Kornimate/medical-research-clean huggingface dataset:
inhalation flow rate-study

Conditions: Bronchiectasis

Summary: study should show feasibility of the device for drug delivery into the lung independently of the severity of impaired lung function.

the aim of the study is to measure inspiratory profiles of patients with non-cystic fibrosis bronchiectasis using the breath activated t-326 inhaler. the following parameters will be derived from the inspiratory profiles: * peak inspiratory flow (pif, in l/min) * inspiratory volume (v, in l) * inspiratory time (t, in s).

Eligibility criteria:
inclusion criteria: * established diagnosis of non-cystic fibrosis bronchiectasis, confirmed and documented by high resolution computed tomography (hrct) or magnetic resonance tomography (mrt) * ability to reproducibly perform spirometry according to american thoracic society/european respiratory society criteria * clinically stable in the opinion of the investigator at the time of the study visit. * male and female patients ≥ 18 years of age. exclusion criteria: * pulmonary exacerbation (as judged by the investigator, based on the clinical condition of the subject and taking into account e.g., febrile infection of the lung, relevant decrease in forced expiratory volume in the first second (fev1) value, increased sputum production, sputum purulence, recent hospitalization) at study visit or within the preceding six (6) weeks. * history of lung transplant. * recent significant hemoptysis (≥ 300 ml or requiring blood transfusion) in the preceding six (6) weeks before screening. * established diagnosis of bronchial asthma. * established diagnosis of cystic fibrosis. * proof of any relevant medical finding or disease in the last three (3) months which might interfere with participation in the study or patient safety (e.g. pneumothorax, uncontrolled hypertension, uncontrolled cardiac arrhythmia, myocardial infarction, cerebral vascular accident). * a relevant disease that is considered to interfere with the study results is any disease that, except for the impairment of lung function, interferes with the patient's ability to inhale from the device. for example, copd per se is usually not considered as a reason for patient exclusion, unless coughing or obliteration of the upper airways with sputum interferes with the patient's ability to inhale from the device. * relevant surgical history in the last 3 months (e.g., but not limited to abdominal, thoracic, ocular or brain surgery). * history or evidence of lung resection, thoracotomy, known aneurysm and severe scoliosis. * pregnancy.

Keywords: device study peak inspiratory flow rate non-cystic fibrosis bronchiectasis t-326 inhaler
the outcome of treatment of traumatised refugees with psychotherapy and/or antidepressants

Conditions: Post-Traumatic Stress Disorder

Summary: the purpose of the study is to investigate the effect of treatment of traumatized refugees with a diagnosis of post-traumatic stress disorder (ptsd). the existing evidence point towards antidepressants of the type ssri and trauma-focused cognitive behavioural therapy being the most effective treatments of ptsd, but very little evidence of treatment effects exist for the group of multitraumatized refugees. this study therefore seeks to investigate the treatment effect of 6 months drug therapy with antidepressants (sertraline and/ or mianserine) and/or trauma-focused cognitive behavioral therapy. a total of 200 individual will undergo treatment. they will be randomized to 4 different groups: antidepressants, psychotherapy, a combination og drug and psychotherapy and a waiting list. outcome measures include symptoms, life quality and function. patients with a diagnosis of drug abuse or psychosis will not be included. the hypothesis is that a combination of antidepressants and psychotherapy will be more effective than either of the two treatment regimes on their own.


Eligibility criteria:
inclusion criteria: * adult traumatised refugee with ptsd exclusion criteria: * psychosis and drug abuse

Keywords: traumatized refugee treatment antidepressants psychotherapy ptsd in traumatized refugees
a culturally sensitive social support intervention

Conditions: Breast Cancer; Breast Neoplasms

Summary: this study is a randomized controlled trial (rct) to assess the impact of a culturally based social support program (i.e. joy luck academy, jla) among chinese american breast cancer survivors.

this study is a randomized controlled trial (rct) to test the health benefits of an education and peer mentor support intervention. chinese american breast cancer survivors who have completed primary treatment will be randomly assigned to either the intervention group or a control group to receive enhanced usual care while waiting for the jla. health outcomes are assessed at baseline, immediately post intervention, and 1 and 4 months follow-ups.

Eligibility criteria:
inclusion criteria: * self-identified to be comfortable speaking chinese (mandarin or cantonese) * having a first breast cancer diagnosis of stages 0-iii * having completed primary treatment (surgery, chemotherapy, or radiotherapy) within the last 36 months exclusion criteria: * unable to read or speak chinese (mandarin or cantonese) * breast cancer diagnosis of stage iv * live outside of the la area

Keywords: chinese cancer survivors quality of life social support
vitamin d and disease activity in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to test blood and tissue samples of people with ulcerative colitis (uc) to see what effects vitamin d may have on the immune system. this research is being done because it could lead to the development of new treatment for people with inflammatory bowel disease (ibd).

patients with uc will be recruited and consented prior to colonoscopy or flexible sigmoidoscopy. all patients will be age 18 or older with a known history of uc that has been confirmed by biopsy and an extent of disease of at least 20cm proximal to the anus. clinical data will be collected on the patient's age, disease duration, family history of ibd, smoking status and history, as well as current medications for ibd through a questionnaire. data will also be collected regarding current vitamin d supplementation (if taking) and dose. prior to the endoscopic procedure, peripheral blood will be drawn into two 10ml red top tubes. at the time of endoscopy, five standard size mucosal pinch biopsies will be obtained from 20cm proximal to the anus. . a bar-coded unique identifier label will be applied to each sample. one biopsy will be placed in formalin. paraffin samples will be maintained at room temperature. following to the endoscopic procedure, the patient's physician will complete a mayo score based on the patients current symptoms and endoscopic disease severity. comparison will be made between disease activity, serum serum 25 hydroxyvitamin d level, and mucosal expression of tight junction proteins as well as proinflammatory cytokines.

Eligibility criteria:
inclusion: * age 18 years old and over * a diagnosis of ulcerative colitis that has been confirmed by biopsy and an extent of disease of at least 20cm proximal to the anus. exclusion: * age \<18 years old * diagnosis of crohn's disease * diagnosis of ulcerative colitis with disease extent \<20cm proximal to the anus
a phase iii study of travoprost/timolol combination in patients with open-angle glaucoma or ocular hypertension

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to demonstrate equivalent safety and iop-lowering effectiveness of two travoprost/timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension. this global study will be conducted in the us (c-07-64, nct00672997) and japan (c-08-08, nct00760539).


Eligibility criteria:
inclusion criteria: * open-angle glaucoma or confirmed ocular hypertension. * mean iop in at least one eye, the same eye(s):22-36 mmhg at 9 am on eligibility visits 1 \& 2 and 21-36 mmhg at 11 am and 4 pm on eligibility visits 1 \& 2. * sign an informed consent form. * discontinued use of all iop-lowering medications(s) for a minimum of 4 days to a minimum of 27 days or more prior to the eligibility 1 visit. * other protocol-defined inclusion criteria may apply. exclusion criteria: * females of childbearing potential who are pregnant, planning to become pregnant during the study period, breast-feeding, or not using adequate birth control measures. * any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension. * history or current evidence of chronic or recurrent severe inflammatory eye disease in either eye. * history or current evidence of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye. * best-corrected visual acuity (bcva) worse than 0.6 logmar in either eye. * severe central visual field loss in either eye. * not able to safely discontinue use of all iop-lowering ocular medication(s) according to the ocular hypotensive medication washout schedule. * history or current evidence of bronchial asthma, or severe chronic obstructive pulmonary disease (copd) that would in the opinion of the investigator preclude the safe administration of a topical beta-blocker. * history or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study. * other protocol-defined exclusion criteria may apply.

Keywords: glaucoma hypertension
a study of pf-07820435 as a single agent and in combination in participants with advanced solid tumors

Conditions: Neoplasms; Non-small-cell Lung Cancer; Melanoma; Squamous Cell Carcinoma of the Head and Neck; Renal Cell Carcinoma; Urothelial Carcinoma; Colorectal Carcinoma; Ovarian Carcinoma

Summary: this study aims to evaluate the safety, and early signals of anti-tumor activity of pf-07820435 when administered alone (part 1a) or in combination with sasanlimab (part 1b; part 2) in patients with selected advanced or metastatic solid tumors. part 1 will be dose-finding and part 2 of the study will further evaluate pf-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor * part 1a: participants with solid tumors where anti-pd-(l)1 is an established treatment. participants must have progressed on or following prior anti-pd-(l)1 therapy if approved, available, tolerable, and eligible * part 1b: participants either meeting part 1a criterion, or participants with "cold" solid tumors where anti-pd-(l)1 therapy is not an established treatment * part 2: participants with nsclc (arm a) must have received platinum-based chemotherapy and anti-pd-(l)1 or have intolerability to or refusal of standard therapies. nsclc participants with known activating mutation(s) must also have received prior approved and available targeted therapy(ies) for the associated mutation(s) or have intolerability or documented refusal of these therapies. participants with uc (arm b) must have received prior platinum-based chemotherapy, anti-pd-(l)1 therapy, or enfortumab vedotin, or have documented intolerability or refusal of the standard therapy(ies). additional cohort indication(s) or dose regimens may be added and defined based on emerging data * at least 1 measurable lesion based on recist 1.1 that has not been previously irradiated (part 1 exceptions permitted after review and approval) * able to provide pre-treatment (and optional on-treatment) tumor tissue exclusion criteria: * active or history of clinically significant gastrointestinal disease and other conditions that are unresolved or pose a risk to study treatment or procedures * active or history of pneumonitis/interstitial lung disease, pulmonary fibrosis requiring treatment with systemic steroid therapy * active or history of clinically significant autoimmune disease or other medical condition that required chronic systemic immunosuppressive therapy within recent 2 years * history of severe immune-mediated adverse event or cytokine release syndrome that was considered related to prior immune modulatory therapy that required immunosuppressive therapy

Keywords: sasanlimab anti-programmed death receptor-1 (pd-1) solid tumor immunotherapy
mind programme for women with breast cancer

Conditions: Breast Cancer Female

Summary: the mind programme for cancer patients was developed by this project pi through the integration of act, mindfulness and cft components specifically adapted to the needs of a cancer population. this intervention aims at improving well-being, preventing subsequent distress, and promoting adaptation to the disease and posttreatment period. a recent pilot study presented preliminary findings on this intervention, suggesting high acceptability and efficacy in improving self-reported psychological health in breast cancer patients undergoing radiotherapy treatment. nevertheless, this study's small sample size, methodology (inactive control group), and exclusive reliance on self-reported data limit the interpretation and generalization of results, creating an avenue for the optimization and further testing of the programme through more robust and reliable methods. the aim of this project is therefore to optimize the mind programme taking into consideration the results from its pilot study and to conduct a randomized controlled trial on the efficacy of the intervention in improving not only mental health outcomes but also biological markers, as well as on its cost-effectiveness, in women with breast cancer. the superiority of the mind programme will be compared to a support group intervention through the analysis of changes in cancer-specific quality of life, depressive symptoms and anxiety severity, psychological experiences, and immunological and epigenetics markers related to mental health and breast cancer prognosis. all participants will receive the intervention that shows better results.


Eligibility criteria:
inclusion criteria: 1. age between 18-70; 2. primary diagnosis of bc (stages between i and iii); 3. undergoing radiotherapy treatment at chuc; 4. able to understand and answer to self-report questionnaires in portuguese. exclusion criteria: 1. currently undergoing any form of psychological intervention; 2. current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation; 3. diagnosis of neurological disease.

Keywords: mindfulness compassion focused therapy acceptance and commitment therapy biological markers cost-effectiveness mental health
validation of a questionnaire to measure cough severity

Conditions: Cough

Summary: to design and validate a questionnaire that allows objective assessment of the severity of chronic cough

chronic cough is a common disease that has important consequences for patients, ranging from physical to psychological and social aspects. however, there is currently no tool to objectively validate cough severity. the aim of the study is to design and validate a questionnaire to objectively assess the severity of chronic cough.

Eligibility criteria:
inclusion criteria: * aged between 30 and 99 years * clinical diagnosis of chronic cough or healthy volunteers * good understanding of spanish exclusion criteria: * non-spanish-speaking patients * inability to complete the questionnaires * failure to sign the informed consent form

Keywords: cough chronic cough
age and gender corrected body mass index

Conditions: Esophageal Cancer

Summary: esophagectomy for cancer is often accompanied with severe preoperative weight loss. body mass index (bmi) values are age-independent and the same for both sexes. from the perspective that these two parameters should actually be taken into account too, we developed a model to calculate "age-gender specific bmi-percentiles" (ag-bmi) and tested this model in relation to survival outcome after esophagectomy for cancer.

age-gender specific bmi percentiles are more accurate compared to the current bmi classes in predicting overall survival (os) after esophagectomy for cancer. furthermore we believe in a more devastating impact on os from underweight and not from overweight. by preoperatively identifying risk patients for poorer os, especially the non-tumoral deaths, this can be a tool to tailor postoperative nutritional strategies to counter further weight loss and bringing postoperative weight to normal ranges.

Eligibility criteria:
inclusion criteria: * any type of esophagectomy exclusion criteria: * preoperative organ metastasis (cm+ or ym+) * esophageal bypass surgery

Keywords: nutritional disorders feeding behavior
designing an implementation strategy for lung screening and smoking cessation treatment in community health centers

Conditions: Smoking Cessation

Summary: tobacco use is the leading preventable cause of death in the us and a major driver of health disparities. among our tools for reducing the harms of tobacco is lung cancer screening (lcs). this study will combine a review of existing qualitative and quantitative data on barriers to lung cancer screening and smoking cessation in underserved populations, a quantitative analysis of predictors of lung cancer screening and smoking cessation treatment use among massachusetts federally qualified health centers (fqhc)s, and a stakeholder advisory group to synthesize these data and select implementation strategies that reflects the critical determinants and the strengths and resource constraints of the federally qualified health centers (fqhc) context.

aim 1) to design an implementation strategy that targets critical components in the delivery of sct or lcs services for patients who smoke. aim 2) to assess the acceptability, appropriateness and feasibility of the implementation strategy among community health center staff.

Eligibility criteria:
inclusion criteria: fqhc implementation team including staff in the intervention fqhcs and their lung screening partners exclusion criteria: fqhc staff or partners who leave the organization before end of study
national network for the study of predictors and prevention of sudden unexpected death in drug-resistant partial epilepsies

Conditions: Drug-resistant Partial Epilepsy

Summary: sudden unexpected death in epilepsy (sudep) is the main concern of professionals and patient associations involved in epilepsy. these represent a priority for the ligue française contre l'epilepsie (lfce). the sudep affect primarily young adults, between 18 and 40 years, suffering from epilepsy uncontrolled by medication. in this population of close to 100,000 people in france, the incidence of sudep is estimated at 0.5%, or nearly 500 deaths per year. it is clear that the majority of these deaths occur in the immediate consequences of a crisis.. investigators suppose that a causal link exists between the occurrence of a sudep and a per / post-critic decline of spo2 below 80 % (75 % of cases, 20 % of controls).the constitution of a cohort of 1500 patients clinically well described and a national database will allow other ambitious projects in a speciality where french centres benefit from a unique knowledge, recognized by their foreign colleagues, but underexploited to date. the lfce (ligue française contre l'epilepsie) is developing structuring actions to facilitate such exploratory studies for the next two years. the high death rate which characterizes the drug-resistant partial epilepsies and, in particular, sudden unexpected deaths in epilepsy (sudep) represents the main axis of research for the ligue française contre l'epilepsie (lfce) as well as for associations of epileptic patients and the european representatives of the international league against epilepsy ( ilae). today, sudep occurrences cannot be anticipated. patients can't be warned against sudep. although the sudep physiopathology remains uncertain, many elements plead for the essential role of a per-and post-critic apnea (central or obstructive). investigators observe that about 20 % of the patients admitted in a eeg-video monitoring - eeg unit for recording their crisis are going to present experience an per / post-critic severe apnea, severe per / post-critic enough to have induce a spo2 \< 80 % decrease. however, today, no study has estimated the link relation between the arisen occurrence of such apneas and the later risk of sudep.


Eligibility criteria:
inclusion criteria: * patients suffering from drud-resistant partial epilepsy ; * patients who are at least 15 years ; * patients for whom a video-eeg monitoring of their seizures was scheduled as part of a pre-surgical assessment ; * patients having a registration number in the rnip (répertoire national d'identification des personnes physiques) or a social security number * patients who have given their written consent ; * patients with a social security exclusion criteria: * patients under 15 years * patients without drug-resistant partial epilepsy * patients without a registration number in the rnip (répertoire national d'identification des personnes physiques) or a social security number) * patient without a consent signed

Keywords: epilepsy sudep spo2
photoplethysmographic dichrotic notch reflexes systemic hemodynamics

Conditions: Vascular Diseases

Summary: changes in the vascular tone of anesthetized patients is common and cause hemodynamic problems. the investigators have previously demonstrated that the shape of the pulse oximetry waveform (photoplethysmography) is closely related to the changes observed in systemic vascular resistence. the main change in pulse waveform is based to the dichrotic notch position. the present study was designed to determine if the dichrotic notch position is related to a local or a systemic change in the vascular tone.

this is a prospective and observational study designed to determine if the changes observed in finger photoplethysmographic waveform of surgical patients is related to a local or a sistemic changes in the vascular tone. the investigators will studied 15 patients undergoing regional brachial plexus anesthesia for upper limb surgeries. photoplethysmography will be continuously recorded in the thumb of the tested hand (anesthetized hand) and in the thumb of the control, opposite hand. duplex color and power doppler will measure flow in the both brachial arteries and in the aorta (supraesternal view). the contour analysis of both, photoplethysmogram and arterial flow velocities will be analyzed, correlated and compared.

Eligibility criteria:
inclusion criteria: * written inform consent * programmed surgery * supine position exclusion criteria: * emergency surgery * peripheral vascular diseases

Keywords: doppler photoplethysmography