linjc16/ctgov huggingface dataset:
Evaluate the Effect of Saxagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The intestinal microflora imbalance has been associated with obesity and type 2 diabetes. The researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in patients with newly diagnosed type 2 diabetes.

Official Title
-----------------
Beijing Chao-yang Hospital, Capital Medical University

Conditions
-----------------
Type 2 Diabetes, Obesity

Intervention / Treatment
-----------------
* Drug: Saxagliptin (Bristol-Myers Squibb Company)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females or males, and aged 20 to 65 years. Newly diagnosed type 2 diabetes HbA1C ≥7% and HbA1C <9% Exclusion Criteria: Hepatic insufficiency (ALT or AST> 1.5*ULN) Renal insufficiency [Creatinine clearance rate (Ccr)]<60ml/min estimated from MDRD equation) Coronary artery disease Thyroid disease Infectious disease Systemic inflammatory disease Cancer Subjects who were taking agents known to influence gut microbiota Pregnant or lactating woman Other conditions at investigator's discretion

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention<br> | Drug: Saxagliptin (Bristol-Myers Squibb Company)<br>* 6-month treatment of Saxagliptin 5mg Qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gut microbiota |  | Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement of intestinal microflora imbalance |  | Bacteroidetes abundances and composition of gut microbiota (baseline, 4 weeks, 8 weeks and 12 weeks) | 
| The change of inflammatory markers | The effect on plasma levels of inflammatory markers, such as IL-1B, IL-6 and TNF-α(baseline, 12 weeks) | The change of inflammatory markers (baseline, 12 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gut Microbiota, inflammatory marker, Glucose and lipid metabolism
Double Trigger in Patients With Low Proportion of Mature Oocytes

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized controlled trial is to determine whether co-administration of GnRH agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval , respectively) can increase the number of mature oocytes in patients with history of low proportion of mature oocytes in previous IVF cycle triggered by HCG.

Official Title
-----------------
Double Trigger in Patients With Low Proportion of Mature Oocytes. A Randomized Controlled Trial

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Drug: Double trigger
* Drug: HCG trigger


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with history of low proportion of mature oocytes in previous IVF attempt (triggered by HCG). Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET attempt Exclusion Criteria: Endometriosis PCOS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double trigger<br>GnRH-agonist and HCG are used to trigger ovulation | Drug: Double trigger<br>* Final follicular maturation is triggered by the coadministration of GnRH-agonist (Triptorelin acetate, decapeptyl 0.2 mg, Slough, United Kingdom) and 10000 IU of HCG, 40 and 34 h prior to oocyte retrieval, respectively<br>|
| Active Comparator: HCG<br>HCG is used to trigger ovulation | Drug: HCG trigger<br>* Final follicular maturation is triggered by a dose of 10000 IU of HCG 36 h prior to oocyte retrieval<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  | First day after oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | The presence of gestational sac detected by ultrasound examination | First 5 weeks after oocyte retrieval | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, HCG, GnRH agonist trigger
Effect of Epidermal Growth Factor Receptor Inhibitors on Magnesium Homeostasis in Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer receiving epidermal growth factor receptor inhibitors may help doctors understand the effect of epidermal growth factor receptor inhibitors on magnesium levels in the body. PURPOSE: This laboratory study is looking at the effect of epidermal growth factor receptor inhibitors on magnesium homeostasis in patients with cancer.

Detailed Description
-----------------
OBJECTIVES: Determine the effects of EGFR inhibitors on magnesium homeostasis in patients with cancer. OUTLINE: This is a pilot study. Patients undergo blood and urine sample collection at baseline and at 2, 4, and 8 weeks during treatment. After finishing treatment, patients are followed periodically for up to 10 weeks.

Official Title
-----------------
Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on Magnesium Homeostasis

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of malignancy Planning to receive therapy with an inhibitor of the EGFR pathway (either on or off a clinical trial and may be monotherapy or combined with other therapies) Normal serum magnesium level Exclusion Criteria: Glomerular filtration rate ≥ 60 mL/min No severe underlying renal dysfunction Normal serum potassium and calcium level No history of primary or secondary hyperparathyroidism PRIOR CONCURRENT THERAPY: No prior EGFR pathway inhibitor

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: laboratory biomarker analysis|laboratory biomarker analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of EGFR inhibitors on magnesium homeostasis |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific
Observational Study of the Development of Low Back Pain After Total Hip Arthroplasty.

Study Overview
=================
Brief Summary
-----------------
The investigators are going to observe the appearance of low back pain in patients who have undergone hip prosthesis surgery.

Official Title
-----------------
Development of Low Back Pain After Total Hip Arthroplasty.

Conditions
-----------------
Low Back Pain, Hip Osteoarthritis, Arthropathy of Hip

Intervention / Treatment
-----------------
* Procedure: Total hip arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age and under 70 years of age, intervened by CTA due to OAC since January 1, 2010 and before January 1, 2021 and who have developed subsequent lumbar pathology. Exclusion Criteria (relative/absolute): Under 18 years of age at the time of the intervention. Over 70 years of age at the time of surgery. Previous low back pain. Bilateral CTA. Previous lower limb or axial fracture. Dysmetria. Vertebral surgery prior to CTA. Scoliosis. Scheuermann's disease. Neoplasms affecting axial skeleton. Bone infections. Neurodegenerative disease. CTA secondary to fractures. CTA replacements.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Total hip arthroplasty|hip prosthesis surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of patients with low back pain | First episode of low back pain | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Low back pain, Psoas muscle, Hip arthroplasty
Endostar Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III NSCLC

Study Overview
=================
Brief Summary
-----------------
The chemoradiotherapy (CCRT) is still a standard treatment for the unresectabl stage III NSCLC.However, prognosis following this treatment is generally poor, with 5-year survival of 15-20%. The result of published HELPER study had showed that Endostar, a kind of angiogenesis agent, in combination with CCRT could improve the efficacy and safety. In order to verify the rusults, the investigators design the current study.

Detailed Description
-----------------
The current study is a observation study in the real world setting. The 500 patients in compliance with Enrollment Criteria will be as the objects of observation. The procedure of study include the period of screening, treating and follow-up. The duration of study is about two and half year. The data entrying will be done by CRC, using the EDC system. CRA will audit the quality of data regularly.

Official Title
-----------------
A Multicenter, Prospective Real World Study on Recombinant Human Endostatin (Endostar) Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III Non-small-cell Lung Cancer

Conditions
-----------------
Unresectable Stage III NSCLC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: untreated pathologically confirmed inoperable stage III NSCLC according to the 8th edition of the American Joint Committee on Cancer staging system; at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)1.1; 18-75 years of age; Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1; 10) FEV1>1.0 L; suitable function of bone marrow, liver, kidney and coagulation Exclusion Criteria: history of other malignant diseases, uncontrolled hypertension, any contraindications to chemoradiotherapy, pregnancy, breastfeeding or preexisting bleeding diatheses. -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progress free survival | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | 3 years | 
| LRFS | Locoregional relapse-free survival | 2 years | 
| DMFS | Distant metastasis-free survival | 2 years | 
| AEs | adverse events | 3 years |
Registry of Right-to-left Shunt Detection by Contrast-enhanced Transcranial Doppler in Chinese Population

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the prevalence and extent of right-to-left shunt (RLS) in Chinese migraineurs, and the morbidity of silent cerebral infarction in migraineurs.

Detailed Description
-----------------
This is a prospective multicenter study of Chinese population. Participants (normal individuals without migraine and migraineurs) are included after standardized diagnostic procedures (TCD and c-TCD). For migraineurs with large RLS further examinations (c-TTE and brain MRI) are required. Up to 10 study sites nationwide will be needed to recruit the planned participant population during a 1-year period. The information of each participants will be registered, including basic facts, the longitudinal headache history, frequency, location, quality, intensity, duration, accompanied symptoms, precipitating and exacerbating factors, with or without aura, MIDAS and HIT-6 questionnaire.

Official Title
-----------------
Registry of Right-to-left Shunt Detection by Contrast-enhanced Transcranial Doppler in Chinese Population

Conditions
-----------------
Right-to-left Shunt, Migraine, Cerebral Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For group 1: Normal healthy individual without migraine. For group 2: Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders. Exclusion Criteria: Subjects with stenotic intracranial or extracranial arteries or intracranial abnormalities diagnosed with TCD.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 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 |
| --- | --- |
| group 1<br>Normal individuals without migraine | |
| group 2<br>Migraineurs | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contrast-enhanced transcranial Doppler |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain MRI |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
right-to-left shunt, contrast-enhanced transcranial Doppler, migraine, silent cerebral infarction
A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.

Official Title
-----------------
Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: LBAL
* Drug: Humira®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female patients from 20 years to 75 years of age when signing Informed Consent. Diagnosed as having RA (Rheumatoid Arthritis) according to the revised 1987 ACR (American College of Rheumatology) criteria for at least 3 months prior to screening Patients who have inadequate response to MTX administered for at least 12 weeks before the beginning of screening period and on a stable dose. Exclusion Criteria: patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-γ release assay at screening patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease patients with any seropositive result for hepatitis B or hepatitis C or HIV patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBAL<br>Adalimumab | Drug: LBAL<br>* Adalimumab<br>|
| Active Comparator: Humira®<br>Adalimumab | Drug: Humira®<br>* Adalimumab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAS28-ESR | DAS is a combined index to measure the disease activity in patients with Rheumatoid Arthritis (RA). DAS28-ESR is calculated by assessing the number of swollen and tender joints (among 28 joints) and measuring the ESR. | Week 24 |
Long-term Follow-up Observation After Surgical Treatment of Peri-implantitis in Multicenter Post Market Clinical Study

Study Overview
=================
Brief Summary
-----------------
The objective of this non-interventional long-term follow-up observation is to evaluate the long-term sustainability of two surgical treatments of peri-implantitis with and without Geistlich Bio-Oss® and Geistlich Bio-Gide® from a previous study

Detailed Description
-----------------
The study is a non-interventional long-term follow-up observation without any study specific procedure outside normal clinical routine. Patients from a previous study are selected to participate in this study within a standard maintenance Programm. Primary and secondary oucomes refer to the previous study

Official Title
-----------------
Non-interventional Long-term Follow-up Observation After Surgical Treatment of Peri-implantitis in Multicenter Post Market Clinical Follow-up (PMCF) Study 13.530.231

Conditions
-----------------
Peri-implantitis

Intervention / Treatment
-----------------
* Other: observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implant survival at the treated site from the previous study Written informed consent Exclusion Criteria: Implant failure at the treated site Severe trauma to implant site causing removal of the implant since the last visit of previous study

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 |
| --- | --- |
| Defect Fill.<br>Observational study of the patients that were treated with biomaterials at the surgery in the previous study | Other: observational study<br>* Observational study<br>|
| No defect Fill.observational<br>Observational study of the patients that were not treated with biomaterials at the surgery of te previous study | Other: observational study<br>* Observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defect fill | The primary outcome measure will be the change of bone levels(defect fill) over 2 years starting 1 year after surgical Intervention as assessed from intra-oral radiographs. In particular, the distances between the most apical implant to bone contact level and a characteristic reference point being the same for all sets of radiographs will be measured. The distance equal to three implant threads (known for the implant system) will be measured with a specific Software. The deeper bone level at baseline will be considered | 2 years after the start of the study |
The Meaning of Suicidality for Older Persons With Suicidal Tendencies and Their Families

Study Overview
=================
Brief Summary
-----------------
The purpose of the proposed study is to examine the phenomenon of suicidality in old age and its unique characteristics. This will be performed through observing the multigenerational aging family from the life-course perspective, which enables the researchers to address life transitions, including crises leading to suicidal tendencies.

Conditions
-----------------
Suicide, Aged, Family

Intervention / Treatment
-----------------
* Other: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hebrew speaking Suicidal Families of elderly suicides Cognitive ability Exclusion Criteria: All others

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Suicidal older persons and their families<br>Suicidal older persons and their families will be interviewed | Other: Interview<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understanding older persons experiencing suicidality and their families | In-depth interviews with older persons experiencing suicidality and their families - in order to understand them. | One and a half hours |