linjc16/ctgov huggingface dataset:
Determining Normal Range for Free Light Chains in Serum Among Twins

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to recruit healthy adult identical and fraternal twins for the collection of one teaspoon of blood to be sent to the Clinical Lab at San Francisco General Hospital. The serum will be tested to determine the reference range for free light chains.

Detailed Description
-----------------
Serum free light chains are used to assist in the diagnosis of multiple myeloma. The test measures kappa (K) and lambda (L) chains, and the calculation of the ratio of kappa to lambda (K/L). Previous studies have shown that the K/L ratio does not change over time (1 year). The hypothesis of this study is that healthy twins will have a K/L ratio that are close to each other in value, suggesting that this ratio is genetically linked.

Official Title
-----------------
Normal Range Study for Free Light Chains in Blood Among Identical or Fraternal Twins

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Device: Free light chains


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects 18-80 years. Must be an identical or fraternal twin (both must be recruited) Exclusion Criteria: Symptoms suggestive of multiple myeloma (e.g., renal insufficiency, anemia, bone pain) -

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy twin<br>Free light chains of twins compared to non-twin siblings | Device: Free light chains<br>* Blood samples will be collected and analyzed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free light chain reference range | Determination of the normal range for free light chains | One month after the completion of the enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
free light chains, healthy twins
Long-term Usage of the Fitbit® Among Medical Residents

Study Overview
=================
Brief Summary
-----------------
This is a one year follow up survey study after a Fitbit® challenge study to determine if wearing a Fitbit® motivates residents to increase their physical activity. This study seeks to determine if residents continue to use the Fitbit® after one year.

Detailed Description
-----------------
Medical training is notoriously stressful. The combination of long work hours, sleep deprivation, clinical responsibilities, and academics leaves little time for residents and fellows to consider their own health maintenance, particularly with regards to physical activity. This is problematic for both the physician and the physician's patients. Numerous studies have shown that physicians who exercise regularly and maintain normal body mass are more likely to counsel their patients on these issues. Additionally, they are more experienced in the benefits of exercise and can counsel their patients on how to incorporate exercise into a busy schedule. This is a one year follow up survey study after a Fitbit® challenge study among TriHealth residents. The purpose of the initial Fitbit® challenge study was to to determine if wearing a Fitbit® motivates residents to increase their physical activity. This study seeks to determine the long-term usage of the Fitbit®.

Official Title
-----------------
Fitbit® Challenge: Can we Motivate Residents to Improve Their Physical Well Being?

Conditions
-----------------
Continuous Fitbit® Use

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residents in training 18 years of age or older Residents who participated the initial Fitbit® challenge study Exclusion Criteria: Physical impairment inhibiting the ability to walk or complete the validated questionnaires

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fitbit® challenger<br>The residents who participated a Fitbit® challenge study about one year ago | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Status of Fitbit® use - descriptive measure | This is a binary outcome, either Yes or No to survey question #20 Do you still wear your Fitbit® originally received as part of the Fitbit® study? | One year after the initial Fitbit® challenge study |
AcrySof Toric Clinical Results

Study Overview
=================
Brief Summary
-----------------
This study is an evaluation of visual outcomes of subjects implanted with the AcrySof Toric Intraocular Lenses (IOLs) Models SN60T3, SN60T4, and SN60T5.

Official Title
-----------------
Clinical Results With the AcrySof Toric Intraocular Lens (IOL)

Conditions
-----------------
Cataracts, Astigmatism

Intervention / Treatment
-----------------
* Device: T3
* Device: T4
* Device: T5


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with cataracts; has astigmatism falling in range of AcrySof Toric lens as assessed by the AcrySof Toric calculator Exclusion Criteria: Ocular comorbidities affecting visual outcome data, Prior refractive surgery, Irregular astigmatism

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| T3<br>Model SN60T3 assigned by AcrySof Toric calculator | Device: T3<br>* Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T3<br>|
| T4<br>Model SN60T4 assigned by AcrySof Toric calculator | Device: T4<br>* Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T4<br>|
| T5<br>Model SN60T5 assigned by AcrySof Toric calculator | Device: T5<br>* Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T5<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | 1 day to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative refractive cylinder |  | 1day to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Toric Intraocular Lens (IOL)
Leukemic Phase of ALCL

Study Overview
=================
Brief Summary
-----------------
Collecting data about the rare leukemic presentation of anaplastic lymphoma to study the characteristics of patients with leukemic phase of ALCL

Official Title
-----------------
Leukemic Phase of ALK+ Anaplastic Lymphoma in Real-life Practice: Experience of a University Clinical Hematology Laboratory

Conditions
-----------------
Anaplastic Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting a leukemic phase of anaplastic lymphoma Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 9 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 |
| --- | --- | --- |
| A retrospective study of the diagnostic description of the leukemic phases of anaplastic lymphoma in real life |  | Files analysed retrospectively from January 01, 2020 to December 31, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anaplastic lymphoma, Leukemic phase
Effect of Intraoperative Paravertebral Block on Postoperative Pain and Recovery in Patients Undergoing Mechanical Correction for Scoliosis

Study Overview
=================
Brief Summary
-----------------
Pain management after scoliosis surgery is challenging for the anesthesiologists. This surgery causes severe postoperative pain and patients undergoing these operations are children or adolescents who are increased pain sensation compared with adults. Therefore, we aim to evaluate whether intraoperative paravertebral block (PVB) decreases postoperative pain in these patients. Thirty-two patients scheduled for mechanical correction due to scoliosis will be divided into PVB (n=16) and control (n=16) groups. Randomly selected patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides. In contrast, PVB are not performed in the control group.

Official Title
-----------------
Effect of Intraoperative Paravertebral Block on Postoperative Pain and Recovery in Patients Undergoing Mechanical Correction for Scoliosis

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Procedure: Paravertebral block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing mechanical correction Exclusion Criteria: The subjects who cannot communicate The subject is a foreigner or illiterate

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum 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
Interventional Model Description: Randomly selected patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides. In contrast, PVB are not performed in the control group.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVB group<br>Patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides | Procedure: Paravertebral block<br>* Randomly selected patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides.<br>|
| No Intervention: Control group<br>PVB are not performed in the control group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | visual analog scale (VAS) (0-10) | 6 hours after the end of surgery |
Effects of Bortezomib-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand what effects Bortezomib, a drug used for multiple myeloma therapy, has on the immune system.

Detailed Description
-----------------
Subjects on this study will be receiving treatment for multiple myeloma according to the standard of care with a regimen containing Bortezomib. If a bone marrow sample is clinically indicated to guide treatment, an additional 1 tablespoon of the specimen will be obtained for further laboratory studies. Approximately 3 tablespoons of blood will be taken for research purposes before therapy with Bortezomib starts. When subjects return for follow-up after cycle 1, 2, and 3 and additional 3 tablespoons of blood will be taken for research purposes. Optional samples of blood may be taken at follow-up visits after cycles 4, 5 and 6 and 1, 3 and 6 months after completing therapy. This study also includes a medical record review.

Official Title
-----------------
Effect of Bortezomib (Velcade)-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Procedure: Blood draws


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed multiple myeloma Therapy with bortezomib alone or bortezomib/dexamethasone being initiated as the standard of care therapy for myeloma by their treating physician Exclusion Criteria: Hypersensitivity to bortezomib, boron or mannitol Treatment with other investigational drugs within 28 days before enrollment Diagnosed or treated for another malignancy within 6 months of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy Use of other myeloma directed therapy (except for dexamethasone) in combination with bortezomib

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Bortezomib treatment<br>Subjects receiving standard of care regimen including Bortezomib | Procedure: Blood draws<br>* Blood draws<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of bortezomib on circulating dendritic cell and T cell populations | Whether treatment with bortezomib reverses measures of tumor mediated immune suppression proving an improved platform for tumor specific immunotherapy | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MM, Bortezomib, Velcade
Patient Preference for Biopsy Notification

Study Overview
=================
Brief Summary
-----------------
Effective communication between physician and patient is fundamental to effective care. The recent introduction of electronic patient on-line portals has the potential to change the communication landscape. The investigators surveyed patients to assess their preferred modality for biopsy notification at 3 institutions with differing patient access to on-line portals, to ascertain what patient preferences are currently and if it has changed from historical preferences. Our hypothesis is that as patients become more familiar with ln-line portals, their preferences will likely reflect familiarity with this modality.

Official Title
-----------------
Patient Preference for Biopsy Notification

Conditions
-----------------
Elevated Risk for Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were 18 years of age or older and English speaking were eligible to participate Exclusion Criteria: Younger than 18, non-English speaking.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Elevated risk for melanoma<br>Individuals at increased risk for melanoma due to past history of melanoma, family history of melanoma, the presence of many moles, the presence of a genetic mutation known to increase the risk of melanoma. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference for biopsy notification | Patients were asked to rank in order of preference their preferred method for being notified of a skin biopsy result | 1 year |
Extra Sitting Time After Spinal Anesthesia for Cesarean Section and Fetal Well-being

Study Overview
=================
Brief Summary
-----------------
After injection of the spinal anesthetic drug, women will be allowed to lie down immediately (0-30 sec) or after three minutes (180 sec) of sitting. The incidence of maternal hypotension and fetal umbilical cord blood pH will be recorded.

Official Title
-----------------
The Effect of Sitting After Spinal Injection of Hyperbaric Local Anesthetic on Fetal Acid-base Balance After Cesarean Delivery

Conditions
-----------------
Complications; Cesarean Section, Hypotension

Intervention / Treatment
-----------------
* Other: Various sitting time


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with elective cesarean delivery at 39-42 wks gestation. Exclusion Criteria: Women who shorter than 5'0 in height, those with primary or pregnancy-induced hypertension, macrosomia, multiple gestation will be excluded. Women with known risks of bleeding or potential hysterectomy such as those with placenta previa or accrete will also be excluded. If the epidural catheter cannot be placed within the specific time frame after the spinal injection, the case will be excluded.
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Active Comparator: Immediately Supine Position<br>Women placed in supine position within 30 seconds after spinal injection of local anesthetic drug. | Other: Various sitting time<br>* Various sitting time<br>|
| Active Comparator: Delayed Supine Position<br>Women placed in supine position after three minutes of seating after spinal injection of local anesthetic drug. | Other: Various sitting time<br>* Various sitting time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of fetal umbilical artery pH below 7.20 |  | At fetal delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of maternal hypotension |  | During cesarean surgery |
Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets

Study Overview
=================
Brief Summary
-----------------
A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is <100mg/dl for patients with high risk and <70mg/dl for patients at very high risk) are screened (hospital-based specialists). The doctors therapy decisions after the screening and possible reasons for these decisions will be documented. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.

Official Title
-----------------
Non-interventional Study Investigating How Effective Secondary Prevention Patients Are Treated to Their LDL-C Targets

Conditions
-----------------
Hyperlipidemias, Atherosclerosis, Coronary Heart Disease, Carotid Stenosis, Peripheral Vascular Diseases, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes who already receive cholesterol-lowering therapy Exclusion Criteria: Patients who do not receive cholesterol-lowering therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients at very high risk<br> | |
| Patients at high risk<br> | |
| Patients at medium risk<br> | |
| Patients at low risk<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholesterol levels | Cholesterol levels from high risk patients after 4 weeks of cholesterol-lowering drug therapy under target values | After 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperlipidemia, Need-to-treat, NIS, Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes
A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical markers of bone in post-menopausal osteoporotic patients aged between 50-65.

Official Title
-----------------
A One Year, Local, Open Label, Multicentre Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on BMD and Biochemical Markers of Bone in PMO Pts Between the Ages of 50 and 65 Years

Conditions
-----------------
Postmenopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: Zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal osteoporosis Patients who has a low bone mineral density at hip or vertebral Patients who has an osteoporotic fracture at hip or vertebra Exclusion Criteria: Hypersensitivity either to the active substance or to any of the excipients or to any biphosphonates. Known metabolic bone disease excluding osteoporosis. Serious systemic disorder treated with drugs interfering with bone metabolism. Significant liver or renal failure Pathologic fracture in the examined body area or elsewhere. Previous anti-osteoporotic treatment within 12 months or less prior to the recruitment. Patients with hypocalcaemia Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 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: Zoledronic acid<br> | Drug: Zoledronic acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - BMD |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Biochemical markers |  | 6 months | 
| Safety - Rate of adverse events and serious adverse events |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarkers, Osteoporosis, Bone Mineral Density