linjc16/ctgov huggingface dataset:
Hip Fracture and COVID-19

Study Overview
=================
Brief Summary
-----------------
Hip fracture in the elderly is a worldwide public health issue and a medical challenge for early postoperative rehabilitation. More than 2 million people are treated annually with an annual incidence between 100 and 300/100,000 (USA, Europe, China), resulting in a cost of billion dollars and a strain on most surgical facilities. In this context, an early surgical management of patient with fracture within the first 24-48h has been shown to reduce morbidity, length of hospital stay and mortality. During the Covid-19 pandemics, a higher risk of 30-day mortality has been reported in patients with pre-operative SARS-CoV-2 infection diagnosed 0-2 weeks, 3-4 weeks and 5-6 weeks before surgery compared with patients who did not have a pre-operative SARS-CoV-2 infection. However, this risk seems to disappear in patients diagnosed with SARS-CoV-2 ≥ 7 weeks before surgery. These findings led to propose delayed elective surgery when the benefit-risk ratio was acceptable (cancer, cardiac surgeries). However, delaying surgery in COVID-19 patients (with high risk of immune and thrombotic disorders) with hip fracture could be questionable as the risk related to COVID-19 could be counteracted by the risk delayed surgery. For assessing the mortality risk related to hip fracture surgery associated with COVID-19, we decided to use the French national hospital discharge records database for comparing the 30-day postoperative mortality in patients with hip fracture and with or without an hospitalization for SARS-COV-2 infection in the 30 previous days before surgery.

Official Title
-----------------
Association Between Covid-19 Disease and Mortality After Hip Fracture Surgery in Elderly: a Multicentre National French Survey

Conditions
-----------------
SARS-CoV2 Infection, Hip Fractures, Surgery

Intervention / Treatment
-----------------
* Procedure: Hip fracture surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 65 yars hip fracture hospitalization care code indicating a surgical procedure Exclusion Criteria: -Patient with hip fracture hospitalization without a care code indicating a surgical procedure

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| COLCOVID<br>adults undergoing hip fracture surgery | Procedure: Hip fracture surgery<br>* Hip fracture surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Mortality | hospital mortality within 30 days of the date of hospital admission for hip fracture | Day 0 to Day 30 |
Choroidal Thickness in Glaucoma Patients and Healthy Controls

Study Overview
=================
Brief Summary
-----------------
With the new software tool (EDI, enhanced depth imaging) of the Spectralis® spectral-domain optical coherence tomography (SD-OCT) it is possible to visualize and measure the choroidal thickness. In glaucoma a vascular component is known. Therefore a difference of choroidal thickness in glaucoma patients and healthy controls is proposed. Trial with medical device

Conditions
-----------------
Glaucoma Patients and Healthy Controls

Intervention / Treatment
-----------------
* Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: for both groups (glaucoma study group and control group): men and women of at least 50 years of age for the glaucoma study group: diagnosis of primary open angle glaucoma (POAG) Exclusion criteria: for both groups (glaucoma study group and control group): less then 50 years of age any pathology of the central retina any optic nerve disorder other then glaucoma retinal vascular disorder for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma for the control group: any diagnosis of glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| glaucoma patients<br>patients with diagnosis of primary open angle glaucoma | Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H<br>* Measurement of the choroidal thickness with Spectralis® SD-OCT<br>|
| control group<br>age matched healthy controls | Device: Spectralis® SD-OCT, Heidelberg Engineering GmbH, H<br>* Measurement of the choroidal thickness with Spectralis® SD-OCT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COV |  | t0 |
Photodynamic Therapy of Acne Vulgaris - a Randomized Blinded Controlled Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluated the efficacy and tolerability of methyl aminolevulinate and 5-aminolevulinic acid photodynamic therapy in patients with moderate to severe facial acne vulgaris in a randomized controlled and investigator blinded trial.

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Procedure: Photodynamic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:18 years or older, good health, more than 12 inflammatory facial acne lesions - Exclusion Criteria:skin type VI, pregnant or lactating woman. Oral retinoid use within one year, systemic antibiotics within 1 month, topical acne treatment within 2 weeks. -

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

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

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 |
| --- |
|Procedure: Photodynamic therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion counts (non-inflammatory and inflammatory) |  |  | 
| Leeds Revised Acne Grading System |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  |  | 
| Side effects |  |  |
Pattern of Use of Bevacizumab or Cetuximab + FOLFIRI Regimen as First-line Treatment in Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Registry Multicenter, prospective observational study Observe adverse events and efficacy in recruited patients for 3 years under real world settings.

Official Title
-----------------
Pattern of Use of Bevacizumab or Cetuximab in Patients With Metastatic Colorectal Cancer When Added to FOLFIRI Regimen as First-line Treatment; Multicenter, Registry Study

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

Intervention / Treatment
-----------------
* Drug: FOLFIRI, target agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients at least 19 years of age with metastatic colorectal cancer who are planned to receive Bevacizumab or Cetuximab in combination with FOLFIRI regimen as first-line treatment Patients who will receive irinotecan, a component of FOLFIRI regimen, using Camtop Injection® Exclusion Criteria: 1) Patients with conditions in which any study drug is contraindicated per the respective approved label.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FOLFIRI, target agent|Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Bevacizumab Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Cetuximab|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of use FOLFIRI regimen and target agents |  | through study completion, 3 years |
Multiple Sclerosis Rehabilitation Study

Study Overview
=================
Brief Summary
-----------------
The effects of routine rehabilitation in MS patients versus no rehabilitation.

Detailed Description
-----------------
Routine rehabilitation inervention in patients with MS. This comprises of medical and nursing input, physiotherapy, occupational therapy, speech pathology, neuropsychology, compared with a control group on the waiting list for rehabilitation intervention. Duration of intervention is 6 weeks.

Official Title
-----------------
'Functioning and Disability' and 'Quality of Life' in an Australian Community Cohort With Multiple Sclerosis.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Behavioral: Physiotherapy
* Behavioral: Occupational therapy
* Behavioral: Speech pathology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of MS (Paty)- Community dwelling participants with known neurological and psychological deficits per EDSS groups.- Age 19-64 years.- Male and female participants.- Residing within 60kms of metropolitan Melbourne.- Have mobility problem.- Adequate cognition (KFS=2). Exclusion Criteria: Patients residing in nursing home and other residential care.- Those with severe cognitive problems KFS>2.-

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 64 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Physiotherapy|nan|
|Behavioral: Occupational therapy|nan|
|Behavioral: Speech pathology|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in fatigue levels and psychological well being (depression, stress and anxiety) in MS patients. Outcome will be measured at 13 months since recruitment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Improvement in function and activities of daily living ie. disability- Quality of life.- Carer Burder in multiple sclerosis.- Utilisation of health services.- 13 months follow up. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mulitple Sclerosis, MS
Preeclampsia Subtypes and Surrogate Markers of CVD Risk

Study Overview
=================
Brief Summary
-----------------
In order to assess surrogate markers of cardiovascular risk in subtypes of preeclampsia, we will conduct a 10-year follow-up study comparing 40 women with a history of early onset preeclampsia; 40 women with a history of late onset preeclampsia and 40 women with a history of normotensive pregnancies. Eligible participants delivered at the Department of Obstetrics at Randers Regional Hospital 1998-2008. Early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.

Conditions
-----------------
Preeclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who delievered at the Department of Obstetrics at Randers Regional Hospital 1998-2008 Exclusion Criteria: Current pregnancy or breastfeeding
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Previously early onset preeclampsia<br>Women with a history of early onset preeclampsia 10 years ago | |
| Previously late onset preeclampsia<br>Women with a history of late onset preeclampsia 10 years ago | |
| Previously normotensive pregnancy<br>Women with a history of normotensive pregnancies 10 years ago | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic Markers of Cardiac Strain |  | 10 years postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers of arteriosclerosis and atherosclerosis |  | 10 years postpartum | 
| Circulating biomarkers of cardiovascular disease. |  | 10 years postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preeclampsia. Cardiovascular Disease (CVD) Risk.
Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis

Study Overview
=================
Brief Summary
-----------------
The recurrence and metastasis of peritoneum is always the lethal consequence for gastric cancer patients, and there is no effective therapy until now. It has been reported by Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free cancer cells and tiny metastasis in abdomen. Refer to the experience of systematic chemotherapy, HIPEC with combination regimen would have a brighter prospect. In this study, the investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety and overall survival would be observed and evaluated.

Official Title
-----------------
Phase 2 Study of Sequential Hyperthermic Intraperitoneal Chemotherapy of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis or Positive Free Cancer Cells in Abdomen

Conditions
-----------------
Gastric Cancer, Metastases to Perineum

Intervention / Treatment
-----------------
* Drug: Oxaliplatin
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proved gastric adenocarcinoma. Peritoneum metastasis is observed or suspected by laparoscopy or radiologic examination,or free cancer cells are detected in peritoneal lavage liquid. Potentially resectable gastric cancer. ALT, AST < 80U/L; Total Bilirubin < 30μmol/L; WBC > 4x10^9/L; PLT > 100x10^9/L; Cr < 1.5 fold normal value. ECOG 0-2 points. Expected survival time longer than 3 months. Informed consent. Exclusion Criteria: Recurrent gastric cancer. Pregnant or lactating women. Allergic to oxaliplatin or paclitaxel. Abnormal liver/kidney function. Serious heart/metabolic disease.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIPEC<br> | Drug: Oxaliplatin<br>* Oxaliplatin 345mg/m2,43℃，30mins<br>Drug: Paclitaxel<br>* Paclitaxel 260mg/m2,43℃，30mins<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | every 3 month postoperation up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of Participants with Adverse Events(III or IV grades according to NCI-CTC) | every 3 month postoperation up to 24 months |
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Pulmonary Diseases

Study Overview
=================
Brief Summary
-----------------
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Pulmonary Diseases

Detailed Description
-----------------
In this patient funded trial, patients with pulmonary disease will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Official Title
-----------------
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Pulmonary Diseases

Conditions
-----------------
Pulmonary Disease, Asthma, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Biological: AlloRx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of pulmonary disease Understanding and willingness to sign a written informed consent document Exclusion Criteria: Active infection Active cancer Chronic multisystem organ failure Pregnancy Clinically significant Abnormalities on pre-treatment laboratory evaluation Medical condition that would (based on the opinion of the investigator) compromise patient's safety. Continued drug abuse Pre-menopausal women not using contraception Previous organ transplant Hypersensitivity to sulfur
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: Treatment Group<br>Single intravenous infusion of 100 million cells | Biological: AlloRx<br>* cultured allogeneic adult umbilical cord derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Forced vital capacity (FVC) | It will be completed for each follow up point. | Four year follow-up | 
| Efficacy: Pulmonary function test | It will be completed for each follow up point. | Four year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Disease, Asthma, stem cell treatment, Chronic Obstructive Pulmonary Disease
Decision Aid - Extreme Prematurity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess in a pilot randomized controlled trial the following PICOT question: In parents facing extreme premature delivery, does the use of an existing validated visual decision aid as compared to standard counseling, reduce the primary outcome of parental decisional conflict? Furthermore, is such a decision aid understood and applicable across differing populations of different ethnic backgrounds and social classes?

Official Title
-----------------
Utility of a Clinically Relevant Decision Aid, for Parents Facing Extremely Premature Delivery

Conditions
-----------------
Prematurity; Decision Support

Intervention / Treatment
-----------------
* Other: Decision Aid
* Other: Standard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physicians who counsel women at the limits of viability women who are receiving counseling at the limits of viability Exclusion Criteria: Known congenital malformations or lethal anomalies, still birth in which the fetuses' death was known before labor.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Decision Aid<br>In this arm of the study, parents will be counseled using a decision aid. | Other: Decision Aid<br> <br> |
| Other: Standard<br>In this arm of the study, parents will be counseled using current standard methods. | Other: Standard<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict | Decisional conflict is the state of uncertainty about the course of action to take when making choices involving risk or uncertainty of outcomes. Decisional conflict is assessed using the Decisional Conflict Scale | within 1 week after consult | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge |  | within 1 week after consult | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Counseling, Limits of viability
Infectious Agents Exposure : Archiving in Dental Plaque

Study Overview
=================
Brief Summary
-----------------
We are studying the possibility of using dental calculus as a reservoir for the genes of an infectious agent that has infected the patient in previous months; as it is done to highlight climate change in ice samples.

Detailed Description
-----------------
From a sample of people who have had a microbiologically well-documented infection, we will study the possibility after genomic amplification to find, three to 12 months after genetic sequences of the infectious agent in the dental calculus of the person. The people will be recruited according to a large panel of infectious agent (gram + and gram bacterium, mycobacteria, parasite, fungus, DNA, RNA or retrovirus) and, of course, the presence of dental calculus.

Official Title
-----------------
Dental Plaque and Infectious Agents Story)

Conditions
-----------------
Infection, Dental Calculus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: three months before, having been infected with a documented pathogen this infection must have been clinically obvious the patient must have dental calculus Exclusion Criteria: to be under 18 years old to be incapable to consenting a tartar removal since the infection

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful detection of pathogen | detection of infectious agent | 3 to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infection, genomic, dental calculus