Kornimate/medical-research-clean huggingface dataset:
long haul covid rehabilitation & recovery research program

Conditions: Post-Acute COVID-19 Syndrome

Summary: the purpose of the study is to assess the physiologic, immunologic, and mental health effects of a rehabilitation program on patients with long haul covid (lhc).

1.0 objectives 1.1 describe the purpose, specific aims, or objectives. the purpose is to assess the physiologic, immunologic, and mental health effects of a rehabilitation program on patients with long haul covid (lhc). 1.2 state the hypotheses to be tested. long haul covid patients who enroll and complete a 10 week program of physiologic and psychological rehabilitation will have reduced long haul covid symptoms, improved physical status, reduced inflammatory markers, and augmented psychological well being.

Eligibility criteria:
inclusion criteria: * long haul covid infection (documented by pcr or patient report) * age \>= 18 years old. * at least 12 weeks since the initial covid infection. * one or more of the following symptom/signs: fatigue, dyspnea, exercise intolerance, post exertional malaise and/or difficulty breathing. * able to perform a cardiopulmonary exercise test. exclusion criteria: * patients is not able to perform technically acceptable pulmonary function tests and symptom-limited cardiopulmonary cycle ergometry tests. * patients who desaturate to spo2 \<80% on screening incremental exercise testing. * patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program. * patients who have taken an investigational drug within one month or six half-lives (whichever is greater) prior to screening visit (visit 1). * pregnant or nursing women. * women of childbearing potential who are not using a highly effective method of birth control. female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. * patients who are currently participating in another interventional study. * malignancy for which the patient has undergone resection, radiation therapy, or chemotherapy within the last 2 years * any other significant disease than covid which, in the opinion of the investigator, may i) put the patient at risk because of participation in the study, ii) influence the results of the study (e.g. insulin or testosterone therapy, systemic corticosteroids, hiv, etc), iii) cause concern regarding the patient's ability to participate in the study.
special drug use investigation for relenza® (zanamivir) (prophylaxis)

Conditions: Influenza, Human

Summary: the purpose of this post-marketing surveillance study is to collect information on efficacy and safety for prophylactic administration of zanamivir in clinical practice in family or persons living with patients with influenza virus infection.


Eligibility criteria:
inclusion criteria: * subjects who meet the study population criteria exclusion criteria: * subjects with a history of hypersensitivity to the ingredients of zanamivir
inclisiran effectiveness in china: a pragmatic randomized trial

Conditions: Coronary Heart Disease

Summary: the current study will be conducted to evaluate the real-world effectiveness of inclisiran relative to standard of care (soc) in chinese patients with coronary heart disease (chd), not only with the low-density lipoprotein cholesterol (ldl-c) change in 1 year, but also the ldl-c test on target for 1 year. this study further aims to assess the adherence, treatment patterns and satisfaction, and safety of inclisiran among chinese patients.

the study is a multicenter, randomized, parallel, open-label, pragmatic trial, to assess the effectiveness of inclisiran in the real-world compared to soc, in patients with chd in china who did not achieve ldl-c goal despite maximally tolerated statin therapy for ≥4weeks stable using. chd patients include patients with acute coronary syndrome and patients with chronic coronary syndrome. after granting informed consent, being screened, and confirmed eligible for the study, participants will be randomized to 2 arms (inclisiran or soc) in a 1:1 ratio. following the randomization, participants start inclisiran or soc adaptation (which means switching to or adding on another/other lipid-lowering therapies (llt\[s\]). this start date is defined as day 0. during follow-up, each participant will follow routine care, and the results of ldl-c tests will be collected for each visit (every 3 months), with an allowable window of ±1.5 months. each patient will be followed up until his/her end of study (eos), which is the earliest of the end of follow-up period (visit 4: approximately 12 months following day 0), lost to follow-up, consent withdrawal, death, and participating in another interventional trial.

Eligibility criteria:
inclusion criteria: 1. signed informed consent must be obtained prior to participation in the study 2. documented diagnosis of chd prior to screening, including acute coronary syndrome (acs) and chronic coronary syndrome (ccs) 3. aged ≥18 years at randomization 4. despite maximally tolerated statin therapy for ≥4weeks stable using prior to screening, ldl-c result at screening not at goal (≥1.8 mmol/l). the maximum tolerated dose of statins also includes patients with statin intolerance or contraindication. exclusion criteria: 1. received inclisiran during the 2 years prior to the screening. 2. received proprotein convertase subtilisin-kexin type 9 (pcsk9) mabs during the 3 months prior to screening. 3. participating in an interventional trial at enrollment 4. having severe liver disorder (child-pugh class c) 5. any other condition that may put the participant at significant risk if the participant participate in the current study, according to investigator's (or delegate's) judgment. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: inclisiran effectiveness lipid-lowering low-density lipoprotein cholesterol test on target
the safety and effectiveness of taneasy and actein in copd patients

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Summary: to evaluate the safety and efficacy of taneasy 600mg granules and actein effervescent tablets 600mg administered twice daily for 14 days in treatment of copd disease.

the study will enroll 40\~60 patients and complete 40 patients.

Eligibility criteria:
inclusion criteria: 1. subjects aged older than 20\~75 years old. 2. able to sign informed consent prior to the study. 3. subjects have copd. exclusion criteria: 1. subjects with known hypersensitivity to acetylcysteine preparations. 2. subjects with other serious medical diseases that are judged by the attending physician to affect the evaluation results (such as: tuberculosis, pneumonia, bronchial asthma, bronchiectasis, cor pulmonale, lung cancer, acute myocardial infarction, acute hepatitis, renal failure, etc.) 3. pregnancy or breast-feeding woman. 4. female subjects or their sexual partners do not use contraception during the trial. 5. joining any drug clinical trial within 3 months prior to dosing. 6. investigator considered to be inappropriate for enrollment. 7. phenylketonuria (pku).
transfusion requirements after head trauma

Conditions: Traumatic Brain Injury

Summary: traht is a pilot randomized clinical trial designed to evaluate safety and feasibility of two red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients


Eligibility criteria:
inclusion criteria: * age equal to or greater than 18 years * moderate or severe traumatic brain injury, defined as glasgow coma scale less than or equal to 12 at hospital admission * hemoglobin lower than 9.0 g/dl within 7 days from hospital admission exclusion criteria: * glasgow coma scale equal to 3 with dilated pupils bilaterally * previous neurological sequelae * pregnant women * jehovah's witnesses * hemorrhagic shock at randomization * moribund patients * unable to provide consent

Keywords: traumatic brain injury blood transfusion
fractionated radiosurgery for painful spinal metastases

Conditions: Neoplasm Metastasis; Neoplastic Processes; Neoplasm Recurrence, Local; Neoplasm, Residual; Pain

Summary: it is the study hypothesis that hypo-fractionated image-guided radiosurgery significantly improves pain relief compared to historic data of conventionally fractionated radiotherapy. primary endpoint is pain response 3 months after radiosurgery, which is defined as pain reduction of ≥2 points at the treated vertebral site on the 0 to 10 visual analogue scale. 60 patients will be included into this ii trial.

the current study will investigate efficacy and safety of radiosurgery for painful vertebral metastases and three characteristics will distinguish this study. 1. a prognostic score for overall survival will be used for selection of patients with longer life expectancy to allow for analysis of long-term efficacy and safety. 2. fractionated radiosurgery will be performed with the number of treatment fractions adjusted to either good (10 fractions) or intermediate (5 fractions) life expectancy. fractionation will allow inclusion of tumors immediately abutting the spinal cord due to higher biological effective doses at the tumor - spinal cord interface compared to single fraction treatment. 3. dose intensification will be performed in the involved parts of the vertebrae only, while uninvolved parts are treated with conventional doses using the simultaneous integrated boost concept.

Eligibility criteria:
inclusion criteria: 1. established histological diagnosis of a malignant tumour (primary or metastatic) 2. vertebral metastasis confirmed via biopsy or radiology 3. pain in the involved spinal region or free of pain under pain medication 4. fully consenting patients, \>18 years old 5. karnofsky performance index ≥60% 6. good or intermediate life expectancy according to the modified prognostic mizumoto score (score ≤ 9) 7. patient must be able to tolerate fixation systems and 30 minutes treatment time 8. discussed in interdisciplinary tumour board 9. the following types of spinal tumours are eligible: * recurrent / residual tumours after surgery * tumours in medically inoperable patients or patients deemed inoperable due to limited life expectancy / tumour load * lesions associated with significant surgical risk exclusion criteria: 1. short life expectancy according to the modified mizumoto sore 2. "radiosensitive" histologies (i.e. lymphoma, sclc, multiple myeloma) 3. non-ambulatory status 4. progressive neurological symptoms/deficit 5. \> 3 involved vertebral levels 6. \> 2 treatment sites 7. spine instability 8. previous radiotherapy at the involved levels

Keywords: spinal metastases vertebral metastases radiosurgery radiotherapy stereotactic body radiotherapy pain
acute exposure of high altitude on cognitive function

Conditions: Pulmonary Hypertension

Summary: randomized crossover trial in patients with pulmonary arterial hypertension (pah) or chronic thromboembolic pulmonary hypertension (cteph) to assess the acute response to high altitude (2500m above sea level) on cognitive functions

low altitude baseline measurements will be performed in zurich (460m) including echocardiography, right heart catheterization, 6 minute walk test, pulmonary function test, clinical assessment and blood gas analysis. randomly assigned to the order of testing, the participants will be tested in low altitude (zurich, 470m) and at high altitude (2500m). during the exposure to high altitude (säntis; 2500m above sea level) for approximately 5 hour, the participants will perform cognitive function test . the results will be compared to low altitude in zurich (470m).

Eligibility criteria:
inclusion criteria: * informed consent * ph diagnosed according to internation guidelines: mpap ≥ 25 mmhg along with a pawp ≤15 mmhg during right heart catheterization at the time of initial diagnosis * ph class 1 (pah) or 4 (cteph) * stable condition, on the same medication for \> 4 weeks * patient live permanently at an altitude \< 1000m asl. exclusion criteria: * resting pao2 ≤7.3 kpa corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed) * severe daytime hypercapnia (pco2 \> 6.5 kpa) * susceptibility to high altitude related diseases (ams, hape, etc.) based on previous experienced discomfort at altitudes. * exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation * residence \> 1000m above sea level * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability * women who are pregnant or breast feeding

Keywords: high altitude cognitive function
dopamine in acute decompensated heart failure (dad-hf) trial

Conditions: Acute Heart Failure

Summary: the aim of this study is to compare the effects of high-dose furosemide versus low-dose furosemide combined with low-dose dopamine on diuresis, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.

worsening renal function (wrf) and hypokalemia related to diuretic use for acute decompensated heart failure (adhf) are common and portend poor prognosis. low dose dopamine infusion improves renal perfusion. whether dopamine infusion improves diuresis and/or reduces renal complication in adhf is not known. the aim of this study is to compare the effects of high-dose furosemide (hdf, 40 mg furosemide bolus iv, followed by continuous iv infusion of 20 mg/h for a total of 8 hours) vs. low-dose furosemide combined with low-dose dopamine (ldfd, 40 mg furosemide bolus iv, followed by continuous iv infusion of 5 mg/h furosemide plus 5μg/kg/min dopamine for a total of 8 hours) on diuresis, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with adhf.

Eligibility criteria:
inclusion criteria: * patients with new york heart association (nyha) functional class iv heart failure according to the american heart association (aha) classification, namely dyspnea on minimal exertion or rest dyspnea, orthopnea, and paroxysmal nocturnal dyspnea * signs of congestion (third heart sound or pulmonary rales on physical examination) * pulmonary congestion on chest x-ray * serum b-type natriuretic peptide levels \> 400 pg/ml or nt-probnp \> 1500 pg/ml * echocardiographic documentation of systolic or diastolic dysfunction * all candidate patients must be: * age \>18 years old * on medical therapy with an ace-inhibitor and/or a β-blocker * experiencing an acute decompensation of known chronic hf * having baseline oxygen saturation \<90% on admission arterial blood gas exclusion criteria: * the investigators will exclude patients with: * acute de novo hf * severe renal failure (serum creatinine \> 200 μmol/l or gfr \< 30 ml/min/1.73m2) * admission systolic blood pressure \< 90 mm hg * severe valvular disease * known adverse reactions to furosemide or dopamine * hf secondary to congenital heart disease * a scheduled procedure with a need for iv contrast dye * a scheduled cardiac surgery within 6 months

Keywords: heart failure dopamine furosemide worsening renal function hypokalemia outcomes prognosis
albumin kinetics in generalized inflammation

Conditions: Major Abdominal Surgery

Summary: the purpose of this study is to determine whether the kinetics of endogenous albumin is altered by the generalized inflammation caused by major abdominal surgery.

albumin infusions have been used for expansion of the plasma volume for more than 60 years, not only in the operating room, but also in trauma and sepsis. however, there is an ongoing debate whether albumin is good or bad for the patient compared to other intravenous fluids, in different situations. our research program aims at exploring this issue, starting by describing how the body handles the endogenous albumin in connection with severe inflammation. the final goal is to improve fluid treatment for these patients. plasma albumin is often decreased in inflammation. however, the underlying mechanisms are not well described. two aspects of albumin kinetics will be covered in this study by measurements immediately before and two days after major abdominal surgery, that will serve as a model for generalized inflammation. albumin fractional synthesis rate will be determined by the incorporation of deuterium labelled phenylalanine into plasma albumin. albumin distribution will be measured as transcapillary escape rate of radioiodinated albumin. by assessment of p-albumin and plasma volume it will be possible to calculate albumin absolute rate of synthesis and albumin absolute flux from the central compartment, respectively.

Eligibility criteria:
inclusion criteria: * written informed consent * patients planned for major abdominal surgery, pancreatic * age ≥ 40 years exclusion criteria: * pregnant or lactating patients * planned peri-operative infusions of albumin or plasma * s-creatinine \> 110 mmol/l * allergy against iodine * other conditions preventing the subject from participating in the study, as judged by the investigator

Keywords: plasma albumin inflammatory reaction systemic inflammatory response syndrome
comparative study between wide local excision and minimal excision of pilonidal sinus

Conditions: Pilonidal Sinus

Summary: comparative study between wide local excision and minimal excision of pilonidal sinus

pilonidal sinus (pns) disease is distributed in young adults who are supposed to be healthy with maximum productivity. wide local excision creates a tissue gap, while the concept of minimal excision preserves healthy tissues with minimal tissue gap. pilonidal disease is a frequent suppurative condition that occurs twice as often in men as in women, usually between the ages of 15 and 30. pilonidal disease is located beneath the skin of the sacro-coccygeal region. it presents acutely as an abscess under tension while the chronic form gives rise to intermittent discharge from pilonidal sinus(es). diagnosis is clinical and usually straightforward. in the large majority of cases, treatment is surgical but there is no consensus as to the 'ideal' technique. acute abscess must be evacuated and an off-midline incision seems preferable. excision is the standard definitive treatment but the choice of wide versus limited excision on the school of thought. minimal excision or debridement of the sinus and/or cavity through a midline or a separate paramedian excision can also be performed, leaving the wounds open or closed. these methods are simple and cost-efficient, and associated with low pain, rapid healing, and a rapid return to normal activity. a disadvantage is the higher recurrence rate; however, these methods can be used repeatedly for recurrences. although recurrence rates seem high at first glance, the procedures can be successfully repeated for recurrences, achieving healing rates of over 90% for 1-2 interventions. future well-designed trials are necessary to aid patient selection.

Eligibility criteria:
inclusion criteria: * patients complaining of primary pns and recurrent pns following minimal excision exclusion criteria: * recurrent pns following wide local excision
single-dose crossover study to evaluate the early bronchodilating effect of flutiform hfa pmdi in adult subjects with mild to moderate asthma

Conditions: Mild to Moderate Asthma

Summary: the primary purpose of this study is to evaluate the early bronchodilating effect of skp flutiform hfa pmdi compared to placebo.


Eligibility criteria:
inclusion criteria: * subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid exclusion criteria: * participation in a prior flutiform study * smoking history within the last 12 months, * significant, non-reversible, pulmonary disease * life-threatening asthma within the last year

Keywords: asthma asthma mild to moderate
clomiphene plus n-acetyl cysteine for induction of ovulation in newly diagnosed pcos.

Conditions: PCOS

Summary: polycystic ovary syndrome (pcos) is one of the most common endocrine disorders, affecting approximately 6-10% of women of reproductive age. anovulation, infertility and hyperandrogenism often co-exist with hyperinsulinaemia and insulin resistance . clomiphene citrate remains the standard drug for induction or augmentation of ovulation. however, it is not equally effective in all situations, and therefore it may require additional expensive drugs such as n-acetyl cysteine, as an antioxidant, has been suggested as an adjuvant in clomiphene-resistant cases .nac may also improve the circulating level of insulin and insulin sensitivity in hyperinsulinaemic women with pcos, and may be useful for the treatment of insulin resistance by ameliorating the homocysteine and lipid profile in pcos .

nac has been used effectively as an adjuvant to clomiphene citrate (cc) for ovulation induction in cc-resistant women with pcos . because it is an insulin sensitizer, nac was proposed as an adjuvant to clomiphene citrate for ovulation induction in patients with polycystic ovary syndrome who are resistant to clomiphene citrate. encouraging results in those patients stimulated us to investigate whether adding nac to the standard treatment with cc results in a higher ovulation rate, higher pregnancy rate, and less cc resistance in women with newly diagnosed polycystic ovary syndrome using a randomized, double-blind, controlled study.

Eligibility criteria:
inclusion criteria: * pcos diagnosed by rotterdam's criteria exclusion criteria: * previous induction of ovulation male factoe infertility tubal factor infertility uterine factor infertility

Keywords: pcos, nac, ovulation induction, clomophen citrate
transplantation of bone marrow mesenchymal stromal cells for periodontal regeneration

Conditions: Chronic Periodontal Disease; Aggressive Periodontitis

Summary: the goal of this study is to evaluate the capacity of allogeneic bone marrow mesenchymal stromal cells (msc) to induce bone regeneration in patients with periodontal disease. msc cultured are loaded on a collagen scaffold, included into autologous platelet rich plasma clot and implanted in the bone defect.

the clinical protocol is designed to evaluate the bone regeneration capacity of allogeneic mscs for the treatment of patients with chronic or aggressive periodontal disease. patients with either a 2- or 3-wall intrabony defects are included in this study. a bioengineering construct, constituted by allogeneic mscs and a collagen scaffold, is incorporated into platelet rich plasma (prp) clot, which is implanted at the bone defect site. follow up of treated tooth are assessed by clinical evaluation, intraoral radiography and cone-beam ct.

Eligibility criteria:
inclusion criteria: * medical healthy * minimum age of 18 years old * diagnosis of chronic or aggressive periodontitis * vertical intrabony defects of three or two walls * ppd \>= 5 mm * radiographic evidence of alveolar bone loss of at least 3 mm * minimim 20 teeth presents in mouth. * informed consent of the patient exclusion criteria: * smoking * pregnancy or lactating * receiving immunosuppressive drugs, anticoagulants, antibiotics or analgesic drugs * diabetics

Keywords: mesenchymal stromal cells periodontal regeneration bone regeneration periodontitis