linjc16/ctgov huggingface dataset:
Pulmonary Rehabilitation and Self-esteem in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
the aim of this study is to evaluate the evolution of self-esteem during a pulmonary rehabilitation program, in COPD patients.

Official Title
-----------------
Effects of Pulmonary Rehabilitation on Self-esteem in Patients With COPD

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with stage 2 to 4 (A to D) COPD admitted to a pulmonary rehabilitation program Patient aged 18 or over Patient able to consent and having signed a consent form Exclusion Criteria: Patient with pain, osteoarthritis or shoulder surgery Patient with a history of Pneumonectomy, lobectomy less than 6 months old Refusal of participation Patient with an inability to complete a pulmonary rehabilitation program in totality Pregnant or breast-feeding women Patient under tutorship or curatorship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| PSI-6 | the physical self inventory- 6 (PSI-6) allows to evaluate self esteem | PSI-6 is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6MWT | The 6-minute walk test allows to evaluate exercise capacity | the 6MWT is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks) | 
| HAD | the hospital anxiety and depressive scale (HAD) measure the anxiety and depression | HAD is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks) | 
| SGRQ | the Saint-George respiratory Questionnaire (SGRQ) measure the quality of life | SGRQ is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks) |
Management of Anticoagulants and Antithrombotics in Patients With CSDH

Study Overview
=================
Brief Summary
-----------------
Primary objective of the study will be to compare, up to 6 months after surgery, number of relapses (post operative re-bleeding) or intracerebral hemorrhage (others than subdural hematomas) and thromboembolic or cardiovascular ischemic events, in patients undergoing surgery for chronic subdural hematoma (CSDH). These data will be correlated to the suspension or not of antithrombotics or anticoagulants before surgery or their re-introduction after surgery.

Official Title
-----------------
Thromboembolic and Hemorrhagic Risk Evaluation in Surgically Treated Patients With CSDH Taking Anticoagulants and Antithrombotics

Conditions
-----------------
Chronic Subdural Hematoma, Anticoagulant-induced Bleeding, Thromboembolic Stroke, Cardiovascular Stroke

Intervention / Treatment
-----------------
* Procedure: CSDH evacuation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Informed consent Evidence of CSDH which needs surgery patients taking antithrombotics or anticoagulants Exclusion Criteria: previous surgery for CSDH

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients taking anticoagulants or antithrombotics | Procedure: CSDH evacuation<br>* Burr hole for chronic subdural hematomas<br>|
| Group 2<br>Controls | Procedure: CSDH evacuation<br>* Burr hole for chronic subdural hematomas<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemorrhagic or thromboembolic events evaluation | hemorrhagic (re-bleedings in surgical field, other cerebral bleedings); thromboembolic events(acute ischemic stroke, acute myocardial infarction, pulmunoray embolism, deep venous thrombosis) | up to 6 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic subdural hematoma, anticoagulants, antithrombotics, thromboembolic disease, cardiovascular risk
The Potential of Sperm Retrieved by Micro-TESE to Fertilize Vitrified/Warmed Oocytes

Study Overview
=================
Brief Summary
-----------------
Couples referred for microdissection-TESE (m-TESE) due to Klinefelter's syndrome, maturation stop in the spermatogenesis, or failed retrieval of testicular spermatozoa by conventional techniques with needle or TruCut are included. The women are stimulated with FSH in IVF protocols and the aspirated oocytes vitrified with usual applied techniques. Fresh sperm retrieved by micro-TESE are used for fertilization of the warmed oocytes. when it is not possible to obtain testicular sperm, the couples are offered fertilization with warmed oocytes. Fertilization, cleavage, implantation and pregnancy rates using sperm from the patients versus from sperm donors will be compared.

Official Title
-----------------
The Potential of Sperm Retrieved by Micro-TESE to Fertilize Vitrified/Warmed Oocytes

Conditions
-----------------
Azoospermia, Nonobstructive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Couples referred for micro-TESE Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Couples where the men have Klinefelter's syndrome, maturation stop in the spermatogenesis or failed retrieval of testicular sperm by conventional techniques with needle or TruCut, and where testicular sperm could be obtained by micro-TESE. | |
| Control group<br>Couples as in the study group, but where testicular sperm could not be obtained by micro-TESE. The oocytes therefore must be fertilized using donor sperm. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cleavage rate | Measurement of % of cleavage among the warmed oocytes | six years | 
| Pregnancy rate | Measurement of serum-hCG and ultrasonography at gestation age week 7 | six years | 
| Fertilization rate | Measurement of % of fertilization among the warmed oocytes | six years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | Measurement of the % of transferred embryos implanting into the uterus | six years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Azoospermia, micro-TESE, Klinefelter's syndrome, Cryptorchidism, Vitrified oocytes
The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether continuous glucose monitoring will improve glucose variability as measured by the coefficient of variation of glucose levels in very young children with T1D. The study adopts an open-label, multi-centre, multinational, prospective registry-based population cohort design contrasting CGM use to SMBG alone in young children with type 1 diabetes over 12 months. The primary endpoint is the difference between treatment modalities (CGM vs SMBG alone) in glycaemic variability, measured as the coefficient of variation of glucose levels, during the 12 months observational period. Other Key edpoints include time in range 70-180 mg/dl, time below range 70 mg/dl and time above range 180 mg/dl.

Official Title
-----------------
The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes - The VibRate Study

Conditions
-----------------
Type 1 Diabetes, Continuous Glucose Monitoring, Children, Glucose Variability

Participation Criteria
=================
Eligibility Criteria
-----------------
Key inclusion criteria: Age below 7 years of age (at inclusion) Type 1 diabetes for at least 6 months Insulin pump user for at least 3 months Treated with rapid or ultra-rapid acting insulin analogue Key exclusion criteria: Physical or psychological disease likely to interfere with normal conduct of the study Untreated coeliac disease or thyroid disease Current treatment with drugs known to interfere with glucose metabolism Subject/carer's severe visual impairment Subject/carer's severe hearing impairment

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 7 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CGM<br>CGM users | |
| SMBG<br>Non-CGM users | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coefficient of variation |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Range | Time in Range 70 - 180 mg/dl | 1 year | 
| Time Above Range | Time in Range above 180 mg/dl | 1 year |
Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL)

Study Overview
=================
Brief Summary
-----------------
The TRAIL study was conducted to examine the effects of escalating doses of an ACE inhibitor, trandolapril, on lowering blood pressure in Stage 1-2 hypertensive patients.

Official Title
-----------------
A Prospective, Open-Label Study to Evaluate the Effect of an Escalating Dose Regimen of Trandolapril on Blood Pressure in Treatment-Naïve and Concurrently Treated Hypertensive Patients (TRAIL)

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Trandolapril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage 1 or 2 Hypertension Exclusion Criteria: Uncontrolled diabetes Subject has a hypersensitivity to ACE inhibitor

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Trandolapril<br>* 0.5, 1,2,4mg/once daily/ for 26 weeks (If BP was not controlled, dose was escalated to the next higher dosage every 4-5 weeks).<br>* Other names: TARKA;|
| Other: 2<br> | Drug: Trandolapril<br>* 0.5, 1,2,4mg/once daily/ for 26 weeks (If BP was not controlled, dose was escalated to the next higher dosage every 4-5 weeks).<br>* Other names: TARKA;|
| Other: 3<br> | Drug: Trandolapril<br>* 0.5, 1,2,4mg/once daily/ for 26 weeks (If BP was not controlled, dose was escalated to the next higher dosage every 4-5 weeks).<br>* Other names: TARKA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of escalating dose regimen of trandolapril in controlling blood pressure |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood pressure, safety. |  | 14 and 26 weeks | 
| BP mmHg incremental and absolute change |  | 14 and 26 weeks | 
| Adverse events |  | Throughout 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Trandolapril
Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies

Study Overview
=================
Brief Summary
-----------------
Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology, the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and has an affinity for prostate cells. Its concentration is directly proportional to cell proliferation. The analogue of choline has the advantage of having a rapid and stable accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after injection). The goal of this study is to assess the feasibility and the accuracy for targeting image guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal ultrasound (TRUS) .

Official Title
-----------------
Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies in Prostate Cancer Patients

Conditions
-----------------
Prostatic Neoplasm, Positron-Emission Tomography, Fluorocholine

Intervention / Treatment
-----------------
* Device: PET Scan ou TEP-TDM
* Device: mpMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspicion of prostate cancer Patients who performed prostate mpMRI and F-Choline 18 PET scan Patient capable of receiving clear informations Patient giving a written consent for their participation via a consent signed by both parents of the patient (or legal tutor) Patient covered by a healthcare insurance Exclusion Criteria: Patients without suspect image of neoplasia after mpMRI and F-Choline 18 PET scan

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate cancer/TEP scan<br> | Device: PET Scan ou TEP-TDM<br>* Performance of the PET/CT using Flurocholine in order to detect the localization of the pathological fixation of the tracer and to determine the place where to take the biopsy<br>|
| Active Comparator: Prostate cancer/mpMRI<br> | Device: mpMRI<br>* Performance of the mpMRI in order to determine the place where to take the biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of image guided prostate biopsy in the zones detected by the TEP scan |  | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of image guided prostate biopsy in the zones detected by the mpMRI |  | at inclusion |
Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence and Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to learn how best to use patient portals to help improve the treatment of mood disorders.

Detailed Description
-----------------
This study is being done in 3 phases. First 2 phases were observational with total enrollment of 300 subjects. The final 3rd phase is interventional and we are anticipating to enroll 50 subjects. It is described below. Patients being treated for depressive symptoms at the University of Iowa, Department of Psychiatry are invited to participate. Participants will complete a remote (phone or video) visit. After being informed about the study and potential risks, those who consent to being in the study will be assigned to one of two groups. They will complete an online survey and receive some basic training on patient portals. After the visit. both groups will be followed for 6 months. Depending on their group assignment, they will complete: two to five phone calls with a study team member and two to five online questionnaires

Official Title
-----------------
Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence, Satisfaction, and Outcomes

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

Intervention / Treatment
-----------------
* Behavioral: ConnectCare


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking, PHQ-9 score of 10 or higher (questions 1-8 only), Taking medication for depressive symptoms, 1 or more appointments scheduled or planned with University of Iowa psychiatry provider in next 6 months, Home computer w/internet access, MyChart (University of Iowa Healthcare's patient portal) account/MyChart enrollment Exclusion Criteria: Psychotic disorder/symptoms, Current substance use disorders (other than alcohol, tobacco, marijuana), Active suicidal ideation within past 1 year, Cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Behavioral: ConnectCare<br>* increased monitoring between clinical mental health visits<br>|
| No Intervention: Group 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9) | measures the severity of depression symptoms | Once per month for 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient portals, treatment adherence
Intravitreal Bevacizumab for the Treatment of Central Serous Chorioretinopathy

Study Overview
=================
Brief Summary
-----------------
Central serous chorioretinopathy (CSC) has been known since it was first described by Von Graefe and termed idiopathic detachment of the macula in 1866, is a well-characterized disorder leading to serous neurosensory elevation of the central macula. The acute form of the disease is associated with focal leakage at the level of the retinal pigment epithelium (RPE) demonstrated with fluorescein angiography (FA). The disorder is self-limited in the majority of patients, who also regain excellent vision. Occasionally, the neurosensory detachment persists and leads to pigment epithelial and photoreceptor damage with visual impairment. The purpose of this clinical study is report the use of intravitreal bevacizumab is a new option in the treatment of the chronic or recurrent CSC.

Conditions
-----------------
Central Serous Chorioretinopathy

Intervention / Treatment
-----------------
* Drug: Intravitreal injection of Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Any visual acuity. Central serous chorioretinopathy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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: Intravitreal injection of Bevacizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Post-Operative Pain Following Abdominoplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this phase 3 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following abdominoplasty.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo- Controlled Trial to Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Post-Operative Pain Following Abdominoplasty

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: VVZ-149 Injections
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between 18-70 years old, inclusive. Female subjects must meet additional criteria according to childbearing potential. Planning to undergo abdominoplasty Ability to provide written informed consent Ability to understand study procedures and communicate clearly with the investigator and staff American Society of Anesthesiologists (ASA) risk class of I to II. Exclusion Criteria: Emergency or unplanned surgery Previous abdominoplasty Pre-existing condition causing preoperative pain around the site of surgery Women who are pregnant or breastfeeding Chronic pain diagnosis and ongoing or frequent use of pain medications

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VVZ-149 Injections<br> | Drug: VVZ-149 Injections<br>* IV infusion of 1000 mg of VVZ-149<br>* Other names: Opiranserin Injections;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* IV infusion of 0 mg of VVZ-149<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Area Under the Curve (AUC) of Pain Intensity for 12 hours post-emergence | Using Numeric Pain Rating Scale (NRS, 0-10 at rest) | 0-12 hours post-emergence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who report mild pain (NRS 0-3) at each time point during 24 hours post-emergence |  | 0-24 hours post-emergence | 
| Total number of requests for rescue medication for 24 hours post-emergence |  | 0-24 hours post-emergence | 
| Total amount of rescue medication consumption for 12 hours post-emergence |  | 0-12 hours post-emergence | 
| Total amount of intra-operative fentanyl use |  | During surgery |