linjc16/ctgov huggingface dataset:
Faslodex 500mg Multiple Dose Tolerability Study in BC Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer

Official Title
-----------------
An Open, Multicentre Phase I Clinical Study to Assess the Tolerability of Fulvestrant 500 mg in Postmenopausal Women With Hormone Receptor Positive Advanced or Recurrent Breast Cancer

Conditions
-----------------
Advanced Breast Cancer

Intervention / Treatment
-----------------
* Drug: Fulvestrant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Postmenopausal woman who fulfils any one of the following criteria: Histological or cytological confirmation of breast cancer Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+). Exclusion Criteria: Having received any one of the following therapy for advanced or recurrent breast cancer 2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc

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

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

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: Fulvestrant|500 mg intramuscular injection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to assess the tolerability of 500mg fulvestrant |  | assessed when all patients have been in the study for 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | each visit | 
| Time to progression |  | assessed when all patients have been in the study for 6 months | 
| ORR |  | assessed when all patients have been in the study for 6 months | 
| Clinical benefit rate |  | assessed when all patients have been in the study for 6 months | 
| Time to response |  | assessed when all patients have been in the study for 6 months | 
| duration of response and changes in serum tumour markers |  | assessed when all patients have been in the study for 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced breast cancer, Faslodex
A Study Comparing Safety Of Abacavir And Lamivudine Administered Once-Daily As A Single Tablet Versus The Same Drugs Administered Twice-Daily As Separate Tablets (ALOHA Study)

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate if subjects who took 600 mg of abacavir and 300 mg of lamivudine once-daily as a single tablet were just as likely to have adverse events compared to subjects who took 300 mg of abacavir and 150 mg of lamivudine administered as separate tablets twice-daily.

Detailed Description
-----------------
A phase IIIB randomized, open-label, multicenter, parallel-arm study to evaluate the short-term safety and tolerability of the abacavir/lamivudine fixed-dose combination tablet administered once-daily or the separate abacavir and lamivudine tablets administered twice-daily, as part of a three or four-drug regimen, in antiretroviral naive HIV-1 infected subjects.

Official Title
-----------------
See Detailed Description

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: Abacavir/Lamivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have HIV-1 infection. Had not received any prior HIV treatment for more than 14 days. At least 1000 copies of HIV-1 RNA. Willing to provide signed informed consent. Exclusion Criteria: Enrolled in other investigational drug studies. Female subjects who are pregnant or breastfeeding. History of allergy or hypersensitivity to abacavir or lamivudine. Certain medical conditions that would make subjects ineligible.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Abacavir/Lamivudine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of treatment-limiting adverse events after starting study drugs. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of abacavir HSR |  |  | 
| completion of educational training |  |  | 
| subject satisfaction with treatment |  |  | 
| adherence to study medications |  |  | 
| change in HIV-1 RNA from BL |  |  | 
| change in CD4 measure from BL. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
1592U89, GR109714, abacavir, lamivudine, fixed-dose combination, once-daily, twice-daily, HIV infection, naive
RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare a 2 immunosuppressant regimen for the treatment of relapsing or refractory necrotizing antineutrophil cytoplasmic antibody (ANCA) associated vasculitides.

Detailed Description
-----------------
The aim of this study is to compare the efficacy of rituximab versus infliximab in relapsing or refractory forms of ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome).

Official Title
-----------------
Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies

Conditions
-----------------
Wegener's Granulomatosis, Churg-Strauss Syndrome, Microscopic Polyangiitis

Intervention / Treatment
-----------------
* Drug: Infliximab
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systemic ANCA positive (+) vasculitides Relapsing or refractory vasculitides, resistant to corticosteroids and reference immunosuppressant therapies Age >18 years old Written informed consent Exclusion Criteria: Newly diagnosed patient Patient that had never received an immunosuppressant before to treat his/her vasculitis Malignancy Pregnancy

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Rituximab | Drug: Rituximab<br>* Rituximab<br>|
| Active Comparator: 2<br>Infliximab | Drug: Infliximab<br>* Infliximab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial or complete remission of the vasculitides |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the safety and adverse effects of both regimens |  | one year | 
| Microscopic polyangiitis |  | one year | 
| Wegener's granulomatosis |  | one year | 
| Churg-Strauss syndrome |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic ANCA+ vascularizes, Relapse, Corticosteroids, Immunosuppressant, Infliximab/rituximab, Patients with relapsing or refractory forms of ANCA, associated vasculitides Microscopic polyangiitis
Genetic Evaluation of AAAS Gene in Early-Onset Achalasia and Alacrima Patients

Study Overview
=================
Brief Summary
-----------------
The AAAS gene has been known to cause achalasia, alacrima, adrenal abnormalities and a progressive neurological syndrome. A considerable proportion of achalasia patients have been known to show alacrima (decreased secretion of tears). However, the genetic mechanism between achalasia and alacrima has not been defined yet. The investigators postulated that some proportions of early-onset achalasia could be correlated with AAAS gene; thus, the investigators aimed to investigate the relationship between the AAAS gene and early-onset achalasia.

Official Title
-----------------
To Find Out the Genetic Relationship Between the Early-Onset Achalasia and AAAS Gene

Conditions
-----------------
Achalasia, Alacrima

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: early age onset primary achalasia patient less than 35 years old Exclusion Criteria: secondary achalasia patients
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 |
| --- | --- | --- |
| Genetic relationship between achalasia and AAAS gene |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relationship between achalasia and AAAS gene
The Effect of Pre Surgery Dog Visits on Post Surgery Consumption of Pain Medication

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to examine the effects of pre surgery dog visits as compared to a costumed character or parents-only on the consumption of pain medication after surgery. It is hypothesized that pre surgery dog visits will reduce post surgical stress and anxiety.

Detailed Description
-----------------
Recent research has revealed that children who are highly anxious prior to surgery experienced more problems post surgery. These problems included reporting of more pain and requested more pain medication during hospitalization and home follow up. Consumption of pain medication may not be the optimal pain management program. In contrast, numerous human-animal interaction studies have shown that animals tend to have a calming effect on people, reduce stress, and lesson anxiety. Therefore, the primary objective of this study is to examine the effect of pre surgery dog visits as compared to a costumed character or parents-only on the consumption of pain medication after surgery.

Official Title
-----------------
The Effect of Pre Surgery Dog Visits on Post Surgery Consumption of Pain Medication

Conditions
-----------------
Post Tonsillectomy Pain

Intervention / Treatment
-----------------
* Behavioral: Therapy dog
* Behavioral: Costumed character
* Behavioral: Parents-only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tonsillectomy and Adenoidectomy (T/A) 4-7 years old Prescribed codeine and/or analgesics for postoperative pain Exclusion Criteria: Participant must not be afraid of dogs, or allergic to animal dander Chronic medical conditions other than T/A Developmentally delayed On psychotropic medications

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 7 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Therapy dog|nan|
|Behavioral: Costumed character|nan|
|Behavioral: Parents-only|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bieri Faces Scale upon arrival, after intervention, and at discharge |  |  | 
| Modified Yale Preoperative Anxiety Scale upon arrival, after intervention, and in surgical preparation room |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
animal-assisted intervention, pre surgery anxiety, post surgery pain medication consumption
Development of the Danish Prospective Sarcoidosis Registry and Baseline Characteristics of a Danish Sarcoidosis Cohort

Study Overview
=================
Brief Summary
-----------------
Development of a Danish Sarcoidosis Registry. Characterization of a cohort of sarcoidosis patients with respect to the baseline epidemiological characteristics, comorbidities, radiology, histopathology, diagnostic investigations and treatment.

Official Title
-----------------
Development of the Danish Prospective Sarcoidosis Registry and Baseline Characteristics of a Danish Sarcoidosis Cohort

Conditions
-----------------
Sarcoidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of sarcoidosis Signed informed consent Exclusion Criteria: Inability or unwillingness to adhere to the study Inability to give informed consent

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

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 |
| --- | --- | --- |
| Characterization of Danish sarcoid patients | Epidemiology and Baseline characteristics of a Danish Sarcoidosis Cohort | 2 years | 
| Feasibility and completion of a Sarcoidosis Registry. | Development of a Danish sarcoidosis registry Data on epidemiology, clinical characteristics, diagnosis and management will be registered | 2 years |
Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry

Study Overview
=================
Brief Summary
-----------------
Anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) is a rare disease seen only in women with a breast implant. Because of the low incidence of this disease and the peculiar histological subtype, French authorities, in accordance with the recommendations of an expert group, recommended the implementation of a BIA-ALCL case registry, in connection with a national Multidisciplinary meeting (Réunion de Concertation Pluridisciplinaire nationale de recours- RCP). This registry is opened in France and in Belgium

Official Title
-----------------
Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry

Conditions
-----------------
Anaplastic Large Cell Lymphoma Associated With Breast Implants (BIA-ALCL)

Intervention / Treatment
-----------------
* Other: BIA-ALCL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with an anaplastic large cell lymphoma associated with breast implants Exclusion Criteria: -

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 |
| --- | --- |
| BIA-ALCL<br> | Other: BIA-ALCL<br>* Observational : no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response |  | 13 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BIA-ALCL
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the safety and efficacy of etanercept in comparison with placebo in a double-blind, parallel, randomized fashion in subjects with idiopathic pulmonary fibrosis (IPF) who failed previous therapy. The treatment period will be up to 1 year. The primary objective is evaluation of safety and efficacy. Secondary: The secondary objective is to evaluate quality of life (QoL) and pharmacokinetics (PK).

Official Title
-----------------
A Double-blind, Parallel, Placebo-controlled, Randomized Study of the Efficacy and Safety of Etanercept in Patients With Idiopathic Pulmonary Fibrosis.

Conditions
-----------------
Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of IPF based on American Thoracic Society (ATS) guidelines Exclusion Criteria: Subjects with end-stage Previous treatment with etanercept or other TNF antagonists (eg, a TNF monoclonal antibody or a soluble TNF-receptor) Receipt of any investigational drug or biological agent within 4 weeks of screening visit

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

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

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
-----------------
Idiopathic Pulmonary Fibrosis, Fibrosis, Pulmonary, Pulmonary Fibroses, Fibroses, Pulmonary
Phase II Study of Growth Hormone in Children With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body weight, and lean body mass in patients with cystic fibrosis. II. Determine the effect of growth hormone on pulmonary function in these patients. III. Determine the impact of this drug on the quality of life in these patients. IV. Determine if the clinical response from this drug is sustained in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive growth hormone subcutaneously (SC) daily for 1 year during the first year only. Arm II: Patients receive growth hormone SC daily for 1 year during the second year only. Quality of life is assessed at baseline and then every 6 months for 2 years.

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: growth hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of prepubertal cystic fibrosis No colonization by Burkholderia cepacia --Prior/Concurrent Therapy-- No prior or concurrent insulin requirement --Patient Characteristics-- Hematopoietic: No hematologic disease Hepatic: No liver disease Renal: No kidney disease Pulmonary: Must be able to perform pulmonary function testing Other: No history of diabetes Must be less than 25% of normal height and/or weight for age and sex

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: growth hormone|nan|

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
-----------------
cardiovascular and respiratory diseases, cystic fibrosis, disease-related problem/condition, genetic diseases and dysmorphic syndromes, quality of life, rare disease
Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia

Study Overview
=================
Brief Summary
-----------------
Bladder and Prostate Sonomorphology in Patients With Symptomatic Benign Prostatic Hyperplasia?

Detailed Description
-----------------
Bladder and Prostate Sonomorphology as a Useful tool for Detecting Bladder Outlet Obstruction in Patients With Symptomatic Benign Prostatic Hyperplasia?

Official Title
-----------------
Bladder and Prostate Sonomorphology as a Useful Tool for Detecting Bladder Outlet Obstruction in Patients With Symptomatic Benign Prostatic Hyperplasia

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Radiation: pelvic Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male patients with LUTS/BPH prostate size > 25 g Exclusion Criteria: urinary retention diabetes mellitus neurologic deficit LUTS medications prior lower urinary tract surgery concomitant bladder pathology small bladder capacity (< 150 ml) urethral stricture evident prostate carcinoma.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ultrasonography<br>pelvic and transrectal ultrasound | Radiation: pelvic Ultrasound<br>* pelvic and transrectal ultrasound<br>* Other names: transrectal ultrasound;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pelvic and transrectal ultrasound | bladder wall thickness, prostate volume, and prostate morphology | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pelvic and transrectal ultrasound in relation to pressure flow study | correlation of the pelvic and transrectal ultrasound parameters to pressure flow study measurements | 18 months |