linjc16/ctgov huggingface dataset:
Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
The pathophysiology of systemic sclerosis (SSc) is still poorly understood and there are no effective treatments for this disease. SSc is a heterogeneous disease with varying severity. The heterogeneity of fibroblast profiles, observed in other fibrosing pathologies, has never been thoroughly explored in the skin of SSc patients. The immune system, and in particular B lymphocytes, plays a central role in the pathophysiology of SSc. The interactions between B lymphocytes and the cells responsible for excess collagen production, i.e. fibroblasts, are not fully elucidated The main objective is to analyze the heterogeneity of fibroblasts and infiltrating immune cells as well as their molecular signature in the skin of patients with SSc

Official Title
-----------------
Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis

Conditions
-----------------
Systemic Sclerosis

Intervention / Treatment
-----------------
* Other: Blood sampling and skin biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman over 18 years of age With a systemic sclerosis meeting the ACR-EULAR 2013 criteria Having signed an informed consent Being insured Exclusion Criteria: Syndrome of overlap with another connective tissue disease according to the international diagnostic criteria Immunosuppressive treatment within 12 months Dosage of current corticosteroid therapy ≥10mg/d Protected minors or adults Pregnant or breastfeeding women Deprived of their liberty Persons in emergency situations Persons who have refused or are unable to give informed consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Systemic sclerosis patients<br>Patients fulfilling the ACR/EULAR criteria for systemic sclerosis | Other: Blood sampling and skin biopsy<br>* Blood sampling and skin biopsy<br>|
| Healthy subjects<br> | Other: Blood sampling and skin biopsy<br>* Blood sampling and skin biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single cell RNAseq transcriptomic analysis of skin |  | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single cell RNAseq transcriptomic analysis of the whole blood |  | At inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic sclerosis, Fibrosis, fibroblasts., Fibroblasts., Immune system., B lymphocytes.
Family Satisfaction in the Intensive Care Unit - a Multicentre Assessment

Study Overview
=================
Brief Summary
-----------------
The primary aim of the present study is to assess satisfaction in a large sample of next of kin in Swiss-German ICUs. Secondary aims are to test the hypothesis that family satisfaction is related to ICU structure and process and to factors related to patients and next of kin. Further, the hypothesis will be tested that proxy assessment is possible, i.e. next of kin rate satisfaction with care similar to patients.

Official Title
-----------------
Family Satisfaction in the Intensive Care Unit - a Multicentre Assessment

Conditions
-----------------
Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: family members of patients staying for > 48 hours in an ICU Exclusion Criteria: lack of consent, insufficient knowledge of German language

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess satisfaction in Swiss-German ICUs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the hypothesis that family satisfaction is related to ICU structure and process To test the hypothesis that proxy assessment is possible |  |  |
Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)

Study Overview
=================
Brief Summary
-----------------
All metal implants release metal ions because of corrosion. Total knee arthroplasty implants have large metal surface areas and therefore substantial potential for corrosion. It is planned to compare changes in serum levels of metal ions in patients after implantation of cemented unconstrained total knee arthroplasty covered with or without a passivating surface. Serum concentrations of chromium, cobalt, molybdenum and nickel will be analyzed and compared between the two groups, as well as with those of 130 control patients without implants.

Official Title
-----------------
A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses

Conditions
-----------------
Osteoarthritis, Metal Ion Levels

Intervention / Treatment
-----------------
* Device: Coated Total Knee Arthroplasty
* Device: Standard Total Knee Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for TKA in primary oder secondary osteoarthritis of the knee Patient's consent Exclusion Criteria: Additional Implants present Allergy against constituents of implant or cement Any malignancies Renal insufficiency Any additional serious disease complicating the participation in this study
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 |
| --- | --- |
| Experimental: Coated Total Knee Arthroplasty<br>allergy coated TKA | Device: Coated Total Knee Arthroplasty<br>* Implantation of a coated Total Knee Arthroplasty<br>|
| Active Comparator: Standard Total Knee Arthroplasty<br>normal TKA | Device: Standard Total Knee Arthroplasty<br>* Implantation of a Standard Total Knee Arthroplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni) |  | 1 y and 5y | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypersensitivity against metal |  | 1 y | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metal ion concentration, total knee arthroplasty, metal hypersensitivity
Probiotic in Treatment of Adult Patients With Drug-resistant Epilepsy

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, double-blind parallel group placebo-controlled clinical trial with the aim of investigating the effect of probiotic versus placebo on drug-resistant adult patients with epilepsy.

Official Title
-----------------
Investigation of Probiotic Effect on Seizure Frequency of Adult Patients With Drug-resistant Epilepsy; A Randomized Double-blind Parallel Placebo-controlled Clinical Trial

Conditions
-----------------
Epilepsy, Treatment

Intervention / Treatment
-----------------
* Drug: Probiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Drug resistant epilepsy Exclusion Criteria: Hypersensitivity to probiotic Acute pancreatitis Pregnancy Breastfeeding Being under treatment with corticosteroids Being under treatment with antibiotics during 2 months before enrollment Need for antibiotic therapy during the study Change in anti-seizure medication within the month before enrollment

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>Familact 2 plus (Zist takhmir pharmaceutical company, Iran), one capsule per day | Drug: Probiotic<br>* Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.<br>* Other names: Placebo;|
| Placebo Comparator: Placebo<br>Similar capsule in shape and size (Zist takhmir pharmaceutical company, Iran), one capsule per day | Drug: Probiotic<br>* Each probiotic capsule contained combination of lactobacillus and Bifidobacterium species.<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in seizure frequency |  | 12 weeks |
Sexual Dysfunction and the Quality of Sexual Life in Patients With Colorectal Cancer and Their Partners.

Study Overview
=================
Brief Summary
-----------------
In this project the main focus is on assessing sexual functioning and the quality of sexual life after the treatment of colorectal cancer in patients and their partners. Patients and their partners complete questionnaires concerning sexual functioning, quality of life, body image, fatigue, anxiety, depressive symptoms, personality factors, and demographic factors. Questionnaires are completed before surgical treatment, 6 weeks, 3 months, 6 months, and 12 months after diagnosis. The results of this prospective study will give insight in 1) the incidence of sexual problems and the extent patients with colorectal cancer and their partners are bothered by these problems across time, 2) the effect of different treatment modalities on sexual functioning, 3) the relation between sexual problems and quality of life, 4) the determinants of sexual problems and the quality of sexual life adopting the biopsychosocial approach of patients with colorectal cancer who have been treated with surgery, radiation and/or chemotherapy, and more specifically to the role of personality and patient factors and sexual functioning/the quality of sexual life.

Official Title
-----------------
Sexual Dysfunction and the Quality of Sexual Life in Patients With Colorectal Cancer and Their Partners.

Conditions
-----------------
Colorectal Cancer Patients and Their Partners

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are diagnosed with colorectal cancer in one of the participating centra, and their partners are asked to participate in this study prior to treatment. Patients have to be between 18 and 75 years old. Exclusion Criteria: Disease recurrence at baseline or metastases. Poor expression of the Dutch language. Dementia. History of psychiatric illness.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Patients with colorectal cancer<br>Patients with colorectal cancer are included | |
| Partners<br>Partners of patients with colorectal cancer are included | |

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
-----------------
Colorectal cancer, Sexual function, Sexual dysfunction, Quality of (sexual) life, Partners, Body image, Anxiety (state and trait), Depressive symptoms, Personality
Uterus Transplantation From Deceased Donor - Gothenburg III

Study Overview
=================
Brief Summary
-----------------
Deceased donor uterus transplantation will be offered to patients that have either been excluded from Gothenburg II because of donor criteria or because of early graft failure in Gothenburg I and II

Official Title
-----------------
Uterus Transplantation From Deceased Donor - Gothenburg III

Conditions
-----------------
Absolute Uterine Factor Infertility, Transplantation, Mrk Anomaly

Intervention / Treatment
-----------------
* Procedure: uterus transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria recipient initially included with IVF and excluded by donor issues of Gothenburg I or II initially included and excluded by early graft failure of Gothenburg I or II age < 40 years no systemic disease no standing medication satisfactory ovarian reserve BMI <35 and at BMI 30-35 waist circumference of < 82 cm absolute uterine factor infertility psychological stable Inclusion criteria donor brain death and suitable as multiorgan donor acceptance for donation of uterus from family or previously by patient age <55 years at least one normal pregnancy and childbirth no previos malignancy no systemic disease no previous major surgery inn abdomen or on uterus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Observational study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uterus transplantation<br>Uterus transplantation | Procedure: uterus transplantation<br>* uterus transplantation from deceased donor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| birth of healthy child |  | 1-5 years after transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infertility, uterus, transplantation, MRKH
Cartilage Tympanoplasty for Recurrent Perforation Full Thickness Versus Partial Thickness Graft

Study Overview
=================
Brief Summary
-----------------
Cartilage tympanoplasty for recurrent perforation full thickness versus partial thickness graft.

Detailed Description
-----------------
To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer

Official Title
-----------------
Cartilage Tympanoplasty for Recurrent Perforation Full Thickness Versus Partial Thickness Graft

Conditions
-----------------
Cartilage Tympanoplasty

Intervention / Treatment
-----------------
* Procedure: Cartilage tympanoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1 -patients with safe chronic suppurative otitis media 2- patients with recurrent perforations 3- patients with conductive hearing loss- 4- patients above 18 years Exclusion Criteria: active infection sensorineural hearing loss compromised immune system 4 - patients age below 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cartilage tympanoplasty|is the reconstruction of the tympanic membrane (TM) by using catilage|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer | To compare between outcomes of full thickness versus partial thickness graft in cartilage tympanoplasty using cartilage slicer | 1 year |
Comparison Among Propofol, Alfentanil and Rocuronium as Adjunct to Sevoflurane Anesthesia for Endotracheal Intubation in Children With Frenectomy

Study Overview
=================
Brief Summary
-----------------
Several methods have been demonstrated to improve intubating conditions during sevoflurane induction in children. These include opioids, propofol, and addition of neuromuscular blocking agents in pediatric patients. But the study about the comparison of these agents has been uncommon. Frenectomy is common procedure to treat ankyloglossia. It is a short procedure performed under general anesthesia. The investigators aimed to compare intubating conditions among children with propofol, alfentanil or rocuronium after sevoflurane induction.

Conditions
-----------------
Ankyloglossia

Intervention / Treatment
-----------------
* Drug: administration of propofol
* Drug: administration of alfentanil
* Drug: administration of rocuronium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children, 1-9 years old scheduled elective frenectomy under general anesthesia Exclusion Criteria: Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 9 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 |
| --- | --- |
| Active Comparator: Propofol group<br>Intravenous administration of propofol 2 mg/kg before intubation | Drug: administration of propofol<br>* intravenous administration of propofol 2 mg/kg before intubation<br>|
| Active Comparator: Alfentanil group<br>Intravenous administration of alfentanil 14 μg/kg before intubation | Drug: administration of alfentanil<br>* intravenous administration of alfentanil 14 μg/kg before intubation<br>|
| Active Comparator: Rocuronium group<br>Intravenous administration of rocuronium 0.3 mg/kg before intubation | Drug: administration of rocuronium<br>* Intravenous administration of rocuronium 0.3 mg/kg before intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubating condition | The investigators will perform the evaluation of intubating condtion through scoring system provided by Viby-Mogensen during intubation procedure. The scoring system is consisted of excellent, good, and poor. | Participants will be followed for the duration of intubation, an expected average of 1 minute. |
cSEMS vs. NEPS in Stricture of Biliary Anastomosis After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Stenosis at the bilio-biliary anastomosis occurs in up to 30% of patients after orthotopic liver transplantation. This study compares endoscopic treatment with implantation of multiple plastic endoprostheses vs. use of a removable, covered self-expandable metal stent (cSEMS).

Detailed Description
-----------------
This is a multi-center randomised trial.

Official Title
-----------------
Comparison of Use of Covered, Self-expandable Metal Stents (cSEMS) and Non-expandable Plastic Stents (NEPS) in Temporary Endoscopic Treatment of Stenosis of the Bilio-biliary Anastomosis After Liver Transplantation

Conditions
-----------------
Stenosis of the Bilio-biliary Anastomosis After Orthotopic Liver Transplantation

Intervention / Treatment
-----------------
* Device: Non-expandable plastic stent (plastic endoprosthesis)
* Device: Covered self-expandable metal stent (cSEMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post-OLT stenosis of the bilio-biliary anastomotic Exclusion Criteria: non-anastomotic stricture stent implatation technically not feasible

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group NEPS<br>implantation of multiple non-expandable plastic stents | Device: Non-expandable plastic stent (plastic endoprosthesis)<br>* plastic stent (plastic endoprosthesis)<br>* Other names: OptiMed, Boston Scientifiv, MTW;|
| Active Comparator: group cSEMS<br>implantation of a self-expandable metal stent (cSEMS) | Device: Covered self-expandable metal stent (cSEMS)<br>* Removable, covered self-expandable metal stent (cSEMS)<br>* Other names: Niti-S biliary stent, fully covered;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of interventions (ERCP) to attain resolution of stenosis | Number of interventions (ERC) in study group cSEMS is compared to number of interventions (ERC) in study group NEPS | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence and severity of complications related to the endoscopic procedures |  | up to 2 months after ERCP | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cSEMS, NEPS, ERCP, biliary stricture, biliary stenosis, liver transplantation