Kornimate/medical-research-clean huggingface dataset:
neovaginoplasty using photoinduced-imine-crosslink hydrogel in mrkh patients

Conditions: Mayer Rokitansky Kuster Hauser Syndrome

Summary: evaluating the effectiveness and safety of neovaginoplasty using photoinduced-imine-crosslink hydrogel in patients with mrkh syndrome by comparing the differences in the degree of squamous epithelialization, vaginal length and width, and sexual life quality.

this is a randomized controlled trial. patients meeting the inclusion criteria will be enrolled in this study: 1)diagnosed with mrkh syndrome; 2)without previous treatments; 3)age: 18-35 years old; 4)voluntary agreement to participate in the study, sign the informed consent form, and demonstrate good compliance with follow-up. a centralized block randomization will be used to randomly assign patients to ensure that there will be an equal number of patients (1:1) in the hydrogel group and control group. the sample size is 20. under general anesthesia and catheterized bladder, the patient was in the lithotomy position. in the connective tissue plane between the bladder and rectum, the vestiges of the müllerian ducts were identified. with the index finger in the rectum as a direction and protection, hegar's dilators of increasing size (4.5-10) were pushed through the dimples gently. after that, a double-barreled canal appeared. then, the raphe between the canals was incised. the neovagina was created. according to the randomization, a vaginal mold spreaded with hydrogel or not was placed. the patients were suggested to wear the vaginal mold continuously over the following 6 months. after that, they were allowed to have the first sexual intercourse. otherwise, the mold wearing time was 1 h daily, until they had sexual activity at least twice a week. the primary endpoint is the degree of vaginal squamous epithelialization 1 month, 3 months, 6 months after surgery. the secondary endpoints include neovaginal length and width, sexual life quality, and surgical complications.

Eligibility criteria:
inclusion criteria: 1. diagnosed with mrkh syndrome; 2. without previous related treatments; 3)18-35 years old; 4)voluntary agreement to participate in the study, sign the informed consent form, and demonstrate good compliance with follow-up. exclusion criteria: 1. with any previous artificial colpoplasty or other related treatment; 2. with history of diabetes or systemic immune system disease.

Keywords: photoinduced-imine-crosslink hydrogel mrkh syndrome neovaginoplasty
carbomedics top hat vs st. jude medical regent valve comparing sizing and hemodynamics

Conditions: Aortic Valve Disease

Summary: the purpose of this study is to compare the sizing and implant techniques between the carbomedics top hat supra-annular valve and the st. jude medical regent valve.


Eligibility criteria:
inclusion criteria: * patients who are indicated for implant with a mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center. exclusion criteria: * patients \< 18 years of age * emergency surgery * pre-existing valve prosthesis * aortic root replacement * active endocarditis

Keywords: aortic valve heart valve valve replacement valve disease
co-administration of pneumococcal conjugate vaccine with dtpa-ipv-hib versus co-administration with dtpa-hbv-ipv/hib

Conditions: Infections, Streptococcal

Summary: the purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal conjugate vaccine when co-administered with dtpa-ipv-hib or dtpa-hbv-ipv/hib in infants as a three-dose primary immunisation course during the first 6 months of life and as a booster dose at 11-12 months of age. the impact of the pneumococcal conjugate vaccine on nasopharyngeal carriage of s. pneumoniae and h. influenzae in children in their first two years of life will also be assessed. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardian(s) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. * a male or female between, and including, 6-12 weeks (42-90 days) of age at the time of the first vaccination. * written informed consent obtained from both parents or from the guardian(s) of the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * born after a gestation period of at least 36 weeks. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * concurrently participating in another clinical study, at any time during the entire study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from one month (30 days) before and up to one month (30 days) after each dose of study vaccine. * previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis b, haemophilus influenzae type b and/or streptococcus pneumoniae. * children for whom hepatitis b vaccination is required according to the local recommendations * history of or intercurrent diphtheria, tetanus, pertussis, hepatitis b, polio, haemophilus influenzae type b disease. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * history of any neurologic disorders or seizures. * acute disease at the time of enrolment. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination * a family history of congenital or hereditary immunodeficiency. * major congenital defects or serious chronic illness. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
ps230005 control-iq 1.5 post-approval study

Conditions: Type 1 Diabetes

Summary: this 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on control-iq technology v1.5 in children with type 1 diabetes ages 2 to \<6 years old. participants will use control-iq technology v1.5 for 12 months in the real-world setting.

the study will recruit participants age 2 to \<6 years old who begin control-iq technology v1.5 use in the real-world setting, with a goal of a minimum of 120 completers at 12 months. all enrolled participants will be monitored from baseline through 12 months following the initiation of therapy with the control-iq 1.5 system. the primary endpoint is the risk of diabetic ketoacidosis (dka) and severe hypoglycemia (sh) events. secondary outcomes include cgm time in range measurements, and patient reported outcomes.

Eligibility criteria:
inclusion criteria: * self-reported type 1 diabetes who have been prescribed the control-iq 1.5 system in the t:slim x2 or mobi insulin pump * age 2 to \<6 years at time of screening * using an insulin approved for use in the pump * using an icgm sensor approved for use with the pump * agreement to use control-iq technology 1.5, and to continue use for at least 12 consecutive months after study enrollment. * agree to provide hba1c result, obtained within the 6-month period prior to enrollment. * ability for parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management. * reside full-time in the united states. * willingness to download the t:connect mobile application to their smartphone and keep it active throughout the study if using a tandem t:slim x2 pump. participants who are unable to use the t:connect mobile application must be willing to manually upload their insulin pump data to tandem source every three months and at the completion of the study. * participant's parent/guardian has read, understood and agreed to participate in the study, and has electronically signed the informed consent form (icf). exclusion criteria: * use of any glucose-lowering therapy other than insulin. * a medical or other condition, or medications being taken that in the investigator's judgement would be a safety concern for participation in the study.

Keywords: type 1 diabetes control-iq control-iq 1.5 tandem mobi t:slim x2 automated insulin delivery
influence of pet/ct radiomic features on the outcome of lung cancer patients

Conditions: Lung Cancer; Image, Body

Summary: radiomics is an attractive field in objectively quantifying image features, and may overcome the subjectivity of visually interpreting computed tomography (ct), or positron emission tomography (pet). it is reported that the features related to treatment response, outcomes, tumor staging, tissue identification, and cancer genetics. therefore, the investigators try to explore the key features for the outcome of lung cancer patients.

radiomic features: pet/ct images, including other kinds of ct serials, were transported into a personal computer. using the open source software of 3d-slicer, volumes of interest (vois) for primary tumor, or even lymph nodes, was semi-automatically or manually segmented. and then, radiomic features were extracted. pet parameters: using combined ct vois, corresponding pet standard uptake value (suv, no unit) were measured. for a foci (either tumor, or lymph node), mean, sum and maximum suv were documented, and were used for training and validating models alongside radiomic features. feature selection: data were analyzed by deep learning or random forests method, and top 20 variables were scored by their contribution to the regression (variable importance, vimp). the generalized features were identified as the same ones between two kinds of image serials (for example, ordinary and thin-section ct, or pet and ct). additionally, when three or more features met the criterion, a lower value of akaike information criterion (aic) which measures the relative quality of statistical models was used to find appropriate features with lower overfitting possibility. model validation: the developed model was validated internally and externally. the internal indices for independent continuous variable were accuracy (bias and absolute bias) and precision (correlation coefficient and r square), and that for independent classified or survival variable was c-index. the patients enrolled from another medical center were used for external validation.

Eligibility criteria:
inclusion criteria: 1. pathologically diagnosed as lung caner. 2. accepted pet/ct scans at the hospitals either affiliated to shanxi medical university or anhui medical university 3. both pet and ct serials can be obtained 4. can be followed for treatment modalities (including chemotherapy regimens, radiotherapy dose, and et al), survival time and status, and other related information. exclusion criteria: 1. simultaneously suffering from the cancers from other tissues and organs 2. have a history of diabetes, chronic heart diseases, or chronic renal failure

Keywords: radomic feature pet ct
neurofeedback rehabilitation based on motor imaging in patients in the immobilization phase

Conditions: Healthy Subjects, Patients With Amyotrophic Lateral Sclerosis, Patients With Shoulder Surgery

Summary: as the prevalence of motor impairment increases with age, the proportion of the population affected by physical limitations is likely to increase in the coming years, considering that one in three people will be over 60 in 2050 (compared to one in five in 2005, insee projections). the possibility of reducing recovery time and / or improving the improvement of motor deficits is today a public health issue. the possibility of developing new therapeutic tools using innovative motor imaging rehabilitation technologies is an opportunity to offer rehabilitation adapted to specific disorders, personalized in relation to the patient's performance, and in continuity with the therapist. in this research project, we will use the principle of neurofeedback rehabilitation (eeg) based on motor imaging with a brain-computer interface. feedback will consist of therapeutic video games.here, we will test the feasibility of such approach in 10 healthy subjects, 10 patients with amyotrophic lateral sclerosis and 10 patients with uppel shoulder surgery.


Eligibility criteria:
inclusion criteria: common to the 3 populations concerned: * patients or subjects of both sexes; * age: 18-70 years; * ability to give consent in writing; * health insurance. a) sla: * patients with amyotrophic lateral sclerosis (defined according to the el escorial criteria: possible, probable or definite), at the time of diagnosis; * percentage of forced vital capacity (fvc) ≥ 65% of the predicted value for age, gender and size. b) patients after a shoulder trauma: patients with scheduled shoulder surgery. c) healthy subjects. exclusion criteria: * dementia (mmse score \<24/30) * pregnancy or patient not having effective contraception. * other neurological, psychiatric or orthopedic disease leading to a motor handicap or an inability to correctly realize the experimental paradigm: interfering with the evaluation of the movements of the upper limb, incapacity to realize the mental imagery of the movement. * visual impairment resulting in an inability to properly view the computer screen. * history of epilepsy or active epilepsy. * contraindication to mri: cardiac or neuronal simulator, ferromagnetic surgical clips, implants and metal objects, intraocular foreign bodies, claustrophobia * persons under guardianship, trusteeship or any other administrative or judicial measure of deprivation of rights and liberty * subject in the exclusion period of another interventional research or participating in any other interventional research or therapeutic trial * presence of another severe progressive pathology

Keywords: eeg, neurofeedback, fmri, als, surgery, upper limbs
comparison between arthrocentesis and rocabado exercises on temporomandibular disc displacement without reduction

Conditions: Temporomandibular Joint Disorders, Articular Disc Disorder (Reducing or Non-Reducing)

Summary: the present study will be designed to compare the short- and medium-term results of arthrocentesis and non-surgical methods rocabado approach in early disc displacement without reduction.

this study will be designed to provide a comparison between the effect of the rocabado approach as a conservative treatment and temporomandibular joint arthrocentesis in temporomandibular joint disc displacement without reduction. delimitations: this study will be delimited in the following aspects: 1. patients: the study group will be composed of sixty-eight patients with temporomandibular joint disc displacement without reduction will be enrolled in the study. group a: it will be composed of thirty-four patients with tmj disc displacement without reduction who are started on the rocabado approach- 4 - 6×6 exercise program. include therapeutic exercise, and patient education focusing on the temporomandibular joint. repeat measurements will be performed on 1st measurement at the baseline before any intervention, 2nd measurement after 8 weeks of treatment by a physiotherapist. group b: it will be composed of thirty-four patients with disc displacement without reduction who are started on tmj arthrocentesis procedure with medical and nursing care. 2. equipment and tools: 2.1-measurement equipment: thera bite rom scale 8-item jaw functional limitation scale (jfls-8) (valid arabic version) visual anlogue scale 2.2-therapeutic procedures: rocabado's 6x6 exercise program and manibulation

Eligibility criteria:
inclusion criteria: * history of a sudden reduction in the mandibular opening. unassisted mandibular opening 35 mm. * mandibular opening with assistance increased by ≥3 mm from * unassisted opening, with a prior history of click, click disappearance, and a sudden decrease in opening. * magnetic resonance imaging (mri) diagnosis of disc displacement without reduction. * persistence of the symptoms indicated in the first item for a maximum of 3 weeks. * clinical diagnosis of unilateral disc displacement without reduction of the temporomandibular joint. exclusion criteria: * history of major jaw trauma. * dentofacial deformity. * psychiatric illness. * chronic headache. presence of other disorders involving the tmj.

Keywords: temporomandibular joint disorders
early antenatal support for iron deficiency anemia

Conditions: Pregnancy Related; Anemia, Iron Deficiency; Anemia of Pregnancy

Summary: this is a randomized, controlled multi-site trial of iron therapy in pregnancy. the purpose of this research is to see if second trimester initiation of intravenous (iv) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.

pregnant singletons diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks and will be randomized 1:1 to either a course of ferumoxytol (510mg x 2 doses 3-8 days apart) or oral iron (325mg) twice daily.

Eligibility criteria:
inclusion criteria: * singleton gestation * gestational age \<24 weeks * baseline hb ≥9.0 and \<11.0 with evidence of iron deficiency anemia iron deficiency anemia diagnosed (at any point in patient history) by: * hb\<11.0 * ferritin\<30 and/or total iron saturation \<20 exclusion criteria: * sickle cell disease (not sickle cell trait) * evidence of acute anemia requiring transfusion or iv iron therapy * major congenital or chromosomal anomaly * previous use of iv iron in this pregnancy * severe cardiac, renal, or liver disease * autoimmune disease (ie systemic lupus erythematosus (sle) * allergy or contraindication to either study drug * history of medication allergy, reaction to iv infusion, or reaction to feraheme or other iv iron products
feasibility and impact of an intensive team-based intervention on type 2 diabetes reversal

Conditions: Type 2 Diabetes

Summary: to evaluate the feasibility of a 6-month multidisciplinary program to reverse type 2 diabetes using the mediterranean diet, intermittent fasting and exercise.

the morbidities associated with type 2 diabetes (db2) are major, including cardiovascular and renal complications, but also cognitive impairment. providing interventions targeting db2 reversal has shown great potential to improve healthy aging. a db2 reversal clinic has been established at the montreal heart institute's épic center, with an approach based on the mediterranean diet and exercise. first-year results showed a 0.6% decrease in hb1ac and an average weight loss at 3 months of 4.5 kg in diabetic patients. this improvement was maintained at 6 and 12 months. although these results are encouraging, the literature in db2 remission shows that a weight loss of 10 kg is the ideal goal. therefore, to offer the possibility of further metabolic improvement at 6 months, three interventions are proposed as additions to the current program: targeting ultra-processed food reduction, motivational coaching and intermittent fasting. the main objective of our pilot study is to determine the feasibility of this improved program in type 2 diabetic patients, aged 18 to 80 years.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * ability to give written consent, to use a smartphone application or complete an adherence/compliance diary, and use a blood glucose and blood pressure machine at home. exclusion criteria: * all types of diabetes other than type 2 * taking the following glucose-lowering agents: insulin, sulfonylureas * bmi \< 18,5 kg/m2 * unintentional weight loss of more than 10 kg in the past year * moderate to severe retinopathy * pregnant or nursing woman * severe organ failure * pathologies predisposing to gastrointestinal bleeding, untreated * recent cholecystitis (3 months) * antibiotic use in the past 3 months, or untreated active infection * known impaired nutrient absorption * uninvestigated new anemia or hb \< 110 g/100 ml * currently following an intermittent or prolonged fasting protocol * currently following a specific diet (vegan, celiac/gluten free, ketogenic) * active diagnoses of psychiatric or neurological illness not controlled for at least 6 months * taking, stopping or adjusting a medication in the last 3 months resulting in an active weight change.

Keywords: mediterranean diet, intermittent fasting, training, lifestyle changes
lidoderm® (lidocaine patch 5%) in diabetic and idiopathic neuropathy

Conditions: Diabetes

Summary: patients with type i or ii diabetes and painful distal symmetric sensorimotor polyneuropathy with dynamic allodynia of the lower extremities, patients with type i or ii diabetes and pain distal symmetric sensorimotor polyneuropathy with no dynamic allodynia of the lower extremities, or patients with idiopathic distal predominantly sensory neuropathy participated in a phase iv clinical trial to assess the efficacy of lidocaine patches in treating painful diabetic neuropathy or idiopathic distal sensory neuropathy.


Eligibility criteria:
inclusion criteria: * at sites 1, 2, and 3 - had painful diabetic polyneuropathy of 3 or more months duration * at site 1 only - had clinical signs and symptoms of distal predominantly sensory polyneuropathy of 3 or more months duration. diagnosis of predominantly sensory polyneuropathy were to be confirmed by either nerve conduction studies (large fiber sensory or sensorimotor axonal neuropathy) or by abnormal epidermal innervations on punch skin biopsy (distal leg/proximal thigh) (herrmann et al., 1999; holland et al., 1997) * had an average daily pain rating for the baseline week of pain ratings equal to 4 or greater on the 0 to 10 numerical pain rating scale * had at least 2 hours of moderate or severe pain intensity due to polyneuropathy daily in the immediately prior 3-month period * were using stable analgesic drug therapy for at least 1 week (regimen and dosages) prior to screening visit, with the exception of acetaminophen and lidocaine for patients undergoing a punch skin biopsy exclusion criteria: * had prior treatment with topical lidocaine, except for use with the punch skin biopsy procedure * were currently under treatment with class i antiarrhythmic agents (such as tocainide and mexiletine) * had any other pain more severe than the painful diabetic or idiopathic neuropathy * had open skin lesions in the area where the lidocaine patches were to be applied