cyrilzakka/clinical-trials huggingface dataset:
Multi-tasking to Hyper-tasking: Investigating the Impact of Next Generation 911

Emergency call centers across the country are preparing for the Next Generation 911 (NG911) initiative, which will allow citizens to place 9-1-1 "calls" using digital technologies such as text messaging, email, Skype or instant messaging, and will expand emergency information sources to also include streaming video, photo uploads, and automatic crash notifications. The impact of these new information and communication technologies on those tasked with using them in time-sensitive emergency situations is unknown. Our study is designed to address the following hypotheses: 1) We hypothesize that NG911 implementation will have a significant effect on telecommunicator stress levels and 2) A resiliency training tailored to the needs of telecommunicators will mitigate the impact on NG911 implementation on stress levels. We will test these hypotheses through the following specific aims:

Aim 1: Measure levels of stress, job satisfaction and job performance among 9-1-1 telecommunicators before and after the NG911 implementation.

Aim 2: Develop and test the efficacy of an evidence-based resiliency training and worker support intervention to improve psychological well-being and job performance of 9-1-1 telecommunicators.

Aim 3: Build an ABM tool of 9-1-1 call centers to improve 9-1-1 telecommunicator workforce training and smooth transitions to future call center innovations.


Eligibility Criteria:
Inclusion Criteria:

* subjects must be 9-1-1 telecommunicators (call receivers and dispatchers) who work at participating call centers and consent to participate.

Exclusion Criteria:

* We will exclude subjects who do not consent to participate
* We will exclude subjects who do not confirm that they are 21 or older.
Psychological Influences on Postoperative Recovery

The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient tonsillectomy or tonsils/adenoids
* ASA I, II

Exclusion Criteria:

* Developmental delay
* ASA III-IV
* Psychotropic medication
* Meds which interfere with metabolism of midazolam
* 36 weeks gestation
Glucose-dependent Insulinotropic Polypeptide (GIP) and Lipid Metabolism

The aim of this proposal is to examine whether endogenous GIP and exogenous GIP alone and in combination with insulin affect gastric emptying (GE), appetite, energy intake, energy expenditure (EE) and plasma levels of triglycerides (TAG), free fatty acids FFA) and glycerol in man.


Eligibility Criteria:
Inclusion Criteria:

* Informed oral and written consent
* Caucasians over the age of 18 years
* Normal 75 g oral glucose tolerance test (OGTT)
* Normal blood haemoglobin concentration
* Normal plasma lipid profile

Exclusion Criteria:

* First-degree relatives with diabetes and familial hypertriglyceridemia
Comparing One Intraarticular Injection of a Novel HYAJOINT Plus With Synvisc-One for the Treatment of Knee OA

Viscosupplementation has been widely used for the treatment of knee osteoarthritis (OA). There is no well controlled trial comparing one injection regimen of HA for the treatment of knee OA. The purpose of this study was to compare the efficacy and safety of one intraarticular injection of a novel crosslinked HA (HYAJOINT Plus) with Synvisc-One for the treatment of knee OA.

In a prospective, randomized controlled, double-blind trial with 6-month follow up, patients with knee OA (Kellgren-Lawrence grade 2 or 3) were randomized to receive one intraarticular injection of 3 ml HYAJOINT Plus (microbial fermented HA, 20 mg/ml) (N=66) or 6 ml Synvisc-One (avian derived HA, 8 mg/ml) (N=66). The primary outcome was change in the visual analog scale (VAS) pain (0-100mm) over 6 months. Secondary outcomes included The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, Timed Up-and-Go test (TUG), single leg stance test (SLS), use of rescue analgesics and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic knee OA with pain for at least 6 months, despite conservative treatment such as analgesics, NSAIDs and/or physical therapy
* average pain on knee movement of 30 mm or greater on a 100-mm VAS

  * grade 2 or 3 knee OA according to the Kellgren-Lawrence grading system based on radiographs taken within the previous 6 months
  * Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.

Exclusion Criteria:

* previous orthopedic surgery on the spine or lower limbs
* disabling OA of either hip or foot
* knee instability, clinical apparent joint effusion or marked valgus/varus deformity
* known allergy to avian proteins or HA products
* women ascertained or suspected pregnancy or lactating
* intraarticular injections within the past 6 months
* infections or skin diseases around the target knee
* any specific medical conditions (rheumatoid arthritis, hemiparesis, neoplasm, etc.) that would interfere with the assessments
Exercise Amenorrhea Stress and Bone Health in Adolescents

This study investigates the role of energy balance and stress in the regulation of hypothalamic-pituitary-gonadal axis in adolescent girls across the fitness spectrum.


Eligibility Criteria:
Inclusion Criteria:

* healthy adolescent girls not taking any medications

Exclusion Criteria:

* Hormonal preparation or birth control within 12 months prior to enrollment
* Galactorrhea
* Clinical Depression
Daclizumab Japanese PK Study

The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of BIIB019 (Daclizumab High Yield Process; DAC HYP) administered as a single subcutaneous (SC) dose (75 mg or 150 mg) Japanese and Caucasian adult healthy volunteers. The secondary objective of this study in this study population is to assess the safety and tolerability of BIIB019 administered as a single SC dose (75 mg or 150 mg).


Eligibility Criteria:
Key Inclusion Criteria:

* Japanese subjects must have been born in Japan, have both parents and grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years or significantly modified their diets since leaving Japan.
* Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 4 months after their last dose of study treatment.
* Body mass index (BMI) within 18 to 30 kg/m2, inclusive.
* Nonsmoker or be willing to abstain from using tobacco and tobacco-containing products for 24 hours prior to clinic admission and during the In-Clinic Period and to smoke no more than 10 cigarettes per day throughout the remainder of the study.
* Must be willing to refrain from all alcohol consumption for 48 hours prior to Day 1 and during the In-Clinic Period and to limit the intake of alcohol to no more than 2 units per day throughout the remainder of the study.

Key Exclusion Criteria:

* History of a positive test result for human immunodeficiency virus (HIV) antibody.
* History of hepatitis or a positive test result for hepatitis C virus antibody (HCVAb) or hepatitis B virus antibody (test for hepatitis B surface antigen \[HBsAg\] and/or hepatitis B core antibody \[HBcAb\]).
* History of tuberculosis (TB) or a positive QuantiFERON®-TB Gold test. There must be no other clinical evidence of TB on physical examination of the subject. Note: Subjects who have had prior adequate prophylaxis treatment for latent TB with an appropriate course of isoniazid or equivalent, per country standards, are not excluded from study participation.
* Subjects with a history of carcinoma in situ and malignant disease, with the exception of basal cell carcinoma that has been completely excised prior to study, are not eligible.
* Treatment with any prescription medication within 2 weeks before Day -1 with the exception of oral contraceptives for women of childbearing potential.
* Treatment with any nonprescription medicinal products (including vitamin/mineral/herbal-containing preparations but excluding acetaminophen) within the 7 days prior to study treatment.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Types of Fixation in Arthroscopic Rotator Cuff Repair

The study will identify if there is a difference of quality of life after surgery between two techniques used in surgery. The two different techniques are either the Single Row Fixation or the Double Row Fixation.

Primary Research Question; What is the difference in disease specific quality of life between patients who undergo a repair of the rotator cuff with arthroscopic technique using single-row fixation, versus double-row fixation, as measured by the Western Ontario Rotator Cuff Index (WORC)at one year post op?

Eligibility Criteria:
Inclusion Criteria:

* Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
* Imaging and intra-operative findings confirming a full thickness tear of the rotator cuff.

Exclusion Criteria:

* Characteristics of the cuff tear that render the cuff irrepairable.
* Significant shoulder comorbidities
* Previous surgery on affected shoulder
* Patients with active workers compensation claims
* Active joint or systemic infection
* Significant muscle paralysis
* Rotatorcuff tear arthropathy
* Charcots arthropathy
* Major medical illness
* Unable to speak or read English
* Psychiatric illness that precludes informed consent
Cholesterol Metabolism in Heterozygous Phytosterolemia

The purpose of the study is to examine the effect of plant sterols on cholesterol absorption and synthesis in people with heterozygous phytosterolemia.

A plant sterol supplementation study will be conducted in individuals who are heterozygous for phytosterolemia compared to non-carriers. The study will use a double-blind, randomised, crossover, placebo-controlled design in which participants will consume 2 treatments including 1.6 g of plant sterol pills and a placebo pill, each for 4 weeks. A 4 week washout period will separate the two treatment periods. Plant sterol concentrations will be measured by gas liquid chromatography and absorption will be measured by the ratio of campesterol to lathosterol in plasma. Cholesterol absorption and synthesis will be measured by dual stable isotope technique, involving simultaneous administration of 13C-cholesterol and deuterium oxide, respectively.

Eligibility Criteria:
Inclusion Criteria:

* heterozygous for phytosterolemia, wild-type.

Exclusion Criteria:

* Pregnant,
* Previous heart attack,
* Kidney disease.
Echocardiographic Manifestation in Patients With Omicron Variant of COVID-19

The cardiovascular scenario associated with omicron, the new variant of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19), remains unclear. We design this observational and prospective study to explore cardiac manifestations in patients with omicron infection by echocardiography.

COVID-19 affects the cardiovascular system, and the presence of cardiovascular disease (CAD) and risk factors is associated with worse clinical outcomes in infected patients. However, there is a paucity of information regarding the cardiovascular scenario associated with omicron, the new variant of SARS-CoV-2 that causes COVID-19. Thus, we expect to perform this study to explore the echocardiographic manifestations in patients admitted to the hospital with confirmed COVID-19 infection, during the current omicron wave in Shanghai, China.

According to published guidelines, with written consent from eligible patients, participants are grouped into the severely ill group, the critically ill group, the mildly ill group, and the healthy control group. The investigators will review medical records and document detailed sociodemographic characteristics for each participant. Circulating levels of cardiac biomarkers such as B-type natriuretic peptide (BNP) and cardiac troponin (cTnI), inflammatory biomarkers such as interleukin 6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP), and blood cell counts are measured in the hospital-based laboratory. To study the cardiac manifestations of the patients, echocardiography is performed using a GE Vingmed Ultrasound System (GE Healthcare, Horten, Norway), and morphological and functional parameters of the heart are measured. Clinical outcomes will be censored at the time of data cut-off, and patients after discharge will continue to be interviewed by telephone. Differences in cardiac manifestations and clinical outcomes between the groups are compared by proper statistical tests.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years old
* Half male and half female
* Admitted to hospital with confirmed omicron infection
* Able to receive an echocardiographic examination
* Written informed consents
* Healthy volunteers, matched for age and gender, are enrolled as the control group

Exclusion Criteria:

* People under the age of 18 years old
* Inability to lie or maintain posture during the echocardiographic examination
Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer

The prognosis for patients with metastatic breast cancer has improved continuously. Systemic therapies alone are not able to cure the disease permanently.

Investigators initiated this randomized controlled multinational and multicenter clinical trial to analyse the impact of a local metastases-directed radiotherapy in addition to standard systemic therapy in patients with oligometastatic breast cancer on progression-free survival and quality of life.

Preferably ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions. Larger lesions or lesions with critical normal tissue involvement should be treated with three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) in moderate hypofractionated radiotherapy (depending on the size and location of the target volume and the decision of the radiooncologist). For critical organs in the target volume, standard fractionated radiotherapy can be used.

Eligibility Criteria:
Inclusion Criteria:

* Metastasized breast cancer - up to 5 clinically manifest (new, progressive, persistent) metastases (a lymph node metastasis and a circumscribed local recurrence are each considered as one metastasis, i.e. also locoregional recurrent breast carcinomas with additional hematogenic metastasis possible)
* maximum of 3 cerebral metastases known
* indication for palliative drug therapy (endocrine therapy and/or chemotherapy and/or treatment with other substances) given according to guidelines (1st-line or further therapy lines, a special regime is not specified)
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
* local radiation of all metastases possible
* presentation of a written declaration of consent
* patient ≥ 18 years

Exclusion Criteria:

* Previous radiotherapy, if this interferes with treatment within the scope of the study
* symptomatic metastases requiring local therapy of all metastases (e.g. pain radiation), a radiation indication (or other local therapy) for individual metastases is not a criterion for exclusion
* known central nervous system (CNS) metastasis without extracerebral metastasis (in these cases, immediate local therapy is mandatory)
* more than three known CNS metastases (no indication for purely local therapy of only the metastases, primary whole brain radiation is indicated)
* multifocal metastasis in one organ with impossibility to comply with the dose constraints for this organ (e.g., no indication for local therapy of only the metastases, primary whole brain radiation is indicated) (e.g. in the liver)
* exclusively regional lymph node metastasis without haematogenic metastases (in these cases local therapy is clearly indicated according to guidelines)
* relevant comorbidity, if this results in restrictions for further therapy
* Incapacity to contract or lack of informed consent
* Pregnancy and lactation
Changes in Grip Strength by Using Bandage Kinesio Taping

The Kinesio Taping® method, therapeutic bandage, is another feature can be used in physical therapy, aiming to muscle enhancement, weakened muscles correction, analgesia, among others, by cutaneous stimulation of mechanoreceptors. This study aims to evaluate the efficiency of the use and effects offered by Kinesio Taping® method, changes in muscle strength of grip in normal subjects for clinical application.

A sample of 45 subjects will be divided randomly into three groups (G1: muscle activation technique; G2: muscle inhibition technique; G3: Placebo Effect) aged over 18 years male or female, where it will be initially measured the strength of grip with a dynamometer Jamar® pressure. Then the Kinesio Taping® bandage will be applied in an "I" format in the wrist flexor muscles of a dominant and non-dominant limb in G1, G2, and G3 groups. Investigators will follow the application protocol suggested by method of technical. To provide the facilitation of muscle activity (G1 group) a Kinesio Taping® bandage will be applied to the muscle starting at its origin up to the location of muscle insertion. For inhibition of muscle activity (G2 group), the bandage will be placed over the muscle starting at the insertion location and ending at the muscle origin. For the control group (G3 group) the bandage will be placed from the lateral extremity to the medial axis. The measurement of grip strength was carried out in four stages: immediately before placing the Kinesio Taping®, 24 h, 48 h, and 72 h after its application. After collecting the data statistical Investigators will held the analysis of the data.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged greater than 18 years and with muscle / nerve integrity of upper limbs, hearing and responsive to verbal commands with understanding the information that aware and according to the study.

Exclusion Criteria:

* Individuals who refused to participate in this research and / or do not meet the inclusion criteria.
A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

The purpose of this study is to assess the efficacy and safety of QL1706 in combination with bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as first-line treatment in patients with advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects participate voluntarily and sign informed consent.
2. Age ≥ 18 and ≤ 80 years old, male or female.
3. Histological or cytological or clinical diagnosis of HCC
4. Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment.
5. No prior systemic therapy for HCC.
6. Child-Pugh ≤7 , no history of hepatic encephalopathy.

Exclusion Criteria:

1. Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
2. History of malignancy other than HCC within 5 years prior to the start of study treatment.
3. History of liver transplantation, or planned to receive liver transplantation.
4. Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion.
5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
6. Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently, or of inferior vena cava.
Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence

This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent.

The primary objective of this study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to signing consent. Secondary objectives included but were not limited to: assessing the success or failure to achieve abstinence (confirmed by at least two methamphetaminenegative urines and no methamphetamine-positive urines) each week during the last two weeks (Weeks 11 and 12) for subjects using methamphetamine 18 or less days during the 30 days prior to signing consent, assessing the safety of bupropion in this study population, assessing other measures of efficacy of bupropion in reducing methamphetamine use or craving, and other psychological assessments of methamphetamine dependence.

It is hypothesized that bupropion, compared to placebo, would be associated with an increase in the proportion of subjects who achieved abstinence (confirmed by at least two methamphetamine-negative urines and no methamphetaminepositive urines) each week during the last two weeks (Weeks 11 and 12) for non-daily users.

Eligibility Criteria:
Inclusion Criteria:

* Must have a DSM-IV diagnosis of methamphetamine dependence as determined by MINI
* Must have at least 1 amphetamine or methamphetamine positive urine specimen after the start of screening and before randomization or provide information to verify recent use if a positive urine sample can't be obtained
* Must report using methamphetamine for 29 days or less during the 30 day period prior signing consent using the timeline follow-back method
* Must be willing and able to comply with study procedures
* Must be able to verbalize and understand consent forms and provide written informed consent
* Must be seeking treatment for methamphetamine dependence

Exclusion Criteria:

* Please contact study site for more information