linjc16/ctgov huggingface dataset:
Post-traumatic Headache Multidisciplinary Study

Study Overview
=================
Brief Summary
-----------------
The study will investigate the effect of pharmacological preventive treatment, education, physiotherapy and psychological counselling on the headache and associated symptoms in patients refered to the Danish Headache Center

Detailed Description
-----------------
Pharmacological interventions are candesartan, amitritylin and gabapentin depending on the headache phenotype. In total 3 visits spanned over 1 year Education is conducted as group sessions of up to 10 patients by two specialist nurses 2 x 90 min Physiotherapy is conducted as group sessions of up to 5 patients by physiotherapists 8 x 60 min plus 2 individual sessions. Psychology is conducted as group sessions of up to 10 patients by psychologist 3x60 min plus option of 1 individual session.

Official Title
-----------------
The Effect of Multidisciplinary Intervention on Patients With Persistent Post-traumatic Headache

Conditions
-----------------
Post-Traumatic Headache, Post-Concussion Syndrome

Intervention / Treatment
-----------------
* Drug: Candesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with post-traumatic headache - Exclusion Criteria: Medication-overuse headache

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

| Intervention/Treatment |
| --- |
|Drug: Candesartan|Multdisciplinary approach|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in headache days | Headache days will be obtained via a validated questionaire | 1 year | 
| Rivermead post-concussion questionare score | Rivermead is a validated questionaire to assess concussion symptoms | 1 year | 
| HADS-scores | HADS = Hospital anxiety and depression scale. A validated tool to assesss depression and anxiety symptoms | 1 year | 
| Self-perceived health | based on EU-SILC validated question on self-perceived health ('How is your health in general?'), which contains five answering categories; 1) very good, 2) good, 3) fair, 4) bad, 5) very bad. | 1 year | 
| Level of physical activity | Based on questionaire, where patients can choose: Low level of physical activity: primarily sedentary activities or light exercise at least 4 hours a week, or | 1 year |
Parameters of Acceptability, Compliance and Efficacy of Fulvestrant in Post-menopausal Patients With Advance Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The objectives of this study is to obtain information of Faslodex use in the treatment of breast cancer in the clinical practice in Argentina.

Detailed Description
-----------------
In Argentina, Faslodex is indicated for treating postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen treatment. This study will provide information regarding the acceptability and compliance of Argentina patients to Faslodex and will provide information regarding the efficacy of this treatment in local population.

Official Title
-----------------
Non-interventional Report on Parameters of Acceptability, Efficacy and Compliance of Fulvestrant in Post-menopausal Patients With Advanced Breast Cancer HR Positive Who Progresses to One Prior Endocrine Therapy With Antiestrogens

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-estrogen therapy or disease progression during anti-estrogen treatment, currently receiving Faslodex Signature of the informed consent Exclusion Criteria: Any contraindication to Faslodex administration

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect real life data of acceptability and compliance on the use of Faslodex in the Argentine population. |  | monthly | 
| To collect real life data of efficacy on the use of Faslodex in the Argentine population. |  | monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Fulvestrant, Faslodex, Acceptability, Compliance, Efficacy
Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether hemodynamic optimization with photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery could decrease the incidence of perioperative complications.

Detailed Description
-----------------
All patients received the photoplethysmography monitoring, but the monitor was blinded in the control group.

Official Title
-----------------
Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery : A Randomized Controlled Study

Conditions
-----------------
Polyp of Large Intestine, Colorectal Neoplasms, Crohn Disease

Intervention / Treatment
-----------------
* Device: Photoplethysmography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years Colorectal surgery Exclusion Criteria: Pregnant women Black skin Chronic renal insufficiency (MDRD <30 ml/min)

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Control group using a hemodynamic standard protocol | |
| Other: Photoplethysmography group<br>Hemodynamic optimization using Photoplethysmography device (ClearSight, Edwards Lifesciences, Irvine, CA) | Device: Photoplethysmography<br>* Use Photoplethysmography for hemodynamic optimization during colorectal perioperative period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of patients presenting at least one complication after colorectal surgery | Two independent experts defined the presence of complication using an a priori classification. | Up to 28 days after surgery (length of hospital stay) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All complications happening after colorectal surgery |  | Up to 28 days after surgery (length of hospital stay) | 
| Real length of hospital stay |  | Up to 28 days after surgery (length of hospital stay) | 
| Perioperative mortality |  | 28 days after surgery |
Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
This is a clinical trial of a cash transfer on symptoms consistent with COVID-19 and adherence to physical distancing guidance.

Official Title
-----------------
Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial (DISTANSE COVID-19 RCT)

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

Intervention / Treatment
-----------------
* Other: Cash transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: trouble making ends meet at the end of the month due to COVID-19 related disruptions Exclusion Criteria: confirmed positive for COVID-19 based on laboratory testing current symptoms consistent with COVID-19

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cash transfer<br> | Other: Cash transfer<br>* Cash transfer of $1000<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms consisent with COVID-19 | 32-item Influenza Patient-reported Outcome (FLU-PRO) symptom score. Higher score is worse. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of close contacts |  | Sum of contacts on days 5, 10 and 14 | 
| Number of participants with positive test for COVID-19 |  | 14 days | 
| Self-reported health based on the single question: In general, would you say your health is.. |  | 14 days | 
| Ability to make ends meet based on the single question: At the end of the month, are you able to make ends meet? |  | 14 days |
Evaluation of the Rate of Consultations in Gynecological Emergencies Under Non-urgent Management

Study Overview
=================
Brief Summary
-----------------
The difference between the demand and the current medical supply poses a real public health problem in terms of the organization of health care systems. For several years in France, there has been an increase in the number of consultations in emergency services, particularly gynaecological ones. The two causes put forward are a change in user behavior with an increase in requests for rapid but non-urgent care and the inadequacy of the supply of care in the private sector. Few studies have been carried out concerning gynaecological emergencies, unlike general emergencies. The aim of this study is to measure the frequency of consultations in gynaecological emergencies for non-emergency reasons. The interest of this study is therefore mainly on the optimization of the care system with the emphasis on the city-hospital network in the management of these patients.

Official Title
-----------------
City-hospital Network: Evaluation of the Rate of Consultations in Gynecological Emergencies Under Non-emergency Management

Conditions
-----------------
Gynecologic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient whose age is ≥ 18 years Patient not pregnant or pregnant < 14 SA Patient admitted for gynecological emergency care at Paris Saint-Joseph Hospital between 01/02/2021 and 30/04/2021 French-speaking patient Exclusion Criteria: Patient under guardianship or curatorship Patient deprived of liberty Patient under court protection Patient objecting to the use of her data for this research

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of gynecological emergency room visits for non-urgent reasons | This outcome corresponds to number of non-emergency gynecological emergency visits out of the total number of gynecological emergencies. | Month 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimization of patient care not requiring urgent care | This outcome corresponds to the the number of patients who were referred to semi-emergency or semi-programmed care facilities. | Month 2 | 
| Hospitalization rate | This outcome corresponds to the number of women hospitalized. | Month 2 | 
| Surgical management rate | This outcome corresponds to the number of women who are operated. | Month 2 |
Clinical Evaluation of the Application of the FilmArray GI Panel in Post-HSCT Diarrhea Patients

Study Overview
=================
Brief Summary
-----------------
This is a prospective single arm study with the study period from June 1st, 2019 to May 31st, 2020. An historical control group will be used in the study, which includes all patients received HSCT but not GI panel detection between June 1st, 2018 to May 31st, 2019. All patients receiving HSCT within the year at SCMC will be enrolled in the study. The stool samples will be collected from each patient at 2-3 time points, including the day before pre-conditioning (T1), 28+-3 days after HSCT (T2), and the day severe diarrhea present (T3). All the stool samples will be detected by the FilmArray GI panel, and the results as well as other clinical information including the laboratory examinations will be recorded and analyzed.

Official Title
-----------------
Clinical Evaluation of the Application of the FilmArray GI Panel in Post-HSCT

Conditions
-----------------
GVHD - Graft-Versus-Host Disease

Intervention / Treatment
-----------------
* Diagnostic Test: FilmArray Gastrointestinal (GI) Panel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤ 18 years old; Receiving HSCT; Legal guardians fully understand and sign informed consent. Exclusion Criteria: Receiving secondary transplantation; Cannot give informed consent or not willing to enroll the study.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: FilmArray Gastrointestinal (GI) Panel|The FilmArray GI Panel tests for 22 of the most commonly associated pathogens related to gastroenteritis-all from one patient sample, one easy to use reagent, and results are available in about one hour.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive rate of FilmArray GI test before and post-HSCT |  | 31 days after HSCT | 
| Compare the FilmArray GI test results generated from the same patients in different time points |  | 31 days after HSCT |
Helicobacter Pylori Sample Collection Protocol Post Therapy Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective is to obtain stool samples from post-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.

Detailed Description
-----------------
Stools will be collected and tested, at a later date, in a clinical performance study with an investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.

Official Title
-----------------
Helicobacter Pylori Sample Collection Protocol POST-THERAPY

Conditions
-----------------
Helicobacter Pylori Infection, Gastric Ulcer, Nausea, Abdominal Pain, Weight Loss, Stomach Ulcer, Loss of Appetite, Bloating

Intervention / Treatment
-----------------
* Other: Post-Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult ≥ 22 years, either gender Subject previously diagnosed with H. pylori infection Subject received and completed FDA approved treatment option Minimum of 4 weeks to one year has lapsed after completion of FDA approved treatment option Subject with a post therapy positive result from a FDA cleared UBT or FDA cleared Fecal Antigen Test Subject will undergo EGD and gastric biopsy as part of routine care to measure H. pylori post-therapy response Biopsy is obtained from antrum and/or corpus and is tested by CRM At least two of the three CRM tests are performed Subject whose EGD with biopsy occurred ≤ 7 days prior to stool collection Willing and able to sign the IRB approved Informed Consent form for this study project Exclusion Criteria: Subject with current severe H. pylori infection Subject ingested compounds that may interfere with detecting of H. pylori, e.g. 4 weeks for antibiotics and 2 weeks for Bismuth preparations or proton pump inhibitors prior to collection Pregnant or lactating Inability or unwilling to perform required study procedures Subject is unable or unwilling to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Post-Therapy|Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori Stool Collection | In vitro diagnostic (IVD) device performance | Through Study Completion, an average of 1 year |
Epiretinal Macular Membrane and Cataract Extraction

Study Overview
=================
Brief Summary
-----------------
The investigators proposed to assess the functional and anatomical outcomes of cataract and idiopathic epiretinal macular membrane extraction in combined and consecutive surgeries.

Detailed Description
-----------------
A retrospective nonrandomized clinical case series study collected 174 consecutive eyes of 174 patients undergoing macular surgery between January 2005 and December 2006. Patients suffering from epiretinal macular membranes (ERM) secondary to uveitis, trauma, or associated with a simultaneous retinal detachment (RD) were excluded. We treated 109 eyes with a combined procedure (group 1) and 65 eyes with a consecutive surgery (membrane surgery and cataract separately)(group 2).

Official Title
-----------------
Idiopathic Epiretinal Macular Membrane and Cataract Extraction : Combined vs Consecutive Surgery

Conditions
-----------------
Epiretinal Macular Membrane, Cataract Extraction

Intervention / Treatment
-----------------
* Procedure: Consecutive surgery
* Procedure: Combined surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients had symptomatic visual loss and needed vitrectomy for ERM removal. Exclusion Criteria: Patients suffering from ERM secondary to uveitis, trauma, or associated with a simultaneous RD were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Combined Surgery<br> | Procedure: Combined surgery<br>* Combined surgery for epiretinal macular membrane and cataract extraction<br>|
| Active Comparator: 2 consecutive surgery<br> | Procedure: Consecutive surgery<br>* Consecutive surgery for epiretinal macular membrane and cataract extraction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined and consecutive surgeries are effective procedures to treat idiopathic ERM. The functional and anatomical results are equivalent in both procedures. |  |  |
Renal Impairment Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see how quickly AZD3355 is taken up in to the blood and leaves the blood in people with normal kidney function or with different degrees of reduced kidney function.

Official Title
-----------------
A Phase I, Open Label, Non-randomized, Parallel Group, Pharmacokinetic Study in Subjects With Normal Renal Function, Moderate or Severe Renal Impairment Receiving a Single Dose of Oral 130 mg AZD3355

Conditions
-----------------
Reflux, Renal Excretion

Intervention / Treatment
-----------------
* Drug: AZD3355


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed informed consent Subjects should have either normal renal function or have a moderate renal impairment or severe renal impairment Exclusion Criteria: History of heart disease Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD3355 65 + 65 mg capsule | Drug: AZD3355<br>* capsule, oral, single dose<br>* Other names: Lesogaberan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic blood samples |  | 15 samples during 0-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic urine samples |  | 8 samples during 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, tolerability, exposure, healthy, renally impaired subjects