linjc16/ctgov huggingface dataset:
COVID-19 in Liver Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Prospective observational study aimed at analyzing the incidence, clinical characteristics and outcomes of COVID-19 in LT in Spain.

Detailed Description
-----------------
Coronavirus Disease 2019 (COVID-19) is a novel viral disease caused by the SARS-Cov-2 infection with a particular predominance of upper and lower respiratory tract symptoms. First diagnosed in China in late 2019, the virus has progressed to a state of pandemia, involving Spain with a important outbreak. While the outcomes of viral infections in solid organ transplant (SOT) recipients tend to be worse than those from the general population due to chronic immunosuppression, there is little information on the incidence and outcomes of COVID-19 in liver transplant (LT) recipients. LT recipients are usually under less immunosuppression than other SOT and the clinical expression and outcomes of COVID-19 may be different to the reported outcomes in other SOT. The Spanish Society of Liver Transplantation, which includes 25 LT programs, has promoted a nationwide registry for LT with COVID-19 to help ascertain the incidence and outcomes and help evidence-based management .

Official Title
-----------------
COVID-19 in Liver Transplant Recipients in Spain: a Nationwide Prospective Study

Conditions
-----------------
Respiratory Failure, Liver Transplant; Complications, COVID19

Intervention / Treatment
-----------------
* Other: Observational only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver Transplant recipient Confirmed (PCR positive) SARS-Cov-2 infection Informed Consent
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19<br>Liver Transplant recipients | Other: Observational only<br>* Observational Study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of COVID19 in LT recipients |  | 12 months | 
| Clinical characteristics of COVID19 in LT recipients |  | 12 months | 
| Survival and Mechanical ventilation / respiratory support |  | 3 months | 
| Observed treatments and immunosuppression management |  | 12 months |
Rituximab in Refractory Primary Membranous Nephropathy

Study Overview
=================
Brief Summary
-----------------
Primary membranous nephropathy (PMN), an autoimmune disease mostly associated with anti-phospholipase-A2-receptor (PLA2R) antibodies, is one of the most common causes of nephrotic syndrome in adults. In 30% to 40% of all cases, patients with PMN undergo spontaneous remission with conservative approaches. Corticosteroids, alkylating agents and calcineurin inhibitors are recommended treatment options in persistent disease activity despite supportive therapies. Nevertheless, patients with refractory disease constitute an important clinical aspect of PMN, and uncontrolled proteinuria may culminate in rapid progression to end-stage renal disease. In recent years, several studies demonstrated the efficacy of rituximab as a treatment option in patients with refractory PMN; however, data regarding daily clinical practice of this agent is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of rituximab in patients with refractory PMN.

Official Title
-----------------
Efficacy and Safety of Rituximab in Patients With Refractory Primary Membranous Nephropathy

Conditions
-----------------
Glomerulonephritis, Membranous

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having biopsy-proven primary membranous nephropathy. Showing resistance to at least one set of prior therapies including corticosteroids, alkylating agents or calcineurin inhibitors. Having a history of rituximab use (375 mg/m2/wk for 2-4 weeks) following resistance aforementioned agents. Exclusion Criteria: Not providing or withdrawing consent.

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 |
| --- | --- |
| Study Group<br>Patients with primary membranous nephropathy who were treated using rituximab (375 mg/m2/wk for 1-4 weeks) following resistance to at least one set of prior therapies including corticosteroids, alkylating agents or calcineurin inhibitors. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Remission | Proteinuria <0.3 g/day, confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal serum creatinine. | 6 months | 
| Partial Remission | Proteinuria <3.5 g/day and a 50% or greater reduction from peak values, confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable serum creatinine. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
membranous nephropathy, rituximab
Uterine Closure at C-section by Stratafix Tissue Control Device: Randomized Case-Control Study

Study Overview
=================
Brief Summary
-----------------
Comparative study of the surgical outcome of 2-layers closure technique of uterine incision in Cesarean section using bidirectional barbed suture (Stratafix) and conventional suture material (Vicryl) regarding the time of closure and the need of secondary additional suturing or tearing of uterine muscles during suturing.

Detailed Description
-----------------
A Randomized prospective case control study to evaluate the surgical outcome of using the new barbed bidirectional tissue controlling device in reducing the time and blood loss at uterine closure during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure is used and the occurrence of any tearing of the uterine muscles at the time closure of the uterine incision will be also studied. These will be the primary outcome measure and the secondary outcome measure will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative fever, and the number of sutures required to close the uterine incision.

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Procedure: Closure of uterine incision at C section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pregnant patients with an indication for delivery by C section Exclusion Criteria: Patient refusing to participate in the study
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Stratafix Tissue control device<br>Closure of Uterine incision at C section | Procedure: Closure of uterine incision at C section<br>* Closure of uterine incision at Cesarean section<br>|
| Other: Vicryl suture<br>Closure of uterine incision at C section | Procedure: Closure of uterine incision at C section<br>* Closure of uterine incision at Cesarean section<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed to close the uterine incision | A model is set to evaluate success and failure according the ime needed to close the uterine incision if more or less than 6 minutes | 6 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss during uterine closure |  | intraoperative during uterine closure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean section, uterine closure technique, materials used
Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors

Official Title
-----------------
A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

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

Intervention / Treatment
-----------------
* Drug: gimatecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Advanced or metastatic cancer 18 years and above Exclusion criteria: Previous treatment with 4 or more cycles of carboplatin; Previous treatment with 2 or more courses of nitrosourea or mitomycin; Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve; Severe and/or uncontrolled medical conditions Other protocol-defined inclusion/exclusion criteria may apply

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily times five schedule<br> | Drug: gimatecan<br> <br> |
| Experimental: Continuous schedule, twice daily<br> | Drug: gimatecan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of dose limiting toxicities in a 56-day treatment period |  | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability assessed by adverse events, serious adverse events |  | 112 days | 
| pharmacokinetics of gimatecan and its metabolites(s) |  | 91 days | 
| response rate assessed by anti-tumor activity |  | 112 days | 
| investigate tumor-specific mutations |  | 57 days | 
| Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC |  | 56 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Maximum Tolerated Dose, Solid Tumors, Dose Limiting Toxicity, Topoisomerase-1 Inhibitor
The DANTE Trial. A Randomized Study on Lung Cancer Screening With Low-Dose Spiral Computed Tomography

Study Overview
=================
Brief Summary
-----------------
High survival rates have been reported for screen-detected Stage I lung cancer patients, but there are concerns about the potential biases of uncontrolled studies. DANTE is a prospective randomized controlled trial exploring the effects of screening with LDCT on lung-cancer-specific mortality, and on the prevalence and incidence rates of lung cancer, stage distribution and resectability rates in a selected high-risk population. The prevalence of a set of biomarkers in sputum and blood samples is also being determined.

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Spiral Computed Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male sex Age 60-74 years smokers of more than 20 cigarettes/day for at least 20 years (actual smokers or ex-smokers from no more than 10 years) Exclusion Criteria: severe cardiopathy advanced BPCO with chronic hypoxaemia (rest SatO2 < 94%) chronic severe renal insufficiency hypertension not controlled with drugs type 2 diabetes or other severe systemic disease severe previous cerebrovascular lesions with permanent invalidity (not self-sufficient). severe vascular lesions with repeated ictus, trophic lesions, or limb loss, if actual smoker Dementia, psychosis, severe depression or maniac-depressive syndrome actual or precedent neoplasia, excepted skin tumor not-melanoma or scaly cells laryngeal and buccal cavity tumor, N0, recovered from more than 10 years or other tumors recovered from more than 10 years transplantation less than 5 years or with rejection episodes in the last 2 years unable subjects

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Spiral Computed Tomography|nan|

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
-----------------
Lung neoplasms, Early diagnosis, Screening, Spiral Computed Tomography, Randomized Controlled Trial
Mandibular Angle Fracture and Interframents Gap

Study Overview
=================
Brief Summary
-----------------
Twenty-five patients with mandibular angle fracture were subjected to reduction and fixation through intra-oral open reduction and semi-rigid min plate fixation near the superior border of the mandible at Champy's osteosynthesis line. The linear inter-fragmentary gap was measured at the inferior border of the mandible after fixation of the fractured bony segments in the final aligned position immediately postoperative on a panoramic radiograph for the mesio-distal plane and a cone beam computed tomography for the bucco-lingual plane to assess any lingual splay. The healing process was clinically followed for 3 months postoperatively for any complications and/or patient complains

Official Title
-----------------
Interfragmentary Gap Discrepancy After Intraoral One-plate Fixation in Mandibular Angle Fracture

Conditions
-----------------
Mandibular Fractures

Intervention / Treatment
-----------------
* Procedure: open reduction and internal fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: minimally displaced mandibular angle fracture which needed intervention via reduction and fixation *medically free Exclusion Criteria: - Patients with multiple mandibular fractures or patients with concomitant maxillary fracture. Patients with severely displaced mandibular angle fracture needing extra-oral open reduction and fixation. Medically compromised patients and patients with abnormalities that impair bone healing

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 |
| --- | --- |
| mandibular fracture group<br> | Procedure: open reduction and internal fixation<br>* The same surgical team have treated all the patients through open reduction via an intra-oral mucosal flap under general anesthesia with insertion and fixation of a 4-6 holes 2.0 miniplate and 5 mm screws at the superior border of the mandible at Champy's osteosynthesis line<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interfragment gap | measure the mesio-distal plane discrepancy in terms of linear inter-fragmentary gap at the inferior border between the fractured mesial and proximal segments by CT | 3 months |
Different Chemotherapy Protocols Combined With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
This study was to evaluate the efficacy ,toxic reaction and safety of different chemotherapy combined with radiotherapy on patients with locally advanced nasopharyngeal carcinoma.

Official Title
-----------------
the General Hospital of PLA

Conditions
-----------------
Drug-Related Side Effects and Adverse Reactions

Intervention / Treatment
-----------------
* Drug: Cisplatin
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18, <70 years old, with locally advanced nasopharyngeal carcinoma. Exclusion Criteria: patients who had accepted radiotherapy before patients with any ather types of cancer

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Docetaxel<br> | Drug: Docetaxel<br>* Docetaxel<br>|
| Active Comparator: Cisplatin<br> | Drug: Cisplatin<br>* radiotherapy combined with Chemotherapy Drugs, Cancer<br>|
| Active Comparator: DocetaxelCisplatin<br>Cisplatin combined with Docetaxel | Drug: Cisplatin<br>* radiotherapy combined with Chemotherapy Drugs, Cancer<br>Drug: Docetaxel<br>* Docetaxel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in toxic reaction | incidence rate of the toxic reaction between three groups | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| over survival | differences of over survival rate between three groups | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Toxic reaction, locally advanced nasopharyngeal carcinoma, Concurrent chemoradiotherapy
Study of Patient Navigation to Promote Colon Cancer Screening

Study Overview
=================
Brief Summary
-----------------
This study will investigate whether patient navigation can increase rates of colorectal cancer screening among linguistically and culturally diverse disadvantaged patients served by urban community health centers.

Official Title
-----------------
Randomized Controlled Trial of Patient Navigation to Increase Colorectal Cancer Screening Rates Among Community Health Center Patients

Conditions
-----------------
Colorectal Cancer Screening

Intervention / Treatment
-----------------
* Other: Patient navigation
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 52-75 who had one visit to a primary care physician in a community health center in each of the 2 previous years and who have not received colorectal cancer screening based on HEDIS criteria. Exclusion Criteria: Current cancer diagnosis, undergoing treatment (or treatment completed within the past year) Severe cardiac disease (high-risk CAD,9 valvular disease, NYHA Class III or IV CHF, EF < 35%) Severe COPD (FEV1< 1liter or on home oxygen) CVA with severe functional impairment (aphasia or hemiparesis) MS with severe functional impairment Renal failure with CrCl< 30 or on dialysis Gastrointestinal symptoms (pain, bleeding, etc) within the past 6 months Chronic active liver disease or cirrhosis, with albumin < 3 or elevated INR Advanced HIV disease (CD4 count <200) Severe lupus (with cerebritis or renal failure as defined above) Severe complications of diabetes (blindness, amputations other than toes) Advanced Dementia Psychosis Paranoia Active substance abuse Schizophrenia Psychiatric hospitalization within the past year

Ages Eligible for Study
-----------------
Minimum Age: 52 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of a Patient Navigator<br> | Other: Patient navigation<br>* Letter and Colorectal Cancer Screening Brochure mailed to patients. Telephone outreach by Patient Navigators.<br>|
| Other: Usual Care<br>No Intervention - usual care | Other: Usual care<br>* Usual care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| completion of colorectal cancer screening |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of detection of polyps and cancers in intervention vs. control groups |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
community health centers, colorectal cancer screening, urban health
Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease.

Study Overview
=================
Brief Summary
-----------------
The angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with diabetic nephropathy. The hypothesis of this study is that adding a diuretic agent (furosemide) will decrease the urine protein, which is a sign of disease, more than an angiotensin converting enzyme inhibitor alone.

Official Title
-----------------
Maximizing the Benefit of RAS Blockade in Diabetic Nephropathy

Conditions
-----------------
Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: Addition of furosemide 20 mg oral bid to baseline regimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proteinuria greater than 1 gram/day serum creatinine < 2.6 for men, < 2.0 for women Exclusion Criteria: blood pressure which cannot be controlled without a diuretic renal diseases other than diabetic nephropathy other disease which would alter renal function during 6 months

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Addition of furosemide 20 mg oral bid to baseline regimen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of protein in the urine after 8 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The estimated glomerular filtration rate after 8 weeks of treatment. |  |  |