linjc16/ctgov huggingface dataset:
Automitochondrial Transplantation Improves Live Birth in Elderly Patients With Low Prognosis After Repeated IVF Failure

Study Overview
=================
Brief Summary
-----------------
The goal to this clinical trial is to study the effectiveness and safety of automitochondrial transplantation of urine derived stem cells(USCs) in in elderly patients with low prognosis after repeated IVF failure. The main questions it aims to answer are: (1）test the effectiveness and safety of automitochondrial transplantation of urine derived stem cells (2) establish intracytoplasmic sperm injection(ICSI) mitochondrial transplantation platform Participants will be asked to:1)urine collections to further culture of autologous USCs 2)ovarian stimulation、trigger eggs、ICSI with autologous mitochondria 3）embryo transfer 4)accept pregnancy follow-up at given point

Official Title
-----------------
Automitochondrial Transplantation Improves Live Birth in Elderly Patients With Low Prognosis After Repeated IVF Failure

Conditions
-----------------
Infertility, Female, Mitochondrial, Elderly, Assisted Reproductive Technique

Intervention / Treatment
-----------------
* Procedure: Autologous USC mitochondrial oocyte transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) At least 35 years old 2) Repeated IVF failure: more than or equal to 2 egg retrieval with poor embryo quality, no transplanted embryos or failed embryo transfer (more than or equal to 4 embryos) 3) Egg number ≤9 4) Participate voluntarily and sign informed consent. Exclusion Criteria: 1: Infertility caused by severe oligospermia, severe intrauterine adhesions, genital tract malformations, thyroid dysfunction and other endocrine, immune system, tumor and genetic diseases

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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: MT transfer<br> | Procedure: Autologous USC mitochondrial oocyte transplantation<br>* Mitochondria are isolated from urine derived stem cells from fresh middle urine of the subjects, and injected into the cytoplasm of mature oocytes together with sperm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate | Live birth rate per embryo transfer cycle (defined as live delivery after ≧28 weeks) | 1year after embryo transfer |
Mentalizing Education in a Psychiatric Out-patient Clinic

Study Overview
=================
Brief Summary
-----------------
Mentalization-based Mental Health Education in a naturalistic patient population from a psychiatric out-patient clinic in North Norway: A randomized controlled study

Detailed Description
-----------------
Half of an unselecected waiting list group of patients (randomized) from a psychiatric out-patient clinic are offered a 6 hour mental health education course abour mentalizing. 1 year follow up period. Primary outcome variable is use of hospital services. Secondary outcome variables are questionnaire scores.

Official Title
-----------------
Mentalizing Education in a Psychiatric Out-patient Clinic in North Norway

Conditions
-----------------
Mental Health Education

Intervention / Treatment
-----------------
* Behavioral: Mentalizing course


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all norwegian speaking patients referred to the outpatient clinic Exclusion Criteria: none

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Patients offered mentalizing course supplemental to treatment as usual | Behavioral: Mentalizing course<br>* 6 hour mental health education course about mentalizing.<br>|
| No Intervention: Control<br>Control group - treatment as usual. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital service us | Contact days (policlinic, inpatient ward and emergency team) | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 item wellbeing questionnaire | Each question is answered on a separate 0-9 point scale. Higher scores means better outcome. | 6 month |
Inflammatory Marker in Ibd and Peripheral Arthritis

Study Overview
=================
Brief Summary
-----------------
The Objective Of This Study Is To Estimate The Correlation Between Disease Activity In IBD, Inflammatory Markers And Peripheral Arthritis After Exclusion Of Other Causes Arthritis

Detailed Description
-----------------
Inflammatory Bowel Diseases (IBD) Are Chronic Relapsing Inflammatory Disorder Of The Gastrointestinal Tract (GIT) , Which Represented Mainly By Ulcerative Colitis (UC) And Crohn's Disease . IBD Is To Be Considered Systemic Disease Since They Are Often Associated With Extra intestinal Manifestation, Especially During Activity, Which Reflect A Pathogenic Mechanism As Arthritis ,Erythema Nodosum ,Pyoderma Gangrenosum , Apthous Ulceration ,Iritis And Uveitis. Peripheral Arthritis (Pa) Is Observed Rather Than Frequently, The Arthritis Involves Predominantly The Joint Of The Lower Limb ,And In Most Cases It Accompanies The Activity Of The Intestinal Disease Pauciarticular, Asymmetric, Migratory And Non Deforming. Predicting Relapse By Measuring Non Invasive Biomarkers Could Allow Early Treatment Adaptation .Several Studies Have Shown A Correlation Between Intestinal Inflammation And Serum C-Reactive Protein Or Fecal Calprotectin Levels .

Official Title
-----------------
Correlation Between Disease Activity of Inflammatory Bowel Disease, Inflammatory Markers and Peripheral Arthritis .

Conditions
-----------------
IBD-Inflammatory Bowel Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1-Pt Above 18 Yrs. 2- IBD Pt. Confirmed By Colonoscopy 3- IBD Patient with Arthritis During Activity Exclusion Criteria: 1-Age Below 18 Yrs. Old 2-Arthritis Of Other Causes Than IBD PT

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Correlation between IBD Patients Presented With Peripheral Arthritis and degree of Disease activity | Estimate The Correlation Between Disease Activity In IBD, Inflammatory Markers And Peripheral Arthritis After Exclusion Of Other Causes Arthritis | 1/2/2023to 1/12/2024 |
Brain Organization, Development, and Response to Intervention in Individual Neonates

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to learn about brain connectivity and if massaging babies shortly after birth has an impact. Half of the recruited babies will receive massage daily while the other half will not, and differences will be observed.

Official Title
-----------------
Brain Organization, Development, and Response to Intervention in Individual Neonates

Conditions
-----------------
Development, Infant

Intervention / Treatment
-----------------
* Behavioral: Neonatal Massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking Ability to give informed consent Exclusion Criteria: Prisoners (vulnerable population) Pregnant women <18 years of age Active psychosis, mania, suicidal ideation (safety) Active substance dependence Non-singleton pregnancy (e.g., twins) Gestational Age <36 weeks (neonates) Neonatal encephalopathy (neonates)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neonatal Massage Received<br> | Behavioral: Neonatal Massage<br>* caregivers providing therapeutic touch techniques on their neonate<br>|
| No Intervention: No Massage Received<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in functional connectivity in the neonatal brain |  | up to 3 months |
Long Term Trajectories of SMA Patients Receiving or Not Disease-modifying Treatments

Study Overview
=================
Brief Summary
-----------------
This is an observational multicenter retrospective and prospective study on natural history of SMA also considering the 'new natural history' secondary to the availability of commercially available therapies. All the patients enrolled to date in the Italian registry, if not part of clinical trials, will be included in the present study.

Detailed Description
-----------------
This is an observational multicenter retrospective and prospective study on natural history of SMA also considering the 'new natural history' secondary to the availability of commercially available therapies. All patients affected by Spinal Muscular Atrophy 5q, irrespective of genotype, phenotype, age, treatment status or gender will be enrolled in the study . The study aims to i) better understand the natural history of the disease in untreated patients in terms of functional aspects, concomitant illnesses, quality of life ii) describe the patterns of disease progression in treated and untreated patients in terms of functional aspects, concomitant illnesses, quality of life iii) Describe all the patients treated with the available therapies in Italy, in terms of demographic (age, location etc..) and epidemiological data All data from patients included in the study will be collected at each visit, following the clinical care protocols of each centre. Following care recommendation patients are generally routinely assessed at least every 6 months and, in many cases, every 4 months. We plan to obtain Longitudinal changes in untreated patients: The possibility to access reliable retrospective data will provide the opportunity to record long term functional data in untreated patients. Yearly analysis of longitudinal changes in treated patients: Two-year results of the validation of new measures (SMA HI, SMAIS): reporting the validation process (inter- and intra-observer reliability, internal consistency) and changes in relation to functional measures

Official Title
-----------------
SMA Natural History Study Evaluating Long Term Trajectories of SMA Patients Receiving or Not Disease-modifying Treatments

Conditions
-----------------
Spinal Muscular Atrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with mutationsin the SMAN1 gene Exclusion Criteria: unable to proviude consent
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 |
| --- | --- | --- |
| motor function using the HFMSE (min score 0, max 74 indicating best performance) | motor scale | 5 years |
Pharmacokinetic Profile of Rosemary Extract Supplement

Study Overview
=================
Brief Summary
-----------------
This study is a clinical trial to observe changes in biomarkers in the blood at pre- and post-supplementation of rosemary extract in healthy adults.

Official Title
-----------------
The Effects of Oral Adminstration of Softgel Capsule Including Rosemary Extract on Pharmacokinetic Profile in Healthy Adults

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Dietary Supplement: Rosemary extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects aged between 25 and 55 years Non-smoker Body Mass Index (BMI) between 20 and 30 kg/m2 Exclusion Criteria: Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, endocrine, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dosage 1<br> | Dietary Supplement: Rosemary extract<br>* Softgel capsule including rosemary extract<br>|
| Experimental: Dosage 2<br> | Dietary Supplement: Rosemary extract<br>* Softgel capsule including rosemary extract<br>|
| Experimental: Dosage 3<br> | Dietary Supplement: Rosemary extract<br>* Softgel capsule including rosemary extract<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration in plasma |  | 24 hours |
Spatially Transcriptomics Reveals Molecular Signatures in CRPS

Study Overview
=================
Brief Summary
-----------------
This observational study aims to understand phenotype-specific molecular signatures in patients with complex regional pain syndrome (CRPS).

Detailed Description
-----------------
Participants who meet the diagnostic criteria for CRPS, aged 19 80 years, and agree to participate in this study will undergo a 4mm-sized skin punch biopsy in the involved limb, as well as the contralateral side (internal control). Spatial transcriptomics will be used to identify immune cell signatures and differentially regulated genes (DEGs) in the epidermis, vasculature, sweat gland, and nerve plexus of the involved ipsilateral (vs contralateral) side of the patient's skin.

Official Title
-----------------
Spatially Resolved Transcriptomics Reveals Phenotype-specific Molecular Signatures in Complex Regional Pain Syndrome

Conditions
-----------------
Complex Regional Pain Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets the Budapest diagnostic criteria Consents to participation in this study Aged between 19 and 80 years old Symptoms and/or signs of sensory, vasomotor, and sudomotor changes Exclusion Criteria: Who do not agree to participate in this study Who has contraindications for skin punch biopsy (e.g. thrombocytopenia, taking anticoagulant drugs)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Numerical Rating Scale (NRS) | Intensity of pain (now, weekly avarege, weekly maximum) | At the time of biopsy | 
| Thermography | Thermography of the involved limb | At the time of diagnosis | 
| Quantitative Sensory Testing (QST) | Vibration Detection Threshold (VDT), Cold Detection Threshold (CDT) | At the time of diagnosis |
AI Prediction Model and Risk Stratification for Lung Metastasis in Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Background: To assist clinicians with diagnosis and optimal treatment decision-making, we attempted to develop and validate an artificial intelligence prediction model for lung metastasis (LM) in colorectal cancer (CRC) patients. Method: The clinicopathological characteristics of 46037 CRC patients from the Surveillance, Epidemiology, and End Results (SEER) database and 2779 CRC patients from a multi-center external validation set were collected retrospectively. After feature selection by univariate and multivariate analyses, six machine learning (ML) models, including logistic regression, K-nearest neighbor, support vector machine, decision tree, random forest, and balanced random forest (BRF), were developed and validated for the LM prediction. The optimization model with best performance was compared to the clinical predictor. In addition, stratified LM patients by risk score were utilized for survival analysis.

Official Title
-----------------
Development and Validation of an Artificial Intelligence Prediction Model and a Survival Risk Stratification for Lung Metastasis in Colorectal Cancer From Highly Imbalanced Data

Conditions
-----------------
Colorectal Cancer, Lung Metastases

Intervention / Treatment
-----------------
* Other: The location of the patient's treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with pathologic confirmation of a primary CRC diagnosis Exclusion Criteria: (1) patients with multiple primary cancers or other malignancies; (2) patients identified via autopsy or death certificate; and (3) patients with uncertain clinical data values
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| validation set 1<br>The validation set 1 was comprised of patients with CRC diagnosed and treated between January 1, 2016, and December 31, 2020, at the Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College. | Other: The location of the patient's treatment<br>* The location of the patient's treatment<br>|
| validation set 2<br>The validation set 2 was comprised of patients with CRC diagnosed and treated between January 1, 2016, and December 31, 2020, at the Second Affiliated Hospital of Harbin Medical University. | Other: The location of the patient's treatment<br>* The location of the patient's treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung metastasis | diagnosed with lung metastasis | through study completion, an average of 3 month |
The Long-term Course of Moderate Tricuspid Regurgitation

Study Overview
=================
Brief Summary
-----------------
To evaluate the long-term clinical outcome of a cohort of patients suffering from moderate tricuspid regurgitation (TR), regardless of its etiology.

Official Title
-----------------
The Long-term Clinical Course of Moderate Tricuspid Regurgitation

Conditions
-----------------
Tricuspid Regurgitation, Heart Failure, Echocardiography

Intervention / Treatment
-----------------
* Other: Echocardiographic evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an echocardiographic diagnosis of moderate TR Patients with echocardiographic and clinical follow-up information available at least 6-months after moderateTR diagnosis. Exclusion Criteria: Absence of an appropriate clinical and echocardiographic follow-up A history of previous TV intervention (either surgical or percutaneous) The presence of concomitant TV stenosis Congenital heart disease Left ventricular assist devices

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Echocardiographic evaluation|Echocardiographic follow-up|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death | Time from diagnosis to all-cause death | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular (CV) mortality | The occurrence of cardiovascular (CV) mortality (defined as death due to advanced heart failure, coronary ischemic heart disease, sudden cardiac death or due to stroke | through study completion, an average of 2 years |
User Evaluation of BGM VGM77

Study Overview
=================
Brief Summary
-----------------
Performance Evaluation by the User of the Blood Glucose Monitoring System VGM77Compliant with DIN EN ISO 15197:2015

Official Title
-----------------
Evaluierung Des Blutglukose Monitoring Systems VGM77 Der Firma Beurer GmbH gemäß DIN EN ISO 15197:2015

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Diagnostic Test: subject
* Diagnostic Test: reference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female patients with hypo-, eu- or hyperglycaemia The written informed consent had to be signed The volunteers must be older than 18 years The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved Exclusion criteria: Pregnancy or lactation Acute or chronic diseases with the risk of aggravation by the measure A current constitution that does not allow participating in the study Participation in another study or activity with the blood glucose measuring system evaluated in the present study Application of substances listed in Appendix A of DIN EN ISO 15197:2015

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subject glucometer measurement<br>Blood glucose measurement BGM for personal use | Diagnostic Test: subject<br>* blood glucose measurement by subject<br>Diagnostic Test: reference<br>* blood glucose measurement with reference<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of system accuracy based on DIN EN ISO 15197 | Assessment of the analytical measurement performance of the blood glucose monitor | 1 Day |