Kornimate/medical-research-clean huggingface dataset:
adaptive androgen deprivation and docetaxel in metastatic castration sensitive prostate cancer

Conditions: Metastatic Castration Sensitive Prostate Cancer

Summary: this is a prospective single center phase iia open label nonrandomized study, which aims to test the hypothesis that the duration of castration sensitive phase of stage iv prostate cancer can be prolonged with adaptive androgen deprivation therapy (adt) and docetaxel.


Eligibility criteria:
inclusion criteria: * biopsy proven prostate cancer and the diagnosis can be established through either prostate biopsy or biopsy of a metastatic lesion. * no androgen deprivation therapy (adt) with lhrh analog for more than 4 weeks after the diagnosis of metastatic prostate cancer. prior adt in the non-metastatic setting is allowed if it was given \> 2 years prior to the diagnosis of metastatic prostate cancer. * achieved \>50% psa decline and \<4 ng/ml psa after the run-in period. * adequate organ function with absolute neutrophil count \> 1000/l, hb \> 10 g/dl, platelet \> 100,000/l, creatinine and liver enzymes within 1.5 folds of upper limits of normal. * no uncontrolled arrhythmia; patients with h/o myocardia infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or muga scan within 6 months of study enrollment. * ecog performance status 0-1. * non-sterilized men who are sexually active with a female partner of childbearing potential treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 weeks after last dose of arsi or docetaxel administration. * ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the subject's behalf. stated willingness to comply with all study procedures and availability for the duration of the study. exclusion criteria: * prior treatments with tak-700/orteronel, abiraterone, apalutamide or enzalutamide. * surgical castration. * documented liver or brain metastases * history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel (including any drugs formulated with polysorbate 80), or lhrh analog (e.g., leuprolide, triptorelin, relugolix, degarelix) * treatment with any investigational compound within 30 days prior to the first dose of study drugs. * diagnosis or treatment for another systemic malignancy within 2 years before the first dose of lhrh analog, or previously diagnosed with another malignancy \& have any evidence of residual disease. patients with early-stage skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. * uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * subjects with delayed healing of wounds, ulcers, and/or bone fractures.

Keywords: prostate cancer
long-term follow-up study of brl-101 for tdt

Conditions: Thalassemia, Beta

Summary: observe long-term safety risk and long-term efficacy after intravenous infusion of brl-101 in tdt subjects.

observe long-term delayed safety risks such as emerging neoplasms, emerging haematological disorders, and long-term efficacy after intravenous infusion of brl-101 in tdt subjects.

Eligibility criteria:
inclusion criteria: 1. provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s) 2. treated with brl-101 for therapy of transfusion-dependent β-thalassemia. exclusion criteria: - there are no exclusion criteria for this study
subcutaneous sterile water injection for relief of low back pain

Conditions: Low Back Pain

Summary: to compare the effect of subcutenous sterile water injection technique with the subcutaneous saline injection technique in the degree and duration of low back pain-relieving during childbirth

study sample: the convenience sample will be recruited randomly on the basic of odd number will have saline injection and even number will be given a placebo (sterile water injection) setting: labor ward in women's health center at assiut university hospital study design: experimental randomized control study sample size: the sample size was calculated using the formula n= (zα+zβ)2 x 2p(1-p)÷d2 ,taking the level of significance as 5%, zα=1.96 and power of the test as 80%, zβ=0.84. p=0.113. a sample size of 165 in each group was calculated. total of 330 women will be studied (165 in each arm) inclusion criteria * in labour (spontaneous or induced * during first stageof labour * primary and multiparous women * a term singleton pregnancy (between 37 + 0 and 41 weeks) * have a fetus in a cephalic presentation * experience back pain assessed by visual analogue scale vas and face pain analogue ( warden v, hurley ac, volicer l.2003) * provide informed consent. exclusion criteria * multiple pregnancy * malpresentation (breech, transverse, shoulder) * previous cs * infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. thrombocytopenia. study tools: 1. personal data questionnaire 2. visual analogue scale and face analogue scale 3. satisfaction scale

Eligibility criteria:
inclusion criteria: * in labour (spontaneous or induced record * during first stage of labour * primary and multiparous women * a term singleton pregnancy (between 37 + 0 and 41 weeks) * have a fetus in a cephalic presentation * experience back pain assessed by visual analogue scale vas and face pain analogue * provide informed consent. exclusion criteria: * women with chronic disease * medical condition associated with pregnancy ( pre-eclampsia- eclampsia- diabetic pregnancy.... etc) * complicated labor process ( obstructed, preterm labor, twins)

Keywords: women severe low back ache labor
post-approval clinical trial of the pcm® cervical disc

Conditions: Radiculopathy; Myelopathy

Summary: on october 26, 2012, the fda granted premarket approval (pma) for the pcm cervical disc. pcm cervical disc is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from c3-c4 to c6-c7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (ct, mri, x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. the purpose of this post-approval study is to evaluate the long-term (7 year) safety and effectiveness of the pcm cervical disc.

a prospective, multi-center, post approval study with concurrent control group consisting of those patients that were enrolled and did not fail in the pcm cervical disc ide clinical study and will to give consent to participate. all of the pcm ide investigational sites who have active patients will be chosen to participate in this study. all patients who are actively participating in the pivotal ide study will be asked to participate in this study. the study consists of follow-up periods only. the follow-up period will last for seven years from each patient's surgery date.

Eligibility criteria:
inclusion criteria: * patients enrolled in the pcm cervical disc ide clinical study * patients willing and able to give informed consent exclusion criteria: * patients considered failure during the pcm cervical disc ide clinical study * patients who were withdrawn during the pcm cervical disc ide clinical study
study of nitazoxanide in the treatment of amebiasis in children

Conditions: Amebiasis

Summary: the purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by entamoeba histolytica in children.


Eligibility criteria:
inclusion criteria: * age 1 to 11 years. * patients with diarrhea (≥3 bowel movements/day) with one or more enteric symptoms such as bloody stools, rectal bleeding or enlarged colon. * positive stool elisa test for entamoeba histolytica within 7 days prior to enrollment. exclusion criteria: * patients with identified causes of diarrhea other than e. histolytica. * use within 2 weeks of enrollment of any drug or therapy with possible anti-protozoal activity. * females who are pregnant, suspected of being pregnant or breastfeeding. * serious systemic disorders incompatible with the study. * history of hypersensitivity to nitazoxanide. * patients in whom the possibility of receiving placebo and not being able to receive immediately an effective treatment will be incompatible with the severity of the patient's illness. * patients with amebic liver abscess. * patients known to have or suspected of having aids. * patient with immune deficiencies.

Keywords: amebiasis entamoeba histolytica
upper gi handling of branded vs. generic alendronate

Conditions: Osteoporosis

Summary: to compare upper gi handling of fosamax and generic, because the main ae profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to the side effect profile.


Eligibility criteria:
inclusion criteria: * post-menopausal females aged greater 55 years * prescribed alendronate 70 mg tablets for a therapeutic indication throughout the previous 3 months and expected to continue on this treatment for the duration of the study * willing to abstain from alcohol for 24 hours before each dose and until the end of each study day * willing to abstain from smoking for 24 hours before each dose and until the end of each study day exclusion criteria: * history of drug hypersensitivity * suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility
simultaneously using traditional chinese medicine (si-ni-tang) to treat septic shock patients

Conditions: Septic Shock

Summary: the purpose of this study is to determine whether simultaneously using the traditional chinese medicine, si-ni-tang, is more effective in the treatment of septic shock patients.

those with hemodynamic instability were the main population of the icu patients, whether the exact etiology leading to the diseases. however, how to maintain adequate hemodynamic status in order to keep the patients with well organs perfusion is the main issue of the intensive care physicians. the choices of vasoactive drugs in the guidelines or experts' suggestions nowadays used are still limited in the western medicine. si-ni-tang, a remedy previously used in ancient china and now widely prescribed in taiwan and china, is used for treating patients diagnosed as shock or heart failure. the investigators are eager to know if there existed any benefit via adding this drug to treat the septic shock patients. therefore, the investigators designed a prospectively randomized double blind control trial to determine whether simultaneously using the traditional chinese medicine, si-ni-tang, is more effective in the treatment of septic shock patients.

Eligibility criteria:
inclusion criteria: * adult patients admitted to our intensive care units are enrolled if their disease diagnosis meets the definition of septic shock * using vasopressor now and the duration from initiation of vasopressor use to the entrance of the study is within 24 hours * nasogastric tube feeding exclusion criteria: * more than one kind of vasopressor is administrated * patients with extremely poor gastrointestinal function and can not tolerate diet feeding * acute myocardial infarction * patients with evidence of major bleeding * expected surgical intervention or scheduled surgery in the subsequent one week * patients who received digoxin for arrhythmia in the past one week

Keywords: septic shock shock reversal icu traditional chinese medicine
a trial to assess the pharmacokinetics, safety, and tolerability of centanafadine capsules in pediatric subjects with attention-deficit hyperactivity disorder

Conditions: Attention-deficit Hyperactivity Disorder

Summary: this is a phase 1b, multicenter, open-label, multiple-dose trial in pediatric subjects (4 - 12 years of age, inclusive) with a confirmed diagnosis of adhd.


Eligibility criteria:
key inclusion criteria: * male or female subjects 4 to 12 years of age, inclusive, at the time of informed consent/assent. * a diagnosis of any adhd subtype based on diagnostic and statistical manual of mental disorders - 5th edition (dsm-5) criteria and confirmed by the mini international neuropsychiatric interview for children and adolescents (mini-kid). key exclusion criteria: * subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychiatric symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (medication, illicit drug use, etc); or subjects with a clinical presentation or history of psychotic symptoms. * subjects with developmental disorders, such as autism spectrum disorder. * subjects with a history of intellectual disability as determined by at least 1 of the following: intelligence quotient \< 70, or clinical evidence, or a social or school history that is suggestive of intellectual disability. * subjects who currently have clinically significant neurological, dermatological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, hiv seropositive status/ aids, or chronic hepatitis b or c. * subjects who have history of clinically significant tachycardia or hypertension.
radiation adherence/toxicity in patients with non-ovarian gynecological cancers

Conditions: Non-ovarian Gynecological Cancers

Summary: the purpose of this study is to investigate the association between the independent activities of daily living (i-adl) component of the comprehensive geriatric assessment (cga) and poor tolerance to radiation treatment in older and younger patients with non-ovarian gynecological cancers.

there are little data regarding the impact of functional age on tolerance to radiotherapy for gynecologic cancers. a comprehensive geriatric assessment (cga) tool which measures functional status (including the instrumental activities of daily living (i-adl)), among many other important geriatric related conditions, was developed by hurria and colleagues. geriatric assessment variables including functional status predicted for toxicity in older patients receiving chemotherapy and surgery for multiple cancer types., 2 we hypothesize that i-adl can be used to predict treatment tolerance in patients of all ages receiving pelvic and/or paraaortic region radiation therapy for gynecologic malignancies.

Eligibility criteria:
inclusion criteria: * ≥age 18 years (no upper age limit) * diagnosis of cervical, vaginal, vulvar, or endometrial cancer with either pelvic radiotherapy or chemoradiotherapy planned as part of standard treatment. * consented for receipt of external beam radiation therapy (ebrt) at the university of north carolina chapel hill * ability to read english (required for cga) * curative treatment intent as defined by their radiation oncologist * negative serum pregnancy test in women of childbearing potential exclusion criteria: * \< age 18 years * incurable cancer as defined by their radiation oncologist * planned radiation for palliative intent only * inability to complete the i-adl section of the cga * prior radiation to areas targeted by radiotherapy within this study * other active, invasive malignancy requiring active ongoing therapy during their radiotherapy with the exception of: * localized squamous cell carcinoma of the skin * basal-cell carcinoma of the skin * other malignancies requiring locally ablative therapy only

Keywords: gynecologic malignancy non-ovarian gynecological cancer cervical cancer vaginal cancer vulvar cancer endometrial cancer
scapular training in stroke individuals

Conditions: Stroke

Summary: in recent publications evaluating scapular kinematics after stroke, it is emphasized that scapular muscles, which affect the performance of upper limbs in daily life, should not be ignored. when the literature is analyzed for these reasons, the studies in which scapular training was added to the treatment plan of upper limb rehabilitation of stroke individuals are inadequate and the existing studies have methodological deficiencies. also, it is seen that studies which investigate the effects of these exercises on scapular kinematics, the parameters of periscapular muscle thickness and shoulder subluxation are not included. the purpose of this study is to examine the effects of scapular training on scapular kinematics, periscapular muscle thickness, shoulder subluxation and upper extremity functionality in stroke individuals. the study was planned to include 2 groups, 1 treatment and 1 control group. the control group will receive neurodevelopmental treatment - bobath exercises, while the treatment group will receive exercises for the muscles around the scapula in addition to neurodevelopmental treatment - bobath exercises. muscle thickness of periscapular muscles, shoulder subluxation, 3d scapular kinematics, upper extremity and trunk performance, pain, activities of daily living and quality of life will be assessed before and after 8 weeks treatment program. as a result; effectiveness of scapular training in addition to neurodevelopmental treatment and relationship between scapular kinematics, periscapular muscle thickness, shoulder subluxation, and upper extremity performance will be examined.


Eligibility criteria:
inclusion criteria: * unilateral ischemic / hemorrhagic stroke for more than 3 months * \> 18 years * mild-moderate upper extremity impairment (fma≥30) * active shoulder elevation ≥ 90° * shoulder girdle muscles spasticity ≤ 2 * mini mental state examination score ≥ 24 exclusion criteria: * body mass index ≤ 30 kg/m2 * having an allergy to adhesive tape * clinical diagnosis of another neurologic disease other than stroke which might effect standing independently * having a history of humerus, clavicle and scapula fracture * having a shoulder surgery such as rotator cuff muscle repair

Keywords: stroke muscle thickness scapula 3-d kinematics upper extremity performance
measuring pain and hydration after tonsillectomy

Conditions: Dehydration

Summary: pain after tonsillectomy remains a key barrier during the post operative period. the published return rate to the emergency department for hydration and pain control is approximately 4%. if we can demonstrate decreased pain or decreased visits to the emergency department post tonsillectomy, patient experiences will be improved and health care dollars spent will be decreased. we will attempt to improve hydration status by encouraging consumption of a novel isotonic hydration solution that is currently commercially available. our study hypothesis is that patients provided an isotonic hydration solution and instructions on avoiding dehydration post operatively will have improved pain control and decreased emergency department visits. improvement in hydration status has the potential of decreasing emergency room visits and subsequent decrease in spending of healthcare dollars. additional benefits of post-operative hydration may include decrease in pain and decrease in post-operative bleeding rates. a new isotonic hydration solution with an improved flavor profile (hoist®) has recently become commercially available. itis very similar to that of pedialyte, a commonly used rehydration solution. pedialyte was designed for rehydration of infants and small children. it has a taste that is not acceptable to many adults and older children. this study will implement the use of hoist as suitable rehydration solution. this study is designed to define the relationship between improvement of patient's hydration through provision of a rehydration solution during the post operative period and decrease in complications requiring return to the emergency room, including dehydration and bleeding, as well as improvement in overall pain control.


Eligibility criteria:
inclusion criteria: * patients undergoing tonsillectomy * patients undergoing tonsillectomy with adenoidectomy exclusion criteria: * patients on anticoagulants * patients younger than 3 years old * patients with chronic pain syndrome

Keywords: dehydration hoist pain control the intervention is to provide a commercially available isotonic hydration solution (hoist®) to the patients. patients will drink this solution post procedure as needed. patients in the control group will use their discretion to drink any solution they feel suitable
moderate to severe bronchiolitis: standard therapy versus therapy with nacl 3% inhalations

Conditions: Moderate to Severe Bronchiolitis

Summary: our study will investigate inhalation therapy of nacl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. the impact on length of hospital stay will be analyzed.

acute viral bronchiolitis is the most common lower respiratory tract infection in the first year of life and leads to a large number of hospital admissions. the only recommended treatment is supportive. however many different types of drug inhalations have been studied but their efficacy remains controversial. our study will compare recommended supportive therapy to supportive therapy combined to hypertonic saline (nacl 3%) inhalations in the treatment of moderate to severe bronchiolitis. this will be the first study to use a true control group with no inhalation.

Eligibility criteria:
inclusion criteria: * children between ages 6 weeks to 24 months * first episode of wheezing * diagnosis of moderate to severe bronchiolitis: the patients are ranked as moderately to severely ill according to the wang clinical severity score exclusion criteria: * children with mild bronchiolitis (wang score \< 5) * children with pre-existent cardiac disease * children with clinically significant chronic respiratory disease * immunocompromised children * children with a gestational age at birth less than 34 weeks * children who received immunoprophylaxis therapy (i.e rsv immune globulin therapy) * children who received corticosteroid in any form in the preceding 2 weeks before presentation * children who received bronchodilators within 24 hours before presentation * children with critical illness at presentation requiring immediate admission to intensive care unit

Keywords: bronchiolitis moderate to severe hypertonic saline nacl 3% inhalations standard therapy wang score in-patients