cyrilzakka/clinical-trials huggingface dataset:
The Munich Adrenaline Cancer Study

Observational studies report associations between physical activity and survival in some types of adult cancer. In addition, some exercise-induced molecules such as catecholamines (e.g., adrenaline) are known to change cancer cell signalling, proliferation and have been linked to clinical outcomes such as survival. The aim of this study is to analyse changes in adrenaline concentration with a single high-intensity interval exercise intervention on a cycle ergometer in children and adolescents during treatment for cancer and to examine the feasibility of the study concept.

Exercise is generally recommended as an adjunct therapy for adult cancer patients as it counteracts the adverse effects of cancer and its treatment. According to epidemiological data, exercise is also associated with a reduced risk of tumour developement and an improval of survival in some tumours. However, the underlying mechanisms by which exercise affects tumour cells are poorly understood in adult cancer patients and mostly unknown in children. Recent studies demonstrate anti-cancer effects of exercise-induced adrenaline through natural killer cell mobilisation and Hippo signalling. In addition, several exercise-induced molecules such as catecholamines (e.g., adrenaline) are known to change cancer cell signalling, proliferation and have been linked to clinical outcomes such as survival. The aim of this pilot study is the analysation of exercise-induced changes in adrenaline concentration in childhood cancer patients and to show feasibility of the study concept. Following recruitment within the first and third cycle of chemotherapy and consent for study participation, all recruited patients perform a single high-intensity interval exercise intervention on a cycle ergometer. Intensity of the intervals is examined both subjectively via a scale for rate of perceived exertion and objectively via changes in lactate concentration pre- and post-exercise as well as heart rate monitoring. Blood samples are taken by trained personnel staff and prepared for processing (centrifuged, snap-frozen). Changes in adrenaline concentration are measured with a commercial ELISA kit. For further identification of metabolites that change with exercise, a non-biased mass spectrometry metabolomics analysis will be used.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed pediatric cancer or relapse
* aged 6-18 years
* between the first and third cycle of chemotherapy
* diagnosis and treatment at the Kinderklinik München Schwabing, Department of Paediatrics and Children's Cancer Research Centre, Technical University of Munich
* German language
* informed consent as documented by signature

Exclusion Criteria:

* Any medical contraindication with respect to a high-intensity interval exercise intervention (e.g., cardiovascular complications, comorbidities, bleeding risk, pain, infection, nausea, orthopedic impairment of the lower extremities)
* inability to follow the procedures and understand the intervention and assessment of the study, e.g., due to cognitive impairment, language problems, psychological disorders etc.
Safety Study of HepaStem for the Treatment of Urea Cycle Disorders (UCD) and Crigler-Najjar Syndrome (CN)

The purpose of this study is to assess the safety and to appraise the efficacy of one cycle of Hepastem (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC) infusions in paediatric patients suffering from CN or UCD.

The study duration: 12 months starting from the day of treatment: 6 months active surveillance and 6 months observation post-infusion.


Eligibility Criteria:
GENERAL:

1. Subject shows patency of the portal vein and branches, with normal flow velocity in the main portal vein as confirmed by Doppler ultrasound and accessibility of the portal vein, or respectively, accessibility of the umbilical vein.
2. Subject (if capable of signing) and parents or legal representative have provided a written informed assent/consent.
3. Female subjects of childbearing potential need to have a negative pregnancy test and must agree to use an acceptable method of contraception throughout the study.

MAIN INCLUSION CRITERIA

Crigler-Najjar Syndrome specific:

* Patient presents with Crigler-Najjar syndrome type 1.
* Patient presents with Crigler-Najjar syndrome type 2, poorly controlled under phenobarbital treatment, or experiencing serious impairment in quality of life.

Diagnosis must be confirmed by genetic mutation analysis if not available.

Urea Cycle Disorders specific:

* Diagnosis of one of the urea cycle disorders of which the disease is of such severity to warrant liver transplantation or alternatives despite full conservative therapy,
* subject experiencing serious impairment in quality of life despite full conservative therapy.

MAIN EXCLUSION CRITERIA

* The subject is 18 years or older at time of screening.
* The subject presents acute liver failure, clinical or radiological evidence of liver fibrosis or cirrhosis, presents or has a history of hepatic or extrahepatic malignancy
* The patient has a non-corrected cardiac malformation, has a known medical or family history of coagulopathy, had or has a renal insufficiency treated by dialysis.
* The subject requires valproate therapy.
* The subject has a thrombosis of the portal vein or persisting impairment of anterograde portal blood flow.
* The subject has a porto systemic shunt or fistula assessed by Doppler US.
* Patients with disease of such severity that liver transplantation is an absolute indication.
Butterfly Sensor With Rev K Version

The primary purpose of this study is to assess the accuracy of the newly released Masimo SpHb Butterfly Sensor with RevK version and compare the results to a blood hemoglobin level analyzed in the UCSF Clinical Laboratories. A secondary purpose is to assess the blood hemoglobin using the Masimo Pronto-7 hand-held device immediately prior to surgery.

* Masimo SpHb™ continuous hemoglobin monitoring The Masimo SpHb™ monitor with the Butterfly Sensor with RevK version will be used to continuously monitor hemoglobin electronically. The Butterfly Sensor will be connected to the 3rd or 4th finger on either the right or left hand.
* Masimo Pronto-7™ intermittent hemoglobin monitoring The Masimo Pronto-7™ is a hand-held, noninvasive device used for intermittent measuring of blood hemoglobin. The device is connected to a re-usable sensor which is clipped onto a finger for quick spot-check readings. A reading from the Pronto-7 will be taken immediately before surgery.
* Blood sampling for hemoglobin determination For the study, about a ½ tsp of blood will be collected from the arterial line placed for the purpose of surgery approximately every hour during the surgery to obtain a hemoglobin measurement to be analyzed in the UCSF Clinical Lab.

Eligibility Criteria:
Inclusion Criteria:

* Male of non-pregnant female 18 y/o or older
* American Society of Anesthesiologists Classification 1,2 or 3
* Scheduled to undergo spine or hip surgery

Exclusion Criteria:

* Pregnant or nursing
* Patients who in the investigators clinical judgement would not be suitable for research
DANA Compared to MACE in Evaluation of Suspected Acute Concussion

The purpose of this study is to compare the sensitivity of the DANA Rapid exam with the MACE cognitive score. The primary hypothesis is that the DANA Rapid exam will be more sensitive for detecting impaired cognitive performance than the MACE cognitive score in the setting of a clinical diagnosis of concussion at the point of injury in the combat setting. A secondary purpose of this study is to examine a serial performance on the DANA Rapid exam in those subjects diagnosed with a concussion. The secondary hypothesis is that the DANA Rapid exam will show improvements in performance during the recovery period after concussion.

In Operations Iraqi Freedom and Enduring Freedom (OIF/OEF), over 60% of combat casualties have been the result of explosive blasts, and many of these critical injuries involve trauma to the head. As a result, traumatic brain injury (TBI) has been deemed a "signature wound" of OIF and OEF. The symptoms of head injuries, particularly of concussion/mild TBI (mTBI), can be sever but subtle, suggesting that early and accurate diagnosis is paramount to a wounded warrior's appropriate medical care. Most first providers in the war theater are medics who could benefit from an improved diagnostic test to better identify service members with concussion/mTBI. The MACE cognitive test is heavily weighted towards memory, is not 100% specific, and does not preclude a diagnosis of concussion being rendered despite a score in the normal range. Thus, an objective test of neurocognitive function, such as the DANA Rapid, that can be rapidly administered in theater by a combat medic would be highly beneficial to accurate clinical diagnosis and timely treatment. The results of the present study will provide information on the predictive value of the newly developed DANA handheld computer in assisting in the diagnosis of concussion in service members who have been blast exposed. If the DANA Rapid exam proves to be equally or more accurate than the MACE in detecting cognitive deficits, these tests and the handheld computer will also contribute to improved health care for service members by minimizing the time between injury and diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Active duty military personnel
* Glasgow Coma Scale (GCS)score of 15, as assessed by the study member at the time of clinical evaluation following involvement in a mandatory event.
* Willingness to participate in the study, ability to communicate and comply with the study protocol and ability to provide informed consent

Exclusion Criteria:

* GCS score of less than 15
A Study to Evaluate Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Participants

This open-label, 2-period, fixed sequence, drug interaction study will investigate the effect of co-administration of itraconazole on the pharmacokinetics of cobimetinib in healthy participants. Participants will receive multiple repeating doses of cobimetinib and itraconazole.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult participants
* Within body mass index (BMI) range 18.5 to 32 kilogram per meter square (kg/m\^2), inclusive
* Creatine phosphokinase levels below 2.5 times the upper limit of normal (ULN) and if elevated, not clinically significant
* Liver function tests for aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase below 2 times the ULN; bilirubin below 1.5 times the ULN; and all liver function test elevations not clinically significant
* In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs
* Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator
* Negative test for selected drugs of abuse at screening and at each check-in
* Negative hepatitis panel (including hepatitis B surface antigen \[HBsAg\] and anti-hepatitis C virus \[HCV\]) and negative human immunodeficiency virus (HIV) antibody screens
* Females non-pregnant or non-lactating
* Males and females (of child-bearing potential) to use two forms of adequate contraception

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs; except that appendectomy, hernia repair, and/or cholecystectomy will be allowed
* History of diabetes mellitus and/or elevated fasting glucose at baseline
* History or presence of an abnormal ECG, which in the Investigator's opinion, is clinically significant
* History of alcoholism or drug addiction within 1 year prior to study start
* Use of any tobacco- or nicotine-containing products (within 6 months prior to study start and during the entire study
* Participation in any other investigational study or biologic agent trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, or exposure to any biological therapy or investigational biological agent within 90 days prior to study entry and during the entire study from study start to study completion, inclusive
Mechanisms to Reduce Mental and Physical Fatigue Following Exercise Training in Older Adults

Fatigue is a strong predictor of negative health outcomes in older adults. The research in this study will compared the effects of 8-weeks of branched chain amino acids (BCAAs: dietary supplements commonly taken to improve muscle growth and exercise performance) added to exercise on fatigue compared to exercise with a placebo (an inactive, harmless substance). BCAAs could have an impact on improving fatigue common in older adults, especially when exercising.

Thirty participants will be asked to participate in this research study. They will be randomized (like a flip of a coin) to exercise + a placebo or exercise + BCAAs for 8 weeks. We would like to examine the effects of the 8-week exercise + dietary supplement program on body composition (fat and muscle), physical activity habits, fatigue, and physical performance (such as walking and strength). We would also like to assess whether these outcomes are controlled by changes in markers (kynurenine metabolites) in the skeletal muscle and blood.

Eligibility Criteria:
Inclusion Criteria:

* Fatigue (participants reporting ≥3 on a 1-10 scale)
* Lack of menses for at least one year for women
* BMI 20-50 kg/m2
* Untrained with regard to structured exercise training (is not currently training more than 2x/week)

Exclusion Criteria:

* Taking an anticoagulant medication that is unable to be discontinued before biopsies
* Allergic to lidocaine
* Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments or training
* Hepatic (LFTs \>2.5xWNL), renal (eGFR\<45), , and uncontrolled psychiatric disease
* Cognitive impairment
* Uncontrolled depression
* Any disease or condition considered to be exclusionary based on the clinical opinion and discretion of the principal investigator
COVID-19 Genomic Sequencing for Nosocomial Outbreak Investigations

This is a tertiary care hospital-based prospective molecular epidemiology study in Montreal, Canada. When nosocomial transmission was suspected by local infection control teams' investigations, SARS-CoV-2 viral genomic sequencing was performed locally for all putative outbreak cases and contemporary controls. Molecular and conventional epidemiology data were confronted in real time to improve understanding of COVID-19 transmission and reinforce or adapt prevention measures.

This study will include infected healthcare workers (HCW) and patients for whom a nosocomial infection in CHUM is suspected. The CHUM laboratory is responsible for COVID-19 diagnostic testing in all eligible HCW and patients. After initial diagnosis on standard PCR testing, samples are maintained at -80. Viral RNA is extracted and next-generation sequencing of the viral genome is performed using Nanopore long read sequencing platform. Preliminary data suggest that SARS-CoV-2 has a "molecular clock" of 2 single nucleotide polymorphism (SNP) per month. The analysis and between-isolate comparaison of those SNP among epidemiologically related cases will allow to support or refute the hypothesis of person to person nosocomial transmission. All infected patients will be matched 1:1 with contemporary community cases to provide a viral genome back catalog and better contextualize molecular epidemiology analyses. Molecular clusters will be reported to infection prevention and control teams and resulting interventions will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in the institution during the study period
* Healthcare workers in the institution during the study period

Exclusion Criteria:

* None
Effect on Beta Cell Function and Glycaemic Control After Insulin and Exenatide Sequential Therapy

Whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy.

The UK Prospective Diabetes Study has shown that β-cell function progressively deteriorates over time in people with type 2 diabetes mellitus,irrespective of lifestyle and existing pharmacological interventions. The progressive nature of type 2 diabetes is one of the major challenges in the treatment of affected patients, and agents that could alter the natural history of this condition would add greatly to current treatment approaches.Short-term intensive insulin therapy of newly diagnosed type 2 diabetes has been proved improving beta-cell function and usually leading to a temporary remission time,but the remission rate in a year is only about 50%. The effect of GLP-1 receptor agonists on beta-cells is stimulation of glucose-dependent insulin release, followed by enhancement of insulin biosynthesis. It is stimulating beta-cell proliferation, induction of islet neogenesis, and inhibition of ß-cell apoptosis. Exenatide is an GLP-1 receptor agonist. Exenatide exerts direct effects on β-cell, which indicates that may contribute to delay disease progression. However, no study has evaluated effect of short-term intensive insulin sequential exenatide therapy model on β-cell function and glycemic remission rate in newly diagnosed type 2 diabetic patients. Our hypotheses is whether GLP-1 receptor agonists sequential therapy in newly diagnosed type 2 diabetic patients can further improve glycemic control, diabetes remission rate and β-cell function after the short-term insulin intensive therapy.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed type 2 diabetes without drug treatment
* 25-70 years old age
* Fasting glucose between 7.0-16.7mmol / L
* BMI at 20 \~ 35 kg/m2 and stable for at least 3 month(weight fluctuations within three months does not exceed 10%)
* females who have no plan of pregnancy during the study

Exclusion Criteria:

* acute or chronic complications of diabetes
* myocardial infarction or cerebrovascular events within three months
* serious gastrointestinal diseases
* other serious concomitant diseases
* liver or kidney dysfunction:Transaminase (ALT and AST) greater than 3 times the upper limit of the normal range or creatinine levels greater than 133μmol / L
* GAD antibodies positive
* history of pancreatitis or pancreatic cancer;
* pregnant or breastfeeding women.
* severe hypertension (blood pressure\> 180/110mmhg)
* using corticosteroids, immunosuppressants and cytotoxic therapy.
Clinical Performance of Ceramic CAD/CAM Crowns

The purpose of this study was to evaluate the clinical performance of laboratory and chairside fabricated monolithic anterior and posterior LDGC CAD/CAM crowns performed by predoctoral students at the University of Toronto and the effect of different patient and provider-related factors on their longevity and to compare them to the metal-ceramic (MC) crowns. A sample of LDGC CAD/CAM crowns (IPS e.max, Ivoclar Vivadent) provided by predoctoral students was evaluated. Crown preparations were made according to the specific criteria and were milled in-house using the CEREC bluecam and Omnicam systems. Crowns were cemented with Rely-X Unicem (3M/ESPE) and Calibra Universal (Dentsply Sirona) resin cements. Clinical assessment of the crowns and supporting periodontal structures was performed following the modified California Dental Association (CDA) criteria. Intra-oral photographs, periapical and bitewing radiographs were taken for further assessment by two evaluators. Two-hundred and fifty-one patients with 275 crowns were examined with a follow-up period of up to 6 years.

The clinical success of the monolithic Lithium-disilicate Glass-ceramic (LDGC) crowns manufactured with computer-aided design (CAD) / computer-aided manufacturing (CAM) technology provided by predoctoral students was not investigated. Thus, the purpose of this study was to evaluate the clinical performance of laboratory and chairside fabricated monolithic anterior and posterior LDGC CAD/CAM crowns performed by predoctoral students at the University of Toronto and the effect of different patient and provider-related factors on their longevity and to compare them to the metal-ceramic (MC) crowns. A sample of LDGC CAD/CAM crowns (IPS e.max, Ivoclar Vivadent) provided by predoctoral students was evaluated. Crown preparations were made according to the specific criteria and were milled in-house using the CEREC bluecam and Omnicam systems. Crowns were cemented with Rely-X Unicem (3M/ESPE) and Calibra Universal (Dentsply Sirona) resin cements. Clinical assessment of the crowns and supporting periodontal structures was performed following the modified California Dental Association (CDA) criteria. Intra-oral photographs, periapical and bitewing radiographs were taken for further assessment by two evaluators. Two-hundred and fifty-one patients with 275 crowns were examined with a follow-up period of up to 6 years. Part 1 evaluated the performance of laboratory-fabricated LDGC CAD/CAM crowns. Part 2 evaluated the performance of chairside LDGC CAD/CAM crowns. Forty crowns were evaluated. Part 3 evaluated the performance of LDGC CAD/CAM and MC crowns using split-mouth design. A total of 25 patients and 50 crowns (25 crowns for each group) were examined.

Eligibility Criteria:
Inclusion Criteria:

* Healthy periodontal tissue Adequate root canal treatment

Exclusion Criteria:

* Parafunctional habits
12-week Pilates Program on Community-dwelling Middle-aged Women

The purpose of this study was to investigate the effects of a Pilates exercise intervention program on functional physical fitness in community-dwelling middle-aged women.

Based on quasi-experimental design with a parallel control group, Subjects were allocated into to intervention group and control group with convenience sampling method. The primary outcome included body composition, basal metabolic rate, and functional physical fitness-comprising cardiovascular capacity (3-minute step test), flexibility (sit-and-reach test), muscular strength of upper limbs (grip-strength test), muscular strength of lower limbs (30 s chair stand test), core strength (bent-knee sit-up test), agility (8-foot timed up-and-go test), static balance (single-leg stance with eyes closed test), and dynamic balance (functional reach test), assessed in both groups before and after the 12-week intervention.

Eligibility Criteria:
Inclusion Criteria:

* Female 45-64 years old in age

Exclusion Criteria:

* cognitive-function impairment
* spinal disease
* unsuitability for engaging in physical activity (e.g., because of severe cardiovascular disease)
* muscular strength affected by medication for nervous system diseases.