Kornimate/medical-research-clean huggingface dataset:
effectiveness of manual lymphatic drainage in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: manual lymphatic drainage is a widely used technique for lymphedema. however, the analgesic effects of this technique could be potentially useful for managing pain in patients with generalized widespread chronic pain, including patients with fibromyalgia.


Eligibility criteria:
inclusion criteria: * women with diagnosis of fibromyalgia. exclusion criteria: * women with heart failure.

Keywords: manual lymphatic drainage randomized clinical trial pain
measuring lung mechanics in patients with copd using the reom handheld portable device

Conditions: Copd

Summary: the purpose the study is to determine the agreement between the information obtained about lung mechanics (lung function) from the rapid expiratory occlusion monitor (reom) handheld portable device with that obtained by conventional oscillometry as well as by pulmonary function testing (pft), in patients with both 'mild' as well as 'very severe' forms of chronic obstructive pulmonary disease (copd). this study also intends to study the user experience with this handheld portable device.

the primary objective of this cross-sectional study is to determine the concordance and agreement between the parameters obtained from the reom, reo1 and reo2, and the conventional resistance parameters obtained by the tremoflo oscillometer device (r19 and r5, respectively) in adults with copd confirmed by diagnostic pulmonary function testing (pft). the secondary objectives are: 1. to investigate the discriminative capacity of the parameters obtained from the reom to distinguish between 'mild' and 'very severe' copd. 2. to collect descriptive information on the participant user experience with the reom. 3. to determine concordance between the parameters obtained from the reom and those obtained from the tremoflo oscillometry device with the 'standard' parameters obtained from each participant's standard pulmonary function tests (pft). hypothesis: we hypothesize in the adult copd patient population that the reom parameter reo1 and tremoflo device parameter r19 will correlate closely, and that the reom parameter reo2 and tremoflo device parameter r5 will correlate closely. we also hypothesize that the reom, in particular, reo2, will be able to distinguish between 'mild' and 'very severe' copd, and that participants will report a positive user experience with the reom.

Eligibility criteria:
inclusion criteria: * males and females aged ≥40 with copd, former/current smokers with a ≥10 pack-year smoking history. * diagnosed with copd by fev1/fvc \< 0.7 using standard pft post-bronchodilator testing, with either 'mild' ('gold 1': fev1 ≥ 80% of predicted value) copd or 'very severe' ('gold 4': fev1 \< 30% of predicted value) copd. * ability to provide informed consent. exclusion criteria: * no existing copd diagnosis * history of co-morbid asthma * current use of home oxygen * any acute exacerbation of copd (aecopd) experienced within 4 weeks of participation in the study * chronic respiratory infection * any contraindication to respiratory testing * inability to participate in reproducible measurements due to physical or cognitive barrier
the effect of dietary fat content on the recurrence of pancreatitis

Conditions: Acute Pancreatitis

Summary: this trial aims to test the effects of two different diets on the recurrence of acute pancreatitis, and acute pancreatitis associated mortality.

around 20% of patients with acute pancreatitis (ap) will go on to have acute recurrent pancreatitis (arp) and 10% progress to chronic pancreatitis (cp). while interventions to avoid recurrences exist for the two most common causes - removal of the cholecyst in the case of biliary, and alcohol seccation in the case of alcoholic - a method to prevent idiopathic pancreatitis is not yet known. although none of the guidelines suggest the administration of low fat diet, it is recommended by physicians to all pancreatitis patients are. our aim is to conduct a randomized controlled trial, to assess the problem of dietary fat reduction on the recurrence of acute pancreatitis patients, who had at least two acute pancreatitis episodes in the preceding 2 year will be approached to participate in the study and to either to be randomized to the 'reduced fat diet' (15% fat, 65% carbohydrate, 20% protein) or to the 'standard healthy diet' (30% fat, 50% carbohydrate, 20% protein; based on who recommendations) group. during the 2 year long followup, participants will receive repeated dietary intervention at 3, 6, 12, 18, 24 months, they will completer food frequency questionnaires and their data regarding mortality, bmi, cardiovascular parameters and serum lipid values will be recorded the effort trial will determine the effect of modified dietary fat content on the recurrence of ap, mortality, serum lipids and weight loss in idiopathic cases.

Eligibility criteria:
inclusion criteria: * individuals with at least two episodes of acute pancreatitis in the 2 years preceding the inclusion with * the last episode being idiopathic, who are * older than 14 years. exclusion criteria: * individuals already receiving regular nutritional guidance (with medical indication), * individuals in critical condition or in terminal stage of cancer (with an expected survival \<2 years) , * individuals undergoing treatment for active malignancy, * individuals with uncontrolled diabetes mellitus (admitted lack of compliance with antidiabetic therapy / hba1c \>6.5% / indication of uncontrolled diabetes mellitus in last 24 months' anamnesis / newly discovered diabetes mellitus) * individuals with known cholecystolithiasis * individuals who are pregnant or nursing * individuals with a bmi \< 18.5 * individuals who are regularly receiving systemic corticosteroids * individuals consuming more alcohol than: 5 units per day or 15 units per week for men; 4 units per day or 8 units per week for women.

Keywords: acute pancreatitis dietary fat low-fat diet pancreatitis recurrence
oligodendrocyte progenitor cell culture from human brain

Conditions: Demyelinating Diseases

Summary: recent developments in the understanding of stem- and progenitor cell differentiation raises hopes that brain damage in chronic neurological diseases may become repaired by systemic or focal transplantation of such cells. clinical trials of stem- or progenitor cell transplantation in multiple sclerosis are currently premature. the researchers developed a protocol for human oligodendrocyte progenitor cell culture from human brain for the treatment of demyelinating disease.

oligodendrocyte progenitor cell line were cultures and will be transplanted into the patient with multiple sclerosis.

Eligibility criteria:
inclusion criteria: * male or female 20-65 years of age * informed consent * has elective craniotomy surgery exclusion criteria: * hiv, hepatitis, and other central nervous system (cns) infections * dementia, alzheimer disease, and neurodegenerative disease

Keywords: all selective craniotomy
the effect of estrogen and progesterone levels on knee and ankle joint laxity

Conditions: Healthy

Summary: the proposed research is an observational study designed to compare estrogen and progesterone serum levels with knee and ankle joint laxity, and muscle reaction time as a measure of neuromuscular function. three groups of women athletes with differing estrogen and progesterone profiles (normal menstrual cycles, amenorrheic, and exogenous estrogen supplementation) and one control group (male collegiate athletes) will be used to compare differences in joint laxity and neuromuscular function. blood levels of estrogen and progesterone will be measured at four time points across the menstrual cycle. joint laxity and muscle reaction time will also be measured at each of these points. the investigator hypothesizes that knee and ankle joint laxity and muscle reaction time will significantly increase with increasing estrogen and progesterone levels.


Eligibility criteria:
inclusion criteria: * pre-collegiate or collegiate athletes

Keywords: joint instability
safety and efficacy of topical cream for post-inflammatory hyperpigmentation skin among malaysians

Conditions: Healthy

Summary: this study was conducted to determine safety and efficacy of topically applied cream containing combination of niacinamide, arbutin, scutellaria baicalensis root extract, centella asiatica extract and camellia sinensis leaf extract for its skin brightening effect on post-inflammatory hyperpigmentation among the malaysian population. the study duration is 20 weeks and the skin assessment will be carried out at baseline, week 4, week 8, week 12, week 16 and week 20.the main questions this study aims to answer are: 1. to determine the efficacy of topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among malaysians. 2. to investigate the safety of topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among malaysians. 3. to assess the participants satisfaction of using topical cream containing natural plant extracts, niacinamide, and arbutin for post-inflammatory hyperpigmentation among malaysians.


Eligibility criteria:
inclusion criteria: * malaysia citizen * healthy adult, aged between 18 to 40 years old. * participants who have post-inflammatory hyperpigmentation on skin exclusion criteria: * participants with skin disorders such as skin infection or skin inflammation. * participants who have undergone any skin and cosmetic treatments such as dermal fillers, botox, laser, chemical peels within the last 3 months. * participant who is taking isotretinoin for the past 6 or 12 months and immunocompromised patients. * pregnant, breastfeeding women or planned for pregnancy during the study period.

Keywords: aesthetic cosmetic post-inflammatory hyperpigmentation (pih)
allogeneic transplantation for patients with acute leukemia or chronic myelogenous leukemia (cml)

Conditions: Leukemia, Lymphocytic, Acute; Leukemia; Leukemia Acute Promyelocytic Leukemia (APL); Leukemia Acute Lymphoid Leukemia (ALL); Leukemia Chronic Myelogenous Leukemia (CML); Leukemia Acute Myeloid Leukemia (AML); Leukemia Chronic Lymphocytic Leukemia (CLL)

Summary: the purpose of the study is to evaluate the overall and disease free survival of recipients who have received g-csf mobilized stem cells from hla matched sibling donors.

allogeneic peripheral blood stem cell transplantation for patients with acute myelogenous leukemia and acute lymphoblastic leukemia in first remission or chronic myelogenous leukemia in first chronic phase

Eligibility criteria:
inclusion criteria:1. any patient with one of the following hematologic malignancies in whom an allogeneic stem cell transplant is warranted: specific disease categories include: 1. acute myelogenous leukemia, 1st or 2nd remission 2. acute lymphoblastic leukemia, 1st or 2nd remission 3. chronic myelogenous leukemia, 1st or 2nd cp, accelerated phase 2. patient age \> 1 month and \< 55 yo 3. patients must have a genotypically hla identical sibling 4. patient must have adequate function as follows: a. total bilirubin \ 50 cc/min as determined by the cockroft-gault formula (to be done if serum creatinine \> 1.5) c. dlco \> 60% predicted d. radionuclide cardiac scan with ejection fraction \>45% 5. patient must be competent to give consent. inclusion criteria (donor): 1. hla identical family member 2. donor or guardian must be competent to give consent 3. donor must have adequate veins for leukapheresis or agree to placement of central venous catheter exclusion criteria:3.2 exclusion criteria (patient): 1. evidence of active infection or active hepatitis 2. positive serologies for hiv-1,hiv-2 or hepatitis b surface ag+ 3. previous allogeneic stem cell/bone marrow transplant 4. pregnant or lactating patients 4 exclusion criteria (donor): 1. donors who for psychologic, physiologic or medical reasons are unable to tolerate pbsc harvest 2. donors who are hiv+ or hepatitis b antigen + 3. history of allergic reaction to g-csf 4. female donors must be post-menopausal or have a negative pregnancy test
mode of action of butyrate in the human colon

Conditions: Irritable Bowel Syndrome (IBS); Healthy

Summary: butyrate has recently gained attention as an important microbial compound in human colon health. several diseases, including irritable bowel syndrome (ibs), have been linked with a loss of butyrate in the colon resulting in the hypothesis that butyrate is important for disease resistance. however, despite a plethora of preclinical evidence about butyrate's role in colon health, data from human studies are insufficient, largely due to the lack of available tools for colon-specific butyrate delivery and sampling. this project will elucidate butyrate's mode of action in the human colon and its implications for gut functioning in ibs and healthy participants by employing a unique in vivo human setting. specifically, the regulatory capacity of butyrate on intestinal barrier function and the transcriptional host responses that are associated with an increase of butyrate in the colon will be determined. moreover, butyrate's role as a signalling molecule for gut hormones and serotonin release will be studied.


Eligibility criteria:
inclusion criteria: * signed informed consent * fulfilled rome iv diagnostic criteria for ibs (for ibs participants) exclusion criteria: * known gastrointestinal diseases * previous complicated gastrointestinal surgery (including e.g. appendectomy or cholecystectomy) * pregnancy or breast-feeding * use of antibiotics within the last 12 weeks before the colonoscopy procedure * regular consumption of probiotics within the last 4 weeks before the colonoscopy procedure * use of laxatives or anti-diarrhoeals within the last 4 weeks before the colonoscopy procedure * use of serotonin selective re-uptake inhibitors (ssri) or serotonin nor-epinephrine re-uptake inhibitors (snri) with the last 12 weeks before the colonoscopy procedure * alcohol or drug abuse * latex allergy * any other clinically significant disease/condition which in the investigator's opinion could interfere with the results of the study.
comparison of secukinumab versus guselkumab in clearing psoriatic plaques refractory to ustekinumab

Conditions: Chronic Plaque-type Psoriasis

Summary: the aim of this study was to describe the effect of direct il-17a inhibition with secukinumab as compared with the selective inhibition of il-23 with guselkumab (p19 subunit blocker) in controlling inflammation in psoriatic plaques that remain active despite treatment with the non-selective il-23 inhibitor ustekinumab (blocker of p40 subunit, shared by il-12 and il 23).

this was a 16-week, randomized, open-label, parallel-group, active-control, phase 2a study comparing secukinumab 300 mg s.c. versus guselkumab 100 mg s.c. in subjects with plaque psoriasis who had an inadequate response to ustekinumab. forty subjects will be randomized 1:1 and treated for 16 weeks. in each patient, a target active refractory skin plaque (tcs ≥6) is described and biopsied at baseline and at study end. the objective of the study was to assess the superiority of secukinumab over guselkumab in achieving clear/almost clear status (tcs 0-2) of the target plaques; and to describe the molecular mechanisms behind this difference

Eligibility criteria:
inclusion criteria: chronic plaque-type psoriasis considered inadequately controlled after treatment with ustekinumab according to the following criteria-: * ustekinumab administered at a dose equal or higher than that on the label for at least 24 weeks. the last administration must be at least 12 weeks before randomization * absolute pasi score of 1-10 at screening * presence of at least 1 refractory skin plaque, defined by a tcs of at least 6 and severity score of at least 2 or 3 (moderate) for each individual item, with an area ≥ 10 cm2 at screening. exclusion criteria: * forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or baseline * drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at baseline * previous treatment with more than one tnfα inhibitor or with il-17a (including secukinumab), il-17r or il-23 (including guselkumab) inhibitors * use of other investigational drugs within 4 weeks before enrolment, or within a period of 5 half lives of enrollment/initiation of the study treatment, whichever is longer * ongoing use of prohibited treatments (see section 6.2.2) * known immunosuppression (e.g., aids) at screening

Keywords: psoriasis plaque psoriasis secukinumab skin condition skin disease itching psoriasis vulgaris immune-mediated systemic disease skin lesions scaly patches papules
a companion study for patients enrolled in prior/parent ipilimumab studies

Conditions: Melanoma

Summary: the purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. in addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com key inclusion criteria * diagnosis of advanced melanoma * prior treatment in a prespecified prior/parent ipilimumab study * men and women 18 years of age and older first reinduction: * no unacceptable toxicity (except select reversible immune-related adverse events) requiring ipilimumab discontinuation * had experienced documented progressive disease after expanded clinical benefit extended maintenance * received ipilimumab at any dose in a parent study * achieved expanded clinical benefit at the time of entry to current study follow-up: * received ipilimumab at any dose in a closing parent study * deemed ineligible for reinduction or extended maintenance treatment or refused treatment as reinduction or extended maintenance at the time of screening in the current study, but consented to follow-up key exclusion criteria * prior treatment with a cd137 agonist or a cytotoxic t-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab * primary ocular or mucosal melanoma

Keywords: ipilimumab previously treated
a prospective, phase ii trial using ctdna to initiate post-operation boost therapy after nac in tnbc

Conditions: Triple-negative Breast Cancer

Summary: positive circulating tumor dna(ctdna) status is associated with worse prognosis in breast cancer, especially triple-negative breast cancer(tnbc). our trial aims to improve the outcome of tnbc patients by using ctdna to identify patients with high relapse risk. ctdna positive patients will be randomized to receive boost therapy or standard therapy indicated in nccn guidelines after nac.


Eligibility criteria:
inclusion criteria: * must have histologically or cytologically confirmed triple negative (er-/pr-/her2-) invasive breast cancer, clinical stage ii-iii at diagnosis (ajcc 6th edition) based on initial evaluation by physical examination and/or breast imaging prior to study registration.er and pr will be considered negative if ≤ 1% of cells stain weakly positive. her2 will be considered negative if scored 0 or 1+ by immunohistochemistry (ihc) or 2+ by ihc associated with a fluorescence in situ hybridization (fish) ratio of \< 2.0 or \< 6 copies per cell. * must receive preoperative (neoadjuvant) chemotherapy. note: acceptable preoperative regimens include those recommended by nccn guidelines. participants who received preoperative therapy as part of a clinical trial may enroll. * ctdna positive at baseline, after nac or after surgery * eastern cooperative oncology group (ecog) performance status 0, 1 or 2 * written informed consent to provide research blood samples and tumor samples * patients must be willing to have frequent blood tests (every 3 months ) and receive a 12 month course of tislelizumab if randomised to tislelizumab treatment on ctdna detection * no evidence of distant metastatic disease on staging scans conducted at the time of diagnosis exclusion criteria: * previously participated in other interventional trials * previous malignancy within 3 years of breast cancer diagnosis * pregnancy or breastfeeding * no written consent * unable to receive standard nac and subsequent radiotherapy(if needed) * active autoimmune disease
low dose atazanavir/r versus standard dose atazanavir/r (lasa)

Conditions: HIV Infections

Summary: this study will compare the efficacy and safety of atv/r at either 200/100 mg or 300/100mg given daily in thai patients in combination with 2nrtis.

to demonstrate non-inferiority of treatment with atazanavir/ritonavir (atv/r) 200/100 mg once daily (od) compared to the control group (atv/r 300/100 mg od) in regards to the proportion of virologic responders (plasma hiv rna \< 200 copies/ml) at 48 weeks in arv-experienced hiv-1 infected subjects.

Eligibility criteria:
inclusion criteria: 1. hiv infected adults aged more than or equal to 18 years 2. received ritonavir boosted pi-based haart for \>3 months prior screening visit 3. history of hiv rna \< 50 copies/ml within 12 months prior to screening visit 4. hiv-rna \< 50 copies/ml at screening visit 5. signed written informed consent exclusion criteria: 1. active aids-defining disease or active opportunistic infection 2. history of virological failure (plasma hiv-rna ≥1,000 copies/ml) while using any ritonavir boosted pi-based haart 3. pregnancy or lactation at screening visit 4. relevant history or current conditions or illnesses that might interfere with drug absorption, distribution, metabolism or excretion e.g. chronic diarrhea, malabsorption 5. use of concomitant medication that may interfere with the pharmacokinetics of the study drugs e.g. rifampicin, proton pump inhibitor 6. history of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study 7. alt ≥200 iu/l at screening visit 8. creatinine clearance \< 60 c.c. per min by cockroft-gault formula at screening visit

Keywords: atazanavir / ritonavir low dose noninferiority safety and efficacy efficacy and safety of lower dose atazanavir/ritonavir in suppressed hiv-infected adults
abbreviated mri for hcc surveillance

Conditions: Hepatocellular Carcinoma; Liver Cirrhosis; Chronic Hepatitis

Summary: this study aims to investigate the clinical feasibility of abbreviated liver mri for hcc surveillance in a high-risk group.


Eligibility criteria:
inclusion criteria: * high risk of hcc development (chronic hepatitis b, chronic hepatitis c, liver cirrhosis) * no history of hcc * on surveillance of hcc using ultrasonography * sign informed consent exclusion criteria: * history of hcc * congestive hepatopathy * iron deposition * any absolute or relative contra-indication of contrast-enhanced mri

Keywords: mri ultrasonography