Kornimate/medical-research-clean huggingface dataset:
the efficacy in treatment of female pattern hair loss using 5% minoxidil solution combinded with zinc supplement

Conditions: Female Pattern Alopecia

Summary: zinc supplement is a popular trace element gave to female pattern hair loss (fphl) patient. but the type of patient, efficacy, and side effect in detail of zinc supplement are not well characterized. the purpose of this study is to determine efficacy and side effect of chelated zinc in fphl who using 5%minoxidil solution.

5%minoxidil solution is standard treatment for female pattern hair loss (fphl) patient. we gave 15mg chelate zinc / placebo drug to patient as an additional trace element. then measure growth of hair by global photograph, microscope hair count, micrometer and record case and side effect during 10 months of treatment.

Eligibility criteria:
inclusion criteria: * female pattern hair loss ( ludwig classification grade 1 and 2 ) exclusion criteria: * underlying disease ; anemia, diabetes, chronic alcoholism, previous gastrointestinal surgery, short bowel syndrome, crohn's disease, digestive disorder, hypo/hyperthyroidism, sickle cell disease, autoimmune disease, iron deficiency * psychologic disorder trichotillomania * diet control * pregnancy or lactation * on supplement diet within 3 month prior to trial

Keywords: female pattern hair loss
capecitabine and oxaliplatin in treating older patients with metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: rationale: drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well giving capecitabine together with oxaliplatin works in treating older patients with metastatic colorectal cancer.

objectives: primary * determine the efficacy of capecitabine and oxaliplatin as first-line treatment, as defined by stabilization or improvement by 1 point on katz's activities of daily living scale, in older patients with metastatic colorectal adenocarcinoma. secondary * determine the toxicity of this regimen in these patients. * determine the percentage of patients who receive the first 3 courses of this regimen (at lower doses) and the percentage of patients who receive all 6 courses of this regimen (at both lower and higher doses). * determine efficacy of this regimen, as defined by recist criteria, in these patients. * determine the pharmacokinetics of this regimen in these patients. outline: this is a multicenter, open-label, nonrandomized study. patients receive oral capecitabine\* once daily on days 1-14 and oxaliplatin\* iv on day 1. treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. note: \*the doses of both capecitabine and oxaliplatin are increased in courses 4-6 in the absence of unacceptable toxicity projected accrual: a total of 60 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of colorectal adenocarcinoma * metastatic disease * requires first-line therapy for metastatic disease patient characteristics: age * over 70 performance status * katz's activities of daily living scale \< 6 (≤ 6 for patients ≥ 80 years of age) life expectancy * more than 3 months hematopoietic * absolute neutrophil count \> 1,500/mm\^3 * platelet count \> 100,000/mm\^3 hepatic * ast and alt \< 2 times normal (5 times normal if due to hepatic metastases) * bilirubin \< 2 times normal (5 times normal if due to hepatic metastases) renal * creatinine clearance \> 30 ml/min other * no clinical neuropathy prior concurrent therapy: biologic therapy * not specified chemotherapy * more than 6 months since prior adjuvant chemotherapy * no prior chemotherapy for metastatic disease endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: stage iv colon cancer stage iv rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum
a phase ii trial of s-1 as maintenance treatment after gemcitabine plus cisplatin regimen chemotherapy in patients with recurrent and/or metastatic nasopharyngeal carcinoma.

Conditions: Nasopharyngeal Carcinoma

Summary: a phase ii trial of s-1 as maintenance treatment after gemcitabine plus cisplatin regimen chemotherapy in patients with recurrent and/or metastatic nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * all proven to have locoregional recurrence after curative treatment and unsuitability for further local treatment, distant metastases at presentation or acquired metastases after curative treatment. the presence of at least one measurable disease, which was defined as lesion that could be measured at least 20 mm in one dimension by conventional computed tomography (ct) or at least 10 mm by spiral ct scan; kps≥70, and a life expectancy of at least 6 months. exclusion criteria: * other malignancy prior to study entry; bone-only metastasis;previous radiotherapy within 4 weeks; previous exposure to gemcitabine;patients with any active, non-controlled infection or other severe systemic diseases, such as congestive heart failure, angina pectoris, respiratory insufficiency and arrhythmia were all rejected at enrollment. other exclusion criteria included concurrent treatment with other investigational drugs, hypersensitivity to platinum compounds,and current pregnancy or breastfeeding.
the immediate effect of defocus spectacles on the choroid thickness using optical coherence tomography on children

Conditions: Myopia

Summary: the purpose is to examine temporary changes in the subfoveal choroid thickness after removal and after resumed use of defocus incorporated multiple segment spectacle lenses (dims).


Eligibility criteria:
inclusion criteria: * myopic children using defocus incorporated multiple segment spectacle lenses (dims) from the ongoing randomized clinical non-inferiority study: "defocus spectacle lenses (dims) versus orthokeratology lenses (okl) for slowing myopia progression in children" (clinicaltrials.gov identifier nct05134935) * myopia at the time of inclusion in the nisdo study: -2.00 to -4.75 d spherical component and up to -2.50 d of regular astigmatism (both eyes) * anisometropia \< 1,5 d cycloplegic spherical equivalent refractive error * best corrected visual acuity (inclusive): 1.0 snellen (equivalent to ≥ 3/5 letter on the 1.0 line = 83 etdrs letters) exclusion criteria: * manifest or intermittent squint * contraindications to the use of okl comprising (not exhaustive): keratoconus, chronic allergic conjunctivitis, and keratoconjunctivitis sicca * previous eye surgery * chronic eye disease demanding daily use of eye drops * non-compliance to eye examinations (unstable fixation or anxiety towards contact lenses)
a randomized, comparative trial of zidovudine (azt) versus 2',3'-didehydro-3'-deoxythymidine (stavudine; d4t) in children with hiv infection

Conditions: HIV Infections

Summary: primary: to compare the relative safety and tolerance of oral zidovudine (azt) versus oral stavudine (d4t) in symptomatic hiv-infected children. secondary: to compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs. at present, azt is considered the drug of choice for initial treatment of most children with hiv infection, although disease progression or drug intolerance is associated with its long-term use. in preliminary studies in children, d4t, another hiv inhibitor, has been well tolerated, although an optimum dose has not been determined.

at present, azt is considered the drug of choice for initial treatment of most children with hiv infection, although disease progression or drug intolerance is associated with its long-term use. in preliminary studies in children, d4t, another hiv inhibitor, has been well tolerated, although an optimum dose has not been determined. patients are randomized to receive either oral azt or oral d4t. treatment continues until the last patient enrolled has received 52 weeks of therapy, or until the study is terminated.

Eligibility criteria:
inclusion criteria concurrent medication: recommended: * pcp prophylaxis. allowed: * immunoglobulin. * erythropoietin, g-csf, and gm-csf. * corticosteroids. * ethionamide or isoniazid for tb if no alternative is available. * pyridoxine (up to 50 mg/day) as vitamin supplement. patients must have: * symptomatic hiv infection. * no more than 6 weeks of prior antiretroviral or immunomodulator therapy (other than steroids and ivig). * consent of parent or guardian. note: * coenrollment on another actg protocol not involving antiretroviral therapy is permitted. prior medication: allowed: * maternal immunomodulator or antiretroviral therapy (including during pregnancy). * antiretroviral therapy prior to 2 months. * up to 6 weeks of prior antiretroviral therapy or specific immunomodulator therapy (other than corticosteroids and ivig). exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * current grade 3 or worse neuropathy / lower motor neuropathy. * other grade 3 or worse clinical or laboratory toxicities. * known intolerance to either azt or d4t. concurrent medication: excluded: * chemotherapy for active malignancy. patients with the following prior conditions are excluded: * history of grade 3 or worse neuropathy/lower motor neuropathy. prior medication: excluded: * more than 6 weeks of prior antiretroviral or immunomodulator therapy. * antiretroviral or immunomodulator therapy within 7 days prior to study entry. ongoing drug or alcohol abuse.

Keywords: acquired immunodeficiency syndrome aids-related complex zidovudine stavudine
compliance: role emerges for success in chronic myelogenous leukaemia (cml): evaluation and optimisation

Conditions: Chronic Myelogenous Leukemia (CML)

Summary: this study on patient's compliance in clinical workaday life aims to assess and to improve cml treatment in germany by means of adherence supporting measures and to increase adherence awareness by physicians and patients.


Eligibility criteria:
inclusion criteria: * adult (\> 18 years) cml patients in the chronic phase * medical history of cytogenetically confirmed cml-cp by the presence of the philadelphia chromosome on bone marrow aspirates (a minimum of 20metaphases is required; fish cannot be used); philadelphia chromosome negative but bcr- abl-positive cml patients can be included * ecog performance status of \< 2 * imatinib treatment for at least 1 year and showing ccyr or mmr * prior treatment with chemotherapeutics such as hydroxyurea or interferon- alpha is allowed * prior periods of accelerated phases are allowed * negative pregnancy test for female patients of childbearing potential within 7 days before initiation of study drug * ability to understand and willingness to sign a written informed consent document prior to any study related screening procedures * written informed consent, including the consent to be called for interviews by the external, neutral institution. exclusion criteria: * patients with prior blast crisis or stem cell transplantation * patients with severe medical condition(s) that in the discretion of the investigator prohibits participation in the study (e.g., clinically significant heart diseases, uncontrolled diabetes, active or uncontrolled infection, impaired gastrointestinal function/diseases) * treatment with drugs or substances, especially those known to modify the cytochrome p450 activity, should be either discontinued or exchanged by different medication (see link for complete list of these medications: http://medicine.iupui.edu/flockhart/table.htm.) * pregnant or breastfeeding women * male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial

Keywords: cml compliance compliance supporting measures complete cytogenetic response mayor molecular remission philadelphia chromosome bcr-abl imatinib tyrosine kinase inhibitor smart blister
development and validation of the swadoc tool

Conditions: Swallowing Disorders; Dysphagia; Disorders of Consciousness; Assessment Tool; Speech Therapy

Summary: background: after a period of coma, patients with severe brain injury may present disorders of consciousness (doc). a wide proportion of these patients also suffer from severe dysphagia. assessment and therapy of swallowing disabilities of doc patients are essential because dysphagia has major functional consequences and comorbidities. dysphagia evaluation in patients with doc is hampered by the lack of adapted tools. the first aim of the study was to develop a new tool, the swallowing assessment in disorders of consciousness (swadoc), and propose a validation protocol. the swadoc tool has been developed to help therapists to apprehend components related to swallowing in patients with doc. the second aim is to appreciate the relationship between patients' level of consciousness and swadoc items and scores. method/design: in this multicentric prospective cohort, 104 patients with doc will be tested three times during two consecutive days with the swadoc tool. statistical analyses will focus on the reliability and validity of the swadoc tool, especially the intra and inter-rater reliability, internal consistency, measures of dispersion and concurrent validity with the fott swallowing assessment of saliva (fott-sas). the level of consciousness will be assessed with the simplified evaluation of consciousness disorders (seconds) and the coma recovery scale-revised (crs-r) discussion: the assessment of swallowing abilities among patients with doc is the first necessary step towards the development of an individualized dysphagia care plan. a validated scoring tool will be essential for clinicians to better apprehend dysphagia in doc patients and to document the evolution of their disorders.


Eligibility criteria:
inclusion criteria : * age above 18-year-old * perfect knowledge of french language before the injury * previous event of coma phase caused by a severe acquired brain injury * medical stability (absence of mechanical ventilation and sedation, no acute medical pathology such as infection or respiratory distress) * no neurological or otorhinolaryngological disease which can impact swallowing prior to the brain injury * minimum of 28 days since the acquired brain injury at inclusion * diagnosis of uws, mcs-, mcs+ or emcs based on the crs-r or seconds * informed consent from legal representative of the patient * affiliated patient or beneficiary of a health insurance plan (for french participants only).

Keywords: swallowing dysphagia disorders of consciousness severe brain injury
surgical intervention and the netest

Conditions: Neuroendocrine Tumor; Gastroenteropancreatic

Summary: the purpose of this study is to evaluate the effect of different surgical resections (r0, r1, r2) on circulating net transcripts (pcr score or netest). a drop in circulating net levels will be correlated with surgical excision. secondly, variation of circulating net transcripts will be correlated to net recurrence to test whether this analysis may constitute an early predictive marker of disease relapse.

biomarker-based tools that can accurately predict gastroenteropancreatic neuroendocrine tumor (gep-net) treatment response and tumor recurrence are currently not available. circulating biomarkers that are associated with gep-nets are limited to measurements of plasma chromogranin a (cga). the investigators have developed a pcr-based tool to quantitate (score) the circulating gep-net molecular signature ("liquid" biopsy) with high sensitivity and specificity. this signature can identify all types of gep-nets including small (1cm) non-metastatic tumors, is significantly reduced after tumor debulking and is decreased following surgical "cure". elevated post-surgical scores are associated with tumor recurrence within 6 months in \~40% of cases. current net treatment protocols are associated with tumor recurrence (progression free survival) ranging from 5-18 months. the majority of patients will experience a relapse within 18 months irrespective of the treatment approach. the investigators hypothesize that a pcr measurement of circulating net mrna can accurately predict the extent of surgical resection (tumor removal) and elevated scores can predict tumor relapse before this occurs. this biomarker protocol seeks to test this hypothesis and evaluate whether changes in plasma cga are as effective in predicting resection and recurrence.

Eligibility criteria:
inclusion criteria: * pathologically confirmed, well differentiated (g1, g2 or g3), local and advanced (metastatic), neuroendocrine tumor of gastro-enteropancreatic origin. * treatment-naïve as well as patients who have received previous therapies. * patients currently on lar with clinically stable disease. * ct or mri documentation of disease. * who performance status ≤2. exclusion criteria: * known history of hiv seropositivity
treatment of clozapine-induced hypersalivation ipratropium bromide

Conditions: Hypersalivation

Summary: hypersalivation (too much saliva) and drooling is a side effect experienced by 31% of people taking the antipsychotic clozapine. this study aims to determine if using the medication ipratropium bromide(ipb)at bedtime will reduce the amount of salivation and the distress people may feel.

with the recent questions regarding the effectiveness of newer atypical antipsychotic medications in treating schizophrenia, clozapine continues to remain the gold standard for treatment-refractory schizophrenia. however, treatment with clozapine continues to be limited by its many side effects. the second most common side effect, occurring in 31% of clozapine treated patients, is hypersalivation or sialorrhea. sialorrhea can be profoundly stigmatizing and functionally disabling in certain patients, and may increase discontinuation rates in this high-risk patient population. several studies have evaluated the efficacy of anticholinergic agents mainly in small, uncontrolled studies or anecdotal reports and are often complicated by difficulties in medication administration and systemic side effects. open label and case series studies have demonstrated promising results with ipratropium bromide (ipb) treatment of clozapine-induced hypersalivation, acting on anticholinergic receptors with minimal systemic absorption. however, no randomized controlled trials have evaluated ipb in the treatment of this problematic side effect.the primary goals of this study is to determine the efficacy of ipratropium bromide in reducing clozapine-induced hypersalivation, as per the toronto nocturnal hypersalivation scale, which is a modified hypersalivation scale incorporating the drooling severity scale and the nocturnal hypersalivation rating scale, and reduced measurements on visual analogue scales for hypersalivation distress and severity. our hypothesis that ipratropium bromide use at bedtime will result in a significant reduction in nocturnal clozapine-induced hypersalivation as measured by the toronto nocturnal hypersalivation scale (tnhs) through its local anticholinergic activity.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder as per dsm iv-tr criteria * receiving clozapine for at least 2 months * no change in their clozapine dose for at least 2 weeks * have a clinical global impression scale score for hypersalivation of greater than or equal to 4 * have the capacity to provide voluntary, informed consent * able to speak english * have a minimum score of 2 on the tnhs prior to study entry * no change in medications for at least 2 weeks exclusion criteria: * subjects with co-morbid medical conditions that could influence hypersalivation (e.g. idiopathic parkinson's disease) * subjects currently receiving ipratropium bromide for the treatment of hypersalivation or other medical conditions * history of narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction * history of an allergic reaction to ipratropium bromide

Keywords: clozapine-induced hypersalivation
single ascending dose study of myk-461 in healthy volunteers

Conditions: Healthy

Summary: the purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of myk-461 in human subjects. this is a randomized, double-blind, placebo-controlled, sequential group, single ascending (oral) dose study in healthy volunteers aged 18-55 years.


Eligibility criteria:
inclusion criteria: * normal body mass index (bmi) * normal lvef * normal electrocardiogram (ecg) * females must not be breastfeeding and must be permanently sterilized or are postmenopausal. exclusion criteria: * any structural abnormalities on echocardiography * positive results of hiv test and/or seropositive for hcv or hbv.

Keywords: hypertrophic cardiomyopathy
a study of pertuzumab in combination with herceptin and chemotherapy in participants with her2-positive breast cancer

Conditions: Breast Cancer

Summary: this 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in participants with locally advanced, inflammatory or early stage human epidermal growth factor receptor 2 (her2)-positive breast cancer. before surgery, participants will be randomized to receive either a) 6 cycles of pertuzumab plus trastuzumab (herceptin), with 5-fluorouracil/epirubicin/cyclophosphamide (fec) for cycles 1-3 and docetaxel for cycles 4-6, or b) fec for cycles 1-3 followed by pertuzumab plus trastuzumab with docetaxel for cycles 4-6, or c) 6 cycles of pertuzumab plus trastuzumab with docetaxel and carboplatin. pertuzumab will be administered at a loading dose of 840 mg intravenously (iv), then 420 mg iv 3-weekly, trastuzumab at a loading dose of 8 mg/kg iv, then 6 mg/kg iv 3-weekly, docetaxel at 75 mg/m\^2 iv, increased to 100 mg/m\^2 iv 3-weekly, and fec and carboplatin iv 3-weekly at standard doses. following surgery participants will receive trastuzumab 6 mg/kg iv 3-weekly for a total of 1 year, as well as adequate chemo-, radio- and hormone therapy. anticipated time on study treatment is 4-12 months, and target sample size is 200-300.


Eligibility criteria:
inclusion criteria: * female participants, age \>/=18 years * advanced, inflammatory or early stage unilateral invasive breast cancer * her2-positive breast cancer * baseline left ventricular ejection fraction (lvef) \>/=55% exclusion criteria: * metastatic disease (stage iv) or bilateral breast cancer * previous anticancer therapy or radiotherapy for any malignancy * other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma * clinically relevant cardiovascular disease * current chronic treatment with corticosteroids of \>10mg methylprednisolone or equivalent