linjc16/ctgov huggingface dataset:
Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip

Official Title
-----------------
A Multicenter, Open-Label, Safety Study of Meloxicam SoluMatrix™ Capsules in Subjects With Osteoarthritis of the Knee or Hip

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Meloxicam Test Capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is male or female ≥ 40 years of age If a participant in the previous MEL3-12-02 study, completed the study and did not discontinue for lack of efficacy or safety Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain If female and of childbearing potential, is nonlactating and nonpregnant Exclusion Criteria: History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease Significant difficulties swallowing capsules or unable to tolerate oral medication Has received any investigational drug (except Meloxicam SoluMatrix Capsules), device, or therapy within 30 days before Screening

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meloxicam Test Capsules<br>One Capsule QD | Drug: Meloxicam Test Capsules<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died. | Baseline to Week 52/Early Termination |
The Impact of Lifestyle Behavior on in Vitro Fertilization (IVF) Outcome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectively examine the impact of various lifestyle habits in both men and women on the outcome of in vitro fertilization. There are 25 infertility centers in the United States which use the electronic medical record collection entity eIVF, made by Practice Highway, to collect medical and demographic information on the patients who are undergoing treatment at these centers. Information on every aspect of each cycle is also electronically collected daily during each cycle. Demographic and lifestyle information will be collected on all patients prior to cycle start and lifestyle habit information will be collected each time a patient logs onto the patient portal, which averages every few days.

Official Title
-----------------
The Impact of Lifestyle Behavior on in Vitro Fertilization (IVF) Outcome

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Behavioral: There is no intervention; this is a survey only study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients include, any patient whose: infertility clinic uses eIVF is scheduled to undergo an IVF cycle has access to the internet on a daily basis can read and understand English logs onto the patient portal on eIVF
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 undergoing IVF<br> | Behavioral: There is no intervention; this is a survey only study<br>* There is no intervention; this is a survey only study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rates |  | Approximately 28 days (1 IVF cycle) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, Lifestyle habits
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination

Study Overview
=================
Brief Summary
-----------------
ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate shocks, in a general population implanted for primary or secondary prevention with a dual or tri chamber device at one year follow-up

Detailed Description
-----------------
The primary endpoint is to demonstrate that 95% of patients implanted with PARAD+ algorithm are free from inapproporiate shock compared to 92.5% in general ICD population.

Official Title
-----------------
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination

Conditions
-----------------
Tachycardia

Intervention / Treatment
-----------------
* Device: PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient eligible for implantation (according to current accepted guidelines, or scheduled for implant (primo-implant, replacement, upgrade) with a Paradym/Paradym RF (CRT-D or DR-ICD) within the next 30 days, or has already been implanted within the last 30 days Patient in sinus rhythm, or patients with paroxysmal atrial tachyarrhythmia or patients with persistent atrial tachyarrhythmia in whom a cardioversion is planned within three months Exclusion Criteria: Any contraindication for ICD therapy Atrial lead not implanted Patient with permanent atrial tachyarrhythmia Patients implanted with a ventricular assist device (VAD)

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
Intervention Model: Single Group Assignment
Interventional Model Description: ICD device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ICD or CRT-D with PARAD+<br>only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator | Device: PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770<br>* PARADYM ICD and CRT-d with PARAD+ algorithm available<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Inappropriate Shock(s) | Percentage of patients presenting with inappropriate shock(s) | 552 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shock(s) Appropriately Delivered | Percentage of shocks appropriately delivered | 552 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary prevention, Secondary prevention
A Single Ascending Dose Study to Evaluate MDK-703 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
MDK-703-101 is a single ascending dose study, to determine the safety, tolerability, and PK/PD of MDK-703 in healthy adult subjects.

Official Title
-----------------
A Phase 1, Randomized, Placebo-controlled, Single-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDK-703 in Healthy Adult Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Biological: MDK-703 or Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs. Exclusion Criteria: 1. Significant history or clinical manifestation of any metabolic, autoimmune, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Single injection of MDK-703 (dose level 1) or matching placebo | Biological: MDK-703 or Placebo<br>* Injection<br>|
| Experimental: Cohort 2<br>Single injection of MDK-703 (dose level 2) or matching placebo | Biological: MDK-703 or Placebo<br>* Injection<br>|
| Experimental: Cohort 3<br>Single injection of MDK-703 (dose level 3) or matching placebo | Biological: MDK-703 or Placebo<br>* Injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse events after single injection of MDK-703 | Adverse events after single Injection | 8 weeks |
Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation

Study Overview
=================
Brief Summary
-----------------
Sixty patients who refer to the emergency ward and need any painful procedure in the ward are randomized into 2 groups. One group is sedated before the procedure using propofol-fentanyl and the other with midazolam-fentanyl, with the same depth of sedation. The two groups will be compared regarding recovery time and other parameters described below.

Official Title
-----------------
Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation in Painful Procedures

Conditions
-----------------
Emergencies

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: Midazolam
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 18 candidate for a painful procedure negative past history of a serious medical condition ASA score 0 and 1 Exclusion Criteria: deep sedation making the patient unable to answer the questions pregnancy allergy to drugs hemodynamic instability failure to consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Experimental: Propofol<br>The patients will receive propofol for sedation in addition to fentanyl | Drug: Propofol<br>* Propofol 1 mg/kg bolus then 500 microg/kg every 2 minutes until sedation level equivalent to Ramsey 3<br>Drug: Fentanyl<br>* Fentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure<br>|
| Active Comparator: Midazolam<br>The patients will receive midazolam for sedation in addition to fentanyl | Drug: Midazolam<br>* Midazolam 0.03 mg/Kg stat and then the same dose repeated every 2 minutes until a sedation level of Ramsey 3 is achieved.<br>Drug: Fentanyl<br>* Fentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery time | Length of time before complete recovery from sedation is achieved | Within one hour after sedation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' Pain perception | Pain perception as measured by verbal numeric rating scale | Within one hour after sedation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
propofol, midazolam, duration of recovery, emergency procedure
Temperature Monitoring in Cardiac Surgery: Agreement Between Different Clinical Methods

Study Overview
=================
Brief Summary
-----------------
Observational study to compare core temperatures obtained by 6 methods in patients undergoing cardiac surgery under cardiopulmonary bypass.

Detailed Description
-----------------
This study compares the core temperatures obtained by means of different probes placed in nasopharinx, pulmonary artery, arterial outlet, venous inlet, bladder and forehead in patients undergoing cardiac surgery under cardiopulmonary bypass.

Official Title
-----------------
Temperature Monitoring in Cardiac Surgery: Clinical Study of Agreement Between Different Measurement Methods

Conditions
-----------------
Temperature Change, Body

Intervention / Treatment
-----------------
* Device: Core emperature monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients requiring a pulmonary artery catheter were included. Exclusion Criteria: Sepsis or previous fever. Previous bladder catheter without termistor Deep hypothermic circulatory arrest.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Core emperature monitoring|Monitoring core temperatures with probes placed in the arterial outlet and venous inlet of extracorporeal pump, pulmonary artery, bladder, nasopharinx and forehead using a doublé-sensor probe|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between different core temperature methods | Agreement between core temperatures obtained in arterial output and venous inlet of CPB, bladder, pulmonary artery, nasopharinx and forehead (Tcore) | 24 temperature measures per patient recorded at 5-min intervals during surgery (8 readings in the pre-CPB period, 8 during the CPB period and 8 aftr CPB period) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Core temperature, Cardiac surgery
Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The major goal of this project is to reduce unnecessary pancreatic resections, namely resection in those patients with non-regional lymph node metastatses that cannot be cured with surgical resection. By combined minimally invasive methods for non-surgical biopsy and highly sensitive molecular assays for cancer cells, we believe we can increase the ability to detect distant lymph node metastases prior to surgical resection, and direct those patients for more appropriate therapy (including possible neo-adjuvant chemotherapy with or without surgery). We hypothesize that the combination of EUS-FNA and polymerase chain reaction (PCR) of a multimarker panel will increase the sensitivity for malignant lymph nodes compared with EUS-FNA cytology in patients with pancreatic ductal adenocarcinoma.

Official Title
-----------------
Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a mass in the pancreas suspicious for adenocarcinoma without biopsy proven distant metastases. Patients who are scheduled for clinically indicated EUS Exclusion Criteria: Patients who are medically unfit for endoscopic sedation or surgery due to severe comorbid disease such as uncontrolled coronary disease, or oxygen dependant pulmonary disease. Patients who have any other malignancy other than basal cell carcinoma within the past 5 years.

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 |
| --- | --- |
| Pancreatic Cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the if molecular biomarkers increase the sensitivity by at least 5% for detection of malignant lymph nodes in patients with pancreatic ductal adenocarcinoma as compared to EUS-FNA cytology of lymph nodes alone. |  | End of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the degree of RNA overexpression of pancreas cancer specific biomarkers in the pre-operative fine needle aspirate of lymph nodes and tumors of patients with pancreatic cancer using a set of pancreas cancer specific biomarkers |  | End of study |
Skin Biopsies in Chemotherapy-Induced Neuropathy

Study Overview
=================
Brief Summary
-----------------
Neuropathy is a common side effect of chemotherapeutics used for the treatment of multiple myeloma, including vincristine, thalidomide and bortezomib. The neuropathy induced by these drugs is often preferentially small fiber. Small fiber neuropathies are difficult to diagnose and quantify using conventional electromyography. Determining intra-epidermal nerve fiber density (IENFD) in skin biopsies from diabetes and AIDS patients has been shown to be a more sensitive and more specific ancillary investigation to establish the diagnosis of small fiber neuropathy. In this study the investigators aim to establish the sensitivity of IENFD measurements in skin biopsies from patients with multiple myeloma treated with bortezomib.

Official Title
-----------------
Skin Biopsies in Chemotherapy-induced Neuropathy

Conditions
-----------------
Multiple Myeloma, Peripheral Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with multiple myeloma receiving bortezomib Exclusion Criteria: Patients not able to provide informed consent Patients with coagulation disturbances or immunocompromised patients

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 |
| --- | --- |
| Patients with multiple myeloma<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraepidermal nerve fiber density/pain intensity | correlation between intraepidermal nerve fiber density and pain intensity | one timepoint, i.e. date of skin biopsy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Peripheral Neuropathy, Bortezomib
Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and meet all other entry criteria to be enrolled and receive PluroGel PN.

Official Title
-----------------
Open Label Trial of Topical PluroGel PN for the Treatment of Patients With Mildly Infected Diabetic Foot Ulcer CLINICAL PROTOCOL PGN-1300X

Conditions
-----------------
Diabetic Foot Ulcer, Infection

Intervention / Treatment
-----------------
* Drug: Plurogel PN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have failed treatment on Protocol PGN-1300X Exclusion Criteria: -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plurogel PN<br>Plurogel PN | Drug: Plurogel PN<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response | Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection. | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wound, Ulcer, Infected, Infection
GLP-1: Acute Effects on Kidney Function in Healthy Men

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate how Glucagon-Like Peptide 1 (GLP-1) affects kidney function in healthy young men. The hypothesis is that GLP-1 induces a positive effect on kidney hemodynamics.

Official Title
-----------------
GLP-1: Acute Effects on Kidney Function in Healthy Men

Conditions
-----------------
Kidney Functional

Intervention / Treatment
-----------------
* Biological: Human GLP-1 (7-36) amide
* Biological: Isotone NaCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy young men Exclusion Criteria: Any chronic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GLP-1<br> | Biological: Human GLP-1 (7-36) amide<br>* 2 hour IV infusion, 1,5pmol/min/kg.<br>|
| Placebo Comparator: Placebo<br> | Biological: Isotone NaCl<br>* 2 hours IV infusion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular Filtration Rate |  | Every 20 minutes for 6 hours |