cyrilzakka/clinical-trials huggingface dataset:
the Pathophysiology of the Onset of Atrial Fibrillation in Obstructive Sleep Apnea

Rationale: Obstructive sleep apnea (OSA) is a highly prevalent, often undiagnosed, modifiable risk factor for atrial fibrillation (AF), as well as AF-related complications and treatment effectiveness. It is unclear which OSA-related pathophysiological mechanism, i.e. intrathoracic pressure shifts, hypoxemia or sympathovagal imbalance, plays the most dominant role, and a better understanding of these mechanisms could provide valuable information in future diagnostic and therapeutic strategies in this population. Objective: The primary objective is to assess the role of OSA-related pathophysiological mechanisms in the initiation of AF by a multi-parametric strategy that combines the estimated parameters. The main hypothesis is that intrathoracic pressure fluctuations are the predominant mechanism. The secondary objective is to validate a nonobtrusive sensing technology based on photoplethysmography (PPG) and diaphragm electromyography (dEMG) measurements as surrogates for gold standard technology based on invasive intraoesophageal pressure (PES) measurement. Study population: Adult patients with paroxysmal AF with nocturnal onset and high risk of OSA based on the STOP-BANG questionnaire. Study design: An observational study in a selected cohort. Subjects are recruited from the AF outpatient clinic of the Catharina Hospital, and referred to Kempenhaeghe Centre for Sleep Medicine for a one-night full PSG, with the addition of dEMG and PPG. The acquired data will be analysed at the Eindhoven Technical University. Main study parameters/endpoints: Primary endpoint: Identification of prognostic factors for the initiation of AF in relation to OSA-related pathophysiological mechanisms..nl


Eligibility Criteria:
Inclusion Criteria:

Paroxysmal or persistent AF

AND

* STOP-BANG score \>5 or STOP-BANG \>4 and typical nocturnal onset of AF
* A positive WATCH-PAT screening
* very high clinical suspicion of OSA, with STOP-BANG score \>3

Exclusion Criteria:

* current adequate treatment of OSA
* Reversible cause of AF
* severe lung disease (COPD Gold IV, pumonary fibrosis, lobectomy) wever esophageal disease (malignancy, stricture, esophagectomy)
A Phase 1/3 Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma

This study is a phase 1/3 study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Refractory or Relapsed Multiple Myeloma


Eligibility Criteria:
\[Main Inclusion Criteria\]

* Male or female with 18 years of age or older.
* Patient must have documented multiple myeloma (MM) according to IMWG criteria
* Patient must have a documented relapsed or refractory disease.
* Patient must have achieved a response (PR or better based on investigator's determination of response by the IMWG criteria) to at least one prior regimen.
* Patient must have a PD as defined by the IMWG criteria on or after their last line of therapy.

\[Main Exclusion Criteria\]

* Patient has received daratumumab or any other drug specifically targeting CD38 previously.
* Patient's disease shows evidence of refractoriness or intolerance to lenalidomide. If previously treated with a lenalidomide-containing regimen, the patient is excluded if he or she:
* Patient is known or suspected of not being able to comply with the study protocol (e.g., psychological disorder) or the patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI

Randomized comparison of abciximab i.v. versus i.c. in patients with STEMI undergoing primary PCI. The hypothesis is, that higher concentration of abciximab i.c. leads to improved epicardial flow, perfusion, reduction of no-reflow, reduction in infarct size and subsequently better outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical symptoms:

   * Angina \< 12 h persistent Angina \> 30 min.
2. ECG-Criteria:

   * ST-elevation \> 1mm in ≥ 2 extremity leads
   * ST-elevation \> 2mm in ≥ 2 contiguous anterior leads
3. Informed consent

Exclusion Criteria:

1. No consent
2. Pregnancy
3. Allergy against abciximab, ASA or heparin
4. Active peptic ulcus ventriculi or duodeni
5. Active non-superficial bleeding
6. Major surgical intervention, intracerebral interventions, puncture central artery \< 4 weeks
7. Active internal bleeding
8. Cerebrovascular complications \< 2 years
9. Known coagulation disorders, thrombocytopenia
10. Arteriovenous malformations or aneurysms
11. Severe Liver or renal dysfunction
12. Severe untreated hypertension
13. Active vasculitis
14. Previous thrombolysis \< 12 h
Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy

The purpose of this study is to determine the safety and efficacy of insufflated bags for electromechanical power morcellation during laparoscopic hysterectomy and myomectomy for tissue removal and to observe the integrity of the bags throughout and after insufflation and power morcellation.

The hypothesis is the bags will remain in tact without leakage from the bags during and after power morcellation using the described contained system, confirming the safety and efficacy of the systems.

Uterine leiomyoma (fibroids) are non-cancerous smooth muscle tumors that can cause heavy menstrual bleeding, pain, and pressure. Common surgical treatment modalities are hysterectomy (removal of the uterus) or myomectomy (removal of the fibroid). Minimally invasive surgical techniques (laparoscopy) are generally recommended due to improved recovery time, decrease infection risk, decreased bleeding risk and overall decreased morbidity and mortality risks.

In order to remove a large uterus or large fibroids laparoscopically, a power morcellator is often used to cut the specimen into smaller pieces that can be removed through small incisions. Due to the concern regarding spread of small amounts of tissue during power morcellation, many surgeons are advocating contained power morcellation, i.e. morcellation inside a specimen bag.

This study will be evaluating the efficacy of contained morcellation using a specific specimen bag. Morcellation will be performed in the designated bag. The bag will then be removed evaluated for any egg albumin leakage. If there is no leakage, it can be inferred that there is no tissue is spread during the contained morcellation process using this bag.

Eligibility Criteria:
Inclusion Criteria:

* adult premenopausal women (equal or greater than 18 years old)
* no symptoms of menopause
* undergoing robotic or laparoscopic total or supracervical hysterectomies or myomectomies for the indication of symptomatic uterine fibroids
* not candidates for specimen removal via mini-laparotomy incision (as deemed by the study surgeon) or who have refused mini-laparotomy
* endometrial biopsy with no suspicion for malignancy

Exclusion Criteria:

* known or suspected malignancy
* peri- or post-menopausal women
* specimen that can be removed without power morcellation (e.g., vaginally or through laparoscopic trocars)
* adults unable to consent.
Effects of Cognitive Behavior Language Therapy for Patients With Post Stroke Aphasia

This study is clinical trial based and the target population in this study is patients with post-stroke aphasia. Cognitive linguistic quick test (CLQT) and Speech Language unhelpful thoughts and belief scale (SLUTBS) will apply as an assessment. Inclusive criteria include diagnosed male and female post-stroke severe aphasia patients above 30 years of age. These participants must have high instance of unhelpful speech language thoughts and belief. Participants in inclusive criteria must not be participated in any other psychotherapy/ speech language intervention program. Participants must sign an informed consent form. Participants having a caregiver who is willing to be present during the period of intervention. Exclusive criteria include individuals below 30 years of age and patients with aphasia caused by non-stroke etiology.

The aim of the study is to check the effects of cognitive behavior language therapy on patients with post-stroke aphasia. So, it will help speech language pathologists to adopt the principles of CBLT intervention to treat aphasia that occurs as a result of aphasia.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female.
* Over 30 years of age.
* All types of diagnosed aphasia.
* Severe aphasia following stroke.
* High instance of unhelpful speech language thoughts and belief.
* Participants who are not participating in any other psychotherapy / speech language intervention program will be included.
* Participants who are willing to sign an informed consent form.
* Participants having a caregiver who is willing to be present during the period of intervention.

Exclusion Criteria:

* Below 30 years of age.
* Patients with aphasia caused by a non-stroke etiology.
A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502

The clinical trial aims to assess the pharmacokinetics, safety and tolerability of HIP1502 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers aged between ≥20 and ≤45 years old
2. Weight ≥ 50 kg, with calculated body mass index (BMI) of ≥ 18 and ≤ 29.9 kg/m2
3. Subject who voluntarily agrees to participate in this study and signs the informed consent form.

Exclusion Criteria:

1. History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, oncological, urinary, psychiatric, gastrointestinal, endocrine, immune, dermatologic or neurologic disorder.
2. With symptoms indicating acute illness within 28 days prior to the first IP administration.
3. Any medical history that may affect drug absorption, distribution, metabolism, and excretion.
4. Any clinically significant activity of chronic medical illness.
5. History of any clinically significant allergic reaction including induced by varenicline (However, mild allergic rhinitis or allergic dermatitis which do not require medication could be included).
6. Positive blood tests for HBs Ag, anti-HCV Ab, anti-HIV Ab, or VDRL.
7. Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration or use of over-the-counter medications (OTC) and vitamin products within 10 days prior to study drug administration.
8. Inability to take standard hospital diet.
9. Donation of blood within 60 days prior to study drug administration or apheresis within 20 days, or blood transfusion within 30 days prior to the first IP administration.
10. Exposure to any investigational drug or placebo within 90 days prior to the last IP administration.
11. Subjects with excessive caffeine intake (more than 5 cups/day), heavy or regular alcohol intake (more than 210 g/week).
12. Any use of tobacco or nicotine within three months.
13. Subjects rejected to use clinically effective contraceptive methods during the study period.
14. Subjects having been deemed inappropriate for the trial as determined by the investigator.
Return to Work After Mild Traumatic Brain Injury

Background:

Patients with mild traumatic brain injury can to some extend experience long-term physical, cognitive, social and behavioral deficits, which have serious implications for employment trajectories and financial independence. These deficits have shown to be more pronounced in women. High socio-economic position such as income, level of education and employment status before the accident have shown to affect return to work. But also cohabitation status, ethnicity and health are important factors. Previously studies are typically self-report studies, and are often small and may suffer from selection bias due to patient nonresponse.

Aim:

The aim of this study is to describe no return to work among patients with mild traumatic brain injury in Denmark and to examine how factors such as age, gender, cohabitation status, socio-economic and pre-injury health factors affect no return to work up to 5 years post-injury.

Hypothesis:

We hypothesize that most patients with mild traumatic brain injury return to work within work 6 months post-injury, and that patients with mild traumatic brain injury injury receive more social transfer payments compared to the general population.

Additionally, we hypothesize that low socio economic position, comorbidities and being single are associated with prolonged no return to work.

Methods:

The present study is an observational national register-based cohort study with long-term follow up of patients with mild traumatic brain injury from 1st of January 2008 - 31st of December 2012 in Denmark. Patients aged 18-60 years diagnosed with concussion from 1st of January 2003-31st of December 2007 in the national patient register will be included in the study. Data will be retrieved from several national databases, including the DREAM database containing data on social benefits and reimbursements.

Primary outcome is no-return to work (nRTW) due to any cause and the following four secondary outcomes are graded and should be regarded as a continuum ranging from health related nRTW, limited nRTW, permanently nRTW and mortality.

The results will be published as two separate scientific articles.


Eligibility Criteria:
Inclusion Criteria:

* ICD-10 code for concussion as action diagnosis (ICD-10: S06.0)
* Working age adults between 18-60 years old at the time of injury
* Gainfully occupied or deemed available for work the week preceding the time of injury

Exclusion Criteria:

* Patients were excluded if they were hospital treated and diagnosed with other major neurological injuries such as spinal cord and column injuries and traumatic brain injuries (TBI) besides the concussion at baseline.
* Patients were excluded, who 5 years prior to baseline (1st of January 1998 - 31st of December 2002) had sustained major neurological impairments including concussions.
* Patients outside of the age limit
* Patients not resident in Denmark
* Patients on unemployment benefits and not economically active at the time of injury
Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty

The purpose of this study is to learn if using a suprainguinal fascia iliaca (SIFI) injection technique (also called a "nerve block") that numbs the nerves going to the side and front of the upper leg will improve pain control after surgery. The SIFI technique uses a numbing solution (local anesthetics) that is injected next to nerves in the hip to reduce pain. This block may affect movement in the leg and make the legs weak. The amount of leg weakness is not known and assessment of this will be included in the study. Many institutions use the SIFI block for patients having total hip replacements, with the hope of providing good pain relief combined with improved mobility after surgery.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* between 18 and 75 years old
* American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total hip arthroplasty

Exclusion Criteria:

* ASA 4 or 5
* revision hip arthroplasty
* diagnosis of chronic pain
* daily chronic opioid use (over 3 months of continuous opioid use)
* inability to communicate pain scores or need for analgesia
* acute hip fracture
* Infection at the site of block placement
* Age under 18 years old or greater than 75 years old
* Pregnant women
* Intolerance/allergy to local anesthetics
* Weight \<50 kg
* Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
* Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
* Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
Validation of the Ontological Addiction Scale

Background:

Bypassing a reductionist view of existing diagnostic categories, ontological addiction theory (OAT) is a new psychological model of human functioning and mental illness. Ontological addiction is a maladaptive condition that stems from an erroneous belief in an inherently existing Self or "I", which is deemed to be the root of all suffering. Five experts from four different countries have created the Ontological Addiction Scale (OAS) to measure the condition and its impact on people's lives. The purpose of this study is to test this scale, evaluating levels of ontological addiction in individuals suffering from emotional or mood disorder, and assess its psychometric properties.

Methods:

This trial will be conducted in compliance with the COSMIN Guidelines. The investigators will collect data from 400 individuals, aged 18 to 70, suffering from emotional or mood disorder, referred to the Therapeutic Center for Mood and Emotional Disorders for an 8-week-mindfulness-based-intervention. Patients will complete the OAS at three time points: one month before the beginning of the therapy, within one week prior to the beginning of therapy, and one year after the end of the therapy. This scale will be completed in conjunction with other practice assessments relating to the psychotherapeutic program. The psychometric properties of the OAS will be assessed.

Discussion:

The Investigators aim to validate a scale assessing a psychological dimension as the root of all mental disorders. The present study may contribute to overcoming limitations of categorical understanding of mental disorders, thus moving toward a more encompassing dimensional comprehension. The scale is responsive to current thinking in modern psychiatry, and it is envisaged that its validation will deeply impact research and care perspectives


Eligibility Criteria:
Inclusion criteria:

An individual must fulfill all of the following criteria in order to be eligible for study enrollment:

* Aged between 18 and 70 years
* Suffering from mood disorder (bipolar or unipolar) and/or emotional disorder (subjective complaint for difficulties to regulate emotions).
* Being referred to the Therapeutic Center for Mood and Emotional Disorders for an 8-week-mindfulness-based-intervention
* Subjects must be able to attend all scheduled visits and to comply with all trial procedures
* Subjects must be covered by public health insurance

Exclusion criteria

* Subject unable to read or/and write
* Psychosis
* Subject who are in a dependency or employment with the sponsor or the investigator
Parent Management Training to Treat Irritability

The goal of this clinical trial is to see if 12 sessions of a Parent Management Training program can treat irritability in children aged 10-14 years old. The main question it aims to answer are:

* Can a Parent Management Training for parents reduce anger outbursts and cranky moods in their children?
* Can Parent Management Training be done in an outpatient clinic and do parents like it?

Up to 18 families can join this study. This study will be used to set up a larger study in the Fall of 2025.

Parent participants will complete 12 sessions of Parent Management Training for Irritability. Each session will be 45-55 minutes weekly. They will also participate in the assessments of their child before, during and after treatment.

Child participants will do assessments before, during and after the Parent Management Training treatment.

Up to 18 families will be consented for this Parent Management Training (PMT) to Treat Irritability study in order to meet the aim of having 12 families complete the study. The child and a parent will complete pre-treatment evaluations about the child's mental health, behavior and cognitive functioning. Participants who meet inclusion criteria (age 10-14 with significant irritability) and do not meet exclusion criteria (e.g. Autism, Bipolar disorder, active PTSD, serious medical issues or Intellectual disability) will be invited to join the trial. All participants will receive the 12 PMT sessions from a licensed mental health professional. The PMT sessions will focus on the parents only, but both the parent and child will complete standardized measures and interview with a clinician in the middle of the treatment. After the 12 sessions of PMT, the parent and child will complete a post-treatment assessment. Pre and post treatments assessments will be compared to determine changes in the child's irritability and other areas of functioning.

Eligibility Criteria:
Inclusion Criteria:

* clinically significant irritability (Clinician Affective Reactivity Index 30 or greater)
* parent or guardian willing to participate in treatment with the child

Exclusion Criteria:

* psychiatric instability (danger to self/others, risky substance abuse)
* current active Post-Traumatic Stress Disorder (PTSD) or a severe active stressor (e.g. child abuse)
* history of severe psychopathology with an established alternate treatment (e.g. autism spectrum disorder, bipolar disorder, schizophrenia, intellectual disability)
* general medical condition that may be driving irritability or prevent generalizable physiologic measures.
* screen positive for an intellectual disability via Wechsler Abbreviated Scale of Intelligence Second Edition (WASI II) estimated Intelligence Quotient (IQ)\<70.
Fasting Time Effects in Time-Restricted Eating (FaTE-TRE)

Over the past century, lifestyles and eating habits have rapidly changed, helping to increase the onset of conditions such as obesity, metabolic syndrome and the risk of cardiovascular and metabolic diseases such as diabetes.

Recently, dietary regimens such as calorie restriction and intermittent fasting have been promoted as new strategies for reducing obesity and related co-morbidities. These strategies have proven effective in reducing body fat, improving blood pressure, lipid profile and insulin resistance in overweight individuals. However, due to the rigidity of these food protocols, the adherence of subjects to the diet is often limited or maintained only for short periods.

Time-Restricted Eating (TRE) is a less extreme form of intermittent fasting, in which the subject's daily calorie intake is consumed only in a certain period of time during the day (normally 8-12 hours). TRE have been able to reduce fat mass, pro-inflammatory markers (eg IL-6, TNF-a) and have improved some biomarkers related to cardiovascular risks (eg Insulin, HDL, TG).

The literature offers numerous versions of intermittent fasting, and the role of fasting duration is not yet fully clear. Thus. the aim of the present study is to investigate the effect od different duration of fasting in a TRE protocol on body composition and lipid and inflammatory profile. Moreover, the study intended to explore the effect of 2 month of TRE on long term maintenance of diet habits, body composition, lipid and inflammatory profile.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18-30 kg/m2
* Stable body weight for at least 3 months

Exclusion Criteria:

* type 2 Diabetes or pre-diabetes for ADA guidelines
* Significant Chronic disease
* recent and acute inflammatory status
* Recent (within 3 months) treatment with anabolic steroids, systemic corticosteroids or estrogen.
* regular exercise training (≥ 2 sessions/week) or ≥ 10,000 steps/day