Kornimate/medical-research-clean huggingface dataset:
moderate or extensive carbohydrate reduction in risk patients

Conditions: Glucose Metabolism Disorders

Summary: risk-patients for diabetes or patients that are diagnosed with this condition but who are not treated with insulin are randomized two times, according to diet and according to the type of support: randomization with regard to carbohydrate restriction (25-30 e% or \< 10e%). randomization with regard to type of psychological support. either according to acceptance and commitment therapy or to traditional cognitive behavioral therapy. both kinds of psychological support is given as group therapy. two-hundred patients are recruited and each patient is followed for two years.

the organizers will recruit 200 patients in the study "to lower glucose levels and reduce weight by exclusion of carbohydrates and inclusion of psychological behavioral support" (lowinchip) at the primary care health center "cithyhälsan centrum" in norrköping. each patient will be followed for 2 years. patients are eligible if they have are above 18 years of age and have a bmi above 28 kg/m2 and also belong to one or more of the following groups: 1) type 2 diabetes that is not treated with insulin. 2) patients that have had gestational diabetes or who have 3) first grade relative with type 2 diabetes. finally 4) pre-diabetic individuals with impaired fasting glucose (6.1-6.9 mmol) or impaired glucose tolerance (capillary plasma glucose 8.9-12-1 after glucose challenge) are also potential participants. patients must not have insulin therapy or severe kidney failure (gfr\< 30). they can also not have severe physical restrictions for activity and they must not have difficulties with understanding written swedish texts. the participants are randomized two times (two by two factorial): randomization with regard to carbohydrate restriction (25-30 e% or \< 10e%). randomization with regard to type of psychological support. either according to acceptance and commitment therapy (act) or to traditional cognitive behavioral therapy. each group will have three group sessions with approximately 8 participants followed by a telephone call by the therapist. each session will be held by the psychologists that are part of the cityhälsan centrum staff. the study has \> 95% power to demonstrate 5% hba1c (mmol/mol) difference between groups with a drop out of 25%.

Eligibility criteria:
inclusion criteria: * diabetes without insulin. patients at high risk for developing diabetes. exclusion criteria: * severe kidney failure. insulin therapy. inability to understand instructions.
dosage of metal ions in the blood of different metal-on-metal prostheses, in correlation with physical activity

Conditions: Hip Osteoarthritis

Summary: prospective study including 6 groups of 20 patients with a total hip prosthesis. five different types of metal-on-metal prostheses are studied, and 1 group with ceramic-on-ceramic prostheses acts as control group. patients undergo a clinical evaluation and blood sampling preoperatively, and 3, 6, 12 and 24 months postoperatively.


Eligibility criteria:
inclusion criteria: * hip osteoarthritis exclusion criteria: -
virtual reality technology for vasectomy pain modulation

Conditions: Vasectomy; Pain, Postoperative; Anxiety Postoperative

Summary: this study will evaluate whether or not wearing a virtual reality (vr) headset reduces pain and anxiety in patients undergoing vasectomy. the headset being used is the smileyscope virtual reality interface, a device already undergoing study for approval by the u.s. food and drug administration (fda) to reduce pain and anxiety in patients aged 4 years and older undergoing needle blood draw or injection procedures. in this study, the smileyscope virtual reality interface is considered an investigational device because it is not yet approved for use in adult males undergoing vasectomy.

vasectomy is a safe and effective procedure for permanent sterilization in males. more than 500,000 vasectomies are performed annually in the united states, and that number is expected to grow rapidly in the coming years. the procedure is safe and can be quickly performed in an outpatient setting. complications of vasectomy are rare, and can include hematoma and infection, spermatic granulomas, and post-vasectomy pain syndrome in rare cases. like all outpatient surgical procedures where the patient is not under general anesthesia, vasectomies involve intraoperative and immediate post-operative pain. while use of the no-scalpel technique and local anesthetic reduces intraoperative pain, expected operative pain is still one of the main reasons patients cite for not undergoing the procedure. in our current study, the investigators aim to further modulate intraoperative pain using virtual reality goggles. in clinical trials, the smileyscope device has been shown to reduce procedural pain in the pediatric population during venipuncture or intravenous cannulation. results from those studies showed a statistically significant reduction in pain during intravenous procedures in the emergency department. this vr headset is undergoing study for approval by the u.s. food and drug administration (fda) to reduce pain and anxiety in patients aged 4 years and older undergoing needle blood draw or injection procedures. currently, this device has been granted entrance to the fda safer technologies program. in this study, the smileyscope virtual reality interface is considered an investigational device because it is not yet approved for use in adult males undergoing vasectomy. the aim of this study is to investigate whether this same virtual reality modality can be utilized to reduce pain during vasectomies.

Eligibility criteria:
inclusion criteria: * adult males 18 years or older who are undergoing elective vasectomy exclusion criteria: * have a serious comorbid illness or condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study * history of chronic pain disorder or chronic narcotic use * significant refractive error, unilateral blindness, epilepsy, or other conditions such as skin infections, cancer, etc. which could compromise the physical function of the headset.
evaluation of the effectiveness of a product containing topical hydrocortisone in the treatment of seborrheic dermatitis of the face

Conditions: Seborrheic Dermatitis

Summary: clinical single-blind randomized comparison with the overall objective of evaluating the clinical efficacy of the products nutracort lotion and nutracort cream in the treatment of seborrheic dermatitis on the face. will be held clinical and perceived efficacy assessment and instrumental measurements. each product will be applied at half face for 7 consecutive days and all applications will be monitored in the research site. 60 volunteers will be recruited. evaluations will be held at the following times: t0 - before the initial application of the product; t1 - 24 hours after starting treatment, t2 - 48 hours after starting treatment, t3 - 72 hours after initiation of treatment, t4 - 96 hours after the start treatment, t7 - 7 days after initiation of treatment.


Eligibility criteria:
inclusion criteria: * healthy subjects * subjects with seborrheic dermatitis on both sides of the face * both sexes * aged 18 to 60 years * skin types i through iv. exclusion criteria: * pregnancy / lactation * skin condition in the area of application of the product * diabetes * immune insufficiency * subjects that are using systemic corticoids * subjects that are using immunosuppressors * skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis * history of reaction to the product category * other diseases or medications that might interfere directly in the study or endanger the health of the subject
virtual reality-based induction to improve positive body image in low back pain patients.

Conditions: Chronic Low-back Pain; Low Back Pain

Summary: the aim of this study is to examine the effects of a virtual reality-based induction to modify positive body image in individuals with low back pain. participants will receive both a positive and a negative induction of the appreciation of body functionality. this induction consists of an elaborated narrative to increase/decrease the appreciation of functionality. in addition, each induction includes a virtual costume representing their body's strengths or weaknesses to enrich the induction. after both induction procedures, participants will perform activities of daily living involving the use of the lumbar region in virtual reality. subsequently, the different variables of interest will be assessed before and after each induction. researchers will analyze changes in the variables of interest after induction procedures compared to baseline.

the aim of this study is to examine the effects of a virtual reality-based induction to modify positive body image in individuals with low back pain. firstly, improvement in the study variables is expected after the positive induction. secondly, the opposite results are expected after negative induction. thirdly, a greater change is expected in the group of patients with low back pain. the whole study is conducted in one single 1-hour session. first, participants will be screened to check eligibility inclusion/exclusion criteria. second, eligible participants will complete baseline measures. third, participants will be exposed to both induction procedures, counterbalancing the order. at the end of each induction, they will have to perform different virtual reality-based tasks of daily life that involve the use of the lumbar region, such as placing books on a bookshelf, throwing objects into a trash can or painting a wall. fourth, state measures will be applied to assess the change in the study variables. the study will be conducted following the principles stated in the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * individuals with low back pain. exclusion criteria: meeting any of the following medical conditions: * spinal tumor, infection or fracture * systemic disease (autoimmune, infectious, vascular, endocrine, metabolic...) * fibromyalgia * cauda equina syndrome * history of spinal surgery * musculoskeletal injury of lower extremities
a study of pain relief in osteoarthritis

Conditions: Osteoarthritis

Summary: the purpose of this study is to compare the safety and pain-relieving ability of vicodin cr to placebo in subjects with osteoarthritis (oa) of the hip or knee.


Eligibility criteria:
inclusion criteria: * males and females ages 21 to 80 * if female, must be of non-child bearing potential or practicing birth control * has osteoarthritis of the hip or knee * requires therapeutic doses of medication for osteoarthritis pain * has sufficient pain to justify the use of around-the-clock opioids exclusion criteria: * is associated with any currently ongoing research study, or has previously participated in a vicodin cr study * is allergic to or has had a serious reaction to hydrocodone, other opioids, or acetaminophen * cannot discontinue pain medications, even for the short time prior to the study start * has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery * has a history of gastric bypass surgery or preexisting severe gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract * has a history of malnutrition or starvation * has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day * has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder * pregnant or breastfeeding females * is incapacitated, bedridden or confined to a wheelchair * has initiated any new therapy or medication for oa within 1 month of screening * has had surgery, certain types of procedures, or received certain medications for osteoarthritis within a specified time frame * has other conditions that may cause pain, such as rheumatoid arthritis or gout

Keywords: osteoarthritis of the hip or knee
impact of postoperative telemedicine visit vs in-person visit on patient satisfaction during the covid-19 pandemic

Conditions: Covid19; Satisfaction, Patient; Telemedicine

Summary: the purpose of this clinical study is to evaluate whether remote video/audio postoperative visits (telemedicine visits) affects patient satisfaction compared to in-person visits during the covid-19 pandemic. if the primary objective of the study is achieved, it would allow better understanding of how telemedicine can be integrated into modern surgical practice to take care of postoperative patients.


Eligibility criteria:
inclusion criteria: 1. patients over 18 years of age inclusive at the time of the study who underwent colorectal surgery and are presenting for their first postoperative visit 2. patients with a computer or phone device with video and audio capabilities exclusion criteria: 1. children \<18 years of age 2. patients with mental disability 3. patients without a computer or phone device with video and audio capabilities 4. patients who require physical intervention during their first postoperative visit (e.g. drain removal, suture removal, staple removal) 5. patients who are readmitted to the hospital prior to their first postoperative visit will be excluded.

Keywords: covid19 patient satisfaction telemedicine
the effect of an azygos vein coil on defibrillation threshold

Conditions: Heart Failure

Summary: when implantable cardiac defibrillators are implanted (icds), the defibrillation threshold (dft), of the amount of energy required to effectively terminate life-threatening arrhythmias is determined. the device is then programmed to discharge a larger amount of energy in order to provide a safety margin. in some patients, the dft is so high, that an adequate safety margin is not programmable. placement of a defibrillation lead in the azygos vein has been found to be helpful in these patients. this goal of this trial is to attempt to quantify the average reduction in the dft (if any) that results from the addition of the azygos lead.

patients undergoing placement of an icd for the primary or secondary prevention of sudden cardiac death will be asked to participate. patients will undergo implantation of a standard right ventricular icd lead at the time of icd implantation. in addition, patient will receive another high voltage icd lead placed in the azygos vein as has been previously described in the literature (1). after sedating the patient, the dft will be determined using a binary search algorithm. this consists of testing the device at a given output for the first shock after inducing ventricular fibrillation (vf). should the shock fail, external defibrillation will be attempted, as is the standard method for performing dft testing. as per the standard method of dft testing, vf will be induced a second time, with the shock strength dependent on the success of the first shock. if the first shock was unsuccessful, the second will be at a higher output. if the first shock was successful, the second will be at a lower output. a third shock will then be delivered, based on the success or failure of the preceding shock to define the dft. of note, as the device can be programmed to give multiple shocks for one episode, vf will not necessarily need to be induced each time. for example, vf could be induced, and the device programmed to give a 20 joule (j) shock followed by a 23j shock if not successful, thus limiting the number of vf inductions required. dft testing will be done using both the standard configuration of high voltage leads as well as using the azygos lead. we hypothesize that using the azygos lead will result in a lower dft.

Eligibility criteria:
inclusion criteria: * any patient undergoing elective placement of an icd for the primary or secondary prevention of sudden cardiac death is eligible. exclusion criteria include any contraindication to endovascular icd implantation which includes but is not limited to; active infection, occluded venous access, or inability to perform dft testing secondary to the inability to sedate the patient or hemodynamic compromise. exclusion criteria: * any contraindication to icd or the inability to place an azygos vein coil.

Keywords: dft congestive heart failure (chf) icd
clinical trial of bioblock covid-19 nasal spray containing anti-sars-cov-2 antibodies derived from bovine colostrum

Conditions: SARS-COV2 Infection; Covid19

Summary: for an antiviral agent to act as an effective biological barrier on nasal mucosal surface, the formulation preferably has to be maintained on the site of action for several hours, and the nasal spray dispenser can be utilized for administering the solution to the upper respiratory tract. a "first-in-man" clinical study of the nasal spray containing anti-sars-cov-2 antibodies derived from bovine colostrum was conducted. the study on healthy volunteers was undertaken to evaluate how long the bovine antibodies would be maintained on the nasopharyngeal surface after administration of nasal spray. in addition, the study enabled to determine which of the two concentrations of antibodies should be used in the final nasal-spray formulation. the volunteers were followed up for 4h after administration of antibody spray and sampling was done at different time-points during this period. the concentration of antibodies from patient samples was measured using elisa analysis. in addition, as this was a "first-in-man" study any adverse events following the administration of spray were also monitored.

to test the nasal biological availability of the bioblock® immunoglobulin preparation, 16 healthy volunteers were recruited in the phase 0 clinical trial. the study was conducted in the premises of the ear clinic of tartu university hospital. the study protocol was approved by research ethics committee of the university of tartu on march 17, 2021 (no 336/t-1). written informed consent in accordance with the declaration of helsinki was obtained from each healthy volunteer. the study group was divided into two subgroups where the individuals were intranasally administered into both nostrils of bioblock® formulation which contained either 0.1 mg/ml or 0.2 mg/ml of the colostrum immunoglobulin preparation (n=8 in both study groups). a filter paper with a volume capacity of 15 µl was placed on the medial nasal surface using surgical forceps and it was kept on nasal mucosa for 10 minutes. following this the bioblock was administered to the nasal cavity. the nasal mucosal sampling was done at 4 timepoints. the samples were analyzed using a cow igg elisa kit.

Eligibility criteria:
inclusion criteria: * healthy individuals * age 18-80 * have not been diagnosed with sars-cov-2 infection (lack of positive pcr test) * have not been vaccinated against sars-cov-2 infection exclusion criteria: * pregnancy * serious allergic or anaphylactic reactions to medications * allergies to milk products * ear-nose-throat pathologies (anatomic and diseases) * immunodeficiency conditions (cancers, hematologic diseases, hiv, congenital immunodeficiency) * viral hepatitis a,b and c * upper airway infections * autoimmune diseases (diabetes, copd, asthma, rhinitis, ra, psoriasis) * concomitant drugs - glucocorticosteroids, biologic drugs, inhalable medications
iron-fortified whole maize flour trial

Conditions: Anaemia

Summary: the purpose of this study is to assess whether nafeedta and electrolytic iron improve iron status of young school children, when added as iron fortificants in whole maize flour.

fortification of staple foods with iron may be an effective method of addressing the problem of iron deficiency. questions however remain of the type of iron fortificants to use, the appropriate fortification levels and suitable food vehicles. cereals form attractive vehicles because they are widely consumed in parts of the world that bear a large burden of the iron deficiency problem. they are however high in phytates and would reduce the bioavailability of commonly used iron fortificants. isotope studies have shown that even in the presence of phytates, iron from nafeedta is relatively more bioavailable than that from other fortificant sources. its efficacy has however not been assessed in human trials. electrolytic iron, on the other hand is widely used and was legislated as the iron fortificant of choice in south africa. its efficacy in a high-phytate vehicle has also not been assessed. we have therefore undertaken to assess the efficacy of nafeedta at two doses, as an iron fortificant in whole flour, and the efficacy of electrolytic iron at a dose similar to the high-dose nafeedta. the results will contribute information on the suitability of these fortificants in whole maize flour, a food commonly consumed in sub-saharan africa.

Eligibility criteria:
inclusion criteria:children: * 3-8 years age (for the purposes of this study this will include children born within the period december 15th 1995- may 1st 2001). * whohave been resident in the area for 6 months or more. * enrolled in the selected schools * able to consume the target amount of porridge, at least 50% of the time during the run-in period * will be present in the study area for the entire study period (april - december 2004). exclusion criteria: * children below 3 years and above 8 years of age (born after december 15th 1995 and before may 1st 2001). * children who have been resident in the area for less than 6 months at the time of recruitment. * children with obvious physical and mental disability. * severely malnourished children. * severely anaemic children (hb \<70g/l).

Keywords: nafeedta electrolytic iron efficacy whole maize flour phytate school-age children controlled trial africa
analysis of the influence of desensitizing treatments on the pulp inflammatory response in bleached teeth

Conditions: Pulp Inflammation

Summary: this randomized, controlled, blinded clinical trial evaluated the effectiveness of different desensitizing protocols in preventing pulp inflammation after bleaching treatment with 35% hydrogen peroxide (ph) (whiteness ph 35%).

thirty healthy third human molars extracted by orthodontic indication were randomized and allocated into five groups (n = 6): cn (negative control): without intervention; cp (positive control): ph; pmb: ph + photobiomodulation with low power laser; cpp: ph + casein phosphopeptide phosphopeptide amorphous calcium phosphate (cpp-acpf); nano: ph + nanohydroxyapatite. the office whitening was performed in two sessions with a single application of 45 min and an interval of 48 hours between them. pulp tissues were removed for immunohistochemical analysis. immunostaining was performed for caspase 3 using an axio scope.a1 microscope.

Eligibility criteria:
inclusion criteria: * lower third molars class i position a * maxillary third molars horizontal position a * absence of caries and enamel fracture * absence of periodontal disease * extraction of third molars for orthodontic reasons * no allergy to the anesthetic and positive pulp sensitivity test exclusion criteria: * calcification in the middle third of the root * drug users or smokers * patients who have already done whitening * root apex with incomplete formation and patients with systemic problems that would make surgery impossible

Keywords: therapies caspase 3 immunohistochemistry