Kornimate/medical-research-clean huggingface dataset:
capsule microbiota transplant therapy for hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: hs is relatively common in the united states with a prevalence of 0.1-1.0%. 1 hs has a dramatic impact on quality of life, significantly more so than other chronic skin diseases, such as psoriasis or atopic dermatitis (ad). hs also has a large economic impact, due to frequent emergency department and inpatient care utilization, and re-hospitalization rates similar to congestive heart failure. unfortunately, few treatment options are effective. there is only one currently fda-approved treatment, adalimumab, but only 40- 60% respond to treatment and over 50% lose response within one year . the overarching goal of this pilot study is to investigate the central hypothesis that oral microbiota transplant therapy(mtt) alters the gut microbiome in patients with hidradenitis suppurativa (hs), influencing cutaneous microbiota via systemically absorbed gut-derived metabolites.


Eligibility criteria:
inclusion criteria: * able and willing to provide informed consent * english speaking * age \>= 18years of age * diagnosis of hidradenitis suppurativa by a dermatologist * women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g. absence of ovaries and/or uterus) must remain abstinent or use a highly effective form of birth control (e.g. oral contraception, transdermal patch, barrier, intrauterine device). periodic abstinence and early withdraw are not acceptable methods * able to comply to study measures in the opinion of the investigator. * stable doses of all medications for 30 days prior to baseline exclusion criteria: * non-english speaking * refusal or inability to provide informed consent * planning on moving within 6 months from start of study * allergy to neomycin or vancomycin * anaphylactic food allergies * pregnancy, breastfeeding or planning pregnancy during study period (negative pregnancy test needed for persons of childbearing potential) * use of any topical or oral antibiotics within 30 days of randomization * use of any oral antibiotics within 90 days of randomization * history of inflammatory bowel disease * extensive bowel resection (e.g., subtotal colectomy, substantial removal of small bowel) * no major bowel surgery within 4 weeks prior to baseline or planned major surgery during the study period * no active skin disease other than hs that could interfere with assessments
a phase 1 study of sp-02l in relapsed or refractory patients with peripheral t-cell lymphoma (ptcl) in korea

Conditions: Peripheral T-cell Lymphoma

Summary: the purpose of this study is to evaluate the safety and tolerability of sp-02l monotherapy in korean patients with relapsed or refractory peripheral t-cell lymphoma (ptcl).


Eligibility criteria:
inclusion criteria: * korean patients aged ≥ 20 years of age at the day of obtaining the informed consent * patients with histologically confirmed diagnosis of the following: * ptcl, not otherwise specified (ptcl-nos) * anaplastic large cell lymphoma (alcl alk-positive/negative) * angioimmunoblastic t-cell lymphoma (aitl) * have relapsed or refractory to at least one prior systemic chemotherapy for the above disease (currently requiring therapy) * have at least 1 evaluable lesion * eastern cooperative oncology group (ecog) performance status of 0 to 2 * life expectancy of at least 3 months
role of topical putrescine (fibrostat) for prevention of hypertrophic scars in mammoplasty patients

Conditions: Hypertrophic Scar

Summary: linked to previous clinical trial e92:069 in which biochemical effect of 1,4 diaminobutane was studied in human scar harvested at revision surgery after a 12 week application. analytical data was collected in this phase of the work completed in 1999. this was then followed by clinical correlation in a scar prevention model with topical application of 1,4 diaminobutane for 12 weeks and measuring duredness , as well photographic and posas score data for quality of scar formation.

in this study, patients were "randomized" into one of 2 study groups described below. they agreed to being treated on the right side or the left with active agent, while the other side was to receive inactive cream. the active molecule is called fibrostat or 1,4 diaminobutane and is a naturally occurring inhibitor of scar formation. the inactive jar contains the vehicle alone without fibrostat. the patients received both cream types to be applied to the appropriate side assigned by the randomization process, one numbered jar each per breast in the order and amount as explained in detail by the patient educator. the cream was applied daily and in the same order, one jar for the right and the other jar for the left consistently. the randomization was performed at the factory with an assigned number recorded on each jar and the jar contents listed and recorded with its assigned number. each jar of active cream is randomly assigned with another jar of inactive cream to form a pair which were both given to the patient. the cream in both jars looks and smells the same. neither the patient nor the study doctor knew which breast as receiving the active agent. in an emergency, this information was to be made available. participation in the study was for 12 weeks. the patients were seen for photos and scar testing using a painless surface testing device called a rex® durometer at 1, 3, 6, and 12 weeks post op. the researcher could decide to take patients off this study if a patient were to develop a rash during the run-in period of 1 week from the cream on either side. the patients could stop participating at any time. however, this was usually accompanied by a valid reason such as lack of transportation to regular follow up appointments. no serious effects were seen and the only patients to stop participation in the study except 1 which was lost to follow-up could be accounted for. the results were revealed to patients at the completion of the 12 week trial.

Eligibility criteria:
inclusion criteria: undergoing breast reduction surgery - exclusion criteria: not pregnant or lactating -

Keywords: prevention of hypertrophic scar
study investigating a delayed-release pancrelipase in patients with pancreatic exocrine insufficiency (pei) due to cystic fibrosis (cf)

Conditions: Cystic Fibrosis; Pancreatic Exocrine Insufficiency

Summary: this study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to cystic fibrosis.


Eligibility criteria:
inclusion criteria: * confirmed cf diagnosis by two positive chloride sweat tests or gene analysis * confirmed pei by historical coefficient of fat absorption \< 70% without supplementation or current or historical fecal elastase \< 50µg/stool (within the last 12 months) * currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months * clinically stable condition without evidence of acute respiratory disease or any other acute condition * stable body weight and agrees to abstain from sexual activity exclusion criteria: * ileus or acute abdomen * history of fibrosing colonopathy, celiac disease, gastrectomy, crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome * history of distal ileal obstruction syndrome within 6 months of enrollment * use of an immunosuppressive drug * any type of malignancy involving the digestive tract in the last 5 years * known infection with hiv

Keywords: cystic fibrosis pancreatic exocrine insufficiency
aspirin improve survival of n2-3 nasopharyngeal carcinoma patients

Conditions: Nasopharyngeal Carcinoma

Summary: nasopharyngeal carcinoma (npc) is one of the most common maligancies of china. in the era of intensity-modulated radiotherapy (imrt), the 5-year overall survival (os) has now reached 85.0% or more. however, even after chemoradiation, the 5-year distant-metastasis rate of patients with n2-3 npc is still 36.7%. aspirin is proven in lab and clinical studies to have the abilities of inhibiting the inflammation which could enhance metastasis of breast and colorectal cancers. and before this study, it was discovered that regular aspirin intake might be associated with distant-metastasis-free survival (mfs) and os independently. so this phase 2 trial was conducted to validate the impact of aspirin on prognosis of n2-3 npc.

nasopharyngeal carcinoma (npc) is one of the most common maligancies of china. in the era of intensity-modulated radiotherapy (imrt), the 5-year overall survival (os) has now reached 85.0% or more. however, the prognosis of the patients with late n (n2-3) diseases remains poor. even after chemoradiation, the 5-year distant-metastasis rate of these patients is nearly 36.7%. additionally, these patients occupies about 30.0% of the whole npc population. to improve the prognosis of the patients with n2-3 npc, there is a need to explore a new, practical and effective method to eliminate the distant metastasis. aspirin is proven in lab and clinical studies to have the abilities of inhibiting the inflammation which could enhance metastasis of many malignant tumors, such as breast and colorectal cancers. and before this study, patients with n2-3 nonmetastatic npc between 2008 and 2011 were retrospectively analyzed, to discovered that regular aspirin intake might be associated with distant-metastasis-free survival (mfs) and os independently. so this phase 2 randomized controlled trial was conducted to validate the impact of aspirin on prognosis of n2-3 npc. this study aim to enroll patients with t1-4n2-3m0 npc. all the patients will be treated with imrt and concurrent chemotherapy of the pf (nedaplatin + 5-flurouracil) regimen. after randomization, patients in the experimental group will also receive daily aspirin of 75mg. the 5-year mfs is the primary endpoint. and the 5-year os and aspirin-related toxicities are the secondary endponits.

Eligibility criteria:
inclusion criteria: * pathologic dianosis of nasopharyngeal carcinoma * stage of t1-4n2-3m0 (uicc/ajcc classification ver. 7) * 18-70 years old * karnofsky performance score \> 70 exclusion criteria: * distant metastasis before or during radiotherapy * severe dysfunctions of liver, kidney, lung, heart of bone marrow which are not fit for radiotherapy * prior malignancies * prior history of radiotherapy, chemotherapy or monoclonal antibody therapy * participation of other drug trials within 3 months * regular use of aspirin before dianosis * contraindication or allergy of aspirin * patients who are considered by the researchers not suitable to participate this trial

Keywords: nasopharyngeal carcinoma n2-3 disease distant metastasis aspirin survival
hlx208 (braf v600e inhibitor) in combination with trametinib in patients with advanced solid tumors

Conditions: Solid Tumor

Summary: a phase i clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of hlx208 (braf v600e inhibitor) in combination with trametinib in patients with advanced solid tumors


Eligibility criteria:
inclusion criteria: * 18y≤age≤75y * good organ function * expected survival time ≥ 3 months * metastatic/recurrent advanced braf+ solid tumors that have been diagnosed histologically and have failed standard treatment * previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage. * ecog score 0-1; * expected survival time of more than 3 months; exclusion criteria: * previous treatment with braf inhibitors or mek inhibitors * symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable). * current or former patients with interstitial lung disease; * active clinical severe infection; * a history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin. * other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
towards recover: outcomes and needs assessment in intensive care unit (icu) survivors of prolonged mechanical ventilation and their caregivers

Conditions: Critically Ill

Summary: advances in critical care medicine have dramatically improved the survival of critically ill patients requiring prolonged mechanical ventilation. however, there are no systematic follow-up, rehabilitation, or psychoeducational interventions for these vulnerable patients or their family caregivers who contribute to survivor recovery and rehabilitation. major barriers to developing these programs for survivors of prolonged mechanical ventilation and their caregivers include the following: 1. there is inadequate information about the determinants of long-term functional outcomes for a diverse group of survivors of prolonged mechanical ventilation. 2. there is inadequate information about the needs of survivors of prolonged mechanical ventilation and their family caregivers across the trajectory of illness (i.e., from the icu to the community). 3. there is a poor understanding of the development of icu-acquired muscle injury. towards recover is the very first study to identify survivors of prolonged mechanical ventilation who are at-risk for poor functional outcomes, to identify elements of the care-giving situation that put caregivers at risk for poor quality of life and mental health, to catalogue the rehabilitative needs of patients and family caregivers across the illness trajectory, and to evaluate the mechanism of critical illness associated muscle injury. the recover program consists of four phases: * phase i: towards recover * phase ii: recover development and pilot testing * phase iii: recover randomized controlled trial * phase iv: long-term implementation of recover


Eligibility criteria:
inclusion criteria: * older than 16 years of age. * mechanically ventilated for a minimum of one week in study icu. exclusion criteria: * catastrophic neurological injury in the opinion of the attending intensivist (ex. grade v sah or massive cva). * pre-existing formal diagnosis of neuromuscular disease. * non-ambulatory prior to hospital or icu admission. * anticipated death or withdrawal of life sustaining treatment within 48 hours. * history of psychiatric illness with documented admission. * patient is not fluent in english. * documented discussion re: imminent withdrawal of life sustaining treatment. * lives greater than 300 km from referral centre. * patient no living at a fixed address. * physician refusal. * patient of sdm (substitute decision maker) refuses consent. * no next of kin of sdm available (if patient unable to provide consent).

Keywords: chronic critical illness mechanical ventilation outcomes weakness quality of life critically ill patients and their family caregiver
multi-center, randomized, double-blind efficacy and safety of cd0271 0.3%/cd1579 2.5 % topical gel in acne vulgaris

Conditions: Acne Vulgaris

Summary: the study hypothesis are based on the assumption that : * cd0271 0.3%/cd1579 2.5% gel provides superior clinical efficacy compared with topical gel vehicle in the overall population and in the subgroup of severe subjects * cd0271 0.3%/cd1579 2.5% gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile


Eligibility criteria:
inclusion criteria: 1. male or female, who is 12 years of age or older at screening visit. 2. clinical diagnosis of acne vulgaris with facial involvement. 3. an iga of moderate (3) or severe (4) at baseline visit. 4. a minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at baseline visit. 5. a minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at baseline visit. exclusion criteria: 1. more than 2 acne nodules on the face at baseline visit. 2. acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment. 3. underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. this includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to investigator's judgment) if he/she participates in the clinical trial. 4. the subject has received, applied or taken some specified treatments within the specified timeframe prior to the baseline visit 5. the subject is unwilling to refrain from use of prohibited medication during the clinical trial. 6. use of hormonal contraceptives solely for control of acne.
changes in workability and employment following the work-related medical rehabilitation pv rehajet

Conditions: Musculoskeletal Diseases or Conditions

Summary: the objective of this observational study is to gain insight into a new approach to rehabilitation in austria, with a particular focus on work-specific exercises that are dependent on the specific work-related needs of the patients. two groups are being observed: one was referred to a three-week work-specific rehabilitation programme immediately upon arrival at the rehabilitation centre, while the other group underwent a three-week medical-focused rehabilitation programme before starting a four-week work-specific rehabilitation programme. researchers will monitor for indications of improvement following completion of the rehabilitation program. as the two forms of rehabilitation are not directly comparable, they will be observed and analysed as two distinct entities. as part of their regular inpatient rehabilitation, participants will complete questionnaires at designated intervals (beginning and end of stay), with follow-up assessments scheduled at six and 12 months post-rehabilitation.


Eligibility criteria:
inclusion criteria: * the study participants are regular patients in the rehabilitation centre bad hofgastein * presence of a disease in the area of the musculoskeletal system * sufficient motivation to maintain professional participation * declaration of consent exclusion criteria: * no completion of all work-specific rehabilitation modules * acute or decompensated disease states with severe functional limitations (i.e. not able to continue with the rehabilitation programme)
peng block vs intrathecal morphine in total hip arthroplasty

Conditions: Total Hip Arthroplasty; Postoperative Pain

Summary: to compare the impact of pericapsular nerve group (peng) block to intrathecal morphine on postoperative analgesia, motor function and side effects in patients undergoing primary total hip arthroplasty under spinal anesthesia.

the study aims to confirm the non-inferiority of peng block vs intrathecal morphine in patients undergoing total hip arthroplasty under spinal anesthesia. non-inferiority will be assessed regarding maximum pain on a numerical rating scale at rest and during active hip flexion and regarding cumulative morphine consumption during 48 postoperative hours. impact on quadriceps muscle motor function and side effects including pruritus, nausea and vomiting and hypotension will also be assessed.

Eligibility criteria:
inclusion criteria: * adult patients with osteoarthritis of the hip scheduled for primary total hip arthroplasty under spinal anesthesia able to provide written informed consent exclusion criteria: * patient unwilling / unable to provide informed consent * contraindications for any of the drugs and procedures included in the study protocol (allergies, local infection, coagulopathy) * high risk for perioperative morbidity/mortality (asa physical status classification iv) * preoperative use of strong opioid analgesia (due to hip pain or other acute/chronic pain condition) * pregnancy * substance abuse post randomization exclusion criteria: * change of surgical plan * violation of study protocol

Keywords: total hip arthroplasty postoperative pain anesthesia, regional
an efficacy and safety study of alz-801 in apoe4/4 early ad subjects

Conditions: Early Alzheimer's Disease

Summary: this study is being conducted to evaluate the safety and efficacy of alz-801 in early alzheimer's disease (ad) subjects with the apoe4/4 genotype. this is a double-blind, randomized trial with one dose of alz-801 compared to placebo.

this is a multi-center, double-blind study that will evaluate 265 mg twice daily (bid) of alz-801, an oral tablet, over 78 weeks as a treatment for subjects (50-80 years old) with early ad who are homozygous for the ε4 allele of the apolipoprotein gene (apoe4 homozygous or apoe4/4). the primary efficacy outcome assessment is a measure of cognition (adas-cog 13). additional measures of global and functional impairments will also be assessed. imaging and soluble biomarkers of ad and neurodegeneration will be measured and a sub-study to evaluate cerebrospinal fluid (csf) biomarkers is also included.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mci or mild dementia due to ad consistent with the national institute on aging-alzheimer's association (nia-aa) working group criteria. * homozygous for the ε4 allele of the apolipoprotein e gene (apoe4/4). * mmse score at screening of 22 to 30 (inclusive). * cdr - global score of 0.5 or 1 and cdr memory box score of ≥ 0.5. * rbans delayed memory index score ≤ 85. * evidence of progressive memory loss over the last 12 months per investigator assessment exclusion criteria: * brain magnetic resonance imaging (mri) indicative of significant abnormality per central reader, other than ad related atrophy. computed tomography (ct) scan acceptable for subjects who cannot undergo mri. * diagnosis of neurodegenerative disorder other than ad. * diagnosis of major depressive disorder (mdd) within one year prior to screening. * currently taking memantine or has taken memantine within 12 weeks prior to the baseline visit. * history of suicidal behavior within one year prior to screening or has ongoing suicidal ideation. * history of seizures, excluding febrile seizures of childhood or a single distant seizure (\> 5 years). * medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.
triple recipient strategy using split, domino, and auxiliary techniques

Conditions: Hepatocellular Carcinoma (HCC)

Summary: the investigators report a case of the simultaneous use of split liver transplantation (slt), domino liver transplantation (dlt) and auxiliary liver transplantation (alt) to achieve "one donor for three recipients".

the investigators report a case of the simultaneous use of split liver transplantation (slt), domino liver transplantation (dlt) and auxiliary liver transplantation (alt) to achieve "one donor for three recipients". three recipients had hepatitis c cirrhosis, argininemia, and hepatocellular carcinoma (hcc), respectively. the investigators performed slt in the first two recipients (an adult and a child), with the donor liver coming from a female who died of severe head trauma. the right lobe of the child, as the "domino liver graft", was transplanted to the postoperative hcc patient, whose left lateral lobe was preserved after tumor resection. all recipients were discharged from the hospital. during the 12 months of follow-up, all three recipients remained alive.

Eligibility criteria:
inclusion criteria: * liver cirrhosis * argininemia * hepatocellular carcinoma exclusion criteria: * patients who do not require an allogeneic liver transplantation.

Keywords: split liver transplantation domino liver transplantation auxiliary liver transplantation argininemia cirrhosis hepatocellular carcinoma