linjc16/ctgov huggingface dataset:
Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The hypotheses of this study are: In the older population with knee OA, When acupoints are chosen for both sleep and pain, there are additive effects on sleep improvement and pain relief (i.e. no interaction). Main effects of acupuncture on sleep improvement and pain relief are anticipated when acupoints are separately targeted for sleep and for pain, respectively.

Official Title
-----------------
Exploring Outcomes and Mechanisms of Acupuncture in Treating Pain and Sleep Disturbance in Knee Osteoarthritis

Conditions
-----------------
Sleep, Pain

Intervention / Treatment
-----------------
* Procedure: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with knee osteoarthritis, diagnosed by the ACR clinical diagnosis criteria for idiopathic OA, with at least Kellgren and Lawrence grading II and above. AND, Present with knee pain at least half of the time. AND, Complain of sleep disturbances associated with knee OA, with Pittsburgh Sleep Quality Index > 5 [36]. Exclusion Criteria: Patients with diagnosis of obstructive sleep apnea (OSA). OR, Patients with dense hemiplegia secondary to cerebrovascular accident. OR, NYHA Class III - patients with heart failure condition limited by minimal activity. OR, Severe COPD with shortness of breath at minimal exertion. OR, Peripheral vascular disease with severe claudication. OR, Dementia with Mini Mental Status Exam score of 20 or less. OR, Patients who received knee intra-articular corticosteroid injection within 4 weeks prior to the study or who received acupuncture treatment within 6 months. OR, Unwilling to come off narcotic pain medication. OR, History of bleeding diathesis or currently on anticoagulation. OR, Patients currently engaged in medical legal cases related to OA or disability.

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- |
| Experimental: Real acupuncture<br>Real acupuncture | Procedure: Acupuncture<br> <br> |
| Sham Comparator: Sham acupuncture<br>Sham acupuncture | Procedure: Acupuncture<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep disturbances as recorded by wrist actigraph, including sleep duration and sleep efficiency. Pain as measured by 0-10 VAS and WOMAC pain scores. |  | at least 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC disability scores, IDEEA gait patterns and activity levels, medication type and amount consumed, side effects, and medical care utilization. |  | at least 3 months |
Lead Mobilization & Bone Turnover in Pregnancy/Lactation

Study Overview
=================
Brief Summary
-----------------
We are examining the role of maternal bone lead turnover during pregnancy and lactation as a potential source of lead exposure for the fetus and the infant (via breast milk). A cohort, ascertained at entry to care, consists of >1000 women to be followed through pregnancy. In the postpartum subjects are recruited for a nested case control study to assess the influence of lactation on maternal bone density, maternal blood lead and breast milk lead.

Conditions
-----------------
Lead Poisoning

Participation Criteria
=================
Eligibility Criteria
-----------------
Positive pregnancy test, age 12-35 and informed consent; Gestation <28 weeks at entry to prenatal care; No history of serious chronic or metabolic diseases, which could affect maternal growth or bone density; Not corticosteroid user or diagnosed use of illicit drugs; Eligible for lactation study: Ascertainment during or participation in the pregnancy study and a negative pregnancy test.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 35 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Pregnancy, Lead Exposure, Lactation, Bone Mineralization, Maternal-Fetal Exchange
Genetics of Recurrent Early Onset Major Depression

Study Overview
=================
Brief Summary
-----------------
This study will identify specific genes that may cause a predisposition to depression in some families.

Detailed Description
-----------------
Depression is a serious medical illness that is often difficult to diagnose and treat. Studies on patterns of depression within families suggest that inherited genes may cause a predisposition to the disorder. People with early onset depression often have more relatives with depression than people whose depression does not begin until later in life. It is likely that several interacting genes cause this tendency towards the disorder, rather than one specific gene. This study will serve to identify particular genes that may cause a susceptibility to depression in order to better understand the brain mechanisms involved with severe depression. In turn, this may aid in the development of new treatments for depression. Participation in this observational study will entail one interview and one blood test. Participants will be interviewed, either in person or by telephone, about their personal and family psychiatric history. The blood sample will be collected at a time and location that is convenient for the participant. Participants may also be asked to invite other family members to participate in the study. For information on a related study please follow this link: http://clinicaltrials.gov/show/NCT00005914

Official Title
-----------------
Genetics of Recurrent Early Onset Major Depression

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of recurrent major depression Has a parent or sibling with a history of recurrent major depression Depression began before the age of 31 Exclusion Criteria: Bipolar I (manic-depressive) disorder Schizophrenia

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major depressive disorder diagnosis | The study will correlate genome-wide SNP genotypes with case vs. control status, defined by presence or absence of major depressive disorder. Participants will attend an interview regarding personal and family history of psychiatric disorders, and give a blood specimen. Genotypes from blood samples will be studied for association with presence of major depressive disorder. | One patient interview session (typically 2 hours), and blood draw (10-20 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depressive Disorder, Family, Genetics
Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Older Cancer Patients Within a Comprehensive Geriatric Assessment - BIS

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to validate uHear™, an iOS-based tool, as a screening tool to detect significant hearing impairment as part of a comprehensive geriatric assessment in patients aged 70 years and older. The pass or fail screening cut-off is defined as having two or more consecutive hearing grades starting from the moderate-severe threshold zone ranging from 0.5 - 2.0 kHz.

Official Title
-----------------
Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Older Cancer Patients Within a Comprehensive Geriatric Assessment - BIS

Conditions
-----------------
Older Cancer Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should have reached the age of 70 or more at enrolment Histologically confirmed diagnosis of solid cancer or hematologic malignancy. All stages of cancer are eligible Patients should be fluent in Dutch or French Patients must receive their primary oncology care in the participating hospital Patients should be cognitively capable of performing the audiology assessment Patients should be scheduled to receive a CGA Patients should have signed informed consent Exclusion Criteria: Patients who do not match the above inclusion criteria Patients presenting with clinically diagnosed Meniere's disease, retrocochlear hearing loss, autoimmune inner ear disease, fluctuating hearing loss or a history of sudden sensory neural hearing loss Patients who already have a hearing aid or a previously diagnosed hearing loss

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- | --- |
| Validation of uHear™ with its new scoring method as a screening tool to detect hearing loss in older cancer patients |  | baseline |
Sleep Study Among Inpatients With TBI in an Acute Rehabilitation Hospital

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to better understand how a daytime nap after training on a motor skill after brain injury improves performance compared with the same amount of time after training spent awake and resting.

Official Title
-----------------
Sleep, Procedural Learning & Therapeutic Engagement Among Inpatients With

Conditions
-----------------
Motor Learning in TBI

Intervention / Treatment
-----------------
* Behavioral: Nap after rehearsal trials


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have a Traumatic Brain Injury. Must have been a Kessler Institute for Rehabilitation inpatient for at least three days. Exclusion Criteria: Bilateral arm fractures, cellulitis or other conditions that prevent safe wearing of the WatchPAT-200/actigragh. Movement disorder or spasticity affecting both upper extremities Patients who are ventilator-dependent. Patients who are on contact precautions for C.diff or other highly contagious diseases. Patients with neurological disorders other than TBI.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nap after rehearsal trials<br>A 30-minute daytime nap after training | Behavioral: Nap after rehearsal trials<br>* Behavioral<br>|
| Placebo Comparator: Resting while awake<br>Placebo condition of 30 minutes between training and retesting in which the half hour is spent resting awake in bed. | Behavioral: Nap after rehearsal trials<br>* Behavioral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement on Motor Functioning Test | Change scores from day 1 to day 3 will be compared in both Nap and No Nap conditions | Three Nights and Three Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
motor learning TBI
Mentalization-Based Group Therapy for Adolescents

Study Overview
=================
Brief Summary
-----------------
This is a prospective parallel group design of group-based Mentalization-Based Therapy for Adolescents (MBT-A) through a pilot randomised controlled trial comparing group-based MBT-A plus treatment as usual (TAU) to TAU alone. As a pilot study, we aim to determine: the effectiveness of our recruitment strategies; compliance with protocol/procedures; trends towards reduced self-harm.

Official Title
-----------------
Efficacy of Mentalization-Based Group Therapy for Adolescents: A Pilot Randomised Controlled Trial

Conditions
-----------------
Deliberate Self-Harm

Intervention / Treatment
-----------------
* Other: Mentalization-Based Group Therapy for Adolescents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-harm behaviour in the past 6 months In receipt of treatment from local Child and Adolescent Mental Health Services Competent and willing to provide written, informed consent. Exclusion Criteria: Severe learning disability or pervasive developmental disorder Acute psychotic episode Eating disorder in the absence of self-harm. Non-English speaking Current involvement in other ongoing treatment research

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBT therapy plus treatment as usual<br>Mentalization based group treatment for adolescents plus standard care | Other: Mentalization-Based Group Therapy for Adolescents<br> <br> |
| No Intervention: Treatment as usual alone<br>Standard care provided by local Child and Adolescent Mental Health Services | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010) |  | 12 weeks | 
| Self-harm and related hospital use as reported in National Health Service patient records |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent
Comparative Study of EDP-420 Versus Another Antibiotic in the Treatment of Community Acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia

Official Title
-----------------
A Randomized, Double-Blinded, Parallel Group, Multicenter Study of EDP-420 Versus Telithromycin for the Treatment of Community Acquired Pneumonia

Conditions
-----------------
Community Acquired Pneumonia

Intervention / Treatment
-----------------
* Drug: EDP-420 / Duration of Treatment - 3 days
* Drug: Telithromycin / Duration of Treatment - 7 days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent respiratory illness with signs and symptoms and chest X-ray consistent with the diagnosis of community-acquired pneumonia. Suitable candidate for oral antibiotic therapy and able to swallow large capsules intact If female, must be non-lactating and at no risk for pregnancy Exclusion Criteria: Other infections Other pulmonary diseases requirement multiple antibacterial medications or long duration of therapy History of hypersensitivity, allergic or adverse reactions to macrolide, ketolide, azalide or streptogramins Evidence of uncontrolled clinically significant disease, malignancy, or other abnormality Requirement of parenteral antimicrobial therapy for treatment of pneumonia Currently receiving or likely to receive any known inhibitors or inducers of cytochrome P450 mediated drug metabolism Immunocompromised subjects

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

| Intervention/Treatment |
| --- |
|Drug: EDP-420 / Duration of Treatment - 3 days|nan|
|Drug: Telithromycin / Duration of Treatment - 7 days|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure 7-14 days after end of therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriological response |  |  | 
| Radiographic response |  |  | 
| Change in signs and symptoms |  |  | 
| Safety |  |  |
Early Goal Directed Therapy for Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury

Official Title
-----------------
Early Goal Directed Therapy for Acute Kidney Injury

Conditions
-----------------
Kidney Injury, Acute

Intervention / Treatment
-----------------
* Procedure: Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years old occurence of the early phase of acute kidney injury stay on intensive care unit Exclusion Criteria: chronic haemodialysis not given informed consent

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients having acute kidney injury<br> | Procedure: Early goal directed therapy during 6 hours after occurence of the early phase of acute kidney injury<br>* Directed therapy during 6 hours after occurence of the early phase of acute kidney injury.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observation of acute kidney injury |  | after 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ failure during first 48 hours and during stay on intensive care unit |  | after 48 hours | 
| Duration of stay on intensive care unit and in hospital |  | t0 | 
| Mortality during stay on intensive care unit |  | after 28 days, 60 days and during stay in hospital |
Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.

Study Overview
=================
Brief Summary
-----------------
Periodic leg movements during sleep is associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between periodic leg movements severity, age, gender, electromyographic power and heart rate response associated with periodic leg movements. Drug-free patients diagnosed with periodic leg movements were included. Clinical data and 24-h polysomnography recordings were analyzed.

Official Title
-----------------
Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.

Conditions
-----------------
Restless Legs Syndrome

Intervention / Treatment
-----------------
* Device: standard 24-h ambulatory polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Restless legs syndrome patients Hospital routine for periodic leg movements diagnosis PLMS index > 0 Exclusion Criteria: Narcolepsy-cataplexy Sleep irregularities and sleep deprivation symptoms Lack of neurological or psychiatric diseases Upper airway resistance syndrome Obstructive sleep apnea Treatment, cerebral lesion, medical illness Medication or drinks affecting sleep and wake state

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 restless legs syndrome<br> | Device: standard 24-h ambulatory polysomnography<br>* A standard 24-h ambulatory ad libitum polysomnography including EEG, electro-oculography (EOG), electromyography (EMG), EKG, was performed by a standard clinical.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude of heart rate response associated with periodic leg movements. | standard 24-h ambulatory ad libitum polysomnography | At diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other Heart rate variability indices: Ptot, very-low-frequency (VLF), low frequency (LF), low frequency normalized units (LFnu), high-frequency normalized units (HFnu), LF/HF. | standard 24-h ambulatory ad libitum polysomnography | At diagnosis | 
| electromyography (EMG) power | standard 24-h ambulatory ad libitum polysomnography | At diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Restless legs syndrome, Periodic leg movements, Heart rate, Heart rate variability, Microarousals, Autonomic nervous system activity