Kornimate/medical-research-clean huggingface dataset:
catheter ablation of atrial fibrillation using hansen medical robotic navigation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) affects as many as 1 in 100 people and reduces the quality of life of large numbers of people in the uk and around the world. catheter ablation is a minimally invasive treatment that has been developed to help eliminate af. it is a complex procedure to perform so only a few hospitals are able to offer this treatment in the uk. a new technology allows the operator to guide their catheters (thin wires) in the patient by using a robotically steered sheath. this allows accurate and precise navigation that may improve the accuracy and integrity of ablation. we aim to prove whether this technology can make af ablation easier and more effective. substudy: platelet reactivity and activation in af, and the impact of curative ablation. blood and urine samples will be taken pre- and 3 months post ablation to see if platelet reactivity and activation are affected by af compared to established normal ranges, and whether curative ablation impacts on this.


Eligibility criteria:
inclusion criteria: * all patients with symptomatic af planned for catheter ablation. exclusion criteria: * age \< 18 years * previous ablation procedure * expected life expectancy \< 6 months * inability or unwillingness to sign consent * pregnancy * contraindications for the ablation procedure o thrombus in the left atrium that fails to resolve with optimal oral anticoagulation therapy

Keywords: catheter ablation robotic navigation
biolux p-iii spain all-comers registry

Conditions: Peripheral Arterial Disease

Summary: the purpose of the biolux p-iii spain registry is to further investigate the safety and clinical performance of the passeo-18 lux drug coated balloon in the treatment of long atherosclerotic femoropoliteal artery lesions in daily clinical practice


Eligibility criteria:
inclusion criteria: * age ≥ 18 years or minimum age as required by local regulations * subject must be willing to sign a patient data release form (pdrf) or patient informed consent (pic) where applicable * subject classified as rutherford class 4, 5 or 6 * tasc c or d lesion(s) in the femoropopliteal artery * lesion length \> 15 cm suitable for endovascular treatment treated with or scheduled to be treated with the passeo-18 lux drug releasing balloon exclusion criteria: * life expectancy ≤ 1 year * subject is currently participating in another investigational drug or device study that has not reached its primary endpoint yet. * subject is pregnant or planning to become pregnant during the course of the study. * rutherford class \<4 * failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations). * intraprocedural decision not to proceed with the passeo18 lux dcb for any reason not related to the device (for instance blood flow limiting dissection after predilatation).
obstructive sleep apnea (osa), oral frailty, dysphagia, continuous positive airway pressure (cpap)

Conditions: Dysphagia; OSA; CPAP

Summary: the purpose of this study is to evaluate the effects of the cpap treatment on oral frailty and dysphagia among osa patients.

the research will be divided into three stages. the first stage will investigate the incidence of osa in patients over 50 years old using the national health insurance research database (nhird). the second stage will examine the relationships among osa, oral frailty, and dysphagia through an observational case-control study with 225 osa patients and 225 controls. the third stage will evaluate the effects of cpap treatment on oral frailty and dysphagia among moderate-severe osa persons through a prospective cohort study with repeat four times measurements.

Eligibility criteria:
inclusion criteria: * age 50 years or older. * medically diagnosed with obstructive sleep apnea (apnea and hypopnea index, ahi, ≥ 5 events per hour). * clear consciousness and able to communicate in mandarin or taiwanese. exclusion criteria: * central sleep apnea patients. * patients with neurological or muscular disorders (such as stroke or parkinson's disease). * patients diagnosed with oral cancer currently undergoing oral treatment.

Keywords: obstructive sleep apnea oral frailty dysphagia cpap
pd-l1 expression on ctcs in hnscc patients underwent curative ccrt

Conditions: Head and Neck Squamous Cell Carcinoma; Circulating Tumor Cell

Summary: head and neck squamous cell carcinoma (hnscc) is the 4th highest incidence of cancer and 6th of cancer death of the males in taiwan. because the patients were mainly middle-aged male, the disease eventually resulted in a huge loss of labor force, productivity and a huge burden of family supports and medicinal costs. unfortunately, the incidence and death of hnscc seemed to be increasing in taiwan. currently, the primary treatments of hnscc are mainly surgery, radiotherapy, chemotherapy or targeted therapy or concurrent chemoradiotherapy. immune checkpoint inhibitors become an emerging treatment in recent days. however, how to select adequate patient by using biomarkers remains an unsolved problem. therefore, investigator have developed a new method for isolation and detection of circulating tumor cells (ctcs) in hnscc patients. moreover, the expression of immune markers (such as pd-l1, pd-l2, pd-1) on ctcs or immune cells might be a good target to study. investigator's preliminary data found ctcs and circulating cancer stem-like cells but not pd-1 expression levels on peripheral t cells in patients with recurrence or metastasis hnscc did not associated with overall survival. therefore, investigators are wondering if pd-l1 more specific due to it expression on cancer cells. therefore, in the 3-year project, investigators will utilize developing device and protocol in first year and then enroll 40 freshly diagnosed participants with head and neck cancer at stage iii-iv with intent to receive curative concurrent chemo-radiotherapy (ccrt), and then analyze ctcs, pd-l1 expression levels on ctcs. blood sample will be taken before, during (definition: 3-6 weeks after start rt) and after (definition: 4 +/-2 weeks after complete ccrt) completion of ccrt. investigators will also enroll 10 health participants and taking blood sample for 3 times and follow up. further statistical tests with clinical conditions (disease status, treatment effects, progression or distant metastasis and death) will be performed to elucidate their clinical significance. hopefully, investigators will clarify the correlation between clinical outcomes and expression of pd-l1 on ctcs in head and neck patients. this could be a new biomarker for clinical cancer care.


Eligibility criteria:
inclusion criteria: * patients with head and neck squamous cell carcinoma with age at diagnosis ≥ 20 years * stage iii-iv according to ajcc 8th ed. * intent to receive curative concurrent chemoradiotherapy (ccrt) * 10 healthy donors without any cancer diagnosis within 5 years exclusion criteria: * p16 positive oropharyngeal cancer * non-platinum based ccrt * previous diagnosed with cancer within 3 years * synchronous cancer * poor compliance, cannot cooperate for blood sampling for ctcs isolation as time schedule or clinical treatment or follow-up
a research study looking at the comparability of 2 different forms of oral semaglutide in healthy people

Conditions: Healthy Volunteers; Type 2 Diabetes

Summary: the aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of semaglutide. the study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in. the participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks. the study will last up to 29 to 31 weeks for each participant. this includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).


Eligibility criteria:
inclusion criteria: * male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. - body mass index (bmi) between 21.0 and 32.0 kg/m\^2 (both inclusive). * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * hba1c equal to or greater than 6.5 % (48 mmol/mol) at screening. * use of tobacco and nicotine products, defined as any of the below: * smoking more than 5 cigarettes or the equivalent per day * not willing to refrain from smoking and use of nicotine substitute products within 48 hours prior to and during the inpatient periods * presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator. * history(a) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant(a). * personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma(a). 1. as declared by the participant or reported in the medical records
cooking classes for young adults with id

Conditions: Intellectual Disability, Mild to Moderate

Summary: the purpose of this study is to examine the feasibility and initial efficacy of a healthy lifestyles intervention for the prevention of weight gain and the promotion of basic life skills related to improving health in transition age young adults with intellectual disabilities.

this is a single arm, longitudinal trial. 30 young adults with intellectual disabilities will be recruited to participate in a 12-week, healthy lifestyles intervention, delivered in person to a group of individuals with id at the center for children's healthy lifestyles and nutrition. participants will be asked to attend one 2 hr group session each week (\~5-6 participants per group). all sessions will have an education component, a hands-on nutrition/cooking lesson, and a group exercise session. additionally, participants will be asked to attend a 20-minute monthly individual goal setting session conducted remotely over zoom video conferencing. all sessions will be conducted by a trained health educator experienced in working with individuals with intellectual disabilities. tablet computers and fitbit wireless activity monitors will be provided to all participants, with study issued hippa compliant zoom and fitbit accounts. outcome assessments will be collected at baseline and after the 12-week intervention.

Eligibility criteria:
inclusion criteria: * diagnosis of an intellectual disability. * age: 18-30 yrs. * functional ability sufficient to understand directions and to communicate through spoken language. * reside in a supported living condition either at home or with no more than 1-4 residents and have a study partner (i.e., parent, staff who agrees to serve as support partner). * wireless internet access in the home. * ability to walk without assistance. * consent from physician to do physical activity. exclusion criteria: * actively participating in another research study
a study to assess the pharmacokinetics and pharmacodynamics of canagliflozin in healthy chinese volunteers

Conditions: Healthy

Summary: the purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and pharmacodynamics (the action of the medication on the body) of jnj-28431754 (canagliflozin) and its main metabolites (break-down products) following 2 different doses of canagliflozin in healthy chinese volunteers. safety and tolerability of canagliflozin will also be assessed.

this study will be a double-blind (neither the investigator nor volunteer knows the assigned treatment), randomized (the treatment is assigned by chance), placebo-controlled (one of the study treatments is inactive), single-dose, 3-way cross over study (all volunteers will receive each of the 3 treatments but in a different order) in healthy chinese volunteers. volunteers will be assigned to 1 of 3 treatment sequence groups (abc, bca, or cab). the treatment sequence will be decided by randomization. treatment a will be a single oral (by mouth) dose of 100 mg of canagliflozin. treatment b will be a single oral dose of 300 mg of canagliflozin. treatment c will be a single oral dose of placebo (inactive medication). each treatment will be given during a treatment period of 5 days duration; each treatment period will be separated by a washout period (a time period with no medication) of at least 10 days. canagliflozin is currently being investigated for the treatment of type 2 diabetes mellitus (t2dm).

Eligibility criteria:
inclusion criteria: * volunteers must be non-smokers for at least 6 months before first study drug administration * volunteers must consume no more than 4 to 5 cups of coffee or tea or 8 cans of cola each day exclusion criteria: * history of or currently active illness considered to be clinically significant by the investigator or any other illness that the investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results * female volunteer is breast-feeding

Keywords: healthy jnj-28431754 canagliflozin pharmacokinetics pharmacodynamics
the attenuating effect of soluble fiber consumption on postprandial glycemia in humans

Conditions: Postprandial Hyperglycemia; Type2 Diabetes; Blood Sugar; High

Summary: the main objective of the current study is to investigate whether consumption of soluble fibers (isomaltodextrin \[imd\], partially digestible maltodextrin) and rs4 starch will lower postprandial glycemia as well as postprandial insulin in human subjects with relatively high fasting blood glucose, when consumed with a specific amount of digestible carbohydrate (rice porridge). the primary outcome of the study is the effect of fibers on postprandial blood glucose, whereas the secondary outcome will be its effect on postprandial blood insulin.


Eligibility criteria:
inclusion criteria: * body mass index (18.5 kg/m² ≤ bmi ≤ 29.9 kg/m²) * no history of abnormal glucose metabolism * no ongoing use of drugs affecting blood glucose levels * fasting blood glucose between 90-110 mg/dl * low dietary fiber intake (less than 15 g per day) exclusion criteria: * diabetic individuals * individuals with history of gastrointestinal disease * pregnant or nursing women
safety study of amg 228 to treat solid tumors

Conditions: Advanced Malignancy; Advanced Solid Tumors; Cancer; Oncology; Oncology Patients; Tumors; Melanoma; Non-small Cell Lung Cancer; Squamous Cell Carcinoma of the Head and Neck; Transitional Cell Carinoma of Bladder; Colorectal Cancer

Summary: the purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of amg 228 in subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * subject must have a pathologically documented, definitively diagnosed, advanced solid tumor * adequate hematological, renal, hepatic, and coagulation laboratory assessments exclusion criteria: * active autoimmune disease, history of autoimmune disease * treatment with immune modulators including * use of warfarin, factor xa inhibitors, or direct thrombin inhibitors * anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days * major surgery within 28 days of study day 1

Keywords: melanoma non-small cell lung cancer (nsclc) squamous cell carcinoma carcinoma head and neck transitional cell carinoma (tcc) bladder colorectal colorectal cancer (crc)
spontaneous pneumothorax in adolescents

Conditions: Pneumothorax, Spontaneous

Summary: pneumothorax is characterized by an abnormal presence of air in the pleural cavity, that is to say between the two layers of the pleura, the membrane that surrounds the lungs and lines the rib cage. "the patient is usually seized with sudden chest pain and difficulty in breathing. in this retrospective research, the investigators wish to carry out an inventory of the management of spontaneous pneumothorax in adolescents within the university hospitals of strasbourg


Eligibility criteria:
inclusion criteria: * adult patient (18-20 years old) * minor patient aged 14-17 years old * any gender * spontaneous pneumothorax without apparent cause, between 14 and 20 years old * patient operated on at the hus between 2010 and 2021 * patient not objecting to the reuse of their data for scientific research purposes. * holders of parental authority who do not object to the reuse of their child's data for scientific research purposes. exclusion criteria: * patient who has expressed his opposition to the reuse of his data for scientific research purposes. * holders of parental authority who have expressed their opposition to the reuse of their child's data for scientific research purposes. * secondary origin of the pathology: cystic fibrosis, postoperative pneumothorax, post-traumatic, * subject having been treated initially in another structure without further information.

Keywords: pneumothorax spontaneous pleural cavity
measles vaccination cash incentives experimental evidence from nigeria

Conditions: Measles

Summary: idinsight is conducting a randomized controlled trial to assess the impact of various sized cash incentives for caretakers of infants that require a 9-month measles vaccination on the completion rate for the vaccine in nigeria. the purpose of the experiment is to help new incentives (ni) determine the optimal size of the incentive as they scale to the north west region of nigeria.


Eligibility criteria:
inclusion criteria: * caregiver and infant registered with the new incentives program * the infant was nine months or older at the start of the study (note there was no upper age limit as new incentives only began enrolling infants in october 2016) * infant had received at least one previous conditional cash transfer for immunization at an all babies are equal initiative clinic, * infant had received their penta-3 vaccine. * the caregiver had provided a phone number (either a personal number or a number of someone who can reach them) during registration. exclusion criteria: * infant had already received a measles vaccine

Keywords: immunization incentives
efficacy of intravenous ibuprofen and paracetamol on postoperative pain and tramadol consumption in shoulder surgery

Conditions: Postoperative Pain Management

Summary: primary aim of this prospective, randomized, double-blind clinical trial is to compare the analgesic effects of intravenous paracetamol and ibuprofen on postoperative pain, and secondary aim is the effects on tramadol consumption and side effects of tramadol in patients who underwent unilateral shoulder surgery.

all surgical procedures are associated with acute pain and inflammation, with varying degrees of severity for patients, causing significant stress and discomfort. effective postoperative pain management in shoulder surgery may reduce complications and improve postoperative care. for postoperative pain, multimodal analgesic techniques are used to provide synergistic effects through different nociceptive mechanisms. various analgesics are used for pain. opioids, commonly used for postoperative pain, are the most popular drug group. side effects such as sedation, respiratory depression, nausea-vomiting, pruritus and urinary retention that develop secondary to opioids may also be reduced by the combination of supplemental analgesics. adjuvant agents, including nonsteroidal anti-inflammatory drugs, may be used in combination with opioids. these drugs not only reduce pain but also control the underlying inflammatory process. in addition, combining nonsteroidal anti-inflammatory drugs and opioids can help to reduce the side effects by minimizing administration of total opioid consumption. intravenous paracetamol is an analgesic and antipyretic agent used as a first step drug for pain and fever control in adults and children. it has been clearly shown that intravenous paracetamol, with analgesic efficacy and good safety profile, reduces analgesic requirements for pain management. it provides better analgesic efficacy and reduces opioid consumption when used in combination with opioids. intravenous ibuprofen is the first and only intravenous nonsteroidal anti-inflammatory drugs approved in the united states for both pain and fever control in adults. it has been reported in multicenter studies that iv ibuprofen is safe and effective in postoperative pain management for orthopedic surgeries.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists scores 1-3 * 18-85 years exclusion criteria: * american society of anesthesiologists scores iv, * under the age of 18, * over the age of 85, * peptic ulcer disease, * hepatic and renal dysfunction, * severe cardiovascular and pulmonary disease, * allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and tramadol, * emergency surgery

Keywords: postoperative pain intravenous ibuprofen intravenous paracetamol shoulder surgery
mechanisms and biomarkers for tumor immunogenicity modulation in cervical cancer

Conditions: Cervical Cancer; Benign Tumor of Uterus

Summary: this study aims to investigate mechanisms that dictate tumor immunogenicity and to explore potential biomarkers that could help predict changes of tumor immunogenicity and therapeutic response in patients with cervical cancer after chemoradiotherapy or surgery.

patients pathologically confirmed with cervical cancer or benign gynecologic tumor that requires chemoradiotherapy or surgery will be recruited to this study. tumor samples, normal epithelium of the cervix or other biological samples will be obtained from patients who will receive surgery to establish the baseline status of tumor/mucosal immunogeneicity. for patients undergoing definite radiotherapy, tumor biopsies, collection of blood samples and microbiota will be performed before and during the course of treatment and when the disease progressed. these biological specimens will be used to investigate signaling pathways that determine tumor immungenenicity and their dynamic changes during treatment and to explore feasible biomarkers that could reflect and help monitor the inter- and intra-patient varariation of tumor immunogenicity.

Eligibility criteria:
inclusion criteria: * pathological proven diagnosis of cervical cancer or benign gynecologic tumor and will undergoing panhysterectomy or pathological proven diagnosis of cervical cancer and will undergoing radiotherapy * tumor accessible for biopsy during the course of radiotherapy or tumor samples could be obtained via surgery * patient must provide study-specific informed consent prior to study entry exclusion criteria: * history of autoimmune diseases * history of immunotherapy * history of pelvic radiotherapy * will receive immunotherapy during the course of treatment * contraindications for biopsy, such as high bleeding risk

Keywords: cervical cancer tumor immunogenicity