Kornimate/medical-research-clean huggingface dataset:
the impact of a home delivered meal service in cancer patients during chemotherapy

Conditions: Cancer; Malnutrition

Summary: cancer patients receiving treatment such as chemotherapy experience a variety of symptoms that interfere with their appetite and their ability to eat and enjoy meals. therefore, adapting meals in a way that responds to these symptoms might be a good strategy to improve patient satisfaction, nutritional status and hence, quality of life. in this vein, the investigators hypothesize that meals from foodforcare at home will contribute to the quality of life of cancer patients undergoing chemotherapy when compared to usual care.

cancer patients receiving treatment such as chemotherapy experience a variety of symptoms that interfere with their appetite and their ability to eat and enjoy meals. several studies suggest that nutritional intake increases when the patient is satisfied about the quality of the meals. therefore, adapting meals in a way that responds to these symptoms might be a good strategy to improve patient satisfaction, nutritional status and hence, quality of life. in this vein, the investigators hypothesize that meals from foodforcare at home will contribute to the quality of life of cancer patients undergoing chemotherapy when compared to usual care. also, the investigators expect that this strategy will have a positive effect on patient satisfaction, other nutrition-related issues, including nausea and vomiting, on nutritional intake per se and hence, on the nutritional status. additional benefits might include reduced use of medication, especially anti-emetics.

Eligibility criteria:
inclusion criteria: * age 18 years or older * diagnosed with cancer * receiving chemotherapy according to a minimum schedule of every 2 weeks * living within a 40 km radius around the radboud university nijmegen medical centre * written informed consent exclusion criteria: * renal insufficiency (mdrd-gfr (glomerular filtration rate) \< 60ml/min and/or proteinuria)\* * dementia or any other condition which makes it impossible to fill out questionnaires correctly * unable to understand or speak dutch * depending on artificial nutrition in the form of oral nutritional supplements, tube feeding or total parenteral nutrition * swallowing or passage problems * proteinuria is defined in case of a protein creatinine ratio \> 0.5g/10mmol or an albuminuria \> 300mg/day. this is checked by default before the start of chemotherapy by the treating physician to decide whether or not the patient is eligible for receiving chemotherapy.
safety and tolerability and efficacy of lcz696 in japanese severe hypertensive patients

Conditions: Severe Hypertension

Summary: this study assessed the safety, tolerability, and efficacy of lcz696 in severe hypertensive japanese patients

summaries for treatment-emergent adverse events, serious adverse events and death were provided by the following actual treatment regimen (actual treatment patients received) in addition to all patients: lcz696 200mg, 400mg, 400mg+other hypertensive medications. summaries for others than above were provided by the following treatment regimen (determined by the maximal treatment patients received) in addition to all patients: lcz696 200mg, 400mg, 400mg+other hypertensive medications.

Eligibility criteria:
inclusion criteria: * satisfy office mssbp ≥180 mmhg or office msdbp ≥110 mmhg at baseline exclusion criteria: * patients show mssbp ≥220 mmhg and/or msdbp ≥120 mmhg * history of angioedema, drug-related or otherwise, as reported by the patient * patients unwilling or not able to discontinue safely the use of current antihypertensive medications during the study, as required by the protocol. * patients have significant cardiovascular co-morbidities * patients who previously entered a lcz696 study and had been randomized or enrolled into the active drug treatment epoch. other protocol defined inclusion/exclusion criteria may apply.

Keywords: hypertension, severe, lcz696
jx09 sad/mad in healthy participants

Conditions: Resistant Hypertension

Summary: this is a phase 1, randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose study in healthy adult to test the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of jx09 when administered to healthy adult subjects.


Eligibility criteria:
inclusion criteria: * male or female aged 18 to 55 years (inclusive) * in good health as deemed by the investigator through a medical evaluation, including medical history, physical examination, and laboratory tests * body mass index (bmi) between 18 and 32 kg/m2, with a minimum weight of 50 kg at screening exclusion criteria: * clinically significant oncologic, infectious, cardiovascular, pulmonary, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, immunologic, renal, psychiatric, or other condition that in the opinion of the investigator or medical monitor would make is unsafe for the participant to join the study or fulfill its requirements. * a clinical abnormality or abnormal laboratory parameter(s) in the opinion of the investigator or medical monitor is likely to introduce additional risk or will affect data interpretation. * postural tachycardia or hypotension. * female of childbearing potential who is pregnant, lactating, or planning to become pregnant.

Keywords: hypertension health volunteer pharmacokinetic food effect
helicobacter pylori eradication with a new sequential treatment

Conditions: Helicobacter Pylori Infection; Non Ulcer Dyspepsia; Duodenal Ulcer; Gastric Ulcer; Chronic Active Gastritis; Gastritis

Summary: eradication rates of helicobacter pylori (h. pylori) with standard triple therapy are disappointing, and studies from several countries confirm this poor performance. the study aimed to assess the eradication rate of a new sequential treatment regimen compared with conventional triple therapy for the eradication of h. pylori infection.

one thousand and forty-nine dyspeptic patients were studied prospectively. h. pylori-infected patients were randomized to receive 10-day sequential therapy \[rabeprazole (20 mg twice daily) plus amoxicillin (1 g twice daily) for the first 5 days, followed by rabeprazole (20 mg), clarithromycin (500 mg) and tinidazole (500 mg, all twice daily for the remaining 5 days\] or standard 7-day therapy \[corrected\] \[rabeprazole (20 mg), clarithromycin (500 mg) and amoxicillin (1 g), all twice daily\]. h. pylori status was assessed by histology, rapid urease test and 13c-urea breath test at baseline and 6 weeks or more after completion of treatment.

Eligibility criteria:
inclusion criteria: * presence of active h. pylori infection * age \>18 years exclusion criteria: * allergy to drug administered * liver or kidney failure * pregnancy * previous treatment for h. pylori infection

Keywords: helicobacter pylori eradication sequential therapy standard therapy
the cross-sectional area of the long head of the biceps tendon and the rotator cuff tear position

Conditions: Rotator Cuff Tears

Summary: the main aim and scope of this study is making measurement and comparison of the cross-sectional area of the long head of the biceps tendon(lhbt) in the patients suffered form rotator cuff tear with different tear positions, and making observation and comparison of the impairment type of the lhbt in the patients suffered from rotator cuff tear with different tear positions. the results may identify the influence of the tear position on the lhbt.


Eligibility criteria:
inclusion criteria: * partial or full-thickness but reparable rotator cuff tear; * small- to large-sized rotator cuff tears being defined by deorio and cofied4; * no improvements after at least 1 month of conservative treatment such as nsaids or corticosteroid injection. exclusion criteria: * massive rotator cuff tears being defined by deorio and cofied; * patients with osteoarthritis of the glenohumeral joint; * trauma or a history of surgery at the shoulder.

Keywords: long head of the bicep tendon rotator cuff tear cross-sectional area
safety and tolerability of different concentrations of an ingenol derivative field therapy in the treatment of actinic keratosis

Conditions: Actinic Keratosis

Summary: the purpose of this study is to determine if the new ingenol derivative gels are as safe as and as well tolerated as ingenol mebutate gel when applied to ak lesions on the forearm for two consecutive days.

various concentrations of new ingenol derivatives will be applied to aks on the forearms. reactions and safety will be compared to a us registered and marketed ingenol gel to ascertain if the new ingenol is at least as safe and as well tolerated as the registered ingenol.

Eligibility criteria:
inclusion criteria: * must be male or female and at least 18 years of age. * female patients must be of non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception * ability to provide informed consent exclusion criteria: * location of the selected treatment area within 5cm of an incompletely healed wound or within 5cm of a suspected basal cell carcinoma or squamous cell carcinoma * undergone cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to visit 2 * use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to visit 2 * use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 2 treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of visit 2 * treatment with 5-fu, imiquimod, diclofenac, or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to visit 2 * use of systemic retinoids * those who are currently participating in any other clinical trial * females who are pregnant or are breastfeeding * those known or suspected of not being able to comply with the requirements of the protocol or provide consent
transcutaneous electrical acustimulation (tea) for gastroparesis

Conditions: Gastroparesis With Diabetes Mellitus

Summary: the device being studied, the transcutaneous electrical accustimulator (tea), will deliver weak electrical current at two specific points, one at the leg and the other at the arm at settings known to improve symptoms involving the digestive system. the study team would like to test if the device will impact the gastrointestinal (gi) symptoms and gastric motility in study participants with gastroparesis.

this study aims to assess if the device will impact the (gi) symptoms and gastric motility in study participants with gastroparesis. this will be done over a 12 week period during which each participant will undergo two visits. there will be two total visits that each follow the same schedule. during the first visit, subjects will undergo a 3-in-1 gastric functional test which is a non-invasive method to assess the gastric motility and visceral pain. this test will entail an egg, ecg, and water satiety drink test for gastric accommodation. following the 3-in-1 gastric functional test, subjects will be randomized and trained on how to use the study device. half of the patients will be assigned to the sham group and half will be assigned to the treatment group. each group will undergo 8 weeks of treatment or 8 weeks of sham stimulation and will receive weekly calls from the study team to check for adverse events and study compliance. following the first 8 week period, subjects will return to the study site to undergo visit two. this will follow the same format as visit 1. at this time, subjects will become unblinded. those who received sham stimulation will be trained on the correct locations for each tea device and will receive an additional 4 weeks of treatment with the device. note: the gastric emptying breathalyzer test (gebt) was removed, and the two-day visits were shortened to one-day to improve patient recruitment and retention.

Eligibility criteria:
inclusion criteria: * at least a 3-month history of diabetic gastroparesis symptoms on an on-going basis; at least one severe gastroparetic symptom or two moderate gastroparetic symptoms (e.g. vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain) during the screening. * documented delayed gastric emptying within past 3 years * stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to the experiment (daily adjustments of insulin doses are permitted if patient has diabetes) exclusion criteria: * currently receiving parenteral feeding or presence of a nasogastric or other enteral tube * history of gastric surgery such as fundoplication, gastrectomy, or vagotomy * symptoms suggestive of gastroparesis with no diagnosis of diabetes * pregnancy or expect to conceive during the course of the study * uncontrolled diabetes mellitus (hba1c \> 11%). * having any implanted medical device, such as cardiac pacemaker or entera device
three dimension laparoscopic versus open surgery for gallbladder carcinoma

Conditions: Gallbladder Cancer; Surgery

Summary: introduction: surgery is the only potential curative approach for the highly lethal gallbladder carcinoma. the laparoscopic surgery has developed rapidly since invented. as a kind of minimally invasive surgery, laparoscopic cholecystectomy including segmentg ivb and v is preferred by most of surgeons. there have been studies comparing intraoperative blood loss, postoperative morbidity, length of hospital stay and costs of laparoscopic cholecystectomy over open surgery. however, randomized controlled trials are still lacking but clearly required to reveal whether the laparoscopic approach or the open surgery is the better option for treating gallbladder carcinoma. we hypothesize that incidence of postoperative complications is lower, and time to functional recovery is shorter after laparosopic compared with open approach, even in an enhanced recovery setting. methods/design: we designed this prospective, randomized, controlled trial with two treatment approaches, laparoscopic versus open surgery for gallbladder carcinoma. the trial hypothesis is that laparoscopic approach has advantages in postoperative recoveries and be equivalent in operation time, oncological results and long-term follow-up compared with open counterpart. the duration of the entire trial is four years including prearrangement, follow-up and analyses. discussion: although several studies have discussed different surgical approaches for gallbladder carcinoma treatment, this trial will be a thorough rct comparing laparoscopic and open surgery for gallbladder carcinoma.


Eligibility criteria:
inclusion criteria: 1. histologically proven gallbladder carcinoma. 2. highly presumed malignancy with difficulties to obtain histological evidence. 3. preoperative staging work up performed by upper abdomen enhanced ct scan and showed no vessel involvment. 4. the subject understands the nature of this trial and willing to comply. 5. ability to provide written informed consent. 6. patients treated with curative intent in accordance to international guidelines. exclusion criteria: 1. distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs. 2. patients with high operative risk as defined by the american society of anesthesiologists (asa) score \>4. 3. synchronous malignancy in other organs. 4. palliative surgery.
screening for autism spectrum disorders using auditory brainstem responses

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study is to develop an auditory brainstem response (abr) based neurological screening method to detect increased risk for autism spectrum disorders (asd) and other neurological conditions in newborns.

in the proposed study, a screening method for neurological deficits, with an emphasis on its application to asd, will be developed and its feasibility demonstrated. the proposed method will utilize high rate stimulation to acquire auditory brainstem responses in order to determine peak latency and amplitude differences in children with asd compared to non-asd. similarly to newborn hearing screening, the output of the screening method will provide an automated pass or refer outcome that can be used by a physician to determine if the child needs further evaluation.

Eligibility criteria:
inclusion criteria: * children with autism spectrum disorder diagnosis * normally developing age- and gender-matched controls exclusion criteria: * permanent or temporary hearing loss at the time of testing. * craniofacial abnormalities

Keywords: autism spectrum disorder
study of the effect of fostamatinib twice daily on blood pressure in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the effect of fostamatinib compared to placebo on ambulatory blood pressure in patients with active rheumatoid arthritis who are taking a disease-modifying anti-rheumatic drug (dmard). the study will last for 57 days.

oskira-abpm: a multi-centre, randomised, double-blind, placebo-controlled, parallel group study of the effect of fostamatinib 100 mg twice daily on 24-hour ambulatory blood pressure in patients with rheumatoid arthritis

Eligibility criteria:
inclusion criteria: * male and female patients aged 18 or over diagnosed with rheumatoid arthritis after the age of 16 * active rheumatoid arthritis defined as: ≥4 swollen joints and ≥4 tender/painful joints (from 28 joint count) and either erythrocyte sedimentation rate ≥28 mm/h, or c-reactive protein ≥10 mg/l. * currently taking one of the following disease-modifying anti-rheumatic drugs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine. * patients without essential hypertension or with essential hypertension if their blood pressure is controlled (\<140/90 mmhg) with anti-hypertensive medications being stable at least 4 weeks prior to randomisation. exclusion criteria: * females who are pregnant or breastfeeding. * certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders * history of liver problems that have required previous investigations * evidence of tuberculosis infection * conditions that preclude or render difficult the 24-hour ambulatory blood pressure monitoring technique.

Keywords: rheumatoid arthritis
evaluation of the efficacy and tolerance of low doses of ethosuximide in the treatment of peripheral neuropathic pain

Conditions: Peripheral Neuropathic Pain

Summary: evaluation of the efficacy and tolerance of low doses of ethosuximide in the treatment of peripheral neuropathic pain

multicenter, randomized, double-blind, placebo-controlled therapeutic trial evaluating the efficacy and safety of low doses of ethosuximide in neuropathic pain patients.

Eligibility criteria:
inclusion criteria: * male or female (under effective contraception: pill, implant, iud, sterilization) aged 18 years or older, suffering from peripheral neuropathic pain (dn4 ≥ 4) for more than 3 months, of intensity ≥ 4 on a numerical scale from 0 to 10, and whose analgesic treatment has been stable for more than a month, * patients affiliated to the french social security system, * patients whose free and informed consent has been obtained. exclusion criteria: * pregnancy (βhcg+ blood) or breastfeeding, * neuropathic pain due to spinal cord or brain injury, phantom limb pain or algohallucinosis, * fibromyalgia or algodystrophy, * chronic pain syndrome that the patient cannot distinguish and/or is more intense than peripheral neuropathic pain, * significant abnormalities in liver (transaminases \> 3n, cholestasis) and renal (mdrd \< 60 ml/min) tests, * ongoing comorbidities: cancer, neurodegenerative pathology * severe depressive disorder in progress (as determined by the clinician), history of suicide attempts or hospitalization for depression, * diabetic patients (contraindicated due to the high sugar concentration of ethosuximide, 3g / 5 ml), * patients who have previously received ethosuximide (epilepsy or clinical trial), * surgery planned throughout the entire trial, * medical and surgical history incompatible with the study, * dependence on alcohol and/or drugs (for compliance purposes), * known allergy to succinimides (ethosuximide, methsuximide, phensuximide), * psychotic disorders, * epileptic patients, * patients benefiting from a legal protection measure (curatorship, guardianship, deprived of liberty or subject to judicial safeguard).

Keywords: ethosuximide t-type calcium channel neuropathic pain
optimal oral hypoglycaemic agents (oha) for combination with insulin glargine (sulfonylurea vs. metformin)

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to find out an optimal regimen of oha (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring hba1c level secondary objective: to compare the incidence of hypoglycemia in each treatment group


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 6 months * treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other su) for at least 3 months prior to the screening visit * 7.0 \< hba1c \< 11 % * fasting serum c-peptide \> 0.33 nmol/l * bmi \< 30 kg/m² * patients who is willing to monitor bg using smbg exclusion criteria: * type 1 diabetes * clinical evidence of active liver disease, or serum alt 3 times the upper limit of the normal range * serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females * active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry) * history of alcohol or other substance abuse * pregnancy or not using contraceptive in childbearing aged women * breast feeding women * history of hypersensitivity to the study drugs or to drugs with a similar chemical structure * treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.