cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Synbiotic Formula in Patient With COVID-19

A series of microbiota were correlated inversely with the disease severity and virus load. Gut microbiota could play a role in modulating host immune response and potentially influence disease severity and outcomes.

Coronavirus can target multiple organs due to the hyperactive immune response with cytokine storms. Several studies have detected SARS-CoV-2 in stool samples and indicated that the virus could spread via faeces. Importantly, COVID-19 uses the same receptor as SARS and this doorway can also be found in the intestine. The cell entry receptor, known as angiotensin converting enzyme 2 (ACE2) receptor mediate entry of SARS-CoV-2 and is highly expressed in small bowel enterocytes. ACE2 is important in controlling intestinal inflammation and its disruption may lead to diarrhoea. In our previous study, stool samples from 15 patients with COVID-19 were analysed. Depleted symbionts and gut dysbiosis were noted even after patients were detected negative of SARS-CoV-2. A series of microbiota were correlated inversely with the disease severity and virus load. Gut microbiota could play a role in modulating host immune response and potentially influence disease severity and outcomes.

In July 2020, there are more than 15 billion confirmed cases globally with 620 thousand deaths. Currently, there are more than 2000 confirmed cases of COVID-19 in Hong Kong. It is important to rebalance the gut microbiota in COVID-19 patients and to improve the symptoms and the quality of life of these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 or above; and
2. A confirmed diagnosis of SARS-Cov.2 infection using the PCR according to the standard of according to Centre for Health Protection, Department of Health, HK and released from isolation at recruitment.
3. Written informed consent obtained

Exclusion Criteria:

1. Known allergy or intolerance to the intervention product or its components
2. Any known medical condition that would prevent taking oral probiotics or increase risks associated with probiotics including but not limited to inability to swallow/aspiration risk and no other methods of delivery (e.g., no G/J tube)
3. Known increased infection risk due to immunosuppression such as:

   * Prior organ or hematopoietic stem cell transplant
   * Neutropenia (ANC \<500 cells/ul)
   * HIV and CD4 \<200 cells/ul
4. Known increased infection risk due to endovascular due to:

   * Rheumatic heart disease
   * Congenital heart defect,
   * Mechanical heart valves
   * Endocarditis
   * Endovascular grafts
   * Permanent endovascular devices such as permanent (not short-term) hemodialysis catheters, pacemakers, or defibrillators
5. Documented pregnancy
Controlling Myopia Progression With Soft Contact Lenses (Contact Lens Control)

This study is to investigate whether novel soft contact lens optical designs can slow myopia progression


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be between 8 and 12 years of age.
2. At least one of the subject's parents or legal guardian must read and understand English or Chinese.
3. The subject's manifest objective refraction (measured with an auto refractor) must be sphere: between -0.25D and -4.50D, and cylinder: \<1.50D in each eye.
4. The subject's best sphere contact lens correction must lie between -0.75D (better of the two eyes)and -4.25D (poorer of the two eyes).
5. The subject's cycloplegic objective refraction must be here: between -0.75D and -4.00D cylinder: \< or equal to 1.00D in each eye.
6. The subject must have 1.00D or less difference in spherical equivalent between the two eyes with cycloplegic refraction.
7. The subject must have a spectacle lens best-corrected visual acuity of 0.8 (20/25) or better in both eyes.
8. The subject's parent or legal guardian must read and sign the STAEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form.
9. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Ocular or systemic allergies or diseases that may interfere with contact lens wear.
2. Systemic disease or autoimmune disease or use of medications (e.g. antihistamine), which may interfere with contact lens wear.
3. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear.
4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Any infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV)
8. Diabetes
9. Anisometropia of greater than 1.00D by cycloplegic refraction.
10. Astigmatism of greater than 1.00D in either eye by cycloplegic refraction.
11. Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
12. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study unless they are off rigid contact lenses for at least 4 weeks.
13. Strabismus in either eye.
14. Pupil or lid abnormality or infection in either eye
15. Central corneal scar in either eye
16. Aphakia in either eye
17. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
18. History of participation in prior clinical trials aimed to control myopia progression.
19. Surgically altered eyes, ocular infection of any type, ocular inflammation.
20. An anterior chamber angle grade 2 or narrower by the Van Herrick method
A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers

This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab). The anticipated time of study duration is 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, age 18 to 65 years inclusive
* Intact normal skin without potentially obscuring tattoos, pigmentation, lesion in the area for intended injection
* A body mass index (BMI) between 18 to 32 kg/m2 inclusive

Exclusion Criteria:

* Volunteers with any known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
* A history of clinically significant gastrointestinal, renal, hepatic, cardiovascular, or allergic disease
Emotion and Motivation in Patients With Psychosis

Anhedonia and avolition reflect emotional and motivational disorders, respectively. However, if these disorders play a major role in the symptomatology of schizophrenia, their mechanisms remain poorly understood, and existing treatments are inefficient on these symptoms. The literature suggests that the impairment does not concern emotion or motivation per se, but rather their influence on cognition. This project aims at using recent advances in the fundamental domain to better understand the cognitive and neuronal mechanisms of the patients' alterations, and especially how emotion and motivation influence cognition in schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia

Exclusion Criteria:

* addiction problem
* invalidating visual sensory problems
* neurological history
* for the healthy volunteers: psychiatric history
Pinloc Versus Hansson Pins in the Treatment of Femoral Neck Fractures.

A prospective randomized study comparing a new implant with three interlocked pins for internal fixation of femoral neck fractures (Hansson Pinloc System, Swemac Linköping, Sweden) versus 2 parallel pins with hooks (Hansson Pins, Swemac Linköping, Sweden).

Patients, who are to be treated with internal fixation due to a femoral neck fracture, will be randomized by the surgeon to Pinloc or Hansson Pins using an on-line randomization system.

The patients will be followed up at open visits at 3 months and 1 year. At two years the patients will be contacted by phone and medical records studied in order to detect any fracture complications.

Eligibility Criteria:
Inclusion Criteria:

* Femoral neck fractures where the preferred treatment is internal fixation.

Exclusion Criteria:

* Unwilling to participate.
Magnesium and Postoperative Pain

With ongoing advancements in healthcare leading to prolonged life expectancy, orthopedic surgeries are increasingly performed in elderly patients. Total knee arthroplasty, in particular, has been increasing with the growing demand for improved mobility and quality of life. Total knee arthroplasty is performed on patients with advanced and painful osteoarthritis of the knees, but it can result in moderate to severe postoperative pain during the recovery period.

To relieve anxiety or stress during surgery under regional anesthesia, sedation can be provided. Dexmedetomidine is a sedative-analgesic agent acting as α2-adrenergic receptor agonist, and its analgesic effect has been well established in various procedures or surgeries.

Magnesium has been reported to produce important analgesic effects including the suppression of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties of magnesium are believed to stem from regulation of calcium influx into the cell and antagonism of N-methyl-D-aspartate (NMDA) receptors in the central nervous system. In this study, investigators will evaluate the reducing effect of magnesium on the post-total knee arthroplasty pain in patients sedated with dexmedetomidine under spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo total knee arthroplasty under spinal anesthesia
* Patients who want to sedation during the surgery
* American Society of Anesthesiologists physical status classification 1 and 2

Exclusion Criteria:

* General anesthesia
* Patients who do not want to sedation during the surgery
* Patients who do not receive patient controlled analgesia postoperatively
* Muscular disease
* Hypermagnesemia
* Atrioventricular block
Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.


Eligibility Criteria:
Inclusion Criteria:

* Active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints
* Active plaque psoriasis at screening
* Inadequate efficacy or lack of toleration to previously administered TNF inhibitor

Exclusion Criteria:

* Non-plaque forms of psoriasis (with exception of nail psoriasis)
* History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA
A Clinical Trial of TQA3038 Injection in Healthy Adult Subjects

This is a phase 1 study in which healthy adult subjects will receive TQA3038 or placebo and will be assessed for safety, tolerability, pharmacokinetics.

In the single ascending dose (SAD) part, healthy adult subjects will receive one dose of TQA3038 or placebo, administered subcutaneously (SC).


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18～60 years.
* Body mass index (BMI) 19 - 26 kg/m\^2.

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation；
* History or evidence of drug or alcohol abuse；
* History of intolerance to SC injection；
Effects of Senior Dance on Risk Factors for Falls

The efficacy of exercise programs to prevent falls among older people is well documented in the literature. However, older people's adherence to these exercise programs has been reported to be suboptimal, varying between 21% and 74%. In addition, about 45% of people aged over 60 years do not meet the minimum recommended level of physical activity. In this context, dance is a promising alternative to traditional exercise programs, as it can positively influence important risk factors for falls, such as sedentary lifestyle, balance impairments and muscle weakness. Nevertheless, a recent systematic review conducted in this area show that the lack of randomized clinical trials as well as the low methodological quality of existing studies do not allow to reach definitive conclusions on the real effects of dance on risk factors for falls. A type of dance that is becoming popular among the older population in Brazil is the Senior Dance. Senior Dance classes consist of different choreographies, which include rhythmic and simple movements with rhythmic folk songs. The concentration required to learn the choreographies challenges balance, motor coordination and cognitive function. Thus the present study is a randomized clinical trial aiming to investigate the Senior Dance effect on balance, mobility and cognitive function, compared with a control group, among older people living in the community. A total of 82 subjects will be randomly allocated into two groups. The intervention group will participate in a 12-week, twice-weekly group-based program of Senior Dance, while the control will be encouraged to maintain their current routine activities. Outcomes measures (balance, mobility and cognitive function) will be evaluated before and after the intervention by an assessor blinded to group allocation. The results of this study will assist health practitioners when prescribing intervention for the older population.


Eligibility Criteria:
Inclusion criteria:

* Community-dwelling aged 60 years or over
* Cognitively intact (defined as a minimum score of 24 points on the Mini Mental Status Examination).

Exclusion criteria:

* Previous stroke with severe neurological impairment
* Progressive neurological disease
* Severe visual deficiency, dizziness or vertigo for less than 3 months
* Inability to maintain a standing position, even with the use of a walking aid or other device
* Any illness that the physician considers as an exercise contra-indication (e.g. uncontrolled angina, acute coronary disease).
* Participants who are currently participating in regular exercise programs including strength training and balance challenge, such as supervised group exercise, Tai Chi, Yoga, or any dance activity.
Caregiver Solutions for Dementia Patients

The goal of this clinical trial is to test a mobile application amongst caregiver's supporting patients diagnosed with Alzheimer's Disease and Related Dementias (ADRD). The main question it aims to answer is: Will caregivers supporting patients diagnosed with ADRD utilize a mobile application to routinely report symptoms of the patients they care for?


Eligibility Criteria:
Inclusion Criteria:

* Caregiver of a Duke patient with Alzheimer's disease or Alzheimer's disease-related dementias (ADRD), participating in the Duke Dementia Family Support Program
* The ability to speak and understand English
* Age \> 18 years

Exclusion Criteria:

* Those unable to speak and understand English
* Age ≤ 18 years
Melatonin Production Delay in Preterm Infants

Objective: Melatonin production is known to be delayed in preterm-born infants up to 6 months of age. This might be related to exposure of preterm infants to continuous lighting in the NICU during a critical period of pineal gland development. The investigators aimed to test the profile of melatonin production in these infants at 9-12 months of age.

Methods: Twenty three term-born and 23 preterm-born infants (gestational age: 29-34 weeks) were studied. The investigators tested nocturnal urinary melatonin excretion, within a repeated measures design, both at 9 and 12 months of age. Nocturnal urine was extracted from diapers and urinary melatonin derivate (6-sulphatoxymelatonin) excretion was analyzed by ELISA assay.

Unlike other organs which show catch up in preterm infants after one year of life, the pineal gland shows persistent delay in melatonin production. This field of research has been neglected lately although there are published recommendations for decrease of bright light in NICUs which prevents melatonin development and production, and also recommendations for melatonin treatment in cases respiration recovery in hospitalized preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* The investigators included healthy mothers with singleton pregnancies and documented prenatal care who were admitted before term (28-34) weeks gestation to the hospital's delivery room with early uterine contractions and entering stage 1 of an anticipated spontaneous vaginal delivery or term infants born at 38-42 weeks of gestation.

Exclusion criteria:

* Mothers who showed signs of fetal distress during labor, or required Cesarean (C)c-section, or had fetuses withand estimated fetal weights \< 10th percentile for gestational age and children diagnosed with

  * Genetic anomalies, congenital heart malformations, gastrointestinal disturbances and central nervous system dysfunction
  * Age \< 9 months, Age \> 9 months month at onset of study
  * Considered medically unstable
Styrian Vitamin D Hypertension Trial

In this randomized, double-blind, placebo-controlled trial we plan to enrol 200 vitamin D deficient hypertensive patients. Our main objective is to evaluate whether vitamin D3 supplementation with 2,800 IU daily for 8 weeks has an effect on 24-hour systolic ambulatory blood pressure (ABP) compared to placebo. In addition, we also aim to evaluate whether vitamin D3 supplementation alters 24-hour diastolic ABP, pulse wave velocity, N-terminal-pro-brain natriuretic peptide (NT-pro-BNP), corrected QT interval (Bazett formula), renin, aldosterone, 24-hour urinary albumin excretion, HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance), triglycerides and HDL-cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* 25-hydroxyvitamin D levels below 30 ng/ml (75 nmol/L)
* Arterial hypertension defined according to recent guidelines as an average office blood pressure on at least two occasions of systolic ≥ 140 and/or diastolic ≥ 90 mmHg or a mean 24-hour ABP of systolic ≥ 125 and/or diastolic ≥ 80, or a home blood pressure of systolic ≥ 130 and/or diastolic ≥ 85 or ongoing antihypertensive treatment which was initiated due to arterial hypertension
* Age of ≥ 18 years
* Written informed consent.

Exclusion Criteria:

* Hypercalcemia defined a serum calcium \>2.65 mmol/L
* Pregnancy or lactating women
* Drug intake as part of another clinical study
* Acute coronary syndrome or cerebrovascular events in the previous 2 weeks
* Glomerular filtration rate (GFR) according to the MDRD formula \< 15 ml/min/1.73m²
* Systolic 24-hour ABP \> 160 mm Hg or \< 120 mm Hg
* Diastolic 24-hour ABP \> 100 mm Hg
* Change of antihypertensive treatment (drugs and/or lifestyle) in the previous 4 weeks or planned changes of antihypertensive treatment during the study
* Any disease with an estimated life expectancy below 1 year
* Any clinically significant acute disease requiring drug treatment
* Chemotherapy or radiation therapy during the study
* Regular intake of more than 880 International Units (IU) vitamin D per day in the last four weeks before study entry or during the study
Pay-it-forward Gonorrhea and Chlamydia Testing Among Men in China

PIONEER is a three-arm, programmatic cluster randomized controlled trial (RCT) to compare effectiveness of three implementation strategies, followed by a mixed-methods implementation evaluation study

The study will be implemented at 12 clinics in Guangdong, China, which will be randomly assigned to one of the intervention arms for delivering gonorrhea testing: a standard pay-it-forward implementation strategy with minimal encouragement to get tested, a community-engaged pay-it-forward strategy, and a control arm in which men pay for their own sexually transmitted disease (STD) test. Data sources will include survey data on acceptability of intervention, intervention appropriateness, feelings and attitudes towards interventions among participants, administrative data about test uptake, treatment rate, and donations, as well as qualitative data to gain insights about men's perceptions and attitudes towards the pay-it-forward interventions strategies, mechanisms driving uptake and donating behaviors. Both survey and qualitative interviews with implementers and organizers about fidelity and adherence to protocol, intention to continue and maintain a pay-it-forward intervention, and barriers and facilitators of implementing the intervention will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* have had sex over the past year
* have not been tested for gonorrhea and chlamydia in the past year
* reside in the city in the past three months
* speak Mandarin Chinese or Cantonese
* mentally capable of providing informed consent to test for gonorrhea and chlamydia
* own a mobile phone

Exclusion Criteria:

* \< 18 years of age
Diagnosis of Lung Lesions by Endobronchial Ultrasound With an Alternative Guide Sheath

The purpose of this study is to examine the usefulness of a balloon covered sheath as a guide sheath in endobronchial ultrasound guided transbronchial biopsy and bronchial brushing cytology for diagnosis of peripheral lung lesions

Flexible bronchoscopy has been applied in the diagnosis of peripheral pulmonary lesions (PPLs) for decades. Without accurate localization, the diagnostic yield for peripheral lung cancers by these procedures is limited and variable. Localization of peripheral lung cancers can be aided by the use of computed tomography or fluoroscopy during fiberoptic bronchoscopy. However, radiation exposure to staffs and patients is always a concern in these procedures.

The clinical application of endobronchial ultrasound (EBUS) included determination of the depth of tumor invasion in tracheobronchial wall, evaluation of tracheobronchial structure before therapeutic bronchoscopy, localization of site of biopsy, EBUS-guided transbronchial needle aspiration, and analysis of peripheral tumor. Under EBUS guidance, the diagnostic yield of transbronchial lung biopsy in patients with peripheral lung cancer by bronchoscopic examination was significantly improved without an increase in the complication rate. More recently, with the aid of a guide sheath (EBUS-GS), EBUS has been shown to increase the diagnostic yield of PPLs, even in patients with fluoroscopy-invisible lung nodules, and avert the need for surgical procedures.

Most recently used GS for EBUS are specified for the EBUS probe with an external diameter of 1.9 mm. Such a thin caliber GS is designed to reach the PPLs, sometimes with an aid of curette, to provide an exact site for repeated obtainment of adequate specimens. We wonder whether a larger caliber sheath transformed from a balloon covered with an external diameter of 2.6 mm without reaching the PPLs, can offer similar effectiveness in diagnosis of the PPLs. The results may provide an alternative way for EBUS-GS especially in those countries where the commonly used GS of EBUS is not available.

Eligibility Criteria:
Inclusion Criteria:

* patients with peripheral pulmonary lesions who are going to receive bronchoscopy

Exclusion Criteria:

* endobronchial abnormalities
* associated lung parenchyma changes, ex. lung collapse or atelectasis