summary
-----------------
Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of life of HIV-positive patients

Official Title
-----------------
Observational Study of the Impact on Quality-of-life of a Switch From a Virologically Effective Regimen to a Regimen Containing a Non-Nucleoside Reverse Transcriptase Inhibitor (QUALVI) Nevirapine (Viramune®) Clinical Phase IV

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NNRTI-naive patients with positive HIV serology, treated with at least triple combination therapy, with a viral load < 500 copies/ml, in whom a new treatment comprising an NNRTI is initiated for a reason other than inefficacy of treatment will be included Patients must read and write French Exclusion Criteria: Patients in whom a new treatment is initiated because of treatment failure new treatment does not comprise an NNRTI
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-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)<br> | Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score |  | Baseline, month 1, 6 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Short version of the Medical Outcomes Study Short-Form General Health Survey-36 (SF12) scores of the study population compared to the general population |  | Baseline, 12 months | 
| Changes in symptom scale score |  | Baseline, month 1, 6 and 12 | 
| Changes in Hospital Anxiety and Depression scale (HADS) |  | Baseline, month 1, 6 and 12 | 
| Changes in cluster of differentiation 4 (CD4) cell count |  | Baseline and month 3, 6, 9, 12 | 
| Changes in viral load |  | Baseline and month 3, 6, 9, 12 | 
| Changes in liver function tests |  | Baseline and month 3, 6, 9, 12 | 
| Changes in total cholesterol |  | Baseline, month 6 and 12 | 
| Changes in triglycerides |  | Baseline, month 6 and 12 | 
| Changes in fasting blood glucose |  | Baseline, month 6 and 12 | 
| Changes in haemoglobin |  | Baseline, month 6 and 12 | 
| Changes from baseline in plasma urea |  | Baseline, month 12 | 
| Changes from baseline in creatinine |  | Baseline, month 12 |
The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.

Study Overview
=================
Brief Summary
-----------------
It is intended to examine the safety and efficacy of desensitization therapy by GB-0998 (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of pre-transplant desensitization. Patients with positive FCXM-T after performing twice double filtration plasmapheresis (DFPP) therapy will receive GB-0998 1g/kg/day for four days.

Official Title
-----------------
The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: GB-0998


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stage 4 or 5 on the CKD classification. Of the patients that wants a living-donor kidney transplant of ABO blood type compatible, patients with positive FCXM-T and negative CDC-T to the donor. Patients with positive FCXM-T after performing twice DFPP therapy Exclusion Criteria: Patients who had taking to continue immunosuppressive drugs or steroids within 4 weeks before obtaining informed consent. Patients who had IVIG therapy, or plasmapheresis therapy within 12 weeks before to informed consent. Patients who had Rituximab within 6 month before to informed consent. Patients who have undergone splenectomy. Patients with severe hepatic disorder or severe heart disorder. Patients with receiving treatment of malignancy. Patients with high risk of thromboembolism. Patients with history of shock or hypersensitivity to GB-0998. Patients with hereditary fructose intolerance or IgA deficiency. Patients with pregnant or probably pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GB-0998<br> | Drug: GB-0998<br> <br> * Other names: Intravenous immunoglobulin (Venoglobulin IH);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative rate of FCXM-T after the fourth administration of GB-0998 |  | at 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVIG, Renal transplantation, desensitization
Trial of Rifaximin in the Treatment of Tropical Enteropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether rifaximin is effective in the treatment of tropical enteropathy in a population of African children at high risk for this disease.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Trial of Rifaximin, a Non-absorbable Antibiotic, in the Treatment of Tropical Enteropathy

Conditions
-----------------
Tropical Enteropathy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: live in single village Exclusion Criteria: acutely malnourished acutely ill chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 Years

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

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

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: Rifaximin<br> | Drug: Rifaximin<br>* 100mg of rifaxin for 7 consecutive days, twice daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* twice daily for 7 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the Urinary L:M Ratio Before and After the Intervention | To initiate the test, each child drank a 100 ml sugar solution containing 5 g lactulose, 1 g mannitol, 1 g sucralose, and 10 g sucrose. Children remained at the village research site for 4 h after ingestion of the sugar solution, during which time all of the child's urine was collected in a sterile cup with 10 mg merthiolate added to limit the bacterial degradation of excreted sugars. The reported values for normal L:M range from 0.03 to 0.12. A value of ≥0.10 was chosen to be indicative of tropical enteropathy. This test was performed at enrollment and then 28 days later. | 28 days |
Anxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD

Study Overview
=================
Brief Summary
-----------------
This study will try to elucidate wheter the impact of a psychiatric intervention in patients hospitalized because an acute exacerbation of COPD and anxiety/depression and reconsulting at 1 and 6 month after discharge.

Official Title
-----------------
A Prospective Randomized Trial to Asses the Efficacy of an Early Psychiatric Counseling Compared to Usual Care in a Cohort of Patients Hospitalized for an Acute Exacerbation of COPD in Prevention of Re-exacerbation

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Anxiety, Depression

Intervention / Treatment
-----------------
* Behavioral: Counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women of any ethnic group Above 40 years old Diagnose with Chronic Obstructive Pulmonary disease (COPD) according to the ATS/ERS guidelines Acute exacerbation of COPD according to the following criteria: a) Cyanosis b) Obnubilations or mental confusion d) Respiratory Rate above 25 per minute e) Failure of ambulatory treatment f) Co-morbidities that worsens respiratory condition g) Dyspnea Exclusion Criteria: Less than 6 months expectancy of life Needing of mechanical ventilation Severe cardiovascular disease Pregnancy Previous diagnosis of depression/anxiety

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Counselling<br>People receiving a psychiatric evaluation after screening (HADS test > 12 points) and revised at 1 and 6 months | Behavioral: Counselling<br>* Visit by a psychiatrist at day-30 and day-180 after discarge<br>|
| No Intervention: Usual care<br>People after screening (HADS test > 12 points) and send to their primary care physician | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the intervention | Counselling vs. usual care on re-hospitalizations | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of diagnosis | Anxiety/depression diagnosis on number of exacerbations at 1 and 6 months, comparing patients with screening on HADS test > 12 | 6 months |
To Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension

Study Overview
=================
Brief Summary
-----------------
A Multi-center, Randomized, Double-blind, Parallel, phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients with Dyslipidemia and Hypertension.

Detailed Description
-----------------
Multicenter, randomized, double-blind, parallel-design, phase III clinical study

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients With Dyslipidemia and Hypertension.

Conditions
-----------------
Dyslipidemia, Hypertension

Intervention / Treatment
-----------------
* Drug: LivaloVA
* Drug: LivaloV
* Drug: VA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hypertension and dyslipidemia Exclusion Criteria: The subject not meet the specified msBP and LDL-C level

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 100 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: JW0101+C2101<br>LivaloVA | Drug: LivaloVA<br>* For 8 weeks(PO, QD)<br>* Other names: JW0101+C2101;|
| Active Comparator: JW0101+C2102<br>LivaloV | Drug: LivaloV<br>* For 8 weeks(PO, QD)<br>* Other names: JW0101+C2102;|
| Active Comparator: C2101<br>VA | Drug: VA<br>* For 8 weeks(PO, QD)<br>* Other names: C2101;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect | change in msSBP and LDL-C level | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy and safety | change in msSBP and LDL-C level | week 8 |
Clinical Factors Associated Floppy Iris

Study Overview
=================
Brief Summary
-----------------
This study is planned to investigate the incidence of intraoperative floppy iris and its relationship with pseudoexfoliation, diabetes, hypertension as well as systemic alpha-1 adrenergic blocker use.

Detailed Description
-----------------
Our aim is to investigate the incidence of intraoperative floppy iris syndrome (IFIS) signs and evaluate the relationship of IFIS signs as well as complete IFIS with pseudoexfoliation, diabetes, hypertension, and alpha-1 adrenergic blocker (A1AB) use. Five-hundred patients will be included in this prospective study. Preoperatively, pupil diameter before and after dilation, presence of pseudoexfoliation, history of diabetes, hypertension, and use of any A1AB will be recorded. Intraoperative adverse events such as pupillary constriction, iris billowing, and iris prolapse from the wound will be noted. Multinomial regression analysis will be used to evaluate the relationship of IFIS signs with pseudoexfoliation, diabetes, hypertension, and A1AB usage. According to the results we will determine the incidence of IFIS in our patient population and evaluate its relationship with alpha-1 adrenergic blocker use. We will also investigate the relationship of floppy iris problems with pseudoexfoliation, diabetes, high blood pressure.

Official Title
-----------------
Clinical Factors Associated With Floppy Iris Signs: a Prospective Study From Two Centers

Conditions
-----------------
Pupil Constriction, Iris Floppiness, Iris Prolapsus From the Wound

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with the diagnosis of cataract who were decided to have phacoemulsification Exclusion Criteria: Previous history of trauma or surgery of the eye, congenital ocular disease including cataract, infection, inflammation, angle closure glaucoma, or medication (topical) that might affect the size and shape of the pupil Only the first operated eye of each patient was included.

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 90 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
-----------------
Alpha-adrenergic blockers, cataract surgery, pseudoexfoliation syndrome, diabetes mellitus, hypertension, pupil
Real World Study of First Line Crizotinib for ALK Rearranged Non-squamous Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study aims to explore the efficacy and safety of Crizotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world.

Detailed Description
-----------------
According to the study of P11014 and P1029, Crizotinib is a first-line therapy for advanced non squamous non small cell lung cancer with positive ALK rearrangement.This study aims to explore the efficacy and safety of clozotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world. Among them, ALK positive was based on NGS test results, exploring the new drug resistance mechanism of ALK under clozotinib treatment mode and consistency between plasma and tissue detection driving genes, and finally assessing the role of plasma dynamic detection driving gene mutation spectrum in predicting disease progression risk. A retrospective study of 120 patients with advanced NSCLC using clozotinib ALK positive mutation was conducted to observe the efficacy and safety of clozotinib regimen in the real world.

Official Title
-----------------
A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ALK Rearranged Advanced Non Squamous Non-small Cell Lung Cancer

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

Intervention / Treatment
-----------------
* Drug: Crizotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18，Pathologically proven ALK positive mutation in advanced non squamous non small cell lung cancer ALK rearrangement detection method is NGS and Ventana Primary treatment of first diagnosis The treatment was Crizotinib 250mg po bid Exclusion Criteria Patients received antitumor treatment before Patients with contraindication of chemotherapy Pregnant or breast feeding women

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 |
| --- | --- |
| Cohorts 1<br> | Drug: Crizotinib<br>* Crizotinib 250mg po bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | Approximately 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | Approximately 1 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small Cell Lung Cancer, ALK rearranged, Crizotinib
Clinical Evaluation of PET-CT for Staging of Colorectal Lung Metastases

Study Overview
=================
Brief Summary
-----------------
Surgery has been available for the treatment of pulmonary metastases in metastatic colorectal cancer and promising overall survival was observed in retrospective studies with selected patients. This study investigated whether the preoperative FDG- PET/CT scan influences survival in this patient group. Furthermore, we tried to identify other prognostic factors associated with overall survival and progression-free survival.

Official Title
-----------------
Clinical Evaluation of PET-CT for Staging of Colorectal Lung Metastases - a Prospective Monocentric Feasibility Study

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: PET-CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years with pulmonary metastases eligible for pulmonary metastasectomy Exclusion Criteria: Second primary cancer within the last 2 years (exception basal cell carcinoma of the skin) Pregnancy, Drug addiction, Renal dialysis

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: PET-CT|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and sites of metastases detected by PET-CT |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET-CT, pulmonary metstasectomy