linjc16/ctgov huggingface dataset:
Safety and Effects of Ramipril Combined With Candesartan

Study Overview
=================
Brief Summary
-----------------
we hypothesized that combination therapy has additive beneficial effects to improve endothelial dysfunction and adipocytokine profiles in patients with hypertension.

Detailed Description
-----------------
Forty patients will be given ramipril 10 mg and placebo, ramipril 10 mg and candesartan 16 mg, or candesartan 16 mg and placebo daily in a randomized, double-blind, placebo-controlled cross-over trial with three treatment arms and two washout periods (each 2 months).

Official Title
-----------------
Cardiovascular and Metabolic Effects of Combination Therapy With Ramipril and Candesartan In Hypertensive Patients

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: ramipril, candesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with mild to moderate hypertension Exclusion Criteria: We will exclude patients with severe hypertension, unstable angina, acute myocardial infarction, or renal insufficiency.

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ramipril, candesartan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of endothelium-dependent dilation among the 3 treatment schemes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endothelial function, insulin resistance, adipocytokines
Glycemic Response Testing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether food ingredient(s) affect glycemic responses.

Conditions
-----------------
Glycemic Response

Intervention / Treatment
-----------------
* Other: Dietary Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18-75 years of age Subject has a body mass index (BMI) ≥ 20.0 and < 35 kg/m² at screening (visit 1). Subject has normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L). Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Investigator on the basis of medical history. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Nutrient formulations without active ingredient<br>4 nutrient formulations without active ingredient and variable level of available placebo ingredient | |
| Experimental: Nutrient formulation with active ingredien<br>4 nutrient formulations with increasing amount of active ingredient | Other: Dietary Intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental area under the blood glucose response curve | Glycemic response calculated from individual glucose measurements upon consumption of control and experimental test food products. The individual glucose measurements will be collected at baseline (prior to consumption of each test food product) and over a 2-hour period following the initiation of consumption of each test food product. The primary outcome is differential treatment-effect on the time-concentration glucose curve over the 2 hours post consumption of each test food product. | 0-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of decline in blood glucose, peak blood glucose, peak insulin and adjusted time concentration area for insulin |  | 0-2 hours |
Glucagon-Like Peptide-1 (GLP-1) Suppression of Alpha Cell Secretion in Type 2 Diabetes Mellitus (T2DM)

Study Overview
=================
Brief Summary
-----------------
The incretin hormone glucagon-like peptide-1 (GLP-1) has known insulinotrophic and glucagonostatic properties. However, inpatients with type 2 diabetes mellitus (T2DM)it is shown, that the beta cell sensitivity towards GLP-1 is decreased, when comparing to healthy controls. Further, these patients have decreased GLP-1 response to a meal. The aim of this study is to elucidate if the diabetic hyperglucagonemia, seen in these patients both during fasting and in a postprandial condition, is coursed by a decreased sensitivity to GLP-1 in the diabetic alpha cell. Ten T2DM patients and ten matched healthy control subjects will be examined on two separate days. Day 1: increasing GLP-1 infusions and Day 2: saline. During both days plasma glucose (PG) will be clamped at fasting level (FPG). Patients with T2DM will be submitted til a Day 3, here PG will be normalized over-night by an adjustable insulin infusion, on the following day the GLP-1 infusion of Day 1 will be repeated. The hypothesis is that these patients have decreased alpha cell sensitivity to GLP-1 as is the case with the beta cell sensitivity. This decreased sensitivity, the investigators speculate, contributes the defect suppression og glucagon and thereby to the increased PG levels seen in T2DM. Further the investigators will elucidate if this sensitivity can be increased by normalizing the diabetic PG to a normal FPG level.

Official Title
-----------------
GLP-1 Suppression of Alpha Cell Secretion in T2DM

Conditions
-----------------
Hyperglycemia, Hyperglucagonemia, Glucose Intolerance

Intervention / Treatment
-----------------
* Other: GLP-1 infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T2DM according to WHO criteria Written consent Age > 18 years Exclusion Criteria: Kidney or hepatic disease Treatment with insulin or glitazone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: GLP-1 infusion|physiological effect of GLP-1|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucagon suppression |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glucagon, GLP-1, hyperglycemia
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

Detailed Description
-----------------
The duration of treatment is 1 day.

Official Title
-----------------
A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Single Dose Study of the Effect of Rofecoxib 50 mg and Valdecoxib 20 mg in Patients With Postoperative Dental Pain

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

Intervention / Treatment
-----------------
* Drug: MK0966, rofecoxib
* Drug: Comparator: valdecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Impaction of a molar tooth requiring removal Exclusion Criteria: Known allergies to the study drug

Ages Eligible for Study
-----------------
Minimum Age: 16 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

| Intervention/Treatment |
| --- |
|Drug: MK0966, rofecoxib|nan|
|Drug: Comparator: valdecoxib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall analgesic effect over 12 hours. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall analgesic effect over 8 hours. |  |  | 
| Time to onset of analgesic, peak analgesic and duration of analgesic effects. |  |  | 
| Overall analgesic, time to onset of analgesic, peak analgesic, and duration analgesic effects |  |  | 
| Safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental surgery, molar removal
BMS-741672 for Diabetic Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether BMS-741672 improves neuropathic pain in diabetic patients.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial to Evaluate the Efficacy and Safety of BMS-741672 in Patients With Diabetic Neuropathic Pain

Conditions
-----------------
Neuropathic Pain

Intervention / Treatment
-----------------
* Drug: BMS-741672
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or 2 diabetics with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 12 months duration Screening HbA1c of ≥ 7% and ≤ 10% BMI ≤ 40 kg/m2 Exclusion Criteria: Patients with clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, central nervous system (CNS), psychiatric, endocrine (other than diabetes), tuberculosis or renal Women of childbearing potential

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: BMS-741672<br>* Tablets, Oral, 100 mg, once daily, 3 weeks<br>|
| Placebo Comparator: B<br> | Drug: Placebo<br>* Tablets, Oral, 0 mg, once daily, 3 weeks treatment period, 2 weeks washout, and 2 weeks follow-up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in weekly average pain score for BMS drug vs. placebo, computed from diary scores |  | recorded during the last 7 days of treatment in each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other glycemic, vascular, and mechanism-based biomarkers will be measured |  | throughout the study |
PAIN-LESS: Understanding and Alleviating Pain for Cancer Patients in Academic and Community Hospitals

Study Overview
=================
Brief Summary
-----------------
This study will increase knowledge of patient preferences for pain treatments, and improve the ability to meet patients pain management needs. This study will assess patient attitudes towards underutilized treatments and identify technologies to increase awareness of such treatments. This study also demonstrate the feasibility of using the Penn Cancer Network in future clinical and cancer control research and better understand how to effectively raise patients awareness of supportive cancer services.

Official Title
-----------------
PAIN-LESS: Understanding and Alleviating Pain for Cancer Patients in Academic and Community Hospitals

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older; Have a primary diagnosis of cancer; Have a Karnofsky functional score of 60 or greater (i.e. ambulatory); Understand written English; Verbally indicate to the RA/RN that they feel physically well enough to complete a survey at the time of approach; Report experiencing nonzero pain (on a scale of 0-10) in the last seven days Exclusion Criteria: An inability to understand the requirements of the survey

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: Survey|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects providing completed surveys |  | 1 year |
Perioperative Assessment of Physical Capacity in Elderly Patients Undergoing Laparoscopic Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
Evaluation of preoperative physical capacity and its evolution in the postoperative period in older patients after undergoing laparoscopic surgery for colorectal cancer, with the test: - Short Physical Performance Battery (SPPB) After the inclusion of the first 10 patients, a preliminary feasibility study will be carried out and thus we have coverage of this pilot study.

Official Title
-----------------
Perioperative Assessment of Physical Capacity in Elderly Patients Undergoing Laparoscopic Colorectal Surgery- Atlas Study

Conditions
-----------------
Colorectal Disorders

Intervention / Treatment
-----------------
* Other: Perioperative assessment of physical capacity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age ≥65 years. ASA I-III Patients with absence of cognitive deficit. Informed consent signed prior to surgery. Exclusion Criteria: Refusal of the patient to participate in the study. Patients with disabilities to give their consent. ASA IV-V. Pregnancy or lactation. Health status that prevent physical exercise, such as unstable heart disease, severe systematic disease, or serious orthopedic conditions

Ages Eligible for Study
-----------------
Minimum 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: Perioperative assessment of physical capacity|Evaluation of physical capacity with the Short Physical Performance Battery (SPPB) questionaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the physical capacity | Evaluation of the physical capacity only with the Short Physical Performance Battery (SPPB) questionnaire | 21 days before surgery | 
| Evaluation of the physical capacity | Evaluation of the physical capacity only with the Short Physical Performance | 21 days after surgery |
Electrical Impedance Tomography (EIT) and Physiotherapy

Study Overview
=================
Brief Summary
-----------------
To compare the effect of different airway clearance techniques on lung ventilation by electrical impedance tomography.

Official Title
-----------------
Effect of Physiotherapy Evaluated by Electrical Impedance Tomography

Conditions
-----------------
Respiratory Disease

Intervention / Treatment
-----------------
* Other: Physiotherapy
* Procedure: Electrical impedance tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old Surgery under anesthesia (PEP and incentive spirometry) or healthy subjects Intervention time before first bed lift Cooperative Can perform devices techniques correctly Exclusion Criteria: Patients with pacemaker, implantable pumps or automatic implantable cardioverter defibrillator Patients with pulmonary disease (acute or chronic) Patients with cognitive problems Presence of patches or wounds in EIT belt zone placement Patients with initial pain > 2/10 Patients with severe obesity (BMI > 35)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive expiratory pressure<br>Use of positive expiratory pressure during 3 minutes | Other: Physiotherapy<br> <br> Procedure: Electrical impedance tomography<br> <br> |
| Experimental: Incentive spirometry<br>Use of incentive spirometry during 3 minutes | Other: Physiotherapy<br> <br> Procedure: Electrical impedance tomography<br> <br> |
| Experimental: manual airway clearance technique<br>Use of manual airway clearance technique during 3 minutes | Other: Physiotherapy<br> <br> Procedure: Electrical impedance tomography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional lung ventilation measured by Electrical impedance tomography |  | Recording by electrical impedance tomography will be performed during 30 minutes |
Impact of Tramadol and Oxycodone on Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Postoperative pain is usually treated with opioids. Among them, oxycodone is popular in the daily practice as it is administered orally and is easily titrated. However, side-effects include increase duration and frequency of apneic episodes. Some authors believe that tramadol has less impact on these apneic episodes during the first postoperative night, based on a trial that reported conclusive results only during the first 2 postoperative hours. The objective of this randomized controlled trial is to compare the effect of postoperative pain treatment of oxycodone with tramadol on apneic episodes during the first and third postoperative nights.

Official Title
-----------------
Impact of Tramadol and Oxycodone on Sleep Apnea

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Drug: Oxycodone
* Drug: Tramadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for orthopaedic surgery on the lower limb under a spinal anaesthesia physical status I-III Exclusion Criteria: planned surgical duration more than 3 hours contraindication to spinal anaesthesia severe respiratory disease patient treated for sleep apnea syndrome allergy to tramadol or oxycodone

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxycodone<br>Postoperative pain treatment with oxycodone | Drug: Oxycodone<br>* Postoperative pain treatment with oxycodone<br>|
| Active Comparator: Tramadol<br>Postoperative pain treatment with tramadol | Drug: Tramadol<br>* Postoperative pain treatment with tramadol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea hypopnea index while lying supine | Apnea hypopnea index while lying supine | Postoperative night 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea hypopnea index in another position than supine |  | Postoperative night 1 | 
| Mean pulse oxymetry |  | Postoperative night 1 | 
| Apnea hypopnea index while lying supine |  | Postoperative night 3 | 
| Apnea hypopnea index in another position than supine |  | Postoperative night 3 | 
| Mean pulse oxymetry |  | Postoperative night 3 | 
| Pains scores (numeric rating scale) |  | Postoperative day 0, 1, 2 and 3 | 
| Opioid (oxycodone or tramadol) consumption |  | Postoperative day 0, 1, 2 and 3 |
Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel in Platinum-Resistant Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every three weeks in combination with docetaxel (Taxotere) in the treatment of patients with non-small cell lung cancer that is resistant to platinum-based chemotherapy.

Official Title
-----------------
Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel (Taxotere) in Platinum-Resistant Non-Small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Non-small-cell Lung

Intervention / Treatment
-----------------
* Drug: TLK286 in combination with docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria include: Histologically confirmed non-small cell bronchogenic carcinoma, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma with squamous cell carcinoma), bronchoalveolar carcinoma, or large cell carcinoma Stage IV or Stage IIIB Progressed during or after first-line therapies with platinum-containing regimens in the advanced or metastatic treatment regimen At least 18 years of age Good performance status (ECOG 0 to 1) Adequate liver, renal, and bone marrow function Exclusion criteria include: Pregnant or lactating women Treatment with more than one cytotoxic therapy Prior radiation to the whole pelvis Unstable medical conditions such as uncontrolled cardiac arrhythmia Patients with known history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80

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

| Intervention/Treatment |
| --- |
|Drug: TLK286 in combination with docetaxel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |