linjc16/ctgov huggingface dataset:
Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples

Study Overview
=================
Brief Summary
-----------------
This is a prospective, observational evaluation study to assess the stability of the analytes tacrolimus, cyclosporine A, everolimus and sirolimus measured with Cascadion™ SM Immunosuppressants Panel. Study is pre-market evaluation for the regions where Cascadion™ SM Immunosuppressants Panel is not on the market yet and post-market evaluation where it is. To assess the stability of tacrolimus, cyclosporine A, everolimus and sirolimus in patient whole blood samples after they are collected, processed and subjected to various storage conditions or freeze-thaw cycles that represent common sample handling conditions in the commercial clinical laboratory setting. Study subjects will undergo one venous sample collection where 30 mL of blood is drawn.

Official Title
-----------------
Cascadion™ SM Immunosuppressants Panel, Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples

Conditions
-----------------
Transplantation Drugs Stability

Intervention / Treatment
-----------------
* Procedure: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Ability to sign informed consent form At least one of the following Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A Kidney or liver transplant patient using everolimus Kidney transplant patient using sirolimus Exclusion Criteria: Inability to provide informed consent Pregnancy or breastfeeding Likely to believe that the sample collection procedure will pose an unusually high risk for subject's physical or mental health or their comfort

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 |
| --- | --- |
| Patient blood sample collection<br>30 mL of whole blood collected from eligible patients in one sampling | Procedure: Blood sampling<br>* Blood sampling from all eligible transplantation patients according to the protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance criteria for claiming the patient samples storage stability | Stability of cyclosporine A, tacrolimus, everolimus and sirolimus in patient whole blood samples will be tested at +15-25°C up to 4 days, at +2-8°C up to 15 days and at -20±5°C up to 31 days. Relative bias at each time point to T0 baseline is calculated for each patient sample separately. The grand average relative bias across all samples, and the associated 95% confidence interval, must be within -15% and +15%. | 5 months |
Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Understanding the quality of life and anorectal function changes in patients with middle and low rectal cancer after surgery can guide patients to recover after surgery and provide a valuable reference for surgeons in the selection of surgical methods. The purpose of this study is to: (1) Investigate the complication rate, recurrence and metastasis rate and survival of patients with middle and low rectal cancer. (2) QLQ-C30 and QLQ-CR29 questionnaires were used to assess the quality of life of patients with low- and middle-level rectal cancer at different periods after surgery. (3) Wexner constipation score and LARS syndrome score for anorectal function after operation for low rectal cancer. (4) The CIPE ejaculatory function score, IIEF-5 International Erectile Function Score, and FSFI-6 Female Sexual Function Index were used to assess the changes in sexual function of patients with low- and middle-position rectal cancer after surgery.

Official Title
-----------------
Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Other: anorectal function test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postoperative patients with middle rectal cancer Postoperative patients with low rectal cancer Exclusion Criteria: (1)Patients refused to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Middle and low rectal cancer<br> | Other: anorectal function test<br>* anorectal function test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | defined as time from the date of sugery to death | five years after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QLQ-C30 | the score of Quality of life questionnaire QLQ-C30 | Every three months after the operation | 
| QLQ-CR29 | the score of Quality of life questionnaire QLQ-C29 | Every three months after the operation | 
| Wexner | the score of questionnaire Wexner | Every three months after the operation | 
| LARS | the score of questionnaire LARS | Every three months after the operation | 
| IIEF-5 | the score of questionnaire IIEF-5 | Every three months after the operation | 
| CIPE | the score of questionnaire CIPE | Every three months after the operation | 
| FSFI-6 | the score of questionnaire FSFI-6 | Every three months after the operation |
Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors

Study Overview
=================
Brief Summary
-----------------
Transradial approach (TRA) reduces vascular complications and access related-bleeding compared to transfemoral approach (TFA). However, this technique has been related to higher radiation exposure during coronary angiography and percutaneous coronary intervention. Previous studies have shown that TRA demands a long learning curve, and procedure success rate increases with operator's experience. Our hypothesis is that the higher radiation exposure during TRA is not a technique issue, but due to operator's expertise. The aim of this study is to evaluate whether experienced operators with either TRA or TFA can perform diagnostic coronary angiography with similar radiation exposure.

Official Title
-----------------
Transradial and Transfemoral Approach by EXPERienced Operators in Daily rouTine (EXPERT): a Randomized, Non-inferiority Trial

Conditions
-----------------
Exposure to Ionizing Radiation, Coronary Heart Disease, Vascular Access Complication

Intervention / Treatment
-----------------
* Other: Trans-radial
* Other: Trans-femoral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for a elective coronary angiography Eligible for either transfemoral or transradial approach Accept to sign the written consent form (WCF) Exclusion Criteria: Refusal to sign the WCF End stage renal failure Urgency/Emergency procedure Contraindication to perform both coronary and left ventricle angiogram Necessity of another vascular angiogram during coronary angiography

Ages Eligible for Study
-----------------
Minimum Age: 21 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trans-radial access<br>Coronary angiography performed through trans-radial access | Other: Trans-radial<br>* Coronary angiography performed through trans-radial access<br>|
| Active Comparator: Trans-femoral access<br>Coronary angiography performed through trans-femoral access | Other: Trans-femoral<br>* Coronary angiography performed through trans-femoral access<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient radiation exposure (mGy) | Patient radiation exposure (mGy) | during coronary angiography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician radiation exposure (in uSv) | Physician radiation exposure (in uSv) | during coronary angiography | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Occupational radiation exposure, Transradial approach, Transfemoral approach
Study to Evaluate Satisfaction After Treatment With Kysse

Study Overview
=================
Brief Summary
-----------------
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Kysse.

Official Title
-----------------
Post Marketing Study to Evaluate Lip Augmentation & Satisfaction With Restylane Kysse

Conditions
-----------------
Lip Augmentation

Intervention / Treatment
-----------------
* Device: Hyaluronic acid
* Device: Hyaluronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated informed consent to participate in the study Adult women and men who intend to undergo lip augmentation Exclusion Criteria: Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics Subjects with a previous implant other than HA in or near the intended treatment site Participation in any other clinical study within three (3) months before treatment

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Restylane Kysse<br>Hyaluronic acid | Device: Hyaluronic acid<br>* Injectable gel for lip augmentation<br>* Other names: Restylane Kysse;|
| Other: Restylane Kysse with other HA<br>Hyaluronic acid | Device: Hyaluronic acid<br>* Injectable gel. Lip Augmentation and other wrinkles/folds<br>* Other names: Restylane Kysse with other Restylane products;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Treatment With Restylane Kysse Using GAIS | The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved. | 8 weeks after last treatment |
Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC)

Study Overview
=================
Brief Summary
-----------------
Integrative Analysis of pulmonary sarcomatoid carcinoma (PSC)

Detailed Description
-----------------
The investigators will analyzed proteomes of paired normal lung tissues and pulmonary sarcomatoid carcinoma with or without metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary pulmonary sarcomatoid carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of lung cancer characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Official Title
-----------------
Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC)

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

Intervention / Treatment
-----------------
* Other: The investigators will extract total protein, DNA and RNA from PSC patients.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤ 70 years with histologically proven LCLC No severe major organ dysfunction World Health Organization (WHO) performance status of 0 or 1 No prior cancer chemotherapy Exclusion Criteria: Age ≥ 70 Severe major organ dysfunction WHO performance status of >1 Prior cancer chemotherapy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal lung tissue<br>Normal lung tissue from PSC patients | Other: The investigators will extract total protein, DNA and RNA from PSC patients.<br>* The investigators will extract total protein, DNA and RNA from PSC patients.<br>|
| PSC tissues<br>PSC tissues from PSC patients | Other: The investigators will extract total protein, DNA and RNA from PSC patients.<br>* The investigators will extract total protein, DNA and RNA from PSC patients.<br>|
| Metastasis tissues<br>Metastasis tissues from PSC patients | Other: The investigators will extract total protein, DNA and RNA from PSC patients.<br>* The investigators will extract total protein, DNA and RNA from PSC patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 years overall survival | 10 years overall survival | 10 years overall survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 years disease-free survival | 10 years disease-free survival | 10 years disease-free survival | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IHC, PSC, Integrative Analysis, WES, RNA sequencing
Efficacy and Safety of Auto-FMT in Preventing aGVHD

Study Overview
=================
Brief Summary
-----------------
To evaluation the efficacy and safety of autologous fecal bacteria transplantation in preventing acute graft versus host disease after haploidentical hematopoietic stem cell transplantation. Bone marrow transplant patients were recruited.

Official Title
-----------------
Efficacy and Safety of Autologous Fecal Bacteria Transplantation in Preventing Acute Graft Versus Host Disease After Haploidentical Hematopoietic Stem Cell Transplantation: a Multicenter, Open, Randomized Controlled Clinical Study

Conditions
-----------------
Graft Versus Host Disease, Acute

Intervention / Treatment
-----------------
* Other: autologous fecal bacteria


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Haplo-HSCT patients; Bacteroidetes >0.1%; inverse Simpson diversity ≥2 Exclusion Criteria: Gastrointestinal diseases；Age>60; or Age<10；Probiotics or prebiotics were taken before enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with auto-FMT<br>The patients in the experimental group took autologous fecal bacteria capsule about 3 weeks after bone marrow transplantation. | Other: autologous fecal bacteria<br>* autologous fecal bacteria transplantation<br>|
| No Intervention: empty capsule<br>The patients in this group took empty capsule about 3 weeks after bone marrow transplantation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Graft-Versus-Host Disease |  | 90 days after haploidentical hematopoietic stem cell transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 90 days after haploidentical hematopoietic stem cell transplantation | 
| Event free survival |  | 90 days after haploidentical hematopoietic stem cell transplantation |
A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral pentamidine).

Detailed Description
-----------------
Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate. Patients are followed for 1 month.

Official Title
-----------------
A Study of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia

Conditions
-----------------
Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
-----------------
* Drug: Trimetrexate glucuronate
* Drug: Leucovorin calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Myelosuppressive or nephrotoxic agents at the discretion of the treating physician. Patients must have: Pneumocystis carinii pneumonia (PCP) confirmed within 15 days prior to study entry. Serious intolerance and/or resistance to standard therapies (such as trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of therapy for the current episode of PCP, or a documented history of such intolerance during a prior episode. Consent of parent or guardian if less than 18 years of age. NOTE: Pregnant women may enroll after the physician and patient have discussed the potential benefit versus risk. Exclusion Criteria Patients with the following prior conditions are excluded: History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate glucuronate.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Trimetrexate glucuronate|nan|
|Drug: Leucovorin calcium|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
-----------------
Trimetrexate, Pneumonia, Pneumocystis carinii, Leucovorin, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome
Double Blind Placebo Controlled Bellis Perenis and Arnica Montana as a Drug for PPH

Study Overview
=================
Brief Summary
-----------------
To look at the antihemmorhagic effect of 2 homeopathic drugs in women post delivery Bellis Perenis and Arnica montana

Detailed Description
-----------------
To look at the antihemmorhagic effect of 2 homeopathic drugs in women post delivery Bellis Perenis and Arnica montana compare it with placebo

Official Title
-----------------
Phase 2 Study of the Effect of Bellis Perenis and Arnica Montana on Post Partum Hemmorhage

Conditions
-----------------
Hemorrhage

Intervention / Treatment
-----------------
* Drug: Bellis Perenis ,Arnica montana


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy women during delivery Exclusion Criteria: Scarred uterus, multifetal ,multiparty,bleeding problems,cesarean sectons,chorioamnionitis

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Bellis Perenis ,Arnica montana|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin levels 2 days post partum |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post partum hemmorhage,Arnica montana,Bellis Perenis
Appendicitis During the National Lockdown During the COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
The study aims to examine whether a nationwide lock-down with an entire population subjugated to social distancing reduces the incidence of appendicitis. If a reduction is detected it supports the hypothesis that infectious disease may play a role in the etiology of appendicitis.

Official Title
-----------------
Change in the Incidence of Appendicitis in a Controlled Environment During the National Lockdown Throughout the COVID-19 Pandemic

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Behavioral: Lock-down and social distancing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered in the Danish National Patient Register during the study period Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Lock-down and social distancing|Lock-down and social distancing during COVID-19 pandemic|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appendectomy | Appendectomy or other surgery for appendicitis | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative length of stay | Postoperative length of stay | 30 days | 
| Mortality | Overall mortality | 30 days | 
| Incidence of complicated appendicitis | Perforated appendicitis or periappendicular abscess | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Pandemic, Incidence