linjc16/ctgov huggingface dataset:
Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to learn about clinical application of pathogenic metagenomic next-generation sequencing to optimize the diagnosis of infection in decompensated cirrhotic patients. The main questions it aims to answer are: mNGS testing in optimizing anti-infective drug use in patients with acute decompensation, including response to empiric antibiotic therapy. Proportion of patients with re-compensation. The positive rate of mNGS in patients with acute decompensated cirrhosis and the characteristics of pathogen.

Official Title
-----------------
Clinical Application of Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection: a Multicenter, Prospective Study

Conditions
-----------------
Cirrhosis, Liver

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old. Diagnosis of cirrhosis, previously known or not, of any etiology, histologically proven or not. Acute decompensation: ascites, digestive hemorrhage or hepatic encephalopathy. Exclusion Criteria: Age > 80 years old. Malignancy of liver or other organs (including leukemia). Receiving immunosuppressive agents for non-hepatic diseases. HIV infection.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| patients received mNGS test<br>After enrolment, patients will receive mNGS test. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive rate of mNGS test in AD patients |  | at enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28- and 90-day transplantation-free mortality |  | at 28-day and 90-day after enrolment | 
| The rate of development of acute kidney injury and acute-on-chronic liver failure |  | up to 12 weeks | 
| Proportion of hospital readmissions due to infections |  | up to 12 weeks | 
| Proportion of progression to SIRS or sepsis |  | up to 12 weeks | 
| Consistency with blood culture results | Concordance of mNGS With Other traditional Testing on Pathogens | at enrollment |
Compassionate Use of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy

Study Overview
=================
Brief Summary
-----------------
The program is to provide access to an experimental drug called pozelimab and to document the long-term safety of pozelimab in patients with Protein-Losing Enteropathy (PLE). CD55-deficient PLE/CHAPLE disease is a rare inherited disease of the immune system. This can be a life-threatening condition that is usually found when patients are children.

Official Title
-----------------
An Open-Label, Expanded Access Program of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy (CHAPLE Disease)

Conditions
-----------------
CD55-Deficient Protein-Losing Enteropathy

Intervention / Treatment
-----------------
* Drug: Pozelimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Clinical diagnosis of CD55-deficient PLE/CHAPLE disease (based on a history of PLE), confirmed by biallelic CD55 loss-of-function mutation detected by genotype analysis (frameshift, nonsense mutations) as defined in the protocol Written informed consent from parent/guardian for minor patients Written assent from minor patients as appropriate (eg, above the age of 6 years or the applicable age per local regulatory requirements) Key Exclusion Criteria: Patients who discontinued the prior pozelimab study due to safety or lack of efficacy Considered by the treating physician as inappropriate for this program for any reason as defined in the protocol NOTE: Other protocol defined inclusion / exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pozelimab|Subcutaneous (SC) administration|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Characteristics of Injury Claims by Chronic Pain Patients

Study Overview
=================
Brief Summary
-----------------
Chronic pain is associated with injuries and disabilities. This prospective observational study explores the injury or disability claims made by chronic pain patients. It evaluates the socio-demographics of the patient population. It explores the impact of pain clinic services on the patients' injury rehabilitation, insurance claim outcome, and socioeconomic situation.

Detailed Description
-----------------
Chronic pain is associated with injuries, disabilities, psychological disorders, and unemployment. Chronic pain patients usually make insurance claims for injury, disability, and unemployment. This prospective observational study explores the injury, disability, and compensation claims made by chronic pain patients. The study evaluates the socio-demographics of the patient population; including their gender, age, ethnicity, occupation, employment status, income, education level, family status, and home location. It explores the impact of pain clinic services on the patients' injury rehabilitation course, insurance claim outcome, and socioeconomic situation.

Official Title
-----------------
Socio-demographics of Injury Insurance Claims by Chronic Pain Patients

Conditions
-----------------
Social Functioning, Chronic Pain, Injuries, Disabilities Multiple

Intervention / Treatment
-----------------
* Behavioral: Behavioral and supportive therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult chronic pain patients patients with injury claim Exclusion Criteria: pediatric patients patients without injury claim

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 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 |
| --- | --- |
| Adult chronic pain patients<br>Adult chronic pain patients who received pain management | Behavioral: Behavioral and supportive therapy<br>* Behavioral and supportive therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who had injury insurance claims approved | Percentage of patients with successful insurance claim approval | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Injury Claim, Disability Claim
Study on the Quantitative Assessment of the Risk of Hepatocellular Carcinoma in Patients With Chronic Liver Disease Using Multi-parameter Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
Quantitative MRI scanning parameters such as T1 mapping, T2 mapping, T1ρ, and elastography are used, combined with clinical and laboratory indicators, to predict the risk of liver cancer in patients with cirrhosis.

Detailed Description
-----------------
Retrospectively and prospectively collect T1 mapping, T2 mapping, T2* mapping, T1ρ, elastography and other multi-parameter MRI sequence images and clinical and laboratory examination data from patients with liver cirrhosis, and conduct 5-year clinical follow-up and monitoring of all enrolled patients. Whether patients develop hepatocellular carcinoma, patients are divided into liver cancer occurrence group and non-hepatocellular carcinoma group according to clinical follow-up results. Cox proportional hazard analysis is used to compare the differences in clinical characteristics, laboratory tests, imaging characteristics, quantitative MRI parameters and other variables between the two groups of patients. , and calculate the hazard ratio for each variable; assign a score to each covariate based on the proportion of the hazard ratio in the multivariable model, and develop a nomogram to predict HCC risk by the total score.

Official Title
-----------------
Study on the Quantitative Assessment of the Risk of Hepatocellular Carcinoma in Patients With Chronic Liver Disease Using Multi-parameter Magnetic Resonance Imaging

Conditions
-----------------
Cirrhosis； Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Aged over 18 years old; 2. Liver function Child-Pugh classification A or B; 3. Patients with chronic liver disease who meet the diagnostic criteria for high-risk groups of liver cancer in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition); 4. Equipped with Gd-EOB-DTPA enhanced MRI scan images, including T1 mapping, T2 mapping, T2* mapping, T1ρ and other sequences; 5. With 5-year follow-up data. Exclusion Criteria: 1. Patients who are unable to undergo MRI scanning due to claustrophobia, abnormal renal function, etc.; 2. Patients who have undergone liver surgery in the past; 3. Patients with major diseases such as heart failure and tumors.

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 |
| --- | --- |
| HCC group<br>Patients who develop HCC during follow-up | |
| non-HCC group<br>Patients who did not develop HCC during follow-up | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCC incidence rate | Rate of HCC among enrolled patients | 5 years |
Radial Extracorporeal Shockwave Therapy (rESWT) for Coccydynia: a Quasi-experimental Case Series

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to assess whether a pain-adapted protocol of rESWT is effective in treating coccydynia.

Official Title
-----------------
Radial Extracorporeal Shockwave Therapy (rESWT) for Coccydynia: a Quasi-experimental Case Series

Conditions
-----------------
Coccyx Injury

Intervention / Treatment
-----------------
* Other: ESWT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years VAS pain level ≥6 Diagnosis of coccydynia (persistent pain in the coccygeal area consistent with coccydynia) Exclusion Criteria: Age <18 years Local or systemic neurological disease Rheumatological disease Malignant disease Previous spinal surgery or spinal disease Coagulopathies Pregnancy VAS pain level <6 Recent (≤6 weeks) trauma to the coccyx

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESWT<br>Effect of ESWT in alleviating pain | Other: ESWT<br>* ESWT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of coccydynia | Management of coccydynia (pain in the coccyx). The main presenting symptom is pain. its management is the primary goal of treatment. The pain VAS was used to monitor patient response and clinical improvement throughout treatment, with patients ranking the severity of their pain at rest, between no pain (0) and worst imaginable pain (10). Patients were asked their pain level before treatment at each session; although, this did not form part of our formal data collection. Treatment continued until patients reported a VAS pain level ≤3, at which point they were discharged from the clinic. | 12 months |
Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects approximately 10-20% of women of reproductive age, Management strategies for PCOS include lifestyle modifications such as diet and physical activity that are the first-line approach to treatment; however, they are reported to be minimally effective in reducing weight or treating PCOS-related symptoms.Pharmacological options are also available; however, they are not explicitly approved for PCOS treatment as they have been primarily used to treat other conditions such as T2DM

Official Title
-----------------
Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome: A Randomized Clinical Trial

Conditions
-----------------
Poly Cystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Metformin Hydrochloride tablet
* Drug: Vildagliptin 50 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria. Exclusion Criteria: Patients with history of diabetes mellitus (Type 1 or 2). Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months Known hypersensitivity or contraindications to use dipeptidyl peptidase-4 (DPP-4) inhibitors Eating disorders (anorexia, bulimia) or gastrointestinal disorders

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

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

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 |
| --- | --- |
| Active Comparator: Metformin<br> | Drug: Metformin Hydrochloride tablet<br>* Metformin Hydrochloride 850 mg oral tablet<br>|
| Active Comparator: Vildagliptin<br> | Drug: Vildagliptin 50 MG<br>* Vildagliptin 50 MG oral tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of luteinizing hormone (LH) | serum luteinizing hormone (LH) | at baseline and after 3 months | 
| Concentration of Follicle-stimulating hormone | Serum Follicle-stimulating hormone | at baseline and after 3 months | 
| Concentration of Free androgen index | serum Free androgen index | at baseline and after 3 months | 
| Concentration of total testosterone | serum total testosterone | at baseline and after 3 months |
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides

Study Overview
=================
Brief Summary
-----------------
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides

Official Title
-----------------
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides

Conditions
-----------------
Tuberculosis, Pulmonary

Intervention / Treatment
-----------------
* Diagnostic Test: Diascopic iON Image Analysis System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Samples sourced from Makerere University's Joint Clinical Research Clinic (JCRC) and Laboratory Exclusion Criteria: No samples from outside Makerere's Domain
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>400 Male and Female Ugandan Africans | Diagnostic Test: Diascopic iON Image Analysis System<br>* A scanning digital optical train that images sputum slides for automated analysis by a tuberculosis detecting algorithm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determined sensitivity and specificity of the iON device by comparing MTB slide results to their associated bacterial culture results from the same specimen(s). | Sensitivity, specificity, and average analysis time were determined. An image database of >40,000 images was also created for internal use. | Study completed over the grant period 2019 - 2022 |
Studying the Clinical Research Experiences of Patients With PTSD

Study Overview
=================
Brief Summary
-----------------
Clinical research participation percentages haven't always been fully representative of a given demographic. The goal is to find out which aspects of a clinical study 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 PTSD patients during clinical trials.

Official Title
-----------------
PTSD Clinical Trials Review: Examining Patient Experiences in PTSD Clinical Trials to Identify Influencing Factors

Conditions
-----------------
PTSD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have a medical diagnosis of PTSD that has been confirmed by a physician. Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed. Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. Exclusion Criteria: Pregnant or lactating woman Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent. 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 PTSD medical study. |  | 3 months | 
| Number of PTSD patients who remain in clinical trial until completion. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD
Clinical Trial to Evaluate the Safety and Pharmacokinetics of JP-1366 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and the pharmacokinetics of the JP-1366 20 mg tablet and capsule oral administration in healthy adult volunteers.

Official Title
-----------------
Phase I Study to Evaluate the Safety and Pharmacokinetics of JP-1366 in Healthy Adult Volunteers

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

Intervention / Treatment
-----------------
* Drug: JP-1366 20mg tablet
* Drug: JP-1366 20mg capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects ≥ 19 years of age Subjects who weigh ≥ 50 kg (or ≥ 45 kg in the case of females) with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2 Exclusion Criteria: Subjects with clinically significant diseases or a medical history related to the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infections diseases, kidney and urinary system, psychiatric and nervous system, musculoskeletal system, immune system, otorhinolaryngology, skin, and ophthalmological system Subjects who have a history of gastrointestinal surgery (except simple appendectomy or herniotomy) or have gastrointestinal disorders that may affect the absorption of the drug Subjects who received inducers or inhibitors of drug metabolizing enzymes Subjects who have hypersensitivity to this drug, ingredients of this drug, or benzimidazoles, or have a medical history thereof Patients receiving drugs containing atazanavir, nelfinavir, or rilpivirine Subjects who are judged ineligible to participate in this study by the principal investigator

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>R → Washout period(7days) → T | Drug: JP-1366 20mg tablet<br>* T : JP-1366 20mg tablet<br>* Other names: Zastaprazan 20mg;Drug: JP-1366 20mg capsule<br>* R : JP-1366 20mg capsule<br>* Other names: Zastaprazan 20mg;|
| Experimental: Sequence B<br>T → Washout period(7days) → R | Drug: JP-1366 20mg tablet<br>* T : JP-1366 20mg tablet<br>* Other names: Zastaprazan 20mg;Drug: JP-1366 20mg capsule<br>* R : JP-1366 20mg capsule<br>* Other names: Zastaprazan 20mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt of Zastaprazan(JP-1366 20mg) |  | Pre-dose(0 hour) and up to 34 hours in each period | 
| Cmax of Zastaprazan(JP-1366 20mg) |  | Pre-dose(0 hour) and up to 34 hours in each period |