Kornimate/medical-research-clean huggingface dataset:
effectiveness of aquatic exercises for improving mental and physical health in adults.

Conditions: Depression; Depressive Symptoms; Anxiety

Summary: objective: to compare the effectiveness between aquatic exercises (water aerobics versus watsu) versus control groups, for improving the outcomes of depression, anxiety, stress, sleep quality, functionality, cognition and quality of life in patients with depression.

introduction: considered as the "21st century disease", depression is a silent disease that stands out for its high prevalence and high morbidity, leading to serious consequences. with treatments made in aquatic environment, among them the water aerobics and watsu. objective: to compare the effectiveness between aquatic exercises versus watsu and versus control group, for improving the outcomes of depression, anxiety, stress, sleep quality, functionality, cognition and quality of life in patients with depression. methods: this study will be a randomized clinical trial, which will last for two months with a follow-up of one month. all participants will be assessed using specific questionnaires for each outcome and an improvement perception scale (ms). seventy eight (78) patients with a medical diagnosis of depression, aged 18 to 60 years, who will be allocated to three groups (26 patients for each group) will be treated. group 1: aquatic exercises (aerobic and resistance), collective session, twice a week lasting 50 min; group 2: watsu (water shiatsu), individual session, twice a week lasting 50 min; group 3: control, people with depression. statistical analysis: normality distribution will be by shapiro-wilk test. for comparisons of the means between and within the outcome groups will be used through generalized estimation equations, with its own syntax, linear distribution and, when necessary, multiple comparisons will be performed using the bonferroni test to identify differences. will be calculated for comparisons between the final and initial moments and initial follow-up in each group, statistics such as: mean difference (95% ci), standard deviation of the difference, effect size (cohen's d). the statistical significance adopted was 5% and the analyzes were performed using the statistical programs spss 22.0 and r 3.2.4. the intention-to-treat analysis will be performed.

Eligibility criteria:
inclusion criteria: * age between 18 and 60 years old; * sedentary and who have not had physical therapy and physical activity in the last three months; * clinical and cognitive conditions for performing pool activities and moderate aerobic exercise; * who have not undergone high complexity surgical procedures in the last six months; no neuro-musculosqueletal diseases; * no contraindications to exercise; such as: urinary and / or fecal incontinence and dermatological diseases; * individuals with a medical diagnosis of depression. exclusion criteria: * if they have up to three absences during the intervention period; * if they have any adverse effects, such as: allergy or dermatitis; * unable to continue study due to change of address or hospitalization.

Keywords: hydrotherapy depression anxiety
a clinical study of sotatercept (mk-7962) in people with pulmonary arterial hypertension (mk-7962-031/lightray extension)

Conditions: Pulmonary Arterial Hypertension

Summary: researchers are looking for other ways to treat pulmonary arterial hypertension (pah). sotatercept is a study medicine that is designed to treat pah. a past study, mk-7962-024 (lightray) (nct06664801), learned about the safety and effects of sotatercept in people with pah. one of the goals of that study was to learn about sotatercept when given at a dose (amount) based on the weight range a person is in (weight-banded doses) compared to when given based on a person's exact weight. this is an extension study, which means people who took part in mk-7962-024 (lightray) may be able to join this study. in this extension study, people will get weight-banded doses of sotatercept. the main goal of this study is to learn about the safety of weight-banded doses of sotatercept and if people tolerate it over a longer period of time.


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: * has completed the treatment period of study mk-7962-024 (lightray) (including visit 11) on study intervention, did not discontinue study intervention, and is able to safely enroll into mk-7962-031 (lightray extension) * has not started treatment with commercially available sotatercept exclusion criteria: the main exclusion criteria include but are not limited to the following: - has current exposure or is planning to begin treatment with an activin signaling inhibitor (other than sotatercept)
a study of barzolvolimab in patients with prurigo nodularis

Conditions: Prurigo Nodularis

Summary: the purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.

the purpose of this study is to assess the efficacy and safety of barzolvolimab (cdx-0159) in adults with prurigo nodularis. there is a screening period of approximately 28 days, a 24-week double-blind treatment period and a 16-week follow-up period after treatment. participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (cdx-0159) by subcutaneous injections of 150 mg every 4 weeks (q4w) after an initial loading dose of 450 mg, 300 mg q4w after an initial loading dose of 450 mg, or placebo q4w.

Eligibility criteria:
key inclusion criteria: 1. males and females, ≥18 years of age. 2. diagnosis of prurigo nodularis by a dermatologist at least 3 months prior to screening with: 1. at least 20 pn nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening. 2. an investigators global assessment for stage of chronic nodular prurigo (iga-cnpg-s) score for pn ≥ 3 at screening and baseline (day 1). 3. severe itch, defined as the mean of the daily worst itch nrs (wi-nrs) score of ≥ 7 during the 7-day period immediately prior to initiation of study treatment. 4. documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable. 5. willing to apply a topical moisturizer (emollient) once or twice a day throughout the study. 6. both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment. 7. willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule. key exclusion criteria 1. pn due to neuropathy, psychiatric disorders or medications. 2. unilateral pn lesions limited to small area on one side of the body (e.g., only one arm affected). 3. active unstable pruritic skin conditions in addition to pn. 4. documented atopic dermatitis (moderate to severe) within 6 months before the start of screening. 5. females who are pregnant or nursing. 6. known hepatitis b or hepatitis c infection or active covid-19 infection. 7. vaccination with a live vaccine within 2 months prior to study drug administration (subjects must agree to avoid vaccination during the study and for four months thereafter). note: inactivated vaccines are allowed such as seasonal influenza for injection. covid-19 vaccination is allowed. 8. history of anaphylaxis. 9. prior receipt of barzolvolimab there are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Keywords: barzolvolimab pn cdx-0159
prophylactic antibiotics for manual removal of retained placenta in vaginal birth: a randomized controlled trial

Conditions: Endometritis

Summary: background: there is scarce evidence regarding the necessity of antibiotic prophylaxis in manual revision of the uterus after labor in cases of residual placenta. methods: a randomized control trial in which parturients for which the placenta was not separated or there is a suspected residual placenta will be divided randomly to two groups: (1) revision of uterus or manual lysis without antibiotic prophylaxis; (2) revision of uterus or manual lysis with antibiotic prophylaxis as following: 24 hours coverage with ampicillin 2 grams\*4, gentamycin 240 mg\*1, clindamycin 600 mg\*3. in cases of allergy to penicillin the antibiotic regimen will be: gentamycin 240 mg\*1, clindamycin 600 mg\*3. outcomes: puerperal fever, endometritis, length of hospitalization after labor, recurrent hospitalization in the first 2 weeks after discharge.


Eligibility criteria:
inclusion criteria: * suspected retained placenta exclusion criteria: * intrapartum fever
a long-term follow-up study to evaluate the safety and efficacy of rgx-501

Conditions: Homozygous Familial Hypercholesterolemia (HoFH)

Summary: this long-term observational study is designed to follow subjects who, during another clinical study, received gene therapy treatment used to treat their homozygous familial hypercholesterolemia (hofh) disease. this study is intended to follow those subjects for up to 5 years since they received treatment to look for any long-term safety concerns. there is no investigational drug or therapy provided as part of this study.

homozygous familial hypercholesterolemia (hofh) is a rare genetic metabolic disorder characterized by absent or severely reduced capacity to catabolize circulating ldl particles by the hepatic ldl receptor. as a consequence, hofh subjects present abnormal total plasma cholesterol (ldl-c) levels, resulting in severe atherosclerosis often leading to early onset of cardiovascular disease. early initiation of aggressive treatment for these patients is therefore essential. unfortunately, despite existing therapies, treated ldl-c levels could remain well above acceptable levels. thus, the functional replacement of the defective ldlr via aav-based liver-directed gene therapy, rgx-501, may be a viable approach to treat this disease and improve response to current lipid-lowering treatments. this is a prospective, observational study to evaluate the long-term safety and efficacy after a single administration of rgx-501. eligible participants are those who previously have enrolled in a clinical study and received a single intravenous infusion of rgx-501.

Eligibility criteria:
inclusion criteria: * to be eligible to participate in this study, a participant must have previously received rgx-501 in a separate parent trial, and the participant or participant's legal guardian(s) is/(are) willing and able to provide written, signed informed consent after the nature of the study has been explained, prior to any research-related procedures. exclusion criteria: * none

Keywords: ldl receptors gene therapy metabolic diseases rare diseases genetic diseases atherosclerosis cardiovascular disease
a study to evaluate safety and efficacy of phx1149t in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this study is to test the efficacy and safety of phx1149t in combination with metformin, a glitazone, or metformin and a glitazone in subjects with type 2 diabetes for 12 weeks. after completing the 12 week double blind part of the study, subjects can enter an open label extension study


Eligibility criteria:
key entry criteria: * type 2 diabetes mellitus, diagnosed at least 4 months but not more than 12 years prior to screening. * male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a bmi of 25 to 48 kg/m2, inclusive. for india the bmi is 23 to 48 kg/m2, inclusive. * current treatment of type 2 diabetes mellitus with a stable dose of metformin of 1500 mg or more (or the highest tolerated dose), or tzd (any labeled dose), or metformin + tzd at doses used in accordance with product labeling for at least 4 weeks (metformin) or 10 weeks (tzd) prior to screening (visit 1). * fasting plasma glucose of 118 - 220 mg/dl (6.6 - 12.2 mmol/l), inclusive; hba1c 7.3% - 11.0%, inclusive; and a fasting plasma c peptide greater than 0.26 nmol/l at screening. for argentina the allowed upper limit of hba1c is ≤ 10.5%. for canada the upper limit will be 10.0% * no type 1 diabetes mellitus or marked diabetic long-term complications.
a double-blinded,double-dummy clinical trial of chinese herbal medicine (mazirenwan) for functional constipation

Conditions: Functional Constipation; Gastrointestinal Disorders

Summary: the objective of this study is to evaluate the efficacy and safety of a chinese herbal proprietary medicine, mazirenwan (mzrw), by comparing with stimulant laxative western medicine (wm), senna, and placebo for patients with functional constipation (fc) in excessive tcm syndrome.

functional constipation (fc) is a common clinical complaint. despite the effectiveness of mazirenwan (mzrw) for alleviating fc symptoms has been proofed in the previous study.given the results of the dose determination study and placebo-controlled study of mzrw, we hypothesize that mzrw is more useful than senna (senokot), a commonly used wm drug for constipation, for fc patients in excessive tcm syndrome.this is a prospective, double-blind, double dummy, randomized, controlled trial. after a 2-week run-in, eligible fc patients (rome iii) in excessive tcm syndrome will randomly be assigned to chm arm (mzrw and wm placebo), wm arm (senna and chm placebo) or placebo arm (chm placebo and wm placebo). patients will undergo an 8-week treatment and an 8-week follow-up.

Eligibility criteria:
inclusion criteria: * either gender aged 18 to 65 years * have fc diagnosed as rome iii criterial * have diagnosis of excessive constipation according to the tcm theory * complete spontaneous bowel movement (csbm) ≦2times/w * severity of constipation≧3pts (7 pts scale from 0 to 6pts) and the overall scoring of constipation-related symptoms≧6pts (6items in 7pts scale) for self symptom assessment in the run-in period * normal colonic evaluation (colonoscopy or barium enema) within 12 months * normal liver and renal function in blood test within 3 months exclusion criteria: * drug-induced constipation * secondary causes of constipation (i.e. medical history of diabetes mellitus and thyroid disease) * abdominal surgery (i.e. caesarean operation) * severe diseases (i.e. cancer and acute present asthma) * allergy to chm (i.e. g6pd deficiency), senna and tartrazine * pregnancy or breast-feeding * psychiatric or addictive disorders

Keywords: randomized controlled trial drugs,chinese herbal constipation/drug therapy
examine the effects of maintaining body core temperature during cabgs

Conditions: Anesthesia; Hypothermia; Coronary Artery Bypass Grafting

Summary: although data on cardioprotective effects (as profile of troponin i)of perioperative maintenance of normothermia during cabgs are already known, little is known about the effects of maintaining normothermia on clinical outcomes of patients submitted to coronary surgery. being acute renal failure (arf) and atrial fibrillation (af) the two most frequent complications of this surgery, this study compare as primary end point the rate of postoperative arf and af in two group of patients, one actively warmed with thermowrap and the control group receiving standard institutional care.


Eligibility criteria:
inclusion criteria: * isolated on pump cabgs * age 18 - 85 * preoperative core temperature 36- 37.5 °c exclusion criteria: * history of fever in the last week * severe renal, hepatic,hematologic or pulmonary disease * chronic atrial fibrillation * history of acute mi in the last week * previous neurologic abnormalities

Keywords: hypothermia/complications/etiology coronary artery bypass/adverse effects
dynamic change of doppler-based renal resistive index in predicting renal recovery

Conditions: Acute Kidney Injury

Summary: the goal of this observational study is to observe the correlation between dynamic changes in the doppler-based renal resistive index (ri) and the occurrence of persistent acute kidney injury (aki) in critically ill patients. the main questions it aims to answer are: * are dynamic changes of ri within 24 or 48 hours associated with the prognosis of aki (no aki, transient aki, persistent aki)? * what are the influencing factors of changes in ri? participants will measure values of ri in patients at admission (0 hour), after 24 hours and after 48 hours, respectively, and collect characters such as age, sex, vital signs, apache ii, diagnosis, renal function, applied drugs, fluid, 72-hour renal function and renal replacement, followed renal replacement and the mortality rate at 28 days.

no aki is defined as no aki occurred within 72 hour after icu admission; transient aki is defined as aki with recovery, which refers to the reduction in aki stage ( (i.e., a decrease of serum creatinine, reversal of oliguria without diuretic therapy, and without need for renal replacement therapy) occurring with 72 hour after icu admission; persistent aki is defined as aki without recovery occurring with 72 hour after icu admission.

Eligibility criteria:
inclusion criteria: • patients admitted to the icu within 24 h of admission. exclusion criteria: * chronic kidney disease stage iii-v; * history of kidney transplantation; * previously known renal artery stenosis or renal vein thrombosis； * cardiac arrhythmia precluding renal doppler measurement; * expected hospital stay \< 72 h； * pregnant patients * last, patients with hospital stays \< 72 h, since they could not be classified as having transient or persistent aki according to our definitions, were secondarily excluded.

Keywords: acute kidney injury renal resistive index prognosis critically ill patients
muscle ultrasound for sarcopenia leading to early detection

Conditions: Sarcopenia

Summary: sarcopenia is an age-related loss of muscle mass that may affect over 25% of individuals over the age of 60 and results in a 3 to 4 times increased likelihood of developing a disability. despite these observations, sarcopenia is rarely subject to a systematic screening process as a part of customary geriatric care. furthermore, when lean body mass (lbm) is measured via dual energy x-ray absorptiometry (dxa) in older adults, it is typically within a reactive, hospital-based, model of healthcare where muscle wasting is only assessed after a loss of functional independence. the investigators propose an affordable, portable screening method with ultrasound imaging to be performed in primary care settings. the investigators long term goal is to identify individuals at risk, and intervene with treatments that may prevent the onset of debilitating loss of muscle function in the elderly.

purpose: the overall goal of this pilot project is to validate a rapid, portable, cost-effective, sarcopenia identification method using diagnostic sonography. this method would be used for screening to aid early detection, diagnosis in clinical settings, and monitoring the effects of formal intervention. the investigators central hypothesis is that the sonographic muscle characteristics will be significantly associated with estimates of lean body mass (lbm) and functional status. research setting: george washington university, exercise science laboratory. participants: subjects will include a healthy young reference group (18 - 29 years of age) and an older comparison group (55 - 75 years of age; n = 15 per group; approximately 50% female), consecutively recruited from george washington university and the surrounding community. implications/significance: diagnostic musculoskeletal ultrasound is a portable, inexpensive modality suitable for bedside use or community health initiatives, and features no exposure to low-dose radiation. it is important to note that dxa is considered a relatively low cost procedure, and dxa-based measures may continue to be used as the standard for the sarcopenia syndrome lbm criterion. consequently, this study will examine if lbm values obtained with ultrasound may serve as a viable proxy of lbm measures obtained with dxa. the innovation in the investigators study is reflected by a proactive approach to sarcopenia screening that is responsive to the growing shift of healthcare from hospitals to alternative, community-based settings.

Eligibility criteria:
inclusion criteria: you are eligible to participate if: 1. you are between the ages of 18 - 29 years, or 55 - 75 years. 2. you must be able to stand comfortably for 10 minutes and walk a short distance (use of assistive devices are acceptable). exclusion criteria: you are not eligible to participate if: 1. you have a medical condition that results in edema. 2. you have had an upper or a lower extremity amputation. 3. you are, or may be, pregnant. 4. you have a body mass index (bmi) \> 30.0.

Keywords: sarcopenia screening geriatrics muscle aging ultrasound
chronic infection with tropheryma whipplei: risk factors related to the host

Conditions: Whipple Infection

Summary: in 2012, a previous work showed that t. whipplei is a common bacterium detected in various situations. a large part of the population is therefore exposed to a t. whipplei but there is that some people probably with immunological and genetic factors predisposing which develop a disease. the association teams with experience in hla-typing will allow us to better identify patients with a risk of chronic complication. the main aim of this study is to evaluate if the hla-drb13 and/or hla-dqb106 typing in patients are risk factors of chronic infection with t. whipplei (defined by classic whipple disease and/ or, endocarditis and/or encephalitis).

since the first isolation of a strain of tropheryma whipplei (t. whipplei) and the development of molecular tools, the natural history of this bacterium continued to clarify. the currently proposed scheme is as follows: after contamination human oral-oral or fecal, patients will develop acute infections such as bacteremia, gastroenteritis and pneumonia. they can then produce specific antibodies. likely depending on the host-related factors, three types of evolution appear to be possible: (i) some patients eliminate the bacteria and develop specific antibodies. (ii) some patients are chronic carriers of the bacterium with a strong immune response. (iii) finally, patients develop subacute or chronic infections, with an insufficient immune response or non-existent answer to t. whipplei. subacute or chronic infections include whipple's disease characterized by histological involvement of the small intestine, as well as localized without digestive impairment, such as endocarditis or encephalitis. despite appropriate antibiotic therapy, patients with whipple's disease will present relapse (30-40% of patients), but also of re-infection with different genotypes of t. whipplei. here the hypothesis is that hla-drb 13 and/or hla-dqb1 06 alleles are associated with the presence of chronic infections with t. whipplei (defined by classic whipple disease and / or endocarditis and/or encephalitis)

Eligibility criteria:
inclusion criteria: * patient with a positive pcr to t. whipplei diagnostics. * patient aged \> or = 18 years old. * patient who does not declined to have his medical records reviewed for research. * patient with health insurance. exclusion criteria: * patient minors (age \<18 years) * pregnant woman, parturient or breastfeeding * adult patient under guardianship . * patient deprived of liberty under court order * patient refusing to sign the informed consent form.