Kornimate/medical-research-clean huggingface dataset:
a study to assess bioequivalence of a new tapentadol extended-release tablet with respect to a tapentadol extended release tablet under fasted conditions in healthy subjects

Conditions: Healthy

Summary: the purpose of this study is to evaluate bioequivalence (biological equivalence of two formulations of a study medication) of a new tapentadol extended release (er) 100 mg tamper-resistant formulation (trf) tablet, to the current tapentadol er 100 mg, prolonged-release formulation 2 (pr2) tablet used in healthy participants under fasted (without food) conditions.

this is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), 2-way crossover (method used to switch participants from one treatment arm to another in a clinical study), single-dose, and single-center study. the study consists of 3 phases: the screening phase, treatment phase, and end-of-study or withdrawal assessment phase. in the treatment phase, participants will receive a single dose of new tapentadol er 100-mg trf tablet (treatment a) and current tapentadol er 100-mg pr2 (treatment b) under fasted conditions in 2 treatment sequences (ab and ba). administration of the study medication will be separated by a washout period (no treatment) of 7 to14 days. approximately 64 participants will be enrolled in this study. safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. the duration of participation in the study for an individual participant will be approximately 5.5 weeks.

Eligibility criteria:
inclusion criteria: * agrees to protocol-defined use of effective contraception * body mass index (bmi) between 20 and 28 kilograms per square meter, inclusive, and body weight not less than 50 kg (bmi is calculated as weight \[kilogram\] divided by square of height \[meter\]) * habitually smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before the first study medication administration exclusion criteria: * history of seizure disorder or epilepsy or mild or severe traumatic brain injury * men with hemoglobin concentrations below 12.5 g/dl or women with hemoglobin concentrations below 11.5 g/dl * positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, or barbiturates at screening or day -1 of each treatment period * positive test for human immunodeficiency virus antibodies, hepatitis b surface antigen, or hepatitis c antibodies * history of a gastrointestinal disease affecting absorption, gastric surgery or history of or current significant medical illness

Keywords: healthy tapentadol tapentadol extended-release tamper-resistant formulation tapentadol extended-release prolonged-release formulation bioequivalence fasted conditions
pseudotumor cerebri headache ten years outcome

Conditions: Pseudotumor Cerebri

Summary: telephone interview on patient who suffered from ptc ten years ago regarding their headache status

the study will followup using existing medical data from patients previously diagnosed with pseudotumor cerebri (ptc) using a telephone contact with patients diagnosed more than 10 years ago. after obtaining verbal consent, conducted interviews to collect information on their headaches and quality of life. data related to ptc was be obtained from medical records. demographic information was be collected using a questionnaire, the hit-6 questionnaire will assess headache severity, and a quality of life questionnaire was be used.

Eligibility criteria:
inclusion criteria: patients who were diagnosed with ptc as children - exclusion criteria: patients has other headache types other than ptc -

Keywords: headache outcome
lethal congenital malformations: palliative therapy from an islamic point of view

Conditions: Congenital Malformations

Summary: to prove that palliative therapy can be practised for congenital lethal malformations within the islamic code of ethics. after defining lethal malformation no respiratory support is offered and newborns are provided with compassionate care.

this is a prospective observational study where all abnormal antenatal ultrasounds are discussed in a weekly prenatal meeting and plans are drawn for management of these abnormal fetal findings. lethal malformations are defined as conditions which will end in death regardless of supportive care. cases are discussed extensively and parents are involved in management decisions. when a decision of non- intervention is reached for a lethal malformation consent of the family is obtained and a plan of non monitoring for the mother is documented together with no resuscitation for the newborn. families who do not consent to such plan are offered full support for the pregnant mother and her newborn. a record of all cases is kept available together with the management plan so that the appropriate action is taken when the the pregnant lady presents for admission. all babies with lethal malformations are recorded whether stillborn or live born and their diagnosis is confirmed. survival time is recorded for each case.

Eligibility criteria:
inclusion criteria:all babies with abnormal fetal ultrasounds - exclusion criteria: normal babies who die in the neonatal period because of other causes not associated with lethal malformations -

Keywords: congenital lethal malformations
preterm birth and biomarkers for cardiovascular disease

Conditions: Preterm Birth; Cardiovascular Diseases

Summary: preterm birth is associated with maternal increased risk of cardiovascular disease later in life. in an observational case- control study, investigators want to evaluate whether women with preterm birth have increased levels of biomarkers for cardiovascular disease, to reveal potential pathophysiological mechanisms in common.

women with spontaneous preterm birth in first pregnancy and a group of matched controls with spontaneous birth in normal time where invited to participate in the study. participants were identified from the biobank of pregnant women in uppsala. levels of cardiovascular biomarkers will be analyzed in plasma samples from the pregnancy and at a follow-up visit where investigators also collect information about other cardiovascular risk factors and lipid status.

Eligibility criteria:
inclusion criteria: * women identified as cases or controls exclusion criteria: * system inflammatory disease * smoking at the time of the pregnancy
dose-finding study of intranasal insulin in healthy participants insulin in healthy participants

Conditions: Out-Of-Hospital Cardiac Arrest; Healthy

Summary: this study is to determine the safety and tolerability of regular insulin (humulin r) when given intranasally (as drops in nostrils). healthy participants will be enrolled to determine the maximum tolerated dose of intranasal insulin.

this is being studied because intranasal insulin may be a way to prevent the brain injury that occurs after a cardiac arrest. cardiac arrest is a life-threatening condition in which the heart suddenly stops beating and there is no blood flow to the body. if cardiac arrest is not treated immediately, it causes sudden death. even when immediate treatment gets the heart beating again, many victims remain comatose and die later from brain injury. nasal insulin, given immediately after a cardiac arrest may prevent or reduce brain injury. nasal insulin reduces brain injury in animal experiments, and has been used to try to improve brain degeneration in patients with alzheimer's disease. however, cardiac arrest patients may need higher doses than patients with alzheimer's disease, therefore, this study is to examine those higher doses.

Eligibility criteria:
inclusion criteria: * good health based on medical history, physical exam, and routine laboratory testing. * female participants must have negative urine pregnancy test or be surgically sterilized or postmenopausal. criteria for menopause are surgical menopause (hysterectomy, oophorectomy) or age \> 45 years with the absence of menses for greater than 12 months. tubal ligation with menses within the past 12 months is not considered to be surgical sterilization. * body mass index (bmi) between 18 kilogram / square meter (kg/m2) and 35 kg/m2. * willing and able to stay at the clinical research facility as required by the protocol * willing and able to comply with the investigational nature of the study and able to communicate well with investigators * ability to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines exclusion criteria: * known allergy to insulin. * preexisting diabetes. * current or previous use of diabetes medication or insulin. * any nasal disease or congestion that may interfere with intranasal drug absorption. * baseline hypoglycemia (blood glucose ≤ 65 mg/dl) or hyperglycemia (blood glucose \> 200 mg/dl) as evident from the screening labs. * active serious disease, such as liver disease, kidney disease, uncontrolled hypertension, clinically significant hypokalemia, and significant or unstable medical illness * blood donation in excess of 500 milliliter (ml) within 60 days prior to the first dose of study medication. * treated with an investigational drug within 30 days. * individuals with inadequate venous access.

Keywords: healthy participants intranasal insulin
the effect of ribose on b-type natriuretic peptide (bnp) levels in congestive heart failure patients

Conditions: Congestive Heart Failure

Summary: the purpose of this research study is to test the effectiveness of corvalen, a medical food, to increase cellular energy sufficiently to change or modify bnp levels in congestive heart failure patients.

b-type natriuretic peptide (bnp), is a blood test commonly used to track the progress of congestive heart failure. corvalen, a medical food, contains d-ribose (ribose), a natural substance that has been shown to improve the amount of energy compounds at the cellular level. congestive heart failure has been associated with a reduced level of high-energy compounds. one researcher has called them an "energy starvation" in congestive heart failure. this study will try to assess if increasing the amount of these energy compounds is sufficient to improve bnp levels. approximately 120 symptomatic congestive heart failure patients will participate in this 3 month study.

Eligibility criteria:
inclusion criteria: * symptomatic adults, m/f, between 18 and 80 years of age * bnp levels equal to or greater than 300 pg/ml. * primary or secondary diagnosis of congestive heart failure at the time of admission (any nyha class) * diagnosis of congestive heart failure for at least 3 months * able to perform 6 minute hall walk * no therapeutic pharmaceutical class changes for at least 1 month * provide informed consent * a 30-day washout period must be achieved for any patient involved in a previous clinical study. exclusion * insulin dependent diabetes (type i) * history of obstructive valvular disease * history of pulmonary hypertension within the last 3 months * history of hypertrophic or alcoholic cardiomyopathy * history of restrictive cardiomyopathy * history of reversible cardiomyopathy * history of non-compliance * pregnancy * current enrollment in any other clinical study

Keywords: elevated bnp levels in chf patients
safety and efficacy study of exc 001 to improve the appearance of scars in subjects undergoing elective abdominoplasty

Conditions: Scar Prevention

Summary: this study will compare how well exc 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. the study will also evaluate the safety of exc 001 in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * subjects must have sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty * subject has chosen to have an elective abdominoplasty * medically healthy with normal screening results * subjects must not be pregnant or lactating exclusion criteria: * females who are currently pregnant or pregnant during the 12 months prior to inclusion in the study, or lactating * participation in another clinical trial within 30 days prior to the start of the study * any other condition or prior therapy, which, in the opinion of the pi, would make the subject unsuitable for this study

Keywords: scarring cicatrix fibrosis pathologic process
biological therapy in treating patients with glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. purpose: phase ii trial to study the effectiveness of biological therapy in treating patients with glioblastoma multiforme.

objectives: i. determine the time to progression in patients with glioblastoma multiforme or anaplastic astrocytoma (primary presentation) treated with surgical resection, radiotherapy, and t cell immunotherapy as initial therapy. ii. determine the toxic effects of this therapy in these patients. outline: patients are vaccinated with irradiated, autologous tumor cells plus sargramostim (gm-csf) intradermally near draining lymph nodes in the groin or axillary regions. this is then followed by 3 consecutive days of intradermal injections of gm-csf only, directly into the vaccine sites. enlarged lymph nodes are then removed 7-10 days later and activated with staphylococcal enterotoxin a (sea) and interleukin-2 (il-2). t cells are expanded ex vivo over approximately 10 days. 1-2 days prior to infusion, oral cyclophosphamide is administered as a one time dose. the lymphocyte infusion is then administered intravenously. based on availability, patients may receive vaccine boosts with additional injections of irradiated autologous tumor cells thawed from the original, cryopreserved collection. patients are followed at 1 month and then every 2 months thereafter. projected accrual: a maximum of 40 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: histologically proven glioblastoma multiforme or anaplastic astrocytoma prior surgical resection and radiotherapy completed approximately 1 month prior to study patient characteristics: age: over 18 performance status: ecog 0-1 or karnofsky 70-100% life expectancy: not specified hematopoietic: wbc greater than 2000/mm3 platelet count greater than 100,000/mm3 hepatic: no active infection with hepatitis b renal: not specified other: not pregnant or nursing fertile patients must use effective contraception during and for 1 month after study no active collagen vascular or autoimmune disease no prior severe reaction to any blood product no other prior malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, carcinoma in situ or the cervix, or stage i or ii cancer in complete remission not immunologically compromised due to chronic conditions not allergic by standard skin testing hiv negative prior concurrent therapy: biologic therapy: no concurrent biologic therapy with immunomodulatory effects (e.g., interleukin-2, interferon alfa) chemotherapy: no prior or concurrent local or systemic chemotherapy endocrine therapy: at least 1 week since prior corticosteroid therapy no concurrent corticosteroid therapy radiotherapy: see disease characteristics surgery: see disease characteristics other: no concurrent antiproliferatives or immunosuppressants

Keywords: adult glioblastoma adult anaplastic astrocytoma adult giant cell glioblastoma adult gliosarcoma
cystic fibrosis (cf) leukocyte genes as biomarkers for novel therapies

Conditions: Cystic Fibrosis; Pulmonary Exacerbation

Summary: presently, effectiveness of treatments for cf lung disease is judged by improvement in lung function (fev1). however, in cf patients, fev1 can range from severely decreased to normal, and improvements may occur slowly. thus, clinical trials require many patients over prolonged periods to evaluate medications. as the pace of drug development accelerates, it is no longer possible to test all of the promising candidate therapies using conventional study designs. a sensitive technique for assessing lung inflammation has been developed which uses the expression of genes located in circulating blood cells. mononuclear cells pass repeatedly through the blood vessels of the lung, and are exposed to many of the inflammatory products that are present in the airways. over the past 4 years the investigators have identified a small group of candidate genes that are unregulated or downregulated in response to antibiotic treatment. the investigators now propose to prospectively test this method of quantifying lung inflammation in a large group of cf patients undergoing treatment of pulmonary exacerbations. blood will be sampled before and after antibiotic treatment for a pulmonary exacerbation, and the relative change in gene expression will be compared to improvement in fev1 and other clinical responses, to determine the utility of this method for use in studies. if successful, this technique could allow for a rapid and noninvasive method to gauge immediate effects by new treatments, and assist caregivers in determining optimal treatment strategies for the individual.


Eligibility criteria:
inclusion criteria: 1. documented diagnosis of cf. 2. age 18 years old or greater. 3. presentation at the start of treatment for a pulmonary exacerbation of cf. 4. ability to perform reproducible pulmonary function tests. 5. willingness to comply with study procedure and willingness to provide written consent. exclusion criteria: 1. participation in an investigational drug study within one month of enrollment. 2. presence of a condition or abnormality that, in the opinion of the principal investigator (pi), would compromise the safety of the patient or the quality of the data.

Keywords: cystic fibrosis pulmonary exacerbation gene expression biomarker inflammation cf pulmonary exacerbation
effect of left posterior pericardiotomy for the prevention of poaf

Conditions: Coronary Artery Disease; Atrial Fibrillation New Onset; Pericardial Effusion

Summary: this study is planned to evaluate the effect of left posterior pericardiotomy for the prevention of postoperative atrial fibrillation after coronary artery bypass grafting. eligible patients will be randomized to be created or not to be created the left posterior pericardiotomy at the end of the operation, and the incidence of postoperative atrial fibrillation will be compared.

postoperative atrial fibrillation (poaf) is a common complication after cardiac surgery, particularly after coronary artery bypass grafting (cabg), and is associated with prolonged in-hospital stay and increased adverse outcomes, including death and stroke. there is evidence that pericardial effusion can trigger the occurence of poaf. therefore, this study is aimed to evaluate the effect of left posterior pericardiotomy for the prevention of poaf after cabg. patients who are planned to undergo off-pump cabg will be randomized to be created or not to be created the left posterior pericardiotomy at the end of the operation, and the incidence of postoperative atrial fibrillation will be compared as the primary outcome. secondary outcomes will include early clinical outcomes and hospital stay.

Eligibility criteria:
inclusion criteria: * patients who are planned to undergo coronary artery bypass grafting * patients aged ≥19 years exclusion criteria: * patients who are planned to undergo other concomitant cardiac procedures (e.g. valve procedures, aorta procedures) * patients who undergo coronary artery bypass grafting using cardiopulmonary bypass * patients who are documented with paroxysmal, persistent, or permanent atrial fibrillation before operation * patients who have a history of cardiac surgery * patients who have a history of pericardial disease * patients who have severe adhesion at left pleural cavity which precludes effective left posterior pericardiostomy * patients who refuse to participate in this study
the value of transanal endoscopic isr

Conditions: Rectal Cancer

Summary: the intersphincteric resection (isr) technique is an alternative for anal preservation in ultra-low rectal cancer. the transanal total mesorectal excision (tatme) technique might compensate for the deficiencies of isr in terms of tumor spillage and poor surgical field exposure. thus, the investigators perform isr through a transanal endoscopic approach (tae-isr), seeking to evaluate the value of this innovative technique in anal preservation in ultra-low rectal cancer.


Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * american society of anesthesiologists (asa) score i to iii * a biopsy proven histological diagnosis of rectal carcinoma * preoperative stage as (y) ct1-3n0-2m0 * lower margin of the tumor less than 5cm from the anus * tumor diameter ≤5cm exclusion criteria: * pregnant or lactating women * synchronous rectal carcinoma * history of colorectal cancer or other malignant tumors * clinical evidence of metastasis * emergency procedure
a study to evaluate the safety and efficacy of domperidone in pediatric participants with nausea and vomiting due to acute gastroenteritis

Conditions: Gastroenteritis

Summary: the purpose of this study is to demonstrate that domperidone suspension plus oral rehydration therapy (ort) is more effective than placebo plus ort at reducing the symptoms of vomiting associated with acute gastroenteritis (ag) within the first 48 hours of treatment administration in pediatric participants with ag and mild-to-moderate dehydration.

this is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), parallel-group, placebo-controlled, multicenter (when more than one hospital or medical school team work on a medical research study) study. the study consists of 3 phases: screening phase (-2 to 0 hours prior to baseline on day 1), double-blind treatment phase (up to 7 days) and follow-up phase (7 days). the duration of participation in the study for each participant is at most 15 days. efficacy and safety of domperidone will be evaluated. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * the participant presents with at least 3 episodes of non-bilious, non-bloody vomiting within the 24 hours prior to visiting the physician's office. the participant has at least 2 signs and symptoms other than vomiting consistent with acute gastroenteritis (ag) (example, fever, nausea, diarrhea, abdominal pain, bloating, or discomfort) within 3 hours prior to visiting the physician's office * the participant has mild-to-moderate dehydration * the participant had at least 1 episode of non-bloody diarrhea within the 24 hours prior to the visiting the physician's office exclusion criteria: * the participant has severe dehydration or severe malnutrition * the participant who has vomiting and clinical symptoms for longer than 72 hours prior to the baseline physician's office visit * the participant needs intravenous (iv) fluid replacement * the participant has chronic severe diarrhea, a previous history of helicobacter pylori infection or received treatment for h. pylori-induced gastritis, active peptic ulcer, celiac disease, crohn's disease, ulcerative colitis, eosinophilic esophagitis, malabsorption, short bowel syndrome, post-viral gastroparesis, cyclic vomiting syndrome, or previous gastrointestinal surgery * the participant has upper respiratory symptoms such as cough, congestion, otitis media or pharyngitis

Keywords: gastroenteritis domperidone pediatric participants