Kornimate/medical-research-clean huggingface dataset:
acute labetalol use in preeclampsia

Conditions: Preeclampsia With Severe Features

Summary: the purpose of this study is to understand if administration of a personalized dose of the anti-hypertensive medication, labetalol, based on patient's body-mass index, will be more effective at controlling severe hypertension during pregnancy, compared to the current standard dosing.

the investigators seek to asses the effect of obesity (bmi\>30) on severe hypertension control in patients with preeclampsia with severe features. the investigators hypothesize that successive administration of 40-60-80 mg of labetolol will reduce time to blood pressure control versus the standard dosing, 20-40-80 mg labetolol, recommended by the american college of obstetricians and gynecologists in 2015.

Eligibility criteria:
inclusion criteria: * bmi ≥ 30 * age ≥ 18 years * gestational age ≥ 24 weeks * singleton gestation * one sustained severe range blood pressure at albany medical center exclusion criteria: * known allergic reaction to labetlol * persistent mild-moderate asthma (≥ 2 rescue inhaler uses per week in the previous month) * obstructive airway disease * bradycardia \< 70 beats/min * heart block \> 1st degree or history of heart failure

Keywords: hypertension labetalol obesity
anal fistula repair with platelet-rich plasma

Conditions: Rectal Fistula

Summary: anal fistula is a very common disease with a high impact on life quality. the only commonly accepted treatment option is surgery. a wide range of operations and techniques have been developed all suffering from a relatively high recurrence rate. the investigators propose the combination of the mucosal advancement flap with application of platelet-rich plasma (prp) in the fistulectomy site. this study aims to test the hypothesis that by applying prp the healing rate of complicated anal fistulas can be improved in comparison to a control group where the operation is performed without addition of prp.


Eligibility criteria:
inclusion criteria: * complicated anal fistula with patient fit for surgical treatment * minimum 6 weeks after * written informed consent exclusion criteria: * age \<18 * pregnancy * drug abuse, drug substitution program * homeless (follow-up difficult) * restricted in legal capacity * simple fistulas requiring fistulotomy * complicated fistulas requiring an anus praeter naturalis
transcriptome assessment after cardiac arrest

Conditions: Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation

Summary: the purpose of this study is to determine whether the blood transcriptome of patients resuscitated after out-of-hospital could be an early predictor of the neurological outcome.

assessing the prognosis of the patients resuscitated after out-of-hospital cardiac arrest (ohca) is still highly challenging. beyond usual neurological markers, experimental and clinical studies have also shown that blood levels of several cytokines or mirna could be significantly different after cardiac arrest in subjects prematurely died as compared to survivors with a good neurological recovery. here the investigators propose to investigate a screening approach assessing simultaneously multiple targets of the post-cardiac arrest syndrome through analysis of the whole transcriptome of patients after ohca. for this purpose, the investigators will collect blood samples from 60 patients after admission at hospital and then 1 and 3 days later. the pittsburgh cerebral performance category of each patient will be evaluated for each patient at day 60 after cardiac arrest. at the end of the collection period, the blood samples will be prepared for whole genome analysis and rna sequencing. the primary analysis of the investigators will be the comparison of the transcriptome at day 0 after cardiac arrest in patients reaching cerebral performance category (cpc) 1 at day 60 as compared to all other patients.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * delay between patients collapse and resumption of spontaneous circulation (rosc) \< 60 minutes * comatose patients rosc with glasgow score \< 7 * patient already registered in the social security system * consent of a family member, if able to understand in the emergency context, or attestation of emergency situation with a follow-up information notice exclusion criteria: * cardiac arrest supposed to be provoked by trauma or sepsis

Keywords: transcriptome messenger ribonucleic acid (mrna) sequencing biomarker cardiac arrest prognostication successful resuscitation
v-sitting posture stabilization versus modified clamshell in patients with non-specific chronic low back pain.

Conditions: Non-specific Chronic Low Back Pain

Summary: the aim of this study is to compare the v-siting posture stabilization and clamshell exercises on pain and disability in patients with non-specific chronic low back pain.

chronic low back pain (lbp) is a common musculoskeletal pain disorder that affects most adults and has the highest prevalence among other chronic musculoskeletal pain disorders. non-traumatic lower back pain can have different etiologies: intervertebral disc related, vertebral body related, and facet joint related and sacroiliac joint related. non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. non-specific low back pain does not have a known pathoanatomical cause. treatment of non-specific chronic low back pain includes manual therapy, exercise therapy, massage, acupuncture, yoga, cognitive behavioral therapy, and intensive interdisciplinary treatment. previous studies have compared the effects of different exercise therapies, other treatment modalities, osteopathic techniques, manual therapies, and yoga and eurhythmy therapy for the management of low back pain. there is very little literature found to evaluate the effects of single movement technique v-sitting exercises and modified clamshell exercises in the management of non-specific chronic low back pain. previous literature showed less treatment sessions and follow up periods as they are barrier to see the exact picture of effects of treatment protocol followed. in contrast longer duration of treatment regime allow deep insight of the effects of the main treatment body. this study will fulfill these literature gaps. this study will find the comparative effects of v-sitting posture stabilization and modified clamshell exercises in the treatment of non-specific chronic low back pain with more treatment sessions in both genders.

Eligibility criteria:
inclusion criteria: * patients with non-specific low back pain for more than 3 months * subjects being able to sustain 5 seconds of isometric hip abduction in the side-lying position * negative crossed straight leg raise test * negative straight leg raise test exclusion criteria: * metabolic bone disease (osteoporosis) * any history of hip pathology * history of trauma * history of systemic disease (rheumatologic disorders, spondylitis, spinal cord disease) * radiculopathy

Keywords: low back pain disability pain intensity chronic pain
comparison of pragmatic posterior capsular stretch and crossbody stretch on the shoulder mobility

Conditions: Shoulder Impingement; Shoulder Pain; Adhesive Capsulitis; Rotator Cuff Tears; Posterior Capsule Tear; Glenohumeral Subluxation; Glenohumeral Dysplasia; Acromioclavicular; Sprain (Strain); Internal Rotation Contracture-shoulder; External Rotation Contracture-Shoulder; Flexion Contracture; Extension Contracture-Shoulder

Summary: various stretches are used to lengthen the posterior shoulder capsule. no study has reported the comparison of the pragmatic posterior capsular stretch and cross body stertch

background: posterior capsular tightness (pct) is frequently seen in shoulders in athletic population and shoulder disoders. pct leads to variation in scapular and humeral kinematics. two techniques considered in our study for regaining normal range of motion at shoulder joint and improving pct, one is the pragmatic posterior capsular stretch (ppcs) \& the other one is cross body stretch (cbs) objective: the aim of our study id to compare the short term/intermediate term effect of ppcs and cbs on range of motion on shoulder joint in healthy individuals. and to evaluate the feedback of subjects regarding both the interventions. methodology: sixty a symtomatic shoulder of 30 subjects (15 males, 15 females) were recruited for this restricted randomised control trials. a simple random sampling technique was used. subjects were screen through a functional movement screening tool of shoulder mobility. the change in hand behind neck and hand behind back will be measured through measuring tape. shoulder rom and functional movements for both the stretches will be campared. particpants will be follwed for 4 weeks for the change in their shoulder range of motion.

Eligibility criteria:
inclusion criteria: * age groups of males and females including 20-35 years * subjects who fall in grade 1 and 2 of functional movement screening of shoulder during the screening process. exclusion criteria: * individual with shoulder pain, fracture or dislocation less than 1 year * individuals with any known shoulder pathology * subjects receiving current physiotherapy treatment * subjects having enough range of motion( can reach t2 hand behind neck)
safety study of mgah22 in her2-positive carcinomas

Conditions: Breast Cancer; Gastric Cancer

Summary: the purpose of this study is to determine if mgah22 is safe when given by intravenous (iv) infusion to patients with her2-positive cancer. the study will also evaluate how long mgah22 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it has an effect on tumors.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed carcinoma that overexpresses her2 by immunohistochemistry (2+ or 3+ positivity by herceptest or equivalent). * progressive disease during or after last treatment regimen. * appropriate treatment history for histological entity. * ecog performance status \<= 1. * life expectancy \>= 3 month. * measurable disease * acceptable laboratory parameters and adequate organ reserve. * baseline lvef \>50% exclusion criteria: * lifetime anthracycline exposure \> 350 mg/m2 of doxorubicin or equivalent * major surgery within four weeks before enrollment. * known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation. * second primary malignancy that has not been in remission for greater than 3 years. treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous intraepithelial lesion on pap smear, localized prostate cancer (gleason score \< 6), or resected melanoma in situ are exceptions and do not require a 3 year remission. * active viral, bacterial, or systemic fungal infection requiring parenteral treatment within four weeks of enrollment. patients requiring any oral antiviral, fungal, or bacterial therapy must have completed treatment within one week of enrollment. * history of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents. * history of deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke within three months of enrollment. * known history of central nervous system (cns) metastatic disease with evidence of residual or recurrent disease upon entry. * new york heart association class iii or iv heart disease.
evaluation of a decision aid tool in rectal cancer patiënts

Conditions: Low Anterior Resection Syndrome; Rectal Cancer

Summary: adapt and evaluate a decision aid for patients with rectal cancer. phase 1 : decision aid testing (delphi) multicentric phase 2: pilot test decision aid

adapt and evaluate a decision aid for patients with rectal cancer. phase1: decision aid testing (delphi) a pilot version of the belgian decision aid was developed and validated through a double delphi procedure. in this study, the assessment is extended to several multicentre experts. the panel consists of ten experts who have extensive knowledge in the field of rectal cancer or scientific research. they are asked to evaluate the information and questions on accuracy, clarity, readability and relevance. they score the items of the decision aid using a 4-point likert-type scale (one (one = totally irrelevant; four = very relevant) and a dichotomous scale (one = clear, two = not clear) to assess relevance and clarity of wording, respectively (see appendix 2 to this application). to quantify the degree of content validity, the content validity index (cvi) is used. phase2: pilot test decision aid the final step of the study is a pilot test of the decision aid with patients who will undergo surgery/watch and wait strategy in the near future and with healthcare professionals who work with the decision aid. the aim is to test the acceptability of the decision aid with the patient and the ease of use with the healthcare professional. with the feedback from the patients and the healthcare professional, the decision aid can be further refined. during the consultation in which the intervention is discussed, the consent to participate will be asked of the patient and also of the informal carer who may be present at that moment. participation in the study means that during this consultation, the caregiver involved will go through the decision aid completely with the patient and any informal carer. after the intervention, they will be asked to give feedback on their experiences with the use of the decision aid. this will be done by means of an interview for the patients, informal carers and care workers involved. the interview with the patient (and informal carer if applicable) will take place at home or in the hospital, depending on their preference. the interview with the caregiver takes place in the hospital where the caregiver works. if the current covid-19 pandemic does not allow for a visit to the patient's home or to another hospital, the interviews will be conducted by telephone or video call.

Eligibility criteria:
delphi procedure inclusion criteria: * expert healthcare professionals caring for patients with rectal cancer exclusion criteria: * none interviews inclusion criteria * patients in which the decision aid was tested * patients with a tumor in the last 10cm of the rectum * healthcare professionals who have used the decision aid tool * informal carer indicated by the patient exclusion * patients who have no treatment choice due to oncological reasons

Keywords: low anterior resection syndrome
a study evaluating efficacy and safety of vx-548 for acute pain after a bunionectomy

Conditions: Acute Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of vx-548 doses in treating acute pain after a bunionectomy.


Eligibility criteria:
key inclusion criteria: * before surgery: * participant scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., austin procedure) and internal fixation under regional anesthesia (mayo and popliteal sciatic block) * after surgery: * participant is lucid and able to follow commands * all analgesic guidelines were followed during and after the bunionectomy key exclusion criteria: * before surgery: * prior history of bunionectomy or other foot surgery on the index foot * history of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) * any prior surgery within 1 month before the first study drug * after surgery: * participant had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy that, in the opinion of the investigator, should preclude randomization other protocol defined inclusion/exclusion criteria may apply
safety study to evaluate the leish-111f + mpl-se vaccine in the prevention of cutaneous leishmaniasis in healthy subjects previously exposed to the leishmania parasite

Conditions: Cutaneous Leishmaniasis

Summary: this study will evaluate the safety of the leish-111f + mpl-se vaccine in adult subjects with a previous exposure to the leishmania parasite (but without current or past history of leishmaniasis).

cutaneous leishmaniasis is a disfiguring disease that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of leishmania disease. all available medical therapies require weeks of treatment and cause significant toxicity. it appears that leishmania infections can be eliminated or prevented by t helper 1 immune responses. these findings argue that a vaccine that generates a t helper 1 response against the parasite will prevent the infection and disease. this is a phase 1, open-label study to evaluate the safety, tolerability and immunogenicity in montenegro skin test (mst)-positive healthy adults of an investigational vaccine being developed for the prophylaxis of cutaneous leishmaniasis. the vaccine, identified as leish-111f + mpl-se, consists of a recombinant three-antigen leishmania polyprotein (leish-111f, 10 μg) together with the adjuvant mpl-se (25 μg). the vaccine will be given to each study subject three times at 4 week intervals.

Eligibility criteria:
inclusion criteria: * must have positive montenegro skin test (reaction \>5 mm) * must be in good general health with normal lab values * negative for hiv, hepatitis b and c exclusion criteria: * history of leishmaniasis or exposure to leishmania vaccine or mpl-se. * pregnant or nursing female

Keywords: leishmaniasis, subunit vaccine, prevention, t cell
how common are sleep disorders and problems with emergence from anesthesia in surgical patients

Conditions: Emergence Delirium; Parasomnias

Summary: emergence delirium (ed), also called emergence agitation or post-anesthetic excitement, is defined as a dissociated state of consciousness, occurring on awakening from general anesthesia, in which children exhibit psychomotor agitation, crying and thrashing and are not consolable for a period of time, usually 5-15 minutes. emergence delirium is a common problem in pre-school children, with estimates of the incidence ranging from 10-70% of children in this age group. these children are agitated, seemingly unaware of their surroundings, and typically do not respond to parents or caregivers. they are therefore at risk for self-inflicted traumatic injury and complications secondary to disruptions of intravenous lines, surgical incisions, or drains. children with ed typically require more resources in the postoperative period than children who do not exhibit ed. predicting the likelihood of ed would allow for better allocation of resources in the post-anesthetic care unit (pacu). the peak incidence of ed in children occurs in the same age range at which the peak incidence of parasomnias (ps) occurs. the description of parasomnias is strikingly similar to the description of ed; the american academy of sleep medicine defines parasomnias as "undesirable physical events or experiences that occur during entry into sleep, within sleep or during arousals from sleep." parasomnias can be diagnosed using a sleep questionnaire. the purpose of this pilot study is to determine the incidence of ed and ps in our population, in order to determine the number of patients necessary to enroll in a larger study to either confirm or reject the hypothesis that ed and ps are correlated.


Eligibility criteria:
inclusion criteria: 1. pediatric patients age 1-6 (inclusive) scheduled for elective ent or urologic surgery 2. asa i or ii 3. presence of a caregiver who is familiar with the child's sleep history exclusion criteria: 1. autism 2. severe developmental delay 3. children receiving clonidine 4. medication for seizures 5. children who have received ed treatment prior to a diagnosis of ed (clonidine, dexmedetomidine, or propofol)
effect of short term versus long term treatment with seton prior to lift surgery for complex anal fistula

Conditions: Anorectal Fistula

Summary: the aim of this study is to compare short term (3 week) with long term (6 months) treatment with seton prior to lift surgery. the main end-points are recurrence rates and complication rates after surgery.


Eligibility criteria:
inclusion criteria: * age between 20 and 65 years * complex anal fistula defined as * anterior fistulas in women * branched fistulas * fistulas in patients with anal incontinence * fistulas traversing more than 30% of the anal sphincter and therefore unsuitable for simple division. exclusion criteria: * crohn's disease in the rectum * previous lift surgery on same side * patient already treated with seton \> 3 weeks * not able or willing to sign informed consent

Keywords: anorectal fistula lift seton
ecg versus ultrasound-guided positioning of the peripherally inserted central catheter (picc) tip

Conditions: Infection; Cancer; Malnutrition

Summary: in the prevention of thrombosis related to catheter placement it is important to have a right position of the catheter tip. therefor we want to assess which technique is the most successful in the placing of a picc.

this is a randomised prospective single blinded study. all adult patients with an indication for picc placement can be included. patients will be randomised into two groups, one with ecg-guided placement followed by ultrasound control and the other with only ultrasound guided placement. after placement, in both groups, control radiography of the chest will be done which will be interpreted by an independent radiologist. for the ecg-guided group the ultrasound control of the tip position will be done by an independent, blind operator, after placement. for the only ultrasound guided placement group, the ultrasound will be done by a second operator during placement.

Eligibility criteria:
inclusion criteria: * all adults with indication for picc exclusion criteria: * age \<18y * pregnant women

Keywords: ecg ultrasound peripherally inserted central catheters picc
cap pilot study for obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnea

Summary: this is a pilot to review the feasibility of a program that assists patients towards therapy compliance by scheduled intervention through the first month of therapy. the hypothesis of this study is that the trial program will function as intended and average patient adherence will be over 4 hours per night.


Eligibility criteria:
inclusion criteria * 21 to 75 years of age * diagnosed with osa (ahi \>5 events/hour) and eligible for continuous positive airway pressure (cpap) treatment under local requirements * must be initiated on program (i.e. received their device) within 12 weeks of cpap titration study * naïve to cpap therapy, i.e have not been prescribed cpap in the past * access to a cellphone exclusion criteria: * contraindicated for cpap therapy * medically unstable condition/diagnosis that is not yet under control * co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study) * periodic leg movement arousal index greater than 15/hr * home titration of longer than 5 days
study to assess safety, tolerability and pharmacokinetics after single dose of azd2516 to japanese healthy subjects

Conditions: Healthy

Summary: the primary purpose of this study is to assess the safety and tolerability of azd2516 following administration of a single dose to japanese healthy subjects.


Eligibility criteria:
inclusion criteria: * weight between 45 to 100 kg and a body mass index (bmi) between 19 to 28 kg/m2 * japanese males aged between 20 to 45 years old (young) and japanese males or females aged between 65 to 80 years old (elderly) exclusion criteria: * history of previous or ongoing somatic or psychiatric disease/condition * abnormalities in ecg that may interfere with interpretation of data.

Keywords: safety tolerability azd2516 pain japanese