linjc16/ctgov huggingface dataset:
A Study of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if ALRT1057 gel is safe and effective in treating Kaposi's sarcoma (KS) when applied to skin .

Detailed Description
-----------------
This is a Phase 3 double-blind study. KS patients are randomized to 1 of 2 treatment arms. They receive either ALRT1057 gel or placebo for 12 weeks. If progressive disease for KS is noted before Week 12, patients are switched to the other blinded treatment arm. If a response or disease progression that has not persisted for at least 4 weeks as of Week 12 occurs, treatment on the blinded arm is continued for up to 4 additional weeks, or until response of disease progression is confirmed. After that time or after 12 weeks of treatment, open-label ALRT1057 may be received.

Official Title
-----------------
Randomized Phase III Vehicle Controlled Trial of ALRT 1057 Topical Gel in Patients With AIDS-Related Kaposi's Sarcoma

Conditions
-----------------
Sarcoma, Kaposi, HIV Infections

Intervention / Treatment
-----------------
* Drug: Alitretinoin


Participation Criteria
=================
Eligibility Criteria
-----------------
Information not available

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke patients. They cause disabled condition of patients in activities of daily life and functional performance, and also accidental falls and subsequent fractures. This study is to evaluate and compare the effects of different phase injection of Botulinum Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone, functional performance, gait pattern and energy consumption in stroke patients.

Conditions
-----------------
Stroke, Spasticity

Intervention / Treatment
-----------------
* Procedure: Botox_A
* Procedure: Botox_B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first-ever stroke, with spasticity within 3-months (MAS=2 3) independent walking 10 meters (with assistive devices) Exclusion Criteria: recurrent stroke, cognition impaired lower limb fracture received anti-spasticity injection in the past

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox_A<br>receiving Botulinum Toxin Type-A (Botox-A, Allergan) at both affected lower extremity (aLE) and upper extremity (aUE) | Procedure: Botox_A<br> <br> |
| Placebo Comparator: placebo_A<br>receiving placebo injection at both aLE & aUE ; receiving Botox-A at both aLE & aUE at 6-month. | Procedure: Botox_A<br> <br> |
| Experimental: Botox_B<br>receiving Botox-A injection at aLE and placebo injection (sterile normal saline) at aUE. | Procedure: Botox_B<br> <br> |
| Placebo Comparator: placebo_B<br>receiving placebo injection at both aLE & aUE ; receiving Botox-A only at aLE at 6-month. | Procedure: Botox_B<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the muscle tone in upper and lower extremity | use modified Ashworth Scale to access elbow, wrist, ankle joint muscle tone 0: normal slight hypertonus, at the end-range 1+: mild hypertonus, catch when limb is moved (<1/2) moderate hypertonus,, limbs moves easily (>1/2) passive movement difficult rigid | 4 weeks after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the gait pattern as walking |  | 4 weeks after intervention |
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Drug: Low Strength IDP-108
* Drug: High Strength IDP-108
* Drug: High Strength IDP-108 under occlusion
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of onychomycosis of the target toenail A positive fungal culture from the target toenail Exclusion Criteria: Any disease or condition that might cause nail abnormalities or may interfere with clinical evaluations Presence of tinea pedis (athletes foot) Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Low Strength IDP-108<br>* Topical application once a day for 9 months<br>|
| Experimental: 2<br> | Drug: High Strength IDP-108<br>* Topical application once a day for 9 months<br>|
| Experimental: 3<br> | Drug: High Strength IDP-108 under occlusion<br>* Topical application once a day for 9 months<br>|
| Placebo Comparator: 4<br> | Drug: Vehicle<br>* Topical application once a day for 9 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in area of infected nail |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mycological results |  | 9 months |
LGI1-antibody Patients Follow-up

Study Overview
=================
Brief Summary
-----------------
Autoimmune encephalitis involve autoantibodies targeting central nervous system, and particularly the synapse or its structure like for LGI1 protein. Anti-LGI1 encephalitis is revealed by an inflammation of the limbic system, with mainly temporal lobe, faciobrachial dystonic or generalized seizures, and cognitive disorders. This disease is rare and its clinical, EEG and radiological characterisation is not sufficiently established. The investigators will evaluate these three aspects for the anti-LGI1 cohort of patients of the National Reference Center of autoimmune encephalitis.

Official Title
-----------------
Clinical, EEG and Radiological Initial and Evolutive Characterisation of LGI1-antibody Patients

Conditions
-----------------
Anti-LGI1 Encephalitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Diagnosis of anti-LGI1 encephalitis based on sera or CSF samples in the National Reference Center of autoimmune encephalitis from 2011/06 to 2019 july 1st. Clinical follow-up in France Exclusion Criteria: Anti-LGI1 antibody associated with another encephalitis antibody Foreign follow-up

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 |
| --- | --- |
| : epileptic LGI1-antibody patients<br>Patients affected by LGI1 antibody encephalitis presenting epileptic seizures as a first symptom Evaluated items: Number of seizures Type of seizures Presence of EEG abnormalities Presence of IRM abnormalities Time before cognitive disorders | |
| cognitive LGI1-antibody patients<br>Patients affected by LGI1 antibody encephalitis presenting cognitive disorders as a first symptom Evaluated items: Presence of EEG abnormalities Presence of IRM abnormalities Time before epileptic seizures | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of epileptic seizures |  | 12 MONTHS |
Treatment of Calcium Deficiency in Young Women

Study Overview
=================
Brief Summary
-----------------
This study looks at the effects of calcium supplementation on bone density in women in their third decade of life. We placed women aged 19-27 who take in low amounts of calcium in their diets in one of two groups. We will give women in one group a placebo (inactive pill) and women in the other group 1500 milligrams of calcium per day (as calcium carbonate). We will monitor the results by looking at the change in bone mineral density measured at the hip, total body, forearm, and spine. Treatment will last 3 years.

Detailed Description
-----------------
This is a randomized, controlled trial of calcium carbonate supplementation (1500 milligrams per day) in third-decade women with low calcium-to-protein intakes. We accept women aged 19-27 on the basis of good health and the 7-day food diary demonstrating a dietary calcium-to-protein ratio (in milligrams:grams) that does not exceed 13. The outcome variable is the change in BMD at hip, total body, forearm, and spine. Treatment lasts for 3 years. We expect that bone mass will increase in both groups but will increase to a greater extent in the calcium-supplemented group than in the nonsupplemented group.

Official Title
-----------------
Treatment of Calcium Deficiency in Young Women

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Calcium supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women in good health Dietary calcium-to-protein ratio (in mg:g, as assessed by 7-day food diary) does not exceed 13 Exclusion Criteria: Smoking Pregnancy Lactation Endocrine disease

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 27 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Calcium supplement|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
-----------------
Bone mass, Calcium deficiency, Dietary calcium, Dietary protein, Osteoporosis, Calcium supplement, Bone density, Bone mass accumulation
Microbial Composition of Breast Milk Collected From Healthy Turkish Women

Study Overview
=================
Brief Summary
-----------------
Breast milk is an optimal source of nutrients for newborns as well as a potential source of bacteria for the intestinal microbiota. However, there are limited number of studies evaluating the relationship between maternal nutrition, breast milk and neonatal intestinal microbiota.

Detailed Description
-----------------
The study was conducted on a total of 20 healthy women following at Obstetrics and Gynecology Department of Gülhane Education and Research Hospital in Ankara Health Sciences University. Sociodemographic characteristics, anthropometric measurements, breastfeeding characteristics were evaluated in the third trimester of the women who underwent routine prenatal care. Breast milk samples were obtained at 16.day postpartum during lactation.

Official Title
-----------------
Evaluation of Microbial Composition in Human Milk From Healthy Women in the Turkish Population: an Observational Cross-sectional Study

Conditions
-----------------
Microbial Community in Breast Milk

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy Age 19-35 years At weeks of 30-36 gestation No history of acute or chronic diseases Term delivery Exclusion Criteria: Alcohol use Smoking Gestational diabetes Type 1 and 2 diabetes Preeclampsia Polycystic ovary Syndrome Thyroid and parathyroid disease Metabolic bone or kidney disease Abnormal liver function Multiple pregnancy Premature and postmature labor Having chemotherapy Taking drugs such as antibiotics and probiotics

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 31 Years

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

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 |
| --- | --- | --- |
| Microbial abundance and diversity | The microbial composition of the breast milk samples was determined by 16S rRNA (ribosomal ribonucleic acid) gene sequencing analysis. | at 16 day postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast milk, microbiota
Faslodex Advanced Breast Cancer Local Chinese Study

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.

Official Title
-----------------
A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal advanced breast cancer with oestrogen receptor positive Progression under first-line anti-oestrogen therapy. Exclusion Criteria: Life-threatening metastasis; contraindication to anastrozole >2 regimens of hormonotherapy for advanced breast cancer

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Anastrozole | Drug: Anastrozole<br>* 1 mg tablet<br>* Other names: ZD1033;|
| Experimental: 2<br>Anastrozole + Fulvestrant | Drug: Fulvestrant<br>* 250 mg intramuscular injection<br>* Other names: ZD9238;Drug: Anastrozole<br>* 1 mg tablet<br>* Other names: ZD1033;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Disease Progression (TTP) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  |  | 
| Clinical Benefit Rate (CBR) |  |  | 
| Time to Treatment Failure (TTF) |  |  | 
| Safety & Tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced breast cancer, fulvestrant, anastrozole
Mesalazine (PENTASA®) in Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
This non-interventional study examines whether the patient's level of information and the consideration of the patient's preference have a positive effect on the compliance and thus also on the therapeutic success.

Official Title
-----------------
Mesalazine (PENTASA®) in Ulcerative Colitis: Correlation of the Information Level With Patient's Compliance in Everyday Practice

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: Mesalazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are treated for the first time with oral PENTASA®, e.g. following first diagnosis of ulcerative colitis for treatment of an acute episode or Following a therapy-free period (no previous mesalazine therapy) or due to poor response or underdosage oder lacking acceptance of the previous medication the patients are re-adjusted to oral PENTASA®, The patients (≥ 18 years) have been informed about the NIS and have given their written consent for participation.

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 |
| --- | --- |
| Mesalazine<br> | Other: Mesalazine<br>* Patient's treated with oral Mesalazine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient compliance: Measured by patient response to a questionnaire |  | Month 0 - Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's level of information: Measured by patient response to a questionnaire |  | Month 0 - Month 12 | 
| Patient's preference for the oral pharmaceutical form: Measured by patient response to a questionnaire |  | Month 0 - Month 12 | 
| Reasons for the therapeutic decision of the physician: Measured by physician responses |  | Month 0 | 
| Laboratory parameters of predefined blood measurements | Faecal calprotectin (including test used), faecal lactoferrin. Number of leukocytes, C-reactive protein, blood sedimentation rate. Haemoglobin, serum iron, serum ferritin, transferrin saturation (TSAT) | Month 0- Month 12 | 
| Ulcerative Colitis Disease Activity Index (UCDAI) | UCDAI = Blood in stool, stool frequency, overall evaluation of the physician, endoscopic evaluation (optional) | Month 0 - Month 12 | 
| Adverse drug reactions: measured by number of patients and event severity |  | Month 0 - Month 12 |
Follow-up Study to Assess Visual Function in Subset of Patients Who Have Previously Participated in the TG-MV-006 and TG-MV-007 Ocriplasmin Studies

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess visual function in up to 44 patients who have previously participated in either of the placebo controlled, ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007).

Detailed Description
-----------------
Non-interventional follow up study consisting of 1 patient visit to perform assessments to assess long term visual function

Official Title
-----------------
Follow-up Study to Assess Visual Function in Subset of Patients Who Have Previously Participated in the TG-MV-006 and TG-MV-007 Ocriplasmin Studies.

Conditions
-----------------
Symptomatic Vitreomacular Adhesion

Intervention / Treatment
-----------------
* Drug: ocriplasmin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent obtained from the patient prior to inclusion in the follow-up study Previous participation in either of the placebo controlled, ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007) Exclusion Criteria: N/A

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ocriplasmin<br>Subjects who were exposed to a single intravitreal injection of 125µg of ocriplasmin in a previous phase III study (TG-MV-006 or TG-MV-007) | Drug: ocriplasmin<br>* Subjects were exposed to a single intravitreal injection of 125µg of ocriplasmin in a previous phase III study TG-MV-006 or TG-MV-007<br>|
| Placebo<br>Subjects who were exposed to a single intravitreal injection of placebo in a previous phase III study (TG-MV-006 or TG-MV-007) | Drug: placebo<br>* Subjects were exposed to a single intravitreal injection of placebo in a previous phase III study TG-MV-006 or TG-MV-007<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of clinically significant abnormality in visual function, including Best Corrected Visual Acuity (BCVA), Spectral Domain Optical Coherence Tomography (SD-OCT) abnormality, and/or Electroretinography (ERG) abnormality | Consenting patients will attend one visit, at which an ocular history, visual acuity (ETDRS) and full ophthalmologic assessment, as well as SD-OCT, and ERG assessment will be obtained. All SD-OCTs and ERGs will be centrally read by a masked and independent central reader. | Visit 1 |