cyrilzakka/clinical-trials huggingface dataset:
A Protocol for a Virtual Reality Exposure Therapy for Fear of Flying.

This study aims to assess whether adding vibrotactile stimulation to visual and auditory stimulation increases the efficacy of VRET for FoF treatment. Eighty-four participants (18-65 years old) will be assigned to one of three intervention arms, namely the VRET with multimodal feedback (visual, auditory, and vibrotactile; VRET-M), the VRET with bimodal feedback (visual and auditory; VRET-B), or the imagery exposure treatment (IET) without sensory feedback. FoF-related symptoms (primary outcomes) will be measured administering the Fear of Flying Questionnaire-II (QPV-II), the Fear of Flying Scale (FFS), and the Visual Analogic Scale (VAS-A) before and after eight sessions of treatment, and at six- and 12-month follow-ups. Anxiety and the sense of presence experienced during exposure sessions (secondary outcome measures: VAS-A and VAS-P) will also be assessed. It is expected that participants in the VRET-M group will report a further reduction of FoF-related symptomatology after the treatment and at follow-ups compared to participants in the VRET-B and IET groups. Likewise, participants in the VRET-M group are expected to show higher sense of presence levels during exposure sessions in comparison to participants in the VRET-B and IET groups. It is expected that the IET group will report the lowest level of sense of presence and the poorest outcome after treatment and at follow-ups.

Participants who meet the inclusion criteria will be invited to participate in the initial treatment session. They will be also required to purchase a flight ticket during the six months after the end of the treatment. Participants will be treated weekly for eight individual sessions. While the first two sessions involve preparation and training, exposure will be conducted between the third and eighth session. The exposure sessions' structure and content will be the same in all conditions. Nevertheless, the VRET-M group will experience vibrotactile cues, while the VRET-B group will not. Furthermore, the IET group will experience its own subjective imagined environment without any external stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5, American Psychiatric Association, APA, 2013) criteria for FoF.

Exclusion Criteria:

* Individuals with a diagnosis of panic disorder, obsessive-compulsive disorder, or psychotic disorder who have received psychotherapy for their FoF, have been taking prescribed medication for their FoF, or have experienced cardiorespiratory disease or an epilepsy attack will be excluded from the study.
Effect of Pilates and Segmental Stabilization in Elderly People With Low Back Pain

INTRODUCTION: Low back pain is an important health condition with great consequences from the socioeconomic point of view and is associated with high costs for the health system, absenteeism at work and reduced functional performance. It is considered one of the most relevant health problems in the elderly, with point prevalence estimates higher than for other musculoskeletal conditions. It can be defined as any pain between the last ribs and the lower gluteal folds, with or without pain in the lower limbs, manifesting itself acutely, subacutely or chronically. OBJECTIVE: To compare the effect of the Pilates method versus segmental stabilization in elderly people with chronic low back pain. METHOD: 60 elderly people with chronic low back pain will participate in the study and will be randomized into two groups: Pilates Group (GP) and Segmental Stabilization Group (SG). The two treatments will have 16 individual sessions, twice a week. Pain will be assessed using the visual analogue pain scale; functional disability, using the Oswestry disability index; excessive fear of movement and physical activity, by the Tampa scale of kinesiophobia; level of confidence in the balance for specific activities, by the ABC scale and; activation of the transversus abdominis muscle by pressure biofeedback. Individuals will be evaluated in four moments: before the first session, after the last session, three and six months after the end of the treatment to verify the effects in the medium term. Patient allocation and assessments will be performed by a blind examiner. Data will be analyzed using the ANOVA procedure and Tukey's Multiple Comparison test. The significance level will be 5%. A hipótese deste estudo é que o grupo que realiza exercícios de Pilates obtém ganhos mais obtem que o grupo que realiza exercícios de estabilização segmentar em todas as variáveis ao final do tratamento.


Eligibility Criteria:
Inclusion Criteria:

* Non-specific low back pain for at least 3 months.
* Intensity of pain equal to or greater than 3 cm.

Exclusion Criteria:

* Specific low back pain.
* Neurological involvement (radiculopathy, myelopathy).
* Previous spinal surgery.
* Any impediment to performing the exercises.
* Having had recent surgeries.
* Being on treatment for low back pain
* Not having cognitive ability to perform the exercises or be submitted to the proposed assessments
* Missing appointments three times in a row.
Prostaglandin F2-alpha (PGF2α) in Vitiligo

study the cutaneous expression of PGF2α in vitiligo patients and compare it with normal control subjects.

Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-segmental vitiligo.
* Both sexes.
* Age \< 18 years old.
* New cases or cases not receiving any medications for at least 3 months ago.

Exclusion Criteria:

* Age: Patients \< 18 years.
* Segmental or universal vitiligo.
* Pregnant and lactating females.
The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache

Evidence-based medicine depends on distinguishing between pharmacological effects and placebo effects in randomized controlled trials (RCT). This proposal seeks to rigorously investigate fundamental questions concerning pharmacological effects, placebo effects and their interactions. Relief of symptoms of acute migraine will be the test condition for this scientific experiment because of migraine's evident clinical significance and the possibility of using participants as their own control during sequential acute migraine attacks. Our overall goal is to elucidate how the pharmacological effects of 100 mg rizatriptan (an FDA-proven effective medication for acute migraine) and the effects of placebo treatment can be modified by varied knowledge and/or expectation ("contextual") conditions. Such knowledge has the possibility to suggest potentially more efficient methodologies to test new medications that can be used to augment and enhance the apparatus of the RCT.

General Aim: To elucidate and clarify what is a pharmacological effect and what is a placebo effect, how such effects vary in different knowledge/expectations contexts, and mutually constitute one another and interact.

General Hypothesis: The measured pharmacological effect of an effective medication (rizatriptan) and the measured effect of placebo treatment are determined significantly by different knowledge/expectations contexts.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be considered for this study if they suffer from classical or common migraine for at least 3 years.
* Candidates will recruited from the clinical case load of Dr. Zahid Bajwa and the headache and pain management center at BIDMC.
* Only patients older than 18 years of age,
* Able to communicate clearly in English,
* Able to give an informed consent will be considered as candidates.
* No limitation of gender or race is justified and thus, it is open to all patients fulfilling criteria for migraine type headache.
* Patients will be able to withdraw from the study at any time.
* They will be included in the study if they meet the criteria for migraine with or without aura (Headache-classification-committee-of-the-International-Headache-Society 1988), if they had \>4 migraine attacks each month for the previous year.

Exclusion Criteria:

* Exclusion criteria will include cardiovascular or cerebrovascular disorders,
* Cardiac risk factors and liver disease,
* Uncontrolled hypertension,
* Peripheral and central nervous system disorders that affect sensory functions (such as sensory neuropathies and chronic pain),
* The use of opiates or other analgesic drugs for any reason, and the use of other prophylactic anti-migraine drugs.
* Any patient with active hepatitis or elevated liver enzymes (based on their BIDMC medical record) will be excluded as well.
* Employees who are under the direct supervision of the investigators will not participate in the study.
One Up, One Down: Analyzing Patient Preference on Cryotherapy Machine Tubing Placement

The purpose of this research study is to better understand patient preference and their satisfaction rates with cryotherapy machines based on the direction of the tubing. This study will evaluate both satisfaction and pain of patients who use the cryotherapy machines in the two groups: tubing facing towards the head, and the other with tubing facing toward the feet.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for an arthroscopic ACL reconstruction (CPT 29888) or MPFL reconstruction/augmentation with internal brace (CPT 27422 or 27429)
* Ages 10-18 years old at the time of surgery
* Patients who have access to a cryotherapy unit at the time of surgery

Exclusion Criteria:

* No ACL reconstruction (CPT 29888) nor MPFL reconstruction/augmentation with internal brace (CPT 27422 or 27429) performed during knee arthroscopy (i.e., isolated meniscus repair, synovectomy/debridement, etc.)
* Patients do not have access to a cryotherapy unit
* Patients less than 10 or older than 18 at the time of surgery
Removal of Erroneous Penicillin Allergy Labels: Implementation Study (REPeAL)

To test the implementation of penicillin allergy de-labelling delivered by the responsible clinical teams and the antimicrobial stewardship teams across all medical, surgical and critical care specialities in a UK hospital using the developed toolkit and a validated penicillin allergy decision support tool.

Aim:

To test implementation of the penicillin allergy de-labelling complex intervention in surgical, medical and critical care patient pathway.

Objectives:

* To use the Institute for Health Improvement (IHI) Model for Improvement methodology to implement the penicillin allergy de-labelling complex intervention in each setting (surgery, medicine, critical care)
* To measure the number of patients meeting inclusion criteria (\>16 with a penA not prescribed first line antibiotics) who have had their penicillin allergy record assessed by the wider clinical teams and separately by the AMS team.
* To measure the patient uptake of penicillin allergy record removal (i.e. the rate of patient declining de-label / DOC).

To interview 10-15 patients and 10-15 healthcare workers to gain insight into the penicillin allergy de labelling process.

Eligibility Criteria:
Inclusion Criteria:

All adult (\>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use.

Exclusion Criteria:

None
A Study of the Safety and How the Body Effects a Drug CNTO 136 in Healthy Male Japanese and Caucasian Volunteers

The purpose of this study is to evaluate the safety, tolerability and how the body affects the drug CNTO 136 in healthy Japanese and Caucasian volunteers.

This is a randomized, placebo-controlled, double-blinded study to assess the safety and pharmacokinetics of CNTO 136. In a randomized trial, study medication (CNTO 136 or placebo) is assigned by chance. Double-blinded means that neither the investigator nor the volunteer know which of the study medication they have been assigned to receive. Pharmacokinetics is the study of levels of CNTO 136 circulating in your blood over time. The study population will all be male and consist of 30 Japanese and 30 Caucasian volunteers. Three dose levels of study agent will be assessed. Participants will be required to stay at the research center after study agent administration for the inpatient portion of the study and then required to return for out-patient visits. One of 3 dose levels of CNTO 136 will be given just under the skin (subcutaneous (SC)). The length of this study will be about 20 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Demonstrate an understanding of the study and sign an informed consent form
* Healthy with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments including complete blood count (CBC), coagulation tests, urinalysis, measurement of vital signs, and ECG
* Japanese volunteers must have been born in Japan, have resided outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents. Caucasian subjects must have Caucasian parents
* Have a weight in the range of 60 kg to 90 kg (inclusive), body mass index (BMI) of 19 kg/m2 to 29 kg/m2
* Nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study.

Exclusion Criteria:

* Currently have, or have a history of, disease or dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system, that is clinically significant in the opinion of the investigator
* Have any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the healthy volunteer will complete the study
* Have evidence of any chronic medical condition requiring prescription medications (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes)
* Currently have any known malignancy or have a history of malignancy
* Have had major or traumatic surgery within 12 weeks of screening or any surgery within 1 week.
´Sit Less, Move More' at Work: mHealth Intervention on Office Employees With Diabetes Type 2.

The objective of the study is measuring the impact of a ´sit less, move more' mHealth intervention at work on the glycaemic control and anthropometric profile of office employees with diabetes type 2 (DT2) at short, mid and long term.

A double-blind randomized controlled trial. Seven Primary Care Centers from Spain (n=5 Catalonia, n=2 Madrid), 2 hospitals (n=1 Catalonia, n=1 Madrid) and 2 companies (occupational health services; n=1 public, n=1 private) will participate in the study. In each center, physicians, nurses, endocrinologists and occupational physicians will recruit patients with DT2 who spend at least 55% of their working hours doing desk-based tasks (OSPAQ) and have a cellphone. Following the CONSORT Statement (2010), volunteers will be randomized into a control (CG) or intervention group (IG) by the research team using a computer program to generate the random sequence. 184 individuals are needed in each group. Main variables: fasting glucose levels, HbA1c, weight, height, BMI, waist circumference. Occupational sitting time and sitting time breaks will be measured using ActivPAL devices. Other variables: physical activity (IPAQ short), quality of life (EuroQool), presenteeism (WLQ), triglycerides, total cholesterol (LDL and HDL), blood pressure and sociodemographic variables.

Intervention: A mHealth program (13 wks) will progressively replace occupational sitting time with light physical activities. Participants from the CG will receive usual care. Multivariate analysis will assess changes over time (post intervention and at 6 months follow up) in the dependent variables; looking at differences between groups. Intention to treat will be applied.

Eligibility Criteria:
Inclusion Criteria:

* DM2 diagnosed office employees according to international criteria.
* Doing sedentary tasks during at least a 55% of their daily work schedule (according to the Occupational Sedentary and Physical Activity Questionnaire: OSPAQ \>55%).
* Having a cellphone .
* Having a minimum work contract of 18.5 hours per week.
* Being able to get up from the chair or to walk by themselves (without any help).

Exclusion Criteria:

* Not having a cellphone.
* Having some pathology/disability/injury which changes their ability and capacity to walk or getting up from the chair.
* Doing less than a 55% of the daily tasks in a sitting position according to the OSPAQ questionnaire.
Serum ANGPTL3, ANGPTL8 and Glypican 4 Concentrations in Relation to the Development of Obesity in Korean Children

ANGPTL3 and ANGPTL8 are emerging molecules involving lipid metabolism. In previous in vivo study using mice, ANGPTL8 regulated the activation of ANGPTL3 which was known to inhibit lipoprotein lipase activity and stimulate lipolysis of adipose tissue. Besides, glypican 4 was identified as a novel adipokine modulating adipocyte differentiation. Thus, the investigators postulated that different serum concentrations of ANGPTL3, ANGPTL8 and glypican 4 might affect progression of obesity in children. The investigators measure these molecules in Korean children, and investigate the association between these molecules and development of obesity.

Participants in this study were selected from the Korean Metabolic disorders \& Obesity Study in Elementary School children (KMOSES), the main aim of which was to comprehensively assess obesity-related metabolic risk factors and to evaluate clinical outcomes in Korean children prospectively. Korean children who were participated in a school-based health examination, were reexamined for the 3-year follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* Participants who were reexamined for the 3 year follow-up assessment

Exclusion Criteria:

* Participants who were not being available for the 3 year follow up assessment
REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness

The aim of this study is to assess the utility of advanced magnetic resonance imaging (MRI) and electroencephalographic (EEG) technologies for predicting functional outcomes in patients with severe traumatic brain injury (TBI).


Eligibility Criteria:
Patients:

Inclusion Criteria:

* Traumatic Brain Injury
* Glasgow Coma Scale score of 3-8 within 24 hours, unconfounded by sedation, paralysis, hypoxia, hypotension, hypothermia, or concurrent medical illness
* Clinical evidence of disorder of consciousness defined as coma, VS, or MCS

Exclusion Criteria:

* History of prior severe brain injury or dementia
* Emergence from MCS at time of initial CRS-R assessment

Healthy Subjects:

Exclusion Criteria:

History of brain injury or neurological disease, psychiatric disease, or any history of diabetes, high blood pressure, heart disease, or kidney disease
A Pilot Study of Needle Size and Pain Perception With Botulinum Toxin A Injections

The purpose of this study is to compare the levels of pain resulting from injections of Botox® for wrinkles on the forehead and between the eyes using two different sized needles (32 gauge and 30 gauge needles).

Subjects will be screened, assessed, and randomized to be injected with onabotulinum toxin A using a 30-gauge needle on one side of the face and injected using a 32-gauge needle on the other side during their first clinic visit. This study is a pilot study designed to determine feasibility of these procedures.

Eligibility Criteria:
Inclusion Criteria:

1. In good health
2. Is a female
3. Is 25-70 years of age
4. Has moderate dynamic forehead/glabellar wrinkles
5. Has willingness and the ability to understand and provide informed consent and communicate with the study staff

Exclusion Criteria:

1. Younger than 25 or older than 70 years of age
2. Pregnant or lactating
3. Is a male
4. Has received the following treatments in the forehead or glabellar region:

   1. botulinum toxin injections in the past 6 months
   2. ablative laser procedure in the past 6 months
   3. radiofrequency device treatment in the past 6 months
   4. ultrasound device treatment in the past 6 months
   5. medium to deep chemical peel in the past 6 months
   6. temporary soft tissue augmentation material in the area to be treated in the past year
   7. semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
   8. permanent soft tissue augmentation material in the area to be treated
5. Has an active infection in the forehead or glabellar region (excluding mild acne)
6. Is allergic to cow's-milk protein
7. Is allergic to albumin
8. Taking aminoglycoside
9. Is currently using anticoagulation therapy
10. Has a history of bleeding disorders
11. Has a mental illness
12. Unable to understand the protocol or to give informed consent
Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen

In this randomized control trial, the investigators hypothesize that late-preterm infants resuscitated with a "low oxygen delivery" strategy (initiation of resuscitation with room air) will result in a significant reduction in oxidant stress without any harmful clinical effects.

The delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Some studies have shown that resuscitation of term newborn infants with room air were safe and of great benefit. A static room air, however, may be inappropriate for resuscitation of preterm infants. The number of late-preterm infants has increased in recent years, which represent approximately 70% of all preterm infants. Our study will evaluate the safety and efficacy of using room air during resuscitation of late-preterm infants and whether this will avoid oxidative stress derived damage and improve outcomes.

Eligibility Criteria:
Inclusion Criteria:

* inborn infant
* gestation 34 weeks to 36 weeks 6 days

Exclusion Criteria:

• known chromosomal or congenital anomalies
A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin

The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a study drug, to test whether the study drug has a real effect), multicenter study of efficacy, safety, and tolerability of canagliflozin in participants with T2DM, who have inadequate glycemic (blood sugar) control on maximally or near-maximally effective doses of metformin \>=1500 mg/day and sitagliptin 100 mg/day. Approximately 200 participants will be randomly assigned to 1 of 2 treatment groups in 1:1 ratio for 26 weeks. During the study the participants will be also provided with diet and exercise counseling (standardized non-pharmacological therapy).

Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of type 2 diabetes mellitus
* Must have a screening HbA1c of \>=7.5% to \<=10.5%
* Must be on metformin \>=1500 mg/day and sitagliptin 100 mg/day (or equivalent fixed dose combination) at a stable dose for at least 12 weeks before screening

Exclusion Criteria:

* History of diabetic ketoacidosis or T1DM, hereditary glucose-galactose malabsorption or primary renal glycosuria
* A myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before screening
* eGFR \<60 ml/min/1.73m2, or serum creatinine \>=1.4 mg/dL for men and \>=1.3 mg/dL for women
* Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis)
* Major surgery (ie, requiring general anesthesia) within 12 weeks before screening