Kornimate/medical-research-clean huggingface dataset:
iui with letrozole versus in natural cycle

Conditions: Intrauterine Insemination; Unexplained Infertility

Summary: rationale intrauterine insemination (iui) is the treatment of first choice for couples with unexplained and mild male factor infertility in many countries, but it is controversial whether ovarian stimulation improves fertility outcomes. in recent retrospectively collected data, we found that in couples with unexplained and mild male factor infertility undergoing iui, ovarian stimulation with letrozole increased live birth rate as compared to natural cycle iui without substantially increasing the multiple pregnancy rate. we therefore intend to perform a randomized clinical trial (rct) on the subject in five reproductive medical centers in different cities in china. objective to test the hypothesis that in couples with unexplained or mild male factor infertility scheduled for an iui program ovarian stimulation with letrozole increases the live birth rate as compared to natural cycle treatment. study design multicenter randomized controlled trial. study population women diagnosed with unexplained or mild male factor infertility scheduled for treatment with iui. intervention women will be randomized for ovarian stimulation with letrozole or to natural cycle iui. in the group allocated to ovarian stimulation, women will receive oral tablets letrozole 5 mg daily from cycle day 3 for 5 days. we will treat the couples for 3 cycles, with a time horizon of 4 months. main study parameters/endpoints primary outcome is live birth resulting from conception within 4 months after randomization. secondary endpoints are clinical pregnancy, multiple pregnancy, miscarriage rates, pregnancy complications, time to pregnancy leading to live birth. nature and extent of the burden and risks associated with participation, benefit and group relatedness the strategies compared are already broadly applied in current practice. no additional risks are expected. there is no benefit for participants, but the results may benefit future infertile couples.


Eligibility criteria:
inclusion criteria in order to be eligible to participate in this study, a participating couple must meet all of the following criteria: * being diagnosed with unexplained or mild male infertility * at least one sided tubal patency, established according to local protocol * normal or mild impairment of semen quality defined as total motile sperm count (tmsc) no less than 5million, based on at least one recent semen analysis exclusion criteria a potential participant who meets any of the following criteria will be excluded from study participation: * woman with double sided tubal pathology * women with irregular cycles, pcos or other endocrine disorders * man with impaired semen quality: total motile sperm count (tmsc) less than 5million
low intensity internet therapy for chronic illness (@liit.ci)

Conditions: Chronic Medical Conditions

Summary: chronic illness (ci) presents a significant and negative effect on quality of life and mental health. further, emotion regulation has been considered of particular importance on the determination of chronic patients' well-being. evidence suggests that acceptance and commitment therapy (act) is an effective approach to improve psychological health in patients with ci. further, there is some, although limited, evidence, that self-compassion training may be also useful in this context, and the inclusion of self-compassion elements in act interventions has even been the focus of attention by recent studies. nevertheless, no study yet has compared the efficacy of these two types of intervention in ci. this is the aim of the present project - to analyse, in a low intensity ehealth intervention context, whether act or compassion focused therapy (cft) present superiority over the other in improving mental health and illness-related outcomes in ci.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 * previous diagnosis of a physical chronic medical condition * easy access to internet and to a computer exclusion criteria: * receiving psychological intervention * diagnosis of a severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or cognitive impairment.
performance characteristics of non-invasive glucose monitoring device prototypes

Conditions: Diabetes

Summary: this clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects

subjects will collect either 8 or 44 daily optical raman readings paired with either 8 capillary blood glucose comparator or 8 capillary blood glucose comparator plus 44 readings using a flash glucose monitoring system in own home with maintaining usual routines. subjects will either collect data for 5 days during a 10 days period or collect data for 90 days during a 40 days period or collect data for 90 days during 6 months period.

Eligibility criteria:
inclusion criteria: * male and female subjects 18 years of age or older * diabetic patients (all types) * skin phototype 1-4 exclusion criteria: * for female participants: pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration * for female participants: breastfeeding * subjects not able to understand and read danish * in investigator's opinion, subject is not able to follow instructions as specified in the protocol * participants not able to hold hand/arm steadily (including tremors and parkinson's disease) * diagnosed with reduced circulation * extensive skin changes, tattoos or diseases on probe application site * known allergy to medical grade alcohol * known allergy to adhesives, applicable to subjects in rsp-16-01 * systemic or topical administration of glucocorticoids for the past 7 days and under investigation * participants undergoing dialysis treatment * medical history or any condition that may, in the opinion of the investigator, compromise the subject's ability to participate * concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff. * participants currently enrolled in another study
immunological reaction of the recipient after cold-stored saphenous venous allograft (bioprotec)

Conditions: Allograft; Cold Temperature; Saphenous Vein

Summary: the study investigators propose to perform a blood test before and after allograft placement in all patients receiving a cold-stored venous allografts at the university hospital of nîmes to study the occurrence of fvfa-related asd in these patients. the aim of this work is to characterize a possible immune reaction generated by the implantation of venous allografts prepared according to the bioprotec method. in case of a proven immune reaction, the study will allow a modification of our current attitude and to exclude patients potentially eligible for renal transplantation at the time of venous allograft placement, or to perform in these patients an allo-compatibility test with the venous allograft preoperatively and thus protect these patients from an increased risk of subsequent organ transplant rejection.


Eligibility criteria:
inclusion criteria: * the patient must be a member or beneficiary of a health insurance plan * patients receiving a scheduled venous allograft within the chu of nîmes for an arterial bypass in the lower limb or an arteriovenous bypass in the upper limb within the framework of the creation of arteriovenous fistulas in dialysis patients, in the absence of available autologous venous material. exclusion criteria: * the subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study * the subject has already been included in the study * the subject refuses to participate * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * patient previously having received a venous allograft or organ transplant * pregnant, parturient or breastfeeding patients
evaluation of the effectiveness of a topical medical device in wound healing and symptom relief in the postoperative period of open excisional hemorrhoidectomy (the emor study)

Conditions: Anus Diseases; Gastrointestinal Diseases; Intestinal Diseases; Cicatrization; Hemorrhoids; Hemorrhoids Third Degree

Summary: this multicenter randomized controlled phase iv trial aims to compare the clinical efficacy of a gel containing a propionibacterium extract and a gel with hyaluronic acid and silver sulfadiazine in the degree of epithelialization of post-operative wounds of open excisional hemorrhoidectomy. the main questions it aims to answer are: * to compare the efficacy of the two medical devices in the degree of epithelialization in the postoperative period of open excisional hemorrhoidectomy, at 0, 10, 20 and 40 days from the beginning of treatment. * to evaluate the effectiveness of these devices in alleviating: pain, itching, burning, and the type of bowel habit participants will be randomized, at the beginning of the study, to one of the two treatments, and the efficacy of the two medical devices will be evaluated at 0, 10, 20 and 40 days from the start of treatment.


Eligibility criteria:
inclusion criteria: * open excisional hemorrhoidectomy, with removal of at least 3 groups * age between 18 and 75 years exclusion criteria: * patients who do not consent to the study * opioid-dependent patients, chronic use of analgesics * fecal incontinence * anorectal neoplasms * immunosuppressive treatments (e.g., chemotherapy, radiotherapy, etc.) * chronic inflammatory bowel diseases * pregnancy * patients with major psychiatric disorders * known allergy to the components of the treatments under study

Keywords: hemorrhoids epithelialization anal diseases hemorrhoidectomy
assessing ptsd after earthquake in turkey

Conditions: Post-Traumatic Stress Disorder

Summary: assessing the prevalence and natural course of ptsd after the 1999 turkish earthquake


Eligibility criteria:
inclusion criteria: * people were in the earthquake area while it occured exclusion criteria: * people were not in the earthquake area while it occured
tramadol simultaneously with sciatic nerve block for calcaneus fracture osteosynthesis

Conditions: Foot Fracture; Pain, Acute

Summary: comparison of duration of efficient analgesia after painful surgical repair od foot fractures between groups treated with sciatic nerve block alone and sciatic nerve block simultaneously with i.m. tramadol

a randomized, double-blinded study in patients scheduled for surgical repair of foot fractures in spinal anaesthesia where two pain treatment modalities would be compared. one group receives sciatic nerve block with standardized dosis od bupivacaine under ultrasound visualisation, while the other group receives the same block but with simultaneous i.m. injection of tramadol (also standardized). both the patient and the anaesthesist are blinded, i.e. the control group receives simultaneously with the block a 0,9% sodium hydrochloride injected. drug or control syringes do not differ, and would be prepared directly before in a randomised, blinded manner by trained co-investigator. both group receive also the same standardised systemic analgetics with no further use of tramadol.

Eligibility criteria:
inclusion criteria: * patients with foot fracture scheduled for surgical repair in spinal anesthesia * informed consent exclusion criteria: * no consent * spinal anesthesia or sciatic nerve block contraindicated * known intolerance to tramadol or other contraindications for the drug

Keywords: sciatic nerve block tramadol foot fracture
neuron specific enolase in ventricular assist device recipients

Conditions: Advanced Heart Failure; Left Ventrucular Assist Device

Summary: an observational study of neuron specific enolase, as a marker of reperfusion injury, in lvad recipients before and following vad implantation.

patients eligible for left ventricular assist device (lvad) typically have severe heart failure, which is characterized by poor cardiac output. the relatively abrupt increase in cardiac output that follows implant of a lvad may cause reperfusion injury. furthermore, selected patients may have particularly severe consequences of such injury, including refractory acidosis and vasoplegia. neuron specific enolase (nse) has been established as a biomarker of reperfusion injury. we hypothesize that changes in nse following lvad will be greater than the changes in nse noted in a control population of patients undergoing non-vad cardiac surgery.

Eligibility criteria:
inclusion criteria: group 1 - pre-vad implantation patients * 18 years and older * lanning to undergo vad implantation group 2 cardiac surgery comparison group * 18 years or older * planning to undergo valve or coronary bypass surgery exclusion criteria: * acute cerebrovascular infarction

Keywords: heart failure left ventricular assist device reperfusion injury neuron specific enolase
childhood metabolic markers of adult morbidity in blacks

Conditions: Healthy; Normal Weight; Overweight

Summary: blacks are at increased risk for obesity, type 2 diabetes mellitus and cardiovascular disease. a common pathogenetic link among these entities is insulin resistance/hyperinsulinemia. the specific aims of this project are: 1) to compare skeletal muscle lipid content (smlc) in black vs white children by computed tomography (ct) scan of the mid-thigh, and assess the relationship to in vivo insulin sensitivity; 2) to test the hypothesis that free fatty acid (ffa) - induced insulin resistance is associated with larger increases in intramyocellular lipid (imcl) in black vs white adolescents; 3) to examine if β-cell insulin secretion in prepubertal black children is more sensitive to the stimulatory effect of ffa than in whites; and 4) to test if the β-cell in black obese adolescents is more susceptible to the lipotoxic effect of ffa compared with whites. the methods to be used are: the well- established ct method as well as magnetic resonance spectroscopy (1h-mrs) to assess smlc and imcl; intralipid infusion to elevate circulating ffa levels; the hyperinsulinemic-euglycemic clamp with stable isotopes and indirect calorimetry to measure insulin sensitivity and substrate turnover; the hyperglycemic clamp to assess insulin secretion; dexa and whole body mri for body composition assessments.


Eligibility criteria:
inclusion criteria: protocols 1 \& 4: * age 11-17 years * male or female * healthy * obese, bmi ≥ 95 percentile * pubertal/tanner stage ii-v * african american or white american, based on self identity with no admixture for 3 generations protocol 2: * age 11-17 years * male or female * healthy * normal weight, bmi 10- 95 percentile * pubertal/tanner stage ii-v * african american or white american, based on self-identity with no admixture for 3 generations protocol 3: * age 8-12 years * male or female * healthy * normal weight, bmi 10-95 percentile * prepubertal/tanner stage i * african american or white american, based on self-identity with no admixture for 3 generations exclusion criteria: * medications which interfere with metabolism * hemocue \< 12 gm/dl in pubertal subjects and \<11gm/dl in prepubertal subjects * positive serum pregnancy test * recent significant weight change or dieting * presence of disease (i.e.diabetes, hypothyroidism, genetic dyslipidemia, etc)
five and ten year results of the cmk21 hip system

Conditions: Osteoarthritis

Summary: five and ten year results of the cmk21 hip system

this study is being conducted to collect long term retrospective and prospective clinical and radiological data to evaluate the safety of revision rate and adverse events, and efficacy of clinical and patient assessment of the cmk21 hip stem in primary total hip arthroplasty.

Eligibility criteria:
inclusion: * the patients enrolled in the study were already operated at the time of the screening. * all the patients with osteoarthritis of the hip who received cmk21 hip stem between 2005 and 2007. * skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.

Keywords: hip prosthesis
the effectiveness of intervention on insulin injection

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of the study is to assess the effectiveness of an intervention for insulin injection initiation based on the transtheoretical model (ttm) for insulin-naïve patients with type 2 diabetes mellitus (t2dm).

according to the transtheoretical model (ttm) proposed by prochaska and diclemente, people will experience different stages of change before the actual behavioral change takes place. ineffectiveness of intervention to instigate behavioral change is largely due to failure to take into account the stage of change in which individuals are. the ttm suggests that decisional balance, which reflects the relative difference between pros and cons, is important for influencing the stage of change. in order to achieve behavioral change, the perceived pros of changing must be strengthened to outweigh the cons. in addition, individual must be self-convinced that the behavioral change is important for themselves. furthermore, the process for behavioral change can be provided to facilitate behavioral change in individuals. the theory of ttm has yet been used to improve the behavior of insulin initiation in insulin-naïve patients with t2dm. thus, this study aims to assess the effectiveness of an intervention for insulin injection initiation based on the ttm in insulin-naïve patients with t2dm.

Eligibility criteria:
inclusion criteria: (1) diagnosed with t2dm for at least half a year; (2) aged 20-70 years old; (3) controlling diabetes only through oral medication, without previous experience in insulin injection; (4) hba1c≧8.5% as measured more than twice in a year; (5) considered suitable and recommended by the doctor to initiate insulin injection. exclusion criteria: (1) unable to communicate with language; (2) incapable of self-administering insulin injection due to visual or muscular impairment.
safety and efficacy study of mepolizumab in churg strauss syndrome

Conditions: Churg Strauss Syndrome

Summary: churg-strauss syndrome is a rare type of systemic vasculitis which occurs almost exclusively in patients with asthma and which is characterized by prominent blood and tissue eosinophilia. the disease has a chronic smoldering course with a permanent need for medium to high corticosteroid doses. available unselective immunosuppressive agents are often insufficient to reduce corticosteroid doses, to induce complete remission and to protect patients from disease flares which occur in more than 50 % of cases. interleukin-5 is the most potent cytokine regulating the production of eosinophil granulocytes which are the major effector cells in churg-strauss syndrome. recently, an increased production of interleukin-5 was demonstrated in churg-strauss syndrome. mepolizumab is a monoclonal igg antibody targeting interleukin-5 and is effective in the treatment of the hes. the hypothesis of this study is, that mepolizumab will induce remission and allow for steroid reduction.


Eligibility criteria:
inclusion criteria: * informed consent * documented history of churg strauss syndrome * active disease * subjects must complete screening and baseline assessment * stable corticosteroid dose of \> 12.5 mg prednisolone for at least one week * treatment with cyclophosphamide (pulse or daily oral) or methotrexate or azathioprin or leflunomide in a stable dose for at least 4 weeks * not pregnant or nursing * negative pregnancy test and agree to practice birth control exclusion criteria: * life threatening disease or other critical illness deemed inappropriate for inclusion in the study by the principal investigator * treatment with other immunosuppressive agents within 4 weeks prior to randomisation * corticosteroid pulse of \> 60 mg within the last three weeks prior to randomisation * known secondary cause of eosinophilia * no history or clinical features of vasculitis * diagnosis of other primary systemic vasculitis * currently active malignant disease * abnormal laboratory values * impaired cardiac function * history of allergic reaction due to monoclonal antibodies * prior treatment with anti-hil-5 monoclonal antibody * exposure to investigational drug within 30 days prior to randomisation * positive pregnancy test
efficacy of new protocols in the treatment of upper limb dysfunctions in patients with cerebral palsy

Conditions: Cerebral Palsy

Summary: immediate and maintaining efficacy of new protocols in the treatment of upper limb dysfunctions in patients with cerebral palsy.

cerebral palsy (cp) is the most common childhood motor disability. spasticity and loss of dexterity are the major problems for motor disability of upper extremity (ue) in patients with cp. this study propose two novel treatment protocols: sensory electrical stimulation (ses) and virtual reality constraint-induced therapy (vrcit) to improve function of ue in patients with cp. investigators hypothesize that combined ses and vrcit treatment have better effect than single therapy (ses or vrcit).

Eligibility criteria:
* inclusion criteria: * diagnosis with spastic cp with gross motor function classification system(gmfcs) levels i-iv * aged 2-24 years * ability to undergo clinical assessment * ability to comprehend commands and cooperate during an examination * exclusion criteria: * chromosomal abnormalities * progressive neurological disorder or severe concurrent illness or disease not typically associated with cp * active medical conditions such as pneumonia or poor physical conditions that would interfere with participation * any major surgery or nerve block in the preceding 3 months * metabolic or hormonal disturbance * cardiovascular disorder * poor tolerance or a poor cooperation during assessment

Keywords: cerebral palsy sensory electrical stimulation virtual reality constraint-induced therapy
endoscopic submucosal dissection versus transanal endoscopic microsurgery for early rectal neoplasms and large rectal adenomas: сomparison of treatment efficacy and safety.

Conditions: Early Rectal Cancer; Large Rectal Adenomas

Summary: transanal endoscopic microsurgery is the main treatment option for rectal tumors such as large adenoma, early cancer because of lower complications and mortality rates and shorter hospital stays rather than conventional surgery. particularly, however, transanal endoscopic microsurgerymust be performed under either general or spinal anesthesia, and expensive surgical instruments are required. colorectal endoscopic submucosal dissection is a novel endoscopic procedure that enables en bloc resection of benign colorectal lesions and early colorectal cancer. endoscopic submucosal dissectioncan be performed under conscious sedation without anesthesia, and there are fewer hospital days than those for transanal endoscopic microsurgery. in the present study, we compared the treatment efficacy and safety between endoscopic submucosal dissectionand transanal endoscopic microsurgery for the treatment of early rectal neoplasms and large rectal adenomas.


Eligibility criteria:
inclusion criteria: * the lower and upper borders of the adenoma or early rectal cancer are located at ≥2 cm and ≤15 cm from the anal verge, respectively. * have signed approved informed consent form for the study * preoperative stage ut0 and/or ut1, mrt0 and/or mrt1 exclusion criteria: * non-epithelial tumors * tumors \</= 3 cm in size * recurrent tumors * suspicion of lymph node metastasis (n + disease) * preoperative stage ut2 and/or mrt2 * mucous or low-grade adenocarcinoma * preoperative stage rm1 and/or um1

Keywords: transanal endoscopic microsurgery endoscopic submucosal dissection minimally invasive surgery