linjc16/ctgov huggingface dataset:
Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)

Study Overview
=================
Brief Summary
-----------------
The study is an observational, multicenter, prospective cohort study aimed at evaluating a 5-year screening programme for chronic kidney disease(CKD) in a population of elderly patients, aged 65 years or more, in China.To analyze the etiology and composition spectrum, the incidence of complications and co-morbidities.To assess the correlation between daily living ability, mental and physical function, quality of life, nutritional status and prognosis.To develop biomarkers of renal aging.

Official Title
-----------------
Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age≥65 years clinical diagnosis of CKD signed informed consent Exclusion Criteria: subjects who have a poor compliance and cannot be scheduled for follow-up subjects participating in other interventional clinical trials ESRD or dialysis Acute kidney injury(AKI) history of solid organ or bone marrow transplantation active malignancy within 24 months prior to screening or metastatic cancer life expectancy less than 6 months； severe cognitive impairment（NYHA III or IV） HIV infection or AIDS subjects cannot be able to complete the assessment including dementia or other mental disorders, limited physical activity, severe visual impairment simple hematuria

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Death |  | 5 year | 
| Incidence of End Stage Renal Disease (ESRD) | ESRD will be defined as estimated glomerular filtration rate(eGFR)<15 mL/min/1.73 m2 or dialysis | 5 year | 
| eGFR decline≥40% |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute coronary syndrome |  | 5 year | 
| Heart failure |  | 5 year | 
| Cerebral stroke |  | 5 year | 
| Peripheral arterial disease |  | 5 year |
Neuropsychological Evaluation of Psychiatric and Neurological Patients

Study Overview
=================
Brief Summary
-----------------
This study will allow researchers to use various types of tests to evaluate cognitive and sensory functions. These tests, referred to as batteries will evaluate attention, executive functions, general intellectual functioning, language, memory, motor functions, orientation, personality, selected sensory and perceptual functions, vigilance (alertness), and visual-spatial functions. Children and adult patient will receive different test batteries. The goals of this research study are to; Create descriptions based on the performance of each patient on the test batteries. Then use this information to relate patient behavior to their neurophysiological, neuroradiological, and biochemical descriptions. Define subgroups of patients based on their neurobehavior in order to decrease the variability of psychiatric diagnoses, treatments, and prognoses.

Detailed Description
-----------------
Neuropsychological tests are used to provide an assessment of cognitive functions in patients with idiopathic generalized epileptic (IGE) disorders and their first-degree relatives. The battery comprises tests designed to tap attention, memory, selected sensory and perceptual functions, vigilance, and visual-spatial functions. Modified batteries have been developed for the assessment of children ages 5-8, and children ages 8-16. The data provided by these batteries are compared with genetic profiles of the same participants that have been ascertained from blood samples analyzed by colleagues at the Mount Sinai School of Medicine/Columbia University in New York City.

Official Title
-----------------
Neuropsychological Evaluation of Psychiatric and Neurological Patients

Conditions
-----------------
Anxiety Disorder, Head Injury, Mood Disorder, Schizophrenia, Seizures

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Patients. Normal volunteers. EXCLUSION CRITERIA: Subjects over 95 years of age. Subjects with a history of alcohol or drug abuse, psychopathology, or central nervous system pathology, other than that which defines group membership, may be excluded.

Ages Eligible for Study
-----------------
Maximum Age: 95 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
-----------------
Memory, Executive Functions, Language, Attention, Visual-Spatial Ability, Motor Behavior, Intelligence, Personality, Visual and Auditory Functioning, Hand and Eye Dominance, Normal Volunteer, Neuropsychiatric Disorders
Development and Validation of an ADL-score Based on FIM and EBI

Study Overview
=================
Brief Summary
-----------------
The aim of this mixed-methods-study is to develop and validate an algorithm to transform FIM (Functional Independence Measure) and EBI (Extended Barthel Index) into an ADL score (Activities of Daily Life) that can be used to compare outcome quality of rehabilitation clinics. The following steps are performed: Development of an ADL-algorithms by experts Validation of the ADL-algorithms in a quantitative approach Finalization of the ADL-algorithms by experts based on study results

Official Title
-----------------
Entwicklung Und Validierung Eines ADL-Scores (Activities of Daily Life) Auf Basis Von FIM (Functional Independence Measure) Und EBI (Erweiterter Barthel-Index)

Conditions
-----------------
Neurologic Disorder, ICF, Medical Rehabilitation, Assessment, Functional Independence, Observational Study

Intervention / Treatment
-----------------
* Behavioral: neurologic rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to in-patient neurologic rehabilitation clinic Exclusion Criteria: No sufficient language skills (German, French or Italian)

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 |
| --- |
|Behavioral: neurologic rehabilitation|in-patient rehabilitation of neurologic disorders|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement FIM-based ADL-score vs. EBI-based ADL-score | Agreement according to Cohens kappa (FIM-based ADL-score vs. EBI-based ADL-score) | within 3 days of admission to rehabilitation clinic | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation FIM-based ADL-score vs. EBI-based ADL-score | Spearman's correlation (FIM-based ADL-score vs. EBI-based ADL-score) | within 3 days of admission to rehabilitation clinic | 
| Difference in FIM-based ADL-score vs. EBI-based ADL-score | Delta in points FIM-based ADL-score vs. EBI-based ADL-score | within 3 days of admission to rehabilitation clinic |
Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers

Study Overview
=================
Brief Summary
-----------------
This study aims to provide clinical validation of EyeQuant, a fully automated retinal image analysis system for computation of vascular biomarkers indicative of cognitive disorders, using retinal fundus photographs collected from patients with mild cognitive impairment, Alzheimer's disease, and vascular dementia.

Official Title
-----------------
Clinical Validation of an Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Indicating Cognitive Decline

Conditions
-----------------
Mild Cognitive Impairment, Alzheimer Disease, Vascular Dementia

Intervention / Treatment
-----------------
* Diagnostic Test: Retinal fundus photography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients older than 18 years and diagnosed with mild cognitive impairment (MCI), Alzheimer's disease (AD), or vascular cognitive impairment and/or dementia (VaD). Exclusion Criteria: Children and subjects with other diagnoses than those mentioned in the inclusion criteria. Patients without the means to visit the clinic on the assigned dates. Patients who are pregnant or are expecting to become pregnant.

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: Cognitive diagnosis<br> | Diagnostic Test: Retinal fundus photography<br>* Fundus photographs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinopathy features identification | The retinal vascular parameters computed using EyeQuant will be compared against the current gold-standard, based on expert annotations | 12 months |
Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer

Official Title
-----------------
An Open, Single.Centre, Phase I/II Study of ZD1839 (Iressa) in Combination With 5-Fluorouracil, Leucovorin and Radiotherapy in Subjects With Resectable Gastric Cancer

Conditions
-----------------
Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC

Intervention / Treatment
-----------------
* Drug: Gefitinib, 5-fluorouracil, leucovorin and radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically-confirmed intestinal GC (T2-T4) Local or locally advanced stage II or stage III gastric cancer of an upper part of the stomach or GE junction Lymph node positive or negative Metastasis negative Resection with curative intent (R0, D2) Chemo- and radiotherapy naïve Measurable lesion according RECIST Written informed consent Exclusion Criteria: Aged below 45 or over 70 Prior gastric surgery Active ILD

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gefitinib, 5-fluorouracil, leucovorin and radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs) |  |  | 
| Parts 2 and 3: Safety and tolerability of gefitinib in combination with 5-FU, LV and radiotherapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parts 2 and 3: |  |  | 
| Objective tumour response rate a week before surgery (CR and PR, RECIST criteria). |  |  | 
| Objective histological response rate in dissected GC specimens taken at surgery, estimated using Evans/Pisters scores |  |  | 
| Exploratory outcome: Parts 2 and 3: sVEGF levels, EGFR activation, Biomarkers such as cyclin D1, IL-1, GI-associated TOP2A, GAS, EST AA552509 |  |  |
Treatment of Anemia in Patients With Cancer Who Are Not Currently Receiving Chemotherapy or Radiotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of different doses of epoetin alfa for treating anemia in patients who have cancer; or patients who no longer have any signs of cancer, but remain anemic as a result of their treatment. These patients should not be currently receiving chemotherapy or radiotherapy. A subject's participation in the study will last approximately 6 months. Subjects will receive weekly doses of epoetin alfa or placebo. Their hemoglobin will be tested every week.

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: epoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight >/=99 lbs ECOG 0-2 Anemia results from cancer, chemotherapy, radiotherapy or an association with hormonal therapy or immunotherapy Screening hemoglobin level of </=11.0 g/dL for men or </=10.0 for women

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: epoetin alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer

Study Overview
=================
Brief Summary
-----------------
This is a self-controlled, open, multiple-center clinical trial.

Official Title
-----------------
A Multiple-center, Self-controlled Open Study to Evaluate Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer

Conditions
-----------------
Acute Gastritis, Gastric Ulcer

Intervention / Treatment
-----------------
* Drug: Selbex
* Drug: Selbex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Age is over 18 years old , men or women Erosive lesions or flat lesions with thin white coating in acute gastritis, acute stage of chronic gastritis with over three lesions (including three lesions) by endoscopy prior to study in 3 days or diagnosed by clinical symptoms and signs; Signed the informed consent forms. Exclusion criteria Patients without inclusion criteria Patients with significant cardiovascular, pulmonary, hepatic, renal or hemopoietic system primary disease Patients with other digestive diseases. Patients with operation on stomach and duodenum. Patients administered with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids Patients with severity trauma, surgery, infection and shock. Patients with any kind of tumor Women either pregnant or breast feeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selbex 50mg (14 days)<br> | Drug: Selbex<br>* 50mg/day, 3 times/day, for 14 days<br>|
| Experimental: Selbex 50mg (56 days)<br> | Drug: Selbex<br>* 50mg/day, 3 times/day, for 56 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic results of ulcer lesion | Heal rate = (healed cases + significant improved cases)/total cases administered ×100 % | 56 days | 
| Total effective rate | Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered ×100 %. | 56 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms improved level |  | 56 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Teprenone, safety, efficacy, acute gastric lesion, chronic gastritis
Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

Study Overview
=================
Brief Summary
-----------------
Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking due to inconsistent design of available studies. The purpose of this study is to evaluate the PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low risk anatomical sites in an evidence based study setting.

Official Title
-----------------
The Role of the 595 nm Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas at Low Risk Anatomical Sites: Outcome of a Double Blind Randomized Placebo Controlled Trial

Conditions
-----------------
Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Procedure: Laser treatment
* Device: SHAM-Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed unpigmented sBCC on the trunk and extremities maximal tumour diameter 30 mm Exclusion Criteria: Fitzpatrick skin type >III pregnancy previous BCC treatment within 4 weeks coagulation disorders photo sensitizing medication any indication of poor compliance

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laser Treatment<br>Pulsed dye laser 595nm | Procedure: Laser treatment<br>* Pulsed dye laser 595nm<br>|
| Sham Comparator: SHAM Treatment<br>using the pulsed dye laser (PDL) laser without releasing a pulse | Device: SHAM-Treatment<br>* using the pulsed dye laser (PDL) laser without releasing a pulse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients satisfaction | questionnaire | 9 months | 
| side effects | questionnaire | 9 months | 
| reduction of tumor diameter and tumor thickness |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
basal cell carcinoma, laser surgery, pulsed dye laser, randomized controlled trial
A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy

Study Overview
=================
Brief Summary
-----------------
Robotic technology has been used for laparoscopic hysterectomies for over 10 years. Mayo Clinic Arizona has used robotics in Gynecology for the last 10 years with well over 500 procedures performed. Similar to the laparoscopic approach, small incisions are utilized with the robotic approach. Robotic instruments differ from laparoscopic instruments in that the tips of the instruments can rotate more like the human wrist. The instruments are attached to the robotic arms which are controlled by your surgeon. The surgeon is seated at the surgeon's console which is located 12 feet from the patient while the surgical assistant is at your bedside assisting in the procedure. This study is being done to compare the procedure times and results after laparoscopic hysterectomies to laparoscopic hysterectomies performed with robotic assistance.

Official Title
-----------------
Laparoscopic Hysterectomy With and Without Robotic Assistance: a Randomized Prospective Trial

Conditions
-----------------
Hysterectomy

Intervention / Treatment
-----------------
* Procedure: Robotic hysterectomy
* Procedure: Standard Hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All subjects eligible for a laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy, and with or without appendectomy will be recruited. Exclusion Criteria: - Patients with malignant disease, pregnancy, gynecologic infection, or requiring procedure on an emergent basis.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot<br>Robotic hysterectomy | Procedure: Robotic hysterectomy<br>* Robotic hysterectomy.<br>|
| Active Comparator: Standard<br>Standard hysterectomy | Procedure: Standard Hysterectomy<br>* Standard hysterectomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Procedure Time - Skin Incision to Skin Closure |  | At skin closure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
robotic, laparoscopic surgical procedures