linjc16/ctgov huggingface dataset:
Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of topiroxostat on urinary albumin excretion and the safety in patients with early stage diabetic nephropathy and hyperuricemia with or without gout. Participants are randomized to placebo (n=20) or topiroxostat (n=40) for 28 weeks. The investigational drugs for this study are supplied by FUJI YAKUHIN CO., LTD.

Official Title
-----------------
Effect of Topiroxostat on Urinary Albumin Excretion in Patients With eARly Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout: a Randomized, Placebo-controlled, Double-blind Phase 2a Trial (UPWARD).

Conditions
-----------------
Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: Topiroxostat BID, (Oral daily dosing for 28 weeks)
* Drug: Placebo BID, (Oral daily dosing for 28 weeks)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes patients Clinically or pathologically diagnosed diabetic nephropathy Hyperuricemic or gout patients Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73m^2 and urine albumin creatinine ratio (UACR) greater than or equal to 45 and less than 300 mg/g Exclusion Criteria: Patient has known non-diabetic nephropathy (other than nephrosclerosis)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active comparator<br>Topiroxostat, (Oral daily dosing for 28 weeks) | Drug: Topiroxostat BID, (Oral daily dosing for 28 weeks)<br>* The dose of topiroxostat is increased up to 160 mg/day in a stepwise manner.<br>|
| Placebo Comparator: Placebo comparator<br>Placebo, (Oral daily dosing for 28 weeks) | Drug: Placebo BID, (Oral daily dosing for 28 weeks)<br>* Subjects randomized to the placebo arm will receive placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urine albumin creatinine ratio |  | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC |  | 28 weeks |
A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.

Study Overview
=================
Brief Summary
-----------------
This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally for five consecutive days, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy does not exist.

Official Title
-----------------
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor.

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: Gimatecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histological or cytological confirmed advanced solid tumors, which have progressed despite standard therapy or for whom no standard therapy exists. Life expectancy of at least 3 months Adequate hematological parameters No major impairment of renal and hepatic function Exclusion Criteria: Gastrointestinal dysfunction, such as gastrectomy and malabsorption syndrome that could alter absorption. Patients who have received any investigational compound within the past 28 days. Patients with other antineoplastic therapy within the last 28 days. Patients known to be HIV or hepatitis virus positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection Patients with a history of allergies to the camptothecin family drug. Other protocol-defined inclusion/exclusion criteria may apply

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBQ707<br> | Drug: Gimatecan<br> <br> * Other names: LBQ707;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Maximum Tolerated Dose of gimatecan |  | 1.8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by adverse events |  | 1.8 years | 
| Characterization of the pharmacokinetic profile of gimatecan |  | 1.8 years | 
| Anti-tumor activity assessed by RECIST |  | 1.8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gimatecan, topoisomerase I inhibitor, advanced solid tumors
National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia

Study Overview
=================
Brief Summary
-----------------
SLE disease in Saudi Arabia is yet not well defined especially in a population with high consanguinity and high inbreeding coefficient . Up until now, there has been no prospective cohort study for SLE patients in Saudi Arabia. As a result, current published literature is focused on retrospective chart reviews which are subjected to many forms of bias. so the investigator proposed this prospective registry which will follow open cohort study design aiming to provide better understanding of disease presentation, course and outcomes especially if complemented by detailed immunological, molecular, genetic and microbiome data.

Official Title
-----------------
National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia

Conditions
-----------------
SLE (Systemic Lupus)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients defined as age greater than 18 years old. Patients should fulfil one of the following classification criteria for SLE (ACR, SLICC or ACR/EULAR criteria). No restriction on time of diagnosis. Exclusion Criteria: Patients who don't fulfil classification criteria mentioned above.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Accrual damage among SLE patients in Saudi Arabia | SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000 (0-150) higher score representing higher disease activity | over 10 years | 
| Disease Accrual damage among SLE patients in Saudi Arabia | SLICC/ACR DI, Systemic Lupus International Collaboration Clinics/ American College of Rheumatology | over 10 years | 
| Disease Accrual damage among SLE patients in Saudi Arabia | Mortality | over 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome | PROMIS ( Patient Reported Outcome Measurement Information Scale) there are several data collection tool for calculating score (will use REDCap auto score). Each question usually has 5 response option ranging in value from one to five. For example, the adult 8-item, the lowest possible score is 8, the highest possible score is 40 | over 5 years | 
| Patient reported outcome | Medication adherence by using Modified Medication Adherence Response Scale (Modified MARS), an overall score of 4 and above is considered adherent. | over 5 years | 
| Fetal and maternal outcomes in patients with SLE | Intrauterine fetal death, Abortion, Still birth, Eclampsia and pre-eclampsia, disease Activity | over 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SLE, Lupus erythematosus, Outcomes, Phenotypes, Observational
Screening for Genes in Patients With Poikiloderma

Study Overview
=================
Brief Summary
-----------------
In the context of this study, the investigators wish to take advantage of high-throughput genetic techniques (microarray and high-throughput exome sequencing) to identify new genes implicated in syndromic poikiloderma so as to improve the diagnostic decision tree in these syndromes, opportunities for genetic counselling for patients and their families and the follow-up of patients, notably with regard to the risk of tumours. This study will make it possible to identify new genes implicated in syndromic poikiloderma and improve the diagnostic strategy proposed to patients with these syndromes, and to propose to patients a confirmed diagnosis, appropriate follow-up, notably with regard to the risk of tumours, genetic counselling to families and eventually an antenatal diagnosis to couples who would like to have one for future pregnancies. The identification of new genetic causes of syndromic poikiloderma will also make it possible to complete the current classification of these syndromes

Official Title
-----------------
Towards an Improvement in Diagnosis and Genetic Counselling in Syndromic Poikiloderma

Conditions
-----------------
Poikiloderma

Intervention / Treatment
-----------------
* Genetic: High-throughput exome sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with syndromic poikiloderma, defined by the association of poikiloderma with other extradermatological clinical signs, normal array-CGH, screening for chromosomal rearrangements, absence of mutations in the genes RECQL4, KIND1 or C16orf57, sporadic or familial involvement. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with poikiloderma<br> | Genetic: High-throughput exome sequencing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of novel genes involved in syndromic poikiloderma |  | day 1 |
Feasibility Study of Preimplantation Genetic Diagnosis for Single-gene Disorders

Study Overview
=================
Brief Summary
-----------------
Preimplantation Genetic Diagnosis (PGD) for monogenic diseases is usually performed by multiplex PCR combining polymorphic microsatellites familial analysis and, where possible, couple-specific mutation detection. Single-cell multiplex PCR developments are costly and time-consuming. We propose to test and clinically validate a targeted next-generation sequencing approach for the PGD for cystic fibrosis. This technique would allow a PGD for probably almost every couple asking for it in our centre, without a previous couple-specific development (but only a preliminary familial analysis). It will be based on haplotyping using a large number of SNPs and mutation detection. A clinical validation will be performed by reanalysing non-transferable embryos obtained after PGD for cystic fibrosis, with couple's informed consent. Concordance of the results between PGD and reanalysis by NGS will be achieved and if validated, this technique may be applied to future PGD for cystic fibrosis in our centre. The same technique may then be applied for other PGD indications for which a set-up is often needed.

Official Title
-----------------
Feasibility Study of Preimplantation Genetic Diagnosis for Single-gene Disorders by Using Nextgeneration Sequencing

Conditions
-----------------
Preimplantation Diagnosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> or = 18 years Couples at risk of transmitting cystic fibrosis asking for a PGD in Strasbourg DNA samples available at the laboratory for: The couple A related with CFTR status known Having signed an informed consent Exclusion Criteria: Inability to give informed consent (understanding difficulties...)

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 |
| --- | --- | --- |
| Monogenic diseases |  | for the duration of hospital stay, up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preimplantation Genetic Diagnosis, PGD, Next-Generation Sequencing, NGS, Single-Gene disorders, Cystic Fibrosis, CFTR, Single-cell analysis, PCR, SNP, Whole Genome Amplification
Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients.

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to an anxiety event in patients with generalised anxiety disorder (GAD). PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
A Multi-Centre,Double-Blind,Randomised-Withdrawal,Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine SR as Monotherapy in the Maintenance Treatment of Patients With GAD Following an Open-Label Stabilisation Period

Conditions
-----------------
Anxiety Disorders

Intervention / Treatment
-----------------
* Drug: Quetiapine SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be male or female, 18 to 65 years of age (inclusive), with a diagnosis of GAD according to DSM-IV criteria 300.02 as assessed by the MINI. Exclusion Criteria: Patients suffering from depressive symptoms, defined as having a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 17 or more at the enrolment visit, will be excluded from participation in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from randomisation to occurrence of an anxiety event |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of an anxiety event |  |  | 
| Change from randomisation in HAM-A/CGI-S scores |  |  | 
| In HAM-A psychic/somatic anxiety factor scores |  |  | 
| In MADRS total score and in MADRS item 10 score (suicidal thought) |  |  | 
| Change in Patient Reported Outcomes (PRO): QLESQ/PSQ/SDS |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Generalised Anxiety Disorder
Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859

Study Overview
=================
Brief Summary
-----------------
The purpose of study AUX-CC-860 is to assess the durability of response of the AA4500 treatment regimen. This study will also evaluate long-term safety and progression of disease in joints.

Detailed Description
-----------------
Phase 3 non-treatment study in which Year 2 to Year 5 year follow-up of subjects who received AA4500 in the 9-month open-label studies (AUX-CC-854 and AUX-CC-856) or the 12-month double-blind with open-label extension studies (AUX-CC-857/AUX-CC-858 and AUX-CC-859). After completion of one of the above mentioned studies, subjects are enrolled and followed once a calendar year for 4 consecutive years with at least 6 months between consecutive visits.

Official Title
-----------------
CORDLESS- Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study

Conditions
-----------------
Dupuytren's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be eligible for this study a subject had to: Have received at least one injection of AA4500 in one of the Auxilium sponsored studies (AUX-CC-854, AUX-CC-856, Studies AUX-CC-857/AUX-CC-858, or AUX-CC-859) and have at least one fixed-flexion contracture measurement after treatment with AA4500 Be able and willing to comply with the yearly assessments outlined in the protocol, as determined by the investigator Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC) Exclusion Criteria: None

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 |
| --- | --- |
| Follow-up<br>Subjects Previously Treated with AA4500 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contracture Measurements |  | yearly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity, concomitant medications, medical history, and adverse events |  | yearly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Dupuytren's Disease, Muscular Diseases, Musculoskeletal Diseases, Contracture Joint Diseases, Connective Tissue Diseases, Dupuytren's Contracture
Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine whether the Air Barrier System (ABS) reduces airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior spinal procedures

Detailed Description
-----------------
The ABS is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne colony-forming units at the surgery site during posterior spinal procedures.

Official Title
-----------------
ABS to Reduce Contamination in Spine Surgery

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Device: Air Barrier System device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients undergoing lumbar and cervical laminectomy with instrumentation. Exclusion Criteria: Active infection Prior prosthesis infection

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No device<br>Subject does not receive ABS system | |
| Experimental: Air Barrier System device<br>Device is deployed adjacent to the surgery site and activated. | Device: Air Barrier System device<br>* Device is deployed adjacent to the surgery site and activated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CFU Density | Colony-forming unit density at incision site (CFU/m3) | Surgical case CFU density will be determined at up to 1 month from completion of surgical cases | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CFU, surgery site
Study of Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Among the risk factors for lower limb osteoarthritis, if obesity is probably the most studied, digital osteoarthritis received increasing interest in recent years. Recent publications have highlighted a link between obesity and digital osteoarthritis, but also a very probable link between digital osteoarthritis and structural progression of knee osteoarthritis. Few data including hip exist and need to be confirmed on larger scale studies. We have with Khoala a national multiregional cohort of symptomatic gonarthrosis and coxarthrosis representative of the general population (which is rarely the case in the literature) including X ray, clinical and biological follow-up (hips and / or knees).

Official Title
-----------------
Study of the Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis (Knee and Hip) in Terms of Severity and Evolution - Khoala Group Ancillary Project / Cohort Khoala

Conditions
-----------------
Digital Arthrosis

Intervention / Treatment
-----------------
* Radiation: Hand X-rays


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men or women aged 40 to 75 years with symptomatic osteoarthritis of the hip and / or knee (femoro-tibial), unilateral or bilateral with a confirmed diagnosis (criteria of the American College of Rheumatology :ACR) and Kellgren and Lawrence radiological stage ≥ 2. Exclusion Criteria: painful hip or knee prosthesis osteotomy in the past

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: X-Rays<br>patients with digital arthrosis and hip/knee arthrosis will practice hand X-rays | Radiation: Hand X-rays<br>* Hand X-rays to assess the digital arthrosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kellgren and Lawrence score | Kellgren and Lawrence score for hip or knee | Change at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris score |  | Harris score at 2 years |