Kornimate/medical-research-clean huggingface dataset:
a medication trial combined with behavior therapy for individuals with obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: this study examines the efficacy of the medication d-cycloserine in the reduction of obsessions and compulsions in individuals with obsessive-compulsive disorder (ocd). all study participants will receive exposure and response prevention, a common form of behavior therapy for individuals with ocd. half (50%) of the participants will be randomly assigned to the placebo condition and the other half (50%) will be randomly assigned to receive d-cycloserine. because all participants will receive 10 sessions of behavior therapy, all participants are expected to improve from this treatment.

the study consists of behavior therapy (exposure and response prevention; erp) for ocd. specifically, it involves exposure to anxiety-provoking situations and response-prevention of any rituals. erp has shown to be effective for many individuals with ocd. all assessments and treatment sessions are at no cost to the patients. 50% of the patients will randomly be assigned to the d-cycloserine (dcs) condition, and 50% of the patients will be assigned to a placebo condition. d-cycloserine is fda-approved for the treatment of tuberculosis. however, recent research in other anxiety disorders has shown that d-cycloserine plus behavior therapy is more effective than behavior therapy alone. this treatment study has two active conditions. that is, all patients will receive behavior therapy and we do expect that everybody will improve from this treatment. however, it may be that those patients in the dcs condition will improve somewhat more than those in the placebo condition. the treatment will be structured with homework and repeated assessments every 4 weeks. assessments are extremely important as they guide the treatment and provide the study investigators necessary information about the treatment. the treatment consists of 10 sessions (twice a week) plus post-treatment and follow-up assessments at 1 and 6 months.

Eligibility criteria:
inclusion criteria: * meets diagnosis for obsessive-compulsive disorder exclusion criteria: * history of psychotic disorders * history of neurological disorders * history of bipolar disorders

Keywords: obsessive-compulsive disorder behavior therapy d-cycloserine medication treatment trial placebo-controlled double-blind randomized
a pilot trial of dextroamphetamine for methamphetamine dependence

Conditions: Methamphetamine Addiction

Summary: the purpose of this study is to assess the safety and effectiveness dextroamphetamine to help methamphetamine users quit or cut down on their use. the study lasts for 9 weeks. eligible participants will attend research visits twice per week, and will receive individual counseling sessions once per week for all 9 weeks. 50% of the participants will receive the active medication while the other 50% will receive the placebo (sugar pill). neither the participant or the study team will know if the participant is receiving the placebo or active drug.


Eligibility criteria:
inclusion criteria: * 18-50 yrs. old exclusion criteria: * pregnant or lactating females * contact site for additional information

Keywords: methamphetamine drug abuse drug treatment addiction meth treatment for methamphetamine dependence
palifermin for the reduction of oral mucositis in patients with locally advanced head and neck cancer

Conditions: Mucositis; Solid Tumors; Stomatitis; Head and Neck Cancer; Squamous Cell Carcinoma

Summary: the purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (hnc).

this study consisted of 2 phases. the acute oral mucositis (om) evaluation phase includes the time from randomization to the time of severe om (who grade 3 or 4) resolution (up to week 12 or up to week 15 for participants whose severe om is not resolved at week 12). in the acute om evaluation phase, participants were randomized to receive either a single iv dose of palifermin or placebo at 180 μg/kg, 3 days before the start of radiotherapy, plus 7 once-weekly palifermin or placebo doses at the same dose level during a 7-week radio/chemotherapy course. in the long-term follow up phase, participants are followed until death, withdrawal of consent, or loss to follow-up. the long-term follow up phase is still ongoing.

Eligibility criteria:
key inclusion criteria: * histologically documented squamous cell carcinoma involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx * newly diagnosed, locally advanced stage head and neck cancer (unresectable/unresected disease); american joint committee on cancer \[ajcc\] stage iii, iva or ivb amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality * at least 50 gray of radiation treatment to areas of the oral cavity/oropharynx mucosa that can be visualized * concurrent chemotherapy regimen of cisplatin 100mg/m\^2 on days 1, 22, and 43 * eastern cooperative oncology group (ecog) performance status (ps) less than or equal to 2 * adequate hematologic, renal and hepatic function * negative pregnancy test by serum or urine * signed informed consent key exclusion criteria: - presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for greater than 3 years)

Keywords: scchn palifermin mucositis oral cavity oropharynx nasopharynx hypopharynx larynx mouth pain mouth sores radiation therapy radiotherapy radiochemotherapy concurrent chemotherapy xerostomia stomatitis mucosa kgf rhukgf keratinocyte growth factor hnc head and neck cancer oral mucositis
post-approval study of the r3 biolox delta ceramic acetabular system - europe

Conditions: Degenerative Joint Disease of Hip

Summary: the purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the r3 delta ceramic acetabular system pma (p150030) by evaluating long-term (10 years after surgery) follow-up results.

this pas is a long-term follow-up of the r3 delta ceramic acetabular system (dod) hips enrolled in the study that was analyzed for the premarket approval application (pma) study. the pma study analyzed 3 year postoperative follow-up data on biolox delta ceramic-on-biolox delta ceramic (dod) and oxidized zirconium-on-crosslinked polyethylene (oxzr/xlpe) hips, enrolled and followed in a european post-market study ("a prospective, multicenter, non-randomized, clinical outcome study of the r3 acetabular system in patients with degenerative hip disease"). the purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the r3 delta ceramic acetabular system pma (p150030) by evaluating long-term (10 years after surgery) follow-up results. hips are evaluated at the following intervals: 5, 7, 10 years postoperative. the primary study endpoint is implant survivorship at 10 years post surgery.

Eligibility criteria:
inclusion criteria: patient is 18-75 years old and he/she is skeletally mature * patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, dysplasia/ developmental dysplasia of the hip) or inflammatory joint disease (e.g., rheumatoid arthritis) * patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk * the patient is willing to comply the follow-up schedule exclusion criteria: patient has active infection or sepsis (treated or untreated) * patient is a prisoner or has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or drug/alcohol abuse, * patients with acute hip trauma (femoral neck fracture)
rehabnytte - a study of rehabilitation processes in specialized care in norway

Conditions: Rehabilitation

Summary: the main objective of the study is to describe function and health related to quality of life during the first year after rehabilitation, to measure the degree and impact of user involvement in the rehabilitation process, assess factors associated with change in work -ability and -participation, and to test measurement properties of a new core set of outcome measures for rehabilitation launched by the norwegian directorate of health.

this is a large multicentre cohort study including patients receiving rehabilitation at 17 rehabilitation centres from norway, \*the rehabnytte consortium. invitation and registration of participants will be conducted by local project coordinators in the period between 01.01.2019 and 31.03.2020. all participants will receive rehabilitation as usual at each centre, and report hrqol, health and function (by proms) through a digital self-reporting system at admission, discharge and after 3, 6 and 12 months. this study seeks to answer several research questions related to the overarching areas: 1. patient reported change of function, health and quality of life during the first year after rehabilitation 2. degree of user involvement in rehabilitation 3. change in work -ability and -participation 4. quality assessment (use of quality indicator set) 5. measurement characteristics (feasibility and responsiveness) of recommended proms in rehabilitation

Eligibility criteria:
inclusion criteria: * patients that participates in inpatient or outpatient rehabilitation programs at one of the participating centers. * age over 18 years * access to internet at home * access to personal secure login with bank id. exclusion criteria: * severely reduced cognitive function * severe mental illness with inadequate consent competence ability to participate * insufficient understanding of norwegian written language.

Keywords: rehabilitation multidisciplinary health care *the rehabnytte consortium
intranasal glucagon and energy balance

Conditions: Obesity

Summary: people who are overweight often find it difficult to lose weight through diet and medications because weight loss reduces the amount of energy spent by the body and increases appetite. glucagon, when given as an injection, reduces appetite and increases the amount of energy spent by the body, even when resting. based on studies in animals, it does so by working on the brain. however, when gives as an injection it raises blood sugar levels by acting on the liver and therefore it is not used as a weight loss drug. it has previously been shown that hormones such as glucagon, when given as a spray through the nose, can reach the brain with no major effect on the liver. importantly it does not increase blood sugar. in this study the research team is investigating whether nasal glucagon reduces appetite and increases energy spent by the body compared to a placebo spray. if it does, it may be a potential treatment for losing weight.

resting energy expenditure, appetite and food intake is being investigated in up to 20 individuals. participants are their own control in a single-blind, placebo-controlled, crossover design. participants are admitted after an overnight fast and allowed to rest for 1 hour before either intranasal glucagon (0.7mg) or intranasal placebo (sterile diluent) is administered. study visits occur 1-3 weeks apart with intranasal glucagon or placebo applied in random order. resting energy expenditure is measured via indirect calorimetry at baseline and over 90 minutes post-spray in 10-20 minute segments. blood samples are taken at baseline and at regular intervals post-spray to measure glucagon, glucose and other hormones/metabolites. appetite is assessed by visual analogue scale at 90 minutes post-spray followed by provision of a buffet-style meal for ad libitum food intake measurement.

Eligibility criteria:
inclusion criteria: * body mass index 25- 40 kg/m2 * hemoglobin in the normal range * normal fasting glucose and hba1c * women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 1 month prior to and after the study. exclusion criteria: * any history of heart disease or clinically significant, active, cardiovascular history * study participant with active hepatic disease (except hepatic steatosis which is frequently seen in overweight/obese individuals) * any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis. * any current or previous history of malignancy * any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (cr \> 1.5 mg/dl) genitourinary, hematological systems, or has severe uncontrolled treated or untreated hyper/ hypotension (sitting diastolic bp \> 100 or systolic \> 180 or systolic bp\<100). * allergy to any study medication * pregnancy or breastfeeding

Keywords: food intake energy expenditure central nervous system appetite
omega-3 supplementation in prevention of aromatase inhibitor-induced toxicity in patients with stage i-iii breast cancer

Conditions: Arthralgia; Breast Neoplasms

Summary: this clinical trial studies the use of omega-3 fatty acid supplementation in preventing aromatase inhibitor-induced toxicity in patients with stage i-iii breast cancer. an omega-3 supplementation may help relieve moderate to severe bone pain and improve joint symptoms caused by aromatase inhibitor-induced arthralgias.

primary objectives: i. to determine the efficacy of the complementary therapy omega-3 fatty acid (n-3 pufa) supplementation in preventing aromatase inhibitor-induced arthralgias (aiias). secondary objectives: i. to prospectively define the population most at risk for developing aiias by the identification and validation of genetic risk predictors and to develop a single nucleotide polymorphism (snp)/gene profile predictive of treatment intervention response. outline: patients are randomized to 1 of 2 groups. group i: patients receive omega-3 fatty acid supplementation orally (po) once daily (qd) for 6 months. group ii: patients receive placebo po qd for 6 months. after completion of study, patients will be followed up periodically.

Eligibility criteria:
inclusion criteria: * women diagnosed with breast cancer stages i-iii initiating first line adjuvant aromatase inhibitor (ai) therapy with any of the fda-approved ais (anastrazole, exemestane, letrozole) * concurrent gonadotropin-releasing hormone (gnrh) agonist therapy is allowed; concurrent breast related radiation therapy is allowed. * prior tamoxifen use is allowed * prior chemotherapy is allowed * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * metastatic malignancy of any kind * rheumatoid arthritis and other types of autoimmune and inflammatory joint disease * ai use \> 21 days prior to study enrollment * known bleeding disorders * current use of warfarin or other anticoagulants * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements * daily use of n-3 pufa concentrates or capsules or any other supplements that might interact with n-3 pufa supplements if \> 375 mg per day of of eicosapentaenoic acid (epa)/ docosahexaenoic acid (dha) within six months of study initiation * pregnant or nursing women * known sensitivity or allergy to fish or fish oil * unable to give informed consent

Keywords: breast cancer postmenopausal stage ia stage ib stage iia stage iib stage iiia stage iiib stage iiic
oms721 compassionate use in patients with thrombotic microangiopathy

Conditions: Thrombotic Microangiopathy

Summary: the purpose of this compassionate use study, for two patients with thrombotic microangiopathy, is to provide expanded access to patients who have participated in the clinical trial oms721-tma-001 and in whom improvement in their disease markers was observed while on treatment or to patients who could otherwise benefit from the treatment. this is a treatment protocol; not a research protocol.therefore, only patients in study oms721-tma-001 deemed eligible by the investigator may participate.

the study is open-label, expanded access study to provide continued oms721 treatment for compassionate use to patients who have participated in clinical trial oms721-tma-001. patients will be eligible if markers of disease activity, such as platelet count, ldh, and haptoglobin, were observed to improve during the study or if the patients disease activity remained stable, but they could be treated with a higher dose that may be beneficial. safety measures of adverse events and laboratory measures will be monitored. markers of disease activity, pharmacokinetics and ex vivo pharmacodynamics will also be monitored.

Eligibility criteria:
inclusion criteria: * have a diagnosis of thrombotic microangiopathy related to ahus, ttp or stem cell transplant. * have completed treatment in clinical trial oms721-tma-001. * investigator determined that continued treatment with oms721 could be beneficial. * aged 18 years or older. exclusion criteria: * hypersensitivity to oms721 or any excipients. * have a serious medical condition that increases the risk of oms721 treatment to the patient.

Keywords: tma, ahus, ttp, stem cell transplant-associated tma
a study to test the effectiveness and safety of a new higher 40mg dose of copaxone® compared to copaxone® 20mg, the currently approved dose

Conditions: Relapse-Remitting Multiple Sclerosis

Summary: this is a study to test if a new higher dose of copaxone is more effective in treating relapsing-remitting multiple sclerosis than the currently available 20 mg dose.


Eligibility criteria:
inclusion criteria: 1. clinically definite ms with disease duration (from onset) of at least 6 months. 2. subjects must have had at least 1 documented relapse within the last year prior to study entry. 3. subjects must have at least 1 and not more than 15 gadolinium (gd)-enhancing lesions on the screening mri scan. 4. subjects must be relapse-free and not have taken corticosteroids (iv, im and/or po) within the 30 days prior to the screening visit. 5. subjects must not have taken corticosteroids (iv, im and/or po) between the screening and baseline visits. 6. subjects may be male or female. women of child- bearing potential must practice a medically acceptable method of birth control. acceptable methods include oral contraceptive, contraceptive patch, or double-barrier method (condom or iud with spermicide). 7. subjects must be between the ages of 18 and 50 years inclusive. 8. subjects must be ambulatory, with a kurtzke edss score of between 0 and 5 inclusive. 9. subjects must be willing and able to give written informed consent prior to entering the study. exclusion criteria: 1. previous use of glatiramer acetate (oral or injectable). 2. previous use of cladribine. 3. previous use of immunosuppressive agents in the last 6 months. 4. use of experimental or investigational drugs, including i.v. immunoglobulin, and/or participation in an investigational drug study within 6 months prior to study entry. 5. use of interferon agents within 60 days prior to the screening visit. 6. chronic corticosteroid (iv, im and/or po) treatment (more than 30 consecutive days) in the 6 months prior to study entry. 7. previous total body irradiation or total lymphoid irradiation (tli). 8. pregnancy or breast feeding. 9. patients who experience a relapse between the screening (month -1) and baseline (month 0) visits. 10. any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse. 11. a known history of sensitivity to mannitol. 12. a known sensitivity to gadolinium. 13. inability to successfully undergo mri scanning.
descriptive, post-marketing, passive surveillance safety study of adacel™ vaccine

Conditions: Pertussis

Summary: to further characterize the vaccine safety profile and to identify any signals of potentially vaccine-related adverse events (aes) not detected during pre-licensure studies.

surveillance using a healthcare organization with large comprehensive medical encounter databases will be used in this study to identify any risks or uncommon events associated with use of the recently licensed adacel vaccine that may occur in routine clinical usage in a large population. no investigational vaccines will be administered in this study. participants will be included in the study on the basis of their having received adacel vaccine as part of routine care.

Eligibility criteria:
inclusion criteria: * receipt of adacel vaccine during the study period exclusion criteria: * none

Keywords: tetanus toxoid, acellular pertussis, diphtheria toxoid
safety and efficacy of pimavanserin in adults with parkinson's disease and depression

Conditions: Treatment of Depression in Adults With Parkinson's Disease (PD)

Summary: the purpose of this study is to assess the efficacy of pimavanserin for the treatment of depression in adults with parkinson's disease.


Eligibility criteria:
inclusion criteria: 1. can understand and provide signed informed consent, request for medical records and/or subject privacy form if applicable according to local regulations 2. has a clinical diagnosis of idiopathic parkinson's disease with a minimum duration of 1 year, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features: 1. rest tremor 2. rigidity 3. bradykinesia and/or akinesia 4. postural and gait abnormalities 3. meets clinical criteria for depression with parkinson's disease as listed in the ninds/nimh guidelines 4. if currently taking an anti-depressant, is being treated with only one ssri or snri antidepressant at a dose within the us fda-approved dose range. subjects who are currently taking a second antidepressant or antidepressant augmentation agent at a sub-therapeutic dose or for an inadequate duration at screening, and can be discontinued from this agent before the baseline visit (in the opinion of the investigator), may be eligible for the study. 5. is on a stable dose of anti-parkinson's medication for 1 month prior to screening 6. if the subject is female, she must be of non-childbearing potential or agree to use two methods of clinically acceptable contraception exclusion criteria: 1. use of an antipsychotic within 3 weeks or 5 half-lives of baseline (whichever is longer) 2. had a myocardial infarction within the 6 months prior to screening 3. has a known personal or family history or symptoms of long qt syndrome 4. evidence of severe or medically significant hepatic or renal impairment on laboratory tests as assessed by the investigator or medical monitor 5. has a history of pd psychosis, schizophrenia, or other psychotic disorder, or bipolar i or ii disorder. 6. actively suicidal at visit 1 (screening) or visit 2 (baseline) 7. is pregnant or breastfeeding 8. has previously been treated with pimavanserin or is currently taking pimavanserin 9. has a sensitivity to pimavanserin or its excipients 10. is judged by the investigator or the medical monitor to be inappropriate for the study additional inclusion/exclusion criteria apply. subjects will be evaluated at screening to ensure that all criteria for study participation are met.