Kornimate/medical-research-clean huggingface dataset:
pilocarpine in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer

Conditions: Head and Neck Cancer; Oral Complications

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. drugs such as pilocarpine may protect normal cells from the side effects of radiation therapy. it is not yet known if pilocarpine may be effective in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer. purpose: randomized, double-blinded, phase iii trial to study the effectiveness of pilocarpine in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer.

objectives: i. determine whether prophylactic use of pilocarpine can shelter unstimulated and stimulated whole salivary flow in patients with head and neck cancer. ii. determine whether prophylactic use of pilocarpine can moderate xerostomia in these patients. iii. determine whether prophylactic use of pilocarpine can reduce the grade and duration of radiation induced mucositis in these patients. iv. evaluate quality of life outcomes between patients receiving pilocarpine versus placebo. v. evaluate the impact of xerostomia on patients receiving irradiation to the head and neck. outline: this is a randomized, double blind study. patients receive a central axis midplane dose of radiotherapy five days per week over 6 to 7 weeks. oral pilocarpine or placebo is administered beginning 3 days prior to radiotherapy, one tablet four times per day for three months. a tablet will be taken 45-60 minutes before radiotherapy. after three months, and after a 3-4 day rest period, all patients receive non blinded pilocarpine for an additional three month period. patients are followed at weeks 4, 13, and 26 after the start of radiotherapy. projected accrual: a total of 244 patients will be accrued (122 per treatment arm).

Eligibility criteria:
disease characteristics: histologically proven oral cavity and/or oropharyngeal squamous cell carcinoma radiation volume to encompass at least 50% of parotid glands and have at least 50 gy delivered to that volume via external beam no salivary gland malignancies or diseases patient characteristics: age: 18 and over performance status: karnofsky 60-100% life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: not pregnant or nursing effective contraceptive method must be used during study no pilocarpine allergy prior concurrent therapy: biologic therapy: not specified chemotherapy: not specified endocrine therapy: not specified radiotherapy: no prior radiotherapy to head or neck surgery: not specified other: no concurrent adrenergic antagonists, cholinergic drugs, anti-cholinergics, or tricyclics

Keywords: oral complications lip and oral cavity squamous cell carcinoma oropharyngeal squamous cell carcinoma
music therapy for patients being weaned from mechanical ventilation

Conditions: Respiratory Insufficiency

Summary: the purpose of the study is to determine whether music therapy interventions can be used as supportive therapy for patients undergoing weaning from mechanical ventilation. the music will support the procedure by serving as a stimulus for relaxation and/or pain and anxiety management.music used is varied according to subject's preferences.

music therapy interventions will be used as supportive therapy for patients undergoing weaning from mechanical ventilation. the music will support the procedure by serving as a stimulus for relaxation and/or pain and anxiety management. the intervention will consist of 40 - 50 minutes of active music therapy and improvisation in which the music is used as a distraction from the hospital setting and the procedure taking place. the intervention will end with 5 to 10 minutes of discussion of music activities/selections to be used between music therapy sessions. the intervention is individualized and can be modified accordingly to the subject's preferences.

Eligibility criteria:
inclusion criteria: * anxiety * weaning sessions less than 8 hours exclusion criteria: weaning trials greater than 8 hours -

Keywords: music therapy mechanical ventilation weaning from mechanical ventilation complementary and alternative therapy
safety and effectiveness study of imiquimod creams in the treatment of external genital warts

Conditions: Genital Warts

Summary: the purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (egw). the secondary objective of this study is to provide information on recurrence of egw. additionally the study will also look at any adverse events associated with the use of the creams. external genital and perianal warts are caused by the infection of human papillomavirus or hpv. hpv infection is a sexually transmitted disease (std). external genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. the warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. they often appear in clusters of three or four, and may grow and spread rapidly. they usually are not painful, although they may cause mild pain, bleeding, and itching.


Eligibility criteria:
inclusion criteria: * in good general health * diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 warts * negative pregnancy test (for women who are able to become pregnant) exclusion criteria: * women who are pregnant, lactating or planning to become pregnant during the study * evidence of clinically significant or unstable disease (such as stroke, heart attack) * have any of the following conditions: hiv infection; current or history of high risk hpv infection (e.g., hpv 16, 18, etc.); outbreak of herpes genitalia in the wart areas; internal warts requiring or undergoing treatment; dermatological disease (e.g., psoriasis) or skin condition in the wart areas * have received specific treatments in the treatment area(s) within the designated time period prior to study treatment initiation.

Keywords: external genital warts perianal warts condylomata acuminata venereal warts hpv types 6 and 11
vitamin d and arterial function in patients with chronic kidney disease

Conditions: Arterial Dysfunction; Chronic Kidney Disease

Summary: the purpose of this study is to determine whether nutritional (cholecalciferol) or active vitamin d (calcitriol) supplementation improves vascular endothelial function in patients with stage iiib and iv chronic kidney disease with vitamin d insufficiency or deficiency. the investigators hypothesize that the use of calcitriol supplementation will result in improved vascular endothelial function as compared to cholecalciferol supplementation.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * chronic kidney disease stage iiib or iv by 4 parameter modified diet in renal diseases formula (estimated glomerular filtration rate \[gfr\] 44-15 ml/min/1.73m2) * vitamin d (d2 + d3) deficient, defined as serum 25(oh)d level \< 30 ng/ml * corrected serum calcium \< 10.2 mg/dl * serum phosphate \< 4.6 mg/dl * serum albumin \> 3.0 g/dl * body mass index \< 40 kg/m2 * ability to give informed consent exclusion criteria: * significant co-morbid conditions that lead the investigator to conclude that life expectancy is less than 1 year * expected to undergo living related kidney transplant in next 6 months * pregnant, breastfeeding, or unwilling to use adequate birth control * history of severe liver disease * nephrotic range proteinuria (\> 3.5 gm/day) * use of active vitamin d analogs within 30 days of randomization

Keywords: chronic kidney disease vitamin d deficiency
ultrasound guided core biopsy vs fine needle aspiration for evaluation of axillary lymphadenopathy

Conditions: Focus: Breast Cancer With Axillary Node Metastasis

Summary: the study was performed to determine if either ultrasound guided core biopsy or fine needle aspiration of an axillary lymph node has superior sensitivity in detecting metastatic carcinoma from the ipsilateral breast.

women with suspected or recently diagnosed breast cancer and ipsilateral abnormal appearing axillary lymph nodes underwent fine needle aspiration immediately followed by core biopsy of the same lymph node.cytology results from the fine needle aspiration (fna)and histology from the core biopsy were compared to surgical pathology from axillary node excision to determine if either method of percutaneous node sampling was more sensitive in detecting metastasis. pain during each procedure was also compared.

Eligibility criteria:
inclusion criteria: * women with breast cancer and abnormal ipsilateral axillary nodes visible on sonography. exclusion criteria: * inability to understand consent form. * emotionally unprepared to discuss possibility of axillary metastasis * node not amenable to core biopsy
yoga for caregivers and persons with dementia

Conditions: Dementia

Summary: the purpose of this research is to determine the feasibility and acceptability of yoga classes for persons living with dementia (plwd) and their care partners. a secondary aim of this study is to examine the impact of yoga on caregiver burden.

participants will be recruited from the d-care study in dyads. both the caregiver and person with dementia must agree to participate. screening will be done either in clinics or by telephone in the participants' homes. the intervention will be conducted in community facilities and participants' homes. the sample size will consist of 10 caregiver/person with dementia dyads. this number was chosen to provide evidence of feasibility of conducting yoga classes with dyads.

Eligibility criteria:
inclusion criteria: * caregivers: providing unpaid care to a family member of friend diagnosed alzheimer's disease and alzheimer's disease related dementias (adrd) * persons with dementia: a diagnosis of dementia; live in the community (assisted living facility is allowed); cognitively able to participate in yoga as determined by study staff exclusion criteria: * non-english-speaking; and practicing yoga or meditation within the last 30 days.

Keywords: dyad caregiver yoga dementia
examining hepatitis c reinfection rates in kenya

Conditions: Hepatitis C

Summary: the goal of this research project is to build upon the testing and linkage to care for injecting drug users (tlc-idu) parent study and describe post-cure hcv reinfection in a population of people who inject drugs (pwids) in kenya.

in addition to describing reinfection in a substance using cohort, we will identify individual predictors of hcv reinfection in kenya, as well as identifying individual utilization intervention approaches and dosing that reduce reinfection risk and treatment cite level risk factors (frequency of visits, community vs hospital location etc.). determining the risk factors specific to reinfection and understanding the impact of concurrent harm reduction interventions will guide service delivery and implementation of hcv elimination strategies in kenya and throughout the region.

Eligibility criteria:
inclusion criteria: 1. live in nairobi or coastal mombasa (coast province including malindi), kenya; 2. are injection drug users (idus) that ever injected any non-prescribed drugs; and able and willing to provide informed consent. 3. participates are in the parent study; 4. complete treatment protocol; and achieve a sustained virologic response (svr). exclusion criteria: not in the above inclusion criteria.
to evaluate the safety of 'shinbaro capsule'in patients with osteoarthritis

Conditions: Osteoarthritis

Summary: this study investigates if shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.


Eligibility criteria:
inclusion criteria: * minimum 19 years old * kellgren stage i \~ iii by acr criteria * stable osteoarthritis during 3 months * be able to perform womac and kks * written consent form voluntarily exclusion criteria: * disease of orthopaedic surgical that could affect to evaluate the efficacy * medication of continuous corticosteroid by oral or articular cavity within 12 weeks * medication of constantly (more than 1 week) antipsychotic drug or narcotic analgesics within four weeks * medical history of hypersensitivity reaction against herbal drug * genetic factors as galactose intolerance, lapplactase deficiency or glucose-galactose malabsorption, etc. * occurrence of oa caused by the injury * diagnosed with psychical disorder, and taking medication * diagnosed with active peptic ulcers, gastrointestinal bleeding, inflammatory bowel disease, severe liver dysfunction, severe renal dysfunction, congestive heart failure, clinically significant ischemic heart disease, peripheral arterial disease, or cerebrovascular diseases * diagnosed with esophagus and gastrointestinal ulceration within 1 year, or treated it * abnormal bleeding (abnormal of platelet or blood coagulation factor, etc.) * positive in fecal occult blood test * gastrointestinal tract surgery except appendectomy * serum creatinine, alt, ast, total bilirubin over unl x 1.5 at screening test * participation in another clinical trials within 4 weeks * not consent about using effectual contraception method during trial * pregnant or lactating woman * medical history of malignant tumor within 5 years * investigator's judgment

Keywords: osteoarthritis shinbaro herbal drug
phase i/ii study of the combination of irinotecan and pof (pofi) and tislelizumab

Conditions: Gastric Cancer Stage IV

Summary: the purpose of the phase i/ii study is to establish the safety of combination of irinotecan and paclitaxel with 5-fu, leucovorin, oxaliplatin and tislelizumab.


Eligibility criteria:
inclusion criteria: 1. patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction. 2. with or without measurable lesions. 3. patients must have a performance status of 0-1 on the eastern cooperative oncology group (ecog) scale. 4. without serious system dysfunction and could tolerate chemotherapy. with normal marrow, liver and renal function: a hemoglobin (hgb) of ≥100g/l (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/l; a platelet count of ≥100×109/l; a total bilirubin (tbil) of ≤1.5 upper normal limitation (unl); a creatinine (cr) of ≤ 1.5 unl; a creatinine clearance rate ≥ 50ml/min (cockcroft-gault); a alanine aminotransferase (alat) and aspartate aminotransferase (asat) of ≤2.5 unl or ≤5 unl in case of liver metastasis. 5. life expectancy ≥3 months. 6. with normal electrocardiogram results and no history of congestive heart failure. 7. with normal coagulation function: activated partial thromboplastin time (aptt), prothrombin time (pt) and inr, each ≤ 1.5 x uln. 8. female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of tislelizumab until 8 weeks after discontinuing study drug. male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug 9. with written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors. 10. with good compliance and agree to accept follow-up of disease progression and adverse events. exclusion criteria: 1. patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer. 2. patients with brain or central nervous system metastases, including leptomeningeal disease. 3. pregnant (positive pregnancy test) or breast feeding. 4. serious, non-healing wound, ulcer, or bone fracture. 5. significant cardiac disease as defined as: unstable angina, new york heart association (nyha) grade ii or greater, congestive heart failure, history of myocardial infarction within 6 months evidence of bleeding diathesis or coagulopathy. 6. history of a stroke or cva within 6 months. 7. clinically significant peripheral vascular disease. 8. inability to comply with study and/or follow-up procedures. 9. patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
placebo-controlled trial in subjects at ultra-high risk for psychosis with omega-3 fatty acids in europe

Conditions: Ultra High Risk for Psychosis

Summary: the purpose of this study is to determine whether omega-3 fatty acids are effective in the prevention of psychosis in individuals at ultra-high risk for psychosis.

purpose is a randomized double-blind placebo-controlled study. main objective is to assess the effectivity of omega-3 fatty acid treatment in the prevention of psychosis. the primary outcome measure is the rate of transition to psychosis as determined through caarms. subjects in the age range of 13-20 years with a higher chance of developing psychosis, as determined by the caarms, are treated for 6 months with omega-3 fatty acids or placebo. this study in conducted at 14 sites in 9 countries.

Eligibility criteria:
inclusion criteria: * written informed consent of the subject. for individuals younger than 18 years of age the parents / legal representatives need to give consent, and the subject can provide assent (whether the latter is required depends on local laws and regulations). * uhr diagnosis as made using the comprehensive assessment of at-risk mental states (caarms) (yung et al., 2005). subjects have to meet one or more of the following criteria: (a) attenuated psychotic symptoms, (b) brief limited intermittent psychotic symptoms (a history of one or more episodes of frank psychotic symptoms that resolved spontaneously within 1 week in the past year), or (c) either the presence of schizotypal personality disorder or a family history of psychosis in a first-degree relative, all three together with a recent decline in function. exclusion criteria: * any clinically significant medical condition that may influence the results of the trial or affect the ability to take part in a trial. * laboratory screening values considered clinically relevant by a medical doctor for transaminases, thyroid hormones or coagulation parameters * current or past dsm-iv diagnosis of psychosis, as measured with k-sads-pl * current treatment with an antipsychotic or mood-stabilising agent * intake of an antipsychotic or mood-stabilising agent in the two weeks prior to study inclusion * intake of an antipsychotic agent equivalent to a total haloperidol use of \>50 mg in the six months prior to study inclusion * a first-degree relative (i.e. parents, offspring or siblings) participating in this study * uhr diagnosis on the basis of attenuated psychotic symptoms that are entirely explained by acute intoxication * current aggression or dangerous behaviour (panss g14 score 5 or above) * current suicidality / self-harm (panss g6 score 7) * current dsm-iv diagnosis of alcohol or substance dependence as measured with k-sads-pl * any current or previous neurological disorder, including epilepsy * history of head injury resulting in unconsciousness lasting at least 1 hour * iq \< 70 * more than 4 weeks of regular omega-3 supplementation (\>2 daily capsules standard strength providing \>600 mg combined epa/dha) within the last 6 months.

Keywords: ultra-high risk uhr psychosis
alpha lipoic acid and chronic lumbosacral radicular pain

Conditions: Radicular; Neuropathic, Lumbar, Lumbosacral

Summary: in this study, we try to evaluate the effect of using ala as an adjuvant treatment in patients scheduled for pulsed radiofrequency treatment (prft) of the affected dorsal root ganglion (drg) for treatment of lumbo-sacral radicular pain.

study design: the study is prospective, randomized, and open label started in august 2013 and was completed in march 2017 at assiut university hospital, pain unit after local ethical committee approval. all patients were informed verbally and in writing about the study, and they signed a detailed written informed consent about the procedure and the nature of the study.

Eligibility criteria:
inclusion criteria: * patients over 18 years with severe chronic lumbo-sacral radicular pain of more than 6 months duration, not responding to medical treatment, and their pain scores were \> 7 were included in the study. exclusion criteria: * coagulopathy, surgical interference, advanced malignancy, known concurrent neurological or neurodegenerative disease, including those with impaired neurotransmission e.g. myasthenia gravis, multiple sclerosis, spinal cord injury, breastfeeding or pregnancy, allergy/sensitivity to lidocaine anesthetic or/ and non-ionic contrast media or/and steroid therapy, active psychiatric or mental conditions and uncontrolled medical condition.

Keywords: lumbosacral radicular pain pulsed radiofrequency alpha lipoic acid
ball exercises and stereotypic behavior in autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorder (asd) is a neuro-behavioral disorder associated with repetitive movements. the role of physical therapist towards an autistic child is most neglected one. therefore, the objective of this study was to see the effectiveness of different ball exercise on stereotypic behavior of children with asd. different ball exercises were implemented for 2 months, 3 sessions per week and every session consist of 35 minutes.


Eligibility criteria:
inclusion criteria: * children diagnosed with asd through experts * having recognized stereotypic behavior * having intellectual deficit (id) and attention deficit hyperactive disorder (adhd) * age ranging between 4-16 years * consented to take part exclusion criteria: * having co-morbidities like schizophrenia and developmental delays * severe cases of asd * showing aggressive behavior * having disease of cardiovascular or respiratory system * children unable to follow the command for exercise completely

Keywords: ball exercises physical therapy