Kornimate/medical-research-clean huggingface dataset:
caesarean and corticotherapy

Conditions: Neonatal Distress

Summary: comparison of two randomized group : * caesarean section planned at 38 weeks after 2 antenatal injections of 12 mg of betamethasone 48 h before. * caesarean section planned at 39 weeks without corticosteroid. the aim is to demonstrate that programming caesarean section at 38 weeks of pregnancy, after antenatal corticosteroid, allows to avoid caesarean section in emergency (because of a labour before 39 weeks), without increasing the neonatal respiratory distress rate.


Eligibility criteria:
inclusion criteria: * woman who needs elective caesarean section exclusion criteria: * multiple pregnancy * toxaemia * rhesus immunization * fetal infection * maternal gastro-duodenal ulcer * mother hiv+ * prior injection of corticosteroid during the pregnancy

Keywords: caesarean section corticosteroids betamethasone neonatal distress
acupressure in patients with sickle cell disease

Conditions: Sickle Cell Disease

Summary: the proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupressure analgesia in patients with sickle cell disease (scd).

this study will help the investigators learn whether acupressure, a non-pharmacological alternative treatment approach, can help manage pain in patients with sickle cell disease. acupressure involves the application of pressure stimulation at specific acupoints on the body. acupressure may help relieve pain and is used for a wide variety of pain conditions. participation in this study will consist of remote self-administered treatment every other day over 5 weeks, followed by 6 months of remote follow-up visits. during participation, subjects will: 1) receive detailed instruction on locating treatment acupoints and completing study procedures remotely, 2) be assigned a treatment kit, 3) answer questions about their personal and health-related information for assessing their health condition before, during, and after the treatment during follow-up sessions, and 4) collect inner eyelid images for examining the hemoglobin level on a weekly basis at steady phase and daily basis during acute vaso-occlusive crisis stage.

Eligibility criteria:
inclusion criteria: * any gender * 14-17 (adolescents) and 18-80 (adults) years old * have been diagnosed with scd and experiencing chronic pain in the past 6 months or vaso-occlusive crisis/crises in the past 12 months. * either outpatient or inpatient or status changing between each other * willing to limit the current and the introduction of any new medications or treatment modalities for control of pain symptoms during the study visits. * willing to stick to the scheduled acupressure treatments every other day for 5 weeks. * fluent in english and capable of giving written informed consent. exclusion criteria: * recent/ongoing alternative pain management with acupuncture/acupressure or acupuncture/acupressure-related techniques within the last 6 months. * presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain or any other chronic pain condition with pain greater than sickle pain. * diseases/conditions history includes but not limited to: * head injury with substantial loss of consciousness * known non-scd-related severe psychiatric illnesses (e.g. current schizophrenia, major depression with suicidal ideation). * significant visual, motor, or auditory impairment that would interfere with ability to perform study visits-related activities

Keywords: sickle cell disease pain acupressure inner eyelid imaging
the effect of histamine h1 receptor antagonist, clemastin, on pacap38 induced headache in migraine patients

Conditions: Migraine Without Aura

Summary: the purpose of this study is to determine the effects of antihistamine (clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (pacap38) as well as on biochemical markers for mast cell degranulation in migraine patients. also, to investigate the occurrence of migraine in migraine patients after infusion of pacap38 in lower dosages than previously investigated. as this has never been done before it is unknown how a lower dose of pacap38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks. our three hypotheses are: 1. pre-treatment with clemastin reduces pacap38 sensitivity and inhibits development of migraine in migraine patients. 2. clemastin inhibits the increase in plasma concentration of tnf-alpha, histamine and tryptase after pacap38-infusion. 3. pacap38 in lower dosages (4, 6 and 8 pmol/kg/min) induces migraine in migraine patients.

the purpose of this study is to determine the effects of antihistamine (clemastin) on migraines triggered by pituitary adenylate cyclase activating peptide-38 (pacap38) as well as on biochemical markers for mast cell degranulation in migraine patients. also, to investigate the occurrence of migraine in migraine patients after infusion of pacap38 in lower dosages than previously investigated. as this has never been done before it is unknown how a lower dose of pacap38 will affect 1) the incidence of migraine attacks, 2) the accompanying symptoms, 3) head pain characteristics, and 4) debut and duration of migraine attacks.

Eligibility criteria:
inclusion criteria: * migraine patients fulfilling ihs criteria for migraine without aura, ages 18-50, 50-100 kg, fertile women must be using safe prevention exclusion criteria: * other types of primary headache than migraine * headache on trial day or later than 48 hours before trial day * migraine up to three days before trial day * any type of cardiovascular disease * clinical signs or patient history of any type of illness that the medical doctor in charge of trials deems relevant for participation
a study of tirzepatide in participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2; Hypoglycemia

Summary: the main purpose of this study is to learn more about how tirzepatide affects the body's response to low blood sugar (hypoglycemia). the study is open to participants with type 2 diabetes. it will last about 42 weeks for each participant.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus (t2dm) for at least 1 year * treated with diet and exercise and stable dose(s) of metformin 3 months prior to study entry with or without 1 additional oral antidiabetic medication (oam) other than metformin. * have a hemoglobin a1c (hba1c) value at screening of ≥6.5% and ≤9.0 % if on metformin only. * have a hba1c value at screening of ≥6.0% and ≤8.5 %, if on metformin and 1 more allowed oam. * have a body mass index (bmi) between 23 and 45 kilograms per square meter (kg/m²) inclusive, at screening * are of stable weight (±5%) \>3 months prior to screening exclusion criteria: * have a history of proliferative retinopathy or maculopathy as determined by the investigator based on a recent (\<6 months) ophthalmologic examination * impaired renal estimated glomerular filtration rate (egfr) \<60 milliliters per minute per 1.73 square meters (ml/min/1.73 m²) calculated by chronic kidney disease epidemiology collaboration (ckd-epi) * have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (gi), endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data * have had acute myocardial infarction, congestive heart failure new york heart association class iii or iv, history of or suspected ischemic heart disease, and/or cerebrovascular accident (stroke \[including transient ischemic attack\])
outpatient parenteral antibiotic therapy in the metropolitan area of cologne

Conditions: Implementation of OPAT in Germany

Summary: many infectious diseases require a therapy that is administered intravenously due to a lack of oral treatments. affected patients often have to stay weeks or even months in hospital just for receiving their therapy although they do not feel severely unwell. outpatient parenteral antibiotic therapy (opat) allows these patients under certain requirements to get discharged from hospital and apply the antibiotic treatment on their own. for these patients quality of life improves by feeling more comfortable at home and being able to participate in everyday life or even go back to work. for the hospitals a reduced inpatient health care means a clear reduction of costs. the benefits of opat are obvious, shown by several studies, and in many countries e.g. the usa opat is a very well established way of treatment. in germany however opat is used very infrequently and not in a standardized manner. this is probably due to inadequate knowledge of this form of treatment and deficits in the outpatient care structure, as opat is not reflected in the remuneration system of the german health care system despite internationally proven benefits. the aim of this study is to identify and analyze possible obstacles to the implementation of opat into the standard patient care in germany regarding financial, structural and medical limitations. therefore the investigators intend to treat 120 patients in the metropolitan area of cologne with opat and observe effectiveness, safety, logistics and acceptance to this kind of therapy. if successful, the project should help to identify the potential of opat for germany. if positive effects and feasibility can be demonstrated in the cologne metropolitan region, opat could become an important therapy option with many advantages for certain patients.


Eligibility criteria:
inclusion criteria: * patients who get opat exclusion criteria: * patients who don't get opat or are not capable to give their informed consent

Keywords: opat infectious diseases implementation
molecular imaging of breast cancer with breast pet/ct

Conditions: Breast Cancer

Summary: this study is a feasibility study to determine if a combined breast pet/ct scanner can image malignant functional activity while determining anatomical structure in the same clinical setting for patients with breast cancer. end-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device. the secondary purpose of this study is to explore protocol parameters with a view to optimizing imaging performance whilst minimizing patient discomfort. imaging results will be compared to histological samples to determine ground truth.

pet is literally a molecular imaging modality. in monitoring the patient's response to a specific chemotherapeutic regime, baseline and subsequent pet/ct scans can be used to quantitatively determine the therapeutic effect of the regime, using the standard uptake value (suv), a common metric in pet imaging. the breast pet/ct system will facilitate molecular imaging of breast cancer using a number of radiolabeled molecules, available both commercially (18-fdg) and from the research environment.

Eligibility criteria:
inclusion criteria: - normal adult volunteers * female, at least 18 years of age * ability to lie motionless for up to 20 minutes patient volunteers * female, at least 18 years of age * diagnostic findings from prior mammography highly suggestive of invasive breast carcinoma (bi-rads category 5) * not pregnant or breast-feeding * ability to lie motionless for up to 20 minutes exclusion criteria: * normal adult volunteers * inability to understand the risks and benefits of the study patient volunteers * recent breast biopsy * diagnostic findings from prior mammography highly suggestive of noninvasive ductal or lobular carcinoma * uncontrolled diabetes * diabetic and blood sugar level \> 200 mg/dl * positive urine pregnancy test or currently breast-feeding * inability to understand the risks and benefits of the study

Keywords: breast cancer
comparison of different doses of intrathecal neostigmine in prevention of post-dural puncture headache

Conditions: Headache

Summary: we hypothesized that; intrathecal administration of neostgmine in spinal anesthesia may have a beneficial role in reduction of the incidence or severity of pdph.

neostigmine will be administered in two different doses (10 \& 20 mic) in addition to 10mg bupivicaine intrathecally for cesarean section compared to control group where 10 mg bupivicaine in addition to 20mic fentanyl will be administered intrathecally. the primary outcome will be detection of the incidence of postdural puncture headache (pdph). a 25-gauge quincke spinal needle will be used for spinal anesthesia.patients indicated for elective caesarean section surgery will be included in the study. the exclusion criteria are contraindications for regional anesthesia including local infection, hemorrhagic disorders, drug hypersensitivity, muscular disorders and central and peripheral neuropathy, and drug abuse history and addiction. other outcomes will include age, asa class, and duration of surgery. sensory and motor function will be assessed every minute until t4 level is reached. hemodynamic status (systolic and diastolic blood pressures, heart rate, and spo2) will be recorded every 3 minutes throughout the surgery and then 4 hourly thereafter, for 24 h postoperatively. recovery time from spinal anesthesia (return of motor power of both lower limbs) will be also recorded by anesthesiologist who is unaware of the group. also the intra-operative and recovery phase complications including nausea, vomiting, itching, dyspnea, respiratory rate less than 10 per min, hypoxia (spo2 less than 92% on room air), bradycardia (hr less than 60bpm), and hypotension (spb less than 90) will be recorded. postoperative assessment will include pain scores "overall 24-h vas score", recorded at 30-min interval for first 4 h and then 4 hourly thereafter, for 24 h postoperatively.

Eligibility criteria:
inclusion criteria: * patients indicated for elective caesarean section surgery exclusion criteria: * contraindications for regional anesthesia including local infection, hemorrhagic disorders, drug hypersensitivity, muscular disorders and central and peripheral neuropathy, and drug abuse history and addiction.
comparative effects of paraffin bath therapy and eswt in patients with de quervain tenosynovitis

Conditions: De Quervain Disease

Summary: there is no study in the literature comparing both paraffin bath therapy and extracorporeal shock wave therapy (eswt) in the treatment of patients with de quervain tenosynovitis. the aim of this study is performing this comparison.


Eligibility criteria:
inclusion criteria: * being 18 years or older * meeting de quervain diagnostic criteria * not having applied any physical therapy modality to the hand-wrist in the last 1 month * not using pain medication in the last 1 month, * not using local anesthetics or steroid injections on the hand-wrist in the last 3 months * have received written consent to participate in the study, and have come to the last control at the 6th week. exclusion criteria: * neurological diseases (especially neuropathies), * malignancy, * rheumatological diseases * pregnancy * history of hand/wrist fracture or surgery * hand/wrist trauma in the last 1 month * coagulation disorder diseases
biomarker(s) for glucocorticoids

Conditions: Addison Disease

Summary: the investigators have shown that patients with adrenal insufficiency (addison's disease), a rare disorder, have doubled the expected mortality rate in sweden despite standard of care glucocorticoid (gc) replacement. one % of the swedish population are, however, receiving gcs for inflammatory diseases, but management is empirical and adjusted to underlying disease activity. the desired anti-inflammatory therapeutic effects cannot be differentiated from the adverse metabolic (osteoporosis, obesity, diabetes mellitus) and immunosuppressive side effects of gc. this frequently results in suboptimal gc therapy with adverse effects due to over-dosing or poor efficacy due to under-dosing. the primary aim is to identify a biomarker for the metabolic effects of gcs. patients with addison's disease completely lack endogenous gcs and can therefore be considered a human gc knock-out model. they can therefore be studied during near-physiological exposure and during gc starvation. this will uniquely allow a very clean biomarker identification model (using transcriptomics, proteomics and metabolomics). the secondary aim is to validate candidate biomarker(s) in a dose-response study using the same patient population. a biomarker of gc actions will make it possible to individualised therapy during pharmacological gc treatment. it would allow gc replacement to be monitored in addison's disease and could become a specific diagnostic tool in patients with gc deficiency and excess (cushings syndrome).


Eligibility criteria:
inclusion criteria: * primary adrenal insufficiency under stable glucocorticoid replacement therapy (15-30 mg of hydrocortisone stable dose the last 3 months) due to autoimmune adrenalitis (disease diagnosed at least 12 months before inclusion), age 20-60 years, bmi 20-30 kg/m2, and ability to comply with the protocol procedures. exclusion criteria: * glucocorticoid replacement therapy for indication other than primary adrenal treatment, any treatment with sex hormones inclusive contraceptive drugs, treatment with levothyroxine, diabetes mellitus, renal or liver failure, significant and symptomatic cardiovascular disease.

Keywords: biomarker glucocorticoids metabolism pharmacology metabolomics
a safety and preliminary efficacy study of cc-99282, alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-hodgkin lymphomas (r/r nhl)

Conditions: Lymphoma, Non-Hodgkin

Summary: the purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of cc-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-hodgkin's lymphomas.

participants with relapsed or refractory non-hodgkin's lymphomas (r/r nhl) who have failed at least 2 lines of therapy (or have received at least one prior line of standard therapy and are not eligible for any other therapy). the dose escalation will evaluate the safety and tolerability of escalating doses of cc-99282 in relapsed or refractory diffuse large b-cell lymphoma (r/r dlbcl) and/or relapsed or refractory follicular lymphoma (r/r fl) participants to determine the maximum tolerated dose (mtd) of cc-99282 as monotherapy. the dose expansion will further evaluate the safety and preliminary efficacy of single agent cc-99282 or the safety and preliminary efficacy of cc-99282 in combination with anti-lymphoma agents in participants with r/r dlbcl and nhl. part b cohort b will further evaluate the potential effects of food on the pk and safety of cc-99282.

Eligibility criteria:
inclusion criteria: * history of non-hodgkin's lymphoma (nhl) with relapsed or refractory disease * has an eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 exclusion criteria: * life expectancy ≤ 2 months * received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting cc-99282, whichever is shorter * is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (gvhd) * impaired cardiac function or clinically significant cardiac disease other protocol-defined inclusion/exclusion criteria apply

Keywords: non-hodgkin lymphomas (nhl) safety efficacy cc-99282 rituximab relapsed refractory pharmacokinetics obinutuzumab tafasitamab valemetostat anti-lymphoma agents
high-resolution anoscopy perceived discomfort study

Conditions: Pain; Anal Cancer

Summary: study should determine if performing the less uncomfortable part of the exam (the perianal exam) results in less recalled discomfort if performed last vs. if performed first.

performance of the perianal examination at the end of the high resolution anoscopy (hra) procedure will lead to patients reporting less discomfort directly following the procedure. the study team hypothesizes at least a 10% decrease in subsequently rated pain scores in the group where the perianal exam is performed last compared to the group where it is performed first.

Eligibility criteria:
inclusion criteria: * present for a previously scheduled high resolution anoscopy procedure * able to participate in an english written survey following the hra procedure exclusion criteria: * undergoing ablation during the hra procedure * inability to tolerate or complete the hra procedure * unwillingness or inability to complete the post-procedure survey * previous participation in the study

Keywords: anoscopy screening perianal examination
improving mental health following early pregnancy loss using a brief cognitive task

Conditions: Post-traumatic Stress Disorder; Miscarriage; Ectopic Pregnancy; Pregnancy Loss; Trauma, Psychological

Summary: this is a randomised controlled trial designed to investigate the impact of a brief-cognitive task based intervention on intrusive memories, mental health symptoms and daily functioning, in women following an early pregnancy loss.

women who have experienced an early pregnancy loss (miscarriage or ectopic pregnancy) will be randomly allocated to either a brief cognitive intervention or a placebo activity. participants will be followed up at week 1, 1 month and 3 months following the intervention. it is hypothesised that those allocated to receive the brief cognitive task-based intervention will develop fever intrusive memories, less severe mental health symptoms and better day to day functioning when compared to women allocated to the placebo activity.

Eligibility criteria:
inclusion criteria: 1. age 18 years and over 2. diagnosis of early pregnancy loss (epl) (missed miscarriage, incomplete miscarriage, complete miscarriage, ectopic pregnancy) 3. fluent in english 4. access to a smart device (e.g. phone or tablet) 5. within 72 hours of epl (including diagnosis of complete miscarriage or completion of treatment for ectopic pregnancy, missed miscarriage or incomplete miscarriage) exclusion criteria: 1. women who, in the opinion of the researcher, are unable to give fully informed consent to the study due to for example learning impairment or language barrier. 2. women with a viable intrauterine pregnancy 3. women with a pregnancy loss occurring after 20 weeks gestation 4. history of severe mental illness or substance misuse
comparative study of high intensity interval training and endurance training in juvenile obesity

Conditions: Obesity

Summary: exercise is an effective strategy to manage juvenile obesity; however this ideal exercise training mode is still unclear. in this study, the investigators compared the health-related effects of high intensity interval training versus endurance training in obese children.


Eligibility criteria:
inclusion criteria: * age between 8 and 12 years * body mass index (bmi) = 95th percentile, according to the first national health and nutrition examination survey * no pharmacological treatment * no evidence of metabolic, hormonal, orthopedic, and cardiovascular disease at the time of the study's commencement * no participation in any regular exercise training program (except physical education classes, two days a week) at least 6 months before the commencement of the study and throughout the protocol. exclusion criteria: * non-obese participants * physically active participants * participants with cardiovascular diseases or any other condition that could preclude the participation in the the exercise training program

Keywords: exercise overweight children