Kornimate/medical-research-clean huggingface dataset:
genetic study of the dilatations of the idiopathic bronchi in french polynesia

Conditions: Idiopathic Bronchiectasis

Summary: bronchiectasis, defined by an increase in bronchial caliber and thickening of the bronchial wall, is associated with recurrent respiratory infections, chronic cough and bronchorrhea, and a frequent progression to chronic respiratory failure. investigator distinguish focal bronchiectasis usually resulting from a localized cause and diffuse bronchiectasis which the possible causes are multiple (immune deficiencies, genetic diseases, auto immune pathologies, aspergillosis broncho -allergic lung, sequelae of pulmonary infections).the etiological assessment is negative in 26 to 53% of cases, defining the idiopathic bronchiectasis. however, the discovery of an underlying cause can change the patient's management (up to 37% of cases). despite the lack of epidemiological data in french polynesia, australian and new zealand studies found a high prevalence of bronchiectasis in polynesians. few clinical studies published in the early 1980s suggested a ciliary origin. due to its geographic characteristics, the polynesian population constitutes an interesting ethnic group. indeed, there is a low genetic mixing and the prevalence of certain genetic diseases like the syndrome of alport or some hereditary retinal dystrophies are high. this type of population is very suitable for discovering new genes in human pathology. investigator decided to conduct an observational study to find an underlying genetic cause of bronchiectasis in polynesians by performing a whole exome sequencing. investigator chose to study index cases defined by an upset of symptoms during the childhood, a family history of idiopathic bronchiectasis, and/or a consanguinity. investigator also want to study healthy first degree relatives, in order to be able to better identify the clinical significant of dna variants and focus the analysis on those that may be pathogenic


Eligibility criteria:
\*patients inclusion criteria: * polynesian adult more than18 years * dilatation of idiopathic bronchi confirmed to thoracic ctscan * negative etiological balance (including sweat test, research of dyskinesia ciliary primitive and immunological check-up) * appearance of symptoms in childhood, or family history of chronic bronchial disease, or notion of inbreeding * signed consent * affiliated with a social security system exclusion criteria: * refusal to participate in the study \*relatives * first-degree healthy relatives * polynesian adult more than 18 years * signed consent * affiliated with a social security system exclusion criteria: * refusal to participate in the study

Keywords: genetic disease idiopathic bronchiectasis polynesia polynesia
a pmcf study to confirm the performance and safety of the lemaitre® tuftex single lumen embolectomy catheter

Conditions: Arterial Thromboembolism

Summary: a post market clinical study to confirm the performance and safety of the lemaitre® tuftex single lumen embolectomy catheter on patients undergoing surgical treatment for the removal of arterial emboli and/or thrombi

this prospective, single arm, post market clinical study was designed to proactively collect clinical data on the lemaitre® tuftex single lumen embolectomy catheters and to confirm its performance in removing arterial emboli and/or thrombi, to identify and analyze emergent risks on the basis of factual evidence, and to ensure the continued acceptability of the benefit/risk ratio. this post market study is sponsored by lemaitre® vascular, inc., the manufacturer of the device. study will take place at 3 to 8 sites in europe, the target sample size is 112 patients.

Eligibility criteria:
inclusion criteria: 1. male and female subject, ≥ 18 years of age at time of enrollment. 2. subject who is scheduled to undergo surgical treatment for the removal of arterial or venous emboli and/or thrombi, where one of the lemaitre® embolectomy catheter will be used. 3. subject signed an informed consent for participation. 4. subject diagnosed with a embolus/thrombus. 5. subjects for whom thrombolytic therapy had failed or was contraindicated. exclusion criteria: 1. co-morbidity that in the discretion of the investigator might confound the results. 2. subjects who are unable to read or write. 3. pregnant or lactating women at time of enrollment 4. subjects who are immune comprised
immunogenicity and safety study of scb-2019 vaccine as a booster to covid-19 vaccine in adults

Conditions: COVID-19

Summary: the purpose of this study is to assess the immunogenicity and safety of the investigational scb-2019 vaccine, administered as a booster dose, to adults who: * received primary series with one of the selected authorized or investigational covid-19 vaccines at least 3 months prior to enrollment. * received primary series and a booster dose of coronavac at least 3 months prior to enrollment.


Eligibility criteria:
inclusion criteria: * male and female participants at least 18 years of age; * individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures; * individuals willing and able to give an informed consent, prior to screening; * healthy participants or participants with pre-existing medical conditions who are in a stable medical condition; * individuals who received primary vaccination series with one of the selected covid-19 vaccines (comirnaty, vaxzevria, or coronavac) ≥3 months prior to enrollment; or received primary series and a booster dose (≥3 months after primary series) of coronavac, ≥3 months prior to enrollment. exclusion criteria: * individuals with fever \>37.5°c (axillary), or any acute illness at baseline (day 1) or within 3 days prior to randomization; * individuals with laboratory-confirmed sars-cov-2 infection at visit 1 (determined by positive rapid antigen test or rt-pcr); * individuals who have received an investigational or licensed covid-19 vaccine prior to day 1 (except for primary series with comirnaty, vaxzevria, coronavac vaccines, or primary and booster dose of coronavac), or plan to receive covid-19 vaccine during the study period; * individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines; * individuals who have received any other investigational product within 30 days prior to day 1 or intend to participate in another clinical study at any time during the conduct of this study.
optical coherence tomography - guided protocol for left main percutaneous coronary intervention

Conditions: Left Main Coronary Artery Stenosis

Summary: lemon aim is to evaluate the feasibility, efficiency and security of a standardized optical coherence tomography (oct) - guided protocol for completion and optimization of left main (lm) percutaneous coronary intervention (pci).

the lemon study (left main oct-guided interventions) is a prospective, multicentre, open-label, interventional , non-randomized trial that investigates the feasibility and efficiency of oct guidance for left main pci in 10 active french interventional cardiology centres. the aim of the study is the appliance of a pre-defined standardized protocol for lm pci . the lm pci strategy is guided by 3 oct runs, according to a pre-determined protocol. the first oct run (run1) is performed before any stent implantation, the second run (run2) is performed after the stent is implanted, pot (proximal optimization technique) is applied and side branch iss rewired through stent struts. the third run (run3) is performed after pci optimization. in case of additional stent optimization, a supplementary oct run is applied in order to assess final result.

Eligibility criteria:
inclusion criteria: * age \>18 * stable or non-stable distal left main lesion (with or without previous coronary artery bypass graft), involving or not left anterior descending and coronary circumflex ostias and requiring percutaneous coronary intervention with a one or two stents strategy * stable or non-stable ostial left anterior descending and/or coronary circumflex lesion requiring percutaneous coronary intervention with involvement of distal left main * syntax angiographic score \<23 * informed consent exclusion criteria: * ostial left main lesion * on-going acute stemi * on-going cardiogenic shock * severe chronic renal failure (cr cl \<30 ml/min/m2) * anticipated technical contra-indication to oct (highly calcified lesions, severe proximal tortuosity)

Keywords: optical coherence tomography (oct) percutaneous coronary intervention (pci).
study to evaluate the efficacy and safety of "allergovac poliplus" in polysensitized patients with allergic rhinitis/rhinoconjunctivitis, with or without asthma

Conditions: Rhinitis, Allergic; Rhinoconjunctivitis

Summary: this is an observational prospective multicenter clinical study, to evaluate the efficacy and safety of the treatment with allergovac poliplus subcutaneous immunotherapy (scit) with a mixture of 2 allergenic extracts (pollens or mites), in polymerized-depot formulation, administered in its different available allergenic extracts mixtures (2 pollens or 2 mites), and in one of the 2 recommended administration schedules (1 day or rapid).


Eligibility criteria:
inclusion criteria: 1. patients aged between 5 and 60 years with allergic rhinitis or rhinoconjunctivitis mediated by ige, caused by sensitization to more than one allergenic source (pollens or mites) and with or without associated mild / moderate asthma. 2. patients susceptible to receive treatment with allergovac poliplus (scit), according to usual clinical practice 3. patients who have given their signed informed consent. exclusion criteria: 1. patients who have received or initiated treatment with allergovac poliplus previously to study inclusion. 2. patients who have received previous immunotherapy treatment, both subcutaneous (scit) and sublingual (slit), with any of the allergenic extracts that they plan to receive, in the 5 years prior to study inclusion. 3. patients who in the opinion of the investigator may present difficulties that prevent the understanding of what was written in the informed consent form or the completion of self-administered questionnaires / scales or the patient's diary. 4. patients who are participating in another clinical trial or observational study with any drug.

Keywords: allergen immunotherapy (ait) rhinitis rhinoconjunctivitis subcutaneous immunotherapy (scit) allergovac poliplus
graded motor imagery in elbow limitation

Conditions: Elbow Fracture; Limitation, Mobility; Pain, Postoperative; Upper Extremity Problem

Summary: this randomized-controlled trial aims to investigate the efficacy of graded motor imagery (gmi) on function, pain, and range of motion (rom) in patients with a posttraumatic stiff elbow.

to investigate the efficacy of gmi on function, pain, and rom in elbow limitation, voluntary patients with elbow limitation, aged between 20-55 years will be randomly divided into two groups: gmi group and standard rehabilitation (sr) group. interventions will be applied for 12 sessions. the patients will be assessed before, after six-week treatment and six-week follow-up. the pain on activity, at rest and at night will be assessed with visual analog scale (vas). pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. rom will be assessed with a digital goniometer. isometric muscle strength will be measured with a handheld dynamometer of elbow flexors and extensors. grip strength will also be assessed. recognise™ will be used for assessing the right-left discrimination. the functional status and kinesiophobia will be evaluated by disabilities arm, shoulder and hand (dash) and tampa scale for kinesiophobia, respectively. the global rating of change will be used to evaluate patient satisfaction. the vividness of movement imagery questionnaire 2 (vmiq-2) will be used for evaluating the individuals' ability to mental imaginary.

Eligibility criteria:
inclusion criteria: subjects will be included with * aged between 20 and 55 years * elbow fracture in the six months before the study * elbow limitation in flexion or extension * being a volunteer to participate * fractures should be managed with surgically * the "standardized mini mental test" result must be at least 24 points exclusion criteria: * malunion or nonunion fracture * the occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing * non-healing wound or infection * previously received physiotherapy for elbow limitation * having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases * could not adjust to the treatment * shoulder, elbow or wrist movement limitation in contralateral upper extremity or absence of limbs in the contralateral upper extremity * having severe visual loss

Keywords: imagery mirror neurons immobilization exercise rehabilitation
role of milk fat globule membranes in dairy foods: health effects in humans

Conditions: Hypercholesterolemia

Summary: investigate the effects of milk fat with or without milk fat globule membranes (mfgm) on blood lipid profile, vascular function, insulin sensitivity, inflammation and gene expression. overweight subjects will be randomized to one of 2 groups with different types of dairy products: 1)butter oil; 2) cream (milk fat with mfgm).

dairy foods are a major component of the nordic diet. epidemiological data suggest potential health effects of dairy foods with regard to obesity related disorders. low-fat dairy foods have shown to be protective, but also high-fat products have been linked to reduced risk in some studies. it is well known that dairy products increase ldl-cholesterol in blood, but effects on glucose metabolism are unclear. intervention trials are needed to clarify the health effects of dairy foods. some data have indicated that cheese and milk may have less hypercholesterolemic effect compared with butter. our hypothesis is that milk fat globule membranes (mfgm), present in all dairy products except butter, can affect blood lipid profile, vascular function, insulin sensitivity, inflammation and gene expression. such idea might explain why different dairy products could have different effects on cholesterol levels. the investigators aim to conduct a controlled study to investigate this. overweight subjects will be randomized to one of 2 groups with different types of dairy products: 1)butter oil; 2) cream (milk fat with mfgm).

Eligibility criteria:
inclusion criteria: * bmi 25-37 * ldl-cholesterol 2.0-4.5 mmol/l exclusion criteria: * use of lipid lowering drugs * diagnosed cardiovascular disease or diabetes * use of extreme diets * food allergies relevant to the study * pregnancy or active lactation

Keywords: saturated fat dairy products milk fat globule membrane cholesterol butter cream
use of disposable spirometer for recovery of pulmonary function

Conditions: Postoperative Complications

Summary: we hypothesize that the addition of modified incentive spirometry to standard postoperative chest physiotherapy will be associated with faster return to baseline/predicted pulmonary function and fewer postoperative pulmonary complications in patients following laparotomy.

the primary objective of this study is to determine how quickly patients' peak expiratory flow measurement returns to baseline or predicted values following laparotomy with or without the assistance of modified incentive spirometry. the secondary objective is to assess the effectiveness of modified incentive spirometry in preventing postoperative pulmonary complications in patients following laparotomy. specifically, this study will track length of stay, mortality, and evidence of pulmonary infection in both treatment and non-treatment arms.

Eligibility criteria:
inclusion criteria: * adult patients who undergo laparotomy at kamuzu central hospital, malawi exclusion criteria: * patients with known pre-existing pulmonary disease * pregnant women * patients who cannot perform maximal expiration for measurement of peak expiratory flow meter because of inability to understand or follow directions and demonstrations * patients with terminal cancer or illness with life-expectancy less than 1 month * patients with burn injuries * patients with illness requiring intubation and mechanical ventilation or postoperative icu admission * patients who require additional operations during the course of their hospital stay

Keywords: spirometry postoperative care
endoscopic trigger finger release

Conditions: Trigger Finger

Summary: the purpose of this study is to compare recovery, scar, and patient satisfaction after retrograde endoscopic trigger finger release versus the standard open surgical treatment.

consecutive patients presenting with trigger finger interested in surgical release of the a1 pulley will be prospectively treated with endoscopic versus open surgical release of the a1 pulley. study measures will include scar assessment based on the patient and observer scar assessment scale (posas) administered at 1 week, 1 month, and 6 months post-operatively, overall satisfaction (scale of 1 to 10), days before return to work, duration of post-operative occupational therapy, pain medication use, operative time, and complication and recurrence rates.

Eligibility criteria:
inclusion criteria: * at least 18 years old * trigger finger diagnosis, recommended for surgical release * be in good health other than the trigger finger * have realistic expectations of surgical results * be willing to undergo surgical or endoscopic treatment * understand and be willing to follow all aspects of the study protocol and have signed and dated the informed consent form and the authorization for use and release of health and research study information (hipaa) form prior to any study-related procedures being performed exclusion criteria: * collagen-vascular, connective tissue, or bleeding disorder * pregnancy * regional sympathetic dystrophy * abscess or infection at time of planned surgery * have a condition or be in a situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Keywords: tendinopathy trigger finger
observation of patients with metastatic colorectal cancer starting chemotherapy combined with bevacizumab (avastin)

Conditions: Metastatic Colorectal Cancer

Summary: this is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate progression free survival (pfs) in a real-life setting in participants with metastatic colorectal cancer (mcrc) starting chemotherapy combined with bevacizumab.


Eligibility criteria:
inclusion criteria: * having colon or rectal metastatic adenocarcinoma, for which the physician decided during the inclusion visit to start a treatment with bevacizumab combined with a 1st, 2nd or 3rd line chemotherapy * having received oral and written information about the survey and not objecting to having his/her data computerized exclusion criteria: - participating in a clinical trial assessing an anticancer treatment
prophylactic cranial irradiation in patients with her-2-positive metastatic breast cancer

Conditions: Breast Cancer

Summary: though brain metastases are a risk in all patients with breast cancer, those with her-2 overexpression are at significantly greater risk. one series estimated a 30% incidence of brain metastases in this population, while another study found an incidence of approximately 40%. traditional systemic therapies do not cross the blood brain barrier to any significant degree or at all, but radiation treatment can be effective in the treatment of intracranial metastases.

the rationale for pci is that the brain is a sanctuary site where cancer cells can remain inaccessible to chemotheraphy and agents such as trastuzumab due to the blood brain barrier, which prevents potentially harmful chemicals such as chemotherapy agents and antibodies such as trastuzumab from reaching the brain. decreasing the incidence of brain metastasis with acceptable effects on neurocognitive function would be a significant improvement in the care of patients with mbc.

Eligibility criteria:
inclusion criteria: * female with her2-positive disease * 18 years of age or older * ecog greater or equal to 2 * life expectancy greater or equal to 6 months * able to complete self administered quality of life evaluations and neurocognitive testing * willing and able to comply with study instructions and commit to all clinic visits for the duration of the study * women of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the baseline visit and must use highly effective birth control during study * signed informed consent form exclusion criteria: * current malignancy in the brain, as determined by screening mri/ct done no more then 6 weeks prior to study treatment with pci * chemo or radiation planned during the period when patients will receive study treatment with pci * prior radiotherapy of the brain * prior stroke or brain hemorrhage in the 6 months prior to screening * history of neurological/psychiatric disorders, including psychotic disorders or demential, or any other reason, which may affect neurocognitive assessment * inadequate renal function * other known previous or concomitant serious illness or medical condition that may interfere with participation in the study

Keywords: prophylactic cranial irradiation her-2-positive met breast cancer
engaging pacific islanders in mental health treatment

Conditions: Depression; Anxiety Disorders

Summary: this study will create and pilot test a culturally grounded intervention (talking story) to increase mental health treatment seeking among pacific islanders with mental disorders (e.g., major depressive disorder, generalized anxiety disorder).

for the clinical trial arm of this pilot/feasibility study, the investigators will conduct a pilottest of the culturally grounded talking story mental health treatment-seeking intervention with 48 pacific islander participants (24 intervention arm, 24 wait-list control) in preparation for larger r01 randomized wait-list controlled testing.

Eligibility criteria:
inclusion criteria: 1. of pacific islander or part pacific islander heritage, 2. must be over 18 years of age, 3. live in los angeles county or surrounding areas, 4. fluent (oral and reading) in english, 5. not have dual comorbidities in major depressive disorder, generalized anxiety disorder, and/or alcohol use disorder (they may have one of these disorders and still participate but not two or three). exclusion criteria: 1. do not meet inclusion criteria, 2. are unwilling to participate, 3. fail to provide or retracts consent, 4. reside outside the target communities.