Kornimate/medical-research-clean huggingface dataset:
phase iii clinical study of domestic recombinant human follitropin for injection to treat who class ii anovulation

Conditions: Anovulation

Summary: the purpose of this study is to evaluate the efficacy and safety of domestic recombinant human follitropin (gonal-f) for injection for treatment of who ⅱ anovulation (including polycystic ovarian syndrome \[pcos\] subjects).


Eligibility criteria:
inclusion criteria: * married infertile women at the age of 21-38. * bmi\<28kg/m2. * according to the detection level of serum estradiol (e2), prolactin (prl), progesterone (p), testosterone (t), luteinizing hormone (lh), follicle stimulating hormone (fsh), subjects were diagnosed of who class ii anovulation or oligo-ovulation, and the above hormone level of the subject is normal or normal after treatment at the beginning of study, and fsh\<10iu/l. * bilateral fallopian tubes are unobstructed proved by hysterosalpingograph or laparoscopic examination within one year, no history of abortion or pelvic infection after the examination, the researcher decide whether the above examination need to repeat. if the subject had salpingoplasty under laparoscope, and the bilateral fallopian tubes are unobstructed after the surgery, there is no need to have the hysterosalpingograph. if it can not be confirmed, it must be done again to prove that the bilateral fallopian tubes are unobstructed. * vaginal b-ultrasound examination shows that there is no ovarian pathological tumor, no hysteromyoma or hysteromyoma\<4cm, and does not affect the endometrial function. * two examinations of spouse semen are normal within six months, or comply with the iui standard. * no history of drug abuse. * voluntarily sign the informed consent form and agree with medication and accepting evaluation according to the requirements of the research protocol. exclusion criteria: * the subject use gonadotropin therapy within the past three months (regardless the result of treatment). * the uterine factors affect pregnancy and other tumors. * pregnancy contraindication, such as genetic diseases, mental diseases, drug abuse, sexually transmitted diseases, severe heart disease and hepatic and kidney function insufficiency. * obscure vaginal bleeding. * subjects are allergic to the application of fsh/hmg and hcg in the past. * other conditions that the researchers think they are not suitable for the clinical trials.
investigation of the efficacy of transcranial magnetic stimulation in patients developing complex regional pain syndrome type 1 in the upper extremity during the subacute-chronic period after ischemic stroke

Conditions: Complex Regional Pain Syndromes

Summary: the aim of our study is to investigate transcranial magnetic stimulation (tms) as a treatment option in complex regional pain syndrome, disseminate it to a broader patient population, and simultaneously demonstrate its applicability in the treatment of complex regional pain syndrome using a novel frequency matching.

after ischemic stroke in the subacute to chronic period, 45 patients developing complex regional pain syndrome in the upper extremity will be divided into three groups: those receiving combined rtms with conventional rehabilitation (occupational therapy and transcutaneous electrical stimulation for pain), those receiving sham rtms with conventional rehabilitation, and those undergoing only conventional rehabilitation. the tms group is planned to include 15 patients, the sham group 15 patients, and the group included in the conventional rehabilitation program only will also consist of 15 patients.

Eligibility criteria:
inclusion criteria: clinical diagnosis of complex regional pain syndrome diagnosis of ischemic stroke exclusion criteria: epilepsy pregnancy cardiac pacemaker, brain pacemaker, cochlear implants

Keywords: complex regional pain syndrome transcranial magnetic stimulation ischemic stroke
restoring tissue and evaluating novel treatments for efficacy in wounds

Conditions: Diabetic Foot Ulcer

Summary: this is an irb-approved multicenter study.this non-inferiority study aims to evaluate differential healing rates between lavior diabetic wound gel and other hydrogels. study therapy will be started in the outpatient setting and followed accordingly.


Eligibility criteria:
inclusion criteria: * foot wound in the setting of diabetes mellitus * written informed consent * minimum wound surface area of 0.7 x 0.7 cm (0.49 square cm) exclusion criteria: * age \< 18 years * noncompliance with study procedures, visit schedule or follow up gangrene and/or untreatable peripheral arterial disease * malignancy of the wound * use of any other hydrogels not being studied in this investigation within 1 month of being enrolled * dry, uninfected, stable pressure ulcers of the heel * dry, stable eschar in arterial wounds * simultaneous participation in competing clinical trials * pregnancy or nursing mothers

Keywords: diabetes diabetic foot ulcer wound hydrogel diabetes mellitus
evaluation of nucleus 6 sound coding algorithms

Conditions: Hearing Loss

Summary: the purpose of the study was to evaluate the features of the nucleus 6 sound processor (cp900 series) on existing nucleus recipients who currently use the previous generation sound processor, the cochlear nucleus cp810 (also commonly known as the nucleus 5), with a cochlear nucleus ci24re, ci512 or ci422 cochlear implant. the features evaluated included an enhanced automatic gain control (eagc), the option to provide acoustic amplification in combination with traditional electric stimulation through an acoustic component, and three input processing algorithms: signal to noise ratio - noise canceller (snr-nc), wind noise reduction (wnr) and automatic scene analyzer (scan). as is customary for a single-subject research design, study results will be analyzed for each subject individually. for evaluations where testing took place under two conditions (i.e. endpoint 2, 3, 4, and 5) a non-inferiority hypothesis test based on the paired comparisons of the % of words correct will be performed. for each subject, the paired difference (p1 minus p2) will be calculated and the mean difference will be tested statistically against a non-inferiority null hypothesis of 10%. successful rejection of the null hypothesis allows for a conclusion that the performance under the test condition 2 (based on the nucleus 6 sound processor) will be non-inferior to the test condition 1 (based on the nucleus 5 sound processor). ho: p1 - p2 ≥ 10% ha: p1 - p2 \< 10% we hypothesize acceptance of the null hypothesis for the nucleus 6 features. testing will be based on a paired t-test with a one-sided 0.05 alpha level. the value of 10% was selected as the non-inferiority margin as one that can be tested with reasonable power and was clinically meaningful.


Eligibility criteria:
inclusion criteria: 1. eight years of age or older 2. ci24re, ci500 or ci422 series nucleus cochlear implant types (commercially approved) 3. at least 3 months experience with the cochlear implant 4. post-linguistic onset of bilateral sensorineural hearing loss, with no congenital component to the hearing loss 5. native speaker of english, the language used to assess speech perception performance 6. willingness to participate in and to comply with all requirements of the protocol exclusion criteria: 1. unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the prosthetic device 2. unwillingness or inability of the candidate to comply with all investigational requirements 3. additional handicaps that would prevent or restrict participation in the audiological evaluations -

Keywords: background noise speech performance wind noise
glycopyrrolate/formoterol fumarate mdi compared with spiriva® as an active control in patients with moderate to severe chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the primary objective of this study is to assess the efficacy of glycopyrrolate/formoterol fumarate mdi relative to individual components (gp mdi and ff mdi) in subjects with moderate to severe copd


Eligibility criteria:
key inclusion criteria: * signed written informed consent * 40 - 80 years of age * clinical history of copd with airflow limitation that is not fully reversible * females of non-child bearing potential or females of child bearing potential with negative pregnancy test and acceptable contraceptive methods * current/former smokers with at least a 10 pack-year history of cigarette smoking * a measured post-bronchodilator fev1/fvc ratio of \< or = 0.70 * a measured post-bronchodilator fev1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values * able to change copd treatment as required by protocol key exclusion criteria: * women who are pregnant or lactating * primary diagnosis of asthma * alpha-1 antitrypsin deficiency as the cause of copd * active pulmonary diseases * prior lung volume reduction surgery * abnormal chest x-ray not due to the presence of copd * hospitalized due to poorly controlled copd within 3 months of screening * clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ecg, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy) * cancer that has not been in complete remission for at least 5 years * treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives other inclusion/exclusion criteria as defined in the protocol

Keywords: copd
adolescent and young adulte scoliosis

Conditions: Idiopathic Scoliosis

Summary: thoracic hypocyphosis and greater lumbar lordosis after correction of idiopathic scoliosis in adolescents and young adults may adversely affect overall sagittal alignment and increase the risk of proximal junctional kyphosis. the objective of this study is to analyze surgical corrections and maintenance of correction over time using modern posterior instrumentation strategies by comparing technical developments.


Eligibility criteria:
inclusion criteria: * major subjects\> 18 years old * subject with a surgical indication for arthrodesis and surgical correction of adolescent or young adult scoliosis * subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research. exclusion criteria: * subject having expressed opposition to participating in the study * subject under guardianship or guardianship * subject under safeguard of justice

Keywords: idiopathic scoliosis thoracic hyperkyphosis cyphosis
minimum dose computed tomography of the thorax for follow-up in patients with resected lung carcinoma

Conditions: Non-small Cell Lung Cancer

Summary: this study is designed to help decide whether a cat scan performed at a very low dose of radiation (minimum dose ct scan) is better than a chest x-ray in detecting recurrence of lung cancer in the chest (after surgery).

lung carcinoma is expected to kill 18,900 men and women in canada in 2004. this is more than the combined total for the next three common cancers. the most important factor that determines patient survival is the stage of disease at presentation. surgical resection is the best chance of cure. however, patients who undergo lung resection with curative intent have a significant incidence of a second lung cancer at 2% per year and a recurrence rate of 38% at 5 years. the current follow-up of these patients relies on periodic physical examination and chest radiography(cxr). however, cxr is insensitive in the detection of lung nodules when compared to standard computed tomography of the thorax (sdct). computed tomography detects smaller lung nodules than cxr however, the radiation dose from a sdct is roughly equivalent to 20 cxr examinations. screening studies using low dose ct of the thorax (ldct) in subjects at high risk for lung cancer have demonstrated that ldct detects three times as many nodules as cxr and four times as many primary lung cancers at one-third the dose of sdct. phantom and clinical work with ldct performed at uhn/msh suggests that a further reduction in radiation dose (minimum dose ct -mndct) is possible for nodule detection. minimum dose ct is performed at a dose one sixth of a sdct.in addition, if mndct is confirmed to be a more sensitive nodule detection technique, it could be used to 1. increase the interval between repeat out-patient assessment and thereby 2. reduce the overall cost of surveillance and inconvenience to the patient and 3. free up clinic time for the surgeon to review more patients and reduce waiting lists

Eligibility criteria:
inclusion criteria: * lung cancer patients undergoing resection with intent to cure exclusion criteria: * age \< 18 years

Keywords: ct scan lung follow-up
brief mindfulness-based intervention for indonesian teacher in rural area

Conditions: Stress, Psychological

Summary: a randomized controlled trial to assess the effectiveness of the brief mindfulness on teachers' perceived stress and their psychological well-being.

teacher in early childhood education (ece) in indonesia is experiencing high intense stress due to work environment, class management, child behaviour problem, and lack administrative support. stress has also shown negatively impact their psychological well-being, quality of teaching, and to children's' executive function. research about stress and the effects on teacher well-being is especially lacking for rural schools. they represent a forgotten minority and thus, teacher from rural area need a prompt and direct support in terms of stress management strategies. this study employs a randomized wait-list controlled trial design (rct) with an assessment before and after treatment. 4-weeks brief mindfulness-based protocol will be given to 40 teachers as experimental group. 40 other teachers receive wait-list treatment will assign as control group. measurement of perceived stress level will be using indonesian version of perceived stress scale (pss), psychological wellbeing will be measure using indonesian well-being scale (iws), and mindfulness traits will be measure using indonesian version of five factor mindfulness questionnaire (ffmq). data analysis using manova and anova to measure the differences between groups and within groups for all tests and constructs measured.

Eligibility criteria:
inclusion criteria: * minimum two years of work experience as early childhood education teacher. * minimum 25 years of age. * scoring moderate (total score 14-26) to high (total score 27-40) perceived stress on pss-10 exclusion criteria: * have received any formal / manualized mindfulness training prior. * have ever been diagnosed with chronic stress or other related mental disorders such as anxiety, depression, ptsd. * people with a history or tendency to commit suicide. * people with addictive substance dependence who are recovering less than one year.

Keywords: mindfulness teacher indonesia perceived stress well-being
characterization of the microbiome in cutaneous t cell lymphoma skin lesions before and after use of apr-td011® (rlf-td011®) spray solution

Conditions: Cutaneous T Cell Lymphoma

Summary: this open-label, pilot study will evaluate the tolerance and change in the microbiome from the use of apr-td011 ((rlf-td011) wound cleansing spray for the treatment of ctcl skin lesions.


Eligibility criteria:
inclusion criteria: * adults with early-stage mycosis fungoides (stages ia-ib) * at least two target lesions that have been present for at least 3 weeks and is at least 10 cm2 , so that at least one lesion may be allocated to each of the treatment regimes * target lesion with swab that is culture positive for staphylococcus aureus, but not to an extent that would require systemic antibiotics * agree to avoid washing or using a topical application at the target lesion starting the night before each scheduled study visit. * agree for the duration of study participation to avoid using dilute bleach or vinegar baths, or other antiseptic use, at the target lesion from screening throughout the study. exclusion criteria: * patients currently or recently (within past 4 weeks) on topical or systemic antibiotics adults unable to provide informed consent, (infants, children, teenagers, pregnant women, prisoners and other vulnerable populations.
an innovative model of pediatric acute mental health and addictions care

Conditions: Mental Health; Mental Disorders; Pediatrics; Emergency Psychiatric

Summary: the investigators will implement and evaluate an integrated, evidence-based bundle of family-centred, pediatric emergency mental health and addictions care.

the investigators will implement and evaluate an integrated, evidence-based bundle of family-centred, emergency mental health and addictions care. this care bundle will provide high value to families, matching resources and services to need while eliminating healthcare inefficiencies and closing care gaps. the bundle will introduce two well-established tools for healthcare providers to use in eds, walk-in clinics, and urgent mental health care appointments. these tools are the ask suicide-screening questions (asq) and heads-ed, an assessment mnemonic (home; education \& employment; activities \& peers; drugs \& alcohol; suicidality; emotions \& behaviours; discharge or current resources). the bundle will also introduce new processes to improve healthcare system efficiencies, navigation and transitions between healthcare sectors. for families who receive care in the ed, the investigators will remove the physician gatekeeper role so that children/youth who are screened as low-risk will be offered a follow-up appointment in an urgent mental health care clinic within 24-48 hours. those who screen as high-risk will see a mental health specialist and undergo a heads-ed assessment. families who follow up in the clinic will receive care that applies a choice and partnership approach (capa). capa is a collaborative approach to healthcare, where healthcare providers work in partnership with children/youth and their parents to identify choices for care that best match individual needs and preferences. study goal: the investigators' goal is the right care, with the right people, at the right place and time. study design: to measure the bundle's impact, the investigators will use an interrupted time series (its) design.

Eligibility criteria:
inclusion criteria: * patient is under 18 years of age * patient came to the emergency department with a mental health and/or addiction concern * patient presented with one of the following cedis complaints: anxiety, bizarre behaviour, concern for patient's welfare, deliberate self-harm, depression/suicidal, homicidal behaviour, insomnia, pediatric disruptive behaviour, situational crisis, violent behaviour exclusion criteria: * brought to the ed by police, peace officer or ems? * held under form 10 * features of schizophrenia, schizotypal and delusional disorders (e.g., hallucinations, delusions, active psychosis) * behavioural syndromes or other medical concerns requiring medical clearance (e.g., eating disorders) * significant self-harm requiring medical clearance (e.g., deep laceration, ingestion, hanging) * barriers to communication at triage (e.g., language) * previous participation in the study

Keywords: emergency psychiatric services healthcare delivery
the safety and efficacy of fecal microbiota transplantation in a population with major depressive disorder

Conditions: Depression; Treatment Resistant Depression

Summary: the primary goals of this proof of concept clinical trial are to determine the effectiveness, safety and tolerability of oral fmt in adults with treatment resistant depression (trd).

this study is a phase 2/3, double-blinded, randomized controlled trial (rct) in which 80 adults with trd being treated with an approved antidepressant medication will be assigned to either fmt capsules or identically appearing placebo capsules. participant will be followed for f for 14 weeks post fmt. this extended observation period will allow us to see, whether fmt leads to sustainable improvements in depression and changes in intestinal microbiome

Eligibility criteria:
inclusion criteria: 1. between 18-65 years of age: participants should be at least 18 years old and not older than 65 years at the day of screening 2. have a primary diagnosis of mdd according to the m.i.n.i. international neuropsychiatric interview (mini)47 3. medical history suggestive of treatment resistant depression (trd). (inadequate response to at least 2 approved antidepressants. at least one of which is in the current episode of depression)48 4. have been on a current treatment with a approved antidepressant at an adequate dose for at least 8 weeks 5. a madrs score of ≥ 19 at screening and visit 2 additional inclusion criteria: - participants who will be included in the ibs-d cohort should have a confirmed diagnosis of ibs-d as indicated by the referring gastroenterologist. exclusion criteria: * 1. participant meets diagnostic and statistical manual of mental disorders (dsm-5)1 criteria for the following conditions according to the m.i.n.i: f) substance use disorder within the last 3 months. \*(criteria should include alcohol and non-alcohol substances except cannabis) g) moderate or severe substance use disorder for cannabis use the last 3 months h) active anorexia nervosa or bulimia nervosa i) schizophrenia or schizoaffective disorder j) active suicidality 2. regular intake of non-steroidal anti-inflammatory drugs, antibiotics, or iron supplements for medical purposes in the 3 months prior to study entry 3. use of prebiotics or probiotics for medical purposes for more than 2 weeks within the last 3 months 4. clinically diagnosed chronic gastrointestinal diseases (ibd, crohn's disease, ulcerative colitis, celiac disease) 5. conditions causing immune suppression 6. not breastfeeding, pregnant or seeking to get pregnant during the course of this study. be using an acceptable method of birth control (implants, injectable, combined oral contraceptives, iuds, sexual abstinence or a vasectomized partner) 7. reported allergy to vancomycin or nitazoxanide

Keywords: fmt fecal microbiota transplantation microbiome gut brain axis major depression
pharmaco-economic study of treatment options in patients with advanced rcc

Conditions: Renal Cell Carcinoma Metastatic; Renal Cell Carcinoma

Summary: this is a retrospective cohort study aiming to collect data on patients' characteristics, resource utilization, adverse events management and calculate costs attributed to current treatments of advance rcc patients who have received at least one prior vegf-targeted therapy in taiwan from national health insurance (nhi) perspective.


Eligibility criteria:
inclusion criteria: * patients with confirmed diagnosis of clear-cell renal cell carcinoma * patients with evidence of metastatic disease * patients who have received at least one previous vegfr-targeted therapy, i.e sunitinib, pazopanib or sorafenib * patients who received care at the selected medical centers, utilizing the national health insurance (nhi) reimbursed system at the time of the disease exclusion criteria: * patients enrolled in any clinical trial involving anti-cancer therapy * pregnant woman

Keywords: advanced or metastatic renal cell carcinoma (rcc)