linjc16/ctgov huggingface dataset:
Effects of Drospirenone-containing or -Not Containing Combined Oral Contraceptives on General and Sexual Well-being

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the symptoms and satisfaction for women taking drospirenone (DRSP)-containing combined oral contraceptives in comparison with women taking other kind of combined oral contraceptives.

Official Title
-----------------
Observational Study on the Effects of DRSP-Containing Combined Oral Contraceptives (Yasmin,Yasminelle) and Other Combined Oral Contraceptives on the General and Sexual Well-Being in COC Users

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: EE30-DRSP (Yasmin, BAY86-5131)
* Drug: Other combined oral contraceptives


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According to the label of the prescribed Combined Oral Contraceptive (COC) first Combined Oral Contraceptive use or previous Combined Oral Contraceptive use intention to use current COC for 1 year at least Exclusion Criteria: Contraindications listed in the label of the prescribed Combined Oral Contraceptive (COC)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: EE30-DRSP (Yasmin, BAY86-5131)<br>* DRSP-containing combined oral contraceptives according to the normal routine praxis<br>|
| Group 2<br> | Drug: Other combined oral contraceptives<br>* Other combined oral contraceptives according to the normal routine praxis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI) |  | at 12 months | 
| Sexual well-being evaluated by the Female Sexual Function Index (FSFI) |  | at 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COC, Combined Oral Contraceptives
KIDNET Versus Meditation/Relaxation - a Dissemination RCTT for Children in Sri Lanka Traumatized by the War and the Tsunami

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation protocol in treating traumatized children in Sri Lanka when applied by locally trained teacher counsellors.

Official Title
-----------------
KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Treatment Trial for Children in Sri Lanka Traumatized by the War and the Tsunami

Conditions
-----------------
Post-Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: KIDNET
* Behavioral: Meditation-Relaxation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with preliminary PTSD diagnosis (except for time criterion) in the age range of 8 to 14 years living in a specific IDP camp after the Tsunami disaster. Exclusion Criteria: Mental retardation, psychosis, any neurological disorder

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 14 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KIDNET<br>Narrative Exposure Therapy for Children | Behavioral: KIDNET<br>* Narrative Exposure Therapy for Children - a short term intervention for the treatment of trauma after war, organized violence, torture, abuse and other detrimental life events<br>|
| Experimental: Meditation/Relaxation<br> | Behavioral: Meditation-Relaxation<br>* a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder |  | pre-treatment, 1 month post, 6 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functioning, Somatic Problems, School grades |  | pre, 1 month post, 6 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post-traumatic Stress disorder (PTSD)
TMS Modulation of Insula-related Brain Networks

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the modulatory effects of repetitive transcranial magnetic stimulation (rTMS) on functional connectivity with the insula. Functional connectivity (FC) measures the interaction between brain regions, and recent neuroimaging studies have used FC to investigate how addiction affects FC among pertinent brain regions. rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain connectivity and could be used therapeutically to treat addiction. However, investigators first need more information on brain FC and how it relates to behavior, in order to guide rTMS target selection.

Official Title
-----------------
TMS Modulation of Insula-related Brain Networks

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Device: repeated transcranial magnetic stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: generally healthy between the ages of 18-55 right-handed Exclusion Criteria: significant health problems (e.g., current and uncontrolled liver, lung, or heart problems) or presence of medical illness likely to alter brain morphology (including history of seizure, history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, and known structural brain lesion) current diagnosis of Axis I psychiatric disorders (e.g., depression, anxiety disorder, schizophrenia) meet DSM-5 criteria for current substance use disorder other than nicotine use of psychoactive medications that would result in a positive urine drug screen Current use of medications known to lower the seizure threshold positive breath alcohol concentration presence of conditions that would make MRI unsafe (e.g., metal implants, pacemakers) among women, a positive urine pregnancy test vision that cannot be corrected to 20/40

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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: Open label<br>Participants will undergo 5 sessions of active rTMS | Device: repeated transcranial magnetic stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional connectivity strength measured with functional magnetic resonance imaging |  | baseline and 1 week |
Treatment of Non-Dislocated Midshaft Both-Bone Fractures

Study Overview
=================
Brief Summary
-----------------
The investigators created a randomized clinical trial to find out what kind of treatment is optimal for non-dislocated both-bone midshaft forearm fractures.

Detailed Description
-----------------
Children who arrive at the emergency unit with a non-dislocated both-bone midshaft forearm fracture will be asked to join the trial. After informed consent we will do a randomization between 6 weeks above elbow cast and 3 weeks above elbow cast in combination with 3 weeks under elbow cast. Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complaints in daily living and complications.

Official Title
-----------------
Above Elbow Cast in Non-Dislocated Both-Bone Midshaft Forearm Fractures in Children: Necessity or Needless Cruelty? A Randomized Trial

Conditions
-----------------
Fracture

Intervention / Treatment
-----------------
* Device: above and below elbow cast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both-bone midshaft forearm fracture Age < 16 years old Exclusion Criteria: Dislocation Fracture older than 1 week No informed consent Refracture Open fracture (Gustillo 2 and 3) Torus fractures of both ulna and radius

Ages Eligible for Study
-----------------
Maximum Age: 15 Years

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

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

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

| Intervention/Treatment |
| --- |
|Device: above and below elbow cast|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pronation and supination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications, function, esthetics, complaints in daily living, X-rays |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fracture, Forearm, Midshaft, Child, Cast
Electroacupuncture for the Treatment of Functional Constipation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of electroacupuncture on functional constipation.

Detailed Description
-----------------
This study will supply significant evidence for using acupuncture to treat functional constipation(FC), and will help us to identify whether it is a therapeutic effect rather than a placebo effect.

Official Title
-----------------
A Randomized Controlled Trial of Acupuncture to Treat Functional Constipation

Conditions
-----------------
Functional Constipation

Intervention / Treatment
-----------------
* Device: acupuncture
* Drug: mosapride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: functional constipation according to the Roman Ⅲ standard; aged between 18 and 65 years old Exclusion criteria: unconsciousness, psychosis or can't express subjective symptoms; pregnant women or women in lactation period; serious diseases of the heart, liver, kidney, and others; bleeding disorders.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mosapride<br>mosapride | Drug: mosapride<br>* Mosapride Citrate tablet（5mg），Dainippon Sumitomo pharmaceutical Co.Ltd,Japan<br>* Other names: GASMOTIN;|
| Experimental: Electro-acupuncture<br>Electro-acupuncture | Device: acupuncture<br>* sterile, disposable needles with a length of 40 mm and a diameter of 0.25 mm (Dongbang® Acupuncture Inc, Korea)<br>* Other names: Park true/sham devices;|
| Sham Comparator: mosapride + sham acupuncture<br>mosapride + sham acupuncture | Device: acupuncture<br>* sterile, disposable needles with a length of 40 mm and a diameter of 0.25 mm (Dongbang® Acupuncture Inc, Korea)<br>* Other names: Park true/sham devices;Drug: mosapride<br>* Mosapride Citrate tablet（5mg），Dainippon Sumitomo pharmaceutical Co.Ltd,Japan<br>* Other names: GASMOTIN;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of defecation per week |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, electro-acupuncture
Fetal Heart Rate Variability

Study Overview
=================
Brief Summary
-----------------
Need statement - a new way to distinguish between a healthy small fetus and a small fetus suffering from deprivation of nutrition and oxygen to prevent unnecessary induction of preterm birth and improve neonatal outcome. Aim - to characterize fetal heart rate variability (fHRV) based on fetal ECG in the normal fetus and in the fetus suffering from growth retardation to evaluate its value and applicability as a supplementary tool in fetal surveillance. Aim of current study - To evaluate the feasibility of NI-FECG from gestational week 20 and onwards and investigate if important factors as length and heart rate pattern affects repeatability of time domain and spectral analyses in fetuses.

Official Title
-----------------
Non-invasive Fetal Electrocardiography (NI-FECG); Repeatability of Time-domain and Spectral Analyses

Conditions
-----------------
Fetal Growth Retardation

Intervention / Treatment
-----------------
* Diagnostic Test: fetal heart rate variability


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Healthy singleton pregnancies Exclusion Criteria: • Fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study 2. Repeatability of FHRV<br> | Diagnostic Test: fetal heart rate variability<br>* No direct intervention, as the study is observational.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard deviation of normal to normal RR-interval (SDNN) | Time domain analysis, measured in ms | 01.04.2020 | 
| Root mean square of successive RR-interval differences (RMSSD) | Time domain analysis, measured in ms | 01.04.2020 | 
| Low frequency power (LF-power) | Spectral analysis, measured in ms^2 | 01.04.2020 | 
| High frequency power (HF-power) | Spectral analysis, measured in ms^2 | 01.04.2020 | 
| LF-power/HF-power | Spectral analysis, ratio | 01.04.2020 |
A Comparison of 4% Articaine Versus 0.5%Bupivacaine for Ambulatory Surgery Under Supraclavicular Block

Study Overview
=================
Brief Summary
-----------------
Effect of 2%Articaine versus 5%bupivacaine in pt undergoing short duration surgery in upper limb

Detailed Description
-----------------
The investigator aim to compare Articaine 2% versus bupivacaine 0.5% in patient undergoing upper limb procedure under ultrasound guided supraclavicular block as regard onset and duration of sensory and motor block

Official Title
-----------------
A Randomized Controlled Trial : Comparison of 4% Articaine Versus 0.5% Bupivacaine for Ambulatory Orthopaedic Surgery Under Supraclavicular Block

Conditions
-----------------
Upper Limb Surgery, Hand Surgery

Intervention / Treatment
-----------------
* Drug: Articaine
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: upper limb surgery ganglion removal k wiring Carapal tunnel Exclusion Criteria: Coagulopathy. infection at site of injection. patient refusal. hypersensitivity.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Articaine group<br>Patients in this group are assigned to recieve 30 ml of Articaine 2% | Drug: Articaine<br>* Supraclavicular block with 30 ml articaine 2%<br>* Other names: Artinebsa;|
| Experimental: Bupivacaine<br>Patients in this group are assigned to recieve 30 ml of bupivacaine 0.5% | Drug: Bupivacaine<br>* Supraclavicular block with 30 ml bupivacaine 0.5%<br>* Other names: Marcaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of sensory block | By pinprick test from 0 to 2 where 0 no sensory block and 2 complete anesthesia | Measured in minutes over 24 hours | 
| Durations of motor block | By Bromage scale from 1 to 4 where 1 no motor power and 4 full motor power | Measured in minutes over 24 hours | 
| Duration of analgesia | Measured by numerical analog scale where 0 no pain and 10 means worst pain | Measured in minutes over 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia | First analgesia required | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Articaine, Bupivacaine, Ultrasound, Supraclavicular block
Oral Manifestations of Aplastic Anemia

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are threefold: 1) to evaluate the prevalence and risks of oral complications in patients with aplastic anemia; 2) to evaluate if oral problems in these patients can predict their response to treatment; and 3) to review complications of dental treatment in these patients in order to establish treatment guidelines. This study will be performed through a review of medical charts of 79 patients with aplastic anemia and 67 patients with schizophrenia who were treated at the National Institutes of Health Dental Clinic between 1993 and 1999. The schizophrenia patients will serve as a control population. Demographic, clinical and radiographic information will be collected for all patients. Additional data collected only for aplastic anemia patients will include medical therapy, disease duration, blood cell counts, oral problems that developed during treatment and treatment response.

Detailed Description
-----------------
The prevalence, risk factors and significance of oral manifestations in aplastic anemia have not been well characterized. Thus, in the present study, through a retrospective chart review, we document the prevalence of oral complications in AA patients and the risks for oral manifestations in a case-control study. Schizophrenic patients represent controls. Information includes the following; demographic, clinical and radiographic information for cases and controls. Additional data collection for only AA patients includes prior medical therapy, CBC and differential, disease duration, new oral manifestations during AA treatment and medical treatment response. We determine if systemic clinical features of AA predict oral manifestations, and if oral manifestations predict treatment outcomes for AA patients. Finally complications following dental treatment are compiled and reviewed to establish initial treatment guidelines for these patients.

Official Title
-----------------
Oral Manifestations of Aplastic Anemia

Conditions
-----------------
Aplastic Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Cases: All aplastic anemia patients evaluated at the NIH dental clinic for consultation between 1993-1999. Controls: All schizophrenic patients evaluated at the NIH dental clinic for consultation between 1993-1999. EXCLUSION CRITERIA: Patients without the diagnosis of aplastic anemia for cases or schizophrenia for the controls.
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
-----------------
Immunosuppression, Treatment Recommendations, Pancytopenia, Schizophrenia, Inpatient Population