linjc16/ctgov huggingface dataset:
Assess the Mid-term Performance of the Mpact Cup in Subjects Requiring Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement.

Official Title
-----------------
A Multi-centre, Prospective Post Marketing Surveillance Study to Assess Mid-term Performance of the Mpact Cup in Subjects Requiring Primary Total Hip Arthroplasty

Conditions
-----------------
Hip Osteoarthritis

Intervention / Treatment
-----------------
* Device: MPact Cup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery. Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use). Patients must be willing to comply with the pre and post-operative evaluation schedule Exclusion Criteria: Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.
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 |
| --- | --- |
| Mpact cup<br>Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head | Device: MPact Cup<br>* Quadra®-H, Quadra®-C, AMIStem®-H or AMIStem®-C femoral stem and Mpact® Acetabular hip system with CoCr Femoral Head or Ceramic MectaCer BIOLOX® Femoral Head<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Harris Hip Scores (HHS) | Assessment of improvement of clinical outcomes following total hip replacement surgery using the Harris Hip Scores | Pre-operative, 3 or 6 months, 1 year, 2 year and 5 year | 
| Change from baseline of implant survivorship | Assessment of bone fracture, implant fracture, neck reabsorption | Post-operative 3 or 6 months, 1 year, 2 year, and 5 year | 
| Change in baseline of Complications | Assessment of Adverse events and serious adverse events | Day of surgery, post-operative 3 or 6 months, 1 year, 2 year, and 5 year. | 
| Change in baseline fixation and wear | Radiographic analysis by measuring Radio Lucent Lines | Post-operative 3 or 6 months, 1 year, 2 year and 5 year | 
| Change in baseline fixation | Radiographic analysis by measuring implant fixation in millimeters | Post-operative 3 or 6 months, 1 year, 2 year and 5 year |
Metabolomic Study in Huntington's Disease (METABO-HD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to study Huntington's disease by metabolomic approach.

Official Title
-----------------
Metabolomic Study in Huntington's Disease

Conditions
-----------------
Huntington Disease

Intervention / Treatment
-----------------
* Biological: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For all groups: age between 20 and 70 years signature of the informed consent covered by social security For presymptomatic group: positive genetic test with CAG repeat length ≥ 37 in HTT gene Unified Huntington Disease Rating Scale ≤ 5 For symptomatic group: positive genetic test with CAG repeat length ≥ 37 in HTT gene The Unified Huntington's Disease Rating Scale motor score ≥ 6 The Total Functional Capacity score ≥ 11 Exclusion Criteria for all groups: participation in another therapeutic trial (3 months exclusion period) pregnancy and breastfeeding persons deprived of their liberty by judicial or administrative decision

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: presymptomatic<br> | Biological: blood sample<br>* blood sample for metabolome analyse<br>|
| Experimental: symptomatic<br> | Biological: blood sample<br>* blood sample for metabolome analyse<br>|
| Other: controls<br> | Biological: blood sample<br>* blood sample for metabolome analyse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolite mass | by chromatography and mass spectrometry | at baseline |
Glycans Bound to Serum Haptoglobin: a Novel Gastric Cancer Tumor Biomarker

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate sensitivity and specificity of newly defined tumor biomarker with gastric cancer pts and cancer-free healthy volunteers.

Detailed Description
-----------------
Measurements of specific glycosylation changes in serum haptoglobin.

Official Title
-----------------
Open, Parallel, Single-Site Study to Evaluate Sensitivity and Specificity of Newly Defined Diagnosed-biomarker for Gastric Cancer Pts and Cancer-free Healthy Volunteers

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: Blood sample(10cc) collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Arm1 (Gastric cancer patient) Inclusion Criteria: Male or female over 19 years Patients with histologically Gastric Cancer (included Gastroesphageal junction) Primary gastric cancer or/and metastatic gastric cancer. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted Exclusion Criteria: Prior or present history of malignancies other than gastric cancer Any condition that confounds the ability to interpret data from the study under the investigational confirmed. Arm2 (Cancer-free healthy volunteers) Inclusion Criteria: Male or female over 19 years Cancer-free status. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted Exclusion Criteria: Prior or present history of malignancies (included gastric cancer) Any condition that confounds the ability to interpret data from the study under the investigational confirmed
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 |
| --- | --- |
| Gastric Cancer patients<br>This arm is composed of the gastric cancer patients. It is perfomed a blood sampling to them after the research registration. | Procedure: Blood sample(10cc) collection<br>* In both groups, serum haptoglobins to be collected and analyzed<br>|
| Cancer-free healthy volunteers<br>This arm is composed of the cancer-free healthy volunteers. It is perfomed a blood sampling to them after the research registration. | Procedure: Blood sample(10cc) collection<br>* In both groups, serum haptoglobins to be collected and analyzed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(Area Under the Curve) |  | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative abundance of glycosylations |  | through study completion, an average of 1 year |
Calcinosis in a Single-Center Scleroderma Population

Study Overview
=================
Brief Summary
-----------------
This is a 10 year study of scleroderma patients with calcinosis 1) to better understand how common and if there are any risk factors for having calcinosis 2) to identify common complications associated with scleroderma-related calcinosis. .

Detailed Description
-----------------
This is a prospective study of scleroderma- spectrum patients focused on soft tissue calcinosis in order 1) to better understand the risk factors (including clinical/laboratory characteristics, and serology) of calcinosis in the scleroderma-spectrum disorders (limited or diffuse systemic sclerosis with or without overlap of inflammatory arthritis and/or myositis). 2) view common complications associated with calcinosis. Better understanding of scleroderma calcinosis would lead to other studies that eventually will define better treatment options for this incurable and often disabling complication.

Official Title
-----------------
A Prospective, Observational Study of Calcinosis in a Single-Center Population With Scleroderma-Spectrum Disorders

Conditions
-----------------
Scleroderma, Calcinosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult scleroderma subjects with and without calcinosis Exclusion Criteria: Subjects unwilling to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| risk factors and outcomes in scleroderma calcinosis | This is an observational study of scleroderma calcinosis to assess possible risk factors (including serologic studies and disease types) as well as common complications that occur in those with scleroderma calcinosis during this time period. We will assess for increased burden of calcinosis with associated musculoskeletal complications from calcinosis over 10 years. No additional intervention will be delivered, other than standard of care for this complication. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scleroderma, calcinosis
Study of Metformin Overdose

Study Overview
=================
Brief Summary
-----------------
The objective of the METINFO study is an observational single-center retrospective and descriptive study. The main objective is to estimate the real mortality rate associated to a Metformin overdose. Second objectives are to estimate the real hospitalization rate related to metformin overdose and to identify the risk factors of a metformin overdose and especially the potential correlation between metformin blood concentration and overdose severity.

Official Title
-----------------
Study of Metformin Overdose in Adult Patients Treated at the University Hospital of Nancy: Single-center Descriptive Retrospective Observational Study

Conditions
-----------------
Metformin Associated Lactic Acidosis

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients benifiting of a metformin blood concentration determination in the period ranging from the 1st of July 2019 and the 1st of July 2021. 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 |
| --- | --- |
| Therapeutic<br>Patients with metformin blood concentration in the therapeutic ranges. | Drug: Metformin<br>* Level of Metformin blood concentration<br>|
| Supratherapeutic<br>Patients with metformin blood concentration above the therapeutic ranges. | Drug: Metformin<br>* Level of Metformin blood concentration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of Mortality Rate |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of Hospitalization Rate |  | 2 years | 
| Identification of Risk Factors |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metformin, Lactic Acidosis, Causality assessment
Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus

Study Overview
=================
Brief Summary
-----------------
This study will be a randomized controlled trial in which there will be comparison of the effectiveness of Karydakis procedure and Limberg flap in treatment of sacrococcygeal pilonidal sinus

Official Title
-----------------
Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus

Conditions
-----------------
Pilonidal Sinus

Intervention / Treatment
-----------------
* Procedure: Karydakis procedure
* Procedure: Limberg Flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pilonidal sinus of any sex and aged 20 years or above Non infected pilonidal sinus Exclusion Criteria: Infected pilonidal sinus Uncontrolled diabetes Patient on immunosuppressive therapy

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Karydakis procedure<br>Karydakis Procedure: In this procedure the pilonidal sinus will be excised by semilunar incision so that the incision line closure will be away from midline. | Procedure: Karydakis procedure<br>* Pilonidal sinus will be excised by Karydakis procedure<br>|
| Active Comparator: Limberg Flap<br>Limberg Flap: In this procedure the pilonidal sinus will be excised by diamond shaped incision and the defect will be closed by random pattern flap. | Procedure: Limberg Flap<br>* Pilonidal sinus will be excised by Limberg Flap<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients presenting with recurrence of pilonidal sinus | Recurrence of Pilonidal Sinus(described as appearance of multiple discharging sinuses in operative site) after surgical procedure | 8 to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of weeks in which the operative wound will be healed | Duration of wound healing (complete epithelization of wound ) | 4 to 6 weeks | 
| percentage of patients developing postoperative pain | postoperative pain( measured by visual analog score with 1 being minimum score and 10 being maximum score) after surgery | 3 days |
A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This 2 part study will explore the pharmacodynamic effects of R1507 in breast cancer tumor cells in female patients with operable breast cancer. In the first part of the study, patients will receive a single dose of R1507, 16mg/kg iv, on day 1; pre-and post-treatment (at breast surgery on day 8) breast tissue samples will be obtained for measurement of IGF-1R expression. If sufficient biological activity is demonstrated, 3 additional cohorts of patients will be entered into Part 2 of the study, to receive a single dose of 9mg, 3mg/kg or 1mg/kg iv R1507, respectively. The anticipated time on study treatment is < 3 months, and the target sample size is <100 individuals.

Official Title
-----------------
An Exploratory Study to Evaluate the Biological Activity of R1507, a Human Monoclonal Antibody Antagonist of the Insulin-like Growth Factor Receptor (IGF-1R) in Women With Operable Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: RG1507


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients, >=18 years of age; invasive, and operable, breast cancer; ECOG Performance Status of 0 or 1. Exclusion Criteria: evidence of metastatic disease; inflammatory breast cancer; prior hormonal or systemic therapy for breast cancer; prior treatment with an agent targetting the IGF-1R pathway; patients receiving concurrent radiotherapy, or who have received radiotherapy within 28 days prior to receipt of study drug.

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RG1507<br>* 16mg/kg, 9mg/kg, 3mg/kg or 1mg/kg iv on Day 1 in one of 4 cohorts of patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in IGF-1R expression |  | From initial diagnosis to tumor excision | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue |  | Days 1, 8 and 31 | 
| Adverse events, laboratory parameters |  | Throughout study |
The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers

Study Overview
=================
Brief Summary
-----------------
Hypothesis Prediabetes patients who have insufficient sleep will have worse glucose tolerance than those with normal sleep duration. Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to a standardized meal

Official Title
-----------------
The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers

Conditions
-----------------
Prediabetes

Intervention / Treatment
-----------------
* Other: Oral glucose tolerance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with prediabetes (HbA1c 5.7-6.4% or history of fasting plasma glucose 100-125 mg/dl) who receive medical care at Ramathibodi Hospital Age 18 or older Can understand Thai (speaking, listening and reading) Agree to participate by written informed consent Exclusion Criteria: Those who depend on others for feeding (such as stroke patients) Shift workers History of congestive heart failure or low ejection fraction Chronic obstructive pulmonary disease, end stage renal disease or chronic liver disease (AST or ALT > 3 times the upper limit of normal) Use of medications: opioids/ narcotics , alpha blockers (prazosin, doxazosin, terazosin), clonidine, methyldopa, nitroglycerin Patients with permanent pacemaker History of previous stroke

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Sleepers<br>Prediabetes patients with normal sleep duration (7-8 hours/ night) as measured objectively | Other: Oral glucose tolerance<br> <br> |
| Experimental: Short Sleepers<br>Prediabetes patients with short sleep duration (<6 hours/night) as measured objectively | Other: Oral glucose tolerance<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GLP-1 Levels in Response to Oral Glucose Tolerance Test | Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prediabetes, Short sleepers, GLP-1