Kornimate/medical-research-clean huggingface dataset:
effect of multiple dosing with bi 201335 on the pharmacokinetics of darunavir co-administered with ritonavir in healthy male and female volunteers

Conditions: HIV Infections

Summary: the objective of the current study is to investigate the effect of multiple oral daily doses of bi 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.


Eligibility criteria:
inclusion criteria: 1. healthy male and female subjects according to the following criteria: medical history, physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram (ecg), clinical laboratory tests 2. age 18 to 55 years (incl.) 3. body mass index (bmi) 18.5 to 29.9 kg/m2 (incl.) and weight greater than 50 kg 4. signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (gcp) and the local legislation. exclusion criteria: 1. any finding of the medical examination (including blood pressure (bp), pulse rate (pr) and ecg) deviating from normal and of clinical relevance 2. any evidence of a clinically relevant concomitant disease 3. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 4. history of photosensitivity or recurrent rash. 5. surgery of the gastrointestinal tract (except appendectomy) 6. diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 7. history of relevant orthostatic hypotension, fainting spells or blackouts. 8. chronic or relevant acute infections 9. history of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 10. intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial 11. participation in another trial with an investigational drug within two months prior to administration or during the trial 12. smoker (more than 10 cigarettes) 13. inability to refrain from smoking on trial days 14. alcohol abuse (more than 30 g/day) 15. drug abuse 16. blood donation (more than 100 ml within four weeks prior to administration or during the trial) 17. alt outside the normal range or any other laboratory value outside the reference range that is of clinical relevance 18. inability to comply with dietary regimen of trial site 19. the subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions 20. positive serology tests for human immunodeficiency virus (hiv) and hepatitis b / c virus 21. vulnerable subjects (e.g. persons kept in detention)
a compassionate treatment protocol for the use of trimetrexate glucuronate with leucovorin protection for patients with pneumocystis carinii pneumonia.

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to provide trimetrexate glucuronate to immunosuppressed patients with pneumocystis carinii pneumonia (pcp) for whom this investigational compound could provide significant medical benefit.

patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * antiretroviral therapy (at the discretion of the treating physician and/or medical monitor). patients must have: * presumptive or definitive diagnosis of pneumocystis carinii pneumonia (pcp). * hiv positivity or be otherwise immunosuppressed. * demonstrated intolerance and/or resistance to trimethoprim/sulfamethoxazole during the course of therapy for the current episode and not candidates for parenteral pentamidine, or a documented history of such intolerance during a prior episode. * consent of parent or guardian if less than 18 years of age. note: * in general, patients who meet the eligibility criteria for other u.s. bioscience-sponsored clinical trials for trimetrexate would not be eligible for this compassionate use protocol. exclusion criteria patients with the following prior conditions are excluded: history of type i hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions to trimetrexate.

Keywords: trimetrexate pneumonia, pneumocystis carinii leucovorin drug therapy, combination acquired immunodeficiency syndrome
drug-drug interaction study of vx-809 and vx-770 in healthy subjects

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to assess the pharmacokinetics and safety of co-administration of vx-770 and vx-809 in healthy adults.

cystic fibrosis (cf) is an inherited disease resulting from defects to a gene known as the cystic fibrosis transmembrane conductance regulator (cftr). cf affects approximately 70,000 children and adults worldwide (30,000 in the united states) and is the most common fatal genetic disease in persons of european descent. despite progress in the treatment of cf with antibiotics and mucolytics, the predicted median age of survival for a person with cf is in the mid-30s. though the disease affects multiple organs, most morbidity and mortality is caused by progressive loss of lung function. this is a phase 1, randomized, double-blind, placebo-controlled, multiple-dose study of orally administered vx-809 and vx-770 in healthy subjects. the study will evaluate safety and tolerability of co-administration of vx-809 and vx-770 in healthy volunteers. enrollment is planned for 24 subjects at 1 clinical site. subjects will be randomized to receive study drug or placebo during three 14-day treatment periods separated by 14-day washout periods. in treatment period 1, subjects randomized to study drug will receive vx-809 every 24 hours. in treatment period 2, subjects randomized to study drug will receive vx-770 every 12 hours. in treatment period 3, subjects randomized to study drug will receive vx-809 every 24 hours and vx-770 every 12 hours. subjects randomized to placebo will receive placebo during all treatment periods.

Eligibility criteria:
inclusion criteria: * male or female subject between 18 and 55 years of age, inclusive * body mass index (bmi) between 18.5 and 30.0 kg/m2, inclusive * subjects of child-bearing potential and who are sexually active must meet contraception requirements * female subject must have a negative serum pregnancy test at screening, day -1, and throughout the study exclusion criteria: * history of any illness that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject. this may include but is not limited to a significant history of cardiovascular, central nervous system, hepatobiliary or renal disease, or a history of mental illness * participated in a clinical study involving administration of either an investigational or a marketed drug within 60 days or 7 terminal half-lives (whichever is longer) before the screening visit * subject who has received vx-770 or vx-809 in a previous clinical study
impact of self-monitoring of salt intake by salt meter in hypertensive patients

Conditions: Hypertension; Salt; Excess

Summary: hypertension is one of the most common chronic medical conditions. the concerned sequelae are the cardiovascular complications, especially acute myocardial infarction and stroke. in thailand, the incidence of hypertension is increasing each year. many clinical studies found that salt intake over the reference level (\>5 g/day) would result in elevated blood pressure (bp) and long-term morbidity. dietary salt reduction campaigns were unsuccessful, in part, due to time limitation in the clinic, lacking of awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. salt meter is a device used to detect sodium content in daily food. it will facilitate monitoring and control of salt intake. the 24-hour urinary sodium excretion is an acceptable method to reflect the quantity of sodium intake. this study aimed to compare the efficacy of salt meter plus dietary education compared with education alone in terms of salt intake reduction, blood pressure, salt taste sensitivity, and vascular consequence.

a randomized-controlled trial was conducted in hypertensive patients whose bp was uncontrolled (systolic bp ≥140 mmhg or diastolic bp ≥90 mmhg) despite therapy or antihypertensive-naïve. patients were randomized to receive salt meter to use in conjunction with dietary education (group a) or receive education only (group b), and were followed up for 8 weeks. dietary education was provided by certified dietician without awareness of patients' allocation. the primary endpoint was change in 24-hour urinary sodium excretion. changes in bp, salt taste sensitivity threshold, cardio-ankle vascular index (cavi), as well as motivation to maintain low salt diet were also analyzed.

Eligibility criteria:
inclusion criteria: * mean sbp 140-179 mmhg or mean dbp 90-109 mmhg (average 3 times) * diagnosed of hypertension for at least 3 months * no adjustment of antihypertensive agents for at least 1 month * 24h urine sodium ≥ 90 mmol/day * egfr ≥ 45 ml/min/1.73 sq.m. exclusion criteria: * egfr \< 45 ml/min/1.73 sq.m. * uacr \> 300 mg/g * serum potassium \> 6.0 mmol/l * serum sodium \< 135 mmol/l * unable to collect 24-hour urine

Keywords: hypertension uncontrolled salt, excess salt meter
the occurence of pancreatic cancer studied in association with newly diagnosed diabetes in the elderly

Conditions: Diabetes Mellitus; Diabetes; Diabetes Mellitus, Type 2; Diabetes type2; Cancer of Pancreas; Pancreas Neoplasm; Pancreas Adenocarcinoma; Pancreatic Cancer

Summary: the aim of this study is to accomplish the early diagnosis of pancreatic cancer, in patients over 60 years of age with newly diagnosed diabetes. only patients with type 2 diabetes are meant to be included. the early diagnosis of pancreatic cancer could be the way to enable efficient cure for the patients.

the prognosis of pancreatic cancer is extremely unpleasant, which can be characterized with a 5-year survival rate of only about 6%. the disease usually pertaining no symptoms at the early phase, this might be one of the causes why it is discovered at a relatively late, inoperable stage - in most of the cases. the success of reducing the high mortality rate of pancreatic cancer could depend on the significant development of early diagnosis and also prevention programs. as the lifetime prevalence of pancreatic cancer is only 1.39%, screening through the whole population would be extremely expensive and difficult to manage. it would be recommended for all the individuals at high risk for pancreatic cancer to be examined. patients newly diagnosed with diabetes have an approximately 8-fold risk for developing this type of cancer, compared to the average population. in addition to this age is also known as an independent risk factor for the pancreatic cancer. recently there has been a biomarker panel identified, which may distinguish between pancreatic cancer and chronic pancreatitis in patients, with high sensitivity and specificity. the aim of this study is to accomplish the early diagnosis of pancreatic cancer, in patients over 60 years of age with newly diagnosed diabetes mellitus using a specific biomarker panel. only patients with type 2 diabetes are meant to be included. diabetes is classified by determining c-peptide levels, representing the endogenous insulin synthesis, also detecting glutamic acid decarboxylase (gada) antibodies, the autoantibody against the pancreatic islet cells. the early diagnosis of pancreatic cancer could be the way to enable efficient cure for the patients.

Eligibility criteria:
inclusion criteria: * patients over 60 years of age * diabetes diagnosed within six months (newly diagnosed) * signed written informed consent exclusion criteria: * continous alcohol abuse * chronic pancreatitis * previous pancreas operation/pancreatectomy * pregnancy * present malignant disease

Keywords: new-onset diabetes mellitus pancreatic cancer biomarker screening
human clinical trial of uterine transplantation in the united kingdom

Conditions: Infertility

Summary: ten patients will undergo uterine transplantation.

ten patients that will be appropriately selected using a variety of physical and psychological assessments. the selected patients will undergo egg retrieval and subsequent freezing of embryos to enable ivf treatment following transplantation. following uterine transplantation, using deceased donor allografts, the patients will be closely monitored for 12 months clinically, radiologically and immunologically until embryo transfer. following successful embryo transfer the patients will continue to be monitored antenatally until they are delivered by caesarean section.

Eligibility criteria:
inclusion criteria: * female * between 18-36 years of age * absolute uterine factor infertility exclusion criteria: * poor ovarian reserve - unsuccessful oocyte retrieval * no intercurrent significant medical or psychiatric co-morbidities * previous oncology patients \<5 years in remission * outside of age range * normal bmi

Keywords: infertility transplant ivf hysterectomy absolute uterine infertility
emotional regulation and impulsivity among adolescents with borderline personality disorder

Conditions: Borderline Personality Disorder; Adolescent Development

Summary: this study aims to better understand the behavioral, neurobiological and hormonal underpinnings of stress and reward reactivity of adolescents suffering from borderline personality disorder compared to healthy adolescents by a multimodal approach based on clinical assessments, structural and functional mri and experimental acute stress exposure.

borderline personality disorder (bpd) is a severe condition associated with intense emotional and behavioral responses to stressful events, impulsivity, and risk-taking behavior. it has been shown to begin in adolescence. however, very few studies have addressed the physiopathology of bpd in adolescents. in order to gather rational information for targeted care, the heterogeneity of bpd determinants needs to be disentangled. to this aim, a multimodal approach to bpd dimensional aspects is proposed. bpd adolescents will be compared to typically developing controls in two complementary experimental designs: (1) monitoring of neurovegetative, hormonal and body motion responses to an acute stress, with the hypothesis that stress reactivity might account for the physiopathology of the disorder; (2) structural and functional imaging (fmri bold) in the context of a reward processing task to delineate the neural/functional basis of bpd risk taking behavior.

Eligibility criteria:
inclusion criteria: * adolescent subject: 13 years ≤ age ≤ 18years * affiliation to social welfare * informed consent to participate in the protocol, consent signed by the major subject or by one of the legal guardians if the subject is a minor * diagnosis of borderline personality disorder according to diagnostic and statistical manual of mental disorders 5 (dsm-5) and abbreviated- diagnostic interview of borderline personality disorder (ab-dib) * somatic and intellectual state compatible with blood sampling and mri examination exclusion criteria: * non-affiliation to social welfare * refusal to give consent and / or to sign informed consent by the subject or his or her legal guardian if the subject is a minor * somatic pathology in progress, or pregnancy (urine test of pregnancy in case of doubt) * contraindication to magnetic resonance imaging: * presence of a ferromagnetic foreign body * subject carrying a pacemaker * subject carrying ventricular bypass valves * claustrophobic topic * subject suffering from the following diseases: * intellectual impairment intellectual quotient (iq) \<70, * claustrophobia, * obsessive compulsive disorder, * tic disorder, * autism spectrum disorder, * attention deficit disorder with or without hyperactivity, * bipolar disorder, * schizophrenia
a trial of shr-1905 in healthy subjects and subjects with mild asthma

Conditions: Asthma

Summary: this study is a phase 1 single dose escalation study of shr-1905 in healthy subjects and subjects with mild asthma. the purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of shr-1905 in healthy subjects and subjects with mild asthma.


Eligibility criteria:
inclusion criteria: 1. ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent, be able to comply with all the requirements and able to complete the study. 2. male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form. 3. total body weight ≥ 45 kg, body mass index (bmi) between 18 and 28 kg/m2 at screening. 4. for healthy subjects, no clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function and thyroid function) and ecg at the investigator's discretion during screening and baseline. exclusion criteria: 1. known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental, nerve, hematology, metabolic disorders, etc. 2. severe injuries or major surgeries within 6 months before screening or plan to do surgeries during the trial. 3. positive hepatitis b virus (hbsag), hepatitis c virus (hcv-ab), human immunodeficiency virus (hiv-ab) at screening. 4. hyper/hypotension which define as systolic blood pressure (sbp) \>140mmhg or \ 90mmhg or \<40mmhg at screening and at check in. 5. clinically significant abnormalities in 12-lead ecg (e.g., for male qtcf \> 450msec, for female qtcf \> 470msec) at screening and at check in 6. positive alcohol breath test during baseline visit. 7. positive nicotine test during screening. 8. positive urine drug screen during screening. 9. participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer (according to the date of signed consent form) which is defined as have consented and used other investigational drugs (including placebo) or trial medical devices 10. any other circumstances that, in the investigator's judgment, may increase the risk to the subject, or associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response
evaluation of cyberknife precision radiation delivery system for unresectable malignant lung cancer

Conditions: Lung Cancer

Summary: this study has two primary objectives. the first objective is to determine the maximal tolerated dose (mtd) that can be delivered with stereotactic radiosurgery in patients with inoperable malignant lung tumors. once the mtd is established, the second objective is to determine the efficacy of radiosurgical ablation of lung tumors in terms of symptoms and radiographic responses.


Eligibility criteria:
inclusion criteria:1.lung tumor \>= 5.0 cm. 2.age \> 18 years, 3.histologic confirmation of malignancy (primary lung or metastatic tumor) 4.deemed unresectable either by radiographic criteria (such as direct invasion of the mediastinum, heart, great vessels, or trachea), by virtue of excessive risk to patient, patient refusal to undergo surgery, or prior operative findings. 5.performance status of 0-2 by eastern clinical oncology group criteria exclusion criteria:1. no chemotherapy within 2 weeks of radiation treatment. 2. refusal to sign informed consent. 3. refusal to take a pregnancy test prior to treatment if the patient is a woman with child bearing potential.
colon cancer risk-stratification via optical analysis of rectal ultrastructure

Conditions: Colon Cancer

Summary: this is a study whose focus is on understanding the clinical utility of rectal ultrastructure in detecting colonic neoplasm. the method uses low-coherence enhanced backscattering spectroscopy (lebs).

the investigators use an optic probe which is a small device that uses light to assess the colon tissue. this probe will be used to identify subjects who do and do not have precancerous changes in the colon by capturing the light reflected back from the rectal wall and that will be assessed without the need for colonoscopy and bowel preparation (i.e unprepped). this device may detect early cancerous changes in colon tissue with higher accuracy than current tests.

Eligibility criteria:
inclusion criteria: - subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance exclusion criteria: * age \<50 * personal/family history of colonic neoplasia * personal history of coagulopathy * (retrospectively) failure to complete or inadequate colonoscopy * any patients harboring non-pathoglocially normal rectum (i.e. presence of lesion, inflammation, polyp, adenomas at rectum)
gemcitabine/oxaliplatin (gemox) vs carboplatin/paclitaxel (cp) in non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin (gemox) with carboplatin + paclitaxel (cp) to determine if there is a difference in response and safety between the two drug combinations for the treatment of advanced non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * newly diagnosed, stage iiib or iv nsclc, chemo or other systemic therapy naive * one (1) unidimensionally measurable lesion * ecog performance status of 0 or 1, no peripheral neuropathy \>grade 1 * patients with clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone at registration will be eligible. patients who have received cranial radiation for brain metastases must be at least 4 weeks from last radiation treatment. * recovery in full from any previous surgical procedure * no history of an acute cardiac or cns event within 6 months of entry or current clinical evidence of congestive heart failure or non-stable coronary artery disease exclusion criteria: * hypersensitivity to any of the 4 study drugs * concurrent immunotherapy or participation in any investigational drug study within 4 weeks * serious uncontrolled intercurrent medical or psychiatric illness and organ allograft * history of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder) * patient is a pregnant or lactating female