cyrilzakka/clinical-trials huggingface dataset:
Dip Home-Based Dipstick Analyzer Performance Evaluation

The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance, including providing a urine sample and scanning the urine strip after placing it on the Color-Board. The user will also complete a questionnaire to collect information regarding the use of the HBDA device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device. The use of the HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18-80 years of age
* Subjects who are healthy or pregnant; or
* Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite
* Subject is capable and willing to provide informed consent.
* Subject has facility with both hands.
* Subject is capable and willing to adhere to the study procedures
MedlinePlus Health Prescriptions: Developing a Pragmatic Approach for Clinic Use

The specific aim of this proposed pilot study is to compare two standardized processes (paper and electronic) to deliver a customized MedlinePlus health information prescription.

The specific aim of this proposed pilot study is to compare two standardized processes (paper and electronic) to deliver a customized MedlinePlus health information prescription.

Primary Hypothesis. Individuals in the paper prescription group will be just as likely to seek information using MedlinePlus compared with individuals in the group who receive the same customized information through an email prescription.

Secondary Hypothesis. Individuals in the paper prescription group will be just as likely to have successful behavioral outcome measures as those in the group who receive the same customized information through an email prescription.

Eligibility Criteria:
Inclusion Criteria:

* one of the 40 target health conditions.

Exclusion Criteria

- absence of at least one of the target 40 conditions
Comparison of Balanced Crystalloids and Normal Saline in Septic Patients

In this prospective randomized controlled trial, investigators attempt to study the effects of acetated Ringer's solution on the prognosis and renal function of patients with sepsis in intensive care unit compared with normal saline, and provide evidence for current fluid resuscitation strategies for sepsis.

During the study period，either normal saline or acetated Ringer's solution will be assigned as resuscitation fluid to the septic patients meeting the inclusion criteria.It is anticipated that about 500 patients will be enrolled during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed sepsis aged 18\~75 and accepted therapy in ICU

Exclusion Criteria:

* Need of Renal replacement treatment
* End-stage renal failure
* pregnant woman
Efficacy of a Novel Walking Assist Device With Auxiliary Laser Illuminator on Stroke Patients

Many patients after acute stage of stroke present with abnormal gait pattern due to weakness or hypertonicity of the affected limbs.

Ambulation training with the use of visual feedback strategy is one of the promising rehabilitation in patients with chronic stroke.

Walking assist device with auxiliary laser illuminator during ambulation training could correct gait parameters, improve balance and basic activity of daily living among stroke patients.

Facilitation of normal gait is a primary goal of rehabilitation on patients with stroke. The investigators aimed to investigate whether walking assist device with auxiliary lser illuminator (laser quad-cane) providing visual feedback during ambulation could improve parameters of gait cycle and function among patients with chronic stroke.

Methods: This was a randomized-prospective study and participants were recruited to each the experimental and the control group equally. Patients in the experimental group (EG) received 30-minutes rehabilitation, consisting of 15 minutes of walking training with laser quad-cane and 15 minutes of traditional physical therapy (such as strengthening and balance training). Patients in the control group (CG) received the same rehabilitation except that the walking training was by conventional strategy without lase quad-cane. The rehabilitation lasted for 4 weeks, twice per week. Gait parameters were measured by Rehab watch as primary outcomes and Berg's balance scale (BBS), timed-up-and-go test (TUG), and Barthel index were used as secondary outcomes. Both the primary and secondary outcomes were measured before the rehabilitation (baseline), 4 weeks (week 4), and 8 weeks (week 8) after the rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Stroke patients at subacute (stroke symptoms between three months to one year) or chronic stage (stroke symptoms more than 1 year)
* with hemiplegia
* with sufficient cognition that could follow the instructions and procedure
* walk independently for a distance of more than 20 meters with or without the use of a walking aid.

Exclusion Criteria:

* Stroke patients with other neurological diseases like Parkinsonism,
* Myopathy
* Multiple sclerosis
* Spinal cord injury that might interfere with walking ability
The Effect of Oketani Breast Massage on Breastfeeding

This study aims to determine the effects of Oketani breast massage on breastfeeding success, breastfeeding self-efficacy and satisfaction of primiparous mothers.

Breastfeeding is the most important factor in infant nutrition. Breast milk is a nutritional source that contains the necessary nutrients for the healthy growth of infants after birth and has many benefits in terms of growth and development. However, although the rate of breastfeeding has increased today compared to the past, it is still not at the desired level. In order to increase breastfeeding rates, breastfeeding trainings and massage should be given starting from the prenatal period. It is important for health professionals to provide training and consultancy to women in order to manage the breastfeeding process correctly, which is important for the health of both the mother and the baby. In this direction, as a result of this study, it is thought that correct breastfeeding behavior and self-sufficiency will be developed in mothers by using the oketani breast massage method. No study has been found in our country where this method is used. In this respect, the study is original. As a result of the study, it is thought that the use of oketani breast massage by health professionals while providing breastfeeding education and consultancy will facilitate the breastfeeding process.

Eligibility Criteria:
Inclusion Criteria:

* To volunteer to participate in the study,
* To be over 18 years of age,
* To be able to read and write,
* To be able to read and understand Turkish,
* To have no hearing, speech or visual impairments,
* To have received breastfeeding training at a pregnancy school,
* To be healthy in the 36th week of primiparous pregnancy.

Exclusion Criteria:

* Obstacles to communication include having a visual, hearing or perception disorder,
* Not being able to read or write,
* Having a psychiatric illness,
* Being multiparous and having a vaginal birth,
* Having a risky pregnancy.
Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women

To evaluate the antitumor activity, toxicity, and effectiveness of the combination of goserelin (Zoladex) and anastrozole (Arimidex) in the treatment of premenopausal women with hormone receptor positive metastatic carcinoma of the breast.

Pre-menopausal women with estrogen and/or progesterone receptor positive, metastatic or recurrent breast cancer were enrolled and treated with goserelin (Zoladex) monthly and began anastrozole (Arimidex) daily for 21 days following the first injection of goserelin. Participants continued on treatment until disease progression or unacceptable toxicity.

Eligibility Criteria:
INCLUSION CRITERIA

* Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive
* Premenopausal, defined as any of:

  1. Last menstrual period within 3 months, or
  2. Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating hormone (FSH) in the premenopausal range, or,
  3. If tamoxifen administered within the past 3 months, plasma estradiol must be in the premenopausal range
* Either positive estrogen and/or progesterone receptor determination by Immunohistochemistry (IHC) or competitive binding assay on metastatic disease, or if not performed on their metastatic disease a positive result on their primary breast cancer specimen.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Granulocytes \> 1500/mm\^3
* Platelets \> 100,000/mm\^3
* Serum glutamic oxaloacetic transaminase (SGOT) \< 2.5 x upper limit of normal
* Total bilirubin \< 1.5 mg/dL
* May have received irradiation to bony sites of disease for pain control or for prevention of fracture. The irradiated site(s) will NOT be evaluable for disease response.
* Must be using effective contraception or not be of childbearing potential
* Signed written informed consent

INCLUSION CRITERIA

* Active, unresolved infection
* Active malignancy other than breast cancer, in situ carcinoma of the cervix, or non-melanomatous skin cancers in the past 5 years
* Prior treatment with an aromatase inhibitor or inactivator
* Prior treatment with an luteinizing hormone-releasing hormone (LH/RH) agonist/antagonist
* Adjuvant chemotherapy within 6 months of study entry.
* Received chemotherapy or hormonal therapy in the 3 weeks prior to enrollment
* Central nervous system metastasis
* Lymphangitic pulmonary metastasis
* Pregnant or lactating
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

OBJECTIVES:

* Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51.

OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response.

PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of melanoma

  * Unresectable stage III or IV disease
  * Mucosal or ocular disease allowed
* Positive HLA-A1, -A2, or -A3 expression

PATIENT CHARACTERISTICS:

Age

* 12 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Hemoglobin \> 9 g/dL

Hepatic

* Liver function tests ≤ 2.5 times upper limit of normal (ULN)

Renal

* Creatinine ≤ 1.5 times ULN

Cardiovascular

* No New York Heart Association class III or IV heart disease

Other

* Weight ≥ 100 pounds
* Not pregnant or nursing
* No other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior vaccination with any of the peptides used in this protocol
* More than 1 year since prior melanoma vaccine therapy
* More than 4 weeks since prior immunotherapy
* More than 4 weeks since prior growth factors
* More than 4 weeks since prior allergy shots

Chemotherapy

* More than 4 weeks since prior chemotherapy

Endocrine therapy

* More than 4 weeks since prior steroid therapy

Radiotherapy

* More than 4 weeks since prior radiotherapy

Surgery

* Prior tumor resection allowed
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)

This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as measured by the confirmation of tumor recurrence and survival for 3 years after surgery for their primary tumors.


Eligibility Criteria:
Inclusion Criteria:

* underwent macroscopically curative resection;
* immunohistochemically confirmed KIT (CD117)-positive tumors;
* judged as being high-risk according to the criteria for risk classification

Exclusion Criteria:

* synchronous double cancer or metachronous double cancer with a disease-free period of ≤5 years;
* received therapy with Imatinib Mesylate prior to study entry;
* cardiac problem of Grade 3 or higher (New York Heart Association (NYHA) criteria)

Other protocol-defined inclusion / exclusion criteria may apply.
Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type

The purpose of this study is to refit habitual wearers of daily disposable contact lenses who currently experience symptoms of dry eye and discomfort during lens wear with a different type of daily disposable contact lens. Ocular signs and symptoms of dry eye will be assessed following the guidelines outlined by the Tear Film and Ocular Surface Society (TFOS) in the Dry Eye Workshop II (DEWS II). The performance of the habitual contact lenses and the study lenses will be determined using different optometric assessments. Study lenses will be worn for one month following a daily disposable wear schedule.


Eligibility Criteria:
Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. As per TFOS DEWS II, have dry eye symptoms (without CL wear) as determined by an OSDI score of ≥13 and at least one of the following:

   1. Tear osmolarity ≥ 308mOsm/L or interocular difference \>8 mOsm/L
   2. Non-invasive tear breakup time of \< 10 seconds in at least one eye
   3. More than 5 spots of corneal staining OR \> 9 conjunctival spots in at least one eye
5. Reports dryness while wearing DD CLs with CLDEQ-8 score ≥ 12 and ≤ 203
6. Habitually wears soft spherical DD CLs with a power between +6.00D and -10.00D
7. Manifest spectacle cyl ≤1.00DC in either eye
8. BCVA ≤0.20 log MAR each eye with habitual \& DT1
9. Acceptable fit with habitual \& DT1
10. Willing to wear DT1 CLs at least 3 days per week and 6 hours per day throughout the study

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
7. Is aphakic;
8. Has undergone refractive error surgery;
9. Has taken part in another clinical research study within the last 14 days;
10. Current habitual wearer of DT1
11. Any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables.

    * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
A Protocol for the Use of Chlorhexidine Gluconate Saturation for the Reduction of Dental Biofilm Formation on Polymethylmethacrylate Restoration

Chlorhexidine gluconate (CHX), as an anti plaque agent, is commonly used with a variety of products. In this study we, the investigators at Hadassah Medical Organization, intend to examine the efficacy of a single dip in CHX of provisional restoration prior to oral cementation. If the protocol is effective, we intend to calibrate it and recommend clinical use of the protocol. The examination of biofilm formation will be both with electron microscope and confocal scanning laser microscope.


Eligibility Criteria:
Inclusion Criteria:

* Any volunteer without systemic condition

Exclusion Criteria:

* Intake of antibiotic drug three months prior to experiment
Perioperative Application of Omega-3 Polyunsaturated Fatty Acids in Gastric Cancer Patients

To evaluate immunomodulatory effects of perioperative application of omega-3 polyunsaturated fatty acids in gastric cancer surgery, the effects of postoperative recovery, the improvement of nutritional status, incidence rate of related complications, and whether it can reduce the average postoperative hospitalization days.

Methods: Choose from 6 to 2013-2013-12 gastric cancer patients, according to inclusion criteriaS to choose the objectS of study from the gastric cancer patients coming to our hospital 2013-06 to 2013-12 .The included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add Omega-3 Polyunsaturated Fatty Acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add Omega-3 Polyunsaturated Fatty Acids 0.2 g/kg. Detect and compare CRP、TNF-α、IL-1、IL-4、lL-6、 IL-8、lL-10 levels of two groups in days before parenteral nutrition and applicating 3rd day and postoperative 1st, 3rd, 5th,and detect liver function in preoperative and postoperative 2nd,5th,7th day. Record postoperative anal exhaust time, postoperative complications, postoperative hospital days, preoperative and postoperative body weight.Results: Trail group patients compared with the control group,Omega-3 Polyunsaturated Fatty Acids can reduce early postoperative inflammatory cytokines release, reduce the postoperative fever time, reduce the incidence of systemic inflammatory response syndrome, promote the recovery of gastrointestinal function, improve the nutritional state of patients, reduce infection and related complications after the surgery and reduce postoperative hospitalization days. Conclusions: Perioperative application of omega 3 PUFA can reduce the release of inflammatory cytokines, regulating cell and humoral immunity, reduce the postoperative fever time, reduce the local inflammation medium that inhibit the gastrointestinal peristalsis, promote the recovery of gastrointestinal function, improve the nutritional state of patients, thereby reducing the occurrence of postoperative infection and related complications, reduce postoperative hospitalization days.

Eligibility Criteria:
Inclusion Criteria:

* Patients coming to FirstJilinU diagnosed gastric cancer by endoscopy and pathology.
* No preoperative treatment, the gastric cancer radical surgery in our hospital is the first treatment.
* Nutrition screening score (NRS 3 or higher).
* Albumin and (or) immune enhancer were not used within two weeks before operation .
* No blood system diseases.

Exclusion Criteria:

* Being in the acute phase of inflammation before operation and emergency surgery.
* Patients combined metabolic diseases such as diabetes, hyperthyroidism, immune system disease or taking immunosuppressants;
* Combined hepatic insufficiency.
* Spleen resected in operation
TENS Reduces Movement-Evoked Pain in People With CLBP

In this cross-over study 25 patients with chronic low back pain (CLBP) were tested for pain relief in 2 conditions: while using the Transcutaneous Electrical Nerve Stimulation (TENS) application and without using it. Primary outcome: Movement-Evoked Pain (MEP). This was measured using the Back Performance Scale (BPS) and a 5-minute walk test (5MWT). Participants performed 5 functional tasks and were asked to rate their pain before, during, and after each movement on a numeric rating score scale. The same principle will be used for the 5MWT: for each walking-minute, 3 pain measurements will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* chronic nonspecific LBP for at least 3 months' duration: non-specific LBP implies that patients are not allowed to have any evidence of specific spinal pathology (e.g., hernia, spinal stenosis, spondylolisthesis, infection, spinal fracture or malignancy).

Exclusion Criteria:

* spinal surgery in the past 6 months
* severe underlying comorbidity (like diagnosed diabetes, cardiovascular problems, etc.),
* pregnant or given birth in the preceding year,
* having initiated a new LBP treatment in the 6 weeks prior to study participation
OpenGo Sensor Insole in Open Wedge HTO

Weight bearing in 40 patients undergoing open wedge high tibial osteotomy (HTO) will be studied during 12 weeks for their post-operative weight bearing using a pressure insole.

Forty patients who are planned for open wedge HTO with deformity in the proximal tibia will be included in the study. The open wedge HTO will be performed in the well known biplanar technique and the TomoFix plate will be used as fixation plate. To analyze the peak pressure and if the patients are able to reassemble the partial weight bearing/ the full weight bearing the OpenGo Sensor Insole (Moticon) will be used during the first 12 weeks after surgery. In addition, x-rays will be analyze for the alignment and angles and clinical scores will be gathered to investigate patient reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Indication for high tibial osteotomy

Exclusion Criteria:

* Impairment of the shoulder which has an influence on the ability for partial weight bearing
Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.

Issues on safety will be addressed in Adverse Events section.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for contrast enhanced MRI of the CNS based on symptoms or previous procedures.

Exclusion Criteria:

* Patients with acute renal insufficiency
* Patients with severe renal disease
* Patients with any contraindication to magnetic resonance imaging.