Kornimate/medical-research-clean huggingface dataset:
negative pressure wound therapy after cesarean delivery

Conditions: Major Puerperal Infection, Postpartum; Wound Complications; Wound Seroma; Caesarean Section Wound Separation; Wound Infection

Summary: this study is aimed at determining whether or not the use of a wound suction device placed on the cesarean incision instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. the study will first look at the infection and wound complication rate in women 6 months prior to the start date of the study by reviewing charts of women who have undergone a cesarean section. the study involves placing a single use, portable wound vacuum over the cesarean section incision and keeping it in place for 72h. the investigators will then compare the rates of wound infection and wound complications between these two groups. it is our hypothesis that negative pressure wound systems will decrease the wound infection and complication rate in this high risk population.

infectious complications have been found to be five times higher in women undergoing a cesarean delivery compared to a vaginal delivery. known risk factors for wound complications are obesity, premature rupture of membranes, diabetes mellitus, hypertensive disorders, emergency cesarean delivery, twin delivery, chorioamnionitis, increased surgical blood loss and preeclampsia. this study is aimed at determining whether or not the use of a suction device placed on the wound instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. the investigators will compare the results from the participants of this study to an existing data set of historical controls who underwent cesarean delivery. the study involves placing a single use, portable negative wound pressure system kept in place while in the hospital after surgery (on average 48-72 hours) in women who meet criteria for increased risk of wound complications. the investigators will then compare the rates of wound infection and wound complications between these two groups.

Eligibility criteria:
inclusion criteria: * 18 years old or older * having a cesarean delivery * has one or more of the following conditions: * bmi \> 30 * anemia * preeclampsia (sever or mild) * hemolysis, elevated liver enzymes and low platelets (hellp) * urgent procedure * rupture of membranes prior to surgery for \> 4 hours * chorioamnionitis * hypertension * diabetes (gestational or pre-gestational) * dense adhesive disease exclusion criteria: * age \< 18 years old * unable to give informed consent

Keywords: cesarean delivery postpartum infection wound complications wound seroma wound separation wound infection negative pressure
drug eluting balloon angioplasty versus nitinol stent implantation in the superficial femoral artery

Conditions: Peripheral Arterial Disease; Arterial Occlusive Diseases; Atherosclerosis; Arteriosclerosis; Cardiovascular Diseases; Peripheral Vascular Diseases; Paclitaxel; Plaque, Atherosclerotic; Critical Limb Ischemia

Summary: the purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the nitinol stent implantation in the femoropopliteal segment.


Eligibility criteria:
inclusion criteria: * patients over 18 years with critical lower limb ischemia, * ruhtherford 3 or higher, * with angiographic documentation of greater than 70% or occlusion in the superficial femoral artery, * with a maximum extension of 10 cm stenosis. * the popliteal artery and at least one leg artery must be patent. exclusion criteria: * pregnancy, * thrombophilia, * coagulation disorders, * presence of active or recent bleeding, * severe allergy to iodinated contrast, * renal or hepatic disease, * acute limb ischemia, * prior surgical bypass or angioplasty (with or without stent) on the target artery, * obstructive disease (stenosis\> 50%) of the aortoiliac segment ipsilateral to the target (if the aortoiliac is pre-treated, the patient may be included)

Keywords: artery atherosclerosis peripheral arterial plaque pta angioplasty femoropopliteal self expandable nitinol stents
breathing and relaxation exercises for asthma: a randomised controlled trial

Conditions: Asthma

Summary: all patients on the gp asthma database in one practice were invited for an asthma physical-therapy assessment, at baseline. volunteers satisfying the inclusion criteria ie - aged between 16 and 70, able to understand, read and write english, give informed consent, willing to attend the surgery to take part in the trial and with no other serious conditions - were invited to participate in the study. patients were randomised either to a control group, receiving 2 more assessments at 6 and 12 months, or for comparison to a group receiving 5 physical-therapy treatments of integrated breathing and relaxation exercises (known as the papworth method (pm)). the two groups would then be compared at 6 and 12 months. hypotheses: 1. the pm of breathing and relaxation training would improve the quality of life for adult patients with asthma in primary care, compared with patients only receiving usual medical care. 2. anxiety and depression, and symptoms from dysfunctional breathing would reduce compared with the control group. 3. respiratory function measurements would improve compared with the control group.


Eligibility criteria:
inclusion criteria: * doctor diagnosed asthma, volunteers from the practice asthma database * 16-70 years of age * able to understand, speak and write english * willing to give informed consent * willing and able to attend the surgery for assessments and treatments exclusion criteria: * serious co-morbid conditions

Keywords: asthma randomised controlled trial breathing exercises relaxation exercises primary care
a single ascending dose clinical trial to find the maximum tolerable dose of hl237 in healthy male subject

Conditions: Rheumatoid Arthritis

Summary: hl237 is a new autoimmune therapeutic agent for rheumatoid arthritis, including the basic structure of biguanide in metformin, an existing diabetes drug. the immune modulating activity of hl237 was demonstrated in animal model. hl237 is a stat3 inhibitor and stat3 is well known for an important regulator inhibiting th17 cells and activating treg cells. therefore, when stat3 activity is inhibited, it is expected to be able to treat autoimmune diseases such as rheumatoid arthritis. this is the first clinical trial to be conducted for the development of hl237 and this clinical trial is for determining the maximum oral dose of hl237 and assessing safety, tolerability, and pharmacokinetic characteristics for each dose group.


Eligibility criteria:
inclusion criteria: * a healthy adult male aged 20 years or older and 45 years old at the time of the screening test * those who weigh more than 55kg but weigh less than ± 20% of ideal body weight * proper contraception during the clinical trial period * after hearing the detailed explanation of the clinical trial, those who decide to participate voluntarily and write agreement exclusion criteria: * clinically significant, a person with a history of neurological, psychiatric, malignant, cardiovascular, respiratory, kidney, endocrine, hematologic, digestive or central disease * a person with a history of gastrointestinal disorders that may affect the absorption of pharmaceuticals for clinical trials (crohn's disease, ulcers, etc.) or gastrointestinal surgery (except for simple cecal surgery or hernia surgery) * a person with a history of hypersensitivity or clinically significant hypersensitivity to the clinical trial drug or additives * a person judged to be inappropriate for the subject by health screening (history of disease, physical examination, vital signs, electrocardiogram, laboratory test, etc.)
using breath metabolites to determine specific virus infection in asthmatic patients

Conditions: Upper Respiratory Tract Infections, Asthma, Exhaled Breath

Summary: respiratory virus infections cause a majority of asthma exacerbations in the fall to spring months. current diagnostic platforms for respiratory viruses have limitations including cost, availability, and invasiveness. the use of noninvasive breath collection to analyze breath metabolites may be used to differentiate virus-infected asthmatics from other causes of acute asthma exacerbations.


Eligibility criteria:
inclusion criteria: * asthma, age ≥12, symptoms/signs of an early asthma exacerbation, ability to provide exhaled breath condensate (ebc) x15 min, body mass index (bmi) ≥18 exclusion criteria: * chronic lung diseases other than asthma (e.g., chronic obstructive pulmonary disease \[copd\], lung cancer, fibrotic lung disease, etc.), smoking in the past 7 days, eating or non-clear liquids \<4 hrs prior to ebc collection, pregnancy
a dose-finding study of tebapivat to assess efficacy, and safety in participants with sickle cell disease (scd)

Conditions: Sickle Cell Disease

Summary: the main purpose of this study is to compare the effect of tebapivat versus placebo on anemia and to detect a dose-response for hemoglobin (hb) response in participants with scd.


Eligibility criteria:
key inclusion criteria: * documented diagnosis of scd (hbss, hbsc \[combined heterozygosity for hemoglobins s and c\], sickle hemoglobin \[hbs\]/β0-thalassemia, hbs/β+-thalassemia, or other sickle cell syndrome variants). * hemoglobin ≥5.5 and ≤10.5 grams per decilitre (g/dl). hemoglobin concentration must be based on an average of at least 2 hb concentration measurements (separated by ≥7 days) collected during the screening period. * if taking hydroxyurea, the hydroxyurea dose must be stable for at least 90 days before randomization. discontinuation of hydroxyurea requires a 90-day washout before providing informed consent. key exclusion criteria: * receiving regularly scheduled red blood cell (rbc) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion); episodic transfusion in response to worsened anemia or vaso-occlusive crisis (voc) is permitted. additionally, a participant who requires episodic transfusion(s) may not have received a transfusion(s) within 60 days before providing informed consent or during the screening period. * \>10 sickle cell pain crisis (scpcs) in the 12 months before providing informed consent. * receiving anabolic steroids that have not been stopped for at least 4 weeks before randomization. testosterone replacement therapy to treat hypogonadism is allowed; the testosterone dose and preparation must be stable for ≥10 weeks before randomization. * hospitalized for an scpc and/or other vaso-occlusive event within 14 days before providing informed consent or within 14 days before randomization. if an scpc occurs during the screening period, the screening period may be extended with medical monitor approval. * receiving treatment with voxelotor, crizanlizumab, or l-glutamine within 90 days before randomization. * platelet count \<lower limit of normal (lln) for the local laboratory or \<150×109/liter (l) (whichever is lower) during screening. platelet transfusions received within 28 days before consent or during screening. * receiving treatment with hematopoietic stimulating agents within 90 days before randomization. * prior exposure to gene therapy or prior bone marrow or stem cell transplantation, including any conditioning regimen.
treatment of schizoaffective disorder using mifepristone

Conditions: Psychotic Disorders; Depressive Disorder, Major; Depressive Disorder

Summary: this study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.

you are invited to participate in a research study which evaluates the effectiveness of mifepristone (ru 486) in rapidly reducing the symptoms associated with schizoaffective disorder. our group believes that the cognitive deficits (a decline in the ability to think clearly) and psychosis (hallucinations or delusions) exhibited in some affective disorders are driven by an excess of stress hormone effects (hypercortisolemia). often the origin of this hormonal imbalance is unknown. current treatment for schizoaffective disorder (characterized by mood swings and hallucinations and/or delusions) involves using a combination of antidepressant medication (for mood elevation), mood stabilizing medications (to prevent extreme high and low moods) and antipsychotic medication (for the correction of altered thinking). while these therapies are often effective, they can take several weeks or longer to work. we hope to uncover a quick, effective, safe therapy for the treatment of individuals with your condition.

Eligibility criteria:
inclusion criteria:the subjects will be 30 inpatients or outpatients with schizoaffective disorder. exclusion criteria:subjects must be between the ages of eighteen and seventy-five without major medical problems.
evaluation of the initial safety and efficacy of keloid lesions treated with mf-4181

Conditions: Keloid

Summary: the objective of the study is to evaluate the initial safety and efficacy of mf-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing surgical revision of keloid scars.


Eligibility criteria:
inclusion criteria: * male or female subjects 15 to 50 years of age each having at least one keloid scar on the ear. (if both ears have keloids, both ears may be treated with e-matrix). * keloids that have not undergone more than two surgical revisions (laser, cryotherapy or surgery) * keloids that have been present for ≥ 1 year. * the keloid must measure ≥ 0.5 cm and not extend onto other portions of the head, neck, or face. * able and willing to give written informed consent. (age 15-17 must have written informed consent of legal guardian). * willing to comply with the follow up schedule for a minimum of 6 months. exclusion criteria: * subjects with history of prior treatment at the study site or prior treatment of the keloid in the previous 6 weeks. * pregnant or planning to become pregnant during the course of the study. * heart disease or history of congestive heart failure. * advanced or poorly controlled diabetes. * current or history of heavy smoking (i.e., 10 pack years) * active local infection at the treatment site and/or systemic infection. * history of or active central nervous system disease. * history of fever, migraine headaches, and/or recurrent upper respiratory infection. * active collagen vascular disease or vasculitis, e.g., systemic lupus erythematosus, polyarthritis, dermatomyositis, systemic scleroderma or thrombotic thrombocytopenic purpura. * unwilling or unable to return for follow-up visits. * unwilling to refrain from use of any other scar treatment therapy/scar improving product, during the study, including steroid injections. * regular, continuous use of systemic corticosteroid therapy or topical corticosteroid use in the area to be treated. * current participation or participation within the last 3 months in the study of an investigational drug, device, or biologic. * unable or unwilling to follow post-operative instructions. * known hypersensitivity to mf-4181, collagen, dextran, or any of its constituent materials. * known hypersensitivities to animal-based products * previous participation in this study to avoid multiple enrollments of an individual subject.
the acute effects of low temperature for long time heat treatment of pork semitendinosus on satiety

Conditions: Healthy Subjects

Summary: cooking meat at low temperatures for prolonged times is widely used among chefs and in food service due to the possibility to obtain a consistent and appealing eating quality. the method is generally termed low-temperature long-time (ltlt) cooking. in ltlt cooking, meat is vacuum-packed and heated at temperatures between 50°c and 65°c in a water bath for several hours. ltlt has several benefits - improved tenderness and juiciness, less cooking loss, better vitamin retention and uncompromised food safety. a recent phd thesis concluded that one of the mechanisms behind the changes in eating quality during ltlt cooking was due to the proteolytic degradation in the muscle tissue. the activity of proteolytic enzymes has shown to be dependent on heating temperature and time where the cathepsins were found to remain active during heat treatment. at 58°c the cathepsin b+l activity is increased compared to 48°c and 53°c and at 55°c compared to 25°c, 40°c and 70°c. a prolonged heating time of 17 hours at 58°c has also shown to increase cathepsin b+l activity. the proteolytic degradation results in the occurrence of peptides and amino acids such as tryptophan, tyrosine, leucine and histidine which could lead to a faster degree of satiety when consumed. according to the aminostatic hypothesis by mellinkoff, a rise in plasma amino acids elicited by protein ingestion could assist in the suppression of food intake and the onset of satiety. the investigators therefore hypothesize that the ingestion of ltlt cooked pork would induce a faster satiety response due to the higher availability of peptides and amino acids prior to digestion. an acute meal study will elucidate this. ltlt cooking will be performed by the "cook-chill" method to mimic real life where meat is rapidly chilled after heat treatment, stored at 0-2°c and reheated and browned prior to serving.


Eligibility criteria:
inclusion criteria: * participants who have provided written informed consent * healthy men * ages between 18 and 60 years * bmi between 18.5 and 30 kg/m2 * pork eaters exclusion criteria: * any food allergy, dislike or special diet of relevance to the study (e.g. vegetarian) * daily use of prescription medicine or over-the-counter drugs affecting appetite, energy expenditure or protein metabolism * use of dietary supplements (including protein supplement, powders, shakes) up to 1 month before the first meal test * irregular eating schedule (e.g. skipping breakfast) * self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months * any known chronic diseases (e.g. cancer, heart disease, diabetes, neurological disorders) * vigorous physical activity more than 10 hours/week * smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes) (\>10 cigarettes per day) * participants who work in appetite or feeding related areas * participation in other intervention studies * participants not able to comply with the study protocol as judged by study personnel
wolff-parkinson-white syndrome anterograde refractory period of accessory duct

Conditions: Wolff-Parkinson-White Syndrome

Summary: the study consists of the realization of a new esophageal stimulation for patients already stimulated 10 years ago. the investigators would like to make a long term evaluation of the evolution of anterograde effective refractory period of accessory duct in the wpw syndrome. this study will be realized by esophageal stimulation.


Eligibility criteria:
inclusion criteria: * 21 \< age \< 64 years * first esophagal stimulation with evaluation of effective anterograde refractory period \> 10 years * informed consent signed * diagnosis of wolff-parkinson-white syndrome * no procedure of ablation of accessory duct exclusion criteria: * ablation of accessory duct * patient with contraindication to esophageal stimulation * patient with contraindication to effort test
reducing self-stigma using brief video intervention

Conditions: Stigma, Social; Mental Health Disorder

Summary: stigma is a profound obstacle to care. self-stigma decreases sense of self-competency, as well as healthcare seeking and treatment adherence and creates barriers to pursuing employment, independent living, and fulfilling social life. for example, people with mental disorders avoid, delay, or drop out of treatment due to a fear of labeling and discrimination or experience treatments as ineffective or disrespectful. therefore, reducing self stigma can reduce self-blame, improve self-confidence and provide support for people living with mental illness. in a prior study, the investigators developed a short video intervention to reduce self-stigma among people with schizophrenia. the investigators would like to test the efficacy of this video using prolific (a crowdsourcing platform). specifically, the investigators are interested in recruiting 1,200 prolific participants, ages 18-35, who mentioned in their profile while enrolling to prolific that they have a mental health condition, and randomized them into watching the newly developed video to reduce self-stigma or participate in the non-intervention control arm. participants will be invited to participate in a follow-up survey 30 days after completing the first survey.

the primary objective of this study is to test the video efficacy in reducing self stigma among 1,200 prolific users who mentioned in their profile while enrolling to prolific that they have a mental health condition (600 in an intervention group, and 600 in a non-intervention control group). the study participants will be invited to participate in a 30-day follow up questionnaire. the investigators hypothesize finding a reduced level of self-stigma among those who watch the intervention video.

Eligibility criteria:
inclusion criteria: * english-speaking * 18-35-year-old * us residents * those who answered yes to "do you have or have you had a diagnosed, ongoing mental health/illness/condition?" exclusion criteria: * non english-speaking * non us residents * age younger than 18 or older than 35 * people who replied no to the question on ongoing mental health