linjc16/ctgov huggingface dataset:
Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
This study investigates the effect of vildagliptin, an inhibitor of the enzyme DPP-4, on the cognitive functioning of elderly diabetic patients with mild cognitive impairment (MCI) documented at mini mental state examination (MMSE). In this prospective study, 60 diabetic elderly people were enrolled and divided according to their glycated hemoglobin (HbA1c) values in 2 groups: Group A, (HbA1c <7.5%, n=30) treated with metformin, and Group B (HbA1c >7.5%, n=30) treated with metformin plus vildagliptin. We evaluated MMSE, fasting plasma glucose (FPG) and HbA1c at baseline and after 24 weeks treatment.

Official Title
-----------------
Effects of Vildagliptin, a DPP-4 Inhibitor, in Elderly Diabetic Patients With Mild Cognitive Impairment

Conditions
-----------------
Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Drug: Vildagliptin 50 MG Oral Tablet
* Drug: Metformin Pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >65 years MMSE score ≥18 and ≤23 diagnosis of diabetes mellitus Exclusion Criteria: heart failure coronary heart disease stroke chronic kidney disease (G3 grade KDOQI) liver cirrhosis chronic respiratory failure depression evaluated by Geriatric Depression (GDS, GDS >15) diagnosis of dementia based on DSM 5 criteria anticholinesterase or memantine therapy

Ages Eligible for Study
-----------------
Minimum 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br>metformin 1 g twice a day for 24 weeks | Drug: Metformin Pill<br> <br> |
| Experimental: Metformin plus vildagliptin<br>metformin 1 g plus vildagliptin 50 mg twice a day for 24 weeks | Drug: Vildagliptin 50 MG Oral Tablet<br> <br> Drug: Metformin Pill<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of cognitive decline | Mini Mental State Examination (MMSE) score from 0 (worse) to 30 points (better). Score ≥18 and ≤23 indicates mild cognitive impairment (MCI). | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Glycated hemoglobin (%) | Laboratory assessment of Glycated hemoglobin | 24 weeks |
Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work

Study Overview
=================
Brief Summary
-----------------
Thoracic outlet syndrome may associate neurologic, arterial and venous symptoms. The responsibility of repetitive movements and postural factors has been mentioned for long. Some tasks are hard to perform, and it seemed interesting to assess the consequences of this syndrome on the work capacity by a questionnaire, at the moment of diagnosis by Echo-Doppler

Official Title
-----------------
Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work

Conditions
-----------------
Thoracic Outlet Syndrome

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A stenosis of at least 80% of arterial stenosis at Echo-Doppler examination during abduction-retropulsion of the arm Actually employed or having been employed Exclusion Criteria: Cognitive or mental impairment Illiteracy Visual impairment Patients having been diagnosed with fibromyalgia, chronic fatigue syndrome or ehler-Danlos syndrome

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with suspicion of thoracic outlet syndrome<br> | Other: questionnaire<br>* Assessment of the impairment at work by a specific auto- questionnaire given after echo-Doppler that confirm the diagnosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of an impairment at work |  | Baseline: one session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of job loss |  | Baseline: one session | 
| Frequency of income loss |  | Baseline: one session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic outlet syndrome, Performance at work
Melanoma Inhibitory Activity (MIA): A Serological Marker for Metastatic Uveal Melanoma

Study Overview
=================
Brief Summary
-----------------
Uveal Melanoma is the most common primary intraocular tumor in adults. Most tumors metastasize to the liver. So far no sensitive or specific serological tumor marker is routinely used. The marker Melanoma inhibitory activity is a promising marker. Study hypothesis is to detect metastatic lesions in an early stage. This would increase life expectance of our patients

Detailed Description
-----------------
Serum is taken from each melanoma patient at every follow up after signed concent. With ELISA the marker MIA is evaluated. An increase of MIA serum level will lead to search for metastasis by oncologists.

Conditions
-----------------
Melanoma, Radiotherapy, Metastatic Disease

Intervention / Treatment
-----------------
* Procedure: Treatment of metastatic disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: uveal melanoma (With/without overt metastatic disease)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Treatment of metastatic disease|nan|

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
-----------------
uveal melanoma, metastatic disease
COX-2 Inhibitor With Concurrent Chemoradiation in Locally Advanced Head & Neck Carcinoma

Study Overview
=================
Brief Summary
-----------------
chemotherapy- and radiotherapy-induced oral mucositis represents a therapeutic challenge frequently encountered in cancer patients.This side effect causes significant morbidity and may delay or interrupt the treatment plan, as well reduce therapeutic index. cyclo-oxygenase 2 (COX-2) is an inducible enzyme primarily expressed in inflamed tissues and tumor. COX-2 inhibitors have shown promise as radio- and chemosensitizer and reduce radio-induced toxicities. we have conducted a phase III, randomized double blind clinical trial to evaluate the toxicity and efficacy of celecoxib, a selective COX-2 inhibitor, administered concurrently with chemotherapy, and radiation for locally advanced head and neck cancer.

Official Title
-----------------
the Role of COX-2 Inhibitor(CELECOXIB) in Combination With Chemoradiation in Locally Advanced Head & Neck Carcinoma, Phase III Randomized Clinical Trial

Conditions
-----------------
Head and Neck Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage III/IV (locally advanced) carcinoma of oropharynx, oral cavity, hypopharynx, larynx, or nasopharynx primary treatment with chemoradiation Exclusion Criteria: distant metastasis incomplete treatment adjuvant chemoradiation after surgery without apparent tumor

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: celecoxib<br>* 100 mg qid<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* 1 cap qid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of celecoxib (response rate and local control) |  | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity of celecoxib |  | 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COX2 inhibitor, head and neck cancer, chemoradiation
AnalyST Treadmill Study

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to collect information on the naturally occurring variations in ST deviations at different heart rates, as detected by the AnalyST and AnalyST Accel Implantable Cardioverter Defibrillators (ICD).

Official Title
-----------------
Clinical Evaluation of ST Segment Deviation Detection by SJM AnalyST and Analyst Accel Implantable Cardiac Defibrillators

Conditions
-----------------
Ischemic Heart Disease

Intervention / Treatment
-----------------
* Device: ICD Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has received or is scheduled to receive a St Jude Medical AnalyST or AnalyST Accel ICD; Patient has documented ischemic heart disease. Exclusion Criteria: Patient has an indication for ventricular pacing; Patient has chronotropic incompetence or insufficiency; Patient has a contraindication to stress testing; Patient is physically unable to complete the stress test protocol; The patient has persistent or permanent atrial fibrillation (AF); Patient is unable to comply with the protocol and follow-up schedule based on geographic location or for any reason; Patient is pregnant; Patient is minor (< 18 years old).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ICD Implant<br>Implantation of a commercially available AnalyST or AnalyST Accel ICD | Device: ICD Implantation<br>* Implantation of a commercially available AnalyST or AnalyST Accel ICD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of start and duration of isoelectric PR intervals |  | 4 weeks | 
| Evaluation of start and duration of ST intervals |  | 4 weeks | 
| Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device |  | 4 weeks | 
| Incidence of ischemic events detected based on the external ECG |  | 4 weeks |
Radiation-Induced Cytokine Cascades and Their Correlation With Central Nervous System Injury

Study Overview
=================
Brief Summary
-----------------
Treatment for brain cancer may include radiation therapy. Radiation therapy is the treatment of tumors with X-rays. This study is related to understanding the side effects of radiation treatment for brain tumors. This study is being conducted by the University of Rochester Cancer Center to compare the extent of side effects of brain cancer treatment with changes in levels of blood proteins called cytokines.

Official Title
-----------------
Radiation-Induced Cytokine Cascades and Their Correlation With Central Nervous System Injury

Conditions
-----------------
Brain Neoplasm

Intervention / Treatment
-----------------
* Radiation: Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient who will be treated to the brain or spinal axis for a CNS tum Patients so treated will be stratified according to whether or not the hypo is included in the treatment fields. Patients receiving external beam radiation to the brain may also be rece chemotherapy or interferon-beta. (Add. #1, 11-9-95) Patients receiving high dose rate (stereotactic radiosurgery) are eligible. Patients must sign a study specific informed consent meeting all federal a guidelines. Patients of any age, including children, are eligible (Add. #3, 11/25/97). Exclusion Criteria: Patients who have a malignancy involving the hypothalamic-pituitary ax Patients who are not treated with irradiation to the brain or spinal axis.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Radiation Therapy|standard of care for the cancer being treated|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Cytokine blood levels |  | 12 weeks from start of radiation |
Acupressure to Treat Nausea and Vomiting in HIV/AIDS Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether acupressure (acupuncture using pressure applied by the hands instead of needles) can help nausea and vomiting in persons with HIV/AIDS.

Detailed Description
-----------------
This is a Phase I trial (a study to evaluate effectiveness in a small number of patients). Patients will get 4 acupressure treatments and will wear acupressure wristbands for 1 week. Patients will write down all drugs they take and will make a note of when they get nausea and vomiting. They also will give written answers to different questions. No drugs will be given as part of this study. Patients will be paid for participating.

Official Title
-----------------
The Acupressure Study

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Procedure: Acupressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are HIV-positive. Have nausea and/or vomiting an average of 2 times per day for at least 1 week.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Acupressure|nan|

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
-----------------
complementary therapies, Acupressure, HIV Infections, Nausea, Vomiting
Contribution of PRF in CDH in Children With Prothetic Patch Closure

Study Overview
=================
Brief Summary
-----------------
Improved management of giant congenital diaphragmatic hernias (CDH) in neonates : decreased risk of morbidity and mortality due to prosthesis release. CDH is a rare disease with a still very dark prognosis, with a high rate of morbidity and mortality in giants forms linked to the release of insufficiently biologically integrated prosthesis. The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.

Official Title
-----------------
Contribution of PRF (Platelet Rich Fibrin) in the Biological Functionalization of Prothetic Patch Closure : in Vitro Study

Conditions
-----------------
Congenital Diaphragmatic Hernias

Intervention / Treatment
-----------------
* Biological: Biological functionalization of the prosthetic materials by PRF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Healthy Volunteers : - Over 18 years of age Neonates: Aged between 1h of life and 28 days of life Born beyond 33 Week of Amenorrhea + 1day and 2kg of birth weight Hospitalized in the medical-surgical centre of Pediatrics of the hospital of Strasbourg For whom a blood sample was prescribed as part of their routine care Exclusion Criteria: Adult Healthy Volunteers : Systemic inflammatory disease Transient inflammatory state Any drug that modifies the coagulation cascade during the 48h preceding the sampling Neonates: Risk of anemia < 7g/DL Current anticoagulant treatment

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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 |
| --- | --- |
| Other: Adult Healthy Volunteers<br> | Biological: Biological functionalization of the prosthetic materials by PRF<br>* The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.<br>|
| Other: Neonates<br> | Biological: Biological functionalization of the prosthetic materials by PRF<br>* The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of cell colonization between neonate biomaterials and the same biomaterials functionalized by Platelet Rich Fibrin of healthy adult volunteers. | Analysis of cell colonization after cell culture. | 7 days |
Study to Evaluate Biomarkers and Clinical Manifestations in Individuals With Glycogen Storage Disease Type III (GSD III)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate potential biomarkers of GSD III.

Official Title
-----------------
Clinical Survey Study to Evaluate Biomarkers and Clinical Manifestations in Individuals With Glycogen Storage Disease Type III (GSD III)

Conditions
-----------------
Glycogen Storage Disease Type III

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed historical diagnosis of GSD III based on pathogenic mutations in the AGL gene on both alleles or GDE deficiency based on biopsy of liver, muscle, or fibroblasts Willing to comply with all study procedures Willing and able to provide written informed consent. If a minor, willing and able to provide written assent and have a legally authorized representative willing and able to provide written informed consent Exclusion Criteria: Presence or history of any condition that, in the view of the Investigator, places the subject at high risk of poor study compliance, interferes with study participation, or interferes with the subject's ability to safely or reliably complete the study assessments Use of any IP within 30 days prior to informed consent/assent or at the time of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No Intervention|No Intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine hexose tetrasaccharide (Hex4): mean and variance |  | Up to Day 35 |
Percutaneous Nephroscopic Treatment of Parapelvic Cysts

Study Overview
=================
Brief Summary
-----------------
Background of the project: The surgical treatment of parapelvic cysts is currently less researched and there is no gold standard for surgery. Previously, in percutaneous nephrolithotomy, we found that fenestration and fenestration drainage in the simultaneous treatment of pararenal pelvis cysts under nephroscopic nephroscopic surgery has clear curative effect, less trauma, and quicker recovery. Objective: To clarify the safety, efficacy and long-term efficacy of percutaneous nephroscopy in the treatment of parapelvic cysts. Nature: Retrospective case cohort study. Basic research process: Retrospective collection of cases in our hospital who underwent percutaneous nephroscopy for the treatment of parapelvic cysts, and comparison of preoperative and postoperative cyst size changes and long-term efficacy.

Official Title
-----------------
Feasible Surgical Treatment of Peripelvic Cyst by Percutaneous Nephroscopy

Conditions
-----------------
Parapelvic Cyst, Kidney Stone, Kidney Diseases, Recurrence

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Has undergone percutaneous nephroscopic surgery for parapelvic cysts Ability to receive study follow-up Exclusion Criteria: Patient refuses or is unable to give consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Parapelvic cyst<br> | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cyst size | Cyst maximum plane diameter | At least 1 year after percutaneous nephroscopy for parapelvic cysts | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parapelvic Cyst, Recurrence, Kidney Diseases