linjc16/ctgov huggingface dataset:
Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention

Study Overview
=================
Brief Summary
-----------------
Antimicrobial prophylactic treatment of recurrent UTI is limited by emerging resistance, antibiotic allergies and intolerances. Intravesical aminoglycoside instillations (IAI) have been shown to reduce recurrence rate, without a short-term decline in kidney function or hearing. Thus far, treatment satisfaction has not yet been assessed, while this may play an important role in treatment adherence and persistence. Moreover, there is no data on the long-term safety of IAI, e.g. regarding the development of (pre)malignant bladder lesions.

Official Title
-----------------
Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention

Conditions
-----------------
Urinary Tract Infections, Recurrent Urinary Tract Infection

Intervention / Treatment
-----------------
* Drug: Intravesical aminoglycoside instillations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Currently receiving or having received (no minimal duration) continuous or post-coital IAI (gentamicin, tobramycin or amikacin) for recurrent UTI prophylaxis and treatment Exclusion Criteria: Exclusively receiving IAI for 'on-demand' treatment of UTI and not prophylactic purposes Receiving IAI as suppressive therapy for chronic prostatitis Presence of a chronic indwelling catheter Patient has objected to the use of his/her data Inability to provide informed consent

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravesical aminoglycoside instillations|Overnight instillation of an aminoglycoside (CIC), varying treatment regimens|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction regarding intravesical aminoglycoside instillations (IAI) | Measured with Treatment Satisfaction Questionnaire for Medication version II (TSQM-II), value ranging from 0 to 100 (with a score of 100 indicating the highest treatment satisfaction) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first UTI recurrence after initiation of IAI |  | First 6 months of IAI | 
| Number of UTI recurrences |  | First 6 months of IAI | 
| Number of UTI recurrences that are treated with IAI alone (no systemic antimicrobial therapy) |  | First 6 months of IAI | 
| Number of patients that wish to (dis)continue IAI |  | 6 months after initiation of IAI | 
| Proportion of patients that have a UTI episode caused by the same MDRO uropathogen as before start of IAI |  | 6 months after initiation of IAI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intravesical treatment
Micronutrient Status During Pregnancy

Study Overview
=================
Brief Summary
-----------------
An adequate micronutrient status during fetal life and infancy is important for optimal development. Dietary practices during pregnancy, lactation and infancy vary among populations and there is today no clear agreement on what constitutes the best diet, including micronutrient supplementation, during this period. There is consequently no clear agreement on what constitutes an optimal biochemical micronutrient status in mothers and infants. Due to substantial physiological changes in plasma volume, hormones, transport proteins and organ function during these periods, the ordinary reference levels or cut off levels used for biochemical assessment of micronutrient status are unsuited to these groups of patients. The objective of the study is to establish cut off levels for important vitamins and trace elements during pregnancy, lactation and infancy in order to ensure an optimal infant neurodevelopment and to study how micronutrient status influence the immunosystem.

Detailed Description
-----------------
The investigators have analyzed micronutrients, including all vitamins and trace elements and related aminoacids and markers of cellular immunoactivation in 160 fertile, unpregnant women, 115 pregnant women from pregnancy week 18, throughout pregnancy and the first 6 postpartum months and their infant at 6 months. Infant gross motor development is associated with micronutrient status, so the investigators will relate gross motor development at 6 months to maternal micronutrient status during pregnancy and postpartum, in order to establish relevant cut off levels for micronutrients and related biomarkers.

Official Title
-----------------
Micronutrient Status in Pregnant and Lactating Women and Their Infants

Conditions
-----------------
Deficiency Vitamins

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy never-pregnant and pregnant women Exclusion Criteria: chronic illness-

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women<br>never-pregnant women | |
| pregnant women<br>pregnant | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in micronutrient status during pregnancy and lactation | Determine adequate vitamin levels in pregnancy and lactation | The investigators will study change in micronutrients during pregnancy and lactation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cobalamin, folate
Ayurveda as Prophylaxis for Suspected COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
Despite worldwide efforts to contain, manage and treat Covid-19, the pandemic is continuing to spread. This calls for an urgent clinically-proven prophylaxis and therapeutic strategy. Recent developments on the use of traditional medicines in Covid-19 management has drawn enough attention to start several research studies. Based on the Indian Traditional Medicine, Ayurveda's community initiatives, preliminary studies, and our experiential knowledge on Covid-19 settings, we propose present study to prevent the development of COVID-19 symptoms in people who live or have come contact with an individual diagnosed with COVID-19.

Official Title
-----------------
Effect of Ayurveda as Prophylaxis for Suspected Covid-19 Patients: Randomised Controlled Trial

Conditions
-----------------
Covid-19

Intervention / Treatment
-----------------
* Other: Ayurveda


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person who has come into contact with confirmed COVID-19, Willing to take study drug as directed Exclusion Criteria: Confirmed current COVID-19 Inability to take medications orally Inability to provide written consent

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Participants randomised into the control group receive conventional standard care given by recommended guideline. | |
| Experimental: Ayurveda<br>Treatment includes a tailored combination of herbs based on individual constitution (based on Ayurveda) nutritional advice, specific consideration of selected food items, specific lifestyle advice, yoga advice along with standard recommendations. | Other: Ayurveda<br>* The Ayurveda intervention is multimodal and following the principles of Ayurveda as a whole medical system, each participants will be treated with individualised care. From the range of proven Ayurvedic Herbs, combination will be decided based on individual participants, his symptoms and his personality.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical confirmation of Covid-19 | Number of participants with symptomatic, lab-confirmed COVID-19 | From date of enrolment to 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ayurveda
An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi)

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1, multi-center, open-label study. During Segment 1, patients are administered a single IV administration of [14C]-iniparib. During Segment 2, patients are administered iniparib with or without additional chemotherapy. Acceptable chemotherapy regimens is limited to those for which previous experience with iniparib exists.

Official Title
-----------------
An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi) Administered at Cycle 1 as a 60-minute Intravenous Infusion to Patients With Advanced Solid Tumors Followed by Extended Treatment With BSI-201 With or Without Additional Chemotherapy

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: Iniparib


Participation Criteria
=================
Eligibility Criteria
-----------------
Male or female patients with advanced solid tumors that are refractory to standard treatment or for which no standard treatment exists; patients must be at least 18 years old. Additional criteria are also required and should be evaluated by the research staff.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iniparib<br>Segment 1: 400 mg [14C]-iniparib single administration Segment 2: Iniparib, 5.6mg/kg, extension treatment with or without additional chemotherapy | Drug: Iniparib<br>* Solution for infusion 60-minute intravenous infusion<br>* Other names: BSI-201;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The excretion balance and systemic exposure of radioactivity after intravenous (IV) administration of [14C]-iniparib |  | Up to 35 days | 
| The pharmacokinetics of iniparib, iodo-amino-benzamide (IABM) and iodo-amino-benzoic acid (IABA) and their contribution to overall exposure of radioactivity |  | up to 35 days | 
| The effects of iniparib on changes in the ECG with special focus on the QTcF interval duration |  | 96 hours | 
| The metabolic pathways of iniparib and identify the chemical structures of the main metabolites. |  | Up to 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical and biological tolerability of iniparib. |  | During treatment and until 30 days post treatment |
Effect of Early Pelvic Binder Use in Emergency Management of Suspected Pelvic Trauma: a Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to evaluate the effect of early pelvic binder use in emergency management of suspected pelvic trauma, compared with the conventional stepwise approach.

Detailed Description
-----------------
There is currently no universal consensus on all aspects of management of pelvic injuries. Among patients with multiple injuries because of blunt trauma, 5%-16% sustain injuries to the pelvic ring, resulting in a mortality rate of 11%-54% primarily due to hemorrhagic shock. In theory, the reduction and stabilization of the pelvic ring can decrease bleeding from the fracture site, as reduction of pelvic volume has been shown to reduce the extent of hemorrhage from such injuries.The application of a pelvic binder has become part of the emergency care of all trauma patients with suspected pelvic fractures, in both the pre-hospital environment and emergency department (ED). The present study aimed to assess the effectiveness of the early use of pelvic binders to treat patients with a suspected high risk of pelvic bleeding from blunt force pelvic fractures.

Official Title
-----------------
Division of Traumatic and General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center

Conditions
-----------------
Pelvic Fracture

Intervention / Treatment
-----------------
* Device: pelvic binder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Traumatic injury requiring a trauma team and at least one of the following: loss of consciousness or Glasgow coma score (GCS) < 13; systolic blood pressure < 90 mmHg; falling from ≥6 m; injury to multiple vital organs; and suspected pelvic injury. - Exclusion Criteria: Not meet the criteria and loss follow up (transfer to other hospital or data not available) -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: pelvic binder|The requirement of angioembolization can be predicted by the presence of intravenous contrast extravasation (ICE) on computed tomography (CT)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood transfusion | Pelvic fracture with hemodynamic unstable | admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| admission mortality | mortality in the same admission | mortality in the same admission |
Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings

Study Overview
=================
Brief Summary
-----------------
This study objective is to assess the accuracy of a specialized pro forma in suggesting the probability of Morbidly Adherent Placenta, its extent and its correlation with intraoperative findings.

Official Title
-----------------
Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings

Conditions
-----------------
Morbidly Adherent Placenta

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age group 28:42 years. Pregnant women in their late third trimester (34 0/7 weeks: 37 0/7 weeks). With a single living fetus in the current pregnancy. A previous delivery by at least 1 cesarean section or history of uterine surgery including (surgical evacuation, myomectomy or endometrium ablation) Having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment. Exclusion Criteria: Cases with a non-previa placenta, posterior low lying placenta or posterior previa placenta. Maternal chronic medical disorders( diabetes mellitus, hypertension) Patients presented with severe attack of bleeding. Patients presented with rupture of membrane. Emergency delivery regardless the cause.

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ultrasound|Ultrasound evaluation, with grayscale and color Doppler imaging.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical significance of ultrasound signs in morbidly adherent placenta(most sensitive US sign) |  | June 2021- July 2022 | 
| Accuracy of our specialized pro forma in assessing extent of morbidly adherent placenta(focal , diffuse) |  | June 2021- July 2022 | 
| Accuracy of our specialized pro forma in assessing depth of invasion of placenta accreta spectrum (accrete, increta and percreta) |  | June 2021- July 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1- Correlation between US signs and intraoperative findings including morbidity and mortality |  | June 2021- July 2022 |
Physical Activity Recommendation Behaviour in German Psychiatrists

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German psychiatrists working with patients with mental disorders.

Detailed Description
-----------------
Physical activity plays an important role in the prevention and treatment of mental disorders. Despite the potential mental health benefits, large proportions of patients with mental disorders do not meet the physical activity recommendations. Psychiatrists play a key role in the recommendation of physical activity to their patients. There are no previous studies that examine physical activity recommendation behaviour in German psychiatrists. The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German psychiatrists working with patients with mental disorders.

Official Title
-----------------
Physical Activity Recommendation Behaviour in German Psychiatrists

Conditions
-----------------
Mental Disorder, Physical Activity

Intervention / Treatment
-----------------
* Diagnostic Test: Online questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician specialized in psychiatry or currently in training for specialization in psychiatry Currently working with patients with mental disorders At least 18 years old Sufficient German skills for answering the questionnaire Exclusion Criteria: None

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psychiatrists in Germany<br>Psychiatrists in Germany currently working with patients with mental disorders | Diagnostic Test: Online questionnaire<br>* Online questionnaire via SoSciSurvey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise in Mental Illness Questionnaire (EMIQ) - German Version | Questionnaire assessing the following areas: knowledge, beliefs, behaviours regarding and participation in physical activity in mental health professionals. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Activity, Mental Disorder, Recommendation Behaviour, Mental Health, Exercise
Epidemiology of Cardiovascular Disease in Elderly Turkish Population

Study Overview
=================
Brief Summary
-----------------
This study will compose a national database of cardiovascular diseases' risk factors, concomitant diseases and the drug usage among the elderly patients in Turkey.

Official Title
-----------------
Epidemiology of Cardiovascular Disease in Elderly Turkish Population

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients signed patient informed sheet and informed consent form patients ≥65 years old patients followed-up cardiology clinics Exclusion Criteria: patients under 65 years old

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| To generate a national database for cardiovascular diseases for elderly patients in Turkey |  | [Recruited and could be analysed at least 2500 patients after 9 months] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Turkey, Epidemiologic