linjc16/ctgov huggingface dataset:
Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder

Study Overview
=================
Brief Summary
-----------------
This is a research study comparing the safety and efficacy of two active study medications for the treatment of bipolar I disorder.

Official Title
-----------------
Olanzapine Versus Active Comparator in the Treatment of Bipolar I Disorder, Manic or Mixed

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: olanzapine
* Drug: risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subject, 18-70 years of age Female subjects of childbearing potential must be using a medically accepted means of contraception Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol Subjects must be considered reliable Exclusion: Female subjects who are either pregnant or nursing Uncorrected hypothyroidism or hyperthyroidism Narrow-angle glaucoma Subjects who present a serious and immediate risk of endangering him or herself

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: olanzapine|nan|
|Drug: risperidone|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar I Disorder
Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?

Study Overview
=================
Brief Summary
-----------------
Labor patients who meet inclusion and exclusion criteria will be consented to be participate in this study to determine if the use of a peanut shaped birthing ball reduces the length of labor and reduces the incidence of cesarean section. Subjects will be randomized at the time of consent to either use the birthing ball or not use the birthing ball from the time of labor analgesia until complete cervical dilation.

Official Title
-----------------
Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia?

Conditions
-----------------
Labor

Intervention / Treatment
-----------------
* Other: peanut shaped birthing ball


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nulliparous >/= 18 years of age not allergic to medications used for labor analgesia no contraindications to labor analgesia ASA I-II EGA >/= 37 weeks Exclusion Criteria: under age 18 Spanish speaking only multiparous EGA <37 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: peanut ball<br>the peanut shaped birthing ball after labor analgesia will be utilized | Other: peanut shaped birthing ball<br>* peanut ball will be utilized<br>|
| No Intervention: no peanut ball<br>the peanut shaped birthing ball will not be utilized during labor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Labor | time in minutes will be calculated from epidural catheter insertion until delivery | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Satisfaction | 11-point scale of 0=not satisfied up to 10=most satisfied of all | length of labor, up to 24 hours | 
| Participant Cesarean Delivery Incidence-Mode of Deliveries | the number of subjects who had to had a cesarean delivery | up to 24 hours | 
| Number of Participants With Post-delivery Complications | Number of participants that had post-delivery complications was reported | up to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor duration
Sleep Quality in Patients With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
The primary focus of this clinical study is the objective and subjective measurements of sleep quality in patients with advanced cancer using opioids. It also examines sleep disturbances and associations between sleep quality and symptoms in order to improve symptom management in patients with advanced cancer. The overall aim of this study is to improve the clinical understanding of sleep quality in patients with advanced cancer using opioids and to improve the understanding of how sleep quality may best be measured in order to improve symptom management.

Official Title
-----------------
Sleep Quality in Patients With Advanced Cancer. A Comparison of Objective Assessments and Self-reports of Sleep Quality

Conditions
-----------------
Sleep Disorders, Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A verified diagnosis of a malignant disease Presence of metastatic/disseminated disease Regularly scheduled oral, subcutaneous, transdermal or intravenous opioid treatment corresponding to step III at the WHO pain ladder with a duration of treatment not less than 3 days Able to comply with all study procedures Signed informed consent according to ICH Good Clinical Practice and national/local regulations Exclusion Criteria: Not consenting to participation Not mastering the language used at the study centre Severe cognitive impairment as judged by the principal investigator Any reason why, in the opinion of the investigator, the patient should not participate Impaired use of the dominant arm Local anatomical illness or abnormalities precluding the use of polysomnography (e.g. facial tumour) having received chemotherapy for more than 4 weeks, having received the previous dose less than 5 days ago and receiving the next dose within the study period.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total sleep time | 1 night total sleep measured for comparison by ambulatory polysomnography (PSG), actigraphy and sleep questionnaires | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep
Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population

Study Overview
=================
Brief Summary
-----------------
Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants

Official Title
-----------------
Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population

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

Intervention / Treatment
-----------------
* Device: Investigational Rainbow SpHb sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female newborn infants of any gestational age requiring at least one (1) blood draw as part of their routine care. Ages: Newborn infants less than 16 weeks postnatal age. Weight: Range from 500 g to 10 kg. Able to obtain written informed consent from parents or legal guardians Exclusion Criteria: Neonatal patients with abnormalities at the planned application sites that would interfere with transilluminating the foot or hand like unusual deformities of limbs, absence of feet, severe edema, localized infections, and other.

Ages Eligible for Study
-----------------
Maximum Age: 16 Weeks

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neonatal Test Subjects<br>All test subjects in this group are neonatal patients who will receive a investigational Rainbow SpHb sensor. | Device: Investigational Rainbow SpHb sensor<br>* Investigational Rainbow SpHb sensor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants | To study the SpHb sensor in neonatal population. | duration of surgery |
Detection of Group A Streptococcus (GAS) in Oral Cavity

Study Overview
=================
Brief Summary
-----------------
The investigators intend to screen children who are suspected of having GAS tonsillitis. From each child we will take a throat culture and saliva sample to screen for molecular evidence of GAS.

Official Title
-----------------
Detection of Group A Streptococcus (GAS) in Oral Cavity Using Molecular Techniques

Conditions
-----------------
Tonsillitis

Intervention / Treatment
-----------------
* Other: sample taking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical evidence of GAS tonsillitis healthy, no chronic illness not a GAS carrier Exclusion Criteria: GAS carrier Active background disease

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: sample taking|throat culture and oral cavity sample|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| molecular detection of GAS compared to throat culture detection | 3 days after taking the oral sample, the investigators will compare it to the throat culture taken at the same time. | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GAS in oral cavity
Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)

Study Overview
=================
Brief Summary
-----------------
This is a study to determine whether albuterol or oxandrolone, alone or in combination, are able to increase strength and muscle mass in patients with FSHD. It also will determine if albuterol given in pulsed fashion will have more effect than when given continuously.

Detailed Description
-----------------
Patients will be randomized to 1 of 4 groups: placebo, pulsed albuterol, oxandrolone, or both pulsed albuterol and oxandrolone. Treatment will continue for 52 weeks unless unacceptable side effects occur. Patients will undergo testing of muscle function. All patients will return for follow-up assessments at Weeks 4, 12, 26, and 52.

Official Title
-----------------
Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy

Conditions
-----------------
Muscular Dystrophies

Intervention / Treatment
-----------------
* Drug: Albuterol
* Drug: Oxandrolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Presence of 4q35 small fragment of less than 40 kb by standard DNA testing Weakness of the facial muscles, including frontalis, orbicularis oculi, or orbicularis oris Weakness of scapular stabilizers or foot dorsiflexors Ambulatory Weakness grade 2 or worse in the arm using upper extremity grading scale Exclusion criteria: Prior use of oral beta-2 agonists for a period of at least 1 year or within the past 3 months Concurrent use of other sympathomimetic agents, antidepressants, or beta-2 receptor blockers Pregnancy Known hypersensitivity to anabolic steroids Any medical or psychological condition that would interfere with the study Requirement for a wheelchair

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Albuterol|nan|
|Drug: Oxandrolone|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Muscle Weakness, Muscular Dystrophy
Arm Pump in Motorcross Training

Study Overview
=================
Brief Summary
-----------------
Arm Pump is a sport specific term drivers use to describe Acute or Chronic Compartment Syndrome of the forearm. Drivers experience pain in the forearms due to increased blood pressure in forearm muscle compartments. No strategies nor methods have been used to diminish the risk to suffer from arm pump within motor cross. This project aims to look at ergonomics of driving and its relationship with the occurrence of arm pump. The investigators will first investigate the experience of motor cross athletes with arm pump through motor cross federations in Belgium and The Netherlands (survey). Two groups of athletes will be selected (20 persons within each group) who will be invited to the motor cross track to investigate their hand grip strength, motor driving position, muscle activity.

Official Title
-----------------
Hand Strength Grip and Ergonomics of Driving as Risk Factors in the Etiology of Arm Pump in Motorcross Training

Conditions
-----------------
Healthy Individuals, Patients With Arm Pump

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recreational or competitive motor cycling athletes with or without arm pump problems signing informed consent participation with their own motor bike Regular training hours Exclusion Criteria: Inactive for more than 2 weeks before participation Pathology at shoulder, elbow or wrist level (except for arm pump)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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 |
| --- | --- |
| persons without arm pump<br> | |
| persons with arm pump<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| motor ergonomics | 2D video-recording will be used to observe motor sitting position | March - June 2014 (3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hand grip strength | Use of hand grip dynamometer (Biometrics) to measure hand grip strength. | March - June 2014 (3 months) |
Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines

Study Overview
=================
Brief Summary
-----------------
This phase 2 study includes two treatment period; 1)Dose- ranging period, Day 0 to 16 weeks, which will assess dose-related safety/tolerance, and the potential to improve the appearance of lateral canthal lines and 2) open-label extension period, 16 weeks to 52 weeks, which will evaluate the long term-safety of MBA-P01

Official Title
-----------------
Phase II, Randomized, Double-blind, Placebo Controlled, Multi-Center, Dose-ranging and Open Label Extension Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Moderate to Severe Lateral Canthal Lines

Conditions
-----------------
Lateral Canthal Lines

Intervention / Treatment
-----------------
* Drug: MBA-P01(Botulinum toxin A)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 to 65 Bilaterally symmetrical moderate to severe lateral canthal lines(LCLs) at maximum smile as assessed by both investigator and subject using FWS Exclusion Criteria: History of facial nerve paralysis Any eyebrow or eyelied ptosis as determined by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBA-P01 24U<br>Experimental group; Dose: 24U | Drug: MBA-P01(Botulinum toxin A)<br>* Intramuscular injection; Dose varies by group<br>|
| Experimental: MBA-P01 12U<br>Experimental group; Dose: 12U | Drug: MBA-P01(Botulinum toxin A)<br>* Intramuscular injection; Dose varies by group<br>|
| Placebo Comparator: Placebo<br>Placebo group; normal saline | Drug: Placebo<br>* Intramuscular injection; normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial wrinkle scale(FWS) change of lateral canthal line at maximum smile | Proportion of subjects achieving at least a 2 grade decrease from baseline and a grade 0 or 1 in Facial Wrinkle Scale (0: none to 3: severe) of LCL at maximum smile, as assessed by the investigator and subject | 4 weeks |
PD-1 Inhibitor Concurrent With Chemotherapy as Neoadjuvant Therapy for TNBC

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to address the following hypotheses: the PD-1 inhibitor Sintilimab 200mg for intravenous (IV) administration will be given together with three-week epirubincin, cyclophosphamide (EC) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments. This regimen will induce higher pathologic complete response (pCR) rate in triple negative breast cancer than historical pCR rates (30-40%) observed with chemotherapy alone.

Official Title
-----------------
PD-1 Inhibitor Sintilimab Concurrent With Epirubicin Cyclophosphamide and Nab-paclitaxel as Neoadjuvant Therapy for Triple Negative Breast Cancer

Conditions
-----------------
Triple Negative Breast Cancer

Intervention / Treatment
-----------------
* Drug: Sintilimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed histologically confirmed stage I-III, ER, PR and HER2 negative invasive breast cancer as defined by the ASCO CAP guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard NCCN practice guidelines. Exclusion Criteria: Patients for whom anthracycline, nab-paclitaxel or antibody therapies are contraindicated.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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: Sintilimab<br> | Drug: Sintilimab<br>* The PD-1 inhibitor Sintilimab 200mg for intravenous (IV) administration will be given together with three-week epirubincin, cyclophosphamide (EC) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic Complete Response (pCR) | Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0). | 21 weeks |
Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy

Study Overview
=================
Brief Summary
-----------------
Search for blood predictive marker (s) for cutaneous radiosensitivity

Official Title
-----------------
Prediction of Appearance of Late Cutaneous Side Effects After RadioTherapy

Conditions
-----------------
Merkel Carcinoma, Radiotherapy Side Effect

Intervention / Treatment
-----------------
* Diagnostic Test: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient treated with surgery and radiotherapy (RT) for histologically proven Merkel carcinoma Previous radiotherapy treatment completed for at least 6 months Absence of prior treatment by chemotherapy or hormonotherapy Patient over 18 years of age Patient affiliated to a social security system Informed consent signed Exclusion Criteria: Presence of another evolutionary cancer Re-irradiation in the same area Absence of available dosimetry data Patient under guardianship or curatorship or safeguard of justice

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br> | Diagnostic Test: blood sample<br>* Search of blood predictive marker (s)<br>|
| Other: radiosensibility group<br> | Diagnostic Test: blood sample<br>* Search of blood predictive marker (s)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification and dosage of blood predictive marker(s) | Concentration of IL-1α, IL-1β, IL-4, IL-6, IL-8, IL-10, TNF-α, TGF-β, IL-13, IL-17 and CRP | 1 blood sample at inclusion | 
| Identification and dosage of blood predictive marker(s) | Concentration of 8-OHdG extracellular, Antioxidant enzymes (catalase, superoxyde dismutase, glutathion peroxydase) | 1 blood sample at inclusion |