cyrilzakka/clinical-trials huggingface dataset:
An Immunity Persistence Study of Booster Dose of Live Attenuated Varicella Vaccine

This an open-label phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 6 and 10 years after booster dose.

A total of 792 subjects aged 2 to 6 years including in per-protocol set (PPS) of immunogenicity assessment from previous phase Ⅲ clinical trial were enrolled. About 3.0ml of venous blood was collected at 6 and 10 years after booster immunization for antibody detection.

Eligibility Criteria:
Inclusion Criteria:

* Subjects in PPS of previous phase Ⅲ clinical trial of varicella vaccine;
* The subjects and/or guardian can understand and voluntarily sign the informed consent form;
* Proven legal identity.

Exclusion Criteria:

* Beyond the blood collection window period;
* History of varicella or shingles;
* History of varicella vaccination since phase Ⅲ clinical trial;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
The Effect of Relactation Support Program on Milk Release

Aim: This study aimed to determine the effect of relactation support program on milk release, mother-infant attachment and maternity role.

Materials and Methods: This single-group pre-test post-test experimental study was conducted with 34 mothers who had 1-4 month old infants, stopped breastfeeding at least 15 days and at most 3 months ago and were registered in the family health centers of a province in the southern Turkey. The relactation support program was completed in 15 days, with eight home visits and seven telephone support sessions. The data were collected using a personal information form, a mother-infant follow-up form, the Maternal Attachment Inventory (MAI) and the Barkin Index of Maternal Functioning (BIMF).

Keywords: Mother-Infant Attachment, Maternity Role, Midwifery, Relactation, Milk Release.

This is a single-group pre-test post-test experimental study. This study was conducted between October 2021 and October 2022 in Family Health Centers (FHCs) in province in southern Turkey. By using the G\*power 3.1 program, the sample size was determined to include 29 mothers/women under 5% margin of error, 95% confidence level, and 95% power of representation.

Eligibility Criteria:
Inclusion Criteria:

For mothers;

* Having no milk release,
* Using no pharmacological agents that may increase milk release,
* Being not pregnant,
* Having no communication problem,
* Being literate,
* Being between the ages of 18-35 years,
* Having singleton gestation in their last childbirth,
* Using no medication that prevents breastfeeding (chemotherapy, etc.). For babies;
* Being healthy
* Having no congenital sucking problem (cleft palate, cleft lip, etc.)

Exclusion Criteria:

For mothers;

* Using any pharmacologic agent to increase milk release,
* Having a diagnosis of psychiatric illness. For babies;
* Having any metabolic disease that may prevent breastfeeding (galactosemia, phenylketonuria, etc.) or any other chronic disease (advanced heart disease, etc.).
LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung

This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.


Eligibility Criteria:
Inclusion criteria:

1. Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.
2. Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.
3. At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
5. Age \>= 18 years.
6. Adequate organ function as defined by the following criteria:

Serum aspartate transaminase(AST) and serum alanine transaminase(ALT) =\< 3 x upper limit of normal (ULN), or AST and ALT =\<5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin =\<1.5 x ULN Absolute neutrophil count (ANC) \>=1.5 x 109/L Creatinine clearance \> 45ml / min Platelets \>= 75 x 109/L

Exclusion criteria:

1. Prior systemic chemotherapy for stage IIIB or IV non-small cell lung cancer. Neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least 12 months has elapsed prior to disease progression.
2. Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.
3. Major surgery within 4 weeks of study randomisation.
4. Active brain metastases
5. Meningeal carcinomatosis.
6. Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured in the opinion of investigator.
7. Known pre-existing interstitial lung disease.
8. Clinically relevant cardiovascular abnormalities as judged by the investigator.
9. Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.
10. Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
11. Pregnancy or breast-feeding.
12. Active hepatitis and/or known HIV carrier
13. Any prohibited concomitant medications for therapy with afatinib or gefitinib
A Clinical Study of CD19/BCMA CAR-T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis

A Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis

POEMS syndrome, amyloidosis, autoimmune hemolytic anemia, vasculitis and other diseases may only show local pathological damage or systemic lesions. If they are not diagnosed and treated in time or poorly controlled, they will progress as the course of the disease progresses. Risk of disability or even death.

Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosed with POEMS syndrome, amyloidosis, autoimmune hemolytic anemia, vasculitis, and the curative effect of conventional hormones, radiotherapy and chemotherapy, protease inhibitors is not good and (or) no effective treatment means.

  2. After glucocorticoids, cyclophosphamide or methotrexate treatments there are still relapsed and refractory diseases, or clearly show intolerance/toxicity to these drugs.

  3. Estimated survival time\> 12 weeks; 4. Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up; 5. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

* Subjects with any of the following exclusion criteria were not eligible for this trial:

  1. History of craniocerebral trauma, conscious disturbance, epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
  2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythm ia in the past;
  3. Pregnant (or lactating) women;
  4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  5. Active infection of hepatitis B virus or hepatitis C virus;
  6. Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids);
  7. Those who have used any gene therapy products before.
  8. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
  9. Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
  10. Those who suffer from other uncontrolled diseases are not suitable to join the study;
  11. HIV infection;
  12. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease

The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with mild or moderate Alzheimer's disease, to assess the safety and tolerability of ZAD3480 and to define the optimal dose(s) to be used in future trials.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent from patient and caregiver
* Clinical prognosis of probable Alzheimer's disease
* Patient must have a caregiver visiting the patient at least three times weekly

Exclusion Criteria:

* Significant neurologic disease or dementia other than Alzheimer's disease
* Major depressive disorder, other major psychiatric disorder
* Use of acetylcholinesterase inhibitor or memantine for treatment of Alzheimer's disease within 8 weeks prior to enrollment
* Impaired vision and/or hearing making cognitive testing difficult
Comparison of Free Gingival Graft and Modified Apical Repositioning Flap Techniques

Attached gingiva, a crucial component of the keratinized tissue, plays a vital role in preserving periodontal health. The free gingival graft (FGG) and modified apically repositioned flap (MARF) techniques are frequently used for addressing issues related to insufficient attached gingiva. The aim of this study was to compare the efficiency of the FGG and the MARF increasing the zone of attached gingiva in 2-year posttreatment.

The study included 15 participants who were both systemically and periodontally healthy, and these participants had a total of 21 teeth (10 for SDG and 11 for MARF). All included teeth had an attached gingiva width ranging from 0.5 mm to 1.5 mm and showed no signs of bone dehiscence. SDG and MARF methods were selected randomly (coin-to-coin). Clinical parameters recorded at baseline, third month, at first and second years were plaque index (PI), pocket probing depth (PPD), keratinized tissue width (KTW), attached gingiva width (AGW), bleeding on probing (BOP), gingival recession (GR) and clinical attachment level (CAL).

Eligibility Criteria:
Inclusion Criteria:

* having ≥15 permanent teeth excluding third molars,
* not using any orthodontic appliance,
* not being pregnant or breastfeeding,
* not having any uncontrolled chronic and/or auto-immune disease,
* not smoking.

Exclusion Criteria:

* having chronic and/or auto-immune disease
* smoking.
Therapeutic Strategy and the Role of Mesenchymal Stromal Cells for ABO Incompatible Liver Transplantation

The purpose of this study is to determine whether MSCs are safe and effective in reducing the primary nonfunction (PNF), acute rejection and Ischemic-type Biliary Lesions (ITBLs) morbidity in ABO-incompatible Liver Transplantation.

ABO incompatible liver transplantations is considered to be a rescue option in emergency transplantation.The A、B antibodies to grafts bind to the graft endothelium and activate complement, which attracts and activates neutrophils and platelets and increases the permeability of the endothelium. The neutrophils exude, the platelets aggregate, and the small vessels of the graft get thrombosed, resulting in ischemic damage,leading nonfunction grafts.In addition, if the A、 B antibodies remain high level, it can lead to acute humoral immune rejection. A lot of research confirmed that the ABO incompatible is a risk factor of postoperative short- and long-term survival. And mesenchymal stromal cells (MSCs) are characterized by the properties of immunosuppressive and regenerative properties, which make MSCs great attractive in treating immunological diseases (including transplant rejection) and organ/tissue ischemic injury. So we conduct this clinical study,to confirm the effect of MSCs in ABO incompatible liver transplantation by comparing the incidence of primary nonfunction, acute rejection, biliary complications and survival rates.

Eligibility Criteria:
Inclusion Criteria:

* First liver transplantation with a ABO-incompatible graft(B→A，AB→A，A→B，AB→B，A→O，B→O，AB→O).
* Ages of 18 or older.
* Patients receive liver transplantation due to benign end stage liver disease.
* Patients or legal agent must be able to give informed consent.

Exclusion Criteria:

* Second or combined organ transplant recipient.
* Combined transplantations such as simultaneous liver/kidney transplants
* Malignant disease.
* Uncontrol bacterial, fungal, viral or parasitic infection.
* Withdraw or unable to finish the follow-up.
* Unwilling to sign informed consent.
Resistance Exercise to Improve Fatigue in Workplace (REW)

Studies show that exercise resistance in workplace can reduce the symptoms of induced labor, however, the effectiveness of such programs depends on the characteristics of the training fatigue. Thus, it is expected that this study the intervention group with training heavy using progressive resistance exercise protocol will be better in reducing fatigue when compare with light training group.

Background: This study is randomized clinical trial with double-blinded. The aim is evaluate the effectiveness the training heavy with resistance exercise program in the muscle fatigue control. Methods: This is a randomized controlled trial by cluster, in which workers who participate in the intervention group will perform resistance exercise protocols; and workers in the comparative group held only stretching exercises and light resistance training with elastic bands. Expected results: strong evidence that fatigue reducing after ten weeks in workers and improve in others outcomes. Not found in literature studies in occupational evaluating this aspect of training.

Eligibility Criteria:
Inclusion Criteria:

* sign informed consent

Exclusion Criteria:

* restriction by the medical department.
Biomagnetic Signals of Intestinal Ischemia

The lack of blood flow to the small intestine causes mesenteric ischemia. Using a Superconducting QUantum Interference Device (SQUID) which measures the magnetic field of the small intestine, we are hoping to identify abnormalities without surgical intervention.

The electrical activity of the small intestine may contain important information that will help us diagnose gastrointestinal diseases. The major impediment to reducing mortality of mesenteric ischemia is the lack of a noninvasive diagnostic test that identifies the syndrome before extensive necrosis occurs. Mesenteric ischemia is caused by the lack of blood flow to the intestine. The Superconducting QUantum Interference Device (SQUID) measures the magnetic field of the intestinal smooth muscle. By comparing normal smooth muscle and that of patients with mesenteric ischemia, we hope to identify abnormal disease states without surgery.

Eligibility Criteria:
Inclusion Criteria:

* Normal Subjects and those diagnosed with mesenteric ischemia

Exclusion Criteria:

* Subjects who report a tendency toward claustrophobia
A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease

A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] due to an exacerbation of Crohn's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Participation in either of the CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] clinical studies in which the subject completed the Week 2 assessment in CDP870-031 \[NCT00152490\] or the Week 6 randomization in CDP870-032 \[NCT00152425\] but whose Crohn's Disease was significantly worse as determined by the investigator and whose Clinical Disease Activity Index (CDAI) score at entry to this study is either (subjects may have received active or placebo treatment):

  1. At least 70 points higher then Baseline (Week 0 CDP870-031 \[NCT00152490\]; Week 6 CDP870 032 \[NCT00152425\] responders) OR
  2. Higher than Baseline (Week 0 CDP870-031 \[NCT00152490\]; Week 6 CDP870-032 \[NCT00152425\] responders) with an absolute score of at least 350 points
* Subjects must be able to understand the information provided to them and give written informed consent

Exclusion Criteria:

* Any exclusion criterion that would have prevented the subject's participation in the qualifying pivotal study (CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\]), although the upper limit of 450 in the CDAI score is not applicable. In addition the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply
University of Michigan Youth Violence Prevention Emergency Department Brief Intervention (Project Sync)

The purpose of this study is to determine whether a brief motivational interviewing intervention given during emergency department care to 14-20 year olds seeking treatment, could reduce youth violence.

This Emergency Department (ED) based study will test the effectiveness of a tailored therapist delivered motivational interviewing intervention, and an informational pamphlet control condition (IC) on reducing violence in 14-20 year olds who present to the Hurley Medical Center (HMC). Eligible adolescents at the Hurley Medical Center (HMC) emergency department (ED) (based on eligibility criteria) will complete a computerized online survey. The goal of the intervention was to examine ways to reduce and prevention youth violence using techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This one-on one counseling approach emphasizes individual choice and responsibility and differentiates between future goals/values and current behavior. At 2-months following their ED visit, eligible adolescents (both from the intervention group and control group) will meet with a research assistant and self-administer an online computerized follow-up survey. An online survey tool will be used for baseline, follow up and post-test surveys. Participants will self-administer the survey at the time of follow up, post-test and baseline.

Eligibility Criteria:
Inclusion Criteria:

1. adolescents (ages 14-20) presenting to the Hurley Medical Center for a medical injury or illness (except exclusions noted below);
2. adolescents will the ability to provide informed assent/consent depending on age;
3. access to a parent or guardian in person or by telephone for parental consent for adolescents ages 14-17 (over 90% of adolescents had a parent/guardian present based on our prior work);
4. currently residing in the intervention or control area;

Exclusion Criteria:

1. adolescents who do not understand English;
2. prisoners;
3. adolescents with abnormal vital signs;
4. adolescents deemed unable to provide informed consent by Emergency Department or research staff (e.g., intoxication, mental incompetence);
5. adolescents treated in the Emergency Department for suicide attempts or sexual assault (because they present in high psychological distress requiring intensive attention and intervention by Emergency Department staff).
Impact of Age on Mortality in Critically Ill Adult Patients in Nepal- a Single Center Retrospective Study of 5 Years.

Rationale: Age is often considered a strong factor that determines the outcomes in critically ill patients. In a resource limited low middle income country (LMIC) like Nepal, the age factor is often considered when making treatment decisions by family especially when considering limiting treatment modalities. Whether or not this consideration of age for outcome prediction is appropriate however is a different discussion especially considering the fact that actual data from Nepalese ICUs are missing.

Study Objective: To find the impact of age on mortality in critically ill patients.

Design: A registry based, retrospective, descriptive study. Sample size: Convenience sampling of all the patients who are admitted to the ICU.

Duration: Retrospective data from the 5-year period between November, 2019 to December, 2024.

Place: Intensive care units (ICUs), Tribhuvan University Teaching Hospital (TUTH).

Interventions: Not applicable Expected results: The study will help determine the mortality of the critically ill adult patients in terms of age.

Age is often considered a poor prognostic factor for most disease conditions. However the effect of age on mortality may not be as simple. Few studies have shown contradicting results such that chronological age exerted no effect on mortality. This may be due to the effect of physiological reserve and well being more than the chronological age.

It has to be noted that with improvement in the overall health care along with the increase in the average life expectancy, ICUs all over the world will be facing a lot more of an "aged" population.

This is even more relevant in our context. The average life expectancy at birth in Nepal has significantly gone up from about 65 years in 2000 AD to 70 years in 2021. This can be expected to improve further with improvements in neonatal and child mortality rates, immunization rates, the health care system delivery and reach. With this, the adult care medicine in Nepal should gear up to face older patients with a new set of challenges including increasing frailty, increasing comorbidities, increased requirements of supportive therapy including rehabilitation and nutrition.

As of now age is often considered a significant factor for making health decisions in Nepal. In a resource limited setting in such an LMICs where a majority of the population lack health insurance coverage, health care costs are borne by the family.

This, when added to the general notion that elderly patients have a poor prognosis, may lead to an unfounded decision to limit treatment decisions including withdrawal of treatments from the ICU.

Rationale and Justification of study This study will help to determine the age related mortality of patients admitted to the ICU. As per the knowledge of the authors, no such large scale studies have been published from Nepal.

Eligibility Criteria:
Inclusion Criteria:

Age\>18 years Admission to the ICU

Exclusion Criteria:

None
Yoga Therapy for Adolescents With Juvenile Idiopathic Arthritis

The purpose of the study is to better understand the effects of a yoga program on adolescents with juvenile idiopathic arthritis (JIA). The investigators want to learn whether or not a yoga therapy based program will decrease pain and improve quality of life in patients with JIA.

This is an 8-week program with home program of online videos.

This is an 8-week program consisting of weekly yoga therapy classes in a public studio. The classes are led by a pediatric occupational therapist who is also a certified internationally accredited yoga therapist (C-IAYT). The initial and final sessions will include an Rheumatologist MD evaluation including a physician global assessment and joint damage assessment (JADI) and visual assessment (VAS). A Visual Analog Pain Scale will and Peds Quality of Life Questionnaire-Arthritis Module 4.0 will be administered. Each yoga class is 75 minutes to include a set-sequence of postures including breathing exercises and final corpse pose (final relaxation).

Eligibility Criteria:
Inclusion Criteria:

* Adolescents with formal diagnosis of JIA, speak and understand English, can get on/off floor independently.

Exclusion Criteria:

* Dependent on assistive device for ambulation; does not understand English, does not have a diagnosis of JIA.