Kornimate/medical-research-clean huggingface dataset:
study of oto-104 in subjects at risk from cisplatin-induced hearing loss

Conditions: Cisplatin Induced Hearing Loss

Summary: this is a multicenter, phase 2 study to assess the feasibility, safety and efficacy of oto-104 given by intratympanic administration in subjects at risk for ototoxicity from cisplatin chemotherapy regimens in the treatment of cancer.


Eligibility criteria:
inclusion criteria: * subject is aged 6 months to 21 years inclusive. * subject is diagnosed with neuroblastoma, hepatoblastoma, osteosarcoma or extracranial germ cell tumors and has not been previously treated with cisplatin or carboplatin. * subject is scheduled to receive a chemotherapy regimen that includes a cumulative cisplatin dose of ≥ 200 mg/m2. * subject has normal baseline auditory function, defined as ≤ 20 db from 2000 to 8000 hz, in both ears and does not have a history of sensorineural hearing loss. exclusion criteria: * subject has middle ear effusion upon clinical examination. * subject has a history of central nervous system radiotherapy that encompasses all or part of the cochlea or will receive such radiation therapy during the course of the study. * subject is receiving sodium-thiosulfate or amifostine therapy with chemotherapy. * subject is currently participating on a separate otoprotection clinical study.
iodine i 131 metaiodobenzylguanidine in treating patients with recurrent, progressive, or refractory neuroblastoma or malignant pheochromocytoma or paraganglioma

Conditions: Neuroblastoma; Pheochromocytoma

Summary: the purpose of this research study is to find how active and safe 131 i-mibg is in patients with resistant neuroblastoma, malignant pheochromocytoma and malignant paraganglioma.


Eligibility criteria:
inclusion criteria for nb: * patients must have the diagnosis of nb in accordance with the international criteria, i.e., either histopathology (confirmed by the mskcc department of pathology) or bm involvement plus elevated urinary catecholamines. * must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy. * patients must have mibg-avid nb and evaluable disease on mibg scan at time of enrollment on protocol * prior therapy: at least 2 weeks should have elapsed since any biologic therapy. three weeks should have elapsed since last dose of chemotherapy. * age \>1 year with a determination that radiation safety restrictions during therapy period can be implemented. * stem cells: patients for high does must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after mibg treatment. patients for low dose do not require cryopreserved autologous hematopoietic stem cell product available. the minimum dose for peripheral blood stem cells is 2 x106 cd34+ cells/kg. * minimum life expectancy of eight weeks * signed informed consent indicating awareness of the investigational nature of this program. inclusion criteria for malignant cct: * patients must have the diagnosis of malignant cct i.e. malignant pheochromocytoma or malignant paraganglioma * patients must have mibg-avid malignant cct and evaluable disease on mibg scan at time of enrollment on protocol * prior therapy: at least 2 weeks should have elapsed since any biologic therapy. three weeks should have elapsed since last dose of chemotherapy. * age between 1 and 21 years and able to cooperate with radiation safety restrictions during therapy period * stem cells: patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after mibg treatment. the minimum dose for peripheral blood stem cells is 2 x106 cd34+ cells/kg. * minimum life expectancy of eight weeks. * signed informed consent indicating awareness of the investigational nature of this program. exclusion criteria: * severe major organ toxicity. specifically, renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 2 or less. a grade 3 hearing deficit is acceptable. * active serious infections not controlled by antibiotics. * pregnant women are excluded for fear of danger to the fetus. therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period. * inability or unwillingness to comply with radiation safety procedures or protocol requirements.

Keywords: metastatic pheochromocytoma recurrent pheochromocytoma regional pheochromocytoma recurrent neuroblastoma 04-148
a study of insulin efsitora alfa (ly3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy

Conditions: Type 1 Diabetes; Diabetes

Summary: the main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (ly3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.


Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening * have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening * have an hba1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening. * have a body mass index of ≤35 kilogram/square meter (kg/m²) exclusion criteria: * have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes * have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening. * have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.

Keywords: type 1 diabetes (t1d)
emergency versus elective cholecystectomy in acute cholecystitis in the era of laparoscopy.

Conditions: Cholecystitis, Acute

Summary: the aim of study is compare outcome of patients undergoing early laparoscopic cholecystectomy within 72 hours from the begging of symptoms to those of patients managed conservatively and operated late after 6-8weeks after the inflammatory reaction has subsided.

acute cholecystitis is considered one of the most common acute surgical problems. it includes typical symptoms of pain in right hypochondrium, fever, increased leucocytes count and abdominal us used to confirm this clinical diagnosis. laparoscopic cholecystectomy (lc) is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent laparoscopic cholecystectomy and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective laparoscopic cholecystectomy . emergency laparoscopic cholecystectomy has advantage of a decreased hospital stay and avoids the risk of emergency admission for non-resolved or recurrent symptoms, which is associated with an increase in morbidity, pain and delayed return to work. also, some trials showed increased morbidity with elective laparoscopic cholecystectomy mostly due to biliary disease while patients await surgery. comparative studies are deficient in evaluation of outcomes of emergency cholecystectomy and elective cholecystectomy in acute cholecystitis. so the interest of our study is to compare between the emergency laparoscopic cholecystectomy and elective laparoscopic cholecystectomy regarding the feasibility and the safety of the first.

Eligibility criteria:
inclusion criteria: 1. age less than 70 years. 2. fit for surgery. exclusion criteria: 1. patients with co-existent common bile duct stones based on imaging and biochemical criteria. 2. patients with pancreatitis . 3. patients with previous upper abdominal surgery. 4. significant medical disease rendering patient unfit for laparoscopic surgery (e.g.chronic pulmonary disease, significant cardiac disease)
efficacy and safety of quetiapine fumarate sustained release (seroquel sr) in the treatment of major depressive disorders

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to demonstrate superior efficacy of quetiapine fumarate sustained release (seroquel) compared with placebo when used as a mono-therapy in the treatment of major depressive disorders please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * patient is able to provide written informed consent before beginning any study related procedures * patient has a documented clinical diagnosis of major depressive disorder * patient is able to understand and comply with the requirements of the study, as judged by a study investigator exclusion criteria: * patients with a history of non-compliance as judged by the study investigator * patients with a known lack of response to previous treatment with quetiapine * patients who have participated in a clinical trial within 4 weeks of randomization

Keywords: mdd depression
breathid® test: a non-invasive modality to detect pancreatic exocrine insufficiency

Conditions: Chronic Pancreatitis; Healthy Volunteers

Summary: 13c breath di-peptide tests are an effective non-invasive tool to detect pancreatic exocrine function in patients with chronic pancreatitis.

the aim of the study is to assess the pancreatic exocrine insufficiency using a 13c labeled di-peptide breath tests in patients with chronic pancreatitis(cp) and show correlation with secretin stimulated endoscopic pancreatic function test (epft). furthermore, a second purpose is to assess the ability to differentiate between non patients with chronic pancreatitis and those without. approximately 30 subjects will be tested with both methods within two weeks of each other.

Eligibility criteria:
inclusion criteria: 1. patients with chronic pancreatitis who meet at least one of the following criteria: * adult men or women \>18 years of age. * endoscopic retrograde cholangiopancreatography (ercp), magnetic resonance cholangiopancreatography (mrcp), or endoscopic ultrasound demonstrating ductal changes consistent with chronic pancreatitis * abnormal secretin pancreatic function test with a peak bicarbonate concentration \<80 meq/l * presence of pathogenomic pancreatic calcifications * pathology proven chronic pancreatitis on surgical specimens 2. females of childbearing potential must be willing to use birth control (iud, oral, transdermal, parenteral contraceptives, or abstinence) 3. patients who can fast for at least 8 hours 4. able to perform the testing and procedures required for the study, as judged by the investigator 5. willing and able to provide written informed consent exclusion criteria: * failure to obtain consent * patients with liver cirrhosis * any co-morbid condition with expected survival \< 1 year * history of extensive bowel resection, multiple abdominal surgeries * women who are pregnant, breastfeeding, or of childbearing potential and not willing to use methods of birth control * uncontrolled diabetes * patients currently receiving total parenteral nutrition (tpn) * recipients of an organ transplant * patients who have consumed \>20cc of alcohol or have taken acetaminophen in the past 24 hours * history of chronic obstructive pulmonary disease or symptomatic bronchial asthma * patients taking drugs that can interfere with 13c di-peptide metabolization

Keywords: cp-chronic pancreatitis dpt-di peptide breath test epft- endoscopic pancreatic function test
mri guided transrectal prostate laser ablation for benign prostatic hypertrophy (bph)

Conditions: BPH; Prostate Hyperplasia; Urinary Frequency/Urgency

Summary: over 100,000 bph procedures are performed annually in the us. the purpose of this study is to evaluate the effectiveness of performing mri guided transrectal laser ablation using a 980 nm laser (visualasetm by medtronic, inc., a minnesota, u.s.a. company) to treat benign prostatic hypertrophy (bph). the laser system will be used to necrotize urological soft tissue within the prostate under mri guidance. this will be a single center, single arm prospective trial with an anticipated enrollment of 10 men. patients who elect this treatment option and choose to be part of the study will be enrolled consecutively.


Eligibility criteria:
inclusion criteria: 1. diagnosis of lower urinary track symptoms (luts). 2. prostate volume of 40 - 200 cc. 3. men ≥ 45 years old. 4. ipss ≥ 15. 5. bph impact index ≥ 5. exclusion criteria: 1. history of prostate or bladder cancer, pelvic radiation, untreated bladder stones, or findings suggestive of likely underlying prostate cancer. 2. need to catheterize to relieve obstruction. 3. daily use of incontinence materials/padding. 4. neurogenic or hypotonic bladder, parkinson's disease, or a history of uncontrolled diabetes. 5. prior interventional or surgical treatment of bph. 6. penile prosthesis. 7. artificial urinary sphincter or collagen bladder injection. 8. urethral stricture. 9. bleeding disorder/coagulopathy. 10. inability to refrain from blood thinners in the peri-procedural period. 11. inability or chooses not to provide informed consent. 12. any serious medical condition which would make proceeding to treatment unsafe. 13. significant contraindication to mri or gadolinium contrast. 14. hip replacement. 15. lack of a rectum. 16. life expectancy of less than two years. 17. unable or unwilling to complete all required questionnaires and follow-up assessments.

Keywords: bph benign prostatic hypertrophy mri prostate lower urinary tract symptoms nocturia incomplete bladder emptying
effect of different nasal stent designs with nasoalveolar molding appliance

Conditions: Cleft Lip; Cleft Lip and Palate

Summary: this study is designed to compare 2 different designs of nasal stents in conjunction with nasoalveolar molding appliance regarding the changes in nose and lip esthetics in infants with cleft lip and palate.


Eligibility criteria:
inclusion criteria: * complete unilateral cleft lip and palate. * younger than 30 day old exclusion criteria: * syndromic patients. * older than 30 days old.
telemedicine optimized burn intervention

Conditions: Burns; Pediatric ALL

Summary: because burn patients and their caregivers often live long distances from regional burn centers, access to expert burn care is limited, resulting in a negative effect on adherence to treatment and a higher risk of wound complication. a novel smartphone application synchronized with a web portal for providers, called the telemedicine optimized burn intervention (tobi), was recently developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging, image transfer, and video-conferencing. the goal of the present study is evaluate tobi compared to face-to-face care as usual for pediatric patients/caregivers visiting a burn center. this study will also assess the feasibility of conducting a larger-scale clinical trial in several burn centers. the app will allow the physician and patient to make instant decisions regarding treatment, allowing for "turn on a dime" treatment decisions, rather than having the patients and families wait for scheduled clinic appointments, often hours away from home. this "on demand" medical care takes an innovative approach to increasing access to burn experts through smartphone technology and addressing adherence to prescribed treatment by increasing communication between provider and patients.


Eligibility criteria:
inclusion criteria: participants will be eligible for enrollment if: 1. the patient (child) is \< 18 years of age; 2. the patient is diagnosed with a partial thickness burn between \<1% tbsa - 20% tbsa by a pediatric burn surgeon; 3. the burn is being treated with advanced burn dressing therapy (e.g., silvadene™, polysporin™, acticoat™, mepilex™, or mepitel™); 4. the burn is evaluated by the musc burn team within 48 hours of injury; 5. the patient's caregiver (parent or legal guardian) is able to speak, hear, and understand english, as determined during study recruitment procedures; 6. the patient/caregiver owns and is capable of using a smart device (an android or ios smartphone) with permission to download tobi app from the google store or appstore; 7. able to comply with outpatient clinic visits. exclusion criteria: * there are no exclusion criteria. all participants who meet inclusion criteria would be eligible to participate in the study.

Keywords: pediatrics telemedicine mobile health burns
self-acupuncture for migraines feasibility study

Conditions: Migraine

Summary: patients who have had a course of acupuncture at the royal london hospital for integrated medicine to manage their migraines, and found it effective, will be taught to do self-acupuncture. this is a feasibility study so the main aim is to test the trial design but the researchers will also explore self-acupuncture's effectiveness, acceptability and safety.

aim: the proposed study will evaluate the feasibility of teaching sa to patients with migraines in the united kingdom national health service setting. methodology: the study will employ a pragmatic, mixed-methods, randomised, parallel-group, exploratory design. the study will compare sa plus standard care versus standard care alone. participants will complete outcome measures at various time points and be invited to take part in a qualitative telephone interview to explore their views on the design of the study and acceptability of the intervention. the researcher will take field notes of the observation of the sa teaching session to explore the acceptability of the sa teaching method. data will be analysed to test the hypothesis.

Eligibility criteria:
inclusion criteria: * adult patients aged 18 years old and over. * patients with migraines (when topiramate and propranolol are unsuitable). * patients who have been referred to the royal london hospital for integrated medicine (rlhim) for a course of at least 6 acupuncture sessions to manage their migraines. * patients who have completed a course of acupuncture for the management of their migraines at rlhim and self-declare that they benefitted from it. * patients must have completed the course of acupuncture within the last 3 to 24 months. exclusion criteria: * patients unwilling to participate (for instance due to needle phobia). * patients currently receiving acupuncture. * patients with severe clotting dysfunction or who bruise spontaneously. * patients unable to complete the questionnaires as judged by the researchers. * patients who have previously been taught or have practiced sa. * patients who are assessed as being unable to do sa (such as if they have poor hand function).

Keywords: migraine acupuncture
community health worker based intervention to improve palliative care

Conditions: Cancer; End Stage Cancer; Malignancy; Advanced Cancer

Summary: the study aims to find out if community health worker (chw) support will improve palliative care outcomes in african american patients with advanced cancer, by comparing the quality of life of patients who are receiving standard care to those whose standard care is supplemented with chw support.

this research is being done to establish the effectiveness of a community health worker based palliative care intervention among african american patients with advanced solid organ malignancies and their care givers. the investigators' long-term goal is to reduce the research-to-practice gap in utilization of evidence-based palliative care (pc) in african americans with advanced cancer. the objectives of this study are to establish the effectiveness of a chw-based palliative care intervention and develop generalizable knowledge on how contextual factors influence implementation.

Eligibility criteria:
patient inclusion criteria: * self-identified african american patients with advanced (ajcc stage iii or iv) solid organ malignancy * \>=18 years old * english speaking * intact cognition and ability to provide informed consent patient exclusion criteria: * participants \< 18 years of age * participants who are already receiving palliative care services caregiver inclusion criteria: * adult (\>=18 years old) caregivers providing informal (unpaid) care to an eligible african american cancer patient (related or unrelated) * english speaking * intact cognition and ability to provide informed consent caregiver exclusion criteria: * participants \< 18 years of age

Keywords: palliative care community health worker
a study of rucaparib in japanese patients with a previously-treated solid tumor

Conditions: Advanced Solid Tumor

Summary: this is a phase 1 open-label, dose-escalation, safety and pharmacokinetic study of rucaparib administered twice daily (bid) to japanese patients with a solid tumor who have failed previous standard treatment for their cancer. a recommended dose of rucaparib for japanese patients will be determined in a dose-escalation portion and then further evaluated in a dose-expansion portion of the study.


Eligibility criteria:
inclusion criteria: * be 20 years of age at the time the informed consent form is signed and of japanese ethnicity (ie, both parents are native japanese and were born in japan). * have a solid tumor that has progressed on standard treatment: * for patients enrolled in the dose-escalation portion, has confirmed solid tumor that is locally recurrent or metastatic * for patients enrolled in the dose-expansion portion, has high-grade serous ovarian cancer, or brca 1/2 mutated breast cancer, or other solid tumor with brca 1/2 or related gene mutation * have to have evaluable disease (i.e. disease can be followed on scans.) * be willing and able to fast for at least 14 hours exclusion criteria: * active second malignancy * prior treatment with any parp inhibitor * symptomatic and/or untreated cns metastases * women who are breastfeeding or pregnant * pre-existing duodenal stent and/or any gastrointestinal disorder that would interfere with drug absorption * requires regular blood transfusions
impact of guided care with the vectra multi-biomarker disease activity (mbda) blood test

Conditions: Rheumatoid Arthritis

Summary: nine months multi-center prospective, randomized observational study, two arm trial to evaluate the effect of mbda score-guided care on disease activity and medical costs.

nine months multi-center prospective, randomized observational study, two arm trial to evaluate the effect of mbda score-guided care on disease activity and medical costs. to investigate whether treatment decisions guided by mbda scores result in reduced disease activity and overall medical cost among patients with ra relative to usual care (uc).

Eligibility criteria:
inclusion criteria: * willing and able to sign an informed consent form (icf) * age at least 18 years old at screening visit * diagnosed with ra according to 1987 or 2010 criteria of the american college of rheumatology * actively managed by a carefirst health care practitioner * currently taking one or more biologic and/or non-biologic dmards listed in appendix 2 * currently has carefirst medical coverage exclusion criteria: * active infection * history of malignancy within the past 5 years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ that has been treated or excised in a curative procedure * current enrollment in another clinical trial * on non-biologic dmard monotherapy or combination therapy with stable disease for ≥6 months * any condition or circumstance that makes it likely the patient will not be able to complete the 9-month trial