Kornimate/medical-research-clean huggingface dataset:
examining the effectiveness of the nicotine patch in male and female smokers - 2

Conditions: Tobacco Use Disorder

Summary: treatment studies have demonstrated that current smoking cessation techniques are less effective for women. the purpose of this study is to determine the role that gender plays on the effectiveness of nicotine replacement therapy. this may lead to improved cessation interventions for all smokers, particularly women.

currently, about 70 percent of smokers who try to quit by using smoking cessation treatments are unsuccessful. treatment studies have demonstrated that current smoking cessation techniques are less effective for women. there is no clear explanation for this difference, but it may involve a differential response to nicotine replacement treatments (nrts) and/or smoking-related stimuli. for women, nrt may be less effective at suppressing withdrawal or blunting the effects of smoking during a quit attempt. women may also be more sensitive to smoking-related stimuli, such as the taste, sight, and smell of smoke. tailoring treatment to the separate needs of subgroups, such as men and women, may produce better outcomes. the purpose of this study is to assess the influence of gender on the effectiveness of transdermal nicotine treatment in a group of male and female smokers. participants in this double-blind, dose-comparison study will complete separate sessions in a random order. each session will last approximately 6.5 hours and will correspond to a specific transdermal patch dose (0, 7, 14, or 21 mg). objectively verified cigarette abstinence will be required before each session. sessions will occur at least 48 hours apart to avoid carryover. cognitive, behavioral, subjective, and physiological measures will occur during study visits. specifically, the nrt dose response to tobacco suppression and cigarette blunting effects will be compared in women and men.

Eligibility criteria:
inclusion criteria: * daily cigarette use of 15 or more cigarettes for at least 2 years * screening co level of or greater than 15 ppm * normal or corrected-to-normal vision * willing to abstain from tobacco products for 8 or more hours prior to testing exclusion criteria: * history of chronic health problems or psychiatric conditions * history of cardiovascular disease, low or high blood pressure, seizures, head injuries requiring hospital care, peptic ulcer, or diabetes * pregnancy (tested by urinalysis) * scores greater than 17 on the beck depression inventory * lack of a high school degree or ged

Keywords: tobacco
safety of evg+rtv administered with other antiretroviral agents for the treatment of hiv-1 infection

Conditions: HIV Infections

Summary: the main objective of this study is to observe the long-term safety of elvitegravir (evg) boosted with ritonavir (rtv) in combination with other antiretroviral (arv) agents in participants who have completed a prior evg+rtv treatment study.


Eligibility criteria:
inclusion criteria: * completion of a prior evg+rtv treatment study without treatment-limiting toxicity. * males and females of childbearing potential must agree to utilize effective contraception methods. * ability to understand and sign a written informed consent form. exclusion criteria: * females who are pregnant or breastfeeding. * participation in any other clinical trial without prior approval from the sponsor. * any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study. * subjects receiving ongoing therapy with contraindicated drugs.

Keywords: phase 2 open-label rollover integrase inhibitor antiretroviral agents highly active antiretroviral activity haart hiv, hiv-1, aids virus, human immunodeficiency virus acquired immune deficiency syndrome virus treatment experienced
autologous adipose-derived stem cell transplantation in patients with lipodystrophy

Conditions: Lipodystrophy

Summary: the aim of this study is to determine the safety of the autologous transplantation of adipose-derived stem cells in the treatment of lipodystrophies.


Eligibility criteria:
inclusion criteria: * lipodystrophies with necessity of fat grafting * accept to participate of the study exclusion criteria: * hiv infection * metastatic malignancy * body mass index \< 20 kg/m² * other severe systemic disease

Keywords: adipose-derived stem cell lipodystrophy
a study to evaluate the efficacy and safety of incb054707 in participants with vitiligo

Conditions: NonSegmental Vitiligo

Summary: the purpose of this study is to evaluate the efficacy and safety of incb054707 over a 24-week placebo-controlled double-blind treatment period, followed by a 28-week double-blind extension period in participants with nonsegmental vitiligo.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of nonsegmental vitiligo. * history of prior vitiligo treatment with a total duration of at least 3 months. * agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit. * willingness to avoid pregnancy or fathering children * further inclusion criteria apply. exclusion criteria: * other forms of vitiligo (eg, segmental) or other skin depigmentation disorders. * uncontrolled thyroid function at screening as determined by the investigator. * women who are pregnant (or who are considering pregnancy) or lactating. * medical history including thrombocytopenia, coagulopathy or platelet dysfunction, q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator. * have evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis. * participants known to be infected with hiv, hepatitis b, or hepatitis c. * laboratory values outside of the protocol-defined ranges. * further exclusion criteria apply.
inflammatory response during anesthesia and surgery

Conditions: Systemic Inflammatory Response Syndrome; Myocardial Ischemia

Summary: the purpose of this study is to investigate the effects of total intravenous anesthesia versus volatile anesthesia on the perioperative inflammatory response during and after major surgery.

patients undergoing major surgical procedures, in particular those undergoing cardiac surgery, develop a severe inflammatory response in up to 50% of cases leading to increased mortality and morbidity. the inflammatory response depends on the surgical procedure and on patient related factors like genetic predisposition and co morbidities. however, in vitro studies showed that the type and duration of general anaesthesia also influences the extent of perioperative inflammation. comparison: total intravenous anesthesia by propofol is compared to volatile anesthesia by isoflurane with respect to development of perioperative inflammatory response. the iras study is a single centre study, executed in the university medical centre utrecht, the netherlands. four different patient groups are included. 1) patients undergoing coronary artery bypass grafting (cabg) with use of cardiopulmonary bypass (cpb), 2) patients undergoing aorta aneurysm repair via endovascular approach and 3) via conventional open procedure, and 4) patients undergoing surgery for replacement of implantable cardioverter defibrillator (icd). the iras is a prospective, randomized clinical trial. patients are randomly assigned to a intravenous or a balanced anaesthesia technique. peripheral blood samples are drawn before, during and up to 72h after surgery.

Eligibility criteria:
inclusion criteria: * patients older than 18 years and planned for elective coronary artery bypass grafting (cabg), aorta surgery or implantable cardioverter defibrillator (icd) replacement exclusion criteria: * emergency operations * patients undergoing combined or re-do procedures * patients who are diagnosed with or undergoing treatment for a steroid or hormone disorder, excluding diabetes * patients suffering from chronic inflammatory diseases * patients suffering form current infections * patients currently treated with steroids * patients undergoing treatment or care for a malignancy * patients participating in another study that may interfere with the endpoints of the iras trial

Keywords: perioperative inflammatory response general anesthesia toll-like receptors
a study evaluating topical recombinant human vascular endothelial growth factor (telbermin) for induction of healing of chronic, diabetic foot ulcers

Conditions: Foot Ulcer

Summary: this is a phase i, double blind, randomized, placebo-controlled study that will enroll approximately 50 adult subjects with type 1 or type 2 diabetes mellitus and chronic, diabetic foot ulcers. the study will be conducted at approximately 12 investigational sites in the united states.


Eligibility criteria:
inclusion criteria: * signed informed consent * 18-80 years old * for females of childbearing potential, use of an effective method of contraception: abstinence; surgical sterilization; oral contraceptives; barrier contraception with either a condom, sponge, or diaphragm in conjunction with spermicidal gel; an intrauterine device (iud); or contraceptive hormone implant or patch * type 1 or 2 diabetes mellitus * single, full-thickness (i.e., extending into the subcutaneous tissue or beyond) ulcer of the foot below the malleolus that does not involve bone, tendons, ligaments, or muscle * chronic ulcer with a duration of ≥ 4 weeks but \< 6 months * ulcer area with sharp debridement of ≥ 1.0 cm\^2 and ≤ 4.0 cm\^2 * ankle-brachial index (abi) of ≥ 0.6 and ≤ 1.2 on the study foot * glycosylated hemoglobin a1c (hba1c) of ≤ 12% exclusion criteria: * history of neoplasia or current neoplasia (with the exception of non-melanoma skin cancer) * proliferative diabetic retinopathy or wet age-related macular degeneration * active ulcer infection or cellulitis of any ulcer * ulcers with an etiology not related to diabetes (e.g., thermal, chemical, radiation insult) * connective tissue disease * active osteomyelitis of the study foot * subjects with ulcers related to an incompletely healed amputation wound * subjects with charcot or other deformity of the study foot involving the study ulcer * immunosuppressive treatment, including radiation therapy, non-inhaled corticosteroids (inhaled corticosteroid ≤ 1000 ug daily dose is acceptable), and chemotherapy * pregnancy or lactation * multiple ulcers in the study foot * renal failure (serum creatinine of \>3.0 mg/dl) * poor nutritional status (albumin of \<3.0 g/dl) * known hypersensitivity to any ingredients of telbermin, placebo, or vehicle, including excipients in the formulation of telbermin or placebo gel (trehalose dihydrate, polysorbate 20, succinic acetic acid, succinic acetic acid disodium, and hexahydrate) * known prior inability to complete required study visits during treatment period * use of any other investigational drug or therapy on the study foot within the past month * previous use of a platelet-derived or other growth factors on the study ulcer within the past 3 months

Keywords: diabetes diabetic diabetic foot ulcer
comparison between natural and artificial cycle in recipient oocyte patients

Conditions: Infertility

Summary: the purpose of this study is to compare the natural cycle (without any medication) with the well-established artificial cycle in an egg donation program.

oocyte donation is an assisted reproduction technique well established. in patients with ovarian function, it is necessary to synchronize the cycle of the egg donor with the recipient, usually through endometrial preparation of the recipient by artificial cycle, by administering a gnrh agonist on day 21 of cycle and then administered increasing doses of estrogen therapy to achieve adequate endometrial thickness. the necessity of synchronization between donors and recipient, has made possible not routinely the natural cycle for oocyte donation. the investigators have recently introduced oocyte vitrification and it allows us to plan the egg donation in a different way. now the investigators can previously cryopreserved donor oocytes and at the time that the investigators have a compatible receiver, then, plan the donation in this study it will be possible compare the results of oocyte donation cycles in terms of pregnancy rate, implantation and liveborn, depending on whether the recipient has made an artificial cycle of preparation endometrial or a natural cycle.

Eligibility criteria:
inclusion criteria: * infertile females with preserved gonadal function * ages 18 - 44 years old included * first oocyte donation cycle exclusion criteria: * bmi: \> 28 * recurrent miscarriages (3 or more) * recurrent of implantation failure * severe male factor * important miomas * \> 44 years old * problems with the drugs used in the study

Keywords: oocyte donation program natural cycle hormone replacement therapy
the effect of goal-directed therapy guided by stroke volume variation and cardiac index in non-severe surgical patients

Conditions: Fluid Therapy

Summary: to evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (svv) and cardiac index (ci) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor. fifty patients (asa ⅰ-ⅱ, 26-55 years old, cardiac functional gradingⅰ) scheduled for gastrointestinal tumor surgery were divided into two groups randomly: group c with ci as the primary judgment and group s with the combination of svv and ci as the primary judgment.

to evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (svv) and cardiac index (ci) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor. methods: fifty patients (asa ⅰ-ⅱ, 18-55 years old, cardiac functional gradingⅰ) scheduled for gastrointestinal tumor surgery were divided into two groups randomly: group c with ci as the primary judgment and group s with the combination of svv and ci as the primary judgment. patients in group c received a therapy with the goal of ci was no less than 2.5l•min-1•m-2 while svv was less than 12% and ci was no less than 2.5l•min-1•m-2 in group s. indexes including map、hr、cvp、ci、svv were recorded at the moment after anaesthetized (t1), when skin was incised (t2), when the intestina was anastomosed (t3) and after the abdomen was closed (t4). sao2、scvo2 and plasma lactic were determined at t1 and t4 and do2,vo2 and ero2 during the surgery were calculated .the volume of fluid, vasoactive drugs use, the incidence of adverse cardiovascular events, the convalescence of intestinal peristalsis, hospital stay and postoperative complications were recorded.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status of grade i-ii * cardiac function classification by nyha of grade i * without high risk factors according to the revised lee cardiac risk index: 1. high-risk type of surgery 2. ischemic heart disease 3. history of congestive heart failure 4. history of cerebrovascular disease 5. insulin therapy for diabetes 6. preoperative serum creatinine \> 2.0 mg/dl * undergoing gastrointestinal tumor surgery exclusion criteria: * patients under 18 years or above 55 years * patients with severe aortic regurgitation * patients with permanent cardiac arrhythmias * patients with intra-aortic balloon pump * patients with severe pulmonary disease * patients with hepatic or renal dysfunction * patients undergoing emergency surgery

Keywords: stroke volume variation cardiac index non-severe patients gastrointestinal surgery
transdermal (tds) oxybutynin (oxytrol(r)) in overactive bladder

Conditions: Overactive Bladder; Urinary Incontinence; Quality of Life

Summary: this study evaluates changes in health related quality of life outcomes in patients using oxytrol(r)


Eligibility criteria:
inclusion criteria: * adult patients with one or more symptom of overactive bladder, including urge urinary incontinence, urgency and/or frequency exclusion criteria: * patients for whom oxytrol(r) is contraindicated. * patients treated with oxytrol(r) prior to participation in this study. * patients residing in long-term care facilities or nursing homes.

Keywords: oxytrol(r) transdermal oxybutynin overactive bladder
post marketing surveillance of jardiance in chronic kidney disease

Conditions: Kidney Disease, Chronic

Summary: study objective is to investigate the safety and effectiveness of long-term daily use of jardiance® tablets in patients with chronic kidney disease under real-world use.


Eligibility criteria:
inclusion criteria: * patients with ckd who are prescribed jardiance® tablets for ckd according to the current japanese package insert and who provided written informed consent prior to enrolment in this study. * patients who have never been treated with jardiance® tablets (including treatment for type 2 diabetes mellitus (t2dm) and/or chronic heart failure (chf)) before enrolment. exclusion criteria: * none
abx-egf in combination with paclitaxel and carboplatin for the treatment of advanced non-small-cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer; Neoplasm Metastasis; Lung Cancer

Summary: rationale: overexpression of epidermal growth factor receptor (egfr) has been observed in kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor prognosis. tgfa and egf, the ligands for egfr, are also overexpressed in some of these tumor types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth. blocking this stimulus by blocking activation of egfr with abx-egf, a fully human monoclonal antibody against egfr, may prevent tumor growth and perhaps shrink tumors. purpose: this is a phase 2 clinical trial to evaluate the safety and efficacy of abx-egf in combination with paclitaxel and carboplatin in the treatment of advanced nsclc.


Eligibility criteria:
for complete inclusion and exclusion criteria, please refer to the investigator. inclusion criteria: - 18 years of age or older. - pathological diagnosis of nsclc. - bidimensionally measurable disease. - tumor tissue available for immunohistochemistry studies. - tumor over-expressing egfr as ascertained by immunohistochemistry. - disease stage iiib with pericardial or pleural effusion, or stage iv. - life expectancy of at least 12 weeks. - adequate hematology function - adequate renal function - adequate hepatic function - ecog score of less than 2. - brain metastases, if present; must be controlled and asymptomatic. exclusion criteria: - calcium \> uln (treatment for hypercalcemia allowed). - use of any investigational therapy within 30 days of abx-egf infusion. - any cancer therapy for nsclc other than radiation therapy, surgery, or steroids. - radiation therapy within 2 weeks before abx-egf infusion. - lvef less than 45% as measured by muga. - symptomatic ventricular arrhythmia or symptomatic conduction abnormality. - myocardial infarction within 1 year before first dose of study drug. - history of cancer that has required treatment or been active within past 5 years, other than nsclc, basal cell carcinoma, or cervical carcinoma in situ. - women (e.g., of childbearing potential, who are post-menopausal for less than six months, not surgically sterilized or not abstinent) who are not willing to use an oral or implanted contraceptive, double barrier birth control, or an iud during the course of the study and for 6 months following treatment. - men not willing to use contraception upon enrollment into this study and for 1 month following treatment. - women who are breast-feeding or have a positive pregnancy test within 72 hours of first study drug administration. - known to be hiv positive. - any patient who's best medical interests would not be met by entry in the study in the opinion of the investigators.

Keywords: advanced non-small-cell lung cancer nsclc carcinoma advanced non-small-cell lung cancer (nsclc)
safety and efficacy study of hetrombopag olamine in chronic idiopathic thrombocytopenic purpura (itp) patients

Conditions: Chronic Idiopathic Thrombocytopenic Purpura

Summary: this study evaluates the safety and efficacy of 6 weeks dosing hetrombopag olamine in chronic idiopathic thrombocytopenic purpura patients. all of the subjects in this study receive hetrombopag.


Eligibility criteria:
inclusion criteria: * inclusion criteria: 1. confirmed diagnosis of chronic itp,a peripheral blood smear or bone marrow examination should support the diagnosis of itp with no evidence of other causes of thrombocytopenia. 2. patients had a platelet count of less than 30,000/µl both in the screening period and baseline. 3. subjects who are refractory or have relapsed after at least one prior itp therapy. 4. previous therapy for itp including rescue must have been completed at least 2 weeks prior to randomization. 5. subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month. 6. a complete blood count (cbc), within the reference range, with the following exceptions. * platelets \<30×109/l is required for inclusion . * hemoglobin: females and males 10.0 g/dl are eligible for inclusion. * absolute neutrophil count (anc) ≥1500/µl (1.5×109/l) is required for inclusion. 7.pt result no exceed normal by more than ±3s,aptt result no exceed normal by more than ±10s. 8.female subjects have a negative result with hcg testing in the screening period and baseline. * exclusion criteria: 1. patients with any prior history of arterial or venous thrombosis，or diagnosis as thrombophilia. 2. subjects diagnosed with tumor. 3. have pre-existing cardiac disease within the last 3 months.no arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a corrected qt interval (qtc) \>450msec or qtc \>480 for patients with a bundle branch block. 4. female subjects who are nursing or pregnant at screening or pre-dose on baseline. 5. treatment with thrombopoietin or an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication. 6. treatment with rituximab or splenectomy within the lat 6 months. 7. subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days or five half-lives (whichever is longer). 8. subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (nsaids) for \>3 consecutive days within 2 weeks of the study start and until the end of the study. 9. any laboratory or clinical evidence for hiv infection.any clinical history for hepatitis c infection; chronic hepatitis b infection; or any evidence for active hepatitis at the time of subject screening.
using a patient-centered mhealth intervention to improve adherence to oral anticancer medications

Conditions: Sarcoma; Lung; Solid Tumor Gastrointestinal

Summary: this study is being done to determine if sending reminder text messages helps patients take their oral anticancer medication (oams) when they are supposed to.


Eligibility criteria:
inclusion criteria: * patient in the sarcoma, solid tumor gastrointestinal (st gi), and thoracic medicine service at msk. * starting a new treatment regimen that includes a single oral anticancer medication * patients must have a mobile phone that can send and receive sms/mms messages and is internet-enabled. * age 18 or older. * ability to speak and read english because we do not have the resources to translate the text messages into other languages. exclusion criteria: * patient expresses inability or unfamiliarity with using sms/mms messaging on their phone and is unwilling to be trained in the use of this technology.

Keywords: texting adherence to oral anticancer medications 16-810