cyrilzakka/clinical-trials huggingface dataset:
Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring

The goal of this interventional clinical trial is to investigate whether combining photoplethysmography (PPG) signals with accelerometer (ACC), gyroscope (GYR), sound, and electrocardiography (ECG) derived smartphone data provides additional insights into the cardiac condition of individuals with and without atrial fibrillation (AF).


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria applicable for all groups:

* At least 18 years old
* Participants must have the ability to understand and provide written informed consent
* Participants must have the ability to understand Dutch

Group specific inclusion criteria:

Group 1: Healthy volunteers

* No cardiac conditions based on medical history.

Group 2: Cardiology patients

* Patients at the consultation or ambulatory unit of Cardiology (pre- cardioversion, pre-pulmonary vein isolation) with AF.
* Patients without AF but with a current cardiac condition (e.g. heart failure with a reduced or preserved ejection fraction) or a history of a cardiac condition (e.g. history of myocardial infarction).

Exclusion Criteria:

* Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device
* Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement
* Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow
* Persons that have a disability to perform the measurements according to the instructions for use
* Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm
Small Intestinal Submucosa Graft for Repair of Anterior Urethral Strictures

The field of research for this study is tissue engineering and the utilization of a small intestinal submucosa graft as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of anterior urethral strictures.

Urethral stricture refers to the abnormal narrowing of the urethral lumen resulting from fibrosis that affects the urethral epithelium and underlying corpus spongiosum. The management of urethral stricture longer than 2 cm a major therapeutic challenge in clinics. Currently available surgical techniques require harvesting of grafts from autologous sites. However, there are numerous disadvantages associated with autografts, such as limited availability and variable quality, donor site morbidity, increased risk of surgical complications; thereby the application of this method is especially limited for large defects.

The hypothesis of this study is that the small intestinal submucosa graft can be used as an alternative biomaterial to buccal mucosa for substitution urethroplasty in urethral stricture patients. The aim of this study is to assess safety and efficacy of surgical treatment of patients with anterior urethral stricture using a small intestinal submucosa graft. The follow-up time for all patients in this study was 5 years. The follow-up regimen includes retrograde and pericatheter urethrography, voiding cystourethrography, uroflowmetry, cystoscopy, and voiding symptoms monitoring. Telephone follow-up will take place in between these assessments.

Eligibility Criteria:
Inclusion Criteria:

* Patients signed informed consent form
* Patients with a single, longer than 2.0 cm and shorter than or equal to 7.0 cm anterior urethral stricture
* Patients undergoing substitution urethroplasty for urethral stricture.

Exclusion Criteria:

* Patients without surgical indication
* Subtotal and total urethral strictures
* Radiation therapy to the abdomen or pelvis
* Lichen sclerosis related strictures
* Patients with previous hypospadias repair
* Neurogenic urinary tract disorders
* Mental disorders
* Patients with a known biologic sensitivity or a cultural aversion to the use of porcine materials.
* Patients with severe dysfunction of heart, lung, liver, kidney and other important organs , endocrine system and blood system.
* Patient with malignant tumor
* Patient who cannot be regularly examined due to any circumstances
* Any clinical state which does not ensure the safe implementation of study procedure (investigator's view)
Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer

The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients.

The study is designed as a multicenter, single-arm, open label, 12 months follow-up clinical trial. Men with localized prostate cancer will be treated with TOOKAD® Soluble VTP under general anesthesia.

Patients will be followed-up for 12 months with patient questionnaires on QoL, erectile and urinary functions, clinical evaluation with study visits at 1, 3, 6 and 12 months , Prostate Specific Antigen(PSA) testing at 3, 6 and 12 months. In addition, they will have biopsy at 6 months (± 2) and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven localized prostate carcinoma diagnosed using prostate biopsy showing:

  * Gleason 3+3 prostate
  * Gleason 3+4 prostate adenocarcinoma is acceptable provided it is not present in more than 2 cores and no more than 50% cancer in any core.
* Clinical stage up to cT2a - N0/Nx - M0/Mx.
* Serum prostate-specific antigen (PSA) ˂ 20ng/ml
* Prostate volume ≥ 25 cc and ≤ 70 cc.
* Male subjects aged 18 years or older.
* Signed Informed Consent Form by the patient.

Exclusion Criteria:

* Unwillingness to accept the treatment.
* Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy)or chemotherapy.
* Any surgical intervention for benign prostatic hypertrophy.
* Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
* Life expectancy less than 10 years.
* Participation in another clinical study involving an investigational product within 1 month before study entry.
* Subject unable to understand the patient's informed consent document, to give consent voluntarily or to complete the study tasks, especially unable to understand and fulfill the health-related QoL questionnaire.
* Subject in custody and or in residence in a nursing home or rehabilitation facility.
* Any condition or history of active rectal inflammatory bowel disease or other factors which may increase the risk of fistula formation;
* Any hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production or use of androgen supplements within the previous 6 months;
* Any history of urethral stricture disease;
* Any history of acute urinary retention within 6 months of study entry
Does the AMH Concentration Depend on the Menstrual Cycle?

During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH (anti-Muellerian Hormone) will be measured in the serum.

During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH will be measured in the serum. Half of the serum samples will immediately be subjected to hormone analysis whereas the other half will be stored frozen at -80 °C. After conclusion of the study the frozen samples will be subjected to re-measurment again a reference laboratory. The aim is to study the stability of the AMH Elecsys Assay under both conditions. The participants will be health women aged between 18 and 40 years. They will be grouped into a younger and an older group. They will be observed during one menstrual cycle, then they will remain unobserved during a second menstrual cycle, and then again they will be observed during a third menstrual cycle.

Eligibility Criteria:
Inclusion Criteria:

* regular menstrual cycles, between 24 and 32 d.
* body mass index between 24 and 32 kg/m2
* no HIV, no Hepatitis B and C
* no smoking

Exclusion Criteria:

* intake of reproductive hormones, including birth control pill
* pregnancy or breastfeeding
* infertility
* polycystic ovary syndrome
Variability of SpO2 Measurements Depending on the Choice of Finger for Sensor Placement

The aim of the project is to experimentally determine the effect of the choice of finger for the placement of a pulse oximeter sensor on the results of measuring peripheral blood oxygen saturation (SpO2) in a healthy person with short-term hypoxia and hypercapnia.

The aim of the project is to experimentally determine the effect of the choice of finger for the placement of a pulse oximeter sensor on the results of measuring peripheral blood oxygen saturation (SpO2) in a healthy person with short-term hypoxia and hypercapnia. This is an intervention prospective study that will take place at the Faculty of Biomedical Engineering, especially on FBMI students. The experiment consists of two phases, in which in the first phase, the volunteers will inhale the hypoxic mixture for five minutes after the stabilization phase. In the second phase, volunteers inhale a hypoxic and hypercapnic mixture. During the experiment, non-invasive SpO2 measurements will be performed continuously on individual fingers of both volunteer hands.

Eligibility Criteria:
Inclusion Criteria:

* Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure and blood oxygen saturation

Exclusion Criteria:

* post-traumatic conditions of the upper limbs affecting the perfusion of the fingers or injuries or skin diseases on the fingers.
* pneumothorax or a condition after cardiovascular surgery.
* anemia, bradycardia, hemoglobinopathy or other diseases of the cardiovascular system, pregnancy, diabetes, hypotension or hypertension.
Sacral Neuromodulation as Treatment for Chronic Constipation

The objective of this study is to study if low level laser therapy will do more good than harm for patients with severe chronic refractory constipation. It is a proof of concept study without a placebo arm.

Patients will be offered the therapy if High-Resolution Colonic Manometry has shown that coordination between colon motility and recto-anal activity is abnormal and that autonomic nervous system assessment suggests a dysfunction of communication between the spinal cord autonomic nerves and the colon-rectum-anus. The therapy consists of a 3 week treatment with a total of 8 sessions of low level laser therapy. Effects will be assessed using symptom and quality of life questionnaires and physiological assessments of colon and pelvic floor function, at 4 weeks and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe chronic refractory constipation
* Must have undergone high resolution colonic manometry that shows abnormal coordination between colonic motility and ano-rectal function.

Exclusion Criteria:

* Pregnant patients
* Known malignancies in the area of treatment
* Active bleeding in area of treatment
* Active deep vein thrombosis
* When tatoos are present at area of treatment
* Patients that are light sensitive
* Patients who take NSAIDS or steroids.
Unobtrusive Technologies for Monitoring of Autonomic Nervous System Function in Elderly Frail Patients

To develop and investigate an unobtrusive technology for long-term monitoring of autonomic nervous system (ANS) function's response to daily physical stressors and exercise training for elderly patients with different frailty stages.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to CR after open heart surgery.
* Age 65 years and older.
* 6-minute walk distance (6-MWD) ≥150 meters.
* Patient's agreement to participate in the study.
* Edomonton Frailty Scale score 5 points and more

Exclusion Criteria:

* Cardiac devices (due to artificially altered heart rate series)
* Diseases in the musculoskeletal system or other organs complicating physical activity and exercise training;
* Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in CR according to study protocol), including chronic heart failure New York Heart Association Class IV, hemoglobin less than 9 g/dL, wound healing disturbance, cognitive or linguistic deficits.
Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis

Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and infection. A majority of people with cystic fibrosis have large quantities of bacteria residing in their lungs. One of the most common and harmful bacteria is called Pseudomonas aeruginosa.

Patients with cystic fibrosis require frequent therapy with intravenous (I.V.) antibiotics to treat lung infections thought to be caused by Pseudomonas aeruginosa. One of the antibiotics frequently used to treat this bacteria is piperacillin-tazobactam. Piperacillin-tazobactam is thought to be the most effective when there is a constant level of drug in the body. The standard way to administer piperacillin-tazobactam is to give several grams 4 times each day as a 30 minute infusion. An alternative way to give piperacillin-tazobactam is by a continuous infusion; a continuous infusion will make it more likely that drug will remain at a constant level in the body. The objective of this study is to determine if administering piperacillin-tazobactam as a continuous infusion is more effective at treating people having a pulmonary exacerbation of cystic fibrosis than a standard 30 minute infusion, 4 times a day.

All patients will receive combination therapy to include piperacillin-tazobactam 400 mg/kg/day (based on piperacillin component, actual body weight) not to exceed 16 grams and tobramycin 12 mg/kg/day extended interval dosing (once daily). Patients randomized to the continuous infusion group will receive a one-time loading dose of 100 mg/kg over 30 minutes followed immediately by initiation of the continuous infusion.

Other antibiotics with activity against Pseudomonas aeruginosa are not allowed. Patients may receive an antibiotic for treatment of Staphylococcus aureus if deemed appropriate.

Other treatments for pulmonary exacerbation of cystic fibrosis will be left up to the control of the treating physician. Patients will receive a total of 14 days of therapy. If deemed appropriate, patients may be discharged to home where they will continue to receive blinded treatment via an infusion pump. Patients will be evaluated after completing their 14 day course of antibiotics (end of therapy).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of cystic fibrosis
2. 8 years of age or greater
3. Chronic or intermittent infection with Pseudomonas aeruginosa as defined by the Leeds Criteria
4. Pulmonary exacerbation as defined by Fuchs et al.

Exclusion Criteria:

1. Admission for greater than 48 hours prior to enrollment
2. Isolation of Burkholderia spp. in a respiratory tract culture in the prior 12 months
3. Current treatment for allergic bronchopulmonary aspergillosis
4. Pregnant or breast feeding
5. History of solid organ transplantation
6. Renal impairment at time of randomization (\< 40 mL/min as calculated by the Cockcroft-Gault equation24 ¬for adults or the Schwartz equation45 for those \< 18 years of age) or receipt of hemodialysis
7. Allergy to study medication
Neural Mechanisms and Predictors of an Ultra-Brief Suicide Prevention Strategy

The current study is a clinical trial, meaning a research study in which human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related behavioral outcomes. Specifically, male and female adults with current suicidal intent will be randomly assigned to receive either a 1-hour session of crisis response planning (CRP) or a 1-hour session of standard crisis risk management (Treatment as Usual). The effects of both conditions on changes in emotion regulation, behavioral inhibition, stress reactivity, and suicide risk will be evaluated post-intervention and at six-month follow-up. Additional assessments of changes in mood and suicidality will be collected daily during the first 10-days following intervention, and then monthly for a duration of six months. A cohort of healthy controls is included in the study but are not randomized to either treatment condition. The investigators hypothesize the following: 1) A single session of CRP will acutely change suicide risk and 2) Individuals who receive CRP will show sustained improvements in measures of suicidality when compared to individuals who received the Treatment as Usual intervention.


Eligibility Criteria:
Inclusion Criteria:

* Generally medically and neurologically healthy
* Age 18 years or older at the time of consent
* Willing and able to give informed consent
* Individuals in the acutely suicidal group: endorse current suicide intent as indicated by a total score of 5 or greater on the Beck's Scale for Suicidal Ideation.

Exclusion Criteria:

* Medical or neurologic condition or neurocognitive dysfunction that would interfere with the study
* Current or past manic/hypomanic episode, schizophrenia, or psychotic symptoms
* Deafness in either ear
* Currently pregnant or trying to become pregnant
* Electroconvulsive therapy (ECT) within the past 6 months
* Current moderate to severe substance use disorder
* Lack of fluency in English
* Positive alcohol breathalyzer test and/or acute drug intoxication the day of the fMRI scans
* Unwilling or unable to sign the informed consent document
* Under 18 years old at the time of enrollment
* Traumatic brain injury from a suicide attempt or another event
* Presence of ferrous-containing metals within the body
* Inability to tolerate small, enclosed spaces without significant anxiety
* Individuals enrolled as controls: no lifetime history of any DSM-5 disorder
* Individuals enrolled as controls: no lifetime history of suicide ideation or intent
Treatment Adhesion in Dialysis Patients Treated With Cinacalcet

Controlling secondary hyperparathyroidism (sHPT) in maintenance hemodialysis (MHD) patients is cumbersome, partly due to patient's non-adherence to prescribed drugs.

The main objective of this study was to assess whether an integrated care (IC) approach, in which adherence data are integrated in the decisional process, led to improved therapeutic control of secondary hyperparathyroidsm and higher percentages of bone metabolism targets as compared to a usual care (UC) approach, in which biological values represent the main stem of the decisional process.

The predefined hypothesis was that patients of the IC group should reach the iPTH targets using 25% less doses of cinacalcet at 6 months than those of the UC group.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients on hemodialysis since more than 3 months
* Patients with secondary hyperparathyroidism treated with Cinacalcet-HCl at a stable dose (30mg/day or more) for at least 1 month before enrolment and indication to Cinacalcet-HCL therapy (iPTH in target values or over target values)
* Patients with secondary hyperparathyroidism with indication to be treated with Cinacalcet-HCL (iPTH ≥ locally pre-defined targets). In this case, patients should be treated at least 1 month with stable dose Cinacalcet-HCL before enrolment

Exclusion Criteria:

* Intolerance to Cincalcet-HCL
* Inability to understand the protocol
* Mental diseases
* Patients suffering from cancer or having a short life expectancy (\<6 months)
* Patients planned for a parathyroidectomy
* Patients having had a parathyroidectomy
* Patient already enrolled in a Cinacalcet-HCL protocol
* Symptomatic hypocalcaemia or total serum calcium \< 1.87 mmol/l
Phase II HDM-SPIRE Safety and Efficacy Study

The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medication usage, Quality of Life and Sleep Quality


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-65 years.
* Moderate to severe rhinoconjunctivitis on exposure to HDM for at least 1 years.
* Mean TRSS ≥10
* Positive skin prick test to Der p and Der f.
* Dep p and Der f specific IgE ≥0.7 kU/L

Exclusion Criteria:

* Diagnosis of asthma requiring Global Initiative for Asthma (GINA) Step 3 (www.ginasthma.org)or higher treatment
* FEV1 \<80% of predicted.
* Clinically significant confounding symptoms of allergy to seasonal allergens during the final evaluation period.
* Significant symptoms of another clinically relevant illness that is likely to affect scoring of rhinoconjunctivitis symptoms.
* Clinically relevant abnormalities detected on physical examination.
* History of severe drug allergy, severe angioedema or anaphylactic reaction to food.
The Effects of Caffeine on Pain-Based Pacing During a Cycling Time-Trial

Caffeine has been shown to consistently improve time-trial performance, warranting restrictions on consumption under regulation of the National Collegiate Athletics Association (NCAA) and World Anti-Doping Agency (WADA). This ergogenic effect is not well understood, possibly occurring as a result of altered metabolism, improved strength, and/or reduced muscle pain. The hypothesis of altered metabolism has recently fallen out of favor while muscular strength has a tenuous relationship with endurance exercise performance. Reductions in muscle pain have been observed during low and moderate intensity endurance exercise, and this may be the mechanism of caffeine's ergogenic effect. In lieu of reducing pain during high intensity exercise, caffeine significantly improves performance. Therefore, caffeine appears to improve the amount of work that can be done for a given muscle pain rating, suggesting that participants may pace based upon sensations of muscle pain during endurance exercise. Most time-trial exercise is conducted in a fixed distance manner, measuring the time it takes participants to cover a given distance. Little research has been conducted on a fixed pain time-trial that would require participants to produce and sustain a given level of muscle pain while measuring the distance covered in an allotted time. A fixed pain time-trial could allow researchers to better understand the effect of pain on endurance performance. The purpose of this study is to examine the effects of caffeine on a fixed pain time-trial.


Eligibility Criteria:
Inclusion Criteria:

* Caffeine Naive (\<40mg per day) physically active 18-35 year old men with no contraindications to exercise.

Exclusion Criteria:

* People who do not match the gender, age or caffeine limits;
* those with contraindications to exercise or who are not physically active