linjc16/ctgov huggingface dataset:
An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection

Study Overview
=================
Brief Summary
-----------------
The TARGET-HBV study engages an observational research design to conduct a comprehensive review of outcomes for patients with CHB infection. The initial phase of the study that enrolled patients treated with tenofovir alafenamide (TAF) was successfully completed. The current protocol (Amendment 1) describes the second phase of the study that will engage research activities for patients being managed for CHB in usual clinical practice in the US and Canada. The study addresses important clinical questions regarding the management of CHB by collecting and analyzing data from patients at academic and community medical centers. TARGET-HBV creates a robust database of real-world data regarding the natural history, management, and health outcomes related to antiviral treatments used in clinical practice.

Official Title
-----------------
An Observational Study of Patients With Chronic Hepatitis B (CHB) Infection

Conditions
-----------------
Hepatitis, Liver Diseases, Hepatitis B

Intervention / Treatment
-----------------
* Other: All approved therapies for the treatment of Chronic Hepatitis B (CHB)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Male or female patients, age ≥18 years Being managed for chronic hepatitis B (CHB), including patients who have achieved functional cure and patients with concurrent delta hepatitis Exclusion Inability to provide written informed consent Known history of Human Immunodeficiency Virus (HIV) History of liver transplantation

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 |
| --- |
|Other: All approved therapies for the treatment of Chronic Hepatitis B (CHB)|All approved therapies for the treatment of Chronic Hepatitis B (CHB).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural history of CHB: Characteristics of CHB infection |  | Up to 10 years | 
| Natural history of CHB: Participant demographics |  | Up to 10 years | 
| Natural history of CHB: Treatment use |  | Up to 10 years | 
| Natural history of CHB: Treatment response |  | Up to 10 years | 
| Time point of clinical response |  | Every 6 months for 10 years | 
| Natural history of CHB: Disease progression |  | Up to 10 years | 
| Adverse event frequency and severity |  | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons for treatment discontinuation |  | Up to 10 years |
Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients

Study Overview
=================
Brief Summary
-----------------
To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China. To track the patients'situations during one year after surgery and to collect the relevant clinical data.

Official Title
-----------------
Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients

Conditions
-----------------
Mitral Valve or Aortic Valve Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients implanted with Perimount 6900PTFX after 2012-11-19 or with Perimount 2800TFX after 2013-8-20 Patients sign the Inform Consent Form (ICF) and agree to join the study Exclusion Criteria: Don't have any specific exclusion criteria.
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 |
| --- | --- | --- |
| Twice echocardiography to evaluate the performance of heart valve | subjects need to do the echocardiography in two follow up visits | Compare the 1st echocardiography at average 6 months after surgery and 2nd echocardiography at 12 months after surgery | 
| The recovery status of patients after surgery |  | The subjects will be followed for the duration of one year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Valve Replacement Surgery, Perimount, Edwards
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to chemotherapy-induced neuropathic pain in patients with cancer.

Detailed Description
-----------------
To determine the safety and efficacy of Cesamet™ in the symptomatic treatment of chemotherapy-induced neuropathic pain. This is a phase IV, multicenter, open label of Cesamet™ at 1 mg daily progressing to 2mg BID in subjects with chemotherapy-induced neuropathic pain. This study has two phases: A pretreatment phase and a treatment phase.

Official Title
-----------------
A Multicenter Trial Evaluating the Safety and Efficacy of Cesamet™ for the Symptomatic Treatment of Chemotherapy-Induced Neuropathic Pain in Patients With Cancer

Conditions
-----------------
Peripheral Neuropathy, Antineoplastic Combined Chemotherapy Protocols

Intervention / Treatment
-----------------
* Drug: Cesamet™ (nabilone)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with chemotherapy-induced neuropathic pain. Chronic daily pain present for at least 2 months. On stable analgesic regimen for one month. Baseline pain score greater than 40mm on a VAS. Exclusion Criteria: Hypersensitivity to compounds in study drug or similar drugs Pregnant or lactating females Drug or alcohol abuse Unstable medical condition

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cesamet™ (nabilone)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Average Pain Score at target site. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Worst Pain Score at target site. |  |  | 
| The Pain at Night Score at target site. |  |  | 
| Quality of Life measures. |  |  | 
| Patient satisfaction with treatment. |  |  | 
| Safety will be assessed through the collection of AEs and vital signs. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, Chemotherapy-induced, neuropathy
Assessment of Clinically Related Outcomes and Biomarker Analysis for Translational Integration in Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
A prospective, observational study on clinical outcomes of surgical management of primary and metastatic colorectal cancer Prospective collection of tissues to explore potential biomarkers in blood and/or primary or secondary cancers and/or normal colon

Detailed Description
-----------------
Prospective project in collecting and assessing clinical outcomes data related to molecular profiling of tumors based on cancer primary or metastatic tissue or tissue from peripheral blood samples. As a future part of the project will be collected patient reported outcomes (PROs) for assessing clinical outcomes in relation to clinical pathways, patient reported results, as well as tumor profiling by molecular methods.

Official Title
-----------------
Prospective, Population-based Cohort Collection of Blood Samples and Tumor Tissue From Patients Operated on for Primary or Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: open and laparoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of colorectal cancer, primary or metastatic (liver), with a treatment intention of planned curative surgery Informed consent to participate Age ≥18 Exclusion Criteria: failure to provide written informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| open and laparoscopic surgery<br>Patients with primary and or metastatic colorectal cancer (CRC) eligible for curative surgery will be included. Subcohorts may be based on either colon cancer, rectal cancer, metastatic cancer, surgery (laparoscopy or open), node negative and node positive disease, and molecular profiling. | Procedure: open and laparoscopic surgery<br>* Curative surgery for either primary (colorectal cancer, crc) or metastatic CRC (liver surgery)<br>* Other names: Liver surgery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-specific survival | Time from surgery to death of cancer | 5-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival | Time from surgery to recurrence of cancer | 3 and 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colon cancer, rectal cancer, liver metastasis, survival, biomarker, molecular profile
Study With a Topical Gel to Treat Common Warts in Adults

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the effectiveness in adults of four different strengths of resiquimod gel applied to common wart(s) five times a week for four weeks. A second purpose is to evaluate the safety of the drug.

Official Title
-----------------
A Three-Stage, Modified-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 5 Times Per Week for 4 Weeks for the Treatment of Common Warts in Adults

Conditions
-----------------
Warts

Intervention / Treatment
-----------------
* Drug: Resiquimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of common warts Two forms of birth control Exclusion Criteria: Pregnant or breast feeding Other types of warts, ie. plantar Currently participating in another clinical study Chronic viral hepatitis B or C

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: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of treated wart(s) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial clearance of treated wart(s) |  |  | 
| Wart recurrence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Warts, Adults, Common Warts, Resiquimod
Sleep Profiles in REM Sleep Behavior Disorder

Study Overview
=================
Brief Summary
-----------------
Rapid eye movement (REM) sleep behavior disorder (RBD) is a sleep disorder in which you act out dreams during REM sleep. Sleep disturbances are very common in RBD, where they negatively impact patients' quality of life and safety. One of the known causes of sleep disturbance is the impairment of the circadian rhythm, or the human sleep/wake cycle. The purpose of this study is to examine the role of disruption of the circadian rhythm in the development of RBD.

Official Title
-----------------
Circadian Rhythms Regulation in Pre-Manifest Synucleinopathies

Conditions
-----------------
Rapid Eye Movement Sleep Behavior Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of RBD as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria within 3 years 40 yrs of age Exclusion Criteria: Other significant neurological disorder Untreated significant sleep apnea and/or current sleep apnea symptoms as assessed by the clinical investigator Co-existent restless legs syndrome (RLS), as assessed by the ICDS diagnostic criteria for RLS Cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA) score of ≤ 23 Presence of depression defined as the Beck Depression Inventory (BDI) score >20 Use of tricyclic antidepressants, MAO inhibitors or selective serotonin reuptake inhibitors since they may induce/worsen RBD, unless on a stable dose of medication for at least 8 weeks Use of medications known to affect melatonin secretion, such as lithium, α- and β-adrenergic antagonists Shift work, currently or within the prior 3 months Travel through ≥ 2 time zones within 60 days prior to the screening

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Participants with RBD<br>Participants with REM Sleep Behavior Disorder | |
| Participants without RBD<br>Age- and gender-matched controls, without REM Sleep Behavior Disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian Amplitude | amplitude and area under the curve (AUC) of serum melatonin and clock gene expression | Study Day 17-18 | 
| REM Sleep Phenomena | REM (rapid eye movement) sleep duration, REM Index, and EMG (electromyographic) activity) assessed via overnight Polysomnography | Study Day 16-17 | 
| Objective Daytime Sleepiness | MSLT (Multiple Sleep Latency Test) assessed via Polysomnography | Study Day 17 |
Prone Versus Left-sided Colonoscopy in Obese Patients

Study Overview
=================
Brief Summary
-----------------
For obese patients, a randomized trial aimed at determining whether colonoscopy performance and patient comfort is improved if a patient is in the prone position (lay on their abdomen) versus the traditional left-sided position.

Conditions
-----------------
Obese

Intervention / Treatment
-----------------
* Other: Prone Position
* Other: Standard Position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >30kg/m2 Elective Colonoscopy Exclusion Criteria: Patients with prior colonic resection, strictures, or known colonic or intra-abdominal malignancy. Patients who are scheduled to have monitored or general anesthesia for their procedure. Emergency colonoscopy Inadequate preparation of the colon as assessed during colonoscopy

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Left-sided Position<br> | Other: Standard Position<br>* The traditional left-lateral decubitus position<br>|
| Experimental: Prone Position<br> | Other: Prone Position<br>* Patients were asked to lay on their abdomen for their elective colonoscopy.<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
-----------------
patients, presenting, elective, colonoscopy.
Sexually Transmitted Infections With Mycoplasma Genitalium: Epidemiological, Clinical, Microbiological, Therapeutic Aspects

Study Overview
=================
Brief Summary
-----------------
Infectious anorectitis is a poorly described clinical entity. Their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly made in gastroenterology and new diagnostic tools are now available) and therapeutic aspects. The proctology center of the Marie Thérèse Center is the leading proctology center in the Ile-de-France region both in terms of recruitment and reputation, and drains a large proportion of patients with anorectitis for specialized care. The clinical microbiology laboratory of the Saint Joseph Hospital Group is linked to the Marie Thérèse Center to provide its expertise in the microbiological and infectious aspects of the management of these infections. In recent years, the analysis of data from this large population of patients referred to the Léopold Bellan proctology center for suspected ano-rectitis has revealed the pathogens Neisseria gonorrhoeae and/or Chlamydia trachomatis. Mycoplasma genitalium (MG) is an emerging pathogen responsible for Sexually Transmitted Infections (STI) and has been described increasingly in recent years. Studies on this pathogen will allow to better identify risk factors and to target optimized prevention and therapeutic management strategies.

Official Title
-----------------
Sexually Transmitted Infections With Mycoplasma Genitalium: Epidemiological, Clinical, Microbiological, Therapeutic Aspects

Conditions
-----------------
Anorectal Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient whose age is ≥ 18 years Patients treated at the Centre de proctologie of the Centre de santé Marie-Thérèse or the GHPSJ (consultation and/or hospitalization) and for whom an anorectal swab will be taken for suspected infectious sexually transmitted ano-rectitis French-speaking patient Exclusion Criteria: Patient under guardianship or curatorship Patient deprived of liberty Patient under court protection Patient objecting to the use of his data for this research

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 |
| --- | --- | --- |
| Clinical forms of these anorectal infection | This outcome corresponds to the clinical presentation : prevalence of clinical signs [fever (Yes/no), ulcerations (yes/no), purulent proctisis (yes/no), erythematosus proctisis (yes/no), condyloma (yes/no)]. | Day 1 |
Longterm Outcome of the Delta III Inverse Prosthesis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to describe the results after > 10 years due to a prosthesis implant.

Detailed Description
-----------------
The aim of the study is to measure the gain of the benefit in function an painreduction which the patient yields with this type of prosthesis in a longterm (> 10 years )outcome. Additionally the long-term results will be compared with the mid-term results and the literature. Furthermore the complications since the mid-term measurement time point will be determined.

Official Title
-----------------
The Reverse Delta III Total Shoulder Prosthesis - Longerm Results in 98 Patients

Conditions
-----------------
Rotator Cuff Tear Arthropathy

Intervention / Treatment
-----------------
* Device: Implantation of a Delta III Prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: implantation of a Delta III - prothesis timeframe (Oct 1998 - Dec 2002) delta-pectoral approach written informed consent Exclusion Criteria: Implantation because of a revision Complaints, which make it difficult to follow instructions or even prevent
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delta III<br>Implantation of a Delta III Prosthesis | Device: Implantation of a Delta III Prosthesis<br>* Implantation of a Delta III Prosthesis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Murley Score |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cASES |  | 10 years | 
| pASES |  | 10 years | 
| SF-36 |  | 10 years | 
| DASH-Questionannaire |  | 10 years | 
| SPADI |  | 10 years | 
| x-ray (Sperling Classification) |  | 10 years | 
| x-ray (Sirveaux Classification) |  | 10 years | 
| Description of the glenoid | Description of the situation: e.g. any dissociation of the gleonid any migration of the glenoid | 10 years | 
| Description of the stem | Description of the situation: e.g. - change of the position | 10 years |
VEGF as a Prognostic Factor for White Matter Damage in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
We hypothesize that misexpression of vascular endothelial growth factor (VEGF) in the Cerebrospinal fluid of preterm infants can be used as a biomarker to predict the risk for developing white matter damage.

Official Title
-----------------
VEGF as a Prognostic Factor for White Matter Damage in Preterm Infants

Conditions
-----------------
Preterm Infants With White Matter Damage, Preterm Infants Developing Normally

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants undergoing lumbar puncture. Exclusion Criteria: Preterm with IVH or known infection or meningitis.

Ages Eligible for Study
-----------------
Minimum Age: 25 Weeks
Maximum Age: 40 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |
| 2<br> | |

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

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