Kornimate/medical-research-clean huggingface dataset:
effect of oral choline supplementation on postoperative pain

Conditions: Postoperative Pain; Inflammation

Summary: this research will test whether consuming additional choline before gynecological surgery decreases postoperative pain.

more than 70% of the patients undergoing surgery in the usa, experience moderate to severe pain after the surgery in spite of being treated for pain. we will test whether choline will produce an effective additional analgesic action for postoperative pain treatment. choline and lecithin are safe and are available for consumers as over-the-counter nutritional supplements. choline supplementation decreases postoperative pain in rodents. also nicotine decreases postoperative pain in humans and since choline acts on the same receptors as nicotine, choline supplementation may be effective as an analgesic without the risks of addiction and the side effects like high heart rate and blood pressure. sixty women between the ages 18 and 60 undergoing open abdominal gynecological surgeries will be studied. we will not study people with chronic pain, drug abuse, and/or nicotine use over the past six months, current pregnancy or breastfeeding, allergy to soy, or inability to take any drug that we will use in the study. patients will take 10 tablets (choline or gelatin powder placebo) the night before surgery. after anesthesia, a second dose will be given into a tube that goes into the patient's stomach. one tablespoon of blood (15 ml) will be drawn five times to measure genetics, changes in levels of plasma choline and inflammatory markers: blood will be drawn at the preoperative visit, three times on the day of surgery and once 24 hours postoperatively. at 24 hours after surgery and on their follow-up visit with their doctor, the patient's surgical wound will be photographed and patients will complete a survey on satisfaction with treatment. primarily we are looking at the pain scores after surgery and secondarily at the pain medication use, plasma choline levels, wound healing and satisfaction with pain treatment. this is a randomized double blind study. patients will consume ten tablets (10g choline or placebo) the night before undergoing gynecological surgery and 10 tablets the morning of surgery. we will measure pain after surgery, baseline and postoperative plasma choline, and test genetics.

Eligibility criteria:
inclusion criteria: * open pelvic surgery * able to swallow pills exclusion criteria: * chronic pain * opioid use * pregnancy * lactation
a prospective study on the treatment of recurrent/refractory/intolerable nsaa with lusutrombopag

Conditions: Aplastic Anemia

Summary: in a prospective, single-arm study, the efficacy and safety of lusutrombopag in the treatment of relapsed/refractory/intolerable non-severe aplastic anemia (nsaa) were explored.

the enrolled patients: were given lusutrombopag at 3mg/qd orally for 12 weeks (the starting dose of lusutrombopag was 3mg, taken once daily. after 2 weeks of continuous administration, the dose was increased by 3mg every 2 weeks based on the platelet count and safety of the subjects. the dose was gradually increased to 9mg/d over a total of 12 weeks). the treatment duration was at least 3 months. when the platelet increase was \ 400×10\^9/l, the drug could be suspended, and the dose was reduced by 3mg when the platelet count decreased to \<200×10\^9/l. in this case, if the lowest dose of 3mg/day was used, the drug could be suspended. responders continued treatment for 6 months. other tpo-ra therapies were not allowed during the study period.

Eligibility criteria:
inclusion criteria: 1. participants must be at least 18 years old, male or female. 2. participants must be diagnosed with nsaa and have a refractory/relapsed/intolerable response to standard-dose cyclosporine (csa). the definition of refractory/relapsed is patients who have been treated with sufficient doses of cyclosporine (3-5mg/kg) for at least 6 months without response or relapse. the definition of intolerable is patients who cannot tolerate csa and have stopped treatment due to significant side effects. 3. participants must meet the following criteria at enrollment: platelets \<30×109/l. 4. baseline liver and kidney function must be within 2 times of normal range. 5. no active infection; no pregnancy or breastfeeding. 6. participants must agree to sign the informed consent form. 7. eastern cooperative oncology group (ecog) performance status score of 0-2. exclusion criteria: 1. other causes of pancytopenia, such as myelodysplastic syndrome (mds). 2. evidence of clonal hematopoietic system bone marrow disease (mds, aml) with cytogenetics. 3. pnh clone ≥50%. 4. received hematopoietic stem cell transplant (hsct) prior to enrollment. 5. received atg treatment within 6 months prior to enrollment. 6. infection or bleeding that cannot be controlled with standard therapy. 7. allergic to ruxolitinib. 8. active hiv, hcv, or hbv infection, cirrhosis, or portal hypertension. 9. any malignant tumor within 5 years, or local basal cell carcinoma of the skin. 10. history of thromboembolic events, myocardial infarction, or stroke (including antiphospholipid syndrome) and current use of anticoagulants. 11. pregnant or breastfeeding (lactating) women. 12. participated in another clinical trial within 3 months.

Keywords: non-severe aplastic anemia lusutrombopag refractory recurrent
to assess the efficacy and safety of incb054707 in participants with hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa; Acne Inversa

Summary: to evaluate the efficacy and safety of incb054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week open-label extension period. all eligible participants will be invited to continue treatment for an additional 48-week long-term extension period (also open label).


Eligibility criteria:
inclusion criteria: * hs disease duration of at least 3 months before screening. * willingness to avoid pregnancy or fathering children. * active hs in at least 2 distinct anatomical areas. * participants agree not to use topical antiseptics on the areas affected by hs lesions during the placebo-controlled 16-week treatment period exclusion criteria: * draining fistula count of \> 20 at screening or baseline. * women who are pregnant (or who are considering pregnancy) or lactating. * medical history including thrombocytopenia, coagulopathy or platelet dysfunction, q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator. * history of failure to treatment of inflammatory diseases with jak inhibitors. * have evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis. * participants known to be infected with hiv, hepatitis b, or hepatitis c. * laboratory values outside of the protocol-defined ranges.
clinical decision support to identify pediatric patients with undiagnosed genetic disease

Conditions: Genetic Disease; Pediatrics; Predictive Model; Clinical Decision Support

Summary: this study will evaluate the effectiveness of sight as a clinical support system to prompt provider/patient discussion and shared decision making regarding the need for genetic testing in the form of a chromosomal microarray. identifying patients at high predicted probability of needing a test in clinical settings will be examined to determine if it decreases the duration of time to testing and increases diagnostic yield. sight requires only data already collected in routine clinical encounters and is calculated prior to a clinical visit at vumc.


Eligibility criteria:
inclusion criteria: * all patients \> 1 year old, \< 20 years of age with a scheduled visit to the vumc pediatric primary care. exclusion criteria: * patients who have been programmatically excluded due to having already received a chromosomal microarray at vumc and patients \> 20 years of age or \< 1 year of age.
most preventable surgical option to reduce primary spontaneous pneumothorax patients' postoperative recurrence: a prospective cohort study

Conditions: Spontaneous Pneumothorax; Recurrence; Surgery

Summary: to investigate the most preventable option to reduce primary spontaneous postoperative recurrence.

pneumothorax is a disease in which air in the lungs leaks into the pleural cavity. it is a disease that occurs most often in young people with active social activities, and it occurs in about 100,000 people in 14 cases. the recurrence rate is as high as 17% to 54%, and the delay of the rehabilitation by the ambulatory with the treatment and prolongation of the hospitalization becomes a problem. it becomes a large failure for the youth who requires early rehabilitation. according to the latest report from the japanese society of surgery, approximately 12,000 pneumothorax surgeries are performed annually in japan. many of them applied absorbent material to the surgical stump (coverage technique). however, there are no prospective studies, and efficacy does not appear adequately tested. it is necessary to accumulate prospective data from multiple centers to investigate the coverage technique's real effect.

Eligibility criteria:
inclusion criteria: 1. patients who have spontaneous pneumothorax diagnosed by radiography and plan to underwent initial vats bullectomy. 2. patients who receive informed consent to attend this study, and the agreements are provided in a document. the consent of parents is also required, in case patients are under 20-years old. exclusion criteria: 1. history of ipsilateral chest surgery. 2. patients who only underwent exploratory surgery. 3. patients who are judged ineligible by the investigator and the attending surgeon.
austrian registry for evaluation of treatment patterns and outcome in patients with advanced pancreatic ductal adenocarcinoma (pdac)

Conditions: Pancreatic Cancer; Advanced Pancreatic Carcinoma

Summary: to systematically collect and analyse real-world data on treatment patterns, clinical outcomes and toxicities among patients with advanced pancreatic ductal adenocarcinoma (pdac) undergoing systematic treatment in austria

1000 adult patients with locally advanced inoperable and/or metastasized pdac undergoing first line chemotherapy

Eligibility criteria:
inclusion criteria: * 18 years, female and male * ecog (eastern cooperative oncology group) scale 0-2 * diagnosis of histologically confirmed locally advanced inoperable and/or metastatic pdac * patients undergoing palliative 1st line therapy with a platinum- or gemcitabine- based chemotherapy in case of previous (neo)adjuvant therapy also patients who receive nal-irinotecan/5-fu/leukovorin as palliative first line are eglible * signed informed consent for prospective patients, for retrospective cases no informed consent is required exclusion criteria: * patients with locally advanced operable pdac who do not receive palliative chemotherapy * patients with locally advanced borderline resectable pdac who do not receive palliative chemotherapy
rehabilitation with an obturator in maxillary defects

Conditions: Mucormycosis

Summary: during the covid-19 pandemic, there was a lot of reporting of covid-19-associated mucormycosis cases. managing this condition posed a new challenge to clinicians. management includes therapeutic drugs and aggressive surgical debridement. due to the unpredictability of disease prognosis and the possible recurrence of the disease, rehabilitation with delayed surgical obturators is beneficial for patients. hence, the current study aimed to evaluate the impact of delayed surgical obturators on quality of life of covid-19-associated mucormycosis patients post-maxillectomies

globally, the prevalence of mucormycosis varied from 0.005 to 1.7 per million population, while its prevalence is nearly 80 times higher (0.14 per 1000) in india compared to developed countries, in a recent estimate of year 2019-2020. among the medical professionals involved in managing patients with mucormycosis, maxillofacial prosthodontists are responsible for prosthetic restoration of lost oral and maxillofacial structures, helping patients to socialize and have an acceptable quality of life after surgical treatment

Eligibility criteria:
inclusion criteria: \*patients who underwent partial, subtotal and hemi-maxillectomy due to covid-19-associated mucormycosis and who needed the prosthetic rehabilitation with delayed surgical obturator. exclusion criteria: * patients who are unwilling for the study. * patients who underwent which bilateral maxillectomies. * patients having extensive palatal mucosal loss.
radiofrequency ablation of genicular nerves for advanced osteoarthrosis of the knee joint 1 year follow-up.

Conditions: Painful Osteoarthritis of the Knee

Summary: pharmacological treatment of pain due to osteoarthritis of the knee often proves to be inadequate and/or cause intolerable side effects. arthroplasty of the knee may offer a solution, but waiting lists may be long or certain patients may not be apt for a surgical intervention. therefore an alternative pain treatment that is effective and has little side effects allowing to offer pain relief to those difficult to manage patients would be an added value in the therapeutic options. we studies the short and long-term effects of radio frequency treatment of the genicular nerves in patients with severe pain due to osteoarthritis of the knee.

radio frequency treatment (rf) of the genicular nerves was found to be effective in a randomized controlled trial. because of the blinding patients were allowed to continue pre-intervention pharmacological treatment, which may have interfered with the outcome. the short follow-up (12 weeks) does not allow drawing conclusion on the duration of the effect. we aimed at assessing the pain reducing effect of rf of the genicular nerves and the duration of the effect.

Eligibility criteria:
inclusion criteria: * patients suffering from pain caused by osteoarthrosis of the knee joint * osteoarthrosis of the knee joint (grade 3-4 according to the kellgren lawrence classification) * pain of moderate to severe intensity (vas≥5, on a 10-point scale) during \>3 months * pain resistant to conservative treatments exclusion criteria: * acute knee pain associated with radicular neuropathy or intermittent claudication, connective tissue diseases affecting the knee, serious neurologic or psychiatric disorders, mental deterioration impeding adequate communication or collaboration, injection with steroids or hyaluronic acids during the previous 3 months, anticoagulant medications, pacemakers, and prior electro-acupuncture treatment

Keywords: radio frequency treatment genicular nerves osteoarthritis of the knee
proof of biological activity of sar100842 in systemic sclerosis

Conditions: Systemic Sclerosis

Summary: primary objective: - to evaluate safety and tolerability of 8-week oral administration of sar100842 in patients with diffuse cutaneous systemic sclerosis. secondary objectives: * to evaluate the pharmacodynamic effect of sar100842 in patients with systemic sclerosis as measured by disease related biomarkers and lysophosphatidic acid (lpa) receptor signaling markers in blood and skin; * to explore the effect of sar100842 on skin thickness in patients with systemic sclerosis as measured by the modified rodnan skin score (mrss); * to explore the effect of sar100842 on quality of life as measured by the scleroderma modified health assessment questionnaire (shaq); * to document long term safety of sar100842 during the extension part.

core part: randomized, double-blind, placebo-controlled study - 8-week treatment extension part for participants completing the core part: open label non-controlled study - 16-week treatment each patient's participation in the study will be approximately 13 or 33 weeks depending on their participation in the extension part: up to 2 weeks of screening, 8 weeks of treatment in the core part, 1 to 30 days wash-out between core part and extension part , 16 weeks of treatment in the extension part and 3 weeks of follow up.

Eligibility criteria:
inclusion criteria : - patients who meet the american college of rheumatology (acr) criteria for systemic sclerosis with diffuse cutaneous involvement and \<36 months since the onset of the first systemic sclerosis manifestation other than raynaud's phenomenon and have a modified rodnan skin score (mrss) ≥ 15 and an area of definite involvement of the dorsal forearm that is considered amenable to repeated 4mm skin biopsies. exclusion criteria: 1. patients with high dose or unstable low dose immunosuppressive drugs, cytotoxic, anti-fibrotic or glucocorticoids drugs at least 4 weeks prior to screening 2. serum creatinine \> 2.0 mg/dl 3. gastrointestinal involvement preventing oral administration of study drug 4. severe cardiac and/or pulmonary disease the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a study of tislelizumab (bgb-a317) versus chemotherapy as second line treatment in participants with advanced esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma (ESCC)

Summary: the purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic escc that had progressed during or after first line therapy.


Eligibility criteria:
key inclusion criteria: 1. histologically confirmed diagnosis of esophageal squamous cell carcinoma (escc) 2. tumor progression during or after first-line treatment for advanced unresectable / metastatic escc 3. at least one measurable/evaluable lesion by response evaluation criteria in solid tumors (recist) v1.1 4. eastern cooperative oncology group (ecog) performance status of 0 or 1 prior to randomization key exclusion criteria: 1. receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable escc 2. history of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization 3. tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator 4. uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage 5. received prior therapies targeting programmed death 1 (pd-1) or programmed death ligand 1 (pd-l1) 6. prior malignancy active within the previous 2 years (exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast) 7. active brain or leptomeningeal metastasis. 8. has active autoimmune disease or history of autoimmune diseases at high risk for relapse 9. known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases, etc 10. known history of human immunodeficiency virus (hiv) 11. has cardiovascular risk factors 12. pregnant or breastfeeding woman. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: unresectable metastatic second-line squamous esophagus chemotherapy paclitaxel docetaxel irinotecan
comparison of two combinations in antiretroviral post-exposure prophylaxis for hiv-1: tenofovir/emtricitabine (truvada ®) + lopinavir/ritonavir (kaletra ®) vs tenofovir/emtricitabine/cobicistat/elvitegravir (stribild ®). prospective, randomized, open.

Conditions: HIV

Summary: the main objective of this study is to compare the tolerability and adherence to a new drug regimen of post-exposure prophylaxis (pep) for hiv,


Eligibility criteria:
inclusion criteria: * age greater than 18 years * have been exposed to hiv, non-occupational and meets the requirements of current recommendations to start with three antiretroviral drugs pep * that adequately informed consent in writing to participate in the study and undergo testing and exploration that entails exclusion criteria: * pregnant women, lactating, or those intend become pregnant during the study period. * subjects who are known or suspected case presents the source resistors to one of the drugs of the pattern of study * contraindicated treatment with the study drugs, or products under investigation
the correlation between the retrobulbar hemodynamics and intrarenal hemodynamics in t2dm patients during the early period

Conditions: Diabetes Mellitus, Type 2

Summary: objective: the main target of this study was to research the early changes of retrobulbar and intrarenal hemodynamics, then to research the correlation between them in type 2 diabetes (t2dm) patients without diabetic kidney disease (dkd) and diabetic retinopathy (dr). method: 35 t2dm patients (diabetes group) without vascular complications and 30 healthy people (control group) were recruited to research the early changes of renal function, retrobulbar and intrarenal hemodynamics, and then to research the correlation between them. the primary endpoints were the intrarenal hemodynamic (bilateral kidney ri) in bilateral interlobular renal arteries were evaluated using doppler sonographic; the secondary endpoints were the retrobulbar hemodynamics ri in the bilateral central retinal artery (cra), posterior ciliary artery (pca), and arteria ophthalmica (oa) were evaluated using color doppler imaging (cdi); the tertiary endpoints were the biochemical endpoints: blood-fat (tc, hdl-c, ldl-c, and tg), fpg, 2hpg, hba1c, and renal function parameters (bun, cr, and gfr); in addition, the albumin excrete rate (aer), urinary albumin/creatinine ratio (uacr) were measured.


Eligibility criteria:
inclusion criteria: 1. the patients were diagnosed with t2dm according to the guidelines of the american diabetes association ; 2. no smoking history, pulmonary disease, cold, nor pulmonary infection within a fortnight; 3. did not have hepatopathy, nephropathy, hyperuricemia, and gastrointestinal disease; and 4. likely to have good compliance and able to visit our hospital for periodic assessments. exclusion criteria: 1. t1dm, gestation and lactation; 2. renal inadequacy,hypohepatia,and heart failure; 3. intensive care with insulin treatment; 4. the patients combined with dr and hypertension (antihypertensive drugs were used); 5. patients with other eye conditions that could affect the blood flow, such as high degree myopia, maculopathy of any origin, glaucoma, and those with a history of laser treatment or intraocular surgery; 6. the patients combinated with dkd; 7. patients with other renal conditions that could affect the blood flow, such as urolithiasis, urinary infection, and renal cyst (diameter \> 3 cm); 8. cholesterol-lowering drugs can not control the blood-fat (tc \> 250 mg/dl, hdl-c \ 170 mg/dl, tg \> 200 mg/dl) adequately.