Kornimate/medical-research-clean huggingface dataset:
a clinical trial to study the safety and efficacy of bone marrow derived autologous cells for the treatment of autism

Conditions: Autism

Summary: this clinical trial is a single arm, single centre to check the safety and efficacy of bone marrow derived autologous mono nuclear cells (mnc) (100 million per dose). trial to be conducted for 36 months.

autism is a developmental disorder that appears in the first 3 years of life, and affects the brain's normal development of social and communication skills. autism is a physical condition linked to abnormal biology and chemistry in the brain. the exact causes of these abnormalities remain unknown,symptoms-children with autism typically have difficulties in: pretend play, social interactions, verbal and non-verbal communication. some children with autism appear normal before age 1 or 2 and then suddenly "regress" and lose language or social skills they had previously gained. this is called the regressive type of autism. people with autism may: be overly sensitive in sight, hearing, touch, smell, or taste.

Eligibility criteria:
inclusion criteria: * patient should suffer from autism. * willingness to undergo bone marrow derived autologous cell therapy. * patient those provide fully informed consent form for the study. * ability and willingness to regular visit to hospital and follow up during the protocol procedures. exclusion criteria: * patients with pre - existing or current systemic disease such as lung , liver ( exception; history of uncomplicated hepatitis a),gastrointestinal, cardiac , immunodeficiency,(including hiv) or laboratory investigation that could cause a neurological defect.history of life threatening allergic or immune- mediated reaction.

Keywords: autism stem cell mncs
development and validation of in vitro cell-based bioassays for nuclear receptor activation

Conditions: Hypogonadism; Estrogens; Testosterone; Androgens

Summary: this is a prospective biobank set up to collect serum from patients with disorders associated with changes in androgens, estrogens or sex hormone-binding globulin (shbg), before and/or after treatment.

in vitro cell-based bioassays may be a technique to measure serum androgen or estrogen bioactivity. in this study investigators are collecting serum (and if possible, urine) samples from different cohorts of patients, before and/or after treatment. the aim is to measure androgens, estrogens and shbg as well as in vitro bioactivity with newly developed cell-based bioassays, and to compare different techniques to each other as well as to clinical endpoints available in the patient's electronic health record.

Eligibility criteria:
inclusion criteria: * known or expected medical condition affecting androgens, estrogens or shbg exclusion criteria: * inability to provide written informed consent * known or suspected bloodborne infectious diseases (e.g. hiv, viral hepatitis etc.) * anemia (\<11 g/dl hemoglobin) or being a jehovah's witness
treatment of ped with amt and autologous serum

Conditions: Corneal Epithelial Defect

Summary: patients with persistent corneal epithelial defects who have not responded to conventional therapy will be randomized to treatment with either amniotic membrane transplantation or autologous serum 20%. outcome measures will be (1) presence or absence of complete re-epithelialization within 28 days and (2) retention of intact epithelium for at least 90 days.


Eligibility criteria:
inclusion criteria: * corneal epithelial defect of more than 14 days that has not responded to conventional therapy exclusion criteria: * under age 18 * pregnant/lactating females * patients with hemoglobin levels \< 12 mg/ml * patients with limbal stem cell deficiency

Keywords: diabetes corneal transplant neurotrophic keratitis post-bacterial keratitis metaherpetic keratitis
prediction of rehospitalization following a sepsis admission using a wearable biopatch

Conditions: Sepsis

Summary: the goal of this observational study is to learn about the utility of biopatches predicting 30-day readmissions in patients discharged from the hospital with sepsis. the main question\[s\] it aims to answer are: • does the application of a biopatch provide data that can improve prediction of an unplanned 30-day readmission following a hospitalization for sepsis. participants will be asked to wear a biopatch on their chest for 30-days following hospital discharge or until readmission to the hospital.

study design: longitudinal cohort study with repeated measure of outcomes and predictors. the biointellisense patch is an fda approved wearable device that is applied to the chest with a 30-day battery lifespan and allows for real-time monitoring of heart rate, respiratory rate, skin temperature, general activity, severe cough episodes, and sedentary body position, among others. outcomes of interest: hospital readmission within 30 days of discharge following an index admission with a diagnosis of sepsis is the primary outcome of interest for this study. we will calculate the positive predictive value (ppv) of readmission prediction as the the primary outcome of interest from the following approaches: analytic score plus biopatch, analytic score alone, lace+ score. secondary outcomes include area under the curve of the receiver operator characteristic (aucroc) of predictive scores (analytic score and biopatch, analytic score alone, lace+ score) and number of patients readmitted to the hospital within 30 days of discharge. protocol for patient selection and application of biopatch: patients who meet "sepsis 3" definition will be identified with institutional review board (irb)-approved screening protocols. our previously derived and validated machine-learning algorithm to predict unplanned 30-day readmissions will then generate daily predictions about 30-day readmission probability which will be recorded, as well as lace+ scores. as a patient approaches discharge, the treatment team and patient (or legally authorized representative) will be approached about potential enrollment. if there is agreement to enroll in this prospective study, then we will apply the patch at the time of discharge. patients will then be followed with the biointellisence patch with augmented and real-time risk predictions based on data obtained from this. for this proposal, we will use data from the biointellisense patch and are not providing clinicians with data on risk of readmission.

Eligibility criteria:
inclusion criteria: age \>= 18 years development of sepsis, defined by recent international guidelines (suspected infection and 2-point change in sequential organ failure assessment (sofa) score), in emergency department or hospital admission to hospital from emergency department exclusion criteria: transition to comfort measures within 6 hours of time of sepsis discharge from the emergency department admission to bone marrow transplant service severe burn or other dermatologic condition that will prevent application to skin
neonatal hearing screening at neonatal intensive care unit

Conditions: Hearing Loss

Summary: hearing loss is one of the most common congenital anomalies . it has been shown to be greater than that of most other diseases and syndromes (eg, phenylketonuria, sickle cell disease) screened at birth. data from the newborn hearing-screening programs in rhode island, colorado, and texas showed that 2-4 of every 1000 neonates have hearing loss. early intervention at or before 6 months of age allows a child with impaired hearing to develop normal speech and language, alongside his or her hearing peers and can prevent severe psychosocial, educational, and language impairment. one of the most high risk population are neonates who spend time in the newborn intensive care unit , exposed to high frequency ventilation, hyperbilirubinemia, low birth-weight, and exposed to ototoxic medications. auditory brainstem response , otoacoustic emissions , and automated auditory brainstem response testing have all been used in newborn hearing-screening programs. otoacoustic emissions are fast objective, efficient, and frequency-specific measurements of peripheral auditory sensitivity are used to assess response of the outer hair cells to acoustic stimuli. to measure otoacoustic emissions, a probe assembly is placed in the ear canal, tonal or click stimuli are delivered, and the otoacoustic emissions generated by the cochlea is measured with a microphone .


Eligibility criteria:
inclusion criteria: * neonates of both sexes. * neonates with in utero infection such as cytomegalovirus, rubella, toxoplasmosis, or herpes. * neonatal indicators, specifically hyperbilirubinemia at a serum level requiring exchange transfusion. exclusion criteria: * neonates whose parent refuse to participate in the study.
treatment of primary basal cell carcinomas of the skin with combination of topical imiquimod and cryosurgery

Conditions: Basal Cell Carcinoma

Summary: the purpose of this study is to evaluate the efficacy of cryosurgery during continuing imiquimod application in the treatment of basal cell carcinoma of the skin.

evaluation of efficacy: * number of patient: n=50 * inclusion criteria: basal cell carcinoma of the skin proven with biopsy * exclusion criteria: (1) size of the tumors \>2cm; (2) distance from the eyelid \ 5 treatment protocol: patients will apply imiquimod daily for 14 days on the tumor and a rim of 2mm around the tumor. on day 14 a session of mild cryosurgery (2 cycles of 10-15 seconds, with open spray liquid nitrogen) will be applied and the patients will continue application of imiquimod for another 3 weeks before being evaluated again. persisting erosion will be considered as persistence of the tumor and imiquimod will be continued for another 3 weeks with/or without a cryosurgery session. the patients will be evaluated at 1,3,6,12 months after discontinuation of imiquimod and yearly thereafter for relapse. in case of clinical relapse, it will be confirmed by biopsy.

Eligibility criteria:
inclusion criteria: * basal cell carcinoma of the skin * size \< or = 2cm * number of tumors \< or = 5 * distance from eyelids, mouth \>1cm exclusion criteria: * size \>2cm number of tumors \> 5 distance from eyelids or mouth \< or = 1cm

Keywords: basal cell carcinoma cryosurgery imiquimod immunocryosurgery
telmisartan and amlodipine fixed dose combination [fdc] trial for the treatment of severe hypertension

Conditions: Hypertension

Summary: the primary objective of this trial is to demonstrate that following eight weeks of treatment the fdc of telmisartan 80 mg plus amlodipine 10 mg (t80/a10) is superior as first line therapy in reducing mean seated trough cuff systolic blood pressure \[sbp\] compared to the monotherapies of telmisartan 80 mg (t80) and amlodipine 10 mg (a10) in patients with severe hypertension. a key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the fdc over both of the monotherapies.


Eligibility criteria:
inclusion criteria 1. ability to provide written informed consent in accordance with good clinical practice and local legislation 2. age 18 years or older 3. patients with severe hypertension as defined sbp greater than 180 mmhg and dbp greater than 95 mmhg at randomisation 4. ability to stop any current antihypertensive therapy without unacceptable risk to the patient (investigators discretion) exclusion criteria mean in-clinic seated cuff sbp \>/= 200 mmhg and/or diastolic blood pressure \[dbp\] \>/= 95 mmhg
feasibility in every day pratice in an ent department and value of the automatic detection of respiratory events

Conditions: Obstructive Sleep Apnea Hypopnea Syndrome

Summary: the use of respiratory polygraphy (rp) in children for the diagnosis of obstructive sleep apnea hypopnea syndrome (osahs) can be challenging: device acceptance, sensors displacement. the automatic analysis of respiratory events has never been evaluated in a pediatric population. the primary objective of this study was to determine the feasibility of pediatric rp in an ent department routine practice. the second objective was to evaluate the reliability of the automatic signal analysis in children.

retrospective single center study of 50 children (32 boys and 18 girls, mean age 5.5 ± 2.3 years) who benefited from an overnight rp in an ent hospitalization department between january and august 2016 for osas suspicion. manual detection of respiratory events was performed by the same ent specialist, and compared to the automatic analysis.

Eligibility criteria:
inclusion criteria: * age between 2 and 12 years * child having performed a ventilatory polygraph for suspicion of obstructive hypopnoea apnea syndrome exclusion criteria: - over 12 years old

Keywords: pediatric obstructive sleep apnea hypopnea syndrome pediatric respiratory polygraphy device acceptance signal quality automatic detection of respiratory events
acute kidney injury in polytrauma patients in intensive care unit

Conditions: AKI (Acute Kidney Injury) Due to Trauma

Summary: acute kidney injury (aki) is a common complication of severe trauma patients and is associated with increased morbidity and mortality.trauma patients have many risk factors for aki such as hypovolemic shock, rhabdomyolysis, massive transfusion, major surgeries and abdominal compartment syndrome.the primary outcome of the study is to correlate between the aki by using rifle criteria and the trauma severity by using iss .the secondary outcomes are ;the length of icu and hospital stay and 28 days mortality in aki patients.

• study population: 60 cases of polytrauma patients who have iss\>15. * inclusion criteria: * age from 18 to 70 years old males or females * injury sensitivity score (iss \>15 ) * exclusion criteria: patients have end stage liver disease, end stage kidney disease, disseminated malignancy or decompensated heart failure. sample size :the calculated sample size is 60 cases of trauma patients. • all patients' data will be recorded on admission and daily for 7 days: * vital signs (blood pressure, heart rate, respiratory rate, body temperature). * lab investigations: complete blood count, international normalized ratio, prothrombin time, arterial blood gases, kidney function tests, liver function tests, creatine kinase, creatine kinase-muscle band, creatinine clearance, serum sodium, serum potassium and serum phosphorus will be requested for all patients at admission then daily follow up by creatine kinase, creatine kinase-muscle band, kidney function tests, serum sodium, serum potassium and serum phosphorus for 7 days. glasgow coma scale (gcs), injury severity score (iss),urine output (ml/kg/h),rifle criteria.,length of icu and hospital stay,28 days mortality.

Eligibility criteria:
inclusion criteria: * • age from 18 to 70 years old males or females * injury sensitivity score (iss \>15 ) exclusion criteria: * patients have end stage liver disease, end stage kidney disease, disseminated malignancy or decompensated heart failure.
efficacy and safety of fertility treatments and fertility preservation

Conditions: Infertility

Summary: this study analyses clinical data prospectively collected for over a decade in several clinical databases. electronic medical records are available since 1998. since 2011 the subgroup of patients that undergo fertility preservation are invited to participate in a prospective study aiming at long-term follow-up after fertility preservation for oncologic and non-oncologic conditions.

in this study, the investigators aim at analyze the treatment outcomes of patients with infertility, their clinical characteristics and biochemical parameters aiming at identifying predictors for the treatment outcomes. for the cohort of patients that have undergone fertility preservation at karolinska university hospital, the investigators aim at investigating efficacy and safety of the procedures. the data can be expanded by using additional databases such as the regional cancer registry and other registries. analysis of data collected will allow the investigation of efficacy and safety of fertility preservation, identification of predictors for fertility outcomes,prediction of future activities and costs of the procedures.

Eligibility criteria:
inclusion criteria: * infertile patients and patients who undergo fertility preservation exclusion criteria: * healthy individuals, fertile population

Keywords: fertility preservation fertility treatment safety efficacy fertility outcomes follow-up cohort
activation failure of knee extensors after anterior cruciate ligament rupture depending on the contraction mode

Conditions: ACL - Anterior Cruciate Ligament Rupture; Activation Failure; Contraction Mode

Summary: the primary objective of the study is to evaluate the impact of acl injury and acl reconstruction on voluntary activation during maximal voluntary contraction (measured by neurophysiological parameters) according to the contraction mode. the goal is to provide elements of knowledge to clinicians about the mechanisms of the activation failure depending on contraction mode, but also the resulting adapted clinical recommendations for conducting rehabilitation, and particularly for the use of different contraction modes. the main hypothesis is that activation failure is not equal according to the contraction mode during maximal voluntary contractions and neurophysiological parameters will be decreased in comparison with non-injured subjects. secondary objectives are: * to analyze the evolution of neurophysiological parameters between sessions interspaced by several months according to the contraction mode. * to observe this time evolution depending on the treatment strategy chosen: rehabilitation or surgery plus rehabilitation.


Eligibility criteria:
inclusion criteria: a. acl-injured groups (surgically or conservatively treated): 1. age between 18 and 50 years 2. free, informed consent signed by the participant and the investigator. 3. session 1: delay of 2 to 6 weeks after injury, with a quiet knee (range of motion 110- 0°, minimal effusion, maximal contraction pain ≤ 2/10) 4. session 2: duration of 36 to 42 weeks after injury, with a quiet knee (range of motion 110-0°, minimal effusion, maximal contraction pain ≤ 2/10) 5. independent person (unprotected: under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision) b. controlgroup: 1. age between 18 and 50 years 2. free, informed consent signed by the participant and the investigator. 3. sport practitioners: at least once per week practicing activities like collective sports, racket sports, combat sports, skiing, or on-loading activities with changing of directions. 4. independent person (unprotected: under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision) exclusion criteria: * 1. subjects fitted with an implanted electronic device such as a cardiac pacemaker 2. professional athlete 3. pregnant women 4. subject with systemic pathology or treatment affecting the musculoskeletal system 5. subject with a history of neurological pathology or traumatic pathology, or pathology that required orthopedic treatment and/or surgery of the knee, hip and/or lumbar spine 6. contraindication to isokinetic testing: incapacitating pain, evolving pathological process, non- healed fracture, unbalanced cardiovascular pathology (angina pectoris, arterial hypertension) 7. contralateral knee injury 8. subject inability to follow procedures or insufficient knowledge of project language 9. data acquisition issue or injury during testing
effects of propofol and sevoflurane on early pocd in elderly patients with metabolic syndrome

Conditions: Postoperative Complications

Summary: the purpose of this study is to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.

by now, a series risk factors of cardiovascular diseases, which are also related to the development of postoperative cognitive dysfunction (pocd), are becoming more common.the investigators don't know whether propofol based anesthesia has a more severe impact on early postoperative cognitive function than sevoflurane in elderly patients with metabolic syndrome. in this study, the investigators want to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.

Eligibility criteria:
inclusion criteria: * aged ≥60 years; * asaⅱor ⅲ * noncardiac surgery and nonneural surgery exclusion criteria: * mini mental state examination \[mmse\] score too low * chronic alcoho and drug abuse * disturbed renal and liver function * history of a cerebrovascular accident * permanent ventricular pacing * preoperative cognitive deficits * lack of cooperation

Keywords: postoperative cognitive dysfunction metabolic syndrome propofol sevoflurane
a comparison of electrical pudendal nerve stimulation and pelvic floor muscle training for female stress incontinence

Conditions: Stress Urinary Incontinence

Summary: the purpose of this study is to determine whether electrical pudendal nerve stimulation is more effective than pelvic floor muscle training with transvaginal electrical stimulation in treating female stress incontinence.

conservative therapy could be considered a choice of treatment for stress urinary incontinence (sui) as it seems to have no side effects and causes significant and long-term improvement in symptoms. pelvic floor muscle training (pfmt) and electrical stimulation are two commonly used forms of conservative treatment for sui. pfmt improves the structural support of the pelvis. however, many patients-especially women-have difficulty identifying and isolating their pelvic floor muscles (pfm) and are unable to perform the exercise effectively. furthermore, patients who can identify the pfm often find that the required daily exercise routine is burdensome. hence, the primary disadvantage of pfmt is lack of long-term patient compliance. electrical stimulation (es) is a non-invasive, passive treatment that produces a muscle contraction. transvaginal electrical stimulation (tes) has almost no side-effects and patient compliance in published reports is 70-85%. tes will result in pfm contraction by indirect nerve stimulation, mainly by polysynaptic reflex responses. the indirect stimulation and reflexive contraction may be the reason why the effect of electrical stimulation is not as good as that of pfmt when performed correctly. by combining the advantages of pfmt and tes and incorporating the technique of deep insertion of long acupuncture needles, we developed electrical pudendal nerve stimulation (epns). in epns, long acupuncture needles of 0.40 х 100 or 125 mm were deeply inserted into four sacral points and electrified to stimulate the pudendal nerves (pn) and contract the pfm. ct transverse plane at the coccygeal apex has showed that the position of the lower needle tip is similar to where (adjacent to pn at alcock's canal) the bion device is implanted for chronic pn stimulation. besides the radiographic evidence, simultaneous records of perineal ultrasonographic pfm contraction, vaginal pressure and pelvic floor surface electromyogram in our previous study have proved that epns can exactly excite pn,contract the pfm and simulate pfmt. our previous study has also proved that epns has a good therapeutic effect on female sui. the purpose of this study is to compare the efficacy of epns to pfmt with tes in treating female sui.

Eligibility criteria:
inclusion criteria: * sui history * positive stress test result * urodynamically confirmed sui * postvoid residual urine volume \<50ml exclusion criteria: * urge incontinence (overactive bladder or detrusor overactivity incontinence) * neurogenic bladder

Keywords: electrical pudendal nerve stimulation pelvic floor muscle training transvaginal electrical stimulation stress urinary incontinence comparative study