cyrilzakka/clinical-trials huggingface dataset:
PET-MR Imaging of Coronary Atherothrombosis

Heart attacks remain a common cause of death throughout the world. The most common initiating event is the formation of a blood clot within the coronary arteries occluding blood supply to the heart. However, we know that thrombus often occurs within the coronary arteries without causing any symptoms, and may be found in patients with stable angina. We wish to investigate whether blood clots within the coronary arteries can be detected in patients who have had a heart attack and in patients with stable angina using combined positron emission tomography and magnetic resonance (PET-MR) imaging. If possible, this may provide a safe and noninvasive means of identifying patients at higher risk of heart attacks.

The study will be conducted in Edinburgh Heart Centre and a total of 40 participants will be recruited from the cardiology wards, outpatient clinics and day case unit. Participants will be asked to undergo a single PET-MRI scan in addition to invasive angiography as part of standard care (non-research procedure). During the invasive angiogram procedure, an additional imaging test may be performed called Optical Coherence Tomography to provide images from within the heart blood vessels.


Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed coronary artery disease undergoing elective invasive angiography OR
* Admitted with acute coronary syndrome diagnosed by two of the following criteria 1) Elevation of cardiac biomarkers (High sensitivity cardiac troponin I greater than 34 ng/l in men and 16ng/l in women) 2) Symptoms of myocardial ischaemia 3) ECG changes indicative of acute ischaemia

Exclusion Criteria:

* Contraindication or inability to undergo MRI scanning
* Renal failure (estimated glomerular filtration rate less than 30mL/min
* Undergoing Primary PCI
* Ongoing myocardial ischaemia or dynamic ECG changes
* Inability to provide informed consent
* Known allergy to gadolinium based contrast
* Women who are pregnant, breastfeeding or of child-bearing potential
Study on the Effect of Eye-covering Pretreatment on Acute Delirium After General Anesthesia in Pre-school Aged Children

Participants (preschool children), because their cognitive ability and anti pressure ability are obviously weaker than adults, most of the children who have this kind of operation and anesthesia stressors will have perioperative anxiety. After eye surgery, they need to bandage their eyes with gauze (single or double), so that the participants are in a state of complete or partial darkness for a certain period of time, which is easy to produce dark phobia. In clinical practice, investigators found that more than 80% of children with advanced ophthalmology were prone to leprosy, resistance, crying and other symptoms after general anesthesia, which brought greater difficulties to nursing. How to improve the cognitive ability of preschool children, reduce the anxiety level of children during the perioperative period, the incidence of postoperative detention and the difficulty of nursing are new topics worthy of exploration.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 3-7;
2. Selective ophthalmological general anesthesia (static inhalation compound: propofol + fentanil intravenous administration; heptaflurane inhalation);
3. No mental disorders, stunting and low intelligence;
4. There is no other history of surgical hospitalization.

Exclusion Criteria:

1. Those who have completed the operation under local anesthesia;
2. People with visual impairment of both eyes;
3. Eyeball removal and/or eye socket implanter;
4. Hearing and language impairment cannot communicate normally;
5. Have a history of taking psychotropic drugs;
6. People with severe organs such as the heart, lungs, brains and kidneys.
Evaluation of V/Q Mismatch as Predictor of Pulmonary Postoperative Complications in Patients Undergoing Major Surgery

Pulmonary postoperative complications (PPC) are among the main causes of surgical complications affecting both postoperative morbidity and mortality. Little is known about the effect of intraoperative VQ mismatch on the occurrence of PPC. In this trial the investigators will evaluate if intraoperative VQ mismatch may predict PPC in a population of patients undergoing major surgery.

Pulmonary postoperative complications (PPC) are among the main causes of surgical complications affecting both postoperative morbidity and mortality. Little is known about the effect of intraoperative VQ mismatch on the occurrence of PPC.

PPC are classically considered associated to the occurrence of intraoperative atelectasis, and therefore to the development of a certain amount of shunt, but this concept have been recently questioned.

Recent studies showed indeed that, despite age is one of the main determinants of PPCs, increasing age is not associated to the increase of intraoperative shunt. Shunt therefore may not be the main determinant of PPC.

In this trial the investigators will evaluate if other causes of intraoperative VQ mismatch (e.g. low V/Q, high V/Q, dead space) may predict PPC in a population of patients undergoing major surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-90 years
* Major elective surgery with general anesthesia
* Intraoperative cannulation of the radial artery for invasive pressure monitoring

Exclusion Criteria:

* Thoracic surgery with one lung ventilation
* Refuse to participate
* Emergency surgery
Series Studies of Bipolar Disorder-Valproate add-on Memantine

All participants should fulfill the following criteria: aged between 18 and 65 years old, and of domestic Han descendants. Participants will be randomly assigned to either the (1) pharmacotherapy (valproate add-on memantine) group; (2) pharmacotherapy (valproate add-on memantine) plus Cognitive Behavior Group Therapy (CBGT) group; (3) valproate add-on placebo plus CBGT group, or (4) valproate add-on placebo only group. A total of 240-320 individuals (60-80 participants per group) will be recruited for this study. For each CBGT group, 12-weekly sessions are scheduled according to patients' preference. The investigators will attempt to understand the effects of pharmaceutical drugs for mood stabilizers add-on neuro-protective drugs, pharmacotherapy with CBGT, mood stabilizer with CBGT, and the use of only traditional mood stabilizers in the treatment of BP II. Comparisons will be made for each type of treatment and possible mechanisms will be examined regarding the pharmacotherapy and CBGT for bipolar disorder patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient aged \>=18 and \<= 65 years.
2. A diagnosis of bipolar II disorder according to DSM-IV-TR criteria made by a specialist in psychiatry.
3. A total of HDRS score at least 18 or YMRS score at least 14 at screen.
4. Signed informed consent by patient or legal representative.

Exclusion Criteria:

1. Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study.
2. Females who are pregnant or nursing.
3. Patient has received memantine or other selective cyclo-oxygenase 2 (Cox-2) inhibitors within 1 week prior to first dose of double-blind medication.
4. Axis-I DSM-IV-TR diagnosis other than bipolar II disorder.
5. Current evidence of an uncontrolled and/or clinically significant medical condition (e.g., cardiac, hepatic and renal failure), which in the judgments of the investigator, would compromise patient safety or preclude study participation.
6. History of intolerance to valproate or memantine or other Cox-2 inhibitors.
7. History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by memantine
8. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to first dose of doubleblind medication.
9. Inclusion in another bipolar disorder study or study for another indication with psychotropic's within the last 30 days prior to start of study.
10. Increase in total SGOT, SGPT, BUN and creatinine by more than 3X ULN (upper limit of normal).
11. Substance-related disorders within 6 months prior to study start, borderline personality disorder, schizophrenia, or other major psychiatric disorders as defined by DSM-IV criteria.
Improving Adherence in Patients With Hypertension - A Novel Use of Communication Technology

Treating hypertension is known to decrease morbidity and mortality. Despite this 70% of patients do not have adequately controlled blood pressure. The main reason for this is non-adherence to recommended drug therapy. Although strategies have been developed to improve adherence many are time consuming and expensive. We propose to use communications technology to develop a novel means of improving adherence to antihypertensive therapy. We will conduct a randomised, single-blinded, controlled study to assess the impact of a real-time, automated reminder system on adherence rates. This will involve adapting two pieces of currently available technology - the electronic pill bottle and the Ambient Globe. The Globe will change colour in response to information received, via a wireless link, from the patient's electronic pill bottle. We hypothesise that this will provide patients with an up to date, but unobtrusive, reminder of their adherence status and thus effect positive behavioural change. We will measure the impact of this intervention on adherence rates as well as assessing patient views and the impact on provider workload. This trial will elucidate the role of communications technology in improving adherence behaviour and allow us to develop further strategies to tackle this major health issue.


Eligibility Criteria:
Inclusion Criteria:

* Prescription of a once-a-day dose of atenolol.
* Morisky Score of less than or equal to 2 (explanation in 'Equitable Selection of Subjects').
* Fluency in English.
* Age 45-65 inclusive.
* Primary Care Physician consent to the patient taking part.

Exclusion Criteria:

* Patients prescribed more than two anti-hypertensive agents.
* Patients prescribed more than four medications in total.
* Patients on secondary prevention following cardiac event or stroke.
* Morisky Score of more than 2.
* Patients with visual impairment or color-blindness.
* Patients with congenital or acquired cognitive impairment.
* Patients with a cardiac pacemaker
Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement

This is randomized controlled trial designed for pregnant women who deliver vaginally at the University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted for postpartum contraception. After informed consent is obtained, eligible study participants will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or within 10 minutes of delivery of the placenta following a normal vaginal delivery. The investigators seek to determine the expulsion rate and complication rate in subjects with IUD immediately after placental delivery compared to insertion at six weeks postpartum or later. The investigators hypothesize that immediate placement safe and has an acceptably low expulsion rate to merit earlier placement in the indigent population.

Unintended pregnancy occurs in nearly half of all pregnancies in the United States. There are many barriers to implementation of long-term reversible contraception in the immediate postpartum period. In our indigent population, a survey of patients showed that nearly 60% of patients who chose an IUD while admitted postpartum never returned for placement, placing them at risk for early repeat pregnancy.

The intrauterine device is a safe and effective form of long-term reversible contraception when placed at 6 weeks postpartum or later with pregnancy rates of only 0.1%. The commercially available Mirena IUD contains levonorgestrel which is released slowly over five years, providing safe, reversible contraception and making menstrual flow much lighter.

This randomized controlled trial will compare traditional placement at 6 weeks or more postpartum versus immediate post-placental placement.

The investigators hypothesize that the expulsion rate of IUDs placed immediately postpartum will be acceptably low in an indigent population to still be cost effective. Studies from the world literature in Egypt and Mexico where IUDs are routinely placed immediately following placental delivery.support this hypothesis. A recent study published in 2010 by Chen et al. showed an approximately 24% expulsion rate.

Six week postpartum IUD placement for contraception will be compared to immediate post-placental IUD placement, to determine whether immediate IUD insertion after delivery has an acceptably low rate of expulsion, infection, perforation and unintended pregnancy, and a high rate of retention, patient satisfaction, and maintenance of contraception.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 15- 45 years of age and received their prenatal care at the University of Louisville OB/GYN clinic
2. Planned vaginal delivery
3. Negative third trimester cultures for Gonorrhea and Chlamydia
4. Desire to use the IUD for contraception

Exclusion Criteria:

1. Uterine anomalies
2. Uterine or cervical neoplasia
3. Past or current breast cancer
4. Chorioamnionitis
5. Acute liver disease
6. Postpartum hemorrhage lasting greater than ten minutes or more than 500 mL blood loss
7. Received prenatal other than at the University of Louisville OB/GYN Clinic
8. Cesarean section
FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.

The aim of this study is to investigate the safety and tolerability of Subcutaneous Immunotherapy treatment (SCIT) with incremental doses of a modified recombinant fish parvalbumin (mCyp c 1) quantified in mass units:

To establish a safe dose of the candidate hypo-allergen in human subjects and To study the pharmaco-dynamics of the hypo-allergen administered to human subjects.

The study is performed as a placebo-controlled double-blinded randomized trial with 24 fish allergic patients allocated into three different groups of eight.

The aim of the FAST project in general is to develop novel recombinant allergen-based therapeutics for the treatment of food allergy. The chosen approach is to modify recombinant allergens into hypo-allergenic molecules to decrease the risk of anaphylactic side-effects and to allow administration of higher doses leading to better efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject from 18 to 65 years old and in general good health as determined by past medical history and physical examination.
* Case history of allergy to fish ingestion.
* Specific IgE to fish by either a positive SPT to cod fish extract or an ImmunoCAP to cod fish above 0.70 kUA/L,(Class 2) at screening.
* Positive Double blind placebo-controlled Food challenge (DBPCFC) with fish within the last two years.
* FEV1 at least 80% of predicted values at screening.
* Subject accepting to comply fully with the protocol.
* For woman of child bearing potential:

  * a negative urine pregnancy test at screening visit,
  * subject must receive a medically effective contraceptive method during the study

Exclusion Criteria:

* Food Anaphylactic Reaction: anaphylactic shock due to fish intake.
* Specific IgE (ImmunoCAP) to fish parvalbumin (rCyp c 1) below 0.35 kUA/L
* Ongoing pollen Immunotherapy (SIT).
* Any clinical condition that contraindicates SIT (EAACI-guidelines).
* Any significant clinical condition that the investigators judged might hamper the patient's safety or the study outcomes, these diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological and endocrine disease.
* Ongoing treatment with betablockers or ACE-inhibitors.
* Impossibility for the patient to comply with the scheduled visits.
* Pregnancy or nursing.
* Uncontrolled asthma.
* Subject who have participated in a clinical trial within 3 months prior to this one.
* Subject with a history of drug or alcohol abuse.
* Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study.
* Patients with concurrent allergy symptoms can be included if patients can manage without antihistamines during screening and treatments.
SARS Cov_2 Incidence of Healthy Health Workers

Since the severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) first emerged in Wuhan, China, on 12 December 2019, it has spread rapidly across the world and developed into a pandemic. The pandemic has affected over 100 countries and regions, with over 132 million confirmed cases of COVID-19. The rapid spread of SARS-CoV-2 has caused considerable harm to public health and the economy. Alongside other laboratory tests and clinical findings of the COVID-19 infection, serological testing may be beneficial for epidemiological monitoring and outbreak control. The determination of antibodies enables confirmation of the SARS-CoV-2 infection in asymptomatic patients in addition to those with typical symptoms. In this study, we aimed to determine the SARS-CoV-2 seroprevalence and the IgG antibody levels among healthcare workers who frequently encountered COVID-19 patients in our hospital.


Eligibility Criteria:
Inclusion Criteria:

Healthy Health Workers - SARS COV-2 PCR (-)

Exclusion Criteria:

Health Workers - SARS COV-2 PCR (+) Pregnancy Autoimmune diseases Received immunosuppressive therapy
Evaluating Human-Machine Interfaces in a Robotic Thumb Orthosis

We plan to investigate whether the Isolated Orthosis for Thumb Actuation (IOTA) can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting.

Many Activities of Daily Living involve precision grasp and fine motor manipulation, such as putting toothpaste on a toothbrush or feeding oneself. However, children afflicted by stroke, cerebral palsy, or traumatic brain injury may lose the ability to actively (and accurately) control the thumb, and specifically abduct/adduct the carpometacarpal (CMC) joint and flex/extend the metacarpophalangeal (MCP) joint. We are testing the Isolated Orthosis for Thumb Actuation (IOTA), a device developed at the Wyss Institute at Harvard University in collaboration with Children's Hospital Boston, for assisting opposable thumb grasping tasks. The IOTA contains an adjustable brace fitted to the thumb and dorsum of the hand that is easy to put on and facilitates grasping motions through flexible cable-driven actuators that assist with CMC joint abduction and MCP joint extension.

In this pilot study, we plan to investigate whether the IOTA can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting.

The hypothesis for this work is that the IOTA will significantly improve the participant's performance on clinically relevant tasks.

Eligibility Criteria:
Inclusion Criteria:

* Be between 7 - 16 years old
* Have a clinical diagnosis of hemiplegic cerebral palsy or hemiplegic stroke causing a thumb contracture affecting one hand
* Not have a diagnosis of dystonia
* Have completed at least a 6-week post-operative period following hand surgery (if applicable; self-reported)
* Be able to follow instructions (as determined by their attending Occupational Therapist)
* Not be allergic to nylon or lycra
A Study of the Safety and Effectiveness of Infliximab in Patients With Plaque-type Psoriasis

The purpose of the study is to evaluate the safety and effectiveness of scheduled and as needed treatment of psoriasis with infliximab. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

This is a phase III, multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled trial evaluating the effectiveness and safety of scheduled and as needed treatment with infliximab in patients with plaque-type psoriasis. This study will also help determine the way to use infliximab in treating patients with psoriasis.

Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures.

Patients will receive infusions of either placebo, 3mg/kg or 5 mg/kg infliximab (Remicade) at weeks 0, 2, 6 14, 18, 22, 26, 30, 34, 38, 42 and 46. Patients receive either 3mg/kg, 5 mg/kg or placebo infusions at week 0, 2, and 6. The 3mg/kg and 5 mg/kg infliximab groups then receive either every 8 week infusions or infusions as needed when their psoriasis is less than 75% improved from baseline. The placebo patients begin infliximab at week 16, 18 and 22 followed by every 8 week infusions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of plaque-type psoriasis for at least 6 months
* Patients with plaque-type psoriasis covering at least 10% of the body

Exclusion Criteria:

* Patients with nonplaque forms of psoriasis
* Patients who have current drug-induced psoriasis
* Patients who are pregnant, nursing, or planning pregnancy (both men and women) within 18 months of enrollment
* Patients who had any previous treatment with infliximab or any therapeutic agent targeted at reducing tumor necrosis factor
Efficacy of Transversalis Fascia Plane Block Versus Wound Infiltration in Varicoselectomy Surgery

Before surgery, patients will be divided into 2 groups as transversalis fascia plane block will be applied and skin infiltration will be applied. Post-operative analgesic procedures will be applied to patients receiving general anesthesia. Postoperative analgesic consumption and pain scores of the patients will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who will undergo Varicocele operation
* ASA I-II

Exclusion Criteria:

* Patients with allergic reaction to anesthesia and analgesia drugs to be used
* Patients who did not want to voluntarily participate in the study
* Severe systemic disease (kidney, liver, pulmonary, endocrine)
* Substance abuse history
* Chronic pain history
* Psychiatric problems and communication difficulties
* History of hematological problem
* Patients with severe hemodynamic instability due to infection, heavy bleeding