cyrilzakka/clinical-trials huggingface dataset:
Young Driver Intervention Study: Preventing Motor Vehicle Crashes

The purpose of this study is to evaluate the effectiveness of a program designed to reduce teen crashes and risky driving by increasing parental monitoring and restriction of their adolescents' driving practices during the first year of licensed driving.

Motor vehicle crashes are the major cause of death and disability among adolescents from 16 through 20 years of age. While adolescents between the ages of 16 and 19 years constitute only 5% of all licensed drivers, they are involved in 15% of the crashes in which they or other occupants are killed. In fact, 16-year-old drivers are more than 20 times as likely to have a crash as the general population of drivers and 17-year-olds are more than 6 times as likely. In addition, for each adolescent motor vehicle fatality, approximately 100 nonfatal injuries occur, making crashes the leading cause of disability due to head and spinal cord injuries in adolescents.

Parents can have a huge impact on adolescent behavior. However, the impact of parenting practices on adolescent driving behavior has not yet been examined. This study aims to determine the efficacy of an intervention designed to increase parents' involvement in, and parental restrictions on, their teens' early driving experiences in order to reduce the number of tickets and crashes among teen drivers. The intervention provides educational materials to parents and adolescents from the time the adolescent gets a learner's permit through the first 6 months of licensure. These persuasive communications are tailored to adolescents' level of driving experience. The intervention materials make explicit the increased risk associated with adolescent driving and methods for reducing risk through increased parental involvement in and restriction of driving.

Participants were recruited in the Connecticut Department of Motor Vehicle offices as adolescents applied for their learner's permits. Participants were randomized to either the intervention group or the control group. The control group received standard information about driving not related to the specific teen risks focused on in the intervention group materials. All participants completed interviews at study entry, licensure, 3 months after licensure, 6 months after licensure, and 12 months after licensure. Parents were asked about their expectations and parenting practices regarding their adolescents' driving behaviors. Adolescents were asked about their driving practices and their parents' rules and restrictions regarding driving. The driving records for each adolescent were obtained from the state motor vehicle administration and examined 18 months after licensure.

Eligibility Criteria:
Inclusion Criteria

* Lives with parent/guardian at least 50% of the time
* Obtains learner's driving permit
* Family members are able to complete interviews in English
Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years

Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Receipt of Seasonal Influenza Vaccine for season 2007/2008
* Receipt of another vaccine within 3 weeks before and after each vaccination
* Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF59 or a similar adjuvant
* Children who are in the local recommendation for influenza vaccination due to underlying diseases
Endobronchial Ultrasound vs Mediastinoscopy in NSCLC

Proper staging of Lung cancer is of paramount concern when determining a treatment regime. Currently the assessment of surgical candidacy is performed with the staging process, mainly the mediastinoscopy. A mediastinoscopy has the ability to access samples of the paratracheal lymph node stations (Levels 2R, 2L, 3, 4R, 4L), as well as the anterior subcarinal lymph node station (Level 7). In comparison, the EBUS-TBNA technique is a real-time procedure that has the potential to access the same paratracheal and subcarinal lymph node stations associated with the mediastinoscopy, but also extending out to the hilar lymph nodes (Levels 10 and 11). Because of the possibility of extended sampling range and a reduction in procedural invasiveness, EBUS-TBNA may represent a more efficient patient centered alternative to mediastinoscopy in the staging of lung cancer patients. Additionally, patients who are have lymph nodes in the N2 region frequently undergo chemotherapy and/or radiotherapy prior to surgery. Assessment of the lymph nodes after chemo/radiation is done using CT scans, as re-mediastinoscopy is a technically difficult procedure. These patients may benefit from EBUS-TBNA.


Eligibility Criteria:
Inclusion Criteria:

A) Age 18 years or older B) Patients with confirmed or suspected non-small cell lung cancer who require a mediastinoscopy as part of their staging investigations of the mediastinum to determine suitability for lung cancer resection will be considered for the trial.

C) Patients with undiagnosed enlarged lymph nodes in the mediastinum suspicious for lung cancer in which a tissue diagnosis is required.

Exclusion Criteria:

A) Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy or a mediastinoscopy or who are not suitable for definitive surgical resection by thoracotomy will be excluded.

B) Patients who have verified stage IV disease or who are not appropriate for lung cancer resection by virtue of direct invasion of mediastinal structures or large parts of the chest wall.

C) Known small cell lung cancer. D) Patients where there is a high clinical suspicion of lymphoma. E) Inability to give informed consent.
A Two Part Trial Investigating an Anti-obesity Drug in Overweight/Obese Male and Female Healthy Volunteers

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the trial drug is eliminated from the body) of NNC 0070-0002-0453 in overweight/obese, but otherwise healthy male and female volunteers. Selected subjects will continue in a follow-up period of up to 5 years.

Due to an unfavourable benefit-risk profile observed during the phase 1 trial for the obesity project, NN9161, Novo Nordisk has decided to terminate further clinical development.

Eligibility Criteria:
Inclusion Criteria:

* FOR TRIAL PART 1, THE FOLLOWING APPLIES:
* Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject
* Overweight/obese males: Body Mass Index (BMI) between 27.0 to 39.0 kg/m2
* Good general health
* FOR TRIAL PART 2, THE FOLLOWING APPLIES:
* Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject.
* Obese male and female subjects: Body Mass Index (BMI) between 30.0 to 39.0 kg/m2
* Good general health.

Exclusion Criteria:

* Aggressive diet attempts within the last 3 months
* Current or history of treatment with medications that may cause significant weight gain
* History of major depressive disorder or history of a suicide attempt or history of any suicidal behaviour
* History of eating disorders
* Any weight change of 5 kg (11 pounds) in the last 3 months
* Tobacco use
* History of alcoholism or drug/chemical abuse
Naltrexone Maintenance Treatment of Alcoholism

The purpose of this study is to determine the long-term effectiveness of naltrexone treatment in alcohol-dependent patients who respond to short-term treatment. Those who respond to short-term treatment will be randomized to a 1-year, double-blind, placebo-controlled maintenance phase with a 6-month posttreatment followup.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol dependence.
* Expresses a desire to cut down or stop drinking.

Exclusion Criteria:

* Currently meets criteria for dependence on substances other than alcohol.
* History of opiate dependence or evidence of current opiate use.
* Significant medical disorders that will increase potential risk or interfere with study participation.
* Liver function tests more than 3 times normal or elevated bilirubin.
* Female patients who are pregnant, nursing, or not using a reliable method of birth control.
* Inability to understand and provide a consent form.
* Treatment with an investigational drug during the previous month.
* Prior treatment with naltrexone.
* Chronic treatment with any narcotic-containing medications during the previous month.
* Sensitivity to naltrexone as evidenced by adverse drug experiences especially with narcotic containing analgesics or opioid antagonists.
* Current treatment with disulfiram.
* More than 6 weeks of abstinence.
* Meets criteria for a major psychiatric disorder and is in need of, or currently undergoing pharmacotherapy.
Prevention of Postoperative Delirium With Donepezil

Patients undergoing hip or knee joint replacement at the age of 70 years or above who are cognitively unimpaired will receive donepezil or matching placebo before (over 5-7 days), during and after (over 7 days) surgery. The incidence of delirium will be monitored at 3 days, 7 days, and 49 days following surgery. We hypothesize that the incidence of delirium can be lowered from 20 per cent to 10 per cent by the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Cognitively healthy, elective hip or knee replacement

Exclusion Criteria:

* Ongoing cholinergic treatment, dementia, delirium, acute physical illness
Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers

This study will evaluate the efficacy and economic impact of a theoretically-based, fully automated, interactive smartphone-based smoking cessation intervention.


Eligibility Criteria:
Inclusion Criteria:

* \>100 lifetime cigarettes
* English or Spanish speaking
* Currently smoke \> 5 cigarettes/day
* Process a smartphone compatible with the project app
* Have a valid email address

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Current use of smoking cessation medications
* Enrolled in a smoking cessation study
* Household member enrolled in the study
* Failure to electronically confirm participation with 14 days of randomization via electronic link sent to participant's smartphone
Short-term Physical Function Outcomes in Severe COVID-19 Patients Admitted to ICU for Invasive Mechanical Ventilation

Little is known about the physical function outcomes in patients with severe COVID-19 patients who are admitted to Intensive Care Unit (ICU) for invasive mechanical ventilation. The purpose of this study is to evaluate the short-term impact on physical function before hospital discharge in subjects with severe COVID-19 who have survived ICU admission for invasive mechanical ventilation.

DESIGN: An observation cohort study conducted in a tertiary hospital.

METHODS: Data will be collected from patients along the ICU-hospital discharge continuum, will be analysed and non-parametric tests will be used to explore association between variables.

Outcome measures: Muscle strength, as a component of physical function, will be evaluated with the Medical Research Council sum score (MRC- SS) at discharge from ICU and at hospital discharge; the Functional Status Score for the ICU (FSS-ICU) will also be assessed at hospital discharge. Data on participants' demographics, ICU admission and hospital admission will also be collected.

SIGNIFICANCE OF THE RESEARCH: Understanding how physical function is affected in patients with severe COVID-19 may help develop future prevention, therapeutic and follow-up strategies that improve quality of care and outcomes in this specific group of patients. Findings from this study may be useful to design future larger cohort studies and experimental trials.

Eligibility Criteria:
Inclusion Criteria:

* subjects diagnosed with COVID-19 who have required admission to ICU for invasive mechanical ventilation;
* have received invasive ventilation \> 24 hours;
* have been successfully weaned from mechanical ventilation \> 48 hours;
* were independently able to mobilise prior to current hospital admission (this includes subjects who used a walking stick or another gait aid to mobilise.

Exclusion Criteria:

* subjects or proxies with inability to communicate in Spanish fluently;
* cognitive impairment prior to ICU admission;
* proven neurological impairment or neuromuscular disorder;
* Cerebrovascular Accident during hospital stay;
* previous organ transplant;
* pregnancy;
* unstable fractures or any other injuries that would require medical bed rest.
Family Centered Services in Cerebral Palsy

To examine the family-centered service characteristics of physiotherapy and rehabilitation services received by children with cerebral palsy (CP) and to investigate the affecting factors.

Children with Cerebral Palsy (CP) attend special education and rehabilitation centers to receive physiotherapy and rehabilitation (PT) services, and it is very important for parents to be informed about the services offered in these centers. Our aim in the study was to examine which factors affect family-centered characteristics and parental perceptions in the PT services received by children with CP. For this purpose, 100 children diagnosed with CP between the ages of 2-18 and their parents were included in the study. The Measure of Processes Care (MPOC) survey was used to assess parents' perceptions of the family-centered features of (PT) services. These perceptions were examined to determine whether they vary depending on the child's age, functional level, parents' educational status, the impact of their disabled children, and health-related quality of life. The Family Impact Scale was used to measure parents' level of influence from their disabled children, and the Nottingham Health Profile survey was used to evaluate their health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Having a child aged between 2 and 18 years diagnosed with cerebral palsy
* Receiving physiotherapy and rehabilitation services for at least one year
* The family's consent to participate in the study and their approval for their child to be assessed by the researcher physiotherapist and for their information to be collected within the scope of the study

Exclusion Criteria:

* Parents over the age of 65
* Parents who do not speak Turkish
* Having another child with a disability
Deep Neuromuscular Block Affect the Quality of Recovery After Laparoscopic Hysterectomy

BACKGROUND: Some studies have revealed that deep neuromuscular block (NMB) improve surgical conditions and alleviated postoperative pain compared with moderate NMB. The present study investigated deep NMB could improve the quality of recovery after laparoscopic hysterectomy

METHODS: seventy-two women with elective laparoscopic hysterectomy were randomly divided into 2 groups: Patients in group A received low-pressure pneumoperitoneum (LPP), which was set at 8-10 mmHg with deep NMB. Patients in group B received standard-pressure pneumoperitoneum (SPP), which was set at 12-14 mmHg with moderate NMB. Primary outcome was the quality of recovery (QoR-15) at 1 day after sugery. The secondary outcomes included postoperative pain, surgical condition, incidence of shoulder pain, the incidence of rescue analgesic drug use, cumulative dose of analgesics, time of first flatus, post-operative nausea and vomiting, time of tracheal tube removal.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅲ
* Scheduled for elective laparoscopic hysterectomy

Exclusion Criteria:

* Inability to give informed consent
* BMI \>35
* Renal or hepatic insufficiency
* History of preoperative psychiatric
* Previous surgery at procedure site
* Neuromuscular disease, pregnancy, and contraindications to study medications.
Cannabinoids Effects on the Pain Modulation System

Effective treatment of acute pain, chronic and persistent is the most important concern in the world today. Although a variety of pain medications including anti-inflammatory painkillers and opiouids, patients continue to suffer from pain constantly. For over a century ,International committees studied the issue of cannabis, and almost uniformly recommended the use of cannabis for various medical applications ,especially those that include pain treatment.

Despite the widespread use of THC in clinical practice, there are few studies on the efficacy of THC In a double-blind, randomized trial. In addition, few studies examined the effect of THC on the experience pain in healthy subjects and most of them did not find an effect on pain experimental induced by capsain. so checking other models of pain such as thermal pain and mechanical pain in addition to checking the influence on the regulation of pain will contribute to understanding the mechanism of action of THC. Understanding the mechanism of action of THC in relieving pain will lead to predicting who will benefit from this treatment and direct patients for selection of appropriate medication according to the damaged mechanism.


Eligibility Criteria:
Inclusion Criteria:

A. Men aged 25-65. B. Were not treated with formulation contains Cannabis C. Can sign an informed consent form. D. Patients have a medical history that supports severe neuropathic pain over Three months And do not respond to other painkillers or suffer from side effects resulting from the use them E. At least moderate pain (more than 40 on a scale of 0-100 visual analogue scale). F. Did not receive epidural injection or invasive treatment in The last month before the entry to study . G. Not drinking alcohol or consuming high concentrations of opioid and Benzodiazifinim over 24 Hours before the experiment (equivalent to 40 mg morphine).

Exclusion Criteria:

A. Patients that found with serious level of anxiety in Patient Health Questionnaire (PHQ-9) . (These patients will be recommended by a doctor appointment with a psychiatrist). B.Patients with psychiatric problems or a family history of psychiatric disorders.

C.Patients with known cardiovascular problems D.Patients with neurological problems from a central source E.Patients taking blood pressure medication F.Patients who are unable to understand and follow the instruction of the study.

G.Diffuse pain syndromes from uncertain origin (like fibromyalgia) H.Alcoholism or chronic use of drugs. I.Malignant
Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease

Up to date there is no placebo-controlled trial to investigate the effect of prucalopride in patients with proven refractory GERD. Therefore, to evaluate the efficacy of prucalopride on the improvement in symptom severity and reflux parameters, we will conduct a randomized, parallel, placebo-controlled, single-blind study. 60 patients with refractory GERD symptoms will receive either placebo or prucalopride (Resolor®) 2 mg for a period of 4 weeks. Symptom severity will be assessed by a validated reflux questionnaire (ReQuest) and reflux parameters (acid exposure time and number of reflux episodes) will be assessed by means of a 24 hour impedance-pH monitoring.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 65 years old.
2. Patients must have proven reflux, documented either by the presence of esophagitis (≥ grade B) at upper endoscopy ("on" PPI b.i.d.) in the 24 months prior to inclusion or pathological reflux parameters (acid exposure time \>4% or number of reflux episodes \>40) on a 24 hour impedance-pH monitoring ("on" PPI b.i.d.) in the 6 months prior to inclusion.
3. History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
4. Daily intake of PPI treatment 12 weeks prior to inclusion, with at least 8 weeks of b.i.d. therapy (at least 2\*20mg of omeprazole or equivalent).
5. Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception do not include oral contraceptives, due to expected diarrhea as side effect of prucalopride. Injectable or implantable methods, intrauterine devices, or properly used barrier contraception are acceptable forms of contraception.
6. Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.

Exclusion Criteria:

1. Systemic diseases, known to affect esophageal motility.
2. Colitis ulcerosa, Crohn's disease, toxic megacolon.
3. Have a cardiovascular disease or QT c\>450 ms
4. Severely decreased kidney function.
5. Severely decreased liver function.
6. Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
7. Number of stools \>3 per day.
8. Major psychiatric disorder.
9. Treatment with prucalopride prior to the start of the study.
10. Concomitant use of medications such as: anticholinergics, baclofen or prokinetics.
11. Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
12. Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.
13. Pregnancy or breast feeding.
14. History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
15. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

The purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear.


Eligibility Criteria:
Inclusion Criteria:

* Currently wearing soft contact lenses
* Replaces lenses on a weekly or longer schedule
* Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

* Requires concurrent ocular medication
* Eye injury or surgery within twelve weeks immediately prior to enrollment
* Currently wearing soft toric lens wearers
* Those who dispose of their soft lenses on a daily basis
* Other protocol-defined inclusion/exclusion criteria may apply