Kornimate/medical-research-clean huggingface dataset:
clinical study of jaktinib in the treatment of patients with moderate and severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to evaluate the efficacy and safety of jaktinib in participants with moderate to severe atopic dermatitis.

the study is divided into two stages, the first stage test (1-12 weeks): the main test; the second stage test (13-24 weeks): the extended test. the main test：the trial set up 4 treatment groups, including 3 dose exploration groups, jaktinib 50mg bid, 75mg bid, 100mg bid group and 1 placebo control group. the extended test：subjects in the placebo group were randomly assigned to receive jaktinib 50mg bid, 75mg bid, and 100mg bid treatments at a ratio of 1:1:1 (randomized in a blinded state and completed by iwrs in the background), the main test group (50mg bid, 75mg bid, 100mg bid group) subjects still maintain the original dose after 12 weeks.

Eligibility criteria:
inclusion criteria: * meet the chinese diagnostic criteria for atopic dermatitis (zhang's criteria) and be diagnosed as atopic dermatitis. * participants must have moderate to severe ad at screening and randomization. * participants must have inadequate response to topical medications within 6 months of screening. * agree to use emollients daily exclusion criteria: * received prior treatment with any oral janus kinase (jak) inhibitor less than 4 weeks prior to randomization. * have received certain types of vaccinations. * participants who do not agree to use adequate contraception during the trial and within 4 weeks after the last dose. * any participants whom the investigator deems inappropriate for participation in this clinical study
a first-in-human phase i study of esg206 in subjects with b-cell lymphoid malignancies

Conditions: B-cell Lymphoid Malignancies

Summary: this is a first-in-human phase i, multicenter, open label, sequential-cohort, dose escalation study of esg206. the purpose is to evaluate the clinical safety, tolerability, pk, and preliminary efficacy and to establish the mtd, if any, and rp2d(s) of esg206 in adult subjects with b lymphoid malignancies.

this is a first-in-human phase i, multicenter, open label, sequential-cohort, dose escalation study of esg206. the study will follow a modified 3+3 dose escalation scheme. dose escalation will continue until identification of mtd or the predicted efficacy dose in the event that a mtd is not identified due to paucity of dlts. toxicity including dose-limiting toxicity (dlt) observed in cycle 1 of the first 28 days will be used to determine escalation to the next dose level as described below. five dose levels are planned. dose choosing will be determined by the smc and the sponsor based on the pharmacokinetics, tolerability and preliminary antitumor activities, as well as other available data. subjects will be monitored for safety, tolerability, and efficacy throughout the study.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent for the trial. * male or female and at least 18 years of age. * subjects must have a histologically confirmed (or documented), incurable b-cell hematologic malignancy that had progressed despite standard of care therapy and for which there was no alternative therapy of proven benefit or no effective standard therapy is available or tolerable. * measurable or evaluable disease. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * subject must have adequate organ function. exclusion criteria: * has had prior chemotherapy, targeted therapy, immunotherapy or any other agents used as systemic treatment for cancer, within 14 days before first dosing. * had major surgery within 4 weeks before first dosing. * had undergone an autologous stem cell transplant within 100 days before first dosing. * evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, or renal disease). * known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients. * pregnant or breastfeeding women. * unwillingness or inability to follow the procedures outlined in the protocol.
whole exome sequencing in finding causative variants in germline dna samples from patients with peripheral neuropathy receiving paclitaxel for breast cancer

Conditions: Breast Carcinoma; Neuropathy

Summary: this research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (dna) samples from patients with peripheral neuropathy receiving chemotherapy for breast cancer. studying samples of germline dna in the laboratory from patients with peripheral neuropathy receiving paclitaxel for breast cancer may help doctors learn more about changes that occur in dna and identify biomarkers related to peripheral neuropathy.

primary objectives: i. to identify, using next generation sequencing, rare variants of large effect size that impact the risk of peripheral neuropathy in patients of african and european descent in the clinical trial ecog-5103 (e5103). outline: previously collected germline dna samples are analyzed via whole exome sequencing.

Eligibility criteria:
inclusion criteria: * european american patients with dna available and designated case or control * african american patients with dna available and designated case or control status * patients who developed grade 2-4 for african american (aa) and grade 3-4 for european american (ea) peripheral neuropathy during their treatment with paclitaxel and who did not develop peripheral neuropathy following a full course of treatment with paclitaxel
a model for predicting the efficacy of conversion therapy for patients with colorectal cancer liver metastases by the detection of 5-hydroxymethylcytosine (5-hmc) in plasma cell-free dna

Conditions: Colorectal Cancer With Liver Metastases

Summary: in this study, the investigators establish a model for predicting the efficacy of conversion therapy for the patients with unresectable liver metastases of colorectal cancer based on the detection of 5-hydroxymethylcytosine (5-hmc) in training group and validate the effectiveness of the model using a validation group.

radical resection is the preferred treatment of colorectal cancer patients with liver metastasas which significantly reduce the survival. however, the majority of the patients cannot receive liver lesions resection resulting from the size, number and bad location. conversion therapy can improve the resection rate of these patients. unfortunately, the efficacy of conversion therapy is still poor in part of the patients. so, it is crucial to distinguish the beneficial ones from the others. the aim of this single center study is to establish a model for predicting the efficacy of conversion therapy for the patients with unresectable liver metastases of colorectal cancer based on the detection of 5-hmc. patients will be eligible for inclusion if they suffer with unresectable liver metastases of colorectal cancer and have not received any anti-tumor treatment. eligible patients will be assigned to effective group (group a) and drug resistance group (group b) according to the evaluation results of multidisciplinary team after 4-8 cycles of conversion therapy about 2-4 months. then, 5-hmc in plasma cell-free dna will be detected and compared between the two groups of patients (training group) to establish a model to predict the efficacy of convertion therapy of other individuals (validation group) who suffer with unresectable liver metastases of colorectal cancer receiving conversion therapy.

Eligibility criteria:
inclusion criteria: * histologically proven colorectal adenocarcinoma * liver metastases were observed by abdominal pelvic ct and / or mri with/without other distant metastases * the liver metastases assessed as unresectable lesions by multidisciplinary team * no other malignancies in medical history * eastern cooperative oncology group score 0-2 * informed consent exclusion criteria: * patients received chemoradiotherapy or other anti-tumor therapy before being enrolled * patients and/or family members can not understand or accept this study * familial adenomatous polyposis, lynch syndrome, acute inflammatory bowel disease * pregnancy or lactation * unsuitable to take part in the clinical trial judged by doctors

Keywords: colorectal cancer liver metastases conversion therapy
does the fecal microbiome influence rotarix immunogenicity

Conditions: Rotavirus Infections; Reaction - Vaccine Nos; Intestinal Bacteria Flora Disturbance

Summary: this is a proposal for a nested case-control study within an ongoing rotavirus vaccine immunogenicity clinical trial karachi, pakistan. the primary study aim is to compare the fecal microbiota composition and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion to rotavirus vaccination. the infants will be matched for vaccination dose, age and breast-feeding practices.


Eligibility criteria:
inclusion criteria: * 6 weeks 0 days to 7 weeks 6 days age at the time of enrollment. * healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study. * written informed consent obtained from the parents or guardians. * availability of baseline fecal sample collected before rotarix vaccination * written informed consent obtained from the parents or guardians for nested study exclusion criteria: * hypersensitivity to any of the vaccine components * use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study. * use of any immunosuppressive drugs. * previous intussusceptions or abdominal surgery. * enrollment in any other trial (besides nct01199874). * birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days. * immunoglobulin and/or blood products use since birth or during the study period. nested study additional exclusion criteria: * positive serum anti-rotavirus immunoglobulin a (\> 20 u/ml) at 6 weeks of age, indicative of prior rotavirus infection

Keywords: rotavirus immunogenicity enteric vaccine vaccine immunogenicity rotavirus vaccine gut microbiome microbiome
plasma citrulline level in relation to absorptive surface

Conditions: Intestinal Failure

Summary: correlation between determination of citrulline in plasma or dried blood reference ranges for healthy children and babies longitudinal follow-up of citrulline in preterm babies


Eligibility criteria:
inclusion criteria: * 0-18 years * preterm babies up to 1.500g * preterm babies over 1.500g exclusion criteria: * gastro-intestinal problems (except for the preterm babies) * congenital metabolic disorders * dysfunction of the liver or kidneys * congenital defects
a phase i study of gp100 human melanoma peptide vaccine with incomplete freund's adjuvant

Conditions: Melanoma

Summary: this is a phase i study of melanoma tumor antigen peptide vaccines. the nine amino acid peptides representing hla-a2 restricted t cell epitope of the melanoma antigen, gp100 will be administered to patients emulsified in incomplete freund's adjuvant, (ifa). the study is designed to evaluate the toxicity, immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously. immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific t cell precursor frequency prior to and after immunization.

this is a phase i study of melanoma tumor antigen peptide vaccines. the nine amino acid peptides representing hla-a2 restricted t cell epitope of the melanoma antigen, gp100 will be administered to patients emulsified in incomplete freund's adjuvant, (ifa). the study is designed to evaluate the toxicity, immunologic effects and potential therapeutic role of repeated doses of gp100 peptide vaccines administered subcutaneously. immune reactivity to the gp100 epitope peptides will be monitored in all patients by analysis of melanoma-specific t cell precursor frequency prior to and after immunization.

Eligibility criteria:
disease characteristics: metastatic melanoma that is hla-a2 positive. no primary melanoma of ocular or mucosal origin. measurable or resected metastatic disease required. prior/concurrent therapy: biologic therapy: no prior (greater than 30 days) or concurrent biologic therapy. chemotherapy: no prior (greater than 30 days) or concurrent chemotherapy. endocrine therapy: no prior (greater than 30 days) or concurrent hormone therapy. no requirement for steroids. radiotherapy: no prior (greater than 30 days) or concurrent radiotherapy. surgery: not specified. patient characteristics: age: 18 and over. performance status: ecog 0 or 1. life expectancy: more than 3 months. hematopoietic: no coagulation disorder. hepatic: bilirubin no greater than 2.0 mg/dl. no hepatitis bsag antibody. renal: creatinine no greater than 2.0 mg/dl. cardiovascular: no major cardiovascular illness. pulmonary: no major respiratory illness. other: no previous allergic reaction to incomplete freund's adjuvant. hiv negative. no active systemic infection. not pregnant or lactating.

Keywords: cancer immunotherapy
targeting taboo thoughts in obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this pilot study is to investigate if a cognitive treatment targeting obsessive beliefs in patients with aggressive obsessions is feasible and effective as an online treatment.

patients with obsessive-compulsive disorder who presents with aggressive obsessions (also known as taboo thoughts e.g. fear of being a pedophile) and mental rituals have shown to respond less well to treatment. thus, there is room for further innovation. the primary objective of this pilot study is to investigate if an internet-based cognitive therapy (i-ct) is feasible and effective in reducing the frequency and distress of aggressive obsessions. the study will also investigate if i-ct is associated with any significant side effects. another objective of this study is to get a power estimate of the treatment effects for a subsequent randomized controlled study (rct). this will be done by using an open pilot study with repeated measurements.

Eligibility criteria:
inclusion criteria: * diagnosis of ocd taboo thoughts as specified in the dsm-5 * ≥ 18 years * situated in sweden * informed consent exclusion criteria: * no signed consent * not fluent speaking in swedish or cognitive abilities to read written material in the study * adjusted pharmacological treatment the last month symptoms that may affect ocd symptoms * substance dependence during the last six months * psychosis * ongoing mania or hypomania * suicidal risk that may affect study participation * personality disorder that may significantly affect the treatment participation * other ongoing psychological treatments that may affect ocd-symptoms * other primary psychiatric diagnosis

Keywords: obsessions cognitive therapy internet
terlipressin + albumin versus midodrine + octreotide in the treatment of hepatorenal syndrome

Conditions: Cirrhosis; Hepatorenal Syndrome

Summary: from 1999, several studies have showed that the use of vasoconstrictors in association with albumin are effective in the treatment of hepatorenal syndrome (hrs). the rationale of the use of vasoconstrictors together with albumin in the treatment of this severe complication of portal hypertension in patients with cirrhosis is to correct the reduction of the effective circulating volume due to the splanchnic arterial vasodilatation.in most of these studies terlipressin, a derivate of vasopressin, has been used as vasoconstrictor as intravenous boluses moving from an initial dose of 0.5-1 mg/4 hr. in some studies midodrine, an alpha-adrenergic agonist, given by mouth has been used as vasoconstrictor at a dose ranging from 2.5 up to 12.5 tid together with octreotide, an inhibitor of the release of glucagon, given subcutaneously at a dose ranging from 10 µg upt to 200 µg tid. to the day, there isn't a study comparing terlipressin + albumin versus midodrine + octreotide + albumin in the treatment of hrs in patients with cirrhosis.thus, the aim of the study is to compare terlipressin + albumin vs midodrine + octreotide + albumin in the treatment of the hrs in patients with cirrhosis.


Eligibility criteria:
inclusion criteria: * patients with cirrhosis and diagnosis of hrs type 1 or 2,serum creatinine \> 2.5 mg/dl exclusion criteria: * diagnosis of hcc with a staging beyond the milan criteria di milano * septic shock (systolic arterial pressure \< 90 mmhg * significant heart or respiratory failure * peripheral arteriophaty clinically significant * previous heart stroke or significant alteration of the ecg

Keywords: cirrhosis hepatorenal syndrome terlipressin midodrine octreotide human albumin effective circulating volume the criteria which will be used for the diagnosis of hrs will be the criteria which were recently published by the international ascites club patients with cirrhosis and type 2 hrs only with serum creatinine value > 2.5 mg/dl all patients with cirrhosis and type 1 hrs
a study to understand is the covid-19 vaccine bnt162b2 is safe in indonesia people

Conditions: COVID-19

Summary: the purpose of this study is to characterize descriptively the bnt162b2 vaccination safety experience among the indonesian people. we will look at adverse events (aes) reported in indonesia vaccine safety website for people 12 years of age and older. aes are unwanted reactions associated with the use of the bnt162b2 vaccine. they may or may not be caused by this vaccine. the secondary data collection will be exclusively from the indonesia vaccine safety website as requested by bpom. this study does not seek additional participants. we will look at reported aes for bnt162b2 vaccine since it became available in indonesia. individual data will be de-identified first before use. this will help protect personal information. we will study the aes associated with the bnt162b2 vaccine in several ways. these include the type of aes and which body parts affected, among others. this will help us understand it the vaccine is safe in indonesian people.


Eligibility criteria:
inclusion criteria: this study will include adverse events reported in indonesia vaccine safety website for individuals 12 years of age and older exclusion criteria: none

Keywords: indonesia vaccine bnt162b2
a study of cisplatin or carboplatin with gemcitabine versus gemcitabine alone as adjuvant therapy in patients with resected or ablation intra-hepatic cholangiocarcinoma

Conditions: Intrahepatic Cholangiocarcinoma

Summary: compare the efficacy of adjuvant chemotherapy with cisplatin or carboplatin and gemcitabine versus gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.

phase iii, multicenter, open label, randomized study of cisplatin or carboplatin with gemcitabine versus gemcitabine alone as adjuvant therapy in patients with resected or ablated intra-hepatic cholangiocarcinoma. subjects will be randomized in a 1:1 fashion to cisplatin or carboplatin with gemcitabine versus gemcitabine alone.

Eligibility criteria:
inclusion criteria: * at least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of intrahepatic cholangiocarcinoma * hematologic function: anc ≥ 1.5 x 10 /l, platelets ≥ 75 x 10 /l, and hemoglobin \> 9 g/dl * adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, ast and alt ≤ 5 uln, albumin ≥ 2.5 g/dl * adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, \> 50 ml/min calculated by the c-g equation * non-pregnant women of child bearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age) * ecog status ≤ 1 at screening exclusion criteria: * subjects will be eligible for the study if they meet all inclusion criteria

Keywords: cholangiocarcinoma gemcitabine carboplatin cisplatin
treatment of ano-perineal fistulas resistant to surgical treatment with a gel and plug of wharton's jelly

Conditions: Anal Fistula

Summary: the purpose of this open, multicenter pilot trial is to evaluate the tolerance of the combination of a gel and a plug made of wharton's jelly in the treatment of ano-perineal fistulas resistant to surgical treatment.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 to 65 years. * patient with a single anal fistula resistant after at least one surgical treatment. fistula may be related to crohn's disease. * patient with an upper transsphincteric or lower transsphincteric fistula. * patient presenting fistula with or without intersphincteric diverticula. * fistula effectively drained with a seton. * informed and consenting patient. * patient who is a member or a beneficiary of a national health insurance plan. exclusion criteria: * pregnant or breastfeeding woman or woman of childbearing age without effective contraception. * patients who have had more than one failed obstruction technique. * patient with more than one internal orifice. * patient with an mri proven abscess. * patient with an uncontrolled infection. * patient with a contraindication to anesthesia. * person deprived of liberty by a judicial or administrative decision. * adult subjected to a legal protection measure or unable to express his / her consent.
study of at-752 in healthy subjects in a dengue human challenge model

Conditions: Dengue

Summary: this study will assess the safety and antiviral activity of at-752 in healthy subjects in a dengue human challenge model

a phase 1, double-blind, randomized, placebo-controlled study to assess the antiviral activity and safety of at-752 in a dengue human challenge model

Eligibility criteria:
inclusion criteria: * must agree to use protocol-specified methods of contraception * negative pregnancy test * willing to comply with the study requirements and to provide written informed consent exclusion criteria: * pregnant or breastfeeding * abuse of drugs * other clinically significant medical conditions