Kornimate/medical-research-clean huggingface dataset:
symptoms, pulmonary function, muscle strength, exercise capacity, and frailty in esophageal atresia vs. healthy peers

Conditions: Esophageal Atresia; Healthy Children

Summary: esophageal atresia is the most common congenital anomaly of the esophagus and is caused by abnormal development of the esophagus during intrauterine life. in children with esophageal atresia, structural abnormalities due to congenital anomalies and tracheoesophageal fistula, tracheomalacia, respiratory problems, recurrent respiratory tract infections, structural abnormalities, surgical interventions for repair and treatment, and decreased physical activity levels may negatively affect pulmonary function, effective coughing, muscle strength, exercise capacity, posture, motor function, and quality of life. this study aims to compare physical characteristics, body composition, pulmonary function and muscle strength, peak cough flow, posture assessment, peripheral muscle strength test, motor function, exercise capacity, physical activity level, fatigue, frailty and quality of life between children with esophageal atresia and their healthy peers.


Eligibility criteria:
esophageal atresia group inclusion criteria: * children with esophageal atresia who are willing to participate in the study * being between the ages of 6-18, * being able to cooperate with the assessments exclusion criteria: * being unable to cooperate with the assessments, * having an orthopedic, neurological or cardiovascular problem that may affect the assessments, * having a lung infection or upper respiratory tract infection in the last four weeks, * being an active smoker, * not being willing to participate in the study, control group inclusion criteria: * being between the ages of 6-18, * being willing to cooperate with the tests to be performed, * being willing to participate in the study. exclusion criteria: * having a musculoskeletal problem that may affect exercise performance, * having any known chronic disease, * having a lung infection or upper respiratory tract infection in the last four weeks, * being an active smoker, * not willing to participate in the study.

Keywords: esophageal atresia exercise capacity physical activity muscle strength
p53 activation in platinum-resistant high grade serous ovarian cancer, a study of pld with apr-246

Conditions: High-grade Serous Ovarian Cancer

Summary: the purpose of this study is to make a preliminary assessment of the efficacy of a combined apr-246 and pld chemotherapy regimen in patients with platinum-resistant recurrent high grade serous ovarian cancer (hgsoc) with mutated tp53. in addition, the study aims to assess the safety profile of the combined apr-246 and pld chemotherapy regimen, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. the trial will enroll at least 25 evaluable patients.


Eligibility criteria:
inclusion criteria: * confirmed high grade serous ovarian cancer, and positive nuclear immunohistochemical (ihc) staining for p53 * disease progression between 4 weeks - 6 months after the last platinum-based treatment was administered * at least a single measurable lesion * adequate organ function prior to registration * toxicities from previous cancer therapies (excluding alopecia) must have recovered to grade 1 (defined by national cancer institute \[nci\] common terminology criteria for adverse events \[ctcae\] version 4.0). chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis * ecog performance status of 0 to 2 exclusion criteria: * prior exposure to cumulative doses of doxorubicin \>400 mg/m2 or epirubicin \>720 mg/m2 * hypersensitivity to pld or to any of the excipients * unable to undergo imaging by either ct scan or mri * evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications * concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ) * is taking concurrent (or within 4 weeks prior to registration) chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). supportive care measures are allowed. palliative limited radiation therapy for pain reduction is allowed

Keywords: ovarian cancer ovarian carcinoma high grade serous ovarian cancer recurrent cancer resistant cancer
nicotine patch safety study

Conditions: Smokers

Summary: the purpose of this study is to evaluate the safety profile of a repeated application of a new transdermal patch compared to a reference product during 3 weeks, in a large population.


Eligibility criteria:
inclusion criteria: * male or female aged more than 18 years * regular smoker motivated to stop tobacco consumption * current smoker of \> or = 20 cigarettes/day and \ or = 5 (for smokers between 10 to 20 cigarettes/day) exclusion criteria: * any visible skin disorder, abnormal skin pigmentation or other dermatologic disease which, in the opinion of the investigator would interfere with the assessment of the different parameters * current or past serious chronic cardiovascular, renal, hepatic, gastrointestinal (including duodenal or gastric ulcer), endocrine, hematological, neuropsychiatric, immunosuppressive condition or allergic disease, myopathies, epileptic seizures, bleeding tendency, cancer * history of angina pectoris, myocardial infarction or stroke in the previous 3 months, coronary artery vasospasm, cardiac arrhythmia, acute stroke * clinically relevant abnormal findings on the physical examination (e.g large scars on the application zone)

Keywords: smoking cessation nicotine tobacco use disorder central nervous system agents
an open label study of levetiracetam monotherapy in patients with newly diagnosed focal epilepsy

Conditions: Epilepsy; Partial Onset Seizures

Summary: the purpose of this study is to evaluate the efficacy of levetiracetam (lev) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the lev 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.


Eligibility criteria:
inclusion criteria: * subject is male or female and aged ≥ 16 years at visit 1 * subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (ia, ib, ic), that are classifiable according to the international league against epilepsy (ilae) classification of epileptic seizures * subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to visit 1 * minimum body weight of 40 kg at visit 1 exclusion criteria: * subject has a history or presence of seizure types other than partial (ia, ib, ic) * subject has an experience of any type of brain surgery in the consecutive 2 years prior to visit 1 * subject has a history or presence of known pseudo-seizures * subject has been treated for epilepsy with any antiepileptic drug (aed) within the 6 months prior to visit 1. however, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to visit 1 * subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
validation of uhear™ as a screening tool to detect hearing impairment in elderly cancer patients within a comprehensive geriatric assessment

Conditions: Hearing Loss; Cancer

Summary: over the last few years, there has been a considerable interest in the development of screening tools to assess the capability of elderly cancer patients to tolerate anti-cancer treatment. therefore, the nccn guidelines in senior adult oncology recommend an assessment of co-morbid conditions that are likely to interfere with cancer treatment and tolerability. as presbyacusis is common in an older population, elderly cancer patients are at high risk for social isolation and a reduced quality of life. therefore, in this project the investigators aim to validatie uhear™ as a quick and reliable screening tool to screen for presbyacusisf in routine clinical oncology practice.


Eligibility criteria:
inclusion criteria: * patients should have reached the age of 70 or more at enrolment * histologically confirmed diagnosis of solid cancer or hematologic malignancy. all stages of cancer are eligible * patients should be fluent in dutch or french * patients must receive their primary oncology care in the participating hospital * patients should be cognitively capable of performing the audiology assessment * patients should have signed informed consent exclusion criteria: * patients who do not match the above inclusion criteria * patients who are visiting the oncology clinic for a second opinion and do not wish to be treated in this clinic * patients presenting with clinically diagnosed ménière's disease, retrocochlear hearing loss, autoimmune inner ear disease, fluctuating hearing loss or a history of sudden sensory neural hearing loss * patients who already have a hearing aid or a previously diagnosed hearing loss
efficacy and safety of danoprevir/r + pr 12week triple therapy in treatment naive non-cirrhotic g1 chc china iii

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to evaluate the efficacy and safety of ritonavir-boosted asc08 (danoprevir) in combination with peg-ifn and rbv in treatment-naive non-cirrhotic patients who have chronic hepatitis genotype 1.


Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * chronic hcv infection (≥ 6 months) * serum hcv rna of ≥ 1 × 104 iu/ml are documented * hepatitis c virus gt1 * never received prior-treatment for hcv with interferon, rbv, or other direct-acting or host-targeting antivirals for hcv * non-cirrhosis patients: non-cirrhosis is defined (1)fibroscan defined as: ˂ 14.6 kpa during screening period, or liver biopsy determined 1 year before recruiting (metavir score ˂ 3);(2) during screening period 9.6\<fibroscan indicator ≤12.9, liver biopsy need to confirm non-cirrhosis. * others as specified in the detailed protocol exclusion criteria: * patients with fibroscan detection value \> 12.9 kpa, or histologic examination for liver cirrhosis patients * presence or history of non-hepatitis c chronic liver disease (e.g. hh, aih, wilson's disease, α1 antitrypsin deficiency, drug- or toxin-induced liver disease) * history of liver cell cancer, or suspected hepatocellular carcinoma (hcc) patients before or during screening , or imaging studies found suspicious nodules, or afp \> 50 ng/ml * positive hepatitis a antibody，positive hepatitis b surface antigen，hiv antibody * presence or history of nervous system diseases and/or mental illness, inability to control oneself or express oneself. * patients with obvious cardiovascular dysfunction * pregnant or nursing female, nor unwilling to take reliable contraception * others as specified in the detailed protocol

Keywords: danoprevir non-cirrhotic chinese hcv g1 svr12
novel neuroradiological workflow for the assisted diagnosis and management of dementia with artificial intelligence

Conditions: Alzheimer Disease; Dementia

Summary: identifying, screening and monitoring individuals at risk of alzheimer's disease (ad) and dementia is a formidable challenge. neuroimaging, and in particular magnetic resonance imaging (mri), is crucial to detect structural neurodegeneration. however, current quantification tools are mainly limited to research contexts and produce non-standardised results. diadema will build a systematic and standardised workflow to support neuro(radio)logical diagnosis. by combining artificial intelligence (ai) and machine learning (ml) the investigators will significantly enhance the clinical diagnosis of ad in neuroradiology. the investigator's main hypothesis is that an efficient workflow and associated higher diagnostic accuracy will substantially reduce healthcare costs, support clinical decision-making, provide second-opinion tools and improve patient care. this dual advance will have a profound impact on the healthcare system, marking an important step in the fight against alzheimer's disease and dementia.


Eligibility criteria:
inclusion criteria: * patients who perform brain magnetic resonance during the last 20 years exclusion criteria: -

Keywords: neuroimaging artificial intelligence (ai) dementia assisted diagnosis magnetic resonance imaging (mri)
the safety and efficacy of the harmonic scalpel in neck dissection

Conditions: Head and Neck Cancer

Summary: recently, the hs has been used in head and neck surgery as an alternative to conventional hand-tied ligation for hemostasis, which is a time-consuming procedure. limited data have been published on the evidence of its safety in nd, especially in radical nd. researchers investigated the safety and efficacy of the harmonic scalpel (hs) in neck dissection (nd), while using conventional hand-tied ligation to a minimum, in terms of operating time, blood loss, drainage and complications.


Eligibility criteria:
inclusion criteria: * preoperative diagnosis of head and neck squamous cell carcinoma * surgery as initial treatment exclusion criteria: * cases in which the nd specimen could not be separated from the primary tumor * past history of neck surgery

Keywords: head and neck cancer neck dissection harmonic scalpel
comparative study of the anne™ one system to diagnose obstructive sleep apnea

Conditions: Obstructive Sleep Apnea of Adult

Summary: the main objective of this study is to evaluate the accuracy of the anne sleep system for the diagnosis of obstructive sleep apnea (osa) in adults

the main object of this study is to evaluate the accuracy of the anne sleep system for the diagnosis of obstructive sleep apnea (osa) in adults. our primary hypothesis is that the anne sleep system is non-inferior compared to polysomnography (psg) for the diagnosis of obstructive sleep apnea

Eligibility criteria:
inclusion criteria: 1. ≥22 years old. 2. subjects with suspected osa based on history and physical who qualify for, and have either a psg or hsat ordered, as determined by their regular provider. subjects with self-reported symptoms of osa based on the stop-bang questionnaire indicating affirmative answers to any of the following: snoring, daytime fatigue/sleepiness/tiredness, partners who have observed the subject stopping breathing or choking/gasping during sleep. persons with a previous diagnosis of osa are also eligible. 3. willingness to give written consent and comply with study procedures exclusion criteria: 1. an unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related to this trial or interferes with the clinical trial and data collection 2. inability to understand instructions 3. has a skin abnormality that precludes assessment 4. has a history of dementia 5. patients with implanted pacemakers or defibrillators 6. subject is pregnant, nursing or planning a pregnancy over the expected course of the study
a multi-center controlled screening trial of safety and efficacy of lithium carbonate in subjects with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: this is a phase ii screening study of lithium carbonate in als. the purpose of this study is to find out if lithium carbonate is safe to be used in people with als and if it can slow the progression of the disease. since there is no placebo in this study, all patients will be taking lithium carbonate.

this is a phase ii screening study. there is no placebo (inactive or 'fake' drug) in this study, meaning that all participants will be taking lithium carbonate. the purpose of this study is to find out if lithium carbonate is safe to be used in people with als and if it can slow the progression of the disease. a recent article was published in a highly regarded medical journal that showed a positive effect of lithium carbonate on an als type mouse. the researchers then studied a very small number of people with als, giving 16 people lithium carbonate with riluzole and giving 28 people only riluzole. the people who took lithium remained stronger for a considerably longer period of time. however, the study was very small and we cannot really tell if lithium works unless a larger study is performed. it is not well understood why lithium carbonate might be helpful but it is believed that it may play a role in protecting the motor nerves from the damage of als. if you choose to participate, you will need to go to your study clinic for research study visits 7 times in one year and you will have 4 telephone interviews during that time. these visits and phone calls could take up to 17 hours in total. caution: lithium is an fda approved drug used for some psychiatric disorders. it is not fda approved for als. lithium has many potentially serious side effects and must only be taken under close supervision of your physician.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of laboratory-supported probable, probable, or definite als * vital capacity of at least 75% of predicted * onset of weakness within 3 years prior to enrollment * if patients are on riluzole, they must be on a stable dose for at least 30 days prior to baseline visit * women of childbearing potential must be surgically sterile or using an effective method of birth control and have a negative pregnancy test * willing and able to give informed consent exclusion criteria: * diagnosis of other neurodegenerative disease * need tracheotomy ventilation or non-invasive ventilation 23 or more hours/day * clinically significant history of any unstable medical condition in past 30 days * history of renal * history of liver disease * current pregnancy or lactation * use of lithium within thirty days of enrollment * significantly limited mental capacity * history of recent drug or alcohol abuse * use of any investigational drug within 30 days prior to enrollment

Keywords: als amyotrophic lateral sclerosis lou gehrig's disease lithium lithium carbonate
postoperative fatigue and nausea related to choice of anaesthetic regimens

Conditions: Fatigue; Nausea

Summary: the purpose of this study is to establish validated outcome measures for postoperative fatigue and postoperative nausea, and to compare clinical impact of postanaesthetic symptoms during first week after propofol or desflurane based anaesthesia.


Eligibility criteria:
inclusion criteria: * patients scheduled for day-surgery laparoscopic cholecystectomy * the patient is able to read and comprehend norwegian language * the patient is cognitive adequate and able to fill in survey forms * the patient has read and signed patient information form exclusion criteria: * serious illness (asa 3-4) * pregnancy or suspected pregnancy * breastfeeding women * contraindications to use of nsaids * serious allergic reaction to anaesthetics * allergy towards egg, soya or peanuts * known or suspected malignant hyperthermia or porphyria * fatigue-related diagnosis * recently received adjuvant therapy (chemotherapy, radiotherapy) * severe chronic pain
ctdna-guided adjuvant chemotherapy in liver metastasis of colorectal cancer

Conditions: Colorectal Cancer; Liver Metastases; Circulating Tumor Cell; Chemotherapy Effect

Summary: the goal of this clinical trial is to compare in resectable colorectal cancer liver metastasis patients.the main question it aims to answer is whether the 3-year progression-free survival rate (pfs) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctdna-negative resectable colorectal cancer liver metastasis patients.participants will undergo ctdna testing after resection of colorectal cancer liver metastasis, and will be randomly assigned to receive adjuvant chemotherapy or "watching and waiting" treatment strategy. the researchers will compare the outcomes between the two groups to see if the pfs between the two groups is similar.


Eligibility criteria:
inclusion criteria: 1. both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy; 2. patients with liver metastatic colorectal cancer who have achieved r0 resection according to mdt evaluation (including patients with metastases treated with ablation therapy that achieved similar r0 resection effects); 3. patients with negative ctdna after surgery; 4. asa grade \<iv and/or ecog performance status score ≤ 2; 5. have sufficient understanding of the study and voluntarily sign an informed consent form. exclusion criteria: 1. patients with distant metastases, including pelvic, ovarian, peritoneal, etc.; 2. patients with a history of other malignancies; 3. patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy; 4. patients who are allergic to any component in the study; 5. patients who have received other tumor-related investigational drug therapy; 6. patients with severe uncontrolled recurrent infections or other serious uncontrolled concurrent diseases; 7. patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases that require comprehensive treatment (including mental disorders), and serious abnormal laboratory tests; 8. patients with a history of severe mental illness; 9. pregnant or lactating women; 10. patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the trial.

Keywords: colorectal cancer liver metastases circulating tumor dna