linjc16/ctgov huggingface dataset:
Consultations in Psychiatry Through Videoconference

Study Overview
=================
Brief Summary
-----------------
Online consulatations through videoconference in the field of psychiatry given to general practitioners will reduce costs of medical treatment and improve service.

Detailed Description
-----------------
CLINICAL STATE, SATISFACTION AND COST EFFECTIVENESS WILL BE CHECKED DURING 1 YEAR OF ONLINE VIDEO CONFERENCE CONSULTATION TO GENERAL PRACTITIONERS. BPRS, HAMILTON ANXIETY AND DEPRESSION AND CGI SCALES WILL BE COMPLETED.COSTS OF MEDICATIONS, NUMBER OF VISITS, LAB AND OTHER EXAMINATIONS, HOSPITALIZATIONS, MISSING WORKING DAYS WILL BE EVALUATED.

Official Title
-----------------
Consultations in Psychiatry Given to GP's Through Videoconference

Conditions
-----------------
Remote Consultation [L01.178.847.652.550]

Intervention / Treatment
-----------------
* Procedure: videoconference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referral by general practitioner Age: >18 - Speaking Hebrew or Russion Exclusion Criteria: CGI>4 Dementia Drug or alcohol addiction -

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

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: videoconference|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expenditures on medications |  |  | 
| No. of visits |  |  | 
| Loss of work days |  |  | 
| Expenditure on lab tests |  |  | 
| Satisfaction |  |  | 
| CGI |  |  | 
| Hamilton |  |  | 
| Somatisation |  |  | 
| GHQ11 |  |  | 
| Q-LES-Q-18 |  |  | 
| No. of consultations |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
general practitioners, psychiatry, videoconference
Possible Manifestation of Rhinitis After Nasal Fracture

Study Overview
=================
Brief Summary
-----------------
We would like to investigate our hypothesis of a higher prevalence of nasal fracture in the history of idiopathic rhinitis (IR) patients compared to healthy controls. Therefore a retrospective analysis of 310 patients with a nasal fracture in the past would be useful to investigate the incidence of IR in this cohort afterwards (5-10 y later).

Detailed Description
-----------------
The patient population will be recruited by sending patient questionnaires (form in addendum) to patients who suffered a nasal fracture five to ten years ago (time period 2005-2013) with nose reposition afterwards under general anaesthesia in the chirurgical day care centre (CDC) of university hospital (UZ) Leuven. The control population (HC) will be recruited by sending a slightly adapted questionnaire (form in addendum) to patients who had surgery of the vocal cords under general anaesthesia in the CDC of UZ Leuven in the same period as the patient group. The control group will be age and sex-matched with the patient group.

Official Title
-----------------
Possible Manifestation of Rhinitis After Nasal Fracture

Conditions
-----------------
Nasal Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of nasal fracture in 2005-2013 and Diagnosis ascertained by a Ear-Nose-Throat (ENT) specialist and Followed by nose reposition surgery under general anaesthesia and Described in the clinical operation report as mobile nose bones OR Available radiography Inclusion criteria of the control group: Presence of problem on vocal cords without previous nasal fracture Surgery of the vocal cords under general anaesthesia in 2005-2013

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the incidence of IR after nasal fracture in the patient population with the incidence of IR in the control group. | Comparison of the incidence of IR after nasal fracture in the patient population with the incidence of IR in the control group. outcome measurement: percentage of participants | at least 1 year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery for nasal fracture
Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

Study Overview
=================
Brief Summary
-----------------
Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.

Detailed Description
-----------------
The optimal management of functional tricuspid regurgitation (FTR) in the setting of mitral valve operations remains controversial. The current practice is both center- and surgeon-specific with guidelines based on non-randomized data. A prospective randomized trial was performed to evaluate the worth of less-than-severe FTR repair during mitral valve procedures. A single center randomized study was designed to allocate patients with less-than-severe FTR undergoing mitral valve surgery to be prophylactically treated + tricuspid valve annuloplasty (TVP- or TVP+). These patients were analysed using longitudinal cardiopulmonary exercise capacity, echocardiographic follow-up, and cardiac magnetic resonance (CMR). The primary outcome was more than mild tricuspid regurgitation (TR) recurrence with vena contracta >3mm. Secondary outcomes were maximal oxygen uptake (VO2 max) and right ventricular (RV) dimension and function.

Official Title
-----------------
Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

Conditions
-----------------
Tricuspid Valve Insufficiency

Intervention / Treatment
-----------------
* Procedure: Tricuspid annuloplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing mitral valve surgery with less than sever tricuspid insufficiency Exclusion Criteria: presence of pacemaker lead through the tricuspid valve acute endocarditis minimally invasive approach Functional mitral valve insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tricuspid annuloplasty<br>Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery | Procedure: Tricuspid annuloplasty<br>* Tricuspid annuloplasty<br>|
| No Intervention: No Tricuspid annuloplasty<br>Control patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of more than mild tricuspid insufficiency |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 max | Physical function capacity measured by VO2 max | 1 year | 
| Right ventricular function | Right ventricle function at the follow up | 5 year |
Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body

Study Overview
=================
Brief Summary
-----------------
Advanced MRI (Magnetic Resonance Imaging) technique called DCE (Dynamic Contrast Enhanced) and DWI MRI can provide valuable information regarding tumor biology and response to treatment through various parameters. Validating stability of these parameters will further establish robustness and reliability of these promising biomarkers.

Official Title
-----------------
Reproducibility and Repeatability of Multifunctional MRI Biomarkers of the Body

Conditions
-----------------
Metastatic Liver Cancer

Intervention / Treatment
-----------------
* Other: DCE MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of metastatic liver cancer proven by pathology At least one liver tumor should be > 2cm in long diameter Patients with viable tumor proven in the other imaging modalities Exclusion Criteria: Severe claustrophobia Presence of MRI-incompatible metallic objects or implanted medical devices in body Renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 Weight greater than that allowable by the MRI table Chemotherapy within 28 days prior to enrollment Prior external radiation therapy to the liver, prior transarterial chemoembolization

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCE and DWI MRI<br>MRI SCAN 1 and MRI SCAN 2 must be completed no less than 2 calendar days (to ensure 24 hours for clearance of gadolinium) and no greater than 14 days apart, and both must be completed prior to new treatment initiation. The same MRI unit and configuration must be used for MRI SCAN 1 and MRI SCAN 2. | Other: DCE MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| repeatability coefficient (RC) | Repeatability coefficient of Ktrans, Kep, Ve, IAUGC60, and ADC value of the index tumor will be measured. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reproducibility of Results, Liver neoplasm, Neoplasm metastasis, Regional Perfusion, Perfusion Magnetic Resonance Imaging
Effects of GCP on Prostate Cancer.

Study Overview
=================
Brief Summary
-----------------
Genistein Combined Polysaccharide (GCP) is derived from adding soy powder to shiitake mushrooms. This concentrated mixture is currently being sold in Japan and the United States and is thought to possibly contain properties that may be useful in treating certain types of cancer.

Official Title
-----------------
Effects of a Genistein Combined Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.

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

Intervention / Treatment
-----------------
* Drug: Genistein Combined Polysaccharide (GCP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be male and have a pathological diagnosis of prostate cancer. No treatment (surgery [RRP], radiation, or hormones) prior to study entry. The patient has decided, after consultation with his own doctor, to have no treatment intervention (surgery [RRP], radiation, or hormones) for the next six months. PSA between 2.0 and 10.0 ng/ml. If PSA is >10.0, patient must have been on Active Surveillance for 12 months prior to study initiation. No known allergy to soy or soy products. The patient is not currently taking more than 2 grams of genistein a day in nutritional or diet enhancing supplements (OTC supplements). - Exclusion Criteria: No pathological documentation of prostate cancer. Allergy to soy or soy products Prior history of treatment for prostate cancer. -
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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Genistein Combined Polysaccharide (GCP)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in PSA serum levels. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stabilization of PSA serum levels. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate, Cancer, Prostate Specific Antigen, C04.588.945.440.770
Pilot Study for a National Screening for Familial Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
A pilot study to study the feasibility of the screening of familial hypercholesterolemia within the setting of the legal medical visits at primary school. The pilot study shall evaluate whether this screening set-up is efficient to detect patients having familial hypercholesterolemia, detect further patients by an adjacent cascade screening of family members, to deliver treatment to these patients and to provide this screening in a cost-effective manner.

Detailed Description
-----------------
Pilot study evaluating the feasibility of a screening for familial hypercholesterolemia. Cross-sectional design. Primary outcome Percentage of screened school children with confirmed familial hypercholesterolemia Participants All children, who attend a public primary school in the city of Luxembourg and are enrolled in the cycle C2.2 (age of 7-8 years; 3rd medical visit at school), cycle C3.2 (age 9-10 years, 4th medical visit at school) and cycle 4.2 (age 11-12 years, 5th medical visit at school) will be invited to participate. Expected number of invited children is around 1600 children/year. Recruitment will take place during the school year 2021/2022 and 2022/2023. The parents/caregivers of these children will receive written information about the screening. They will receive as well a questionnaire on the family history of premature cardiovascular events and known FHC disease. Without informed consent, the child cannot be included in the screening program. All children with signed informed consent will have a finger prick for a capillary blood test in the setting of their medical school exam by an external study nurse (not the school nurse) All data (pseudonymised) on each participant will be entered in the online data base for further analysis.

Official Title
-----------------
Pilot Study for a National Screening for Familial Hypercholesterolemia

Conditions
-----------------
Familial Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Attending primary school in the city of Luxembourg and invited for the legal medical visit Exclusion Criteria: 1. No parental informed consent

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 13 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| familial hypercholesteromia | percentage of screened primary school children with hypercholesterolemia | 2021-2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of children screened | number screened/number invited | 2021-2024 | 
| percentage of families screened | index case family screening | 2021-2024 |
Music During Diagnostic Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
Office Hysteroscopy is associated with a level of anxiety that could condition tolerability of the procedure by the patient. The aim of this study is to evaluate the impact of music on anxiety state, expected and received pain by patients during office hysteroscopy.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients candidates for office hysteroscopy in menopausal status or in childbearing age Exclusion Criteria: Previous diagnostic hysteroscopy and/or RCU Current or recent pelvic Inflammation Invasive cervix cancer Ongoing pregnancy
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 |
| --- | --- | --- |
Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents

Study Overview
=================
Brief Summary
-----------------
To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.

Official Title
-----------------
GH Therapy in Partial GHD Adolescents : Evaluation of Efficacy Based on Body Composition and Comparison of 2 Different Doses of Genotonorm®. Open-Label, Randomised, Comparative, Controlled, Parallel-Group, Multi-Center Phase IIIB Clinical Trial.

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Procedure: Blood sample
* Procedure: Radiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females : Chronological age > or = 15 years and < or = 20 years for females Chronological age > or = 17 years and < or = 20 years for males GHD of childhood onset treated for at least 2 years Last GH injection at least 12 months before baseline visit Exclusion Criteria: Turner's syndrome Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT > 2 X ULN

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 20 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 |
| --- |
|Procedure: Blood sample|nan|
|Procedure: Radiography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment. |  |  |
Ultrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection in Recalcitrant Plantar Fasciitis Treatment

Study Overview
=================
Brief Summary
-----------------
A randomized controlled study to search for the efficiency of tibial nerve block vs local corticosteroid injection of the plantar fascia.

Detailed Description
-----------------
Three groups will be formed. After ESWT therapy, if the patients still suffer from pain (> 5 points, visual analog scale(0-10points), participants will be included in the study. One group will receive conversational therapy. Second group will be treated with local corticosteroid injection. And third group will be treated with tibial nerve block. Before-treatment, after one week, after six weeks and after 3 months evaluation of the patients will be performed.

Official Title
-----------------
Ultrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection: A Randomized Controlled Study for Recalcitrant Plantar Fasciitis

Conditions
-----------------
Plantar Fascitis, Tibial Nerve, Injections, Ultrasonography

Intervention / Treatment
-----------------
* Device: Injection
* Device: Tibial nerve block
* Other: Conservational therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recalcitrant plantar Fasciitis Exclusion Criteria: -

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 |
| --- | --- |
| Experimental: Recalcitrant Plantar Fasciitis/Conservational<br>After ESWT therapy patients suffer from extreme pain will recieve only conservational therapy (26 patients) | Other: Conservational therapy<br>* Only exercise and foot insoles<br>|
| Experimental: Recalcitrant Plantar Fasciitis/Local<br>After ESWT therapy patients suffer from extreme pain will receive local steroid injections | Device: Injection<br>* Local corticosteroid injection<br>|
| Experimental: Recalcitrant Plantar Fasciitis/Tibial nerve<br>After ESWT therapy patients suffer from extreme pain will receive tibial nerve block | Device: Tibial nerve block<br>* Tibial nerve block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS-Pain | A scale on 0-10 points. 0 points indicate no pain, and 10 points show worst pain ever | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plantar Fascitis, Tibial Nerve, Injections, Ultrasonography