linjc16/ctgov huggingface dataset:
Automatic Detection of Falls and Near Falls

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to develop an algorithm to automatically detect falls and near falls, in the elderly and in Parkinson's Disease patients. Subjects will arrive at the investigators' gait laboratory for assessment. A sub-group of the subjects, will receive a monitoring device, to be worn at home for three days.

Detailed Description
-----------------
The aim of this study is to develop a detailed algorithm which will automatically detect falls and near falls, in the elderly as a general population prone to falls. The algorithm will be used as well in patients with Parkinson's Disease representing neurodegenerative diseases. All participants will arrive at the investigators' gait laboratory for an inhanced assessment, including neurological examination, various questionnaires. A sub-group of the subjects, will receive a monitoring device, to be worn at home for three days.

Official Title
-----------------
Automatic Detection of Falls and Near Falls

Conditions
-----------------
Falls, Missteps

Intervention / Treatment
-----------------
* Device: Hybrid (3-d accelerometers, and gyroscopes)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Older Adults Parkinson's Disease Patients Idiopathic Fallers Exclusion Criteria: Walking Aid Other Neurological Diseases than PD Significant Disturbance in Vision/Hearing History of CVA Significant Orthopedic Problem Dementia

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hybrid (3-d accelerometers, and gyroscopes)|A 3 D accelerometer worn on the lower back or leg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 D acceleration |  | during assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
falls, Missteps
Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of echinacea therapy and osteopathic manipulation for the prevention of further ear infections in children with recurrent ear infections (otitis media).

Detailed Description
-----------------
Acute otitis media (inflammation of the middle ear) occurs in 60% of infants during the first year of life and in 85% by age 3. Approximately 17% of children suffer recurrent otitis media during the first year of life. Following acute otitis media, middle ear fluid effusions can persist for weeks to months. Approximately 40% of children with middle ear effusions have mild to moderate hearing loss for the duration of the effusion, and several studies have found evidence for impaired speech and language development among children with prolonged middle ear effusion. Since antibiotic use has become widespread, concern has emerged regarding antibiotic resistant S. pneumoniae strains and other bacteria. Children with recurrent otitis media commonly receive prophylactic antibiotic therapy or surgical insertion of tubes to prevent accumulation of middle ear effusion. The prevalence of pediatric use of complementary alternative medical (CAM) approaches for prevention of otitis media has not been widely quantified. This study will evaluate the use of osteopathic manipulation and echinacea therapy to prevent ear infection in children with recurrent otitis media.

Official Title
-----------------
Osteopathic Manipulation and Echinacea for the Treatment of Recurrent Ear Infections in Children

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Procedure: Craniosacral Osteopathic Manipulative Treatment
* Drug: Botanicals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 60 Months

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 |
| --- |
|Procedure: Craniosacral Osteopathic Manipulative Treatment|nan|
|Drug: Botanicals|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy of Human Placental Graft in Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy of full-thickness placental allograft in chronic wound healing

Detailed Description
-----------------
To evaluate the efficacy of Revita full thickness placental allograft in improving wound closure rates and mean closure time in diabetic foot ulcers (DFUs) as compared to the current standards of wound care treatment

Official Title
-----------------
A Clinical Investigation Into the Efficacy of Full-thickness Human Placental Graft (Revita) in Diabetic Foot Ulcers

Conditions
-----------------
Diabetic Foot

Intervention / Treatment
-----------------
* Other: Revita Allograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients 18-80 years old Diagnosis of Type 1 or 2 Diabetes Mellitus Foot ulcers >1cm2 and <25cm2 for 4 weeks or more prior to enrollment Able to give consent to participate Compliance with all aspects of protocol and follow-up Exclusion Criteria: Male and female patients younger than 18 years old Male or female patients older than 80 years old Smoking, and any additional health risk factors contraindicated with Revita use Involvement in any other ongoing studies

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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Treatment<br>Will receive Revita allograft for wound treatment | Other: Revita Allograft<br>* Human placental allograft<br>|
| No Intervention: Control<br>Will receive current standard of care for wound treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Wound Closure | 100% epithelization | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent(%) Healed | Percentage of wound healed | 12 weeks |
Clinical Hypnosis During Insemination or Embryotransfer

Study Overview
=================
Brief Summary
-----------------
Does clinical hypnosis or relaxation music improve the pregnancy rate if reproduction techniques are required?

Official Title
-----------------
Prospective Off-center Randomised Trial of Clinical Hypnosis Versus Relaxation Music

Conditions
-----------------
Reproduction Dysfunction

Intervention / Treatment
-----------------
* Other: clinical hypnosis or relaxation music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned insemination or embryo transfer Exclusion Criteria: under age not able to understand German

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Relaxation music<br> | Other: clinical hypnosis or relaxation music<br>* 25 minute tape recording<br>|
| Experimental: Clinical hypnosis<br> | Other: clinical hypnosis or relaxation music<br>* 25 minute tape recording<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Outpatient follow up after insemination / embryotransfer for 4 weeks | 4 weeks after insemination / embryotransfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire: Intervention rating |  | 5 minutes before and 5 minutes after insemination / embryotransfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clinical hypnosis, relaxation music, reproduction techniques, insemination, embryo transfer, pregnancy rate
The Effects of Medical Clowns in Children Undergoing Blood Tests

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that the participation of therapeutic clowns in the pediatric emergency department procedure room would reduce anxiety, improve the level of cooperation children can provide and avoid some of the adverse effects.

Detailed Description
-----------------
Research has demonstrated that cognitive psychological techniques, including distraction, can increase pain tolerance. Humor can be an important intervention, able to reduce stress to both the child and the parent. In the last decade there has been a rapid growth in the presence of therapeutic clowns in hospital, particularly in pediatric settings. If therapeutic clowns are shown to positively affect any of the parameters being measured in this study, they should be included as aprt of the standard of care in the pediatric emergency setting.

Official Title
-----------------
Evaluation of the Effect of Hospital Clown's Performance in the Procedure Room of a Pediatric Emergency Department: A Randomized Controlled Trial

Conditions
-----------------
Pain, Anxiety

Intervention / Treatment
-----------------
* Behavioral: clown


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children needing venous blood sampling or the insertion of an intravenous canula Exclusion Criteria: Children whose blood work or intravenous line must be accomplished rapidly for therapeutic reasons Absence of a parent during the procedure Abnormal development according to parents

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 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 |
| --- | --- |
| Active Comparator: Clown<br>A clown is present during venipuncture | Behavioral: clown<br>* a distraction technique is performed by a clown during venipuncture<br>|
| No Intervention: No clown<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | recorded by the child | at the end of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental anxiety level | recorded by the parent | at the end of the procedure | 
| Procedure's success rate | recorded by the nurse | at the end of the procedure | 
| Overall report of procedure's comfort | recorded by the nurse | at the end of the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medical clown, Pediatric emergency medicine, Emergency procedures
Sevoflurane Protective Effect on Ischemia-reperfusion Injury. Multicenter, Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the possible protective effect of anesthetic technique balanced(with sevoflurane) compared with total intravenous anesthetic technique (propofol,remifentanil). The hypothesis is that the Sevoflurane may exert protective effect in regard to the ischemia-reperfusion injury induced on the microsurgical breast free flap during transfer to receiving area. The investigators will evaluate the continuous flap tissue oximetry and the level of biochemical markers.

Official Title
-----------------
Sevoflurane Protective Effect on Ischemia-reperfusion Injury in Patients Undergoing Reconstructive Plastic Surgery With Microsurgical Flap. Multicenter, Randomized Controlled Trial.

Conditions
-----------------
Microsurgical Free Flaps

Intervention / Treatment
-----------------
* Drug: Balanced anesthesia
* Drug: Total intravenous anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient selected for plastic breast surgery With microsurgical Free flap Over 18 y Asa I/II Exclusion Criteria: Unusual reaction to anesthetic drugs Suspect for malignant hyperthermia Vasculopathic disease Coagulation disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Total intravenous anesthesia<br>Total intravenous anaesthesia | Drug: Total intravenous anesthesia<br>* Propofol 3-4 µg/ml and remifentanyl 1-3 ng/ml according target-controlled infusion<br>* Other names: TIVA-TCI;|
| Experimental: Balanced anesthesia<br> | Drug: Balanced anesthesia<br>* Et-Sevo maIntained 1,8-2%, remifentanyl according target-controlled infusion maintained 1-3 ng/ml<br>* Other names: Inhalation anesthesia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| continuous tissue oximetry (NIRS) |  | 20 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Markers |  | Preoperative and 24 hours post operative | 
| Lactate Clearance |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Balanced anesthesia, Inhalation anesthesia, Reperfusion injury, Microsurgical Free flap
Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria

Study Overview
=================
Brief Summary
-----------------
This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria)

Official Title
-----------------
Linezolid vs. Vancomycin/Oxacillin/Dicloxacillin in the Treatment of Catheter-Related Gram-Positive Bloodstream Infections

Conditions
-----------------
Bacterial Infections, Gram-Positive Bacterial Infections, Bacteremia

Intervention / Treatment
-----------------
* Drug: Linezolid
* Drug: Vancomycin
* Drug: Oxacillin
* Drug: Dicloxacillin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a central indwelling catheter with signs and symptoms of infection Exclusion Criteria: Patients with tunneled catheter which cannot be removed. Patients with evidence of endovascular infection including endocarditis. Patients with infection of permanent intravascular devices. Patients who have received more than 1 day of another antibiotic before enrollment. Patients with HIV and low CD4 count.

Ages Eligible for Study
-----------------
Minimum Age: 13 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

| Intervention/Treatment |
| --- |
|Drug: Linezolid|nan|
|Drug: Vancomycin|nan|
|Drug: Oxacillin|nan|
|Drug: Dicloxacillin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The empiric treatment of patients with complicated skin and skin structure infections (cSSSI) related to an indwelling catheter; |  |  | 
| The empiric treatment of patients with gram-positive catheter-related bloodstream infections. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy of linezolid compared to vancomycin/oxacillin/dicloxacillin.2.Incidence of late metastatic sequelae associated with S. aureus infections in patients treated with linezolid |  |  |
CANDIS-II: Evaluation of the Cognitive-behavioral Treatment Programme CANDIS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of the cognitive-behavioral treatment program CANDIS among n=450 patients with cannabis use disorders in a mulicenter randomized-controlled clinical trial (n=11 outpatient treatment centers).

Official Title
-----------------
Evaluation of the Cognitive-behavioral Treatment Programme CANDIS in the German Outpatient Treatment Service System (CANDIS-II)

Conditions
-----------------
Cannabis Use Disorders

Intervention / Treatment
-----------------
* Behavioral: Cognitive-behavioral treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: motivation to change cannabis use age 16 or older current (12 mth) regular cannabis use (at least 2 days a week) informed consent to the study procedures and assessments Exclusion Criteria: current alcohol or any illicit drug dependence syndrome according to DSM-IV other than due to cannabis lifetime history of any psychotic disorder current severe episode of Major depression current panic-agoraphobic disorder (severe) severe learning disability, brain damage or pervasive developmental disorder currently acute suicidality not fluent in german language any other current treatment for cannabis use disorders

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Individual psychotherapy including cognitive behavioral components, motivational interviewing techniques and case management | Behavioral: Cognitive-behavioral treatment<br>* 10 sessions of individual psychotherapy including cognitive-behavioral treatment, motivational enhancement and a psychosocial problem training.<br>* Other names: delayed treatment control group;|
| No Intervention: 2<br>Delayed treatment control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abstinence, defined as no evidence of cannabis use during the past 4 weeks as evidenced by self report and a negative urine screen; number of times a cannabis product was used in the past 4 weeks; retention rate |  | at the end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cannabis, dependence, marijuana, CBT, efficacy of CBT for cannabis use disorders
The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma

Study Overview
=================
Brief Summary
-----------------
Extraction of laboratory data from blood tests prior to surgical and chemotherapy and other histological, clinical and instrumental data related to the patient's history from the digitized medical Digitized medical records and analysis of the same. The medical records of 1000 patients from January 1, 2000, until December 31, 2020

Official Title
-----------------
The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma

Conditions
-----------------
Sarcoma, Ewing

Intervention / Treatment
-----------------
* Other: patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis; Patients with age ≥ 2 years; Minimum follow-up duration of 2 years; Medical records, complete blood work and instrumental examinations; Regular follow-up. Exclusion Criteria: Patients with Ewing's sarcoma or osteosarcoma who have received medical treatment (surgery radiotherapy or chemotherapy) in other institutions prior to admission to the Rizzoli Orthopaedic Institute.

Ages Eligible for Study
-----------------
Minimum Age: 2 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<br>Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis | Other: patients<br>* Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year survival | Evaluation of 5-year survival in relation to histologic, laboratory, clinical, and instrumental laboratory, clinical and instrumental factors | at baseline (Day0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of local recurrence | Evaluation of the rate of local recurrence and distant metastasis in relation to prognostic factors histological, laboratory, clinical and instrumental factors; | at baseline (Day0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sarcoma; ewing