linjc16/ctgov huggingface dataset:
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines

Study Overview
=================
Brief Summary
-----------------
An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines

Official Title
-----------------
A Multicenter, Randomized, Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines

Conditions
-----------------
Glabellar Frown Lines

Intervention / Treatment
-----------------
* Biological: AbobotulinumtoxinA dose level 1 or 2
* Other: placebo
* Biological: AbobotulinumtoxinA dose 3
* Biological: AbobotulinumtoxinA dose 4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe glabellar lines at maximum frown as assessed by the Investigator using a photographic scale Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale Exclusion Criteria: Botulinum toxin treatment in the face within 9 months prior to study treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Intramuscular single treatment | Other: placebo<br>* Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines<br>|
| Experimental: AbobotulinumtoxinA dose level 1 or 2<br>Intramuscular single treatment | Biological: AbobotulinumtoxinA dose level 1 or 2<br>* Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines<br>|
| Experimental: AbobotulinumtoxinA dose level 3<br>Intramuscular single treatment | Biological: AbobotulinumtoxinA dose 3<br>* Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines<br>|
| Experimental: AbobotulinumtoxinA dose level 4<br>Intramuscular single treatment | Biological: AbobotulinumtoxinA dose 4<br>* Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Composite Responders at Month 1 | composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grade improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA) | Month 1 after treatment |
Chiropractic Manual Therapy in Infantile Colic

Study Overview
=================
Brief Summary
-----------------
Efficacy of chiropractic manual therapy in infants with excessive crying behaviour. Influence of parental bias in reporting crying behaviour.

Conditions
-----------------
Infantile Colic

Intervention / Treatment
-----------------
* Procedure: Manual therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Excessive crying, infant less than 8weeks of age, born at gestational age 37 weeks or later, otherwise healthy Exclusion Criteria: Not accepted for chiropractic care

Ages Eligible for Study
-----------------
Maximum Age: 8 Weeks

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chiropractic manual therapy<br> | Procedure: Manual therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily crying diary |  |  |
Autoantibody Specificity and Response to IVIG in ITP

Study Overview
=================
Brief Summary
-----------------
The objective of this human study was to evaluate the association between the specificity of anti-platelet autoantibodies and response to IVIG treatment.

Detailed Description
-----------------
Immune thrombocytopenia (ITP) is a common autoimmune bleeding disorder, in which platelet surface GPIIb/IIIa and GPIb/IX are the two most frequently targeted autoantigens. Our previous studies in animal models of ITP demonstrated that intravenous immunoglobulin G (IVIG) could protect against anti-GPIIb/IIIa-mediated thrombocytopenia but failed to ameliorate ITP induced by most anti-GPIb/IX antibodies. The objective of this human study was to evaluate the association between the specificity of anti-platelet autoantibodies and response to IVIG treatment.

Official Title
-----------------
Autoantibody Specificity and Response to Intravenous Immunoglobulin G (IVIG) in Immune Thrombocytopenia (ITP): a Retrospective Cohort Study

Conditions
-----------------
Immune Thrombocytopenia (ITP)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) the diagnosis of ITP was based on the presence of isolated thrombocytopenia and the absence of any obvious initiating and/or underlying cause of the thrombocytopenia in accordance with the recently released international consensus guidelines,(2) a diagnosis was established during the 4 weeks prior to initiation of IVIG treatment, (3) age ≥ 18 years, (4) a platelet count of ≤ 20 × 109/L, and (5) a bleeding score ≥ 9 at the time of admission according to the clinical scoring system described by Khellaf et al. to assess the severity of hemorrhage. Exclusion Criteria: a history of any ITP-specific treatment administered prior to or concomitantly with the IVIG

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| IVIG therapy in ITP<br>IVIG therapy in untreated adults with severe ITP | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initial response | The criteria for an initial response was a platelet count ≥ 30 × 109/L and doubling of the baseline count within 7 days of dosing (confirmed on at least 2 separate occasions at least 7 days apart), and absence of bleeding. | within 7 days of dosing |
Montalcino Aortic Consortium: Precision Medicine for Heritable Thoracic Aortic Disease

Study Overview
=================
Brief Summary
-----------------
The Montalcino Aortic Consortium (MAC) will provide the infrastructure to assemble large cohorts of patients with mutations in known heritable thoracic aortic disease (H-TAD) genes, define the phenotype associated with these genes, and determine genetic and environmental modifiers of H-TAD.

Detailed Description
-----------------
The MAC will provide the infrastructure to assemble large cohorts of patients with mutations in known H-TAD genes, define the phenotype associated with these genes, and determine genetic and environmental modifiers and other biomarkers of H-TAD. Recruitment of large numbers of patients world-wide will improve the precision of data used to predict disease risks. Retrospective and prospective study designs will be used to fully characterize the different stages of H-TAD (i.e. susceptibility, presymptomatic, and symptomatic) and other complications associated with the H-TAD genes, and examine clinical and environmental factors that define risk of aortic dissections. The data from MAC will provide the critical clinical information for precise management of thoracic aortic disease and other complications caused by mutations of these genes and improve the medical management and outcome of patients with genetically triggered, lethal vascular diseases.

Official Title
-----------------
Montalcino Aortic Consortium: Precision Medicine for Heritable Thoracic Aortic Disease

Conditions
-----------------
Aortic Aneurysm, Aortic Dissection, Aortic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients and their relatives with a confirmed pathogenic, likely pathogenic variant, or variant of unknown clinical significance in at least one of the H-TAD genes (i.e. TGFBR1, TGFBR2, SMAD3, TGFB2, TGFB3, ACTA2, MYH11, MYLK, PRKG1, MAT2A, MFAP5, LOX, COL3A1, FOXE3, and FBN1). Patients of all ages, sex and race for which informed consent can be obtained. Exclusion Criteria: Patients without a confirmed causative variant for H-TAD.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with causal mutations in the known H-TAD genes<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with aortic dissection | Aortic Dissection | 20 years | 
| Number of participants with aortic aneurysm requiring repair | Aortic repair | 20 years | 
| Number of participants who died due to an aortic dissection/rupture or postoperative complications | Mortality due to aortic disease | 20 years | 
| Number of participants with aortic dilation | Aortic dilation | 20 years | 
| Rate of aortic growth | Aortic diameter | 20 years |
Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity.

Study Overview
=================
Brief Summary
-----------------
Oxidative stress has been reported to play a role in melasma pathophysiology. The objective of the study is to compare oral superoxide dismutase (GLISODin) to placebo, in combination to sunscreen to decrease melasma severity.

Official Title
-----------------
Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity. A Prospective Randomized Placebo-controlled Study

Conditions
-----------------
Melasma

Intervention / Treatment
-----------------
* Drug: Glisodin
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically diagnosed melasma in adult patient signed inform consent Exclusion Criteria: Pregnant women Other pigmentary disorder of the afce Use of depigmentant agent in the month before the inclusion Use of topical steroid, tretinoin, hydroquinone in the month before the inclusion Coeliac disease or allergy to gluten

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug<br>Glisodin : 2 capsules of GliSODin, 500mg of GliSODIn per day. Preferably to take in the morning during breakfast | Drug: Glisodin<br>* 500 mg/day between 12 weeks<br>|
| Placebo Comparator: No Drug<br>2 capsules of PLacebo, 500mg of Placebo per day. Preferably to take in the morning during breakfastbo | Other: placebo<br>* Placebo group (20 patients) will receive 2 pills of placebo per day + sunscreen for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of melasma | Change from Baseline of the Modified Melasma Area and Severity Index (mMASI) total score at 12 months. The MASI is 0 à 24 : Front 0.3(D)(A)+ right malar 0.30(D)(A)+ left malar 0.30(D)(A)+ chin 0.1(D)(A) | At baseline and at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of patient: VAS (Visual Analog Scale) | Change from Baseline of quality of life at 12 months (Visual Analog Scale with a graduation from 0 to 10) | At baseline and at 12 weeks | 
| Satisfaction of the patients: VAS (Visual Analog Scale) | Change from Baseline of satisfaction of the patients total score at 12 months (Visual Analog Scale with a graduation from 0 to 10) | At baseline and at 12 weeks |
Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism

Study Overview
=================
Brief Summary
-----------------
The project is aimed to determine the value of synacthen infusion on the results of adrenal venous sampling in patients examined for primary aldosteronism

Detailed Description
-----------------
We aim to compare the results of adrenal venous sampling performed without and during synacthen infusion.

Official Title
-----------------
Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism

Conditions
-----------------
Primary Aldosteronism

Intervention / Treatment
-----------------
* Drug: Synacthen infusion during adrenal venous sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed primary aldosteronism Exclusion Criteria: Inability to undergo unilateral adrenalectomy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synacthen<br>Synacthen infusion during adrenal venous sampling | Drug: Synacthen infusion during adrenal venous sampling<br>* Adrenal venous sampling during Synacthen infusion<br>|
| No Intervention: Without Synacthen<br>Adrenal venous sampling without Synacthen | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To verify whether Synacthen infusion may influence the results of adrenal venous sampling in patients with primary aldosteronism |  | End of clinical examination procedure, i.e. within 4 week after adrenal venous sampling is performed. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adrenal adenoma, arterial hypertension, primary aldosteronism
Compare Bleeding Risk Between Cold and Hot Snaring Polypectomy for Small Colorectal Polyp: a Randomized Control Trial

Study Overview
=================
Brief Summary
-----------------
In this randomized control trial the investigators aim to compare the bleeding complication between cold snaring and hot snaring polypectomy with a large sample size.

Detailed Description
-----------------
The investigators will enroll subjects who receive screening or surveillance colonoscopy with small colorectal polyp, 4 to10 mm in size, from multiple centers in Taiwan. Subjects who are less than 40 years old and has contraindication will be excluded from this study. All the candidates for enrollment will sign the inform consent at the outpatient clinic. Once the candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy will be randomized into either cold snaring or hot snaring polypectomy group. In the group with cold snaring, polypectomy will be done without electrocautery. In the hot snaring group, the polypectomy will be performed with electrocautery. The bowel preparation and colonoscopy insertion are the same in both groups as conventional colonoscopy method. The colonoscopy will be performed by experienced endoscopies who performed more than 100 polypectomies per year.

Official Title
-----------------
Comparison of the Bleeding Risk Between Cold and Hot Snaring Polypectomy for Small Colorectal Polyp: a Randomized Control Trial

Conditions
-----------------
Colorectal Polyp

Intervention / Treatment
-----------------
* Device: Polypectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidate has the target lesion, polyp sized 4 to 10 mm, at colonoscopy Exclusion Criteria: Subjects who are less than 40 years old and has contraindication will be excluded from this study

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold snaring<br>Polypectomy will be done without electrocautery | Device: Polypectomy<br>* Polypectomy during colonoscopy is considered effective to reduce the incidence and mortality of colorectal cancer<br>|
| Active Comparator: Hot snaring<br>Polypectomy will be performed with electrocautery | Device: Polypectomy<br>* Polypectomy during colonoscopy is considered effective to reduce the incidence and mortality of colorectal cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed bleeding rate | Anal bleeding with spontaneously stop; drop of Hb more than 2 gm/dl in comparison with baseline; transfusion needed; hemostasis by : colonoscopy, angiography, surgery | 2 weeks |
Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)

Study Overview
=================
Brief Summary
-----------------
The objective of this post-marketing surveillance study is to evaluate the incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan basd on prescribing information under the conditions of general clinical practice and also to grasp the following items; Unknown adverse drug reactions (ADRs) Incidence of ADRs to medical products in actual clinical practice Factors influencing safety of ambrisentan Factors influencing efficacy of ambrisentan Prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use (VOLIBRIS® is a trademark of Gilead Sciences, Inc,. that GSK uses under license.)

Official Title
-----------------
Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Drug: Ambrisentan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must use ambrisentan for the first time Exclusion Criteria: Subjects with hypersensitivity to ambrisentan Subjects who is pregnant or might be pregnant Subjects with severe hepatic disorder
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed ambrisentan<br>Subjects with pulmonary arterial hypertension (PAH) prescribed ambrisentan during study period | Drug: Ambrisentan<br>* Ambrisentan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan |  | 1 year | 
| The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage |  | 1 year | 
| The number of adverse events and clinical course in subjects with hepatic dysfunction |  | 1 year |
Acute Pain Trajectories and Persistent Pain After Breast Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
Persistent pain after breast cancer surgery (PPBCS) is a significant clinical problem, affecting between 25 and 50% of patients. Several factors are associated with the development of PPBCS, including acute postoperative pain. The analysis of pain trajectories through mixed model modeling is an alternative to static pain measures, improving precision and providing information on the time course of pain resolution. Our aim was to investigate if the characteristics of pain trajectories during the first postoperative week are correlated with the persistence of pain 3 months after breast cancer surgery.

Official Title
-----------------
Acute Pain Trajectories as a Predictive Factor for Persistent Pain After Breast Cancer Surgery

Conditions
-----------------
Breast Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for breast cancer surgery General anesthesia Exclusion Criteria: Previous breast surgery Reconstructive surgery scheduled during follow-up Day-surgery patients Inability to understand the questionnaires

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population<br>The study population consists of adult surgery patients, scheduled for breast cancer surgery at St-Luc University Hospital. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of pain 3 months after surgery, assessed with the Brief Pain Inventory questionnaire. Yes/No |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute pain trajectories (7 days) after surgery | The pain trajectory is the vector of 7 verbal numerical pain scores (from 0 to 10) recorded in a pain diary over the first 7 postoperative days | One postoperative week |