bioihbjkbjnl/mcl2 huggingface dataset:
Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)
Condition: COVID-19; Corona Virus Infection; SARS (Severe Acute Respiratory Syndrome); SARS-CoV-2
MeSH terms: Infections; COVID-19; Severe Acute Respiratory Syndrome; Coronavirus Infections; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a clinical study for the prevention of SARS-CoV-2 infection in adults exposed to the
      virus. This study will enroll up to 2000 asymptomatic men and women 18 to 80 years of age
      (inclusive) who are close contacts of persons with laboratory confirmed SARS-CoV-2 or
      clinically suspected COVID-19. Eligible participants will be enrolled and randomized to
      receive the intervention or placebo at the level of the household (all eligible participants
      in one household will receive the same intervention).
    

Detailed description: 
      This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded
      study of Hydroxychloroquine (HCQ) post-exposure prophylaxis (PEP) for the prevention of
      SARS-CoV-2 infection in adults exposed to the virus.The overarching goal of this study is to
      assess the effectiveness of HCQ PEP on the incidence of SARS-CoV-2 detection by polymerase
      chain reaction (PCR) to inform public health control strategies.This study will enroll up to
      2000 asymptomatic men and women 18 to 80 years of age (inclusive) at baseline who are close
      contacts of persons with PCR-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a
      pending SARS-CoV-2 PCR test. Eligible participants will be enrolled and randomized 1:1 to HCQ
      or ascorbic acid at the level of the household (all eligible participants in one household
      will receive the same intervention). Participants will be counseled about the preliminary in
      vitro data on HCQ activity against SARS CoV-2 and equipoise regarding efficacy in humans.The
      duration of study participation will be approximately 28 days.
    

Intervention name(s): Hydroxychloroquine Sulfate; Ascorbic Acid
Intervention type(s): Drug; Drug
Intervention description(s): Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy; Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.
Other intervention name(s): HCQ arm; Placebo arm
Intervention MeSH terms: Ascorbic Acid; Hydroxychloroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: novel coronavirus; post-exposure prophylaxis
Identification and Treatment of Diabetes In Solid Organ Transplant Recipients
Condition: Complications of Transplanted Organs and Tissue
Study type: Interventional

Summary: 
      The purpose of this study is to determine the influence of post-transplant diabetes on
      medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to
      18 years of age and their families.
    

Detailed description: 
      This study seeks to understand how organ transplant patients are affected by the development
      of diabetes, and to test whether early diagnosis of diabetes and comprehensive professional
      support will:

        1. facilitate the adjustment of children and their families to the rigors of diabetes care

        2. improve adherence to medication regimens

        3. reduce acute complications of diabetes and organ rejection.
    

Intervention name(s): Psychologist Support; Pediatric Certified Diabetes Educators (CDEs) Support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will complete several psychological questionnaires that are intended to cover a broad spectrum of physical, mental, and emotional aspects of the health of participants; the Behavior Assessment System for Children (BASC) ,the Children Depression Inventory (CDI 2), the Pediatric Quality of Life Inventory Transplant Module (PedsQL), and the Wechsler Abbreviated Scale of Intelligence II (WASI-II). Data gathered from this testing will be used to guide the provision of psychological care to address psychosocial challenges inherent to the care of children with transplant related diabetes.; Pediatric Certified Diabetes Educators (CDEs) are specially trained to teach diabetes self-management to children and their families. Participants who are diagnosed with diabetes will receive individualized support from a CDE in conjunction with their routine transplant care.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetes; Endocrinology; Pediatrics
Evaluating the Effects of Information Leaflets in Adult Aural Rehabilitation
Condition: Hearing Impairment
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      Knowledge about how to manage hearing aids is an important factor in hearing aid success, but
      studies show that this knowledge ranges from good to poor, even among experienced adult
      hearing aid users. Information leaflets is a common tool in healthcare to give information
      with the purpose to increase theoretical knowledge and change behaviour, and illustrations in
      these leaflets can provide additional understanding for all kinds of patients.

      The primary aim of this aural rehabiliation study was to evaluate participants' knowledge
      about placement in a noisy environment, directional microphone and telecoil function at
      baseline and postintervention and assessing their perceptions of the benefits of an
      information leaflet. Additional aim was to investigate whether, an information leaflet with
      illustrations and accompanying text about hearing aid functions have additional effects on
      participants' knowledge compared to an information leaflet without illustrations.
    


Intervention name(s): Information leaflets with illustrations about hearing aid functions; Information leaflets with only text about hearing aid functions
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The information leaflet contains written information with simple illustrations about placement in noisy environments, how to use a telecoil and about directional microphones function in hearing aids. The time spent presenting the information leaflet was approximately ten minutes.; The information leaflet contains written information about placement in noisy environments, how to use a telecoil and about directional microphones function in hearing aids. The time spent presenting the information leaflet was approximately ten minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aural rehabilitation; hearing aid functions; hearing aid knowledge; information leaflet; visual aids
Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      This is a single centre, open label, prospective, randomized study on the prophylactic effect
      of moderate aerobic endurance training versus relaxation training in patients with migraine.
    


Intervention name(s): Relaxation Training; Aerobic endurance Training
Intervention type(s): Other; Other
Intervention description(s): Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.; Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Statins for Pulmonary and Cardiac Complications of Chronic HIV - Coordinating Center
Condition: HIV Seropositivity
MeSH terms: HIV Seropositivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Hypothesis: Statin therapy will decrease inflammation and slow progression of cardiopulmonary
      abnormalities in HIV.
    

Detailed description: 
      Growing evidence indicates that chronic obstructive pulmonary disease (COPD) is an important
      cause of respiratory impairment in HIV+ persons and will likely increase as the HIV+
      population continues to age. In the HIV-uninfected population, COPD frequently co-exists with
      cardiac disease including atherosclerosis and pulmonary hypertension (PH). The investigators
      work has demonstrated that a syndrome of "cardiopulmonary dysfunction" exists even in
      non-smoking or antiretroviral-treated HIV+ individuals. The investigators have found that
      HIV+ individuals have a high prevalence of respiratory symptoms, airflow obstruction, and
      diffusing capacity (DLco) abnormalities that occur concurrently with cardiac co-morbidities,
      including radiographic measures of atherosclerosis and elevated echocardiographic pulmonary
      artery pressures. This syndrome is marked by inflammation with elevated levels of cytokines
      and hsCRP, peripheral T-cell activation, and increased sputum neutrophils as well as
      elevation of NT-proBNP, a marker of heart strain. Importantly, the investigators have shown
      that DLco impairment and elevated NT-proBNP are significant independent predictors of
      mortality in HIV, indicating that cardiopulmonary dysfunction is likely highly clinically
      relevant and identifies a vulnerable population in whom the investigators lack effective
      interventions.

      Statins have anti-inflammatory effects in the lung and vasculature that might benefit
      cardiopulmonary dysfunction in HIV. These agents have a long history of clinical use in
      cardiovascular disease and are currently being investigated as disease-modifying drugs for
      HIV, COPD, and PH. In preliminary analyses, the investigators have found that HIV+
      individuals who received statin therapy within the past year were significantly less likely
      to have impaired DLco and had lower pulmonary artery pressures, lower NT-proBNP, lower
      peripheral cytokines, and fewer sputum neutrophils despite being older and having a greater
      smoking history than those not using statins.
    

Intervention name(s): Placebo; Rouvastatin calcium
Intervention type(s): Drug; Drug
Intervention description(s): suger pill manufactured to mimic crestor pills
Other intervention name(s): Crestor
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HIV; lung; lipids; no lipid lowering medication; normal liver and kidney function; on stable ART regimen; not pregnant
Rosuvastatin Efficacy and Safety Evaluation in Hypercholesterolaemic Patients
Condition: Hypercholesterolaemia
MeSH terms: Hypercholesterolemia
Study type: Observational

Summary: 
      This is a single-arm, phase IV, open-label, prospective, non interventional study to evaluate
      the efficacy, tolerability and safety of rosuvastatin administered for 24 weeks in
      approximately 900 Greek subjects with hypercholesterolemia under normal clinical practice.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary Care
      
Keywords: Rosuvastatin; hypercholesterolaemia
Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional

Summary: 
      The outcome of this trial will reveal the possibilities of the retinal implant to improve the
      situation of patients with hereditary retinal blindness caused by degenerations of the outer
      retina. This pilot study will give important information on safety and efficacy of
      sub-retinal implants.
    

Detailed description: 
      Although the design of the chip with a possible resolution of up to 1500 image points has the
      potential of providing object recognition, the quality of the image transmitted in this first
      human application cannot be foreseen. On the other hand clinical experience teaches us that
      even bare light recognition improves mobility of patients because of the ability to localize
      bright light sources such as windows or lamps.
    

Intervention name(s): Retina implant is surgically placed into subretinal position
Intervention type(s): Device
Intervention description(s): Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation & mobility.
Other intervention name(s): Retina Implant, subretinal implant, vision prosthesis,; medical device for restoration of vision
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Legal blindness; Retinopathy pigmentosa; Hereditary condition; Photo-receptor degeneration; Retina implant; Subretinal implant
To Evaluate the Efficacy and Safety of 1146A Nasal Spray in Adult Participants With Symptoms of Common Cold
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be conducted in adult participants with symptoms of common cold assessing if
      1146A nasal spray reduces the severity of symptoms of the common cold compared to placebo.
      The study will also evaluate the safety of 1146A compared to placebo.
    

Detailed description: 
      This will be a multi-center, randomized, parallel-group, double blind, 2-arm, placebo
      controlled study to evaluate the efficacy and safety of 1146A in adult participants with
      symptomatic common cold in an outpatient setting.
    

Intervention name(s): Carbomer 980 (1146A); Placebo
Intervention type(s): Drug; Other
Intervention description(s): Test product containing carbomer 980 gel; Reference product containing vehicle without carbomer 980 gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Continuous Use of COCs
Condition: Pregnancy Prevention
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to determine if continuous COC use leads to higher continuation
      rates over 12 months of follow up than use of the standard 28-day COC regimen.
    

Detailed description: 
      Family Health International has recently initiated a USAID funded study to investigate the
      pregnancy rates, continuation rates, and acceptability of COCs in women taking COCs by the
      21/7 cyclic regimen compared with the continuous use of COCs with bleeding-signaled
      hormone-free intervals. The primary objective is to determine whether continuous COC use
      leads to higher 12-month continuation rates than use of the standard 28-day COC regimen.
      Secondary objectives are to 1) compare pregnancy probabilities through 6 and 12 months
      between the continuous use group and the 28-day group 2) compare COC continuation rates
      through 6 months between the continuous use group and the 28-day group 3) compare
      acceptability of the two COC regimens 4) to compare bleeding and other side effects between
      the continuous use group and the 28-day group 5) to compare hemoglobin/hematocrit between the
      continuous use group and the 28-day group
    

Intervention name(s): Oral contraceptives--ethinyl estradiol, levonorgestrel
Intervention type(s): Drug
Intervention description(s): 3 visits - screening/enrollment, 6-months and 12 months
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Contraceptive Agents; Contraceptives, Oral; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: AE adverse event; AIDS acquired immunodeficiency syndrome; ALT (SGPT) alanine aminotransferase; ART antiretroviral therapy; AST (SGOT) aspartate aminotransferase; DCF data collection forms; DMC Data Monitoring Committee; FDA (U.S.) Food and Drug Administration; GCP Good Clinical Practice guidelines; HB sAg Hepatitis B surface antigen; ICH International Conference of Harmonisation; IND Investigational New Drug Application; IRB Institutional Review Board; IU international units; mg milligram(s); mm3 cubic millimeter(s); PCR polymerase chain reaction; SAE serious adverse event; µg microgram; ULN upper limit of the normal range; WB Western Blot
Infusion Laboratory: Protocol 1 - Selegeline - 2
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of selegiline on the subjective and
      physiological effects of cocaine challenge in chronic crack abusers, and to evaluate clinical
      safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack
      dependent population.
    

Detailed description: 
      To develop a medication for the treatment of cocaine addiction using a medical human
      physio-neuro-psycho-immunology laboratory setting. To characterize this cocaine abusing
      population on a variety of psychological and physicologically measures over time from
      withdrawal through pere and post cocaine administration. To determine the effects of
      selegeline on the subjective and physiological effects of cocaine challenge in chronic crack
      abusers. To evaluate clinical safety issues pertaining to selegeline, to cocaine and their
      interaction in a chronic crack dependent population.
    

Intervention name(s): Selegiline
Intervention type(s): Drug
Intervention MeSH terms: Selegiline
Primary purpose: Treatment
Keywords: cocaine dependence
Short Time Low PEEP Challenge and Mini Fluid Challenge
Condition: Intraoperative Care; Fluid Responsiveness
Study type: Observational

Summary: 
      Optimizing fluid therapy is one of the main concerns for anesthesiologists during the
      intraoperative period. It becomes even more important in high-risk long lasting surgeries as
      pancreaticoduodenectomy. Therefore evaluating fluid responsiveness prior to fluid loading is
      highly recommended. To the best of our knowledge there is no study comparing the abilities
      short time low PEEP challenge and mini fluid challenge in predicting fluid responsiveness.
    


Intervention name(s): Fluid Loading
Intervention type(s): Other
Intervention description(s): Hemodynamic and ventilatory parameters will be recorded at five time points (T1 - T5). After baseline meausrements (T1), additional 5 cmH2O PEEP will be applied to patients for 30 seconds (short time low peep challenge, SLPC). Prior to PEEP lowering T2 measurement will be performed. T3 measurement will be performed one minute after PEEP is decreased to its initial value and will be recorded as the second baseline. Thereafter, 100 ml isotonic saline will be infused over one minute (MFC). T4 measurement will be performed one minute after MFC is completed,. Lastly, T5 measurement will be performed three minutes after additional 400 ml of isotonic saline is infused within 10 minutes to complete 500 ml of fluid loading.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing pancreaticoduodenectomy
      
Keywords: Intraoperative monitoring; fluid therapy
Cluster-RCT Collective Nasopharyngeal COVID-19 Testing Amongst Pupils
Condition: Peer Group; Parents
Study type: Interventional

Summary: 
      Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a
      nasopharyngeaal swab test?
    

Detailed description: 
      In order to control the outbreak of cluster infections on school during the COVID-19
      pandemic, regular rounds of collective nasopharyngeal swab testing were organized. However,
      it is unclear under which circumstances nasopharyngeal swab testing is better accepted by
      young children. Due to the closing of schools, and the different logistic situations in
      schools, a natural pragmatic RCT formed. In some cases, children could observe their peers
      before having their own test, while for others the view was blocked. Also, sometimes parents
      would be present during a test procedure when the school was closed, while they were not
      present when the school was open. To date, it is unclear whether these two variable elements
      influence a child's resistance to be tested. Therefore a cluster-randomized controlled trial
      with testing site as the unit of randomisation will be set-up. Four conditions will be
      tested. On the individual level, the resistance of their peers before their own testing will
      be taken into account. The aim of the study is to compare whether (1) the visibility of
      nasopharyngeal swab testing on their peers and (2) the presence of their parents impacts a
      child's resistance towards the test. Additionally, the impact of whether or not their peers
      resisted the test impact predicts the likelihood of their own resisting behaviour.
    

Intervention name(s): Parent and peer presence
Intervention type(s): Other
Intervention description(s): Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Public Health; Pediatric; Nasopharyngeal; Collective testing
Brain and Peripheral Electrical Stimulation in Chronic Low Back Pain: a Factorial Design
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of brain and peripheral electrical
      stimulation on chronic non-specific low back pain patients.
    


Intervention name(s): Transcranial direct current stimulation (tDCS); Transcutaneous electrical nerve stimulation (TENS)
Intervention type(s): Procedure; Procedure
Intervention description(s): Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively; Technique based on the application of low-voltage electrical current to the skin through relatively large electrodes that are placed over the pain area.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
DBS of the Third Ventricle for Cluster Headache and Obesity
Condition: Cluster Headache; Obesity
MeSH terms: Cluster Headache; Obesity; Headache
Study type: Interventional

Summary: 
      Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity
      treatment.
    


Intervention name(s): Deep Brain Stimulation V3
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment