cyrilzakka/clinical-trials huggingface dataset:
The Role of Levosimendan as Inotropic Agent in Acute Aluminum Phosphide-induced Cardiotoxicity

To evaluate the potential role of levosimendan as an inotropic agent in aluminum phosphide-induced cardiotoxicity

Aluminum phosphide (ALP) is a well-known fumigant known also as rice pill or wheat pill. It is considered an ideal pesticide since it is effective to preserve stored grains against insects and rodents without leaving residues, in addition to its availability and low cost. In Egypt, it has become a common method of suicide over the last few years because it is cheap and easily accessible. Cardiomyocytes are one of the main targets for ALP. ALP-induced cardiotoxicity involves detrimental effects such as direct myocardial tissue damage, hypoperfusion, myocarditis, pericarditis, and arrhythmias leading to circulatory failure. Levosimendan, an inotropic agent, enhances cardiac contractility through calcium sensitization with minimal oxygen demand and, in turn, decreases the risk of arrhythmia. However, limited studies have investigated the role of levosimendan in the treatment of ALP induced cardiotoxicity.

Eligibility Criteria:
Inclusion Criteria:

Patients with acute ALP intoxication admitted to ICU of PCC-ASUH and developed cardiotoxicity with Poisoning Severity Score (PSS) 2 (moderate) or 3 (severe) that led to cardiogenic shock and necessitated administration of vasoactive medications

Exclusion Criteria:

* Pregnant patients
* The presence of pre-existing diseases such as hematologic, pulmonary, hepatic, renal, immunologic, central nervous system, or endocrine system disorders that made patients unsuitable for the present study.
* Patients with underlying cardiac disease and ECG changes, especially prolonged QTc intervals.
* Patients co-ingested drugs or toxins with cardiovascular toxicity.
* Patients had been previously administered with inotropic agent other than agents under the current study as a preconsultation treatment.
* Patients had received any other investigational medicinal products within 30 days or were enrolled in any other interventional trials with the potential to interact with Levosimendan or affect ALP induced cardiotoxicity
The Effects of Telerehabilitation in Patients With COPD

Chronic Obstructive Pulmonary Disease is a serious public health problem worldwide and it is a leading cause of mortality and morbidity. Nowadays, COPD patients are increasing in all societies and the problems that arise during the life of these patients increase the need for care and rehabilitation. Pulmonary rehabilitation has proven to be the best supportive treatment for individuals with COPD. However, there are difficulties in rehabilitation practices in terms of the fragility of patients, transportation and access problems. Telerehabilitation allows patients who cannot access rehabilitation due to their geographical, economic or physical disabilities to benefit from rehabilitation services. There are different studies demonstrating the effect of telerehabilitation in COPD patients and confirming that it is safe, but it is a developing area and has a limited area of use.

In this randomized controlled study, it is aimed to examine the effect of telerehabilitation training on respiratory functions, exercise capacity, quality of life, fatigue and psychosocial factors in individuals with COPD via video conferencing including respiratory exercises and postural exercises.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
* Not having an attack in the last 2 months
* Volunteering to participate in the study
* Being between the ages of 40-80
* To have a device that can be used in telerehabilitation application and an active internet connection.

Exclusion Criteria:

* Unstable angina, previous myocardial infarction, severe congestive heart failure resistant to medical therapy, uncontrolled hypertension, cancer, neurological or musculoskeletal disorders with functional limitations
* Currently addicted to alcohol or drugs
* Having an injury to the lower extremity such as sprains, sprains or fractures in the last 6 months, not being able to perform independent ambulation
* Having serious vision and hearing problems
* Having severe cognitive impairment
Bupivacaine Injection of Eye Muscles to Treat Strabismus

This study seeks to determine if bupivacaine injection of eye muscles can make them stronger and stiffer, and thereby correct the position of eyes that are turned in or mis-aligned, a condition generally termed strabismus. It seeks further to find out the different effects of various concentrations or formulations of bupivacaine, and whether addition of Botox to other eye muscles can add to the effect of bupivacaine and enhance the correction of strabismus.

Patients eligible for inclusion in the study will be age 8 to 95 years and have an eye deviation (strabismus) that is potentially subject to surgical correction.

The eye alignment will be measured. The eye muscles may be measured by MRI. The eye will be anesthetized by eye drops. One or more eye muscles will be injected with bupivacaine. Botox® will be injected into the antagonist muscle in some cases to increase the effect of the bupivacaine.

Data on the strabismus deviation, any side effects of the drug injection, and the eye muscles as measured by MRI, will be recorded at intervals after injection. These data will be compared with the like measurements taken before injection.

The primary outcome will be the eye alignment change at 180 days. A secondary outcome will be the change in muscle size, strength, or stiffness.

For large strabismus deviations not fully corrected by a first injection, a second injection can be made. Follow-up alignment and muscle measurements will be as for the initial injection.

Eligibility Criteria:
Inclusion Criteria:

* Clinical pattern of strabismus of 5 prism diopters or more

Exclusion Criteria:

* Active eye infection
Cryoablation With Vestibular Expansion for the Treatment of Paroxysmal/Short-course Persistent Atrial Fibrillation

The purpose of this study was to verify the safety and efficacy of routine and extended vestibular ablation in the treatment of paroxysmal/short-course persistent atrial fibrillation.

The purpose of this study was to verify the safety and efficacy of routine and extended vestibular ablation using the Medtronic Arctic Front AdvanceTM catheter in the treatment of paroxysmal/short-course persistent atrial fibrillation

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old ≤ age ≤ 85 years old;
2. Patients with paroxysmal/short-term persistent atrial fibrillation;
3. Be able to understand the purpose of the research, voluntarily participate in the research and sign the informed consent.

Exclusion Criteria:

1. Echocardiography shows that the left atrium diameter is greater than or equal to 45mm;
2. Preoperative CT or esophageal echocardiography suggests that there is a thrombus in the left atrium/left atrial appendage;
3. Those who have undergone left atrial ablation or left atrial surgery;
4. Those who have received simple left atrial appendage occlusion;
5. New York heart function class (NYHA) class III or IV congestive heart failure or LVEF (%) less than 40%;
6. Those who have undergone valve repair;
7. Preoperative electrocardiogram or Holter confirmed the presence of typical atrial flutter or other supraventricular tachycardia (holding The duration is greater than 30 s);
8. Secondary atrial fibrillation, including uncontrolled hyperthyroidism, acute alcoholism, cardiac surgery postoperative atrial fibrillation, etc.;
9. History of acute coronary events or percutaneous coronary stent intervention within 6 months before enrollment;
10. Those with a history of cardioverter-defibrillator (ICD) implantation or a history of cardiac resynchronization therapy (CRT);
11. History of stroke or transient ischemic attack within 6 months before enrollment;
12. Those with obvious bleeding tendency who cannot receive postoperative systemic anticoagulation;
13. Severe structural heart disease, including moderate to severe mitral insufficiency or stenosis, previous myocardial infarction, hypertrophic cardiomyopathy, etc.;
14. Combined with other serious diseases, the life expectancy is less than 12 months;
15. Women who are pregnant, breastfeeding and planning to become pregnant;
16. Have participated in or are participating in clinical investigators of other drugs or devices within 3 months before enrollment;
17. Other conditions assessed by the investigator to be unsuitable for inclusion in this study, such as persons with mental disorders or mental disorders.
Use of Methylphenidate in Children and Adolescents in France

The use of methylphenidate in children and adolescents in France from 2010 to 2015

To describe the use of methylphenidate in children and adolescents in France from 2010 to 2015

Eligibility Criteria:
Inclusion Criteria:

* children and adolescents (0-17 years)
* registered in the French Health Insurance Database from 2012-2015
RESTORE Trial: A Pilot RCT of Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) for Veterans With CPTSD

Complex Post traumatic Stress Disorder (CPTSD) is now recognized as a separate trauma-based psychological condition to PTSD. CPTSD is a broader diagnosis that includes the core PTSD symptoms (re-experiencing in the here and now, avoidance, and sense of current threat) plus an additional set of symptoms that are collectively referred to as 'disturbances in self-organisation' (DSO). DSO symptoms capture pervasive psychological disturbances that are associated with traumatic exposures and that are distributed across three clusters: difficulties in affect regulation (AR), negative self-concept (NSC), and disturbances in relationships (DR).

There are no effective interventions for CPTSD. It is therefore of paramount important to identify effective interventions to treat veterans with CPTSD. The present study will be one of the first to investigate the effectiveness of a novel, modular intervention for CPTSD. Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR) is a person-centered intervention that involves targeting the symptoms of CPTSD clusters sequentially using concrete modules (i.e., specific number of sessions targeting specific clusters of symptoms).

The overall aim of this study is to establish the feasibility, acceptability and preliminary effects of ESTAIR in treating CPTSD. To achieve these aims, the investigators will conduct a pilot randomised controlled trial (RCT), with a sample of 60 military veterans meeting the diagnostic criteria for CPTSD, and with two treatment arms: ESTAIR vs. a treatment-as-usual (TAU) condition.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older) in the caseload of Combat Stress
* Armed forces veteran (United Kingdom)
* Help-seeking for trauma-related psychological distress
* Meeting diagnostic criteria for CPTSD, as measured by the ITQ (Cloitre et al., 2018)
* Proficiency in English language
* Signed informed consent provided

Exclusion Criteria:

* Severe psychotic disorder (defined by previous clinical diagnosis)
* Current alcohol or drug use disorder
* Serious cognitive impairment
* Planned concurrent additional treatment
Does Botulinum Toxin Type-A Injection an Effective Way of Relieving Pain in Myofascial Pain Syndrome Patients or Not

In this research prilocaine and botulinum toxin (BoNT-A) interventions prospectively compared to find out the effect of BoNT-A injection on myofascial pain syndrome (MPS).

The main question it aims to answer is: Does Botulinum Toxin Type-A an Effective Way of Relieving Pain in Myofascial Pain Syndrome or not?

For this purpose thirty-eight patients randomly assigned into two study groups. While BoNT-A injection group (BIG group n=19) treated with 20 units of toxin to each trigger point (TP), remaining treated with 2 ml prilocaine (PIG group n=19) with same procedure.

Pre-treatment, 2nd and 6th weeks findings were clinically recorded.

Visual Analog Scale (VAS), 4-Point Verbal Rating Scale (VRS), Pain Pressure Threshold (PPT), Short Form-36 (SF-36) and Beck Depression Inventory (BDI) tools were used to evaluate findings of the research.

Eligibility Criteria:
Inclusion Criteria:

Thirty eight patients (27 female, 11 male) admitted to the PM\&R (physical medicine and rehabilitation) department with at least one TP identified at neck, upper back and lower back muscles were included to the study.

Exclusion Criterias:

Recent any injection to TP within the last 2 months, Diagnosed with fibromyalgia syndrome, Having respiratory or cardiovascular diseases, Allergies, Having psychiatric disorders, History of shoulder or cervical intervention within the last year, Cervical myelopathy, radiculopathy, Failure of cooperation.
MRD-guided Prognosis Prediction and Adjuvant Treatment Based on CTC and ctDNA in NSCLC

This is a prospective cohort study, which aims to evaluate the effectiveness and superiority of a novel minimal residual disease-guided prognosis monitoring and adjuvant treatment in stage IIA-IIIC non-small cell lung cancer.

This observational study is a single-center, prospective cohort study, which aims to detect minimal residual disease (MRD) using circulating tumor cells (CTC) and circulating tumor DNA (ctDNA). To evaluate the effectiveness and superiority of MRD detection, we enroll operable or inoperable IIA-IIIC stage NSCLC patients, and single-cell RNA sequencing and genomic sequencing would be performed for CTC and ctDNA, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be signed before implementing any enrollment-related procedures;
2. Age ≥18 years old;
3. Patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging)；
4. There is no special restriction on the source of genetic test report.
5. According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one radiographically measurable lesion.
6. Have not received any previous systemic antitumor therapy for advanced diseases.
7. No serious abnormalities of hematopoietic function, heart, lung, liver, kidney function and immune system.
8. ECOG score: 0-1;
9. Expected survival time \> 3 months.

Exclusion Criteria:

1. Received surgical treatment for lung tumors.
2. Received neoadjuvant chemotherapy or radiotherapy.
3. Received cellular therapy within the last 1 year.
4. Treated but uncontrolled diabetes, mellitus, asthma, autoimmune diseases and other chronic diseases.
5. Participated in other clinical trials (including research vaccines, drugs, medical devices, etc.) within one month.
Implementation Study of Enhanced Medication Therapy Management in Primary Care Practice

The purpose of this study is to identify challenges and successes associated with implementing an enhanced medication therapy management service in primary care practice.

The specific aim of this study is to implement a Medication Therapy Management (MTM) service in primary care that is enhanced by the incorporation of pharmacogenomics (PGx) and medication risk mitigation (MRM) factor technology and is standardized by a systematic approach to evidence- and personalized-based medicine. The primary objective is to implement the systematic approach to delivering an enhanced MTM service in a primary care setting. Secondary objectives include: determine how successful the communication between prescriber and pharmacist is within implementing the service, determine how PGx testing can be incorporated into primary care prescribers' daily work flow, determine if patients are receptive to PGx testing, determine how satisfied prescribers are with an enhanced MTM clinical service and their confidence to conduct on their own, and determine if enhanced MTM optimizes or changes drug therapy for patients.

Eligibility Criteria:
Inclusion Criteria:

* Receiving primary health care from Elmwood Family Physicians; and
* Medicare beneficiary; and
* Currently prescribed at least 7 medications, or prescriber feels patient would benefit from enhanced medication therapy management, or actual or suspected medication-related problem

Exclusion Criteria:

* Not willing to participate in the study and sign informed consent; or
* Non-English speaking or designated surrogate as translator not available
Influence of Bottle-Type on Infant Feeding Behaviors

The objective of the proposed research is to conduct a within-subject, experimental study that will describe mothers' feeding practices during typical bottle-feeding conditions and will examine whether removal of visual cues related to the amount of milk/formula in the bottle will alter these feeding practices. The investigators hypothesize that mothers will show higher levels of infant-directed feeding practices and lower levels of mother-directed feeding practices when using opaque, weighted bottles compared to when using standard, clear bottles. The investigators also hypothesize that infants will consume less breast milk or formula when fed from opaque, weighted bottles compared to when fed from standard, clear bottles.


Eligibility Criteria:
Inclusion Criteria:

* Mothers must be 18 years or older
* Infants must be between 0- and 6-months of age
* Infants must be prior to the introduction of solid foods

Exclusion Criteria:

* Preterm birth
* Medical conditions that interfere with feeding
Acute Treatment of Migraine With e-TNS

The main objective of this study is to assess the efficacy of the Cefaly® device as an acute treatment of migraine attack in adult patients. The patients will be applied either an active or placebo external neurostimulation for 1 hour during a migraine attack, and will report the pain on a visual analog scale before and after the treatment.


Eligibility Criteria:
Inclusion Criteria:

* History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction)
* Having a migraine attack lasting at least 3 hours
* Migraine pain intensity stabilized for at least 1 hour
* Frontal, retro-, or peri- orbital headache.

Exclusion Criteria:

* Pregnant women
* Patients having received Botox treatment in the prior 4 months
* Patients having received supraorbital nerve blocks in the prior 4 months
* Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
* Patients with only temporal or occipital headache
* Patients using opioid medication
* Patients having taken abortive migraine medication in the prior 3 hours
* Allodynia: intolerance to supraorbital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 5 minutes of neurostimulation).
* Implanted metal or electrical devices in the head
* Cardiac pacemaker or implanted or wearable defibrillator
* Patient having had a previous experience with Cefaly®
Hormonal Regulation of Body Weight Maintenance

The investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults. The detailed investigation and analysis of the variability and dynamics of the endocrine circuits responding to a negative energy balance and weight loss will be accompanied and enhanced by specific clinical projects targeting peripheral and central-nervous aspects of hormonal counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and potential therapeutic approaches will be studied.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 27 kg/m2 (adults)

Exclusion Criteria:

* weight loss of more than 5kg in the last 2 months
* pregnancy, breastfeeding
* patients with:

  * severe heart failure
  * impaired hepatic or renal function
  * anaemia
  * disturbed coagulation (biopsies will not be taken in those subjects)
  * infection, malabsorption
  * severe hypertension
  * cancer within the last 5 years
  * eating disorders or any other psychiatric condition that would interact with the trial intervention
  * any other endocrine disorder
* changes of smoking habits or diets within the last 3 months prior to study inclusion
Automated & Coached Web-based Programs to Improve and Strengthen Romantic Relationships

This study investigates the effectiveness of self-help, web-based programs to improve romantic relationships and related outcomes. Couples will be randomly assigned to complete the OurRelationship program, the ePREP program, the OurRelationship program with the addition of a coach, the ePREP program with the addition of a coach, or a wait-list control group and followed for six months.

Nationwide, lower-income (LI) couples (those with household incomes \<200% of the federal poverty level) - many of whom are also African American, Hispanic/Latino, or rural couples - face numerous challenges to their relationships. Chief amongst those challenges are: 1) higher risk of relationship problems and 2) lack of access to effective relationship services to prevent or intervene with relationship distress. Compared to higher-income couples, LI married and cohabiting couples are significantly more likely to divorce or separate and report lower relationship quality. Unfortunately, LI couples are least likely to receive interventions to prevent or solve relationship problems. To overcome these barriers, we propose to test the effectiveness of two effective web-based curricula - OurRelationship and PREP Online.

A total of 1,246 LI couples will be recruited nationwide and randomly assigned to the ePREP program, the OurRelationship program, the ePREP program plus a coach, the OurRelationship program plus a coach, or a wait-list control group and followed for six months. Once randomly assigned to group, couples will be assessed at one month, two months, four months, and six months following randomization. After couples randomized to the wait-list control group finish their waiting period, they will be able to select the program they would like to complete (OurRelationship or ePREP) but will not complete research assessments during or following their participation in the program.

Eligibility Criteria:
Inclusion Criteria:

1. They are married, engaged, or have been cohabiting with their partner for at least six months
2. They are both located in the United States
3. Both partners are willing to participate in the study
4. Both partners are between the ages of 18 and 64 (inclusive)
5. Couples report a household income at or below 200% of the Federal Poverty Level.

Exclusion Criteria:

1. Severe domestic violence
2. Inadequate internet connection
3. Previous participation in OR, PREP-O, in-person PREP, or its variants
4. Current participation in other relationship programs
5. Current participation in an evaluation funded by Administration for Children and Families