cyrilzakka/clinical-trials huggingface dataset:
Smartphone-based Virtual Reality Exposure and Standard Relaxation Training for Anxiety on an Inpatient Psychiatric Unit

The purpose of this study is to compare a smartphone-based virtual reality exposure with standard relaxation training for anxiety and associated symptoms (including pain) on an inpatient psychiatric unit, and whether patients find it usable and beneficial.

The study is open only to inpatients on a specific Mayo Clinic Rochester psychiatric hospital unit, the Mood Disorders Unit. Two different techniques for reducing anxiety will be tried. The first time patients report anxiety, they will be asked to listen to a 15 minute audio CD guiding them through relaxation strategies. The second time patients are anxious, they will be given a cardboard VR goggle set and will view 15 minutes of unguided VR. Before and after each session, they will fill out a short survey of anxiety and related symptoms (including pain ratings) and their reaction to each technique. They will be asked to try each technique at least once during your hospital stay.

Eligibility Criteria:
Inclusion Criteria:

- Hospitalized on inpatient Mayo Clinic Mood Disorders psychiatric unit (Generose 3W).

Exclusion Criteria:

* Inability to understand English.
* Patients with primary substance use disorders, primary psychotic disorders, major neurocognitive disorders and active self-harm behaviors and seizure disorders
DyeVert Pilot Trial

The purpose of this study is to evaluate the usability characteristics of DyeVert™ during normal clinical use and to understand the amount of contrast media (CM) diverted from the subject and saved over a total angiographic procedure.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is indicated for a coronary angiogram or percutaneous coronary procedure
2. The subject is ≥ 18 years of age
3. The subject (or subject's legal representative) is willing and able to provide appropriate informed consent.

Exclusion Criteria:

1. Subject is undergoing a STEMI procedure
2. The subject is female and currently pregnant
3. In the investigator's opinion, the subject is not considered to be a suitable candidate
Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant

The main purpose of this trial is to assess the efficacy and safety of sitagliptin in enhancing engraftment following umbilical cord blood transplantation (recovery of blood counts after transplant).

Umbilical cord blood (UCB) is more commonly used for transplantation in children but is being used in adults more often. However, because adults are larger than children, the relatively smaller stem cell dose in UCB is major limitation for transplantation in adults and engraftment can be delayed. This study is trying to find out if the drug sitagliptin can be used to increase and speed up engraftment in adults receiving UCB transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have one of the following disease types:

  * Acute myeloid leukemia (AML) with disease features as described in the protocol.
  * Acute lymphoblastic leukemia (ALL) with disease features as described in the protocol.
  * Myelodysplasia with disease features as described in the protocol.
  * Chronic myelogenous leukemia (CML) with disease features as described in the protocol.
  * Patients with aggressive non-Hodgkin's lymphoma (NHL), including diffuse large cell lymphoma, mediastinal B-cell lymphoma, transformed lymphoma, mantle cell lymphoma, and peripheral T cell lymphoma, who also have one of the disease features as described in the protocol.
* At least 35 days following start of preceding leukemia induction cytotoxic chemotherapy.
* For patients in remission, there should be no readily available consenting HLA-matched related donor who is either matched fully matched or mismatched at only one locus of HLA-A, -B, and DRB1.
* No availability of a readily available HLA-matched volunteer unrelated donor (8 of 8 allele match at HLA-A, -B, -C and -DRB1).
* Patients must have a matched or partially matched UCB unit with \>/= 2.5 x10\^7 nucleated cells/kg of recipient weight at the time of cryopreservation.
* No current uncontrolled bacterial, viral or fungal infection (defined as currently taking medication and progression of clinical symptoms).
* No HIV disease.
* Non pregnant and non-nursing.
* Required baseline laboratory values as described in the protocol.
* Signed written informed consent.

Exclusion Criteria:

* Symptomatic uncontrolled coronary artery disease or congestive heart failure.
* Severe hypoxemia with room air PaO2\<70, supplemental oxygen dependence, or DLCO\<50% predicted.
* Patients with central nervous system (CNS) involvement refractory to intrathecal chemotherapy.
* Prior allogeneic or autologous hematopoietic stem cell transplant in the last 6 months.
* Patients who are taking other insulin secretagogues and/or insulin.
* Patients who have hypersensitivity to sitagliptin.
* Patients with a history of pancreatitis, cholelithiasis, alcoholism, or fasting hypertriglyceridemia (\> 2 x ULN).
Prospective Study of Minimally Invasive Spine Surgery

The population of the US is aging. They remain more active and place greater demands on their musculoskeletal system. A key problem is that pain and disability of age related spinal disorders will increase. Problems such as Degenerative Lumbar Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis are age related problems that are treated with spinal fusion when non-operative treatment fails. Traditional open surgery poses significant risk for patients in this age group. The use of minimally invasive spinal surgery techniques provides an opportunity to treat these patients with less morbidity than traditional open surgery.


Eligibility Criteria:
Inclusion Criteria: Inclusion Criteria:

* Patient age 21 - 90 years.
* Diagnosis of Spondylolisthesis, degenerative disk disease, and degenerative scoliosis (any curve magnitude).
* A spinal fusion is being undertaken via the minimally invasive approach.
* The patient agrees to follow-up for routine care for at least 2 years post-operatively.

Exclusion Criteria:

* Inability for post-operative follow-up
Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy

The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* 18 to 65 years of age
* Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)

Exclusion Criteria:

* If female, postmenopausal or surgically menopausal
* Triglycerides (TG) \>400 mg/dL
* Creatine phosphokinase (CPK) \>3 × the upper limit of normal (ULN)
* Body Mass Index (BMI) \>35 kg/m2
* Uncontrolled diabetes mellitus (HbA1c \>10%)
* Renal dysfunction (blood urea nitrogen \[BUN\] or creatinine \>2 × ULN)
* Hepatic dysfunction (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>2 × ULN)
* Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous month
ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer

The purpose of this study is to compare progression-free survival in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo in combination with carboplatin+paclitaxel.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of: - Epithelial ovarian carcinoma - Fallopian tube carcinoma - Primary serous peritoneal carcinoma
* Radiologically documented measurable disease according to RECIST criteria assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging MRI) or radiologically documented non-measurable (but evaluable) disease.
* Advanced disease not amenable to curative surgery or radiotherapy at the time of study entry with evidence of disease recurrence or progression at least 6 months following treatment cessation of first-line platinum- containing therapy

Exclusion Criteria:

* Clinical evidence of central nervous system (CNS) metastases
* Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneum
* Tumour of borderline malignancy
Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants

The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 6 to 12 weeks of age at the time of the first dose of the vaccination.
* Written informed consent obtained from the parents or guardians of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a normal gestation period of between 37 and 41 weeks + 6 days inclusive.
* Subjects for whom the vaccination history is available from vaccination diary cards or medical charts.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the routine infant vaccines.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Gastroenteritis (GE) within 7 days preceding the study vaccine administration.
* Previous confirmed occurrence of RV GE.
* Previous vaccination with rotavirus vaccine or planned use during the study period.
Understanding Reactions to Emotional Material in the Media During COVID-19

This feasibility study aims to adapt a protocol usually run in the laboratory in the Psychology Department for healthy participants (including the trauma film paradigm (James et al., 2016) and a simple cognitive task intervention) to remote (online) delivery. The motivation for this was restrictions to running in person laboratory experiments during the COVID-19 pandemic.

Participants will view film footage with COVID-19 related and potentially traumatic content (e.g. of seriously ill or dying patients in hospitals). Following film viewing, participants will be randomly allocated to either the experimental condition (simple cognitive task intervention, i.e. a memory cue followed by playing the computer game "Tetris" with mental rotation instructions) or the control condition (attention placebo, i.e., a memory cue followed by listening to a podcast for a similar duration). Any intrusive memories induced by the film (analogue trauma) will be monitored in a daily diary. It is predicted that the film (analogue trauma) will generate intrusive memories. If intrusive memories are generated, then it is predicted that participants in the experimental condition will report fewer intrusive memories related to the film (analogue trauma) during the following week than participants in the control condition.

The development of this paradigm may inform the future development of a simple technique to prevent intrusive memories e.g. after repeated media consumption related to the COVID-19 pandemic.

This is a between-groups experimental study with healthy participants informed by prior laboratory work. It includes two sessions and a seven-day daily diary in between sessions. In this feasibility study, for the first time all study procedures will be delivered remotely rather than in a laboratory because of the COVID-19 pandemic. The primary outcome is the number of intrusive memories related to the film (analogue trauma) recorded in a daily electronic diary during the following week (week 1).

The first aim is to investigate if the film (analogue trauma) will generate intrusive memories. The second aim is, if intrusive memories are generated, to investigate if participants in the experimental condition will report fewer intrusive memories of the film (analogue trauma) than participants in the control condition.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65
* Fluent in spoken and written Swedish
* Willing to watch a video containing emotional, distressing footage
* Have access to an internet enabled smartphone/computer

Exclusion Criteria:

* Have participated in a study in which similar stimuli were used
* Currently receiving treatment for a mental health problem (e.g. depression, anxiety, ADHD, addiction), including psychological therapy, counselling or medication
* Neurological illness (e.g., epilepsy)
* Planning to undertake a stress-inducing examination (e.g. university examination or driving test) during the week of study participation.
Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia

The purpose of this study is to identify biological markers that might predict premature infants who are at a higher risk for developing BPD, and to correlate the presence of these markers with infant symptoms and lung function in the first year after discharge from the hospital.

Bronchopulmonary dysplasia (BPD) is a common form of lung injury that can be triggered by premature birth and the unavoidable exposures to treatments regularly used for premature infants,including mechanical ventilation and oxygen as well as conditions that occur frequently among premature infants including infection. Almost all infants who are born prematurely are exposed to either mechanical ventilation, extra oxygen, and many will develop at least one infection; however, not all premature infants will develop BPD. There is currently no way to identify those infants who are at risk for developing BPD, nor are there prognostic or diagnostic tests to determine the severity of lung disease in the first year after discharge from the hospital.

The application of UPLC-tandem mass spectrometry for quantification of urinary biomarkers of oxidative stress is an important technical innovation that will permit sensitive and reproducible analyses of urinary biomarkers with minimal sample preparation to better define disease phenotypes. Establishing a direct correlation between biomarkers of oxidative stress and GRP will accelerate investigation into the mechanisms leading to chronic pediatric lung disease and childhood origins of pulmonary disease.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age at birth 23-0/7 to 27-6/7 weeks post-menstrual age

Exclusion Criteria:

* Are not considered to be viable (decision made not to provide life-saving therapies)
* Have congenital heart disease (not including PDA and hemodynamically insignificant VSD or ASD)
* Have structural abnormalities of the upper airway, lungs or chest wall
* Have other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development
* Unlikely to return to the clinic for follow-up visits
Effect Of Pressure Biofeedback on Deep Cervical Muscle Training Among University Teachers.

The aim of this study is to investigate the effect of pressure biofeedback on deep cervical muscle in university teachers suffering from neck pain, Functional Disability and muscle endurance.

The purpose of this study will be to determine whether training of deep cervical flexor muscles with pressure biofeedback has any significant advantage over conventional training for pain and disability experienced by university teachers with neck pain. This study will be a randomized control trial with double blinded protocol. Patient will be randomly allocated in two groups. the experimental group received deep cervical flexor muscles training with pressure biofeedback and conventional exercises. The control group received deep cervical flexor muscles training with only conventional exercises.

Eligibility Criteria:
Inclusion Criteria:

* Both gender
* age between 24 to 45 years
* At least 4 years of teaching experience and average 8 hours of working per day
* Chronic Neck pain score of more than 5 on numeric pain rating scale
* Mild to moderate disability Score on neck disability index

Exclusion Criteria:

* Participants with any ongoing treatment for neck pain
* History of cervical spine surgery or reported any neurological signs.
* History of any congenital or acquired postural deformity, spinal cord compression, tumour, instability, fracture, inflammatory disease or infection.
PG2 Injection 500 mg in Acute Stroke Study (Pass)

The primary objective of this study is to evaluate the efficacy of PG2 Injection 500 mg versus placebo, administered intravenously within 3-6 hrs of stroke onset to patients with an acute ischemic stroke, as determined by Modified Rankin Scale (mRS) score at Day 90.

The secondary objectives are as follows:

* To evaluate the efficacy of PG2 Injection 500 mg versus placebo as determined by Barthel Index (BI) score at Day 90.
* To evaluate the efficacy of PG2 Injection 500 mg in reducing the risk of recurrent stroke, cardiovascular events and death of all causes.
* To evaluate the safety of PG2 Injection 500 mg treatment

Randomized, double-blind, placebo-controlled multi-center study of intravenous (IV) PG2 Injection 500 mg starting within 3-6 hrs of the onset of acute ischemic stroke

Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with acute ischaemic stroke
2. Patient, or a family member with legally authorized responsibility, has given informed consent
3. Age ≥20 years
4. Infusion of study medication can be started within 3-6 hrs of stroke onset.
5. NIHSS score of ≥ 7 - 24

Exclusion Criteria:

1. Intracranial haemorrhage (ICH) identified by CT or MRI
2. Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient having an NIHSS score of \< 6 at randomization
3. Pre-stroke mRS score of ≥ 2 (indicating previous disability)
4. Known allergy to Astragalus membranaceus or its mayor derivatives (polysaccharides)
5. Patients who are eligible for tPA treatment and has been treated with tPA.
6. Participation in any investigational study in the previous 30 days
7. Any terminal illness such that patient would not be expected to survive more than 1 year
8. Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study (this applies to patients with severe microangiopathy such as haemolytic uremic syndrome or thrombotic thrombocytopenic purpura). The judgment is left to the discretion of the Investigator
9. Pregnant women (clinically evident)
10. Previous stroke within last three months
11. Past history or clinical presentation of ICH, arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm.
12. Current use of oral anticoagulants with prolonged prothrombin time (INR \> 1.6)
13. Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hrs and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range
14. Clinically significant hypoglycaemia (blood sugar \< 50mg/dl)
15. Uncontrolled hypertension defined by a blood pressure \> 185 mmHg systolic or \>110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of "aggressive treatment" is left to the discretion of the responsible Investigator
16. Major surgery within the preceding 14 days which poses risk in the opinion of the Investigator
Egg Consumption and Muscular Adaptations

Eggs may be a viable alternative to various types of supplemental proteins given its similar ratings on various measures of dietary protein quality.

The investigators hypothesis is that whole eggs would create a greater improvement in skeletal regulatory markers, hormonal responses and body composition than egg white ingestion in resistance-trained men.

The aim of this investigation was to compare the effects of whole egg versus egg white ingestion (daily and after training sessions) during 12 weeks of resistance training on skeletal muscle regulatory markers, hormonal responses and body composition in resistance-trained men. Specific aims of the study are to:

To investigate the extent to which both whole egg and egg white ingestion will improve anabolic factors, fat free mass, fat mass and decrease catabolic markers after 12 weeks of resistance training in resistance-trained men.

Eligibility Criteria:
Inclusion Criteria:

* performing resistance training at least three times a week for 1 year prior to the start of the study
* not taking any dietary supplements or medications for at least 1 year prior to the start of the study
* no known medical issues
* no alcohol consumption or smoking for at least 1 year prior to the start of the study
* no egg allergy/sensitivity.

Exclusion Criteria:

* non-willingness to continue nutritional or exercise protocols
* participation in exercise other than the prescribed resistance training program
* consumption of dietary supplement (other than egg) during the study period
* Missing more than one resistance training session or post-exercise egg consumption throughout the study period
A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis

Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation.

The main objective of the study is to evaluate safety and efficacy of bezafibrate plus ursodesoxicolic acid in patients with PBC and inadequate response to UDCA.


Eligibility Criteria:
Inclusion Criteria:

* PBC diagnosis (consistent with American Association for the Study of Liver Disease \[AASLD\]:

  * History of elevated alkaline phosphatase levels.
  * Anti-mitochondrial antibodies positivity
  * Histopathologic evidence of nonsuppurative cholangitis and destruction of small or medium- sized bile ducts.
* Use of ursodeoxycholic acid (UDCA) for at least 12 months at enrollment at a therapeutic dose (13 to 15 mg per Kg per day).
* Evidence of a suboptimal biochemical response to UDCA, defined by the presence of one of the Paris II criteria.
* Written informed consent.
* Age ≥ 18 years.

Exclusion Criteria:

* Hepatic decompensation (ascitis, variceal upper gastrointestinal bleeding, hepatic encephalopathy).
* Coexistence autoimmune hepatitis.
* Bilirrubin \>3mg/dl.
* For females, pregnancy or breast-feeding.
* Hepatocellular carcinoma.
* History or presence of spontaneous bacterial peritonitis.