Kornimate/medical-research-clean huggingface dataset:
flexible, intensive insulin therapy in patients with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: to prospectively evaluate the long term metabolic and psychological effects of flexible intensive insulin therapy (fit) courses in an unselected population of type 1 diabetic patients at the university of basel hospital. we hypothesize that both metabolic control and psychological parameters will improve.


Eligibility criteria:
inclusion criteria: * all patients participating in 5 consecutive fit courses that began between april 2002 to april 2004 exclusion criteria: * none

Keywords: flexible insulin therapy diabetes education diabetes insulin weekly ambulatory sessions
a study of hqk-1001 in patients with sickle cell disease

Conditions: Sickle Cell Disease; Sickle Cell Anemia; Sickle Cell Disorders; Hemoglobin S Disease; Sickling Disorder Due to Hemoglobin S

Summary: the purpose of this study is to evaluate the safety and tolerability of three dose levels of hqk-1001 administered once daily for 26 weeks in subjects with sickle cell disease.


Eligibility criteria:
inclusion criteria: * established diagnosis of scd * males and females between 12 and 60 years of age, inclusive * at least 3 episodes of a scd-related crisis or complication in the 3 years prior to screening or 1 episode of acute chest syndrome in the 5 years prior to screening * if receiving hydroxyurea, must be receiving a stable dose for at least 6 months prior to screening * if hydroxyurea treatment has been discontinued, at least 3 months have elapsed since last dose * if transfusion in the 4 months prior to screening, then hba level \< 20% at screening * average of the initial two hbf levels ≥ 2.0 % within ≤ 7 days prior to the initial dose of hqk-1001. the two must be obtained ≥ 24 hours apart * ability to swallow tablets * able and willing to give informed consent and assent (if applicable) * if subject is a woman of child-bearing potential (wcbp), she must have a negative serum pregnancy test within 7 days of first dose of hqk-1001 * if a subject is a wcbp, she must agree to use an effective form of contraception within 7 days of the initial dose of hqk-1001 and for one month after hqk-1001 discontinuation * sexually active male subjects (with wcbp partners) must agree to use latex condoms or ensure that their partner(s) use an effective form of contraception * in the view of the investigator, subject is able and willing to comply with necessary study procedures exclusion criteria: * more than 4 hospitalizations for acute sickle cell related events in the previous 12 months prior to screening * pulmonary hypertension requiring oxygen therapy * qtc \> 450 msec (male) or 470 msec (female) on screening ecg (qt corrected by fridericia's formula) * assigned to a regular transfusion program * use of erythropoiesis stimulating agents within 90 days of screening * alt \> 3x upper limit of normal (uln) * serum creatinine \> 1.2 mg/dl * a serious, concurrent illness that would limit ability to complete or comply with the study requirements * an acute vaso-occlusive event within 3 weeks prior to screening * creatine phosphokinase (ck) \> 20% above the uln * an acute illness (e.g., febrile, gi, respiratory) within 72 hours prior to screening * history of syncope, clinically significant dysrhythmias or resuscitation from sudden death * chronic opiate use, which, in the view of the investigator, could confound evaluation of an investigational drug * current abuse of alcohol or drugs * received another investigational agent within 4 weeks or 5 half-lives, whichever is longer, prior to screening * currently pregnant or breast feeding a child * known infection with hiv-1 * infection with hepatitis b or hepatitis c, such that patients are currently on therapy or will be placed on therapy during the trial
effect of triple pre-rehabilitation on radiotherapy for head and neck cancer patients

Conditions: Triple Pre-rehabilitation; Radiotherapy; Head and Neck Cancer

Summary: to evaluate the intervention effect of triple pre-rehabilitation on head and neck cancer patients with radiotherapy, and process evaluation to further optimize the intervention program. the pre-rehabilitation intervention was develped previously based on the process of evidence-based-nursing, including interventions of nurtrtion, exercise, and psychology.


Eligibility criteria:
inclusion criteria: * 18≤ age \< 75 years old * the pathological diagnosis of hnc included nasopharyngeal cancer, oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, salivary gland cancer; * plan to receive radiotherapy * basic communication skills * volunteer to participate in this study. exclusion criteria: * combined with other malignant tumors * distant metastasis * inability to measure body composition, such as metal in the body or inability to stand alone * with contraindications to exercise (such as cardiovascular and cerebrovascular diseases, respiratory diseases, etc) * complicated with severe liver and kidney function damage * previous diagnosis of other cancers * pregnant or lactation women.
guanfacine to treat borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: this study is designed to investigate whether guanfacine (tenex) is an effective treatment for borderline personality disorder (bpd), an illness often characterized by unstable mood and impulsive aggression. guanfacine stimulates activity in the front portion of the brain, a region associated with attention and the control of behavior. we believe that guanfacine may improve symptoms of bpd by improving attention and aiding regulation of behavior.

this is an 8-week treatment study designed to test whether guanfacine is an effective treatment for borderline personality disorder (bpd). prior to taking the study medication, subjects will have medical and psychiatric evaluations, complete self-report questionnaires, do a functional mri scan, and complete a set of cognitive tests. while taking the study medication, participants will meet weekly with a study doctor and be administered interviews and questionnaires. at the end of the 8-week trial, participants will be asked to repeat the mri scan and cognitive tests.

Eligibility criteria:
inclusion criteria: this study includes men and women between the ages of 18 and 55 who meet criteria for borderline personality disorder with impulsive aggression. exclusion criteria: subjects must not currently be taking any psychiatric medications. subjects must not meet criteria for current substance dependence, current major depression, bipolar disorder, or schizophrenia-spectrum disorders.

Keywords: borderline personality disorder guanfacine impulsivity aggression affective instability
reliability and validity of urdu version of the king's health questionnaire

Conditions: Urinary Incontinence

Summary: this study is aimed to translate king's health questionnaire into urdu language and to test its reliability and validity among pakistani women with urinary incontinence.


Eligibility criteria:
inclusion criteria: * having symptoms of urinary incontinence * age 21 or more than years * sufficient literacy to complete questionnaire exclusion criteria: * being unable to complete questionnaires due to language and cognitive limitations * pelvic organ prolapse * concomitant neurological disorders

Keywords: urinary incontinence king's health questionnaire reliability validity
does exercise and heat increase the lightsensibility in patients with erythropoietic protoporphyria

Conditions: Erythropoietic Protoporphyria

Summary: the purpose of the study is to evaluate the effect of exercise and heat on the light sensibility of patients with erythropoietic protoporphyria


Eligibility criteria:
inclusion criteria: erythropoietic protoporphyria, age 14 to 70. - exclusion criteria: * not able to exercise
comparison of day-time and night-time operations of supracondylar humeral fractures

Conditions: Supracondylar Fracture; Morbidity

Summary: this study aims to investigate that performing supracondylar humerus fracture operations during daylight hours may have better results than performing them at night.

supracondylar humerus fractures are one of the most common traumatic fractures seen in children and their treatment usually requires immediate closed reduction and percutaneous pinning (crpp). the presence of neurovascular complications associated with this fracture is considered an orthopedic emergency. for this reason, depending on the patient's operation time, the procedure should be performed at night under emergency conditions. sleep deprivation, which is common in healthcare professionals, may affect patient safety due to disruptions in treatments and surgical procedures by reducing physician performance.

Eligibility criteria:
inclusion criteria: * aged 5 to 12 years * had supracondylar humeral fractures, * underwent crpp * under general anaesthesia * american society of anesthesiologists (asa) physical status i to iii exclusion criteria: * surgical procedures outside the operating room * parental refusing the study protocol

Keywords: supracondyler humerus fracture night time operation sleep deprivation closed reduction and percutaneous pinning crpp
impact of an evidence-based electronic decision support system on diabetes care

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the feasibility of the use of an evidence-based decision support system (ebmeds) in daily belgian family medicine and to study the effectiveness of ebmeds use on improving diabetes care.

the purpose of this study is to assess the feasibility of the use of an evidence-based decision support system (ebmeds) in daily belgian family medicine and to study the effectiveness of ebmeds use on improving diabetes care. specific research questions are: * does family physicians use the ebmeds system in daily practice? * does the use of the ebmeds system by family physicians leads to an improvement in diabetes control compared to the control group?

Eligibility criteria:
inclusion criteria: * patients are 18 years or older. * patients have their electronic medical records registered by one of the included family physicians. medical records are not centralized in belgium. patients are free to choose any physician, and can even see several physicians at the same time. to encourage a patient to have their medical records held by a single physician, 'global medical records' werr introduced a decade ago. in return for a registration fee, patients can choose a main general practitioner who keeps their central medical records. this registration is a requirement for patient inclusion in the trial. patients with 'global medical records' are reimbursed a larger proportion of the consultation fees by the health insurance fund. * patients have an established diagnosis of diabetes at the baseline time point of the study (identified as having (1) an icpc (international classification of primary care) code of diabetes or (2) a prescription for a diabetes-specific or (3) the necessary labo results to confirm diabetes) exclusion criteria: * pregnancy * cognitive impairment

Keywords: decision support systems, clinical evidence-based practice family practice
safety and efficacy of dalbavancin versus vancomycin in the treatment of catheter-related bloodstream infections

Conditions: Bacteremia

Summary: this is a study to evaluate a new medication dosed once a week in the treatment of bacterial infections in the blood from intravenous catheters (cr-bsi). the primary objective is to evaluate the efficacy and safety of dalbavancin in the treatment of adults with cr-bsi relative to a standard of care treatment, vancomycin.


Eligibility criteria:
* the patient or his/her legally authorized representative has given informed consent by means approved by the investigator's irb/ec; * \> 18 years of age; * had one or more central venous catheters at the time initial signs of infection were evident; * creatinine clearance \<50 ml/min; * bilirubin \> 2x the upper limit of normal; * treatment with an antibiotic effective against gram-positive bacterial infections for more than 24 hours within 48 hours of study medication initiation, * prolonged antibiotic therapy for cr-bsi anticipated (i.e., \>2 weeks)
participant-reported outcomes with the accu-chek® solo micropump system

Conditions: Diabetes Mellitus, Type 1

Summary: this interventional device study aims to compare mainly standard multiple daily injection (mdi) therapy vs. accu-chek® solo micropump system and investigates participant satisfaction. in addition, a third arm is included to compare to only similar product on the market which is omnipod. the third arm is for data collection purpose.


Eligibility criteria:
inclusion criteria: * diagnosed type 1 diabetes mellitus * at least 6 months experience with mdi therapy * age ≥18 years and age ≤ 65 * able to perform carbohydrate counting * clinically suitable for csii including willingness to measure blood glucose at least 4 times per day or to use flash or real-time continuous glucose monitoring consistently * hba1c between 7.5% (58 millimoles per mole (mmol/mol)) and 9.0% (75 mmol/mol) (determined within the last 2 months) * ability and willingness to read and understand study materials (participant information, data protection and written consent form, all questionnaires etc.) and to comply with study procedures * ability and willingness to use investigational devices independently and respond to alarms after training and run-in phase * using a blood glucose (bg)-meter or real-time continuous glucose monitoring device that can be downloaded via accu-chek® smart pix or willingness to use a compatible meter that will be provided for the duration of the study exclusion criteria: * prior insulin pump use * relevantly impaired hypoglycemia awareness * history of \>1 hospitalization due to severe hypoglycemia within the previous 3 months * history of \>1 hospitalization due diabetic ketoacidosis within the last 3 months * significant manifestation of diabetes-related late complications * pregnant or planning to become pregnant or breastfeeding * known allergic reactions to plaster adhesive * chronic use (therapy lasting for more than 3 months) of steroids in adrenal suppressive doses, immunosuppressive medication, or chemotherapy * serious or unstable chronic medical or psychological condition(s) * addiction to alcohol or other substance(s) of abuse as determined by the investigator * psychological condition rendering the participant unable to understand the nature and the scope of the study * plans for relocation or extensive travel * participation in another clinical study within 4 weeks prior to the screening visit * dependency on sponsor or investigator (e.g. co-worker or family member)
safety and efficacy of truetear™ for the treatment of meibomian gland disease

Conditions: Meibomian Glands; Dry Eye Syndromes

Summary: this study will compare the safety and efficacy of truetear™ to standardized moist heat compress (thermalon® dry eye compress) for the treatment of meibomian gland disease (mgd).


Eligibility criteria:
inclusion criteria: * dry eye disease or meibomian gland disease as evaluated by standard participant evaluation for dryness (speed) score, schirmer test, tear film breakup time and other applicable objective measures at the screening and baseline visits. * use of an artificial tear product, lid hygiene, omega-3 supplementation, antibiotics for the treatment of dry eye disease or meibomian gland disease within one year of the screening visit. exclusion criteria: * chronic or recurrent epistaxis, coagulation disorders or other conditions that may increase the risk of bleeding. * history of nasal or sinus surgery. * vascularized polyp, deviated septum or severe nasal airway obstruction at the screening visit. * intraocular and extraocular surgery in either eye within three months of the screening visit or refractive surgery within twelve months of the screening visit. * cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head.
study of 6b11-ocik injection treatment in patients with recurrent drug-resistant ovarian cancer

Conditions: Recurrent Ovarian Carcinoma; Platinum-resistant Ovarian Cancer

Summary: this is an open, single-arm, phase i clinical trial to evaluate safety and efficacy and of 6b11-ocik injection in the treatment of recurrent drug-resistant ovarian cancer

this is a phase i clinical trial of cytotoxic t cell injection induced by dendritic cells loaded with 6b11 anti-idiotype minibody (6b11-ocik injection) for recurrent drug-resistant ovarian cancer. main purpose of this research is to determine the maximum tolerable dose (mtd) of 6b11-ocik injection in the treatment of patients with ovarian cancer. moreover, secondary purpose is to evaluate the effect of 6b11-ocik injection on the immune system of patients, the efficacy of autologous 6b11-ocik injection in the treatment of patients with ovarian cancer obtain and the correlation between oc166-9 antigen expression and efficacy of 6b11-ocik injection. thirdly, exploratory purpose is to evaluate the effect of 6b11-ocik injection on laboratory examination.

Eligibility criteria:
inclusion criteria: 1. 18-70 years old patients. 2. diagnosed as ovarian cancer, who had relapsed after initial treatment; relapse after drug resistance: clinical remission after early chemotherapy, but progression or relapse within 6 months after chemotherapy,or achieve no response after early chemotherapy. 3. administered with doxorubicin. exclusion criteria: 1. symptomatic and uncontrolled brain metastasis or pia meningeal metastasis; patients with spinal cord compression; symptoms related to central nervous system lesions or symptoms indicating disease progression; 2. corticosteroid drugs (or analogues) or drugs effecting the immune system were administered before infusion in 4 weeks. 3. patients with interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonia; 4. women with positive serum pregnancy test or lactation;
very low calorie diet for diabetic kidney disease

Conditions: Diabetic Kidney Disease

Summary: the purpose of this study is to determine whether a very low calorie diet will stabilize or improve diabetic kidney disease.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * age \> 18 * body mass index ≥ 30 * presumed or biopsy-proven diabetic nephropathy * estimated gfr \< 40 ml/min/1.73 meters squared * proteinuria \> 0.5 gm/day * motivated to lose weight * stable medical co-morbidities * using an ace inhibitor or angiotensin receptor blocker agent (unless contraindicated) exclusion criteria: * inability to sign informed consent * life expectancy of \< 1 year * expected need for initiation of dialysis within 9 months * type 1 diabetes * recent myocardial infarction or stroke (past 3 months) * unstable angina * active cancer * pregnancy/lactation * serious psychiatric diseases * substance abuse * uncontrolled hypertension (\> 180/110) * ineligible for vlcd based on laboratory data

Keywords: determine effects of diet on renal and other parameters
warmsmart warming protocol

Conditions: Hypothermia

Summary: hypothermia during surgery and in the postoperative period is associated with adverse outcomes including impaired drug metabolism, cardiac morbidity, shivering, impaired immune function, coagulopathy, and increased use of hospital resources. several clinical studies have demonstrated that maintenance of normothermia during the perioperative period significantly reduces morbidity. mercury biomed has developed a patient-warming system, warmsmart, that potentially transfers adequate heat through hands and feet based on the physiological principle of peripheral arterio-venous shunt vaso-dilation. the technology works as a two-step process by selective thermal stimulation along the spinal cord to up-regulate blood flow to arterio-venous shunts and triggering arterio-venous shunt vasodilation and by applying circulating water heat exchangers to the palmar and plantar glabrous skin to warm highly perfused shunts in that area. general anesthesia reduces the vasoconstriction threshold (triggering core temperature) by 1-2°c, thus promoting arteriovenous shunt dilation. it remains unknown, though, whether cervical spine warming further augments arterio-venous shunt dilation during general anesthesia. if spine heating proves unnecessary under anesthesia, mercury biomed's warmsmart warming could be simpler and less expensive. investigators therefore propose to test the hypothesis that cutaneous heating near the cervical spine does not further augment arterio-venous flow in fingers during general anesthesia. investigators propose to enroll ten patients. the patients will be pre-warmed and warmed intraoperatively with forced-air to maintain a core temperature near 36°c. a thermazone® device capable of heating the cervical spine area will be positioned behind the patient's neck upon arrival in the operating rooms. additionally a forced-air warmer will be positioned appropriately and activated as soon as practical, usually after prepping and draping. ambient temperature will be maintained near 20°c. after about one hour of anesthesia when temperature and other factors are stable, investigators will start a 30-minute observation period. thereafter investigators will activate the cervical spine warming system for 30 minutes (warming measurement period) and thereafter have a 30 minutes control period again. measurements will be recorded such as mean-skin temperature, distal esophageal temperature, mac fraction, mean-arterial pressure and finger blood flow.


Eligibility criteria:
inclusion criteria: 1. body-mass index 20-33 kg/m2; 2. age 18-70 yrs; 3. asa physical status 1-3. exclusion criteria: 1. serious skin lesions on the hands or arms; 2. history of serious vascular disease in the arms, including raynaud's syndrome; 3. pre-operative fever or infection; 4. surgery expected to be supine and in neutral position.