linjc16/ctgov huggingface dataset:
The Role of Cobamamide Supplements in Malnourished Patients

Study Overview
=================
Brief Summary
-----------------
The trial is conducted to observe the effectiveness of cobamamide supplements in improving the clinical state malnourished patients.

Official Title
-----------------
The Role of Cobamamide Supplements in Malnourished Patients

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Drug: Adenosylcobalamin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 70 years old Diagnosis of malnutrition based on 2019 GLIM criteria Participant agree to join the trial by signing infomed consent. Exclusion Criteria: Malignancy (ECOG IV) and bowel obstruction Patients who unable to tolerate oral intake and in total parenteral nutrition Bowel disorder that caused severe malabsorbtion Patients who refuse to join the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The patient is given Cobamamide 2 x 3000 mg for 28 days. | Drug: Adenosylcobalamin<br>* The drug contains Cobamamide / Adenosylcobalamin with dose of 3000 mg.<br>* Other names: Cobazim 3000;|
| Placebo Comparator: Control<br>The patient is given placebo 2 x 1 capsule for 28 days. | Drug: Placebo<br>* The drug doesn't contain any properties or substances for treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Appetite | Using the Council on Nutrition Appetite Questionnaire to evaluate the appettite changes | 28 days | 
| Nutritional Status | Using the Subjective Global Asssessment form to assess the changes in nutritional status | 28 days | 
| Bioimpendance Analysis Result | Changes in Muscle Mass | 28 days | 
| Vitamin B12 (1) | Serum B12 Level | 28 days | 
| Vitamin B12 (2) | Methylmalonic Acid Level | 28 days | 
| Pre-albumin | Prealbumin Level | 28 days | 
| Laboratory result (1) | Serum ureum and creatinine level | 28 days | 
| Laboratory result (2) | ALT and AST level | 28 days | 
| Laboratory result (3) | Complete Blood Count | 28 days |
RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up

Study Overview
=================
Brief Summary
-----------------
The objective of the RELIEF Study is to compare the safety, effectiveness and patient experience outcomes in real-world subjects treated with different modalities for symptomatic BPH.

Official Title
-----------------
RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Device: UroLift System
* Other: Watchful Waiting or BPH Medications
* Device: Other Surgical Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of symptomatic BPH Exclusion Criteria: Prior surgical intervention for treatment of BPH Unable or unwilling to give informed consent or unwilling to complete all required questionnaires and follow-up assessments

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UroLift System<br>Therapy to be treatment with the UroLift System. | Device: UroLift System<br>* The UroLift System is a procedure that utilizes tiny implants to lift and hold the enlarged prostate tissue out of the way so it no longer blocks the urethra.<br>|
| Watchful Waiting or BPH Medications<br>Subjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications. | Other: Watchful Waiting or BPH Medications<br>* Subjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications.<br>|
| Other Surgical Intervention<br>Physician decides the best course of therapy to be a surgical intervention other than the UroLift System. | Device: Other Surgical Intervention<br>* Physician decides the best course of therapy to be a surgical intervention other than the UroLift System.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify responders of IPSS change | Change of >3 points in IPSS score from baseline to the 3 months post-treatment visit. | 3 months post-treatment visit |
US vs MRI for Stress Injuries

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to determine whether or not there is a correlation between MRI and ultrasound for the diagnosis of lower limb stress injuries. Patients that are seen at the University of Iowa Sports Medicine Center with a suspected diagnosis of a lower limb stress injury will be recruited. These patients will undergo a diagnostic ultrasound of the affected region prior to undergoing an MRI of that region. Then, the ultrasound findings will be compared to the MRI findings to determine if a correlation exists.

Official Title
-----------------
Correlation Between MRI and Ultrasound for Diagnosis of Lower Limb Bone Stress Injuries

Conditions
-----------------
Stress Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age 18-50 MRI confirmed tibial or metatarsal stress injury Exclusion criteria: -Prior history of stress fracture or fracture in the affected limb at the region of concern.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic Ultrasound<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| US correlation to MRI |  | 1 year |
Changes in Angle Kappa and Corneal Back Elevations After Laser in Situ Keratomileusis in Myopic Astigmatism

Study Overview
=================
Brief Summary
-----------------
Refractive errors and corneal astigmatism are associated with changes in angle kappa and corneal back elevation at the thinnest point in Pentacam. The purpose of this study is to track: The effect of anterior corneal astigmatism treatment on angle kappa and corneal back elevation.

Detailed Description
-----------------
This prospective observational study will be settled in Ain Shams University Hospital, Cairo, Egypt.

Official Title
-----------------
Changes in Angle Kappa and Corneal Back Elevations After Laser in Situ Keratomileusis in Myopic Astigmatism

Conditions
-----------------
Refractive Errors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myopic astigmatism Exclusion Criteria: Corneal scar

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases with high myopic astigmatism<br>Cases having myopic astigmatism more than 1.5 diopter | |
| Cases with not high astigmatism<br>Cases having astigmatism less than 1.5 diopter | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Track changes in angle kappa | Track changes in angle kappa with changes in corneal astigmatism | through study completion, an average of 2 years |
A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to look if the study drug, tirzepatide, gets into the breast milk and if yes, how long it takes the body to get rid of it. The study drug will be given as a single injection under the skin in healthy lactating females. For each participant, the total duration of the study will be approximately 8 weeks, including screening.

Official Title
-----------------
A Study to Evaluate Tirzepatide Concentrations in Breastmilk Following Administration of Single Dose of Tirzepatide by Subcutaneous Injection in Healthy Lactating Females

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Tirzepatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who are overtly healthy females as determined by medical evaluation Female participants who delivered normal-term infant (at least 37 weeks gestation) and are at least 6 weeks postpartum at the time of screening Body mass index (BMI) between 18.5 and 40.0 kilograms per meter squared (kg/m²), inclusive Female participants who has well-established lactation and is breastfeeding her infant. Note: Breastfeeding must be discontinued prior to the administration of tirzepatide on Day 1 and not resumed for the remaining duration of the study until a follow-up visit (or for total of 29 days after tirzepatide dosing for participants who discontinue early). Exclusion Criteria: Have a history of inadequate lactation (for multiparous females who have previously breastfed) Have confirmed type 1 or type 2 diabetes mellitus Regularly use known drugs of abuse or show positive findings on drug screen

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

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirzepatide<br>A single dose of tirzepatide administered subcutaneously (SC) | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve in Breast Milk From Zero to Infinity (AUC [0-∞]) of Tirzepatide | PK: AUC (0-∞) of Tirzepatide | Predose up to 30 days postdose |
Identification of Integrin ab Expression in Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
It has been reported that the expression rates of integrin αvβ3 and integrin αvβ5 in NSCLC are 89% and 100%, respectively. Among RGD (Arg-Gly-Asp) peptides, cRGDyK peptide (cRGD) known as integrin ανβ3 and ανβ5 antagonist has been widely used for targeting various cancers including NSCLC, glioblastoma, and colon carcinoma as well as prostate cancer. In this study, the investigators aim to analysis the expression of integrin ανβ3 in lung cancer patients.

Detailed Description
-----------------
Patient samples: From the Human Resource Bank of the Institute of Pathology, Korea University, the investigators collected paraffin-embedded tissue sections from 61 patients with NSCLC (adenocarcinoma =50, squamous cell carcinoma = 11) who had undergone surgical treatment for NSCLC at Korea University Guro Hospital between 2015 and 2018 under the IRB of Guro Hospital 2019GR0460. Samples were excluded when patients had undergone perioperative chemo- or radiotherapy. Among the tissues excised from lung cancer patients, lung cancer and normal tissue were classified as pathologically, defined as normal tissue and cancer tissue, and stained with an integrin ανβ3 primary antibody.

Official Title
-----------------
Identification of Integrin ab Expression in Lung Cancer Patients for Clinical Application of Cancer-Target Fluorescent Contrast Agent for Image-Induced Precise Lung Cancer Surgery

Conditions
-----------------
Expression of Integrin ανβ3 in Lung Cancer

Intervention / Treatment
-----------------
* Biological: Lung cancer types


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NSCLC (adenocarcinoma or squamous cell carcinoma) who had undergone surgical treatment for NSCLC at Korea University Guro Hospital between 2015 and 2018 Exclusion Criteria: patients had undergone perioperative chemo- or radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| lung cancer<br>adenocarcinoma and squamous carcinoma | Biological: Lung cancer types<br>* Cancer tissue matched to normal tissue, all from the same patient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| integrin expression level | Integrins expression level categorized to high and low | 20 months |
Exploring Brain Molecular Imaging and Blood Biomarkers in Subjects With Glucocerebrosidase Mutations: Toward a Precision Medicine Approach to Characterize Parkinson's Disease Clinical Trajectories

Study Overview
=================
Brief Summary
-----------------
Glucocerebrosidase (GBA) mutations are the most common risk factor for Parkinson's Disease (PD). GBA-related PD(GBA-PD) exhibits a more malignant phenotype as compared to no-carriers. Still, the mechanisms behind the increased malignancy in GBA-PD are not well understood. The definition of biomarkers able to stratify PD clinical trajectories in PD is therefore crucial to identify effective treatments and support diagnosis.The investigators will examine the role of GBA-mutations in accelerating a-synuclein (a-syn) and synaptic pathologies in PD by combining neuroimaging (positron emission tomography-PET), biochemical and clinical features. This will illuminate the pathophysiology underlying GBA-mutations in PD and identify biomarkers for the malignant PD phenotype. Also, the investigators will combine longitudinal clinical and imaging/biochemical features to define a prognostic algorithm for predicting disease faster progression in GBA-PD and monitoring disease trajectories in unaffected GBA carriers.

Official Title
-----------------
Exploring Brain Molecular Imaging and Blood Biomarkers in Subjects With Glucocerebrosidase Mutations: Toward a Precision Medicine Approach to Characterize Parkinson's Disease Clinical Trajectories

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Diagnostic Test: FDG-PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PD diagnosis according to MDS-PD criteria and for GBA-PD group, presence of heterozygous GBA mutations; disease duration 3-7years. Exclusion Criteria: other neurological or systemic diseases; presence of mutations in another PD gene; impossibility or unwillingness to perform FDG-PET.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: FDG-PET|Among other neuroimaging techniques, FDG-PET represents a unique tool to study the early metabolic alterations associated with neurodegeneration, both at the group and individual subject level.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FDG-PET to measure cerebral metabolism between Parkinson's subjects with a mutation in GBA gene (MP-GBA) compared to patients with idiopathic Parkinson's. | Differences in expression levels of posterior cerebral metabolism between Parkinson's patients with GBA mutation and idiopathic Parkinson's patients. | 3 years |
Assessing Factors in Tinnitus Patients' Clinical Study Experiences

Study Overview
=================
Brief Summary
-----------------
Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative. The goal is to identify the obstacles and challenges that prevent participation in tinnitus clinical studies, as well as the reasons for withdrawal or discontinuation. The insights gained from this study will ultimately benefit those with tinnitus who may be invited to participate in clinical research in the years to come.

Official Title
-----------------
Examining Variables Affecting Patient Participation in Clinical Trials for Tinnitus

Conditions
-----------------
Tinnitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with tinnitus Willing to comply with all study related procedures and assessments Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: No documented diagnosis of tinnitus Any other health problems that would prohibit safe participation in the study Pregnant or planning to become pregnant while enrolled in the study

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 tinnitus patients who decide to enroll in a clinical study |  | 3 months | 
| Rate of tinnitus patients who remain in a clinical study to completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tinnitus
Examining Clinical Research Participation for Substance Abuse Disorder Patient

Study Overview
=================
Brief Summary
-----------------
Clinical study participation percentages haven't always been fully representative of a given demographic. The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through. The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future substance abuse disorder patients during clinical trials.

Official Title
-----------------
Exploring the Clinical Trial Journey of Patients in Substance Abuse Disorder Clinical Trials

Conditions
-----------------
Substance Abuse Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed. Participant has a diagnosis of substance abuse disorder. Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. Exclusion Criteria: Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent. Pregnant or lactating woman Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results

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 substance abuse disorder clinical study. |  | 3 months | 
| Number of substance abuse disorder patients who remain in clinical trial until completion. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
substance abuse disorder
Swiss Childhood Health and Nutrition Survey 2023

Study Overview
=================
Brief Summary
-----------------
This study will repeat previous studies done in 2002, 2007 2012 and 2017/18, in order to monitor the trend in the prevalence of overweight and obesity in 6-12 year old children in Switzerland over the entire period. Furthermore, additional risk factors will be assessed for the later development of NCD using a questionnaire comparable to the one used in 2017/18.

Detailed Description
-----------------
A total of ca. 2500 children will be recruited throughout Switzerland and their height, weight, waist circumference as well as percentage body fat will be measured. In addition, children will be asked to complete a questionnaire on some aspects of their diet, physical activity, health and socioeconomic background. Data will be compared to previous surveys conducted since 2002 to monitor trends in overweight and obesity prevalence in Switzerland. The results from the questionnaire will be used to investigate risk factors for obesity and the later development of NCDs.

Official Title
-----------------
Swiss Childhood Health and Nutrition Survey 2023

Conditions
-----------------
Childhood Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 6 and 12 years Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- | --- |
| Prevalence of overweight and obesity | Based on weight and height measurements BMI-zscores will be calculated for the classification into the different weight status groups. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference | waist circumference in cm | baseline | 
| percent body fat | percent body fat as calculated from 4 skinfold thickness measures | baseline | 
| physical activity | Assessed using a questionnaire as hours per week | baseline | 
| Nutrition | Assessed using a food frequency questionnaire (never to several times a week) | baseline | 
| General health | Assessed using a questionnaire | baseline | 
| Parental education | Assessed using a questionnaire on a 5 item scale ranging from obligatory schooling (lowest rating) to university degree (highest rating) | baseline | 
| Country of birth | Assessed in a questionnaire | baseline |