linjc16/ctgov huggingface dataset:
Effectiveness of KOS-862 in the Treatment of Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a potential drug known as KOS-862 or Epothilone D has an effect as a 2nd line treatment in non-small cell lung cancer (NSCLC) for patients having failed one prior platinum-containing chemotherapy regimen.

Detailed Description
-----------------
To determine the antitumor activity, based on the confirmed objective response rate, of KOS-862, administered intravenously weekly for 3 weeks every 4 weeks, in patients with non-small cell lung cancer (NSCLC) whose disease has progressed following initial chemotherapy for advanced or metastatic disease.

Official Title
-----------------
A Phase 2 Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: KOS-862


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Measurable disease One previous treatment of a platinum based drug such as cisplatin or carboplatin At least 3 weeks since last surgery/radiation/chemotherapy Exclusion Criteria: Brain metastases Changes in the rhythm of your heart that are considered significant as determined by an ECG tracing

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: KOS-862|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NSCLC |  |  |
Comparison of Two Dosages of Heparin Before Extracorporeal Circulation

Study Overview
=================
Brief Summary
-----------------
In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery.

Detailed Description
-----------------
In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery. The first dosage will be 300 IU per kilogram of REAL weight, the second dosage will be 300 IU per kilogram of IDEAL weight.

Official Title
-----------------
Comparison of Two Dosages of Heparin Before Extracorporeal Circulation

Conditions
-----------------
Extracorporeal Circulation; Complications

Intervention / Treatment
-----------------
* Diagnostic Test: ACT (Activated Clotting Time)
* Drug: Heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted for cardiac open chest surgery Exclusion Criteria: Patient's refusal Antithrombin III factor < 75% Patient under treatment by heparin IV

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One arm will receive 300 IU of heparin based on real weight, and the other arm will receive 300 IU of heparin based on ideal weight.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real Weight<br>Injection of 300 IU of heparin based on REAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection. | Diagnostic Test: ACT (Activated Clotting Time)<br>* Measure of ACT in the two arms in order to determine if injection of heparin based on ideal weight is better or not than those one on real weight.<br>Drug: Heparin<br>* 300 IU of heparin<br>|
| Experimental: Ideal Weight<br>Injection of 300 IU of heparin based on IDEAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection. | Diagnostic Test: ACT (Activated Clotting Time)<br>* Measure of ACT in the two arms in order to determine if injection of heparin based on ideal weight is better or not than those one on real weight.<br>Drug: Heparin<br>* 300 IU of heparin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACT performance | Measure of ACT to be > 400 seconds to allow extracorporeal circulation, but also < 700 seconds to avoid excessive bleeding. | 1 minute |
A Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152

Study Overview
=================
Brief Summary
-----------------
A randomized, open-labeled, oral dose, crossover design clinical trial to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects.

Detailed Description
-----------------
This study is to evaluate pharmacokinetics and safety between DWC20151 and DWC20152 in healthy male subjects. Study design is randomized, open-labeled, oral dose, crossover design. This study will conducted with 2 separated part (Part A, Part B).

Official Title
-----------------
A Randomized, Open-labeled, Oral Dose, Crossover Design Clinical Trial to Evaluate Pharmacokinetics and Safety Between DWC20151 and DWC20152 in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: DWC20151
* Drug: DWC20152


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects (18 55 years) Exclusion Criteria: Who has allergy to investigational product

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br>To study effect of DWC20151 on DWC20152 PK | Drug: DWC20151<br> <br> |
| Experimental: Part B<br>To study effect of DWC20152 on DWC20151 PK | Drug: DWC20152<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) |  | 0 72hr | 
| Area under the plasma concentration versus time curve (AUC) |  | 0 72h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male
Angelman & Rett Syndrome: Interaction and Communication

Study Overview
=================
Brief Summary
-----------------
We aim to describe the communicative and sensory profile of children with Angelman syndrome or Rett syndrome and their use of augmentative and alternative communication. In addition, parents are surveyed regarding parent-child interaction and access to communication support.

Official Title
-----------------
Parent-child Interaction and Communication in Families Who Have a Child With Rett Syndrome or Angelman Syndrome

Conditions
-----------------
Behavior, Child, Parent-Child Relations, Communication

Intervention / Treatment
-----------------
* Behavioral: Observation
* Behavioral: Parental experiences


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Angelman or Rett syndrome Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 14 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 |
| --- | --- |
| Child w Angelman/Rett syndrome<br>Children with Angelman or Rett syndrome, up to 14 years of age | Behavioral: Observation<br>* Describe communication and sensory profile using standardized tests and observations.<br>|
| Parent<br>Parents of Children with Angelman or Rett syndrome | Behavioral: Parental experiences<br>* Survey parents' experiences with parent-child interaction and augmentative and alternative communication.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Communication profile | Scores on language tests | 1 day One-time measurement | 
| Parent interaction | Scores on social tests | 1 day One-time measurement |
Cardiac Magnetic Resonance in Children With Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
This protocol will exploit novel state of the art cardiovascular magnetic resonance techniques to examine important changes in the heart in children with muscular dystrophy. The purpose of this study is to compare cardiac magnetic resonance (CMR) with the collected cardiac outcome data obtained in protocol: PITT1109 - Cardiac Outcome Measures in Children with Muscular Dystrophy.

Official Title
-----------------
PITT0110 - Cardiac Magnetic Resonance: A Parallel Protocol to Cardiac Outcome Measures in Children With Muscular Dystrophy

Conditions
-----------------
Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, Limb Girdle Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant enrolled in the CINRG study: PITT1109 - Cardiac Outcome Measures in Children with Muscular Dystrophy Exclusion Criteria: Pregnant woman (when uncertain, participants will undergo urine testing) or lactating women Decompensated congestive heart failure (unable to lie flat during CMR) Impaired renal excretory function (calculated Glomerular Filtration Rate less than 30mL/min) Contra-indications to Magnetic Resonance Imaging: Cardiac pacemaker or implantable defibrillator Cerebral aneurysm clip Neural stimulator Metallic ocular foreign body Harrington-rod Any implanted device (i.e. insulin pump, drug infusion device) Claustrophobia Metal shrapnel or bullet

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac, muscle, pediatric, dystrophy
A Follow-up Study of Asymptomatic Infections and Diagnosed Patients With Covid-19 in Shanghai

Study Overview
=================
Brief Summary
-----------------
This study is to clarify the distribution characteristics, host and clinical characteristics, disease outcome and risk factors, changes of multiple organs such as cardiopulmonary function and changes in social and psychological indicators during long-term follow-up of omicron variant asymptomatic infections and diagnosed patients

Official Title
-----------------
A Follow-up Study of Asymptomatic Infections and Diagnosed Patients With Covid-19 in Shanghai

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SARS-Cov-2-RNA positive informed consent signed Exclusion Criteria: informed consent rejected
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 infections<br>SARS-Cov-2 RNA postive | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term outcomes，changes of clinical characteristic and social psychology | the 3rd，6th，9th month，average one year discharge from hospital | 10 years |
The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors

Study Overview
=================
Brief Summary
-----------------
Patients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue tumors will receive wide local excision and be prospectively randomized as to either receive or not receive radiation therapy.

Detailed Description
-----------------
This is a randomized study. Patients undergo surgical excision of all gross disease and then are randomized to Arm I or Arm II. Arm I: Radiotherapy. Involved-field irradiation. Arm II: No further treatment.

Official Title
-----------------
The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors

Conditions
-----------------
Sarcoma, Neoplasms

Intervention / Treatment
-----------------
* Procedure: radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Biopsy-proven grade I soft tissue sarcoma or one of the following benign but highly invasive soft tissue tumors: Abdominal and extra-abdominal fibromatosis (desmoid, aggressive fibromatosis), Dermatofibrosarcoma protuberans, Intramuscular lipoma (infiltrating lipoma), Diffuse lipomatosis, Leiomyoma of deep soft tissue, Diffuse giant cell tumor of tendon sheath (proliferative synovitis). No clinical evidence of metastases in regional nodes or more distant sites. No primary intraperitoneal or retroperitoneal tumors. Resection of all gross tumor at the time of surgical excision required (margins may be pathologically positive or negative). No von Recklinghausen's disease. PRIOR/CONCURRENT THERAPY: Biologic Therapy: Not specified. Chemotherapy: No prior chemotherapy for sarcoma. Endocrine Therapy: Not specified. Radiotherapy: No prior radiotherapy for sarcoma. Surgery: No more than 4 months since definitive surgery for primary lesion or recurrence. No prior amputation. PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: Not specified. Hematopoietic: Not specified. Hepatic: No cirrhosis. Renal: No evidence of severe renal impairment. Cardiovascular: No ischemic heart disease. OTHER: No prior malignancy except basal cell carcinoma. No serious infection. No active bleeding disorder. No severe concomitant disease.
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 |
| --- |
|Procedure: radiotherapy|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
-----------------
Adjuvant Radiotherapy, Low-Grade Sarcoma, Radiotherapy, Randomized Study, Sarcoma, Surgery
Hepatocellular Research Registry

Study Overview
=================
Brief Summary
-----------------
This is a registry of human hepatocytes (liver cells) for research purposes.

Detailed Description
-----------------
Patients scheduled for partial hepatectomy/liver surgery are asked permission to use their discarded liver tissue for purposes of studying: how drugs/medicines affect the liver and the effects of storing liver cells in the cold or freezing.

Official Title
-----------------
CellzDirect: Hepatocellular Research Registry

Conditions
-----------------
Hepatocytes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons undergoing partial hepatectomy/liver surgery for any reason. Exclusion Criteria: Persons with known HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) A diagnosis of hepatocellular carcinoma without negative serologies A diagnosis of cholangiocarcinoma, where the total bilirubin has ever been greater or equal to 3.0 The presence of a biliary drainage tube Active sepsis

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 |
| --- | --- | --- |
Study to Test an Approved Product in the Early Treatment of Migraine (0462-065)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine while the pain is still mild.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Examine the Efficacy of Rizatriptan 10 mg Tablet Administered Early During a Migraine Attack While the Pain is Mild

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: MK0462, rizatriptan benzoate / Duration of Treatment: 1day
* Drug: Comparator: placebo / Duration of Treatment: 1 day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6-month history of migraine Migraine attacks typically mild when they begin with 1-4 migraine attacks per month Exclusion Criteria: Heart disease High blood pressure

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0462, rizatriptan benzoate / Duration of Treatment: 1day|nan|
|Drug: Comparator: placebo / Duration of Treatment: 1 day|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who are pain free at 2 hours postdose. |  |  | 
| Tolerability as measured by subjective adverse experience reporting. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with 24 hour sustained pain freedom |  |  | 
| Percentage of patients free at 30/45/60/90 minutes postdose |  |  | 
| Percentage of patients with associated symptoms at 2 hours |  |  | 
| Percentage of patients requiring rescue med between 2 & 24 hours |  |  | 
| Percentage of patients with functional disability at 2 hours |  |  |
Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity

Study Overview
=================
Brief Summary
-----------------
To assess potential benefits associated with both intermittent (use for 3 weeks, remove for 1 week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR use among women either with BV or at high risk for BV. The investigators will also recruit women who are HSV2-infected.

Official Title
-----------------
Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity

Conditions
-----------------
Bacterial Vaginosis

Intervention / Treatment
-----------------
* Drug: NuvaRing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18-40 year old women BV+ by Amsel criteria and Nugent score OR history of BV in the prior 6 months Willing to use the NuvaRing as directed Not intending or wishing to become pregnant over the course of the study Capable of providing written informed consent Exclusion Criteria: Current pregnancy Desire/intent to become pregnant over the course of the study Women who are less than 6 weeks postpartum Contraindications to hormonal contraceptive use per package insert, including history of deep vein thrombosis, smoking in women older than 35 years Current IUD Unable to comprehend consent material because of language barrier or psychological difficulty

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyclic NuvaRing CVR Use<br>CVR use for 3 weeks, remove for 1 week, then replace | Drug: NuvaRing<br> <br> |
| Experimental: Continuous NuvaRing CVR Use<br>CVR use for 4 weeks, then replace | Drug: NuvaRing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of BV-associated bacteria by qPCR and high-throughput sequencing tests |  | Up to 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of vaginal defensins and cytokines |  | Up to 8 months | 
| Rates of incident BV |  | Up to 8 months | 
| Rates of HSV-2 viral shedding among HSV-2-infected women assessed by PCR |  | Up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HSV-2, Contraceptive Vaginal Ring
Factors Affecting the Prognosis of Early Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
To elucidate factors affecting survival of early stage ovarian cancer

Detailed Description
-----------------
To analyze factors affecting survival of early ovarian cancer, such as cell type, cell grade, intraoperative rupture, and laparoscopy vs. laparotomy, etc.

Official Title
-----------------
Factors Affecting the Prognosis of Early Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Procedure: staging surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: early stage ovarian cancer Exclusion Criteria: Nil.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: staging surgery|laparoscopic or laparotomic staging surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors affecting overall survival of early ovarian cancer |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors affecting progression-free survival of early ovarian cancer |  | 10 years |