Kornimate/medical-research-clean huggingface dataset:
misoprostol in the treatment of postpartum hemorrhage

Conditions: Postpartum Hemorrhage

Summary: postpartum haemorrhage (pph) remains a leading cause of maternal mortality, despite treatment with conventional methods. uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. in this randomised controlled trial (rct), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing pph. women with measured blood loss greater than or equal to 500 mls in 4 karachi hospitals who give consent will be given locally routine treatment for pph. in addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. the primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.


Eligibility criteria:
inclusion criteria: * all women delivering vaginally with clinically diagnosed pph requiring uterotonics exclusion criteria: * refusal to give consent for participation or if the woman is too distressed to give consent * woman is not entitled to give informed consent (e.g. minors without a guardian) * woman who had a caesarean section * delivery is regarded as abortion (gestational age \< 28 weeks)

Keywords: postpartum haemorrhage misoprostol
marijuana cue-reactivity & seeking behavior in regular cannabis users

Conditions: Marijuana Abuse

Summary: the purpose of the proposed study is to examine the relationship between marijuana reminders, or "cues", craving for marijuana, and marijuana use. the principal investigator is also assessing whether n-acetylcysteine, can reduce marijuana craving or use.

this study involves three screening sessions that could last about 3 hours each. part of this study will be conducted on an inpatient unit where the participant will live for 4 straight nights. during the inpatient stay participants will participant in experimental sessions where they will be asked to smoke cigarettes containing either marijuana or placebo (a blank). participants will be asked to take capsules that could contain n-acetylcysteine or placebo (blank). participants will be asked to complete questionnaires and have vital signs (blood pressure, heart rate) monitored. participants will be asked to participate in overnight sleep recordings, a polysomnogram (psg).

Eligibility criteria:
inclusion criteria: * participants will be healthy individuals 21-55 year olds who use marijuana. * marijuana use will be verified by self-report and thc-positive urine samples. -participants must meet dsm 5 criteria for cannabis use disorder and be willing to participate in research but not seeking treatment. exclusion criteria: * candidates with the following conditions will be excluded: * serious psychiatric illness (e.g. psychotic or bipolar disorder * recent (past 5 years) suicide attempts * major depression that is not substance-induced) * substance use disorders (sud) other than cannabis or nicotine use disorders and mild alcohol use disorder * neurological diseases (e.g. stroke, seizures) * cardiovascular problems (e.g. myocardial infarction, angina, systolic bp \>160 or \ 95 mmhg, clinically abnormal ecg) * pulmonary diseases (e.g. asthma, tb) * systemic diseases (e.g. hepatitis, autoimmune, cushing syndrome) * cognitive impairment (\<80 iq) * past-month exposure to medications that increase study risk (e.g. toxicity to major organs, asthma inhalers) * women who are pregnant (urine hcg), lactating (self-report), or if heterosexually active and not using (self-report) medically approved birth control measures (oral/depot contraceptives, iud, condom/foam, sterilization, tubal ligation) * seeking treatment for a substance use disorder. * individuals unable to give voluntary informed consent will be excluded. applicants interested in treatment will be excluded from the study and referred to a treatment program.
decision coaching for youth and parents considering insulin delivery methods for type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: a pre-/post-test design. youth with type 1 diabetes and their parent(s) were referred to the intervention by their diabetes physician. decision coaching guided youth and their parents in completing a patient decision aid that was pre-populated with evidence on insulin delivery options. primary outcomes were youth and parent scores on the low literary version of the decisional conflict scale (dcs).

a pre-/post-test design was used. youth with type 1 diabetes and their parent(s) were referred to the intervention by their diabetes physician. eligible participants were youth under 18 years old with t1d and their parents, who were considering a change in insulin delivery method, capable of participating in the decision making process, and able to read and speak english or french. no lower age limit was set for youth participants, provided the youth and parent(s) could participate in the consent or assent process. family dyads (youth and one parent) and family triads (youth and two parents) were included. the intervention was decision coaching guided by the ottawa decision support framework for youth with type 1 diabetes and their parents using a patient decision aid that was pre-populated with evidence on insulin delivery options.

Eligibility criteria:
inclusion criteria: * youth with type 1 diabetes and their parents * considering a change in their insulin delivery method * capable of participating in the decision making process * able to read and speak english or french exclusion criteria: * using an insulin pump
effectiveness of video-based multicomponent treatment for fibromyalgia plus face-to-face sesions

Conditions: Fibromyalgia

Summary: the aim of this study was to examine the effectiveness of two video-based multicomponent programs: fibrowalk virtual and the fibrowalk virtual plus face-to-face sessions for patients with fibromyalgia (fm) compared to treatment-as-usual (tau) only. the investigators posit that fibrowalk virtual plus face-to-face sessions, due to the best results obtained with the fibrowalk carried out completely face-to-face versus the results of the fibrowalk virtual, can help patients with fm to experience more ubiquitous clinical improvement than tau or fibrowalk virtual alone.

fibrowalk therapy has shown better results when performed in a natural environment face-to-face. due to the state of the pandemic, it is necessary to study different forms of approach. it is proposed what number of face-to-face sessions would be necessary to add to the virtual fibrowalk program to achieve the same or similar effectiveness as in the totally face-to-face format. this is a tree-arm rct focused on the safety and potential effectiveness of the multicomponent program virtual fibrowalk as coadjuvant of treatmentas- usual (tau) vs. tau alone and on the comparation of the face-to-face sessions added to virtual fibrowalk. * virtual fibrowalk combines multicomponent approach based on pain neuroscience education (pne), therapeutic exercise, cognitive behavioural therapy (cbt) and mindfulness training. * face-to-face sessions added to virtual fibrowalk combines de same components than fibrowalk virtual and added 4 face-to-face sessions (1 per mounth) to resolve doubts and reinforce the main concepts of therapy. * the main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia and fear avoidance

Eligibility criteria:
inclusion criteria: * adults from 18 to 75 years-old. * 1990 american college of rheumatology (acr) classification criteria + the 2011 modified acr diagnostic criteria for fibromyalgia * able to understand spanish and accept to participate in the study. exclusion criteria: * participating in concurrent or past rcts (previous year). * comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. alzheimer) that that would limit the ability of the patient to participate in the rct.

Keywords: fibromyalgia multicomponent treatment chronic pain pain neuroscience education therapeutic exercise cognitive behavioural therapy mindfulness randomized controlled trial virtual format
study evaluating the effects of ima-638 on allergen-induced airway responses in subjects with mild atopic asthma

Conditions: Asthma

Summary: primary purpose of the protocol is to determine if ima-638 prevents a mild asthma attack by a subject with mild asthma inhaling an allergen.


Eligibility criteria:
inclusion criteria: inclusion criteria: * generally healthy, men and women with mild allergic asthma, aged 18 to 60 years * only asthma med is short-acting bronchodilator used not more than twice weekly * fev1 greater than 70% predicted and a demonstrated baseline late response to allergen induction exclusion criteria:
effect of heatwaves on glycemic control in people with type 1 diabetes treated with artificial pancreas

Conditions: Type 1 Diabetes

Summary: to analyze the effect of heatwaves on interstitial glucose in adult patients with type 1 diabetes mellitus treated with artificial pancreas

observational retrospective study to analyze the effect of heatwaves on interstitial glucose in adult patients with type 1 diabetes mellitus treated with advanced hybrid closed-loop systems in the castilla-la mancha region (southcentral spain). main objective is the difference in time in range of intersticial glucose between 3.0-10 mmol/l (70-180 mg/d) measured throught real-time continuous glucose monitoring during the two consecutive greatest heatwave during summer 2024 (5th-26th august) comparted to the following period (27th august to 17th september). data analysis is conducted using spss (chicago, il) statistics software. results are presented as mean ± sd values or percentages. a paired student's t-test or a wilcoxon signed-rank test were used for the analysis of differences. comparisons between proportions were analyzed using a chi-squared test. a p value \< 0.05 was considered statistically significant. the protocol was approved by the reference castilla-la mancha public health institute ethic committee.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * older than 18 years old * using advanced hybrid closed-loop systems (ahcl) * paired active ahcl data from the heatwave periods and two consecutive weeks exclusion criteria: * younger than 18 years old * not using ahcl * not having active paired ahcl data from the analyzed periods

Keywords: advanced hybrid closed-loop artificial pancreas heatwave climate change global warming
gut microbiome dynamics in metastasized or irresectable colorectal cancer

Conditions: Colorectal Cancer Metastatic

Summary: in this study the characteristics and alterations of the gut microbiome during chemotherapy for metastasized or irresectable crc are studied, as well as the relation between the gut microbiome and the effects of chemotherapy.

although systemic treatment for metastasized or irresectable colorectal cancer (crc) is becoming increasingly effective, overall survival is still poor and side effects of current treatment modalities are substantial. there is an urgent need for novel therapies, and in addition, better predictive tools are needed to select the right drug to the right patient. new data suggest that modulation of the microbiome of the gut might provide opportunities to increase anti-tumor efficacy of immunotherapy. whereas the relation between the gut microbiome and immunotherapy is intensively studied, the relation between the gut microbiome and efficacy of conventional chemotherapy is unknown. a better understanding of the composition, function and dynamics of the gut microbiome before and during chemotherapy might help to identify factors that can be influenced during the treatment of patients with metastasized or irresectable crc. therefore, in this study the characteristics and alterations of the gut microbiome during chemotherapy for metastasized or irresectable crc are studied, as well as the relation between the gut microbiome and the effects of chemotherapy.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients with histologically confirmed crc with an indication for palliative systemic anti-tumor therapy (any combination of chemotherapy with/without anti-vegf of anti-egfr therapy) * measurable disease according to recist v1.1. * stored pathological specimens available * life expectancy ≥ 12 weeks * signed informed consent form * ability to comply with protocol exclusion criteria: * previous (neo)adjuvant chemotherapy \< 6 months * previous radiotherapy on the small or large intestine \< 1month * previous surgery of the small or large intestine \< 1 month * uncontrolled inflammatory bowel disease * participation in a study with a potential effect on the gut microbiome

Keywords: colorectal cancer gut microbiome
effects of substance p on headache induction in healthy individuals

Conditions: Healthy Volunteers Only

Summary: substance p is a signaling molecule that has been implicated in the pathogenesis of headache. this study aims to ascertain whether administration of substance p can induce headache in healthy adults.

substance p is a vasoactive signaling molecule that belongs to the tachykinin family of peptides. it is expressed in multiple cells, including primary afferents of the trigeminal ganglion that innervate the meninges and its arteries. the best-known function of substance p is its role in pain transmission, and several lines of evidence has implicated substance p in the pathogenesis of headache. this study aims to ascertain whether intravenous infusion of substance p induces headache in healthy individuals who have no past or current history of primary or secondary headache disorder, except for infrequent episodic tension-type headache. for this purpose, we will conduct a randomized, double-blind, placebo-controlled, 2-way crossover trial.

Eligibility criteria:
inclusion criteria: * age 18 to 65 years of age upon entry into screening * a body weight of 50 to 100 kg * provision of informed consent prior to initiation of any study-specific activities/procedures. exclusion criteria: * any history of a primary or secondary headache disorder, except for infrequent episodic tensiontype headache * any first-degree relatives with a history of a primary headache disorder, except for infrequent episodic tension-type headache * any history of moderate to severe traumatic brain injury * any history of cardiovascular disease, including cerebrovascular diseases * any history of pulmonary disease * any other clinically significant disorders, conditions, or diseases that might impact the safety of the subject or interfere with the study's evaluation, procedures, or completion, aside from those mentioned above. this includes any relevant medical history or evidence that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results * the subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior * female subjects of childbearing potential with a positive pregnancy test during any study visit * cardiovascular disease of any kind, including cerebrovascular diseases * hypertension (systolic blood pressure of ≥150 mmhg and/or diastolic blood pressure of ≥100 mmhg) prior to the start of infusion on the experimental day * hypotension (systolic blood pressure of ≤90 mmhg and/or diastolic blood pressure of ≤50 mmhg) * abnormalities on the electrocardiogram that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results * daily use of any medication other than contraceptives * intake of any medication other than contraceptives within 48 hours of infusion start * intake of caffeine, nicotine, and alcohol within 12 hours of infusion start * headache of any intensity within 48 hours of infusion start

Keywords: headache
histidine-tryptophane-ketoglutarate (htk) vs university of wisconsin (uw) perfusion in clinical pancreas transplantation

Conditions: Diabetes Mellitus; Pancreas Transplantation

Summary: graft preservation in clinical pancreas transplantation is based on hypothermia achieved by topic cooling and cold in situ flushing using special perfusion solutions designed to attenuate the effects of ischemia/reperfusion and prolong cold ischemia tolerance. for pancreas transplantation, university of wisconsin (uw) solution is the most commonly used perfusate. however, over the last years, histidine-tryptophan-ketoglutarate (htk) solution has been increasingly used for abdominal organ procurement. retrospective reports published so far have demonstrated the safety of both perfusion solutions. however, to date, no prospective study comparing both perfusion solutions has been published. aim of this study was to prospectively evaluate early pancreas graft function in clinical pancreas transplantation after organ perfusion with htk vs. uw solution. the study hypothesis is that htk is not inferior to uw for organ perfusion during procurement in clinical pancreas transplantation.


Eligibility criteria:
inclusion criteria: * brain dead, heart beating organ donor * donor age 10 - 50 years * donor body mass index \< 30kg/m2 * pancreas cold ischemia time \< 20 hours * written informed consent of the pancreas recipient exclusion criteria: * missing written consent * pancreas retransplantation * recipient participation in another study

Keywords: pancreas clinical, donor pancreas clinical, preservation solutions organ preservation and procurement, surgery organ procurement, ischemia reperfusion injury organ preservation and procurement
intensive medical treatment for nephropathy caused by type 2 diabetes with hypertension

Conditions: Type 2 Diabetes Mellitus; Hypertension

Summary: to observe the effect of intensive medical treatment for type 2 diabetic patients with hypertension: to discover whether or not intensive medical treatment improves proteinuria, and the difference between the clinical meaning of responder and non-responder (criteria: 50% reduced proteinuria continuing 6 months or more during the observation period.)

it is reported that the risk of a cardiovascular event occurring is 1.78 times higher in patients with diabetic nephropathy (dn) than in patients without dn. it is also reported that angiotensin ii receptor blockade (arb) prevents the progression of dn in diabetic patients with early phase nephropathy beyond its blood pressure lowering effect. the guidelines by the japanese society of hypertension 2004 recommended that it was necessary to control blood pressure (bp) below 130/80 mmhg in all diabetic patients. this has become the universal target bp for the prevention of cardiovascular events in hypertensive patients. on the study of intensive medical treatment \[including angiotensin-converting enzyme inhibitor (acei)\], it is reported that acei not only prevents the progression of dn in microalbuminuria but also decreases proteinuria \ 1 g/day.

Eligibility criteria:
inclusion criteria: type 2 diabetic patients with hypertension, with all 5 of the criteria listed below: 1. age 20 years and above 2. blood pressure \>125/75 mmhg 3. urinary protein creatinine ratio 1g/g・cr or urinary protein \>1 g/day 4. presence of diabetic retinopathy 5. already performing dietary management * there were no limitations on serum creatinine. * bp was recorded 3 times while the patient was seated and averaged. * the subjects in this study were outpatients with written informed consent. exclusion criteria: 1. another definable renal disease other than dn 2. collagenosis 3. malignant hypertension with emergent treatment 4. severe hypertension (diastolic bp \>120 mmhg) 5. severe chronic heart failure or acute myocardial infarction in the past 6 months 6. atrial fibrillation or severe arrhythmia 7. anamnesis of cerebrovascular disease with neuropathy 8. anamnesis of anaphylaxis or chronic dermatopathy 9. severe hepatic disease 10. pregnancy 11. anamnesis of anaphylaxis from angiotensin ii receptor blocker 12. patients are judged to be inapposite by the attending physician

Keywords: type 2 diabetes mellitus hypertension angiotensin ii receptor blocker diabetic nephropathy
breestim and tdcs for neuropathic pain management - healthy subjects

Conditions: Pain Management

Summary: this study looks at the effect of combined breathing-controlled electrical stimulation (breestim) and transcranial direct current stimulation (tdcs) on neuropathic pain after spinal cord injury, amputation, or brain injury. the hypothesis is that a single session of combined breestim and tdcs will produce an additive analgesic effect. this record covers the study in a population of healthy volunteers. note that this study will also enroll spinal cord injury patients, brain injury patients, and amputation patients and that this study as applied to these other populations will be covered in separate clinicaltrials.gov records.


Eligibility criteria:
inclusion criteria: * between 18 and 75 years * male and female subjects * healthy subjects (i.e., no recent injuries or pain) exclusion criteria: * recent injuries or pain * have a pacemaker, or other metal and/or implanted devices * have amputation in their arm(s) * have spinal cord injury (sci) involving impairment of arms * have cognitive impairment from brain injury or are not able to follow commands, or to give consent * have asthma or other pulmonary disease * are not medically stable * have preexisting psychiatric disorders * alcohol or drug abuse * have a history of seizures/epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants. * mini-mental state examination (mmse), a brief 30-point questionnaire test that is commonly used in the literature, will be used to screen for cognitive impairment. a brain injury patient with a score of 24 or lower on mmse will be excluded.