cyrilzakka/clinical-trials huggingface dataset:
Physical Activity in Patients With Severe Mental Illness

The aim of the study was to evaluate the applicability of the Physical Activity Scale (PAS) in relation to patients with severe mental illness. The study hypothesised that physical activity levels among patients with severe mental illness was significantly lower than healthy controls. The physical activity level of patients with severe mental illness attending Aarhus University Hospital, Risskov in comparisons with healthy controls matched on gender and age was assessed with PAS.

The study population of interest was psychiatric in- or outpatients from Aarhus University Hospital , Risskov, some of whom were referred for physiotherapeutic treatment. The patients were compared with healthy controls matched on gender and age, recruited from hospital staff including administrative employees.Patients and controls were included in the study after giving informed consent, according to the Declaration of Helsinki 2008. All participants assessed their physical activity level by completing the PAS questionnaire twice within a time period of 5-7 days for evaluation of the test-retest reliability of PAS. For patients, PAS was administered as an interview, and for controls as a self-questionnaire. Several physiotherapists (PTs) were involved in interviewing the patients.

In total, 47 hospitalized patients or outpatients and 28 controls were included in the study. In comparison with controls, the physical activity level of daily life of the patients was statistically significantly lower, even though the average physical activity level of the healthy controls was just above 'moderate physical activity'.

There was a satisfactory test-retest reliability of PAS when applied to both mentally ill patients and healthy controls. PAS was found to be an applicable method for evaluating physical activity levels in patients with severe mental illness, and also useful in measuring changes in physical activity levels.

Eligibility Criteria:
Inclusion Criteria:

* All in and outpatients attending psychiatric treatment at Aarhus University Hospital, Risskov

Exclusion Criteria:

* Physical disablement, subject to coercive treatment
DSP-3025 Study of Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season

Investigate safety/tolerability after a single dose intranasal administration of DSP-3025 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg
* No clinically relevant abnormal findings
* History of cedar and/or Japanese cypress pollen induced seasonal allergic rhinitis for at least the previous 2 years (only Allergic rhinitis)

Exclusion Criteria:

* Acute illness which requires medical intervention
* Definite or suspected personal history of adverse drug reactions or drug hypersensitivity
* Clinical relevant disease or disorder (past or present)
* A history of asthma
Coronavirus Disease of 2019 (COVID-19) Health Education Initiative for School Safety

The purpose of this study is to compare COVID-19 knowledge, experiences, and health behaviors between participants who received the health initiative and those who did not.


Eligibility Criteria:
Inclusion Criteria:

* Parents/guardians of students enrolled in:
* Arch Creek Elementary, Fulford Elementary
* Greynolds Park Elementary
* Sabal Palm Elementary
* North Miami Middle school,
* John F Kennedy (JFK) Middle School
* North Miami Senior High
* North Miami Beach High
* Booker T. Washington High
* Able to read and write in English, Spanish, or Creole at a 5th grade level

Exclusion criteria:

* Does not speak:
* English
* Spanish
* Creole
Study Evaluating Food Effect and QTc in Patients With Advanced Malignancies

Phase 1 2-part study to evaluate the effect of food on pharmacokinetics of pelabresib (CPI-0610) and the effect of pelabresib on QTc in patients with advanced malignancies


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Confirmed diagnosis of an advanced malignancy for which no effective standard treatment options are available
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2

Exclusion Criteria:

* Chronic or active conditions and/or concomitant medication use that would prohibit treatment
Sorrel 25R Injector - Sorrel Clinical Study Protocol

A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers.

A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers.

The study will enroll up to 25 healthy adult subjects. Each subject will perform a maximum of 5 visits during the study over a period of approximately 2 months; a virtual visit for informed consent, two in-person visits for device evaluation, and two follow-up virtual visits to evaluate the skin and surrounding tissue for adverse events.

Eligibility Criteria:
Inclusion Criteria:

Age 18 to ≤ 40 years.

Subject understands the English language, understands the risks, benefits, and alternatives to this research study, and is willing and able to give written informed consent.

Subject has no active signs/symptoms of a viral infection for 10 days prior to visit # 2.

Body Mass Index between 20 to 35 kg/m2 (inclusive).

Subject willing and able to comply with study procedures.

American Society of Anaesthesiology Physical status (ASA PS) classification 1

Exclusion Criteria:

Current use of aspirin at a daily dose \> 81 mg,

Current use of any medication that may adversely affect blood coagulation (i.e. warfarin, Xarelto, Eliquis etc.)

Presence of any tattoos, discoloration, acne, scars, bruises, cuts, abrasions, rashes, hernias, or inflammation within the skin or subcutaneous tissue of the abdomen that could interfere with the infusion of saline or observation of study results, at the discretion of the investigator..

History of significant skin allergy, irritation, or hypersensitivity to medical adhesives or adhesive tape.

History of significant allergic reaction to medical saline solution.

History of significant allergic reaction to the skin antiseptic solutions alcohol or chlorhexidine.

History of any neurologic disease that may affect the perception of pain/discomfort (stroke, peripheral neuropathy).

Current use of any medication that may affect the perception of pain/discomfort (opioids, NSAIDs, topical local anesthetics) at the discretion of the investigator.

Current use of any medical condition or medication that to the opinion of the investigator may affect the risk for a serious adverse event

Female of childbearing age with a positive pregnant test, or currently breast feeding.

Study subject refuses to allow clipping of excess abdominal hair at the site of device placement

Any current or unstable cardiac, pulmonary, hepatic, renal, neurologic, gastrointestinal, endocrine, immune, endocrine, musculoskeletal, coagulation disorder, or infectious disease which in the opinion of the Investigator would place the subject at risk or influence the conduct of the study, or interpretation of the results.

Current participation in another clinical drug or device study.

Inability of the subject to comply with all study procedures.

Inability of the subject to understand the information required for monitoring their infusion sites.
Hypnosis for Children Undergoing Anorectal Manometry

Partially blinded randomized controlled trial investigating the effect of a brief session of hypnosis prior to anorectal manometry in children


Eligibility Criteria:
Inclusion Criteria:

* Children aged 4-18 who are scheduled to undergo anorectal manometry testinf.
* ASA classification I to II.
* Both parents and children have sufficient English language proficiency.
* Both parents and children are willing to fill out the questionnaires involved in this study.

Exclusion Criteria:

* ASA classification III, IV (children with a chronic or severe disease).
* Children with a metabolic, endocrine or neuromuscular disorder or mental illness.
* Children with anorectal malformations or previous anorectal surgery.
* Children with developmental delay
* Children with diagnosed emotional or behavioral disorders
A Retrospective Study of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis

The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC） in progressive pulmonary fibrosis.

The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC） in progressive pulmonary fibrosis. The main question it aims to answer are: • The diagnostic rate of MDD1 or MDD2 based on TBLC. • The rate of hemorrhage, pneumothorax, acute ILD exacerbation and mortality. Participants' medical records will be collected by us.

Eligibility Criteria:
Inclusion Criteria:

Patients with PPF, ≥18 years of age, unclassified ILD, HRCT ≤3 months, forced vital capacity (FVC)≥50% predicted value, pulmonary carbon monoxide diffusion (DLCO)≥35% predicted value, echocardiography ≤12 months, estimated pulmonary systolic blood pressure ≤40 mmHg, Body mass index (BMI)≤35 kg/m2.

Exclusion Criteria:

Patients with platelet counts below 50,000e+9/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC
Cholate Clearance in Fontans

HepQuant is an assay to measure liver function in other forms of liver disease such as hepatitis C. It measures the ability of the liver to process an naturally occurring substance called cholate and has been shown to predict clinical outcomes in some patient populations.

The Fontan survivor is a patient who has undergone surgery or a series of surgeries that result in a functional single ventricle. The liver is particularly vulnerable to disease including congestion, fibrosis, and even cirrhosis. Currently liver function in the Fontan is not well-characterized and the HepQuant assay could help answer this question.

A novel test called HepQuant® is an assay that has been used to measure liver function in other types of liver disease. In these populations, it is hoped that the assay may show more subtle or sub-clinical liver abnormalities that blood tests alone cannot detect. HepQuant® is a test that examines the ability of the liver to process a substance called cholate, which is a naturally occurring substance in the body. Cholate gets to the liver 2 ways: through the gut (by mouth) or through the blood (IV or intravenous). The test involves administering oral and IV cholate which is labeled. This label is NOT radioactive, but can act as an indicator/marker for evaluation purposes.

The purpose of this study is to develop a reliable means of measuring liver function in the Fontan survivor by examining cholate clearance. The investigators aim to 1) explore any association between level of cholate clearance and measurement of heart and liver function and 2) determine whether cholate clearance can predict clinical outcomes such as heart failure, ascites (development of fluid in the abdomen which can result from heart failure or liver failure), and need for heart transplant.

Eligibility Criteria:
Inclusion Criteria:

* s/p Fontan operation
* cardiac catheterization or cardiac MRI within 1 year of enrollment

Exclusion Criteria:

* pregnant or breastfeeding
* unable to comprehend and/or give informed consent
* sensitivity to human serum albumin, or its preparations
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System.

A study to compare pain differences between using MedJet needle-free drug-delivery system with standard of care treatment for cutaneous T-cell lymphomas and cutaneous B-cell lymphomas in participants.

Participants will undergo treatments on two morphologically and anatomically matched target lesions, preferably on opposing sides of the body.

The first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with CTCL (cutaneous T-cell lymphomas) or intralesional TAC (triamcinolone acetonide) using a syringe/needle with participants with CBCL (cutaneous B-cell lymphomas).

The second plaque will be treated using a needle-free injector system. After the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded.

In order to account for 20% dropout, 11 patients per group (a needle free and a traditional treatment group in CBCL patients and the same two groups in CTCL patients) will be recruited.

Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years of age
2. Diagnosed with primary cutaneous lymphoma defined by either:

   * A board-certified dermatologist, OR
   * Dermatology Nurse Practitioner, OR
   * Skin punch biopsy
3. The presence of plaque-type primary cutaneous lymphoma lesions with at least two plaques that are at least two cm² in areas of the trunk, buttocks, or extremities that are either:

   * Symmetrically located on contralateral body site OR
   * Within the same body site but separated by ≥ 1 cm
   * Both plaques must be similar in size as much as possible
4. Able to give informed consent under IRB approval procedures

Exclusion Criteria:

1. Known allergy or hypersensitivity to triamcinolone acetonide
2. Known allergy to topical bexarotene or topical nitrogen mustard
3. Pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study.
4. Inability to provide informed consent
5. Diagnosis of erythrodermic mycosis fungoides or Sezary syndrome
6. Use of topical corticosteroids to target lesions within 1 week prior to baseline visit
7. Use of radiation therapy to target lesions within 1 week prior to baseline visit
Stented Biliary Anastomosis in Living Donor Liver Transplantation

Determination of biliary complications in stented group compared to duct to duct anastomosis without stent

30 patients included in the study. patients will be randomly allocated in two equal groups. In group A anastomosis will be done on intraductal stent and in group B anastomosis done without stent .the patients will be followed for one year to compare the result of two groups as regard biliary complications.

Eligibility Criteria:
Inclusion Criteria:

* adult patients eligible for a liver transplantation
* patients' written informed consent signed.

Exclusion Criteria:

* biliary reconstruction requires a hepatico-jejunostomy for anatomical/biliary disease reason.
Phase II Study of Pandemic Influenza Vaccine

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is the leading candidate to cause the next influenza pandemic. This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza Vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Adults

Exclusion Criteria:

* Previous vaccination with an influenza Vaccine containing the H5N1 strain
* History of clinically significant medical conditions
* History of Guillian-Barre Syndrome or active Neurological disease
A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room

In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.

In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.

This study is designed to compare the efficacy and safety of Quetiapine with the routine "cocktail for treatment of agitation.

The primary purpose of this study is to determine the efficacy and safety of Quetiapine by using high dose Quetiapine (300 mg) PO to treat agitated patients in the psychiatric emergency room.

The secondary purpose is to test the immediate effect on agitation caused by illicit drug abuse or the alcohol abuse.

Eligibility Criteria:
Inclusion Criteria:

1. English or Spanish speaking patients
2. Provision of written informed consent-English and Spanish
3. Males and females age 18 to 60 years. Females who are pregnant by inspection should not be included.
4. Provision at diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV) criteria for Axis I documented who present in an agitated state. PANSS-EC score should be \>15.
5. Ability, in the treating physician's opinion, to co-operate with taking oral medication

Exclusion Criteria:

1. Pregnant females who will thus receive routine care in the treating physician's opinion
2. Unstable medical illness
3. Withdrawal stage from any illicit drugs
4. Psychosis that prohibits participation in trial
5. Females of childbearing age where pregnancy cannot be confirmed or denied by screening
6. Patients who required continued intervention or prolonged restraint
Thorax Computed Tomography Severity Score and Outcome in COVID-19 Patients

The most common thorax Computed tomography (CT) findings are multifocal ground-glass opacities and peripheral consolidation in patients with COVID-19. Septal thickening, bronchiectasis, pleural thickening, and subpleural involvement may also be observed. Although these findings are not specific to COVID-19, the severity of pulmonary involvement is expected to be correlated with thorax CT findings.

Thorax computed tomography severity score defined by Yang et al. can be used to evaluate the severity of pulmonary involvement in COVID-19 patients. We aimed to investigate whether the initial thorax computed tomography severity score can predict mechanical ventilation requirement and mortality in COVID-19 patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* COVID-19 confirmed by positive RT-PCR and/or antibody testing
* CT scan at intensive care unit admission

Exclusion Criteria:

* Loss of CT data
* Chronic lung disease findings by CT that may lead to misinterpretation
* RT-PCR results unavailable or negative
* Terminal cancer
Will Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Change Primary Treatment

The study is a prospective randomised multicenter trial assessing the additional value of breast MRI in women under 56 years of age with newly diagnosed breast cancer. Will preoperative breast MRI change treatment regimen? Will preoperative breast MRI reduce the number of primary surgeries? Will preoperative breast MRI increase the rate of mastectomies? Will preoperative breast MRI be cost effective?

Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred)

Eligibility Criteria:
Inclusion Criteria:

* Women under 56 years of age
* Newly diagnosed breast cancer
* Swedish or English speaking

Exclusion Criteria:

* Claustrophobia
* Pregnancy
* Renal failure
* Metal items in patients
A Study to Evaluate 4DCT Controls

The purpose of this study is to use CT motion pictures (4DCT) to visualize and record how much space there is between certain wrist joint bones, both without any resistance and with light resistance to the movement, during a single scanning visit.


Eligibility Criteria:
Inclusion Criterion:

* Age ≥ 18 and ≤ 60 years.
* Control subjects without any history of wrist injury or disease.

Exclusion Criteria (applied to both wrists for control subjects):

* Previously-diagnosed rheumatological conditions or connective tissue diseases;
* Inability to be appropriately positioned in the scanner for the imaging;
* Congenital malformations of the wrist or forearm;
* Diagnosed wrist osteoarthritis
* Age under 18 or over 60.
Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women

* Preliminary scientific studies, in both animals and humans suggest that oral consumption of hydrolyzed collagen acts on the bone remodeling process by stimulating the activity of osteoblasts responsible for bone formation while improving the bone mineral density and biomechanical resistance of long bones.
* The objective of this clinical research is to measure changes in biomarkers of bone turnover in postmenopausal healthy women, not osteoporotic, in response to consumption of hydrolyzed collagen for three months.
* For this, we propose to measure blood and urinary markers of formation and bone resorption before consumption, then 45 and 90 days after daily consumption of 10 g of hydrolyzed collagen.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women
* Aged between 55 and 65 years
* Primary or secondary amenorrhea for at least 5 years
* BMI ≥ 20 kg/m2 and \< 27 kg/m2
* DXA \> 2.5 SD
* No history of fragility fracture bone
* Not under guardianship
* Not on hormone replacement or any osteoporotic therapy
* Covered by Social Security
* Negative serology for hepatitis B/C and HIV
* Written informed consent form signed.

Exclusion Criteria:

* Bone density \< 2.5 SD (standard deviation)
* Endocrine disease
* No history of fragility fracture bone
* Dietary disorder (anorexia, bulimia)
* Hormone replacement therapy
* Inclusion in another clinical study
* Subjects receiving over 4,500 Euros in the last 12 months (including the present study)
* Subjects presenting risk of non-compliance in the opinion of the recruiting doctor.