cyrilzakka/clinical-trials huggingface dataset:
Sleep Self-management in Pregnancy Using a Personalized Health Monitoring Device

Pregnancy-associated sleep disorders are a common acute experience in pregnancy experienced by up to 82% of women. Sleep disorders are associated with increased risk for pre-eclampsia, gestational diabetes, longer labor, cesarean birth, and postpartum depression, and are higher among pregnant women of lower socioeconomic status. Traditional clinical management of sleep disorders in pregnancy includes education and counseling on sleep hygiene and sleep positioning, dietary modifications, relaxation, iron supplementation, weight management, and physical activity, yet education-based behavioral interventions show minimal effectiveness for improving sleep among pregnant women. These methods typically do not incorporate objective self-monitoring, which is an important behavior change technique. In pregnancy, objective self-monitoring on a day-to-day basis is particularly important as sleep disorders may worsen as pregnancy progresses.

Computer-based personalized health monitoring (PHM) devices may serve as an effective tool with which pregnant women can self-manage sleep through incorporation of regular feedback. This strategy may be beneficial not only for women with pregnancy-associated sleep disorders but also for pregnant women with less severe sleep disruptions that experience daytime sleepiness, fatigue, and decreased quality of life. PHM devices have been used to promote weight loss, diet, and physical activity changes but no studies have specifically targeted sleep among pregnant women. The purpose of this pilot study is to establish the feasibility and acceptability of conducting a 12-week intervention for sleep self-management with pregnant women using a PHM device, in order to refine the intervention for a larger, randomized trial.


Eligibility Criteria:
Inclusion Criteria: at time of recruitment (t0) women must:

1. be age ≥ 18
2. 14 to \<24 completed weeks gestation of pregnancy

2) have no known maternal or fetal complications 3) have a smartphone compatible with the study PHM device 4) have internet access 5) be English speaking 6) be receiving prenatal care.

Exclusion Criteria:

1. pre-existing diabetes mellitus or hypertension
2. diagnosed sleep disorder
Analysis of Respiratory System Mechanics and Inflammatory Response During Orthotopic Liver Transplantation (SPPLIT Trial)

During orthotopic liver transplantation (OLT), respiratory system function may be severely impaired for several reasons including anaesthesia effects, hyperdynamic volume state with fluid overload and ischemia reperfusion injury. In particular, reperfusion syndrome is characterised by the release of several inflammatory mediators such as cytokines and oxygen free radicals which may contribute to alveolar endothelial barrier dysfunction. The object of this study is to investigate the respiratory system mechanics impairment in its partitioning between lung and chest wall.

We hypothesize that impairment of respiratory system mechanics (of both lung and chest wall) occurs after reperfusion phase of liver. This impairment is associated with the systemic inflammatory response following liver reperfusion.


Eligibility Criteria:
Inclusion Criteria:

* orthotopic liver transplantation
* valid informed consent

Exclusion Criteria:

* Age \< 18 yrs
Adaptive Immune Response to Seasonal Influenza Vaccination (AIGI)

AIGI (Adaptive Immune Response to Seasonal Influenza Vaccination) is a prospective clinical study aiming at studying the kinetics of vaccine-specific antibody production after seasonal influenza vaccination in health care workers.

AIGI (Adaptive Immune Response to Seasonal Influenza Vaccination) is a prospective clinical study aiming at elucidating the kinetics of vaccine-specific antibody production after seasonal Influenza vaccination in health care workers at the Greifswald University hospital. Participants were recruited before their intended vaccination.

Participants received the influenza vaccine Vaxigrip Tetra 2020/2021 by Sanofi Pasteur Europe.

Within the study, volunteers donate peripheral blood by venipuncture on the day of vaccination as well as 7 and 14 days after vaccination. EDTA plasma and peripheral mononuclear cells (PBMCs) are prepared and stored at -20 °C.

Volunteers are also asked to complete a standardized questionnaire on each day of blood sampling. Questionnaires collect data about physical characteristics, seasonal influenza vaccinations, current infections, medication, immune relevant diseases and side effects of the vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Planned participation in seasonal influenza vaccination
* Completion of the 18th year of life
* verbal and written consent given

Exclusion Criteria:

* current infectious diseases
* underweight (BMI\<18,5)
* blood coagulation disorders, anemia or similar diseases
* known congenital or acquired immunodeficiencies
Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones

The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.

The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.

Picterus JP bilirubin estimates from a Samsung S7 will be compared with three smartphones with different camera types and a TcB measurement The clinical outcomes will be compared to our camera validation systems. Skin color measurements using a spectrophotometer will be used for technical optimization of the camera validation system

Eligibility Criteria:
Inclusion Criteria:

* Infants born with gestational age \> 37 weeks.
* Birth weight ≥ 2500 grams
* Age 1 - 14 days

Exclusion Criteria:

* Infants showing signs of inborn disease.
* Infants with skin rash or other skin disease that affects the skin where measurements are performed.
* Infants transferred to the pediatric ward for medical treatment.
* Infants that have received phototherapy in the last 24 hours
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-363, KITE-753, KITE-197, and anitocabtagene autoleucel in participants of Kite-sponsored interventional studies.


Eligibility Criteria:
Inclusion Criteria:

* The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable
* The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted
* In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation

Exclusion Criteria: none
Safety and Efficacy Registry of Yinyi Stent (SERY-II)

Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may prevent these complications.


Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years old
* both gender
* native coronary lesion
* narrowing \> 70%
* vessel size 2.5-4.0 in diameter

Exclusion Criteria:

* without informed consent,
* ST elevation myocardial infarction within 7 days,
* patient with ≤ 70% coronary narrowing at target lesion,
* left main lesion,
* multivessel narrowing need more than 3 stent implantations,
* by-pass graft,
* abnormal liver function before randomization,
* active hepatitis or muscular disease,
* impaired renal function with serum creatinine level \> 3mg/dl,
* impaired left ventricular function with LVEF \< 30%,
* participate in other studies.
Effect of Subtalar and Talocrural Joint Mobilization on Foot Ranges and Posture in Diabetic Patients

The aim of this research is to determine the Effects of mobilizations on foot ranges and posture in people with Type 2 Diabetes Mellitus. Randomized controlled trials will be done at Dr. Akbar Niazi Teaching Hospital ANTH, Bhara kahu Islamabad. The sample size will be 42. The subjects were divided in two groups, with 21 subjects in Group A and 21 in Group B. Study duration is 6 months. Sampling technique applied was Non probability Convenience Sampling technique. Both males and females of aged 45-65 having Type 2 Diabetes were included. Tools used in the study are Spirit Level Mobile Application (android)-Smartphone Goniometer, Foot Posture Index-6 and DN4-Douleur Neuropathique 4 Questionnaire.

Diabetes mellitus is a heterogeneous metabolic disease due to insulin disturbance affecting around 422 Million people worldwide according to the WHO it is characterized by hyperglycemia and ischemia, as a result of defects in insulin secretion. Type 2 diabetes mellitus (T2DM) ranks highly on the international health agenda as a global pandemic and as a threat to human health and global economies. The number of people with T2DM worldwide has more than doubled during the past 20 years. Lower extremity musculoskeletal complications are frequently observed in people with diabetes mellitus (DM) and peripheral neuropathy (PN) and include limited joint mobility, impaired strength, atrophy causing increased stiffness of articular capsule, ligaments and tendons. Ankle planter flexion and dorsiﬂexion was found to be decreased preventing the ankle from reaching its closed-pack position by holding the ankle in a hyper supinated position. People with DMPN have a dorsi flexed foot and ankle position resulting in slow gait with prolonged disease secondary to the peripheral effect of the disease on other body systems.

According to Abate and colleagues there is a 24% reduction in ankle plantar-flexion range of motion in people with DM. Manual mobilizations have proved to decrease the stiffness at ankle joint improving the ranges in previous studies Previous literature have shown that Interventions to address foot and ankle plantar-flexion mobilizations could improve its function by increasing flexibility reduce the risk of plantar ulceration. Distraction of the distal tibiofibular joint has been thought to increase space and decrease impingement in the talocural joint to allow full ankle dorsiflexion.

Eligibility Criteria:
Inclusion Criteria:

* Indoor patients Diabetes mellitus type 2
* Both male and female gender
* Age between 45-65 years
* With \& without Peripheral Neuropathy

Exclusion Criteria:

* Any neurological impairment Patients with Foot Ulcer / Amputation
* History of Surgical procedure of Lower Limb
* Trauma/ recent fracture of lower limb
* Patients with severe retinopathy
* Congenital Foot Deformity
* Osteoarthritis of Ankle joint
Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* serum creatinine \> 1.1 mg/dL
* glomerular filtration rate (GFR) \< 50 mL/min

Exclusion Criteria:

* age \< 18 years
* use of radiographic contrast media during the last 21 days
* history of dialysis
* cardiac insufficiency class III-IV
* emergency procedures
Speech Perception Impairment Follow Complete Recovery of Sudden Sensorineural Hearing Loss

At present, few research on the auditory perception function and possible neural mechanisms of unilateral sudden hearing loss patients with complete or partial recovery of peripheral hearing.This project evaluate the speech perception function in noise of unilateral sudden hearing loss patients with with complete and partial hearing recovery by cognitive behavioral experiments, event-related potentials (ERPs) and functional magnetic resonance imaging (fMRI), and longitudinal follow-up to explore its underlying neural mechanisms.

In clinical practice, many unilateral sudden hearing loss patients with complete and partial recovery of peripheral hearing still complain of hearing discomfort, especially difficulty in speech recognition in noisy environments. At present, there is still a lack of research on the auditory perception function and possible neural mechanisms of unilateral sudden hearing loss patients with complete or partial recovery of peripheral hearing. From the perspective of cognitive psychology, this project uses cognitive behavioral experiments, event-related potentials (ERPs) and functional magnetic resonance imaging (fMRI) to evaluate the reverberation environment of unilateral sudden hearing loss patients with complete and partial hearing recovery, and longitudinal follow-up to explore its underlying neural mechanisms. The investigators hope to understand the possible difficulties of binaural processing and auditory perception in patients with unilateral sudden deafness, and to explore the changes of central and cortical functions. This study not only has important guiding significance for the treatment and rehabilitation of patients with unilateral sudden deafness, but also expands the research group on auditory perception function and the psychological and neural mechanisms involved in binaural processing, which has important theoretical significance.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old;
* patients with unilateral idiopathic sudden sensorineural hearing loss (at least three adjacent frequencies of hearing loss ≥ 30 dB );
* the first onset;
* Contralateral hearing is normal; 5) Hearing is cured after treatment

Exclusion Criteria:

* Sudden deafness with possible definite etiology, such as Meniere's disease, large vestibular aqueduct syndrome, trauma, retrocochlear tumor, etc.;
* Severe underlying diseases, heart disease, blood disease, pregnancy, breastfeeding, etc.;
* Suffering from other central diseases that may affect speech perception disorders, such as Alzheimer's disease, etc.;
* Those who cannot cooperate with the whole study inspection;
* Those who do not agree to be enrolled or refuse to sign the informed consent form;
* Those who are using may affect the Medications or treatments for speech perception disorders.
Airway Management for Trigeminal Thermal Coagulation

Airway management of patients undergoing thermal coagulation of the Gasserian ganglion is very delicate. This is because of the specific operation site and moreover patients should recover quickly from anesthesia to follow verbal intraoperative commands of the surgeon. Endotracheal intubation or laryngeal mask of course hinders the patient from speaking. An obvious alternative airway management, as performed in this preliminary study, is a nasopharyngeal placed tube.

The purpose of the present study is to objectify the gas exchange in patients during this new ventilation technique.


Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing thermal coagulation of the Gasserian ganglion

Exclusion Criteria:

* Body weight over 100 kg
* Recurrent nasal bleeding
* Patients suffering from reflux disease
* Additional risk of aspiration (e.g. hernia diaphragmalis)
Insulin-Glucose-Glucagon Network: Defining a Type 1 Diabetes Progression Index

The type 1 Diabetes (T1D) TrialNet Pathway To Prevention (PTP) Study assesses and recruits at-risk subjects into clinical trials aimed at preventing the development of full blown T1D. Thousands of first and second degree relatives of persons with T1D are screened for autoimmune abnormalities and positive subjects are followed with metabolic and autoantibody tests. The investigators' ancillary study us designed to test whether characterization of the insulin- glucose-glucagon (IGG) interactions in participants in the PTP study can provide new information about the early stages of the disease. When completed, this study will improve the understanding of the pathogenesis of the early stages of T1D and provide new quantitative tools for prediction and evaluation of insulin-glucagon-glucose interactions relevant to individuals at risk for developing T1D, thereby enabling future preventive intervention trials.

The goal of the proposed ancillary studies is to establish whether characterization of the insulin-glucagon-glucose (IGG) interactions in first and second degree relatives of patients with type 1 diabetes (T1D) can provide new information about the pathogenesis, prediction, and progression of the early stages of the disease. The project will enroll individuals from the "Living Biobank" of the TrialNet Pathway to Prevention (PTP) study who are phenotyped with respect to a variety of risk factors, including immunological abnormalities. To the best of available knowledge, the IGG relationships in general and the glucagon phenotype in particular have not been studied in this population. It is known, however, that in T1D the release of glucagon is altered, which is manifested by abnormal postprandial suppression and defective response to hypoglycemia. Several reports indicate that glucagon becomes dysregulated prior to the development of T1D, but comprehensive studies aiming to understand in detail the insulin-glucagon co-dynamics in people at risk for T1D have never been performed.

Thus, the goal now is to expand the investigators' existing methodology and transfer expertise in clinical testing and analysis of the IGG system to characterize the IGG interactions in individuals at risk for developing T1D.

Eligibility Criteria:
Inclusion Criteria:

* Individuals 12 to 45 years old which have a brother, sister, child, or parent with type 1 diabetes, or
* Individuals 12-20 years old who have have a cousin, aunt, uncle, niece, nephew, half-brother, half-sister, or grandparent with type 1 diabetes.

Exclusion Criteria:

* Have diabetes already (type 1 or type 2)
* Have a medical condition or being been treated with medications that might interfere with the study
Verification of Pulse Oximetry in Neonatal Population

The purpose of this his post-market, observational study titled Verification of Pulse Oximetry in the Neonatal Population is to gather data to further support the accuracy of Nonin's pulse oximeters when used in the neonate population. Neonates who are currently undergoing arterial blood gas (ABG) sampling, as part of their medical care will be recruited to participate in this study for collecting opportunity samples. Nonin's PureLight® noninvasive sensor will be applied to a foot of the neonate; an adhesive wrap secures the sensor to the neonate. The sensor immediately begins obtaining SpO2 and pulse rate measurements which are sent to the oximeter module for display on the Electronic Data Collection System (EDCS). At the time the prescribed ABG is drawn, the EDCS must have a marker captured to identify the end of the ABG for SpO2 comparison. The SpO2 accuracy of pulse oximeter will be measured by comparing SpO2 readings of the pulse oximeter to values of SaO2 (opportunity samples) determined by a CO-oximeter.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age: 25 weeks to full term
* Weight range: No minimum or maximum range
* Age: up to 1 month (30 DAYS)
* Gender: Both
* ABGs as part of their medical care, to be analyzed by co-oximeter
* Consent signed by at least one legal guardian

Exclusion Criteria:

* Presence of any skin irritation or breakdown on the foot
* Foot impediments which would preclude proper placement of the sensor
* Clinical condition precluding the use of adhesive materials
* Cessation of ABGs during study enrollment
A Study of Circulating Exosome Proteomics In Gallbladder Carcinoma Patients

This research will be the first study for exosome purified from blood in gallbladder carcinoma patients. Proteomics studies will be done in both tumor tissue and the circulating exosome from blood specimens. Then, the potential prognostic and predictive biomarkers will be searched by bioinformatics to find the correlations between exosome biomarkers and gallbladder carcinoma.

Background:

Exosomes are formed by inward budding of late endosomes, producing multivesicular bodies (MVBs), and are released into the environment by fusion of the MVBs with the plasma membrane. It has been demonstrated that the content and function of exosomes depends on the originating cell and the conditions under which they are produced. Tumor exosome production, transfer and education of bone marrow cells supports tumor growth and metastasis.

Aims of the study:

Proteomics studies will be done in both tumor tissue and the circulating exosome from the gallbladder carcinoma patients. Then, the potential prognostic and predictive biomarkers will be searched by bioinformatics to find the correlations between exosome biomarkers and gallbladder carcinoma.

Materials and Methods:

The investigators will conduct a case-control study in 11 hospitals from China. Cases will be the patients with newly-diagnosed gallbladder carcinoma. The controls will be matched （1：1）by sex，race and age which will be selected from the patients receiving cholecystectomy due to gallstones from the same hospital with the cases. A total of 50 patients with gallbladder carcinoma will be recruited. The investigators will obtain the blood and tumor tissue samples for further analysis of proteomics studies. Exosome from blood specimens will be isolated and purified by sucrose gradient ultracentrifugation. The potential prognostic and predictive biomarkers will be searched by bioinformatics to find the correlations between exosome biomarkers and gallbladder carcinoma. Data will be collected from January 2018 to December 2018.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with gallbladder carcinoma by imaging tests (cases) Diagnosed with chronic cholecystitis by imaging tests (hospital controls)

Exclusion Criteria:

* The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases