linjc16/ctgov huggingface dataset:
Anticoagulation, Vitamins, and Endothelial Function

Study Overview
=================
Brief Summary
-----------------
Determine whether low or high dose B vitamin therapy will lower homocysteine and thrombomodulin in patients anticoagulated with warfarin.

Detailed Description
-----------------
We hypothesize that 1) both high and low dose B vitamin therapy will lower homocysteine in patients anticoagulated with warfarin and 2) high dose B vitamin therapy will lower thrombomodulin in patients anticoagulated with warfarin. To accomplish these specific aims, we proposed a double- blind randomized controlled trial of 6 months duration comparing 2 different multivitamin regimens differing only in the doses of the following 3 vitamins. The multivitamin for the control group has no folic acid, B2, B6, or B 12. The multivitamin for the intervention group has 5 ing folic acid, 1.7 mg B2, 100 mg B6, and I mg B12. Participants age 50 and older, 150 in each group, are being recruited from the Anticoagulation Clinics at the Baltimore VAMC and neighboring centers. Clinical and risk factor information is being obtained through a face-to-face interview. Blood is being drawn for analyses of homocysteine and vitamin levels (University of Colorado Health Science Center) and thrombomodulin (Baltimore VAMC Hemostasis and Thrombosis Laboratory). Data analysis will be conducted according to the intention to treat principle using ordinary least squares regression models.

Official Title
-----------------
Anticoagulation, Vitamins, and Endothelial Function

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Drug: Vitamin B


Participation Criteria
=================
Eligibility Criteria
-----------------
Males and females ages 50 years or greater On warfarin therapy for at least 3 months No active inflammatory process No physician prescribed B vitamins Excluded - women of child-bearing age

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 95 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vitamin B|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
geriatrics, vitamin B complex, thrombomodulin, anticoagulants
Effect of Infant Placement on Iron Stores in Infancy: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is a pilot study designed to assess the safety of placing an infant on the mother's abdomen at the time of delivery, prior to clamping the umbilical cord and the effect of placing the infant on the mother's abdomen on the infant's iron stores. It is possible that placing the infant on the mother's abdomen (above the placenta) may lower the infant's iron stores during early infancy.

Official Title
-----------------
The Effect of Infant Placement at Delivery on Iron Stores in Early Infancy: A Pilot Study

Conditions
-----------------
Iron Deficiency, Anemia

Intervention / Treatment
-----------------
* Procedure: perineum maintained
* Procedure: abdominal placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy pregnant women 37 - 42 weeks of gestation vaginal delivery prenatal care initiated prior to 20 weeks of gestation Exclusion Criteria: maternal diabetes intrauterine growth restriction hypertensive disorders of pregnancy chronic hypertension requiring medical therapy Apgar score less than 7 at 5 minutes unusual bleeding prior to delivery alloimmunization maternal hemoglobinopathy need for immediate infant resuscitation preventing adherence to protocol
Sexes Eligible for Study
-----------------
Female

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: perineum<br>infants maintained at the level of the perineum until umbilical cord clamping | Procedure: perineum maintained<br>* infants maintained at the level of the perineum until umbilical cord clamping<br>|
| Experimental: abdomen<br>infants placed on the maternal abdomen prior to cord clamping | Procedure: abdominal placement<br>* infants placed on the maternal abdomen prior to umbilical cord clamping<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum ferritin level at 4 months of age |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood parameters (hemoglobin and hematocrit) |  | 2 months and 4 months | 
| serum ferritin at 2 months |  | 2 months | 
| blood parameters (hemoglobin and hematocrit) at 24 hrs of age |  | 24 hrs. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iron stores, anemia, iron deficiency, infancy, placental transfusion, iron deficiency in infancy, anemia in infancy, placement of neonate
Topical Anesthesia in Small Gauge Vitrectomy

Study Overview
=================
Brief Summary
-----------------
The use of topical anesthetics is a non invasive option avoiding local or general anesthesia in small gauge vitrectomy without causing intolerable pain

Official Title
-----------------
Pain Scale in the Use of Topical Anesthesia in Small Gauge Vitrectomy

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pseudofaquic or faquic, male or female, 18 to 80 years, primary vitrectomy Exclusion Criteria: Combined surgery Non cooperative patients

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: vitrectomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain scale of pain
Effect of Vitamin A Supplementation on Iron Metabolic Homeostasis of Preschool Children in Sichuan,China

Study Overview
=================
Brief Summary
-----------------
The investigators plan to perform a randomized, mutual-control and double-blinded cohort study to further exploit the vitamin A supplementation on iron metabolic homeostasis (including iron reserve, mobilization and absorption status in the same population) compared with solely iron and vitamin A plus iron.

Official Title
-----------------
Effect of Vitamin A Supplementation on Iron Metabolic Homeostasis of Preschool Children in Sichuan,China

Conditions
-----------------
Iron Metabolic Homeostasis

Intervention / Treatment
-----------------
* Drug: iron and vitamin a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: apparent health; Hb concentration>60 g/L; C-reaction protein (CRP)<10 mg/L; parental or guardian approval of participation in all aspects of the study; and parental/guardian agreement to avoid the additional use of vitamin and mineral supplements during the investigation. Exclusion Criteria: does not match the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iron tablet, vitamin a capsule<br>children in Group I received a 200,000 IU vitamin A capsule just one time initially; Group II received ferrous sulfate (element Fe 1-2 mg/kg•day) once a day for 6 months;. | Drug: iron and vitamin a<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin |  | 6 months | 
| hemoglobin |  | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin a, preschool children, iron metabolic homeostasis, supplementation effect
Treating Gnathic Form of Mesial Occlusion in Early Adolescence Patients

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study was to evaluate the immediate and previous results of the effectiveness of non-surgical orthopedic treatment in children aged 12-14 years with gnathic forms of mesial occlusion by the method of dentoalveolar compensation using a permanent apparatus with a palatal expanding screw.

Official Title
-----------------
Treating Gnathic Form of Mesial Occlusion in Early Adolescence Patients: A Clinical Trial

Conditions
-----------------
Gnathic (Skeletal) Mesial Occlusion

Intervention / Treatment
-----------------
* Device: dentoalveolar compensation method
* Device: face mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a gnathic (skeletal) mesial occlusion patients age 12-14 years patients who underwent orthopedic treatment Exclusion Criteria: change of residence severe form of gnathic mesial occlusion congenital anomalies of the dento-maxillo-facial area

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 14 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 |
| --- | --- |
| The experimental group<br>The experimental group included 26 patients - orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw. | Device: dentoalveolar compensation method<br>* orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw<br>|
| The comparison group<br>The comparison group included 20 patients - orthopedic treatment was performed using a face mask. | Device: face mask<br>* orthopedic treatment was performed using a face mask.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dentoalveolar compensation method | orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw | 2014-2020 | 
| face mask | orthopedic treatment was performed using a face mask | 2014-2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early adolescence, orthodontic practice, orthodontic treatment
Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment

Study Overview
=================
Brief Summary
-----------------
Persistent pain, sensory disturbances, lymphedema and functional impairment are frequently occurring late effects of breast cancer treatment. The investigators have previously published data on 3253 women treated for breast cancer in Denmark in the period 2005-2006. Very few studies have examined how these late effects change in time. The aim of this study is to examine in a well defined patient population any change in the prevalence of persistent pain, sensory disturbances, lymphedema and functional impairment, as well as risk factor profile.

Official Title
-----------------
Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment

Conditions
-----------------
Breast Cancer, Pain, Post Operative Pain, Lymphedema, Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with primary breast cancer between 2005-2006 Participated in a study in 2008 Exclusion Criteria: Recurrent or new primary cancer Metastatic cancer Reconstructive surgery

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer survivors<br>Women treated for breast cancer, without signs of recurrence or metastasis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of persistent pain | Prevalence of pain in the breast area, axilla, side of chest or arm, as a yes/no variable | 6-7 years post operative | 
| Prevalence of patients changing pain status from the 2008 survey |  | 6-7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of sensory disturbance |  | 6-7 years | 
| Prevalence of self reported lymphedma |  | 6-7 years | 
| Prevalence of functional impairment |  | 6-7 years | 
| Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment |  | 6-7 years | 
| Prevalence of patients changing status of sensory disturbances and self reported lymphedma |  | 6-7 years | 
| Risk factors associated to changing status of sensory disturbances and lymphedema |  | 6-7 years post operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, persistent pain, neuropathic pain, lymphedema
Pulse Corticosteroid Therapy and Effect on Brain Water Diffusivity

Study Overview
=================
Brief Summary
-----------------
In daily clinical use, pulse high dosis corticosteroids are used to treat cerebral edema in different pathological situations ( surgery, trauma, tumors...). Dehydration can theorically concern extra-cellular or intracellular water, or both. The relative proportion of those two components are not known, as well their kinetics. Diffusion Weighted Imaging ( DWI) is a none invasive and none toxic technique to study those phenomena.We can also study the diffusivity anisotropy not using a Gaussian distribution but rather a non- gaussian one, more close to the reality ( q Space Imaging ). Finally, we can study the compartment redistribution between slow and rapid water molecules diffusion by bi-exponential decomposition of the diffusion signal, corresponding, theorically, respectively to the intra- and extra-cellular component. Hypothesis : The high dosis steroid pulse therapy modifies or not the water free diffusion in DWI and qSI ? Is there a modification in the diffusivity of both rapid and slow component ?

Conditions
-----------------
Systemic Lupus Erythematosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systemic Lupus Erythematosus normal neurological exam informed consent 18 yo or more Exclusion Criteria: abnormal neurological exam younger than 18 years old

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic Lupus Erythematosus, Corticosteroid, Pulse therapy, Diffusion weighted imaging, q Space Imaging
Preparation of Patients for Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This was a prospective randomised trial of metabolic therapy including antioxidants and cellular energisers to determine whether this therapy could improve the results of cardiac surgery. The hypothesis was that the metabolic therapy could improve clinical recovery.

Detailed Description
-----------------
Objective Perioperative therapy with antioxidants and metabolic substrates has the potential to reduce oxidative stress and improve recovery from cardiac surgery, particularly in elderly and high risk cases. The aim of the study was to assess the effect of perioperative metabolic therapy at a biochemical and clinical level in cardiac surgical patients. Methods Patients (n = 117, mean age 65 ± 1.0 years, 74% male) undergoing elective coronary artery bypass graft (CABG) and/or valve surgery were randomized to receive for a minimum of 2 weeks before and one month after surgery, either metabolic therapy (coenzyme Q10, magnesium orotate, lipoic acid, omega-3 fatty acids and selenium) or placebo. Biochemical and clinical outcomes were assessed.

Official Title
-----------------
Preparation of Patients for Cardiac Surgery

Conditions
-----------------
Coronary Artery Bypass Graft Surgery, Cardiac Valve Surgery

Intervention / Treatment
-----------------
* Dietary Supplement: Metabolic therapy
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective coronary artery bypass graft (CABG) and/or valve surgery Exclusion Criteria: urgent or emergency surgery NYHA class IV heart failure taken antioxidant supplements in the previous month
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metabolic therapy<br>Metabolic therapy with antioxidants and cellular energisers | Dietary Supplement: Metabolic therapy<br>* Coenzyme Q10 - 100 mg tds Magnesium orotate - 400 mg tds Lipoic acid - 100 mg tds Omega-3 fatty acids - 300 mg (in 1 g fish oils) tds Selenium - 200 µg<br>|
| Placebo Comparator: Placebo<br>Placebo tablets | Dietary Supplement: Placebo<br>* Placebo tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin release |  | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | 1 month | 
| Rate of atrial fibrillation |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac, surgery, metabolic, supplements, antioxidant
Study Examing The Effect Of Omeprazole On Safety, Tolerability And How The Body Processes An Experimental Drug

Study Overview
=================
Brief Summary
-----------------
Experiment in the test tube indicated that CP-945,598 becomes less soluble with increase of pH (less acidity). Changes in stomach acid levels may affect the solubility of CP-945,598, therefore, alters its availability in the blood. Omeprazole decreases acid levels in stomach. This study will compare the time course of drug concentrations in the body, safety, and tolerability of CP-945,598 given with and without omeprazole.

Official Title
-----------------
A Phase 1, Open-Label, Fixed Sequence Study To Evaluate The Effect Of Multiple Dose Administration Of Omeprazole On The Single Dose Pharmacokinetics Of CP-945,598 In Healthy Overweight And Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: CP-945,598
* Drug: CP-945,598


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Body Mass Index (BMI) of 26.6 to 40.5 kg/m2. Exclusion Criteria: Non-prescribed use of drugs or abuse of recreational drugs; recent treatment with experimental drugs or herbal experiments; EKG and blood pressure measurements falling outside of protocol-specified limits; history of regular alcohol or tobacco use exceeding protocol-specified limits; medically important health conditions; recent use of prescription or non-prescription medications.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CP-945,598<br> | Drug: CP-945,598<br>* Administration of CP-945,598 alone in period 1<br>Drug: CP-945,598<br>* Adminstration of CP-945,598 with omeprazole in period 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of drug concentrations in serum from blood samples collected at 4 days before given omeprazole, and after second single dose of CP-945,598 on days 1-6, 8. |  | 1 day | 
| Measurement of drug concentrations in serum from blood samples collected at various times after first single dose of CP-945,598 on days 1-6, 8, 15. |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECGs on the first and last day of the study |  | 2 days | 
| Saftey laboratory tests (chemistry, hematology, urinalysis) on the first and last day of the study |  | 2 days | 
| Vital signs (blood pressure, heart rate and respiratory rate) on the first and last day of the study |  | 2 days |