cyrilzakka/clinical-trials huggingface dataset:
P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy

The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Bile acids may alter maternal cardiomyocyte function like fetus.Increased P-wave duration and P-wave dispersion have been reported in various clinical settings. The investigators hypothesized that PWD and p wave duration may affect in pregnancy with ICP.

Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy-specific liver disease. The most frequent laboratory abnormality is elevation of serum bile acid levels in ICP.

Bile acids increases both maternal and fetal circulation in ICP. The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Raised maternal bile acid levels have been associated with fetal distress and arrhytmia in fetus.

P-wave dispersion (PWD) is defined as the difference between the maximum and the minimum P-wave durations measured on a 12-lead surface electrocardiogram (ECG). Increased P-wave duration and PWD have been reported in various clinical settings, including atrial flutter, coronary artery disease, hypertension, rheumatic mitral stenosis, mitral annular calcification, obstructive sleep apnea, and obesity.

So the investigators think that bile acids may alter maternal cardiomyocyte function as fetus. The investigators hypothesized that PWD and p wave duration may affect in pregnancy with ICP.

The aim of this study is to investigate maternal P-wave duration and dispersion changes in pregnant women with intrahepatic cholestasis of pregnancy .

Eligibility Criteria:
Inclusion Criteria:

- Pregnants who with ICP

Exclusion Criteria:

* Chronic liver disease
* Disease during current pregnancy
* Multiple pregnancies
Comparison of Active Release Technique and Bent Leg Raise In Osteoarthritis.

The objective of the study was to compare the effects of active release technique and bent leg raise on hamstring flexibility, functional outcomes, and pain in patients with knee osteoarthritis.

Knee Osteoarthritis is a common progressive degenerative joint disease. Muscular weakness and other structural abnormalities can cause low back pain. Hamstring muscle being a postural muscle has an increased tendency to become tight. In this study, participants with knee osteoarthritis having hamstring tightness were included. Active Release Technique and Bent Leg Raise technique have been used to increase flexibility in hamstrings in these patients with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed patients of Knee Osteoarthritis
* Hamstring length less than 160 degrees
* Minimum history of 3 months
* Willing to participate

Exclusion Criteria:

* Patients who have passive knee extension more than 160 degrees
* Patients with less than 3 months history
* Patients who have osteoarthritis of other than the knee joint
* Patients with history of fracture
* Patients with post surgical history
ARTISS a Single-centre Randomised Control Study

The Influence of ARTISS on post-operative abdominal drainage and seroma formation in DIEP/MS-TRAM free flap breast reconstruction patients.

The principle aim of the study is to investigate the effect of ARTISS on abdominal wound drainage whether this could result in earlier drain removal and earlier patient discharge from hospital. The primary outcome investigated will be post- operative abdominal drainage duration in days which is vital information during this Covid pandemic to reduce hospital stay (and therefore possible Covid exposure) which could result in earlier discharge from hospital, as well as significantly reducing cost of the procedure to the NHS and frees in-patient beds for more efficient use of resources.

Eligibility Criteria:
Inclusion Criteria:

* Female adult (age 18-80)
* Patients planned for immediate or delayed DIEP/MS-TRAM breast reconstruction

Exclusion Criteria:

* Patients who are unable to consent or do not consent
* Clotting disorder
* Pregnancy
* Individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).
* COVID positive
* Known previous allergic reactions to ARTISS
Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function

The purpose of this study is to assess the low-intensity focused ultrasound pulsation (LIFUP) neuromodulation on emotion processing in healthy individuals, and to assess the overall safety of the LIFUP to stimulate or inhibit brain activity in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Must be right-handed
* Must be illicit drug-free at the time of scanning as appropriate (verified by negative urine drug screen)
* Must be healthy (without medical, neurological, psychiatric illness)
* Must be psychotropic medication free (≥ 14 days)

Exclusion Criteria:

* Must not be a smoker
* Females must not be pregnant or nursing
* Must not suffer from claustrophobia
* Must not meet exclusion criteria for MRI scanning (i.e., non-fixed magnetizable objects)
* Must not have ongoing, chronic, or relapsing/remitting medical, psychiatric,or neurological illness as determined by a combination of history, medical record, and/or examination.
Pre-exercise Ingestion of a Low Glycaemic Index Rice-based Mixed Meal Increases Fat Oxidation and Endurance Running in a Hot-humid Environment

The objective of this research is to determine the influence of low and high glycemic index Malaysian pre-exercise mixed meals on endurance exercise performance in a hot-humid environment. Glycemic index (GI) is a method used to classify CHO-containing foods based on their influence on postprandial blood glucose when compared to the response on blood glucose after ingesting the same amount of CHO from a reference food (glucose or bread). Low GI (LGI) foods are digested and absorbed more slowly as compared to high GI (HGI) foods, resulting in a stable rise in blood glucose levels.

The participants were trained male endurance long-distance runners. On the day of experimental trials, they consumed pre-exercise rice-based mixed meal, either LGI or HGI 3 hours before endurance running exercise. After that, they ran for 45 minutes at constant running speed equivalent to 70% VO2peak, followed by 10km time-trial. The respiratory gases, blood measures, rectal and skin temperature were measured throughout the running test.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* age 18-35 years old
* trained (peak oxygen consumption (V̇O2peak): ≥ 55 mL.kg-1.min-1)
* training volume (\&gt;150 min, ≥ three times per week)
* competing at the national level
* \&gt;2-year of running experience
* tier 2 (trained) or tier 3 (highly trained) runners (McKay et al. 2022)
* no allergies to any test foods

Exclusion Criteria:

* diagnosis of chronic diseases (i.e. diabetes mellitus, hypertension, cardiovascular disease)
* bone, muscle or joint impairments
* on medication
* currently smoking
* use of illicit drugs
* use of dietary supplements
* on any particular diet
Amantadine to Speed Awakening After Cardiac Arrest

This study evaluates if amantadine will increase the rate of awakening in patients resuscitated from cardiac arrest but comatose (not following commands) after their resuscitation. Half of the participants will receive amantadine and the other will receive placebo.

Amantadine has been used to help patients awaken following traumatic brain injury, but it has not been studied in patients with anoxic brain injury.

Amantadine is a dopamine agonist and may help with stimulating the brain to awaken. The investigators will randomize subjects who remain comatose 72 hours following resuscitation from cardiac arrest to either amantadine or placebo. They will be treated with either amantadine or placebo for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Non traumatic cardiac arrest
* Age 18 and older
* Defibrillation and/or chest compressions by healthcare providers
* Return of spontaneous circulation

Exclusion Criteria:

* Written do not attempt resuscitation (DNAR) reported to providers before randomization
* Known prisoner or pregnancy
* Lack of motor response to pain and absent N20 response on somatosensory evoked potentials prior to randomization
* Initial CT demonstrating brain edema (defined as grey white ratio \<1.2)
* Presence of malignant pattern on EEG at time of randomization
* Next of kin unwilling to provide supportive care for at least one week after enrollment
* Presently using other dopaminergic agent
Repeatability of Blood Glucose Responses to Resistance Exercise in Type 1 Diabetes

This study proposes to examine the impact of time of day (morning versus afternoon) on the variability of blood glucose responses to high resistance exercise in a single group of patients with type 1 diabetes. Participants will be asked to wear a continuous glucose monitor during the 3 weeks of testing. During the six exercise sessions (three in the morning while fasted and three in the afternoon), participants will complete the same resistance exercise protocol.

Pre-test measures: Interested participants will be invited to the Physical Activity and Diabetes Laboratory on the main campus of the University of Alberta. They will be asked questions related to their physical activity levels and medication, and blood pressure will be measured to assess their eligibility. Where participants are eligible, anthropometric characteristics will be measured using standard protocols, as will blood pressure. A blood sample will be drawn for assessment of HbA1c. Participants will be introduced to the weight lifting equipment and the proper lifting techniques associated with each exercise prior to performing a standardized test to determine the maximum weight they can safely lift eight times while maintaining proper form (8 repetition maximum - 8RM).

Testing sessions: Participants will be asked to arrive at the lab either between 7 and 8 am in a fasting state, or between 4 pm and 5 pm. The three morning and three afternoon testing sessions will have identical exercise protocols. Participants will be asked to perform three sets of eight repetitions of seven different exercises (bench press leg press, shoulder press, leg curl, lat pulldown, abdominal crunches, seated row) at their pre-determined 8RM. Participants will be asked to match their food and insulin intake as closely as possible on testing days to avoid having these as confounders.

A continuous glucose monitor (CGM) sensor will be subcutaneously inserted by one of the investigators (trained by a group from the CGM manufacturer) into the anterior abdominal area of the participant in the morning of the day prior to the first testing session. CGM will store glucose data every 5 minutes for up to 7 days. During this time, participants will be asked to wear an accelerometer to allow for the objective assessment of background physical activity and sleep quality. Along with this device, they will fill out an activity and sleep log to improve the analysis of the data.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes diagnosed for at least 1 year
* aged 18 to 55 years

Exclusion Criteria:

* HbA1c \> 9.9%
* frequent and unpredictable hypoglycemia
* change in insulin management strategy within two months of study
* using closed-loop insulin delivery
* injuries that would contraindicate resistance exercise
* blood pressure \> 140/95
* severe peripheral neuropathy
* a history of cardiovascular disease
* severe proliferative retinopathy
Ambulation for Latency During Expectant Management of PPROM

Ambulation in pregnancy has been proposed to decrease stress and anxiety, increasing preterm birth. Whether ambulation is causally related to latency is unknown. The FitBit will be used for tracking the number of steps taken daily by each participant, and for encouraging the intervention group to walk. The FitBit is the most widely used physical activity tracker in medical research, and its use has been validated for research use in pregnant women. The purpose of the study is to evaluate whether ambulation in patients with preterm premature rupture of the membranes (PPROM) prolongs latency.


Eligibility Criteria:
Inclusion Criteria

* Pregnant women aged 12-55
* Gestational age 23 0/7 to 35 0/7 weeks
* PPROM confirmed by clinical diagnosis which includes sterile speculum examination with pooling, ferning, and nitrazine tests, or the Amnisure ROM Test
* Planned inpatient expectant management with delivery goal \>=7 days from enrollment
* Ability to provide informed consent in English or Spanish

Exclusion Criteria

* Imminent delivery
* Transverse or footling breech presentation (if multiple gestation, presenting fetus)
* Unstable lie (if multiple gestation, presenting fetus)
* Funic presentation (if multiple gestation, presenting fetus)
* Active vaginal bleeding
* Regular, painful contractions (\>=3 in 10 minutes for 30 minutes or more) consistent with labor
* Clinical contraindication to ambulation as determined by the managing physician
* Physician declines to have the patient approached for participation
* Lethal fetal anomalies
Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid

The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat cancer pain in patients who have not been treated with a strong opioid.

This is a multicenter, prospective, open-label (all people know the identity of the intervention) and observational study. Patients selected for the proposed study are patients complaining of cancer pain who visit or are hospitalized at the research centers during the study, who are not being treated with strong continuous opioid (narcotic medication used against the pain), and who require cancer pain control with hydromorphone, at the investigator's discretion. The study will evaluate the changes in pain relief, level of sleep deprivation, and the patients' quality of life before and after administration of hydromorphone.

Eligibility Criteria:
Inclusion Criteria: - Patients who complain of cancer pain and who require administration of hydromorphone HCl - Patients who can follow the requirements of the overall study, including completion of filling out the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, at the investigator's discretion - Signed informed consent Exclusion Criteria: - Patients who received strong continuous narcotic analgesics (eg morphine, fentanyl, oxycodone, hydromorphone) within 4 weeks prior to administration of the study drug - Patients who have a medical history of receiving drugs in the past or currently, or of drug abuse - Patients who did not agree to conduct the approved methods for contraception during the study - Patients who have sustained injuries in physical functions or diseases which may cause abnormalities in absorbing the study drug, excessive accumulation and metabolic or elimination disorder - Patients who are receiving Monoamine Oxidase Inhibitors (MAO) inhibitors or who are within 2 weeks from discontinuation - Patients who need to be excluded based on precautions in the user manual of the study drug, notice and contradictions, at the investigator's discretion
The Norwegian Immunotherapy in Multiple Myeloma Study

The goal of this observational study is to study the effectiveness and complications of novel immunotherapies used in the treatment of multiple myeloma in routine care in Norway. The aim is to close knowledge gaps, generate evidence for future clinical trials and contribute to future consensus on how to monitor for adverse events, and what mitigation strategies should be implemented, so that we can increase patient survival and quality-of-life.


Eligibility Criteria:
Inclusion criteria

* Participants age ≥ 18 years
* Prior diagnosis of one of the following

  * Multiple myeloma as defined according to IMWG criteria
  * Primary plasma cell leukemia as defined according to IMWG consensus definition
  * AL-amyloidosis as defined according to IMWG criteria
* Planned treatment with one of the following outside clinical trials (list to be amended based on approvals within the EU):

  * Teclistamab (Tecvayli)
  * Elranatamab (Elrexfio)
  * Talquetamab (Talvey)
  * Idecabtagene vicleucel (ide-cel/Abecma)
  * Ciltacabtagene autoleucel (cilta-cel/Carvykti)

Exclusion Criteria:

* None
Muscle Anabolic Response to β2-adrenergic Stimulation With Increased Amino Acid Availability.

The purpose of the project is to investigate the effect of amino acid availability on the muscle anabolic response to beta2-adrenergic stimulation in young healthy men and women.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40
* Physically active \>5 hours a week
* Maximum oxygen uptake classified as high or very high

Exclusion Criteria:

* Active smoker currently or within the past 5 years
* Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
* Chronic or acute illness deemed by the responsible study physician to affect the test parameters
* Deviation from the study protocol
* Lean mass index \>21 kg/m²
* Pregnancy
* Smoker
* Blood donation during the past 3 months
Recovery at the Post Anaesthetic Care Unit After Hip and Knee Arthroplasty

To clarify patient related problems in the Post Anaesthetic Care Unit (PACU) immediately after fast-track hip and knee arthroplasty.

In this prospective, consecutive, observational cohort study we examine:

1. Patient related problems in the PACU after hip and knee arthroplasty simply to answer the question "Why in PACU?", using a modified version of the national guidelines for patient observation in PACU.
2. The time spent in PACU with the modified version of the national guidelines for patient observation in PACU.
3. If the modified version of the national guidelines for patient observation in PACU results in patient related problems in the ward afterwards.

Eligibility Criteria:
Inclusion Criteria:

* primary, unilateral, total hip or knee arthroplasty by one of three surgeons using the same technique, and under spinal anaesthesia

Exclusion Criteria:

* Bilateral arthroplasty
* Revision arthroplasty
* General anaesthesia
BodyGuardian Respiration and Activity Validation Testing

This project will compare BodyGuardian (BG) device measurements of breathing and activity levels to the gold standard measurement techniques of gas exchange using a mouthpiece connected to flow and gas analyzers measures for breathing and metabolic rate (indirect calorimetry) for activity, We are hopeful these comparisons will help us improve upon the measurements being made in the current version of the BG device.

BodyGuardian remote monitoring system is an FDA 510 cleared device used to perform remote monitoring of cardiac patients. BodyGuardian (BG) is a novel remote care platform. It incorporates an adhesive strip sensor with in-built electrodes attached to a rechargeable module that can determine an ECG signal and bio impedance. The module also has a 3-way accelerometer. ECG, physical activity and respiration can be assessed using these sensors. Although ECG data is reliable, there are doubts regarding the clinical meaning and validity of the activity and respiration data.

The BG reports respiration rate and activity level (on a scale of 0 to 100). This data is being used as input into other clinical algorithms including onboard ECG arrhythmia detection as well as clinical care algorithms for heart failure decompensation prediction.

Respiration data is not uniformly reported and there is still doubt regarding its validity. BG breathing measurements will be compared to gold standard measurement techniques of gas exchange using a mouthpiece connected to flow and gas analyzer. Activity data is reported but the investigators do not know how the value translates into clinically used objective parameters of activity e.g. METS. BG activity measurements will be compared to the gold standard activity measurements using metabolic rate (indirect calorimetry)

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers between the ages of 18-80
* Heart Failure Patients/ Volunteers between the ages of 18-80

Exclusion Criteria:

* Healthy - Non Ambulatory. With Pacemaker. Not able to sign consent.
* Hospitalized in last 6 months for fractures, myocardial infarcts, cancer related surgery, chemo therapy. Allergies to silicone or acrylic hydrogel adhesives, fragile skin, and/or pregnancy
* Heart Failure - Non Ambulatory. With Pacemaker. Not able to sign consent.
* Hospitalized in last 6 months for fractures, cancer related surgery, chemo therapy.
* Allergies to silicone or acrylic hydrogel adhesives, fragile skin, and/or pregnancy.
Evaluating of the Safety, Pharmacokinetics and Pharmacodynamics of QL1205 and Lucentis® in Patients With Wet AMD

This is a randomized, double-blind, two-group parallel, positive-controlled clinical Phase I trial comparing the safety, pharmacokinetics and pharmacodynamics of QL1205 and Lucentis® in patients with wet age-related macular degeneration.

This is a phase I, randomized, double-blind, two-group parallel, positive-controlled clinical trial at four centers.

The primary objective is to assess the initial clinical safety of intravitreal injection of QL1205 or Lucentis® in patients with wet age-related macular degeneration (wet-AMD).

The secondary objective are to assess the initial clinical effectiveness and pharmacokinetic characteristics of intravitreal injection of QL1205 or Lucentis® in patients with wet age-related macular degeneration (wet-AMD).

Subjects would sequentially enrolled according to the protocol in one of two cohorts.Subjects would receive a single 0.5mg of QL1205 or Lucentis® once a month for three months through vitreous injection.

Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent form, and willing to receive follow-up according to the time stipulated by the trial;
2. Aged ≥50 years or ≤80 years, male or female (including the boundary value);
3. The target eye must meet the following requirements; Has newly occurring or relapsed subfoveal and perifoveal active choroidal neovascularization (CNV) lesions secondary to AMD; The total area of all types of lesions is ≤30 mm2(the area of 12 optic discs); The best corrected visual acuity is 78-19 letters (equivalent to Snellen visual acuity of 20/32 to 20/400); No refractive media opacity or myosis affecting fundus examination;
4. The best corrected visual acuity of the subject's non-target eye is ≥19 letters (equivalent to Snellen visual acuity of 20/400).

Note: If the subject's eyes both meet the inclusion criteria, the investigator will determines the target eye from a medical point of view.

Exclusion Criteria:

Patients with any of the following eye conditions:

1. The investigator judges that the target eye is currently suffering or used to suffer from non-exudative AMD disease affecting macular detection, or ocular diseases affecting central visual acuity (including central venous obstruction, diabetic retinopathy, uveitis, vascular striation, pathological myopia, retinal detachment, macular hole, etc.);
2. The target eye's CNV is secondary to diseases other than AMD, such as trauma, pathological myopia,etc.;
3. Either eye has previously received drug treatment for CNV (e.g., Lucentis, Avastin, Eylea, Composin, Acaconac, triamcinolone, steroids, etc.)
4. The target eye has subretinal hemorrhage, and hemorrhagic area is ≥ 50% of the total area of the lesion, or the subfoveal bleeding area is ≥ 1 optic disc area;