cyrilzakka/clinical-trials huggingface dataset:
A Phase 3 Lot-consistency Clinical Trial of Live Attenuated Varicella Vaccine

The purpose of this study is to evaluate consistency, immunogenicity and safety of live attenuated varicella vaccines manufactured at commercialized scale in aged 1-3 years children.

The study is a single-center, double-blind, randomized, bridging clinical trial. The purpose of this study is to evaluate the consistency between each two lots of live attenuated varicella vaccines, to evaluate the non-inferiority of the immunogenicity of live attenuated varicella vaccines manufactured at commercialized scale compared to trial-scale, and to evaluate the safety of live attenuated varicella vaccines. 1197 healthy Chinese children aged 1 to 3 years old were randomly assigned into four groups in the ratio 2:2:2:1. Children in the first three groups were administered with one dose of live attenuated varicella vaccines manufactured at commercialized scale, and children in the last group were administered with one dose of live attenuated varicella vaccines manufactured at trial-scale .

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer between 1-3 years old;
* legal identity;
* Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.

Exclusion Criteria:

* Prior vaccination with varicella vaccine or with history of varicella infection;
* Axillaty temperature \> 37.0 °C before vaccination;
* History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
* Epilepsy (except febrile seizures), history of seizures or convulsions, a family history of mental illness, autoimmune disease, or immunodeficiency;
* Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases;
* Acute disease or acute stage of chronic disease within 7 days prior to study entry;
* Receipt of any blood product, immunosuppressant, hormone, other investigational medicine(s) within 30 days prior to study entry;
* Receipt of any live attenuated vaccine within 1 month prior to study entry, or receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
* Any significant abnormity of heart, lung, liver, spleen, lymph nodes, or pharynx;
* Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded.
FINPOP 2015: Incidence, Methods, Complications and Quality of Life of Pelvic Organ Prolapse Operations in Finland 2015

The aim of this study is to investigate the safety and effectivity of pelvic organ prolapse (POP) surgery. In this multi center study the population consists of POP operations done in Finland year 2015.The study is prospective and validated questionnaires are used to measure the symptoms of POP and the quality of life before and six months after the operation. Methods and complications of surgery are reported by doctors in all 40 participant hospitals.

Patients awaiting for surgical procedure for a symptomatic pelvic organ prolapse (POP) are recruited for the study. The recruiting is done in 41 hospitals in Finland, at gynecological outpatient clinics. Participants are given information of the study and give a written approval to join the study. Participants are asked to fill in questionnaires, that measure the quality of life. Three validated questionnaires are used: Pelvic Floor Distress Inventory PFDI-20, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire PISQ-12 and health-related quality of life instrument 15D. These questionnaires are sent to participants 6 months, 2 and 5 years after the surgical treatment. The participants are also asked to report adverse effects related to the treatment and their satisfaction to the treatment. Information about the surgical procedure (i.e. type and duration of the procedure, blood loss, antibiotic and thrombosis prophylaxis) by the operating doctors. Both immediate and delayed treatment-related adverse effects are also reported by the doctors. Data is partly collected by questionnaires filled in internet. All the collected data is protected by high security and coded before analyses. Permission of protocol used in this study is given by the Ethical Committee of University of Eastern Finland and Finnish National Institute for Health and Welfare.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic pelvic organ prolapse
* Mental and psychological ability to understand the study information and to give an approval
* Knowledge of Finnish or Swedish language

Exclusion Criteria:

* Other than Finnish or Swedish language
* Psychological disability to understand the study information
Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)

The purpose of this study is to develop blood tests and urine tests that can tell doctors how much radiation a person has been exposed to. Doctors know how much radiation patients are exposed to in certain medical situations. An example of this would be radiation treatment for cancer. Radiation treatment machines are programmed to give exact doses of radiation.

MSKCC patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have blood drawn and urine collected for use in the validation and refinement of new methods for rapid high-throughput radiation biodosimetry. These blood and urine samples will be collected before, and at defined times after TBI. Blood sampling will occur in the same manner that it does during routine patient care during HSCT.

Eligibility Criteria:
Inclusion Criteria:

* Patients greater than 4 years of age at Memorial Sloan-Kettering Cancer Center
* Must be undergoing hematopoietic stem cell transplantation (either autologous or allogenic) in conjunction with a conditioning regimen that includes TBI (single or multiple fraction)
* Functional central venous catheter

Exclusion Criteria:

* No subjects will be excluded from the proposed research study for demographic reasons. Treatment with growth factors, such as keratinocyte growth factor (KGF), will not be grounds for exclusion.
* Subjects who will receive radiation therapy within 5 days prior to TBI will be excluded.
* Subjects who will receive systemic antineoplastic chemotherapy within 7 days prior to TBI not have research bloods collected. Only urine will be collected from these patients.
* Based on current knowledge, we will not a priori exclude patients based on disease status (ie, patients in or out of remission will be included in this study), type of disease(ie, chromosomal breakage syndromes), or previous therapies (unless exclusion criteria is met).
Evaluation of MBL Around Implants Placed in Crestal or Subcrestal Positions: a RCT

The objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest

The objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest. Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant). Patients will be recalled for oral hygiene maintenance and prosthetic controls at 1year, 3 years, 5 years after final restoration.

Eligibility Criteria:
Inclusion Criteria:

1. Absence of 2-4 teeth in the posterior region of the maxilla or mandibular;
2. Bone volume sufficient for implants with 4.1-mm size and 8- to 12-mm height and with no need for hard or soft tissue augmentation for implant treatment;
3. Periodontally healthy.

Exclusion Criteria:

1. Systemic diseases that may affect bone and soft tissue healing, such as diabetes, osteoporosis, Paget's disease, and patients with cancer;
2. Uncontrolled periodontal disease or poor oral health with neither good nor adequate plaque control;
3. Parafunctional habits, such as the grinding or clenching of teeth;
4. Smoking habit (more than 10 cigarettes per day);
5. Pregnancy and breastfeeding.
Assessment of Prepulse Inhibition for Shock Pain Reduction

Patient tolerance of pain from discharges of implantable cardioverter defibrillators (ICD's) is highly variable. It can be influenced by psychological factors, physical condition and the number of shocks delivered.

It has been shown that cutaneous pain perception can be reduced by delivery of a weak , low voltage pulse (prepulse)prior to the delivery of a stronger shock.

A prepulse delivered before a high voltage ICD shock will decrease discomfort compared to a shock of equal energy without a prepulse.


Eligibility Criteria:
Inclusion Criteria:

18+ Approved indication for implantation of an ICD Able and willing to provide informed consent Independently complete and understand the Mini Mental State Evaluation

Exclusion Criteria:

Pregnancy Cannot understand English or French Contraindicated for defibrillation testing because of risk of thromboembolism Deaf or hard of hearing, making the acute testing difficult to conduct having pain or anxiety to the extent that, in the opinion of the investigator, the results would be confounded.

Having a Class I bradycardia pacing indication, requiring ongoing pacing support.

Visual problems which preclude reading the computer screen for the VAS test Severe musculoskeletal disorder that makes it difficult to undergo testing in the recumbent position Do not achieve a score \>24/30 on a Mini Mental State Exam
Investigating the Effects of Hydroxyvitamin D3 on Multiple Sclerosis

Investigating the effects of hydroxyvitamin D3 on clinical, radiologic and immunomodulatory markers in MS patients: A randomized, clinical trial- a pilot study

Vitamin D deficiency/insufficiency is a risk factor for developing MS and is linked to increased disease activity in those with established disease. Several clinical trials have already been conducted to consider the effect of vitamin D supplementation on clinical outcomes of the disease but the findings were inconsistent.

This paradox may be explained by supplementation dose, trial duration and also an insufficient rise in serum 25-hydroxyvitamin D to be effective on immunomodulatory pathways and consequent clinical outcomes.

Of note, it was revealed that MS patients have a lower rise in serum 25-hydroxyvitamin D \[25(OH)D\] levels compared with healthy controls (HCs), when given the same amount of oral cholecalciferol supplementation.

Cholecalciferol is the main vitamin D supplement that was used in these trials. When vitamin D3 is ingested, it is incorporated into chylomicrons and enters the lymphatic system. The chylomicrons then enter into the bloodstream via the superior cava. Most of the vitamin D is incorporated into the body fat.

Vitamin D3 in the circulation and the vitamin D3 that is slowly released from the body fat into the circulation is converted in the liver to 25(OH)D3, taking approximately 6-8 weeks to achieve a steady state concentration of 25(OH)D3.

The more rapid increase in serum concentrations of 25(OH)D3, by treatment with calcifediol instead of cholecalciferol, may provide an advantage through rapid entry into its target innate and adaptive immune cells, resulting in the paracrine/autocrine production of 1α,25(OH)2D which interacts with the vitamin D receptor (VDR) to modulate immune function.

Eligibility Criteria:
Inclusion Criteria:

1. MS type: relapsing-remitting MS (RRMS)
2. older than 18 year-old
3. Vitamin D deficiency/insufficiency (25(OH)D\<30 ng/ml

Exclusion Criteria:

1. medications or disorders that would affect vitamin D metabolism
2. history of other chronic disorders
3. history of conditions that could lead to high serum calcium levels
4. pulse therapy in the last 3 months
5. history of attack in the last 3 months
6. using corticosteroid in the last 3 months
7. be pregnant
Arginine/Omega-3 Fatty Acids/Nucleotides Nutritional Supplement in Treating Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy

RATIONALE: Giving a nutritional supplement containing arginine, omega-3 fatty acids, and nucleotides to patients undergoing chemotherapy and radiation therapy may stimulate the immune system and help the body build a stronger immune response.

PURPOSE: This phase II trial is studying how well an arginine/omega-3 fatty acids/nucleotides nutritional supplement works in treating patients with stage III or stage IV head and neck cancer undergoing chemotherapy and radiation therapy.

OBJECTIVES:

* Assess the effects of immunomodulator arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) administered via percutaneous gastrostomy during adjuvant chemoradiotherapy in patients with stage III or IV epidermoid head and neck cancer.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy 5 days a week for 6½ weeks. Patients receive cisplatin IV during weeks 1, 4, and 7 of radiotherapy. Patients also receive arginine/omega-3 fatty acids/nucleotides oral supplement (Oral IMPACT®) via percutaneous gastrostomy tube 3 times daily for 5 days before each chemotherapy treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of head and neck cancer meeting the following criteria:

  * Epidermoid carcinoma
  * Stage III or IV disease
* Must have percutaneous gastrostomy tube in place
* Must have undergone prior surgery for head and neck cancer within the past 6-8 weeks
* No cerebral metastases

PATIENT CHARACTERISTICS:

* WHO performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy \> 3 months
* WBC \> 4,000/mm³
* ANC \> 2,000/mm³
* Platelet count \> 100,000/mm³
* PTT ≥ 50%
* Creatinine \< 130 μmol/L
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No severe sepsis
* No requirement for parenteral nutrition
* No pre-existing digestive pathology that results in bowel obstruction, nausea, vomiting, and/or abdominal pain \> grade 1

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
The Effect of Aromatherapy for First Dental Visit Patients

First dental visit experience is strongly correlated with dental anxiety, the aim of this protocol is to explore the efficacy of olfactory aromatherapy for the reduce of dental anxiety and pain in first-visit patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients who never visited dental clinics before;
* Patients who need dental treatment, such as resin filling, root canal treatment, periodontal initial treatment, tooth extraction, etc;
* Patients and their guardians who are able to understand the purpose of the study and volunteer to take part in the study;
* Patients who are intellectually sufficient to complete the anxiety scale;
* Be able to complete all assessments and follow-up during the study.

Exclusion Criteria:

* Patients who are allergic to the ingredients of the essential oils used in the experiment or to the materials used in the dental treatment;
* Patients who underwent only an oral examination;
* Patients with severe heart disease, hypertension, respiratory disease, or other systemic conditions that were not eligible for trial participation;
* Pregnant or lactating women;
* People with depressive symptoms, anxiety disorders or other mental illnesses that affect their mood state;
* People who are using sedative or analgesic drugs;
* Recent or current users of essential oils;
* Any circumstances considered by the investigator to be inappropriate for participation in this study.
Narrative Exposure Therapy (NET) for Victims of the Recent Flood Disaster in Burundi

In the aftermath of natural disasters, e.g., flood disasters, there is a great need for humanitarian assistance in the domain of psychological support. This is particularly true in post-conflict settings because people have suffered severely from multiple traumatic events and situations during their lives. The Narrative Exposure Therapy (NET) is a short-term, culturally sensitive treatment approach that aims to reduce Posttraumatic Stress Disorder (PTSD) symptoms.

The investigators want to provide evidence, that NET is an effective and efficient module to assist people in the aftermath of natural disasters using the example of the recent flood disaster in Burundi. In addition the investigators aim to explore, how traumatic incidences and maltreatment during childhood may influence treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Individuals severely affected (e.g., who had lost their children) by the flood disaster in Bujumbura
* All participants were part of the emergency program of the Red Cross Burundi who assisted those most affected by the flood disaster in Bujumbura
* Inclusion criteria for therapy: High degree of symptoms of posttraumatic stress disorder according to the Posttraumatic Symptom Scale - Interview (PSSI)

Exclusion Criteria:

* Pregnancy
* Current substance dependence
* Psychotic symptoms
Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors

An open, non-randomized, multicenter, single-arm dose-escalation design, phase 1 trial to study the safety, tolerability, pharmacokinetics and efficacy of JYP0322 in patients with ROS1+ locally advanced/metastatic solid tumors .

JYP0322 is an orally available inhibitor of ROS1 (coded by the gene ROS1). Molecular fusions are present in several different tumor types, including non-small cell lung cancer (NSCLC), glioma, etc. Patients with locally advanced or metastatic cancer with a detectable molecular fusion in targets of interest may be eligible for enrollment.

Phase 1 will assess safety and tolerability of JYP0322 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in the dose expansion portion of the study.

Eligibility Criteria:
Key Inclusion Criteria

* Adult patients age 18 years or older.
* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a ROS1 molecular fusion.
* Measurable disease according to RECIST version 1.1
* Life expectancy of at least 3 months
* Other protocol specified criteria

Key Exclusion Criteria:

* Current participation in another therapeutic clinical trial.
* Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
* A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.
* Known active infections (bacterial, viral including HIV positivity).
* Other protocol specified criteria
The Efficiency of CAMS (Chinese Academy of Medical Sciences)-2016 Trial for Pediatric Acute Myeloid Leukemia

The purpose of this study is to evaluate that whether the AML (acute myeloid leukemia)-CAMS (Chinese Academy of Medical Sciences)-2016 regimen, includes risk-stratified therapy and the use of Dasatinib in CBF (Core binding factor)-AML, can improve the outcome in childhood AML.

Primary AML includes CBF(Core binding factor)-AML and non-CBF-AML. After the second course of therapy, CBF-AML are stratified into two risk groups: low-risk children are defined as those with CR after MAE or CAG, high-risk children are those with CR after consolidation course 1 or IAE. Non-CBF-AML patients in remission are stratified into three risk groups: low-risk children are defined as those with t(1；11)(q21；q23) , GATA1, NPM1/IDH1/IDH2 without FLT3/ITD,or an age younger than 2 years without high-risk factors; high-risk children are those with CR after consolidation course 1 or IAE or with abnormalities of monosomy 7, 5q- , t(16;21), t(9;22) (Philadelphia chromosome \[Ph1\]), FLT3/ITD,-17/TP53, RPN1-MECOM, RUNX1-EVI1, MLF1-NPM1, PRDM16-RPN1, DEK-NUP214, ETV6(TEL)-HLXB9(MNX1), NUP98-NSD1; intermediate-risk children are those who were not in either a low-risk or high-risk group.Low-risk children were treated only with chemotherapy, regardless the availability of a suitable HSCT donor. All high-risk children were allocated to Allo-hematopoietic stem cell transplantation (HSCT) in the first remission, including unrelated bone marrow transplantation (BMT). Auto-HSCT is recommended for intermediate-risk children. No prophylactic cranial irradiation is included in the protocol. Patients are treated on an inpatient basis during each treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosis of de novo Acute Myeloid Leukemia

Exclusion Criteria:

* Children with Down's syndrome and acute promyelocytic leukemia, hybrid acute leukemia
The Effectiveness of Rehabilitation in Gait Recovery After Knee or Hip Arthroplasty

This study aims to evaluate the effectiveness of rehabilitation on gait recovery in subjects after knee or hip arthroplasty. Assessment is performed the day after admission (T0) and the day of discharge (T1), in a post-acute rehabilitation hospital, through an optoelectronic system (BTS DX-400). Other functional scales are administered to the subjects. during the rehabilitation period, subjects received conventional physiotherapy.


Eligibility Criteria:
Knee and Hip Arthroplasty subjects

Inclusion Criteria:

* Subjects \> 18 years;
* Both Sexs;
* Knee or Hip Arthroplasty in the previous 3-4 days before admission;
* Subjects with clinical stability at admission (Hemoglobin \> 9 g/l).

Exclusion Criteria:

* Fever at admission;
* Any rheumatic or systemic diseases;
* Previous surgery at the lower limbs (6 months before admission) or other arthroplasties at the lower limbs;
* MiniMental State Examination \< 24;
* Other neurologic disorders.

For the healthy volunteers

Inclusion Criteria:

* Subjects age-matched with the subjects in the hip and knee group.

Exclusion Criteria:

* Any disorder that could negatively affect gait perfomance.
Avascular Bone Necrosis in Sickle Cell Disease: a Pediatric Study.

Avascular necrosis (AVN) is a serious complication of sickle cell disease, especially in pediatric patients where the prevalence is between 3% and 8% and are more frequent in patients with multiple vaso-occlusive crisis (VOC). The prevalence of AVN is usually made by a study of the hip through radiography, whereas other possible sites of ischemic infarcts are evaluated only in case of specific symptoms. In addition, bone infarcts may be the trigger for additional VOC.

In this study, we want to investigate the presence of possible bone lesions even in asymptomatic or paucisymptomatic children.

This is a prospective interventional and monocentric study whose objective is to describe the prevalence of osteonecrosis in children with sickle cell disease in Italy


Eligibility Criteria:
Inclusion Criteria:

* Female or male patients diagnosed with sickle cell anemia (HbSS, HbS/β0, HbS/β+, HbSC) with or without known avascular lesions
* Age ≥ 7 and \< 18 years at the moment of signed consent
* Written informed consent/assent, according to local guidelines, signed by patient and/or guidelines, signed by the patient and/or at least one parent or legal guardian

Exclusion Criteria:

* - Any contraindication to perform Nuclear Magnetic Resonance Magnetic Resonance Imaging (MRI)
* Inability to obtain informed consent/assent