linjc16/ctgov huggingface dataset:
TransForm™ Occlusion Balloon Catheter Registry

Study Overview
=================
Brief Summary
-----------------
The primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures

Detailed Description
-----------------
This is a prospective, single-arm, non-randomized, multi-center, observational registry. The expected duration for study enrollment is approximately 6 months-1 year. Study participation for each subject will be completed upon removal of the guide catheter post-procedure. Up to 140 subjects will be enrolled at up to 15 study sites. A given site will be allowed to enroll a maximum of 20 subjects. Enrollment in the registry occurs after a signed Informed Consent Form has been obtained, and the index procedure starts.

Official Title
-----------------
TransForm™ Occlusion Balloon Catheter Registry

Conditions
-----------------
Intracranial Aneurysms

Intervention / Treatment
-----------------
* Device: TransForm™ Occlusion Balloon Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject or legal representative is willing and has provided informed consent. Subject is scheduled to undergo a neurointerventional procedure that may include the use of the occlusion balloon catheter. Subject is over 18 years of age. Exclusion Criteria: Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon Catheter. Subject's pregnant

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TransForm™ Occlusion Balloon Catheter<br>TransForm™ Occlusion Balloon Catheter | Device: TransForm™ Occlusion Balloon Catheter<br>* TransForm™ Occlusion Balloon Catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheters Visualized That Reached Intended Target | The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization. | intra-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic Assessment on Catheter | Visibility of TransForm™ OBC on angiography | intra-procedure | 
| Procedural Technical Success | Ability of TransForm™ OBC to Perform as Intended | post-procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coil embolization, TransForm™ Occlusion Balloon Catheter, Registry, Neurointerventional procedures
Multi-centre Study of HTL0018318 in Patients as an add-on to Standard-of-care

Study Overview
=================
Brief Summary
-----------------
Multi-centre study of HTL0018318 in patients with Alzheimer's disease as an add-on to standard-of-care

Detailed Description
-----------------
This is a multi-centre study conducted in four countries. A total of 60 subjects with Alzheimer's disease who are on standard-of-care will be enrolled to receive one of 3 active HTL0018318 or placebo for a period of four weeks

Official Title
-----------------
A Phase 1b Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study to Determine the Safety and Tolerability of HTL0018318 in Subjects With Alzheimer's Disease Receiving Standard-of-care

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: HTL0018318
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnostic evidence of Alzheimer's disease according to the 2011 National Institutes of Aging-Alzheimer's Association (NIA-AA) criteria Participants with Alzheimer's disease on stable standard of care Exclusion Criteria: Presence of illness apart from Alzheimer's disease that could contribute to cognitive dysfunction A current or history of clinically significant suicidal ideation within the past 6 months Subjects who have been on anti-cholinergic and/or anti muscarinic treatment

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 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: Low dose<br>HTL0018318 | Drug: HTL0018318<br>* HTL0018318<br>|
| Experimental: Medium dose<br>HTL0018318 | Drug: HTL0018318<br>* HTL0018318<br>|
| Experimental: High dose<br>HTL0018318 | Drug: HTL0018318<br>* HTL0018318<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 |
| --- | --- | --- |
| Treatment emergent adverse events (TEAEs), Safety and Tolerability |  | Baseline to Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease
In Vitro Study of Peripheral Blood Mononuclear Cell Function in Healthy Individuals and Patients

Study Overview
=================
Brief Summary
-----------------
Peripheral blood mononuclear cells (PBMC) will be collected from healthy volunteers and patients who present with different diseases that involve or implicate the immune system dysregulation (HIV infection, autoimmune diseases and cancer). These PBMC will be studied in vitro for a number of functional parameters, including generating soluable factors that inhibit HIV infection, developing patterns of immune dysregulation, and inducing apoptotic T cell death. The purpose of such studies is to obtain insight into the mechanisms of natural resistance to viral infections, AIDS pathogenesis, and disease-induced immune dysregulation.

Detailed Description
-----------------
Peripheral blood mononuclear cells (PBMC) will be collected from healthy volunteers and patients who present with different diseases that involve or implicate the immune system dysregulation (HIV infection, autoimmune diseases and cancer). These PBMC will be studied in vitro for a number of functional parameters, including generating soluable factors that inhibit HIV infection, developing patterns of immune dysregulation, and inducing apoptotic T cell death. The purpose of such studies is to obtain insight into the mechanisms of natural resistance to viral infections, AIDS pathogenesis, and disease-induced immune dysregulation.

Official Title
-----------------
In Vitro Study of Peripheral Blood Mononuclear Cell Function in Healthy Individuals and Patients

Conditions
-----------------
Cell Function

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Greater than or equal to 18 years old. Documented HIV infection by current DoD criteria (1 ELISA, 2 Confirmatory Western Blot) or by one of the following tests; DNA PCR, RNA PCR, p24 antigen test, viral culture assay. CD4 lymphocyte cell count greater than 300 mm(3). EXCLUSION CRITERIA: Unable to provide informed consent. Unable to meet the minimum (150 days) and maximum (395 days) research visit interval requirements.

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
-----------------
Cellular Immunity, HIV-infected, Immune Deficiency, Cancer, Transplantation
A Registered Cohort Study of Inflammatory Demyelination Disease

Study Overview
=================
Brief Summary
-----------------
This study will provide further insights into the natural course of Inflammatory demyelination disease including clinical features，progression, related antibody spectrum and drug treatment effect

Official Title
-----------------
A Registered Cohort Study on Natural Course and Drug Efficacy of Inflammatory Demyelination Disease

Conditions
-----------------
Demyelinating Autoimmune Diseases, CNS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient or inpatient Meet the diagnostic criteria of Inflammatory Demyelination Disease. Voluntary participation and informed consent signed by the applicant or his/her family. Exclusion Criteria: Severe complications Poor prognosis (<1 year survival) Severe mental disorder and inability to cooperate with the examination.
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 |
| --- | --- | --- |
| The correlation between clinical phenotypes and Serum antibodies | Different clinical subtypes of Demyelinating Autoimmune Diseases have different course and prognosis.It may be related to different serum antibodies. | from date of enrollment until the date of death from any cause,assessed up to 20 years |
Understanding the Phenomena of Aging and Rupture of Breast Implants

Study Overview
=================
Brief Summary
-----------------
Breast implants, like all implantable medical devices, are subject to wear and tear as they age in the body. In addition to this wear and tear, they are subject to external trauma, whether accidental during daily life, during insertion or during mammography. The kinetics and mechanisms of aging are poorly studied and the phenomenon of implant rupture is not elucidated. However, studies of older generation implants have shown that implant rupture is correlated with the duration of implantation.

Official Title
-----------------
Understanding the Phenomena of Aging and Rupture of Breast Implants

Conditions
-----------------
Aging of Breast Implants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Female adult (≥18 years old) operated on at the HUS for a change of breast prosthesis, aesthetic or reconstruction, between 2022 and 2024 having not expressed, after information, her opposition to participate in this research. Exclusion criteria: Women who have expressed their opposition to participating in the study ruptured prosthesis, associated with a LAGC-AIM, excessive perspiration interfering treatments and associated diseases, history

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mechanical properties of breast implants will be evaluated by uniaxial tensile tests |  | After extraction of breast implants | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Prosthesis Implantation, Aging of breast implants, Rupture of breast implants
Dexamethasone and Etoricoxib for Pain Prevention Following Periodontal Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether preemptive medication with dexamethasone or etoricoxib provides better pain management and control than placebo following periodontal surgery.

Official Title
-----------------
O Uso de Dexametasona e Etoricoxibe Para a prevenção e Controle da Dor pós-operatória após Cirurgia Periodontal

Conditions
-----------------
Pain Control

Intervention / Treatment
-----------------
* Procedure: Open Flap Debridement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting moderate or severe periodontitis after nonsurgical periodontal treatment with clinical signs of inflammation Exclusion Criteria: Pregnant Diabetes mellitus Heart diseases Allergic to components of the medications Risk of endocarditis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo 1 hour before surgery | Procedure: Open Flap Debridement<br>* Open flap debridement - access flap + scaling and root planning<br>|
| Experimental: Etoricoxib<br>Etoricoxib 1 hour before surgery | Procedure: Open Flap Debridement<br>* Open flap debridement - access flap + scaling and root planning<br>|
| Experimental: Dexamethaone<br>Dexamethasone 1 hour before surgery | Procedure: Open Flap Debridement<br>* Open flap debridement - access flap + scaling and root planning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | hourly for the 8 first hours after surgery 3 times a day on the following 3 days | up to 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, pain assessment
Effectiveness of Electro-acupuncture and Manual Therapy on Pain and Fucntion in Patients With Sciatica

Study Overview
=================
Brief Summary
-----------------
The aims of the study are: To study the pain efficacy of an electroacupuncture and manual therapy protocol versus the use of manual therapy in patients with sciatica. To study the efficacy on function of an electroacupuncture and manual therapy protocol versus the use of manual therapy in patients with sciatica.

Official Title
-----------------
Effectiveness of Electro-acupuncture and Manual Therapy on Pain and Fucntion in Patients With Sciatica

Conditions
-----------------
Sciatica, Electroacupuncture, Manual Therapy

Intervention / Treatment
-----------------
* Other: Electroacupuncture
* Other: Manual therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged from 18 to 50 years old. Diagnosis of sciatica Exclusion Criteria: Pregnancy. Fear of needles. Coagulation disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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
Interventional Model Description: Electroacupuncture and manual therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture and manual therapy<br>Electroacupuncture in several points and manual therapy in the lumbar spine | Other: Electroacupuncture<br>* Electroacupuncture in several point<br>Other: Manual therapy<br>* Manual therapy in the lower spine.<br>|
| Active Comparator: Manual therapy<br>Manual therapy in the lumbar spina | Other: Manual therapy<br>* Manual therapy in the lower spine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale for pain | Pain measurement: 100-mm visual analog scale (VAS), horizontal line ranging from 0 mm (nopain) to 100 (worts imaginable pain) | up to 5 weeks | 
| Oswestry Low Back Pain Disability Questionnaire | This questionnaire has been designed to give us information as to how your back or leg pain is affecting your ability to manage in everyday life. | up to 5 weeks |
The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesis that premature infants receiving a commercially available liquid protein modular will have improved growth when compared with premature infants receiving a commercially available powder protein modular.

Official Title
-----------------
The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU

Conditions
-----------------
Problem With Growth of an Infant

Intervention / Treatment
-----------------
* Dietary Supplement: Powder protein modular
* Dietary Supplement: Liquid protein modular


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants less than 2000 gms at birth, receiving maternal breast milk Exclusion Criteria: Infants receiving formula

Ages Eligible for Study
-----------------
Maximum Age: 40 Weeks

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>infants in this arm will receive the current treatment that is standard of care for these infants, powder protein modular to achieve 4 gm/kg/day | Dietary Supplement: Powder protein modular<br>* Infants will receive powder protein modular to achieve 4 grm/kg/day<br>|
| Experimental: experimental<br>this group will receive a liquid protein modular that recently became commercially avaliable, to achieve the same protein of 4 grm/kg/day as the powder comparision group | Dietary Supplement: Liquid protein modular<br>* Infants will receive a commerically avaliable liquid protein modular to provide 4 grm/kg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth in premature infants (percentile ranking at 36 weeks CGA) |  | birth to 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI tolerance | abdominal distention, feeding tolerance | birth to 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
premature infant feeding protein
An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This is a four week open label trial of ALLOPURINOL to the treatment regime of ten (10) poorly responsive patients with schizophrenia, monitoring their response and side-effects. No change in medication is required.

Official Title
-----------------
An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Allopurinal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with schizophrenia and poor response (no prospect of discharge because of symptoms) Exclusion Criteria: Over 65 Renal or liver disease Diabetes Hypertension Taking thiazides or ACE inhibitors

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allopurinal treatment<br>Allopurinal 300mg once daily by mouth for four weeks | Drug: Allopurinal<br>* 300mg once daily by mouth for four weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia | Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst) | baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simpson Angus Scale for Parkinsonism | Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst) | baseline and 4 weeks |
Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This mechanistic study is designed to investigate the effect of vildagliptin on the sensitivity of the a-cell to glucose under hypoglycemic conditions in patients with type 2 diabetes (T2DM).

Official Title
-----------------
A Single-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Effect of Vildagliptin on Glucagon Counterregulatory Response During Hypoglycemia in Patients With Type 2 Diabetes.

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

Intervention / Treatment
-----------------
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with T2DM, diagnosed at least 6 weeks prior to visit 1, who have had no treatment with oral antidiabetic agents for at least 12 weeks prior to study entry (visit 1) and no treatment with oral antidiabetic agents at any time in the past for > 3 consecutive months >/= 18 years Body mass index in the range of 22-35 kg/m2 HbA1c </=7.5% Exclusion Criteria: Type 1 diabetes Acute metabolic diabetic complications Evidence of significant diabetic complications Insulin treatment within the past 6 months Other protocol-defined inclusion/exclusion criteria may apply

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: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucagon counterregulatory response to hypoglycemia of the last 30 min of the 2.5 mM hypoglycemic clamp after 4 weeks treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucagon counterregulatory response to hypoglycemia assessed as glucagon Cmax of the 2.5 mM hypoglycemic clamp step after 4 weeks treatment |  |  | 
| The 'insulin secretion rate relative to glucose' at the hypoglycemic clamp step after 4 weeks treatment |  |  | 
| Change from baseline on hemoglobinA1c (HbA1c)and fasting plasma glucose |  |  | 
| Safety based primarily on frequency of adverse events, number of notable abnormal laboratory values, and frequency and severity of hypoglycemic events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin, glucagon, hypoglycemia