linjc16/ctgov huggingface dataset:
Combined HCC-MFCCC

Study Overview
=================
Brief Summary
-----------------
Combined hepatocellular and mass-forming cholangiocarcinoma (cHCC-MFCCC) is a rare tumor. The aim of this study was the analysis of the outcome comparing such tumor with classic hepatocellular carcinoma (HCC) and mass-forming cholangiocarcinoma (MFCCC).

Detailed Description
-----------------
The institutional prospectively maintained database was queried, and 20 patients with cHCC-MFCCC were identified. A 2:1 match was performed with 40 patients operated in the same period for HCC, and with 40 operated for MFCCC. Only T1 or T2 patients N0 M0 were considered. Primary endpoint was the overall survival (OS) and disease-free survival (DFS).

Official Title
-----------------
Survival After Hepatectomy for Combined Hepatocellular Cholagiocarcinoma

Conditions
-----------------
Liver Carcinoma, Hepatocellular Carcinoma, Cholangiocarcinoma, Surgery

Intervention / Treatment
-----------------
* Procedure: Hepatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: positive histology for cHCC-MFCCC, HCC, and MFCCC complete clinical, surgical, pathological and follow-up data. Exclusion Criteria: patients preoperatively treated with chemotherapy, radiofrequency ablation or trans-arterial therapies were excluded. patients operated for recurrent disease and/or with non-radical surgery patients with missing data were also excluded

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 |
| --- | --- |
| cHCC-MFCCC<br>Patients affected by combined HCC-MFCCC | Procedure: Hepatectomy<br>* Removal of a part of the liver<br>* Other names: Liver surgery;|
| HCC<br>Patients affected by classical HCC | Procedure: Hepatectomy<br>* Removal of a part of the liver<br>* Other names: Liver surgery;|
| MFCCC<br>Patients affected by classical MFCCC | Procedure: Hepatectomy<br>* Removal of a part of the liver<br>* Other names: Liver surgery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival analysis | Analysis of overall and disease-free survival of patients resected for cHCC-MFCCC versus those resected for HCC versus those resected for MFCCC | From 3 months after surgery up to 60 months after surgery |
Perinatal Outcomes in Umbilical Cord Entanglement

Study Overview
=================
Brief Summary
-----------------
Umbilical Cord Entanglement and Perinatal Outcomes.

Detailed Description
-----------------
Umbilical Cord Entanglement and Perinatal Outcomes neonatal outcomes and the effect on mode of delivery

Official Title
-----------------
Assiut University,Faculty of Medicine

Conditions
-----------------
Umbilical Cord; Complications, Affecting Fetus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all vaginal deliveries with or without Umbilical Cord Entanglement Exclusion Criteria: multible pregnancy
Sexes Eligible for Study
-----------------
Female

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perinatal outcomes | number of neonates with bad Apgar score | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delivery outcome | number of vaginal deliveries switch to S.C | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
umbilical cord
Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

Study Overview
=================
Brief Summary
-----------------
This research study will test the comfort of two noninvasive respiratory monitoring sensors (the connection to a monitor worn by a person-not the monitor). The two sensors, Masimo Rainbow Acoustic Monitoring sensor and Oridion Smart Capnoline Plus H sensor, are cleared by the U.S. Food and Drug Administration (FDA) and currently used in the clinical setting. People who enter into the study will wear the two interfaces, one after the other, for 20 minutes each (10 minutes with a small flow of air to the nostrils and 10 minutes without) and rate the comfort of each with a seven question survey. A total of 30 participants will be recruited.

Official Title
-----------------
Comfort Evaluation of Non-Invasive Respiratory Monitor Interfaces

Conditions
-----------------
Respiratory Device Comfort

Intervention / Treatment
-----------------
* Device: Respiratory monitor patient interface.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal body temperature Between the ages of 19-65 years Self-report as feeling to be in typical health No skin irritation face or neck where a sensor would be placed. School of Health Professions student Exclusion Criteria: Any injury or condition that would affect assessment of comfort.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 49 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Device interface comfort assessment<br>Single group rates one noninvasive respiratory monitoring interface and then another. | Device: Respiratory monitor patient interface.<br>* Wear each interface for 20 minutes<br>* Other names: Oridion Smart Capnoline Plus H sensor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort Rating Self-Report Instrument | A seven-question written instrument constructed in the style of descriptive analogue to evaluate multiple facets of device comfort. Answer choices allow either ordinal ranking (one requires a ranking on a continuous time scale). | 5 Minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient Monitoring, Capnography, Human Engineering
Efficacy of Automated Bolus Calculation in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that non-optimal basal-bolus insulin treated patients with type 2 diabetes can achieve better metabolic control by counting carbohydrates with concurrent use of an automated bolus calculator. Additionally, the investigators propose that this intervention will lead to improvement in patient related outcomes.

Official Title
-----------------
Efficacy of Advanced Carbohydrate Counting and Automated Bolus Calculation in Insulin-treated Type 2 Diabetes Patients: The BolusCal2 Study

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Device: Automated bolus calculator
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes > 1 year Age 18 years or older HbA1C > 64 mmol/mol (8.0 %) Treatment with multiple daily insulin injections (basal and prandial insulin) ≥ 6 months GAD-antibody negative Naïve to bolus calculators Exclusion Criteria: Pregnancy or breast feeding Gastroparesis Severe nephropathy (eGFR<30 mL/min/1,73 m2) Use of sulfonylurea

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carb counting and bolus calculator<br>Education in carb counting and the use of an automated bolus calculator | Device: Automated bolus calculator<br> <br> Other: Education<br> <br> |
| Placebo Comparator: Carb counting<br>Education in carb counting and manual calculation of insulin bolus | Other: Education<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent below, in or above the glucose target 4-10 mmol/l measured by continuous glucose monitoring (CGM) |  | 6 months | 
| Frequency of blood glucose measurements assessed by meter download before randomization and at each visit |  | 6 months | 
| Frequency of hypoglycemia (below 2.8 mmol/L or unconsciousness/ need of medical assistance) |  | 6 months | 
| Change in diet habits/diet composition | Assessed by electronic diet recordings | 6 months | 
| Change in treatment satisfaction | Using questionnaire | 6 months |
Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II

Study Overview
=================
Brief Summary
-----------------
The study is a follow up of NCT01844362. Uterus transplantation will be performed from live donors to patients with uterine factor infertility. If will be performed before transplantation. Organ procurement from the donor will be performed by robotic assisted laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months after transplantation. After birth of 1-3 children the uterus will be removed by hysterectomy,

Detailed Description
-----------------
The study is a follow up of NCT01844362. Uterus transplantation will be performed from live donors to patients with uterine factor infertility. If will be performed before transplantation. Organ procurement from the donor will be performed by robotic assisted laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months after transplantation. After birth of 1-3 children the uterus will be removed by hysterectomy.

Official Title
-----------------
Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II

Conditions
-----------------
Infertility, Female

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age below 38 years absolute uterine factor infertility BMI<30 Exclusion Criteria: systemic disease psychiatric disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 38 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: uterus transplantation|Uterus transplantation from live donor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live births after uterus transplantation | Assessed by records from birthing unit and Swedish National Birth registry | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of children after uterus transplantation | Assessed by growth parameters and neuropsychiatric tests (Bayley Mental Scale, M-CHAT, CBCL, WPPSI-IV) | 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infertility, uterus, transplantation
Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

Study Overview
=================
Brief Summary
-----------------
EUROSCUP Fixe is intended for use in primary and revision total hip replacement surgery. Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. As part of post market vigilance, EUROS will collect data on EUROSCUP Fixe performances and safety

Detailed Description
-----------------
Post market observational study. This study is retropective and prospective, non comparative.

Official Title
-----------------
Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup

Conditions
-----------------
Hip Arthropathy, Hip Osteoarthritis, Hip Necrosis, Hip Fractures, Hip Dysplasia, Hip Arthritis

Intervention / Treatment
-----------------
* Device: Hip arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who received EUROSCUP Fixe. Patient informed of its participation to the study Patient aged between 18 and 80 years old (<80). Exclusion Criteria: Patient presenting a contraindication to EUROSCUP Fixe implantation. Patient who refused to participate to the study Vulnerable subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EUROSCUP Fixe<br>120 patients who received EUROSCUP Fixe | Device: Hip arthroplasty<br>* Hip prosthesis surgical implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of EUROSCUP Fixe | Collect the safety of the device trought complications occurence rate | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performances of EUROSCUP Fixe | Collect the performances of the device trought clinical scores | 1 year | 
| Radiological performances of EUROSCUP Fixe | Collect the performances of the device trought radiological evaluation | 1 year | 
| Survival of EUROSCUP Fixe | Assess the survival rate of the device | 10 years |
Treatment of Pilonidal Cyst With Holmium Laser

Study Overview
=================
Brief Summary
-----------------
Observational study on the treatment of pilonidal cyst with Holmium laser. Single-centre retrospective study of medical data from patients' medical records

Detailed Description
-----------------
From the medical records of a series of patients treated for pilonidal cysts with Holmium laser: Primary objective: to assess the rate of healing at 1 month after Holmium laser treatment (healing being defined as no dressing) Secondary objectives: to assess the following: Healing rate at last follow-up (1 month after surgery) Recurrence rate at last follow-up (1 month after surgery) Consumption of >1 level analgesics in the week and month following the procedure Duration of nursing care

Official Title
-----------------
Treatment of Pilonidal Cyst With Holmium Laser

Conditions
-----------------
Pilonidal Cyst

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 years or older, who has been informed of the research; Patient with a pilonidal cyst treated with Holmium Laser during a scheduled procedure. Exclusion Criteria: Patient under legal protection, guardianship or curatorship; Patient who has indicated his opposition to the use of his data. Patient undergoing emergency surgery for an abscess

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Healing rate | explanatory analysis of the healing rate at Month 1 | Month 1 |
Phase 1b Study of CCX872-B in Patients With Pancreatic Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
This is an open-label phase 1-b study to evaluate the safety and efficacy of CCX872-B in patients with pancreatic adenocarcinoma also receiving FOLFIRINOX chemotherapy.

Official Title
-----------------
An Open-label Phase 1b Study to Evaluate the Safety and Efficacy of CCX872-B in Patients With Pancreatic Adenocarcinoma

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: CCX872-B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed non-resectable pancreatic adenocarcinoma with or without metastases Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2 Anticipated life expectancy ≥ 12 weeks Radiographically measurable disease acc. to RECIST 1.1 Use of adequate contraception (as described in protocol) Ability to provide written informed consent and comply with study requirements Exclusion Criteria: Received other cancer treatment or investigational drug within 4 weeks prior to screening Women who are pregnant or breastfeeding Had major surgery within 4 weeks of first dose of study drug Inadequate liver, renal or bone marrow function within 2 weeks of first dose Serious concurrent illness, altered medical status or any uncontrolled medical condition Any infection requiring antibiotic or anti-viral treatment within 4 weeks of screening Known active HIV, HBV or HCV infection Inability to swallow tablets History or presence of any medical condition or disease which, in the opinion of the investigator, may place the subject at unacceptable risk for study participation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CCX872-B<br>150 mg once or twice daily given orally for at least 12 weeks | Drug: CCX872-B<br>* Tablets (oral administration)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 24 weeks | 
| subject incidence of Grade 3 or 4 adverse events |  | 24 weeks |
Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation.

Official Title
-----------------
Comparative, Randomized, Double-blind Study of the Efficacy of Eductyl® Versus Placebo for Treatment of Patients With Dyschesia Treated by Rectal Rehabilitation

Conditions
-----------------
Dyschesia

Intervention / Treatment
-----------------
* Drug: Eductyl suppository
* Drug: Placebo suppository


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female over 18 years Patients with dyschesia Prescription of rehabilitation for dyschesia Exclusion Criteria: Rectal diseases Pain killers Pregnant women Breast feeding patients Non-compliant patients

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eductyl suppository<br> | Drug: Eductyl suppository<br>* one suppository every morning during 21 days<br>|
| Placebo Comparator: Placebo suppository<br> | Drug: Placebo suppository<br>* placebo suppository every morning during 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation on VAS of intensity of symptoms |  | Day -7, 0, 3, 7, 10, 14, 17, and 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy on change symptoms and safety of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation |  | Day 0 and 21 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyschesia treatment, Rehabilitation, Dyschesia