linjc16/ctgov huggingface dataset:
Follow up Patients With Thoracolumbar Spondylodiscitis Surgically Treated by Posterior Approach

Study Overview
=================
Brief Summary
-----------------
To evaluate the long term outcomes of patients with thoracolumbar spondylodiscitis treated surgically by posterior approach. Outcomes include bony fusion, neurological improvement, pain improvement, implant related complication, recurrence of infection and or reoperation rate

Detailed Description
-----------------
spondylodiscitis is characterized by infection that primarily affects the intervertebral disc and adjacent vertebrae. The estimated incidence of spondylodiscitis, ranging from 0.2 to 10 per 100,000 inhabitants per year, has increased in recent years, which is likely associated with an aging population, higher prevalence of chronic disease, and more effective diagnostic techniques. Spondylodiscitis is a life-threatening disease with a mortality rate of 2-20% that is often associated with potential complications, such as paraspinal abscess, epidural abscess, meningitis, spinal instability, and neurologic deficiency. The relapse rates were reported to be as high as 32% in the literature. The aims of this study are to evaluate improvements, complications, recurrence and reoperation rates in Assiut university hospitals.

Official Title
-----------------
Long Term Follow up of Patients With Thoracolumbar Spondylodiscitis Treated Surgically by Posterior Approach in Assiut University Hospitals

Conditions
-----------------
Spondylodiscitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • All patients had thoracolumbar spondylodiscitis from number 1 thoracic vertebra till number 1 sacral vertebra. Treated surgically by posterior approach only. Exclusion Criteria: • Patients with incomplete follow up. Multifocal discitis.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bony fusion success | the degree of bridging bone across the fused vertebral bodies by using x-ray, CT scan and MRI if needed | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Oswestry disability index | for patient quality of life postoperative | 2 years | 
| visual analogue scale | the amount of pain sensed by the patient pre and post-operative | 2years | 
| American spinal injury Association (ASIA) Impairment score | to asses neurological outcomes pre operative and at 2 years follow up. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spine surgery, discitis, Spondylitis
Latinx Teen Depression Treatment Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is determine facilitators of and barriers to receiving evidence-based psychotherapy for depression for Latinx adolescents from multiple stakeholder perspectives.

Official Title
-----------------
Barriers, Facilitators, and Preferences Regarding Depression Treatment From the Perspectives of Latinx Adolescents, Parents, and Healthcare Providers

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 13-17 self-identify as Hispanic/Latinx diagnosed with Major Depressive Disorder or Persistent Depressive Disorder/Dysthymia referred to psychotherapy or prescribed medication for depression. Healthcare providers: Self-identify as regularly providing clinical care to Latinx adolescents with depression be in a role in which they can refer to or provide depression treatment. Exclusion Criteria: Teens will be excluded if they are experiencing intense psychological distress or imminent thoughts of suicide or have any condition in which, in the opinion of the investigator, precludes the study team from obtaining informed assent of the teen

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Latinx Adolescents<br> | |
| Parents of Latinx Adolescents<br> | |
| Healthproviders<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of preferences for depression treatment generated from focus groups |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of barriers to depression treatment among Latinx Adolescents from focus groups |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Latinx adolescents, psychotherapy, Focus groups
Treatment of Pelvic Organ Prolapse by PIVS Versus Surgeon Cut Mesh

Study Overview
=================
Brief Summary
-----------------
Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The investigators will compare data from the chart, telephone interviews and physical examinations between those who underwent mesh placement to those who underwent placement of PIVS.

Conditions
-----------------
Pelvic Floor Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who underwent surgery for pelvic floor prolapse Exclusion Criteria: Women who did not have surgery for pelvic floor prolapse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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 |
| --- | --- | --- |
| Satisfaction with study outcome |  | six to twelve months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of the surgery: pain, vaginal erosion by tape, bleeding |  | Within six to twelve months after study |
A Protein Supplementation and Exercise Strategy to Promote Muscle Protein Anabolism in Frail Elderly People

Study Overview
=================
Brief Summary
-----------------
The present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population.

Official Title
-----------------
A Protein Supplementation and Exercise Strategy to Promote Muscle Protein Anabolism in Frail Elderly People

Conditions
-----------------
Sarcopenia

Intervention / Treatment
-----------------
* Dietary Supplement: Protein drink
* Other: Resistance exercise training
* Dietary Supplement: Placebo drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Frail elderly individuals Able to understand and perform the study procedures Exclusion Criteria: Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol) No recent history (within 2 years) of participating in any regular resistance exercise training program (general questionnaire) Use of anti-coagulation medication (except of Acetyl Salicyl acid) Presence of coronary heart disease (ECG) Renal insufficiency (eGFR <60 mL/min/1.73 m2) Allergic or sensitive for milk proteins

Ages Eligible for Study
-----------------
Minimum 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance exercise training and protein drink<br> | Dietary Supplement: Protein drink<br>* Protein drink twice a day during 6 months.<br>Other: Resistance exercise training<br>* Resistance exercise training twice per week during 6 months.<br>|
| Placebo Comparator: Resistance exercise training and placebo drink<br> | Other: Resistance exercise training<br>* Resistance exercise training twice per week during 6 months.<br>Dietary Supplement: Placebo drink<br>* Placebo drink twice a day during 6 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skeletal muscle mass |  | Baseline, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical performance |  | Baseline, 3 months and 6 months | 
| Blood will be collected to assess parameters related to the outcome measures |  | Baseline, 3 months and 6 months | 
| Dietary intake |  | Baseline, 3 months and 6 months | 
| Physical activity |  | Baseline, 3 months and 6 months | 
| Cognitive performance |  | Baseline and 6 months | 
| Blood pressure |  | Baseline, 3 months and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sarcopenia, frail elderly, protein drink, resistance exercise, Skeletal muscle mass, muscle mass in elderly
Prospective Study Assessing the Validity of Y-PAS (Yale Preoperative Anxiety Scale) to Predict Patients Undergoing Magnetic Resonance Imaging Without the Use of Sedation/General Anesthesia

Study Overview
=================
Brief Summary
-----------------
The mYPAS (Modified Yale Preoperative Anxiety Scale) is a quick, easy, validated and gold standard assessment tool to measure pediatric anxiety in the perioperative period. Therefore the objective of the current prospective study is examine if the mY-PAS is an effective screening tool to differentiate patients who would succeed versus fail for MRI without sedation/anesthesia.

Conditions
-----------------
Magnetic Resonance Imaging

Intervention / Treatment
-----------------
* Device: MRI simulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients and parents who are willing to participate in the simulated practice MRI on the day of or prior to their scheduled MRI. Exclusion Criteria: patients/parents who refuse to go through the practice MRI sessions.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MRI<br>Patients who undergo simulated practice MRI on the day of or prior to their scheduled MRI. | Device: MRI simulation<br>* It is not a working MRI machine but sounds and feels just like the real machine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score | Modified Yale Preoperative Anxiety Scale | Immediately following MRI simulation |
Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.

Official Title
-----------------
Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema

Conditions
-----------------
Emphysema

Intervention / Treatment
-----------------
* Device: Lung Volume Reduction Coil (LVRC)
* Device: Coils


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient > 35 years of age unilateral or bilateral emphysema Patient has stopped smoking for a minimum of 8 weeks Read, understood and signed the Informed Consent form Exclusion Criteria: Patient has a history of recurrent clinically significant respiratory infection Patient has an inability to walk >140 meters Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Patient is pregnant or lactating Patient has clinically significant bronchiectasis Patient has had previous LVR surgery, lung transplant or lobectomy Patient has been involved in other pulmonary drug studies with 30 days prior to this study Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 100 Years

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

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: permanent Coil(s) implant, QOL measure<br>Coil implantation as treatment. Treatment is permanent implant. | Device: Lung Volume Reduction Coil (LVRC)<br>* Implantation of Lung Volume Reduction Coil(s) (LVRC)<br>* Other names: Lobectomy;Device: Coils<br>* Lung Volume Reduction Coil(s)<br>* Other names: Lobectomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Assessment. | Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ) | Three + Months Follow-Up Visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LVRS (Lung Volume Reduction Surgery), LVRC (Lung Volume Reduction Coil), Emphysema, coil, RePneu
Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Sunphenon, a green tea extract containing 95% egcg, given daily as oral medication over a period of 18 months has anti-inflammatory and neuroprotective properties in patients with relapsing-remitting multiple sclerosis as assessed by magnetic resonance imaging and clinical examination (EDSS and MSFC).

Detailed Description
-----------------
This multicentric, national study investigates the efficacy and safety of EGCG in patients with relapsing-remitting multiple sclerosis.

Official Title
-----------------
Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)

Conditions
-----------------
Relapsing-remitting Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: epigallocatechin-gallate (Sunphenon)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female subjects age 18 to 60 relapsing-remitting course of MS stable treatment with glatiramer acetate at least 6 months prior to inclusion Exclusion Criteria: primary or secondary progressive forms of MS clinically relevant heart, lung, liver, kidney diseases regular hepatotoxic co-medication drug addiction alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: verum<br>Sunphenon plus glatiramer acetate | Drug: epigallocatechin-gallate (Sunphenon)<br>* 200 mg twice daily, after 3 months 400 mg twice daily<br>|
| Active Comparator: placebo<br>placebo plus glatiramer acetate | Drug: placebo<br>* 2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of new T2 lesions on brain MRI performed after 18 months of Sunphenon treatment compared to baseline MRI in the verum arm versus placebo |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of brain atrophy under treatment with EGCG vs. placebo |  | 18 months | 
| Safety and tolerability |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple sclerosis, inflammation, neurodegeneration, neuroprotection
Comparison Between Fetal Thigh Soft Tissue Versus Hadlock's Formula in Estimation of Fetal Weight by Ultrasound

Study Overview
=================
Brief Summary
-----------------
We are going to do 2d ultrasound to compare between hadlock's formula and thigh soft tissue formula in expecting the after birth fetal weight and to find which of these formulas to be more accurate

Detailed Description
-----------------
We are going to do 2d ultrasound to 200 pregnant women between 38 weeks to 40 weeks singleton pregnancy in Ain Shams University Maternity Hospital to measure the expected fetal weight by hadlock's formula and thigh soft tissue formula and then we are going to measure the actual fetal weight after birth of these 200 fetuses and to find out which formula to be more accurate in estimation of fetal weight

Official Title
-----------------
Accuracy of Two Dimensions Ultrasonography of Fetal Thigh Soft Tissue Versus Hadlock's Formula in Estimation of Fetal Weight

Conditions
-----------------
Estimation of Fetal Weight

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age 38 - 40 wks Singleton uncomplicated pregnancies Normal amniotic fluid volume Exclusion Criteria: Women with one of the following conditions: Fetuses with congenital anomalies, The biometric measurements of those, which were unable to ascertain due to reasons like deeply engaged head, very thick abdominal wall etc.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 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 |
| --- | --- |
| pregnant women<br>we will measure expected fetal weight by ultrasound by hadlock's formula and thigh soft tissue for each pregnant woman | Diagnostic Test: Ultrasound<br>* Samsung H60 Ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal weight | hadlock's 4th formula and thigh soft tissue formula | 38 weeks to 40 weeks of gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hadlock, thigh soft tissue
Prevalence of Overweight and Obesity in Adult Patients Suffering From Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
A registry of individuals with type 1 diabetes that visited the Department of Endocrinology of the University Hospitals of Leuven is established. The objective of this registry is to phenotype patients with type 1 diabetes and obesity and their response to treatment with regard to their outcomes

Detailed Description
-----------------
A registry/database is constructed with data of the individuals with type 1 diabetes that visited the Department of Endocrinology of the University Hospitals of Leuven. Data will be obtained from all visits in terms of sociodemographics, disease origin and disease impact including but not limited to glycemic control, medical history, comorbidities, complications, clinical parameters, anthropometric parameters, biochemical blood values, medical therapy, lifestyle, ...

Official Title
-----------------
Prevalence of Overweight and Obesity in Adult Patients Suffering From Type 1 Diabetes and Its Effect on Treatment and Associated Co-morbidities

Conditions
-----------------
Type 1 Diabetes, Obesity

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Type 1 Diabetes
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 1 diabetes<br>Individuals with type 1 diabetes | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of patients with type 1 diabetes and obesity | Prevalence of obesity in type 1 diabetes | Up to 100 years |