Kornimate/medical-research-clean huggingface dataset:
phase iii clinical study of vc005 tablets in adult patients with moderate to severe atopic dermatitis

Conditions: Moderate to Severe Atopic Dermatitis

Summary: this clinical trial is a multicenter, randomized, double-blind, controlled phase iii clinical study


Eligibility criteria:
inclusion criteria: (1）the patient understands and voluntarily signs the informed consent form (icf), and has the willingness and ability to complete the regular visits,treatment plans, laboratory tests and other experimental procedures required by the program. (2) male or female patients aged ≥18 and ≤75 years at the time of signing the icf. (3) meet hanifin-rajka diagnostic criteria at screening and have atopic dermatitis （ad) symptoms for at least 1 year prior to baseline. (4) at screening and baseline, meets criteria for moderately severe ad based on the investigator's assessment of 3 of the following:eczema area and severity index (easi) score ≥12;psoriasis area severity index (iga) score ≥3;ad involvement in ≥10% of the body surface area (bsa). (5) recent (within 1 year prior to screening) topical treatment for ad with inadequate or intolerant clinical response, as determined by the investigator exclusion criteria: (1) inability to swallow the test drug or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunt, or the presence of a gastrointestinal disorder (e.g., crohn's disease, ulcerative colitis, or short bowel syndrome) or other malabsorption condition that interferes with the absorption of the drug; (2) current or history of lymphoproliferative disorders or presence of signs or symptoms suggestive of possible lymphoproliferative disorders of lymphoid tissue, including lymphadenopathy or splenomegaly; malignancies of any kind, or a history of any malignancy within the 5 years prior to screening (except for completely resected carcinoma in situ of the cervix or non-metastatic squamous cell or basal cell carcinoma of the skin or papillary carcinoma of the thyroid gland); (3) patients with prior thromboembolism (including deep vein thrombosis, pulmonary embolism, arterial thrombosis, etc.) or other high-risk groups prone to thromboembolism; (4) patients with a history of herpes virus infection within the last 1 month or those with recurrent episodes of herpes zoster (≥2), disseminated herpes zoster, disseminated herpes simplex, or those for whom herpes zoster or herpes simplex infections cannot be excluded at this time;
effectiveness and safety in patients with crohn´s disease in clinical routine

Conditions: Crohn's Disease

Summary: the purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with crohn's disease (cd) who are treated as recommended in the product label.

this study was a 60-month prospective, multicenter, observational study of adalimumab in adult participants with cd who resided in germany. visits were scheduled every 3 months for the first year and every 6 months thereafter. participants continued in the study for a maximum of 60 months or until discontinuation from adalimumab therapy.

Eligibility criteria:
inclusion criteria: - severe, active crohn's disease in patients with insufficient response to a complete and adequate therapy of glucocorticoid and/or immunosuppressive drug and/or hypersensitivity against such a therapy or in patients where such a therapy is contraindicated. exclusion criteria: - hypersensitivity against the drug or one of the other ingredients.

Keywords: routine clinical setting long-term efficacy and safety crohn's disease humira® adalimumab
changes in serum vitamin d level after different loading doses of cholecalciferol

Conditions: Hypovitaminosis D

Summary: it is a clinical trial to observe increase in serum vitamin d level and clinical symptoms after 3 different doses of cholecalciferol given either intramuscularly or oral.

a prospective, interventional study was conducted in department of rheumatology, bsmmu, dhaka, bangladesh from october 2015 to january 2017. one hundred and five clinically healthy adults of age 21-39 with serum vitamin d concentration were enrolled in the study. serum vitamin d level was estimated by chemiluminescent micro particle immunoassay method at baseline and 3 months after the intervention. the participants were divided into three groups using random number table. group a was given 6 lakh iu of cholecalciferol im stat dose, group b was given 6 lakh iu of cholecalciferol orally with a glass of milk stat dose and group c was given 2 lakh iu of cholecalciferol orally once a month for 2 months followed by tablet cholecalciferol 1000 iu daily.

Eligibility criteria:
inclusion criteria: * hypovitaminosis d (serum 25 oh d \< 20 ng/ml) exclusion criteria: * chronic disease causing vitamin d deficiency like ckd, nephrotic syndrome, liver disease, hyperparathyroidism, history of skin graft, malabsorption, hyperthyroidism, drugs like anticonvulsants, glucocorticoids, haart current pregnancy lactose intolerance previously treated with bolus vitamin d supplementation within previous three months

Keywords: hypovitaminosis d cholecalciferol mehadose
ibi310 in combination with sintilimab in patients with advanced biliary tract cancer

Conditions: Advanced Biliary Tract Cancer

Summary: this research study is designed to establish whether the combination of ibi310 \& sintilimab has efficacy in patients with advanced btc


Eligibility criteria:
inclusion criteria: 1. the subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol. 2. aged ≥18 years. 3. patients with unresectable or relapsed or metastatic advanced biliary tract cancer,and diagnosed by histology/cytology (except carcinoma of ampulla). 4. had progressed after receiving at least first-line systemic treatment (if a patient has progressed within 6 months after receiving systemic treatment during adjuvant chemotherapy or concurrent radiochemotherapy, she will be deemed to have received first-line treatment). 5. patients who have never received any anti-pd-1, anti-pd-l1/l2 antibody, anti-ctla-4 antibody, or other immunotherapy. 6. the subject must have at least one measurable lesion as the target lesion (according to recist v1.1). a measurable lesion in the radiation field from previous radiotherapy or local treatment, can also be chosen as the target lesion if confirmed progression. exclusion criteria: 1. diagnosis of other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, radically resected carcinoma in situ and/or thyroid papillary carcinoma. 2. patients who have previously received organ or bone marrow transplantation. 3. patients with acute or chronic active hepatitis b or c infection, hepatitis b virus (hbv) dna\> 2000 iu/ml or 104 copies/ml; hepatitis c virus (hcv) antibody positive and hcv-rna \>103 copies/ml;. patients with acute or chronic active hepatitis b or c infection who have received nucleotide antiviral therapy and are below the above standards can be selected. 4. uncontrollable hypertension, systolic blood pressure ≥150 mmhg or diastolic blood pressure ≥100 mmhg after best medical treatment, history of hypertensive crisis or hypertensive encephalopathy. 5. pleural effusion, ascites, and pericardial effusion with clinical symptoms or requiring drainage , patients who only shows with a few pleural effusion, ascites, and pericardial effusion by imaging and with no clinical symptoms can be selected.
quilt-3.025: a phase 2 study of amg 479 in relapsed or refractory ewing's family tumor and desmoplastic small round cell tumors

Conditions: Askin's Tumors; Desmoplastic Small Round Cell Tumors; Estraosseous Ewing's Tumor; Ewing's Family Tumor; Ewing's Sarcoma; Primitive Neuroectodermal Tumors (PNETs); Sarcoma

Summary: single-arm, open-label study of amg 479 in up to 35 subjects with ewing's family tumors (efts) and desmoplastic small round cell tumors (dsrcts) who have progressed or recurred after at least one prior chemotherapy regimen. an exploratory cohort of an additional up to 10 subjects with prior exposure to anti-igf-1r therapy and who have progressed or recurred after at least one prior chemotherapy regimen will also be assessed.


Eligibility criteria:
male and female subjects ≥ 16 years of age with a diagnosis of eft or dsrct who have relapsed or progressed after at least one prior chemotherapeutic regimen will be eligible for this study. before any study-specific procedure, the appropriate written informed consent must be obtained. inclusion criteria: disease related subjects with pathological or histological diagnosis of ewing's family tumor or desmoplastic small round cell tumor. * measurable disease as defined by recist. * documented failure of at least one prior chemotherapy regimen for their disease. * eastern cooperative oncology group (ecog) performance status ≤ 2. demographic * males or females ≥ 16 years old. * signed written informed consent. * able to comply with visits and procedures. laboratory * willing to provide existing and/or newly acquired tumor samples. * diabetic subjects (type 1 or 2) must have hgba1c \< 8.0% and fasting blood glucose level \< 160 mg/dl. general * must be willing and able to use birth control (double barrier protection or abstinence) during and for 6 months after the study * prior exposure to another anti-igf-1r therapy will only be allowed for a limited number of additional subjects (up to 10) in an exploratory cohort exclusion criteria disease related * known brain metastasis. * history of bleeding diathesis. * history of another malignancy. * history of chronic hepatitis. * documented prior history of human immunodeficiency virus. laboratory * absolute neutrophil count \< 1.5 x109/l. * platelet count \< 100 x 109/l. * hemoglobin \< 9 g/dl. * pt \> 1.5 x institutional upper limit of normal (iuln) or ptt \> 1.0 x iuln. * serum creatinine \> 1.5 x iuln. * aspartate aminotransferase (ast) \> 2.5 x iuln or alanine aminotransferase (alt) \> 2.5 x iuln (\> 5.0 x if liver metastases present). * total bilirubin \> 1.5 iuln (\> 3.0 x with documented gilbert's syndrome) medication * antitumor treatment within 21 days of study day 1. * anticoagulation therapy within 28 days of study day 1. * major surgery within 28 days of study day 1. general * other investigational procedures are excluded. * inability to tolerate intravenous administration. * subject is pregnant (eg, positive hcg test) or is breast feeding.

Keywords: amg 479 igf-1r insulin-like growth factor insulin-like growth factor receptor ewing's sarcoma
audio distraction for traction pin placement

Conditions: Lower Extremity Fracture

Summary: traction pin placement is a common way to temporarily manage femur fractures and unstable acetabular fractures while awaiting surgery. skeletal traction is thought to reduce patient discomfort by improving fracture alignment as well as relaxing muscle spasm pain felt from the broken bone by stretching out the leg. skeletal traction may also help prevent articular surface damage in the hip by decreasing joint pressure. despite the benefits of skeletal traction, insertion of the traction pin can be a painful and unpleasant experience for the patient. our study hopes to see if listening to music with headphones during insertion of the traction pin decrease patient pain and anxiety.

given that skeletal traction is the current standard of care at our institution; our study will focus on the use of audio distraction during placement of skeletal traction and the effect on patient discomfort. there have been multiple studies examining the use of various distraction techniques for pain and anxiety, mainly with patients undergoing gi procedures, such as colonoscopy. the goal of our study is to investigate the use audio distraction with music from an mp3 player and headphones, and the effect on patient anxiety and pain during the placement of a skeletal traction pin. provider-perceived patient cooperation and procedure difficulty will also be assessed. this is a prospective randomized controlled trial at regions hospital in saint paul, mn and jackson memorial hospital in miami, florida to compare primary outcomes of subjects between audio distraction and no audio distraction groups during traction pin placement. recruitment of patients for inclusion in this study will be completed by the orthopedic resident placing the skeletal traction pin. patients will be recruited for inclusion in this study after determining the medical need for placement of a skeletal traction pin. routine care will be provided by the orthopedic resident for skeletal traction pin placement. those included in this study and randomized into the treatment arm will be given an mp3 device and headphones to listen to a genre of music of their choosing in addition to being treated to the current routine care. those randomized into the control arm will be treated to the current routine care without any use of music. patients will be randomized into 2 groups; audio distraction with music versus control group with no music.

Eligibility criteria:
inclusion criteria: * conscious, oriented, able to give informed consent * medical need for distal femoral or proximal tibial skeletal traction pin placement exclusion criteria: * medical contraindication to skeletal traction * endotracheal intubation * unable to participate in verbal communication throughout the procedure and in the recovery phase * sensory impairment to pain * inability to make accurate mark on vas 2/2 cognitive, motor or visual deficiencies.

Keywords: skeletal traction audio distraction
lgmd r1 natural history study

Conditions: Calpain-3 Deficiency Limb Girdle Muscular Dystrophy Type 2A; Limb Girdle Muscular Dystrophy; Limb Girdle Muscular Dystrophy Type R1; LGMD2A

Summary: this is a 24-month, observational study of 100 participants with limb girdle muscular dystrophy type r1, also known as capn3.

limb girdle muscular dystrophies (lgmd) are a group of over 30 heterogenous genetic disorders which have in common a pattern of weakness affecting proximal muscles of the shoulders and hips. lgmd type r1 (lgmdr1; also lgmd2a) is due to loss of function of the muscle structural gene calpain 3 (capn3) and causes progressive weakness and muscle wasting, which can lead to loss of ambulation or the ability to maintain a job. lgmdr1 is one of the most common lgmds in the united states and has no fda approved therapies but is amenable to gene replacement strategies, regenerative medicine approaches, or myostatin based approaches. there have been rapid advances in gene delivery therapies for duchenne muscular dystrophy and for lgmdr4 that have set the stage for targeted therapeutic development for all lgmds, and lgmdr1 in particular is at a crossroads: the pace of therapeutic development has outstripped the efforts at clinical trial preparedness. there is a need for a more rigorous natural history study to assist in the design of clinical trials; in particular, identifying biomarkers for early phase development and clinical outcome assessments (coas) for drug approval studies. this study will enroll 100 subjects across participating sites in the grasp-lgmd research consortium. no treatment will be administered as part of this study. a subset of 80 patients will undergo mr scans at selected imaging sites. study visits will occur at baseline day 1, baseline day 2, month 12, and month 24.

Eligibility criteria:
inclusion criteria: 1. age between 12-50 at enrollment 2. clinically affected (defined as weakness on bedside evaluation in a pattern consistent with lgmdr1) 3. genetic confirmation of lgmdr1 (presence of homozygous or compound heterozygous pathogenic mutations in capn3). 4. must be able to provide written informed consent and be willing and able to comply with all study requirements. note: adult participants must be able to provide consent themselves. legally authorized representatives are not permitted to consent on behalf of adult participants. exclusion criteria: 1. have contraindications to mri or mrs (e.g., non-mr compatible implanted medical devices or severe claustrophobia) 2. non-ambulatory as defined by those who are not able to walk 10 meters without assistive devices (ankle foot orthotics excluded) 3. positive pregnancy test at any timepoint during the trial 4. have dominantly inherited capn3 mutations (lgmdd4) 5. any other illness that would interfere with the ability to undergo safe testing or would interfere with interpretation of the results in the opinion of the site investigator.

Keywords: lgmd limb girdle muscular dystrophy lgmd r1 lgmd2a capn3
my-hypercvad in the treatment of relapsed refractory adult acute lymphoid leukemia

Conditions: Lymphoid Leukemia

Summary: the patient receive 2 different drug combinations on this study. the first combination will consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate, doxorubicin liposomal or doxorubicin, vincristine, ara-c (cytarabine) and dexamethasone). the second combination will consist of another intensive chemotherapy regimen (methotrexate and ara-c \[cytarabine\]).


Eligibility criteria:
inclusion criteria: * diagnosis of all (any type included), in patients who: * have relapsed after conventional chemotherapy\* or, * are refractory to at least 1 cycle of chemotherapy\* * ecog performance score of 0-3 * adequate hepatic and renal function, as defined by serum transaminases \<2.5x uln, bilirubin \<1.5xuln, and creatinine \<1.5x uln. * age 18 years or greater. * documentation of written informed consent to participate in the trial. * willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. * at least 3 weeks from prior chemotherapy or other investigational anticancer therapy with full recovery from prior toxicities. * either men or women, accepting to practice effective contraception during the entire study period unless documentation of infertility exists. exclusion criteria: * treatment with any investigational agent within 3 weeks prior to study therapy. * major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure. * presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to: * presence of central nervous system (cns) leukemia. * active uncontrolled bacterial infection. * known human immunodeficiency virus (hiv) infection. * significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina), or a major thromboembolic event (myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last 6 months. * pregnancy or breast-feeding. * malabsorption syndromes

Keywords: relapsed all refractory all relapsed adult acute lymphoid leukemia
two year developmental follow-up for premod2 trial (premature infants receiving milking or delayed cord clamping)

Conditions: Neurodevelopmental Abnormality

Summary: an extension of the premod2 trial, the premod2 follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received ucm or dcc. this prospective multi-national randomized controlled trial (rct) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.

the premod2 follow-up trial will examine the difference in early childhood neurodevelopmental outcomes of subjects enrolled in the premod2 umbilical cord milking (ucm) vs. delayed cord clamping (dcc) trial, using standardized neurologic and developmental assessments at 22-26 months corrected age (ca). the corrected age may be extended out to 42 months ca due to covid-19 pandemic for undetermined period of time.

Eligibility criteria:
inclusion criteria: * children enrolled in the premod2 non-inferiority trial at birth who survive to 2 years corrected age. exclusion criteria: * children enrolled in the premod2 non-inferiority trial at birth who did not survive or are lost to follow-up.

Keywords: neurodevelopmental impairment, prematurity disability umbilical cord milking delayed cord clamping
targeting the gut microbiome for prader-willi syndrome treatment

Conditions: Prader-Willi Syndrome

Summary: the gut microbiome has recently emerged as a major contributor to obesity, systemic inflammation, and metabolic disease. furthermore, intestinal bacteria are crucial players in the gut-brain axis, regulating a broad range of central nervous system processes, from satiety mechanisms to anxiety and social behavior. thus, targeting the microbiome is being actively investigated as a therapeutic strategy for a wide array of diseases, including obesity, anxiety, depression, and autism. among all intestinal bacteria, bifidobacterium animalis spp. lactis (bal) has shown promise for obesity treatment in experimental animal models and human subjects, improving body composition and metabolic health, and reducing energy intake. moreover, tryptophan metabolism, a crucial regulator of satiety mechanisms and anxiety, is a main target of bal. given that clinical manifestations of prader-willi syndrome (pws) include hyperphagia, anxiety, altered body composition, and metabolic dysregulation, the aforementioned effects of bal might prove highly beneficial for children with pws. here, the investigators will test this hypothesis by performing a randomized double-blinded placebo-controlled crossover clinical study to assess the effects of bal supplementation on an array of clinical manifestations of pws. children with pws will undergo a 3-month placebo/probiotic treatment period, a 3-month washout period, followed by a 3-month probiotic/placebo supplementation. anthropometric, biochemical, and psychological data as well as biological samples will be obtained at the beginning of the study, and after each of the study periods, with a total of four time-points. specifically, the investigators will determine body composition by dxa analysis; metabolic health by assessing glucose and lipid metabolic parameters as well as circulating hormonal and cytokine levels; thermoregulation by non-invasive thermal imaging; and hyperphagia and emotional and behavioral problems by applying parental-rated validated questionnaires.


Eligibility criteria:
inclusion criteria: * diagnosed with prader-willi syndrome with genetic confirmation * on a stable diet and medication regimen for at least the last two months before enrollment exclusion criteria: * current enrollment in or discontinuation within the last 30 days from a clinical trial * presence of other medical problems that would preclude study participation * patients with a history of bariatric surgery * unsuitable for inclusion in the study in the opinion of the investigator
nutritional adequacy of a fodmap diet in children

Conditions: Functional Gastrointestinal Disorders in Children

Summary: this pilot study aims to establish whether a low fodmap diet is safe in children with functional gastrointestinal disorders. the practicality of implementing this diet will be evaluated as well as symptom improvement and quality of life. a larger intervention trial, if deemed appropriate, will then follow to assess symptom efficacy in children.


Eligibility criteria:
inclusion criteria: * patients aged 10-16 years * informed consent and assent obtained * patients with diagnosed fgid according to rome iii criteria: i.e. category h2b (irritable bowel syndrome) and h2d (childhood functional abdominal pain) exclusion criteria: * patients with other gastrointestinal conditions (e.g. coeliac disease, inflammatory bowel disease) * patients with food allergies * patients with a weight for age below -2 standard deviations (sd) (below 0.4th centile) on the uk who growth charts. * patients with known micronutrient deficiencies determined by blood levels prior to study * patients without informed consent and assent obtained

Keywords: functional gastrointestinal disorders fgid children fodmap