linjc16/ctgov huggingface dataset:
Circadian Sleep-wake Cycles and Light Therapy in Borderline Personality Disorder

Study Overview
=================
Brief Summary
-----------------
Individuals with borderline personality disorder (BPD) frequently suffer from emotional instability, daytime fatigue and sleep disturbances. The investigators examined circadian rhythms, sleep and well-being in women with BPD under their habitual life conditions with and without light treatment. Treated women diagnosed with BPD were investigated during 3 weeks without and 3 weeks with morning LT. Rest-activity cycles were continuously measured using wrist actigraphy, together with proximal skin temperature. Saliva samples were collected weekly to determine the diurnal melatonin rhythm. A range of self-ratings and questionnaires were used to assess depression and clinical state throughout the 6-week protocol. Ten matched healthy women followed the same 6-week protocol without light treatment.

Official Title
-----------------
Circadian Sleep-wake Cycles, Well-being and Light Therapy in Borderline Personality Disorder

Conditions
-----------------
Borderline Personality Disorder, Sleep Disturbances, Depression

Intervention / Treatment
-----------------
* Other: light therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Borderline Personality Disorder (DSM IV-criteria) German-speaking normal ocular function Exclusion Criteria: lack of compliance

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: light therapy<br>Morning bright light treatment (at 8000 lux for 40min, daily during 3 weeks) | Other: light therapy<br>* early morning exposures to bright light, 8000lux for 40min, daily during 3 weeks<br>|

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
-----------------
Circadian rhythms, Sleep-wake cycles, Melatonin, Borderline Personality Disorder, Light therapy
Vitamin A and Azithromycin for Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
Patients seen with acne lesions not having responded to existing treatments will be offered a placebo or a topical preparation consisting of Vitamin A USP with or without Azithromycin for a duration of 4-6 months USP for the objective of resolving the lesions without systemic side effects and via weekly follow-ups.

Detailed Description
-----------------
The concentrations of the active ingredients is based on the enclosed articles and the formulations have been modified with an objective of minimizing the side effects.

Official Title
-----------------
Treatment of Acne for Cases Resistant to Currently Available Measures Via Vitamin A With or Without Azithromycin in Topical Formulations

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Vitamin A
* Drug: Azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with active lesions Exclusion Criteria: Patients on a treatment Asymptomatic patients

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 45 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin A<br>retinyl palmitate USP | Drug: Vitamin A<br>* Vitamin A 2-3 % concentration<br>* Other names: retinyl palmitate;|
| Experimental: Azithromycin with Vitamin A<br>USP grade ingredients | Drug: Vitamin A<br>* Vitamin A 2-3 % concentration<br>* Other names: retinyl palmitate;Drug: Azithromycin<br>* azithromycin monohydrate<br>* Other names: azithromycin monohydrate;|
| Active Comparator: Azithromycin<br>azithromycin monohydrate | Drug: Azithromycin<br>* azithromycin monohydrate<br>* Other names: azithromycin monohydrate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement (dimensions) of acne lesions | follow-up focussed on observation of changes | Every 4 weeks up to16 weeks |
OCD Among Patients With Burns

Study Overview
=================
Brief Summary
-----------------
Estimating the prevalence of OCD symptoms among patients with burns

Conditions
-----------------
Obsessive-Compulsive Disorder, Burns

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with burns for at least 6 months and are under treatment Exclusion Criteria: Was not defined

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
COVID-19 PCR Test Results in Asymptomatic Pregnants

Study Overview
=================
Brief Summary
-----------------
In order to prevent contamination from the pregnant women hospitalized in this clinic, the RT-PCR test is performed from the oropharyngeal and nasal swab sample taken before hospitalization. In addition, the same test is done before each operation and before the operation. The aim of the study is to scan these tests retrospectively and to determine the rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine the importance of the measures to be taken in the pregnant women who undergo intervention.

Official Title
-----------------
COVID-19 PCR Test Results in Asymptomatic Pregnants Admitted for Birth and Other Interventions in Our Clinic

Conditions
-----------------
COVID-19, Asymptomatic Pregnant

Intervention / Treatment
-----------------
* Diagnostic Test: Reverse transcription polymerase chain reaction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic pregnant women who will give birth in this clinic, dilatation and curettage due to missed abortion, cerclage due to cervical insufficiency, medical evacuation due to fetal anomaly, and routine PCR test taken for service for some treatments. Exclusion Criteria: Having any COVID-19 infection symptoms (fever, cough, weakness, shortness of breath, sore throat, etc.)
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Reverse transcription polymerase chain reaction|PCR test is performed from the oropharyngeal and nasal swab samples taken before admission to each pregnant to prevent contamination from the pregnant women hospitalized in this clinic. In addition, the same test is done before each operation and before the operation. The aim of the study is to scan these tests retrospectively and to determine the rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine the importance of the measures to be taken in the pregnant and undergoing pregnant women.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of positive COVID-19 cases in asymptomatic pregnant women |  | 1 day |
Study of Atomoxetine in Children With ADHD to Assess Symptomatic and Functional Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether changes in the symptoms of ADHD show a relationship with changes in functioning in children with ADHD treated with atomoxetine over a 3-month period.

Official Title
-----------------
A 3 Month Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder; Symptomatic and Functional Outcomes.

Conditions
-----------------
Attention-Deficit/Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Atomoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 11 years 8 months of age at Visit 1 so that all testing will be completed before the child reaches age 12. Patients must have moderately severe symptoms of ADHD. Patients must be able to swallow study drug capsules. Exclusion Criteria: Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder. Patients must not have taken atomoxetine prior to starting the study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 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 |
| --- |
|Drug: Atomoxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the correlation of change in score on an ADHD rating scale with the change in score on a functional rating questionnaire at 3 months post atomoxetine initiation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understand the relationships between ADHD symptoms, functional outcomes, and quality of life |  |  | 
| Explore the impact of data collection time points on efficacy, quality of life, and functional outcome |  |  | 
| Assess the efficacy of atomoxetine |  |  | 
| Use data collected to validate the WFIRS-P questionnaire |  |  |
VLDL-triglyceride Under Acute Hyperinsulinaemia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate and compare the lipid metabolism in lean and obese individuals. We want to investigate the effect of postprandial hyperinsulinaemia on VLDL-triglyceride metabolism

Official Title
-----------------
VLDL-triglyceride Under Acute Hyperinsulinaemia

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Food (fat free meal)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Written consent Exclusion Criteria: Known diseases Alcohol abuse Smoker Regular use of medicine

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Lean male | Dietary Supplement: Food (fat free meal)<br>* Fat free meal (40% of REE)<br>|
| 2<br>Males with type 2 diabetes | Dietary Supplement: Food (fat free meal)<br>* Fat free meal (40% of REE)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VLDL metabolism |  | Few hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VLDL, Kinetics, Hyperinsulinaemia, Obesity
Prospective, Observational Study of Low-risk Criteria for Node Metastasis in Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of low risk criteria for lymph node metastasis, that was determined by KGOG-2014 retrospective study, in women with endometrial cancer.

Detailed Description
-----------------
The Korean Gynecologic Oncology Group (KGOG) undertook a multi-center retrospective study to develop a preoperative prediction model for lymph node metastasis in endometrial cancer (KGOG-2014). This retrospective multi-center study showed that the accurate identification of a low-risk group for lymph node metastasis among the patients with endometrial cancer can be achieved with the new criteria using preoperative MRI and serum CA-125 assay. In this study, serum CA125 levels and three MRI parameters (deep myometrial invasion, lymph node enlargement, and extension beyond uterine corpus) were found to be independent risk factors for nodal metastasis. Based on the success of KGOG-2014, Korean Gynecologic Oncology Group initiated this prospective, multi-center observational study to validate our prior prediction model.

Official Title
-----------------
Multi-center Prospective Observational Study for the Validation of Preoperative Low-risk Criteria for Lymph Node Metastasis in Endometrial Cancer

Conditions
-----------------
Endometrial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a histologic diagnosis of endometrial cancer before surgical staging. Patients with a preoperative magnetic resonance imaging (MRI) and serum CA-125 within 4 weeks from surgical staging. Patients who underwent adequate systemic lymph node dissection during surgical staging. Exclusion Criteria: Patients with a histologic feature suggesting sarcoma or squamous cell carcinoma
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Sensitivity/Specificity |  | 2014-12-31 | 
| Negative predictive value |  | 2014-12-31 | 
| Diagnostic odds ratio |  | 2014-12-31 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometrial cancer, lymph node metastasis, lymphadenectomy, risk criteria
Transforaminal Lumbar Interbody Fusion in PEEK Oblique Cages With and Without Titanium Coating

Study Overview
=================
Brief Summary
-----------------
Clinical outcome with regard to oswestry disability index and lumbar fusion rate after implantation of titanium coated PEEK cage and common PEEK cage

Detailed Description
-----------------
Cages made of polyetheretherketone (PEEK) and titanium materials reliably produce successful fusion rates and good clinical outcomes. However, there is a paucity of studies that have assessed the optimal material of cage systems. The primary objective of this study was to compare the Oswestry Disability Index (ODI) after instrumented transforaminal lumbar interbody fusion (TLIF) using either titanium-coated polyetheretherketone (TiPEEK) or common PEEK cages. Secondary objectives were to assess differences in fusion rates and differences in pain and in quality of life between these groups.

Official Title
-----------------
Randomized Evaluation of Bone Ingrowth After Intervertebral Body Fusion With Either MectaLIF® PEEK or MectaLIF® TiPEEK Oblique

Conditions
-----------------
Vertebral Fusion

Intervention / Treatment
-----------------
* Device: PEEK
* Device: TiPEEK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persistence of low back pain, sciatica and spinal claudication after conservative treatment attributed to L3 to L5 lumbar segments. Exclusion Criteria: previous lumbar spinal surgery body mass index >35 kg/m²

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lumbar fusion with PEEK cage<br>Control arm | Device: PEEK<br>* Procedure/Surgery: TLIF fusion with common PEEK cages.<br>|
| Other: Lumbar fusion with TiPEEK cage<br>Study arm | Device: TiPEEK<br>* Procedure/Surgery: TLIF fusion with titanium coated PEEK cages.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome assessed by Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK | Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion result | Fusion rate after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lumbar spine; Fusion; Titanium; PEEK
Safety and Efficacy of the LVIS and LVIS JR Devices in the Endovascular Treatment of Intracranial Aneurysms

Study Overview
=================
Brief Summary
-----------------
A French, multicenter, prospective, observational, real life assessment of the safety and efficacy of LVIS and LVIS JR devices in the treatment of intracranial aneurysms

Detailed Description
-----------------
This is a multicenter observational study. Treatment and follow-up visits will be done as per standard of care. The purpose of this study is to collect data on safety of the devices used since the French reimbursement. 130 patients will be enrolled over an 18-month recruitment period. All patients will be followed for at least 12 months.

Official Title
-----------------
A French, Multicenter, Prospective, Observational, Real Life Assessment of the Safety and Efficacy of the Low Profile Visualized Intraluminal Support (LVIS and LVIS JR) Devices in the Treatment of Intracranial Aneurysms

Conditions
-----------------
Intracranial Aneurysm

Intervention / Treatment
-----------------
* Device: LVIS and LVIS JR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device LVIS or LVIS JR, either scheduled or emergency ( Bail-out stenting ) Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: LVIS and LVIS JR|Braided coil assist stents used for aneurysm embolization|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate |  | 1 year | 
| Morbidity Rate | Number of adverse events with clinical impact related to the procedure and/or the device | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical effectiveness | Number of patients with mRS>2 | 1 year | 
| Anatomical effectiveness | Number of patients with complete occlusion of the treated aneurysm | 1 year | 
| Retreatment rate |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aneurysm, endovascular
Expanded Access to Mepsevii

Study Overview
=================
Brief Summary
-----------------
Individual patient expanded access requests may be considered for patients who have no other treatment options

Detailed Description
-----------------
Expanded access may be available outside of the US in countries prior to approval by the local regulatory agencies. For full details, please visit the links provided below.

Conditions
-----------------
MPS VII, Mucopolysaccharidosis VII, Sly Syndrome

Intervention / Treatment
-----------------
* Drug: Mepsevii


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mepsevii|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Expanded Access, Compassionate Use
Diagnostic Usefulness of Interferon Gamma Release Assay for Active Tuberculosis in Immunocompromised Patients

Study Overview
=================
Brief Summary
-----------------
For diagnosis of active tuberculosis, interferon-γ release assay based mycobacterium tuberculosis specific antigen may show higher sensitivity than tuberculin skin test in immunocompromised patients. Therefore, interferon-γ release assay have a role as a rapid diagnostic adjunctive methods for active tuberculosis in immunocompromised patients.

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient suspicious of active tuberculosis with immunocompromised condition Immunocompromised condition patients with solid cancer with chemotherapy hematologic malignancy organ transplantation immunosuppressant ESRD on renal replacement therapy diabetes advanced liver cirrhosis Exclusion Criteria: Patients with less than 20 years who don't agree the participation of study hypersensitivity history to tuberculin pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| immunocompromised group<br> | |
| non-immunocompromised group<br> | |

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
-----------------
suspicious of tuberculosis, immunocompromised patients