cyrilzakka/clinical-trials huggingface dataset:
Characterization of the Pattern of Consumption and Withdrawal Syndrome From Dual Cannabis and Tobacco Use

Aims: To characterize the pattern of cannabis and tobacco use and withdrawal symptoms in people who start treatment for cannabis use disorders (exclusive cannabis, concurrent and/or simultaneous with various tobacco products) through an aplication game and considering the type of users. Methodology: Mixed-methods research composed of three studies. Study I: qualitative participatory action study aimed at exploring the experiences and preferences of the cannabis users on the use of apps. This information will be instrumental in the co-design of the app. Study II: prospective longitudinal study aimed to establish consumption patterns and transitions between substances and to validate the scale of cannabis withdrawal symptoms in the Spanish population. Sample size: expected RR=1.20, α =0.05, β= 0.20, losses= 20% (n=282). Study III: qualitative study to explore participants' experiences during the process of quitting cannabis and / or tobacco. Expected results: Characterization and prediction of variables that influence cannabis and tobacco cessation/ reduction and describe withdrawal symptoms according to consumption patterns with aim of improving the design of future interventions.


Eligibility Criteria:
Inclusion Criteria:

* Smokers (at least 1cig./week)
* Undertreatment for Cannabis
* \>=18 years-old
* Under clinical follow-up
* Informed consent
* Have a Smartphone

Exclusion Criteria:

* Severe cognitive impairment
* 3-month follow-up not guaranteed
Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease

This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of the treatment period (Week 12). Secondary endpoints include effects on liver fat content and other liver and lipid markers, as well as effects on safety and tolerability, and pharmacokinetic (PK) measurements.


Eligibility Criteria:
Inclusion Criteria:

1. Minimum of 10% liver fat as assessed by MRI - Proton Density Fat Fraction
2. Fasting serum LDL-C \>130 mg/dL at screening, \>110 mg/dL on lipid lowering medications
3. Any one of the following:

   1. Triglycerides ≥150 mg/dL or receiving prescription medication for elevated triglycerides.
   2. Systolic blood pressure \>130 mmHg or diastolic blood pressure ≥85 mmHg or receiving prescription medication for hypertension.
   3. Waist circumference \>40 inches (men) or \>35 inches (women)
4. Body mass index (BMI) 18.50 - 40.00 kg/m2 inclusive at screening
5. Provide a personally-signed and dated informed consent document

Exclusion Criteria:

1. Females of childbearing potential and males unwilling to use barrier birth control method (condom) throughout the study
2. Resting 12-lead ECG showing QTc \>450 msec, any tachyarrhythmia or morphology change, or any other clinically significant abnormality
3. Cardiovascular event requiring hospitalization in the past year
4. History or presence of thyroid disorder
5. History of malignancy in past 5 years
6. LDL-C ≥190 mg/dL or familial hypercholesterolemia
7. Significant hepatic or renal function test abnormalities
Acceptability of Lactacyd Femina

To demonstrate the safety and acceptability of the gynaecological formulation.


Eligibility Criteria:
Inclusion Criteria:

* Integral skin in the tested region

Exclusion Criteria:

* Pregnancy or breastfeeding women
* Use of anti-inflammatory or immune-suppression drugs
* Topical medication use at the tested region
* Active cutaneous gynaecological disease which may interfere in study results
* Personal history of allergic disease at the area to be treated
* Allergic or atopic history

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Continuous Glucose Monitoring for Personal Protective Equipment Evaluation

Diabetes mellitus (DM) affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Current obstetric practice is complicated by the emergence of the SARS-COV-2 pandemic, resulting in morbidity and mortality secondary to complications of COVID-19. Care coordination among the teams caring for women admitted for antepartum, intrapartum, and postpartum care with suspected or confirmed COVID-19 is required to conserve PPE and minimize staff exposure. The investigators propose a pilot proof of concept randomized study to evaluate the utility of Dexcom-G6 continuous glucose monitors for assessment of glycemic control in pregnant and postpartum women with insulin-requiring diabetes mellitus during hospitalizations, as a proof of concept in the efforts to reduce the number of point of care glucose tests needed, reduce staff exposure, and conserve PPE use.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-50 years with a viable singleton or twin intrauterine pregnancy between 8 0/7 and 41 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
* Diagnosis of pre-gestational or gestational diabetes mellitus A2, admitted to the hospital for labor or other antepartum admissions (besides DKA or glucoregulation)
* Able to understand the study, and having understood, provide written informed consent in English
* Infants who survive to hospital discharge who are born to women enrolled in the study

Exclusion Criteria:

* Participation in another trial that may influence the primary outcome, without prior approval
* Higher order pregnancy
* History of severe skin allergy to adhesive products or CGM
* DKA, admission for glucoregulation
* COVID-19 PUI or confirmed positive
Optimization of NIBS for Treatment of Addiction

The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.


Eligibility Criteria:
Inclusion Criteria:

1. Providing informed consent to participate in the study.
2. 18 to 85 years old.
3. Having a diagnosis of OUD, in the setting of CP:

   * OUD of more than 6 months duration as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) \[64\] and a positive urine toxicology screen.
   * or OUD patients who still feel craving or have not received more than 60 mg of methadone/day from the Methadone program.
4. Lives in the immediate area with no plans to relocate

Exclusion Criteria:

1. The subject is pregnant.
2. Recently started on antiepileptic drug therapy.
3. History of illegal stimulant use as demonstrated by urine toxicology.
4. . Ingestion of poppy seeds or herbal teas containing Papaveris Fructus (may cause a positive opiate test for morphine, codeine \[66, 67\]).
5. History of neurological disorders involving stroke, brain tumors, or epilepsy as self- reported (note patients will also be evaluated via electroencephalography (EEG) at baseline 1 week prior to stimulation and any patient showing abnormal EEG activity will be removed)).
6. History of unexplained fainting spells as self-reported.
7. History of head injury resulting in more than a momentary loss of consciousness as self-reported.
8. History of brain surgery as self-reported.
9. Contraindications to tDCS applied in conjunction with TUS:

   * Metal in the head, or
   * Implanted brain medical devices.
10. Suffering from severe depression (with a score of \>30 in the Beck Depression Inventory (BDI), PHQ-9≥10).
11. Active malignancy.
12. History of suicidal behavior or suicide attempts.
The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery

This trial was conducted to evaluate the effectiveness of the chest physiotherapy techniques to prevent pulmonary collapse based in an score applied in the patients submitted of the mitral valve surgery, after their ICU discharge.

Patients were allocated in groups according their pulmonary function (FVC: forced vital capacity), the respiratory muscle performance (MIP: maximal inspiratory pressure; MEP: maximal expiratory pressure), the oxygenation level (SpO2), the pulmonary auscultation; respiratory frequency (f); the ability to expectorate and the functional independence.

The group I was allocated those patients which presented decrease of up to 50% of forced vital capacity (FVC) of preoperative period, SpO2\>92%, minimal pulmonary auscultation alterations; frequency (f) between 15 and 25 ipm; able to expectorate without assistance; independence to sit; respiratory. In these patients were randomized for two interventions: a) Deep breathing exercises: diaphragmatic exercises; inspiratory sighs; maximal inspiration exercises. Each kind of exercises was repeated 10 times; b) volume-targeted incentive spirometer: used Coach® three sets of 10 repetitions.

Patients allocated in the group II presented FVC\> 30% \<49% of preoperative period, ≥ 88% SpO2 \<92%, necessity of oxygen therapy, abnormal pulmonary auscultation, f\> 25 \<31ipm; dependence to expectorate and to sit.. They were assisted by: a) Intermittent Positive Pressure Breathing (IPPB) with PEEP - through ventilator (Bird Mark 7™) with exhalation valve spring load set at 10 cmH2O. b) CPAP - 10 cmH2O associated with oxygen support to obtain SpO2≥ 95% with electronic device (Sullivan®) Each session consisted of 20 minutes, twice daily, one in the morning and another in the afternoon.

All of the patients were conducted in effort to mobilize upper and lower limbs. On the first day, the patients walked at least 50 meters, by increasing the distance to at least 150 meters on the fourth day. Outcome measures were recorded at day 5 of the interventions.

The study were conducted with individuals of both gender, aged between 18 and 60 years, candidates for mitral valve surgery, up to a maximum 2nd valve replacement. Patients unable to perform the functional tests were excluded and patients with signs of neurological disorders; hemodynamic instability, respiratory disorders and mechanically ventilated for more than 48 hours .

Eligibility Criteria:
Inclusion Criteria:

* Patients for mitral valve surgery, up to a maximum 2nd valve replacement

Exclusion Criteria:

* Patients unable to perform the functional tests
* Patients with signs of neurological disorders; hemodynamic instability, respiratory disorders and mechanically ventilated for more than 48 hours
Endothelial Function Evaluation in Patients With PAOD Treated With Sulodexide + Conventional Treatment (CT) Vs CT Alone

A randomized Multicentric open-label controlled trial. The primary objective of the study is to assess the improvement of endothelial function under sulodexide + conventional treatment or conventional treatment alone in patients with Leriche-Fontaine stage II peripheral arterial obstructive disease (systolic ankle brachial index ABI \< 0. 9).

A randomized Multicentric open-label controlled trial. The primary objective of the study is to assess the improvement of endothelial function under sulodexide + conventional treatment (antiplatelet therapy; plus ACE inhibitor; plus Statin in patients with cholesterol total level \> 1,35 g/l) or conventional treatment alone in patients with Leriche-Fontaine stage II peripheral arterial obstructive disease (systolic ankle brachial index ABI \< 0. 9).

Criteria for efficacy evaluation are the assessement of the improvement of the Digital Thermal monitoring between base line (day 1) and day 180 measured by Vendys® and the measurement of the correlation between the Digital Thermal monitoring and the following parameters at base line, day 90 and day 180:

* Von Willebrand factor blood level.
* Clinical assessment as per pain free walking distance and maximum walking distance, as measured by walking machine.
* Fibrinogen blood level. Also an assessment of the study medication observance (patient's compliance) will be done.

Safety assessment will be done through the collection of the adverse events occurred during the study.

Eligibility Criteria:
Inclusion Criteria:

* Intermittent claudication.
* A systolic ankle brachial index ABI \< 0. 9
* An age of over 40 years
* At least one cardiovascular risk factor (active or weaned Smoking, diabetes mellitus, hypertension, lipid disorders, obesity, and erectile dysfunction) or a history of coronary artery disease or transient ischemic stroke or established.
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion Criteria:

* withdrawal of informed consent
* participation in another clinical trial with investigational drugs within the last 12 weeks or during the present trial period
* history of hypersensitivity to the investigational/conventional drugs
* Non claudicating patients and patients with critical ischemia
* Arteritis of non-atherosclerotic origin
* Patients treated with the oxalate or Naftidrofuryl Pentoxifiline Cilostazol or within 3 months that preceded the inclusion
* Patients receiving other agents that alter the secretion of NO (such as Sildenafil and Tadalafil) less than 2 weeks before inclusion
* Patients receiving a regimen based on nitrates or molsidomine or Bosentan
* Patients receiving Anti Vitamin K medication (AVK)
* Hemorrhagic accident dating less than 15 days before inclusion
* Heparin treatment or any treatment by low molecular weight heparins during the study for a continuous period of more than 10 days or a cumulative time during the study for more than 21 days.
Follow-up of Person-centered Care of Young Adults With Rheumatic Disease

The purpose of the study is to study how a person-centered structured team caretaking of young adults (16-23 years) with newly diagnosed rheumatoid arthritis (RA), spondartrit (SpA) and psoriasartrit (PsA) in routine clinical care affect and predict the patient's health and ability to manage their everyday lives. Also included in the project is a long-term follow-up (up to 50 years) where the investigators want to investigate factors predicting good general health, low disease activity, good physical function, and comorbidity.


Eligibility Criteria:
Inclusion Criteria:

* 16-23 years
* newly diagnosed RA according to the ACR / EULAR 2010 criteria, SpA according to CASPAR criteria, or AS according to the ASAS criteria.
* Ability to understand the Swedish language in speech and writing.

Exclusion Criteria:

* Existing rheumatic disease
* Other healthcare demanding serious illness
Comparison of Modified Broselow Tape and Cole Formula

This study aimed to determine the accuracy of modified Broselow tape measurements compared to Cole formula in predicting the size of uncuffed endotracheal tubes in Indonesian pediatrics

110 subjects were given informed consent before enrolling the study and randomized into two groups, modified Broselow Tape and Cole formula. Preoperatively, prediction of suitable ETT size was performed based on Cole formula and Modified Broselow Tape. In the operating theatre, general anesthesia induction was performed with sevoflurane 4-8 vol%, fentanyl 2 μcg/kg BW, and atracurium 0.5 mg/kg BW. Laryngoscopy was performed, and an uncuffed polyvinyl chloride endotracheal tubes, whose size was based on the Cole formula, was inserted. An appropriate size of the endotracheal tube was confirmed if the endotracheal tube could go through the cricoid ring smoothly, and no air leakage found when ventilating with an inspiratory pressure of 15-20 cmH2O. The surgery and anesthesia would proceed if the correct size of the endotracheal tube were successfully inserted. If the tube couldn't pass the cricoid smoothly or air leakage was found when ventilated with an inspiratory pressure of 15-20 cmH2O, the endotracheal tube should be replaced with a bigger or smaller size.

Eligibility Criteria:
Inclusion Criteria:

* pediatrics aged 1 - 6 y o
* ASA I-II
* patients went through elective surgery with Genaral anesthesia
* Need to intubated with uncuffed ETT

Exclusion Criteria:

* patients with growth and development disorders
* patients whom height that was out of range in modified Broselow tape
* patients with possible airway difficulty or obstruction
* patients with respiratory diseases, underweight and obese
Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft

Anterior cruciate ligament injuries are one of the most common sports knee injuries. Their effect on the knee joint can be detrimental with patients experiencing instability and progressive damage of the intraarticular structures. Therefore, anterior cruciate ligament reconstruction (ACLR) is often indicated. Multiple graft option exist, including autograft, allograft and xenograft tissues, with autografts being considered as a first-choice source of reconstructed ligament in most cases. Two most common harvested autografts are hamstring tendons (semitendinosus or semitendinosus and gracilis tendons; ST or STG) and patellar tendon with two bone blocks (bone - patellar tendon - bone; BPTB). However, in the recent literature there is an increasing trend towards use of quadriceps tendon autograft (QT). Multiple techniques of harvesting this graft were described, including both partial and complete thickness of the tendon. Another issue is whether bone block from the upper pole of the patella is harvested along with the soft tissues (quadriceps tendon bone graft, QTB).

The aim of this study is to add to the body of knowledge concerning full-thickness quadriceps tendon-bone autograft (QTB) used in ACLR. The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC), the Knee injury and Osteoarthritis Outcome Score (KOOS) and retear rate.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic knee anterior and rotatory instability after ACL injury;
* Primary ACLR cases

Exclusion Criteria:

* Active inflammation of the knee;
* Revision cases;
* Additional PLC, PCL or PFJ injuries (MCL and meniscal lesions are not exclusion criteria);
* Fractures around the knee
Changing Lower Back Pain Through Virtual Reality

The main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with virtual reality (VR) manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without VR (control group).

Chronic pain is considered an urgent global public health problem. One of the most prevalent chronic pain pathologies worldwide is low back pain (LBP). Kinesophobia (fear of movement) has been largely associated with pain intensity, disability, worse quality of life and chronification in LBP; while physical reconditioning has been proposed in clinical practice as a key element in the treatment of LBP.(20-22) However, the efficacy of physical reconditioning programs developed so far would require considerable improvement. The induction of illusions in virtual reality (VR) through visual cues could be a valid alternative to evoke motion illusions and be able to modify proprioceptive integration, acting on kinesiophobia, in turn. The main objective of this randomized controlled trial is to investigate the efficacy of a 6-week therapeutic exercise program, performed with VR manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises (experimental group), on pain and disability, kinesiophobia, range of motion (ROM), catastrophizing, quality of life, and physical fitness in patients with chronic non-specific low back pain compared to the same therapeutic exercise program without VR (control group).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic non-specific lower back pain according to the European COST B13 guideline.
* Pain score of 3 or higher on the Numeric Rating Scale (NRS) in the last 6 months.

Exclusion Criteria:

* Presence of spinal tumor.
* Presence of infection.
* Presence of fracture.
* Presence of systemic disease.
* Presence of fibromyalgia.
* Presence of cauda equina syndrome.
* Previous spinal surgery.
* Presence of musculoskeletal injuries of the lower extremities.
Patients With Severe Eosinophilic Asthma Treated With Benralizumab

Retrospective, multicenter, routine clinical practice study with consecutive inclusion of adult patients with severe eosinophilic asthma receiving benralizumab treatment.

Retrospective study studying severe eosinophilic asthma. Patients with this disease who are on benralizumab treatment for at least 4 months before the start of the study will be included.

The purpose of this study is to analyze the predictive factors of response in patients with this type of disease treated with benralizumab, who obtain a complete response during their follow-up.

The results of the study will be obtained through the review of medical records, where demographic characteristics such as age, gender and smoking will be assessed; presence of comorbidities; clinical-functional variables; response variables (exercises, cycles of oral corticosteroids, admissions, visits to the emergency room or unscheduled, cumulative dose of oral corticosteroids, absenteeism from work) and side effects.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (over 18 years of age) diagnosed with severe eosinophilic asthma on benralizumab treatment for at least 4 months from the start of the study.

Exclusion Criteria:

* Patients for whom no previous history is available or who do not meet the inclusion criteria.