cyrilzakka/clinical-trials huggingface dataset:
Role of Doxycycline in Chronic Rhinosinusitis With Nasal Polyps

To evaluate the efficacy of Doxycycline as an adjunct to systemic steroids in the treatment of chronic rhinosinusitis with nasal polyps

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a disease of the nose and paranasal sinuses characterized by mucosal thickening and polyp formation. The prevalence of CRSwNP in the general population ranges between 1 and 4%. It mostly affects adult individuals. The treatment of CRSwNP can include the use of steroids, antibiotics, saline nasal spray, mucolytics, topical/systemic decongestants, topical anticholinergics, anti-leukotrienes or receptor blockers, and antihistamines. Steroids have a multitude of effects, including inhibition of cytokine synthesis, reduction of the number of eosinophils and activated eosinophils, anti-oedema effects and reduction of transudation. Topical corticosteroid therapy is not effective in all patients, leading to the use of systemic glucocorticosteroids and/or sinus surgery to control the disease. As a new approach, antibiotics are being used to treat CRSwNP particularly in patients with disease exacerbated by the Staphylococcus aureus enterotoxin. Antibiotics with anti- inflammatory effects can be used to treat patients with chronic rhinosinusitis without polyps, which might be the precursor to CRSwNP. Long-term treatment with these drugs, in selected cases, may be effective when corticosteroids fail. Doxycycline has dual action: it has well described, broad-spectrum antibacterial activity against S aureus as well as anti-inflammatory properties. It appears to be effective in treatment of several chronic inflammatory airway diseases.

Eligibility Criteria:
Inclusion Criteria:

1- Adult patients (aged 18 and over) with bilateral nasal polyps confirmed by nasal endoscopy and CT scan.

Exclusion Criteria:

1. CRS without nasal polyps.
2. Unilateral nasal polyps.
3. Pregnant and lactating women.
4. Patients younger than 18 years old.
5. Subjects with known allergic reaction to steroids or tetracyclines, hypertension, diabetes (type 1 and 2), glaucoma, tuberculosis, herpes infection are excluded.
6. If any major complications to the drugs in use appeared in process.
A Study to Assess the Safety, Tolerability and Preliminary Efficacy of HH-120 for the Treatment of COVID-19

This is a randomized, double-blind, placebo-controlled Phase 1 study in participants over the age of 18 years with mild to moderate COVID-19. This study aims to assess the safety, tolerability and preliminary antiviral effect of HH-120. This study includes dose escalation phase and dose expansion phase.


Eligibility Criteria:
Inclusion Criteria:

* The escalation phase:

  1. Participants are aged 18 to 65 years (inclusive at the time of informed consent)
  2. Participants are mild or moderate COVID-19 patients.
  3. Participants have one or more mild or moderate COVID 19-related symptoms as defined by the FDA (see the Diagnosis and Main Criteria for Inclusion) with the onset of symptoms ≤ 3 days prior to the randomization.
* The expansion phase:

  1. Participants are ≥18 years of age at the time of randomization.
  2. Participants are mild or moderate COVID-19 patients.
  3. Participants have one or more mild or moderate COVID 19-related symptoms as defined by the FDA (see the Diagnosis and Main Criteria for Inclusion) with the onset of symptoms ≤ 5 days prior to the randomization.

Exclusion Criteria:

* Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
* Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the PI's (or delegate's) opinion, could adversely affect the safety of the participant or that might interfere with the conduct of the study.
* Presence of any underlying physical or psychological medical condition that, in the opinion of the PI, would make it unlikely that the participant will comply with the protocol or complete the study per protocol.
* Have known allergies to any of the components used in the formulation of the study intervention.
Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65

People living with HIV are living longer as their disease is controlled with antiretroviral medications. Yet they are experiencing frailty more often and more than ten years earlier than those without HIV. In elderly persons without HIV, frailty is associated with decreased muscle strength and chronic inflammation. Less is known about what is driving early frailty in HIV or effective prevention measures for aging adults with HIV.

It may be that having HIV infection impairs energy production by mitochondria within the cells and contributes to the muscle weakness and inflammation accompanying frailty in people living with HIV . This study will examine the impact of six weeks of moderately paced walking on energy production in the cells, inflammation markers and frailty scores in people living with well-controlled HIV who are aged 50 to 65.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 50 to 65
* Documentation of HIV infection from Medical Provider
* Currently receiving antiretrovirals
* HIV viral load less than 50 iu/mL for at least six months
* CD4 count at least 350 cell/mm3 for the last six months
* Willing and able to walk at least 30 minutes 3 times weekly within 30 minutes of UMB
* Speaks English

Exclusion Criteria:

* Current smokers
* Weight less than 110 pounds
* Subjects taking long-term corticosteroids equivalent to 10mg/day or more, or immunomodulators
* Subjects with conditions known to affect inflammatory or mitochondrial function other than HIV, such as rheumatoid arthritis, gout, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, diabetes, Parkinson's disease, Alzheimer's disease, active hepatitis, sleep apnea or autoimmune diseases.
* Current drug or alcohol use or dependence or unstable mental health conditions that, in the opinion of the investigator, would interfere with adherence to study requirements
Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren

The investigators will conduct a n=5,400 Phase 3, double-blind, individually randomised placebo-controlled clinical trial of 5 years' duration in primary schools in City of Cape Town Metropolitan Municipality, Western Cape Province, Republic of South Africa.

The primary objective of the trial is to determine whether a weekly oral dose of 0.25 mg (10,000 IU) vitamin D3, administered for three years, reduces risk of acquisition of latent tuberculosis infection (LTBI) in Cape Town primary schoolchildren.

Statistical analysis will be performed on an intention-to-treat basis to compare acquisition of LTBI in intervention vs. control arms during three-year follow-up. The primary analysis will be logistic regression with presence/absence of LTBI at follow-up as the outcome, adjusted for a random effect of school of attendance.


Eligibility Criteria:
Inclusion Criteria:

* Pupil enrolled in Grades 1-4 of participating primary schools
* Age 6-11 years at enrolment
* Pupil gives written informed assent to participate in main trial
* Pupil's parent / legal guardian gives informed consent for pupil to participate in main trial

Exclusion Criteria:

* Age ≤5 years or ≥12 years at enrolment
* Previous positive Interferon-Gamma Release Assay (IGRA) or Mantoux test
* Previous treatment for LTBI or active TB
* Clinical signs of rickets
* History of myalgia on walking
* Inability to rise unaided from squatting position
* Taking supplemental vitamin D at a dose \>400 IU daily or equivalent in the previous month
* Diagnosis of any chronic illness other than asthma
* Suspected HIV infection in child with parent or legal guardian declining to have child HIV-tested
* Use of any regular medication other than asthma medication
* Plans to move away from study area within 3 years of enrolment
* Unable to swallow one placebo softgel with ease
* Positive Quantiferon-TB Gold Plus test at screening
Pro-thrombotic Status in Patients with SARS-Cov-2 Infection

The present study is ideated to prospectively investigate in patients with severe acute respiratory syndrome (SARS) due to Coronavirus 19 (SARS-Cov-2) infection and moderate-severe respiratory failure the patterns and changes in platelet reactivity, thrombotic status and endothelial function. The observed patterns and changes will be related with inflammatory status, myocardial injury and outcomes

Preliminary evidences suggested that patients with SARS-Cov-2 infection and concomitant presence of cardiovascular risk factors (i.e. arterial hypertension) and/or cardiovascular history (i.e. prior myocardial infarction) are at poor prognosis. The first reports from China suggested in patients with SARS-Cov-2 infection a heightened inflammatory burden associated with significant changes in coagulative status (i.e. low platelet count, increased D-dimer) and dysfunction of micro-vessels in pulmonary circulation.

No data are available about patterns and changes in platelet reactivity, activation of coagulation factors and endothelial function during SARS-Cov-2 infection.

The present study is ideated to fill this gap. Patients with moderate to severe respiratory failure due to SARS-Cov-2 infection will be enrolled. One blood sample will be obtained from each patient at the early, mid and late stage of disease. Several markers of platelet, coagulation and endothelial function will be related with laboratory, clinical, electrocardiographic, imaging (transthoracic echocardiogram, pulmonary ultrasonography, computed tomography) and outcome data.

To better describe typical patterns of disease regarding inflammation, platelet function and coagulation alteration, data from cases will be compared with control groups negative for SARS-CoV-2 infection, but with ST-segment elevation myocardial infarction or moderate-severe respiratory failure due to other agents.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate-severe respiratory failure (PaO2/FiO2 \<200)
* Diagnosis of SARS-CoV-2 infection + one of the following

  1. invasive mechanical ventilation (cohort A)
  2. non invasive mechanical ventilation (cohort B)
  3. only oxygen support

Exclusion Criteria:

* Previous chronic use of P2Y12 inhibitors
* Need for chronic oral anti-coagulation therapy
* Know disorder of coagulation or platelet function
Evaluation of ESPAIR, an Educational Therapy's Program of Patients With Renal Insufficiency Before Kidney Transplant

Treatment care of end-stage renal insufficiency is an important public health issue. The balance between patients waiting for a kidney transplant and available graft raises questions. Because of the non-adherence, risk of graft loss is increased to 7 times so in this trial patients will experiment an educational therapy's program as soon as they register on the transplant list.


Eligibility Criteria:
Inclusion Criteria:

* Patient with renal insufficiency on dialysis or not
* Registered on transplant list

Exclusion Criteria:

* Patient with psychological disorder
* transplantation from living donor
* Patients with renal transplant antecedent
Micropulse Transscleral Diode Laser Cyclophotocoagulation (MP-TSCPC) as a Treatment Modality for Glaucoma Patients

The study objective was to evaluate the efﬁcacy and safety of transscleral cyclophotocoagulation (TSCPC) using micropulse diode laser treatment in patients with various types of glaucoma.

Evaluation of the efﬁcacy and safety of a new form of transscleral cyclophotocoagulation (TSCPC) using micropulse diode laser treatment in patients with various types of glaucoma.

In this study, 810 nm infrared diode laser radiation in the micro- pulse mode was used in conjunction with a G probe (IRIDEX Medical Instruments, Mountain View, CA, USA).

The laser settings ranged from 2000- 2500 mW of 810 nm infrared diode laser set on micro- pulse mode, delivered over 100-200 seconds (envelope of micropulses) depending on severity of the case and other patient factors. With duty cycle 31.3% (This translates to 0.5 ms "on" time and 1.1 ms "off" time), which allows the tissue to cool down between laser shots, thus greatly reducing thermal damage.

Eligibility Criteria:
Inclusion Criteria:

* Patients previously diagnosed with glaucoma if they had uncontrolled Intraocular pressure despite maximal tolerated medical therapy.
* Patients who are unable to maintain compliance with the prescribed topical medications.
* Patients who need filtering glaucoma surgery for controlling Intraocular pressure but are not generally fit for the surgery.
* Patients who refused incisional procedures like subscleral trabeculectomy.

Exclusion Criteria:

* Patients who were unable to give informed consent.
* Patients who had undergone previous conventional transscleral diode laser cyclophotocoagulation (TSCPC).
* Patients with signiﬁcant scleral thinning deﬁned as thinning of more than one clock hour noticed on scleral transillumination.
* Patients with ongoing ocular infection or inflammation.
To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.

A multicenter, randomized Phase II/III clinical study to evaluate the efficacy and safety of GenaKumab in the treatment of active systemic juvenile idiopathic arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, with the remaining before age 2 years old or more and \& lt; 18 years old;
* 2001 ILAR classification criteria for the diagnosis of confirmed sJIA 2 or more months: onset age must \& lt; At 16 years of age, symptoms included: ≥1 case of arthritis, accompanied by or prior to ≥2 weeks of recurrent fever, including remittenor fever for ≥3 consecutive days (maximum daily body temperature ≥39 ° C, body temperature falling below 37 ° C between 2 heat peaks), accompanied by at least one of the following symptoms: ① a transient, non-fixed erythematous rash; ② systemic lymph node enlargement; Swelling of the liver and/or spleen; ④ Serositis.
* Agree to use effective means of contraception throughout the study period and for 6 months after the end of treatment.

Exclusion Criteria:

* Pregnant or lactating female subjects
* A history of allergic reactions to investigational drugs or to molecules with similar structures; Those who cannot be given intramuscular injections；
* History of pericarditis, myocarditis, serositis, bacterial heart valve or endocarditis within 6 months before screening; Patients who had been diagnosed with MAS within 6 months prior to screening, or had relevant symptoms and signs at screening, and were suspected of having MAS as assessed by the investigators；
* There are other rheumatic diseases such as Kawasaki disease, polyarteritis nodosa and so on. History of autoinflammatory diseases such as familial Mediterranean fever, high IgD syndrome, NLRP3-related autoinflammatory diseases；
* Patients with a history of interstitial lung disease, pulmonary fibrosis, alveolar proteinosis, or pulmonary hypertension; Patients with a history of repeated invasive fungal infection; In the 7 days prior to randomization, there were infections that required control with systemic antigenic microbiotics (including antibacterial, antiviral, antifungal, etc.)；
* Subjects with a history of TB exposure or suspected TB symptoms.
Superiority of On-demand PrEP Versus PEP on Using Doxycycline for Preventing STI in MSM

The goal of this clinical trial is to compare the effectiveness of doxycycline taken for on-demand pre-exposure prophylaxis (DoxyODPrEP) and its post-exposure use (DoxyPEP) in preventing bacterial sexually transmitted infections (STI), including chlamydia, gonorrhoea, and syphilis among men who have sex with men (MSM). The main questions it aims to answer are:

1. Is DoxyODPrEP superior to DoxyPEP?
2. Are both regimens safe?
3. Does the MSM community accept the use of doxycycline to prevent bacterial STI?

Participants will be asked to take doxycycline according to the study arm they are randomly assigned to, and attend regular clinical follow-ups during the 2-year observation period. Researchers will compare the bacterial STI incidences between the two groups to see if DoxyODPrEP is superior to DoxyPEP.

Participants would be randomly assigned to either DoxyODPrEP or DoxyPEP arm, and be instructed to take doxycycline with the respective dosing schedule. They would be followed up for 24 months for nucleic acid amplification test (NAAT) and antibody tests against bacterial STI, namely chlamydia, gonorrhoea, and syphilis. The subjects and investigators would not be blinded due to its open-label nature, as the two arms' dosing schedules are different. Participants in the DoxyODPrEP arm would be instructed to take two doxycycline hyclate 100mg capsules orally 2-24 hours before sex, and one 100mg capsule each 24 and 48 hours after loading dose. If they have sex within 48 hours after the loading dose, they would be asked to continue a daily 100mg until two days after the last sex. Participants in the DoxyPEP arm would be instructed to take two doxycycline hyclate 100mg capsules orally within 24 hours and up to 72 hours after each sex. At each clinic visit, urine, and pharyngeal and rectal swabs would be self-collected on-site by the participants following instructions. Pill count would be performed for each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* has had sex with another male in the past six months
* normally reside in Hong Kong
* can communicate in written and spoken Chinese or English
* willing and able to give written informed consent
* being willing and able to attend scheduled study clinic visits
* at risk of STI (had condomless sex with more than one man in the past 12 months, history of STI diagnosis in the past 12 months, inclination to have condomless sex, and other HIV-PrEP-eligible criteria)

Exclusion Criteria:

* Being allergic to tetracycline class medicines
* Currently taking medications that are contraindicated with doxycycline
* Using antibiotics for more than 14 days in the month preceding enrolment
Food Choices in Healthy Weight Women

This study will examine differences in habituation to foods high in sugar and fat content versus those that are not, in normal weight women.

Participants will complete two experimental sessions, in which habituation to chocolate cake and dried apricots will be measured, with each session measuring habituation rate to one food. Upon arrival to the session, participants will write down what they have consumed and the minutes of physical activity they have engaged in during the previous 24 hours. Participants will rate their feelings of hunger and fullness using a 100mm VAS. They will also rank their liking of the food being used in the session using a 100mm VAS. Participants will be given a peanut butter flavored granola bar, containing 190 kcal, and be instructed to consume all of the bar.

Next, participants will complete a computer generated task to measure habituation to a food (chocolate cake or apricots). The computer task will be programmed at a variable interval of 120 ± 42 seconds (VI-120) reinforcement schedule, so that participants will be rewarded one point for the first response made after approximately 120s have passed. The computer task consists of two squares, one that flashes red every time a mouse button is pressed and another square that flashes green when a point is earned. The habituation phase will be 24 minutes, divided into 12, 2-minute trials, during which participants can earn points towards access to 75 kcal portions of the food that is being measured. Participants will receive the food immediately after each point is earned to consume and can continue to play the computer task while eating. Participants will be instructed that when they no longer want to earn access to the food they can go to another table and engage in the activities provided (i.e., reading magazines). After the computer task, participants will rate their feeling of hunger, fullness, and liking of the food. During the computer task the number of consecutive two-minute time blocks before responding ceases, as well as the overall pattern of responding, will be measured.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) 18.5 to 24.9 kg/m2
* nonsmokers
* not allergic to the foods used in the investigation
* must like the foods in the investigation (scoring \> 50 mm on a visual analogue scale \[VAS\])
* be willing to consume the foods
* not have dietary restrictions
* not be a restrained eater (scoring \> 12 on the Three Factor Eating Scale)
* not be on medications that influence appetite
* not planning to change their diet or physical activity during the time frame of their study participation
* not dieting or trying to lose weight.

Exclusion Criteria:

* BMI outside of the range 18.5-24.9
* smoker
* food allergies
* does not like the foods used in the study
* has dietary restrictions
* is a restrained eater
* on medications that may influence appetite
* planning on changing diet or physical activity during time frame of the study
* dieting
* trying to lose weight
Healthier Living Canada

This study will evaluate the effectiveness of an online Chronic Disease Self-Management Program for participants in Canada living with chronic health conditions. This pilot will look for improvements in health status, health behaviors and health care utilization.

The Healthier Living with Ongoing Health Problems online workshop provides self-management and self care skills training for people with long-term health conditions such as heart disease, lung disease, diabetes, multiple sclerosis, asthma and others. The workshop is delivered via the Internet over a six-week period. This is a pilot project, which means that it is being run for a limited time to test out its format and its usefulness for participants in Canada. A similar programme has been implemented in the USA, UK, and Australia, but it has to be tried now in Canada to see its usefulness for people in this country. .

The Online workshop is aimed at helping you to take better care of yourself and to better manage your health condition. It is hoped that at the end of the workshop you will be able to do the things you want to do and maintain the relationships that are important to you.

With the facilitators and other workshop participants, you will discuss:

* Dealing with fatigue/tiredness
* Dealing with difficult emotions
* Dealing with your physical symptoms
* Solving the problems caused by your condition
* Starting and maintaining an appropriate exercise or activity programme
* Managing medications
* Communicating better with health care professionals
* Communicating better with your friends, family and colleagues

Eligibility Criteria:
Inclusion Criteria:Adults 18 and over living with any chronic or long term health condition such as heart disease, lung disease, diabetes. Exclusion Criteria:Not meeting the inclusion criteria