cyrilzakka/clinical-trials huggingface dataset:
Effect of Dexmedetomidine on Pain Due to Propofol Injection

Propofol is commonly used IV anesthetic, it has been formulated in a concentration of 10 mg/ml in a fat emulsion consisting of 10% soybean oil (long-chain triglycerides). When used for anesthetic induction, propofol causes pain on injection in 28%-90% of patients. pain probably results from a direct irritant effect. Several methods have been used to reduce this pain. Lidocaine pretreatment has been commonly proposed to decrease propofol induced pain, but its failure rate is between 13-32%. Dexmedetomidine is highly selective alfa-2 adrenoreceptor agonist. Alpha-2 receptors are located on blood vessels where they inhibit norepinephrine release. Investigators, therefore, speculated that dexmedetomidine could attenuate the pain due to injection of propofol. Investigators conducted a study to determine the efficacy of dexmedetomidine in decreasing pain due to injection of propofol.

Propofol solution is fat emulsion consisting of soyabean oil. When used for anesthetic induction, propofol causes pain or discomfort on injection. Many factors appear to affect the incidence of pain, which includes site of injection, size of vein, speed of injection, buffering effect of blood, temperature and composition of propofol solution and concomitant use of drugs such as local anaesthetics and opiates.

Pain on injection of propofol can be immediate or delayed. Immediate pain probably results from a direct irritant effect whereas delayed pain probably results from an indirect effect via the kinin cascade. Delayed pain has latency of between 10 and 20 s. The pain produced is usually described as tingling, cold, or numbing, at its worst, a severe burning pain proximal to the site of injection. This sensation tends to occur within 10-20 s of injection and lasts only for the duration of injection. Despite this discomfort, the incidence of phlebitis is less than 1%.

Several methods have been used to reduce this pain with limited success. Lidocaine pretreatment is commonly used to decrease propofol induced pain, but its failure rate is between 13-32%.

Dexmedetomidine is an selective alfa-2 adrenoreceptor agonist with supraspinal, spinal, and peripheral actions. Alpha-2 receptors are located on blood vessels where they inhibit norepinephrine release. Investigators, therefore, speculated that dexmedetomidine could attenuate the pain due to injection of propofol.

Eligibility Criteria:
Inclusion Criteria:

* ASA I \& II
* Both gender
* Age 18-60
* Elective surgery

Exclusion Criteria:

* Patients taking sedatives or analgesics in the past 24 hours
* History of allergic reactions to anesthetic drugs,
* Atrio-ventricular conduction defects
* Cardiovascular disease and
* Pregnant
Comparison of Three Pre-oxygenation Strategies

Study objective: Comparing the efficacy of three different preoxygenation strategies, i.e. non-rebreather face mask (NRM), bag-valve-mask (BVM) with and BVM without additional positive end-expiratory pressure (PEEP) in three subgroups of spontaneously breathing volunteers.

Study endpoints

Primary Endpoint:

Difference in expiratory oxygen concentration (FeO2) at the end of the 3 min preoxygenation sessions.

Secondary endpoints:

* Difference in Oxygen Reserve Index (ORi) at the end of the 3 min preoxygenation sessions.
* Changes in regional ventilation from baseline to 1.5 min and 3 min into the preoxygenation sessions, assessed using electrical impedance tomography (EIT)
* Time to reaching an Oxygen Reserve Index (ORi) ≥ 0.5
* Time to reaching an Oxygen Reserve Index (ORi) =1
* Time to Oxygen Reserve Index (ORi) back to baseline after the 3 min preoxygenation sessions.

Number of participants 15 participants per subgroup, i.e. 45 participants in total.

Inclusion criteria

* Normal-weight adults (body mass index, BMI 18.5-24.9 kg/m2) with an "American Society of Anesthesiologists Physical Status Classification System (ASA) " score of I or II
* Adults with a BMI 25-39.9 kg/m2 with and ASA score \<3
* Healthy (ASA I) children aged 6-12 years Exclusion criteria ASA 3, Age \< 6 and age 12-18, pregnant women, missing informed consent, signs and symptoms of an acute respiratory illness on the study day.

After informed consent and a medical check-up, baseline measurements will be done for 10 minutes (peripheral oxygen saturation SpO2, ORI, regional ventilation). Then the participants will undergo 3 different preoxygenation sessions with the 3 interfaces (i.e. non-rebreather facemask with reservoir and a bag-valve-mask with and without PEEP) in a randomized order and a 20 min washout between the sessions. Each preoxygenation session is conducted in a supine position and will be proceeded until the measured FeO2 (end expiratory O2 fraction) reaches 90% or up to a maximum time of 3 min. Afterwards 10 min of SpO2, ORI and regional ventilation measurements will follow.


Eligibility Criteria:
Inclusion Criteria:

* Normal-weight adults (BMI 18.5-24.9 kg/m2) with an "American Society of Anesthesiologists Physical Status Classification System (ASA) " score of I or II
* Adults with a BMI 25-39.9 kg/m2 with and ASA score \<3
* Healthy (ASA I) children aged 6-12 years

Exclusion Criteria:

* ASA 3
* Age \< 6 and age 12-18
* pregnant women
* missing informed consent
* signs and symptoms of an acute respiratory illness on the study day
A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects

This project consists of a prospective case design. Study candidates will include all patients ages 18 and over who were evaluated at UCSD and found to have a critical-sized humerus, femur, or tibia segmental defect that would be fixed through surgery. Patients who consent to study participation will receive the TRUMATCH Graft Cage for their long bone segmental defect repair. Data on healing rates, complication rates, re-operation rates, time to return to normal activity, and pain levels will be collected for each participation. After 3 years of data collection, we will analyze this data to provide further insight on the utility of the TRUMATCH Graft Cage. Given the significant difficulty with repairing segmental long bone defects, it is imperative to evaluate novel systems to appropriately manage these injuries.


Eligibility Criteria:
Inclusion Criteria:

* Humerus, femur, or tibia segmental defects requiring surgery
* Evaluation and treatment at UCSD
* Ages 18 year and older
* Abiltiy to understand the content of the patient information/informed consent form

Exclusion Criteria:

* Any not medically managed severe systemic disease
* Their doctor has decided that it is in the patient's best interest to receive a different method of repair
* Their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study
* Pregnancy or women planning to conceive within the subject participation period (1 year) note: pregnancy will be self-reported and no test will be performed to test for it
* Prisoner
* Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.
A Study of Treatment Patterns and Clinical Outcomes in First Line Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (1L R/M SCCHN) Participants in Europe

The purpose of this observational study is to collect real-world data that describes treatment patterns and clinical outcomes in participants with first line recurrent/metastatic squamous cell carcinoma of the head \& neck (1L R/M SCCHN).


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Participants are included in Cohort 1 - Augment if they meet the following criteria:

* Adults18 years or older
* Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx between 01-Jun-2017 and 31-June-2018.
* Prescribed 1L treatment for R/M SCCHN
* Treatment history and response available for medical chart abstraction from date of diagnosis until death or the end of the study in living participants
* Have available for review one month of follow-up data available post initiation of 1L R/M SCCHN therapy
* Informed consent form (ICF) signature/collection of living participants, as required by country regulation and local ethics committees

Participants are included in Cohort 1 if they meet the following criteria:

* Adults 18 years or older
* Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx and larynx between 01-Jan-2014 and 31-Dec-2016.
* Prescribed 1L treatment for R/M SCCHN
* Treatment history and response available for medical chart abstraction from the date of diagnosis until death or the end of the study in living participants
* Have available for review one month of follow-up data post initiation of 1L R/M SCCHN therapy
* Informed consent form (ICF) signature/collection of living participants, as required by country regulation and local ethics committees

Exclusion Criteria:

Participants were excluded from either cohort if they meet the following criteria:

* Were enrolled in a cancer treatment-related clinical trial since the diagnosis of R/M SCCHN
* Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary site, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma).
Feasibility Study of an Online Self-management Program for Chronic Non-cancer Pain

Based on a mixed-methods design, the objective of this trial is to assess the feasibility and acceptability of the "Agir pour moi" program, an 8-week online self-management program for chronic non-cancer pain (CNCP). The investigators will also explore its potential effects on self-efficacy, pain interference, pain severity, anxiety, depression, catastrophizing, and global impression of change in adults with CNCP awaiting services from a chronic pain multidisciplinary treatment center.

The mixed-methods sequential explanatory design combines a quantitative questionnaire-based study with a subsequent in depth qualitative approach.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* live with CNCP for more than 3 months;
* read and understand French easily;
* have access to a computer and high-speed Internet;
* be available to take part in the project for 6 to 8 months;
* not having started a new treatment for pain within the last month;
* agree to notify the team before starting a new treatment;
* be able to give informed consent.

Exclusion Criteria:

* be supported by a multidisciplinary treatment center or be likely to be in the short term;
* having participated in a CNCP self-management program within the last year;
* be awaiting scheduled surgical treatment within six months.
Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy

This is a prospective, controlled, open-label, pharmacokinetic study. This study aims at studying the PK of ledipasvir, sofosbuvir, and GS-331007 metabolite in HCV infected children with hematological malignancy.

In this study, patients in both treatment groups will receive 12 weeks of treatment with a ﬁxed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (LDV/SOF) orally, once daily with food.

In this study, patients in both treatment groups will receive 12 weeks of treatment with a ﬁxed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (LDV/SOF) orally, once daily with food, as prescribed by the attending physician.

Twelve eligible HCV-infected patients with hematological malignancy and 12 matching HCV control patients without haematological malignancy or co-morbidities will be enrolled in the study.

At baseline, careful history of the recruited patients including demographic characteristics (age, height, weight, and gender), comorbidities, medication history, familial history, social history, blood transfusion history, time on maintenance chemotherapy, and baseline laboratory tests will be documented. The baseline laboratory tests will include renal function tests (serum creatinine), liver function tests (bilirubin, albumin, AST, and ALT), international normalized ratio (INR), alpha fetoprotein (AFP), complete blood count (CBC), degree of liver fibrosis by Fibroscan, and viral load by PCR.

Followup will be done for all participants at baseline, after 12 weeks of treatment, and after 12 weeks from the end of treatment. A Forth visit will be done after 10 days of treatment for the evaluation of the steady state PK parameters of LDV\\SOF in those patients.

Eligibility Criteria:
Inclusion Criteria:

* Children (6 to \< 12 years of age and/or weighing 17.5 to \< 35 Kg).
* Chronic HCV genotype 4 infection for at least 6 months without cirrhosis (confirmed by Fibroscan).
* Naïve patients to previous anti-HCV treatment.
* Diagnosed with hematological malignancy and on maintenance chemotherapy.

Exclusion Criteria:

* Known hypersensitivity to any of the study medications.
* Ongoing treatment with any interacting medications like carbamazepine, fosphenytoin, phenytoin, oxcarbazepine, phenobarbital, and rifampin.
* History of any comorbid illness that may interfere with the pharmacokinetics of the study drugs or prohibit the compliance with the study protocol such as;

  1. Decompensated liver disease as shown by the presence of ascites, encephalopathy, or a history of variceal hemorrhage.
  2. The ongoing treatment of other types of cancer or blood disorders.
  3. Co-infection with human immunodeficiency virus (HIV), or hepatitis B virus.
  4. Renal dysfunction.
  5. Active infection that is currently producing symptoms.
It´s Up To You: Update and Digitalization of a Universal School-based Prevention Intervention for Drug Initiation and Use

This non-randomized cluster-controlled trial examines the effectiveness of the digitalized and updated version of the It´s Up To You - program, a universal school-based prevention intervention for drug initiation and use targeting youth aged between 12 and 17 years.

The goal of this non-randomized cluster-controlled trial targeting youth aged between 12 and 17 years is to examine whether the updated and digitalized version of the preventive intervention named "It´s Up To You" program is effective in preventing drug use initiation and reducing drug use.

Participants in the experimental group will receive 6 sessions conducted by trained teachers. Each session will target a program module about the following topics: (1) What about drugs? (2) A way to start (3) Ana has fun (4) What do you connect to (about the use of the internet and social networks)? (5) Two versions of the same story, and (6) How do my parents come in?

Researchers will compare the experimental group receiving the "It´s Up To You" program to a control group receiving the usual teaching activities regarding substance use prevention. The main goal is to see if participants in the experimental group report lower substance (alcohol, tobacco, and cannabis) use and initiation after the intervention and at a 3-month follow-up related to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Schools having secondary education
* Schools located in Spain.
* Schools willing to participate under the conditions of the study

Exclusion Criteria:

* Schools applying the original "It´s Up To You" prevention program
Oversewing Staple Line of The Gastric Remnant

Background: Roux-en-Y gastric bypass (RYGB) is a surgery with low rate complications. However, it is not exempt from them, and 1-6% suffer complications such as postoperative bleeding. Many intraoperative techniques have been evaluated to reduce postoperative bleeding, like the oversewing or reinforcement of the staple line. This study aims to evaluate the rate of postoperative bleeding in the oversewing of the staple line of the gastric remnant group versus the stapling only group.

Methods: This is a 2-center, case-control study. The investigators randomly selected two groups who underwent RYGB or OAGB: group A (n=225) with oversewing from 2019-2020 and group B (n=225) with stapling only between the period of 2017-2018; both groups with similar demographic characteristics.

This case-control study was conducted in the International Unit of Bariatric and Metabolic Surgery of "Clinica La Sagrada Familia" located in Maracaibo, Venezuela, and in "Grupo Medico Santa Paula" Caracas, Venezuela. All procedures were performed by a single experienced bariatric surgeon during the period 2017-2020. The Ethics committees of Clinica "La Sagrada Familia" and "Grupo Medico Santa Paula" approved this study. The investigators selected 225 patients (group A) from the period 2019-2020 where the stapling line of the gastric remnant was oversewn and another group of 225 patients (group B) from the period of 2017-2018 with stapling alone.

Eligibility Criteria:
Inclusion Criteria:

* Our inclusion criteria were patients older than 18 years, body mass index (BMI) \> 30kg/m2 with or without comorbidities that underwent RYGB or one anastomosis gastric bypass (OAGB).

Exclusion Criteria:

* We exclude from our study any patient with psychiatric disorder, open surgery history, history of previous bariatric surgery, non-controlled comorbidity at the moment of surgery, and patients under the age of 18
Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis

Cystic fibrosis (CF) is a disease caused by a mutation in the gene that makes the cystic fibrosis transmembrane regulator protein. As a result mucus stagnation, obstruction and plugging take place in the respiratory and gastrointestinal tract, the biliary and pancreatic duct, and in the reproductive system. The objective of this study is to determine the safety and tolerability of 3 days of daily dosing of OligoG CF-5/20 versus placebo in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, male subjects aged 18 to 65 years inclusive
* Normal pulmonary function; i.e. FEV1 ≥ 80% of predicted (for age, sex, height and race) and FEV1/FVC ratio ≥ 0.7
* Subject's pre -study physical examination, vital signs and electrocardiogram (ECG) are normal or do not show any clinically significant abnormalities as determined by the investigator
* Subject's pre - study laboratory screen are normal or, if outside of the laboratory reference range, not considered clinically significant

Exclusion Criteria:

* History of any clinically relevant chronic respiratory disorder, including asthma
* Current smoker or smoked within the last 12 months
* History of significant drug or alcohol abuse (defined by the investigator). Subjects with a positive screen for alcohol or drugs of abuse at screening/admission will be excluded from participation in the study.
* Subject who has inhaled any drug in the last 30 days prior to Day 1
* Subject who has received one or more days of systemic pharmacological treatment in the 14 days immediately prior to Day 1
* Participation in a New Chemical Entity clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks
* Subjects with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, haematological or metabolic disorder
The Effects of Autonomous Sensory Meridian Response (ASMR) on Sleep Quality Improvement in Adolescents

Background: This study explored the therapeutic impact of ASMR on sleep problems in high school students.

Methods: The study involved sixty participants, divided evenly into four groups: three intervention groups (A, B, C) and one control group. For five consecutive days, the intervention groups engaged in pre-sleep ASMR listening sessions lasting 10, 20, and 30 minutes, respectively. Sleep quality was evaluated using mobile application tools and the subjective Sleep Quality Scale.

Background: In recent years, there has been a notable surge in sleep-related challenges among adolescents. The emergence of Autonomous Sensory Meridian Response (ASMR) content across various social media platforms has sparked interest in its potential to address these issues. This study explored the therapeutic impact of ASMR on sleep problems in high school students.

Methods: The study involved sixty participants, divided evenly into four groups: three intervention groups (A, B, C) and one control group. For five consecutive days, the intervention groups engaged in pre-sleep ASMR listening sessions lasting 10, 20, and 30 minutes, respectively. Sleep quality was evaluated using mobile application tools and the subjective Sleep Quality Scale.

Eligibility Criteria:
Inclusion Criteria:

* Haven\&#39;t heard an ASMR trigger tone before.

Exclusion Criteria:

* heard an ASMR trigger tone before.
Comparison of the Efficacy of Peloid Therapy and Paraffin Treatment in Carpal Tunnel Syndrome

This study compares the effectiveness of peloid therapy and paraffin treatment in carpal tunnel syndrome. Patients who have already received 2 weeks of peloid therapy or 15 sessions of paraffin treatment will be assessed. Pain and symptom severity are assessed using the Visual Analog Scale (VAS) and Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Electrophysiological examinations will also be conducted at the same time points: baseline, 4 weeks post-treatment, and a 12-week follow-up.

Our study will include 60 patients aged 18-65 who visited the outpatient clinics of Beylikdüzü State Hospital between January 1, 2024, and September 1, 2024, and were diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological examinations. These patients received either peloid or paraffin treatment. Patients with symptoms persisting for a minimum of 3 months will be included in the study. In this study, pain levels will be evaluated using the Visual Analog Scale (VAS), and the type and severity of symptoms will be assessed with the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). At our hospital, the standard paraffin treatment consists of 15 sessions, administered 5 days per week, while the peloid therapy consists of 10 sessions, also administered 5 days per week. The VAS, BCTQ scores, and electrophysiological evaluations of the patients will be assessed at the 4th and 12th weeks post-treatment. Electrophysiological parameters including median nerve distal motor latency (MMNDL), median nerve distal sensory latency (MNSDL), sensory nerve conduction velocity (SNCV), compound muscle action potential (CMAP), and sensory nerve action potential (SNAP) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years old.
* Patients diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological evaluations.
* Patients experiencing symptoms for a minimum of 3 months.

Exclusion Criteria:

* Patients diagnosed with neuropathic conditions such as polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
* Patients with a history of previous injections or surgery for carpal tunnel syndrome.