linjc16/ctgov huggingface dataset:
A Pilot Study to Evaluate the Contribution of the Saphenous Nerve in Ankle Pain of Patients With Degenerative Joint Disease of the Ankle

Study Overview
=================
Brief Summary
-----------------
To assess the pain scores before and after saphenous nerve block placement in patients with degenerative joint disease of the ankle

Official Title
-----------------
A Pilot Study to Evaluate the Contribution of the Saphenous Nerve in Ankle Pain of Patients With Degenerative Joint Disease of the Ankle

Conditions
-----------------
Degenerative Joint Disease of the Ankle

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients evaluated with osteoarthritis who are surgical candidates for ankle fusion or total ankle replacement. Registered patients at Mayo Clinic in Florida with scheduled visit to see Dr.Whalen Exclusion Criteria: Patients with lower extremity diabetic neuropathy History of prior trauma of ankle with residual nerve injury Current medication of pregabalin or gabalin Allergy to lidocaine.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Saphenous nerve block<br>Data collection after saphenous nerve block placement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle pain | Patient's ankle pain will be assessed prior to and after the nerve block. The study will assess if pain score is lower after the saphenous nerve block | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ankle, saphenous nerve block
First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784

Study Overview
=================
Brief Summary
-----------------
This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled, randomized, single center design. In addition the bioavailability of two different liquid formulations will be compared.

Official Title
-----------------
One-center, Randomized, Placebo-controlled, Double Blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses (5-1000 mg, Solution) of BAY1214784 Including the Relative Bioavailability of BAY1214784 Administered as Solution With Two Different Concentrations in 56 Healthy Postmenopausal Women

Conditions
-----------------
Clinical Trials, Phase I as Topic

Intervention / Treatment
-----------------
* Drug: BAY1214784
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female subjects Age 45 to 65 years Body mass index (BMI) above/equal 20 and below/equal 30 kg/m2 Postmenopausal state Exclusion Criteria: Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal Known or suspected malignant or benign tumors Known or suspected liver disorders, relevant kidney diseases, known cardiovascular diseases, known metabolic disorders Regular use of medicines

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY1214784<br>Dose 1 to 7 of BAY1214784 | Drug: BAY1214784<br>* Escalating doses of 5, 20, 60, 150, 300, 600, 1000 mg of BAY1214784; single dose administration; liquid dosage form<br>|
| Placebo Comparator: Placebo<br>Placebo Dose 1 to 7 of BAY1214784 | Drug: Placebo<br>* Dose 1, 2,3, 4, 5, 6 and 7 of respective placebos; single dose administration; liquid dosage form<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | Up to 2 weeks after dosing | 
| Severity of adverse events (mild, moderate, severe) |  | Up to 2 weeks after dosing |
Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test if recombinant follicle stimulating hormone (rFSH) given in individual doses, according to a nomogram we have constructed based on our results from a previous study, results in more patients maturing 2-3 follicles compared to standard dose.

Official Title
-----------------
Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study

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

Intervention / Treatment
-----------------
* Drug: rFSH drug dose
* Drug: Standard rFSH dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 25-39 years First stimulation with rFSH only Indication for intrauterine insemination with standard rFSH starting dose Regular menstrual bleeding with a cycle between 21-35 days Two ovaries Bilateral tuba patency Semen analysis must be sufficient for insemination according to the diagnostic analysis. Exclusion Criteria: More than three former stimulated intrauterine insemination cycles

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 39 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 |
| --- | --- |
| Active Comparator: Individual or standard rFSH dose<br>Patients were randomized to recieve individual (50, 75 or 100 IU/day) or standard (75 IU/day) rFSh dose. The individual dose was prescribed according to a dosage nomogram based on the patient's body weight (kg) and the total antral follicle count (Freiesleben NC et al., RBMOnline 2009;17:632-64). | Drug: rFSH drug dose<br>* Individual rFSH dose (50, 75 or 100 IU rFSH/day)<br>|
| Active Comparator: Standard rFSH dose<br>Standard dose of rFSH | Drug: Standard rFSH dose<br>* Standard rFSH dose was 75 IU/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of mature follicles in the study and control group. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cycles where the rFSH dose is changed. |  |  | 
| Number of cycles cancelled or converted to in vitro fertilisation. |  |  | 
| Pregnancy rate. |  | October 2008 |
Multicenter Observational Study to Validate a New Index for Sleep Fragmentation Analysis: Sleep Diversity Index (SDI)

Study Overview
=================
Brief Summary
-----------------
The investigators want to validate the Sleep Diversity Index as a diagnosis tool of sleep fragmentation on 405 patients who will perform a polysomnography under spontaneous breathing.

Detailed Description
-----------------
Sleep fragmentation is one of the main problems of sleep disorders especially in respiratory failure. During this last decade, several indicators of sleep fragmentation were introduced but none of them seems to take into account the succession of sleep stages. To tackle with this problem, The investigators used the Shannon entropy index for modelling sleep stages diversity from an hypnogram and for assessing more accurately sleep quality by quantifying its fragmentation. The investigators developed a new tool we called Sleep Diversity Index (SDI). In a retrospective study, the investigators calculated Sleep diversity index for 55 healthy subjects and 56 patients with suspected sleep apnea syndrom. Using the receiver operating characteristic (ROC) curves the threshold of fragmentation was determined at 20%. If SDI is lower than 20%, then sleep is considered as non-fragmented and otherwise, sleep is considered as fragmented. To validate our SDI it is necessary to compare this diagnosis tool to a gold standard based on the clinician diagnosis and a mathematical diagnosis index created from objective criteria of polysomnography. The investigators propose a multicenter study to validate the SDI as a diagnosis tool of sleep fragmentation.

Official Title
-----------------
Multicenter Observational Study to Validate a New Index for Sleep Fragmentation Analysis: Sleep Diversity Index (SDI)

Conditions
-----------------
Sleep Fragmentation

Intervention / Treatment
-----------------
* Other: Polysomnography under spontaneous breathing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spontaneous polysomnography Exclusion Criteria: Insomnia Patients with psychoactive drug having an important effect on sleep

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: Polysomnography under spontaneous breathing|Patient will come to the sleep laboratory to perform the polysomnography under spontaneous breathing prescribed by the clinician|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between mathematical analysis and clinician interpretation of polysomnographic datas recorded under spontaneous breathing | In order to determine the fragmentation of patient's sleep with two different approach and test the sleep diversity index . | One night |
Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil

Study Overview
=================
Brief Summary
-----------------
The objective is to evaluate the safety and initial efficacy of the Omrix Anti-Adhesion (AA) kit, Adhexil™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.

Detailed Description
-----------------
Adhexil™ contains the components that form the anti-adhesive barrier, BAC and Thrombin. Thrombin is a sterile solution, containing highly purified human thrombin. BAC is a sterile, solution whose principal component is a concentrate of human fibrinogen. Adhexil™ is supplied in two vials and an application device.

Official Title
-----------------
A Prospective, Controlled, Randomized, Multi-Center, Exploratory Pilot Study Evaluating the Safety and Potential Trends in Efficacy of Adhexil

Conditions
-----------------
Bilateral Ovarian Disease

Intervention / Treatment
-----------------
* Biological: Anti adhesion agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients aged 18-45 years at screening Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease Exclusion Criteria: Pregnant (including ectopic pregnancy) or breastfeeding patient Patients with a documented diagnosis of cancer Patients with a lymphatic, hematologic or coagulation disorder Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™ Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants. Patients who have participated in another clinical study within 30 days of enrolment. Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Post surgery adhesion prevention treatment | Biological: Anti adhesion agent<br>* Adhesions prevention<br>* Other names: Adhexil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries |  |  |
Comparison of the Effect of Neck Collar, Act-as-Usual, and Active Mobilisation Early After a Whiplash Injury

Study Overview
=================
Brief Summary
-----------------
Background: Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after forced flexion-extension trauma to the cervical spine. Mechanisms behind WAD are virtually unknown, as are the possible effects of early intervention. This trial was undertaken to compare the effect of three early intervention strategies for the prevention of developing chronic WAD following acute whiplash injury. Methods: 458 participants were randomised to one of 1) stiff neck collar, 2) advice to act-as-usual, or 3) an active mobilisation regime. Participants were followed for one year and treatment effects were compared in terms of lasting neck pain, headache, disability and sick-leave.

Official Title
-----------------
A Randomized Early Intervention Study Comparing the Effect of Stiff Neck Collar, Act-as-Usual and Active Mobilisation on the One Year Outcome Following Whiplash Injury.

Conditions
-----------------
Whiplash Injury

Intervention / Treatment
-----------------
* Behavioral: neck collar; advice to act-as-usual; active mobilisation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Been exposed to rear-end or frontal car collision Experienced symptoms within 72 hours 18 - 70 years Exclusion Criteria: Could not be enrolled within 10 days of the collision Fractures or dislocations of the cervical spine Amnesia for the accident Unconsciousness in relation to the accident Injuries other than the whiplash injury Average neck pain during the preceding 6 months exceeding 2 on a box scale 0-10, where 0= no pain and 10= worst possible pain Significant pre-existing somatic or psychiatric disease Alcohol or drug abuse Does not read or understand Danish.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: neck collar; advice to act-as-usual; active mobilisation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck pain intensity |  |  | 
| Headache intensity |  |  | 
| Neck disability |  |  | 
| Sick leave during the 12 month after inclusion |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication |  |  | 
| Number of non-painful complaints |  |  | 
| General health |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
whiplash injuries, neck pain, exercise movement techniques, immobilisation
A Community-Based Educational Intervention to Improve Colorectal Cancer Screening

Study Overview
=================
Brief Summary
-----------------
This study investigates the facilitators and barriers to colorectal cancer screening in underserved populations with a focus on African American, Latinx, and Asian (Chinese) in the Sidney Kimmel Cancer Center catchment area. Learning what encourages people and what keeps people from getting colorectal cancer screening may help researchers develop an educational tool for colorectal cancer screening that addresses colorectal cancer knowledge, beliefs, and cultural factors in underserved populations.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. Develop a culturally tailored colorectal cancer education intervention for underserved and under-represented populations with a focus on African American, Latinx, and Asian (Chinese) in the Sidney Kimmel Cancer Center catchment area. OUTLINE: KEY CONTACT INTERVIEWS: Participants participate an interviews over 60 minutes focusing on identifying facilitators and barriers to colorectal cancer screening, essential cultural factors to include in the educational intervention, and insights into the best use of the National Cancer Institute (NCI)'s Screen to Save materials. FOCUS GROUPS: Participants attend focus groups over 60-90 minutes to examine and define further facilitators and barriers to colorectal cancer, cancer knowledge and beliefs, essential cultural factors to include in the educational intervention, insights into the best use of the NCI's Screen to Save materials, and identification of factors to consider for dissemination and sustainability. After completion of study, participants are followed up for up to 12 weeks.

Official Title
-----------------
A Community-Based Educational Intervention to Improve Colorectal Cancer Screening

Conditions
-----------------
Colorectal Carcinoma

Intervention / Treatment
-----------------
* Other: Interview
* Other: Focus Group
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Focus Groups may be facilitated in Chinese (Mandarin), English, or Spanish depending on participant preference Exclusion Criteria: • Individuals who do not meet the inclusion criteria Individuals who have been diagnosed with colorectal cancer

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Interview|Complete interview|
|Other: Focus Group|Attend focus groups|
|Other: Questionnaire Administration|Ancillary studies|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful completion of the key contact interviews and focus groups leading to the development of the culturally tailored educational intervention |  | Up to 4 years |
Pain Impact Assessment of the Relational Touch During Arterial Puncture in ICU (TORREA)

Study Overview
=================
Brief Summary
-----------------
Study objective is to assess the interest of the relational touch before an arterial puncture to reduce pain on patient in intensive care unit.

Official Title
-----------------
Pain Impact Assessment of the Relational Touch During Arterial Puncture in ICU - TORREA

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: relational touch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission in Intensive Care Unit Communicating patient (able to rate their pain on a numerical scale) Need for a radial arterial puncture for conducting blood tests, apart for the emergency Non-opposition of the patient Exclusion Criteria: Age under 18 Tetraplegic patient or having a sensitivity disorder on the limb to be punctured No radial pulse perception

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Relational touch before the first arterial puncture and the second arterial puncture without relational touch | Procedure: relational touch<br> <br> |
| Experimental: B<br>First arterial puncture without relational touch and relational touch before the second arterial puncture | Procedure: relational touch<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the variation in pain score (evaluation on a numerical scale 0 to 10) between the measurement made before the arterial puncture and during the arterial puncture. | At the first and second arterial puncture | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in consumption of analgesics and hypnotics | At the first and second arterial puncture | 1 day | 
| Blood pressure and heart rate variation | At the first and second arterial puncture | 1 day | 
| Patient satisfaction score | At the first and second arterial puncture | 1 day | 
| Number of arterial punctures needed before success | At the first and second arterial puncture | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intensive care, Arterial puncture, Cross-over, Relational touch, Pain