cyrilzakka/clinical-trials huggingface dataset:
IBS-C Questionnaire Study

The study is a multi-centre, observational study which enrolls 150 IBS-C patients and 150 non-IBS-C patients in China.

The potential study subject will be identified by the investigators by face-to-face visit, and there will be only 1 visit in this study. Every patient will complete both ROME IV and the Simplified Diagnosis Tool during the visit, and in the same day.

The study will collect results of the ROME IV and the Simplified Diagnosis Tool. Sensitivity and specificity of simplified diagnosis methodology compared with ROME IV will be analysed after all the data has been collected.

Eligibility Criteria:
Inclusion Criteria:

Group 1 (IBS-C)

* ≥18 years old
* Decrease of frequency of bowel movement (\<3 time per week), change of stool consistency (stool that is hard and difficult to pass, Bristol Types 1 to 3), or other 'constipation symptoms' judged by investigators.
* With abdominal symptoms such as abdominal pain, bloating, and abdominal discomfort, or other 'constipation symptoms' judged by investigators.
* Result of ROME VI marked as 'IBS-C'.

Group 2 (non-IBS-C)

* ≥18 years old
* Decrease of frequency of bowel movement (\<3 time per week), change of stool consistency (stool that is hard and difficult to pass, Bristol Types 1 to 3), or other 'constipation symptoms' judged by investigators.
* With abdominal symptoms such as abdominal pain, bloating, and abdominal discomfort, or other 'constipation symptoms' judged by investigators.
* Result of ROME VI marked as 'Non IBS-C'.

Exclusion Criteria:

* Individuals with a cognitive condition and unable to finish the questionnaire.
* Individuals have an acute or chronic non-GI condition that can be associated with constipation; e.g., central nervous system cause (Parkinson's disease, spinal cord injury, and multiple sclerosis), pseudo-obstruction, colonic inertia, megacolon, megarectum, bowel obstruction, descending perineum syndrome, solitary rectal ulcer syndrome, systemic sclerosis.
* Individuals who had been diagnosed with the following organic health problems likely to affect GI symptoms:

  * Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
  * cancer anywhere in the GI tract or current infection of the GI tract.
  * Pelvic floor dysfunction. (i.e., disease that is not adequately treated or stable with therapy.)
  * Any history of colon surgeries.
* Individuals who participate in any interventional study currently.
* Not suitable for the study judged by investigators.
Workplace Exercise Intervention in Administrative Personnel to Reduce Spinal Pain

The goal of this Clinical trial is to compare treatments in sedentary administrative personnel with back pain. The main question it aims to answer:

The benefits of a workplace intervention with therapeutic exercise and pain education compared with only therapeutic exercise intervention

Participants will perform active pauses in their workplace with a web-based program that consists of videos or images of exercises and pain education information.

Researchers will compare a group Therapeutic exercise and pain education intervention with a group therapeutic exercise only to see if pain education plus exercise is a more beneficial intervention in reducing back pain in symptomatic administrative personnel.

Introduction: Musculoskeletal pathologies are one of the leading causes of disability for the population worldwide, with office workers being one of the most affected groups. This study aims to design and implement a programme of therapeutic exercise and pain education in the workplace to reduce musculoskeletal pathology. The use of therapeutic exercise interventions at work is an economical and feasible option in which it is essential to consider biopsychosocial aspects when designing a successful treatment.

Methods: Mixed methodology study. Phase 1: A qualitative study with a phenomenological approach using semi-structured interviews to determine factors related to office workers' expectations about pain, maintaining static postures at work and implementing active breaks. Phase 2: Implementation of a Randomised Controlled Trial considering current scientific evidence and the results of the first phase with two intervention groups. A group in which therapeutic exercise will be performed at work with pain education, compared to a group implementing only exercise at the workplace.

Discussion: This study is a comprehensive and pragmatic intervention to implement therapeutic exercise in the workplace, considering workers' expectations regarding their pain and the implementation of active breaks. The use of digitalisation in the implementation of therapeutic exercise and pain education in office workers is a feasible and low-cost option. It can improve office workers' quality of life by increasing motivation and adherence to such interventions.

Eligibility Criteria:
Inclusion Criteria:

* More than 80% of the working day is in a seated position.
* Workers who have a computer or mobile device with an internet connection.
* Workers with more than three months of pain in the back area due to a non-specific cause.

Exclusion Criteria:-

* Part-time workers.
* Pathologies that cause chronic pain.
* Radiculopathies or symptomatic disc herniations/protrusions.
* Inability to perform low-moderate intensity exercise.
* People who are active in their daily lives outside of work willing to report that they meet the minimum stipulated by the WHO (a minimum of 10,000 steps per day and 75-150 minutes of vigorous-moderate physical activity per week).
* Undergoing physiotherapy treatment through public health or a private company.
* Workers on sick leave or during pregnancy.
Effectiveness of Prazosin in Bulimic Patients Experiencing Nightmares Due to PTSD

This research is being done to find out how effective Prazosin is in the treatment of bulimic patients experiencing distressing nightmares using subjective and objective measures.

To the investigators knowledge, there is no treatment trial for prazosin use in patients with bulimia nervosa struggling with nightmares, looking at either objective or subjective measures. The investigators plan to probe the effectiveness of prazosin in bulimic patients experiencing nightmares due to PTSD using both subjective and objective measures in order to improve future clinical care. The effects of prazosin on decreasing nightmares and bulimic symptoms on subjective scales and effects on sleep architecture using objective polysomnogram (PSG) measurements will help inform targeted psychopharmacologic and psychotherapeutic strategies to improve clinical care of bulimic patients struggling with distressing dreams secondary to PTSD. This study will be performed in two phases. Phase A will involve eight participants who will be tested using subjective scales (mentioned below). If Phase A data analysis leads to detection of a signal of efficacy 2 more participants will be recruited to participate in phase B of this trial using objective polysomnogram measurements. The results from this project will aid in establishing a fully powered clinical trial for treatment of nightmares in bulimic patients and improve outcomes in this high risk population.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45
* Clinical diagnosis of Bulimia Nervosa with complaint of nightmares secondary to PTSD

Exclusion Criteria:

* Restless leg syndrome
* Narcolepsy
* Sleep Apnea
* Neurological disorders
* Pregnancy
* cardiac abnormalities
* significant electrolyte abnormalities
* Use of steroids, beta blockers, prazosin
* Alcohol/substance abuse
Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Acuvue Oasys 1-Day for Astigmatism Contact Lenses

Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double-masked (subject and investigator), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria, subjects will be dispensed study lenses according to unique randomization tables that will be provided to each Investigator. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.


Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

The subject is not eligible to participate in the study if the subject is:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.
Study of the Durability of Glycemic Control With Nateglinide

This multi-center, randomized controlled study aims to evaluate the durability and efficacy of nateglinide therapy for long term glycemic control compared with glimepiride.

Selected patients will be randomly assigned to receive nateglinide or glimepiride.

Previous treatment with oral antidiabetic drugs (metformin, a-glucosidase inhibitor, nateglinide or sulfonylurea) will be discontinued. After a 1 month wash-out period (if 6.5 ≤ HbA1c ≤ 8.5), patients will take randomly assigned drugs for 24 months.

Patients will be met by the trial investigator every 3 months following randomization. At each visit, patients whose HbA1c is \> 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure. We will evaluate the durability of nateglinide in comparison with that of glimepiride based on the withdrawal rate.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* age\>=18years
* no anti hyperglycemic agent for 3 months or low-dose oral hypoglycemic therapy

  * metformin≤1g/day, acarbose≤300mg/day, voglibose≤0.9mg/day, nateglinide≤270mg/day, gliclazide≤80mg/day, glimepiride≤2mg/day, glibenclamide≤5mg/day (nateglinide or sulfonylurea \<6months)
* 6.5% ≤ HbA1c ≤ 8.5%

  * patients on no anti hyperglycemic agent for 3 months : HbA1c at screening
  * patients on oral hypoglycemic therapy in 3months : HbA1c after wash-out

Exclusion Criteria:

* attending other clinical trials in 3months
* type I diabetes mellitus
* taking systemic steroid in 1month or requiring steroid therapy during clinical trial
* acute myocardial infarction in 6months
* alcoholics, pituitary or adrenal insufficiency, severe ketosis, diabetic ketoacidosis
* severe liver disease or AST, ALT ≥ 2.5 x ULN
* renal insufficiency (serum creatinine \> 2.0mg/dl)
* other severe diabetic complication
* drug hypersensitivity history to nateglinide or sulfonylurea
* pregnant or plan to become pregnant during the clinical trial, lactation
Natural History and Patient Journey in Atrial Fibrillation: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.

The trajectory of atrial fibrillation (AF) patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the AF incidence, mortality and case-fatality, the investigators implemented a longitudinal cohort study with the linked electronic health records of 5.6 million population in the UK from 1998 to 2016 (CALIBER). A matched case-control study design was used to investigate the causes of hospitalization and death comparing individuals with and without incident AF.


Eligibility Criteria:
Inclusion Criteria:

* The investigators identify individuals aged 18 years or older and registered in the current primary care practice for at least one year.

Exclusion Criteria:

* Individuals are excluded if they had a prior history of AF before study entry.
Efficacy of Natural Vitamin E Tocotrienol on the Treatment of Surgical Scars

The overall goal of this study is to determine the efficacy of tocotrienol (TCT), a natural form of vitamin E, in preventing or reducing scar formation in human skin wounds as well as the basal levels of TCT in normal human skin and adipose tissue.

Scar formation is the physiological and inevitable end point of mammalian wound healing and there is substantial evidence that inflammation is an essential prerequisite for scarring. Although scar tissue restores the normal skin barrier, the new tissue is inferior in structural, aesthetic, and functional respects. The mammalian wound healing response may have originated during the time of high susceptibility to infection. Therefore, we may have developed speed optimized wound healing where a multiple redundant compensating rapid inflammatory response allows the wound to heal quickly without infection. The scar is then the price mammals have to pay for evolutionary survival after being wounded.

Tocotrienol may be an effective tool to prevent or reduce normal, hypertrophic, or keloid scarring by mediating the inflammatory response. Tocotrienol is a safe and convenient treatment that could be used by mouth or topically. There has never been a study on the effectiveness of tocotrienol in preventing or reducing scar formation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Non- smoker
* No current medications that alter liver metabolism (e.g., Phenobarbital, HmG co-A inhibitors, etc.)
* Non- pregnant or non-breastfeeding
* No current use of dietary supplements containing vitamin-E
* Not actively abusing drugs or alcohol

Exclusion Criteria:

* Under 18 years of age
* Prisoners
* Current smoker
* Pregnant or breastfeeding
* HIV diagnosis
* Viral hepatitis diagnosis
* Immunosuppressive therapy
* Actively abusing drugs or alcohol
* Current use of dietary supplements containing vitamin-E
Cluster Resistance Training and Older Adults

This project will focus on improving power in older adults, since power is related to performance of daily activities and memory and decision making. The study will compare cluster set resistance training, where you can rest during a set, to traditional set resistance training where all repetitions in a set must be completed without any between-repetition rest. If cluster set resistance training is better than traditional set resistance training, it could be more beneficial than existing methods in improving independence in older persons.


Eligibility Criteria:
Inclusion Criteria:

* Montreal Cognitive Assessment Score \> 23
* No memory complaints

Exclusion Criteria:

* Uncontrolled cardiovascular or neuromuscular disease that prevents participation in a training program
* Any systemic inflammatory or autoimmune conditions such as rheumatoid arthritis, system lupus erythematosus, or other serious concomitant medical illness
* Unresolved injury or surgery to the upper or lower limbs.
Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of asthma and:
* Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
* FEV1 ≥50% and ≤90% of predicted normal at screening
* An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling a total dose of albuterol/salbutamol of 360/400 MDI

Exclusion Criteria:

* Smoking history of ≥ 10 years
* Patients with a diagnosis of COPD
* Patients who have been previously intubated for a severe asthma exacerbation/ attack
* Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
* Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
* Patients with Type I or uncontrolled Type II diabetes mellitus

Other protocol-defined inclusion/exclusion criteria may apply
The Effect of Tea Breaks on Cerebrovascular Perfusion During Desk Work

Sedentary behaviour of healthy subjects may have a detrimental impact on cerebral blood flow as well as cognitive measures related to mood and alertness. In this study we focus on the impact of leaving the desk to consume a cup of tea at regular intervals during a sedentary working day.

Prolonged desk work has detrimental impact on cerebral blood flow as well as cognitive measures related to mood and alertness caused. These effects might be prevented by taking short breaks with physical activity. Usually, desk workers have short breaks during office times for either a visit to the restroom or to enjoy for a moment a (hot) drink. Consumption of tea has been associated with benefits related to attention, alertness, mood and creativity. This study focuses on the impact of physically leaving the desk to prepare and consume a cup of tea at regular intervals during a sedentary working day.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females, age at screening \> 18 and \< 60 years;
* BMI \> 18 and \< 30 kg/m2
* Apparently healthy
* Agreeing to be informed about medically relevant personal test-results by a physician
* Informed consent signed
* Sedentary working individuals (≥6 hours desk work per day, ≥4 days per week)

Exclusion Criteria:

* Reported physical exercise ≥4 hours per week
* Taking medication (including food supplements and traditional medicines) which may interfere with study measurements, as judged by the PI
* Reported participation in another nutritional or biomedical trial (involving an intervention of at least 1 week) 3 months before the screening or during the study
* Reported participation in night shift work 2 weeks prior to screening or during the study. Night work is defined as working between midnight and 6.00 a.m.
* Reported consumption of \> 14 units (female subjects) and \> 21 units (male subjects) alcoholic drinks in a typical week.
* Reported use of any nicotine containing products in the 6 months preceding the study and during the study itself.
* If female, is pregnant (or has been pregnant during the last \< 3 months ago) or will be planning pregnancy during the study period.
* If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period.
* Reported weight loss/gain (\> 10%) in the last 6 months before the study.
* Being an employee of Unilever or an employee or a student working in RISES LJMU that is directly involved in this study.
Does Cannabidiol Attenuate the Acute Effects of ∆9-tetrahydrocannabinol Intoxication in Individuals Diagnosed With Schizophrenia? A Double-blind, Randomised, Placebo-controlled Experimental Study

This study will recruit schizophrenia patients who use cannabis recreationally. Each participant will attend the laboratory on three occasions: an initial visit to check that they are safe to join the study and two days of testing.

Participants will be administered, in a randomized order, a pre-treatment with either CBD (1000mg) orally or a matching placebo. On both experiments, participants will then inhale cannabis containing THC. The THC administration will follow a standardised inhalation procedure using a medical-grade vaporizer device.

Participants will complete a series of tasks measuring cognition, psychosis, anxiety and other subjective experiences.

The study will be carried out at the NIHR-Wellcome Trust Clinical Research Facility at King's College Hospital.


Eligibility Criteria:
Inclusion criteria:

* Age 18-65 years.
* Clinical diagnosis of schizophrenia (i.e. documented as such in the patient's clinical records and satisfying ICD-10 criteria for F20)
* Clinically stable for at least three months (since discharge from hospital, home treatment team, or prior clinical deterioration, and with agreement from the patient's responsible clinician)
* Regular (at least weekly) cannabis use for the past 3 months or more
* Evidence from either clinicians or from the patient that cannabis use exacerbates their symptoms or increases their risk of relapse
* Treatment with regular doses of antipsychotic medication for at least 1 month, confirmed by a blood test at the baseline visit, and with the participant agreeing to be maintained at a stable dose over the course of the experiment
* The participant agrees to abstain from cannabis use for at least 24hours prior to study visits
* The participant is willing to have an intravenous cannula inserted to collect blood samples on experimental visits
* Sufficiently fluent English
* Providing written informed consent

Exclusion criteria:

* Extreme cannabis use: participant is estimate to be using over 1gram of cannabis/day
* Dependence on alcohol or illicit substances other than cannabis as defined by ICD-10
* Pregnancy (current or planned) or breastfeeding
* Physical health disorder or another mental health disorder that the study psychiatrist judges may influence the patient's ability to tolerate the procedure, or that may alter the results of the study.
* Taken part in any drug study within the last 3 months or taking part in another study over the course of the trial
* Drug sensitivity/allergy to cannabis or Lorazepam
* Unlikely to be able to complete the study sessions for any reason, as judged by the study psychiatrist

Additional criteria which must be met on experimental visits:

* Negative alcohol breath test
* Negative urine drug screen (apart from cannabis and prescribed medication)
* Negative urine pregnancy test
* Stable mental state as judged by the study psychiatrist
Incubator Weaning of Moderately Preterm Infants

The objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants.

The hypothesis of this study is that length of hospital stay (from birth to discharge) will be decreased among moderate preterm infants weaned from an incubator to an open crib at a lower versus higher weight, 1600g vs. 1800g.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age 29 0/7 to 33 6/7 weeks at birth
* Birth weight less than 1600 grams
* Greater than 48 hours of age
* Current weight less than 1540 grams
* In an incubator

Exclusion Criteria:

* Receiving phototherapy
* Receiving respiratory support (including CPAP, ventilation, HFNC \> 2 LPM)
* Receiving blood pressure support
* Designated for transfer to referral hospital while in incubator
* Known major congenital or chromosomal anomaly