Kornimate/medical-research-clean huggingface dataset:
penguin cold caps in the prevention of hair loss in breast cancer patients

Conditions: Breast Cancer

Summary: the goal of this study is to estimate the efficacy of penguin cold caps in preventing or reducing hair loss in patients receiving (neo)adjuvant chemotherapy (one of four common regimens) for early stage breast cancer.

this will be a phase ii prospective, open label, non-randomized study conducted to determine the safety and efficacy of penguin tm cold cap system in preventing or reducing chemotherapy-induced alopecia in patients with early stage breast cancer undergoing chemotherapy. eligible subjects will be enrolled to one of 4 study arms (table 5) determined by type of chemotherapy. subjects will have early stage breast cancer of any receptor subtype, for which standard of care includes chemotherapy. eligible subjects will be enrolled at providence portland medical center (ppmc) and providence st. vincent medical center (psvmc). the penguintm cold cap therapy will be administered to all enrolled subjects according to the dosing schedule specified by the study arms. penguintm cold caps is a portable scalp cooling system which uses gel-filled cold caps that are cooled on dry ice and exchanged every 30 minutes in order to maintain optimum temperature. its unique crylon gel formula is specifically created to maintain cold temperatures for much longer periods of time than other conventional cooling gels and foams. no scalp preparation is required before use.

Eligibility criteria:
inclusion criteria: * at least ≥ 18 years of age * diagnosis of stage i-iii breast cancer for whom neoadjuvant or adjuvant cytotoxic chemotherapy (act/hp, tch/p, tc, or t/h) is planned. * willing and able to provide informed consent. * availability of caretaker(s) to accompany participant and facilitate cold-cap placement/exchanges using the recommended technique. * women of childbearing potential must use acceptable measures to avoid becoming pregnant during study period and for 30 days after last dose of chemotherapy. exclusion criteria: * pre-existing alopecia (dean's scale ≥ 1) * another malignancy that required active treatment with systemic chemotherapy within 2 years of study recruitment. * prior radiotherapy treatment involving head. * pre-existing chronic severe headaches or migraines. * skin conditions that in the opinion of pi would be at risk of worsening with study. * cold sensitivity or cold agglutinin disease * cryoglobulinemia * cryofibrogenemia * history of current evidence of any condition, therapy or abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, such that trial participation is not in the best interest of the subject.

Keywords: breast cancer alopecia hair loss scalp cooling penguin cold caps
concussion treatment in older adults

Conditions: Concussion, Mild

Summary: the purpose of this study is to conduct the first randomized control trial for targeted treatments for concussion in adults 50 years or older. participants will be enrolled at their first concussion clinical visit (v1) and their second study visit will occur after (up to 7 days) or concurrently with the participant's second concussion clinical visit, typically (but not limited to) between 21-31 days from v1.

although concussion is a common occurrence in older adults, we know little about the injury in this at-risk population. certain management tools that might be appropriate for adolescent and young adult populations may not be appropriate for use in older adults who may have sensory, cognitive, and neuro-motor limitations. this study will help to develop initial evidence for targeted treatments for concussion in older adults. the study will utilize a two group design with permuted block random assignment to intervention and usual care/control groups. all participants will complete the following assessments at their initial and follow-up visit appointments: cognitive screening (learning, memory, language, executive functioning), concussion and mood symptom questionnaires, and neuro-motor screening. the primary outcomes for this study will be total symptom severity score (i.e., symptom burden) on the concussion clinical profiles screening (cp screen) and patient global impression of change (pgic). secondary outcomes will include: short falls efficacy scale (sfes), dizziness handicap inventory (dhi), patient health questionnaire-9 (phq-9), patient health questionnaire-15 (phq-15), generalized anxiety disorder - 7 (gad-7), posttraumatic stress disorder checklist (pcl-5), pittsburgh sleep quality index (psqi), neuro-quality of life (qol) v2.0 - cognition function (short version), headache impact test (hit-6), id migraine, neck disability index (ndi), vestibular ocular motor screen (voms), timed-up-and-go (tug), repeatable battery for the assessment of neuropsychological status (rbans). all outcomes will be treated as continuous.

Eligibility criteria:
inclusion criteria: * 50 years of age or older * diagnosed concussion within the last 4 days - 12 months * must be recruited at their initial concussion appointment * ability to read/write to complete study assessments/testing exclusion criteria: * diagnosed neurological disorder (stroke, dementia, epilepsy) * diagnosed major psychiatric disorders other than depression/anxiety (e.g., schizophrenia) * diagnosed with moderate to severe brain injury or past brain surgery/malformations

Keywords: concussion mild traumatic brain injury treatment older adults
dose-finding study of lik066 compared with placebo or sitagliptin to evaluate change in hba1c in patients with diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of the study is to evaluate the efficacy, tolerability and short-term safety of lik066 to support dose selection for phase 3.


Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of t2dm by standard criteria 2. drug-naïve patients, defined as patients not having received any anti-diabetic medication previously, 3. currently untreated patients , who, after the diagnosis of t2dm, have received anti-diabetic medication for not more than 12 consecutive weeks, and have not received any anti-diabetic treatment within 12 weeks prior to visit 1 4. patients being treated with mono-therapy for at least 8 consecutive weeks prior to visit 1 with the following oads: metformin, dipeptidyl peptidase-4 inhibitors (dpp-4i), su, glinide, alpha-glucosidase inhibitor (agi) 5. hba1c ≥ 7 to ≤ 10.5% at visit 1 for drug-naïve/currently untreated patients 6. hba1c ≥ 7 to ≤ 9.5% at visit 1 for patients treated with oad monotherapy 7. hba1c ≥ 7 to ≤ 10.5% at visit 199 for all patients 8. age: ≥18 and ≤ 75 years old at visit 1 9. bmi ≥22 to ≤45 kg/m2 at visit 1 exclusion criteria: 1. fpg ≥270 mg/dl (15 mmol/l) for drug-naïve/currently untreated patients or ≥240 mg/dl (13.3 mmol/l) for patients on oad monotherapy at visit 1 2. insulin treatment \>4 consecutive weeks in the last 6 months, corticosteroid use \>7 days in the last 8 weeks, use of growth hormones in the last 6 months, or use of weight control products \> 4 weeks in the last 6 months 3. history of acute metabolic complications, cv disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea 4. significant lab abnormalities such as tsh outside of normal range, uacr\>300 mg/g creatinine, egfr \<60 ml/min/1.73m2, hemoglobin \<12 g/l in men and \<11 g/l in women, hematuria 5. ecg abnormalities including av block, long qt syndrome or qtc\>450 msec for men and \>470 msec for women 6. history of malignancy 7. women of child-bearing potential not using effective methods of contraception other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes mellitus, sglt inhibitors, dose-response
evaluation of a new critical pathway for treatment of acute bacterial skin and skin structure infections (absssi)

Conditions: Acute Bacterial Skin and Skin Structure Infections

Summary: this study will evaluate a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) for the treatment of absssi compared to usual care.


Eligibility criteria:
inclusion criteria: * presents to the emergency department (ed) and meets the clinical definition for acute bacterial skin and skin structure infections (absssi) * known or suspected gram-positive infection. exclusion criteria: * known or suspected gram-negative infections, anaerobic infections, or fungemia * known or suspected infections that are severe, life threatening or are not included in the absssi food and drug administration (fda) guidance * injection drug users with a fever * severe neurological disorder leading to immobility or confined to a wheelchair * bilateral lower extremity involvement of the suspected infection.

Keywords: critical pathways health facilities clinical protocols patient satisfaction absenteeism anti-bacterial agents quality of life economics, medical health resources health resource utilization acute bacterial skin and skin structure infection (absssi)
the microcirculation in acute myocardial infarction (micro-ami)

Conditions: STEMI

Summary: this study investigates the association between the microvascular resistance at the time of primary percutaneous intervention, with microvascular obstruction on cmr and blood markers of myocardial damage.


Eligibility criteria:
inclusion criteria: * \>18 years old * cardiac symptoms of \> 20 mins chest pain or equivalent. * ecg criteria consistent with stemi (stemi) * proceeding with percutaneous angioplasty * assent/ consent to the study exclusion criteria: * known allergy to adenosine or gadolinium * chronic atrial fibrillation * renal impairment with egfr \<30 * contraindication to angiography * contraindication to cmr (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for cmr scanner) * cardiogenic shock * patients with special communication needs or altered consciousness. * patients who do not give assent/consent to the study
tincat lgbtq+ smoking cessation via asynchronous telehealth

Conditions: Tobacco Use Disorder; Tobacco Use Cessation

Summary: the purpose of this study is to assess the efficacy of a novel telehealth-based intervention to reduce tobacco use among lgbtq+ people.

after being informed about potential risks and screened into the study, patients will be randomized into the treatment or control group. control group participants will complete 7 sessions based on quit.gov smoking cessation planning. intervention participants will complete 7 sessions of individualized asynchronous telehealth sessions.

Eligibility criteria:
inclusion criteria: * age 18 and over * live in greater austin * identify as lgbtq+ * current smokers * high speed internet access exclusion criteria: * exceed screener cutoff for suicide risk * exceed screener cutoff for borderline personality disorder * report current active substance use other than tobacco that interferes with functioning
a 28 - 90 days study to evaluate the safety, tolerability, and efficacy of caspofungin injection as empirical therapy in indian adults with persistent fever and neutropenia (0991-053)(completed)

Conditions: Fungal Infection

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.


Eligibility criteria:
inclusion criteria: * patient has a low white cell count (less than 500/mm3) for at least 96 hours * patient is indian and is greater than 18 years of age * patient received chemotherapy for blood disorders and blood cancers exclusion criteria: * patient has an invasive fungal infection * patient has a bacterial infection that is not controlled * patient has allergy to the class of antifungals of study drug * patient is not expected to survive at least 5 days * patient is pregnant or breast-feeding
high nucleotide meal consumption in uric acid and metabolic health

Conditions: Healthy

Summary: the production of protein rich animal products is associated with a large environmental burden, and with ethical considerations. additionally, the over-consumption of meat might be associated with detrimental effects to health. using mycoprotein, a food ingredient derived from the fermentation of a fungus, as a meat substitute could result in environmental benefits, and could have a role in managing obesity, diabetes and improving metabolic health. however, naturally produced mycoprotein has a high nucleotide content and little is known about the impact of nucleotides in uric acid levels and other health markers. the aim of this study is to investigate the effect of a meal based on nucleotide rich mycoprotein on uric acid concentrations and other markers of health.


Eligibility criteria:
inclusion criteria: * bmi between 18 and 30 exclusion criteria: * on medication (except contraception) * smokers * diagnosed with any metabolic or cardiovascular conditions * bmi \ 30
cbt-i intervention for insomnia in newly diagnosed cancer patients

Conditions: Cancer; Chronic Insomnia

Summary: to determine the efficacy of a cbt-i intervention in improving sleep and other quality of life outcomes during cancer treatment. to assess the feasibility and acceptability of a cbt-i intervention among newly diagnosed cancer patients.

the proposed study will be a randomized controlled trial design. participants will be randomized to either a cbti treatment or a wait list control condition. the intervention is shuti, a validated web based version of cbti, which will take place over seven weeks and will include a combination of face to face and telephone sessions, and email updates. all participants will have a face to face meeting with the doctoral student at enrollment. during the intervention period, all participants will be contacted by telephone at week 1, 3, and 6 to check in and to encourage participant engagement. however, during phone calls with control participants, no advice regarding sleep will be given and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study. participants in shuti will additionally be provided the the doctoral student's phone number and will be encouraged to contact her if they have any questions during the intervention. they will also have the option of setting up appointments for face to face meetings during a clinic appointment if they desire additional therapist guidance. pretreatment, all participants will complete a two week sleep diary and multiple self report measures. at the end of the intervention, all participants will complete a two week sleep diary and multiple self report measures again.

Eligibility criteria:
inclusion criteria: * newly diagnosed with i-iii non-metastatic cancer * scheduled to begin chemotherapy or radiotherapy * chemotherapy or radiotherapynaïve * meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month) * chronic insomnia has been defined in previous research:as the presence of (1) three or more episodes of insomnia (i.e., ≥ 30minutesol, ≥ 60minute wake after sleep onset (waso), or ≤ 6.5 hour total sleep time (tst) per night) of per week and (2) daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month. * interested in behavioral sleep treatment * have the permission of their oncologists to participate. exclusion criteria: * untreated alcohol or substance abuse or dependence, bipolar, or psychotic disorder * medical conditions such as seizure disorder, restless leg disorder, or parkinson's disease * untreated sleep disorders such as sleep apnea

Keywords: insomnia sleep cbt-i intervention shuti
multimodal intervention in patients with non-specific chronic low back pain: the healthy back project

Conditions: Pain, Chronic; Neurologic Manifestations; Back Pain; Low Back Pain; Behavior, Health

Summary: low back pain is one of the most common health problems seen in the primary care. chronic low back pain is localized between the inferior limit of the ribs and the sacral region, and persist more than 12 weeks. in most cases, it is attributed to a non-specific cause and classified as non-specific chronic low back pain (nsclbp). no previous study has included a multimodal supervised program in patients with nsclbp. the primary aim of this study is to determine the effectiveness of exercise + behaviour change + education + mindfulness programs (intervention 1) and an intervention including intervention 1 following functional resistance training (intervention 2) on endogenous pain modulation, disability, muscle strength/endurance, quality of life, gait parameters, levels of physical activity, sedentary behaviour and psychological health in patients with nsclbp.


Eligibility criteria:
inclusion criteria: * be previously diagnosed with nsclbp pain by a healthcare professional according to the criteria established by o'sullivan et al1. * intend to participate in the intervention and perform all the tests included in the study. * able to read and understand informed consent, as well as the objective of the study. * able to walk and move without outside help. * able to communicate without problems. exclusion criteria: * be under 20 years or over 65 years old. * having acute or terminal illness. * having medical prescription that prevents the performance of the tests. * having injury or circumstance that makes it impossible to perform the tests correctly. * having other physical or mental illness that prevents participating in the intervention.

Keywords: exercise behaviour change education mindfulness pain strength
effects of a combination of polyphenol-rich extracts, prebiotics, and hydrolyzed fiber on the quality of life of patients with irritable bowel syndrome (ibs)

Conditions: IBS - Irritable Bowel Syndrome

Summary: the aim of the study is to demonstrate a beneficial effect in reducing symptoms that negatively affect the quality of life of ibs patients, and to demonstrate a positive effect on inflammatory and intestinal function markers.

the double-blind, randomized, placebo-controlled study will be conducted on 48 patients (18-55 years old) with irritable bowel syndrome (ibs). the study will consist of 2 months of supplementation with three parallel arms: 1) probiotic strains and prebiotic (partially hydrolyzed guar gum); 2) probiotic strains, prebiotic (partially hydrolyzed guar gum) and elderberry and chokeberry fruit extract; 3) placebo.the study will assess symptoms associated with ibs, using the ibs-qol questionnaire and the bristol stool formation scale. markers of inflammation and intestinal barrier permeability , will be determined in blood and stool samples collected from patients.

Eligibility criteria:
inclusion criteria: * diagnosed irritable bowel syndrome. * women and men, 18-55 years old. * signed informed consent. exclusion criteria: * intake of supplements containing plant extracts, polyphenols or anthocyanins, and supplements containing fiber, probiotics and prebiotics. * participation in another clinical trial. * inability to swallow an oral study drug/placebo. * oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, aids, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study. * women who are pregnant, planning to become pregnant during the study, or breastfeeding,

Keywords: ibs gastrointestinal diseases probiotic prebiotic plant extract polyphenol-rich extracts
therapeutic recommendations based on clinical history and video documented pbs-score

Conditions: Clubfoot

Summary: determine the relationship between the pbs-score and treatment recommendations provided by senior pediatric orthopedic surgeons.

in conjunction with the assessments of video documented pbs-score items (described in study i), treatment recommendations from six to eight experienced pediatric orthopedic surgeons from four different countries will be collected. their recommendations will be based on the included items of the pbs-score, and patient history including age of the child, pirani score, initial treatment (need for tenotomy), and reported compliance to orthotic use.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in swedish, english, portuguese, urdu, or pashto. exclusion criteria: * syndromic clubfoot

Keywords: pbs-score peva treatment clubfoot
atkins diet for difficult-to-control headaches in teenagers

Conditions: Chronic Daily Headache

Summary: this is a 3-month pilot study of 10 adolescents with chronic daily headache. teens will be placed on a modified atkins diet and followed with 2 subsequent visits to assess for headache improvement.

patients are placed on the diet and followed with various measures for 3 months. if the diet is helpful it is continued. patients are still being enrolled as of 9/6/06.

Eligibility criteria:
inclusion criteria: * ages 12-19 * minimum 15 headaches/month for at least 3 months * tried 2 preventative medications previously exclusion criteria: * prior use of the atkins diet for more than 1 week * pregnancy * significant heart or kidney disease * dangerously underweight * using acute pain medications more than 11 days in the past month * medications being changed

Keywords: headache atkins ketosis intractable
effects of escitalopram on the sleep eeg power in patients with major depressive disorder

Conditions: Depressive Disorder, Major

Summary: the main objective was to compare the differences of psg parameters and plasma melatonin levels before and after treatment with escitalopram for 8 weeks. polysomnography (psg) was detected over a night and blood samples were collected at 4 h intervals for 24 h from 13 male healthy controls and 13 male mdd patients before and after treatment with escitalopram for 8 weeks. the outcome measures included the levels of plasma melatonin, psg parameters (include sleep architecture and power analysis) and scales.

1. design and participants: the patients with mdd were screened from the hospital, age- and gender-matched healthy controls were recruited by advertising from the community who signed written informed consent before participation. 2. assessments: the 17-item hamilton depression rating scale (hrsd-17) , montgomery-asberg depression rating scale (madrs), the clinical global impression-severity scale (cgi-s), and 14-item hamilton anxiety scale (hama) were assessed at baseline and after 8 weeks' treatment with escitalopram for patients with mdd. as for healthy volunteer, these measures were evaluated only once. in addition, all participants were assessed pittsburgh sleep quality index (psqi) and insomnia severity index (isi). 3. treatment: each patient was provided with escitalopram. 4. collection of peripheral blood samples: test the levels of plasma melatonin at 4 h intervals for 24 h from all participants. 5. sleep and eeg recordings: the psg of participants was evaluated for one night at baseline (all participants) and 8 weeks treatment (mdd). 6. analysis the psg architecture and power ratio.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of mdd; 2. hamilton rating scale for depression 17-items (hrsd-17) total scores ≥ 22; 3. male patients aged between 18 and 45 years exclusion criteria: 1. significant suicide risk by hrsd suicide scores \> 2; 2. accompanied with psychiatric symptoms; 3. treated with mect within 6 months.