Kornimate/medical-research-clean huggingface dataset:
to improve lung function and symptoms for emphysema patients using zephyr valves

Conditions: COPD; Heterogeneous Emphysema

Summary: to compare the clinical outcomes of endoscopic lung volume reduction (elvr) using pulmonx zephyr valves vs. standard of care (soc) in the treatment of heterogeneous emphysema subjects in a controlled trial design setting.


Eligibility criteria:
inclusion criteria: 1. obtained informed consent. 2. diagnosis of heterogeneous emphysema with a heterogeneity index of ≥10 % between target and adjacent lobes. 3. subjects of both genders of at least 40 years of age. 4. 15 % predicted ≤ fev1≤ 45% predicted. 5. tlc \> 100% and rv ≥ 180% predicted. 6. 150 meters \< 6mwd \< 450 meters. 7. non-smoker \>8 weeks prior to signing the informed consent. 8. cv negative target lobe. additional inclusion criterion french cip\*: - if treated in france, subject must be entitled to french social security exclusion criteria: 1. any contraindication for bronchoscopic procedure. 2. evidence of active pulmonary infection. 3. history of 2 or more exacerbations requiring hospitalization over the past 12 months. 4. known pulmonary hypertension that according to the physician will be unsuitable for ebv treatment. 5. myocardial infarction or other relevant cardiovascular events in the past 6 months. 6. significant bronchiectasis seen at ct scan. 7. greater than two tablespoons of sputum production per day. 8. prior lvr or lvrs procedure. criterion 8 french cip wording\*: prior lung transplant, median sternotomy, lvr or lvrs procedure (including lobectomy). 9. pulmonary nodule requiring follow-up within any lobe. 10. pregnant or nursing women. french cip wording\*: subject is pregnant or lactating, or plans to become pregnant within the study timeframe. 11. hypercapnia (paco2 \> 7.33 kpa). 12. current diagnosis of asthma. 13. \> 25mg prednisolon (or equivalent) use/days. 14. any other condition that as judged by the investigator may make follow-up or investigations inappropriate. 15. evidence of pleural adhesions or earlier pulmonary surgery. 16. severe bullous emphysema (\> 1/3 hemithorax) 17. any subject that according to the declaration of helsinki is unsuitable for enrollment. additional exclusion criteria in the french cip\*: * history of allergy to silicone and/or nitinol. * if treated in france, subject is a "personne vulnerable" as defined by french regulation. * simultaneous participation in another drug and/or medical device related clinical.

Keywords: endoscopic lung volume reduction endobronchial valves
option: a trial to assess the safety & efficacy of ms1819 in patients with exocrine pancreatic insufficiency due to cystic fibrosis

Conditions: Exocrine Pancreatic Insufficiency (EPI); Cystic Fibrosis (CF)

Summary: the primary objectives of this study are to assess the safety and efficacy of ms1819-sd vs porcine pancreatic enzyme replacement therapy (pert) in patients with exocrine pancreatic insufficiency (epi) due to cystic fibrosis (cf).

this is a phase 2, open-label, multi-center, 2x2 crossover study assessing the safety and efficacy of ms1819-sd (spray dried) vs porcine pert given at the same dose that was being administered during the pre-study period. ms1819-sd will be assessed in a 2x2 crossover including at least 30 patients completing both periods.

Eligibility criteria:
inclusion criteria: 1. cystic fibrosis, based on 2 clinical features consistent with cf, plus initial diagnostic sweat chloride ≥ 60 mmol/l 2. under stable dose of porcine pert 3. a fair or better nutritional status 4. fecal elastase \<100 µg/g 5. standard-of-care medications including cystic fibrosis transmembrane conductance regulator (cftr) modulators are allowed exclusion criteria: 1. history or diagnosis of fibrosing colonopathy 2. any chronic diarrheal illness unrelated to pancreatic insufficiency 3. alanine aminotransferase (alt) or aspartate aminotransferase (ast) level ≥5 ×upper limit of normal (uln), or total bilirubin level ≥1.5 ×uln at the screening visit 4. feeding via an enteral tube during 6 months before screening 5. forced expiratory volume ≤30% at the screening visit

Keywords: exocrine pancreatic insufficiency epi cystic fibrosis cf pancreatic enzyme replacement therapy (pert) lipase
atezolizumab and bevacizumab combination recommended in a multidisciplinary consultation meeting in caen for hepatocellular carcinoma (abchcaen)

Conditions: Atezolizumab and Bevacizumab in Hepatocellular Carcinoma

Summary: in france primary liver cancers (plc) is the fourth leading cause of cancer-related death in men, and the seventh in women. the number of new cases per year is predicted to increase by 26.5% between 2020 and 2040. hepatocellular carcinoma (hcc) account for 75% to 85% of plc. it occurs mostly on cirrhotic livers. diagnosis remains late in almost half of the patients so that a palliatif treatment is frequent. in advanced cases sorafenib has been so far the first line systemic therapy since 2008. in 2020 a phase 3 study has demonstrated a better overall survival in patients treated with bevacizumab associated with atezolizumab as compared to sorafenib (19.2 months vs 13.4 months) and a better quality of life. noweday immunotherapy is recommended in first line in cases of ecog 0/1 unresectable hcc without liver insufficiency. however the study included 70% of viral liver diseases while hcc are related to alcohol and steatohepatitis in 50% of cases in france. moreover patients with high risk of oesophageal variceal bleeding were excluded. recent real life data published worldwide confirm the bitherapy efficacy and good tolerability. by contrast french data are scarces, with a single serie of 43 patients in which median overall survival was estimated to 12 months. our main aim is to determine the overall survival of hcc patients treated with atezolizumab and bevacizumab in caen from april 2021.


Eligibility criteria:
inclusion criteria: * age superior or equal to 18 years * patients with advanced hepatocellular carcinoma * treatment validated in multidisciplinary consultation meeting exclusion criteria: * patients with another kind of liver cancer

Keywords: hepatocellular carcinoma immunotherapy
giant cell arteritis and pet scan (gaps) study

Conditions: Giant Cell Arteritis

Summary: giant cell arteritis (gca) is a medium to large vessel vasculitis with a predilection for the superficial cranial and intrathoracic arteries. diagnosing the condition and predicting which patients will develop large vessel complications remains a challenge. there are limitations with temporal artery biopsy, magnetic resonance angiography and ultrasound of temporal arteries and american college of rheumatology classification criteria. positron emission tomography (pet) has been shown to be a useful modality in detecting inflammation in large intra-thoracic vessels but previously has not been able to accurately detect fdg uptake in the superficial cranial arteries due to poor spatial resolution. newer scanners can perform finer cuts of the head and can detect uptake in these arteries. this study has three main components: 1. cross sectional study assessing the accuracy of pet uptake in the superficial cranial and intrathoracic arteries of suspected gca patients for the diagnosis of gca 2. cohort study assessing the prognostic implication of fdg aortic uptake on aortic diameter at 24 months 3. cohort study assessing the th1 and th17 cytokine profile in patients with and without fdg pet uptake at 0, 6 and 24 months


Eligibility criteria:
inclusion criteria: * rheumatologist, neurologist or ophthalmologist suspect diagnosis of gca * age \> 50 * meet at least 2 of 1990 american college of rheumatology classification criteria for gca 1. age \>= 50 2. esr \>= 50 3. new onset localised headache 4. temporal artery abnormality (tenderness or decreased pulsation) 5. positive biopsy (will not be available at time of enrolment) exclusion criteria: * corticosteroid therapy for \> 72 hours before first pet scan * prolonged corticosteroid therapy (\> 1 week) for another indication in past 6 months * history of vasculitis or connective tissue disease * active malignancy
digital pet/ct using [ga-68]psma vs. [f-18]naf for evaluation of osseous metastatic involvement in prostate cancer patients

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate a radioactive diagnostic study drug, which is called gallium-68 prostate specific membrane antigen (\[ga-68\]psma) for detection of bone metastasis in patients with prostate cancer. for imaging the investigators will use a fda approved imaging technology, digital positron emission tomography (pet/ct). the investigators would like to know if digital pet/ct using \[ga-68\]psma provides accurate information about the extent of bone metastases. therefore, the investigators will compare\[ga-68\]psma pet/ct with flourine-18 \[f-18\] sodium fluoride (naf), which is a high resolution bone scan. \[f-18\]naf is fda approved and the reference standard for evaluating the presence of bone metastases.\[ga-68\]psma is an investigational (experimental) drug that works by binding to prostate specific membrane antigen, which is overexpressed in prostate cancer. \[ga-68\]psma is experimental because it is not approved by the food and drug administration (fda) at university hospitals. however, fda approval has been obtained for this study protocol by an investigational new drug (ind) application.


Eligibility criteria:
inclusion criteria: * 1) patients must have a history of prostate cancer * 2) patients have known or highly suspected osseous metastatic involvement defined by the referring physician based on clinical history and/or findings from standard of care imaging. * 3) patients ≥ 18 years old * 4) patients able to tolerate pet/ct scans * 5) informed written consent must be given and signed exclusion criteria: * 1. subjects who do not meet the noted inclusion criteria * 2. patients \< 18 years old * 3. subjects who refuse to give or are unable to sign the informed consent * 4. anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks * 5. patients with a known allergy against ga-68 psma or f-18 naf

Keywords: bone metastasis pet/ct
a safety, tolerability and preliminary efficacy study of liris® 400 mg in women with interstitial cystitis (ic) and hunner's lesions

Conditions: Chronic Interstitial Cystitis

Summary: the purpose of the study is to evaluate if liris 400 mg is safe and tolerable when administered to women with interstitial cystitis with hunner's lesions, and to evaluate any change in the bladder or in ic symptoms, following liris administration.


Eligibility criteria:
inclusion criteria: * women age 18 and older * interstitial cystitis with history of hunner's lesions in the bladder * moderate to severe bladder discomfort * confirmation of hunner's lesions in bladder * able to report symptom (pain and voiding frequency) in a diary throughout the study exclusion criteria: * pregnant women * history or presence of bladder cancer * history or presence of any condition that would make it difficult to evaluate bladder symptoms

Keywords: hunner's lesion
acquisition of full oral feeding and further oral disorders in extremely preterm infants

Conditions: Oral Disorders

Summary: extremely premature infants (born before 29 weeks) frequently present oral disorders. the management of these patients require assisted ventilation, enteral nutrition, and intensive daily care (procedural pain, exposure to pain, noise, and light), which can have a negative impact on their development. and more specifically on the development of oral skills. in the past decades, the standard of care has evolved and is based on less "aggressive" care and the implication of parents as caregivers. recent data on the incidence of oral disorders in extremely premature babies are not currently available. these oral disorders have significant short-term and long-term consequences. during hospitalization, it leads to a delay in the acquisition of full oral feeding, which is defined as the absence of need for tube feeding, and is associated with prolonged hospitalization. it is also associated with a delayed development of orality, which is essential for the proper psychomotor, and cognitive development of premature infants. strategies have been proposed to support the acquisition of oral feeding autonomy and to prevent oral feeding disorders, including tactile stimulation of orality consisting in stroking cheeks, peri-oral and intra-oral structures, but there is still no consensus on the best way to support the development of orality in this population. in this context, a tactile stimulation protocol of orality, has been implemented in the past years, in the neonatal unit of the croix-rousse hospital, based on data published in the literature. it is performed on a daily basis by nurses, and physiotherapists. in this general context marked by a less aggressive management of orality, and the implementation of an orality stimulation protocol, the main objective of oraprem study is to determine the corrected gestational age of oral feeding autonomy in a population of extremely premature infants born recently. secondary objectives are 1) to analyse risk factors of delay in oral feeding autonomy, to define a subgroup of high-risk infants who could benefit from reinforced interventions to stimulate orality, and 2) to calculate the incidence of oral feeding disorders up to 24 months.


Eligibility criteria:
inclusion criteria: * infants born at a gestational age ≤ 28 weeks * born between january 1, 2018 and december 31, 2021 * admitted in the first three days of life in the neonatology department of the croix-rousse hospital * discharged directly to home (or to a nursery) exclusion criteria: * infants re-transferred to another department during hospitalization * infants with a severe pathology requiring surgical management in the first weeks of life. inguinal hernia repair is not concerned * severe malformation * refusal of the parents
study on the relationship between mobile phone addiction and functional gastrointestinal disorders

Conditions: IBS - Irritable Bowel Syndrome

Summary: a cross-sectional study was conducted to collect the relevant data of college students' mobile phone addiction and fgids (ibs, fd) in the form of questionnaire, so as to understand the situation of college students' mobile phone addiction and the incidence of fgids (ibs and fd), and explore the correlation, so as to provide new ideas and scientific basis for the prevention, diagnosis and treatment of fgids among college students.

this study adopts the method of cross-sectional survey to collect the relevant data of chinese college students' mobile phone addiction and fgids (ibs, fd) in the form of online and face-to-face questionnaire, so as to understand the situation of chinese college students' mobile phone addiction and the incidence of fgids (ibs, fd), and explore the correlation, so as to provide new ideas and scientific basis for the prevention, diagnosis and treatment of fgids.

Eligibility criteria:
inclusion criteria: * college students from all over the country, over 17 years old, have a physical examination before entering school * sign the informed consent form, voluntarily participate and fill in the questionnaire exclusion criteria: * people with diabetes, hyperthyroidism or hypothyroidism, peptic ulcer, inflammatory bowel disease, digestive tract tumor or severe medical and surgical disease * history of abdominal surgery (such as esophagus, stomach, small intestine, colon, rectum, appendix, gallbladder, hysterectomy, cesarean section) * recently, there are some alarm symptoms, such as relieving black stool, bloody stool, hematemesis, abnormal anemia, fever, abnormal weight loss (no intention to lose weight, weight loss 5 kg in 3 months), change of defecation habits, dysphagia and so on * in the past 4 weeks, he has taken drugs that affect the judgment of gastrointestinal symptoms, such as anti-inflammatory painkillers, diazepam drugs, anti-anxiety drugs, depressants and so on

Keywords: ibs，fd，mpa
sildenafil for meniere's disease

Conditions: Meniere's Disease

Summary: meniere's disease affects a person's sense of balance. an attack can last 20 minutes to 2 hours or longer. symptoms include rotational vertigo, hearing loss, tinnitus and a sensation of fullness in the affected ear and may be associated with nausea and vomiting. one hypothesis is that meniere's disease is caused by the excessive accumulation of fluid in the balance tubes within the inner ear. sildenafil may alleviate the symptoms due to its vasodilatory activity. the purpose of this study is to assess the safety and efficacy of sildenafil (viagra) compared with placebo on symptoms during one acute attack.


Eligibility criteria:
inclusion criteria: * active meniere's disease (2 or more definitive spontaneous episodes of vertigo 20 minutes or longer, plus hearing loss on at least 1 occasion, tinnitus or aural fullness) with confirmed diagnosis exclusion criteria: * pregnant or breast feeding females or fertile females unwilling to use agreed contraceptive methods * severe meniere's diseased (more than 8 attacks per month) * previous ear surgery * intratympanic perfusions of steroids or gentamicin; requiring other medications contraindicated for viagra (eg. nitrates) * with medical conditions that make viagra contraindicated
metformin versus orlistat in obese polycystic ovary syndrome (pcos) patients

Conditions: Obesity

Summary: the purpose of this study is to compare the influence of orlistat and metformin on obesity treatment in obese pcos women.

in a randomized clinical trial study, 80 obese women with bmi≥30, oligomenorrhae, hirsutism and presence of \> 12 ovarian follicles (2-10mm diameter), were evaluated. in metformin group , metformin was administered for patients 1500 mg daily for three months. in orlistate group, patients used orlistat tablets (120 mg, 3 times a day) for three months. bmi, serum lh and fsh levels, serum triglyceride and cholesterol levels and also patients' ovulation was compared before and after treatment.

Eligibility criteria:
inclusion criteria: * bmi\>= 30 * pcos exclusion criteria: * drug use during last three months

Keywords: metformin orlistat pcos obese
a study of the efficacy of ons to reduce postoperative complications associated with pancreatic surgery

Conditions: Pancreatic Cancer; Chronic Pancreatitis

Summary: this is a single center, open label, randomized trial, involving 150 patients undergoing pancreatic surgery. patients will be randomized at the time of enrollment to receive from 5-7 days of ons supplementation combined with resistance training and nutritional education compared to standard of care, consisting of nutritional education alone. this proof of concept study is intended to demonstrate the ability of pre-habilitation to improve patient-related outcomes following pancreatic surgery, specifically postoperative complications. the rationale for using the designated oral nutrient supplementation is to preserve muscle mass, and decrease weight loss.

patients undergoing pancreatic surgery for either chronic pancreatitis or known/suspected pancreatic cancer represent the study population for this clinical trial. study subjects randomized to one of the ons arms will be asked to consume the drink during the study intervention. study visits immediately preoperative, and 1, 3, and 6 months following surgery will be in-person visits. if subjects are unable to return to our institution for subsequent clinical care, these telephone interviews will be collected and acquisition of locally obtained laboratory tests will be attempted. assessments performed during postoperative visits include: * vital signs and physical examination * blood samples * performance status and strength * quality of life measures * postoperative complications and hospital readmissions (if any)

Eligibility criteria:
inclusion criteria: 1. age 40-89 at the time of study enrollment. 2. undergoing pancreatectomy for either chronic pancreatitis or pancreatic cancer. 3. ability and willingness to complete study related documents and activities. exclusion criteria: 1. severe malnutrition that in the judgment of the patient's supervising physician or an investigator would not permit surgical intervention without preoperative nutritional support (enteral or parenteral). 2. subject is receiving (or planned to receive) enteral tube feeding or parenteral nutrition at the time of screening or before surgery. 3. surgery is planned within 7 days of enrollment (i.e., inadequate time to offer the study intervention). 4. known allergy to soy or milk, which are included in the oral supplement. 5. the inability to refrain from using a non-study oral nutritional supplement or fish oil supplementation (unless prescribed for treatment of hyperlipidemia). 6. pregnancy, incarceration, or inability to provide written informed consent.
aromatherapy and anxiety study

Conditions: Anxiety Related to Pain Related to an Intraarticular Injection; Pain Related to an Intraarticular Injection

Summary: while intra-articular injections can alleviate pain in orthopedic patients, this can be an anxiety-provoking experience. adult patients scheduled to receive an injection at the study location will be randomly assigned to one of three groups. the control group (c) will receive the current standard of nursing care. the first experimental group (a) will receive a guided meditation prior to receiving the injection. the second experimental group (b) will receive an elequil aromatab and the same guided meditation prior to receiving the injection.

the objective of the study is to measure the difference in anxiety levels of adult orthopedic patients in need of intra-articular injections who receive a guided meditation only prior to their injection, compared to those who receive a guided meditation and an aromatherapy elequil aromatab prior to injection, as well as compared with those who receive the usual standard of care

Eligibility criteria:
inclusion criteria: * patient has an in-office appointment at the nyu langone ambulatory care-23rd street location with either the ortho a \& b (primarily those patients who may be seeking knee or hip replacement surgery), hand, or primary sport clinics. * patient has an order for an intra-articular injection (as determined by clinic md) and has consented to receiving that treatment. * patient is english speaking. exclusion criteria: * patient has a cognitive or physical disability that would interfere with their ability to complete the study's pre and post assessments with rn. * patient is found on the pre-injection assessment form to have an intolerance or allergy to lavender, sandalwood, or strong scents in general.