linjc16/ctgov huggingface dataset:
Peripheral Heating and Glucose Tolerance

Study Overview
=================
Brief Summary
-----------------
Effect of peripheral heating on glucose tolerance

Official Title
-----------------
Peripheral Heating and Glucose Tolerance

Conditions
-----------------
Glucose Tolerance

Intervention / Treatment
-----------------
* Device: Peripheral Heating
* Device: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years Exclusion Criteria: Open wounds on feet or legs Peripheral neuropathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral Heating<br>Peripheral Heating | Device: Peripheral Heating<br>* Peripheral heating of the feet<br>|
| Sham Comparator: Sham<br>Sham | Device: Sham<br>* Sham<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose concentrations |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin concentrations |  | 1 hour | 
| Blood flow |  | 1 hour |
A Real-World Study for the TECNIS Synergy™ Intraocular Lens

Study Overview
=================
Brief Summary
-----------------
This is a prospective and retrospective, single-center, single-arm, open-label clinical study of the TECNIS Synergy™ IOL. The study will enroll up to 100 subjects from a single site in China. All implanted subjects will be followed for 12 months postoperatively.

Official Title
-----------------
A Real-World Study Evaluating Clinical Outcomes in China for the TECNIS Synergy™ Intraocular Lens Model ZFR00V

Conditions
-----------------
Cataracts

Intervention / Treatment
-----------------
* Device: Model ZFR00V


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients at least 22 years of age Have/had a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation or a history of implantation with TECNIS Synergy intraocular lens Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian Exclusion Criteria: Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit Planned monovision correction (one eye designated for near correction). Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the course of the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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: TECNIS Synergy IOL<br>Model ZFR00V | Device: Model ZFR00V<br>* Investigational intraocular lens replaces the natural lens removed during cataract surgery in one or both eyes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean monocular postoperative DCNVA |  | 6 months | 
| percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCNVA |  | 6 months |
An Open-labeled Trial of Ramipril in Patients With Migraine

Study Overview
=================
Brief Summary
-----------------
Physiology of migraine involving renin-angiotensin systems (RAS) has been implicated. Ramipril is a broadly-used angiotensin-converting enzyme inhibitor. The investigators attempt to test the efficacy of ramipril on the prophylaxis of migraine attacks.

Official Title
-----------------
An Open-labeled Trial of Ramipril in Patients With Migraine

Conditions
-----------------
Migraine With Hypertension

Intervention / Treatment
-----------------
* Drug: Ramipril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic migraine are included in this study. Migraineurs should be aged 20 to 70 years old with the ability to read and understand the self-report scales, including the headache diary, used in this study. Exclusion Criteria: Medication overuse headache are excluded in this study. Treatment with other ACEI or medication that may affect ARS Treatment with migraine prophylactic medications or anti-hypertensive agents including β adrenergic receptor or calcium channel blockers Past history of hepatic or renal dysfunction; an abnormal electrocardiography; a psychiatric disorder; a history of substance abuse; pregnancy or lactation; use of anti-psychotics, antidepressants, or anti-anxiety drugs.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ramipril<br>open label single arm trial | Drug: Ramipril<br>* ramipril 2.5mg twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| headache frequency | headache days | 12 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
migraine,, ramipril,, hypertension
Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced solid malignancies. The study is designed to determine the maximum tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion, and to characterize the pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310 Injectable Emulsion. Additionally, evaluation of side effects as a function of dose, and observation of any anti-tumor effects of SN2310 Injectable Emulsion will be made.

Detailed Description
-----------------
This is a Phase 1 open-label study of SN2310 Injectable Emulsion in patients with advanced solid malignancies who have failed conventional therapy. SN2310 Injectable Emulsion will be administered intravenously every 21 days. The study is designed to determine the maximum tolerated dose and dose-limiting toxicity of SN2310 Injectable Emulsion; to characterize the pharmacokinetics of SN2310 and SN-38 following intravenous administration of SN2310 Injectable Emulsion; to evaluate side effects as a function of dose level; and, to observe any anti-tumor effects of SN2310 Injectable Emulsion.

Official Title
-----------------
A Multicenter Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors

Conditions
-----------------
Breast Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Pelvic Neoplasms, Lung Neoplasms

Intervention / Treatment
-----------------
* Drug: SN2310 Injectable Emulsion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of solid tumor with disease progression despite standard therapy and/or for which no other solid therapeutic option exists ANC > 1,500 cell/mm3, platelets > 100,000/mm3 and Hgb > 9 g/dl At least one unidimensionally measurable lesion per RECIST Negative serum or urine pregnancy test, if female of childbearing potential Exclusion Criteria: Female who is pregnant or lactating History of chronic diarrhea

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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>SN2310 Injectable Emulsion | Drug: SN2310 Injectable Emulsion<br>* Escalating doses given IV every three weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose |  | December 2008 | 
| Dose-Limiting Toxicity |  | December 2008 | 
| Adverse Events |  | December 2008 | 
| Pharmacokinetic parameters for SN2310 and SN-38 |  | December 2008 |
A Study With NLY01 in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a Phase 2a study designed to assess the effect of NLY01 in patients with type 2 diabetes. Patients will be monitored for safety, pharmacokinetics, and pharmacodynamic effects on glycemic control.

Official Title
-----------------
A Phase 2a Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NLY01, a PEGylated Exenatide, When Administered as a Single Dose in Subjects With Type 2 Diabetes

Conditions
-----------------
Type2 Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: NLY01
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subject with type 2 diabetes for at least one year Willing to continue treatment with metformin at the same dose and frequency until and (if applicable) to pause any treatment with a second oral antidiabetic Body Mass Index (BMI) 22.0 to 35.0 kg/m^2, Exclusion Criteria: History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), that may place the subject at increased risk as determined by the investigator Any prior exposure to an exenatide-based product (BYETTA and BYDUREON) History of gastroparesis History of severe hypoglycemia in the past 6 months If female, pregnant or breastfeeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NLY01 (2.5 mg)<br> | Drug: NLY01<br>* NLY01, a PEGylated form of the anti-diabetic peptide exenatide<br>|
| Active Comparator: NLY01 (5.0 mg)<br> | Drug: NLY01<br>* NLY01, a PEGylated form of the anti-diabetic peptide exenatide<br>|
| Active Comparator: NLY01 (10 mg)<br> | Drug: NLY01<br>* NLY01, a PEGylated form of the anti-diabetic peptide exenatide<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Treatment Emergent Adverse Events |  | 35 days | 
| Number of Incidences of Adverse Events |  | 35 days | 
| Plasma glucose | Change of fasting glucose profiles | 24 hours | 
| Change in serum insulin | Change in 24 hour serum insulin | 24 hours | 
| Change in plasma glucagon | Change in 24 hour plasma glucagon concentrations | 24 hours |
Amyloidosis Typing Using Mass Spectrometry-based Proteomics: a New Accurate Tool for Difficult Typing

Study Overview
=================
Brief Summary
-----------------
The main objective is to establish that a new technique of amyloidosis typing by Proteomics (based on nanoLC-MS/MS mass spectrometry) allows typing in > 90% of observations in patients whose Amyloidosis is reported to have failed typing (impossible typing, uncertain or inconsistent) with the traditional anatomopathological approach, and this in a cohort of 40 patients identified consecutively in the Department of pathological anatomy and cytology of the University Hospital of Toulouse and included prospectively.

Official Title
-----------------
Amyloidosis Typing Using Mass Spectrometry-based Proteomics: a New Accurate Tool for Difficult Typing

Conditions
-----------------
Amyloidosis

Intervention / Treatment
-----------------
* Diagnostic Test: Amyloidosis typing using mass spectrometry-based proteomics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Amyloidosis by Red Congo staining and birefringence in polarized light on tissue sampling Immunolabeling Amyloidosis typing impossible (no frozen sample available) or inconclusive (doubtful) or inconsistent with clinical, biological, genetic and iconographic data Signature of the informed consent form Exclusion Criteria: Insufficient tissue material to perform the new technique Person placed under judicial protection Pregnant and breastfeeding women

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Inclusion of 40 patients identified by the Department of Anatomy and pathological cytology at the University of Toulouse.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amylose typing<br>Amyloidosis typing by nanoLC-MS/MS in patients diagnosed with Amyloidosis but unable to be typed | Diagnostic Test: Amyloidosis typing using mass spectrometry-based proteomics<br>* Amyloidosis typing using nanoLC-MS/MS method<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amyloidosis typing | Amyloidosis typing rate with the new technique | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return the result | Time to return the result with the new technique (time in days) | Day 0 | 
| Concordance | Agreement between the proteomic conclusion and the clinical judgement (binary answer : yes/no) | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mass spectrometry based proteomic analysis, NanoLC-MS/MS, Amyloidosis typing
Complement Component 3c and Tumor Necrosis Factor-α in Patients With Human Papillomavirus-Induced Cutaneous Warts

Study Overview
=================
Brief Summary
-----------------
The investigators explore the role of the complement pathway and T helper 1 immune response in clinical response to Candida immunotherapy via complement component and tumor necrosis factor, respectively.

Detailed Description
-----------------
39 patients are enrolled in the study They suffer from chronic recurrent cutaneous warts Patients receive Candida antigen immunotherapy vial intra-lesional injection every 2 weeks till complete resolution or the maximum of 5 sessions Blood samples are withdrawn before and after intervention C3, C4, MBL, C3C and TNF alpha serum levels are measured

Official Title
-----------------
Complement Component 3c and Tumor Necrosis Factor-α in Patients With Human Papillomavirus-Induced Cutaneous Warts

Conditions
-----------------
Warts

Intervention / Treatment
-----------------
* Biological: Candida antigen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic multiple cutaneous Exclusion Criteria: Hypersensitivity to Candida antigen Fever Immunosuppressive disorders Previous wart therapy in the last month

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wart Patients<br>Patient receive 0.1 mL of diluted preparation of candida solution at 2 weeks interval for the maximum of 5 sessions | Biological: Candida antigen<br>* Patient receive candida antigen immunotherapy and blood samples will be withdrawn before and after intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of warts | 100% clearance of warts | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Reappearance of warts | 6 months |
Tailoring Mindfulness Interventions for Families Managing Chronic Health Conditions

Study Overview
=================
Brief Summary
-----------------
This is not an intervention or treatment study. It is an observational qualitative data study about tailoring a mindfulness intervention to assist families managing chronic health conditions.

Detailed Description
-----------------
This is not an intervention or treatment study. It is an observational qualitative data study. Collecting information from virtual audio only interviews from between 30 and 40 US adults about whether a mindfulness intervention would assist families managing chronic health conditions; and if so, how should it be tailored to meet their needs.

Official Title
-----------------
PEP (Parent and Child-Informed, Environmentally-Responsive Pediatric Asthma) Study

Conditions
-----------------
Mindfulness, Chronic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking and either a long-time mindfulness practitioner/instructor or an adult managing a chronic health condition for yourself or a close family member Exclusion Criteria: unable to complete an audio interview in English lasting 30-60 minutes

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| what families managing chronic illness want in a mindfulness intervention | structured open ended questions analyzed with grounded theory- no quantitative data will be captured | 30 to 60 minute interview |
Influence of Oxytocin on Romantic Jealousy

Study Overview
=================
Brief Summary
-----------------
The aim is to evoke romantic jealousy between couples and investigate whether oxytocin has effect on it.

Detailed Description
-----------------
In a double-blind, between- subject placebo (PLC) controlled design,investigators plan to test the effect of intranasal oxytocin on romantic jealousy evoked by the Imaginary of Partner's Infidelity Task and Cyberball Game in romantically attached subjects.

Conditions
-----------------
Sexual Infidelity, Emotional Infidelity, Jealousy

Intervention / Treatment
-----------------
* Behavioral: Sexual Infidelity Condition
* Behavioral: Emotional Infidelity Condition
* Behavioral: Neutral Condition
* Behavioral: Player in Jealousy Condition
* Behavioral: Player in Non-Jealousy Condition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy couples in romantic relationship for more than 3 months and have intimate experience with each other before. Exclusion Criteria: medical or psychiatric illness

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 30 Years

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>Oxytocin nasal spray | Behavioral: Sexual Infidelity Condition<br> <br> Behavioral: Emotional Infidelity Condition<br> <br> Behavioral: Neutral Condition<br> <br> Behavioral: Player in Jealousy Condition<br> <br> Behavioral: Player in Non-Jealousy Condition<br> <br> |
| Placebo Comparator: Placebo<br>Placebo nasal spray | Behavioral: Sexual Infidelity Condition<br> <br> Behavioral: Emotional Infidelity Condition<br> <br> Behavioral: Neutral Condition<br> <br> Behavioral: Player in Jealousy Condition<br> <br> Behavioral: Player in Non-Jealousy Condition<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arousal and jealousy ratings as assessed by Likert Scales | Oxytocin effect on arousal and jealousy on sexual and emotional infidelity sentences | 145 Minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxytocin effect, romantic jealousy, Arousal Rating, Jealousy Rating