linjc16/ctgov huggingface dataset:
Renal Colic and Urolithiasis in Poland

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyze the prevalence, effect on quality of life, and treatment-related behaviors for renal colic and urolithiasis in a population-representative sample of Poles. We will be using an Internet interview format for renal colic and urolithiasis evaluation. The study will include respondents representative for age and place of residence with adequate proportions of respondents from urban and rural areas.

Official Title
-----------------
Population-level Prevalence, Effect on Quality of Life, and Treatment Behavior for Renal Colic and Urolithiasis in Poland

Conditions
-----------------
Renal Colic, Urolithiasis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - consent to participate Exclusion Criteria: - lack of consent to participate

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Population-level and representative cohort<br> | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of renal colic and urolithiasis in Poland | Prevalence of renal colic and urolithiasis in Poland | December 2023 - December 2024 |
Exploring Engagement Dynamics Among Individuals Impacted by Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
The study seeks to delve into the firsthand experiences of patients diagnosed with bladder cancer who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. By joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future bladder cancer patients and play an active role in advancing medical research.

Official Title
-----------------
Participation Trends in Bladder Cancer Clinical Trials - Exploring Engagement Dynamics Among Individuals Impacted by Bladder Cancer

Conditions
-----------------
Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has self-identified as planning to enroll in a clinical trial Patient has been diagnosed with bladder cancer Patient is a minimum of 18 years or older Exclusion Criteria: Patient does not understand, sign, and return consent form Inability to perform regular electronic reporting Patient is pregnant

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 |
| --- | --- | --- |
| Number of patients who decide to participate in a bladder cancer clinical research |  | 3 months | 
| Rate of patients who remain in bladder cancer clinical research to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bladder cancer
Ultrasound-guided Genicular Nerves Block

Study Overview
=================
Brief Summary
-----------------
Most of arthroscopic ACL repairs are day case surgeries associated with moderate postoperative pain and discomfort. So , finding an effective and safe, analgesic technique with minimal complications is our goal for fast recovery and short hospital stay. in this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.

Detailed Description
-----------------
In this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.

Official Title
-----------------
US-guided Genicular Nerves Block for Pain Control After Arthroscopic Anterior Cruciate Ligament Repair: A Prospective, Double Blinded, Randomized Controlled Study

Conditions
-----------------
Genicular Nerve Block for Pain in ACL Arthroscopy

Intervention / Treatment
-----------------
* Procedure: Genicular Nerves Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both genders age 18 - 65 ASA i, ii, iii Exclusion Criteria: ROM less than 90 advanced renal or liver diseases patient refusal substance abuse site infection known sensitivity to any of study drugs

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Genicular Nerves Block
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: genicular nerve block group<br>patients will receive genicular nerves block | Procedure: Genicular Nerves Block<br>* US guided genicular nerves block<br>|
| No Intervention: control group<br>patients will not receive genicular nerves block | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative VAS | vas score | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total morphine consumption | morphine onsumpton | 24 hours | 
| time to first morphine analgesia | rescue analgesia | 24 hours | 
| range of motion | rom | 24 hours | 
| post operative MAP | map | 24 hours |
The Effectiveness of Continuous Ketamine Infusion (KONTINUE)

Study Overview
=================
Brief Summary
-----------------
There are different treatment for chronic pain. One possible treatment is intravenous infusions of ketamine.

Detailed Description
-----------------
Ketamine continuous intravenous infusion for 4 days in Hospital with 0.5 mg/kg/day associated with Magnesium Sulfate 1000mg/day. Evaluation schedules will be performed at day 15,30 and 60.

Official Title
-----------------
Effectiveness of Continuous Ketamine Infusion Associated With Magnesium Sulfate for Management of Patient With Chronic Pain : a Prospective Observational Study

Conditions
-----------------
Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Pain lasting for more than six months without contraindication to treatment Exclusion Criteria: Inability to give consent Severe psychiatric disorder

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 |
| --- | --- | --- |
| Long-term effectiveness | Improvement of the numerical scale - score 0 to 10 - 10 is the worst | 1 month | 
| Long-term effectiveness | Clinical Global Impression of Change (CGI-C) - score 1 to 7 - 7 is the worst | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | Neuropathic Pain Symptom Inventory (NPSI) - score 0 to 10 - 10 is the worst | 15, 30, 60 days | 
| Variation of quality of life | Short Form 12 health survey | 15, 30, 60 days | 
| Variation of quality of life | Hospital Anxiety and Depression scale - score 0 to 21 - 21 is the worst | 15, 30, 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Neuropathic pain, Chronic pain, Fibromyalgia, Musculoskeletal diseases
Cutaneous Sensory Block Area of the Laparoscopic Assisted Transversus Abdominis Plane Block

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to assess the size and location of cutaneous sensory block area after dual laparoscopic assisted transverse abdominis plane block (L-TAP) with ropivacaine in patients undergoing laparoscopic cholecystectomy. L-TAP is applied as a medial subcostal infiltration between midclavicular and central sternal lines and a lateral subcostal infiltration between midclavicular and anterior axillary line bilaterally.

Official Title
-----------------
Cutaneous Sensory Block Area of the Laparoscopic Assisted Transversus Abdominis Plane

Conditions
-----------------
Cholecystolithiasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing elective laparoscopic cholecystectomy in a day surgery setting able to give oral and written consent Exclusion Criteria: prior surgery to the upper abdominal wall known sensory deficits of the abdominal wall or thorax allergy to local anesthetics pregnancy

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 |
| --- | --- | --- |
| Cutaneous Sensory Block Area (CSBA) | Assessment of the CSBA was done within the duration of the cutaneous sensory effect of the laparoscopic transverse abdominis plane block. A gauze dipped in alcohol was tapped on the skin of the abdominal wall from the midsagittal line using a star-shaped approach with its center at the umbilicus to indicate cutaneous sensory changes in cold perception. Changes were marked on the skin, confirmed twice, and a connecting line drawn to determine the CSBA. The was size of the CSBA was calculated, and the location (supraumbilical or infraumbilical and medially or laterally to a vertical line through the anterior superior iliac spine. | 1.5 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transversus abdominis plane block
Turkish Version of Multidimensional Outcome Expectations For Exercise Scale (MOEES

Study Overview
=================
Brief Summary
-----------------
The Multidimensional Outcome Expectations For Exercise Scale (MOEES) was developed to assess the multidimensional outcome expectations of exercise. The Turkish validity and reliability study of the scale, originally in English, has not been conducted before. The aim of this study is to develop the Turkish version of the Multidimensional Outcome Expectations For Exercise Scale (MOEES), and to report its reliability assessment.

Detailed Description
-----------------
The Turkish version of The Multidimensional Outcome Expectations For Exercise Scale (MOEES) will be asked face to face with patients diagnosed with cardiac disease.

Official Title
-----------------
Investigation of the Validity and Reliability of the Turkish Version of Multidimensional Outcome Expectations For Exercise Scale (MOEES)

Conditions
-----------------
Health Care Acceptor Health Knowledge, Attitudes, Practice Patient Participation

Intervention / Treatment
-----------------
* Other: validity and reability study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years. Be diagnosed with heart disease. Having at least one of the cardiac risk factors (hypertension, diabetes mellitus, hyperlipidemia/dyslipidemia, overweight or obesity (BMI>25), physical inactivity (less than 150 minutes of moderate-intensity exercise per week). To agree to participate in the study. Being able to write and speak in Turkish. Exclusion Criteria: < 18 years. Lack of cooperation. No heart disease. Mental retardation.

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 |
| --- | --- |
| patients diagnosed with cardiac disease<br> | Other: validity and reability study<br>* Validity and reliability assessment of the Turkish version of the Multidimensional Outcome Expectations For Exercise Scale (MOEES).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability and Validity of MOEES by Correlation Analysis. | with MOEES will be researched | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tampa Scale of Kinesiophobia for Heart | The kinesiophobia levels of the patients will be evaluated. | 6 months | 
| International Physical Activity Questionnaire | The physical activity levels of the patients will be evaluated. | 6 months |
A Global Prospective Observational Registry of Patients With Pompe Disease

Study Overview
=================
Brief Summary
-----------------
This is a global, multicenter, prospective, observational registry of patients with Pompe disease, including those with late-onset pompe disease (LOPD) and infantile-onset pompe disease (IOPD). Both untreated patients and those being treated with an approved therapy for Pompe disease are eligible to participate. The objectives of the registry are: To evaluate the long-term safety of Pompe disease treatments through collection of data that describe the frequency of adverse events (AEs)/serious adverse events (SAEs) occurring in Pompe disease patients To evaluate the long-term real-world effectiveness of Pompe disease treatments To evaluate the long-term real-world impact of Pompe disease treatments on quality of life (QOL) and patient-reported outcomes (PROs) To describe the natural history of untreated Pompe disease

Official Title
-----------------
A Global Prospective Observational Registry of Patients With Pompe Disease

Conditions
-----------------
Pompe Disease

Intervention / Treatment
-----------------
* Biological: Cipaglucosidase alfa
* Drug: Miglustat
* Biological: Alglucosidase alfa or Avalglucosidase alfa
* Other: Untreated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of LOPD or IOPD based on documented deficiency of GAA enzyme activity and/or GAA genotyping Exclusion Criteria: Patients who are currently receiving investigational therapy for Pompe disease in a clinical trial, a compassionate use program, or an expanded access program (EAP)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cipaglucosidase alfa/Miglustat-treated patients<br> | Biological: Cipaglucosidase alfa<br>* Enzyme Replacement Therapy (ERT) via intravenous infusion<br>* Other names: ATB200, Pombiliti;Drug: Miglustat<br>* Participants received ATB200 co-administered with AT2221 (Miglustat)<br>* Other names: AT2221, Opfolda;|
| Other Enyzme Replacement Therapy (ERT)-treated patients<br> | Biological: Alglucosidase alfa or Avalglucosidase alfa<br>* Patients prescribed other commercially available ERT after local regulatory approval<br>* Other names: Myozyme, Lumizyme, Nexviazyme, Nexviadyme;|
| Untreated patients (those who are not currently receiving any medical therapy for Pompe disease)<br> | Other: Untreated<br>* Patients who are not currently receiving any medical therapy for Pompe disease.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety | Data that describe the frequency of AEs/SAEs occurring in Pompe disease patients | 5 years |
Effect of Compound Amino Acid Tablets on Nutritional Status of Patients With Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To investigate whether compound amino acid supplementation can further promote protein synthesis and improve nutritional status for lung cancer patients.

Official Title
-----------------
Effect of Compound Amino Acid Tablets on Nutritional Status of Patients With Lung Cancer

Conditions
-----------------
Amino Acid Deficiency, Malnutrition, Lung Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: amino acid tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NRS2002 >=3 scores lung cancer patients low albumin or hemoglobin informed consent Exclusion Criteria: Acute and critical patients; Severe liver and kidney dysfunction; Patients with gastrointestinal bleeding or intestinal obstruction; Pregnant women, lactating women, people with mental illness, and people without independent behavior ability.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>compound amino acid supplement | Dietary Supplement: amino acid tablet<br>* multiple essential amino acids supplements<br>|
| Placebo Comparator: control group<br>placebo | Dietary Supplement: amino acid tablet<br>* multiple essential amino acids supplements<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of albumin |  | after 42 days after the intervention |
A Close Examination of Patient Experiences in Cluster Headache Clinical Research

Study Overview
=================
Brief Summary
-----------------
Historically, participation in clinical studies is highly skewed towards particular demographic groups of people. This research will invite several participants to gather a wide range of information on clinical trial experiences for cluster headache patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of cluster headache. The data collected from this study will help improve future outcomes for all cluster headache patients as well as those in under-represented demographic groups.

Official Title
-----------------
An Observational Study Assessing the Experience of Patients Undergoing Active Cluster Headache Clinical Trials

Conditions
-----------------
Cluster Headache

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has been diagnosed with cluster headache Patient has access to a home internet connection in order to provide regular updates through the course of the study Participant must be 18 years of age or older Exclusion Criteria: Patient has an ECOG score of 4 or higher Patient is not able to provide consistent digital updates as per study requirements Patient does not complete or agree to terms outlined in the Informed Consent Form

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 |
| --- | --- | --- |
| Rate of patients who decide to enroll in a cluster headache clinical study. |  | 3 months | 
| Number of cluster headache patients who remain in clinical research until completion. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cluster Headache
HS2 US Liver Reader Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to to assess the ability of 5 Gastro-Intestinal (GI) surgeons, within liver surgery, the readers, to identify pre-defined anatomical landmarks in liver images processed by HS2, and assessment of landmark distance between CT and Holographic visualization (HV).

Detailed Description
-----------------
This is a retrospective investigation of Computer Topographies (CTs)/ Holographic visualization based on CTs retrieved from patients with metastases in the liver from colorectal cancer. The study consists of: Preparations at Day 0. The reader is not involved in the preparation Using of HS2 and evaluation at Day 1-2 Calculation at Day 3. The study will enroll eligible subject's images.

Official Title
-----------------
HS2 US Liver Reader Study

Conditions
-----------------
Reader Study

Intervention / Treatment
-----------------
* Device: Holocare Studio 2 (HS2)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Livers with colorectal cancer liver metastasis CTs from individuals 22 years or older CTs retrieved from US hospitals CTs from patients treated in the US At least 1 visible liver lesion to complete detection of L1 Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| Readers<br>5 trained GI surgeons within liver surgery (the readers) will identify pre-defined anatomical landmarks in liver CT images that have been processed by HS2 | Device: Holocare Studio 2 (HS2)<br>* 3D HV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of all pre-defined landmarks. | All readers able to identify all pre-defined landmarks. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between CT and HV distance. | Comparison between CT and HV distance in mm between a marker in a defined center of each portal landmark (difference less than 8.0 mm). | 3 days | 
| Comparison of image quality between CT and HV. | Comparison of image quality between CT and HV on a 5-graded scale (1=HV significantly poorer quality than CT, 2=HV somewhat poorer quality than CT, 3=HV as good as CT, 4=HV somewhat better than CT, 5=HV significantly better than CT). More than 50% should be scored as HV as good as CT or better. All five readers scoring 3 or higher. | 3 days | 
| Evaluate ease of use. | Evaluate ease of use on a 5-graded scale (1=very difficult, 2=difficult, 3=neither difficult nor easy, 4=easy, 5=very easy). All five readers scoring 4 or 5. | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Holographic visualization