linjc16/ctgov huggingface dataset:
Comparison of Two Vaginal Mesh Kits in the Management of Vaginal Prolapse

Study Overview
=================
Brief Summary
-----------------
Our study is a non-randomized prospective study compared two groups matched for anterior/apical POP-Q grade: 84 received Elevate Ant™ single-incision mesh (group A) and 42 Perigee™ transvaginal mesh (group B). The study hypothesis was that the Elevate Ant™ mesh would provide better apical correction than the Perigee™ mesh. One- and 2-year follow-up comprised anatomic assessment (POP-Q) and QoL (PFDI-20, PFIQ-7, PISQ-12). Success was defined as 2-year POP-Q ≤1. Secondary endpoints were function and complications.

Official Title
-----------------
A Prospective Comparison of Two Vaginal Mesh Kits in the Management of Anterior and Apical Vaginal Prolapse: Long Term-results for Apical Fixation and Quality of Life

Conditions
-----------------
Vaginal Prolapse

Intervention / Treatment
-----------------
* Device: Elevate Ant™
* Device: Perigee™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic patient presenting with POP-Q grade ≥3 anterior or apical prolapse

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 |
| --- | --- |
| Group A<br>group received Elevate Ant™ single-incision mesh | Device: Elevate Ant™<br>* Surgery with Elevate Ant™<br>|
| Group B<br>group received Perigee™ transvaginal mesh | Device: Perigee™<br>* Surgery with Perigee™<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of anatomic correction rates in the vaginal apex at 1 year between two mesh kits |  | 1 year post-surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaginal prolapse, mesh kit, anatomic assessment, quality of life
68Ga-FAPI PET/CT for the Detection of Adenoid Cystic Carcinoma(ACC)

Study Overview
=================
Brief Summary
-----------------
This study was used to study the diagnostic value of 68Ga-FAPI, a novel fibroblast activating inhibitor, in metastatic adenoid cystic carcinoma（ACC）

Detailed Description
-----------------
68Ga-FAPI is a positron labeled inhibitor of fibroblast activating protein, which has been widely used in malignant tumor imaging in recent years. Adenoid cystic carcinoma (ACC) is a rare epithelial malignant tumor, which usually originates from salivary glands. Its typical characteristics are long clinical course and high rate of distant metastasis. The purpose of this study was to investigate the clinical value of 68Ga Fapi pet/ct in metastatic adenoid cystic carcinoma.

Official Title
-----------------
Peking Union Medical College Hospital

Conditions
-----------------
68Ga-FAPI PET/CT, Metastatic Adenoid Cystic Carcinoma

Intervention / Treatment
-----------------
* Drug: 68Ga-FAPI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with ACC suspected metastatic tumor,and being able to provide basic information and sign the written informed consent form Exclusion Criteria: claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-FAPI PET/CT<br>Imaging was performed 30-60 minutes after injection of 2-4mci 68Ga-FAPI tracer | Drug: 68Ga-FAPI<br>* 68Ga-FAPI were injected into the patients before the PET/CT scans<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value of 68Ga-FAPI in ACC | The maximum and mean standard uptake values (SUVmax and SUVmean) were measured in the background of lesion, liver, muscle and mediastinal blood pool, respectively. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lesions detected by 68Ga-FAPI PET/CT | The number of target lesions in each organ system was calculated by 68Ga-FAPI PET/CT | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
68Ga-FAPI, PET/CT, Adenoid Cystic Carcinoma
Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants

Study Overview
=================
Brief Summary
-----------------
This is a single arm dose escalation study of recombinant human keratinocyte growth factor given to patients undergoing allogeneic bone marrow transplantation who are at high risk for graft versus host disease (GVHD).

Detailed Description
-----------------
Completion date provided represents the completion date of the grant per OOPD records

Official Title
-----------------
Safety and Efficacy of Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants

Conditions
-----------------
Graft Versus Host Disease

Intervention / Treatment
-----------------
* Drug: recombinant human keratinocyte growth factor


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligible for full intensity bone marrow transplant (BMT) conditioning but who lack a 6/6 HLA idential sibling donor

Ages Eligible for Study
-----------------
Minimum Age: 3 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: Prevention
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: recombinant human keratinocyte growth factor|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
-----------------
graft versus host disease, bone marrow transplant, alternative donor
Fetal Intrapartum Heart Rate FHR/ECG Study

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the association between certain markers in the blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the device under study.

Detailed Description
-----------------
The purpose of the study is to: evaluate the association between serologic markers of neonatal brain injury and the specific FHR monitoring findings using the investigational device; investigate the relationship between selective serotonin reuptake inhibitor (SSRI) antidepressants and the QT interval of the fetal heart. Specifically, examine the potential association between maternal SSRI use and the fetal QT interval,and; develop the capacity to measure uterine contractions during labor using non-invasive electrodes that measure the electrical signal from the uterine muscle. For this study, the investigational device will not be used to diagnose or treat as it will be used in concert with the current standard of care monitors.

Official Title
-----------------
Fetal Intrapartum Heart Rate FHR/ECG Study

Conditions
-----------------
Abnormality in Fetal Heart Rate or Rhythm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women in their third trimester and Women in labor (the progressive effacement and dilatation of the cervix) who are having their fetus' heart rate monitored continuously will form the eligible population for recruitment into our study 18 years old or older Women with the diagnosis of fetal intrauterine growth restriction may be included. Exclusion Criteria: Speakers of languages other than English Gestational age less than 24 weeks 0 days

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Quantitative FHR patterns predictive of adverse neonatal outcome | 1)quantitative analysis of fetal heart-rate (FHR) data recorded during labor using advanced mathematical techniques, including pattern-recognition analysis using EKG stickers applied to the maternal abdomen. | During Labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine contraction measurement | Uterine contraction monitoring using skin surface electrodes | During Labor |
Primary Liver Cancer Cohort of South China

Study Overview
=================
Brief Summary
-----------------
This longitudinal observational cohort study was designed to investigate factors that influencing the occurrence and long-term survival of patients with primary liver cancer. Basic informations and detailed diagnosis informations (AJCC/TNM stage, MELD score, Child-Pugh score, and BCLC stage) were collected by professional doctors. Clinical outcomes (death, recurrence, and metastasis) will be followed up every two years after therapy.

Detailed Description
-----------------
Primary liver cancer (PLC) is highly malignant with high mortality which is particularly popular in China. Many factors are believed to associate with the occurrence and prognosis of liver cancer. This longitudinal observational cohort study was designed to investigate factors that influencing the occurrence and long-term survival of patients with primary liver cancer.

Official Title
-----------------
Factors Influencing the Occurrence and Long-term Survival of Patients With Primary Liver Cancer: A Cohort Study in South China

Conditions
-----------------
Primary Liver Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-80 years consistent with primary liver cancer diagnostic criteria first diagnosis (from diagnosis to admission interval of less than a month) did not do any treatment of liver cancer Exclusion Criteria: refused to participate in this study suffering from more than two kinds of primary tumors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Time of Death | The exact death time of each participants will be checked in the government medical records system | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of recurrence | Time of recurrence will be obtained by telephone interview or medical treatment records | From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 10 years | 
| Time of metastasis | Time of metastasis will be obtained by telephone interview or medical treatment records | From date of diagnosis until the date of cancer metastasis or date of death from any cause, whichever came first, assessed up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Liver Cancer; Cohort Study
Epidiolex and Drug Resistant Epilepsy in Children

Study Overview
=================
Brief Summary
-----------------
This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy.

Detailed Description
-----------------
This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy. The study consists of an 8 week baseline, titration, and treatment of Epidiolex in a daily dosage up to 25 mg/kg/day, with an optional secondary titration schedule after 26 weeks of treatment up to a maximal daily dosage up to 50 m/kg/day until End of Treatment, followed by a taper-down period, and a safety follow up. Treatment will be provided for a total of 52 weeks with an interim analysis conducted 12 weeks after achieving maximal dose (either 25 mg/kg/day or optimal dose with regards to safety and tolerability) and at the end of 1 year of treatment with treatment extensions conducted beyond 52 weeks until such time as there is market authorization for Epidiolex, if Epidiolex becomes unavailable, or the study is terminated. Cessation of Epidiolex administration will be concluded with a taper period and follow-up visit 4 weeks after the taper.

Official Title
-----------------
An Open Label, Multi-Center Study to Investigate the Safety of Cannabinoid (GWP42003-P) in Children With Medication Resistant Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Cannabidiol (Epidiolex)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient should have history of trying at least four antiepileptic drugs (AEDs), including one trial of a combination of two concomitant drugs, without successful seizure control. Vagal nerve stimulation, RNS deep brain stimulation, or the ketogenic diet can be considered equivalent to a drug trial. Patient must be taking two or more AEDs at a dose which has been stable for at least four weeks. A State of Georgia resident. Exclusion Criteria: Patient is diagnosed as having Dravet Syndrome or Lennox-Gastaut Syndrome and eligible for a GW Pharmaceutical-Sponsored Clinical Trial. Patients who have been part of a clinical trial involving another investigational product in the previous six months.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cannabidiol (Epidiolex)|Daily dosage up to 25 mg/kg/day with an optional up titration to a maximal daily dosage up to 50 m/kg/day until End of Treatment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Eliminating HCV Infection Among PWUD

Study Overview
=================
Brief Summary
-----------------
Identify 300 PWUD with chronic, viremic HCV infection and engage them in a multidisciplinary, generalizable model of care and initiate HCV treatment

Official Title
-----------------
Micro-elimination of HCV Infection Among People Who Use Drug (PWUD) in British.Columbia: A Comprehensive, Multidisciplinary, Scalable Programmatic Approach

Conditions
-----------------
Hepatitis C, Chronic, Drug Use

Intervention / Treatment
-----------------
* Drug: Epclusa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to review, sign and date the IRB/IEC approved informed consent form Age ≥19 years Documented HCV RNA positive for 6 months or more, with any HCV genotype Active PWUD (ongoing drug use or documented use within the previous 6 months) OR active enrolment in an opiate substitution program Exclusion Criteria: Previous DAA-based HCV treatment Pregnant or breast-feeding Indications of decompensated liver disease Diagnosis of active hepatocellular carcinoma Positive test at the time of screening for hepatitis B surface antigen (HBsAg) Frequent injecting drug use that is judged by the treating physician to compromise subsequent HCV treatment safety Inability or unwillingness to provide informed consent or to actively engage in care leading to the initiation of HCV treatment

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epclusa|HCV treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of individuals enrolled in the study who initiate HCV treatment |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of individuals enrolled in the study who achieve sustained virologic response |  | 72 months |
Clinical Identification of Fall Risk Early After Unilateral Transtibial Amputation

Study Overview
=================
Brief Summary
-----------------
All participants attend for two testing sessions at either Royal Talbot Rehabilitation Centre or the centre where they received inpatient physiotherapy services. All participants will be tested at discharge and at six months post discharge. Personnel used to score and administer the balance tests at six months will be blinded to pre-test scores, subject background, as well as, mobility and fall history in the six months post discharge. At discharge participants will perform two successful Four Square Step Tests (FSST, and will be videotaped performing the Timed Up and Go Test (TUGT. The turn measure will be scored from this TUGT. Participants will also complete the Locomotor Capabilities index (LCI). At the six-month test participants repeat balance and mobility tests and LCI, as well as being interviewed to ascertain fall history since discharge.

Detailed Description
-----------------
Subjects: All unilateral trans-tibial amputees with prosthesis at discharge, who are over 18 years of age, willing to participate and give informed consent. Subjects will be excluded if visually unable to perform tests, cognitively unable to follow testing procedures or being discharged into supported accommodation. Identify scores for unilateral trans-tibial amputees for; FSST, TUGT and turn measure items: (1) steps, (2) time and (3) steadiness & fluency of movement. Evaluate the validity, predictive value, sensitivity & specificity of the balance and mobility measures for falls and community ambulation with trans-tibial amputees.

Official Title
-----------------
Clinical Identification of Increased Fall Risk Early After Unilateral Transtibial Amputation

Conditions
-----------------
Amputation

Intervention / Treatment
-----------------
* Behavioral: outcome measures and self report


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years unilateral transtibial amputee Exclusion Criteria: visually unable to perform tests cognitively unable to perform tests unable to provide informed consent not being discharged into supported accommodation

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

| Intervention/Treatment |
| --- |
|Behavioral: outcome measures and self report|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
-----------------
falls, mobility, activity level
Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.

Detailed Description
-----------------
This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels. Additional information will be obtained related to the natural variability of disease activity in SLE patients.

Official Title
-----------------
A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus

Conditions
-----------------
Lupus Erythematosus, Systemic

Intervention / Treatment
-----------------
* Drug: epratuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has SLE by American College of Rheumatology revised criteria (meets >/= 4 criteria) Has had SLE for at least 6 months prior to study entry Has at least one elevated autoantibody level at study entry Has moderately active SLE disease at study entry in any body/organ system (Full criteria not present here due to length of considerations. The protocols should be consulted regarding the complete list of entry criteria.) Exclusion criteria: Active Severe Lupus as defined by BILAG Index Level A in any body system or organ Allergy to human antibodies or Murine Prior therapy with other anti-B cell antibodies

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: epratuzumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
study of epratuzumab in systemic lupus erythematosus, systemic lupus erythematosus, SLE