Kornimate/medical-research-clean huggingface dataset:
does lah may improve the pregnancy outcomes?

Conditions: Pregnancy Outcomes

Summary: a defect in the hatching stage is considered an important cause of implantation failure. therefore, assisted hatching (ah), which involves artificial disruption of the zona pellucida, has been proposed as a method for improving the capacity of the embryo to implant. but the advantage of using laser to facilitate the hatching process of embryos in art practice is debatable, and an optimum strategy for performing lah remains elusive. therefore, the aim of this study was to evaluate the effects of laser-assisted hatching(lah) on clinical outcomes. patients were randomly divided into control and lah groups. the zona pellucida was thinned or drilled with a diode laser. relevant parameters are recorded to evaluate the validity of lah in art.

hatching is a very important process for successful implantation involving the breaking of the embryo out of the zona pellucida at the blastocyst stage. inadequate hatching of the blastocyst might lead to implantation failure in art. currently, a variety of ah techniques have been used including zona thinning and the opening or complete removal of the zona by laser. but the advantage of using laser to facilitate the hatching process of embryos in art practice is debatable, and an optimum strategy for performing lah remains elusive. therefore, the investigator aim to discuss the effectiveness of lah in art. in this study, patients were randomly divided into control and lah groups. a quarter of zona pellucida of the cleavage-stage embryo was thinned to 6.6 μm. all operation was performed in the empty region without contact to the blastomere in order to minimize the blastomere damage. the zp of blastocyst was drilled with laser, the zp opening 20% of its initial length. the operation was performed in the opposite region of icm in order to minimize the damage. in the control group, embryos were transplanted without lah. the rate of clinical pregnancy, live-birth, miscarriage, multiple gestation were evaluated. this research intends to discuss whether lah can improve the clinical outcomes in art, and further choice the appropriate lah action site.

Eligibility criteria:
inclusion criteria: * patients undergoing ivf/icsi-et cycle； * the zone pellucida of the cleavage-stage embryo is thicker than 8 μm. exclusion criteria: * number of embryos transferred per cycle \>2; * the transferred embryos including fresh and frozen cycle in the same cycle; * embryos developed from the frozen-thawed oocytes.

Keywords: laser-assisted hatching (lah) zona pellucida cryopreservation pregnancy outcomes
efficacy and safety of mate extracts on decrement of body and abdominal fat in obese subjects

Conditions: Obesity

Summary: obesity is a major health issue worldwide; there is a constant raise in obesity related death each year.

the primary aim of the study was to investigate the effect of mate extracts in korean subjects on body fat and abdominal fat, double blind, placebo-controlled clinical trial. thirty obesity subjects with bmi ≥ 25 kg/㎡ and waist-hip ratio (whr)≥ 0.90 for men and ≥ 0.85 for women were for 12 weeks.

Eligibility criteria:
inclusion criteria: * volunteers aged 19 to 65 years * 25 kg/m2 ≤ bmi ≥35 kg/m2 * ability to give informed consent exclusion criteria: * significant variation in weight (more 10%) in the past 3 month * cardiovascular disease, neurologic or psychiatric disease, renal, pulmonary and hepatic abnormalities * history of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease (crohn's disease) or gastrointestinal surgery (a caesum or enterocele surgery are included) * laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the sutdy * allergic or hypersensitive to any of the ingredients in the test products * pregnancy or breast feeding * used antipsychosis drugs therapy within past 2 months * history of alcohol or substance abuse (21 units/week over) * participation in any other clinical trials within past 3 months

Keywords: mate extracts obesity abdominal fat
nkt role in the regulation of the inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Primary Sclerosing Cholangitis

Summary: inflammatory bowel diseases (ibd) include crohn's disease (cd) and ulcerative colitis (uc). these diseases are a public health problem because they concern many patients (1 case in 1000). ibds are characterized by dysregulated immune response against luminal antigens causing chronic inflammation of the gut in genetically predisposed individuals. their exact cause is unknown and there is currently no cure. the primary sclerosing cholangitis (psc) is a liver inflammatory disease of unknown origin that is known to be strongly associated with ibd. an important clinical observation highlights the mild symptoms of ibd when associated to the psc. conversely, treating psc by liver transplant or immunosuppressive drugs is associated with a progression of intestinal inflammation. based, on these clinical findings that suggest a protective effect regulator of liver inflammation on intestinal inflammation, and on the results obtained by our group in mouse models that identified the natural killer t cell (nkt) as essential in control of experimental colitis, the project aims to determine, using pcr, if the expression of nkt cell markers are increased in the colon of patients with psc+ibd compared to patients with ibd alone or psc alone.


Eligibility criteria:
inclusion criteria: * patients with psc alone, ibd alone or psc + ibd * obtention of oral and written consent * patients affiliated with the social security system exclusion criteria: * minor patient * suspicion of malignant lesion of the colon * inability for information * person unable to consent, and not benefiting from a legal protection regimen * person deprived of liberty
fidgety movements in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: very low birth weight infants who are at risk for chronic lung diseases may also be at risk for brain anomalies such as increased echogenicity, leukomalacia and intracranial hemorrhage. infants with bronchopulmonary dysplasia have been reported to have worse neurodevelopmental outcomes than healthy infants. it has also been pointed out that babies with prolonged and recurrent apneas during sleep may have weak general movements (gms) repertoire. it has been mentioned that motor development retardation may also occur in neurodevelopmental diseases, genetic diseases and chronic lung diseases, as well as in cystic fibrosis. in infants with cystic fibrosis, motor development may be affected by increased incidence of hospitalization, previous infections, malnutrition, respiratory and digestive system disorders. there is no research done with gms assessment to determine motor dysfunction in infants with cystic fibrosis and this topic is open to research. having more information about the motor development of babies by determining the motor characteristics and motor performance of infants with cystic fibrosis, it may be possible to start the disease-specific physiotherapy and rehabilitation programs as early as possible. for this reasons, in the study the investigators aimed to investigate the characteristics of gms in the "fidgety" period of 3-5 month term infants diagnosed with cystic fibrosis, to determine the motor performances and to investigate the relation between the gms characteristics and the features of the disease. the hypotheses the investigators have set for this study are listed below; ho: spontaneous movements of the "fidgety" period of infants diagnosed with 3-5 months of cystic fibrosis are not different from normal infants. h1: spontaneous movements of "fidgety" period of infants diagnosed with cystic fibrosis between 3-5 months are different from normal infants.


Eligibility criteria:
inclusion criteria: * being diagnosed with cystic fibrosis * being between the postterm 3rd and 5th months exclusion criteria: * having congenital anomalies, * having an ongoing infection, * risk of high or low neurological impairment due to perinatal stroke, perinatal asphyxia, intra / peri-ventricular hemorrhage (ivh / pvl), bronchopulmonary dysplasia, * fidgety movements evaluation results; being abnormal (af), sporadic (f +/-) or non-f (f-) * baby's family does not want to be involved in the work

Keywords: general movements, fidgety movements, motor optimality score
a study of intravenously administered tamiflu (oseltamivir) in patients over 13 years of age with influenza

Conditions: Influenza

Summary: this partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of tamiflu (oseltamivir) in patients with influenza. adult and adolescent patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. investigators and patients are blinded to knowledge of the assigned dose of tamiflu. there is an option to convert to oral tamiflu after 6 intravenous infusions. the anticipated time on study treatment is 5 days, with an optional treatment extension of a further 5 days, if necessary. there will be a non-randomized, open-label treatment group for patients with moderate/severe renal impairment or renal failure. intravenous dose levels and frequency will be adjusted appropriately to their renal situation.


Eligibility criteria:
inclusion criteria: * adult and adolescent patients, 13 years of age and older * diagnosis of influenza * ≤ 144 hours between the onset of influenza-like illness and first dose of study drug non-randomized, open-label treatment group: * patients with moderate/severe renal impairment or renal failure with creatinine clearance 10-60 ml/min exclusion criteria: * clinical evidence of severe hepatic decompensation at the time of randomization * acute ischemia or significant arrhythmia
to evaluate the therapeutic equivalence and safety in treatment of scalp psoriasis

Conditions: Scalp Psoriasis

Summary: to demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis.

multi-center, double-blind, randomized, placebo controlled, parallel-group study comparing test and reference products to a placebo control in the treatment of scalp psoriasis

Eligibility criteria:
inclusion criteria: * healthy male or non-pregnant female aged ≥18 years * all male subjects had to agree to use accepted methods of birth control with their partners, from the day of the first application of the study drug to 30 days after the last application of the study drug * willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits * a clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp exclusion criteria: * female subjects who were pregnant, nursing, or planning to become pregnant during study participation * known hypersensitivity to calcipotriene, betamethasone dipropionate, other corticosteroids, or to any ingredients in the study drugs * current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis
geriatric psychiatry and pharmacovigilance

Conditions: Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders

Summary: the purpose of this observational multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. elderly people are at higher risk for developing side effects under pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and often polypharmacy. furthermore gerontopsychiatric patients can often not articulate their symptoms clearly, for example due to pronounced cognitive impairment. the aim of the study is to gain valid data of possible adverse drug reaction rates, their potential risk factors and outcome, as well as medical prescription practises. to assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the five participating study sites. at baseline demographic data, previous and present disorders, use of drugs, previous and present medication, quality of life, cognitive function, physical examination results, laboratory results and ecg will be assessed. afterwards patients are visited weekly and screened for possible adverse drug reactions. all adverse drug reactions will be coded in the meddra-system. in case of a possible serious adverse drug reaction serum levels of all psychotropic substances applicated will be assessed. drug combinations will be analysed using an established advanced bioinformatic tool (mediq). diagnosis, medication intake and possible adverse drug reactions are documented continually. 2 weeks after discharge from the ward, patients will be contacted by phone to assess catamnestic data.


Eligibility criteria:
inclusion criteria: 1. age 65+ years old 2. inpatients treated at one of the geriatric psychiatry study sites. 3. signed consent form ( patient and/or legally authorized custodian) exclusion criteria: 1. patients that are incapable to give their informed consent and are not under legally authorized custodianship.

Keywords: geriatric psychiatry pharmacovigilance
comparing perclose to statseal in conjunction with perclose in femoral 6 french arteriotomy closure

Conditions: Arterial Occlusion; Cardiovascular Diseases; Atherosclerosis; Hematoma

Summary: the purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transfemoral procedures with 6 french access. both devices are approved by the fda for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. it is believed that the use of both devices in combination compared to the perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that patients would need to lay flat.


Eligibility criteria:
inclusion criteria: * patient undergoing diagnostic angiography or pci with femoral access who undergo perclosetm closure. * catheterization with a 6fr system * those with a planned radial approach will also be enrolled given the possibility of changing to femoral access in the catheterization lab if radial access is not possible given radial artery spasm, significant patient discomfort with a contraindication to greater levels of sedation, inability to transverse guidewire into the aortic root, inability to engage coronary artery or deliver equipment, or other clinically indicated reason. exclusion criteria: - candidates for this study will be excluded if any one of the following criteria is true: * use of a hemostasis method or device besides perclosetm (perclose may not be used in situations of heavy calcification, presence of dissection, etc). * patients undergoing catheterization only from the radial, brachial, ulnar, or distal radial (snuffbox) artery approach. * use of an anticoagulant other than unfractionated heparin or bivalirudin. * any use of glycoprotein inhibitors or cangrelor. * use of sheathless guides. * any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion. * any active treatment with oral anticoagulants continued during course of procedure. * presence of arteriovenous dialysis fistula in the ipsilateral leg. * any physical deformity or trauma / injury of the leg that would prevent proper placement or function of the hemostasis band. * inability of the patient to personally consent for the study. (no surrogate consent) * cardiogenic shock, emergent procedures (high risk myocardial infarctions), or any clinical instability as assessed by the physician performing the procedure.
the effect of oxymetazoline gel on anal pressure and incontinence in spinal cord injury patients

Conditions: Fecal Incontinence; Spinal Cord Injury

Summary: this is an double blinded, cross-over study to determine the effect of oxymetazoline gel on anal resting pressure and fecal incontinence in patients with spinal cord injury. approximately 17 subjects are expected to complete this 10 weeks study that will include two treatment periods of 4 weeks each, and one 2 weeks wash out period.


Eligibility criteria:
inclusion criteria: * signed written informed consent. * male or female subjects 18 to 55 years of age; * spinal cord injury that occurred at least 3 months from randomization day and less than 3 years from randomization day. * at least 4 unwanted/unexpected incontinent events/week exclusion criteria: * known allergy to oxymetazoline or silicone. * pregnancy or lactation. * active cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities; * type 1 diabetes mellitus; * insulin treated type 2 diabetes mellitus; * renal insufficiency. * liver insufficiency. * malignant disease within 5 years of screening; * history of rectal surgery. * history of hiv, hepatitis b, hepatitis c. * has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion. * has used, in the last 1 week, drugs that may affect blood coagulation, such as aspirin (at a dose above 500 mg/day), warfarin, sintrom, enoxaparin, nadroparin, heparin, clopidogrel, ticlopidine. * hypertension (blood pressure over 150/105 mm hg in screening visit) * unable to understand the use instruction, as judged by the investigator.
brianstorm - early identification of patients with brain metastases

Conditions: Metastatic Rectal Adenocarcinoma; Brain Metastases

Summary: a single arm observational study investigating the incidence of brain metastasis in patients with cancer recti and lung metastasis

in this study the investigators want to investigate the incidence of brain metastasis in a selected high-risk group of patients with metastatic colorectal cancer. possible prognostic biological aspects will be investigated by translational analysis of biological samples. the study population consists of patients with metastatic rectal cancer and presence of lung metastasis. the patients will undergo a standard mri scan of the brain including injection of intravenous contrast. if positive finding, images will be evaluated at the multidisciplinary tumor board for potential treatment options according to clinical practice. standard follow-up program is followed, as per clinical practice. if the initial mri scan of cerebrum detects brain metastasis this will be treated and followed as per clinical practice. translational blood samples will be drawn at inclusion and at every imaging schedule up til 5 times

Eligibility criteria:
inclusion criteria: * primary rectal tumor location * diagnosis of lung metastasis made by histo- or cytopathology, or by clinical and imaging criteria. * able to understand written information * consent to samples for translational research exclusion criteria: * contraindications for mri priorly treated or known brain metastases
safety and efficacy of remote ischemic preconditioning in patients with aneurysmal subarachnoid hemorrhage after aneurysm clipping

Conditions: Subarachnoid Hemorrhage, Aneurysmal; Cerebrovascular Disorders; Brain Diseases; Stroke; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases

Summary: this study was designed to evaluate the safety and efficacy of remote ischemic regulation (ric) in patients with aneurysmal subarachnoid hemorrhage (asah) undergoing craniotomy. aneurysmal subarachnoid hemorrhage is a life-threatening condition that occurs when an aneurysm ruptures in the brain causing bleeding in the subarachnoid space. cerebral aneurysm clipping are usually needed to stop the bleeding and stabilize the patient's condition. remote ischemic regulation (ric) is a non-invasive treatment that uses a blood pressure cuff to temporarily block and restore blood flow to the arm or leg. research suggests that this process may help protect the brain and improve recovery from brain injury or surgery. although ric has shown potential to improve outcomes in patients with other types of brain injury, its effect on patients with asah who undergo cerebral aneurysm clipping is unclear. this study will evaluate whether ric can reduce complications, improve brain function, and enhance overall recovery in patients. the findings will help determine whether ric should be included in the standard treatment regimen for patients with asah.


Eligibility criteria:
inclusion criteria: 1. imaging examination confirmed aneurysmal subarachnoid hemorrhage. 2. responsible aneurysms received craniotomy clipping within 24 hours. 3. 18≤ age ≤80 years old. 4. informed consent of the participant or legally authorized representative exclusion criteria: 1. patients with other types of cerebral hemorrhage. 2. prior neurological impairment (mrs score \>1) or mental illness may confuse neurological or functional assessment. 3. severe comorbidities with a life expectancy of less than 90 days. 4. refractory hypertension (systolic blood pressure 180\>mmhg or diastolic blood pressure 110\>mmhg). 5. ric contraindications: severe soft tissue injury of lower limbs. 6. simultaneously participate in another research program to study a different experimental therapy. 7. any condition that the investigator believes may increase the patient's risk.
clinical accuracy of the wellostationx

Conditions: Fever

Summary: this study evaluates the clinical accuracy of the wellostationx, an automated non-touch self-service electronic thermometer using an infrared sensor of the surface of the forehead to screen for fever.

traditionally, body temperature is measured using a contact thermometer placed on the forehead, in the mouth, ear, armpit or rectum. non-contact thermometers allow a person's temperature to be taken with no contact with the person, reducing the discomfort of having to sit still for several minutes. additionally, there is no need for disinfection between patients to occur, allowing for easier and faster use when screening large numbers of people. this study is to evaluate the clinical accuracy of the wellostationx, a non-contact thermometer by comparing its measurements with that of the gold standard welch allyn suretemp oral thermometer.

Eligibility criteria:
inclusion criteria: * male or female. * 5 years and up. * signed informed consent form. exclusion criteria: * use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the test. * immunization within seven days of the test