cyrilzakka/clinical-trials huggingface dataset:
Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma

This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects. Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been demonstrated, the mild to moderate side effects of all of these agents are not predicted to cause prohibitive toxicity. A brief phase I portion will be included in this trial, to optimize doses of the 3 agents prior to proceeding with the phase II trial.

Upon determination of eligibility, patients will be receive:

Bevacizumab + Erlotinib + Imatinib

A brief phase I dose escalation study will be performed to define the imatinib dose that will be used.

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic or unresectable clear cell renal carcinoma confirmed by biopsy
* Previous nephrectomy is required
* Maximum of 1 previous systemic regimen for metastatic disease.
* Able to perform activities of daily living with minimal assistance
* Measurable disease
* Adequate bone marrow, liver and kidney
* Written informed consent.

Exclusion Criteria:

* Age \< 18 years
* Treatment with more than 1 previous systemic regimen
* History of heart attack within 6 months
* Clinically significant cardiovascular disease
* Moderate to severe vascular disease.
* Active brain metastases.
* History or evidence by physical examination of brain tumor
* Seizures not controlled with standard medical therapy
* history of stroke or other serious disorders of the nervous system
* Clinical history of coughing or vomiting blood within the past 3 months.
* PEG tubes or G tubes
* Chronic therapy with NSAIDS or other platelet inhibitors
* Proteinuria
* Nonhealing wound, ulcer, or long bone fracture
* Clinical evidence or history of a bleeding disorder
* Requiring full dose anticoagulation with coumadin
* Receiving chronic steroid therapy
* Significant medical conditions.
* Tumors other than clear cell
* History of stroke within 6 months.
* History of abdominal fistula,perforation,or abscess within 6 months.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Deep Tissue Massage on Pain and Comfort After Cesarean

The aim of this study to determine the effect of deep tissue massage applied to the back on pain and comfort after cesarean section. Personal information form was used as data collection form, Visual Analog Scala was used to assess pain, and Postpartum Comfort Questionnaire was used to assess comfort.

Material and Method

This research was conducted between May 2019 and November 2019 in Inonu University Turgut Ozal Medical Center Training and Research Hospital. When power analysis was performed, the sample size was calculated to be at least 81 women for each group (81 experiments, 81 controls). Experimental group received deep tissue massage twice at 11st and 23rd hours after cesarean section. Data collection form for experimental and control groups before the first massage; Visual Analog Scala was applied four times before and after both massages. After the second massage, both groups were re-administered. Descriptive statistics and independent t-test were used for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Pain severity is 45 mm or more according to the Visual Analogue Scale (VAS),
* Having a single and healthy newborn,
* Does not respond negatively to any attempt to touch like massage,
* Women whose tissue integrity is complete and healthy in the area to be massaged were included in the sample.

Exclusion Criteria:

* Those with cesarean section with general anesthesia,
* Any problems diagnosed before birth and at birth (such as oligohydramnios, preeclampsia, heart disease, diabetes, placenta previa)
* Any complications related to the mother and baby in the postpartum period (bleeding, hypertension, babies taken to the neonatal intensive care unit, etc.),
* Those who received repeat doses other than routine narcotic analgesics (0.5 mg in the first 30 minutes) were not included in the study.
Psoriasis and the Risk of Cardiovascular Disease. A Prospective Study

There is growing evidence that psoriasis is a systemic disorder which enhances atherosclerosis and the risk of cardiovascular disease. Epidemiological studies have shown an independent association between psoriasis and atherosclerosis, stroke and coronary artery disease. The main goal of this on-going study is to register data which will enable the identification of new markers of atherosclerosis activity and carotid plaque instability in patients with severe psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old, psoriasis for more than 5 years, moderate to severe psoriasis (PASI \>10 or systemic treatment)

Exclusion Criteria:

* familiar hypercholesterolemia, ongoing infections and cancer disease
Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma

RATIONALE: Collecting and storing samples of blood and tissue from family members of patients with cancer to test in the laboratory may help the study of cancer in the future.

PURPOSE: This clinical trial is collecting blood and tissue samples from family members of patients with pancreatic disease, pancreatic cancer, and melanoma.

OBJECTIVES:

* To collect clinical history, family history, and blood and/or tissue samples from family members of patients diagnosed with pancreatic diseases, pancreatic cancer, or melanoma.
* To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers.

OUTLINE: Study participants undergo collection of blood and/or tissue samples as well as survey data for inclusion in a familial data and tissue registry. Participants complete two baseline surveys regarding their personal, family, health, and environmental exposure histories and regarding their opinions on cancer and cancer screening. Patients also complete a follow-up survey at 1 year and undergo review of their medical records.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Has at least 2 blood relatives with pancreatic cancer (both must be related)
  * Has at least 1 blood relative with pancreatic cancer and 1 with melanoma (both must be related)

PATIENT CHARACTERISTICS:

* Mentally competent and able to provide informed consent
* Able to understand and read English

PRIOR CONCURRENT THERAPY:

* Not specified
Norwegian Psychomotor Physiotherapy in Patients With Long-lasting Musculoskeletal Pain.

The aim is to examine the effect of Norwegian Psychomotor Physiotherapy (NPMP) in employees with long-lasting musculoskeletal pain compared to employees receiving Cognitive Patient Education in combination with active individual physiotherapy (COPE-PT) on pain, function, quality of life and sick-leave

The NPMP is based on the assumption that patients with long-lasting problems, physical and/or psychological, may react with general aberrations related to posture, respiration, and movements, as well as with muscular tension and skin changes.

Employees With Long lasting musculoskeletal pain problems, working in the Municipality of Bergen, will be invited to participate in an Randomized Clinical Trial (RCT), and randomized to either receive Norwegian Psychomotor Physiotherapy (NPMP) or a series of Cognitive Patient Education in combination with active individual physiotherapy (COPE-PT). The aim is to examine the effect of NPMP compared to those receiving COPE-PT on pain, function, quality of life and sick-leave.

Eligibility Criteria:
Inclusion Criteria:

* Patients With neck,shoulder and/or widespread pain
* Pain (≥ 3 Numeric Pain Rating Scale (NPRS)
* Functional problems measured with Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ), Neck Disability Index (NDI) and/or Shoulder Pain and Disability Inventory (SPADI)-been sick-listed for 4-8 weeks, or on the brink of becoming sick-listed, or having had residual neck- and shoulder complaints problems during the last two years with several short-term sick-leaves.
* =/6 American College of Rheumatology (ACR) tender points,
* Reduced Relaxation and Flexibility from the Global Physiotherapy Examination (GPE)

Exclusion Criteria:

* Sick-listed \> 6 months
Doctor-Parent Interactions With Medical Scribes

The purpose of the study is to collect outcomes related to a quality improvement project assessing the feasibility and effectiveness of a medical scribe program in which medical scribes accompany clinicians during their visits with patients. The medical scribes involved in the project are professional scribes and medical students who will accompany clinicians during patient visits and takes notes, enabling the clinician to engage more directly with the patient.

The study has several specific objectives. This study aims to examine the impact of using medical scribes on (1) patient experience (e.g. patient satisfaction) (2) clinician experience (e.g. stress load, burnout, evaluation of the visit, amount of time spent after hours inputting notes), and (3) clinician-patient interaction (e.g. patient and clinician engagement during the visit).

Eligibility Criteria:
Provider Participants

Inclusion Criteria:

1. Attending clinicians with privileges at Penn State Hershey Children's Hospital and/or the Penn State Hershey Internal Medicine. This may include attending MDs or DOs and Nurse Practitioners (NPs).
2. Voluntary participation in the medical scribe QI project.
3. Consents to participate in the study.

Exclusion Criteria:

1. Clinician is not participating in the scribe project.
2. Clinician does not consent to participate in the research portion of this project.

Patient Participants

Inclusion Criteria:

1. Patient (if 18 years or older) or parent/guardian (P/G) of patient being seen by a participating clinician.
2. Patient was not seen by a resident or medical student prior to meeting with clinician.
3. English speaking/reading.
4. Patient or P/G has capacity to consent.

Exclusion Criteria:

1. Patient is seeing a clinician who has not consented to participate in the research portion of the study.
2. Non-English speaking/reading.
3. Patient or P/G lacks capacity to consent.
Integrating SPOZ Technology to Support and Enhance the Vitality Acupunch (VA) Exercise Program for Older Adults With Dementia

This project aims to examine the effects of a six-month VA exercise program incorporate the SPOZ technology in improving the disease dysfunction and functional fitness deterioration of older adults with dementia in adult daycare centers.

A cluster-randomized controlled trial will be conducted to examine the effects of a six-month VA exercise program incorporate the SPOZ technology in improving the disease dysfunction, functional fitness deterioration (balance, lower muscle endurance, gait speed, handgrip strength, cardiorespiratory endurance, muscle endurance, agility, body flexibility), activities of daily living, instrumental activities of daily living, and sleep quality of older adults with dementia in adult daycare centers. Using convenience sampling, 10 adult daycare centers with 122 older adults will be recruited, and then cluster-randomized by the daycare centers to an experimental or a control group. The experimental group will receive a 40-minute program 3 times a week for 6 months; the control group will maintain their routine activities. The two groups will be measured at three time points: before the intervention, and at three months and six months of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as dementia by a physician, or
* screened by the SPMSQ as dementia
* age 65 and older

Exclusion Criteria:

* have severe cardiopulmonary disease
* have physical mobility impairment
* have spinal cord injury
Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis

The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of ocular allergy to cats.
* Positive skin prick allergen reaction to cat dander.

Exclusion Criteria:

* Use of any topical or systemic corticosteroids, immunosuppressive agents, antihistamines, decongestants, NSAIDs, or asprin during the two weeks prior to enrollment into the study.
* History of severe asthma, reactive airway disease or bronchial obstruction.
* Ocular surgery or trauma in the last year.
FFOCT for the Diagnosis of Prostate Cancer

Primary objective :

The primary objective is to evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation.

Secondary objective:

* Evaluate predictive values of FFOCT for cancer detection on prostate biopsy cores
* Evaluate the value of FFOCT for cancer characterization on prostate biopsy cores
* Evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores
* Evaluate the learning curve of FFOCT evaluation on prostate biopsy cores
* Evaluate FFOCT procedure time

Research in optical imaging has led to the development of the Full Field Optical Coherence Tomography (FFOCT) technology, which allows to image fresh tissues up to a depth of a few hundreds microns. The system is a microscope coupled with an interferometer. A halogen light source is used to illuminate the tissue specimen and a reference mirror. The light retro diffused by the specimen is combined with the light reflected by the mirror, and the interference signal is measured. Multiple Grey scale images are obtained and automatically stitched to obtain a complete slide throughout the specimen. The feasibility of the technique has been reported in various pilot studies, as well as the absence of any potential tissue harm and subsequent pathological artifact caused by the process.

FFOCT could be used as an additional detection tool for prostate cancer screening. The use of extended systematic trans-rectal ultrasound-guided (TRUS) prostate biopsies has led to over-diagnosis and over-treatment. Also, the number of unnecessary biopsies has increased, along with the morbidity of the procedure. Performing a "pre-pathological" evaluation of biopsy cores during the biopsy procedure would be of significant help to determine the nature of targeted areas and guide the number of biopsies to perform.

We hypothesize that FFOCT imaging of prostate biopsy cores would allow a cancer detection rate not statistically different from pathological analysis.

Eligibility Criteria:
Inclusion Criteria:

* - Patient aged 45 to 75 years old included
* - PSA level 4.0 ng/mL
* - Patient referred for trans rectal ultrasound-guided prostate biopsy with additional MRI-targeted biopsies
* - Patient no opposed to participate in the study
* Patient affiliated to the French National Social Security System

Exclusion Criteria:

* Known prostate cancer
* Patients unable to understand the course of the study
Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Insulin Products / Long-term Treatment"

The purpose of this study is to investigate the safety and efficacy of long-term treatment with pioglitazone (Actos Tablets) in the routine clinical setting in combination with an insulin product in patients with type 2 diabetes mellitus who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy.

This is a special drug use surveillance on long-term use of newly co-administered pioglitazone tablets (Actos Tablets) as part of routine medical care in patients with type 2 diabetes mellitus who have poorly controlled blood glucose when using an insulin product in addition to diet therapy and exercise therapy; this survey is designed to determine the safety and efficacy of long-term use of pioglitazone tablets (Actos Tablets) in the routine clinical setting in combination with an insulin product (the planned sample size, 1000.) The usual adult dosage is 15 mg of pioglitazone administered orally once daily before or after breakfast. Dose adjustment will be made according to gender, age, and symptoms with an upper limit of 30 mg.

Eligibility Criteria:
Inclusion Criteria:

Participants with type 2 diabetes mellitus assumed to have insulin resistance who responded inadequately when using an insulin product in addition to diet therapy and exercise therapy who meet the following criteria at enrollment.

1. Participants treated with an insulin product for at least 4 weeks
2. Participants who started Actos Tablets for the first time after the start of an insulin product
3. Participants likely to be available for a 52-week observation and evaluation after the start of co-administration of Actos Tablets

Exclusion Criteria:

Participants with contraindications to Actos Tables and insulin products treatment
Comparison of Heparin Types; Efficacy and Safety

Heparin, a blood thinner, is used routinely in Open-heart surgery. Do different brands of this drug have differing clinical effects despite both having exactly the same regulation and marketing specifications?


Eligibility Criteria:
Inclusion Criteria:

* will be undergoing cardiopulmonary bypass for coronary artery disease
* has provided written informed consent

Exclusion Criteria:

* Allergy or intolerance to Heparin
Nutrients-fortified Egg Consumption on Eczema Condition in Individuals With Eczema

The study aims to assess the effects of daily consumption of nutrients-fortified eggs on eczema condition in individuals with eczema.

It is hypothesised that daily consumption of nutrients-fortified egg, which is rich in antioxidants, will improve eczema conditions in individuals with eczema as compared to consumption of regular eggs.

Eczema refers to a group of conditions that induces inflammation of the skin. Of which, atopic dermatitis is the most common type. Eczema is common in children, and can continue to adulthood. Eczema is a chronic condition with no known cure.

Anti-inflammatory agents have been shown to protect against atopic dermatitis. Vitamin D, E and polyunsaturated fatty acids are known to confer excellent anti-inflammatory benefits.

This is a double-blinded, randomized, parallel study and all subjects will complete a 12-week study period. The study was designed based on previous research which reported that omega-3 supplementation significantly decreased blood IgE concentration (-29.0 ± 11.1, mean ± SD) compared to placebo supplementation (-7.7 ± 14.6, mean ± SD).

Eligibility Criteria:
Inclusion Criteria:

1. English-literate and able to give informed consent in English
2. Male and female subjects, aged between 21 and 59 inclusive
3. Healthy individuals with no comorbidities or on regular medication
4. BMI between 18.5-25 kg/m2
5. Mild to moderate severity of eczema, which will also be determined using our questionnaires during screening visit

Exclusion Criteria:

1. Significant change in body weight (3 kg or more) in the past 3 months
2. Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week
3. Known food allergy to eggs
4. Taking dietary supplements which may impact the study results
5. Had been diagnosed or with a history of gastrointestinal disorders e.g. irritable bowel syndrome, constipation, diverticulitis
6. Current smokers
7. Consumes more than 2 alcoholic drinks per day i.e. one drink is defined as either 150ml of wine, 340ml of beer/cider or 45ml of distilled spirit
8. Taking lipid-lowering and blood pressure controlling medications less than 3 years
9. Pregnant or lactating women, or planning to conceive in the next 6 months
10. Unwilling to stop the medication of eczema during the study, either topical creams or oral medications
11. Hierarchical link (professional and familial ties) with the research team members
12. Participating in another clinical study
13. Having blindness in one eye or more, previously diagnosed eye diseases, or have had eye surgery
14. Low quality macular pigment optical density results, determined during screening visit
Dietary Intervention, Gestational Weight Gain and Gestational Diabetes.

The aim of this pilot study is to conduct a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women in two maternity care clinics and explore the effect of the intervention on gestational weight gain and the prevalence of gestational diabetes between the intervention and control groups.

Half of the women are allocated to the intervention group and another half for the control group. The intervention group will get written material of healthy diet during pregnancy as well as emphasized nutritional guidance given by public health nurses at each visit in the maternity care clinic. There will also be two group meetings with a dietitian. The control group will get the same written material, but otherwise basic care and guidance at each visit in the maternity care clinics. The collected data of both groups include the information on weight gain, the result of an oral glucose tolerance test and 4 day food records, Three factor eating questionnaire (TFEQ R-18) and Binge Eating Scale (BES).

Eligibility Criteria:
Inclusion Criteria:

* Age less than 35 years
* BMI 25 or over
* healthy, no chronic medical conditions
* singleton pregnancy
* first trimester of pregnancy at the time of recruitment

Exclusion Criteria:

* Age 35 and older
* BMI less than 25
* chronic medical conditions
* multiple pregnancy
* pregnancy at second or third trimester at the time of recruitment
Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous

The purpose of this study is to assess health-related Quality of Life (QoL) changes in participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT) undergoing hemodialysis and receiving paricalcitol intravenous (iv).

The scientific purpose of this study is to obtain data on the use of paricalcitol iv in real-life clinical practice and the effect it has on participant health-related QoL. In this study, paricalcitol iv will be prescribed on an on-label basis in an everyday setting. The RAND 36-Item Health Survey results will be collected for a 6-month period (every 3 months) in order to assess the effect of paricalcitol iv on participant health-related QoL.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic kidney disease stage 5 undergoing hemodialysis and receiving paricalcitol iv for more than 1 month.
2. Patients with a RAND 36-Item Health Survey completed 10 to 35 days before paricalcitol iv initiation
3. Patients with baseline parathormone ≥ 300 pg/mL
4. Patients willing to give their informed consent to participate in the study.
5. Patients should not receive vitamin D-related compounds or cinacalcet for 3 months prior to entering the study
6. Patients must be on steady regimen for anemia, hypertension and diabetes for the past 30 days

Exclusion Criteria:

1. Patients with a history of clinically significant intolerance or sensitivity to vitamin D or any ingredients of the product.
2. Patients with persistent hypercalcemia or evidence of vitamin D toxicity.
3. Patients with a continuous increase in serum (calcium x phosphorus) product greater than 65.
4. Pregnant or lactating female patients.
5. Patients who have previously undergone parathyroidectomy