Kornimate/medical-research-clean huggingface dataset:
study evaluating the effects of oprelvekin on cardiac repolarization in subjects with chemotherapy induced thrombocytopenia

Conditions: Severe Thrombocytopenia

Summary: this is an open-label study in which oprelvekin will be administered for the prevention of severe low blood platelet cell counts (cells in your blood that keep bleeding and clotting stable) in adults with cancer who are taking chemotherapy (anti-cancer drug) that has a side effect of blocking your bone marrow from making platelet cells. the purpose of this study is to learn more about the effects of the recommended dose of oprelvekin on the heart's electrical cycle.


Eligibility criteria:
inclusion criteria: * men and women must be 18 to 65 years of age, with nonmyeloid malignancies for whom oprelvekin is indicated. * at least one documented occasion of adequate hematologic recovery from previous or current chemotherapy. * adequate renal and hepatic excretory function. exclusion criteria: * a marked baseline prolongation of qt/qtc interval (eg, repeated \[two out of three readings\] demonstration of a qtcf interval \>450 msec. * additional risk factors for torsades de pointes including heart failure (subjects that have functional class iii or iv congestive heart failure), hypokalemia, hypomagnesemia, or hypocalcemia. * a pace maker or defibrillator. * a history of lqts, syncope, seizure, or the unexplained cardiac-related death of a family member at less than 30 years of age. * requirement of concomitant prescription or non-prescription medications or dietary supplements that have a risk of causing torsades de pointes or prolonged qt/qtc interval.
theta burst stimulation plus habit override training for compulsive behaviors

Conditions: Compulsive Behavior; Obsessive-Compulsive Disorder

Summary: this project seeks to identify causal neural mechanisms underlying unwanted, repetitive behaviors (compulsions). using non-invasive brain stimulation coupled with practice in a computer task, we will modulate activity in a target brain region and measure effects on compulsive behaviors and related measures. this work could ultimately lead to the ability to treat compulsions more effectively by targeting the regions of the brain that can help or hinder attempts to overcome compulsions.


Eligibility criteria:
inclusion criteria: participants will: 1. be between the ages of 18 and 60 years 2. endorse problematic compulsive behaviors, per self-report and clinician-administered measures. 3. agree to video taping of structured clinical interview 4. report that they will reside in the pittsburgh area for at least 5 weeks exclusion criteria: 1. failure to meet standard mri inclusion criteria: those who endorse claustrophobia, those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, implanted uterine devices, metal braces, or other metal objects in their body, especially in the eye. dental fillings do not present a problem. plastic or removable dental appliances do not require exclusion. history of significant injury or surgery to the brain or spinal cord that would impair interpretation of results. pregnancy, determined by pregnancy tests on females. 2. medical contraindications for transcranial magnetic stimulation (tms): 1. presence of a neurologic disorder or medication therapy known to alter seizure threshold (e.g., stroke, aneurysm, brain surgery, structural brain lesion, brain injury, frequent/severe headaches) 2. recurrent seizures or epilepsy in participant or family history of hereditary epilepsy 3. pregnancy 4. metallic implants in body or other devices that may be affected by magnetic field 5. significant heart disease or cerebrovascular disease 6. medications with strong seizure threshold lowering potential or which may interfere with the efficacy of tms (e.g., clozapine, stimulants) 3. acute suicidality or other psychiatric crises requiring treatment escalation 4. changes made to treatment regimen within 4 weeks of baseline assessment 5. reading level \<6th grade as per participant self-report 6. presence of bipolar, psychotic, autism spectrum, or substance use disorder (i.e. current problematic use of mood altering drugs such as cocaine, opiates, amphetamines, and barbiturates) 7. presence of movement disorder or tics affecting manual responses 8. inability to read text from 2 feet away (corrective lenses allowed)
benign prostatic hyperplasia in taiwan

Conditions: Prostatic Diseases

Summary: primary objective: * to assess the sexual function of benign prostatic hyperplasia patients secondary objective: * to evaluate the association between lower urinary tract symptoms severity and sexual disorders * to compare the sexual function, urinary symptoms and quality of life of benign prostatic hyperplasia patients on xatral 10mg od among the different regions * to correlate the male sexual health questionnaire(mshq) and 5-item version of the international index of erectile function (iief-5) * to assess the onset of action of xatral 10mg od * to assess the peak urinary flow rate * to assess the safety and the tolerability of xatral 10mg od


Eligibility criteria:
inclusion criteria * male suffering from moderate to severe lower urinary tract symptoms (luts), suggestive of symptomatic benign prostatic hyperplasia (bph) * sexually active * sexual attempts at least once per month exclusion criteria * known history of hepatic or severe renal insufficiency * unstable angina pectoris * concomitant threatening-life condition * previous transurethral resection of the prostate (turp) * had a minimally invasive procedure within 6 months prior to inclusion * planned prostate surgery or minimally invasive procedure during the whole study period * active urinary tract infection or acute prostatitis * neuropathic bladder * diagnosed prostate cancer * patients having received 5-reductase inhibitors or lower urinary tract symptoms (luts) related phytotherapy or anti-muscarinics drug for oab or 1-blockers within 1 month prior to inclusion * patients receiving any treatment for erectile dysfunction within 1 month prior to inclusion * history of postural hypotension or syncope * known hypersensitivity to alfuzosin * patients illiterate or unable to understand or to complete the questionnaires * patients having participated in any clinical study in the past month * prostate specific antigen (psa)\> age specific prostate specific antigen value, without using prostate biopsy to rule out prostate cancer the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
laparoscopic gynecology curriculum for residents

Conditions: Hysterectomy for Abnormal Uterine Bleeding

Summary: gynecologists are currently using laparoscopy to perform many surgeries traditionally approached by laparotomy. the technical skills required for laparoscopic surgery are different than the skills required for laparotomy, causing a prolonged learning curve. currently there is no standardized laparoscopy curriculum for gynecology residents. this study aims to develop a specific evidence-based surgical skills gynecologic curriculum that could be instituted in residency programs at a national and international level. the investigators will then validate the curriculum using obstetrics and gynecology residents through a cognitive examination, a technical skills examination, and a video recording of performance in the operating room. hypothesis: the investigators aim is to design a standardized evidence-based comprehensive laparoscopic curriculum that focuses on cognitive knowledge, surgical skills, and team training exercises. the investigators hypothesize that residents in the experimental curriculum-trained group will perform better than the residents in the traditional residency curriculum-trained group on a cognitive examination, a technical skills examination, and in the operating room. the operating room performance will be judged by blinded experts on a previously validated evaluation tool.


Eligibility criteria:
inclusion criteria: * novice residents (defined as having performed less than 10 laparoscopic salpingectomies) * patients undergoing uncomplicated right-sided salpingectomies prophylactically at the time of laparoscopic hysterectomy, laparoscopic salpingo-ophorectomies, or laparoscopic-assisted vaginal hysterectomies. exclusion criteria: * residents who have performed more than 10 laparoscopic salpingectomies * residents in pgy3 or higher * patients with multiple prior abdominal surgeries, high bmi, significant adnexal pathology, and extensive endometriosis

Keywords: laparoscopy surgical skills team training obstetrics and gynecology curriculum
evaluation of the long-term safety and effectiveness of suzetrigine (suz) in participants with painful diabetic peripheral neuropathy (dpn)

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of suz and long-term effectiveness of suz in treating pain associated with dpn.


Eligibility criteria:
key inclusion criteria: • completed the final visit in the treatment period (i.e., week 12) and subsequent 7-day period (to allow for taper of blinded capsule study drug) in a parent study such as vx24-548-110 or vx24-548-111 key exclusion criteria: * any sensory abnormality (excluding dpn) * history of drug intolerance in a parent study that would pose an additional risk to the participant in the opinion of the investigator * current participation in an investigational drug trial (other than a parent study) other protocol defined inclusion/exclusion criteria may apply.
pld combined with cisplatin in the treatment of advanced poorly differentiated thyroid carcinoma

Conditions: Poorly Differentiated Thyroid Carcinoma

Summary: this is a prospective, multicenter, open label phase ii clinical trial. 30 advanced poorly differentiated thyroid carcinoma patients who were histopathologically confirmed inoperable were enrolled in this study.

subjects will receive the treatment regimen as follow: intravenous infusion of liposomal doxorubicin 35 mg/m2, d1; cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles. stop the treatment if the patients have progressed or intolerated to the toxicity. the primary endpoint is disease control rate(dcr), the secondary endpoint is overall survival (os), progression-free survival (pfs), safety and quality of life assessment(qol).

Eligibility criteria:
inclusion criteria: 1. volunteer to participate and sign the informed consent form; 2. age :18-70 years old; 3. histopathologically confirmed inoperable advanced poorly differentiated thyroid carcinoma; 4. previously received surgery, i131 treatment, radiotherapy, chemotherapy patients can be enrolled； 5. at least one measurable lesion according to the solid tumor efficacy evaluation criteria (recist 1.1); 6. expected survival time ≥ 3 months; 7. karnofsky score ≥70; 8. blood test：anc ≥1.5×109/l； plt ≥75×109/l；hb ≥90g/l; 9. liver function:serum bilirubin (sb) level:≤ normal upper limit（uln）2 times; aspartate aminotransferase(ast) and alanine aminotransferase(alt) ≤ uln 2.5times; or ≤ uln 5times if liver metastases are present; 10. renal function: serum creatinine ≤ uln 1.5times; 11. lvef ≥ 50%; 12. no serious complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, noncancerous fever \> 38℃; 13. subjects are well-behaved, able to undergo the follow-up efficacy and adverse reactions according to the program requirements. exclusion criteria: 1. active or uncontrolled severe infection (≥ctcae grade 2 infection)； 2. previously received anthracycline-based regimen: the cumulative dose of doxorubicin at or above 500 mg / m2 or the cumulative dose of epirubicin reached or exceeded 800 mg / m2; 3. the new york heart association (nyha) graded class ii or above heart disease patients previously or at present; 4. patients with cns disorders or cns metastases; 5. allergic to chemotherapeutic drugs or their excipients or intolerant patients; 6. received any other test drug treatment within 30 days of the first chemotherapy administration; 7. pregnant or lactating women; 8. arterial/venous thrombosis occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis, and pulmonary embolism; 9. history of aneurysm; 10. neurological disorders with a history of epilepsy or ataxia require treatment; 11. a history of drug abuse and incapable of abstinence or mental disorder; 12. a history of peripheral neuropathy and the muscle strength is below level 3; 13. suffering from other diseases and complications of hand-foot syndrome; 14. researchers think it is not suitable for enrolling.
o-rads mri system on early detection of ovarian cancer

Conditions: Ovarian Cancer (OvCa); Ovarian Cancer Metastatic

Summary: this study is designed to prospectively enroll individuals with suspected or potential risk of ovarian cancer across multiple centers. the investigation will implement rational optimization of the recommended imaging sequences and interpretation protocols within the standard ovarian-adnexal reporting and data system (o-rads) mri framework. by integrating comprehensive clinical parameters and histopathological correlations, we aim to validate the diagnostic efficacy and reproducibility of the optimized protocol against the standard o-rads mri system. the ultimate objective is to establish a refined methodology for accurately diagnosing early-stage or low-burden ovarian malignancies, thereby improving prognostic outcomes of patients with ovarian cancer.


Eligibility criteria:
inclusion criteria: * patients meeting either of the following criteria based on initial diagnostic pelvic ultrasound findings (pelvic mass or pelvic effusion) suspicious for ovarian malignancy or at elevated risk for ovarian cancer: 1. postmenopausal women or females ≥45 years with pelvic mass or effusion on ultrasound; 2. postmenopausal women or females ≥45 years with serum ca125 ≥35 u/ml; 3. females ≥35 years with a confirmed family history of ovarian or breast carcinoma; 4. females ≥35 years harboring pathogenic/likely pathogenic brca1/2 germline mutations; 5. females ≥35 years with brca1/2 mutations, non-suspicious adnexal lesions on ultrasound but planning prophylactic adnexectomy with availability of serial pathological sectioning. ② ability to comply with the study protocol and adhere to scheduled follow-up assessments. ③ provision of written informed consent. exclusion criteria: * ① pregnant individuals * patients with histopathologically confirmed ovarian cancer * ovarian malignancy diagnosed by pet-ct at this institution ④ patients undergoing neoadjuvant chemotherapy for confirmed ovarian cancer ⑤ claustrophobia precluding tolerance of mri examination ⑥ contraindications to mri: cardiac pacemakers, ferromagnetic implants, or high-risk metallic foreign bodies ⑦ history of gadolinium-based contrast agent (gbca) hypersensitivity or intolerance ⑧ severe renal insufficiency (glomerular filtration rate \<30 ml/min/1.73 m²)
bioequivalence of two formulations of biphasic insulin aspart 50 in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 in healthy male subjects.


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history and physical examination, as judged by the investigator * body mass index (bmi) between 19.0-30.0 kg/m\^2 * glycohemoglobin (hba1c) within laboratory normal range * non-smokers exclusion criteria: * the receipt of any investigational drug within the last 3 months prior to this trial. * clinically significant abnormal haematology, biochemistry, urinalysis or ecg (electrocardiogram) screening tests, as judged by the investigator * liver enzyme values (alat and asat) exceeding 2 times the upper reference limit according to the local laboratory * history of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive urine drug screen and breath alcohol screen) * hiv (human immunodeficiency virus), hepatitis b or c positive * subjects with a first-degree relative with diabetes mellitus * a history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions
efficacy and safety of oral bt-11 in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open-label extension (ole) period. the purpose of this study is to evaluate the efficacy and safety of oral bt-11 compared to placebo in subjects with uc. this study includes 3 periods: induction, maintenance, and an optional ole period.


Eligibility criteria:
key inclusion criteria: 1. . male and female subjects aged 18 to 75 years, inclusive. 2. . diagnosis of uc for at least 3 months prior to screening. 3. . uc, as defined by a total mayo score of 4 to 10 inclusive at baseline with a mes 2 (confirmed by central reader). 4. . able to participate fully in all aspects of this clinical trial. 5. . written informed consent must be obtained and documented. key exclusion criteria: 1. . a diagnosis of cd, indeterminate colitis, or presence or history of the fistula with cd. 2. . modified truelove and witts criteria (2: 6 bloody stools per day and one or more of the following: pulse \> 90 bpm, temperature \> 37.8°c, hemoglobin \ 30 mg/i). 3. . disease activity limited to distal 15 cm (proctitis). 4. . treatment with an immunosuppressant (azathioprine, 6- mercaptopurine \[6-mp\]) within 25 days prior to randomization. 5. . unable to attend study visits or comply with procedures. 6. . concurrent participation in any other interventional study. 7. . prior enrollment in the current study and had received study treatment.
effects of additional fentanyl to epidural bupivacaine for post-thoracotomy pain in neonates

Conditions: Congenital Cystic Adenomatoid Malformation

Summary: the study exams whether adding an opioid to the epidural infusion of a local anesthetic in neonates will significantly improve the quality of the postoperative analgesia.

the purpose of this study is to evaluate the best pain medication to be infused in the epidural catheter. at chop, the medication infused in the epidural catheter following a chest operation in neonates is a local anesthetic (bupivacaine). however, even with this continuous infusion, neonates still require multiple doses of intravenous opioids (i.e. morphine) because of persistent or constant pain. the administration of intravenous opioids in neonates can have many side effects, such as respiratory depression (reduced breathing rate), sedation, urinary retention (inability to pass urine), itching, nausea and vomiting it has been well documented that by adding a small dose of any opioid to a local anesthetic given through an epidural catheter, the feeling of postoperative pain can be significantly improved in older children and in adults. it is not known whether the addition of an opioid to a local anesthetic is beneficial in neonates. in this study, we are comparing the standard local anesthetic (bupivacaine) with a combination of bupivacaine and a small dose of an opioid (fentanyl). this is a randomized study and the type of medication given into the epidural catheter will be chosen on the day of the operation by a random drawing (like flipping a coin). your child could receive one of the following: 1. bupivacaine 0.1% 2. bupivacaine 0.1% with fentanyl 2mcg/ml neither you nor your doctors will know which arm of the study your child is in. in case of emergency, the pharmacy can tell your doctor what medication your child is receiving.

Eligibility criteria:
inclusion criteria: 1. infants 0-6 months of age who require a thoracotomy for lung resection. 2. parents accept the placement of an epidural catheter. exclusion criteria: 1. premature infants 2. patients allergic to fentanyl and/or bupivacaine. 3. known medical contraindications. -
atrasentan in treating patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase iii trial to determine the effectiveness of atrasentan in treating patients who have prostate cancer that has not responded to hormone therapy.

objectives: * determine the safety of atrasentan in patients with hormone-refractory prostate cancer. * determine the pharmacokinetics of this drug in these patients. outline: this is an open-label, multicenter study. patients receive oral atrasentan once daily for 3 years in the absence of disease progression or unacceptable toxicity. patients are followed at 1 month and then every 3 months for 2 years. projected accrual: approximately 1,400 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of hormone-refractory prostate cancer * completed protocol abbott-m00-211 or abbott-m00-244 within the past 30 days * disease progression or * active in trial when double-blind treatment period ended patient characteristics: age * 19 and over performance status * karnofsky 60-100% life expectancy * not specified hematopoietic * wbc at least 3,000/mm3 * absolute neutrophil count greater than 1,000/mm3 * platelet count at least 100,000/mm3 * hemoglobin at least 9 g/dl hepatic * bilirubin less than 1.5 mg/dl * ast and alt no greater than 1.5 times upper limit of normal renal * creatinine clearance at least 40 ml/min cardiovascular * no new york heart association class ii-iv heart disease pulmonary * no significant pulmonary disease requiring chronic or pulse steroid therapy within the past 3 months other * fertile patients must use 2 effective methods of contraception (1 must be barrier contraception) during and for 8 weeks after study * no reason that would preclude study * no significant comorbid condition that would preclude study prior concurrent therapy: biologic therapy * not specified chemotherapy * at least 4 weeks since other prior cytotoxic chemotherapy * no other concurrent cytotoxic chemotherapy endocrine therapy * not specified radiotherapy * at least 4 weeks since prior radionuclides * no concurrent radionuclides surgery * not specified other * at least 4 weeks since prior investigational agents * no concurrent antiretroviral therapy for hiv-positive patients * no concurrent participation in another investigational study

Keywords: adenocarcinoma of the prostate recurrent prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer stage iv prostate cancer
iatrogenic drug risk in people over 75, with or without cognitive disorders, from an inventory of their family pharmacy

Conditions: Elderly; Iatrogenic Drug Risk

Summary: many hospitalizations or emergency room visits are due to problems of iatrogenic medication, especially in elderly patients who are very often polymedicated. moreover, they are more at risk because of fragility. this has an important socio-economic impact. it therefore seems important to act upstream of these adverse events and a review of the drugs available in the homes of elderly patients seems a good starting point.


Eligibility criteria:
inclusion criteria: * patient over 75 years with or without cognitive disorders exclusion criteria: * refusal to participate

Keywords: elderly iatrogenic drug risk family pharmacy