linjc16/ctgov huggingface dataset:
Post-marketing Surveillance Study for Evaluation of Dotarem Safety

Study Overview
=================
Brief Summary
-----------------
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI techniques and application methods.

Detailed Description
-----------------
Diagnostic efficacy was assessed by the following endpoints: diagnostic value (yes/no) and imaging quality (5-step scale from excellent to very poor). Safety was evaluated on the basis of the frequency and seriousness of adverse events that occurred following Dotarem injection.

Official Title
-----------------
Evaluation of Dotarem Safety

Conditions
-----------------
Contrast-enhanced MRI With Dotarem

Intervention / Treatment
-----------------
* Procedure: MRI with Dotarem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing routine MRI using the MRI contrast medium Dotarem Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- |
| All included patients<br>All included patients underwent MRI with Dotarem | Procedure: MRI with Dotarem<br> <br> * Other names: MRI with gadoteric acid/gadoterate meglumine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse Events | The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded. | From the beginning of the MRI procedure to 30-60 min after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Value | Diagnostic value was evaluated by answering yes or no to the following question Were you able to make a diagnosis based on the test results ? | During MRI procedure | 
| Image Quality | Image quality was evaluated with a 5-step scale from excellent to very poor (excellent/very good; good; moderate; poor and very poor) | During MRI procedure |
Intraoperative Floppy Iris Syndrome in Korean Patients Taking α1-Adrenergic Receptor Antagonists

Study Overview
=================
Brief Summary
-----------------
Intraoperative floppy iris syndrome (IFIS) is a recently described condition observed during cataract surgery. It has been hypothesized that irreversible atrophy of the iris dilator muscle associated with α1-adrenergic receptor antagonists (α1-ARA) is responsible for IFIS. However the prevalence of IFIS in Korean population is not reported. The purpose of this study is to evaluate the prevalence and clinical manifestations of IFIS in relation to iris anatomical change in Korean patients taking α1-ARA.

Official Title
-----------------
Intraoperative Floppy Iris Syndrome in Korean Patients Taking α1-Adrenergic Receptor Antagonists

Conditions
-----------------
Intraoperative Floppy Iris Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of cataract korean patients Exclusion Criteria: history of iridocyclitis, iris neovascularization, or prior iris surgery traumatic cataracts, zonular dialysis, or cataracts associated with ocular disease (e.g., uveitis)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| α1-ARA Group<br>All patients on α1-ARA(α1-adrenergic receptor antagonists) medication who underwent cataract surgeries. | |
| Control Group<br>Age and sex-matched control subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of intraoperative floppy iris syndrome |  | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
occurrence of
Obese Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety in Obese Patients With Type 2 Diabetes

Conditions
-----------------
Obesity, Diabetes Mellitus, Non-Insulin-Dependent, Obesity in Diabetes

Intervention / Treatment
-----------------
* Drug: Rimonabant (SR141716)


Participation Criteria
=================
Eligibility Criteria
-----------------
BMI must be greater than 27 and less than 40 Treated Type 2 Diabetes on single therapy treatment for at least 1 year Stable weight (variation of less than 5 kg within 3 months prior to screening visit)

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rimonabant (SR141716)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Obesity
Brazil Nut Consumed on the Metabolic Profile, Oxidative Stress and Nutritive Microcirculatory Patterns

Study Overview
=================
Brief Summary
-----------------
The purpose this research is to check if Brazil Nuts consumed improvement the metabolic profile, state redox and endothelial function in obese adolescents.

Detailed Description
-----------------
The purpose this research is to check if Brazil Nuts consumed improvement the metabolic profile (lipid profile, glucose, insulin), state redox (about glutathione peroxidase, isoprostane and LDL-ox) and endothelial function (by videocapillaroscopy) in obese adolescents (12-18 years).

Official Title
-----------------
The Effect of Brazil Nut Consumed on the Metabolic Profile, Oxidative Stress and Skin Microcirculatory Patterns in Obese Female Adolescents

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

Intervention / Treatment
-----------------
* Dietary Supplement: Brazil Nut


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pubertal girls obese (BMI > 30 kg/m) - Exclusion Criteria: Consumption of nuts Loss weight before the research chronic disease (hypertension) -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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

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: Brazil Nuts<br>The first group consumed the brazil nuts and the other group placebo (lactose pills) | Dietary Supplement: Brazil Nut<br>* During 16 weeks the adolescents consumed 3-5 nuts/day<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
-----------------
obese, brazil nuts, oxidative stress, microcirculatory, metabolic profile
Safety/Efficacy Study of Restylane® in Lip Augmentation

Study Overview
=================
Brief Summary
-----------------
To determine the safety and effectiveness of Restylane® when used for lip augmentation.

Official Title
-----------------
A Randomized, Evaluator-Blinded, No-Treatment-Controlled Study of the Effectiveness and Safety of Restylane® in the Augmentation of Soft Tissue Fullness of the Lips

Conditions
-----------------
Lip Augmentation

Intervention / Treatment
-----------------
* Device: Restylane®
* Device: Non-Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must meet established lip fullness criteria Exclusion Criteria: Allergic to injectable hyaluronic acid, local topical anesthetics or nerve blocking agents; Conditions/procedures that could interfere with lip fullness evaluations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Restylane® Treatment | Device: Restylane®<br>* Restylane® injections in the lips<br>|
| No Intervention: Non-Treatment<br>Non-Treatment Arm | Device: Non-Treatment<br>* Non- Treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Response | Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at week 8 as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full. | Baseline and at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Response | Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at post-baseline time points as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full. | Baseline and at weeks 12, 16, 20 and 24 |
Glenohumeral Internal Rotation Deficit in Non-pitcher Overhead Athletic Athletes: Case Series Analysis of Athletes

Study Overview
=================
Brief Summary
-----------------
In this observational case series the investigators would like to investigate wether or not the strenuous activity exerted on over head athletic athletes (ie. javelin throwers, discus throwers) may incite injury on their shoulders. The investigators understood that these athletes had to perform repeated throwing motions and yet reports on their effects are very limited. This condition in the long run may contribute to injury and affecting performance of the athletes. The investigators found that these relationships have not been looked at closely by others and largely overshadowed by athletes in other fields; such injury patterns had been described in details in baseball pitchers but not in other athletes.

Detailed Description
-----------------
Description of protocol: In this study, the investigators would recruit athletes from the national athletics federation training in our city. Data collection: History taking: complaints of shoulder stiffness need for prolonged warm-up pain discomfort relating to the shoulders Physical examination: Bilateral shoulder range of motion (internal and external rotation) Posterior shoulder flexibility test (denotes internal rotation deficit) Scapular malpositioning, inferior medial border prominence, coracoid pain and malposition and dyskinesis of scapular movement (SICK) scapula rating Notes: measurements are taken by at least two investigators separately and compared to ensure accuracy. Results are presented in a table and analysed.

Official Title
-----------------
Glenohumeral Internal Rotation Deficit in Non-pitcher Overhead Athletic Athletes: Case Series Analysis of Athletes

Conditions
-----------------
Shoulder Injuries, Shoulder Syndrome, Injury;Sports, Sport Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Performed overhead throwing motions in their athletic skills Athletes have competed in regional and national level Undergoing active training Exclusion Criteria: Apparent anatomical deformity Sustaining injury(ies)
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 |
| --- | --- | --- |
| Glenohumeral internal rotation deficit | A deficit of >20 degrees between dominant and non-dominant shoulder | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shoulder, glenohumeral internal rotation deficit, throwing athletic athlete
Impact of Catecholamine Spill-over on Outcome After RDN and EP Ablation

Study Overview
=================
Brief Summary
-----------------
Despite a rapidly increasing number of renal denervation (RDN) procedures, only little is known regarding the patient or procedural characteristics influencing the outcome. None of the detectable variables like number of ablation points, temperature rise, impedance drop, have been shown to correlate with the blood pressure (BP) reduction. In this study, the investigators assess different patient and procedural characteristics, like exact patient medication, stress hormones, heart rate variability, and focus on the change of the catecholamine spill-over, and the impact on BP and heart rate after RDN and after EP ablation. The investigators hypothesize the correlation between reduction of catecholamine spill-over due to denervation and the BP reduction. In this study, the investigators will assess 40 patients undergoing RDN and 40 patients undergoing EP ablation.

Official Title
-----------------
Impact of Patient-specific and Procedural Characteristics Like Catecholamine Spill-over on the Long-term Outcome After Renal Denervation and EP Ablation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medically-indicated renal denervation Age over 18 years written informed consent Exclusion Criteria: pregnancy expected compliance problems current participation in other studies

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Renal denervation (RDN)<br>Change of catecholamine spill-over during RDN | |
| Electrophysiology (EP) Ablation<br>Change of catecholamine spill-over during EP ablation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catecholamine norepinephrine and epinephrine (pg/ml) | Measurement the differences of norepinephrine and epinephrine (pg/ml) in the renal vein and artery before and after the ablation | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the ablation on 24-hour blood pressure (mmHg) and heart rate (beats/min) | Complete measurement of 24-hour systolic, diastolic, and mean arterial blood pressure (mmHg) and heart rate (beats/min)before and after ablation | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RDN, renal denervation, catecholamine, spill-over, blood pressure, electrophysiology, ablation
Abscopal Effect of Radiotherapy and Nivolumab in Relapsed Hodgkin Lymphoma After Anti-PD1 Therapy

Study Overview
=================
Brief Summary
-----------------
The aim of the trial is to improve efficacy of nivolumab in patients with relapsed or refractory HL who recently progressed on anti-PD1 therapy. Nivolumab is highly effective and well tolerated in rrHL, nevertheless CR-rates are low and a considerable proportion of patients suffers from progressive disease. Localized RT induces an immunogenic effect which might work synergistically and facilitate augmented systemic (i.e. abscopal) responses in combination with nivolumab.

Official Title
-----------------
Abscopal Effect of Radiotherapy and Nivolumab in Relapsed Hodgkin Lymphoma After Anti-PD1 Therapy

Conditions
-----------------
Classical Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Other: Nivolumab plus radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Progression of refractory or relapsed cHL during treatment with an anti-PD1 agent At least two distinct FDG-avid HL-lesions with at least 5 cm distance between them, and one of them considered eligible for irradiation with 20Gy based on localization and prior RT exposure Age at registration ≥ 18 years Exclusion Criteria: Nodular-lymphocyte predominant HL (NLPHL) or composite/greyzone lymphoma Lymphoma involving the central nervous system Naïve to treatment with anti-PD1 targeting antibodies

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Nivolumab 240 mg i.v. at 2-weekly intervals combined with 20Gy radiotherapy (RT) to a preferably progressive and not pre-irradiated single lesion. Nivolumab will be continued for a maximum of 18 months or until disease progression or unacceptable toxicity. | Other: Nivolumab plus radiotherapy<br>* Nivolumab 240 mg i.v. at 2-weekly intervals combined with 20Gy radiotherapy (RT) to a preferably progressive and not pre-irradiated single lesion. Nivolumab will be continued for a maximum of 18 months or until disease progression or unacceptable toxicity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abscopal response rate (ARR-6) | Abscopal response rate (ARR-6) with abscopal response centrally confirmed as restaging result after RT to a single lesion and at least four but not more than six nivolumab infusions (RE-6 result) | 12 weeks |
Observation of Patients With Metastatic Colorectal Cancer Starting Chemotherapy Combined With Bevacizumab (Avastin)

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate progression free survival (PFS) in a real-life setting in participants with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.

Official Title
-----------------
A Cohort Survey of Patients With Metastatic Colorectal Cancer Starting a Chemotherapy in Combination With Avastin®

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Other: Observational Chemotherapy
* Drug: Concomitant Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having colon or rectal metastatic adenocarcinoma, for which the physician decided during the inclusion visit to start a treatment with bevacizumab combined with a 1st, 2nd or 3rd line chemotherapy Having received oral and written information about the survey and not objecting to having his/her data computerized Exclusion Criteria: - Participating in a clinical trial assessing an anticancer treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Observational Chemotherapy/Bevacizumab<br>Observed patients receiving chemotherapy with concomitant bevacizumab | Other: Observational Chemotherapy<br>* No intervention - Observational standard practice chemotherapy<br>Drug: Concomitant Bevacizumab<br>* No intervention - Observational concomitant bevacizumab<br>* Other names: Avastin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Kaplan Meier estimates of median progression-free survival according to the metastatic line of treatment, for a median follow-up of 18, 15 and 13 months, respectively | within 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall Survival (OS) was defined as the time between the treatment start (date of the first infusion of bevacizumab) and death from any cause. Kaplan Meier estimates of median overall survival were calculated for the metastatic lines of treatment, with a median follow-up of 18, 15 and 13 months, respectively. | Up to 36 months | 
| Quality of Life - Global Health Status | Participants rated their quality of life (global health status) on the European Organization for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ C-30), with total scores ranging from 0 (worst) to 100 (best). | Baseline, 6 and 12 months |