cyrilzakka/clinical-trials huggingface dataset:
Massage Versus Cold Water Immersion for Fatigue-induced Biomechanical Alterations

The optimization of recovery to alleviate the effects of fatigue in athletes can provide valuable performance advantage. However, despite the growing body of literature regarding effects of different interventions in fatigue, there is still lack of clarity regarding the efficacy of interventions on running economy and, particularly, fatigue-induced biomechanical alterations. Therefore, the aim of this study was to compare the effects of massage and cold water immersion for enhancing recovery and alleviating fatigue after an exhausting training session. We hypothesized that both massage and cold water immersion would enhance biomechanical parameters compared with a control condition and hence would improve subsequent running economy.

In this randomized controlled all the subjects (n=48) will performed the same protocol. The protocol will begin with a exhausting training session (20-min warm-up consisted of 15-min of continuous self-paced running followed by 5-min of fast-finish progression runs increasing speeds (from approximately 60% to 80% of maximal heart rate, participant controlled), 10 x 500 m sprints at 90% of maximal heart rate with a 2-min rest period between bouts and a recovery phase consisting of 10-min of slow jogging). Twenty-four hours after this exhausting training, subjects will perform an incremental running test on a treadmill (Pre-intervention test) where subjects will start at 12 km/h for 6 min after which speed will be increased by 2 km/h every 6 min until a 16 km/h trial is completed. At the end of each stage, participants will rate their perceived exertion using the 10-point Modified Borg rating of perceived exertion scale (RPE scale). One hour after this test, in one protocol subjects will receive the massage intervention, (Massage group); other group will receive a cold water immersion intervention (Cold water immersion group); in the other group (Control group) participants will rest passively in a sitting position for 30-min period. To evaluate the relevance of the changes induced by the interventions (massage, cold water immersion, passive rest) subjects will repeat the treadmill test 48 hours after the first test (72 hours after the exhaustive training).

Eligibility Criteria:
Inclusion Criteria:

* Recreationally active (current participation in races and a 10-km race time\<34.5-min)

Exclusion Criteria:

* Suffered from any injury within the preceding 4 months.
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.

This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris. The first 12 weeks of the study involves randomized, double-blind treatment with active FMX-101, 4% or matching vehicle. Subjects who successfully complete the 12-week double blind portion of the study will be offered the opportunity to continue in the trial for up to an additional 40 weeks (for a total of 1 year) and receive open-label treatment with FMX-101, 4%.

Eligibility Criteria:
Inclusion Criteria:

* Has facial acne vulgaris with:

  * 20 to 50 inflammatory lesions (papules, pustules, and nodules)
  * 25 to 100 noninflammatory lesions (open and closed comedones)
  * No more than 2 nodules on the face
  * IGA score of moderate (3) to severe (4)
* Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study

Exclusion Criteria:

* Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations
* Sunburn on the face
Teaching Neuraxial Ultrasonography With a Virtual Reality Simulator of Spine

As one of the most extensively practiced regional block, neuraxial anesthesia is the basic skill for anesthesiologist to acquire. Recently, virtual reality (VR) has been proposed as a new simulation training method to enhance medical education. The aim of our study is to evaluate the practical skills of ultrasound scan and the satisfaction of students who undergo training using VR versus traditional didactic lecture.

This is a prospective, single-center, randomized control trial to evaluate the performance of spine ultrasound scan after different training methods. Participants were randomly divided into two groups receiving different training methods: VR spine simulator or traditional didactic teaching. After the training, participants were required to perform a preprocedural spine ultrasound scan on healthy volunteers using the stepwise technique taught in the didactic teaching session. The participants needed to acquire three key ultrasound views during the scan and recognize the anatomic structures in three ultrasound views.

Eligibility Criteria:
Inclusion Criteria:

* anesthesia residents in our department

Exclusion Criteria:

* having previous experience of spine ultrasonography training
* having previous experience of spine ultrasound scan.
A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood

BI 1810631 trial formulation 1 (TF1) is currently used in clinical trials, but is planned to be replaced by another formulation (principle) in future clinical trials and on the market. This trial intends to bridge pharmacokinetics (PK) between the two formulation principles. For this, relative bioavailability of TF1 and new formulation (NF) is assessed. Moreover the trial intends to inform on the effect of food and of the proton pump inhibitor rabeprazole on the PK of BI 1810631 after administration as NF in order to inform management of food and concomitant medications.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 45 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 weight divided by height squared (kg/m2) (inclusive)
* Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* further exclusion criteria apply
The Effect of Ischemic Training on Exercise Endurance

The purpose of this study is to determine if reducing blood flow to an exercising muscle during exercise training will enhance the training effect on that muscle in people who have limited exercise because of congestive heart failure

The objective of this study is to determine whether reduction of blood flow during stair-stepping and cycling ergometer leg exercise will contribute to an improvement in whole body exercise capacity or submaximal exercise endurance in patients with mild congestive heart failure. Two groups of 25 patients with mild to moderate CHF, aged 30-70, will be trained for 12 weeks. The experimental group will train with pressure cuffs inflated on one thigh and lower leg during exercise. The cuff will be applied on alternate legs during training, such that each leg has the same duration of ischemic training. The control group will train for a similar duration and intensity without pressure cuffs on the legs. Pre and post training measures will include VO2peak, exercise duration at 30% VO2peak, 6 minute walk test, Minnesota Living with Heart Failure questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Mild Congestive Heart Failure
* Must be able to exercise

Exclusion Criteria:

* Venous or arterial thrombus
* Lower extremity arthritis
* Blood clotting abnormalities
* Claudication
* Peripheral vascular disease
* Evidence of deep vein thrombosis on ultrasound
Dosimeter Location in Pain Physicians

The primary objective is to determine if there is a significant difference in radiation readings between dosimeters worn on the chest versus the hand of interventional pain management physicians and elucidate which dosimeter had higher readings.

The secondary objective is to track incidences of physician glove breaches in both groups to assess if wearing hand dosimeters is associated with an increased risk of this event.


Eligibility Criteria:
Inclusion Criteria:

* Physicians actively performing fluoroscopy procedures at the Comprehensive Pain Center.

Exclusion Criteria:

* Those that do not want to participate in the quality improvement project.
Phosphorus Absorption in Healthy Adults and in Patients With Moderate Chronic Kidney Disease

Chronic kidney disease (CKD) affects approximately 26 million Americans with many more at risk for disease development. Elevated serum phosphorus (P) and related abnormalities in P homeostasis due to progressive loss of kidney function are primary driving forces behind cardiovascular dysfunction and mortality in CKD patients. Intestinal P absorption is an critical aspect in P homeostasis but has been understudied, particularly in the early stages of CKD progression. This study aims to determine P absorption in patients with moderate CKD compared to healthy adults.


Eligibility Criteria:
Inclusion:

Men and women ages 30-75 years old, any race

Moderate CKD, based on the last set of labs done in the past year, defined as:

Glomerular Filtration Rate (GFR) category G3a (eGFR 45-59 mL/min) with A2 or A3 albuminuria or proteinuria by positive dipstick or urine protein/creatinine ratio (UPCR); -or- G3b (eGFR 30-44 mL/min), with or without evidence of albuminuria (any A1-A3) or proteinuria. (Figure 1)

-or- Healthy control with no diagnosis or evidence of CKD

Female subjects must be post-menopausal, surgically sterile, or confirmed not pregnant by pregnancy test and not breastfeeding.

Subjects must be on stable doses of medications (except those noted in exclusion criteria) for at least 6 weeks prior to the study

Exclusion:

Plans to initiate dialysis within 6 months

Labs based on the last set done in the past year:

Hypercalcemia defined as serum calcium \> 10.5 mg/dL

Hyperkalemic \> 5.5 mg/dL Prescribed a phosphate binder medication

Small bowel resection, bariatric surgery. Medically unstable or poorly controlled hypertension, diabetes, or gastrointestinal disorders in the opinion of the physicians on the study team

Calcitriol, ergocalciferol, cholecalciferol, vitamin D analogs, calcimimetics, PTH analogues, calcium supplements, multivitamins/mineral and other medications that may alter phosphorus metabolism - must be off for at least 6 weeks prior to study
Medico Economic Evaluation of Dermal Substitute Integra® for Coverage of Inferior Limb Traumatic Skin Loss

Comparison of 2 techniques of surgery on patients with inferior limb traumatic wounds: the innovative technique Integra® and the technique of reference: the flap surgery.

Traumatic skin loss with bone or tendon exposure essentially affects inferior limbs. There are considered serious as they often lead to functional and esthetical consequences, and they generally affect young people.

Flap surgery is the treatment of reference for these skin losses. This technique requires expensive material and a lot of medical staff. The intervention and duration of hospitalisation are often long with heavy medication. Post surgery complications or disabling sequelea involve surgical re-interventions which increase duration of hospital stay and medical staff availability.

The dermal substitute Integra® (Integra LifeSciences Corporation) is an advanced wound care device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone layer). This medical device allows formation of a neoderm. The silicon layer is a temporary layer which is removed when the neoderm is totally built. This surgery is fast, non-invasive, with short hospital stay and limited complications which can be treated easily.

Objective of the study: to assess medico-economic interest of innovative surgery using dermal substitute Integra® compared to the reference using flap surgery in the treatment of traumatic skin loss of inferior limbs. Assessment will be based on re-interventions incidence, long-term functional and esthetical scar results and total cost of each technique.

Study design: multicenter, randomized, open label, parallel design, clinical trial in 12 French plastic surgery / burn care centres.

Planned number of enrolled patients: 120 (80 patients receiving Integra® and 40 patients receiving the flap surgery). Patients will be randomized in 1 of the 2 groups, with an imbalance in favour of the innovative technique.

Duration of enrollment: 24 months Duration of patient follow up: 18 months

Eligibility Criteria:
Inclusion Criteria:

* patient with skin loss traumatic or chronic wound
* wound located from mid third of the leg to distal extremity of feet
* with muscle and/or tendon and/or bone and/or articulation exposure
* requiring a first surgical intervention for the coverage of the skin loss
* patient eligible to the Integra® surgery techniques
* patient with social security affiliation
* written informed consent signed by the patient or representative

Exclusion Criteria:

* Bone fracture located in the skin loss
* Non traumatic wound
* Wound with muscle exposure only
* Immunocompromised patient
* Allergy to bovine collagen, glycosaminoglycans or silicon
* patient with an healthstate that compromise the 18 months Follow-up
* pregnant women / who intend to become pregnant within the 18 months of follow-up
* Patient under administrative or legal supervision
Improving Accuracy of Landmarks for Neuraxial Blocks in Pregnancy: The Sacral Anatomical Interspace Landmark (SAIL) Technique

This study is a randomized clinical trial to evaluate the accuracy of the novel SAIL technique compared to the classic intercristal line technique in estimating the L4-L5 interspace for labor epidural or spinal anesthesia placement. The investigators hypothesize that the SAIL technique will be more accurate in successfully locating the L4-L5 interspace in pregnant women than the classic intercristal line technique.

The current standard technique aiming at identifying the L4-L5 intervertebral space as a reference point before performing a neuraxial block relies on the correct clinical estimation of the intercristal line. The classic intercristal line technique uses an imaginary line that intersects the iliac crests to determine a safe puncture level to access. In pregnant women, the classic technique fails to identify the safe puncture level 40 % of the time.

The newly proposed Sacral Anatomical Interspace Landmark (SAIL) technique consists of using the sacral bone to determine a safe puncture level to access.

Lumbar ultrasound will determine the accuracy of each clinical technique in identifying the L4-L5 interspace (target).

Eligibility Criteria:
Inclusion Criteria:

* Ultrasound-determined gestation age greater than or equal to 37 weeks
* Expressed interest or indication for epidural anesthesia
* Patients in the first stage of labor

Exclusion Criteria:

* Patients perceived or indicating that she is unable to cooperate with positioning
* BMI greater than 45 kg/m2
* Previous spine surgery or known spinal deformities
* Impaired decision making abilities
* non-English speaking
Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations

This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.


Eligibility Criteria:
Inclusion Criteria:

* Cytogenetically confirmed Ph+ CML-CP Any prior dose of Imatinib
* Imatinib 400 mg daily for ≥7 consecutive days prior to imatinib trough collection
* Imatinib trough plasma concentration \<850 ng/mL

Exclusion Criteria:

* Prior documented failure events as defined by ELN guidelines:
* Loss of CHR, CCyR, or clonal progression/Ph+
* Less than CHR at 3 months after diagnosis
* No CyR at 6 months after diagnosis
* Less than PCyR at 12 months after diagnosis
* Less than CCyR at 18 months after diagnosis
* Prior accelerated phase or blast phase CML
* Previously documented T315I mutation
* Previous treatment for CML with any other tyrosine kinase inhibitor except for imatinib
* Patients who had any other treatment for CML (transplant) except interferon +/- ara- C, imatinib, hydroxyurea and/or anagrelide
* Impaired cardiac function
* Patients receiving therapy with strong inhibitors of CYP3A4 or medications that prolong the QT interval and cannot be either discontinued or switched to a different medication prior to starting study drug.
* Any other malignancy that is clinically significant or requires active intervention.
* Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from prior surgery
* Treatment with other investigational agents within 30 days of Day 1
* Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of nilotinib
* Sexually active male and female patients taking nilotinib unwilling to use adequate contraception throughout the trial and 3 months following discontinuation of study drug
Effect of Different Doses of Tomato Lycopene on Blood Pressure in Pre-hypertensive Otherwise Healthy Subjects

Effect of different doses of tomato extract (contain Lyc-o-Mato 6% Oleoresin which Contain: 5, 15 mg lycopene , in addition to Beta-carotene (0.15%), phytoene, and phytofluene (1%); and vitamin E (2%), phospholipids (15%), and phytosterols (0.6%) suspended in tomato oleoresin oil) compared with synthetic lycopene on blood pressure and plasma lycopene levels in never treated pre-hypertensive otherwise healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Aged 35-60,
* No antihypertensive treatment in the past or present,
* 135\< SBP\< 145 or 85\<DBP\<95,
* Informed consent signed,

Exclusion Criteria:

* Unwilling to participate in the study,
* Treated essential,
* secondary or complicated hypertension,
* SBP lower than 135 or higher than 145 mmHg,
* DBP lower than 85 or higher than 95 mmHg,
* Use of other medications (statins, NSAI ect..),
* Known allergy to tomato, carotenoids, or vitamin E,
* Diabetes Mellitus,
* Obesity BMI\>32,
* Significant dyslipidemia,
* Patients with ischemic pain, S/P MI, PTCA or CABG, LVH or CHF,
* Smoker,
* Valvular heart disease,
* PVD,
* Cerebrovascular disease, s/p CVA, TIA,
* Any kind of kidney disease (creatinine\>1.6),
* Chronic liver disease(elevated AST and ALT at least by 2 times of the normal range),
* Alcohol abuse,
* History of GI disease or surgery,
* History of malignancy in the past 5 years,
* History of autoimmune disease,
* Participation in other researches protocol
PD-1 Immune Checkpoint Inhibitors and Immune-Related Adverse Events: a Cohort Study

The objective of our study is to assess the risk of immune-related adverse events associated with PD-1 inhibitors use compared to standard chemotherapy use in patients with non small cell lung cancer, using nationwide healthcare database.

This observational, retrospective cohort study will evaluate the risk of immune-related adverse events associated with PD-1 inhibitors use compared to standard chemotherapy use in patients with non small cell lung cancer, using nationwide healthcare database. PD-1 inhibitors will be defined as nivolumab, pembrolizumab, and atezolizumab. Standard chemotherapy will be defined as cytotoxic chemotherapy or tyrosine kinase inhibitors (epidermal growth cell receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors). The investigators will assess exposure on the cohort entry using the intention-to-treat approach with the 6-month exposure risk window from the first PD-1 inhibitor prescription to avoid bias from informative censoring. Immune-related adverse events will be defined by using pre-specified algorithms using diagnosis and corticosteroid prescription records (high dose of oral corticosteroids, defined as ≥ 30 mg/day, or systemic corticosteroid injection) to reduce outcome misclassification. The investigators will use a multivariable Cox proportional hazard model to estimate hazard ratio (HR) and 95% confidence intervals (CI). The model will be adjusted for pre-existing autoimmunity, history of lung cancer surgery, radiation therapy, tyrosine kinase inhibitor use, and previous systemic corticosteroid use. All analyses will be undertaken using SAS 9.4 (SAS Institute Inc., Cary, NC, USA).

Eligibility Criteria:
Inclusion Criteria:

* Individuals who were diagnosed with lung cancer (ICD-10: C33-C34) between 2017 and 2018.

Exclusion Criteria:

* Individuals less than 18 years of age
* Individuals received any systemic anticancer therapies in 2007
* Having no records of prescription of PD-1 inhibitors or standard chemotherapy at least once between 2017 and 2018
* Individuals received treatments indicated for small cell lung cancer (etoposide, ifosfamide, irinotecan, belotecan, and topotecan) on or before the first date of standard chemotherapy to restrict study subjects to patients with non small cell lung cancer only.