linjc16/ctgov huggingface dataset:
A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and tolerability of zoledronic acid in preventing skeletal-related events in patients with prostate cancer

Official Title
-----------------
A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates

Conditions
-----------------
Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent must be obtained Age > 18 years Histologically confirmed diagnosis of carcinoma of the prostate Current (or previous) objective evidence of metastatic disease to the bone Currently receiving 1st line hormonal therapy with LHRH agonists or other hormonal treatments ECOG performance status of 0, 1, or 2 Exclusion Criteria: Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 60 ml/minute or less Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) WBC<3.0x1'000'000'000, ANC < 1500/mm3, Hgb<8.0 g/dL, platelets < 75 x 1'000'000'000/L. Liver function tests >2.5 ULN, serum creatinine >1.5 ULN. Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol. Known hypersensitivity to zoledronic acid or other bisphosphonates Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study Other protocol-defined inclusion / exclusion criteria apply.

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

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

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: ZOL446 (zoledronic acid)<br> | Drug: Zoledronic acid<br> <br> |

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
-----------------
Zoledronic acid, SRE, Prostate cancer
Ultraviolet Exposure, Antioxidant Use and Skin Erythema at Extreme High Altitude

Study Overview
=================
Brief Summary
-----------------
With the increasing tourism and adventure travel into extreme environments comes the need to reassess the required protection against ultraviolet (UV) radiation and possible other oxidative stresses. This is an observational study of UV radiation exposure and skin erythema while at extreme altitude (Mt. Everest). In addition to UV exposure, skin erythema, antioxidant use (such as vitamins C and E) will be measured. Hypothesis: UV radiation at extreme altitude has larger effects on the skin than at sea level; therefore requiring an adjustment of the antioxidant use for adequate protection. The skin is an accurate reflection of UV and oxidative stress exposure The efficacy of oxidatives stress is reflective of the ethnicity of the individual.

Detailed Description
-----------------
The literature widely acknowledges the deleterious effects of UV radiation on skin health, via production of oxidative free radicals. Consequently, there have been numerous studies on the potential dermatological/anti-carcinogenic benefits of anti-oxidants, such as vitamins C and E, melatonin, green tea, zinc, and selenium. There is, however, a limited amount of literature on the quantity of UV exposure in high-risk settings, such as extreme altitude and equatorial zones. Currently, there is no literature on UV exposure on Mount Everest. Additionally, the efficacy of antioxidants (topical or systemic) has not yet been established in this environment. This will be an observational study where the principal investigator will collect accumulated ultraviolet exposure at different extreme altitudes during a 6 week period of a summit expedition on the north side of Mt. Everest. Included in the data collection will be patient demographics, time, altitude, temperature, use of anti-oxidants, sunscreen (weighed), and skin erythema (spectophotometer).

Official Title
-----------------
Observational Study of Skin Erythema by Spectrophotometer, and UV Exposure With Viospore Ultraviolet Monitors at Extreme Altitude (Mt. Everest, North Side)

Conditions
-----------------
Altitude, Ultraviolet Rays, Antioxidants, Oxidative Stress, Erythema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants part of the expedition who are willing to wear the monitor, and disclose information of diet/antioxidant supplements and topical sunblock. Exclusion Criteria: Participants who are unwilling to carry the UV monitor or disclose their demographics
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Environmental Medicine, Altitude, Ultraviolet Rays, Antioxidants, Oxidative Stress, Erythema
Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)

Study Overview
=================
Brief Summary
-----------------
To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients.

Conditions
-----------------
Immune System Diseases, Autoimmune Diseases, Lupus Erythematosus, Systemic, Skin and Connective Tissue Diseases, Connective Tissue Disease

Intervention / Treatment
-----------------
* Biological: CDP7657
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers and subjects with SLE Exclusion Criteria: Severe neuropsychiatric or severe renal SLE History of chronic, recurrent, or recent severe infection Significant hematologic abnormalities History of cancer, heart failure, renal disease, liver disease or other serious illness

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDP7657<br>CDP7657 in dose escalating cohorts | Biological: CDP7657<br>* Ascending single doses of CDP7657<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo: 0.9% sodium chloride aqueous solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety of CDP7657 as per Adverse Event (AE) reporting |  | Day 0 to 119 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) |  | Day 0 to 119 | 
| Time corresponding to Cmax (Tmax) |  | Day 0 to 119 | 
| Terminal elimination half-life (t 1/2) |  | Day 0 to 119 | 
| Plasma levels of anti-CDP7657 antibodies |  | Day 0 to 119 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus, SLE
Compliance With Antibiotic Treatment in General Practice

Study Overview
=================
Brief Summary
-----------------
The guidelines of The Norwegian authorities concerning the use of antibiotics in general practice state that for several common diseases such as pneumonia and tonsillitis, antibiotics should be given four times daily instead of three times daily. The study´s aim is to see whether the patient compliance is significantly reduced in antibiotic regimes of 3 or 4 daily doses as compared to 1 or 2 daily doses.

Detailed Description
-----------------
All patients given antibiotic tablets, independent of diagnosis and medicament, are included. All patients give a written consent. Within a week after the end of the treatment all patients are contacted by one of the authors and asked a few standardized questions concerning their compliance with the treatment.

Official Title
-----------------
Compliance With Antibiotic Treatment in General Practice

Conditions
-----------------
Patient Compliance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient given antibiotics for any cause Exclusion Criteria: Use of mixture instead of tablets Tablets administrated by public health care services
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 |
| --- | --- | --- |
Bio-assay Development and Implementation for Fungal Infection Detection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the newly developed biosensor can be used to detect and quantify fungal cells in human blood samples.

Detailed Description
-----------------
The study discussed here is part of a broader research project (IOF project) that is aimed at the development and implementation of a point-of-care devices, in which Fiber-Optic Surface Plasmon Resonance (FO-SPR) is used as a detection system. This project includes the development and implementation of the (FUNGDETECT) sensor for fast and accurate detection of fungal pathogens in human blood samples. In first instance, the sensor will be tested in buffer solutions spiked with a known amount of Candida albicans cells. Further validation of the prototype includes detection of these cells in human blood samples. In a first experiment, detection of yeast cells will be performed in blood samples from 5 healthy volunteers each spiked with yeast cells from different Candida spp.. A second experiment includes the detection in blood samples from 15 patients who suffer from a candidemia. The blood samples will be collected from patients of University Hospitals (UZ) Leuven.

Official Title
-----------------
Bio-assay Development and Implementation for Fungal Infection Detection

Conditions
-----------------
Candidemia

Intervention / Treatment
-----------------
* Other: Candidemia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers for validation of the (FUNGDETECT) sensor (Spiked blood samples) Candidemia Exclusion Criteria: None

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 |
| --- | --- |
| Candidemia<br>0 | Other: Candidemia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Candida albicans with the newly developed FUNGDETECT sensor in blood samples from patients with candidemia due to Candida albicans | Patients in the hospital and suspected to have a Candida infection will be tested for Candida infections via blood cultures. Blood samples for patients with a positive test will be taken immediately after the positive result and used to validate the FUNGDETECT sensor. | Blood samples will be collected at baseline from patients directly after informed consent is given | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Candida bloodstream infection, Detection fungal cells, Fiber-Optic Surface Plasmon Resonance (FO-SPR)
AggreGuide 325 mg. Aspirin Study for Aspirin Induced Platelet Dysfunction

Study Overview
=================
Brief Summary
-----------------
To test the AggreGuide A-100 AA Assay's effectiveness for detecting aspirin induced platelet dysfunction.

Official Title
-----------------
AggreGuide 325 mg. Aspirin Study for Aspirin Induced Platelet Dysfunction

Conditions
-----------------
Platelet Dysfunction Due to Aspirin Ingestion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 Exclusion Criteria: on aspirin in prior week medical history of platelet disorders contraindications to aspirin

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 |
| --- | --- | --- |
| Platelet Activity Index (PAI) before and after ingestion of aspirin | PAI is the proprietary reporting unit of the Aggreguide. It is related to the amount of platelet aggregation in the sample of whole blood. | 2 - 30 hours post aspirin ingestion |
Ph1 Marinol Interaction Study - Part 1 - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant interactions before conducting outpatient studies.

Official Title
-----------------
Phase 1, Pilot Study to Examine the Cardiovascular Effects of Smoked Marijuana, Interactions With Oral Dronabinol, and Effects of Dronabinol on Withdrawal in Marijuana Dependent Volunteers

Conditions
-----------------
Marijuana Dependence

Intervention / Treatment
-----------------
* Drug: Dronabinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be between the ages of 18 to 45 years of age Must be in good general health Must meet DSM-IV criteria for marijuana dependence and are non- treatment seekers at the time of study Must be able to provide written informed consent Must be able to provide 1 marijuana positive urine specimen (> 50 ng/mL) within the 28-day screening period If female and of child bearing potential, must agree to use birth control. Exclusion Criteria: Please contact site for more information.

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

| Intervention/Treatment |
| --- |
|Drug: Dronabinol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular responses |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
marijuana dependence
Pain Satisfaction Survey

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to survey pain management satisfaction in patients with non-cancer pain.

Detailed Description
-----------------
This is a multi-center, Observational study consisting of a one time survey to assess pain management satisfaction for patients with non-cancer pain. The purpose of this study is to develop a large clinical database for the results of the pain management satisfaction questionnaire. All information collected from hospitals will be used to evaluate patient satisfaction of pain management and to improve the quality of life for patients with non-cancer pain Observational study - No study drug administered

Official Title
-----------------
A Clinical Survey on Satisfaction of Pain Management in Patients With Non-cancer Pain in Taiwan

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

Intervention / Treatment
-----------------
* Other: Non-cancer pain management survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have visited out patient department (OPD) and who are actively treated for pain Exclusion Criteria: Patients with cancer pain Patients with known or suspected psychotic disease or mental retardation

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 |
| --- | --- |
| 001<br> | Other: Non-cancer pain management survey<br>* Non-cancer pain management survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore pain management satisfaction in patients with non-cancer pain in Taiwan. |  | Visit 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect the information about Quality of Life in patients with non-cancer pain |  | Visit1 | 
| To collect information about medication for pain management |  | Visit1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-cancer pain, Pain
Comparison of Haptic Orientation in Negative Dysphotopsia

Study Overview
=================
Brief Summary
-----------------
Previous studies attempted to understand the dysphotopsia phenomenon by examining intraocular lens type, anterior capsule depth, iris-to-lens depth, lens refractive material, clear cornea incision wounds and anterior capsulorrhexis. However, there is limited literature in understanding haptic orientation and negative dysphotopsia; postulated theories and anecdotal reports relate to horizontal haptic orientation and the lateralization of rays such that light is received both in smaller width and anterior to the peripheral retina; however, no formal studies currently exist.

Official Title
-----------------
Comparison of Horizontal and Vertical IOL Haptic Orientation in Negative Dysphotopsia.

Conditions
-----------------
Negative Dysphotopsia

Intervention / Treatment
-----------------
* Device: Acrylic lens implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with bilateral cataracts that are visually significant meeting standard criteria for removal and select standard monofocal lens implantation. Exclusion Criteria: Patients with any prior refractive surgery including prior cataract surgery, corneal ocular pathology, iris atrophy/damage, retinal or optic nerve pathology. Patients with history of peripheral vision loss. Patients selecting multifocal or toric lens implantation.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vertical orientation of Haptic orientation<br>The orientation of the IOL haptic will be implanted in the vertical position during routine cataract surgery | Device: Acrylic lens implantation<br> <br> |
| Other: Horizontal orientation of Haptic orientation<br>The orientation of the IOL haptic will be implanted in the horizontal position during routine cataract surgery | Device: Acrylic lens implantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of negative dysphotopsia after cataract surgery at 6 months | Presence of negative dysphotopsia in the vertical IOL placement compared to horizontal IOL placement | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of negative dysphotopsia after cataract surgery at 1 week | Presence of negative dysphotopsia in the vertical IOL placement compared to horizontal IOL placement | 1 week | 
| Presence of negative dysphotopsia after cataract surgery at 1 month | Presence of negative dysphotopsia in the vertical IOL placement compared to horizontal IOL placement | 1 month |