linjc16/ctgov huggingface dataset:
Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning in Patients With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Remote ischemic conditioning (RIC) is a therapeutic strategy for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. It remains unknown whether this can be used in retinal ischemic diseases. The purpose of the present study is to examine if the autoregulation of retinal vessel diameters in diabetic patients change after remote ischemic conditioning and if the observations are different from what have been observed in normal persons.

Official Title
-----------------
Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning in Patients With Type 1 Diabetes

Conditions
-----------------
Retinal Ischemia, Diabetes Complications, Ischemia, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Other: Remote Ischemic Conditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes type 1 Diabetic retinopathy Exclusion Criteria: Previous treatment for diabetic retinopathy Other ocular and systemic diseases requiring treatment Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 31 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Ischemic Conditioning<br> | Other: Remote Ischemic Conditioning<br>* Brief reversible restriction of blood flow to upper limb in four cycles of 5 minutes of inflation at 200mm Hg followed by 5 minutes of deflation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter change of retinal vessels | Diameter change from baseline in percent. | Immediately after and one hour after |
Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in patients with Myelodysplastic Syndrome (MDS)

Detailed Description
-----------------
This Phase 1-2a study is an open label, dose-ranging study of TLK199 Tablets in patients with all World Health Organization or French-American-British classification types of myelodysplastic syndrome (MDS). In Phase 1, the safety, pharmacokinetics, and hematologic response rate with TLK199 Tablets will be evaluated. The Phase 1 dose-ranging stage is designed to determine the maximum tolerated dose or optimal biologic dose of TLK199 Tablets. Evaluation of the pharmacokinetics of TLK199 Tablets will be conducted. In Phase 1, an additional 12 patients will undergo pharmacokinetic evaluation under fed conditions at the selected Phase 2a dose. In Phase 2a, further safety and hematologic responses by the modified International Working Group MDS response criteria will be studied.

Official Title
-----------------
Phase 1-2a Dose-Ranging Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

Conditions
-----------------
Myelodysplastic Syndrome (MDS)

Intervention / Treatment
-----------------
* Drug: Ezatiostat Hydrochlorine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of MDS Documented significant cytopenia for at least 2 months Adequate liver and kidney function Ineligible for stem cell bone marrow transplantation At least 18 years of age Discontinuation of growth factors (e.g., G-CSF) within 3 weeks of study entry Exclusion Criteria: Prior bone marrow transplant Failure to recover from any prior surgery or any major surgery within 4 weeks of study entry Pregnant or lactating women Other investigational drugs within 14 days of study entry Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose Escalation Study of TLK199 Tablets From 200 mg Per day To 6000 mg Per Day | Drug: Ezatiostat Hydrochlorine<br>* Oral Tablets in 2 Divided Doses, Dose Escalation From 200 mg Per Day to 6000 mg Per Day on Days 1-7 of each 21 Day Cycle.<br>* Other names: Telintra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose or Optimal Biologic Dose |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Pharmacokinetic Parameters, Hematologic Response Parameters |  | 6 months |
Infusion Laboratory: Protocol 5 (Flupenthixol) - 14

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate clinical safety issues pertaining to flupenthixol, to cocaine, and to their interaction, and to determine how pretreatment with flupenthixol modifies the subjective as well as physiological effects of cocaine. Taken together, these relatively D-1 selective agents can help determine the extent to which DA-1 binding affects the reinforcing effects of stimulants.

Official Title
-----------------
Infusion Laboratory: Protocol 5 (Flupenthixol)

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Flupenthixol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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 |
| --- |
|Drug: Flupenthixol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of drug craving |  |  | 
| History, incidence and amount of drug use |  |  | 
| Type and severity of stimulant withdrawal symptoms |  |  | 
| Characterization of study population |  |  | 
| Population incidence of symptoms of depression, po |  |  | 
| Frequency and intensity of drug use and sexual beh |  |  | 
| Evidence of change in neurophysiology and brain ac |  |  | 
| Evidence of change in subjective responses to coca |  |  | 
| Clinical physiological response to cocaine challen |  |  | 
| Degree to which study medication influences change |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Study of Coronary Heart Disease (CHD) & Heart Failure (HF) Risk in Prostate Cancer Patients, Taking Casodex or Not

Study Overview
=================
Brief Summary
-----------------
A retrospective cohort study performed in the GPRD,UK. All patients with incident prostate cancer identified between 1 Jan 1999 and 31 Dec 2005 and a frequency-matched cohort of the general population will be followed- up for two outcomes; CHD including acute myocardial infarction or death from coronary heart disease and HF until Dec 31, 2006. Outcomes will be validated through requests to primary care physicians. Incidence rate´ratios of CHD and HF in the two cohorts will be calculated. In the cohort of prostate cancer the relative risk of CHD and HF associated with the use of bicalutamide compared to non-use will be estimated.

Official Title
-----------------
A Pharmacoepidemiological Study on the Association Between Bicalutamide Treated Prostate Cancer and Risk of Coronary Heart Disease (CHD) and Heart Failure (HF) in the General Practice Research Database (GPRD)

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least two years enrollment with the general practitioner Exclusion Criteria: Patients with cancer before start date of the study

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 84 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Prostate cancer patients treated with bicalutamide or not | |
| 2<br>General population cohort | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary heart disease including acute myocardial infarction and death from CHD |  | From study start 1 Jan 1999 through 31December 2006 | 
| Heart Failure |  | From study start 1 Jan 1999 through 31December 2006 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, pharmacoepidemiology study
Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008

Study Overview
=================
Brief Summary
-----------------
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).

Official Title
-----------------
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Surface antigen inactivated influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Subjects eligible for enrollment into this study are male and female adult volunteers Exclusion Criteria: Any serious disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 84 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Fluvirin<br> | Biological: Surface antigen inactivated influenza vaccine<br>* 1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the antibody response to each influenza vaccine antigen |  | 21 days post-immunization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of the study vaccine in the study population |  | Throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza vaccine
Analgesia in Knee Arthroscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Pain relief in knee Arthroscopic Surgery is essential for rapid recovery of function.

Detailed Description
-----------------
Intra-articular analgesia is useful in reducing patients' postoperative disability. It anticipates and prevents the onset of pain, and helps avoid the need for additional drugs. Usually it is possible to reach good analgesia in the immediate postoperative period by the administration of analgesic drugs. Recently, intra-articular administration of different anaesthetic substances with a local action (e.g. bupivacaine) has been introduced in clinical practice. The aim of the administration of these substances should not be the reduction of postoperative pain, but its prevention.

Official Title
-----------------
Intra-articular Dexamethasone vs Intra-articular Dexamedetomidine

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Dexmedetomidine
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for knee arthroscopy under spinal anaesthesia Exclusion Criteria: Diabetes Mellitus Contraindication to spinal anesthesia Patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br>patients will receive intra-articular 8 mg dexamethasone added to 18 mL 0.25% bupivacaine into the knee joint. | Drug: Dexamethasone<br>* patients will receive intra-articular 8 mg dexamethasone added to 18 mL 0.25% bupivacaine into the knee joint.<br>|
| Active Comparator: Dexmedetomidine<br>patients will receive intra-articular 1ug/kg dexmedetomidine added to 18 mL 0.25% bupivacaine into the knee joint. | Drug: Dexmedetomidine<br>* patients will receive intra-articular 1ug/kg dexmedetomidine added to 18 mL 0.25% bupivacaine into the knee joint.<br>|
| Placebo Comparator: Control<br>patients will receive intra-articular 18 mL 0.25% bupivacaine and 2mL isotonic saline into the knee joint. | Drug: Saline<br>* patients will receive intra-articular 18 mL 0.25% bupivacaine and 2mL isotonic saline into the knee joint.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain free time | VAS | 48 hours |
The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool

Study Overview
=================
Brief Summary
-----------------
In our study, we aimed to investigate the relationship between STOP-BANG and 4-Variable Screening questionnaires in postoperative period in patients who underwent bariatric surgery.

Official Title
-----------------
The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool in Preoperative Bariatric Surgery Patients

Conditions
-----------------
Hypoxia, Bariatric Surgery

Intervention / Treatment
-----------------
* Procedure: hypoxia
* Procedure: normooxy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI>40 bariatric surgery patients Exclusion Criteria: malignancy patients who are unable to complete the questionnaire patients who needs laparotomy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: bariatric surgery patients<br>patients aged 18-65 years with ASA status II-III, BMI>40 who were undergoing bariatric surgery operation | Procedure: hypoxia<br>* It was accepted that hypoxia developed in patients with SpO2< 92 or falling over 20% compared to preoperative values.<br>Procedure: normooxy<br>* It was accepted that patients with SpO2 between 100-92 mmHg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SpO2 | Peripheral Oxygen Saturation | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STOP-BANG | The value of STOP-BANG questionnaire | preoperative 24 hours | 
| 4-V Tool | The value of 4-V Tool | preoperative 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stop-bang, bariatric surgery, obesity, hypoxia
An Observational Study of Lung Cancer Related Symptoms and Disease Control Rate in Patients With Non-Small Cell Lung Cancer Receiving First-Line Platinum-Based Chemotherapy With or Without Avastin (Bevacizumab)

Study Overview
=================
Brief Summary
-----------------
This prospective observational study will evaluate the evolution of lung cancer related symptoms and their correlation with the disease control rate (complete response, partial response and stable disease) in patients with non-small cell lung cancer initiating first-line treatment with standard platinum-based chemotherapy with or without Avastin (bevacizumab). Data will be collected from each patient at baseline and after 4-6 cycles of chemotherapy.

Official Title
-----------------
Observational, Epidemiological and Non Interventional Study Evaluating the Evolution of Lung Cancer Related Symptoms and Its Correlation With Disease Control Rate in Patients With Non-Small Cell Lung Cancer (NSCLC) Initiating First-line Treatment With Platinum Based Standard Chemotherapy.

Conditions
-----------------
Non-Squamous Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Histologically or cytologically confirmed non-small cell lung cancer Initiating first-line treatment with standard platinum-based chemotherapy, with or without bevacizumab Exclusion Criteria: Contraindications to the use of platinum-based chemotherapy

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung cancer related symptoms (LCSS questionnaire) |  | up to approximately 6 months (4-6 cycles of chemotherapy) | 
| Correlation of lung cancer related symptoms and disease control rate (complete response, partial response, stable disease according to RECIST criteria) |  | approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency/severity of lung cancer related symptoms (LCSS questionnaire) |  | approximately 2 years |
A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.

Official Title
-----------------
A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas

Conditions
-----------------
Anal Fistula

Intervention / Treatment
-----------------
* Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)
* Device: Flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over eighteen years old Clinical diagnosis of primary anal fistula categorized as transsphincteric, suprasphincteric, or extrasphincteric in nature Pre-placement of seton required for at least 6 weeks prior to surgical treatment Willing to sign informed consent and share data with study sponsor and Surgisis AFP manufacturer Exclusion Criteria: Recurrent fistula tracts J-pouch fistulas Superficial fistulas Fistulas with active abscess, infection, or acute inflammation History of Chron's Disease History of Ulcerative Colitis History of HIV or other immune system disease History of collagen disease History of radiation to the anorectal region Allergies to pig tissue or pig products Religious or cultural objection to the use of pig tissue

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Surgisis® AFP | Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)<br>* Surgical placement of the Surgisis AFP is performed under general anesthesia.<br>* Other names: Surgisis Biodesign;|
| Active Comparator: 2<br>Flap | Device: Flap<br>* Advancement flap surgery is performed; no anal fistula plug is placed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing Success | Healing was defined as closure of external opening with absence of abscess, drainage and pain. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anal fistula, fistula in ano, anorectal fistula