linjc16/ctgov huggingface dataset:
Metal Ion Serum Concentrations in Patients With Total Hip Replacements

Study Overview
=================
Brief Summary
-----------------
Other research studies have shown that the levels of metals in the blood are slightly increased after patients receive a total hip replacement. We want to learn whether these elevated levels are associated with any adverse effects. We hope this study will help us identify which type of patients have elevated levels of metal in their blood.

Detailed Description
-----------------
It is suspected that the concentration of the metals chromium, cobalt and titanium in the blood will be higher in people with an all metal total hip prosthesis than in those with a plastic and metal prosthesis. To find out if this is true, we will test blood samples for the levels of metal in the blood and compare the values from 3 groups of people: people with metal on metal hip replacements loosening of a plastic and metal prosthesis and evidence of osteoarthritis and are awaiting a total hip replacement.

Official Title
-----------------
Cobalt, Chromium and Titanium Serum Concentrations in Patients With Metal-on-Metal vs. Metal on Polyethylene Total Hip Replacements

Conditions
-----------------
Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group 1 - unilateral hip replacement with metal on metal prosthesis, well functioning. Group 2 - loosening of plastic and metal prosthesis Group 3 - osteoarthritis of the hip and awaiting total hip replacement Exclusion Criteria: renal dysfunction other types of metal implants or dental prostheses rheumatoid arthritis hip infection

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?
-----------------
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
-----------------
metal ion concentration
Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)

Study Overview
=================
Brief Summary
-----------------
IMPAHCT-FUL: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (LTE) Trial is a follow up study to establish the long-term safety of AV-101. The long-term effects of AV-101 on efficacy measures will also be assessed. Subjects who successfully complete the 24-week placebo-controlled parent trial (AV-101-002) will be offered the opportunity to continue into this LTE study. Subjects who enroll in the study will receive one of three active AV-101 doses until such time as the optimal dose has been selected in the parent study.

Official Title
-----------------
A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002 (IMPAHCT-FUL)

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: AV-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: To be eligible, a participant is required to be or have: Consented to participate in the LTE and has successfully completed the placebo-controlled 24-week Study AV-101-002. Key Exclusion Criteria: Subjects meeting any of the following criteria: The Investigator believes that it would not be in the best interest of the subject to be included in the LTE e.g., for clinical or social reasons. Subjects who were not compliant with study medication in AV-101-002 as assessed by the Investigator.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low dose AV-101<br> | Drug: AV-101<br>* AV-101 (imatinib) administered via dry powder inhalation<br>|
| Experimental: medium dose AV-101<br> | Drug: AV-101<br>* AV-101 (imatinib) administered via dry powder inhalation<br>|
| Experimental: high dose AV-101<br> | Drug: AV-101<br>* AV-101 (imatinib) administered via dry powder inhalation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AV-101 | as measured by Incidence of Adverse Events | Through Study completion, anticipated to be approximately 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lungs, Pulmonary Arterial Hypertension, Pulmonary, PAH, AV-101, IMPAHCT-FUL, imatinib, IMPAHCT
Incidence of Venous Thromboembolism and Professional Practices in Brest Area

Study Overview
=================
Brief Summary
-----------------
The aim of this study estimate VTE incidence. Investigators prospectively record all cases of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) of the lower limbs diagnosed between March 1, 2013 and February 28, 2014 in hospitals and in the community.

Conditions
-----------------
Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) diagnosis confirmed Patient living in Brest area from time of diagnosis Exclusion Criteria: invalid diagnosis asymptomatic event Main residence patient out of Brest area.

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 |
| --- | --- | --- |
| Gathering information about potential factors predisposing Thromboembolic disease and treatments undertaken. | After two years, all medication given to the patient to treat his initial VTE will be recorded, as well as the ongoing of thromboembolic disease | two years after VTE | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous Thromboembolism, professional Practices
Clinical Outcomes of Peroral Endoscopic Myotomy

Study Overview
=================
Brief Summary
-----------------
Esophageal outflow obstruction is characterized by failure to relax the lower esophageal sphincter (LES), resulting in impaired flow of ingested food into the stomach. The subsequent stasis of ingested food leads to symptoms of dysphagia, regurgitation, chest pain, and weight loss. The core objective of the treatment of esophageal outflow obstruction is to disrupt the LES and reduce its pressure to allow esophageal emptying. Therapeutic options include pharmacologic therapy, Botulinum toxin injection, pneumatic balloon dilation, and surgical myotomy with partial fundoplication. In addition, peroral endoscopy myotomy (POEM) has recently been introduced as a minimally invasive treatment, but there have a few studies regarding long-term outcomes. The aim of this study is to evaluate clinical outcomes of POEM for esophageal outflow obstruction.

Detailed Description
-----------------
Prospective study

Official Title
-----------------
Clinical Outcomes of Peroral Endoscopic Myotomy for Esophageal Outflow Obstruction

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Other: peroral endoscopic myotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were diagnosed as esophageal outflow obstruction Patients with informed consent Exclusion Criteria: Diagnostic uncertainty Patients who are not suitable for general anesthesia

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Peroral endoscopic myotomy (POEM)<br>Patients who received POEM | Other: peroral endoscopic myotomy<br>* The procedure consists of four steps: 1) mucosal incision 10-15 cm above the esophagogastric junction to allow entry into the submucosa, 2) creation of a submucosal tunnel until the lower esophageal sphincter is reached, 3) myotomy of the circular muscle layer, and 4) closure of the mucosal entry with endoclips.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with Eckardt score <3 after the procedure |  | 1 month after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events which are related to the procedure |  | within 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
achalasia, POEM, outcome
An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).

Official Title
-----------------
An Open-Label, Long-Term, Extension Study to Evaluate the Safety and Efficacy of KRN23 in Adult Subjects With X-Linked Hypophosphatemia

Conditions
-----------------
X-linked Hypophosphatemia

Intervention / Treatment
-----------------
* Drug: KRN23


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Satisfactory completion of KKP's sponsored KRN23-INT-001 clinical trial eGFR ≥ 60 mL/min Corrected Ca < 10.8 mg/dL For female of child-bearing potential, a negative serum pregnancy test A willingness to utilize adequate contraception and not become pregnant [or to have their partner(s) become pregnant] during the study Additional inclusion criteria apply Exclusion Criteria: Subject experienced a safety-related event in the KRN23-INT-001 study Pregnant or lactating female subject or pregnant or female planning to become pregnant during the study Receipt of a live (attenuated) vaccine (except for influenza vaccines) during the course of the KRN23-INT-001 study and/or of this study Condition which could present a concern for either the subject's safety or difficulty with data interpretation Additional exclusion criteria apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KRN23<br>Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses) | Drug: KRN23<br>* Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Efficacy of Repeated SC Injections of KRN23. | Safety and efficacy of repeated SC injections of KRN23, from Baseline, as assessed by serum phosphorus levels, immunogenicity, adverse events and clinically significant changes in vital signs and laboratory testing. | 13.5 months,(50 visits) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Effect of Repeated SC Injections of KRN23 | Effect of repeated SC injections of KRN23, from baseline, on pharmacodynamic parameters (serum phosphorus) | 13.5 months, (50 visits) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
XLH
Effect of Polymorphisms in the IL-1 Gene Complex on the Development of Chronic Hepatitis and Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of polymorphisms in the IL-1 gene complex on the development of chronic hepatitis and hepatocellular carcinoma.

Detailed Description
-----------------
We analyzed single-nucleotide polymorphisms in the genes for interleukin-1a, interleukin-1b, interleukin-1-receptor antagonist, interleukin-1-receptor type I, and interleukin-1-receptor type II in 400 normal control and patients (chronic hepatitis and hepatocellular carcinoma). Genotypes were tested for an association with development of chronic hepatitis and hepatocellular carcinoma by multivariable analysis. A second cohort of 1200 normal control and patients (chronic hepatitis and hepatocellular carcinoma) was independently analyzed for the genotype associations identified in the first cohort.

Official Title
-----------------
Effect of Polymorphisms in the IL-1 Gene Complex on the Development of Chronic Hepatitis and Hepatocellular Carcinoma

Conditions
-----------------
Carcinoma, Hepatocellular, Hepatitis B, Polymorphism, Genetic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal controls Cases of chronic hepatitis and hepatocellular carcinoma Exclusion Criteria: Pregnant women

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?
-----------------
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
-----------------
Hepatitis B, Carcinoma, Hepatocellular, Polymorphism, Genetic
Safety and Efficacy of Bimatoprost/Timolol (Ganfort®) Ophthalmic Solution in Korea

Study Overview
=================
Brief Summary
-----------------
This study is a Post-Marketing Surveillance study to evaluate the safety and efficacy of bimatoprost/timolol (Ganfort®) Ophthalmic Solution to treat open-angle glaucoma or ocular hypertension in Korea.

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: bimatoprost/timolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with Ganfort® for open-angle glaucoma or ocular hypertension in clinical practice. 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 |
| --- | --- |
| Ganfort®<br>Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice. | Drug: bimatoprost/timolol<br>* Bimatoprost/timolol (Ganfort®) treatment for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.<br>* Other names: Ganfort®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events and Adverse Drug Reactions | An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded. | Up to 51 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicated an improvement. The median total treatment duration for participants was 63.0 days. | Baseline, Week 4 |
Phase I Multiple-Ascending Dose (Japan)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin in diabetic Japanese subjects administered for 14 days

Official Title
-----------------
A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Dapagliflozin in Diabetic Japanese Subjects

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Dapagliflozin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese male and female subjects Ages 20 to 70 years old Established diagnosis of T2DM BMI < 32 kg/m2 Fasting glucose ≤ 240 mg/dL, while on antidiabetic diet alone HbA1C 6.0 - 10.0% Exclusion Criteria: Symptomatic T2DM defined as polyuria and/or polydipsia within 2 months of enrollment History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome History of incontinence or bladder dysfunction including nocturia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>2.5 mg | Drug: Dapagliflozin<br>* Tablets, Oral, once daily up, to 14 days<br>|
| Experimental: Arm 2<br>10 mg | Drug: Dapagliflozin<br>* Tablets, Oral, once daily up, to 14 days<br>|
| Experimental: Arm 3<br>20 mg | Drug: Dapagliflozin<br>* Tablets, Oral, once daily up, to 14 days<br>|
| Placebo Comparator: Arm 4<br> | Drug: placebo<br>* Tablets, Oral, 0 mg, once daily, up to 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, vital signs & physical exam |  | scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21 | 
| ECGs |  | scr, Days -1, 1, 2, 7, 12, 13, 14, 15, 21 | 
| Clinical labs |  | scr, Days -1, 2, 7, 12, 14, 15, 21 | 
| Urine safety markers |  | Days -1, 1, 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hr PK blood & urine samples |  | Days 1 & 14 | 
| Serum glucose, serum insulin, serum c-peptide |  | Days -1, 1, 14 | 
| Serum fructosamine |  | Days -1, 14, 4 h | 
| OGTT |  | Days -2, 13 (after 10 h fast) | 
| 24h urine |  | Days -1, 1 & 14 for glucose, creatinine & calcium |
Outcome Study of Complex Distal Radius Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information about how people do after different treatments of a broken wrist to see if one treatment has better results.

Detailed Description
-----------------
Complex distal radius fractures are a common problem treated by orthopaedic surgeons. The purpose of this study is to compare the outcome between complex distal radius fractures treated with open reduction and internal fixation using a volar fixed angled plate versus and external fixator versus DRV. The hypothesis is that the volar fixed angled plate will have a superior outcome both radiographically and clinically.

Official Title
-----------------
Outcome Study of Complex Distal Radius Fractures: Open Reduction Internal Fixation (ORIF) With A Volar Fixed Angled Plate Versus A Distal Radius Volar (DRV) Plate Versus External Fixation

Conditions
-----------------
Distal Radius Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: distal radius fracture Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Wrist Range of Motion | An improvement of all aspects of wrist motion (extension, flexion, supination and pronation) over one year post-op. | one year post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of the Arm, Shoulder and Hand (DASH) and Patient Rated Wrist Evaluation (PRWE) scores | An improvement of the DASH and PRWE scores over one year post-op. | one year post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
distal, radius, fractures