Kornimate/medical-research-clean huggingface dataset:
roll over study for patients who have completed a previous oncology study with olaparib

Conditions: Ovarian Cancer; Breast Cancer

Summary: the rationale of the rosy-o study is to continue to provide study treatment for patients who have participated in a parent study with olaparib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the investigator.

rosy-o is an open label, non-randomised, multicentre,international trial for patients who have completed a parent study using olaparib and who are deriving clinical benefit from continued treatment as judged by the investigator. patients will be rolled-over from the parent study and will continue the study indefinitely, until they meet one of the treatment discontinuation criteria

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated, written icf. 2. patient is currently deriving clinical benefit, as judged by the investigator, from continued treatment in an az parent study using an astrazeneca (az) compound that has met its endpoints or has otherwise stopped. 3. patient participating in a prior oncology study with an az compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close. exclusion criteria: 1. ongoing, unresolved, grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study. 2. currently receiving treatment with any prohibited medication(s). 3. concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. 4. permanent discontinuation from the parent study due to toxicity or disease progression. 5. local access to commercially-available drug at no cost to the patient is permitted by local regulation.

Keywords: her2-ve metastatic brca mutations cancer
an observational prospective study to characterize patients initiating enerzair® breezhaler®, with or without sensor, as a maintenance treatment for asthma

Conditions: Asthma

Summary: this is an observational, descriptive, open-label, prospective, 6-month study including a group of patients with a first prescription of ind/gly/mf with sensor and a group with a first prescription of ind/gly/mf without sensor.

patients will be invited prospectively and sequentially to participate in the study when attending a participating community pharmacy with a first prescription of ind/gly/mf with sensor or ind/gly/mf without sensor. therefore, the invitation for the patient to participate in the study will occur only after the therapeutic decision has taken place

Eligibility criteria:
inclusion criteria: * male and female patients aged ≥18 years * self-reported diagnosis of asthma * individual filling a first prescription of ind/gly/mf with or without sensor in a participating community pharmacy for himself/herself (excluding caregivers). * individual capable and willing to perform the study assessments. exclusion criteria: * no exclusion criteria.

Keywords: asthma sense study enerzair breezhaler maintenance treatment
evaluation of the impact of spo2 averaging time on performance of an automatic fio2 control system: a randomized study

Conditions: Neonatal Respiratory Distress; Very Low Birth Weight Infant

Summary: the aim of the study is to determine the preferred oximeter averaging setting during automated control of fio2 (a-fio2) in infants receiving respiratory support and supplemental oxygen.

there are 7 different averaging time settings available with prico (acutronic medical systems ag, hirzel, switzerland), but after over a year of experience there is no clear clinical impression of the best setting. therefore, a small systematic study is needed to determine the optimal guidelines.

Eligibility criteria:
inclusion criteria: * all vlbw on respiratory support and oxygen requirements after 2 weeks of age in the nicu are eligible after parental informed consent is obtained. exclusion criteria: * parental informed consent is not obtained * recording device for automated control of fio2 is not available

Keywords: spo2 averaging time pulse oximetry automatic oxygen control
collaborative care to alleviate symptoms and adjust to illness in chronic heart failure (casa) trial

Conditions: Chronic Heart Failure

Summary: chronic heart failure is an important public health problem as it is a leading cause of disability, hospitalization, death, and costs. people who live with advanced chronic heart failure suffer from numerous symptoms that affect their daily lives. the investigators are conducting a randomized clinical trial to evaluate a symptom management and psychosocial care intervention to improve health status (symptom burden, functioning, and quality of life). the results will be directly relevant to patients and families who suffer with this illness, as well as to providers, payers, and other researchers.


Eligibility criteria:
inclusion criteria: * age 18 years of age or older * able to read and understand english * consistent access to a telephone * patients have a primary care or other provider who is willing to facilitate intervention medical recommendations * a diagnosis of heart failure with at least one of the following: \[hospitalization primarily for heart failure in the year prior (including current); taking at least 20 mg oral furosemide (or equivalent) daily in a single or divided dose; brain natriuretic peptide(bnp) ≥ 100 or n-terminal prohormone of brain natriuretic peptide(nt-probnp) ≥ 500; ef≤40%\] * report a low health status (kccq-sf≤70) * bothered by at least one target symptom: \[pain; depression; fatigue; breathlessness\] exclusion criteria: * previous diagnosis of dementia * active substance abuse or dependence, defined by either a diagnosis of abuse or dependence or an audit-c ≥ 8, or self-reported substance abuse in the past 3 months * comorbid metastatic cancer * nursing home resident * heart transplant recipient * lvad recipient

Keywords: quality of life symptoms palliative care symptom management disease management health delivery
concurrent radiotherapy and weekly chemotherapy of pf for postoperative locoregional recurrence of esophageal cancer

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy of 5-fu and cisplatin in patients with postoperative locoregional recurrence of esophageal squamous cell carcinoma.

the most optimal management for postoperative locoregional recurrence of oesophageal squamous cell carcinoma is still controversial. several studies have reported the feasibility and efficacy of concurrent chemoradiotherapy (ccrt), mostly with three-weekly or four-weekly schedule of chemotherapy. however, treatment compliance was not quite satisfactory, probably due to treatment-related toxicities. since ccrt with weekly chemotherapy regimens have demonstrated a favorable toxicity profile as well as promising survival in certain types of cancer, the investigators aimed to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy with 5-fluorouracil (5-fu) and cisplatin for patients with postoperative locoregional recurrence of oesophageal squamous cell carcinoma in the investigators center.the prescribed dose of radiotherapy is generally 60gy/28fr to tumor and 50gy/28fr to the clinical target volume.the concomitant chemotherapy is cisplatin 25mg/m2 on day 1, 5-fu 1176mg/m2 on day 1-3, repeated weekly for 4 weeks.

Eligibility criteria:
inclusion criteria: 1. r0 resection for primary esophageal squamous cell carcinoma with two-incision esophagectomy (ivor lewis approach)25 or three-incision (right thoracotomy, midline laparotomy and left cervical incisions) esophagectomy with cervical esophagogastric anastomosis. 2. absence of previous thoracic radiotherapy. 3. cervical and/or thoracic postoperative recurrence (biopsy proven or positron emission tomography/computed tomography (pet/ct) proven or follow-up computed tomography (ct) showed progression of disease). 4. absence of distant metastasis at recurrence. 5. eastern cooperative oncology group (ecog) performance status (ps) ≤ 2 exclusion criteria: 1. younger than 18 or older than 70 years of age. 2. eastern cooperative oncology group (ecog) performance status of 3 or above 3. other cancer history. 4. serious cardiac, liver, or pulmonary disease. 5. previous radiotherapy history

Keywords: radiotherapy esophageal carcinoma chemotherapy
reliability and validity of the athlete fear avoidance questionnaire in turkish

Conditions: Athletic Injuries

Summary: high levels of fear avoidance can lead to chronic pain and disability and can predict rehabilitation time in the sports-related injury population. therefore, taking fear avoidance into account may be useful in creating the most appropriate and effective rehabilitation plan, thus shortening the time to return to play. the aim of our study is to verify the validity and reliability of the athlete fear avoidance questionnaire (afaq) in turkish.

sports injuries are a frequent occurrence that many athletes experience annually. although sports injuries cause physical pain and disorders, they also have a psychological impact. one common psychological response to sports injuries is the fear of re-injury. other potential psychological reactions of an injured athlete include anxiety, depression, frustration, tension, and decreased self-esteem. psychological responses to sports injuries are typically highest immediately after the injury and decrease during the rehabilitation process. however, they often relapse just before returning to sports. if left unaddressed, these heightened psychological responses can impede rehabilitation progress and delay the return to sport. currently, there are several scales available to measure an athlete's readiness to return to play, such as the sports inventory for pain and the injury-psychological readiness to return to sport scale. however, it is important to note that some of these surveys were conducted with student populations rather than athletes. additionally, these scales are designed to be applied at the end of the rehabilitation process. the athlete fear avoidance questionnaire (afaq) was specifically developed to assess fear avoidance or pain-related fear in athletes. the fear avoidance model was developed to explain how individuals experiencing exaggerated pain perception separate 'pain experience' and 'pain behavior' from the actual pain sensation. high levels of fear avoidance can lead to chronic pain and disability and can predict rehabilitation time in the sports-related injury population. therefore, considering fear avoidance may be helpful in developing an appropriate and effective rehabilitation plan, ultimately reducing the time required to return to play. the purpose of our study is to validate and assess the reliability of the athlete fear avoidance questionnaire (afaq) in turkish.

Eligibility criteria:
inclusion criteria: * being a licensed athlete for at least 5 years, being active in sports and training for the last 1 year, and weekly training intensity of at least 5 hours per week. exclusion criteria: * it was defined as having a history of visual, mental or systemic disease.

Keywords: athlete fear avoidance questionnaire (afaq)
imaging biomarker for early detection of treatment efficacy during breast cancer neoadjuvant chemotherapy

Conditions: Breast Cancer

Summary: this is a single-arm, single-institution pilot study that will collect preliminary data to be used in the design of a subsequent study to assess whether changes in fdm (functional diffusion maps) derived from primary breast cancer diffusion weighted mri images can serve as an early predictor of response to treatment, and whether the magnitude of the change correlates with the effectiveness of treatment.

this trial has a two-step, sequential design, with continuation to the second part of the trial being dependent on the positive results in the first part. in part one of the trial, the investigator will compare intrapatient variability in fdm performed at two timepoints prior to chemotherapy (chemotherapy will be chosen by the treating physician and will not be assigned as part of this study), with the change in fdm before and approximately one week after a dose of chemotherapy, to establish that treatment-related changes in fdm will occur in this clinical setting. if there are positive results in part one, then the investigator will proceed to the second half of the trial. in part two, the investigator will examine changes in fdm that occur one week after each type of chemotherapy is administered, which will be compared to pathologic response, radiological response, and clinical response.

Eligibility criteria:
inclusion criteria: * patients must have a primary measurable, biopsy proven, invasive breast carcinoma with the primary tumor intact. the tumor should be staged clinically as t2-t4 (minimum size \>2.0 cm). * patients must have a breast tumor that is resectable or potentially resectable following neoadjuvant chemotherapy and be willing to undergo resection, if indicated, after chemotherapy. * patients may not have received prior chemotherapy or radiation therapy for their current breast cancer. * patients may not have had a clip placed into the tumor that is not compatible with mri. * patients must be deemed eligible for neoadjuvant chemotherapy, as assessed by the clinical investigator. * age \> 18 years. * patients must have an ecog performance status (eastern cooperative oncology group performance status: an attempt to quantify cancer patients' general well-being and activities of daily life. the score ranges from 0 to 5 where 0 is asymptomatic and 5 is death.) of 0 - 1. * patients must not be pregnant or breast-feeding. patients with reproductive potential must consent to the use of effective contraception while on the study. * patients must have no contraindications to mri (magnetic resonance imaging) exams. patients who require sedation with general anesthesia to complete an mri are not eligible for the study. * patients may have no ferrous metal implants or medical devices which would exclude mri. * patients must be capable of lying flat in an mri magnet for 30-60 minutes on 4 occasions. * weight must be less than 275 pounds. * patients must have the ability to understand and willingness to sign a written informed consent document.
a trial of aspirin on recurrence and survival in colon cancer patients

Conditions: Colon Cancer; Adjuvant Therapy

Summary: the purpose of this study is to determine whether acetylsalicylic acidis effective on the recurrence and survival of colon cancer patients.

the purpose of this study is to determine the effect of 80mg acetylsalicylic acid (given orally once daily for 5 years) on 5 year overall survival (os) for stage ii and iii colon cancer patients of 45 years of age and older. preclinical, epidemiologic and clinical evidence suggest that acetylsalicylic acid use may reduce overall cancer risk and mortality in colon cancer patients. it is a phase iii double blind placebo controlled, randomized trial of adjuvant low-dose acetylsalicylic acid in colon cancer patients. patients will be stratified at randomization by centre, age (\<70 and ≥70 years) chemotherapy use (any versus none) and disease stage.

Eligibility criteria:
inclusion criteria: * age ≥45 years * patients must have tnm stage that is one of the following: pt3-4; n0-2 and m0, or pt1-2 and n1-2 (uicc stage ii and iii) (in case of \>1 tumour: largest tumour is stage ii or iii) * patients must have completed surgical resection (r0) (both laparoscopic and open surgery) within 12 weeks of randomisation exclusion criteria: * patients with rectal cancer (defined as tumour within 15 cm from the anal verge) * patients currently taking oral anti-coagulants or use of lmwh * patients currently taking acetylsalicylic acid for any reason * patients with a history of bleeding disorders or active gastric or duodenal ulcers * patients currently taking high dose systemic glucocorticoids.(≥ 30 mg predniso(lo)n) * patients with (suspected) (non-) polyposis syndrome (fap/afap, map, lynch syndrome) * patients with \>100 polyps of the colon or a known hereditary syndrome of the colon in a first degree family member * allergy or intolerance to salicylates. * patients with a history of other malignancies in the last 5 years, except for scc or cin. * presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Keywords: acetylsalicylic acid colon cancer survival
octreotide efficacy and safety in first-line acromegalic patients

Conditions: Acromegaly

Summary: primary acromegaly is a clinical and metabolic disease caused by growth hormone (gh) hypersecretion from a pituitary adenoma and is an insidious, chronic disease that is associated with bony and soft tissue overgrowth. goals of therapy are to eradicate the tumor, suppress gh secretion, normalize igf-i levels, and preserve normal pituitary function. this study will evaluate the safety and efficacy of octreotide as primary therapy for the treatment of acromegaly and as therapy for patients with acromegaly and a pituitary macroadenoma or microadenoma.


Eligibility criteria:
inclusion criteria: * males and females 18 and \< 80 years old. * recently diagnosed not previously treated patients with acromegaly. * presence of a pituitary tumor (microadenoma or macroadenoma), documented by a mnr performed in the 12 weeks before enrolment. * absence of nadir suppression of the nadir of gh to \< 1.0 ng/ml, after oral administration of 75 g of glucose (ottg). * igf-i levels over normal upper limits, e.g. 97 percentile (age- and sex-matched). * tolerance shown with a test of a subcutaneous injection of octreotide * written informed consent before any procedure specific to the study. inclus exclusion criteria: * previously treated patients with any therapy for acromegaly, including surgery, radiotherapy, bromocriptin, and somatostatin analogues. * compression of optic chiasm that produces any impairment of field of vision. * need of surgery to improve any neurological sign or symptom associated with a direct incidence on the tumour. * intolerance to octreotide or to any component of sandostatin® lar® preparation. * patients with an hepatic condition such as cirrhosis, active or persisting chronic hepatitis, or other hepatopathy of fast evolution. * pregnant women * history of alcohol or drug abuse in the six months prior to the inclusion visit. * patients suffering from any condition that may jeopardize the interpretation of study results or may impede to obtain informed consent * intake of an investigational drug during the study and 30 days before patient inclusion in this study other protocol-defined inclusion / exclusion criteria may apply.

Keywords: acromegaly otreotide tumor reduction
rigid video stylet vs conventional lightwand intubation

Conditions: Hoarseness; Intubation; Sorethroat

Summary: lightwand is a useful alternative device for intubation but scooping movement can induce damage and microbleeding of oral mucosa, postoperative hoarseness,sore throat. optiscope is rigid video stylet which has camera on distal tip of device. in many previous studies, rigid video stylet has proven advantages compared with other intubating devices.


Eligibility criteria:
inclusion criteria: * patients scheduled for cervical spine surgery under general anesthesia * aged between 20- 80 yrs exclusion criteria: * patient who disagrees to participate this study * patient who has history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders * patient who has congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation or foreign bodies in the upper airway
a treat-to-target strategy using pan-enteric capsule endoscopy (pce) in paediatric crohn's disease (cd).

Conditions: Inflammatory Bowel Diseases; Children, Only

Summary: this prospective, interventional study aims this to determine the efficacy and safety of a pce-based treat-to-target strategy in order to achieve mucosal healing (mh) and deep remission (dr) of pediatric crohn's disease (cd) over 52 weeks.

this first prospective study on mucosal healing (mh) and deep remission (dr) in pediatric crohn's disease aims to evaluate: * the ability of pan-enteric capsule endoscopy (pce) to assess mh and dr rates at three time points and to guide a treat-to-target strategy was the primary outcome sought. * the efficacy of a "treat-to-target" strategy to mh and dr rates over 24 and 52 weeks was evaluated as a secondary outcome; * comparison between pce, biomarkers, magnetic resonance enterography (mre) and small intestine contrast ultrasonography (sicus) in evaluating intestinal inflammation.

Eligibility criteria:
inclusion criteria: * diagnosis of crohn's disease made at least 3 months before the enrolment; * subject was referred for endoscopic and imaging follow-up in crohn's disease * signed informed consent. exclusion criteria: * subject has dysphagia * subject has renal insufficiency * subject is known structuring crohn's disease identified by magnetic resonance enterography (mre) or small intestine contrast ultrasonography (sicus). * subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the magnetic resonance enterography findings and clinical judgment of the investigator.

Keywords: colon capsule endoscopy
clinical efficacy and safety of leflunomide in egyptian patients with active rheumatoid arthritis

Conditions: Active Rheumatoid Arthritis

Summary: a phase iv, multi-centric, prospective, observational study to assess the clinical efficacy and safety of leflunomide in egyptian patients with active rheumatoid arthritis. (clear)

clear is a phase iv, multi-centric, prospective, observational study to assess the clinical efficacy and safety of leflunomide as first-line therapy and as add-on therapy to other dmards (such as methotrexate, hydroxychloroquine, sulfasalazine) with or without steroids use in egyptian patients with active rheumatoid arthritis.

Eligibility criteria:
inclusion criteria: 1. active rheumatoid arthritis patients selected according to the acr/eular classification 2010 criteria with score ≥ 6 points. 2. male or female patients aged 18-60 years old. 3. leflunomide naïve patients or patients with previous leflunomide administration (after at least 6 month wash out period from date of baseline visit) who will be prescribed leflunomide at the sole decision of the treating physician. 4. patients with or without another dmards including methotrexate, sulfasalazine and/or hydroxychloroquine with or without steroids use who experienced therapy resistance, inadequate response or intolerance. 5. patients read, understand and signed informed consent prior to inclusion. 6. patients willing to complete and literate in the language of the available health assessment questionnaire (haq disability index) either alone or with minimal assistance from caregivers and/or trained site personnel. exclusion criteria: 1. female patients who are pregnant or lactating at the time of inclusion or those who are planning for pregnancy within the coming year from the time of inclusion to the study. 2. patients with contraindications to active constituent of leflunomide. 3. patients with severe concurrent infection (necessitating iv antibiotics or hospitalization). 4. patients with history of non-treated hepatitis b \&/or c infection. 5. patients with history of severe liver disease (child c class). 6. patients with history of severe renal insufficiency (creatinine clearance ≤30 ml/min.).

Keywords: ra