linjc16/ctgov huggingface dataset:
Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Non-cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for non-cardiac surgery.

Official Title
-----------------
Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Non-Cardiac Surgery

Conditions
-----------------
Knee Disease, Prostate Cancer, Spine, Open, Hip Osteoarthritis

Intervention / Treatment
-----------------
* Biological: fresh frozen plasma
* Biological: prothrombin complex concentrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing spine surgery, open radical prostatectomy, hip arthroplasty, knee arthroplasty Exclusion Criteria: oral anticoagulants, warfarin

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fresh frozen plasma<br>according to the Thromboelastography (TEG) test, CK r-time prolongation, fresh frozen plasma transfusion (FFP) is performed | Biological: fresh frozen plasma<br>* transfusion of fresh frozen plasma<br>|
| Experimental: prothrombin complex concentrate<br>according to the Thromboelastography (TEG) test, CK r-time prolongation,prothrombin complex concentrate (PCC) administration | Biological: prothrombin complex concentrate<br>* prothrombin complex concentrate administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration from the time diagnosing r-time prolongation to the time achieving bleeding control |  | 1 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red Blood Cell amount | Red Blood Cell transfusion amount during surgery | 1 hour | 
| FFP amount | FFP transfusion amount during surgery | 1 hour | 
| Platelet amount | Platelet transfusion amount during surgery | 1 hour | 
| r-time | CK r-time after PCC or FFP | 10 min | 
| CRT-MA | CRT-MA after PCC or FFP | 10 min | 
| CFF-MA | CFF-MA after PCC or FFP | 10 min | 
| Bleeding | Postoperative bleeding amount | 6 hour | 
| oxygenation profile | PaO2/FiO2 ratio | 1 hour |
HRAD-Vascular Access

Study Overview
=================
Brief Summary
-----------------
The perioperative setting is a common site of pediatric anxiety and distress. Perioperative anxiety in pediatric patients can result in uncooperative behavior, poor postoperative outcomes, and trauma. Given the fast-paced nature of the perioperative environment, many anxiety measures are too time consuming for clinical implementation prior to surgery. Pediatric anesthesiologists need reliable and efficient assessment tools to quickly measure childhood distress to target prophylactic and therapeutic interventions.

Official Title
-----------------
Validation of a Novel Anxiety Scale (HRAD) During Vascular Access Procedures

Conditions
-----------------
Anxiety, Vascular Access

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants who is undergoing vascular access Exclusion Criteria: Clinically unstable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vascular Access<br>Patients undergo vascular access procedure. | Other: No intervention<br>* There will be no intervention apply to study participants.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of HRAD± to mYPAS during vascular access procedure | Correlation between HRAD and mYPAS was assessed by using Fleiss' Kappa. HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation. mYPAS contains 5 items (activity, vocalisation, emotional expressivity, state of apparent arousal, and use of parent). The total score ranges from 0 to 22. Higher scores mean higher levels of anxiety. | during vascular access procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of HRAD± to OBDS-R during vascular access procedure | Correlation between HRAD and mYPAS was assessed by using Fleiss' Kappa. HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation. OSBD-R contains 8 items (information seeking, crying, screaming, restraint, verbal resistance, emotional support, verbal pain, flail) | during vascular access procedure |
Metabolic Effects of Early Time-restricted Carbohydrate Consumption

Study Overview
=================
Brief Summary
-----------------
In this clinical trial, the investigators aim to examine the impact of a 12-week early time-restricted carbohydrate consumption diet on weight loss and glucose metabolism in patients with overweight/obesity and type 2 diabetes

Official Title
-----------------
Effects of Early Time-restricted Carbohydrate Consumption on Weight Loss and Glucose Homeostasis in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2, Obesity, Nutrition, Healthy, Weight Loss

Intervention / Treatment
-----------------
* Behavioral: eTRC diet
* Behavioral: Control diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-75 years both males and females type 2 diabetes Exclusion Criteria: type 1 diabetes insulin treatment pharmacological treatment for weight loss pregnancy other acute or chronic conditions influencing body weight and glucose metabolism

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eTRC diet<br> | Behavioral: eTRC diet<br>* 12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) focusing on the distribution of macronutrients within the day so as to avoid carbohydrate consumption after lunch<br>|
| Active Comparator: Control diet<br> | Behavioral: Control diet<br>* 12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) without any recommendations on the distribution of macronutrients within the day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Change in plasma levels of glycated hemoglobin | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance | Glucose tolerance will be measured as the area under the curve of plasma glucose levels in response to a 180-minute mixed meal tolerance test (MMTT) | 12 weeks | 
| Body weight loss | Change in body weight | 12 weeks |
Molecular Characterization of Penile Cancers in Developing Countries

Study Overview
=================
Brief Summary
-----------------
This study explores penile squamous cell carcinoma (PSCC) in Brazil, a rare cancer associated with factors like poor hygiene and HPV infection, using next-generation sequencing to investigate its genomic profiles in 24 deceased patients with advanced PSCC.

Detailed Description
-----------------
This study focuses on penile squamous cell carcinoma (PSCC), a rare cancer that is more prevalent in underdeveloped regions such as Africa, Asia, and South America, with Brazil having one of the highest incidence rates due to socioeconomic factors. PSCC is primarily associated with risk factors like poor local hygiene, smoking history, phimosis, and human papillomavirus (HPV) infection. The research aims to understand the genomic profiles of PSCC and their correlation with clinical characteristics, particularly in circumcised vs. non-circumcised populations in Brazil. The study will employ next-generation sequencing (NGS) on tumor specimens from 23 deceased patients with advanced PSCC who received treatment in Brazilian cancer sites.

Official Title
-----------------
Molecular Characterization of Penile Cancers in Developing Countries

Conditions
-----------------
Penile Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men ≥ 18 years of age; Diagnosis of locally advanced or metastatic squamous-cell penile carcinoma; Have received at least one treatment for advanced disease (surgery, radiotherapy and/or chemotherapy); Available representative tumor block of formalin-fixed and paraffin-embedded (FFPE) archive, from primary or metastasis; Patients must be already deceased at time of data collection. Exclusion Criteria: Patients without medical record available (lost, empty or irretrievable clinical information).

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

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

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 |
| --- | --- | --- |
| Biomarker Profiling of Penile Carcinoma by NGS | The study employs state-of-the-art molecular analysis methods, including next-generation sequencing (NGS) using a targeted panel (FoundationONE CDx) that assesses 324 genes. | Through study completion, an average of 2 years |
An Observational Study of Subcutaneous Infusion of ABBV-951 to Assess Change in Disease Activity and Adverse Events In Adult Japanese Participants With Advanced Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Parkinson's disease (PD) is a neurological condition, which affects the brain. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to assess how safe and effective ABBV-951 is in treating participants with Parkinson's disease in real world setting. ABBV-951 is an approved drug being developed for the treatment of PD in Japan. Approximately 250 adult participants over 15 years with a diagnosis of PD who are prescribed ABBV-951 by their physicians will be enrolled in this study across Japan. Participants will receive ABBV-951 as prescribed their physician and followed for 52 weeks. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.

Official Title
-----------------
A Post-marketing Observational Study for ABBV-951 in Patients Diagnosed With Advanced Parkinson's Disease (aPD)

Conditions
-----------------
Parkinson's Disease (PD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with advanced Parkinson's disease (aPD). Prescribed ABBV-951 as physicians' decision according to the approved label for treatment of aPD. Given informed consent (or by her/his legal representative, if it's a requirement from the participating hospital/clinic) for participating this study. Exclusion Criteria: Prior treatment with ABBV-951 for PD. Currently participating in interventional clinical trials.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| ABBV-951<br>Participants will receive ABBV-951 as prescribed by their physician. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing Infusion Site Infections | Percentage of participants with infusion site infections following the commencement of ABBV-951 will be assessed. | Up to 52 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease (PD), advanced Parkinson's disease (aPD), ABBV-951
Promotion of Healthy Eating Behaviors in Type 2 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
Intervention designed to promote healthy eating in patients with type 2 diabetes.

Official Title
-----------------
Promotion of Healthy Eating Behaviors in Type 2 Diabetes Patients

Conditions
-----------------
Healthy Lifestyle, Diabetes

Intervention / Treatment
-----------------
* Behavioral: Healthy eating


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age Type 2 diabetes Poor dietary habits Exclusion Criteria: Micro and macro-vascular complications Poor glycemic control Food allergy

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Healthy eating<br>* Promotion of healthy eating<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma triglycerides | Plasma triglycerides (mmol/L) assessed using chemistry kits on an analyzer platform | Before - 16 weeks | 
| Change in blood glucose | Plasma blood glucose (mmol/L) assessed using chemistry kits on an analyzer platform | Before - 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in waist circumference | Waist circumference in cm assessed using steel tape | Before - 16 weeks |
Pediatric Relapsing Polychondritis : Diagnosis and Management in a French Retrospective Study

Study Overview
=================
Brief Summary
-----------------
The incidence in pediatrics is very low (about 3.5 per million per year according to a 2015 study) and therefore the data on the pathology very poor, especially on the therapeutic level. Without appropriate treatment, the disabling sequelae, even involving the vital prognosis, are significant. However, in paediatrics, therapeutic habits have been extrapolated from adult data and lack precision. Existing treatments are almost composed of immunomodulatory and/or immunosuppressive treatments. Different therapeutic lines have been introduced over the years and a better understanding of the pathology. More recently, biotherapies have been introduced in this pathology, but data on their effectiveness remain limited. Data on the evolution under therapy in children are thus still poor. Complications related to the pathology that can jeopardize the vital prognosis and the response to treatment for this pathology deserve to be studied in order to be known and if possible avoided. The aim of the study is to describe French practices and compare the lines of treatment proposed for juvenile atrophic polychondritis.

Official Title
-----------------
Pediatric Relapsing Polychondritis : Diagnosis and Management in a French Retrospective Study

Conditions
-----------------
Relapsing Polychondritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Minor subject aged 1 to 17 years Diagnosis of atrophic polychondritis between 01/01/2008 to 31/12/2022. Subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research. Exclusion criteria: Subject (or his parents) having expressed his (their) opposition to participating in the study Associated pathologies that cannot be related to the diagnosis of atrophic polychondritis and whose prognosis can lead to biases in the efficacy and/or complications related to treatments.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 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 |
| --- | --- | --- |
| Therapeutic effectiveness of the various treatments proposed depending on the degree of initial clinical involvement | The aim of this study is to bring together the experiences of the various reference and competence centers in France concerning the clinical presentation, management and follow-up of children with relapsing polychondritis. | Files analysed retrospectively from from January 01, 2008 to December 31, 2022 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polychondritis, Relapsing Polychondritis, Pediatric Relapsing Polychondritis
Fib to Alb Ratio in Type 2 Dkd

Study Overview
=================
Brief Summary
-----------------
Aimed to investigate the association of fibrinogen to albumin ratio (FAR) with DKD type 2 and to prove its possible role as a novel biomarker to predict and prevent DKD progression.

Detailed Description
-----------------
Diabetic kidney disease (DKD) is the most prevalent chronic kidney disease. Around 3540% of patients with type 2 diabetes mellitus (T2DM) will go on to develop DKD. DKD is characterized by albuminuria and reduced estimated glomerular filtration rate (eGFR), both of which are independent risk factors for end-stage kidney disease (ESKD), cardiovascular events, and death. DKD accounts for a significant increase in mortality among diabetic patients and is a grave threat to their clinical outcome. Inflammation plays a major role in the development of DKD. Serum fibrinogen (FIB) is a biomarker of coagulation and inflammation. Elevated serum FIB is an independent risk factor of DKD progression to ESKD in patients with T2DM. Albumin (ALB) has anti-inflammatory functions and antioxidant properties. Hypoalbuminemia is associated with a poorer renal prognosis in patients with T2DM and DKD. Fibrinogen to albumin ratio (FAR) is a more significant prognostic marker than each single marker itself in cancer study.

Official Title
-----------------
Fibrinogen to Albumin Ratio (FAR) as a Risk Factor for Type 2 Diabetic Nephropathy(DN)

Conditions
-----------------
CKD, Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 yrs. 50 Pts with type 2 DM that have DKD (presence of albuminuria in association with diabetic retinopathy) and 50 pts with type 2 DM but have no DKD. Exclusion Criteria: Age below 18 yrs. Pts with ESKD, manifested cardiac valvular disease, acute infection, history of hepatitis, pts with DKA and Cancer. Pt who refused to contribute in this study

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association of fibrinogen to albumin ratio (FAR) with DKD type 2. | investigate the association of fibrinogen to albumin ratio (FAR) with DKD type 2. | baseline |
MESNA Injection for TMJ Internal Derangement

Study Overview
=================
Brief Summary
-----------------
The pathogenesis of temporomandibular disorders focusing on the biochemistry of the synovial fluid in various stages of temporomandibular joint disease. The role of inflammation has been investigated and proposed as an underlying mechanism of pain and dysfunction of temporomandibular joint. MESNA (sodium 2-mercaptoethanesulfonate) was approved several years ago and marketed in several formulations as a mucolytic agent in the respiratory field, since it breaks the disulfide bonds between polypeptide chains of mucus. The tissue distribution of MESNA is negligible, and the elimination of the substance is rapidly and completely achieved by kidney

Official Title
-----------------
Treatment of Temporomandibular Joint Internal Derangement Using MESNA Injection

Conditions
-----------------
TMJ Disorder

Intervention / Treatment
-----------------
* Drug: Mesna Injection
* Drug: Arthrocentesis with ringer solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with TMJ internal derangement with reduction Exclusion Criteria: inflammatory or connective tissue disease autoimmune disease history neurologic problems
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-articular injection with MESNA solution<br>1 ml of MESNA will be injected intra-articular | Drug: Mesna Injection<br>* 1 ml of MESNA will be injected using 20-guage needle in he upper compartment of TMJ in patient with internal derrangement.<br>|
| Active Comparator: Arthrocentesis with ringer solution<br>ringer solution will be used for arthrocentesis | Drug: Arthrocentesis with ringer solution<br>* Two 20-gauge needles will be placed into upper joint space as entry and exit points for washing.The arthrocentesis will be performed with 100 ml of lactated Ringer's solution to eliminate the inflammatory mediators present in the synovial fluid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal interincisal opening (MIO) | a digital caliper will be employed to measure the maximum interincisal opening pre and postoperative | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint pain | pain will be assessed on a visual analogue scale (VAS) with a score between 0 and 10, 0 means no pain and 10 means severe pain | 6 months | 
| clicking sound | yes or no questionnaire,yes mean clicking is present and no means clicking disappeared | 6 months |