cyrilzakka/clinical-trials huggingface dataset:
The Effects and Safety of Low Calcium Dialysis on Coronary Artery Calcification in Maintenance Hemodialysis Patients

This study aim to observe the preventive effect and the long term safety of low calcium dialysis on coronary artery calcification in Maintenance hemodialysis (MHD) patients.

MHD patients recruited in this study were randomly divided into two groups: routine dialysis group (with dialysate calcium concentration 1.5mmol/L) and low calcium dialysis group (with dialysate calcium concentration 1.25mmol/L). All patients were dialyzed thrice weekly for 4 hours with a bicarbonate-based solution. They were followed up in every dialysis interview during the 1-year study, the occurrence of all adverse reactions associated with dialysis were recorded during the study. All patients received heart spiral CT examination before and at the end of the study. Coronary artery calcification was assessed by a certain professional who was not affiliated to the dialysis center.

Eligibility Criteria:
Inclusion Criteria:

* Maintenance hemodialysis (MHD) patients who dialyze thrice weekly in our hospital with serum iPTH \<500pg/ml, adjusted serum calcium≧8.4mg/dl in two serial tests.
* Patients who have no chronic infection or malignant tumour and with relatively stable heart and lung function.
* Patients who signed informed consent documents at the time of enrollment in the study.

Exclusion Criteria:

* Patients whose heart or lung function are poor, or with unstable hemodynamics.
* Patients who are diagnosed active pulmonary tuberculosis, AIDS, malignant tumour, or decompensated liver cirrhosis.
* Patients who are unable or unwilling to cooperate with the researchers in the treatment and follow-up.
Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).

The entire study consists of a 12-week wash-in/wash-out period followed by a 12-month treatment period. Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 2 to 75 years
* Subjects with primary humoral immunodeficiency, namely with a diagnosis of: CVID (Common Variable Immunodeficiency) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or XLA (X-linked Agammaglobulinemia)
* Written informed consent

Exclusion Criteria:

* Newly diagnosed PID
* Evidence of an active serious infection at the time of screening (i.e., but not limited to: bacteremia/septicemia, pneumonia, fungal osteomyelitis)
* Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma
* Known hyperprolinemia
* Hypoalbuminemia, protein-losing enteropathies, and any proteinuria
* Allergic reactions to immunoglobulins or other blood products
* Known antibodies to Immunoglobulin A (IgA)
* The subject is receiving steroids (oral and parenteral, daily ≥ 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants
* Female who is pregnant, breast feeding or planning a pregnancy during the course of the study
* Participation in a study with an investigational product other than (IVIG) within 1 month prior to enrollment
* A positive result at screening on any of the following viral markers: Human Immunodeficiency Virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV)
* Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration \> 2.5 times the upper normal limit (UNL)
* Creatinine concentration \> 1.5 times the UNL
* Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
Postoperative Pain After the Removal of Root Canal Filling Material

The aim of this study was to evaluate the intensity and duration of postoperative pain after the removal of root canal filling material in retreatment procedures of upper incisor teeth with chronic apical periodontitis, using different techniques.

The patients were assigned to three groups of 45 patients, according to the method used to remove old canal filling material. The presence of postoperative pain was assessed after 6, 12, 24, 48, and 72 hours, 7 days, and finally after 10 days.

The hypothesis of this study: there would be no difference in postoperative pain intensity among the groups.


Eligibility Criteria:
Inclusion Criteria:

* asymptomatic incisor teeth with chronic apical periodontitis
* patients between 18-55 years of age

Exclusion Criteria:

* patients with systemic disease
Steps for PRosTAte Cancer Health and Survival (SPaRTACuS): Pilot Study of a Walking Intervention to Improve Health and Quality of Life in Prostate Cancer Patients

The purpose of this study is to determine whether sustainable daily physical activity is effective in improving biological indicators of health and self-reported quality of life in men with prostate cancer.

Living with prostate cancer is a unique challenge faced by millions of men across the globe. Existing research has indicated many potential methods of attenuating prostate cancer progression and preserving patients' quality of life, but is lacking in definitive conclusions regarding the effectiveness of these methods in practice. This study seeks to further investigate the impact of post-diagnosis physical activity on biological indicators of health and self-reported quality of life in a cohort of men with prostate cancer in Sweden. Participants are randomized to either a walking intervention group, which encourages walking 10,000 steps per day for one year, or to a standard-or-care control group, and followed for 11 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 80 years or younger
* Histologic confirmation of prostate cancer
* Clinically or pathologically staged as locally advanced or early metastatic prostate cancer
* Diagnosis within 1 year of study enrollment
* Willing and able to walk 10,000 steps per day

Exclusion Criteria:

* Age greater than 80 years old at enrollment
* Inability to understand the language spoken in host country
* Physically unable to walk 100 meters unassisted
* Diagnosed with dementia or severe psychiatric disease
* Any prior cancer diagnosis
* Has experienced a myocardial infarction or stroke within six months of cancer diagnosis
A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With Systemic ALK(+) ALCL

With the development of molecular biology and precise medical treatment, new challenges have been raised in the diagnosis and treatment of non-Hodgkin lymphoma (NHL) in children. In recent years, the criteria for clinical staging and efficacy evaluation of NHL in children have been updated. Studies in Germany and the United States have shown that pathological types of systemic anaplastic large cell lymphoma (ALCL) in children and adolescents, minimal disseminated disease (MDD) in peripheral blood or bone marrow and minimal residual disease (MRD) are significantly associated with prognosis, suggesting that these factors need to be combined in risk stratification of ALCL patients. Recent studies have also suggested that PET/CT is helpful in evaluating residual lesions in patients with lymphoma after chemotherapy. In order to keep pace with the times in the diagnosis, clinical staging, risk stratification, efficacy evaluation and treatment of NHL in children. We adjusted the original NHL-BFM-90/95 regimen, mainly in the aspects of clinical staging, efficacy evaluation, risk stratification and treatment regimen，etc.

Research purpose:

1. To study the efficacy and safety of SCCCG-ALCL-2017 regimen in children with systemic ALK-positive anaplastic large cell lymphoma.
2. To explore the correlation between MDD or MRD in peripheral blood or bone marrow and the treat response and survival.
3. To explore the feasibility of risk stratification combined with adverse pathological types, dangerous organ invasion and MDD.
4. To investigate the effect of vinblastine maintenance chemotherapy on survival of patients with MRD-positive in peripheral blood after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age \< 18 years old
2. Pathologically confirmed systemic ALK-positive anaplastic large cell lymphoma
3. Newly diagnosed patients
4. Informed consent of guardian of children patients

Exclusion Criteria:

1. Secondary immunodeficiency disease
2. Second neoplasm
3. Primary cutaneous anaplastic large cell lymphoma
4. Recurrent and progressive patients.
Understanding Genetic Incidental Findings in Your Family (UNIFY Study)

Currently, there is no clear legal or ethical guidance about how researchers and IRBs ought to proceed when the research participant in a biobank is deceased and there is clinically relevant information that could be disclosed to family members. This study is designed to test a procedure offering genetic information to family members of research participants who participated in a pancreatic cancer biobank in a Health Insurance Portability and Accountability Act (HIPAA) -compliant design.

To develop, prototype, and evaluate a novel procedure for offering probands' genetic results to family members. The intervention is to offer a deceased research participant's actionable germline genetic research finding, and depending upon the choice made by the next of kin, a disclosure of the research finding by a genetic counselor in a family conference call. Using mixed methods (quantitative and qualitative), the investigators will assess decision making, family communication, and actions and responses in individuals from families in which a proband is known to have a deleterious germline mutation in one of several known cancer susceptibility genes.

Eligibility Criteria:
Family members and others authorized to receive health information of participants enrolled under Institutional Review Board (IRB) #354-06 and #355-06 who carry one of several known cancer susceptibility genes.

* Mentally competent and able to provide informed consent
* Able to understand and read English
Hematology Biobank : Invitro Study of Blood Disorders

This is a bio repository of blood specimens from subjects with different Hematological disorders.

There has been a marked increase in our knowledge of Blood Disorders in the last decade. Much of this knowledge comes from examining blood specimens from patients and subjecting these samples to red cell, plasma, serum or DNA analyses. We propose to set up a Hematology biobank, which will include patient histories, their medical progress and a linked but de-identified bank of blood samples. This will enable us to have a large database, which can be used to learn more about these diseases.

The Hematology biobank will use whole blood, red blood cells, plasma, serum and/or DNA.

Eligibility Criteria:
Inclusion Criteria:

Above 18 years of age and able to consent

Exclusion Criteria:

None
Lactobacillus Brevis CD2 Preventing Oral Mucositis

A pilot study on efficacy of Lactobacillus CD2 lozenges in preventing oral mucositis (OM) by high-dose chemotherapy with autologous hematopoietic stem cell transplantation. To test whether the probiotic Lactobacillus brevis CD2 lozenges can reduce the incidence and severity of high-dose chemotherapy conditioning regimen induced OM in patients undergoing HSCT.

Clinical activity will be defined as reduction in the incidence of chemotherapy induced OM in the patients undergoing HSCT.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Karnofsky Performance Score ≥ 70%.
* Confirmed histological diagnosis of multiple myeloma for which HSCT is as approved modality of therapy
* Patients eligible to receive high-dose chemotherapy as part of conditioning regimen
* Concomitant co morbid condition if present, controlled by ongoing treatments (e.g. hypertension, diabetes and so on)
* Serum creatinine \< 1.8mg/dl
* Total bilirubin \< 2mg/dl
* Liver enzymes within three times of normal limit
* Expected survival \> 6 months.

Exclusion Criteria:

* Pregnant women and lactating mothers
* Patients with history of HIV infection
* Patients who have taken any other investigational product in last 4 weeks
* Patients having untreated symptomatic dental infection
* Patients with WHO Grade 3 or 4 oral Mucositis
* Other serious concurrent illness
* Inconclusive hematological diagnosis
* Patients with signs and symptoms of systemic infections
* Patient's/guardian's refusal to sign informed consent
Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)

This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition.

In this proof-of-concept study, our multidisciplinary team will conduct a pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition. We will randomly assign 21 cancer patients with newly created ostomies for cancer treatment with curative intent and their primary caregivers to the PRISMS or usual care groups (21 patient-caregiver dyads, a total of 42 individuals). PRISMS is defined as a personalized psychoeducational website including monitoring and personal feedback. We will conduct pre- and post-assessments of QOL and PRO (symptoms) at baseline upon enrollment and 2 months later.

Eligibility Criteria:
Inclusion Criteria:

Patients must:

* have been surgically treated for colorectal, bladder, ovarian, cervical, or uterine cancer with curative intent;
* be within one month of hospital discharge of a newly created ostomy with curative intent;
* be able to read and speak English;
* be 18 years or older;
* have a caregiver who is willing to participate in the study;

Caregivers must:

* be 18 years or older;
* be able to read and speak English;
* be identified as the primary caregiver by the patient;
* have not themselves been diagnosed with cancer or received cancer treatment during the study (to ensure that patients and caregivers focus their efforts on care of the patient).

Exclusion Criteria:

Patients and their caregivers will be excluded if they:

* are unable to read, speak, or understand English;
* have more than one type of ostomy;
* have other cancer diagnosis (excluding non-melanomatous skin cancer); or
* have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).
Canadian Community Utilization of Stroke Prevention Study - Emergency Department

Atrial fibrillation (AF) is a common heart condition, and increases the risk of stroke by six times. There are several medications (blood thinners) that can prevent strokes in AF patients. Many AF patients present to the emergency department, but about half of AF patients leave without prescription of a blood thinner. The study aims to evaluate if adding options like giving a patient education kit, encouraging emergency room physicians to prescribe a blood thinner and providing a specialized AF clinic to patients will increase the number patients receiving blood thinners to prevent strokes.

This is a knowledge translation study will occur in three consecutive phases: Phase 1 is a retrospective chart review of all patients who presented to the emergency department (ED) with ECG documented AF during 1 year prior to study commencement. The main purpose of Phase 1 is to determine if oral anticoagulants (OACs) were prescribed for eligible AF patients at ED discharge. In Phase 2 a low-intensity intervention will be applied in the ED during 6 months, involving physician education, distribution of an AF patient education package, short-term OAC prescription, and a follow-up letter to the patient's family physician. After a one month transition phase, a high intensity intervention will be applied during 6 months in Phase 3. Phase 3 incorporates the Phase 2 intervention, and adds immediate follow-up (within 48-72 hours) in a community AF clinic run by a nurse/pharmacist who is supervised by a specialist in AF.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present to the emergency department with electrocardiographically documented atrial fibrillation on a 12 lead ECG

Exclusion Criteria:

* Prosthetic or mechanical mitral or aortic valve
* Known rheumatic heart disease
* Unable to provide informed consent
* Will be admitted to hospital
* Life expectancy of \< 6 months
* Metastatic malignancy
Crestal Sinus Technique Using Autologous Fibrin Glue Vs Sticky Bone With Simultaneous Implant Insertion.

prospective comparison of minimal Invasive Crestal Sinus Technique Using Autologous Fibrin Glue Vs Sticky Bone with simultaneous implant insertion.

The aim of this study is to evaluate the clinical and radiographic outcomes of applying fibrin glue versus sticky bone in conjunction with crestal sinus lift technique associated with simultaneous implant insertion.

Eligibility Criteria:
Inclusion Criteria:

- a) Patients should be willing to be present for regular timely follow up. b) Residual bone height range from 5 to 9mm c) Patent ostium of maxillary sinus. d) Patients having missing maxillary posterior teeth. e) Patient cooperation and compliance are indispensible for a predictable clinical outcome.

f) Patients free from any systemic disease

Exclusion Criteria:

* 1) Patients with systemic disease that prevent surgical intervention or bone healing.

  2) Patients with acute or chronic maxillary sinusitis. 3) Patients with cyst, tumor or root tips at the planned surgical site. 4) Heavy smoker patients. 5) Elderly patients (over 60 years). 6) Patients with Poor oral hygiene or aggressive periodontal diseases. 7) Lack of motivation or inability to maintain oral hygiene.
Oxaliplatin in Rectal Cancer

* Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study
* Phase II: To determine the treatment efficacy according to response rates from phase I.


Eligibility Criteria:
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

* ECOG: 0-2
* Histological proved rectal adenocarcinoma
* No chemotherapy treatment on the previous 6 months before inclusion.
* No previous pelvic radiotherapy treatment

Exclusion Criteria:

* Important Biological abnormality (renal, hepatic and/or hematological)
* Intestinal occlusion or subocclusion
* Peripheral neuropathy
* Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.
* Participation in other trials on the previous 4 months.
A Randomized, Double-blind Clinical Investigation to Evaluate the Use of the Relievion™ Device in Treating Migraine.

This study will evaluate the clinical performance and safety of a self-administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relievion™).


Eligibility Criteria:
Inclusion Criteria:

* History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III (International Classification of Headache Disorders) beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
* Capable of cooperating with the study protocol and to sign an informed consent.

Exclusion Criteria:

* Patients having received Botox treatment in the head region in the prior 4 months.
* Patients having received supraorbital or occipital nerve blocks in the prior 4 months.
* History of Medication Overuse Headache.
* Patients using opioid medication.
* Allodynia: intolerance to supraorbital and/or occipital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 3 minutes of neurostimulation).
* Implanted metal or electrical devices in the head (not including dental implants).
* Patient having had a previous experience with the Relievion™ device.
* Patients who have concomitant epilepsy.
* History of neurosurgical interventions.
* Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
* History of drug abuse or alcoholism.
* Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
* Skin lesion or inflammation at the region of the stimulating electrodes.
* Personality or somatoform disorder.
* Pregnancy or Lactation.
* Women of reproductive age not using efficient contraceptive method.
* History of cerebrovascular event.
* Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).
Comparison of Two Exercise Therapy Protocols in Patients With Bruxism

The main purpose of this planned research is to investigate the effectiveness of three different methods used for the treatment of bruxism. Two of these are physiotherapy-specific exercise treatment protocols (1.posture and proprioception exercises 2. Jaw area strengthening exercises) and a control group, (occlusal splint therapy) will take place during the study.

The current study is planned as a parallel group, randomized controlled trial. Patients who apply to Adnan Menderes University Faculty of Dentistry between June 2022 and January 2023 and diagnosed with bruxism after the examination will be screened for the study. Aydın Adnan Menderes University Faculty of Dentistry is a hospital that serves an average of 400 patients per day.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of sleep Bruxism according to the criteria of the International Classification of Sleep Disorders (ICSD) of the American Academy of Sleep Medicine (AASM) (5);
2. 18-50 age range
3. The diagnosis of awake bruxism, which was determined by a positive answer to the questions of the questionnaire developed according to Pintado's recommendations (6);
4. Pain around the jaw is 3 or more on the visual analog scale (7)
5. Patients who volunteered to participate in the study

Exclusion Criteria:

1. Systemic and/or degenerative disorders
2. Neurological or psychiatric diseases (excluding anxiety and depression)
3. Use of drugs that affect sleep or motor behavior
4. Arthrogenic or mixed temporomandibular disorder
5. Axis I myogenic TMD according to investigational diagnostic criteria for temporomandibular disorders (RDC/TMD)
6. Patients using total prosthesis
7. Direct trauma or previous surgical intervention in the orofacial region
8. Patients using muscle relaxants and non-steroidal anti-inflammatory drugs.
9. Patients using removable prostheses
10. Patients who have received any treatment for bruxism
11. Patients who did not want to participate in the study