linjc16/ctgov huggingface dataset:
Funen Anorexia Nervosa Study - Retrospective Cohort Study and 10 Year Follow-up Study

Study Overview
=================
Brief Summary
-----------------
The aim of the study are: Retrospectively to study the clinical characteristics and features (somatic, psychological and social variables) of patients treated in Center for Eating Disorders, Odense University Hospital 1994-2004. To study the predictive power of the psychosocial and morphometric data with regard to drop outs, relapse and outcome. To investigate eating habits, social functions and quality of life in weight recovered and chronicly ill patients with eating disorder.

Conditions
-----------------
Anorexia Nervosa, Eating Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated in Center for Eating Disorders, Odense University Hospital 1994 - 2004. Exclusion Criteria: Patients, who according to the primary clinical evaluation was found not to suffer from eating disorder. Patients who at admission did not live in the Funen County.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anorexia Nervosa, Eating disorder, Quality of life
Epidemiology of Sepsis in China

Study Overview
=================
Brief Summary
-----------------
Sepsis is a common cause for morbidity and mortality in critically ill patients. In USA, the incidence of sepsis is about 3/1000 population. However, the incidence of sepsis varies among different clinic trails. In addition, clinician empirical select antibiotic according to the epidemiology of sepsis, however, the etiology of sepsis is various in different studies. In China, the MDRO is much higher than western country. There is no study about the epidemiology of sepsis in China. Therefore, it is necessary to conduct a study about it in China.

Detailed Description
-----------------
Sepsis,especially severe sepsis is a major cause of admission to the intensive care unit (ICU) and death. In USA, the incidence of sepsis is about 3/1000 population. However, the incidence of sepsis varies among different clinic trails. Between 6 and 54% of patients admitted to ICUs have severe sepsis and the mortality rate for these patients varies from 20 to 60%. There is no exactly results of incidence of sepsis in China. In addition, clinician empirical select antibiotic according to the epidemiology of sepsis, however, the etiology of sepsis is various in different studies. In EPIC II study, the organisms of sepsis include Gram-positive microorganisms (69.8%),Gram-negative microorganisms(62.2%) and fungi (17%). In China, the MDRO is much higher than western country. In contrast to EPIC II study, one study in China showed that the organisms of sepsis include Gram-positive microorganisms (14.5%),Gram-negative microorganisms(62.5%) and fungi (2.2%). Therefore, it is necessary to conduct a study about epidemiology of sepsis in China.

Official Title
-----------------
Chinese Epidemiological Study of Severe Sepsis.(CHESS Study)

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: Observational study, none intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sepsis patients who admitted into ICU during research period (include patients with sepsis at ICU admission and patients who has new sepsis during ICU period) Exclusion Criteria: The patients with second sepsis in ICU
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational study, none intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence |  | Patients will be assessed up to 90 days | 
| Mortality |  | Sepsis and severe sepsis patients will be assessed up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| etiology |  | The pathogen of sepsis will be assessed up to 90 days |
Project:Intensive Habilitation (PIH)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to document that taking part in this program is beneficial for the child, its parents and local professionals. The study hypothesis are: Intensive training will speed up the childs motor, cognitive and social development. Intensive habilitation will increase the childs family's empowerment Children having participated in this intensive habilitation will speed up their process of development further than children in the control group The cooperation between first and second line health service is strengthened by participation in the intensive habilitation program The professionals in the first line(community)in Norway that participates in this program increases their empowerment and motivation

Official Title
-----------------
Project:Intensive Habilitation (PIH) -a New Norwegian Multidisciplinary Program for Intensive Training for Children With Disabilities

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Behavioral: PIH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: About three years of age Cerebral Palsy Multidisciplinary diagnosed - Exclusion Criteria: Not have Pervasive Developmental Disorder (PDD) No Specific Speech and Language Disorders No Serious Sensory Defects -

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PIH<br>Intensified training of children with CP. Functional training (motor, speech, executive function). Coaching of parents by psychologist, individually and in groups. | Behavioral: PIH<br>* Intensified training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PEDI |  | dec 2006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSI |  | Dec 2006 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral palsy, Functional training, preschool children, Gross Motor Functional Classification Level, Gross motor functional Measure test, Pediatric Evaluation of Disability Inventory, Parental Stress Index
GEM 1.5 mg b.i.d. to 4.5 mg b.i.d. Versus Lorazepam in GAD (0777-026)

Study Overview
=================
Brief Summary
-----------------
This study will determine the effectiveness of MK0777 GEM versus Lorazepam in the treatment of patients with generalized anxiety disorder. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Conditions
-----------------
Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: MK0777


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been diagnosed with Generalized Anxiety Disorder Women of childbearing potential must use a double-barrier methods of contraception and must have a negative blood pregnancy test at the beginning of the study Exclusion Criteria: History of drug or alcohol abuse Have previously participated in another study using MK0777

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: MK0777|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Reducing Urethral Pain During Urodynamic Test - Comparison Between Lidocaine Gel and Paraffin Oil

Study Overview
=================
Brief Summary
-----------------
Our purpose is to compare between intraurethral lidocaine gel and paraffin oil in reducing urethral pain during urodynamic test.

Detailed Description
-----------------
Patients will be randomized into two groups: 1) Lidocaine Gel 2) Paraffin Oil. They will fill out 1 visual analogue scale (0-10) for urethral pain during the test.

Official Title
-----------------
Reducing Urethral Pain During Urodynamic Test - Comparison Between Lidocaine Gel and Paraffin Oil

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

Intervention / Treatment
-----------------
* Drug: Lidocaine Gel
* Drug: Paraffin Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All men who will be referred for urodynamic test Exclusion Criteria: Active infection Permanent Catheter

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

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

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 |
| --- | --- |
| Active Comparator: Lidocaine gel<br>Intraurethral Lidocaine gel 2% | Drug: Lidocaine Gel<br> <br> |
| Experimental: Paraffin Oil<br>Intraurethral injection | Drug: Paraffin Oil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue scale (0-10) for pain | patients will fill ou the scale before, during and immediately after the test | up to 1 hour after the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urodynamic, Paraffin oil, Lidocaine gel, Pain
High Dose Chemotherapy and Allogeneic Hematopoietic Cell Transplant for Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
To evaluate the role of allogeneic hematopoietic cell transplantation in the treatment of NHL.

Detailed Description
-----------------
To determine safety and toxicity of a regimen of high dose chemotherapy with allogeneic peripheral blood progenitor cell transplantation; determine the efficacy of the procedure by following clinical outcomes and quality of life measures; and evaluate graft versus host disease incidence and severity with regimen.

Official Title
-----------------
High Dose Chemotherapy and Allogeneic Hematopoietic Cell Transplantation for Non-Hodgkin's Lymphoma

Conditions
-----------------
Lymphoma, Non-Hodgkin, Blood and Marrow Transplant (BMT), Lymphomas: Non-Hodgkin

Intervention / Treatment
-----------------
* Procedure: ablative allogeneic hematopoietic cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Morphologically confirmed relapsed non-Hodgkin's lymphoma Age: >18 and <61 years of age Signed informed consent Exclusion Criteria:Hepatic dysfunction defined by serum transaminases >2.5X normal values Serum creatinine of > 2 mg/dl or creatinine clearance < 60 ml/min Diseases other than non-Hodgkin's lymphoma Prior bone marrow transplant procedure Severe psychological or medical illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 61 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: ablative allogeneic hematopoietic cell transplantation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Toxicity |  |  | 
| Efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute and chronic GVHD |  |  |
Evaluation of a Neck Strengthening Program to Reduce the Risk of Sport-related Concussion

Study Overview
=================
Brief Summary
-----------------
Evaluation of a neck strengthening program as a potential intervention to reduce the risk of sport-related concussion in youth contact and collision sport athletes.

Detailed Description
-----------------
This is a pilot study to investigate the effect of a supervised 8 week strengthening intervention in male and female youth contact and collision sport athletes. Participants will complete a supervised strengthening exercise intervention involving manual resistance exercises administered by a strength coach with pre- and post-intervention assessments of neck size and strength.

Official Title
-----------------
Evaluation of a Neck Strengthening Program as a Potential Intervention to Reduce the Risk of Sport-related Concussion

Conditions
-----------------
Sport-related Concussion, Brain Concussion, Healthy

Intervention / Treatment
-----------------
* Other: Neck Strengthening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Contact/collision sport athletes (for example, american football, soccer, rugby, lacrosse, ice hockey, field hockey, basketball, wrestling, boxing, martial arts, water polo) Exclusion Criteria: History of concussion (suspected or diagnosed) in the previous 6 months History of neck pain or injury in the previous 6 months History of migraine headaches History of personal or parental history of a diagnosed anxiety disorder

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Body Strengthening (Only)<br>All participants will complete a general resistance exercise training program. | |
| Experimental: Body Strengthening + Neck Strengthening<br>Participants assigned to the neck strengthening group will complete additional supervised exercises specifically designed to strengthen the neck. | Other: Neck Strengthening<br>* Targeted neck strengthening exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Head linear velocity |  | Change from baseline to end of 8 week intervention. | 
| Head angular velocity |  | Change from baseline to end of 8 week intervention. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Concussion, Contact sport, Collision sport, Neck strengthening
Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients

Study Overview
=================
Brief Summary
-----------------
Endometrial polyps are one of the main causes of infertility in women. In this work we propose an alternative, effective, economical and safe treatment: the use of misoprostol

Detailed Description
-----------------
The prevalence of uterine polyps has been estimated in the general population at 10-15%, while in infertile patients it ranges from 6-32%. Its etiology is considered as multifactorial. Polyps induce a local inflammatory response in the endometrial cavity, causing infertility. The treatment of choice considered gold standard is the excision by hysteroscopy, however, improvement has been shown in patients with conservative management due to the regression rate of 27%. There are no recommended drugs to provide a definitive treatment for uterine polyps. Misoprostol is a synthetic analogue derived from prostaglandin E1 that has stimulating effects on the smooth muscle fibers of the uterus, causing contractions of the myometrium, which cause endouterine evacuation. The present study shows a possible utility of misoprostol for the conservative treatment of uterine polyps.

Official Title
-----------------
Misoprotol as a Treatment for Endometrial Polyps in Infertile Patients

Conditions
-----------------
Endometrial Polyps in Infertile Patients

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with uterine polyps diagnosed by endovaginal ultrasound and/or hysterosonography, female ≤ 45 years of age Exclusion Criteria: Patients older than 45 years, polyps larger than 60 mm, who did not perform surveillance and/or minimum assessment 6 months after medical management

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expulsion rate of endometrial polyps |  | 7 days after misoprostol has been applied | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate after expulsion |  | 14-21 days after positive β-human Chorionic Gonadotropin (β-hCG) | 
| The pregnancy rate after expulsion in patients with primary sterility |  | 14-21 days after positive β-hCG |
Safety and Efficacy of Firmagon® (Degarelix) for Injection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of Firmagon® (degarelix) for injection under the conditions of general clinical practice in Korea.

Official Title
-----------------
Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Firmagon® (Degarelix) for Injection

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: degarelix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are eligible for the treatment of Firmagon® (degarelix) for injection according to the approved product label, and Firmagon® (degarelix) treatment decided before study enrolment. Moreover, patient should have not previously received Firmagon® (degarelix) for injection before the study commencement date at each site. - Indication: treatment of advanced, hormone-dependent prostate cancer. Exclusion Criteria: Patients with previous or concurrent known hypersensitivity to any component of the drug.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Firmagon®<br>Treatment according to standard clinical practice. | Drug: degarelix<br> <br> * Other names: Firmagon®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Up to 12 months |
Study Evaluating the Safety & Efficacy of DVS-223 SR for Relief of Vasomotor Symptoms Associated With Menopause

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of 4 doses of desvenlafaxine-233 sustained release (DVS-233 SR) as compared to placebo for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as its influence on sleep parameters and other health outcomes indicators.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled Efficacy and Safety Study of DVS-233 SR For Relief of Vasomotor Symptoms Associated With Menopause

Conditions
-----------------
Vasomotor Symptoms

Intervention / Treatment
-----------------
* Drug: DVS-233 SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy, postmenopausal women; at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). Minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week at screening: Moderate hot flush: warm sensation with sweating, does not disrupt activity. Severe hot flush: hot sensation with sweating, disrupts activity. Subjects must have body mass index (BMI) less than or equal to 40 using the nomograph for BMI. Exclusion Criteria: Hypersensitivity to venlafaxine (Effexor or Effexor XR). Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks prior to screening; use of transdermal hormone products within 8 weeks prior to screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to screening; use of intrauterine progestins within 8 weeks prior to screening; use of progestin implants or estrogen injectables within 3 months prior to screening; use of estrogen pellet or progestin injectables within 6 months prior to screening. History of a seizure disorder other than a single childhood febrile seizure.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DVS-233 SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to assess the efficacy and safety of 4 doses of DVS-233 SR as compared to placebo for the treatment of moderate to severe VMS associated with menopause. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objectives are to assess the effects of DVS-233 SR as compared to placebo on sleep parameters and on health outcomes indicators |  |  |