linjc16/ctgov huggingface dataset:
Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. This a clinical trial to study the efficacy and safety of three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2 diabetes.

Official Title
-----------------
Trial to Investigate the Efficacy and the Safety of Thrice-Daily NN2000-Mix70 (NovoRapid 70 Mix) Compared to Twice-Daily NN-X14Mix30 (NovoRapid 30 Mix) in Subjects With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks HbA1c at least 7.5% and below 10.0% Exclusion Criteria: Proliferative retinopathy or maculopathy requiring acute treatment Impaired hepatic and/or renal function Cardiac diseases Uncontrolled hypertension Known hypoglycemia unawareness or recurrent major hypoglycemia

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C (HbA1C) |  | After 16 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C, after 28 weeks of treatment; Plasma glucose levels |  |  |
Nutritional Counseling in Systemic Immunoglobulin Light-chain Amyloidosis

Study Overview
=================
Brief Summary
-----------------
Poor nutritional status is common in patients with systemic immunoglobulin light-chain (AL) amyloidosis and has been associated with mortality and impaired quality of life (QoL). We investigated whether nutritional counseling is beneficial to the maintenance of nutritional status and QoL in AL outpatients.

Official Title
-----------------
Nutritional Counseling in Systemic Immunoglobulin Light-chain (AL) Amyloidosis: a Prospective Randomized, Controlled Trial.

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

Intervention / Treatment
-----------------
* Other: Nutritional counseling
* Other: General dietary advices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment naïve patients with with systemic immunoglobulin light-chain amyloidosis Availability to planned measurements and to written informed consent Exclusion Criteria: Age < 18 years Indication to organ transplantation Indication to autologous stem cell transplantation Need to start or ongoing dialysis Ascites or massive edema Need to start or ongoing artificial nutrition

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional counseling<br>Nutritional counseling consists in: personalized dietary prescription associated with regular (every 3 weeks) dietetic advise by a registered dietician. Follow-up evaluations take place also during the visits scheduled by the Amyloidosis Center | Other: Nutritional counseling<br>* Nutritional counseling consists in: personalized dietary prescription associated with regular (every 3 weeks) dietetic advise by a registered dietician. Follow-up evaluations take place also during the visits scheduled by the oncologists<br>|
| Other: General dietary advices<br>General dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the Amyloidosis Center | Other: General dietary advices<br>* General dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the oncologists<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Change in body weight at 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Change in quality of life at 12 months | 12 months | 
| Overall survival | Overall survival at the end of study | 12 months |
Spermatozoa Morphology Selection by Thermotaxis

Study Overview
=================
Brief Summary
-----------------
This study aims to eventually assess the usefulness of thermotaxis for sperm selection in routine clinical practice.

Detailed Description
-----------------
As the world's total fertility rate decline, every year more couples require assisted reproductive technologies (ART) in order to achieve their desire to become parents. However, these techniques are not guaranteed solutions and still many couples with unexplained infertility fail to conceive. One of the reasons might be the relative selection of spermatozoa for the following ART. To minimize a poor selection made by the operator and to standardize spermatozoa selection, we suggest a new method might be used in combination with the routine spermatozoa selection techniques. Thermotaxis might be used in the ART setting as a tool to select the best spermatozoa as human spermatozoa after capacitation responds positively to a temperature gradient change. Moreover, this might be the possible navigation mechanism of spermatozoa in the female genital tract. We hypothesize that spermatozoa selected by thermotaxis behavior might increase the morphologically normal spermatozoa number in the cohort used during ART. The aim of this study is to evaluate if thermotaxis is a good method for selecting morphologically normal sperm for ART.

Official Title
-----------------
Sperm Selection by Thermotaxis: a Novel Technique to Enhance Assisted Reproductive Technologies' Outcomes

Conditions
-----------------
Male Infertility

Intervention / Treatment
-----------------
* Other: Sperm selection by thermotaxis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: ≥18 and <40 years old. Spermatozoa concentration >15 x 10⁶ /mL in all sperm analysis performed in the last 24 months. Spermatozoa mobility >32% in all sperm analysis performed in the last 24 months. Spermatozoa morphology >4% in all sperm analysis performed in the last 24 months. Signed and dated informed consent Exclusion Criteria: Use of antibiotics, intravenous illicit drugs, chemotherapy or radiotherapy usage in the last 3 months. Active smoking (during the preceding 12 months). More than 3 days prior to the last ejaculation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Sperm selection by thermotaxis|Selection of healthy sperm by thermotaxis procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of normal spermatozoa morphology | Analysis of sperm samples following thermotaxis (intervention) versus the controls (without thermotaxis). | 11 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spermatozoa selection, Thermotaxis, Testicular and sperm biology
A Trial to Investigate the Effectiveness of Testosterone Treatment in Men With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, prospective, placebo-controlled, double-blind randomized Phase II clinical trial assessing the effect of testosterone treatment vs. placebo treatment for 96 weeks duration on whole brain atrophy in men with MS.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: testosterone
* Drug: placebo gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men, aged 18-60, with a diagnosis of multiple sclerosis by 2010 revised McDonald Criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Testosterone gel<br>Apply gel once a day for 96 weeks | Drug: testosterone<br> <br> |
| Placebo Comparator: Placebo gel<br>Apply gel once a day for 96 weeks | Drug: placebo gel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole Brain Atrophy |  | 96 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MS
Oxytocin Effects on Likeability After Being Liked or Disliked

Study Overview
=================
Brief Summary
-----------------
The current study aimed to investigate oxytocin effect on the response after the experience of being liked or disliked.

Detailed Description
-----------------
In a double-blind, between-subject, placebo controlled design study, the researchers aimed to investigate the intranasal OXT (40IU) treatment on rating response after being liked or disliked in healthy male subjects. All subjects completed a range of questionnaires measuring personality and affective traits and levels of anxiety: Positive and Negative Affect Schedule (PANAS) , State-Trait Anxiety Inventory (STAI) , Beck Depression Inventory (BDI), Cheek and Buss shyness Scale (CBSS),Autism Spectrum Quotient (ASQ), Empathy Quotient(EQ) before self-administration.Study participants were led to believe that other participants had formed an opinion on their likability based on their appearance in a photograph and they passively viewed the responses (like or dislike) from 'other participants'. After that, they rated 'other participants' about likeability (how much do you like the person), accuracy (have you seen the person), feeling (how good do you feel), and tendency (how much would do like have him/her as a friend). Likeability, tendency, feeling and accuracy were included into analysis as dependent variables.

Conditions
-----------------
Social Behavior

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects without past or current psychiatric or neurological disorder Exclusion Criteria: history of head injury; claustrophobia; medical or psychiatric illness.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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 nasal spray<br>Oxytocin nasal spray | Drug: Oxytocin<br> <br> |
| Placebo Comparator: Placebo nasal spray<br>Placebo nasal spray | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxytocin effect on likeability after being liked or disliked | Likeability rating was included into analysis as dependent factor. | 2 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship status may influence oxytocin effect | subjects were subdivided into two subgroups | 2 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Likeability, Being liked
MelaFind Evaluations for Patients With Multiple Nevi

Study Overview
=================
Brief Summary
-----------------
We have added objectives 4-6 to our updated study: Study Objective 1: To determine whether the distribution of MelaFind scores is different for different patients with multiple nevi, and whether such distributions can be utilized to identify signature lesions for a given patient. Study Objective 2: To investigate whether distributions of quantitative ABCD parameters differ among patients and whether these qABCD parameters identify signature lesions. Study Objective 3: To determine the feasibility of defining and using relative thresholds to improve the specificity of MelaFind without sacrificing its high sensitivity. Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for different patient and lesion characteristics. Study Objective 5: To identify patient and lesion characteristics that result in the highest variability of MelaFind scores for a given lesion. Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual threshold for lesions to be considered for biopsy to rule out melanoma on patients with multiple nevi.

Official Title
-----------------
MelaFind Evaluations for Patients With Multiple Nevi

Conditions
-----------------
Clinically Atypical Pigmented Skin Lesion

Participation Criteria
=================
Eligibility Criteria
-----------------
Cutaneous lesions examined with MelaFind must satisfy all of the following inclusion criteria: Inclusion Criteria: The lesion is pigmented (i.e., melanin, keratin, blood) The diameter of the pigmented area is not < 2 mm, and not > 22 mm The lesion is accessible to the MelaFind The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form; Cutaneous lesions that meet any of the following exclusion criteria will not be accepted: Exclusion Criteria: The patient has a known allergy to isopropyl alcohol The lesion has been previously biopsied, excised, or traumatized The skin is not intact (e.g., open sores, ulcers, bleeding) The lesion is within 1 cm of the eye The lesion is on mucosal surfaces (e.g., lips, genitals) The lesion is on palmar hands The lesion is on plantar feet The lesion is on or under nails The lesion is located on or in an area of visible scarring The lesion contains foreign matter (e.g., tattoo, splinter, marker)
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 |
| --- | --- | --- |
| Multiple values and standard deviations of MelaFind scores for pigmented skin lesions |  | 1 month |
Plasma Homocysteine Distribution in the United States

Study Overview
=================
Brief Summary
-----------------
To describe the distribution of homocysteine and prevalence of hyperhomocysteinemia with emphasis on race, sex and age. To determine the extent to which hyperhomocysteinemia is associated with status of folate and vitamin B12. Finally, to describe the relationships between prevalence of hyperhomocysteinemia and prevalence of cardiovascular disease and assess the importance of this risk factor as a cause of vascular disease among US adults. The study was renewed for one year to investigate normal homocysteine concentrations among children and to identify nutritional and non-nutritional determinants of total homocysteine concentrations in children.

Detailed Description
-----------------
BACKGROUND: Hyperhomocysteinemia, a condition of elevated plasma homocysteine concentrations resulting from impaired sulfur amino acid metabolism, may be a powerful risk factor for occlusive vascular disease. However, little is known about the distribution of hyperhomocysteinemia in the general population. Furthermore, inadequate nutritional status might be a strong determinant of hyperhomocysteinemia, but its importance at a population level (as measured by the prevalence of hyperhomocysteinemia associated with inadequate nutrition) has received little study. Finally, levels of homocysteine associated with elevated risk of vascular disease have not been clearly established. DESIGN NARRATIVE: Using previously collected plasma samples, studies were conducted on the distribution of homocysteine and prevalence of hyperhomocysteinemia with emphasis on race, sex and age. Investigations were undertaken on the extent of the relationship of hyperhomocysteinemia to folate and vitamin B12. Finally, the relationships were described between prevalence of hyperhomocysteinemia and prevalence of cardiovascular disease and the importance of this risk factor as a cause of vascular disease among US adults was assessed..

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hyperhomocysteinemia

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Evaluation the TECNIS IOL in Both Eyes VS the ReZoom IOL in One and TECNIS IOL in the Opposite

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the visual performance of two cohorts of patients who received multifocal intraocular lenses following cataract and clear lens extraction surgeries. Comparing visual outcomes of patients who were implanted with TECNIS Multifocal IOLs in both eyes versus patients implanted with TECNIS Multifocal in one eye and ReZoom Multifocal IOL in the opposite eye.

Detailed Description
-----------------
Stable post operative cataract and clear lens extraction patients who have been implanted with either the TECNIS Multifocal IOL in both eyes or TECNIS Multifocal IOL in one eye and theReZoom Multifocal IOL in the opposite eye. Study Design-A retrospective chart review to collect visual outcomes to determine lens performance. Patient satisfaction questionnaire will be administered to determine spectacle independence.

Official Title
-----------------
A Retrospective Evaluation Comparing Post Operative Visual Outcomes in Patients Implanted With the TECNIS IOL in Both Eyes Versus the ReZoom IOL in One Eye and TECNIS IOL in the Opposite Eye

Conditions
-----------------
Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone surgery and received either the TECNIS Multifocal Intraocular lens in one eye and the ReZoom Multifocal Intraocular lens in the other will be evaluated. Males and Females with ages ranging from 42 years to 86 years old. Exclusion Criteria: Patients who have subsequently developed any visual limiting problems (e.g. corneal, retinal, infection) which could potentially limit their post operative visual potential.

Ages Eligible for Study
-----------------
Minimum Age: 42 Years
Maximum Age: 86 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 |
| --- | --- |
| TECNIS/ReZoom<br>Patients who received a TECNIS multifocal IOL in one eye and a ReZoom multifocal IOL in the opposite eye. | |
| TECNIS/TECNIS<br>Patients who received TECNIS multifocal IOLs in both eyes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected visual acuity at distance and near |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Satisfaction |  | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Visual outcomes, Patient satisfaction