Kornimate/medical-research-clean huggingface dataset:
irinotecan and carboplatin in treating patients with newly diagnosed extensive-stage small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving irinotecan together with carboplatin may kill more tumor cells. purpose: this phase ii trial is studying how well giving irinotecan together with carboplatin works in treating patients with newly diagnosed extensive-stage small cell lung cancer.

objectives: primary * determine the response rate in patients with newly diagnosed, previously untreated extensive stage small cell lung cancer treated with irinotecan and carboplatin. secondary * determine the progression-free and overall survival of patients treated with this regimen. outline: this is a multicenter study. patients receive irinotecan iv and carboplatin iv on days 1 and 8. treatment repeats every 21 days for 6 courses. projected accrual: a total of 55 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed small cell lung cancer * extensive stage disease * newly diagnosed, treatment-naive disease * at least 1 unidimensionally measurable lesion * no massive pleural or pericardial effusion by chest ct scan * manageable effusions allowed patient characteristics: age * over 18 performance status * ecog 0-2 life expectancy * more than 3 months hematopoietic * wbc ≥ 3,000/mm\^3 * absolute granulocyte count ≥ 1,500/mm\^3 * hemoglobin ≥ 9.0 g/dl hepatic * alt or ast ≤ 2 times upper limit of normal * bilirubin ≤ 1.5 mg/dl renal * creatinine normal cardiovascular * no myocardial infarction within the past year * no uncontrolled hypertension * no unstable angina * no congestive heart failure * no ventricular arrhythmia requiring medical intervention * no other serious cardiovascular disease pulmonary * arterial oxygen pressure (pa o_2) ≥ 70 mm hg * no interstitial pneumonitis or pulmonary fibrosis by chest x-ray other * not pregnant or nursing * no uncontrolled diabetes * no severe infection * no paralytic or obstructive ileus * no serious diarrhea * no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix that is in complete remission prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * no prior radiotherapy to the chest * other prior radiotherapy allowed surgery * at least 2 weeks since prior surgery and recovered

Keywords: extensive stage small cell lung cancer
indirect pulp capping with resin modified glass ionomer

Conditions: Caries, Dental; Pulpitis

Summary: in deep carious lesions, presenting risk of pulp exposition, a treatment option is the partial caries removal of carious tissue followed by provisional restoration, while this approach is called indirect pulp capping. the aim of this double-blinding controlled randomized clinical trial is to evaluate the success of indirect pulp capping using only resin-modified glass ionomer, while the additional layer of calcium hydroxide was used as control. the sample of 112 molars and/or premolars (n=56), presenting deep carious lesions, from patients with age between 15 and 30 years treated in dental clinic at department of dentistry of federal university of sergipe. the selected carious lesions must be reached 2/3 of dentin, observed in bite-wing radiography, without pulp involving and/or other factor that to compromise the evaluation. after detailed anamneses, the selected teeth will be radiographed e all carious tissue from surrounding walls will be removed. at the floor of cavity, the carious tissue will be partially removed using hand dentin excavators, remaining the caries-affected dentin and avoiding the pulp exposition. the removed carious tissue from the floor of cavity will be evaluated for presence of lactobacilos e estreptococos mutans, while the remaining dentin will be evaluated for consistency, colour and humidity. randomly, the cavity will be provisionally restored with: control - dress and cement of calcium hydroxide followed resin-modified glass ionomer; or experimental - only resin-modified glass ionomer. the distance between the base of restoration and the pulp cavity cap will be measured by bitw-wing radiography. the patients will be re-evaluated after 15 days, while the teeth with compromised pulp vitality will be excluded from the study. the remaining patients will be evaluated after 6 months. the distance between the base of restoration and the pulp cavity cap will be measured again, followed by provisional restoration removal. the remaining caries-affected dentin from floor of cavity will be fully removed and a bacteriological evaluation performed. the consistency, colour and humidity of this tissue will be evaluated too. finally, the permanent restorations will performed.


Eligibility criteria:
inclusion criteria: * molars and pre-molars presenting carious lesions involving 2/3 inner of dentin tissue. exclusion criteria: * teeth presenting signs of irreversible pulpits or necrose, cervical lesion and/or root exposition, or with carious lesion reaching the pulp.
a switch to doravirine/islatravir (dor/isl) in participants with human immunodeficiency virus type 1 (hiv-1) who are virologically suppressed on antiretroviral therapy (art) (mk-8591a-051)

Conditions: HIV-1 Infection

Summary: the primary objectives of this study are to evaluate the safety and tolerability of a switch to doravirine/islatravir (dor/isl) compared with continued baseline antiretroviral therapy (art), through week 48; and to evaluate the antiretroviral activity of a switch to dor/isl compared with continued baseline art at week 48. the primary hypothesis is that dor/isl is non-inferior to continued baseline art, as assessed by the percentage of participants with hiv-1 ribonucleic acid (rna) ≥50 copies/ml at week 48, with a margin of 4 percentage points used to define non-inferiority.


Eligibility criteria:
inclusion criteria: * is hiv-1 positive with plasma hiv-1 rna \<50 copies/ml at screening * has been receiving continuous, stable oral 2-drug or 3-drug combination (± pk booster) art with documented viral suppression (hiv-1 rna \<50 copies/ml) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen * female is not a participant of childbearing potential (pocbp); or if a pocbp uses an acceptable contraceptive method or abstains from penile-vaginal intercourse as their preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator exclusion criteria: * has hiv-2 infection * has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator * has a diagnosis of an active acquired immunodeficiency syndrome (aids)-defining opportunistic infection within 30 days prior to screening * has active hepatitis b virus (hbv) infection * has chronic hepatitis c virus (hcv) infection consistent with cirrhosis * has a ≤5 years prior history of malignancy * is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome p450 3a (cyp3a ) inducers * has taken long-acting hiv therapy at any time * is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to day 1 through the study treatment period * has a documented or known virologic resistance to dor
education nutritional video for gestational diabetics

Conditions: Gestational Diabetes

Summary: the purpose of this research study is to find out if watching an educational video about nutrition helps participants learn about how different foods affect their blood sugar and how gestational diabetes affects pregnancy.

* patients diagnosed with gestational diabetes receive standard nutritional counseling at their first high risk clinic visit. all patients agreeing to participate in the study will at this visit fill out a knowledge questionnaire prior to receiving counseling. * patients will be randomized into standard counseling or standard counseling plus educational video using block randomization that has been integrated into the redcap survey. once the initial survey is completed the redcap program will inform the patient whether they are randomized to video or no video. * patients randomized to video will watch the video will watch the video on a clinic designated computer. patients randomized to no video will not watch a video. * at the next high risk clinic visit one to two weeks later all patients will fill out the same fill out the same questionnaire in addition to the the problem areas in diabetes (paid) questionaire. * english-speaking patients will view the english version of the video, and spanish-speaking patients will view the spanish version of the video in either english or the dubbed spanish version. * a spanish version of the patient hand-out will be provided in an amendment, prior to their use with spanish- speaking patients.

Eligibility criteria:
inclusion criteria: * any diagnosis of diabetes in pregnancy * received at least one session of nutritional counseling from the registered dieticians exclusion criteria: * age \< 18 * patients without diagnosis of diabetes
the effect of sleeve gastrectomy on food preference

Conditions: Severe Obesity

Summary: this is a questionnaire asking about the sleeve gastrectomy surgery and how has it altered food preferences before and after surgery.

participants that will undergo the sleeve gastrectomy surgery by dr. drake bellanger's, will be asked to participant in a questionnaire survey. once given the consent to participate, a food preference questionnaire (fpq) will be administered at a pre-operative visit and then a six-week follow up visit at dr. drake bellanger's office.

Eligibility criteria:
inclusion criteria: * male or female, 18 years or over, who will undergo a sleeve gastrectomy for obesity by dr. drake bellanger. exclusion criteria: * women who are pregnant or nursing.

Keywords: gastrectomy
a phase 3 long-term extension study to assess the long-term safety and efficacy of pegtibatinase treatment in participants ≥5 to ≤65 years of age with classical homocystinuria (hcu) (ensemble)

Conditions: Homocystinuria

Summary: the goal of this long-term extension (lte) study is to evaluate the safety and efficacy of pegtibatinase in patients with classical homocystinuria (hcu). patients who are active in the phase 1/2 compose study or those who complete the 24 weeks of treatment in the phase 3 harmony are eligible to participate. participants will be in this clinical study for up to about 13 months including: * a treatment period of up to 104 weeks * a 4-week safety follow-up period

overall design: this is a global, multicenter, single-arm, open-label study. participants who meet all eligibility criteria may transition from other pegtibatinase studies and enroll into this lte study for long-term safety, efficacy, and clinical assessments of pegtibatinase treatment. all participants will follow a protocol of self-administration of pegtibatinase unless exempted. during the ensemble study, an optional protein tolerance modification (ptm) sub-study will also be conducted for eligible participants.

Eligibility criteria:
inclusion criteria: * participants active in the compose study or who completed the 24-week blinded period on the full target dose of study intervention in the phase 3 harmony study exclusion criteria: * participant permanently discontinued from study intervention treatment in a previous pegtibatinase study due to serious ae (sae) or intolerance

Keywords: classical homocystinuria hcu cystathionine beta synthase deficiency
effect of dexamethasone on postoperative inflammatory factors

Conditions: Inflammation

Summary: this topic foe randomized prospective study.detection of elderly patients with lunmbar spinal postoperative inflammatory substances in the blood and drainage of liquid level ,clear whether low-dose dexamethasone can inhibit the inflammation, the observation of elderly patients with lumbar spinal postoperative drainage star, to explor whether low-dose dexamthasone can reduce postoperative incision drainage, thus impove the postoprative drainage tube pull rate within three days, which in turn reduce because of the place a retrograde infection caused by drainage tube.

a total of 100 patients undergoing posterior lumbar disc fusion were randomly divided into control group (group c,n=50) and dexamethasone group (group d,n=50). group d was given 0.15mg/kg dexamethasone (2ml) intravenously after anesthesia induction. group c was also intravenously injected with 2ml normal saline after anesthesia induction.on this basis, monitor the main results and secondary results

Eligibility criteria:
inclusion criteria: * adult patients ≥65years of age * american society of anesthesiologists (asa) physical status 2-4 * elective or expedited non-cardiac surgery of at least 2 hours dura- tion under general anaesthesia * requiring a hospital stay of at least one postoperative night * a surgical skin incision \>5 cm in length or multiple incisions with a total incision length of \>5 cm exclusion criteria:· * poorly controlled diabetes (hba1c\>9.0%) * endovascular procedure with a small (\<5 cm length) skin incision ophthalmic surgery * planned dexamethasone (or other corticosteroid) therapy (eg, history of intractable ponv, maxillofacial surgery, intracranial neurosurgery) * recent (\<2 weeks since end of treatment) infective episode requir- ing treatment with antibiotics * chronic antibiotic therapy (eg, for bronchiectasis, cystic fibrosis etc)

Keywords: intravenous dexamethasone inflammation qor15 drainage
transpulmonary thermodilution and transesophageal echocardiography in early septic shock

Conditions: Septic Shock

Summary: the purpose of this study is to assess the concordance of therapeutic changes proposed after an early hemodynamic evaluation (hemodynamic profile) in septic shock patients using jointly the transpulmonary thermodilution technique and transesophageal echocardiography (tee).

each patient will be assessed by both the transpulmonary thermodilution technique and tee (h0). the two assessments will be performed in random order (central randomization stratified by participating center), but within 30 minutes (no change of ongoing treatment during the assessment period). two investigators not involved in patient care and blinded to the results of the alternative technique will performed independently the hemodynamic assessment using one of the two modalities for hemodynamic assessment tested in the study. they will interpret the results at bedside and propose a therapeutic change to the attending physician, according to the hemodynamic profile. the latter will finally: precisely identify the clinical problem to be solved (e.g., therapeutic target of the surviving sepsis campaign not reached, tissue hypoperfusion), choose a therapy adapted while taking into account the clinical scenario and the results of both the transpulmonary thermodilution and tee, evaluate the efficacy of this treatment (problem solved or not) and its tolerance (potential side-effect attributable to the treatment). in addition, the presence or resolution of signs of tissue hypoperfusion will systematically be assessed at h6, h12 and h24. primary and secondary outcomes will be assessed by an independent committee of experts.

Eligibility criteria:
inclusion criteria: * ventilated patient in sinus rhythm with septic shock requiring a hemodynamic assessment exclusion criteria: * \< 18 yr-old * pregnancy * contra-indication for tee, non sinus rhythm, aplasia, prior participation to the study, hemodynamic assessment using any other technique than those tested in the study.
aging, aged garlic, vascular function and muscle oxygenation

Conditions: Aging; Hypertension; Dyslipidemias; Abdominal Obesity

Summary: the number of elderly individuals affected by cardiovascular diseases has been increasing in our country. garlic (allium sativum) has been associated with decrease of reactive species of oxygen, hypertension, high cholesterol, platelet aggregation, blood coagulation and especially cardiovascular diseases. the present study evaluated the effects of a garlic supplementation on vascular function and blood pressure in the elderly at cardiometabolic risk. twenty-eight elderly individuals were submitted to an ingestion of four capsules of an aged garlic extract (kyolic® aged garlic extract™). muscle oxygenation and function were measured 180 min after interventions. urinary thiosulfate, blood nitrate, nitrite, systolic blood pressure (sbp), diastolic blood pressure (dbp) and heart rate (hr) were measured at baseline and 180 min after interventions.


Eligibility criteria:
inclusion criteria: * cardiometabolic risks * cardiovascular diseases exclusion criteria: * cancer; * hiv positive; * alcohol or drug abuse within the past 6 months previous the visit 1; * garlic allergy;

Keywords: aging aged garlic functional food vascular function muscle oxygenation exercise performance
smart use of medication for the treatment of adolescent severe obesity

Conditions: Adolescent Obesity

Summary: this study will examine the timing and sequence of using adjunct obesity pharmacotherapy for adolescents with severe obesity who do not respond to lifestyle modification therapy alone.

this project is studying the best time to add weight loss medication to diet and exercise for helping adolescents who carry extra weight. all participants start with a lifestyle modification program and some participants may also receive study medication.participants must be 12-17 years of age and carry extra weight. the program will last for 48 weeks.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed assent form; * provision of signed and dated informed parental consent form from at least 1 legal parent/guardian; * stated willingness to comply with all study procedures and availability for the duration of the study; * bmi \>/= 1.2 times the 95th percentile or bmi \>/= 35 kg/m2, whichever is lower; * tanner stage \>/= 2; * male or female, aged 12-17 at time of consenting; * for females of reproductive potential: when sexually active, agreement to use highly effective contraception (oral contraceptive pill, intra-uterine device (iud), or implant) during study participation; * for males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. exclusion criteria: * contraindications to phentermine or topiramate use according to package inserts, including: history of glaucoma; current or recent (\< 14 days) use of monoamine oxidase inhibitor; known hypersensitivity to sympathomimetic amines; current pregnancy, plans to become pregnant, or if sexually active refusal to use 2 forms of birth control; history of cardiac disease including coronary artery disease; clinically significant cardiac arrhythmias; heart failure or uncontrolled hypertension; * diabetes (type 1 or 2); * presence of cardiac pacemaker; * current or recent (\<6 months prior to enrollment) use of weight loss medication(s); * current use of weight-altering medication(s) (e.g., atypical antipsychotic, metformin) unless dose has been stable for past 6 months; * current use of other sympathomimetic amine such as attention-deficit hyperactivity disorder (adhd) stimulants; * seizure disorder (other than infantile febrile seizure); * previous bariatric surgery; * recent initiation of change in dose (\< 3 months prior to enrollment) of anti-hypertensive or lipid medication(s); * tobacco use * history of or current diagnosis of schizophrenia, psychosis, mania, chemical dependency; * unstable depression or anxiety that has required hospitalization in the past year; * any history of suicide attempt; * suicidal ideation or self-harm within 12 months prior to enrollment; * bicarbonate \< 18 mmol/l; * creatinine \> 1.2 mg/dl; * history of cholelithiasis; * history of nephrolithiasis; * untreated thyroid disorder; * hyperthyroidism; * breastfeeding
therapy for migraine prevention in children 6-11 years of age

Conditions: Migraine Disorders; Headache Disorders

Summary: the aim of this study is to evaluate the effect of spn-538 for the prophylaxis of migraine in pediatric patients 6 to 11 years old.

the study is to assess the efficacy and safety of spn-538 in reducing the monthly migraine headache frequency in pediatric patients with migraine. spn-538 (or matching placebo) will be administered in patients diagnosed with migraine with or without aura based on the international headache society criteria. the frequency of the migraine attack will be assessed as the primary outcome measure.

Eligibility criteria:
inclusion criteria: * otherwise, healthy male or female (6 to 11 years of age at the time of screening) with a history of migraine with or without aura for at least 6 months prior to screening, 3 to 14 headache days (migraine and non-migraine) per month during the 3 months prior to screening and during baseline period, and a pedmidas disability score of \> 10 and \< 50. exclusion criteria: * subjects with chronic migraine (\>14 headache days per month), cluster headaches, or migraine aura without headache and, with \> 14 headache days during the baseline period. * use of migraine preventive medication other than topiramate within 14 days prior to the start of the baseline period; or used onabotulinumtoxina (botox®) 3 months prior screening and non-pharmacologic complementary and alternative prophylactic approaches for migraine prevention. * failure to respond to topiramate prophylaxis therapy (2 to 3 mg/kg/day) for a minimum of 3 months, or to more than 2 clinical trials with an established prophylactic anti-migraine regimen. * current use or history of antipsychotics, antimanics, barbiturates, benzodiazepines, muscle relaxants, β-blockers, tricyclic antidepressants, aeds, calcium channel blockers, corticosteroids (i.e., systemic, inhaled or topical), daily nsaids, sedatives, serotonin selective reuptake inhibitors (ssris), non-selective reuptake inhibitors (nsris), high-dose magnesium supplements (≥600 mg/day), high-dose riboflavin (≥100 mg/day), calcitonin gene-regulated peptide (cgrp) receptor antagonists, omega-3, melatonin or cannabidiol (cbd) oil. * overuse of analgesic or migraine-specific agents for acute treatment of migraine (\>10 treatment days/month of ergot-containing medications or triptans; or \>15 treatment days/month with simple analgesics (including non steroidal anti-inflammatory drugs \[nsaids\]) * diagnosis of psychiatric disorder (e.g., psychosis, bipolar disorder, major depression, generalized anxiety disorders), or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation). * subjects with seizures or a history of seizure-like events. * known history of visual field defects, neurological disorder or structural disorder of the brain from birth; head trauma or previous cns surgery. * evidence of active suicidal ideation and/or suicidal behaviors, pregnancy, active liver disease or abnormal kidney function.