linjc16/ctgov huggingface dataset:
Maastricht Neck Study: Cervical Range of Motion in Whiplash Patients

Study Overview
=================
Brief Summary
-----------------
Rationale: Neck complaints are often caused by motor vehicle accidents and particular after rear-end collision. Patients complain about neck pain after a whiplash trauma, which lead to mobility restrictions of the cervical spine. It is estimated that 20% develop a chronic pain disorder after 1 year, called a chronic whiplash syndrome. Objective: the primary objective is to investigate the natural course of active-and passive range of motion and principally the difference score between active-and passive cervical range of motion after a whiplash trauma. The secondary objectives are: investigate the predictive value of active-and passive range of motion and chronicity. Further, the correlation between the degree of restriction of the active and passive backward flexion and chronicity will be investigated. Finally, the correlation between the possible predictive factors such as pain, ideas and feeling about pain, memory and attention, events of the last year and complaints after the motor vehicle accident and chronicity are examined. Study design and study population: a prospective cohort of 100 whiplash patients which underwent a measurement of the cervical movements and gave permission to recontact them for further research.

Official Title
-----------------
MaNeS (Maastricht Neck Study): Development of Chronic Disability in Neck Pain Patients After a Motor Vehicle Accident

Conditions
-----------------
Whiplash Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients have had a measurement of the cervical range of motion. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Whiplash patients<br>The cohort is based on 100 whiplash patients which underwent the measure procedure to obtain cervical range of motion. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active- and passive cervical range of motion measured with the 3Space InsideTrak HP system. |  | 31-12-2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the correlation between active- and passive cervical movement restraints and: NRS, TSK, PCS, NDI, CES-D, TAS, EPQ, CFQ, Holmes-Rahe scale, Rand 36, PSS-SR |  | 31-12-2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Range of motion, articular, Cervical spine
Specified Drug Use-results Survey of Graceptor in Patients With Kidney Transplantation (Switching From Cyclosporine)

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation when converted from cyclosporine

Official Title
-----------------
Specified Drug Use-Results Survey of Graceptor® Capsules 0.5mg, 1 mg, and 5 mg in Kidney Transplant Patients

Conditions
-----------------
the Maintenance Phase After Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Graceptor®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are converted to Graceptor® from cyclosporine in the maintenance phase after kidney transplantation. Patients who meet one or more of following criteria Decrease in kidney function: GFR (or eGFR) less than 60 mL/min, or investigator's decision Hypertension: systolic/diastolic blood pressure 130/80 mmHg or more or treatment with an antihypertensive drug Hyperlipidaemia: LDL cholesterol 120 mg/dL or more, or treatment with an antihyperlipidemic drug Rejection: antibody mediated rejection by Banff classification borderline changes or more severe, or investigator's decision Other adverse events and patients who cannot continue cyclosporine treatment based on investigator's decision
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 with kidney transplantation who converted the immunosuppressant from cyclosporine to Graceptor ® | Drug: Graceptor®<br>* oral<br>* Other names: FK506;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of treatment continuation (incidence of rejection, death, graft loss, or adverse event) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function, hypertension, hyperlipidaemia, other adverse events |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tacrolimus, cyclosporine, Graceptor®, kidney transplantation
Post-COVID-19 Epidemic Depression Assessment in Adults in South Punjab Pakistan

Study Overview
=================
Brief Summary
-----------------
To assess the depression in adults especially in post COVID-19 duration in the rural and urban settings.

Detailed Description
-----------------
This study is designed to assess the prevalence of depression after the general and smart lockdown in various areas. This study includes both genders of any age.

Official Title
-----------------
Post-COVID-19 Epidemic Depression Assessment in Adults in South Punjab Pakistan

Conditions
-----------------
Depression, Anxiety

Intervention / Treatment
-----------------
* Other: service of questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Any individual who can respond to the given questionnaire, with or without any ailment will be included in this study - Exclusion Criteria: Unconcious and non-cooperative individuals -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single group<br>Respondents will be given survey form, filled and will be collected back | Other: service of questionnaire<br>* Respondents will be given a survey form only and after filling this will be collected back<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence estimation of depression in adults | % prevalence of depression in adult population of south punjab will be assessed | study will be completed in 15 days maximum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Anxiety, Epidemiology
Mineralocorticoid Receptor in the Treatment of Severe Depression

Study Overview
=================
Brief Summary
-----------------
The proposed research aims to compare the onset of action and the efficacy of fludrocortisone, a mineralocorticoid receptor agonist vs. spironolactone, a mineralocorticoid antagonist, vs. placebo as augmentation to a selective serotonin reuptake inhibitor (SSRI) in 65 inpatients with severe depression. The study will also explore the utility of the hypothalamic-pituitary-adrenal (HPA) axis in predicting treatment response. The study will be a 5-week randomized and double-blind trial of fludrocortisone vs. spironolactone vs. placebo during three years.

Official Title
-----------------
Mineralocorticoid Receptor in the Treatment of Severe Depression: A Randomized, Double Blind, and Placebo Controlled Trial

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Drug: Spironolactone
* Drug: fludrocortisone
* Drug: escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Depressed male and female inpatients according to DSM-IV Age between 18 and 70 years Minimum of 17-items Hamilton Depression Score of 18 Informed consent signed Exclusion Criteria: Relevant medical or neurological disorders Pregnancy or unsure contraception Relevant psychiatric comorbidity Active alcohol or other substance abuse/dependance Contraindications to SSRI, fludrocortisone, or spironolactone Steroid medication

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: Spironolactone|nan|
|Drug: fludrocortisone|nan|
|Drug: escitalopram|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Standardization of Laparoscopic Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Incisional hernias are one of the most frequent complications in abdominal surgery. Laparoscopic repair is widely used but even not standardized. Existing data from different study designs show no representative data resulting in a lack of comparability and evidence. Therefore the standardization of operative techique has been proposed by the LIPOM-study group and will be assessed in a prospective manner.

Detailed Description
-----------------
Data are scheduled for publication.

Official Title
-----------------
Standardization of Laparoscopic Intraperitoneal Onlay Mesh Augmentation for Incisional Hernia Repair: Impact on Clinical Outcomes and Quality-of-Life - Open Prospective Observational Multicentre Cohort Study

Conditions
-----------------
Incisional Hernia

Intervention / Treatment
-----------------
* Procedure: Laparoscopic incisional hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary incisional hernia Hernia size EHS W 1-2 Hernia location EHS M 1-5, L 1-3 Clinical symptoms or progressive growth of hernia Exclusion Criteria: Recurrent incisional hernia Ventral hernie Hernia size > EHS W 2 Hernia location EHS L 4, ASA >3 Prospective mesh overlap < 5 cm Malignant disease

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 |
| --- | --- |
| Laparoscopic incisional hernia repair<br>Incisional hernia, LIPOM | Procedure: Laparoscopic incisional hernia repair<br>* Standardized laparoscopic incisional hernia repair with mesh<br>* Other names: LIPOM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate |  | until 12 mths postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, Quality of Life | Pain measured by numeric rating scale. QoL measured by Carolina Comfort Scale. | until 12 mths postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lapraoscopy, incisional hernia repair, mesh
Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and efficacy of gonadotropin-releasing hormone (GnRH) antagonist therapy versus placebo in patients with moderate to severe rheumatoid arthritis.

Official Title
-----------------
Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Cetrorelix
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult between 18 years and above Moderate to severe disease activity Negative pregnancy test for women of childbearing potential Use of reliable method of contraception (non-hormonal) by sexually active female patients Exclusion Criteria: Patients who are pregnant or breastfeeding Patients taking biologic therapy or prednisolone >7.5mg

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cetrorelix | Drug: Cetrorelix<br>* 3-5 mg s.c. on days 1-5<br>|
| Placebo Comparator: 2<br>NaCl solution | Drug: Placebo<br>* 3-5 ml NaCl s.c. on days 1-5<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group |  | From baseline to day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in DAS28 (CRP/ESR) |  | From baseline to day 2/5 /10/15 | 
| Change in anti-CCP level |  | From baseline to day 2/5/10/15 | 
| Change in cytokine level |  | From baseline to day 2/5/10/15 | 
| Change in ACR core set measures |  | From baseline to day 2/5/10/15 | 
| Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders |  | Baseilne to day 2/5/10/15 | 
| Adverse events | Number of patients with adverse events (and serious adverse events) up to day 15 in each group | Baseline up to day 15 | 
| Proportion of patients with DAS28low disease activity/remission |  | Baseline to day 2/5/10/15 | 
| Change in HAQ scores |  | From baseline to day 5/10/15 | 
| Correlation between percent changes in hormones, disease activity and biomarkers | This endpoint is not directly related to clinical efficacy. Hormones include LH, FSH, oestradiol, testosterone,and cortisol. Biomarkers include immunologic markers, bone markers and cardiovascular markers. This secondary endpoint was sent to authorities during the study before unblinding. | By day 2, 5, 10 and 15 |
A Trial to Evaluate the Loading Dose Required to Achieve Therapeutic Serum Teicoplanin Concentration Timely

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the standard dosage of teicoplanin is adequate to produce timely the trough level > 10 mg/L, which is considered to be effective in the treatment of methicillin-resistant Staphyllococcus aureus (MRSA) bacteremia.

Detailed Description
-----------------
In our hospital, the minimum inhibitory concentration of 100 MRSA isolates in 2003 for teicoplanin is 2 mg/L. Due to its time-dependant bacteriocidal effect, the trough level should exceed 10 mg/L, particularly in the elderly, for MRSA bacteremia. However, it is known that standard dosage of teicoplanin often produces inadequate serum trough levels, and MRSA infections may recurred. Therefore, to evaluate the loading dose required to achieve therapeutic concentration timely, we compare the trough levels between those given standard dose (6 mg/Kg) and those given increasing loading dose (12 mg/Kg). We also monitor the occurrence of adverse drug effects and clinical response.

Official Title
-----------------
A Randomized Single Blind Parallel Control Trial to Evaluate the Loading Dose Required to Achieve Therapeutic Serum Teicoplanin Concentration Timely

Conditions
-----------------
Staphylococcal Infections

Intervention / Treatment
-----------------
* Drug: teicoplanin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 16 years of age who have blood culture-proven MRSA bacteremia and did not receive teicoplanin or vancomycin in the previous one month are enrolled. Exclusion Criteria: Those who are allergic to teicoplanin or who have the need to use higher doses, 12 mg/kg/dose, such as endocarditis, osteomyelitis, septic arthritis and burn patients, are excluded.

Ages Eligible for Study
-----------------
Minimum Age: 16 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

| Intervention/Treatment |
| --- |
|Drug: teicoplanin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of the trough level attaining 10 mg/L at different timing |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the occurrence of adverse drug effects |  |  | 
| the correlation between the trough level and the patients' characteristics |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
teicoplanin
The Nutritional Status and Food Intake of Community Health Agents

Study Overview
=================
Brief Summary
-----------------
This research had as a goal to characterize the social demographic profile, nutritional status, the presence of chronic non-transmissible diseases and food intake of the community health agents who belong to five family health units in the east zone of Sao Paulo City.

Detailed Description
-----------------
It's a descriptive, exploratory and quantitative study developed among 88 individual.

Official Title
-----------------
Community Health Agents From East Zone of Sao Paulo City, Brazil: A Look at Their Nutritional Status and Food Intake

Conditions
-----------------
Nutritional and Metabolic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be an agent comunnity health who belong in the family health unit choosed to participate of this study; Assign the autorization to participate of the study; Answer a questionary of health, social demographic profile and food intake. Exclusion Criteria: Refuse to participate or assign the autorization; Don´t answer the questionary of health and food intake; Don´t participate of the nutricional status evaluation.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family Health Program; Food consumption; Nutritional status
Impact of Vaccination in Acute COVID-19

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the association between vaccination with one of the four SARS-CoV-2 vaccines authorized for use in the European Union-BNT162b2, ChAdOx-1S, mRNA-1273 or Ad.26.COV2.S-and progression to critically severe disease among adult patients with PCR-confirmed acute COVID-19.

Official Title
-----------------
The Impact of Vaccination in a Cohort of Patients Hospitalized for Acute COVID-19

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 yers or more hospitalized for acute COVID-19 PCR confirmed infection with SARS-CoV-2 Exclusion Criteria: hospitalized for other conditions

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 |
| --- | --- |
| vaccinated patients with COVID-19<br> | Biological: vaccination<br>* patients who received COVID-19 vaccine<br>|
| unvaccinated patients with COVID-19<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number (%) with critically severe disease |  | assessment performed at a minimum 30 days after admission |
Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome (FAS)

Study Overview
=================
Brief Summary
-----------------
Evaluating the efficacy of a video about FAS to determine whether it has an impact on knowledge about FAS and their likelihood to participate in risk taking behavior.

Detailed Description
-----------------
Teenage mothers are asked to participate in the study and then randomized into an intervention or control group. Both groups take a multiple choice survey and then are randomized to either watch a video about FAS or not. After the video (or not for the controls) they then take a post video short answer survey. The survey results are then scored and statistical analysis performed to determine whether the video intervention increased their knowledge about FAS and their likelihood to drink alcohol during pregnancy.

Official Title
-----------------
Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome

Conditions
-----------------
Fetal Alcohol Syndrome, Teen Pregnancy

Intervention / Treatment
-----------------
* Other: An educational video about Fetal Alcohol Syndrome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant teens aged 12 to 16 years Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 16 Years

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

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

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 |
| --- | --- |
| Experimental: Intervention<br>The group selected to watch the video. | Other: An educational video about Fetal Alcohol Syndrome<br>* A 20 minute video about FAS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether an educational video on FAS increases maternal knowledge on the subject and affects their likelihood to drink alcohol. |  | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fetal Alcohol Syndrome, Teen pregnancy