linjc16/ctgov huggingface dataset:
Staccato Loxapine Pulmonary Safety in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pulmonary safety of 2 doses of Staccato Loxapine within a day in patients with COPD.

Detailed Description
-----------------
To address the possibility that inhalation of loxapine may have adverse pulmonary effects, we studied two 10-mg inhaled doses of loxapine or placebo were given 10 hr apart to subjects with chronic obstructive pulmonary disease (COPD). The objective was to determine the time course and reversibility of pulmonary effects for inhaled loxapine compared with placebo.

Official Title
-----------------
Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Inhaled Loxapine
* Drug: Inhaled Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of COPD for at least 6 months with pre-bronchodilator FEV1 ≥40% of predicted value and >15 pack-year history of cigarette smoking. Exclusion Criteria: History of asthma, or any other acute or chronic pulmonary disease.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled Loxapine<br>Staccato Loxapine, 10 mg doses x 2, 10 hours apart | Drug: Inhaled Loxapine<br>* Staccato Loxapine, 10 mg x 2 doses, 10 hours apart<br>|
| Placebo Comparator: Inhaled Placebo<br>Staccato Placebo,inhalations x 2, 10 hours apart | Drug: Inhaled Placebo<br>* Staccato Placebo, inhalations x 2 , 10 hours apart<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1 from baseline by spirometry |  | at each post-treatment time point (15 min to 34 hr) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FVC from baseline by spirometry |  | at each post-treatment time point (15 min to 34 hr) | 
| Treatment emergent adverse events |  | Post-treatment time points | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Staccato Loxapine, COPD, pulmonary safety
Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia (0653-141)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
Gather additional efficacy and safety (pharmacovigilance) information in the usual daily care in patients with Dyslipidemia on ezetimibe under real conditions in Colombia associated with statins.

Official Title
-----------------
Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia

Conditions
-----------------
Lipid Metabolism Disorder

Intervention / Treatment
-----------------
* Drug: ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old Lipid Metabolic Disorder as Per ATP III who have not reached the goals and who are on statins for at least 4 weeks Or those who require LDL reductions Over 50% to reach the ATP III goals or who need statins in accordance their risk score Exclusion Criteria: Pregnancy, Breast Feeding Moderate/Sever Liver Disease: Child Score > Or = To 7 Fibrates Terminal Disease Contraindications To Receive ezetimibe Contraindications To Receive Statins Mental Disability Hypersensitivity To ezetimibe On another Clinical Research Trial

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ezetimibe|Ezetimibe 10 mg daily was added during 4 weeks. The patients continued taking their usual Statin without titrating the dose.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile |  | Over 8 Weeks |
Regular Physical Exercise and Salt Diet on Coronary Artery Disease in Patients With Prehypertension(RESTRAIN Pre-HT)

Study Overview
=================
Brief Summary
-----------------
The epidemic data shows that prehypertension is associated with cardiovascular disease, and heavy dietary salt intake could improve the developing of hypertension. We detected the risk factors of coronary atherosclerosis of prehypertensive patients with different levels of salt intake. The aim of this multicenter prospective, randomized controlled study is to evaluate regular physical exercise and salt diet effects on progression of coronary artery disease in patients with prehypertension.

Official Title
-----------------
Regular Physical Exercise and Salt Diet Effect on Progression of Coronary Disease in Patients With Prehypertension

Conditions
-----------------
Coronary Atherosclerosis, Cardiovascular Disease

Intervention / Treatment
-----------------
* Behavioral: physical exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 45-75 Admission systolic BP between 120 and 139mmHg or diastolic BP between 80 and 89mmHg coronary artery stenosis was 30%-70% - Exclusion Criteria: with a history of myocardial infarction, coronary revascularization, congenital heart disease and cerebrovascular diseases -

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- |
| lifestyle counseling<br>physical exercises | Behavioral: physical exercises<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fatal and nonfatal myocardial infarction, or coronary revascularization |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prehypertension, coronary atherosclerosis, cardiovascular disease
Teriflunomide's Therapeutic Mechanisms of Action in Patients With Relapsing Remitting Multiple Sclerosis.

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to characterize the effect of teriflunomide on the activation of B-cells, as well as its capacity to modify B-cell cytokine secretion. The in-vitro identified effects of teriflunomide on the expression of B-cell activation markers, costimulatory and antigen presenting molecules, as well as on cytokine secretion, will then be confirmed in a cohort of Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with this medication.

Official Title
-----------------
Characterization of Teriflunomide's Therapeutic Mechanisms of Action in Patients With Relapsing Remitting Multiple Sclerosis.

Conditions
-----------------
RELAPSING REMITTING MULTIPLE SCLEROSIS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis of RRMS according to McDonald's diagnostic criteria, age 18-55, an extended disability status score (EDSS) of 1.5-5.5. Exclusion Criteria: - Previous treatment with DMT.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- | --- |
| Percent Inhibition of activated/memory B-cells derived from RRMS patients. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cytokine Secretion Profile of T-cells stimulated by teriflunomide treatment |  | 1 year | 
| Measure the effect of oral teriflunomide on the cytokine secretion as measured in the ex-vivo obtained longitudinal samples from the treated patients. |  | 1 year | 
| Measure the effect of oral teriflunomide on the B cell activation as measured in the ex-vivo obtained longitudinal samples from the treated patients. |  | 1 year |
Haloperidol vs. Risperidone in the Treatment of Aggression in Psychotic Inmates

Study Overview
=================
Brief Summary
-----------------
This study examines the efficacy of haldol versus risperdal in the treatment of aggression in psychotic prison inmates. It is hypothsized that risperdal will be more effective in decreasing aggression than haldol.

Official Title
-----------------
Efficacy of Risperidone Versus Haloperidol in the Treatment of Aggression and Hostility in Psychotic Inmates

Conditions
-----------------
Psychosis, Aggression

Intervention / Treatment
-----------------
* Drug: risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:age 18 or over, psychotic disorder diagnosed on SCID, inmate at correctional facility for at least 2 weeks - Exclusion Criteria: active withdrawal from substances of abuse, non-psychotic individuals, pregnant women, people unable to give informed consent, patients on mood stabilizers -

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
NEFA (Non Esterified Fatty Acid) , Adipose Factors Behind Insulin Sensitivity

Study Overview
=================
Brief Summary
-----------------
We want to asses the role of adipose tissue for metabolic complications to obesity before and after weight loss (surgery).

Official Title
-----------------
The Role of Adipose Tissue in Atherogenic Conditions in Man - Mechanisms and Interventions

Conditions
-----------------
Obesity, Non-obese Controls

Intervention / Treatment
-----------------
* Other: Obese
* Other: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria obese: Bariatric surgery with laparoscopic gastric by-pass Exclusion Criteria obese: diabetes mellitus typ 2 with insulin treatment and/or glitazones oral or parenteral steroid treatment complicated psychiatric disease Warfarin use Inclusion Criteria non-obese controls: BMI under 30 Exclusion Criteria non-obese controls: diabetes oral or parenteral steroids treatment complicated psychiatric disease Warfarins use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Obese<br>Obese patients undergoing gastric by-pass surgery | Other: Obese<br>* gastric bypass<br>|
| Other: Control group<br>Cholecystectomy and anti-reflux surgery | Other: Control group<br>* Cholecystectomy and anti-reflux surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity, adipose tissue function and gene function | Performed with hyperinsulinemic euglycemic clamp before and two years after surgery. Subcutaneous and visceral fat biopsy at the time of surgery. | two years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | DEXA (Dual-Energy X-ray absorptiometry), before and two years after surgery | two years after surgery | 
| Vascular function | Non invasive ultrasound of vascular stiffness, before and two years after surgery | two years after surgery |
KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

Study Overview
=================
Brief Summary
-----------------
Strabismus surgery for children is a very common procedure, with a high incidence of emergence delerium in the recovery room. A combination of intravenous ketamine/dexmedetomidine, or ketodex, has been previously shown to reduce emergence delerium in children undergoing adenotonsillectomy. Here, we study its application in strabismus surgery.

Official Title
-----------------
KETODEX for Emergence Delirium in Children Undergoing Outpatient Strabismus Surgery

Conditions
-----------------
Emergence Delirium, Strabismus

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I/II children undergoing outpatient strabismus surgery Exclusion Criteria: anything not meeting the above

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| control<br>pediatric patients undergoing outpatient strabismus surgery, and not receiving ketodex | |
| study<br>pediatric patients undergoing outpatient strabismus surgery, and receiving ketodex | Drug: Dexmedetomidine<br>* see descriptions<br>* Other names: ketamine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Anesthesia Emergence Delirium scale scores | A low total score would indicate less emergence delirium | up to 6 hours in recovery room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wong-baker or numeric pain scores, depending on age | A low total score would indicate less pain | up to 6 hours in recovery room | 
| discharge time | time the patient is actually discharged from recovery room | up to 24 hours |
Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain

Study Overview
=================
Brief Summary
-----------------
The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).

Official Title
-----------------
A Randomized, Double-blind, Multi-center, Placebo-controlled, 3-treatment Arm, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain

Conditions
-----------------
Grade I/II Ankle Sprain

Intervention / Treatment
-----------------
* Drug: diclofenac diethylamine gel 2.32%
* Drug: diclofenac diethylamine gel 2.32%
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Acute sprain of the lateral ankle, Grade I-II . Exclusion Criteria: Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient. Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diclofenac diethylamine gel 2.32% gel twice a day<br>drug | Drug: diclofenac diethylamine gel 2.32%<br>* diclofenac diethylamine gel 2.32% twice a day<br>|
| Experimental: diclofenac diethylamine gel 2.32% gel three times a day<br>drug | Drug: diclofenac diethylamine gel 2.32%<br>* diclofenac diethylamine gel 2.32% three times a day<br>|
| Placebo Comparator: placebo<br>placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Pain on Movement on Day 5 (Change From Baseline). | Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome. | baseline and day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankle sprain, soft tissue injury
Intraosseous Administration of Mesenchymal Stromal Cells for Patients With Graft Failure After Allo-HSCT

Study Overview
=================
Brief Summary
-----------------
Multipotent mesenchymal stromal cells (MSCs) participate in the formation of bone marrow niches for hematopoietic stem cells. Donor MSCs can serve as a source of recovery for niches in patients with graft failure (GF) after allogeneic bone marrow (BM) transplantation. Since only few MSCs reach the BM after intravenous injection, MSCs were implanted into the iliac spine. Preliminary results suggest that MSCs participate in the restoration of niches for donor hematopoietic cells or have an immunomodulatory effect, preventing repeated rejection of the graft. Perhaps intraosseous implantation of MSCs contributes to the success of the second transplantation of hematopoietic stem cells and patient survival.

Official Title
-----------------
EFFECTIVENESS AND SAFETY OF INTRAOSSEOUS ADMINISTRATION OF MESENCHYMAL STORMAL CELLS FOR PRIMARY GRAFT FAILURE AFTER ALLOGENEIC STEM CELL TRANSPLANTATION

Conditions
-----------------
Mesenchymal Stem Cell Transplantation

Intervention / Treatment
-----------------
* Biological: MSC administration (intraosseal)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with primary graft failure after allo-HSCT Available MSC for this patient Exclusion Criteria: N/A

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: MSC administration (intraosseal)|MSCs will be administered under local anesthesia to the iliac crests after receiving informed consent from the patient.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engraftment | Engraftment | 28-day |
Impact of the Microbiota on the Likelihood of Renal Graft Rejection

Study Overview
=================
Brief Summary
-----------------
Identification of a bacterial signature in the blood or stool that may be associated with acute rejection in patients treated with Nulojix during their first year of transplant.

Detailed Description
-----------------
Gut microbiota as well as the signature of the 16S plasma bacterial DNA and bacterial metabolites of patients on the date of transplantation and during the first year after transplantation will be analyzed. The phenotype of the patients' T lymphocytes will be analyzed at the same time. These data will be correlated with the occurrence of acute cell rejection during the first year of transplantation

Official Title
-----------------
Impact of the Microbiota on the Likelihood of Renal Graft Rejection

Conditions
-----------------
Kidney Transplant Rejection

Intervention / Treatment
-----------------
* Drug: Belatacept Injection [Nulojix]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients called for a kidney transplant Induction therapy with Simulect, maintenance therapy with Nulojix, mycophenolate acid and steroids Patient having signed the informed consent Exclusion Criteria: Multiple grafts combined or sequential Induction therapy with polyclonal antibodies HIV or active viral infection such as hepatitis B or C Active bacterial infection Pregnancy or breastfeeding at time of inclusion Patient unable to express their consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Kidney transplanted patients treated with Nulojix<br>Patients treated with Simulect as induction, and with Nulojix®, mycophenolic acid and steroids as maintenance therapy during the first year of kidney transplant. | Drug: Belatacept Injection [Nulojix]<br>* Drugs administrated are part of the usual care<br>* Other names: Steroid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute rejection occurence | Occurence of cellular rejection according to the BANFF 2017 | 1 year or rejection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut and circulating microbiota | 16S DNA sequencing | 1 year or rejection | 
| Lymphocyte phenotype | CD3+CD4+CD57+PD1-, CD3+CD8+CD28low, CD3+CD8+CD45RA phenotype | 1 year or rejection | 
| Glomerular filtration rate | CDK-EPI creatinine equation | 1 year or rejection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbiota, Belatacept, Second signal inhibitor