cyrilzakka/clinical-trials huggingface dataset:
Effectiveness and Safety of IV Zemplar in Patients on Hemodialysis and With Secondary Hyperparathyroidism Using iPTH/100 as Initial Dose

The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH\>300pg/mL) and that require dialysis at least 3 times per week.

The study will be carried out in three dialysis centers in Peru. Each patient enrolled in the study will be followed during a 6 month period from the time of inclusion. Study visits will occur at Baseline and at Weeks 4, 8, 12 and 24 during the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>=18 years old with secondary hyperparathyroidism (PTH\>300pg/mL, measured in the last 2 weeks).
* Patients on hemodialysis who require starting therapy with IV paricalcitol (de novo).
* Patients attending 3 hemodialysis sessions per week.
* Patients signing the informed consent approved by the Ethics Committee. If any individual is not capable of giving his/her consent, it can be obtained from a next of kin or from his/her legal representative, according to local laws and regulations.
* The decision to initiate treatment is upon the investigator and the decision to treat patients with IV paricalcitol must not be based on the inclusion of the patient in the study or any other way. The decision to treat a patient with IV paricalcitol will be taken prior to asking the patient to participate in the study.

Exclusion Criteria:

* Patients with any concomitant clinical condition that, according to the investigator's opinion, might impede an adequate assessment of the treatment response.
* Patients with severe hyperparathyroidism (PTH\>3000pg/mL).
* Patients with a serum calcium level greater or equal to 10.5mg/dL, phosphorus greater or equal to 6.5mg/dL, or those with Calcium X Phosphorus product 65 (measured at least 2 weeks before the study).
* Patients with neoplastic disease.
* Pregnant or lactating women.
* Known hypersensitivity and/or toxicity to vitamin D metabolites and/or to other ingredients of the product.
* Having participated in another study with an investigational product or device within the previous 30 days or having planned to participate in another study within the same period of time as the actual study.
* Use of vitamin D analogue during the last 3 months prior to the inclusion to this study.
An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit

The diagnostic cohort study could will be use to verify the clinical performance of the AQP4 -immunoglobulin G detection kit and whether it has a good correlation with the clinical diagnosis results. The applicability and accuracy of the kit in clinical diagnosis will be verified according to the measured data.


Eligibility Criteria:
Inclusion Criteria:

1. The patients who were diagnosed with NMOSD , and the cell-based assay was used to determine the AQP4-IgG-seropositive patients;
2. AQP4-IgG is negative in health people with age and sex matching and determined by cell-based assay;
3. Female or male, age 14-80;
4. Patients or authorized family members volunteered to participate in this study and signed informed consent.

Exclusion Criteria:

1. Patients with coagulation disorders;
2. Infection-related encephalitis;
3. Immune-related encephalitis;
4. A patient with severe mental illness who cannot cooperate clinically;
5. A patient with severe jaundice.
A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)

The descriptive purpose of this study is to characterize clinical and nonclinical factors of participants with CD, participant flow and visits to other specialists in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of electronic medical records. The clinical and nonclinical factors include: demographic and baseline clinical characteristics, lifestyle, relapses, complications, day hospital visits, surgery, presence of complications such as perianal fistulas and complex perianal fistulas. The predictive purpose of this study is to develop a statistical predictive model with the information obtained from the descriptive purpose, in the hospitals of the healthcare network of the Autonomous Community of Madrid, capable of assigning any participant diagnosed with CD a probability of reaching a prototypical clinical condition or a probability of experiencing certain clinical complications.

This is a retrospective and non-interventional study of participants with CD. The study will collect data from electronic medical records (EMRs) of the participants in the hospitals of the healthcare network of the Autonomous Community of Madrid with implementation of EMRs and will describe the determining factors and develop a statistical model for predicting likely outcomes in participants with CD. This study will conduct an additional substudy to evaluate the performance of the system through a human assessment to be performed by the clinical experts at each participating site.

The study will have a retrospective data collection from EMRs of the participants referring to last 5 years.

The study will enroll approximately 3000 participants. All participants will be enrolled in one observational cohort.

This multi-center trial will be conducted in Spain. The overall time for data collection in the study will be approximately 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with CD from the medical centers participating in the study.
IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.

The purpose of this study is to assess the safety and tolerability and to determine the dose of IPH5201 that can be used as monotherapy or in combination with durvalumab +/- oleclumab in subjects with advanced solid tumors.

Study D6770C00001 is a Phase 1, first-in-human, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, and immunogenicity of IPH5201 in adult subjects with advanced solid tumors, when administered as monotherapy or in combination with durvalumab ± oleclumab.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects; age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Subjects diagnosed with advanced solid tumors.
* For Part 1 and Part 2 (IPH5201 in monotherapy or combined with durvalumab):Subjects must be refractory to standard therapy or for which no standard therapy exists.
* For Part 3 (IPH5201 combined with durvalumab and oleclumab): Subjects must have received and radiologically progressed on 1 prior line of systemic therapy for metastatic pancreatic ductal adenocarcinoma.
* Subjects must have at least 1 measurable lesion according to RECIST v1.1.
* Subjects must provide tumor specimens .

Exclusion Criteria:

* Receipt of any conventional or investigational anticancer therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1 antibodies) within 21 days of the planned first dose.
* Receipt of agents targeting CD73, CD39, or adenosine receptors.
* Concurrent enrollment in another therapeutic clinical study.
* Any toxicity (excluding alopecia) from prior standard therapy that has not been completely resolved to baseline at the time of consent.

  * No toxicity leading to permanent discontinuation of prior IO therapy
  * Subjects must not have required the use of additional immunosuppression other than corticosteroids
* Active or prior documented autoimmune or inflammatory disorders within the past 5 years
* Cardiac and vascular criteria:

  * Presence of myocardial infarction or unstable angina , or stroke, within 6 months.
  * Congestive heart failure, serious cardiac arrhythmia requiring medication, or uncontrolled hypertension
  * History of severe hypertension
  * History of any grade of blood clot within 6 months
* Active infection, including tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); or human immunodeficiency virus (HIV)
* Uncontrolled illness including certain lung diseases, uncontrolled diabetes, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study.
* Other invasive malignancy within 2 years.
* Major surgery within 28 days prior to first dose
* Female subjects who are pregnant or breast feeding
Evaluation of PET-CT Using Somatostatin Agonists Labeled With Gallium68 in Neuroendocrine Tumors

Gastro-Entero-Pancreatic tumors (GEPs) are a subset of Neuroendocrine tumors (NETs) derived from the primitive gut and include digestive and bronchial NETs.

Historically, the gold standard in their functional exploration is the "conventional" somatostatin receptors scintigraphy (SRS) labeled with Indium-111 (Octreoscan®). This reference imaging is complementary to Tomography (CT) and liver MRI. However SRS sensitivity is moderate (60 %), because of its intrinsic detection limits, which could delay the diagnosis or lead to inappropriate therapy.

The use of somatostatin agonists (DOTATOC, DOTATATE, DOTANOC), radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of TNE with a gain in sensitivity of over 20% compared to SRS. Furthermore, patient irradiation and imaging protocol are significantly reduced.


Eligibility Criteria:
Inclusion Criteria:

* • Age ≥ 18,

  * Patient with one of the following situations : suspicion of GEP, initial staging of non-metastatic GEP, GEP with unknown primary tumor, Restaging of GEP justifying focused therapeutic approach
  * Reference imaging within the last 3 months: multiphasic thoracoabdominal CT scan, liver MRI and SRS (SPECT/CT).

Exclusion Criteria:

* Pregnant or breast-feeding woman
* Other cancer disease
* GEP with grade 3 tumours
* Non GEP TNE (paragangliome, medullar thyroid cancer)
Nutritional Counseling vs. Nutritional Supplements for NASH - a Randomized Prospective, Open Label Pilot Study

The main aim of the study is to determine if an oral supplementation of the LCS has a beneficial effect by itself or even enhances the beneficial effects of a moderate life-style intervention on the progression of NAFLD in humans.


Eligibility Criteria:
Inclusion Criteria:

- Elevated M30 antigen levels (cutoff: \>200 - 800 U/L) at screening AND hepatic steatosis on ultrasound

OR histologically confirmed NASH

- Age 18 to 75 years

Exclusion Criteria:

* Alcohol intake of more than 30 g/d (men) or 20 g/d (women)
* Treatment with ursodeoxycholic acid (UDCA), Vitamin E or other investigational NASH drugs 3 months prior to randomization
* Treatment with medications or substances that may induce secondary NASH (e.g., tamoxifen, corticosteroids, amiodarone, methotrexate) or ameliorate NASH (TNF-antagonists)
* Treatment with phenprocoumon or warfarin
* Hepatocellular carcinoma or non-hepatic malignancy
* Decompensated cirrhosis (Child B,C) or a history of decompensation
* Liver disease unrelated to NASH, including chronic viral hepatitis B/D or C, autoimmune hepatitis, Wilson's disease or clinical manifest iron overload
* Bariatric surgery within the last 5 years
* BMI \<18,5 kg/m2 or BMI \>45 kg/m2
* Liver transplantation
* Heart failure (New York Heart Association Class II - IV)
* Myocardial infarction, instable coronary artery disease , coronary artery intervention or stroke in the previous 6 months
* Instable chronic obstructive pulmonary disease, chronic inflammatory bowel disease or rheumatoid arthritis.
* Instable renal insufficiency (changes in serum creatinin \> 50% in the last 3 month) or terminal renal insufficiency requiring dialysis
* Uncontrolled hypertension (blood pressure \> 180/90 despite therapy)
* Uncontrolled diabetes mellitus defined by hemoglobin A1c \> 9
* Food allergies requiring strictly dietary adherence
* Pregnant or nursing women
* Chronic pancreatitis or history of recurring acute pancreatitis
Intervention to Reduce Sedentary Time

The purpose of this study is to determine whether the researchers can help people change the amount of time they spend in sitting activities and whether this change might improve health outcomes.

Specific Aim 1: Determine feasibility of a 12-week home and telephone based intervention in older adults with mild cognitive impairment targeting both the impaired individual and their study partner to help initiate and maintain behavior change. We will recruit KUADC registry participants with MCI and their caregivers (as study partners). Behavioral interventions are more effective when there is built in social support. We will evaluate feasibility in terms of successful recruitment and retention of participants, 10% or less of technological failures, rate of participant concerns addressed by phone and at home visits, acceptability of the intervention to participants (measured by questionnaires during home visits).

Specific Aim 2: Determine whether a 12-week home and telephone based intervention results in reduced total sitting time and shorter bouts of sitting in older adults with MCI and their caregivers. Electronic postural monitors will record sitting time for a duration of one week at three time points (pre-intervention, mid-intervention, and post-intervention). The intervention includes 1) feedback from baseline monitoring, 2) educational and goal setting session with the participants and research staff, 3) wrist worn monitors that alert wearers to sitting times \>30 minutes, 4) home and telephone visits to address physical, psychological, and home environment barriers to behavior change. Changes in sitting time and breaks from sitting will be compared between baseline, mid-intervention, and post-intervention measurement occasions.

Specific Aim 3: Determine whether sedentary behavior intervention results in improved insulin sensitivity and glycemic control. To evaluate whether reduced sitting results in meaningful metabolic changes, we will measure postprandial insulin and glucose, and body composition, and evaluate changes from pre- to post- intervention adjusting for relevant covariates.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the University of Kansas (KU) Alzheimer's Disease Center (ADC) Registry
* Clinical Dementia Rating (CDR) = 0.5
* Inactive status as determined by the Measure of Older Adults' Sedentary Time (MOST) questionnaire
* Retired or \<20 hours/week in an office
* Lives with partner in a community dwelling setting

Exclusion Criteria:

* Unable to stand or walk unassisted
* Inadequate visual, auditory, or English language capacity
* Adhesive allergy
* Current uncontrolled Type 2 diabetes
* Unwilling to change sitting behavior
Radiotherapy Plus Concurrent Nimotuzumab or Cisplatin in Stage II-III Nasopharyngeal Carcinoma

This is a Phase III trial to study the effectiveness of nimotuzumab versus cisplatin combined with intensity-modulated radiation therapy (IMRT) in treating patients with stage II-III nasopharyngeal carcinoma.

Scheme:

Eligible stage II and III NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.

- Arm Cisplatin: cisplatin 40mg/m2/week in concurrent with IMRT

- Arm nimotuzumab: nimotuzumab 200mg/week in concurrent with IMRT

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
* histologically confirmed positive EGFR expression
* Stage II and III NPC patients（according to the 8th AJCC edition）
* Male and no pregnant female
* Age between 18-65
* Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL
* Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<2.0×upper limit of normal (ULN)
* Adequate renal function: creatinine clearance ≥60 ml/min
* Satisfactory performance status: Karnofsky scale (KPS) \> 70
* Without radiotherapy or chemotherapy
* Patients must give signed informed consent

Exclusion Criteria:

* Evidence of relapse or distant metastasis
* History of prior malignancy or previous treatment for NPC
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
* Pregnancy or lactation
Baseline Concentration of Direct Oral Anticoagulant and Incidence of Adverse Event Measure And See (MAS)

The MAS Study is an observational, multicentre, prospective cohort study in Non valvular Atrial fibrillation (NVAF) patients treated with one of the direct oral anticoagulants (DOACs) available in Italy for NVAF patients.

The general aim is to deepen the knowledge of DOAC treatment in NVAF patients, by measuring the plasma concentration of anticoagulant drugs and their correlation with any adverse events that may occur during treatment.

The MAS Study is an observational, prospective cohort study, double blind, multicentre, international and no Profit. Anticoagulation clinics, affiliated or not to the Italian FCSA, will be asked to take an active part in the study, provided they have the facilities for blood sampling and processing.

4000 consecutive NVAF outpatients, 1000 for each single drug, starting anticoagulation with one of the four DOAC (apixaban, dabigatran, edoxaban, rivaroxaban) will be enrolled at the moment of the first prescription. Patients will receive the type and dosage of DOAC on the base of clinical characteristics at the discretion of the attending physician, as the normal clinical practice, and the study will not influence the decision of the type and dosage of DOAC.

The primary study objective is to evaluate the possible relationship between DOAC anticoagulant levels at the trough, measured at steady state (within the first 2-4 weeks of treatment) and occurrence of bleeding and thromboembolic events during the subsequent one year follow up

Eligibility Criteria:
Inclusion Criteria:

* NVAF patients starting DOAC anticoagulation
* age \> 18 years
* ability to give written informed consent
* availability, as part of the normal withdrawals, to the blood sampling for the study purpose
* availability for 12-months follow-up

Exclusion Criteria:

* age \< 18 years
* indication for electrical cardioversion at the moment of drug prescription
* participation in Phase II or III clinical trials
* indication for treatment different from NVAF
* not suitable to give or not giving informed consent
* not available for blood collection or follow-up
Haploidentical Hematopoietic Cell Transplantation for Children With Hematologic Malignancies and Myelodysplasia

This is a Phase I/II study designed to evaluate the kinetics of hematopoietic reconstitution and the incidence of acute chronic GVHD after partially matched related donor hematopoietic cell transplantation using an αβTCR/CD19+ cell depleted graft.

Less than 30% of patients undergoing hematopoietic cell transplantation (HCT) will have an HLA-matched sibling donor. There is a high likelihood of being unable to identify a perfect HLA matched unrelated donor, and the time to procure the marrow if such a donor is available is generally \>3 months. An emerging body of literature suggests that related haploidentical HCT with innovative graft engineering may provide equal, or possibly superior, outcomes to conventional unrelated donors. This protocol is designed to test the hypothesis that HCT using an αβT cell / CD19+ B cell depleted graft from partially matched related donors will result in rapid, durable hematopoietic engraftment and rapid immune reconstitution with an acceptably low risk of severe acute and chronic GVHD.

Eligibility Criteria:
Inclusion Criteria:

* Patient lacks an HLA matched sibling donor.
* Meets criteria nonhematopoietic organ function according to NCH BMT SOP09.
* If subjects have received a first HCT, they must be eligible for a second HCT if their disease has recurred.
* High resolution HLA and KIR typing
* The subject cannot have an active untreated infection. Viremia by PCR analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti- fungal therapy and be asymptomatic.
* Negative pregnancy test for females ≥11 years of age or post- menarche.
* Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the Investigator. (Non-childbearing potential defined as pre-menarche, greater than one year post-menopausal or surgically sterilized).
* Subjects must be ≤30 years at the time of consent.
* Signed consent by parent/guardian and assent if appropriate for subjects \< 18 years of age. Signed consent by patient/subject if ≥18 years of age.

Exclusion Criteria:

* Patient does not have a suitable donor who is willing and able (meets donor criteria).
* Patient has donor-specific anti-HLA antibodies at the time of enrollment
* Patient reports a history of allergic reactions to murine protein

Donor Eligibility:

* The donor must be ≥18 years of age at the time of the informed consent conference.
* The donor must be a related donor
* The donor will be evaluated according to the current NCH BMT SOP 04 and must meet all criteria.
* The donor must be able and willing to undergo G-CSF mobilization and stem cell apheresis.
* The patient does not have donor specific anti-HLA antibodies
The Status of Asthma in the Korean Military Personnel

The aim of this study is to evaluate the status of allergic diseases in the Korean military personnel.

ISAAC (International Study of Asthma and Allergies in CHildhood) questionnaires are sent to military personnel in the republic of Korea. Military personnel are randomly selected representative of the number of soldiers in each area. We perform methacholine provocation test and MAST for current wheezer after informed consents.

Eligibility Criteria:
Inclusion Criteria:

* Korean military personnel who can respond questionnaire

Exclusion Criteria:

* Person who refuse to participate in this study