linjc16/ctgov huggingface dataset:
Botox on Vulvar Vestibulitis

Study Overview
=================
Brief Summary
-----------------
The study seeks to evaluate the effect of botulinum toxin on vulvar vestibulitis (VVS) after local injection with Botox, a potential treatment to relieve patients of vulvar pain, reducing the need for painkillers, and improving the sexual quality of life of the patients.

Detailed Description
-----------------
Vulvar vestibulitis (VVS) is characterized by pain confined to the vulvar vestibule that occurs upon touch and attempted introitus entry ( e.g. intercourse, tampon insertion), with minimal associated clinical findings. The aetiology of VVS is not well established and many variables have been associated with the condition, e.g. neuropathy secondary to inflammation. Injection of Botulinum Toxin is tested as a therapeutic option for this condition. A temporary paralytic effect on the surrounding skeletal muscle hypertonicity is seen and earlier in cases described as a successful treatment of pelvic floor dysfunction, dyspareunia and interstitial cystitis.

Conditions
-----------------
Vulvar Vestibulitis, Vulvar Diseases

Intervention / Treatment
-----------------
* Drug: Botulinum toxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vulvar vestibulitis Safe birth control Exclusion Criteria: Treated earlier with Botulinum toxin Ongoing vulvar infection Age<18 Skin disease Pregnancy Myasthenia gravis Amyotrophic lateral sclerosis (ALS) Diabetes Using: Calcium antagonists; Aminoglycosides; Magnesium sulfate; Systemic steroid treatment

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum toxin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce vulvar pain on a visual analogue scale (VAS). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics |  |  |
Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.

Official Title
-----------------
An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency

Conditions
-----------------
Growth Hormone Disorder, Growth Hormone Deficiency in Children

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Growth failure due to growth hormone insufficiency (GHD) Turner syndrome: established diagnosis according to sex chromosome analysis, or Growth retardation in children with chronic renal disorders Exclusion Criteria: Pregnancy Breast feeding women Suspected or know allergy to trial product Participating in any other trial involving other investigational products within the last 3 months Previous participation in the trial Other daily injection therapy (non-growth hormone, e.g insulin-therapy)

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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: somatropin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of acceptance |  | after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Adverse Events (AE) |  |  | 
| Compliance |  |  |
Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne

Study Overview
=================
Brief Summary
-----------------
This is a Phase II, randomized, vehicle-controlled, double-blind, multi center study to evaluate the efficacy and safety of topically applied MBI 226 1.25% and 2.5% Acne Solutions as anti-acne preparations in human subjects with facial acne vulgaris.

Official Title
-----------------
A Phase II, Randomized, Vehicle-Controlled, Double-Blind, Multi-Center Study to Evaluate Safety and Efficacy of MBI 226 1.25% and 2.5% Acne Solutions Applied Topically for 12 Weeks to Subjects With Acne Vulgaris

Conditions
-----------------
Acne, Acne Vulgaris, Propionibacterium Acnes

Intervention / Treatment
-----------------
* Drug: MBI 226 Acne Solutions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 12 years and older Presence of inflammatory and non-inflammatory lesions Exclusion Criteria: Acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.) Active facial cysts or any nodulocystic lesions

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MBI 226 Acne Solutions|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - percent change from Baseline to Week 12 in inflammatory acne lesion counts |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single continuous endpoints: |  |  | 
| • Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts |  |  | 
| • The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts |  |  | 
| Multiple continuous endpoints: |  |  | 
| • Percent change from Baseline to Weeks 3, 6, 9 and 12 in inflammatory acne lesion counts |  |  | 
| • Percent change from Baseline to Weeks 3, 6, 9 and 12 in non-inflammatory acne lesion counts |  |  | 
| • Percent change from Baseline to Weeks 3, 6, 9 and 12 in total acne lesion counts |  |  | 
| Categorical endpoints: |  |  | 
| • Dichotomized Physicians Global Severity Assessment scores at Week 6 and Week 12 |  |  | 
| • PGSA absolute scores at Week 6 and Week 12 |  |  | 
| • PGSA absolute scores over Baseline, Week 6 and Week 12 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acne vulgaris, acne, Propionibacterium acnes, topical, inflammatory, non-inflammatory, lesion counts, lesions
Vitamin C as an Adjunct in Periodontal Treatment in Type 2 Diabetes Mellitus Patients

Study Overview
=================
Brief Summary
-----------------
Periodontitis patients with uncontrolled type 2 diabetes mellitus will receive non-surgical periodontal treatment and then be supplemented with daily 500 mg vitamin C (test group) or placebo (control group) for 2 months. Clinical parameters will be retrieved at baseline, at the end of week 4 and at the end of week 8.

Official Title
-----------------
The Effect of Vitamin C as an Adjunct in Periodontal Treatment in Uncontrolled Type 2 Diabetes Mellitus Patients

Conditions
-----------------
Periodontitis, Diabetes Mellitus Type 2 With Hyperglycemia

Intervention / Treatment
-----------------
* Drug: Vitamin C 500 MG Oral Capsule
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: uncontrolled type 2 diabetes mellitus periodontitis Exclusion Criteria: complications from diabetes mellitus, e.g., renal insufficiency receive insulin diseases that interfere with wound healing, e.g., HIV receive one of the followings: tetracycline, acetaminophen, NSAID, warfarin, aluminum-containing antacids, barbiturates, phenobarbital, pentobarbital, secobarbital, hormone replacement therapy, chemotherapeutic drug, protease inhibitor receive other vitamins or antibiotics within 6 months smoking pregnancy
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: test group<br>vitamin C 500 mg oral capsule | Drug: Vitamin C 500 MG Oral Capsule<br>* non surgical periodontal treatment+vitamin C 500 mg/day for 2 months<br>|
| Placebo Comparator: control group<br>placebo | Other: placebo<br>* non surgical periodontal treatment+placebo for 2 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sulcus bleeding index | bleeding upon probing of gingival sulcus from the most severe periodontitis tooth | baseline, change from baseline sulcus bleeding index at 4 weeks, change from baseline sulcus bleeding index at 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uncontrolled type 2 diabetes mellitus, periodontitis, non surgical periodontal treatment, vitamin C
Biomarker Analysis of Solid Cancers Such as Gastrointestinal Cancer

Study Overview
=================
Brief Summary
-----------------
To prospectively collect ascites, pleural fluid, circulating tumor cells and derived primary cultures from metastatic cancer patients. The specimens will be analyzed using DNA/RNA/proteomic approaches.

Official Title
-----------------
Biomarker Analysis of Solid Cancers Such as Gastrointestinal Cancer

Conditions
-----------------
Sarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed gastrointestinal, genitourinary, sarcoma, rare cancer Written informed consent body fluid derived from cancer, available for drainage and collection Exclusion Criteria: patients who do not give informed consent form for research use of biomaterials/biospecimens
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker analyses to predict treatment response in metastatic cancer | Using patient derived tumor cells, predictive biomarker analyses (DNA, RNA protein levels etc) will be assessed. | 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastrointestinal, Genitourinary, Rare Cancer
Alumina Matrix Composite Ceramic Bearing Total Hip Arthroplasty in Patients Younger Than 30 Years

Study Overview
=================
Brief Summary
-----------------
This study will evaluate clinical outcome on patients who undergo cementless 4th generation ceramic (BIOLOX®delta, CeramTec GmbH, Plochingen, Germany) on ceramic (CoC) bearing total hip aArthroplasty (THA) in patients younger than 30 years.

Conditions
-----------------
Advanced Hip Disease

Intervention / Treatment
-----------------
* Device: THA using 4th generation CoC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: younger than 30 years advanced hip disease Exclusion Criteria: older than 30 years

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 30 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: THA<br> | Device: THA using 4th generation CoC<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate of 4th generation ceramic-on-ceramic THA | survival rate of 4th generation ceramic-on-ceramic THA end point for best senario ; any reoperation end point for moderate senario ; loosening end point for worst senario ; osteolysis | 5 years |
Gonadotrophin Releasing Hormone Agonist Addition for Luteal Support in In-vitro Fertilization and Embryo Transfer Cycles

Study Overview
=================
Brief Summary
-----------------
The study was designed to investigate the effect of luteal-phase administration of gonadotrophin releasing hormone agonist(GnRHa) on pregnancy outcomes in in-vitro fertilization-embryo transfer.

Official Title
-----------------
Gonadotrophin Releasing Hormone Agonist Addition for Luteal Support in In-vitro Fertilization and Embryo Transfer Cycles

Conditions
-----------------
GnRHa;LPS

Intervention / Treatment
-----------------
* Drug: Gonadotrophin releasing hormone agonist(GnRHa)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 37 years; One or more high quality embryos have been got in IVF/ICSI treatment; To transfer at lest 2 fresh embryos; Uterine endometrial thickness ≥ 7mm; Patients have signed informed consents. Exclusion Criteria: ≥3 IVF/ICSI/FET cycles and no pregnancy; Polycystic ovary syndrome(PCOS); uterine malformation; endometriosis patients with a history of recurrent pregnancy loss.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRHa group<br>Intervention: additional GnRHa for routine LPS GnRHa group receive three injections of GnRHa(Decapeptyl) ,0.1 mg s.c. on the day of ET, and D3 and D6 after ET in addition to routine LPS. | Drug: Gonadotrophin releasing hormone agonist(GnRHa)<br>* GnRHa group receive three injections of GnRHa(Decapeptyl) ,0.1 mg s.c. on the day of ET, and D3 and D6 after ET in addition to routine LPS.<br>|
| No Intervention: control group<br>Control group receive only the routine LPS. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | up to 12 months |
Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.

Detailed Description
-----------------
The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. Subsequent to the implantation of the SIELLO leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.

Official Title
-----------------
Master Study of the SIELLO Pacemaker Leads

Conditions
-----------------
Cardiac Pacemaker Syndrome

Intervention / Treatment
-----------------
* Device: Pacemaker therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the indications for pacemaker therapy Understand the nature of the procedure Give informed consent Able to complete all testing required by the clinical protocol Available for follow-up visits on a regular basis at the investigational site Exclusion Criteria: Meet none of the pacemaker indications Meet one or more of the contraindications Have a life expectancy of less than six months Cardiac surgery in the next six months -Enrolled in another cardiac clinical investigation- Have other medical devices that may interact with the implanted pacemaker
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: Siello pacemaker lead<br>Patients with Siello Pacemaker lead | Device: Pacemaker therapy<br>* Implantation of the SIELLO pacemaker leads<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication free rate of all SIELLO leads |  | 3 month follow-up visits | 
| Ventricular threshold of SIELLO T (passive fixation) |  | 3 month follow-up visits | 
| Atrial threshold of SIELLO S (active fixation) |  | 3 month follow-up visits | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leads, pacemaker, efficacy, safety
Using Vibroacoustic Therapy in a Patient With Co-infection and COVID-19

Study Overview
=================
Brief Summary
-----------------
This article describes a case of successful treatment of a 59-year-old man with sepsis as a result of periprosthetic infection against the background of severe SARS-CoV-2-19, who was hospitalized for 59 days, 57 of which were in the intensive care unit. Vibroacoustic pulmonary therapy, the concept of noninvasive ventilation, syndrome therapy, combination antibiotic therapy taking into account the pathogen and antibiotic sensitivity were used in the treatment.

Detailed Description
-----------------
During the pandemic caused by SARS-CoV-2-19, the whole world faced difficulties. Nevertheless, surgeons had to perform surgical treatment for patients who needed immediate help with a confirmed coronavirus infection [1, 2, 3]. Periprosthetic joint infection is a severe and undesirable consequence after arthroplasty [4, 5]. Patients with coronavirus infection and bacterial infection correlate with an unfavorable outcome [6, 7, 8] The effect of vibroacoustic therapy in the treatment of various conditions has not been sufficiently studied [9, 10]. This clinical case describes the complex therapy of a patient with a periprosthetic infection on the background of SARS-CoV-2 using a vibroacoustic pulmonary device.

Official Title
-----------------
Complex Treatment Using Vibroacoustic Therapy in a Patient With Co-infection and COVID-19: Case Report.

Conditions
-----------------
SARS CoV 2 Infection

Intervention / Treatment
-----------------
* Device: vibroacoustic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: P/F less 300 torr COVID-19 Virus Infection Exclusion Criteria: children acute stroke acute coronary syndrome DVT implanted pacemaker rib fracture infection on chest

Ages Eligible for Study
-----------------
Minimum Age: 59 Years
Maximum Age: 59 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: vibroacoustic therapy|Vibroacoustic respiratory therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of time spent on ventilation | Changing of the time spent by patients on mechanical ventilation | 1-2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periprosthetic joint infection, SARS-CoV-2, co-infections, case report., vibroacoustic therapy
Observational Real-world Evaluation of Cost of Infections of Rheumatoid Arthritis (RA) Patients on Biologics

Study Overview
=================
Brief Summary
-----------------
To quantify the incremental cost of infections in patients treated with etanercept, adalimumab or infliximab versus abatacept.

Official Title
-----------------
Observational Real-world Evaluation of Cost of Infections of RA Patients on Biologics

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older; Have a diagnosis of of rheumatoid arthritis (ICD-9:714x.xx); Have been enrolled for at least 6 months for the 6 months assessment and 12 months for the 12 months assessment; are enrolled in a health plan between February 2006 and June 2009 have claims indicating at least one use of either abatacept, etanercept, adalimumab or infliximab for at least 6 months for teh 6 months assessment and 12 months for the 12 months assessment Exclusion Criteria: Patients not continuously eligible for health plan benefits for the same evaluation periods will be excluded Patients who are on other biologics in the 6 and 12 month post-index period will be excluded (ex. those in the abatacept cohort will be excluded if they also have claims for etanercept in the 6 and 12 month post-index period). Patients on biologics 6 months prior to the biologic index date will also be excluded Patients with diagnosis for other non-RA conditions commonly treated with biologics (ex. Crohn's disease) during the 6 month pre-index period.

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 |
| --- | --- |
| Patients with rheumatoid arthritis new to abatacept.<br> | |
| Patients with rheumatoid arthritis new to etanercept<br> | |
| Patients with rheumatoid arthritis new to adalimumab<br> | |
| Patients with rheumatoid arthritis new to infliximab<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental total and component (inpatient, outpatient and pharmacy) direct costs due to infection in patients treated with etanercept, adalimumab or infliximab versus abatacept |  | 6 months | 
| Incremental total and component (inpatient, outpatient and pharmacy) direct costs due to infection in patients treated with etanercept, adalimumab or infliximab versus abatacept. |  | 1 year |