Kornimate/medical-research-clean huggingface dataset:
management of non obstructive azoospermia in men

Conditions: Male Infertility; Azoospermia, Nonobstructive

Summary: this study predicts the factors of successful micro testicular sperm extraction in azoospermia patients in male infertility

primary outcomes: these factors were the age, testicular size, hormonal, evidence of varicocles and the out come of micro_tese secondary outcomes: make good decision for micro-tese with low economic laboratory and radiology requirement as every failed microtese-icsi procedure exposes the couple to an emotional, financial burden and increase the incidence of complication such as bleeding, hematoma and testicular atrophy

Eligibility criteria:
inclusion criteria: non obstructive azoospermia with no genetic abnormalties as klinefelter syndrome * redo micro tese exclusion criteria: * obstructive azoospermia and bilateral congenital absent of vas
a follow-up study investigating long term treatment with nintedanib in patients with progressive fibrosing interstitial lung disease (pf-ild)

Conditions: Lung Diseases, Interstitial

Summary: the main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with progressive fibrosing interstitial lung disease (pf-ild) who have complete (and did not prematurely discontinue trial medication in) the phase iii parent trial, inbuild® (trial 1199.247).


Eligibility criteria:
inclusion criteria: * male or female patients who completed the inbuild® trial as planned and who did not prematurely discontinue blinded treatment. * signed and dated written informed consent in accordance with ich-gcp and local legislation prior to admission to the trial. * women of childbearing potential (wocbp)1 must continue to use highly effective methods of birth control per ich m3 (r2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. a list of contraception methods meeting these criteria is provided in the patient information exclusion criteria: * any disease that may put the patient at risk when participating in this trial. reconsider carefully all exclusion criteria of the inbuild® trial. however, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in inbuild®, if the investigator's benefit-risk assessment remains favourable. * patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial * patient not compliant in parent trial (inbuild®), with trial medication or trial visits, according to investigator's judgement. * previous enrolment in this trial. further exclusion criteria apply.
adult b-all treated by cart cell bridging allogeneic hematopoietic stem cell transplantation

Conditions: Adult B Acute Lymphoblastic Leukemia

Summary: this is an open, single-arm, phase i/phase ii clinical study to evaluate efficacy and safety of chimeric antigen receptor t cell immunotherapy (car-t) in the treatment of relapsed refractory (r/r) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.

this trial openly recruited 50 patients into the group and were given car-t treatment. patients participating in clinical trials will be tested and evaluated in terms of treatment safety, efficacy, and response duration. as assessed by clinicians, adult b-all patients who meet the enrollment criteria, after adequate communication, the patient or family members voluntarily join the clinical study, and are willing to bridge allogeneic hematopoiesis within 3 months after enrollment using car-t therapy。

Eligibility criteria:
inclusion criteria: 1. be diagnosed a kind of relapsed or refractory haematopoietic and lymphoid malignancies: 2. ecog score≤2; 3. to be aged 1 to 65 years; 4. more than a month lifetime from the consent signing date. exclusion criteria: 1. serious cardiac insufficiency, left ventricular ejection fraction\<50%; 2. has a history of severe pulmonary function damaging; 3. merging other progressing malignant tumor; 4. merging uncontrolled infection; 5. merging the metabolic diseases (except diabetes); 6. merging severe autoimmune diseases or immunodeficiency disease; 7. patients with active hepatitis b or hepatitis c; 8. patients with hiv infection; 9. has a history of serious allergies on biological products (including antibiotics); 10. has acute gvhd on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month; 11. pregnancy or lactation women; 12. any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
comparison of centurion® vision system with balanced tip and the infiniti® vision system with the mini flared kelman (mfk) tip during cataract extraction surgery of hard lenses

Conditions: Cataracts

Summary: the purpose of this study is to demonstrate that the centurion® vision system (cvs) used with the 45° balanced tip will result in less cumulative dissipated energy (cde) than the lnfiniti® vision system (ivs) used with the 45° mini-flared kelman (mfk) tip during cataract extraction surgery via phacoemulsification of cataract grades nii- niv \[lens opacities classification system ii (locsii)\].


Eligibility criteria:
inclusion criteria: * willing and able to consent for participation; * willing and able to attend postoperative examinations per protocol schedule; * cataract in at least one eye with a nuclear opalescence of ii-iv (via locsii) followed by posterior chamber intraocular lens (iol) implantation; * other protocol-specified inclusion criteria may apply. exclusion criteria: * planned multiple procedures, including laser phaco, lasik, lri's etc. during surgery or the course of this study; * severe conditions of acute or chronic diseases or illnesses that would increase the operative risk or confound the result of this investigation; * untreated or uncontrolled glaucoma; * previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes; * poorly dilating pupil or other pupil defect; * current or previous use of an alpha-1-selective adrenoceptor blocking agent or antagonist of alpha 1a adrenoceptor (eg, flomax®, hyntrin®, or cardura®); * severe retinal disorders; * corneal disease or retinal detachment; * other protocol-specified exclusion criteria may apply.
interoception in anorexia nervosa

Conditions: Anorexia; Anorexia Nervosa; Electrocardiogram; EEG

Summary: anorexia nervosa is a serious psychiatric illness whose causes remain poorly understood, and which remains difficult to treat to this day. many clinical manifestations of this disease can have their origin in abnormalities in the perception of signals coming from inside the body, but this remains to be demonstrated. in recent years, research in healthy subjects has shown how the brain constantly perceives the viscera (heart, lungs, stomach). the examiners will use these new, objective and validated methods to explore how the brain processes information from the viscera (interoception) in anorexic patients. in practice, they will quantify the coupling between the cardiac cycle and involuntary eye movements, as well as between the respiratory cycle and voluntary actions such as pressing a button. finally, by simultaneously recording the electrical activity of the brain, and that of the stomach, the examiners will measure the coupling between the brain and the stomach. all these measurements, which will be compared between a population of patients and healthy subjects, will make it possible to determine whether anorexic patients have an alteration in the perception of their internal body signals and whether this damage affects several organs.


Eligibility criteria:
inclusion criteria - an groups: * females * 6 to 25 years old * diagnostic of an according to dsm-5 criteria * no past or current psychotic disorders * no current substance abuse or dependence (excluding tobacco). * no current psychiatric medication inclusion criteria - control groups: * females * age : matched for the an group * no present or past eating disorders * no past or current psychotic disorders * no current substance abuse or dependence. * no current psychiatric medication exclusion criteria for both groups: * age below 16 years and above 25 years, * past or current psychotic disorders, * current substance abuse or dependence (excluding tobacco) * opposition to participation has been expressed. in addition, for the control group, * subjects with present or past eating disorders or current mental disorders will be excluded.
feasibility and preliminary efficacy of an opioid stewardship program in hospitalized patients with chronic pain

Conditions: Opioid Dependence; Chronic Pain

Summary: this study aims to investigate the feasibility and preliminary efficacy of an enhanced opioid stewardship program, tailored to the needs of hospitalized patients with chronic pain with opioid dependence, incorporating real-time guidance from an addiction medicine and pain-trained physician/pharmacist team, using a pilot randomized clinical trial format. findings from this research may improve pain management and decrease risk of opioid-related adverse events among patients with chronic pain.

the primary objective of this study is to determine whether an enhanced opioid stewardship program, tailored to the needs of patients with chronic pain, is feasible to implement in a hospital setting. one secondary objective is to determine whether an enhanced opioid stewardship program increases use of guideline-based opioid care. the other secondary objective of this study is to determine whether an enhanced opioid stewardship program reduces pain frequency, intensity, and interference and decreases the risk for opioid-related adverse events among adult patients with chronic pain hospitalized on medical units at yale-new haven hospital, york street and saint raphael campuses. this is a pilot randomized controlled trial of 100 adult participants. it is prospective and focus primarily on feasibility. there will be up to 3 study visits with each participant, which will take place during hospitalization or in the first week after hospital discharge.

Eligibility criteria:
inclusion criteria: * admitted at yale new haven hospital (ysc and src) on medical units * identified as having chronic pain and prescribed opioids * have opioid dependence (evidenced by ongoing opioid prescription, meeting diagnostic and statistical manual of mental disorders-5 criteria for opioid use disorder, or clinical history) exclusion criteria: * active cancer * current pregnancy * hospice care/comfort measures only * admission to inpatient psychiatry * completed or planned addiction medicine consult during hospitalization
firm observational clinical unicenter study on guillain barré syndrome

Conditions: Guillain-Barre Syndrome (GBS)

Summary: the aim of this retrospective observational single-center cohort study is to gain a deeper understanding regarding the frequency, the clinical and electrophysiologic characteristics (e.g., the diagnostic work up), complications, treatment regimes, and their associations with specific courses of disease and outcomes in adult patients with the suspected or proven diagnosis of gbs.

guillain barré syndrome (gbs) is a rare and life-threatening neurological emergency. the aim of this retrospective study including adult gbs patients from the last 15 years treated at the university hospital of basel is to assess data regarding diagnostic workup, treatment, clinical course including complications and outcomes.

Eligibility criteria:
inclusion criteria: * suspected diagnosis of gbs, who have been treated at the university hospital of basel from 01.01.2005-28.02.2021 exclusion criteria: * patients with documented refusal of the general consent.
the impact of hip exercises on pelvic floor muscle strength and function in older women with urinary incontinence

Conditions: Urinary Incontinence; Geriatric Syndrome

Summary: this is a prospective cohort study of 30 older women ages 65 and older with urinary incontinence (ui) who will under go a standardized 12-week hip muscle exercises (isometric strengthening of hip external rotators with progressive resistance training).

this is a prospective cohort study of 30 older women ages 65 and older with urinary incontinence (ui) who will under go a standardized 12-week hip muscle exercises (isometric strengthening of hip external rotators with progressive resistance training). participants will take part in a 12-week hip muscle exercise program (weekly supervised hip exercises with resistance progression) plus a home program with the same exercises 3 days per week. the exercise program will be administered by the licensed physical therapist with special focus in hip strength. the change in pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) pre- to post hip muscle exercises. changes in ui symptom severity, and impact of ui symptoms on quality of life will be assessed. objective measurement of pelvic floor muscle strength will be obtained using a perineometer. ui symptom severity and quality of life will be measured using validated questionnaires (pfdi and pfiq, respectively).

Eligibility criteria:
inclusion criteria: * women ages ≥65 * ui for at least the last 3 months ui will be defined using the following (a widely-accepted definition in epidemiologic studies) scores 3 - 12 on the validated 2-item incontinence severity index (isi) exclusion criteria: * women unable to follow-up, not willing to, or unable to participate in the exercise intervention program * prior or current treatment for ui including previous fda approved medications for ui, prior surgery for ui within the past 12 months * pelvic organ prolapse beyond the hymen * potential causes or conditions associated with neurogenic bladder (multiple sclerosis, parkinson's disease, stroke, spinal cord injury) * urinary retention, incomplete bladder emptying (via bladder scan, \>150ml post-void residual) * conditions (neurological or musculoskeletal) that compromise mobility, requiring assisted device for ambulation or wheel chair * diagnosis of dementia or cognitive impairment (montreal cognitive assessment \[moca\] \<25, mild cognitive impairment)
a clinical trial to prevent the complications of insulin resistance (including type-2 diabetes)

Conditions: Insulin Resistance; Diabetes Mellitus

Summary: the goal of this study is to aggressively treat insulin resistance and its clinical manifestations when they first appear in childhood, and to prevent the subsequent progression towards impaired glucose tolerance and type-2 diabetes. in the process of this clinical trial, we will learn more about the early manifestations of insulin resistance, its treatment, and its relationship to obesity and type-2 diabetes through parallel in-vivo and in-vitro studies.


Eligibility criteria:
inclusion criteria: 1. obese patients (wt \> 95th percentile for age, for adults increased bmi \> 27) greater than 5 years of age 2. and/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism 3. siblings and parents of patients with insulin resistance. siblings and parents will be included only in the case of documented insulin resistance in the index subject. insulin resistance will be documented by ogtt and/or ivgtt. 4. family history of type ii diabetes. exclusion criteria: 1. critically ill patients, patients will congestive heart failure, renal or liver insufficiency 2. inability to give consent. 3. history of poor compliance with physician's recommendations
the efficacy and safety of acupuncture for prophylaxis of menstrually related migraine

Conditions: Menstrually Related Migraine; Electroacupuncture

Summary: acupuncture is commonly used for the prevention of migraine and tension-type headaches, and has been found to be effective in reducing both the frequency and severity of these conditions. however, studies on acupuncture for menstrually related migraine (mrm) are limited, and current research has not been able to determine whether its efficacy is due to the actual therapeutic effects of acupuncture or psychological benefits. to address this issue, the investigators have designed a clinical trial to evaluate the efficacy of acupuncture for mrm.


Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for mrm according to the ichd-3, with a documented history of mrm for at least 12 months; 2. have a confirmed diagnosis of migraine by a neurologist; 3. aged 18-45 years; 4. have regular menstrual cycles (28 ± 7 days) with menstruation lasting 3-7 days; 5. have experienced ≥3 headache days during each menstrual cycle (days -2 to +3) and ≥5 total headache days per cycle over the past 3 months and baseline period; migraine attacks must last 4-72 hours without acute medication, or at least 2 hours when treated; 6. have completed a headache diary during the screening period (covering at least one full menstrual cycle), demonstrating good compliance; 7. headache diary data during screening period must meet the ichd-3 criteria for mrm and fulfill criteria (4) and (5); 8. voluntarily sign the informed consent. exclusion criteria: 1. irregular menstrual cycles, defined as cycle length outside the range of 28±7 days or menstruation duration \ 7 days; 2. presence of secondary headache disorders, facial neuralgia, or cranial neuralgia; 3. combined with serious primary diseases such as cardiovascular, hepatic, renal, gastrointestinal, or hematological disorders that may interfere with the treatment protocol, or comorbid neurological conditions such as epilepsy, parkinson's disease, or other central nervous system disorders; 4. headache symptoms caused by other conditions, such as moderate to severe head or neck trauma, perimenstrual infections, intracranial tumors, intracranial infections, endocrine or metabolic disorders; 5. receipt of preventive treatment for headache within 1 month prior to the screening visit; 6. afraid of needles or received acupuncture treatment within 3 months; 7. unwillingness to undergo the study intervention or failure to sign the informed consent.
evaluation of vx-659/tez/iva in cystic fibrosis subjects 6 through 11 years of age

Conditions: Cystic Fibrosis

Summary: this study will evaluate the pharmacokinetics (pk), safety, tolerability, efficacy, and pharmacodynamic effect of vx-659, tezacaftor (tez), and ivacaftor (iva) when dosed in triple combination (tc) in cystic fibrosis (cf) subjects with f/f or f/mf genotypes. the study was discontinued after completion of part a due to sponsor's discretion.


Eligibility criteria:
key inclusion criteria: * homozygous or heterozygous for f508del mutation (f/f or f/mf genotypes) * forced expiratory volume in 1 second (fev1) value ≥40% of predicted mean for age, sex, and height. key exclusion criteria: * clinically significant cirrhosis with or without portal hypertension * lung infection with organisms associated with a more rapid decline in pulmonary status. * solid organ or hematological transplantation. other protocol defined inclusion/exclusion criteria may apply.
a post-market observational study with the easyendotm universal linear cutting stapler in standard laparoscopic and robot-assisted laparoscopic roux-en-y gastric bypass (rygb) surgery

Conditions: Obesity; Roux-en-Y Gastric Bypass

Summary: the primary purpose of this observational registry is to evaluate the safety of the easyendotm universal linear cutting stapler and reloads from ezisurg medical when used to create anastomoses during standard and robot-assisted laparoscopic roux-en-y gastric bypass (rygb) surgery. stapler performance during surgery as well as post-operative pain and the clinical efficacy of the procedures will be determined as secondary objectives.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years of age at study entry. * patient and investigator signed and dated the informed consent form prior to the index-procedure. * patient has a bmi ≥ 35 kg/m2 with one or more related co-morbidity. * patient has a bmi ≥ 40 kg/m2. * patient is eligible for standard laparoscopic or for robotic-assisted laparoscopic rygb surgery. exclusion criteria: * patient is unable / unwilling to provide informed consent. * patient has a history of bariatric surgery. * patient is unable to comply with the study protocol or proposed follow-up visits. * patient has a contra-indication for standard laparoscopic or robot-assisted laparoscopic rygb surgery.
pediatric pain optimization after tonsillectomy

Conditions: Obstructive Sleep Apnea; Tonsillitis; Pain, Procedural

Summary: the purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery.

this is a single center, randomized, double blind, parallel-group dose escalation investigation which will compare post operative pain control indices for patients receiving short acting versus long acting opioids as intraoperative analgesics. surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. subjects are randomized 2:1 to either long-duration (methadone) or short-duration opioid (fentanyl, hydromorphone) through the perioperative period. exploratory data will be collected for up to 30 days post-operatively.

Eligibility criteria:
inclusion criteria: * children ages 3 to 17 years old * presenting for elective tonsillectomy +/- adenoidectomy * provide informed consent / assent (as appropriate) exclusion criteria: * history of liver or kidney disease * females with positive pregnancy test * severe sleep apnea (sleep study with apnea hypopnea index (ahi) \> 10) * consistent daily opioid use for chronic pain ( \>3 months)