linjc16/ctgov huggingface dataset:
Rectovaginal Fistula in Post-Radiotherapy Advanced Cervical Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To investigate the associated risk factors of rectovaginal fistula

Detailed Description
-----------------
To investigate the associated risk factors of rectovaginal fistula in cervical caner patients after radiotherapy

Official Title
-----------------
Rectovaginal Fistula in Post-Radiotherapy Advanced Cervical Cancer Patients

Conditions
-----------------
Locally Advanced Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rectovaginal fistula Cervical cancer Exclusion Criteria: Nil

Ages Eligible for Study
-----------------
Minimum Age: 54 Years
Maximum Age: 74 Years

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

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 |
| --- | --- | --- |
| Rate of associated comorbidity or intervention | Rate of associated comorbidity or intervention in patients with rectovaginalfistula | 12 months |
BLADDER CANCER SCREENING AMONG DIABETIC PATIENTS

Study Overview
=================
Brief Summary
-----------------
patients om metformin from diabetic clinic were checked for bladder cancer

Official Title
-----------------
BLADDER CANCER SCREENING AMONG DIABETIC PATIENTS ON METFORMIN THERAPY IN A WEST AFRICA SUB-REGION

Conditions
-----------------
Bladder Cancer, Diabetes

Intervention / Treatment
-----------------
* Other: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 150 people attending diabetic clinic Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 86 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: metformin<br>metformin 500mg | Other: metformin<br> <br> * Other names: glucophage;|
| No Intervention: not on metformin<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of diabetic patients on metformin therapy |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pathology
Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling

Study Overview
=================
Brief Summary
-----------------
Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.

Detailed Description
-----------------
Bacterial infections can be distinguished by analysis of the volatile organic compounds found in breath. In patients with suspected Influenza infection, nasal air samples will be taken and analyzed by Multicapillary Ion mobility spectrometry (MCC IMS). Routinely all patients undergo polymerase chain reaction (PCR) analysis of nasopharyngeal swabs for Influenza. MCC IMS spectra will be compared between infected and non infected patients by cluster analysis and discrimination analysis. If the number of infected patients exceeds 50 an additional validation cohort will be investigated sequentially otherwise validation will be performed during the Influenza epidemic 2021. Due to decreasing numbers of Influenza-A- Infections study was opened to also include patients with suspected SARS-CoV-2 infections.

Official Title
-----------------
Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Diagnostic Test: MCC IMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected Influenza infection Exclusion Criteria: later than 48h after admission and detection of Influenza infection later than 32 days after admission and detection of SARS-CoV-2- infection no written 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infected<br>patients with detected Influenza RNA in nasopharyngeal swabs | Diagnostic Test: MCC IMS<br>* Diagnosis by MCC IMS<br>|
| not infected<br>patients without detected Influenza RNA in nasopharyngeal swabs | Diagnostic Test: MCC IMS<br>* Diagnosis by MCC IMS<br>|
| SARS CoV2<br>patients with SARS-Cov-2 infection | Diagnostic Test: MCC IMS<br>* Diagnosis by MCC IMS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cluster Analysis of MCC IMS spectra. | Cluster Analysis of MCC IMS spectra will be obtained immediately after sampling | immediatly after sampling |
Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

Study Overview
=================
Brief Summary
-----------------
Phase I study of SPARC1023 alone and in combination with carboplatin

Detailed Description
-----------------
Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.

Conditions
-----------------
Solid Tumor in Advanced Stage

Intervention / Treatment
-----------------
* Drug: SPARC1023 I
* Drug: SPARC1023 II


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years ECOG Performance Status ≤ 1. Estimated life expectancy of at least 12-weeks; Measurable disease as per RECIST guideline (Version 1.1); Exclusion Criteria: Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer Known hypersensitivity to the study drugs Treatment with any anti-cancer agents within 28 days of study entry Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARC1023 I<br> | Drug: SPARC1023 I<br>* IV administration<br>|
| Experimental: SPARC1023 II<br> | Drug: SPARC1023 II<br>* IV administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of MTD | MTD for SPARC1023 in combination with carboplatin will be determined. MTD will be defined as the SPARC1023 dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects. | One 21-day treatment cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishing the pharmacokinetic profile | Plasma levels of SPARC1023 and Carboplatin will be determined and PK parameters viz. Cmax, AUC0-t, AUC 0-∞, MRT, Tmax, t½ , Kel, Vd for SPARC1023 in combination with carboplatin will be evaluated. | One 21-day treatment cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
solid, tumor, taxane, platinum
Long-Term Follow-up Protocol

Study Overview
=================
Brief Summary
-----------------
The main objective of this prospective, observational, long-term follow-up (LTFU) study is to evaluate the long-term safety profile of the gene therapy products evaluated by Krystal Biotech, Inc. which have a shared backbone of HSV-1, in participants who received at least one dose of investigational product (IP).

Detailed Description
-----------------
Due to the guidelines for gene therapy for vectors which may undergo latency/ reactivation, Krystal Biotech, Inc. has established a Long-Term Follow-up Protocol which will identify and mitigate the long-term risks to the participants receiving their gene therapy products and capture delayed adverse events in participants, annually, for 5-years following the last study visit. Additionally, it will allow the Sponsor to further understand the persistence of the gene therapy products used in their parent treatment protocols.

Official Title
-----------------
A Prospective, Observational, Long-Term Follow-Up (LTFU) Study to Evaluate the Long-Term Safety of the Krystal Biotech, Inc. Gene Therapy Backbone Products Using HSV-1 Backbone

Conditions
-----------------
Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult and pediatric participants who received at least one gene therapy treatment in a previous Krystal Biotech, Inc. sponsored study, and have discontinued or completed the parent treatment protocol (which do not have the LTFU embedded into the parent protocol), as applicable. Consent/Assent must be obtained by the participants (and, parental/legal representative, when applicable) prior to any study-related data being collected. Participant is willing and able to adhere to the protocol requirements. Exclusion Criteria: Participants who enroll into a non-Krystal Biotech, Inc. interventional gene therapy clinical trial will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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 |
| --- | --- | --- |
| Serious Adverse Events (AE) | Incidence of delayed Adverse Events suspected to be related to a Krystal Biotech HSV-1 vector backbone investigational product. A Serious Adverse Event (SAE) is any untoward medical occurrence (whether considered to be related to gene therapy or not) that: Is fatal Is life-threatening (places the participant at immediate risk of death) Requires inpatient hospitalization or prolongation of existing hospitalization Is a persistent or significant disability/incapacity, or Is a congenital abnormality/birth defect | 5 years |
Strain-Encoded Magnetic Resonance Imaging in Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The aim of the study was therefore to evaluate whether myocardial deformation imaging performed by SENC allows for quantification of regional left ventricular function and is related to transmurality states of infarcted tissue in patients with acute myocardial infarction (AMI).

Detailed Description
-----------------
CMR was performed in 38 consecutive patients with AMI 3±1 days after successful reperfusion using a clinical 1.5 Tesla MR-scanner. Ten healthy volunteers served as controls. SENC is a technique that directly measures peak circumferential strain from long-axis views and peak longitudinal strain from short axis views. Measurements were obtained for each segment in a modified 17 segment model. Wall motion and infarcted tissue were evaluated semi-quantitatively from SSFP cine sequences and contrast-enhanced-MR-images and were then related to myocardial strain. Comparison of peak circumferential strain assessed by SENC and MR-tagging was performed.

Official Title
-----------------
Strain-Encoded Magnetic Resonance Imaging for Evaluation of Left Ventricular Function and Acute Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: cardiac MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with AMI after successful reperfusion Healthy volunteers in control group Exclusion Criteria: No reperfusion

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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 |
| --- | --- |
| 1<br>Patients presenting to hospital with AMI | Procedure: cardiac MRI<br>* cardiac MRI at one time point for group 1 after intervention for group 2 at any time point<br>* Other names: cardiac resonance magnetic imaging;|
| 2<br>healthy volunteers as control group | Procedure: cardiac MRI<br>* cardiac MRI at one time point for group 1 after intervention for group 2 at any time point<br>* Other names: cardiac resonance magnetic imaging;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular function |  | 01.01.2007 until 01.02.2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transmurality |  | 01.01.2007 until 01.02.2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMI,, Reperfusion, successful
Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the effect of a primary care intervention on reducing suicidal ideation and depression in older patients.

Detailed Description
-----------------
Suicide rates are highest in late life; the majority of older adults who die by suicide have seen a primary care physician in preceding months. Depression is the strongest risk factor for late-life suicide and for suicide's precursor, suicidal ideation. The aim of the study was to determine the extent to which an intervention taht combined treatment guidelines with care management reduced rates of depression and suicide ideation in older primary care patients. The study randomized 20 primary care practices from New York City, Philadelphia, and Pittsburgh regions into intervention or usual car. The used a two-stage sampling design that resulted in a representative sample with an oversample of depressed patients (total n=1238 subjects including 598 with a depression diagnosis and 640 with no depression diagnosis). Patients were assessed at baseline, 4, 8, 12, 18 and 24 months.

Official Title
-----------------
Prevention of Suicide in Primary Care Elderly: Collaborative Trial

Conditions
-----------------
Depression, Suicide, Attempted

Intervention / Treatment
-----------------
* Behavioral: treatment guidelines and depression care management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: upcoming appointment with primary care clinician Exclusion Criteria: inability to give consent minimental status examination <18 ability to communicate in English

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: treatment guidelines and depression care management|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale |  |  | 
| Scale for Suicide Ideation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause and cause-specific mortality |  |  | 
| disability (Sf12; instrumental activities of daily living) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, suicide, geriatric, elderly, primary care
A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the impact of topical corticosteroids on the safety and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment to placebo in the long-term management of Atopic Dermatitis

Detailed Description
-----------------
Study includes an interim short-term, open label period. Patients could also receive a second course of open label treatment dependent on disease exacerbation.

Official Title
-----------------
A Multi-Center Study to Assess the Impact of Topical Corticosteroids on the Safety and Efficacy of Protopic Ointment in the Short-Term Treatment of Atopic Dermatitis and to Assess Protopic in the Long-term Management of Atopic Dermatitis

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Drug: Protopic
* Drug: Corticosteroid
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must have Atopic Dermatitis Patient must be at least 2 years of age Exclusion Criteria: Patient is pregnant or breast feeding an infant

Ages Eligible for Study
-----------------
Minimum Age: 2 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1A<br> | Drug: Protopic<br>* topical<br>* Other names: FK506 ointment;|
| Active Comparator: 1B<br> | Drug: Corticosteroid<br>* topical<br>|
| Experimental: 2<br>Open label | Drug: Protopic<br>* topical<br>* Other names: FK506 ointment;|
| Experimental: 3A<br> | Drug: Protopic<br>* topical<br>* Other names: FK506 ointment;|
| Placebo Comparator: 3B<br> | Drug: placebo<br>* topical<br>|
| Experimental: 4<br>Open label | Drug: Protopic<br>* topical<br>* Other names: FK506 ointment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reporting cutaneous adverse events overall |  | Day 4 through end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Effectiveness, Treatment Efficacy, Immunomodulator, Topical, Tacrolimus, Topical, Dermatitis, Atopic, Eczema, Atopic, Atopic Dermatitis
Adipocytokines and Polycystic Ovary Syndrome (PCOS)

Study Overview
=================
Brief Summary
-----------------
Inflammation may play a role in the development of polycystic ovary syndrome (PCOS). In this study, the investigators investigated the expression of different mediators of inflammation in fatty tissue and in blood in women with and without PCOS.

Official Title
-----------------
Adipose Expression of Leptin, Adiponectin and IL-6, and Plasma Levels of Adipocytokines in Lean and Obese Women With PCOS

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with PCOS were included according to the Rotterdam diagnostic criteria for PCOS. Control women met none of the criteria for PCOS Exclusion Criteria: Oc´s within the last three months, or other medication known to alter glucose/insulin metabolism Other known chronic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women with polycystic ovary syndrome<br> | |
| women without polycystic ovary syndrome<br> | |
| women from 18-40 years of age<br> | |

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
-----------------
The independent effect of PCOS and obesity on adipose expression and plasma levels of adipocytokines
Efficacy and Safety of Bongros-BMP Compared to Bio-oss for Regeneration of Alveolar Bone Tissue After Maxillary Sinus Floor Augmentation

Study Overview
=================
Brief Summary
-----------------
The purpose of this Clinical study was to evaluate the Efficacy and Safety of bongros-BMP compared to Bio-oss for Regeneration of alveolar bone tissue after Maxillary sinus floor augmentation.

Conditions
-----------------
Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation

Intervention / Treatment
-----------------
* Drug: Novosis(bongros/BMP-2)
* Drug: Bio-oss


Participation Criteria
=================

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Novosis(bongros/BMP-2)<br> | Drug: Novosis(bongros/BMP-2)<br> <br> |
| Active Comparator: Bio-oss<br> | Drug: Bio-oss<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |