Kornimate/medical-research-clean huggingface dataset:
a switch-over study of the safety and efficacy of isu302 in patients with type 1 gaucher disease

Conditions: Gaucher Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of isu302 in patients with type 1 gaucher disease previously treated with imiglucerase.


Eligibility criteria:
inclusion criteria: * patient diagnosed with type-1 gaucher disease * patient who was stably treating gaucher disease with cerezyme® and who was maintaining the usage and dosage of cerezyme® for at least 6 months prior to study drug administration * patient aged 2 years or higher * female patient with contraception during the study period (oral or injectable contraceptive hormones, intrauterine device, physical devices using condom, sponge form, jelly, and femidom, and abstinence) * patient who signed the informed consent form after hearing the detailed explanation about this study * definition of the stable treatment of type-1 gaucher disease: * no neurologic deficit * normal hemoglobin concentration, and platelet count that has increased to ≥100,000/㎣, or maintained to 100,000/㎣ * normal or no deteriorated bone mineral density * normal or no deteriorated splenomegaly or hepatomegaly exclusion criteria: * patient who participated in other clinical studies within 90 days before study drug administration * patient with unstable hemoglobin and platelet counts for at least 6 months before study drug administration * patient with hypersensitivity to cerezyme® * patient positive to hiv antibody, hepatitis b antigen, and hepatitis c antibody * patient with fe, folic acid, or vitamin b12-deficcient anemia * patient who received miglustat within 6 months before study drug administration * patient who received erythrocyte growth factor or chronic systemic corticosteroids within 6 months before study drug administration * patient who had clinically significant splenic obstruction within 12 months before study drug administration * pregnant or lactating patient * patient who had serious concurrent diseases such as infectious diseases or drug-addicted patient * patient who was considered inappropriate for this study by the investigators or sub-investigators

Keywords: type i gaucher isu302 imiglucerase
timing for arteriovenous fistula creation and its effect on target organs in patients with chronic renal failure

Conditions: Renal Failure, Chronic

Summary: the timing for arteriovenous fistula (avf) creation and its effect on target organs in patients with chronic renal failure will be investigated by multicenter prospective cohort. lower estimated glomerular filtration rate (egfr) patients (egfr\<10ml/min 1.73m2 for patients without diabetic kidney disease, and egfr\<15ml/min 1.73m2 for diabetic kidney disease) and higher egfr patients (egfr 10-15ml/min 1.73m2 for patients without diabetic kidney disease, and egfr 15-20ml/min 1.73m2 for diabetic kidney disease) will be proposed to undertake avf creation. maturation rate and time of avf will be followed up in 3 months; primary and secondary patency rate of avf, avf construction on cardiac structure, function, encephalopathy, cerebral vascular lesions and cognitive function will be followed up in the next 2 years. this multicenter will provide evidence to develop guideline of timing for avf creation


Eligibility criteria:
inclusion criteria: * patients with chronic renal failure, without avf creation; * estimated glomerular filtration rate (egfr) \<15ml/min 1.73m2 for patients without diabetic kidney disease, and egfr\<20ml/min 1.73m2 for diabetic kidney disease; * all study subjects must agree to participate in the study and provide written informed consent. exclusion criteria: * patients with the history of arteriovenous graft, or central venous catheter, or peritoneal dialysis catheter placement; * contraindications to avf construction: * allen's test is positive, or arterial diameter\<2 mm; venous diameter\<2.5 mm or venous occlusion/stenosis. * local infection. * have any other uncontrolled medical condition (severe heart failure, malignancy, severe coagulation disorders ). * mental illness that makes the patients unable to complete the trial. * female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception.
patient reported outcomes, postoperative pain and pain relief after day case surgery (poppy)

Conditions: Pain; Post Operative Pain; Opioid Use; Chronic Pain

Summary: around 3 out of 4 operations in the uk are performed as day-case, meaning the patient goes home on the same day of their operation. hospitals usually do not follow up patients after day-case operations so we do not know very much about their short or long-term recovery. some patients, even those who have had small operations, can develop persistent pain afterwards that continues for a long time (months to years). these patients may end up taking strong painkillers for a long time and this risks serious side effects and long-term health problems. the poppy study aims to find out what recovery from day-case operations is like from the patient's point of view. we will look at the first week after patients' operations and then at 3 months to see if they are in pain, and if so what pain relief they are taking. all adults over the 5-day study period having day-case operations in the uk, with an anaesthetist, will be eligible if they have access to a smartphone. patients will be recruited on the day of their operation from over 100 nhs hospitals. some relevant information about the patient's current health, operation and anaesthetic will be recorded from their notes. afterwards participants will get a text message at days 1, 3 and 7 and the at 3 months. these will connect to a data secure online questionnaire about pain, recovery, and what medications they are taking. a small number of participants with ongoing pain at 3 months will be invited to take part in a structured interview to understand their experience in more depth. this study will provide important information that may be used to improve care of patients having day-case operations and plan future research studies aimed to prevent persistent pain and long-term use of strong painkillers.


Eligibility criteria:
inclusion criteria: * aged 18 years or older on day of surgery * day-case surgery as defined by national day surgery delivery pack (need ref) * an anaesthetist must be present for case. * the procedure must involve one or more of: sedation, regional anaesthesia, central neuraxial anaesthesia or general anaesthesia exclusion criteria: * less than 18 years of age on day of surgery * no anaesthetist involved with the procedure (such as local anaesthesia provided by a surgeon) * overnight stay (admission to hospital) * participant lacking capacity for consent * diagnostic and/or minimally invasive procedures (e.g., radiology, endoscopy, or cardiology procedures) * pregnancy or obstetric related procedures (pregnancy per-se is not an exclusion criterion). * currently breast feeding * ophthalmic procedures * no access to smartphone and email * prisoners eligibility for qualitative component: as above, plus reporting ppsp and/or ppou at day 97 post operative
rood's approach and oxaliplatin-induced peripheral neuropathy in colorectal cancer patients

Conditions: Colorectal Cancer; Peripheral Neuropathy

Summary: oxaliplatin-induced chronic peripheral neuropathy is of major concern to oncologists and patients as it has been shown to affect patients' health-related quality of life. although a number of interventions have been implicated, none of them can be recommended for clinical use. this therapeutic failure reflects a poor understanding of the real mechanism of oxaliplatin-induced neuropathy. however, oxidative stress is identified to be one of the main biomolecular dysfunctions in this neuropathy. rood's approach is a neurophysiological approach that is based on reflexes of the central nervous system in which the sensory stimulation provides desired muscular response and was specially designed for patients with motor control problems. it was developed by margeret rood in 1940. according to rood, sensory stimulation can activate or deactivate the receptor by facilitation or inhibition, which makes it possible to get the desired muscular response.

so, the purpose of the study is to investigate the efficiency of rood's approach on oxaliplatin-induced peripheral neuropathy in colorectal cancer patients.

Eligibility criteria:
inclusion criteria: * the patient can participate in the study if they had at least one cycle of oxaliplatin chemotherapy. * colorectal cancer patients who have oxaliplatin-induced peripheral neuropathy, the patients included in the study with mild to moderate neuropathy according to mtns. * patients from both genders. * their ages range from 18 to 60 years old. exclusion criteria: * patients who had a history of any other neuropathy as diabetic neuropathy. * patients with an unstable medical condition during chemotherapy. * patients who are starting new therapy or dose modification during the study period. * patients with morbid obesity "body mass index \>40%". * patients with a history of non-surgically repaired nerve compression injuries such as carpal tunnel, brachial plexopathy, spinal stenosis, and spinal nerve root compression. * patients with a history of central nervous system primary or metastatic malignancy.

Keywords: rood's approach oxaliplatin-induced peripheral neuropathy colorectal cancer
comparison of episiotomy scissors and basiq-4 episiotomy device in mediolateral episiotomy

Conditions: Episiotomy Wound

Summary: episiotomy is an obstetric intervention performed to facilitate, accelerate and / or prevent third and fourth degree perineal tears by cutting the vagina at the end of the second stage of labor. postpartum perineal pain affects patients' lives significantly and causes negative effects on work life, social life and family relations. median episiotomy is associated with 3-4 times increased anal sphincter injury as well as easy recovery. therefore, mediolateral episiotomy is preferred in europe. the common feature was that scissors are used in previous studies and the incision was made from the central to the distal. a randomized controlled clinical study is planned to compare the scissors and episiotomy device basiq-4, which carries scalpel, holding apparatus, and cuts from distal to the center in mediolateral episiotomy. this is the first study in humans in this field.

pregnant women who applied to ege university gynecology and obstetrics department delivery room service and had vaginal delivery will be included in the study after obtaining their consent. when the cases meeting the inclusion criteria will be taken to the delivery table for delivery, verbal consent will be obtained by the physician if the need for episiotomy is determined by the physician in the second stage of delivery. following the administration of 10 ml of 1% lidocaine, mediolateral episiotomy will be opened with scissors or basiq-4 according to computer generated randomization. the presence of shoulder dystocia during delivery, the number of moves for episiotomy incision, the duration of stage 2, fetal weight, the degree of perineal injury, any additional injury, and urethral injury will be recorded in the prepared case form. then, the episiotomy incision will be continuously sutured with 2-0 slow dissolving polyglactin 910 suture material for all cases. the length of episiotomy after suturing and the length of perineal injury, if any, will be measured with a sterile ruler and recorded on the case form. postpartum discharge is carried out 48 hours after birth in accordance with the ministry of health regulations. participants will be reassessed during discharge in terms of pain with the visual pain scale (vas). the cases will be evaluated by the study team again, and notes regarding episiotomy length, infection, pain, incision separation, fecal incontinence, rectovaginal fistula, and painful defecation will be recorded on the case form six months after delivery. participants will be requested to fill fsfi forms to evaluate their sexual lives.

Eligibility criteria:
inclusion criteria: 1. nulliparous singleton pregnancies \> 37th gestational week 2. estimated fetal weight between 3000-4000g 3. the need for an episiotomy in the second stage of labor 4. vertex presentation exclusion criteria: 1. additional internal disease 2. inability to communicate in turkish and english 3. multiple pregnancy 4. episiotomies in emergency situations without crowning the baby's head 5. using vacuum device at birth
evaluation of the effectiveness of a web-based treatment program for depression for the reduction of depressive symptoms

Conditions: Depression

Summary: 200 persons with depression are recruited via internet depression forums devoted to depression and are randomly assigned either to the online program deprexis or to a wait-list control condition. all participants receive free-of-charge online access to deprexis either immediately or with an eight week delay. prior to intervention and eight weeks later, both groups are assessed via an anonymous online survey which was implemented using the software package opst®. the survey consists of different questionnaires. the beck depression inventory (bdi) represents the primary outcome. it is assumed that the severity of depressive symptoms will improve to a significantly greater extent in the deprexis than in the wait-list control condition in the course of eight weeks.

deprexis is a web-based intervention that can be obtained online (www.deprexis.com). deprexis encompasses 10 content modules with a strong focus on evidence-based cognitive-behavioral techniques, either from its so-called first (behavior-oriented), second (cognitive-oriented) or third wave (e.g. mindfulness and acceptance): (1) psychoeducation, (2) behavioral activation, (3) cognitive modification, (4) mindfulness and acceptance, (5) interpersonal skills, (6) relaxation, physical exercise and lifestyle modification, (7) problem solving and (8) expressive writing and forgiveness, (9) positive psychology and (10) dreamwork and emotion-focus interventions. the ten modules are framed by one introductory and one summary module. communication is carried out online via simulated dialogues. patients have to respond to narrative text messages from the virtual therapists in multiple-choice response fashion, enabling them to express doubt, to affirm a particular message or to request more information. text messages are aided with drawings, photographs and animations. the program is adaptive and selects exercises and contents on the basis of the subject's response. the modules are sequential and each module refers and builds upon previous one. modules can (and should be) repeated within the intervention period.

Eligibility criteria:
inclusion criteria: * registration in a moderated online forum exclusively for affective disorders * (externally) confirmed diagnosis of a unipolar depression * informed consent (provided online in line with regulations by the hamburg department of data security) exclusion criteria: * unable to provide informed consent * diagnosis of bipolar or schizophrenia spectrum disorders * substantial neurological impairment (e.g. dementia) * acute suicidal tendencies as assessed with the suicide behaviors questionnaire-revised (sbq-r). subjects excluded for this reason are provided various emergency contacts and phone numbers.

Keywords: depression online-therapy deprexis self-help
rebooting infant pain assessment: using machine learning to exponentially improve neonatal intensive care unit practice

Conditions: Acute Pain

Summary: a multi-national multidisciplinary team will be working collaboratively to build a machine learning algorithm to distinguish between preterm infant distress states in the neonatal intensive care unit.

unmanaged pain in hospitalized infants has serious long-term complications. our international team of knowledge users and health/natural science/engineering/social science researchers have come together to build a machine learning algorithm that will learn how to discriminate invasive and non-invasive distress. a sample of 400 preterm infants (300 from mount sinai hospital and 100 from university college london hospital \[uclh\]) and their mothers will be followed during a routine painful procedure (heel lance). pain indicators (facial grimacing \[behavioural indicators\], heart rate, oxygen saturation levels \[physiologic indicators\], brain electrical activity) during the painful procedure will be used to train the algorithm to discriminate between different types of distress (pain-related and non-pain related).

Eligibility criteria:
* qualitative interviews * inclusion criteria: * parents of a child currently in the nicu or * health professionals currently working in the nicu. * exclusion criteria: * participants who cannot communicate fluently in english * quantititative data capture (video, eeg, ecg, spo2) * inclusion criteria: * infants born between 28 0/7 weeks 32 6/7 weeks gestational age * infants who are within 6 weeks postnatal age * infants who are undergoing a routine heel lance * exclusion criteria: * infants with congenital malformations * infants receiving analgesics or sedatives at the time of study (aside from sucrose), * infants with history of perinatal hypoxia/ischemia at the time of study. * infants with diaper rash or excoriated buttocks

Keywords: nicu (neonatal intensive care unit) artificial intelligence pain assessment
denosumab to prevent high-turnover bone loss after bariatric surgery

Conditions: Bariatric Surgery Candidate; Bone Loss

Summary: bariatric surgery leads to bone loss and increases fracture risk. this study evaluates whether denosumab can prevent the high-turnover bone loss that occurs after roux-en-y gastric bypass (rygb) and sleeve gastrectomy (sg) surgery.

bariatric surgery is a highly effective weight loss treatment, but one of the unintended side effects of these procedures is high-turnover bone loss and metabolic bone disease. denosumab is a monoclonal antibody to rankl that acts as a potent inhibitor of bone resorption. the investigators are conducting a randomized placebo-controlled trial to evaluate the ability of denosumab to prevent bone loss after rygb or sg surgery in older adults. at the conclusion of the study, all participants will be given zoledronic acid.

Eligibility criteria:
inclusion criteria: * postmenopausal women who are planning rygb or sg surgery * men aged ≥ 50 years who are planning rygb or sg surgery exclusion criteria: * prior bariatric surgery * weight = 400 lbs (due to limitations of bone imaging equipment) * renal disease * hypercalcemia or hypocalcemia * hypomagnesemia * serum 25-oh vitamin d (25ohd) \< 20 ng/ml * hyperparathyroidism * liver disease (ast or alt \> 2 x upper normal limit) * hct \< 32% * history of malignancy (except basal cell carcinoma) in the past 1 year * significant cardiopulmonary disease * major psychiatric disease * history of celiac disease or inflammatory bowel disease * excessive alcohol or substance abuse * paget's disease, primary hyperparathyroidism, or any other known congenital or acquired bone disease other than osteoporosis * current hyperthyroidism or use of levothyroxine with tsh \< 0.1 uiu/ml * current use of loop diuretics * current use or use in the past 12 months of oral bisphosphonates or dmab * current use or use within the past 3 months of serms or calcitonin * current use or use within the past 3 months of estrogen * use of testosterone therapy if dose has changed within the last 3 months, or if dose change or discontinuation is planned in the upcoming 18 months * any current or previous use of teriparatide, strontium, or any parenteral bisphosphonate * use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months * extensive dental work involving extraction or dental implant within the past 2 months or planned in the upcoming 18 months * dxa bmd t-score of \< -3.0 at pa spine, total hip, or femoral neck * current use of anti-vegf drug
fractional co2 laser versus microbotox injection in the treatment of wide facial pores: a split face comparative study

Conditions: Skin Abnormalities

Summary: 1. evaluation of fractional co2 laser as a treatment option for wide pores in skin type (iii - vi) 2. evaluation of mesobotox as a new modality for improving wide pores appearance. 3. comparison of both treatment modalities in treatment of enlarged pores.

skin pores (sp), as they are called by laymen, are common and benign features mostly located on the face (nose, cheeks, etc) that generate many aesthetic concerns or complaints. enlarged skin pores refer to conditions that present with visible topographic changes of skin surfaces. although not a medical concern, enlarged pores are a cosmetic concern for a large number of individuals. enlarged facial pores affect individuals of different ages, sexes, and races for which many seek treatment. the exact patho-mechanism of enlarged facial pores is not completely understood. possible causes include genetic predisposition, seborrhea, aging, increased ultraviolet exposure and comedogenic products. the treatment of dilated facial pores is difficult, and the ideal modality is not established yet. many treatment modalities reduce facial pores' count and area, including oral and topical medications as well as different wavelengths of laser. different ablative and non ablative lasers have been used in the treatment of dilated pores with variable outcomes. the short-term results showed that treatment with low energy level co2 fractional laser therapy could be a safe and effective option for patients with fitzpatrick skin types iii and iv who are concerned with enlarged pores. microbotox also called mesobotox, is the injection of multiple microdroplets of diluted onabotulinum toxin a into the upper dermis. it has been previously used in study to decrease pore size and to improve skin texture. microbotox has been proved to be effective in improving the sheen and texture of the skin, as well as decreasing sweat and sebum production and enlarged pores as it causes atrophy of sebaceous glands, which subsequently causes tightening of the skin envelope.

Eligibility criteria:
inclusion criteria: 1. patient with wide facial pores any grade. 2. sex: male and female patient. 3. age groups: patient above 18 and below 45 years old. 4. co-operative patient. exclusion criteria: 1. patient below 18 and above 45 years old. 2. patient with systemic illness or other dermatological disease. 3. patient who receive topical treatment for facial wide pores in past month. 4. patient who receive systemic treatment for facial wide pores in past 2 month.