Kornimate/medical-research-clean huggingface dataset:
depression prevention in older spousally-bereaved adults

Conditions: Depression

Summary: using an indicated prevention approach, investigators propose to enroll 150 spousally-bereaved adults aged 60 years and older in the first 12 months after spousal death who are at high risk for major depression disorder because of subthreshold symptoms of depression. a confirmatory efficacy trial will be conducted in which participants will be randomly assigned to (a) self-monitor sleep, meals, and physical activity for 12 weeks using digital monitoring plus motivational health coaching (well; n=75); or (b) enhanced usual care (euc, usual care plus study assessments, n=75). objective actigraphic measures of the 24-hour pattern of day and nighttime activity - known as the rest-activity rhythm - will be measured to evaluate circadian rhythms as a mediator of treatment outcomes. participants will be assessed at baseline, months 1 \& 2, post-intervention, and 3, 6,12, 18-months post-intervention. in addition, the investigators will include a subset of participants bereaved by covid-19 (or suspected as bereaved by covid-19). participants in this subset will undergo the same research procedures as the main cohort. participants in both the main cohort and subset determined to be fully eligible will be randomized into two groups with a total of: usual care (euc;n=125) and well (well; n=125).

the primary aim of this r01 application is to test the efficacy of a new behavioral intervention that targets the timing and regularity of sleep, meals, and physical activity to stabilize circadian rhythms, for reducing symptoms of depression during the spousal bereavement period.

Eligibility criteria:
inclusion criteria: * aged 60 years and older; * spousally (or partner) bereaved up to 12 months (includes bereaved as a result of covid-19); * at-risk for major depressive disorder (mdd), based on high-risk markers defined as subthreshold symptoms of depression (hamilton depression rating scale score of \> or = 9), together with absence of current mdd, post-traumatic stress disorder, or persistent complex bereavement disorder exclusion criteria: * current diagnostic and statistical manual diploma in social medicine (dsm-5) criteria for syndromal mood, psychosis within the last 12 months; * dementia/cognitive impairment; telephone interview cognitive screening (tics) \<19; * acute suicide risk; based on herbeck et al. protocol for suicide risk management; * patients taking new psychotropic medications after spousal death to stabilize depression including antidepressants and benzodiazepines \>4 days/week for more than two months. individuals who have been on a stable dose for at least 1 month and agree not to change during participation, unless it is medically necessary, will be included.
health coaching to effect lifestyle behaviour change

Conditions: Prediabetes; Prehypertension

Summary: a health coaching intervention in those with pre-disease (pre-hypertension or pre-diabetes) but without pre-existing cardiovascular disease will effectively help participants change their lifestyle behaviour and prevent or delay onset of cardiovascular disease.


Eligibility criteria:
inclusion criteria: * age 40-60 years * last recorded fasting blood glucose between 6.0 abd 6.9 mmol/l * last recorded blood pressure between 130-139 mmhg systolic and/or85-89 mmhg diastolic exclusion criteria: * diagnosis of diabetes on the chart * diagnosis of hypertension on the chart * taking an anti-diabetic medication * taking an antihypertensive medication
bilateral retromuscular rectus sheath block catheters usage for early postoperative analgesia after laparotomic gastrectomy.

Conditions: Postoperative Pain

Summary: in early postoperative period, the occurrence of severe pain after open major upper gi surgery is a significant issue. the study is aimed to access the efficiency of rectus sheet block with continuous bupivacaine infusion catheters into retromuscular space in providing an effective pain relief, decreasing opioid consumption and enhancing postoperative recovery.

this prospective randomised case-control experimental study is being conducted in riga east university hospital (latvia). patients with total or subtotal open gastrectomy were divided into two groups - half patients in the block group and half patients in the control group. in the block group and control group, retromuscular catheters in the m. rectus abdominis sheath is going to be placed before fascia closure. catheters will be placed under the direct supervision of a surgeon throughout the operation wound on both sides of the incision. after surgery patients in the block group will receive continuous 0.125% (10-12 mg/h) bupivacaine infusion through rectus sheath catheters for 72 h. additionaly ketorolac or trimeperidine infusion will be performed if vas of pains more than 30mm. if pains continue, additional opioids will be performed. patients in the control group received 0,9% nacl solution 72 hours by using the same "easy pump" system, and ketorolac or trimeperidine injection if necessery pain intensity will be assessed in both groups using 0-100 mm visual analog scale (vas) at 24, 48 and 72 hour intervals after surgery at rest and during movement (by asking the patient to bend legs). postoperative complications, hospital stay, comorbidities, the time taken to start walking after the surgery, bowel movements (time until first stool) were all examined.

Eligibility criteria:
inclusion criteria: * open laparotomy and gastrectomy exclusion criteria: * acute surgery
efficacy of mefenamic acid and hyoscine for pain relief during saline infusion sonohysterography in infertile women

Conditions: Infertility

Summary: the infertility patients who are performed saline infusion sonohysterography (sis) for studying the pathology inside the uterine cavity has pain. from pilot study the pain score is 6.80. it will have more benefits if we can manage this procedure with less or no pain. many studies have tried to decrease pain such as types of catheter, intrauterine lidocaine infusion. some have real effects but no study with oral mefenamic acid or hyoscine before the procedure.the drugs are safe and easy to administration and chief.


Eligibility criteria:
inclusion criteria: * infertility female * no history of hsg or hysteroscopy exclusion criteria: * vaginal or pelvic infection * abnormal pap smear * contraindications for mefenamic acid including upper and lower gi ulcers, bleeding disorder, asthma or allergies, renal disease, using warfarin,aspirin, lithium, history of mefenamic acid or hyoscine allergies

Keywords: infertility saline infusion sonohysterography pain hyoscine mefenamic acid women
phase i hypofractionated stereotactic boost (radiotherapy) for non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this study will help researchers test the safety of hypofractionated dose of radiotherapy (hysbst) at different dose levels before or after chemo-radiation for non small cell lung cancer.

patients are assigned to sub-group 1 or 2 based on the primary lesion size and location. this protocol will utilize a standard 3 + 3 phase i design with three patients enrolled per cohort. patients will be offered the opportunity to participate in the blood specimen component of the study. patients will be followed up to 2 years post radiation therapy. sub-group 1 will receive hysbst for 1 week. weeks 2-7 will be standard chemo-radiation therapy. patients have the option of consolidative chemotherapy at week 12. sub-group 2 will receive standard chemo-radiation therapy for weeks 1-6 then receive hysbst during week 7. patients have the option of consolidative chemotherapy at week 12. hysbst dose escalation for each sub-group is listed below: optional: 4 gy x 4 daily fractions level 1: 5 gy x 4 daily fractions level 2: 5.5 gy x 4 daily fractions level 3: 6 gy x 4 daily fractions dlts will be based on events occurring during the course of hysbst. chemo-radiation therapy is defined as: standard carboplatin \& paclitaxel doublelet regimen with weekly carboplatin auc 2/week and paclitaxel 45 mg/ m2/ week during conventionally fractionated imrt image-guided imrt to 60 gy, 5 x per week for 6 weeks consolidative chemotherapy is defined as carboplatin auc 6 and paclitaxel 200 mg/m2 every 21 days x 2 cycles will be given after all radiotherapy is delivered.

Eligibility criteria:
inclusion criteria: * stage ii - iii non small cell lung cancer exclusion criteria: * primary tumor directly invading into any mediastinal structures, such as the heart, major blood vessels, esophagus, trachea, and the proximal bronchial tree. * prior chemotherapy for nsclc * prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. * severe, active co-morbidity * pregnancy or women of childbearing potential * any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin * uncontrolled neuropathy ≥ grade 2.

Keywords: non-small cell lung cancer radiotherapy therapy
safety and efficacy study of lb80380 in the patients with lamivudine-refractory chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of the study is to investigate the safety and the antiviral activity of ascending multiple oral doses of lb80380 for 12 weeks in adults with lamivudine-refractory chronic hepatitis b infection.

lb80380, an oral prodrug, is a promising candidate nucleoside analogue with antiviral activity against wild-type hbv. lb80380 is undergoing clinical development by lg life sciences for use in the treatment of chronic hbv infection and for treatment of lamivudine-resistant disease. in this study, the treatment period was divided into two parts: a 4-week treatment period with dose escalation assessment (part 1), followed by an 8-week extension period (part 2). during part 1, patients received lb80380 and lvd 100 mg once daily for 4 weeks. each patient was then given only lb80380 for an additional 8 weeks (part 2) unless dose-limiting toxicity (dlt) was observed during part 1. at each dose level, all patients were to complete at least part 1 of the treatment period before enrolment into the next dose group could commence. dose escalation to the next group was not to be initiated if more than two patients experienced dlt during part 1 in the previous dose group. additionally, patients enrolled in lb80380 150mg and 240mg groups who agreed to participate in the pharmacokinetic (pk) analyses visited the study site the day before week 12 for blood sampling. follow-up period was 24 weeks, and patients were treated with adefovir dipivoxil during the follow-up period. during the study, patients were evaluated for changes from baseline in serum hbv dna. safety was evaluated on the basis of occurrence of aes and changes from baseline in clinical laboratory parameters, physical examination findings, and vital signs.

Eligibility criteria:
inclusion criteria: * compensated chronic hepatitis b patient * presence of serum hbsag for more than 6 months. * presence of hbeag for more than 1 month with compensated liver disease * confirmation of ymdd mutants (m552v, m552i and its related double mutant at l528m) by genotyping of the ymdd motif using line probe assay (inno-lipa hbv dr assay) * screening hbv dna value higher than or equal to 1,000,000 copies/ml (measured by the cobas amplicor hbv monitor™ assay) * screening alt value between 1.5 and 10 x uln exclusion criteria: * co-infection with hepatitis c or d virus (hcv or hdv) or hiv * pregnancy or breast-feeding * previous treatment with nucleoside analogue or any other treatment for hbv except for lamivudine within 6 months prior to study entry * treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry. * de-compensated liver disease * screening alpha-fetoprotein (afp) value \> 20 ng/ml, and a follow-up ultrasonography performed prior to baseline shows findings indicative of hcc. * presence of anti-hbs at screening

Keywords: chronic hepatitis b lamivudine resistant ymdd mutant type
evaluation of the effects of preoperative breathing exercises on preoxygenation period

Conditions: Pre-operative Exercise

Summary: the aim of this observational study is to compare the effects of preoperative breathing exercises during the preoxygenation period in patients undergoing abdominal surgery.

patients who are planned for abdominal surgery under elective conditions and who meet the inclusion criteria will be divided into 2 groups after routine preoperative preparations. the 1st group will start at least 5 days before the preoperative period and until the preoperative period, a minimum of 5 minutes of effective triflo exercise will be performed 4 times a day under the supervision of a nurse, and the 2nd group (control group) will not be exercised except for routine preoperative preparation. age, existing chronic diseases, body mass index, haemoglobin levels, smoking status, presence or absence of lung disease, spo2 values before and at the end of respiratory exercise (in the preoperative respiratory exercise group) will be recorded. all patients will be monitored with ecg, spo2, non invasive blood pressure, masimo. after the patients are taken to the operating table, they will be preoxygenated with oxygen at fio2 100% at 10 l\\min in supine position, with the anaesthesia mask placed on the patient's face so that there is no leakage. patients will be preoxygenated until eto2 concentration reaches 85%. when preoxygenation is started, the timer will be started and the time to reach ori:0.55 and the time to reach eto2 85% will be measured and recorded with a timer. preoxygenation time will be limited to a maximum of 5 minutes and patients who do not reach eto2 concentration 85% or ori:0.55 within 5 minutes will be noted.

Eligibility criteria:
inclusion criteria: * patients who will undergo elective abdominal surgery under general anesthesia * between the ages of 18-65 * both genders * asa i-iii risk group * patients who accept and give consent to participate in the study exclusion criteria: * patients who did not agree to participate in the study * patients younger than 18 years old and older than 65 years old * patients with advanced heart failure * conditions where the patient is uncooperative (e.g. dementia, alzheimer's) * patients who refuse to breathe through the mask before eto2 reaches 85% or more after the preoxygenation process begins * patients who cannot reach the eto2 level of 85% within five minutes * deeply anemic patients (hb\<8 gr/dl) * patients with neurological sequelae * patients with conditions that may prevent effective preoxygenation (those with long beards, patients with a nasogastric tube, etc.)
simplification and implementation of awake fibreoptic orotracheal intubation

Conditions: Anesthesia; Trachea; Intubation

Summary: awake fibreoptic intubation (afoi) is a classic and standard method for some special patients which is also difficult for anesthesiologists to learn and master. the procedure is sometimes hard and often takes about 20-30 min. most of patients have a strong sense of discomfort. investigators conducted the research to study the simplification and feasibility of afoi.

many studies have studied the sedative drugs and regional anesthesia related to awake intubation. however, several problems of afoi are existing including long operation time, patients' strong discomfort, coughing and resistance. and, to investigators' knowledge, there was a lack of a fixed procedure for the implementation of afoi. investigators conducted the research and aimed to study the simplification and feasibility of a new afoi method based on years of clinical theory, practice and experience.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists' physical status i-ii patients 2. aged 18-75 years 3. mallampati grade i-ii 4. body mass index 18.5-28 kg·m-2 exclusion criteria: 1. allergic to the drugs involved in the study 2. neck mass or infection 3. drug or alcohol abuse 4. pregnant

Keywords: awake fiberoptic intubation
pancreatic islet function, insulin sensitivity, and chronic complications in pre-diabetes

Conditions: Prediabetic State; Obesity; Metabolic Syndrome X

Summary: we, the investigators at national taiwan university hospital, want to compare patients' islet cell function, insulin sensitivity and risk of chronic complications with normal subjects. moreover, we want to examine whether they are at a higher risk of having metabolic syndrome and to answer whether we should screen the phenotypes of metabolic syndrome in impaired fasting glucose (ifg) and impaired glucose tolerance (igt) patients. then, we want to examine the association between insulin sensitivity and islet functions.

we, the investigators at national taiwan university hospital, want to compare patients' islet cell function, insulin sensitivity and risk of chronic complications with normal subjects. moreover, we want to examine whether they are at a higher risk of having metabolic syndrome and to answer whether we should screen the phenotypes of metabolic syndrome in impaired fasting glucose (ifg) and impaired glucose tolerance (igt) patients. then, we want to examine the association between insulin sensitivity and islet functions.

Eligibility criteria:
inclusion criteria: * fasting glucose 100-125 mg/dl or oral glucose tolerance test (ogtt) 2 hour glucose 140-199 mg/dl * diabetes mellitus exclusion criteria: * pregnancy * children \< 18 years old

Keywords: metabolic syndrome
phase i study of cisplatin plus osi-7904l in patients with solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a phase i, open-label, dose escalation, study of the combination of cisplatin and osi-7904l given on day 1 every 21 days in patient who have advanced solid tumors.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * advanced and/or metastatic solid tumor for which no effective therapy is available * ecog performance status 0-2 * adequate bone marrow, hepatic and renal function exclusion criteria: * patients with active or uncontrolled infections * neurotoxicity \>= grade 2 * symptomatic brain metastases which are not stable
a study of vanzacaftor/tezacaftor/deutivacaftor (vnz/tez/d-iva) in healthy adult panelists

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the flavor (basic tastes, aroma, texture, mouthfeel) of vnz/tez/d-iva fixed dose combination (fdc) granules.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * panelists are trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations. key exclusion criteria: * history of any illness or clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant. * sensitivity to vnz, tez, or d-iva. * pregnant, nursing, or planning to become pregnant during the study other protocol defined inclusion/exclusion criteria may apply.
a study to evaluate efficacy and safety of sublingual tnx-102 sl tablet taken at bedtime in patients with fibromyalgia

Conditions: Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Rheumatic Diseases

Summary: the use of low-dose cbp dosed nightly at bedtime for fm was supported by the results of tonix' tnx-cy-f202 phase 2b study (also referred to as the bestfit study). the tnx-cy-f202 study provided evidence that tnx-102 sl 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other fm symptomatology. the present trial is designed to assess the safety and efficacy of tnx-102 sl 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.


Eligibility criteria:
inclusion criteria: * diagnosis of primary fibromyalgia (2010 acr criteria) * male or female 18-75 years old * for patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressant therapy * willing and able to withdraw specific therapies (ask pi) * medically acceptable form of contraception (female only) * signed informed consent exclusion criteria: * arthritis, lupus and other systemic auto-immune diseases * regional or persistent pain that could interfere with assessment of fibromyalgia pain * bipolar and psychotic disorders * increased risk of suicide * significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities. * inability to wash-out specific medications (ask pi) * known hypersensitivity to cyclobenzaprine * others: seizure disorders, severe/untreated sleep apnea, bmi\>40

Keywords: pain sleep
surgical site infection in perforated appendicitis after peritoneal lavage with super-oxidised solution

Conditions: Perforated Appendicitis

Summary: this study is to evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing surgical site infection after open surgery for perforated appendicitis.

open appendicectomy for perforated appendicitis is associated with significant morbidity from surgical site infection. the standard practice is to perform peritoneal and wound lavage using normal saline solution. the investigators propose the use of superoxidized solution for peritoneal and wound lavage to decrease the incidence of surgical site infection. superoxidized solutions contain hypochlorous acid (hocl) which has bactericidal properties. the reactive oxygen species that is produces damages cell wall membrane of unicellular organisms, however remains safe when in contact with human or animal tissue. it is commonly used for topical treatment of wounds.

Eligibility criteria:
inclusion criteria: 1. patients between the age 13 and 70 years 2. diagnosed with perforated appendicitis intra-operatively 3. undergo open appendicectomy via lanz incision exclusion criteria: 1. surgical technique: laparoscopic appendicectomy or mid-line laparotomy 2. patients on steroid treatment and immunosuppressant therapy.

Keywords: perforated appendicitis super-oxidised solution surgical site infection peritoneal lavage