linjc16/ctgov huggingface dataset:
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)

Study Overview
=================
Brief Summary
-----------------
This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.

Official Title
-----------------
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Interferometric Synthetic Aperture Microscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18 years of age or older Signed informed consent form Women who have been histologically diagnosed with carcinoma of the breast prior to surgery Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure Exclusion Criteria: Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast) Neoadjuvant systemic therapy All T4 tumors Previous radiation in the operated breast Prior surgical procedure in the same quadrant Implants in the operated breast Pregnancy Lactation Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Interferometric Synthetic Aperture Microscopy|Optical coherence tomography with interferometric synthetic aperture microscopy will be used to image ex vivo breast tissue specimens.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With All Positive/Close Margins Correctly Identified With the Device |  | 1 week after surgery | 
| Number of Margins With False Positive Device Readings |  | 1 week after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tumor margin, Imaging, Lumpectomy, Breast cancer, Optical coherence tomography
Physical Activity and Gestational Complications

Study Overview
=================
Brief Summary
-----------------
The association between physical activity and several complication of pregnancy will be evaluated .

Detailed Description
-----------------
The association between physical activity and several complication of pregnancy will be evaluated. Patients with complications of pregnancy will be recruited. Physical activity will be evaluated using questioner or smart bracelet.

Official Title
-----------------
Physical Activity and Gestational Complications

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Device: smart bracelet.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women Exclusion Criteria: Non pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>smart bracelet. | Device: smart bracelet.<br>* Physical activity will be evaluated using smart bracelet.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Gestational Complication |  | 40 weeks |
Intermittent Antimalaria Treatment With SP in African Children

Study Overview
=================
Brief Summary
-----------------
- intermittent preventive treatment with SP in children to evaluate efficacy and safety of this drug combination in children in northern Ghana

Detailed Description
-----------------
Sulfadoxine and pyrimethamine have long been used for malaria prevention and treatment. In this study, following suggestions of WHO, these drugs are used for intermittent treatment. It will be tested if this approach reduces the number of malaria attacks and ameliorates the severity of the disease It will also be determined if anemia due to malaria, which is prevalent in northern Ghana, may be reduced Moreover, the interaction between red cell polymorphisms such as HbS, HbC, alpha-thalassemia and glucose-6-phosphate dehydrogenase deficiency and SP will be examined

Official Title
-----------------
Intermittent Treatment With Sulfadoxine-Pyrimethamine for Malaria Control in Children: A Randomised, Double Blind, and Placebo-Controlled Clinical Trial

Conditions
-----------------
Malaria, Anemia

Intervention / Treatment
-----------------
* Drug: Sulfadoxin (12.5) Pyrimethamine (250 mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent by parents or guardian no concomitant serious disease age >2 months Exclusion Criteria: serious allergy or hypersensitivity to sulfonamides or pyrimethamine no severe hepatic or renal dysfunction serious breach of study protocol

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 4 Months

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sulfadoxin (12.5) Pyrimethamine (250 mg)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and safety of IPTi with SP |  |  | 
| Impact of IPTi on incidence on malaria attacks |  |  | 
| Impact of IPTi on anemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interaction between erythrocyte polymorphisms and SP |  |  | 
| Influence on parasite multiplicity |  |  | 
| Impact on child development |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intermittent preventive treatment, IPTi, Malaria control, Ghana
Evaluation of the Performance of Non-molded Soft Contact Lenses

Study Overview
=================
Brief Summary
-----------------
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.

Detailed Description
-----------------
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.

Official Title
-----------------
Evaluation of the Performance of Non-molded Soft Contact Lenses

Conditions
-----------------
Ametropia

Intervention / Treatment
-----------------
* Device: Soft contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, good health, age >17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood & signed consent form. Exclusion Criteria: Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: soft contact lens<br> | Device: Soft contact lens<br>* Soft contact lens<br>* Other names: Custom O2Optix;|
| No Intervention: non-lens wear<br>control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision. | baseline | 
| Visual Acuity | level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision. | 9 month | 
| Neovascularisation | length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration. | baseline | 
| Neovascularization | length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration. | 9 month |
Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Second arm: patients for which the Fibrin Fleece will be applied directly on the active bleeding site.

Official Title
-----------------
A Prospective, Randomized, Single-Blind, Standard Care Controlled, Multi-Center, Phase II Study Evaluating the Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

Conditions
-----------------
Hemostatic Techniques, Nephrectomy

Intervention / Treatment
-----------------
* Biological: Fleece


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective open partial nephrectomy Patients must be willing to participate in the study, and provide written informed consent Exclusion Criteria: Patients with a tumor diameter greater than 4 cm Any additional surgical intervention other than partial nephrectomy Patients with only one functional kidney Patients with known intolerance to blood products or other components of the product

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: I<br>patients who will be treated in accordance with standard of care | Biological: Fleece<br>* Fibrin Patch<br>|
| Active Comparator: II<br>patients for which the Fibrin Fleece will be applied directly on the active bleeding site. | Biological: Fleece<br>* Fibrin Patch<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of successes at 10 minutes following randomization |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of successes at 5 minutes following randomization |  | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients undergoing elective open partial nephrectomy surgery, Excision of a kidney
Changes of Plantar Pressure After Knee Reconstructive Surgery

Study Overview
=================
Brief Summary
-----------------
Knee reconstructive surgery (knee prosthesis, osteotomies) often results in changes of alignment of the lower limb axis. This affects also biomechanics of the hindfoot. There is a lack of understanding what changes of alignment of the lower limb causes to the ankle. The investigators want to evaluate the effects of knee surgeries onto the plantar foot pressure investigated by means of static and dynamic pedography.

Official Title
-----------------
Evaluation of Static and Dynamic Foot Pressure Measurement After Implantation of Knee Joint Prostheses or Alignment Surgeries of the Knee

Conditions
-----------------
Knee Pain Treated With Knee Arthroplasty

Intervention / Treatment
-----------------
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients planned for knee surgery willing to participate at this study Exclusion Criteria: No informed consent
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 |
| --- | --- |
| Study group<br>Patients with knee surgery undergo plantar foot pressure measurement pre- and postoperatively | Procedure: Surgery<br>* Implantation of knee joint prosthesis or deviation osteotomies of the knee<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot pressure curve preoperatively | scale | -1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot pressure curve postoperatively | scale | 1 year |
Adiponectin and Ethnic Differences in Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to measure and compare levels of the circulating protein adiponectin and adiponectin's association with insulin sensitivity in Mexican Americans and non-Latino white subjects. The investigators also aimed to examine associations between nutritional factors and adiponectin levels.

Official Title
-----------------
Adiponectin as an Independent Determinant of Ethnic Differences in Insulin Resistance

Conditions
-----------------
Insulin Resistance, Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: none- observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-60 years of age BMI 20.0-34.9 m/kg2 Mexican American with at least 3 grandparents born in Mexico or white with no grandparents of Latino descent. Exclusion Criteria: pregnancy breastfeeding diabetes mellitus blood pressure > 160/100 mmHg creatinine > 1.5 mg/dl or glomerular filtration rate (GFR) < 60 liver function tests > 3x upper limit of normal (ULN) h/o heart failure h/o eating disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| non-Latino white<br>no Latino ancestry, Caucasian | Other: none- observational study<br> <br> |
| Mexican American<br>Mexican American ancestry | Other: none- observational study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total adiponectin concentration |  | measured once during second study visit, in fasting condition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | Calculated from insulin and glucose values obtained during IV glucose tolerance test. | Measured once, during second study visit. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin resistance, ethnic disparities, adiponectin
The Epidemiology of Recurrent Spontaneous Abortion Associated With Thrombophilla

Study Overview
=================
Brief Summary
-----------------
RSA is a multifactorial disorder resulting from genetic factors, anatomic factors, autoimmune disorders, endocrine dysfunction, thrombophilia, life style factors, and maternal infections. However, the underlying causes remain undetermined in up to 50% of cases. In this clinical cohort study, we intended to get an epidemiological evidence for patients with recurrent spontaneous abortion associated with thrombophilla.

Official Title
-----------------
Shanghai First Maternity and Infant Hospital

Conditions
-----------------
Recurrent Pregnancy Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman who had 2 miscarriages before 12(th) week of gestation.Signed consent form. Exclusion Criteria: having experienced severe allergies, trauma history and/or operation history within 3 months; with a history of mental illness and/or family history of mental illness limb disabled taking medicine within one month suffering major events or having mood swings with a history of recurrent pregnancy loss having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine) chromosome aberrations in anyone of the couple.

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

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

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 |
| --- | --- | --- |
| D-Dimer |  | through study completion, an average of 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI in kg/m^2 |  | through study completion, an average of 3 year | 
| platelet aggregation time |  | through study completion, an average of 3 year | 
| anticardiolipin antibody |  | through study completion, an average of 3 year |
Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly

Study Overview
=================
Brief Summary
-----------------
ProMO aims to investigate the effectiveness of a newly developed ONS in increasing body weight, muscle mass and function in malnourished elderly compared to standard care.

Official Title
-----------------
Evaluating the Efficacy of a Novel Oral Supplement in Tackling Malnutrition in the Elderly

Conditions
-----------------
Malnutrition, Muscle Health

Intervention / Treatment
-----------------
* Dietary Supplement: ONS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 65+ at risk of malnutrition/ malnourished Exclusion Criteria: • Mental status that is incompatible with the proper conduct of the study Illness of such severity that life expectancy is considered to be less than 12 months Use of diabetes medication (e.g. insulin, methformin) Use of an oral nutritional supplement in the previous three months Participating in any regular exercise training program (≥2h/w) Renal insufficiency (eGFR <30 mL/min/1.73 m2) Unstable organ failure or organ failure necessitating a special diet Chronic corticosteroids use Recent (previous 2 months) use of antibiotics Recent (previous 3 months) change in habitual medication use (e.g statins and thyroxin) Recent blood donation (<1 month prior to Day 01 of the study) Not willing or afraid to give blood during the study Allergic or sensitive for milk proteins Reported vegan or macrobiotic life-style Drug and/or alcohol abuse (current consumption of more than 21 alcoholic drinks per week) Individual unable to give informed consent Current participation in other research from the Division of Human Nutrition Not having a general practitioner Personnel of Wageningen University, department of Human Nutrition, their partner and their first and second degree relatives

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONS1<br>new product | Dietary Supplement: ONS<br>* randomized clinical trial involving different ONS strategies<br>|
| Active Comparator: ONS2<br>usual care | Dietary Supplement: ONS<br>* randomized clinical trial involving different ONS strategies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lean body mass |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  | 12 weeks |