Kornimate/medical-research-clean huggingface dataset:
pinguin (postpartum intervention in women with gestational diabetes using insulin)

Conditions: Insulin-dependent Gestational Diabetes

Summary: the aim of the study is to prove the efficacy of the oral intake of vildagliptin in a daily dose of 100 mg in scope of the development of type 2 diabetes in women with insulin dependent gestational diabetes in their last pregnancy not longer than 9 months after birth. in this randomized, placebo-controlled, double-blinded clinical phase ii study, 140 participants aged 18 years or older and an insulin dependent gestational diabetes in their last pregnancy should be included and treated with vildagliptin or placebo over 24 months, followed by a 12 months observation period. exclusion criteria are pregnancy and lactation as well as a clinical overt diabetes or islet autoimmunity. the null hypothesis is that there is no significant difference of diabetes incidence (according to ada criteria 1997) in both groups. primary endpoint is the clinical manifestation of diabetes, secondary endpoints include the improvement of beta cell function (evaluable by c-peptide measurement) and of insulin sensitivity by the treatment with vildagliptin.


Eligibility criteria:
inclusion criteria: * women with insulin-dependent gestational diabetes during the last pregnancy * \< 9 months after delivery * age 18 years or older * contraception during intervention period (at least 24 months) exclusion criteria: * pregnancy or lactation * gada or ia-2a positivity * clinical overt diabetes
a study of arry-334543 in patients with advanced cancer

Conditions: Advanced Cancer

Summary: this is a phase 1 study during which patients with advanced solid tumors will receive investigational study drug arry-334543. this study has 2 parts. in the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will not cause unacceptable side effects. approximately 70 patients from the us and canada will be enrolled in part 1 (completed). in the second part of the study, patients will receive the best dose(s) and schedule(s) of study drug determined from the first part of the study and will be followed to see what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. approximately 40 patients from the us and canada will be enrolled in part 2 (completed).


Eligibility criteria:
key inclusion criteria (part 2): * histologically or cytologically confirmed diagnosis of erbb2+ breast cancer, pancreatic, squamous cell head and neck, hepatocellular, hepatobiliary, glioblastoma, ovarian, prostate, upper gi, colorectal, non small cell lung, or bladder cancer or other relevant cancers if approved in advance by the sponsor. * measurable disease (at least 1 target lesion) according to modified recist. * failed at least one previous therapeutic regimen and either no longer a candidate for standard therapy, has no standard therapy available, or chooses not to pursue standard therapy. * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1. * must consent to allow the sponsor access to an archival histological specimen or to have a pre-dose tumor biopsy. * additional criteria exist. key exclusion criteria (part 2): * uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days). * use of an investigational medication or device within 30 days prior to first dose of study drug. * major surgery within 30 days prior to first dose of study drug. * radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites). * pregnancy or lactation. * known positive serology for the human immunodeficiency virus (hiv), hepatitis b and/or hepatitis c. of note, if a patient has hepatocellular carcinoma, then they may be enrolled even if they are positive for hepatitis b and/or hepatitis c. * additional criteria exist.

Keywords: erbb2+ breast cancer her2+ breast cancer
diammine silver fluoride in arresting enamel caries lesions on babies' occlusal surfaces

Conditions: Dental Caries

Summary: this study aims to verify the actual possibility of using silver diammine fluoride (sdf) in arresting enamel caries lesions on occlusal surfaces of primary molars in babies. besides, the cost-efficacy and also parental acceptability of using sdf will be evaluated. for this, 100 babies 1-3 years will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of barueri, sao paulo, brazil. the caries diagnosis will be conducted using the international caries detection and assessment system (icdas). babies with initial lesions will be randomized concerning the treatment in group a (sdf) and group b (fluoride varnish). participants will be examined in the baseline and followed by 6, 12, 18 and 24 months. as primary outcome, caries progression into dentine will be considered. acceptability reported by parents after treatments, the time and estimated money spent for treating will also be collected. social and biological data that could be related to efficacy of techniques will be also collected. multilevel analyses will be performed to check which technique will be most effective and possible factors associated to its efficacy. discomfort, acceptability and costs will be compared between/among the approaches used to arrest enamel caries lesions.


Eligibility criteria:
inclusion criteria: * babies 1 to 3 years; * babies with initial dental caries lesion. exclusion criteria: * parents who do not consent.

Keywords: dental caries deciduous tooth
safety and efficacy study of tll018 in the treatment of ulcerative colitis

Conditions: Ulcerative Colitis

Summary: a study to investigate the safety and efficacy of tll018 compared with placebo in subjects with moderate to severe ulcerative colitis.

this is a phase 2, multicenter, randomized, double-blind, parallel dose groups, placebo-controlled dose ranging study to evaluate the safety and efficacy of 3 doses of tll018 as an induction therapy in subjects with moderate to severe uc. eligible subjects will be randomized to receive one of the following treatments: tll018 low dose, tll018 middle dose, tll018 high dose, or placebo. all subjects may remain on a stable dose of conventional therapy used prior to enrollment. subjects will be assessed for safety, tolerability, and response to treatment. samples for pharmacokinetics (pk) and pharmacodynamics (pd) biomarker analyses will be collected throughout the study according to the schedule of assessments (soa) for potential correlation to clinical outcomes. further participation may continue beyond the initial 8 weeks for another 5-week extension period of therapy.

Eligibility criteria:
inclusion criteria: * male and female subjects ≥ 18 and ≤ 75 years of age at baseline. * capable of giving informed consent and complying with study procedures. * normal renal function or mild renal impairment as determined by the investigator following review of clinical laboratory test results. * laboratory and medical history parameters within the protocol-defined ranges. * diagnosis of uc for 90 days or greater prior to baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia, and/or malignancy. appropriate documentation of biopsy results consistent with the diagnosis of uc, in the assessment of the investigator, must be available. * active uc with a full mayo score of 6 to 12 points and endoscopic subscore of 2 or higher confirmed by central reader. * subject must have received covid-19 vaccine \>2 months before first dose of study drug. exclusion criteria: * pregnant or nursing women. * clinically significant history of cardiovascular, hematologic, renal, hepatic, bronchopulmonary, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the investigator. * current and/or recent history of a clinically significant infection. * any history of malignancies, except for non-melanoma skin cancers (unless it is metastatic). * positive blood screen for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c antibody. * any condition or finding that in the investigator's opinion would put the subjects or study conduct at risk if the subjects were to participate in the study. * current diagnosis of crohn's disease (cd) or diagnosis of indeterminate colitis (ic). * current diagnosis of fulminant colitis and/or toxic megacolon, or active clostridium difficile colitis. * subject with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy. * subject with previous exposure to jak inhibitor (eg, tofacitinib, baricitinib, filgotinib, upadacitinib).
safety of hrx215 in patients after minor and major liver resection

Conditions: Colorectal Liver Metastases; Liver Resection

Summary: the goal of this clinical trial is to learn if hrx215 is safe and tolerable in adults who have undergone surgical removal of metastatic tumor(s) due to colorectal carcinoma in the liver. the main question it aims to answer are: 1. to learn about the safety of hrx215 2. to learn about how the body absorbs, distributes, and gets rid of hrx215 . researchers will compare hrx215 to a placebo (a look-alike substance that contains no drug) to see what medical problems participants have when taking hrx215. participants will: take hrx215 or a placebo twice a day for 28 days daily visits for 7 days for checkups and tests which may either be in the hospital or outpatient after 3 days. clinic visits every two weeks for the next two visits. the visit at two weeks may be a home visit or clinic visit. additional clinic visits 3 months and 6 months after the start of treatment

the study is designed to evaluate primarily the safety of hrx215, first after minor liver resection and, when safety is established, in those patients after major liver resection. participants will start treatment within 1-3 days after liver resection and will receive 28 day treatment with hrx215 twice daily or placebo with follow up visits 3 and 6 months after completion of treatment. the pharmacokinetics will be compared with the results of the phase i studies, whereas efficacy will be evaluated only descriptively. secondary objectives will include evaluation of differences in liver volume recovery postoperatively and clinical outcomes including days in the icu and 90 day mortality in participants who receive treatment with hrx215 vs. placebo.

Eligibility criteria:
inclusion criteria: 1. stable male and female patients between 18 and 75 years within 1-3 days after extended resection of the right or left liver lobe due to metastases of a colon carcinoma, but otherwise normal liver parenchyma proven by histopathology assessment of a liver biopsy within 3 months before surgery and liver functional parameters. 2. for the pilot phase less extended resections (remnant liver volume \&gt;69%) are required) 3. percentage of remnant liver volume (rlv) 28%-50% (randomized part of the study) - exclusion criteria: 1. liver cirrhosis 2. preoperative presence of clinical ascites 3. any other liver cancer 4. bmi \&gt;35 kg/m2 5. asa score\&gt;4 6. cc score \&gt;0: all patients with pre-operatively or intra-operatively diagnosed peritoneal carcinosis or other pre-op or intra-op findings which would deem the patient to be unresectable, are excluded. 7. incomplete liver metastasis resection -
a study of abt-751 in patients with recurrent breast cancer after taxane (taxol or taxotere) therapy.

Conditions: Breast Cancer

Summary: the purpose of the study is to determine if abt-751 will decrease tumors, and determine how long the tumor shrinkage can be maintained in patients with breast cancer after having had taxol or taxotere. patients will receive abt-751 by mouth daily for 21 days. patients will be off drug for 7 days before starting the next cycle of drug.


Eligibility criteria:
inclusion criteria * stage iiib or iv breast cancer. * recurrent tumor after or while on taxane therapy (taxol or taxotere). * able to tolerate normal activities of daily living. * adequate bone marrow, kidney and liver function. exclusion criteria * pregnant or breast feeding. * no anti-tumor therapy (including hormonal therapy or herceptin) within 4 weeks of the start of abt-751 administration.
myopenia and mechanisms of chemotherapy toxicity in older adults with colorectal cancer

Conditions: Colorectal Cancer; Sarcopenia

Summary: this study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.

this is a prospective cohort study that examines the impact of myopenia on chemotherapy toxicity in overall survival (os) in older adults with newly diagnosed metastatic colorectal cancer (crc) receiving 5-fluouracil (5fu)systemic chemotherapy. the study also explores the mediating influence of genetic variation in the association between myopenia and chemotherapy toxicity.

Eligibility criteria:
inclusion criteria: * newly diagnosed metastatic crc or newly recognized metastatic recurrence of crc \>= to 3 months (12 weeks) from completion of treatment of non-metastatic crc. * planning to or recently started to undergo undergo immunotherapy and/or 5-fu based chemotherapy as a first line of treatment. 5-fu chemotherapy can be 5-fu alone or in combination with oxaliplatin and/or irinotecan +/- immunotherapy. capecitabine is also acceptable. * estimated life expectancy \>= 6 months. * patients must be able to comprehend english or spanish (for questionnaire completion). * ability to understand and the willingness to sign a written informed consent document. * patient eligibility is not dependent on bmi or weight. patients with a significant (+- \> 10%) body weight change in the previous 12 months are eligible for this study. exclusion criteria: * patients enrolled on hospice. * prior systemic chemotherapy for metastatic colorectal cancer (ok if adjuvant chemotherapy completed \>= 3 months (12 weeks) prior to this disease disease recurrence and treatment). * patients may not be receiving any other investigational agents. * no untreated brain metastases. patients with treated brain metastases are eligible. * patients on or planned to undergo radiation therapy in near future.

Keywords: colorectal cancer myopenia sarcopenia chemotherapy geriatric-oncology
clinical relevance of nicardipine induced hypoxemia in the intensive care unit

Conditions: Hypoxemic Respiratory Failure; Side Effect; Hypertensive Emergency

Summary: in the context of postoperative hypertension in the intensive care units, or after resusitation of hypertensive patients, intravenous antihypertensive drugs are often used. among those drugs, nicardipine is an effective drug, but with side effects such as inhibition of pulmonary vasoconstriction. only preclinical studies have investigated the pathophysiology of this mechanism, and no clinical study have proven its clinical relevance. the aim of this study is to establish the incidence of nicardipine induced hypoxemia and to compare it to another antihypertensive agent, urapidil.

prospective observational study in 4 intensive care units in one general hospital and one university hospital. once nicardipine or urapidil infusion is started, data collection of respiratory related information such as type of ventilation, arterial partial pressure of oxygen, blood pressure, cardiac frequency. statistical analysis for two qualitative variables: group (nicardipine or urapidil) and occurrence or worsening of hypoxemia. secondary outcoumes analysed such as maximal drop of blood pressure, evolution of the pao2/fio2 ratio, length of hospital stay, duration of mechanical ventilation in the ventilated patients. analysis for different subgroups : patients with known atelectasis, postoperative of cardiac surgery, neuro-intensive care.

Eligibility criteria:
inclusion criteria: * major patient * with acute arterial systolic hypertension over 140mmhg * requiring intravenous administration of one of the two following drugs : urapidil or nicardipine exclusion criteria: * patient ventilated under nitrogen monoxyde * contraindication to nicardipine or urapidil * refusal of the patient or his relatives * patient treated for pulmonary hypertension
evaluation of gastrointestinal motility with smartpill

Conditions: Gastrointestinal Motility

Summary: the purpose of this study is to evaluate the clinical usefulness of a capsule (smartpill\~) measuring ph, pressure and temperature from within the entire gi tract to determine gastric emptying time, combined small and large bowel transit time and total transit time. in addition, the capsule will characterize pressure patterns and provide motility indices for the antrum and duodenum. it is believed that the condition of your digestive system can have a large impact on your overall physical health. therefore,the investigators would like to assess whether using the pill device helps to determine any functional problems in patients in the icu. the investigators are studying icu patients because any change in their condition can have a large impact on their recovery.


Eligibility criteria:
inclusion criteria: * suffered from traumatic or non-traumatic intracranial hemorrhage and were admitted to an intensive care unit (icu) at university of louisville hospital * sedated and had tracheal intubation and mechanical ventilation * older than 18 years exclusion criteria: * younger than 18 years * multiple injuries, especially abdominal trauma or inflammatory bowel disease * history of complicated abdominal surgery or unknown type of abdominal surgery * clinical evidence of ileus or suspected bowel obstruction * a pacemaker

Keywords: endoscopy, video capsule motility, gastrointestinal
pain control following sinus surgery

Conditions: Sinusitis; Opioid Use; Opioid Abuse; Narcotic Use; Otolaryngologic Disease; Postoperative Pain; Pain

Summary: given the ongoing national opioid epidemic, an increased interest has developed in optimizing opioid prescribing practices of physicians, including otolaryngologists. endoscopic sinus surgery (ess) is one of the most commonly performed surgeries by otolaryngologists with over 250,000 ess's performed annually in the u.s. multiple studies have shown that, compared to the amount patients actually consume, otolaryngologists prescribe a high quantity of opioids to patients recovering from ess). it has been shown that these excess opioid medications contribute to prolonged use or abuse by the patient, family members, or friends. the purpose of this study is to better understand the pain management requirements of patients who undergo ess for recurrent acute rhinosinusitis (rars) or chronic rhinosinusitis (crs). this prospective, randomized, multi-institutional controlled trial will aim to determine the degree to which pain following ess can be adequately controlled by non-opioid medications. it will also determine whether post-ess narcotic use can be avoided entirely, or at least significantly limited. patients will be randomized into two groups, each of which will receive a stepwise analgesic regimen consisting of acetaminophen and oxycodone or acetaminophen and ibuprofen. pain will be assessed daily using visual analog scales (vas) and the brief pain inventory (bpi). the results of this study will help to develop a standardized approach to pain management in the post-ess setting and help to elucidate the role of non-opioid pain medications. the ultimate goal would be to positively affect opioid prescribing patterns among surgeons who perform ess in order to significantly reduce the quantity of opioids prescribed to patients while continuing to adequately manage patients' pain.


Eligibility criteria:
inclusion criteria: * 18 years or older * english-speaking * scheduled to undergo endoscopic sinus surgery for sinusitis (crswnp, crssnp, or rars) * can commit to follow up for at least one postoperative visit exclusion criteria: patients undergoing a septorhinoplasty (septoplasty permissible if patient will also undergo sinus surgery) * doyle splints to be used * alcohol or opioid use disorder * history of chronic pain disorders * regular use of acetaminophen/nsaids (\>4x per week) * patients who use narcotics or neuromodulating drugs (e.g. gabapentin, nortriptyline)more than 2x per week on average. * gastrointestinal ulcers or bleeding * chronic kidney disease/known decreased renal function (estimated glomerular filtration rate \<60) * liver cirrhosis or other hepatic impairment * prior adverse reaction to opioids or nsaids * other contraindications to any drug classes in either group.
probiotic ameliorates adult allergic rhinitis and modulates gut microbiota

Conditions: Allergic Rhinitis

Summary: assessing the clinical efficacy of weizmannia coagulans bc99 in alleviating allergic rhinitis symptoms, improving gut microbiota, and reducing adverse reactions in patients.


Eligibility criteria:
inclusion criteria: 1. voluntarily and in writing, sign an informed consent form agreeing to participate in this study; 2. able to complete the study as required by the trial protocol; 3. age between 18 and 65 years old; 4. meet the diagnostic criteria for allergic rhinitis established in the "chinese guidelines for the diagnosis and treatment of allergic rhinitis (2022 revised edition)"; 5. symptoms: presence of two or more symptoms such as sneezing, watery rhinorrhea, nasal itching, and nasal congestion, with daily symptoms lasting or accumulating for more than 1 hour, which may be accompanied by eye itching, tearing, and redness of the eyes and other ocular symptoms; 6. signs: pale and edematous nasal mucosa, which may be accompanied by watery secretions. exclusion criteria: 1. use of drugs affecting the gut microbiota (including antimicrobial agents, probiotics, intestinal mucosal protective agents, traditional chinese patent medicines, etc.) for more than 1 week within 1 month prior to screening; 2. patients with coexisting pulmonary tuberculosis; 3. patients with coexisting allergic asthma; 4. patients with nasal polyps or severe nasal septum deviation; 5. patients with severe systemic diseases or malignant tumors; 6. individuals with congenital genetic diseases or congenital immunodeficiency diseases; 7. regular use of probiotics or prebiotics within 6 months prior to the screening period; 8. patients with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel diseases, etc.); 9. individuals with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.); 10. patients with sinusitis, otitis media, or respiratory tract infections; 11. individuals allergic to any components of the probiotics used in this trial; 12. pregnant or lactating women or those planning to conceive in the near future; 13. those who discontinue the test sample or take other medications midway, making it impossible to determine efficacy or with incomplete data; 14. recent use of products similar to the test function, affecting the judgment of the results; 15. participants who cannot participate in the trial due to their own reasons; 16. other participants deemed ineligible by the researcher.