linjc16/ctgov huggingface dataset:
Prospective Observational Study to Predict the Response of Biliary Tract Tumors to Immunotherapy

Study Overview
=================
Brief Summary
-----------------
A prospective, observational study to explore multidimensional biomarkers for predicting the efficacy of immunotherapy In biliary tract tumors

Detailed Description
-----------------
Patient with unresectable advanced or metastatic biliary tract tumors will be enrolled and plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment. To explore the biomarkers, tumor tissues, acquired from puncture biopsies at baseline, will be collected and investigated by genomic panel sequencing , transcriptome sequencing, and mIHC. Meanwhile, baseline peripheral blood and feces were also collected for detection of plasma proteins, genomes, and metagenomes. Finally, the investigators will analysis and explore predictive biomarkers of immunotherapy in biliary tract tumors.

Official Title
-----------------
Prospective Observational Study on Prediction of Response to First-line Immunotherapy in Patients With Biliary Tract Tumors

Conditions
-----------------
Biliary Tract Tumor, Cholangiocarcinoma

Intervention / Treatment
-----------------
* Other: Blood samples, tumor biopsy specimens will be collected


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old; Imaging evaluation indicates unresectable advanced or metastatic biliary tract tumors (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma); Confirmed as adenocarcinoma by histology; Has not received systemic therapy in the past (patients who have not progressed within six months after the completion of neoadjuvant therapy or adjuvant therapy can be enrolled); At least one measurable lesion according to RECIST 1.1 standard; Plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment; Sign informed consent, has good compliance and can cooperate with follow-up. Exclusion Criteria: Suffering from other active malignant tumors within 5 years or simultaneously; Unable to collect baseline plasma or tissue samples.

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 |
| --- | --- |
| Immunotherapy combined with chemotherapy<br> | Other: Blood samples, tumor biopsy specimens will be collected<br>* Blood samples, tumor biopsy specimens at baseline will be collected<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying predictive biomarkers of immunotherapy response | ldentifying predictive biomarkers of immunotherapy response by detecting differences in genome and transcriptome sequencing between responder and non-responder patients | 1 year |
FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype

Study Overview
=================
Brief Summary
-----------------
The aim of this interventional study is to investigate the correlation between Magnetic Resonance Phenotype and levels of FKBP51s protein pre and post surgery in adult patients affected by Glioblastoma

Official Title
-----------------
FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Diagnostic Test: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Diagnosis of Glioblastoma with surgery criteria Brain MRI with contrast both pre and post surgery Exclusion Criteria: No availability of radiological documentation Glioblastoma diagnosis not confirmed by Histological examination Withdrawal of ICF

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br> | Diagnostic Test: Blood sample<br>* Blood sample pre and post surgery to determine the level of FKBP51s protein<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between FKBP51s protein concentration in Blood Cells and Disease flow |  | 1 week | 
| Correlation between FKBP51s protein concentration in Blood Cells and Disease flow |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between FKBP51s protein concentration in Blood Cells and PDL1 expression, Brain MRI phenotype and survival |  | 1 year |
Nutritional Management of Post COVID-19 Cognitive Symptoms

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to learn about in brain fog complaints associated with long-COVID in people aged 22-50-years. The main questions it aims to answer are: the natural course of brain fog complaints the effect, if any of supplemental dietary oil on brain fog complaints Participants will be asked to undergo some brain testing (X-rays and questions. Treatments they'll be given will be one of two supplemental oils to consume daily. Researchers will compare outcomes in the two different oil groups to see if it has any effect on brain fog complaints.

Detailed Description
-----------------
Randomized placebo-control clinical trial comparing two types of nutritional oil and evaluating the impact, if any, on subjective complaints of long-COVID cognitive changes.

Official Title
-----------------
Nutritional Management of Post COVID-19 Cognitive Symptoms

Conditions
-----------------
Long COVID

Intervention / Treatment
-----------------
* Dietary Supplement: medium chain triglyceride oil
* Dietary Supplement: Safflower oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed COVID infection, at least 3 months previously, with ongoing cognitive complaints all other medical conditions stable, and on stable doses of medications (if required) Exclusion Criteria: COVID infection not confirmed by PCR or Rapid test unable to speak English pre-COVID cognitve complaints, and/or medical diagnoses affecting cognitive function

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 50 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
Interventional Model Description: Randomised placebo-controlled clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Medium chain triglyceride oil 15ml tid x 5 months | Dietary Supplement: medium chain triglyceride oil<br>* Medium chain triglyceride oil<br>|
| Placebo Comparator: Placebo<br>Safflower oil 15mls tid x 5 months | Dietary Supplement: Safflower oil<br>* Safflower oil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognigram(R) | computer-based cognitive test | 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment | Cognitive test | 12-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain fog; confusion; memory loss; functional decline
Ointment to Prevent Scar After Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate the efficacy and Safety of INV-001 administration for the prevention of scar after thyroidectomy. Participants will be asked to apply ointment on their scar for 12 weeks.

Detailed Description
-----------------
to evaluate the efficacy -investigator check POSAS and VSS

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of INV-001 Administration for the Prevention of Scar After Thyroidectomy

Conditions
-----------------
Scar

Intervention / Treatment
-----------------
* Drug: INV-001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who got thyroidectomy due to Thyroid cancer has scar longer than 3 cm Exclusion Criteria: have history about Keloid or Hypertrophic scar have infection on surgical site

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br>low dose ointment | Drug: INV-001<br>* Patient will be assigned to one of three arms.<br>|
| Experimental: High dose<br>high dose ointment | Drug: INV-001<br>* Patient will be assigned to one of three arms.<br>|
| Placebo Comparator: Placebo<br>same ingredient with active drug except API | Drug: INV-001<br>* Patient will be assigned to one of three arms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observer overall opinion of POSAS | POSAS POSAS: Patient Observer Scar Assessment Scale | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observer overall opinion of POSAS | POSAS: Patient Observer Scar Assessment Scale | 3, 6 weeks |
Radiological Evaluation of Sarcopenia in Patient Received Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Radiological evaluation of sarcopenia in patients receiving chemotherapy

Detailed Description
-----------------
Evaluation of muscle mass by using sonoelastography and computed tomography

Official Title
-----------------
Radiological Evaluation of Sarcopenia in Patient Received Chemotherapy

Conditions
-----------------
Sarcopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cancer patients receiving chemotherapy referred to radiodiagnosis department for routine examination Patients must be between 18 and Exclusion Criteria: Previous or current history of any musculoskeletal or neurological disorder including strokes. Systemic atrophy affecting CNS ( Huntington disease ,hereditary ataxia ,spinal muscular disorder and related syndromes ,post polio syndrome ) Central nervous system demyelinating disease ( Multiple sclerosis , acute disseminated demyelinated syndromes.. Corticosteroids undertaken currently or for the past 3 years with doses >5mg/day.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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 |
| --- | --- | --- |
| Radiological evaluation of sarcopenia in patients receiving chemotherapy | Using sonoelastography and computed tomography in evaluation of muscle mass in patients received chemotherapy by measurement of muscle thickness ,echogencity ,cross sectional area ,fasicle length,pennation angle, strain ratio,shear wave velocity | April 2025 |
Attitudes Towards Back and Back Pain in German-speaking Switzerland

Study Overview
=================
Brief Summary
-----------------
This research aims to assess the cross-cultural validity and reliability of the German version of the Back-PAQ (Back-PAQ_G) within the German-speaking Swiss population. The target population for this study includes individuals with and without back pain and primary care healthcare professionals. This includes physicians, physiotherapists, and nurses. The participants will be asked to fill out the Back-PAQ_G and similiar questionnaires online.

Official Title
-----------------
Assessing the Cross-cultural Validity and Reliability of the German Version of the Back Pain Attitudes Questionnaire (Back-PAQ_G) Within the German-speaking Swiss Population

Conditions
-----------------
Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living within the German-speaking part of Switzerland Exclusion Criteria: Insufficient German language skills

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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 |
| --- | --- | --- |
| Back Pain and Attitudes Questionnaire | The Back-PAQ_G contains 34 statements about the lower back and back pain that have to be rated as true, uncertain or false. Scores range from 34 to 170. The higher the score, the more unhelpful attitudes toward the back and back pain are present. Participants will receive the German version of the Back-PAQ (Back-PAQ_G). | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tampa Scale of Kinesiophobia | The TSK examines fear of movement and injury. The TSK applies to individuals with and without pain. The scores range from 11 to 44. A higher score on the completed questionnaire implies high kinesiophobia and an existing somatic focus. The participants of the study receive the German version of TSK-GV with eleven questions. | baseline | 
| Fear Avoidance Belief Questionnaire | The FABQ examines fear avoidance attitudes about the effect of work and activity on lower back pain. The questionnaire applies to individuals with low back pain. The maximum score is 96. A high score indicates a strong fear-avoidance posture for low back pain. Participants with current low back pain receive the validated German version of the FABQ with 16 questions. | baseline |
EXPERIMENTAL STUDY A.R.C.O. (CANCER CAREGIVER REMOTE ASSISTANCE)TELEHEALTH HOME MEDICATION VS/OUTPATIENT MEDICATION OF CENTRAL VENOUS CATHETER PICC (PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER)

Study Overview
=================
Brief Summary
-----------------
Cancer patients need central venous access according to the different types of chemotherapy and support drugs for their treatment path. The presence of a central vascular access brings mechanical issues, thrombotic and infectious complications that can undermine the patient's health and the life of the catheter, therefore the management of venous accesses is clinically relevant. The prevention of infections remains mainly based on correct hand washing and compliance with aseptic techniques. This is a multicenter intervention study is composed by a single experimental arm (home) and a calibration arm (outpatient). The study is designed to evaluate that the complication rate recorded in the two groups are similar.

Official Title
-----------------
EXPERIMENTAL STUDY A.R.C.O. (CANCER CAREGIVER REMOTE ASSISTANCE) TELEASSISTED HOME DRESSING VS/ OUTPATIENT DRESSING OF PICC CENTRAL VENOUS CATHETER (PERIPHERAL INSERTION CENTRAL VENOUS CATHETER)

Conditions
-----------------
Infections

Intervention / Treatment
-----------------
* Device: Caregiver operations with medication accessories
* Device: Nurse operations with medication accessories


Participation Criteria
=================
Eligibility Criteria
-----------------
Share patient choice availability at the patient's home at least once a week availability during on line appointment time with the tutor/video

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - home group<br> | Device: Caregiver operations with medication accessories<br>* After at least an initial outpatient medication (24/72 hours), home medication every 7 days (caregiver) for a total of 10 weeks.<br>|
| Active Comparator: Arm 2 - outpatient calibration<br> | Device: Nurse operations with medication accessories<br>* Outpatient medication every week (for a total of 10 weeks). Patients adhering to this arm will be followed at the IGAV nursing clinic of the IFOs.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | To compare the incidence of complications found in peripherally inserted central venous catheter (PICC) management in outpatient (calibration arm) vs home management to test the hypothesis that the incidence of catheter-related complications in the home management group is not higher than that observed in the outpatient group. | 10 weeks |
The Israeli Study for Islet Autoantibodies Screening in Families of Type-1 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
We aim at establishing a research program that will offer screening for the presence of Islet Autoantibodies (IA) in relatives of people with Type 1 Diabetes (T1D). Relatives of people with diabetes, children, and adults from our clinic and all over Israel will be offered to participate in the study. The presence of IA will be evaluated using the Detection by Agglutination-PCR (ADAP) technology developed by Enable Biosciences, which is 1,000-10,000 times more analytically sensitive than currently used methods.. When positive in the screening, multiple antibodies will be confirmed by a second sample analyzed by the ADAP technology and by a radio binding assay (RBA). People positive for one or more antibodies (stage 1 or 2 T1D) will be referred to attend an educational program at our center. This program will include diabetes education emphasizing DKA prevention as well as stress assessment for the families involved and stress alleviating interventions. After the educational visit, people at risk of developing diabetes will be referred to further follow-up and evaluation under routine medical care at our center.

Official Title
-----------------
The Israeli Study for Islet Autoantibodies Screening in Families of Type-1 Diabetes Patients

Conditions
-----------------
Type 1 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First degree family member (sibling or parent) of a known T1D patient Age 2-45 years Signing an informed consent Exclusion Criteria: Known diabetes of any kind (type 2, MODY) Have a previous history of being treated with insulin or oral diabetes medications. Currently be using systemic immunosuppressive agents (topical and inhaled agents are acceptable)

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Positive Islet Autoantibodies |  | Screening visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage 1 diabetes, stage 2 diabetes
Infections and Latent Autoimmune Diabetes in Adults

Study Overview
=================
Brief Summary
-----------------
Infections are proposed risk factors for type 1 diabetes in children. The investigators will examine whether a diagnosis of infectious disease also confers an increased risk of latent autoimmune diabetes in adults.

Detailed Description
-----------------
The investigators will use data from a population-based Swedish case-control study (ESTRID) with incident cases of LADA (n=597) and matched controls (n=2386). History of infectious disease are ascertained through national and regional patient registers. The investigators will estimate adjusted odds ratios (OR) with 95% CI for ≥1 respiratory (any/upper/lower), gastrointestinal, herpetic, other or any infectious disease episode, or separately, for 1 and ≥2 infectious disease episodes, within 0-1, 1-3, 3-5 and 5-10 years before LADA diagnosis/matching. Stratified analyses will be performed based on HLA risk genotypes and GADA levels.

Official Title
-----------------
Infections and Genetic Susceptibility in LADA and Type 2 Diabetes

Conditions
-----------------
Latent Autoimmune Diabetes in Adults, Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 35 years or older, residing in Scania or Uppsala county. Exclusion Criteria: Less than 35 years

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- |
| LADA<br>Classification of LADA based on age ≥35 years at diagnosis, GADA positivity (≥10 U/ml) and C-peptide concentrations of ≥0.2 nmol/L (IMMULITE) or ≥0.3 nmol/L (Cobas). | |
| Type 2 diabetes<br>≥35 years, GADA negative and C-peptide concentrations of &gt;0.60 (IMMULITE)/&gt;0.72 (Cobas) nmol/L. | |
| Controls<br>≥35 years, free of diabetes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LADA | ≥35 years at diagnosis, GADA positivity (≥10 U/ml) and C-peptide concentrations of ≥0.2 nmol/L (IMMULITE) or ≥0.3 nmol/L (Cobas). | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type 2 diabetes | also ≥35, GADA negative and had C-peptide concentrations of >0.60 (IMMULITE)/>0.72 (Cobas) nmol/L. | Up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Latent Autoimmune Diabetes in Adults, Infections, Diabetes Mellitus, Type 2 diabetes, Case-Control Studies, register study