cyrilzakka/clinical-trials huggingface dataset:
Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy

The purpose of the study is to evaluate whether a caffeine-based cream can reduce the rates of reconstructive complications in patients with tissue expander based reconstruction requiring post-mastectomy radiation therapy when compared to a placebo cream.


Eligibility Criteria:
Inclusion Criteria:

* Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted)
* Patient has undergone mastectomy with tissue expander-based reconstruction and require post-mastectomy radiation therapy (PMRT) per the - Stage DCIS (0) -III breast cancer, excluding any patients with inflammatory breast cancer at presentation.
* Patient will receive irradiation of the chest wall. Additional fields to treat the regional nodes including the supraclavicular / axillary and/or internal mammary chains is allowed but not required. If a patient requires a boost field to the chest wall, scar and/or nodal region this is allowed.

Exclusion Criteria:

* Patient with skin changes or inflammatory carcinoma at presentation Patient has (cT4b-d)
* unhealed wound in the radiation field
* Patient has allergy to Caffeine
* Patient has systemic lupus erythematosus or scleroderma that increases the risk of radiation dermatitis development
* Patient will receive concurrent chemotherapy with radiation. (Patient is allowed to take concurrent hormonal therapy or Trastuzumab)
* Planned accelerated or hypofractionated fractionation.
* Previous radiation to the ipsilateral breast or chest wall or thoracic region.
* Anyone who will require bolus use during radiation (per physician discretion) as this will increase rates of acute toxicity interfering with measurement of the primary study endpoint.
* All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy. Pregnant women will be excluded from the study.
Dailies Total 1 Sphere Contact Lenses

CL discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society in their seminal report on contact lens (CL) discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear." A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs. This same review alarmingly found that the frequency of CL dropout was about 20% across the many studies aimed at evaluating this condition, which is surprising given the introduction of better soft CL materials and daily disposable CLs over the past 20 plus years.

Dailies Total1 (DT1), which is a relatively new daily disposable CL, is a commonly used trouble shooting CL for patients who have failed with other CLs because DT1 utilizes advanced material technology that is specifically aimed at improving CL comfort. While DT1 is commonly used in these struggling patients, the literature currently lacks a targeted study aimed at understanding the frequency of successfully refitting CL dropouts into this advanced CL. Thus, the purpose of this study is to determine the frequency that past CL wearers who failed because of dryness or CL discomfort who can comfortable wear DT1.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18-40
* Past contact lens wearers who have best corrected 20/20 visual acuity or better
* Participants will have had to have worn contact lenses for at least 1 year in the past
* Dropped out of contact lenses in the past 2 years do to discomfort or dryness
* Scores of 3 or less on the SPEED questionnaire
* Be able to be refit into Dailies Total1 Sphere contact lenses
* Provide a glasses prescription that is less than 3-years-old

Exclusion Criteria:

* Past rigid contact lens wearers
* A past history of being diagnosed with dry eye or ocular allergies
* Known systemic health conditions that are known to alter tear film physiology
* History of viral eye disease
* History of ocular surgery
* History of severe ocular trauma
* History of corneal dystrophies or degeneration
* Having active ocular infection or inflammation
* Currently using isotretinoin-derivatives or ocular medication
* Pregnant or breast feeding
The Evaluation of Lung Cancer Patient Treated With Epidermal Growth Factor Receptor Tyrosine Kinase

To evaluate Non-Small Cell Lung Cancer (NSCLC) patients clinical profile and the outcome after treatment with Gefitinib in Pulmonary Oncology Outpatient Clinic Dr. Soetomo General Hospital, Surabaya, Indonesia.

Primary Objective: To determine the efficacy of Gefitinib in NSCLC patient harboring a positive EGFR mutation.

Secondary Objective: To evaluate the subjective response of NSCLC patients harboring a positive EGFR mutation who treated with Gefitinib.

Safety Objective: To evaluate the safety and tolerability of Gefitinib in NSCLC patient harboring a positive EGFR mutation.

Eligibility Criteria:
Inclusion Criteria:

* NSCLC based on histopathologic examination
* Adenocarcinoma and/or nonadenocarcinoma based on histology examination
* Clinical stadium stage IIIB and IV
* Age 16-70 years old
* Received gefitinib as therapy
* At least completed 2 (two) data sets of RECIST 1.1 evaluations during the study period from January 2013 until July 2015

Exclusion Criteria:

* Missing data of any variables of the treatment outcomes in the medical record
The Effect of Education Programme on School Age Children's Attitudes Towards Children With Special Needs

As individuals with special needs take more roles in social life and become more visible, the importance of social acceptance of individuals with special needs has increased.Especially being accepted by their peers with normal development and developing as a part of the society will reduce the burden of care in the society and enable children with special needs to lead a life worthy of human dignity.With this study, it is aimed to support children with normal development to form positive attitudes with awareness training. Qualitative and quantitative data will be used together and the attitude before and after the training will be examined descriptively.

Attitudes of normally developing children towards special children may be hurtful and affect their development negatively. For this reason, by conducting an educational process in which they can develop positive attitudes, social acceptance of children with special needs can be increased, their development and psychosocial support systems can be established. Within the scope of the advocacy and health promotion role of paediatric nursing, it has the responsibility to create an environment that supports the development of children with special needs and to carry out social awareness studies. In this context, children in the school period, where attitudes, behaviour patterns and habits begin to take shape, should be supported in developing positive attitudes.In this planned study, an eight-week training process will be carried out. It is planned to reveal more comprehensive results by using qualitative and quantitative data collection methods together in the evaluation of attitude changes before and after the training.

Eligibility Criteria:
Inclusion Criteria:

* Without any disability
* Parents and siblings do not have a disability
* Have the ability to read and write in Turkish
* No child with a disability in their class
* Children aged 9-10 years attending primary school in Mersin province

Exclusion Criteria:

* With any disability
* Parents and siblings have a disability
* No ability to read and write in Turkish
* A child with a disability in their class Written, verbal consent is not obtained
Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults

This study is conducted to compare the immunogenicity, reactogenicity and safety of Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Age: 50 to 70 years old.
* Good physical condition as established by clinical examination and history taking at the time of entry.
* Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
* Written informed consent obtained from the subjects

Exclusion Criteria:

* Positive at screening for anti-HBV antibodies.
* Elevated serum liver enzymes
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Hepatomegaly, right upper quadrant abdominal pain or tenderness.
* Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Simultaneous participation in any other clinical trial.
* Previous vaccination with a recombinant hepatitis B vaccine.
* Previous vaccination with an MPL containing vaccine.
* Administration of immunoglobulins in the past 6 months and during the whole study period
* Vaccination one week before and one week after each dose of the study vaccine
Patient-Reported Outcome Measurement in Heart Failure Clinic

This is a randomized study evaluating the effect of routinely collecting a standardized questionnaire of heart failure health status during heart failure clinic visits. Participants will be randomized to early or delayed implementation of a validated health-related quality of life survey (the Kansas City Cardiomyopathy Questionnaire). Participants randomized to early implementation will be given this 12-question survey at each heart failure clinic visit at the beginning of the study; their heart failure clinician will have access to survey results but will continue to manage participants based on standard treatment practice. Patients randomized to delayed implementation will start receiving the survey at each clinic visit one year later. By comparing the health status and treatment rates between early and delayed implementation, this study will determine the impact of standardized health status assessment on patient outcomes and clinician decision-making.


Eligibility Criteria:
Inclusion Criteria:

* Stanford Heart Failure clinic visit during enrollment period

Exclusion Criteria:

* Seen in amyloid clinic
Posterior Minimally Invasive Plate Osteosynthesis (MIPO) for Humerus Diaphyseal Fractures

The primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate.

The primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate.

Clinical

* Pain
* ROM

Functional

* Constant Score
* MEPS
* QuickDASH

Radiological

- Bone union

Complications

* Infection
* Nerve injury

Eligibility Criteria:
Inclusion Criteria:

* Closed diaphyseal humerus fracture at the junction of the middle third with distal

Exclusion Criteria:

* Open fractures, proximal humerus extension, distal articular compromise, polytrauma, more than 2 weeks of trauma
Deep Needling at Zhongliao Point to Stimulate the Sacral Nerve for the Treatment of Slow Transit Constipation

Clinical Study on the Treatment of Colonic Slow Transit Constipation by Deep Acupuncture at Zhongliao Point Stimulating Sacral Nerve

1. Observing the clinical efficacy of deep acupuncture at Zhongliao point to stimulate the sacral nerve in the treatment of slow transit constipation of the colon through changes in main research indicators such as defecation frequency, stool shape, and fecal weakness.
2. Clarify the technical focus and difficulties of deep needling at Zhongliao point to stimulate the sacral nerve in the treatment of colonic slow transit constipation, providing a basis for guiding clinical promotion and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meets the diagnostic criteria for Slow transit constipation deficiency of both qi and yin;
* Age 18-65 years old;
* I have not been treated with intestinal motility drugs in the past month.
* Those who have informed consent and voluntarily participate in signing an informed consent form, adhere to medical advice for treatment, and undergo regular follow-up visits.

Exclusion Criteria:

* Other Traditional Chinese Medicine Syndrome Differentiation Types of Constipation.
* Concomitant severe heart, lung, and kidney diseases, neurological diseases, and metabolic diseases;
* Discovering organic lesions such as colorectal cancer and colorectal hyperplasia through colonoscopy, abdominal pelvic CT, or barium enema;
* Patients with severe mental illness or mental illness or cognitive impairment.
* Children, pregnant women, lactating women, and pregnant women.
* Those who stop taking medication at will or use other medications on their own during treatment, do not follow medical advice for treatment, or have incomplete information that affects the judgment of results, safety, and efficacy.
* Have a history of abdominal surgery.
* History of needle sickness.
* People with a tendency to bleed.
Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses

This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.

This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.

Eligibility Criteria:
Inclusion Criteria:

* Has had a self-reported oculo-visual examination in the last two years.
* Is between ages 40-75 years, inclusive and has full legal capacity to volunteer.
* Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule.
* Is able to participate in Parts A and B related to this work.
* Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive).
* Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
* Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
* Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.
* Currently wears soft contact lenses.
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination.

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
Goal-Directed Therapy in Cancer Surgery

The purpose of this study is to determine whether a goal-directed resuscitation therapy within the first 8 hours after major abdominal cancer surgery reduces postoperative complications compared to a standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICU in immediate postoperatory of major abdominal surgery for cancer treatment
* Age over 18 years-old

Exclusion Criteria:

* Weight under 55 kilograms or over 140 kilograms;
* Contra-indication for invasive hemodynamic monitoring;
* Expected ICU permanence less than 24 hours;
* Active bleeding
* Vasoplegic shock with noradrenaline dose higher than 1mcg/kg/min
* Enrolled in other study
* Refuse to consent
Use of Plantar Flexion Resistant Ankle-Foot Orthosis in Stroke Patients With Genurecurvatum Gait

Hypothesis 1:

Ho: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has no effect on knee hyperextension control in stroke patients with genurecurvatum gait.

H1: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has an effect on knee hyperextension control in stroke patients with genurecurvatum gait.

Hypothesis 2:

Ho: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has no effect on pelvic movements in stroke patients with genurecurvatum gait.

H1: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has an effect on pelvic movements in stroke patients with genurecurvatum gait.

Kinematic evaluation of the gaits of stroke patients in 3 different situations will be made in the motion analysis system. Patients will be asked to walk at a normal walking pace for a distance of only 5 meters. Patients will walk the 5-meter distance first without the Ankle-Foot Orthosis, then with the Ankle-Foot Orthosis adjusted at 3 degrees of dorsiflexion, and then with the Ankle-Foot Orthosis adjusted at 5 degrees of dorsiflexion.

Eligibility Criteria:
Inclusion Criteria:

* At least 6 months have passed since the stroke incident
* Ambulating with or without a walking aid (walker, cane or tripod)
* Being between 0-3 points according to the Modified Rankin Scoring
* Getting a score of 24 or above from the Mini Mental Test
* Presence of hyperextension in the stance phase of gait
* Volunteering to participate in the study

Exclusion Criteria:

* Having a history of more than one stroke
* Known presence of dementia
* Having a known orthopedic, psychiatric or other neurological disease
* There is a situation that prevents communication
* Having a history of surgery involving the lower extremities and gait
Vitamin B6 Supplementation and Mood States in College Women Taking Oral Contraceptives

Purpose of Study The purpose of this crossover study was to determine how vitamin B6 supplementation impacts mood states in college age (18-25 y) women that use oral contraceptives, in comparison to a placebo treatment.

Hypothesis Daily supplementation of vitamin B6 (100 mg) over a 4-week period will improve mood states in college age women (18-25 y) with marginal vitamin B6 status that use oral contraceptives, compared to the placebo treatment.

This study is a 12-week, randomized, double-blinded crossover trial. After eligibility is confirmed through prescreening and onsite screening assessments (screening visit; \~30 minutes), participants will sign the consent form and enter the trial. Participants are stratified by age, BMI, and length of oral contraceptive use and randomized by a coin flip into the experimental group (B6 supplement) or control group (low does vinegar pill). Participants will visit the test site in the fasted state (no food or drink with the exception of water for 10 hours) on 4 occasions (pre and post weeks 1-4 and pre and post weeks 9-12) These visits are approximately 30 minutes long. At the start of the trial, participants are instructed to take the provided pills once daily for four weeks. For weeks 5-8, participants will not take any pills (the washout period). Daily pill consumption will resume during weeks 9-12 (the crossover treatment). Participants are their own control in this crossover trial.

All participants are instructed to maintain their normal exercise and eating patterns consistently throughout the duration of the 12-week study. Additionally, participants are instructed not to start any new medications or nutritional/herbal supplements. To promote compliance, participants will have a calendar to check off each day that the pills are consumed during the study.

Anthropometric data are collected and fasting blood draws are performed at weeks 0, 4, 9 and 12. Fasting blood samples will be tested for B6 and associated metabolites. Additionally, mood assessments, including the Profile of Mood States and the Beck Depression Inventory will be administered at weeks 0, 4, 9 and 12.

Eligibility Criteria:
Inclusion Criteria:

* Female who has taken a combined oral contraceptive (estrogen with progestin) consistently for at least one year
* Healthy by self-report; no active disease state, depressive state, or prescription medication use (exception: OC)
* 18-25 years of age
* Nonsmoking
* Not pregnant or lactating if female
* Not a regular user of supplements aside from multivitamin/mineral supplement
* Dietary B6 at or below the RDA (1.3 mg/day)
* Not vegetarian/vegan
* Not a competitive athlete

Exclusion Criteria:

* Unwilling to take a vitamin supplement or placebo daily as prescribed during the 12 week study
* Unable to meet with investigators and provide a fasting blood sample on 4 occasions over a 12 week period
Effect of an Investigational Compound on Tolerability of Extended Release Niacin (0524A-023)(COMPLETED)

This is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of MK0524 to improve the tolerability of extended-release niacin. There will be 6 scheduled clinic visits and 3 treatment arms.


Eligibility Criteria:
Inclusion Criteria:

* Patient is appropriate candidate for niacin therapy
* Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C \<130 mg/dL at V1
* Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C \<130 mg/dL at V1
* Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C \<160 mg/dL at V1
* Patient has TG \<500 mg/dL (5.65 mmol/L) at V1
* A patients historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria
* ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA

Exclusion Criteria:

* Patients with unstable doses of medications
* Pregnant or lactating women, or women intending to become pregnant are excluded
* Patients with diabetes mellitus that is poorly controlled, unstable or newly diagnosed
* Patients with: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year)