Kornimate/medical-research-clean huggingface dataset:
cyclophosphamide drug interaction study in cancer patients

Conditions: Nausea and Vomiting, Chemotherapy-Induced

Summary: this study is designed to evaluate the potential pharmacokinetic interaction between oral gw679769 and iv (intravenous) cyclophosphamide when administered to cancer patients.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of cancer. * undergoing chemotherapy with a cyclophosphamide regimen with a cyclophosphamide dose of 500 - 700 mg/m2 and a cycle duration of 14-28 days. * adequate hematologic, renal and hepatic function. exclusion criteria: * pregnant or lactating. * cns (central nervous system) metastases. * active systemic infection or any other poorly controlled medical condition. * patients cannot take cyp3a4 inhibitors within 7 days of study treatment or cyp3a4 inducers within 48 days of study treatment.

Keywords: cyclophosphamide cinv chemotherapy induced nausea and vomiting
active reference (fluoxetine) fixed-dose study of vortioxetine in paediatric patients aged 12 to 17 years with major depressive disorder (mdd)

Conditions: Depressive Disorder, Major

Summary: evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a dsm-5™ (diagnostic and statistical manual of mental disorders, 5th edition) diagnosis of major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * the patient is a male or female, aged ≥12 and ≤17 years at screening (patients who turn 18 years during the study will be allowed to continue in the study). * the patient has major depressive disorder (mdd), diagnosed according to dsm-5™. * the patient has a children depression rating scale - revised (cdrs-r) total score ≥45 at the screening visit and at the baseline. * the patient has a clinical global impression - severity of illness (cgi-s) score ≥4 at the screening visit and at the baseline * the patient has provided assent to participation and parent(s)/legal representative (s) signed the informed consent form. exclusion criteria: * the patient has participated in a clinical study \<30 days prior to the screening visit. other protocol defined inclusion and exclusion criteria may apply

Keywords: paediatric patients
safety study of viaskin peanut to treat peanut allergy

Conditions: Peanut Allergy

Summary: this study evaluates the safety of viaskin peanut 250 mcg in the treatment of peanut allergy in children from 4 to 11 years of age. subjects will receive either viaskin peanut 250 mcg or a placebo for a period of 6 months, after which all subjects will be receiving the active treatment up to a period of 3 years under active treatment.


Eligibility criteria:
inclusion criteria: * physician-diagnosed peanut allergy; * a peanut skin prick test (spt) with a wheal largest diameter ≥8 mm; * a specific-peanut immunoglobulin e (ige) ≥14 ku/l; * subjects following a strict peanut-free diet. exclusion criteria: * generalized dermatologic disease * spirometry forced expiratory volume in 1 second (fev1) \<80% of the predicted value, or peak expiratory flow (pef) \<80% of predicted value; * receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy; anti-tumor necrosis factor drugs or anti-ige drugs (such as omalizumab) or any biologic immunomodulatory therapy; * prior or concomitant history of any immunotherapy to any food allergy (for example epit, oit, slit, or specific oral tolerance induction).
evaluation of an intervention based on cell phones

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of the study was to assess the effect of an individualized intervention based on cell phones to improve glycemic control in patients with type 2 diabetes attending epidemiology research unit in cuernavaca, morelos. mexico

in this study before randomization, the participants received workshops on diet, physical activity, glycemic index of foods. bandura´s theoretical model was used in the voice messages sent to the intervention group.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus \> 10 years * glycated hemoglobin \>7% exclusion criteria: * take insulin regularly * pregnant woman * woman who expected to be pregnant the next 6 months * 24 hrs creatinine \< 30 ml/minute

Keywords: cellular phones type 2 diabetes glycated hemoglobin glycemic control
efficacy and safety of pregabalin for pain following total knee replacement

Conditions: Osteoarthritis; Postoperative Pain

Summary: pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.


Eligibility criteria:
inclusion criteria: * subjects with osteoarthritis (oa) undergoing elective tka under regional anesthesia (neuroaxial with or without peripheral nerve block). * subjects able to demonstrate sufficient psychomotor dexterity and cognitive capacity to use patient controlled analgesia/patient controlled epidural analgesia if used as part of the standard of care. * the subject's preoperative health is graded as american society of anesthesiology class 1 to class 3 exclusion criteria: * subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or subjects with planned second knee total knee arthroplasty at time of present procedure. * subjects with inflammatory arthritides (i.e., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis); lyme disease. * subjects with fibromyalgia and or other chronic pain syndromes

Keywords: opioid
a safety and efficacy study of dimebon in patients with huntington disease

Conditions: Huntington Disease

Summary: the purpose of this study is to determine if dimebon is safe and effective for the treatment of cognitive impairment in huntington disease.

this study is a multicenter phase 3, randomized, double-blind, placebo-controlled safety and efficacy study of dimebon treatment in subjects with huntington disease (hd). the study will evaluate dimebon 20 mg three times daily (tid) administered orally (po) for six months (26 weeks) compared with matching placebo tid for the primary safety and efficacy analyses. safety and tolerability will be assessed by recording of adverse events and by monitoring of vital signs, physical examinations, safety laboratory evaluations, and 12-lead electrocardiogram(ecg)assessments.

Eligibility criteria:
inclusion criteria: * have clinical features of hd and a cag polyglutamate repeat expansion ≥ 36 * have cognitive impairment as noted by the following: 1. a screening mmse and a baseline (pre-dose) mmse score between 10 and 26 (inclusive); and 2. a subjective assessment of cognitive impairment with decline from pre-hd levels by the investigator after interviewing the subject and caregiver; * are willing and able to give informed consent * aged 30 years or older * have a caregiver who assists/spends time with the subject at least five days per week for at least three hours per day and has intimate knowledge of the subject's cognitive, functional, and emotional states, and of the subject's personal care. exclusion criteria: * had onset of symptoms prior to age 18 * have any major medical illness or unstable medical condition within 180 days of screening that may interfere with the subject's ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data

Keywords: huntington dimebon hd huntingtin
comparison of the postoperative analgesic effects of spsipb and tpb in mastectomy operations

Conditions: Mastectomy; Peripheral Nerve Block; Pain Management

Summary: breast cancer is the most common malignancy in women, and surgery is one of the cornerstone treatments for breast cancer. postoperative pain can significantly reduce patients' quality of life and acute pain may even trigger chronic pain syndrome. nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications. in this study; it was aimed to compare the analgesic effectiveness of serratus posterior superior intercostal plane block and thoracic paravertebral block in the postoperative period in patients who underwent mastectomy.


Eligibility criteria:
inclusion criteria: * patients aged 18-80 years * american society of anesthesiologists (asa) score i-ii-iii * body mass index (bmi) between 18-30 kg/m2 exclusion criteria: * patients under 18 and over 80 years of age * asa score iv and above * patients with a history of bleeding diathesis * bmi below 18 or above 30 kg/m2

Keywords: mastectomy serratus posterior superior intercostal plane block thoracic paravertebral block
female sling procedure

Conditions: Urinary Incontinence,Stress

Summary: in trans-obturator tape (tot), tension and location of the tape in mid urethral zone are directly related to the postoperative clinical outcome. recurrence of symptoms of stress urinary incontinence has been related to tape migration in previous studies. the study aimed to increase the success rate of tot procedure through a new surgical technique using a 2 paramedian vaginal incisions.

the investigator innovated a new technique that involves a 2 paramedian vaginal incisions that allow more tape stabilization with sparing the dissection along the whole urethra ensuring intact overlying tissues and to create a tunnel in between the 2 incisions to pass the tape, making it supported proximally and distally with normal undissected tissues. the study aims to assess the success rate of tot and tape migration using a new surgical technique versus the standard procedure using vertical incision.

Eligibility criteria:
inclusion criteria: * adult female patient complaining of pure stress incontinence confirmed by stress test of urodynamic study exclusion criteria: * patients with neurological disease, pelvic organ prolapse, previous urethral or pelvic floor surgery will be excluded from our study.
autonomic effects of stimulation in sci

Conditions: Spinal Cord Injury

Summary: this study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise endurance time and heart rate recovery during arm cycle ergometry. in addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment.

this study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise endurance time and heart rate recovery during arm cycle ergometry. in addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment. the study will consist of 7 visits, that will be between 3-4 hours in duration, separated by no less than 3 days. visit 1 will consist of determining baseline autonomic function and screening visit. the participant will undergo a sit up set to determine hypotension and orthostatic hypotension and complete a couple surveys. visits 2 and 3 will determine which site the stimulation parameters should be on the spine, either t7-t8 or t11-12. the site that increases seated systolic blood pressure will be used for the rest of the study. visits 4 and 5 will consists of putting the electrode at the optimal spot on the spine and completing a submaximal arm ergometry exercise and the other visit will be a sham visit. visits 6 and 7 will consist of assessing core temperature when in a cool environment with the stimulator on and off.

Eligibility criteria:
inclusion criteria: * injury more than 1 year ago, non-ambulatory * level of lesion c3-t1, ais a or b * stable prescription medication regimen for at least 30 days * must be able to commit to study requirements of 7 visits within a 60-day period exclusion criteria: * extensive history of seizures * ventilator dependence or patent tracheostomy site * history of neurologic disorder other than sci * history of moderate or severe head trauma * contraindications to spine stimulation * significant cardiovascular disease * active psychological disorder * recent history (within 3 months) of substance abuse * open skin lesions over spine at levels targeted for stimulation (t7/8, t11/12) and pregnancy

Keywords: orthostatic hypotension exercise hypotension body core temperature blood pressure
effect of segmental control program on hamstring peak torque in patients with non-specific low back pain

Conditions: Chronic Low-back Pain

Summary: the purpose of this study is to investigate the effect of segmental control exercises program on hamstring peak torque, pain, function, and rom in patients with non-specific low back pain.

low back pain (lbp) is a significant health problem internationally characterized by various biophysical, psychological, and social dimensions affecting functioning, societal participation, and personal financial prosperity.the reported prevalence of lbp was high, especially for chronic non-specific low back pain, approximately 15.4%. of which chronic low back pain was about 2.5 times more prevalent in the working population compared to the non-working group. recently, there has been a focus on lumbar stabilization exercises that prove to be effective and may be superior to general exercises for lbp management. the approach is aimed at improving the neuromuscular control, strength, and endurance of the active subsystem stabilizing the spine. several groups of muscles are particularly targeted namely, the transverses abdominis and the multifidus muscles that are central to maintain spinal and trunk stability. but also other core muscles are involved. so this study will be conducted to investigate the effect of segmental stabilization exercise on low back pain. forty-five patients will be allocated to three groups. first experimental will receive segmental stabilization phase 1 and phase 2, second experimental will receive segmental stabilization phase 1 and 3, the third one is the control group and receives traditional treatment

Eligibility criteria:
inclusion criteria: 1. the patients had ns lbp patients with age from 20 to 40 years for both genders. 2. the lumbar region of back pain lasts for 4 weeks \& more has not been diagnose as a specific disease or spinal abnormality. 3. mild to moderate disability according to the oswestry disability index (odi) (up to 40%). 4. shortening of hamstring. 5. the study populations must be willing to participate in the study. exclusion criteria: 1. neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor, cardiovascular disease. 2. psychiatric/mental deficit 3. patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment.

Keywords: segmental stabilization exercise low back pain peak torque
phase ii trial of consolidative thoracic radiotherapy for es-sclc after standard care of chemo-immunotherapy

Conditions: Small-cell Lung Cancer

Summary: this is an open-label, single arm phase ii study designed to evaluate the efficacy and safety of thoracic radiotherapy for extensive-stage small-cell lung cancer treated with pd-1/pd-l1 plus etoposide platinum followed by pd-1/pd-l1 maintenance therapy

this study a single arm prospective phase ii study. all the enrolled patients will be patients with es-sclc who did not have pd (determined as per the recist v1.1) after 6 cycle of platinum-based chemotherapy in combination with an anti-pd-1/l1. then, those enrolled patients would be treated with thoracic radiotherapy concurrently with pd-1/pd-l1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.

Eligibility criteria:
inclusion criteria: 1. age between18 years and 80 years at time of study entry 2. ecog performance status of 0 or 1 3. body weight \>30 kg 4. adequate bone marrow, liver and kidney function 5. life expectancy of at least 3 months 6. at least one measurable (recist 1.1), thoracic lesion that can be irradiated with 45 gy/15 fractions 7. histologic or cytologic confirmation of small cell lung cancer 8. stage iii-iv disease (tnm v8) 9. adequate pulmonary function with fev1 \>1 l or \>30 % of predicted value and dlco \>30 % of predicted value 10. patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment - exclusion criteria: 1. previous chemo-, immuno- or radiotherapy for sclc 2. major surgical procedure last 28 days 3. history of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or hiv 4. uncontrolled intercurrent illness 5. other active malignancy 6. leptomeningeal carcinomatosis 7. immunosuppressive medication 8. pregnant or breastfeeding women

Keywords: thoradic radiotherapy immune checkpoint inhibitors chemo-immunotherapy
laser acupuncture versus tap water iontophoresis on hyperhidrosis

Conditions: Hyperhidrosis

Summary: the purpose of the present study is to assess the effect of laser acupoints on subjects with hyperhidrosis in comparison to tap water iontophoresis

the study will be randomized control trial pre and post-experimental design. anonymity and confidentiality of all procedures will be assured in compliance with relevant laws and institutional guidelines. all patients will sign two copies of a consent form before the beginning of data collection. subjects will be recruited using publicly distributed posters and by online social media, subjects their hyperhidrosis examined by hyperhidrosis disease severity scale, perceived stress scale. recruited subjects will be randomly assigned to laser acupoint or tap water iontophoresis groups. the participants and assessor will be blinded for the study hypothesis.

Eligibility criteria:
inclusion criteria: * volunteer subjects from mit physical therapy students complained from hyperhidrosis examined by hyperhidrosis disease severity scale, perceived stress scale. exclusion criteria: * subjects will be excluded if they had musculoskeletal diseases and visceral disorders or had any operations or recent injury
neoadjuvant sbrt in localized advanced hnscc

Conditions: Head and Neck Squamous Carcinoma

Summary: the response rate of hnscc to immune checkpoint blockade was not satisfied. improving the mpr rate of neoadjuvant immunotherapy through the combination with other treatment methods is an important way to further improve the prognosis of such patients. this study aims to explore the efficacy and safety of pd-1 monoclonal antibody with neoadjvant sbrt and chemotherapy. the triple mode not only can increase the effectiveness of neoadjuvant therapy，meanwhile，the in situ tumor vaccine inoculation effect generated by enhancing the release of specific antigens after tumor radiotherapy with pd-1 monoclonal antibody achieves a sustained anti-tumor immune effect throughout the body， reducing postoperative adjuvant radiotherapy and chemotherapy. the triple mode has important exploratory value in achieving high quality and long-term survival for patients, and may provides a more efficient mode for locally advanced hnscc.

locally advanced hnscc patients would receive pd-1 antibody and chemotherapy with or without sbrt covering gtv of primary disease and metastatic nodes , followed by surgery. pathological response was measured .neoadjuvant pd-1 antibody and chemotherapy with certuxmab was also tested

Eligibility criteria:
inclusion criteria: 1. pathologically confirmed initially resectable localized advanced head and neck squamous cell carcinoma，and plan for surgical resection. 2. immunohistochemical confirmed the hpv status through p16 immunostaining. 3. male or female, between the aged from 18 to 70 years, 4. able to provide informed consent, comply with agreements, and sign research specific consent documents. 5. zps is less than 2. 6. adequate bone marrow, liver and kidney, heart , lung and other physiological function determined by researchers, able to tolerate neoadjuvant anti-pd-1, anti-egfr, and radiation therapy. 7. subjects are willing and able to comply with visits, treatment regimens, laboratory tests, and other requirements of the study as spe. exclusion criteria: 1. any clinical illness, such as hemorrhage, active infection, or mental illness, that can hinder safe participation or adherence of research procedures. 2. patients who cannot accept radiotherapy in standard treatment. 3. long term maintenance of oral steroids (≥ 20mg prednisone equivalent per day) is required, excluding patients with inhaled, local, or non absorbable steroids. 4. autoimmune diseases, including but not limited to inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathy (such as guillain barre syndrome), etc.
testing feasibility of motivational interviewing for patient-reported cancer pain goals

Conditions: Other Cancer

Summary: this research study is evaluating the acceptability and feasibility of using a cognitive behavioral intervention called motivational interviewing to help persons with pain from cancer set goals for managing that pain.

this study is being conducted to evaluate a new way that clinicians can help identify the goals that cancer participants have for managing their pain. this new method uses discussion between a patient and a clinician, in this case a registered nurse, during which one or more goals may be set. at this time, there are no tested methods that clinicians can use for helping patients set these kinds of goals.

Eligibility criteria:
inclusion criteria: * at least 18-years of age * has an appointment with dfci ambulatory palliative care service for cancer-related pain * can speak english exclusion criteria: -diagnosis of delirium or other cognitive impairment

Keywords: other cancer