cyrilzakka/clinical-trials huggingface dataset:
Web-based Symptom Monitoring and Survival in Advanced Stage Lung Cancer

The goal of this clinical trial is to investigate if weekly symptom monitoring of patients with advanced lung cancer is associated with better survival and improved quality of life compared to standard follow-up.

Each week, participants in the intervention group will be asked to respond to an electronic weekly questionnaire covering 11 items related to current health status.

This is a prospective, multicentre, randomized, two-armed, open-label trial in which participants will be randomised to standard follow-up according to current management guidelines for lung cancer (control arm) or with the addition of weekly web-based symptom monitoring (intervention arm). Both study groups will be asked to fill out quality of life questionnaires before randomisation and every three months. In addition to comparing survival and quality of life, the study will also assess progression free survival, performance status, eligibility for second line anti-neoplastic treatment and health care consumption.

All subjects will be followed for 24 months. Updated data on survival will also be collected up to 5-years.

By innovative use of an IT platform already in use in Swedish cancer care, this trial will evaluate potential benefits of systematic symptom monitoring in patients with advanced lung cancer. If corroborating earlier reports of marked survival benefits, the results of this trial could change clinical practice and current guidelines for follow-up of lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytology proven non-small cell lung cancer (NSCLC)
* NSCLC stage III or IV
* ≥ 18 years
* ECOG performance status 0- 2
* Eligible patients should have initiated first-line treatment for advanced or metastatic disease with chemotherapy and/or immunotherapy, radiochemotherapy or targeted treatment
* Patients are eligible for inclusion if they have responded to first-line treatment with stable disease, or better, at the first radiological evaluation performed up to six months after start of treatment
* Stable disease, or better, on radiological assessment within 28 days of enrolment (CT scan or FDG-PET/CT. Cerebral MRI if known brain metastasis)
* Initial web-based application score of ≤ 6
* Basic computer literacy
* Bank-ID (electronic identification system) and access to "1177 Vårdguiden"
* The subject has given written consent to participate in the study

Exclusion Criteria:

* Symptomatic brain metastases
* Pregnancy, breastfeeding, or planned pregnancy
* Persons under guardianship or deprived of liberty
* Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
* Treatment or disease which, according to the investigator, can affect treatment or study results
* Ongoing participation in another interventional clinical study
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy

This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures performed in subjects with symptomatic obstructive hypertrophic cardiomyopathy (oHCM \[also known as HOCM\]) who are eligible for SRT based on ACCF/AHA 2011 and/or ESC 2014 guidelines.


Eligibility Criteria:
Key Inclusion Criteria:

* At least 18 years old at screening and body weight \> 45 kg at screening
* Diagnosed with oHCM consistent with current ACCF/AHA 2011 and meet their recommendations for invasive therapies
* Referred or under active consideration within the past 12 months for SRT procedure and willing to have SRT procedure
* Has documented left ventricular ejection fraction (LVEF) ≥ 60% at Screening
* Has documented oxygen saturation at rest ≥ 90% at Screening

Key Exclusion Criteria:

* Persistent or permanent atrial fibrillation and subject not on anticoagulation for ≥ 4 weeks prior to screening and/or not adequately rate controlled ≤ 6 months prior to screening
* Previously treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[ASA\])
* For individuals on beta blockers, calcium channel blockers, or disopyramide, any dose adjustment of these medications \< 14 days prior to screening or an anticipated change in regimen during the first 16 weeks of the study
* Any medical condition that precludes upright exercise stress testing
* Paroxysmal, intermittent atrial fibrillation with atrial fibrillation present at screening
* Prior treatment with cardiotoxic agents, such as doxorubicin or similar
* Has a history or evidence of any other clinically significant disorder, condition, or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement

The Hypertension Canada Clinical Practice Guidelines for blood pressure measurement using AOBP recommend against any wait time prior to commencing the measurement. The recent AHA guidelines however call for a 5-minute rest first. In uncontrolled hypertension, AOBP is typically higher than the daytime readings from ambulatory blood pressure monitoring (ABPM), but this is not the case for patients with controlled hypertension.

Objective:

Does a 5 minute rest or no rest before measurement using AOBP provide the most accurate reading in patients with controlled and uncontrolled hypertension, and in patients with white coat hypertension compared to daytime ABPM?

Implications:

Through this study, we hope to:

(i) Advance the understanding of the role of AOBP in measuring blood pressure. (ii) Determine whether a 5-minute rest, or no rest at all is needed prior to AOBP measurement.

(iii) Assess the relationship of AOBP to daytime ABPM for patient with controlled and uncontrolled hypertension and in patients with white coat hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Referred for ABPM
* Written informed consent

Exclusion Criteria:

* Unable to perform AOBP or ABPM for some reason
HT-3951 vs. Placebo in Stroke Rehabilitation

This is a randomized, double-blind, placebo-controlled parallel group outpatient study that will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in medically stable subjects following ischemic stroke.


Eligibility Criteria:
Main Inclusion Criteria:

* Age range between 21 to 85 years, inclusive, at the Screening Visit
* Subjects who have experienced an ischemic stroke documented by CT or MRI resulting in an upper extremity deficit that, in the opinion of the Investigator, warrants the need for rehabilitation therapy
* Medically stable subjects who are able to be randomized to study medication beginning between ≥ 2 and ≤ 52 weeks post-stroke
* Subjects who have initiated, are undergoing, have completed or agree to begin physical or occupational rehabilitation for at least 2 weeks prior to study Day 1.
* Mild to moderate unilateral upper extremity motor impairment characterized by FMA-EU score of \> 18
* Modified Rankin Scale score of 1 to 4

Main Exclusion Criteria:

* History of stroke within 6 months prior to the subject's current episode of ischemic stroke (History of transient ischemic attacks or ischemic stroke (nonhemorrhagic) more than 6 months prior to the current ischemic stroke are acceptable.)
* Subjects with unresolved upper or lower motor deficits (e.g., range of motion or strength deficits) from any prior stroke
* Significant hemorrhagic stroke
* Any history of seizure disorder or a spontaneous seizure that had occurred at any time after the stroke
* Apraxia that, in the Investigator's opinion, would likely reduce the ability of the subject to participate in the study or confound study outcome measures
* Moderate to severe aphasia and/or severe language deficits
* Severe sensory loss in affected hand
* Moderate to severe hemispatial neglect or anosognosia involving the affected arm
* Absent proprioception at the elbow or shoulder joints
* Excessive spasticity in the affected elbow, defined as a score of greater than or equal to 3 on the Modified Ashworth Spasticity scale (MAS)
A Single Dose Study Investigating the Elimination as Well as the Tolerability of PD 0332334 in Healthy Subjects as Compared to Patients With Impaired Kidney Function.

1. To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body.
2. To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.

Additional Study Purpose Details: Investigation of the pharmacokinetics, safety, and tolerability of a single dose of PD 0332334 in patients with impaired renal function.

On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers OR subjects with kidney impairment

Exclusion Criteria:

1. Receiving hemodialysis
2. clinically significant or unstable medical disease other than kidney disease
Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method

It is well known that airway management can be difficult during pregnancy. Increased risks for difficult intubation in pregnant women have been often reported. Thus, pregnancy is regarded as a period of high anesthesiologic risk.

Generalized weight gain is a well known factor influencing the upper airway in pregnant women. However, the modifications of the airway itself are less well documented.

The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave allowing the analysis of the longitudinal cross-sectional area profile of the examined cavity. It is a noninvasive and harmless method.

The aim of the study is to evaluate by acoustic reflection method the physiological modifications of the upper airways during pregnancy.

Women enrolled in the study will undergo an acoustic recording during the first, second, and third trimester of pregnancy, as well as two days and one month after delivery. Forty pregnant women will be included in this monocentric, prospective, open labelled study.

Moreover, a single acoustic recording will be performed in 10 other pregnant women undergoing an MRI for obstetrical purpose. The estimated caliber of the upper airways by MRI and acoustic method will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who attend the routine ultrasound control in our institution before 14 weeks of pregnancy will be invited to participate in the study.
* Women are eligible for the study if they are:

  * healthy (no previous disease, hypertension, nor obesity),
  * 18 years or more
  * with a singleton live fetus at the routine ultrasound scan
  * with a normal pregnancy.

Exclusion Criteria:

* Pregnancy complications
* Multiple pregnancy
* High risk for preterm labor
* Underlying diseases that could interfere with the results (such as pre-existing upper airway problems) and participation.
Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients

The purpose of the present study is to evaluate the benefit of biofeedback training on the capacity of chronic low back pain patients to decrease their lumbar paraspinal muscles activity during trunk full flexion and its relationship with changes in clinical outcomes. To do so, twenty patients with nonspecific mechanical low back pain will be recruited and all participants will take part in four sessions of supervised biofeedback training, consisting of 5 blocks with at least 12 trunk flexion-extension tasks. It is hypothesized that participants will have improved neuromechanical parameters with the biofeedback training and that this improvement will be positively associated to changes in clinical outcomes. This study will also allow for generation of preliminary data, in order to plan for a larger randomized control trial.


Eligibility Criteria:
Inclusion Criteria:

* Being between 18 and 60 years of age.
* Presence of non-specific chronic low back pain.

Exclusion Criteria:

* Prior surgery or major spine trauma.
* Lumbar scoliosis greater than 20°.
* Neuromuscular disease.
* Malignant tumor.
* Uncontrolled hypertension.
* Infection.
* Neurological deficit.
* Symptomatic lumbar disc herniation.
* Pregnancy.
* Recent lumbar cortisone injection.
* Active lower body injury and/or disabling pain limiting the capacity to complete the experimentation.
* Being under medications known to impair physical effort and pain perception.
Study of Clinical Response to Acute Metformin by Leveraging Evaluations During a Mixed Meal Tolerance Test for Exploring Glycemia and GeneticS

The purpose of this research study is to examine whether specific genes (e.g. SLC16A11) affect how human beings respond to food and a medication that is commonly used to treat type 2 diabetes. The food the investigators will be studying is specially prepared to contain protein, carbohydrate, and fat. The drug the investigators are studying is metformin. The investigators hypothesize that physiological responses to the meal and to the medication will differ between carriers and non-carriers of genes associated with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Adult males or non-pregnant females
* Age 18-79
* Able and willing to give consent relevant to genetic investigation

Exclusion Criteria:

* Women who are pregnant, nursing, or at risk of becoming pregnant
* Currently taking any medications used for the treatment of diabetes
* History of liver disease and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times upper limit of normal (ULN)
* Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation
* Currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
* Contraindications to safe use of metformin, including planned radiologic or angiographic study requiring contrast within one week of the study completion
* Planned changes to any prescribed medications, specifically diuretics, during study enrollment
* Participation in any other interventional study during the study duration
* Conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric bypass surgery
* Dietary restrictions that would prevent consumption of a MMTT
* Objection or inability to take metformin
Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload

Fighter pilots have to perform tasks requiring high mental workload during moderate-intensity acceleration phases (2 to 3G) that can last several minutes. When these accelerations are performed in the body axis (+Gz), they induce a redistribution of blood flow in the lower limbs associated with a decrease in cerebral blood flow, partially compensated by activation of the sympathetic nervous system (baroreflex).

The main hypothesis is that the effects of these prolonged accelerations, even of moderate intensity (\<+4Gz), could impair pilots' ability to perform complex cognitive tasks, with potential consequences for flight safety and mission conduct.

Moreover, flight missions are often performed after sleep debt, which is known to induce cardiovascular responses, sympathetic nervous system activation and impaired mental performance.

The secondary hypothesis is that sleep debt (3h of time spent in bed) may increase the impairment of cognitive performance during prolonged acceleration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject (male or female);
* Tobacco consumption \< 5 cigarettes per day or nicotine-free vapour;
* Regular physical activity (between 1 and 8 hours per week);
* Affiliated or entitled to a social security scheme;
* Having given their consent.

Exclusion Criteria:

* Presenting an active medical pathology or a history \<6 months (cardiological, renal, hepatic, cutaneous, neurological, psychiatric...), or a significant deviation from normal values observed during questioning, clinical examination or electrocardiogram (ECG);
* BMI \> 30 (cardiovascular risk factor);
* Have a medical contraindication to sporting activities;
* Taking a medical treatment;
* Habitual sleep duration \< 6 hours;
* Presenting a sleep disorder confirmed by questionnaire (Pittsburgh Sleep Quality Index Questionnaire \> 5);
* Pregnant or breastfeeding
* Not covered by a health insurance plan;
Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

Evaluate individual differences in the expression of opioid withdrawal symptoms in persons with opioid use disorder (OUD) while completing a clinically-indicated medication taper.

Individuals who have opioid use disorder and are interested in being tapered off of opioids will be admitted to a residential research unit for an 11-day period. All participants will be maintained on morphine for 5 days. During this period participants will complete 2 sessions (on two different days) wherein participants will receive an intramuscular injection of naloxone to precipitate a short withdrawal syndrome. Participants will take a capsule prior to both sessions that will contain either placebo or the opioid withdrawal medication lofexidine. Beginning on day 6 participants will be tapered off of morphine using lofexidine (as clinically indicated). At the end of the study all participants will be able to transition to buprenorphine maintenance or receive oral naltrexone and an injection of Vivitrol (extended release naltrexone), consistent with standard of care practices. Investigators will collect a variety of biological samples and questionnaire ratings during the study and primary outcomes will be measures of withdrawal collected throughout the study. Investigators will use these data to learn more about why individuals express opioid withdrawal symptoms differently, which will help inform how to change current treatment practices to be more effective for persons with OUD.

Eligibility Criteria:
Inclusion Criteria:

* 18 years - 65 year old
* Opioid-positive urine sample
* Current opioid use disorder with evidence of physical dependence
* Interest in undergoing opioid taper

Exclusion Criteria:

* Evidence of physical dependence on alcohol or benzodiazepines that requires medical intervention
* Being pregnant or breastfeeding
* Enrolled in methadone or buprenorphine maintenance treatment
* Clinically significant hypotension (\<90/60mmHg) or bradycardia (\<45bpm)
* History of myocardial infarction
* Subjects who are positive for hepatitis B surface antigen and/or hepatitis C antibody with liver function tests outside the normal range (persons with a positive hepatitis C antibody and normal liver functions tests are NOT excluded from the study)
* Significant mental health or physical disorder, or life circumstances, that is expected to interfere with study participation
A Cross-sectional Study Evaluating Pregnancy Related Use of Vitamins and Medication

This cross-sectional study will try to give answers to the following project aims:

* To provide an overview of the prevalence of health products' use among Belgian pregnant women (prescription and OTC medication, vitamin supplements, phyto-therapeutics, dermatologic products), including where pregnant women buy or get their health products (online web survey).
* To document women's beliefs about medication during pregnancy and their information desire (online web survey).
* To determine the current vitamin status among pregnant women and to reveal clinical targets for supplementing deficiencies in this population (blood sample analysis).

The study will be performed at the obstetrics department of the University Hospitals of Leuven (campus Gasthuisberg).

We aim to include 300 pregnant women (100 per trimester), of which 150 women will be asked to determine their vitamin status (50 per trimester).


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who visit the obstetrics department of the University Hospitals of Leuven
* ≥18 years
* Able to understand Dutch, French or English

Exclusion Criteria:

* \<18 years
* Don't able to understand Dutch, French or English
Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia

This is a single center, single-blind randomized cross over design trial that will compare the impact of intra-nasal naloxone vs. intra-nasal saline administration during experimental hypoglycemia on day one on responses to experimental hypoglycemia on day two. Investigators intend to enroll 18 individuals to obtain the complete data sets from 15 participants. Expected duration of subject participation is 10-12 weeks. This study will consist of two 2-day intervention visits separated by approximately 8 weeks.

This is a single center, single-blinded randomized cross over design trial, that will compare the impact of IN naloxone vs. IN saline during experimental hypoglycemia on day one on the responses to experimental hypoglycemia on day two. 18 participants will be studied twice, 8 weeks apart. On each occasion participants will undergo a 2 hour hypoglycemic clamp (target 50 mg/dl) in the morning and in the afternoon on day one and then again on the morning of day 2. During the morning clamps, samples will be collected for later measurement of serum epinephrine, glucagon and cortisol levels and participants will be asked to complete a hypoglycemia symptom questionnaire. 3 intranasal doses (4 mg each) of naloxone hydrochloride or IN saline will be administered to the subject on day 1. Plasma will be collected for measurement of naloxone concentrations on day 1 primary outcome is the difference in peak epinephrine secretion during the morning episodes of hypoglycemia on days one and two, thus each participant will have two observations: one from their naloxone experiment and one from their saline experiment.

Secondary endpoint will be naloxone pharmacokinetics including maximum concentration (Cmax), time to maximum concentration (Tmax) and area under the curve (AUC)

Eligibility Criteria:
Inclusion Criteria:

1. Subjects are capable of giving informed consent.
2. Female subjects must be post-menopausal for at least 1 year, or surgically incapable of bearing children, or practicing at least one or more of the following methods of contraception for three months prior to, and during the study: hormonal, intrauterine device (IUD), or barrier method in combination with a spermicide.
3. Subject should be medication free, other than hormonal birth control, for 48 hours before through 24 hours after study drug administration. If the need for medication is identified during this time period, it will be discussed with and approved by the PI.

Exclusion Criteria:

1. Women who are pregnant.
2. Women who are breastfeeding.
3. Subject has a known hypersensitivity to naloxone.
4. Subject with hypertension
5. Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease
6. Subject has taken or used any investigational drug or device in the 30 days prior to screening.
7. Subject has taken either prescribed or over the counter medication for 48 hours prior to study drug administration on either of the study days, other than hormonal birth control.
8. History of narcotic or heroin abuse.