Kornimate/medical-research-clean huggingface dataset:
3 year retrospective analysis of ivf in comparison with invocell

Conditions: Infertility

Summary: retrospective chart review of data on the use of traditional ivf and invocell ivc collected from clinics using both technologies. the retrospective data will be utilized for a comparison of the two methods.

the following aspects of data will be collected to support the analysis of the two methods * procedure details for including oil overlay and incubation time frame * characteristics of embryo quality and phase of development and transfer rates * clinical pregnancy rate * live birth rate secondary: data regarding safety * adverse events noted by the women that received ivf and invocell ivc * adverse events noted for the offspring

Eligibility criteria:
inclusion criteria: * subjects that have received infertility treatment with either invocell ivc or standard ivf during the same timeframe. all subjects treated with the standard of care ivf method during the same timeframe that the center used invocell ivc were included in the retrospective data collection. exclusion criteria: * not applicable
impact of tramadol addiction on dental anesthesia success

Conditions: Dental Pain and Sensation Disorder; Anesthesia, Local; Addiction, Opioid

Summary: the aim is to investigate and to find a correlation between tramadol addiction misuse among algerian males and dental local anesthesia success while performing dental care and oral surgeries.

local anesthesia is by far the most important part of pain control in dentistry, it is the cornerstone that makes many dental procedures possible, not only for the patient but also for the dentist and dental hygienists. since the pain and the dentist are almost synonymous for the patient, this makes dental anesthesia the most widely administered drugs in the dental clinics. hence, the failure of local anesthesia in oral medicine presents an undesirable outcome both for the patient and for the practitioner. the intraoperative pain being prevented by the administration of a local anesthesia must be followed by the management of the postoperative pain which can be often intense and thus requiring drugs administration. these drugs could be nonopioid or opioid analgesics which are also frequently used in general medicine as tramadol. tramadol is 2-(dimethyl amino)-methyl)-1-(3'-methoxyphenyl) cyclohexanol hydrochloride. it is 4-phenyl-piperidine analogue of the opioid drug codeine. it is generally well tolerated with few and rare side effects. moreover, comparative studies have mostly shown that tramadol is more effective than nsaids for post operative pain control. however, its misuse is increasingly growing and has become obvious in algeria. tramadol addiction has become very frequent, and its unjustified use is expanding. this might be attributed to the fragility of the health system and the replacement of the qualified pharmacists by non-qualified helpers or assistants.

Eligibility criteria:
inclusion criteria: * males * ≥18 years old \<65 * without comorbid conditions (hypertension, diabetes, asthma etc..) * tramadol addicted (regular tramadol user) * only tramadol addicted, if any other drugs are regularly consumed, the patient is excluded. exclusion criteria: * females * ˂ 18 years old * with comorbid conditions (htn, diabetes, epilepsy etc..) * ≥ 65 years old men. * not addicted to tramadol or addicted to other drugs with it.

Keywords: tramadol addiction local anesthesia dentistry carpule
the psiqs study - user experience with pro-set

Conditions: Diabetes Mellitus, Type 1

Summary: open label, randomized 2-period cross-over study comparing two continuous subcutaneous insulin infusion sets ; minimed® pro-set® with bd flowsmart™ technology and minimed® quick-set®


Eligibility criteria:
inclusion criteria: * must be between 13 and 70 years of age (inclusive) * must have been previously diagnosed with type 1 diabetes mellitus * must be using one of the following medtronic insulin pumps with the paradigm connector (note 670g excluded) for at least 6 months prior to enrollment. these pumps must have the ability to upload data to medtronic carelink therapy management software. 1. minimed paradigm revel™ insulin pump - models 523 (1.8 ml reservoir) and 723 (3 ml reservoir) 2. minimed 530g pump - models 551 (1.8 ml reservoir) and 751 (3 ml reservoir) 3. minimed 630g system * must have been using the medtronic enlite cgm for at least 3 months prior to enrollment, and are currently doing so * must routinely insert their own infusion set (may be inserted manually or with an inserter or with an integrated set/inserter, i.e. mio) * if instructed, must be willing to insert all assigned infusion sets with a mechanical inserter * must have another form of insulin delivery available (i.e. vial and syringe or pen and pen needle) * must agree to continue using current medtronic enlite cgm throughout the study * willing to have insulin pump, bgm and cgm data downloaded into medtronic carelink therapy management software (requires subject carelink logon id and password) * in stable health status with no acute or significant illness, in the opinion of the investigator or designee * able to read, write and follow instructions in english * able and willing to provide informed consent * able and willing to comply with study procedures exclusion criteria: * pregnant (self-attestation) or nursing * currently using a body-worn patch insulin infusion pump, e.g. omnipod or v-go * currently using the medtronic model 670g pump and associated cgm * current or past participation in previous bd study dbc-16scarl21 * history of bleeding disorder or easy bruising. * currently taking anti-platelet therapy or anticoagulants (use of up to 81 mg per day of aspirin is permitted). * known blood borne infections. * history of recurrent dermatological condition or skin disorder (e.g. psoriasis, eczema, pre-existing dermatitis). * skin abnormalities, anomalies or conditions (e.g. sunburn, tattoos, extensive scarring, lipohypertrophy) located at or very close to the intended insertion site. * physical condition that restricts dexterity and may limit ability to perform study procedures (i.e. severe neuropathy or arthritis of the hands; self-reported) * currently participating in any other clinical investigation that conflicts with this study * employed by, or currently serving as a contractor or consultant to bd, medtronic or study site * any other condition the investigator or designee deems to pose an unacceptable risk to the subject in the study
a study to evaluate the safety and effectiveness of the technols 217z zyoptix system for hyperopia

Conditions: Hyperopia; Astigmatism

Summary: a study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.


Eligibility criteria:
inclusion criteria: * hyperopia with or without astigmatism. exclusion criteria: * contraindications to lasik.
somatostatin analogues as a volume reducing treatment of polycystic livers (resolve)

Conditions: Polycystic Liver Disease

Summary: the aim of this study is to determine the effect of lanreotide on polycystic liver and kidneys in patients with autosomal dominant polycystic kidney disease.

the aim of this single center observational study is to assess the effect of lanreotide on polycystic liver and kidney. this is achieved by assessing total liver and kidney volume, and several urinary markers that could predict kidney damage or kidney dysfunction, such as gfr, blood pressure, and urinary tubular damage markers and serum biomarker fgf23. the investigators aim to include 43 patients affected by a polycystic liver due to adpkd. the duration of the trial will be 28 weeks. the treatment will be 24 weeks and the first screening visit will take place four weeks before start of treatment. eligible patients will be invited to participate.

Eligibility criteria:
inclusion criteria: * patients with adpkd with polycystic liver (\> 20 liver cysts) * renal function mdrd \>40 ml/hr * informed consent, patients are willing and able to comply with the study drug regimen and all other study requirements exclusion criteria: * kidney transplantation * renal failure requiring hemodialysis * use of oral contraceptives or estrogen suppletion * women who are pregnant or breastfeeding * history of cardiac/pulmonary disease; symptomatic gallstones, pancreatitis, etc * intervention (aspiration or surgical intervention) within three months from baseline * treatment with somatostatin analogues within three months from baseline * mental illness that interferes with the patient ability to comply with the protocol * drug or alcohol abuse within one year from baseline * abnormal liver function tests, as determined by blood test (except isolated elevated ggt and ap, which occurs frequently in pld) * clinical diagnosis of pancreatitis * diagnosis of diabetes mellitus, as determined by blood test and medical history * use of drugs that can interact with lanreotide, such as cyclosporin
long-term safety study of paricalcitol injection in chronic kidney disease patients with hemodialysis (hd)

Conditions: Secondary Hyperparathyroidism; Hemodialysis

Summary: the purpose of this study is to evaluate the long-term safety of paricalcitol injection. subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, m10-309 (nct00667576).

the first 12-week period in this study was a dose-response study reported as study m10-309 (nct00667576). only subjects who completed 12 weeks in nct00667576 were enrolled into this study (m10-312). baseline in this study was the same as baseline in nct00667576. the duration of treatment in study m10-312 was 40 weeks (for a total of 52 weeks, including nct00667576).

Eligibility criteria:
inclusion criteria: * patients who completed 12 weeks of study m10-309 (nct00667576). exclusion criteria: * patients taking drugs that affect intact parathyroid hormone (ipth), calcium, or bone metabolism. * patients with progressive malignancy or clinically significant hepatic disease. * patients who developed severe cerebrovascular/cardiovascular disease during the dose-response portion of the study (i.e., during m10-309, nct00667576). * patients with uncontrolled diabetes during the dose-response portion of the study (i.e., during m10-309, nct00667576).

Keywords: secondary hyperparathyroidism hemodialysis paricalcitol
prehabilitation in esophageal cancer care

Conditions: Esophageal Cancer

Summary: prehabilitation utilizes the preoperative period to prevent or attenuate the treatment-related functional decline and its consequences. this project aims at testing feasibility and effectiveness of multimodal prehabilitation in esophageal cancer care.

while evidence on prehabilitation is mounting, upper gastrointestinal surgery still remains under-investigated. this trial aims to explore the effect of prehabilitation over the whole perioperative trajectory, including neo-adjuvant treatment (nat). multimodal prehabilitation includes exercise, nutrition therapy, and mental distress coping strategies. in the context of a multimodal approach, the two groups follow different exercise prescriptions: high-intensity interval supervised training prescribed accordingly cardiopulmonary exercise testing (cpet)-derived variables, versus a home-based program. for both groups, multimodal prehabilitation is prescribed over the whole preoperative period, including during nat.

Eligibility criteria:
inclusion criteria: * patients with non-metastatic esophageal cancer undergoing neo-adjuvant chemotherapy and surgery. exclusion criteria: * co-morbid medical, physical and mental conditions that contraindicate exercise or oral nutrition
molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas in salvage radiotherapy for prostate cancer

Conditions: Prostate Cancer

Summary: this is a phase ii prospective sing-arm trial that is recruiting 60 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by psma pet. participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. participants will be follow-up as per standard of care up to 5 years post-treatment.


Eligibility criteria:
inclusion criteria: * men older than 18 years old. * histologically proven initial diagnosis of adenocarcinoma prostate cancer. * previous radical prostatectomy. * biochemical relapse with local or regional recurrence proven on psma pet. * five or less positive nodes on the psma pet. * ecog 0-1 exclusion criteria: * presence of para-aortic lymph nodes or distant metastasis. * chronic pelvic inflammatory disease. * contraindication for radiation treatment. * previous radiation treatment within the pelvis

Keywords: prostate cancer adenocarcinoma psma pet radical prostatectomy recurrence
cognitive effects of interferon in patients with melanoma

Conditions: Melanoma

Summary: interferon alpha is the only approved adjuvant biologic therapy for individuals diagnosed with high risk malignant melanoma (stage 2 or 3). there is evidence that interferon has some adverse cognitive effects on patients, but there are limited data. the investigators hypothesis is that compared to patients with melanoma who do not receive interferon, patients who have melanoma and are treated with interferon will show an objective decrease in performance on neurocognitive assessment. this study will enroll patients with melanoma who qualify for interferon, and either decide to undergo interferon treatment or choose watchful waiting instead. all patients will be assessed with a cognitive testing battery twice. observation patients will undergo testing at their first appointment in which they consent to the study, as well as at their next physician visit, approximately 3 months from the first visit. interferon patients will be tested immediately prior to starting interferon, as well as immediately after completing high dose interferon.


Eligibility criteria:
inclusion criteria: * patients diagnosed with high risk malignant melanoma (defined as american joint committee on cancer stage iib or greater) electing to undergo treatment with either adjuvant interferon alpha-2b, or observation only. * age 18 years or older. * karnofsky performance status greater than 60. * fluent english speaker. exclusion criteria: * history of neurologic or psychiatric disease that will affect patient's ability to complete protocol tests. * clinical or radiological evidence of brain metastasis. * any condition, which in the opinion of the investigator makes the subject unsuitable for study participation.

Keywords: melanoma interferon cognition
a study of the safety and efficacy of fabrazyme in patients with fabry disease

Conditions: Fabry Disease

Summary: people with fabry disease have an alteration in their genetic material (dna) which causes a deficiency of the alpha-galactosidase a enzyme. fabrazyme (agalsidase beta) is a drug that helps to break down and removes certain types of fatty substances called "glycolipids". these glycolipids are normally present within the body in most cells. in fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase a is not present, or is present in small quantities. the build up of glycolipid (globatriaosylceramide or gl-3) levels in these tissues in particular is thought to cause the clinical symptoms that are common to fabry disease. this study analyzed the safety and efficacy of fabrazyme in the treatment of patients with fabry disease that previously participated in the agal-008-00 (nct0074984) study.


Eligibility criteria:
inclusion criteria: * patients must have successfully completed the previous double-blind study agal-008-00 (nct00074984) * patients must provide written informed consent prior to study participation * female patients of childbearing potential must have a negative pregnancy test prior to each dosing and all female patients must use a medically accepted form of contraception throughout the study exclusion criteria: * the patient was unable to complete agal-008-00 (nct00074984) * the patient has undergone kidney transplantation or is currently on dialysis * the patient has diabetes mellitus or presence of confounding renal disease * the patient has a clinically significant organic disease or an unstable condition that precludes participation * the patient is unwilling to comply with the protocol requirements

Keywords: alpha-galactosidase a a-gal r-hagal fabry gl-3 fabrazyme
trismus trial of therabite vs wooden spatula in head and neck cancer patients

Conditions: Oropharyngeal Cancer; Oral Cancer

Summary: the trial will compare exercises using therabite® versus wooden spatulas to prevent or relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer.

trismus is defined as a tightening of jaw opening. the negative impact of trismus on the quality of life of head and neck cancer patients is well established. it affects eating, drinking, speaking and social function and is often as debilitating as any disfigurement resulting from treatment. the use of jaw exercises using a therabite appliance following treatment has been shown to reduce the level of trismus in small studies. many uk centres, however, use stacked wooden spatulas inserted between the incisors as a means of passive exercise. there is anecdotal evidence that suggests the use of exercises prior to treatment may help reduce the severity of the trismus experienced by the patient. this study will enrol 112 head and neck cancer patients allocated by chance to use either the therabite or wooden spatula and patients will be asked to perform mouth exercises on a daily basis for 6 months. there is a need to evaluate both the clinical effectiveness and cost-effectiveness of therabite as opposed to wooden spatulas to determine whether they should be adopted as standard care in head and neck cancer patients. in this pilot trial, the investigators will measure benefits of therabite to patients, as compared to usual care with wooden spatulas. mouth opening will be the key outcome for the study.

Eligibility criteria:
inclusion criteria: * provision of signed, written informed consent * aged 18 years and older * able to read and write english sufficiently to be able to complete questionnaires * stage 3/4 oral and oropharyngeal cancer patients undergoing: primary chemoradiotherapy or surgical free flap plus post operative radiotherapy or post operative chemoradiotherapy * all patients will receive 60-70 gy in 30-35 fractions over 6 to 7 weeks to the region of the pterygoid muscles. * all patients will have at least some trismus as indicated by subjective tightening in the jaw. exclusion criteria: * \<12mm mouth opening (cannot use therabite) * anatomically unable to use therabite for example patients who may only be partially dentate and to use the therabite would place extreme stress on the existing teeth * cognitive impairment as judged by the clinicians * international patients treated who will not have routine uk follow up. * previous surgery or rt to the head and neck prior to this diagnosis * any patient who has no subjective tightening of the jaw.

Keywords: trismus therabite wooden spatula head and neck cancer
spinal stabilization exercises for low back pain in adolescents with idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis; Low Back Pain

Summary: 1. do spinal stabilization exercises demonstrate immediate and long-term effects of weight weeks of spinal stabilization exercises as measured by pain intensity and quality of life scores? 2. does eight weeks of spinal stabilization exercises improve back muscle endurance in adolescents with idiopathic scoliosis (is) with low back pain (lbp), compared to a one-time treatment (control)? hypotheses: the research hypothesis for question 1 is: participants who receive eight weeks of spinal stabilization exercises will demonstrate significantly improved pain intensity and quality of life scores compared to participants who receive a one-time treatment after eight weeks of the intervention period and at six-month follow-up. the research hypothesis for question 2 is: participants who receive eight weeks of the spinal stabilization exercises will demonstrate significantly improved back muscle endurance, compared to participants who receive a one-time treatment after eight weeks of intervention.

although idiopathic scoliosis (is) is the most common type of scoliosis, no studies have evaluated the effectiveness of physical therapy exercises for managing low back pain (lbp) in this population. spinal stabilization exercises are of particular importance in adolescents with is due to possible reduced spinal stability from structural deformity. spinal stabilization exercises have been reported to prevent recurrent episodes of lbp in the adult population. however, standardized treatment options cannot be recommended for lbp in adolescents with is, because the investigators are not certain if spinal stabilization exercises will have the same effect on this patient population. given the high prevalence of lbp in ais and limited evidence of conservative interventions, researching the effectiveness of spinal stabilization exercises is warranted. currently, there are two common practices for managing adolescents with is who have lbp: 1) supervised physical therapy and 2) a one-time treatment with no follow-up. no studies have examined which of these two approaches is superior. this study will provide information on optimal management of lbp in ais. if there is no difference in outcomes between these two approaches, a one-time visit will be the optimal choice of treatment since it is more cost-effective and less burdensome for the family. if the outcomes favor the eight-week supervised physical therapy, specifically the spinal stabilization exercises, this treatment approach should be recommended for managing lbp in ais.

Eligibility criteria:
inclusion criteria: * adolescents (ages 10-17), * idiopathic scoliosis, * low back pain (\> 2/10 on numeric pain rating scale) exclusion criteria: * other pathology of lumbar spine (like spondylotic lesion), * current treatment (like bracing and chiropractic care), * back pain located beyond the lumbar spine

Keywords: back pain scoliosis home exercise program
a single-dose study of tivozanib in subjects with hepatic impairment and normal hepatic function

Conditions: Hepatic Impairment

Summary: this phase 1, open-label, single dose study is designed to evaluate the pharmacokinetics, safety and tolerability of a single 1.5 mg tivozanib dose in subjects with varying degrees of hepatic impairment and normal hepatic function.


Eligibility criteria:
inclusion criteria: * bmi between 18 to 38 kg/m2 * diagnosis of chronic or stable hepatic insufficiency, with a child-pugh classification scores of mild, moderate or severe. exclusion criteria: * current or previous history of hepatic carcinoma, hepatorenal syndrome, portacaval shunt surgery, significant hepatic encephalopathy, severe ascites, or pleural effusion * currently undergoing dialysis * poor peripheral venous access * pregnancy or lactation