cyrilzakka/clinical-trials huggingface dataset:
The Designer D-dimer Deep Vein Thrombosis Diagnosis (4D) Study

This is a cohort study that will assess a new diagnostic management strategy for suspected Deep Vein Thrombosis in outpatients.The new diagnostic strategy is designed to reduce the use of ultrasound testing on the day of presentation, and reduce repeat ultrasound testing a week after an initial normal test.

This is a prospective, multicentre, cohort study that will assess a new diagnostic management strategy for suspected Deep Vein Thrombosis in outpatients. The new diagnostic strategy is designed to reduce the use of ultrasound testing on the day of presentation, and reduce repeat ultrasound testing a week after an initial normal test. Less ultrasound testing will be performed because: i) more patients will have deep vein thrombosis excluded by combinations of Clinical Pretest Probability and D-dimer results on the day of presentation; and, ii) in those who still need an ultrasound, a repeat ultrasound a week after a normal result will only be performed if the D-dimer result is markedly abnormal at initial presentation. The safety of this management strategy will be established by demonstrating a very low rate of proximal Deep Vein Thrombosis or Pulmonary Embolism during 90 days follow-up in patients who had anticoagulant therapy withheld in response to negative diagnostic testing. Diagnostic test utilization will be assessed. All clinical outcomes will be adjudicated by a central independent adjudication committee that will be blind to initial D-dimer measurements and patient management.

Eligibility Criteria:
Inclusion Criteria:

1) Consecutive outpatients (i.e. non-hospitalized patients) with clinically suspected Deep Vein Thrombosis.

Exclusion Criteria:

1. Age less than 18 years.
2. Treated with full-dose anticoagulation for ≥ 24 hours before D-dimer was measured.
3. D-dimer level known before Clinical Pretest Probability documented.
4. Ultrasound of the leg performed before Clinical Pretest Probability was documented
5. Ultrasound was or will be performed in a patient with low Clinical Pretest Probability and a d-dimer \<1000(or equivalent), or with Moderate Clinical Pretest Probability and a D-dimer \<500 (or equivalent) (e.g. suspected bleeding).
6. Ongoing need for anticoagulant therapy.
7. Suspected Pulmonary Embolism.
8. Superficial venous thrombosis that requires, or may require, anticoagulant therapy.
9. Life expectancy less than 3 months.
10. Previously confirmed episode of Deep Vein Thrombosis.
11. Geographic inaccessibility which precludes follow-up.
12. Known pregnancy.
An Interocular Comparative Study of Unilateral Cataract

The purpose of this cross-sectional study is to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships.

Great advances have been made in managing pediatric cataracts during the last several decades; these advances have contributed to a decrease in the incidence of postoperative complications and improvement in visual outcomes.Early cataract removal and replacement with an intraocular lens (IOL) represent the most appropriate treatments to avoid irreversible amblyopia.Although screening and timely surgical intervention play a key role in improved best corrected visual acuity (BCVA) among pediatric patients with cataracts, determining the prognosis for an individual remains difficult, particularly for unilateral cataract.

Few studies have focused on the interocular differences in ocular anatomic parameters other than axial length in unilateral pediatric cataract after surgery, the significance of which for the possible interocular visual functional difference remains unclear. Therefore, the investigators conducted this cross-sectional study to compare bilateral anterior segment parameters, macular thickness, and BCVA at 3 months after uncomplicated unilateral pediatric cataract extraction with primary IOL implantation to explore any possible interocular differences and their possible relationships.

Eligibility Criteria:
Inclusion Criteria:

* Children with uncomplicated surgeries
* Children who were younger than 10 years old
* Children with unilateral total cataract

Exclusion Criteria:

* Premature birth
* Microphthalmia
* Micro-or Megalocornea
* Keratoconus
* Glaucoma
* Traumatic or complicated cataracts
* Vitreous and retinal diseases
* Any previous surgeries
Effect of Vitamin C on Allergy Skin Test

This study will assess the effect of taking vitamin C on allergy skin test.

Allergic rhinitis (AR) is an Immunoglobulin E (IgE) mediated inflammation of the nasal cavity. House dust mite is the most common causative allergen. The skin prick test is the preferred method to confirm allergy. This test is interpreted by measuring the skin wheal reaction in response to allergen application and histamine. Prior studies have shown that Vitamin C may have antihistamine effect that may reduce the wheal reaction in skin prick test thus cause difficulties to interpret the results. Current guidelines do not recommend cessation of vitamin C prior to skin prick test. This will require further study in order to further understand the effect of vitamin C in commercially available dose on the skin prick test wheal reaction. In this randomized placebo controlled trial, consecutive participant visiting the ENT clinic with allergic rhinitis and prior positive skin prick test towards dust mite will be screened for inclusion and exclusion criteria. Participants will either receive vitamin C 1000mg daily for 7 days or placebo. The skin prick test will be performed after one week of intervention and the area of the wheal reaction area (mm2) and longest diameter (mm) recorded. This will be compared between the two groups. The expected outcome is that participants with oral supplementation of vitamin C will have reduced SPT wheal reaction compared to placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Participants above 18-years old
* Participants with history at least 2 symptoms of rhinitis triggered by dust
* Positive SPT to Dermatophagoides pteronyssinus with wheal reaction of at least 5 mm done within the past 1 year.

Exclusion Criteria:

* Prior skin prick test result form do not include a tracing of the wheal reaction.
* Prior skin prick test was not performed in HCTM.
* Participants who are actively smoking or who have smoked cigarette or vaped in the past 6 months
* Participants with skin conditions affecting the volar aspects of the arm.
* Participants on beta-blockers
* Participants contraindicated for skin prick test (pregnancy, history of anaphylaxis, poorly controlled asthma)
* Participants on long term supplements (multivitamin, traditional supplement)
* Participants contraindicated for vitamin c (vitamin c allergy, kidney dysfunction, history of kidney or bladder stones, hyperuricemia, thalassemia, G6PD deficiency, sickle cell disease, hamatochromatosis)
* Participants at risk of vitamin C deficiency (hyperthyroidism, elderly, beastfeeding, diarrhoea, restricted diet secondary to inflammatory bowel disease, anorexia or cancer)
Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy Volunteers

To evaluate whether IN-C004 absorbs oral mucosa in healthy volunteers.

An Open-label, Single-dose Clinical Study

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥19.0 kg/m2 and ≤27.0 kg/m2 with a body weight ≥ 45 kg at screening.

Exclusion Criteria:

* History or evidence of clinically significant disease
* History of drug/alcohol abuse
* Participated in other studies and received investigational products within 6 months prior to the first study dose.
* Not able to use a medically acceptable contraceptive method throughout the study.
Black Raspberry Confection in Preventing Oral Cancer in Healthy Volunteers

This clinical trial studies black raspberry confection in preventing oral cancer in healthy volunteers. Black raspberry contains ingredients that may prevent or slow the growth of certain cancers.

PRIMARY OBJECTIVES:

I. To select an optimal black raspberry confection based on altered gene expression and chemical profiles in healthy individuals exposed to 3 black raspberry-based amorphous functional confections with modulated bioactive release rate at two doses (4 g and 8 g).

OUTLINE: Participants are randomized to 1 of 6 arms after 2 weeks.

ARM I: Participants receive black raspberry (BRB) confection 1 fast release orally (PO) 4-6 hours apart thrice daily (TID) for 2 weeks.

ARM II: Participants receive BRB confection 2 fast release PO 4-6 hours apart TID for 2 weeks.

ARM III: Participants receive BRB confection 1 intermediate release PO 4-6 hours apart TID for 2 weeks.

ARM IV: Participants receive BRB confection 2 intermediate release PO 4-6 hours apart TID for 2 weeks.

ARM V: Participants receive BRB confection 1 prolonged release PO 4-6 hours apart TID for 2 weeks.

ARM VI: Participants receive BRB confection 2 prolonged release PO 4-6 hours apart TID for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Be healthy, free-living adults
* Be a non-smoker (defined as adults who have never smoked or who have not had a cigarette in the past ten years)
* Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition and alternative supplements for the duration of the study
* Agree to follow a berry-restricted diet and to document any accidental consumption of restricted foods each day of the study
* Agree to abstain from mouthwashes

Exclusion Criteria:

* Have an active metabolic or digestive illness including malabsorptive disorders, renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome
* Have an active or a recent history of any condition that causes altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, and blood dyscrasias
* Have a known allergy or food intolerance to ingredients in study products (black raspberries),other berries, wheat, or soy
* Are strict vegans (no consumption of animal, fish or egg products)
* Are planning to conceive, or are currently pregnant or lactating
* Are heavy alcohol consumers (defined as an average consumption of greater than 2 drinks/day)
* Have a history of oral cancer or currently undergoing treatment of oral cancer
* In the last month have had any active oral lesions or maladies or currently have any oral disease or obvious open sores in the oral cavity or surrounding the oral opening
* Have strong gag reflex or problems swallowing that prohibit buccal brushing of the oral cavity
* Have been on an antibiotic regime lasting for one week in the last 6 months
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).


Eligibility Criteria:
Inclusion Criteria:

* Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
* Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
* If female, must meet the contraception requirements.

Exclusion Criteria:

* Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
* Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
* Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
* Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
* Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
* Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
Sleep Apnoea Management by a Communication Based Technology (ICT)

This project develops a new form of management of subjects with suspected SAHS and different sleep disorders by applying Information and communications technologies (ICT).

Sleep apnea hypopnea syndrome (SAHS) is a prevalent disease with significant morbidity resulting in long waiting lists and high health care costs. Therefore, alternative cost-effective approaches are urgently needed. A possible procedure is telemedicine based on ICT.

The design of the study is prospective, randomized, controlled, open and parallel.

A ICT-based out of hospital management of SAHS is implemented to be compared with the classical in-hospital management.

The main objectives were the evaluation of both groups and the analysis of efficacy and cost effectiveness of two SAHS management programs.

This is a 3 month randomized, with parallel groups study. Participants will be patients with suspicion of SAHS derived to the Investigators' Sleep Unit.

Patients are randomized in two groups; 1) classical in-hospital group: polysomnography or home respiratory polygraphy (HRP), CPAP titration and treatment and hospital follow-up; and 2) ICT group: 3 consecutive HRPs, automatic CPAP treatment and control by phone/video conferences and data transmission by using a custom designed platform.

Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of SAHS
* Use of Smartphone and internet

Exclusion Criteria:

* Severe hypersomnia
* Central apneas or other sleep disorder
* Previous CPAP treatment
* Unstable diseases
* Profession of risk
* Not able to complete questionnaires
* No written informed consent
Preference of Life-Sustaining Treatment Among Patients With End Stage Renal Disease

Although patients with kidney disease can rely on dialysis to prolong their lives, the complexity of the disease, the variability of the course of the disease, and the uncertainty of the prognosis often delay the discussion of issues at the end of life, and the deterioration of the condition often makes it impossible for the patient to express clearly or rationally. Treatment thoughts or preferences. Sufficient time is needed to think and discuss issues related to life treatment. Discuss with patients as soon as possible to help draw up end-of-life care plans, help patients realize end-of-life care preferences, assist family members to make complex treatment decisions, and alleviate medical providers' moral distress. Domestic life-sustaining treatment research is mostly signed by DNR for cancer patients and retrospective investigation of medical records, and seldom focuses on kidney disease patients and life-sustaining treatment survey preferences other than DNR content. This study sought to understand patients with kidney disease's preferences for life-sustaining care during disease progression, and to understand whether prognostic perceptions, symptom distress, dementia, and decision conflict affect patients' preferences. Pre-collected convenient sampling is expected to include 200 patients diagnosed with chronic kidney disease stage 5 or end-stage renal disease, including patients who have received regular dialysis. The survey will be conducted with a single questionnaire. There are five questionnaires, including: demographic characteristics, chronic kidney disease prognosis cognition And life-support treatment information questionnaire, short-form recall symptom assessment scale, loss of memory scale and decision-making conflict scale; after the researcher explains, the patient fills in by himself or the researcher fills in after the patient answers. It is expected that the results of the study will help clinical practitioners to understand the changes in the management of medical care for kidney disease patients when the disease worsens and assist in the management of patients' medical care, echoing the importance of advancing medical care planning in this population, for the future development of kidney disease A reference for care guidelines for debilitated patients, thereby improving care quality and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

1. Over 20 years old.
2. Patients diagnosed with chronic kidney disease stage V or end-stage renal disease, and glomerular filtration rate less than 15ml/min/1.73m2; or patients receiving regular blood or peritoneal dialysis treatment.
3. Those who have normal cognitive function (such as: able to read newspapers and magazines, and communicate with others), and can communicate in Mandarin and Taiwanese.

Exclusion Criteria:

1. Severe cognitive impairment or visual or hearing impairment that makes it impossible to answer questions.
2. Critically ill patients.
3. Patients with chronic mental illness or their related diagnosis records.
Upper Arm Training With Armeo Spring for Stroke

The purpose of this study is to assess the clinical outcomes of upper extremity training using the Armeo Spring system in a chronic post-stroke population with impaired upper extremity function.

The Armeo Spring system is an adjustable arm orthosis that has received FDA 510K clearance. It passively counterbalances the weight of the arm, thereby reducing the effort required to overcome gravity during the performance of upper-limb movements. The device provides subjects with augmented feedback via a virtual environment (i.e. computer games). The tasks to be performed in the virtual environment are designed to achieve functional movements, such as arm reaching movements.

The goal of the study is to assess the clinical outcomes of upper extremity training using the Armeo Spring system in a chronic post-stroke population with impaired upper extremity function. The Armeo Spring system is equipped with a grip sensor that subjects squeeze with their hand to interact with virtual objects during the games. In a first phase of the study, we attempted to replace the grip sensor that is part of the system with a sensorized glove, to facilitate a more natural movement of hand opening/closing. However, we experienced technical difficulties with the sensorized glove and decided to abandon this aim for the purpose of gathering data about the clinical outcomes of upper extremity training using the Armeo Spring system.

Eligibility Criteria:
Inclusion Criteria:

* Male and female, community dwelling, age 18-70
* First-time non-traumatic ischemic or hemorrhagic stroke at least 3 months prior to study enrollment
* Score of 15-55 out of 66 on arm motor Fugl-Meyer scale
* The ability to extend \>=10 degrees at metacarpophalangeal and interphalangeal joint of all digits

Exclusion Criteria:

* Cognitive impairment that may interfere with understanding instructions for motor tasks and assessment tools
* Inability to operate the Armeo system (subjects must have sufficient range of movement to enable calibration of the virtual workspace)
* Participation in other forms of therapy/intervention for upper extremity motor recovery
Evaluation of the Quality of the Transfusion Practice at Rigshospitalet, Copenhagen University Hospital

The purpose is to evaluate and improve transfusion practice


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized at Rigshospitalet, Copenhagen University Hospital

Exclusion Criteria:

-
Surveillance for Early Liver Injuries Caused by Zhuanggu Guanjie Pill

This is a prospective registry study to surveil early liver injuries caused by Zhuanggu Guanjie Pill (ZGGJ Pill) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to ZGGJ Pill.

The primary objectives of this study include:

(i) The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of ZGGJ Pill; (ii) The record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) The specimen collection of surveiled individuals. (iv) The attempt to establish a predictive model to screen susceptibilities to ZGGJ Pill.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals in accordance with indications for ZGGJ Pill, including osteoarthritis, and lumbar muscle strain;
2. The age range of 18 to 70 years；
3. Individuals taking ZGGJ Pill over 2 weeks;
4. Abnormalities of serum biochemistry achieving one of the criteria as follows:

   (i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) ≥2 folds of upper limit of normal (ULN); (ii) total bilirubin (TBiL) ≥ 2 ULN; (iii) alkaline phosphatase (ALP) ≥ 2 ULN;
5. Individuals can provide informed consent form.

Exclusion Criteria:

1. Individuals without indications for ZGGJ Pill;
2. Inconformity with the ZGGJ Pill drug label;
3. Individual taking ZGGJ Pill within 2 weeks;
4. Individuals taking other hepatotoxic drugs combined with ZGGJ Pill, simultaneously;
5. Inconformity with the diagnostic criteria for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.
Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System

Multi-center, prospective, open-label, single arm study. The study aims to evaluate the safety and efficacy of Laser Assisted Liposuction procedure performed with the LipoLife system. The study will include twenty (20) eligible subjects, that are willing to undergo abdominal or outer thighs laser-assisted liposuction. Five to twenty (5-20) subjects out of this study group should also be eligible for facial fat grafting. Follow up visits to evaluate study endpoints will take place at 1, 3 and 6 months after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with excessive fat in the lower abdomen or subjects with excessive fat in the outer thighs that are willing to undergo laser-assisted liposuction
* Estimated fat harvesting of 1-3 liters
* Subjects (5-20) eligible for facial fat grafting of at least 5 cc for each cheek
* Between 18 and 70 years of age
* Provided written Informed Consent

Exclusion Criteria:

* Body Mass Index (BMI) \>35
* Sever skin laxity
* Positive pregnancy test
* Current smoker
* Presence of known malignancy
* Active infection in the treatment area
* History of autoimmune disorder (e.g., Systemic Lupus Erythematosus \[SLE\])
* History of connective, metabolic or atrophic skin disease
* History of keloid scarring
* Chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment
* Subjects with immune system diseases
* Subject unable to follow post-treatment instructions
* Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.