cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy

Ultraviolet (UV) phototherapy is a standard treatment for many inflammatory dermatological diseases, including psoriasis. The systemic effects of UV phototherapy are still not well studied. There are several factors that may affect patient's cardiovascular (CV) risk during UV phototherapy. Atherosclerosis is now known to have an inflammatory origin and to be frequently associated with psoriasis. In this study the investigators aim at studying the effect of psoralen-UVA phototherapy on several biomarkers of CV risk in patients with psoriasis with or without atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Disease affecting \> 10% body surface area
* Patient willing to commit to 3 sessions weekly for 3-6 months without interruption

Exclusion Criteria:

* Disease severity less than 10% body surface area
* Patients unable to commit for therapeutic schedule due to work or residence issues.
* pregnant and lactating females
* photosensitive dermatoses
The Clinical Efficacy and Safety of Drug-coated Balloon

Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated on the balloon. Treating in-stent restenosis (ISR) with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology (ESC) guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.

Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB in primary large vessels is non-inferior to drug-eluting stent (DES), there is no large-scale RCT or cohort studies to compare the clinical effects of DCB and DES.

Despite several theoretical benefits of DCB, the procedural-related complications cannot be entirely prevented, such as acute elastic retraction and severe dissection, which would affect coronary blood flow or lead to acute vascular occlusion.

Some studies have suggested that optimization of the procedural technique can reduce the occurrence of complications and target lesion failure in the long-term. Proposed criteria include adapting cutting or scoring balloon for pre-dilatation, residual stenosis\<30% post-DCB, maintaining TIMI flow=3, DCB dilation time\<60s, and appropriate balloon to vessel ratio\> 0.91. However, such proposed technique and criteria have not been evaluated in the real-world clinical practice.

This current study is designed to investigate the efficacy and safety of DCB in the real world and exploring the optimal procedural configurations.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who received PCI with one or more drug-coated balloons (DCB)
2. Patients who did not received drug-eluting stent implantation

Exclusion Criteria:

1. Currently participating in another trial or participants unable to comply to follow-up
Acceptance and Commitment Therapy (ACT) and Carers

Background: Research has extensively documented the adverse impact that caring for an individual with an acquired brain injury can have including financial difficulties, social isolation, family tension and conflict, relationship difficulties, role adjustment and psychological distress (Foster et al., 2012). Research has indicated that Acceptance and Commitment Therapy (ACT) shows promise for increasing wellbeing and psychological flexibility in caregivers and could be a useful intervention for use with this population.

Aims: The primary aim of this study is to investigate the feasibility of using an ACT intervention to enhance the wellbeing and the psychological flexibility of carers using the Population, Intervention, Control, and Outcomes (PICO) framework. Methods: The current study is a randomised control design, exploring the feasibility of comparing the efficacy of an ACT intervention to Enhanced Treatment As Usual (ETAU), to improve the wellbeing of the carers of adults with an acquired brain injury (ABI). Participants will be recruited from the Brain Injury Rehabilitation Trust (BIRT) in Glasgow, Scotland and randomly assigned to either an ACT intervention group or TAU control group. Both will be assessed in parallel to one another completing a range of baseline and post-baseline measures. Applications: This feasibility study will provide information for further research on the utilisation of an ACT intervention to improve the wellbeing of carers and whether this is an acceptable intervention for this population.


Eligibility Criteria:
Inclusion Criteria:

* full time or part time carer for an adult with an acquired brain injury

Exclusion Criteria:

* learning disability
* not proficient in English
A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients

The primary objective of this study is to compare the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole in morbidly obese patients and non-obese patients. The secondary objectives are to assess the pharmacodynamics (the study of the action or effects a drug has on the body) and to assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.

This is an open-label (all people involved know the identity of the intervention), parallel-group, Phase 1 study in morbidly obese and non-obese men and women. A total of 25 patients (12 morbidly obese and 13 non-obese) patients will be enrolled in the study. Morbidly obese and nonobese patients are matched individually 1:1 by age (±10 years), sex, and renal function (as defined by creatinine levels in the urine). There are 4 phases in the clinical study: the pretreatment (screening/baseline) phase of up to 21 days; the 2-day open-label treatment phase when each patients receives a single 2-hour intravenous (directly into the vein) infusion of ceftobiprole 500 mg followed by multiple (up to 15) blood and urine samples drawn over the 24 hours following study drug administration; and the follow-up phase of approximately 1 week after the last blood sample when each patient will be monitored by telephone for development of new adverse events and assessment of ongoing adverse events. Each patient receives a single 2-hour infusion (directly into the vein) of ceftobiprole 500 mg

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) =or \> 40 kg/m2 or normal BMI between 18-30
* Blood pressure 90-140 mm
* Non-smoker

Exclusion Criteria:

* History of medically significant illness
* Uncontrolled hypertension
* Uncontrolled high blood cholesterol and triglycerides
The Effectiveness of Drawing Interventions

The study will consist of two stages. The first stage of the study expects to find associations within dependent variables: depression level, resourcefulness, spiritual resourcefulness, and spiritual health in older adults. The second stage estimated that art drawing interventions will be effective for improving depression levels, resourcefulness, spiritual resourcefulness, and spiritual health.

A cross-sectional research design will be used in the first stage, and the second stage of the research will be an intervention and longitudinal study with a randomized control trial design. In the first stage, four instruments will be applied, such as the Geriatric Depression Scale (GDS), Resourcefulness Scale (RS), Spiritual Resourcefulness Scale (SpRS), and Spiritual Screening Tool for Older Adults (SSTOA), to measure the levels of depression, resourcefulness, spiritual resourcefulness, and spiritual health of older adults at nursing homes in Indonesia. Three hundred older adults will be recruited through purposive sampling in the first stage of the study, while 128 participants will be recruited and randomized and assigned to both the experimental and control groups. There will be 64 subjects in each group. The art drawing intervention will be applied and last for 6 weeks in the experimental group. Five times of examinations about the related variables will be performed at the first week before intervention implemented (T0); the second measure will be performed 3 weeks after the intervention started (T1); 6 weeks of drawing intervention, the third examine will be tested (T2); and 1 and 2 months after the intervention completed, the participants will be asked to test for the T3 and T4

Eligibility Criteria:
Inclusion Criteria:

1. Currently live in nursing home
2. Have no physical impairment.
3. Have been staying in nursing home for at least 6 months.
4. Speak Bahasa Indonesia

Exclusion Criteria:

1. Have been diagnosed with psychiatric illness.
2. Have been diagnosed with severe physical disorders such as advanced cancer or motor impairments
Neurovascular Coupling in Subjects With Amblyopia

Amblyopia is a developmental condition that is characterized by reduced vision of the eye due to the presence of a sensory impediment during visual development, such as strabismus (ocular misalignment) or anisometropia (unequal refractive error), occurring early in life. Recent studies in humans and animals point towards a cortical locus for the processing deficit in amblyopia, revealing sensory deficits at the signal cell level. If changes in retinal neuronal function are also present, is unknown.

Like in the brain, blood flow in the retina is coupled to neuronal activity. This phenomenon has been measured by different study groups with non invasive techniques in the brain and retina. It has been shown in previous studies that stimulating the retina with diffuse luminant flickering light increases retinal vessel diameter and blood flow. However, it is unknown whether this is also the case in the retina of amblyopic eyes. Additionally, the introduction of blood oxygen level dependent (BOLD) fMRI also makes it possible to directly access the vascular response in the brain to visual stimuli.

Therefore, the aim of the present study is to investigate the effect of luminant flickering light on retinal vessel diameter and retinal blood flow in subjects with amblyopia. Also, oxygen saturation in retinal vessels will be assessed as well as pattern ERG for assessment of retinal function. Additionally, a high resolution image of the visual pathway will be taken with 7 Tesla MRI to investigate whether anatomical or functional alterations are present.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 55 years
* Non-smokers (for at least 6 months)
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings except amblyopia on one eye resulting from anisometropia or strabismus with a visual acuity of Snellen ≤ 0.3 with best correction on the amblyopic eye and Snellen 0.9 or better in the contralateral eye (for subjects with amblyopia)
* Normal ophthalmic findings with visual acuity of Snellen ≥ 1.0 in both eyes (for control subjects)

Exclusion Criteria:

* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence or history of a severe medical condition as judged by the clinical investigator
* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptives)
* Blood donation during the previous three weeks
* Pregnancy, planned pregnancy or lactating
* Any metallic, electric, electronic or magnetic device or object not removable except dental fillings
* Claustrophobia
* Epilepsia, history or family history of seizures
Regional Anesthesia of Cesarean Section

Beta trace protein assay is an indicator of post-spinal CSF leak that predicts the degree of post-spinal headache.

Beta trace protein is specific for CSF only and it is a quantitative analytic test.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old
* free medical history.
* free obstetric history.

Exclusion Criteria:

* high risk pregnancy.
A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219)

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of aprepitant for the prevention of post-operative nausea and vomiting (PONV) in pediatric participants.

Post-operative aprepitant plasma concentrations will be evaluated with a non-compartmental analysis (NCA) at each dose and for each age cohort. Full PK profiles analyzed using population PK modeling and simulation will be described in a separate report.

Because the opportunity to collect specimens for PK analyses in children will be limited, a flexible sparse sampling scheme using ranges of collection times will be utilized which will limit the burden to participants.

Eligibility Criteria:
Inclusion Criteria:

* Participant enrolled at birth should be at least 37 weeks gestation and ≥3 kg of weight
* Scheduled to receive general anesthesia AND must have at least one of the following risk factors for post-operative nausea and vomiting (PONV) in addition to receiving general anesthesia:

  1. scheduled to have a surgery with an associated risk of PONV: tonsillectomy, adenoidectomy, strabismus surgery, dental surgery, hydrocelectomy, orchidopexy or herniorraphy; OR
  2. scheduled to have an operative procedure associated with PONV: intraoperative opioid use or anticipated opioid administration within the first 24 hours following surgery.

Exclusion Criteria:

* Emergency surgery for a life-threatening condition
* Scheduled to receive propofol for maintenance of anesthesia (Note: propofol is permitted for induction of anesthesia).
* Expected to receive opioid antagonists (e.g., naloxone, naltrexone) or

benzodiazepine antagonists (e.g., flumazenil)

* Scheduled to undergo cardiac or neurosurgery
* Vomiting caused by any organic etiology (such as gastric outlet

obstruction or small bowel obstruction)

* Vomiting within 24 hours prior to surgery
* Participant had a nasogastric or oral gastric tube intra- or post-operatively for suctioning gastric contents (note: nasogastric or oral gastric tube intra- or post-operatively could only be used for feeding. Participants were to be excluded if a nasogastric or oral gastric tube for suctioning was routinely used for the type of surgery being performed)
* Active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, or a history of any illness which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk to the participant
* Use of any illicit drugs, including marijuana or has current evidence of alcohol abuse
Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage

To evaluate the role of lactulose in prevention of clinically overt hepatic encephalopathy (HE) in the setting of acute upper gastrointestinal bleeding in cirrhotic patients

Variceal hemorrhage occurs in 25 to 35 % of patients with cirrhosis and accounts for 80 to 90% of bleeding episodes in these patients. Around 25-30 percent of patients develop hepatic encephalopathy. Development of hepatic encephalopathy in patients with gastrointestinal bleed can cause increase morbidity with higher hospital costs in these patients. To date no randomized trial has been done in terms of prevention of encephalopathy in gastrointestinal hemorrhage. One trial has compared lactulose in combination with antibiotic against mannite, showed equal efficacy in both groups. No study has been done evaluate the efficacy of lactulose in prevention of encephalopathy in these patients.

We hypothesize that prophylactic use of Lactulose decreases the risk of development of hepatic encephalopathy with upper GI bleed in cirrhotics.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* All acute gastrointestinal bleeding in cirrhotics without hepatic encephalopathy at the time of admission in ER

Exclusion Criteria:

* Increased α-fetoprotein level/ Documented hepatoma
* Portal or hepatic vein thrombosis
* Large-volume or tense ascites requiring repeated therapeutic paracentesis
* Serious recurrent or ongoing co morbid illness (e.g., severe renal, cardiac, or respiratory failure; sepsis)
* Pregnancy
* Not willing to give consent to participate in the study
* Patients who are unable to read and write
* ER arrival time \> 12 hrs from index bleed
Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury

The purpose of this pilot study is to investigate whether gait specific robotic supported bodyweight supported treadmill training and lower extremity strength training have similar beneficial effects on walking function and other outcomes.

Although task-specific training has been promoted during the last years to improve function, recent studies showed that after an incomplete spinal cord injury, strength, but not complex movement coordination, is affected. In this randomized cross-over trial we investigate the effectiveness of a task-specific 4 week Lokomat training with a 4 week (unspecific) lower extremity muscle strength training on walking-related and other outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Time since lesion \> 1 year
* Outdoor mobility SCIM III \< 5
* Stable walking capacity

Exclusion Criteria:

* participating on other training studies
* osteoporosis
* psychiatric diseases
* epilepsia
* body weight \> 130 kg
* cardiac pacemaker
Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane

The purpose of this study is to compare the neonatal outcome and infant neurologic outcome whose mother were treated with cefazolin plus clarithromycin for one week or until delivery after preterm premature rupture of membrane.


Eligibility Criteria:
Inclusion Criteria:

* preterm premature rupture of membrane(PPROM), PA 22+0\~34+0wks
* ROM \<72 hrs before randomization
* cervical dilatation \<3cm
* uterine contraction less than 4 times per 1 hr

Exclusion Criteria:

* Major fetal malformation
* Rupture of the membrane \>72hrs before randomization
* Vaginal bleeding
* IIOC (incompetent internal os of cervix)
* Placenta previa
* Gestational diabetes or overt diabetes
* Hypertensive disorders in pregnancy
* Liver cirrhosis
* Acute renal failure
Ileostomy Observation Study

Inflammatory bowel disease (IBD) which is associated with low bone mineral density is divided into 2 major disease entities: Crohn's disease and ulcerative colitis. Medical therapy is directed at controlling symptoms and reducing the underlying inflammatory process. Studies have reported that 60% of patients with Crohn's disease and 15%-30% of patients with ulcerative colitis require surgical intervention for the management of their disease. In the United Kingdom almost 13,000 ileostomy procedures are undertaken annually. A 29.4% prevalence of low bone mineral density (BMD) was reported in a cohort of US patients with IBD and ileostomy who were \>5 years postoperative. Possible risk factors for bone loss in patients with IBD and ileostomy are considered to include malabsorption secondary to bowel resection, malnutrition and more aggressive disease and inflammation which led to bowel resection in the first place . These factors also contribute to reduced intestinal absorption of nutrients and vitamins including B \& D subsequently leading to potential health complications including low BMI and low lean body mass. It has been reported that IBD patients who have surgical intervention to create ileal pouches also have low levels of vitamin D.

Surgical procedures such as an ileostomy alter the normal anatomy and physiology of the small intestine. Bile acid (BA) malabsorption which is common to IBD is caused by impaired conjugated BA reabsorption and a consequence, numerous pathological sequelae may occur, including the malfunction of lipid digestion . Further, bacterial overgrowth can lead to deconjugation of bile salts, leading to formation of free bile acids, again inducing dietary fat malabsorption, which in turn can lead to vitamin D deficiency. As vitamin D is a fat-soluble vitamin, malfunction of lipid digestion or absorption is problematic.

Given the paucity of data in the area of ileostomy patients BMD, vitamin D status and calcium intake, we will establish baseline observations within the Northern Ireland (NI) population with an observational study to assess bone mineral density (Dexa), collecting ileal fluid and plasma samples assessing vitamin D status, calcium, dietary intake and other measures including questionnaires on quality of life and exercise.


Eligibility Criteria:
Inclusion Criteria:

* undergone an ileostomy and be more than 2 year post-operative
* non smoking

Exclusion Criteria:

* not undergone an ileostomy and/or is less than 2 year post-operative
* smoker.
Effects of Scapular Strength Exercise for Patients With Lateral Epicondylalgia

the aim of the study is to determine whether a scapular strength exercise program combined with a conventional exercise program in epicondylar region in patients with lateral epicondylalgia produces statistically significant improvements in pain in the short and medium term compared to a conventional exercise program.

It is a single-blind clinical trial design, with third-party evaluation. There are two groups, the control group and the experimental group. In the control group, only the conventional exercise program for epicondylar muscles will be performed and the experimental group will also perform a scapular exercise program. Group assignment is randomized using the G\* POWER software program, following the inclusion and exclusion criteria. Variables related to pain, functionality, pressure pain threshold, prehensile strength and quality of life will be measured. The study will last 7 months.

Eligibility Criteria:
Inclusion Criteria:

* tenderness over the epicondyle.
* Clinical diagnosis of LD for at least 3 months.
* Positive Mills and Maudsley test

Exclusion Criteria:

* Patients with carpal tunnel syndrome, rheumatoid arthritis, cervical root syndrome, rotator cuff tendinopathy.
* Fractures or surgical history in the shoulder or elbow.
* History of elbow immobilization.
* Limitation in range of motion of the shoulder.
* Having undergone upper limb surgery in the last 6 months
* Unhealed wound in the region in the treatment area
* Impairment at a cognitive level that makes understanding with the therapist impossible.
* Neural entrapment of the radial nerve.
* Corticosteroid infiltration in the upper limb to be treated.