bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Homeopathic Nasal Formulation for Management of Experimental Rhinoviral Colds
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Common colds affect many people and are the cause of bothersome symptoms such as runny or
      stuffy nose, sore throat, headache and sneezing. Common colds can also cause more severe
      illnesses in certain groups of people like the elderly, people with chronic lung diseases
      such as asthma.

      This study is designed to test whether a non-drug (homeopathic) nasal spray will reduce the
      incidence of colds, decrease cold related symptoms or shorten the length of the cold.
    

Detailed description: 
      Common colds are the most frequent type of respiratory infection, and although the clinical
      manifestations are usually not life threatening or debilitating, they cause annoying symptoms
      such as nasal congestion, rhinorrhea, malaise, sore throat and sneezing, that can interfere
      with activities of daily living. Furthermore, colds can cause more severe illnesses in
      certain people including: infants, the elderly, and people with asthma, chronic lung
      diseases, or immune deficiency.

      This clinical trial is designed to test whether a new homeopathic formulation has beneficial
      effects on the management of common colds that have been induced by inoculation of rhinovirus
      into the nose of healthy subjects.

      The objective of this research clinical study is to evaluate the effectiveness of a
      homeopathic nasal formulation for the management of experimentally-induced common colds as
      indicated by a reduction in:

        -  Cold incidence compared to placebo,

        -  Symptom severity compared to placebo

        -  Cold duration compared to placebo

        -  Infection rate compared to placebo

        -  Duration of virus shedding compared to placebo or

        -  Amount of virus shedding compared to placebo
    

Intervention name(s): homeopathic nasal spray
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: homeopathic; common cold; Research Subjects
A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B
Condition: Hemophilia
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics and pharmacodynamics of rhFVIIa at three dose
      levels. The results will help identify the most optimal doses to take forward to the Phase
      2/3 studies where bleedings in hemophilia patients with inhibitors will be treated with
      rhFVIIa.
    


Intervention name(s): rhFVIIa
Intervention type(s): Biological
Intervention description(s): Patients will be administered low, intermediate and high doses of rhFVIIa
Other intervention name(s): Coagulation Factor VIIa (Recombinant)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Manipulative Treatment of Children With Neck and Back Pain
Condition: Neck Pain; Back Pain
MeSH terms: Back Pain; Neck Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of manipulative treatment of children
      with neck and back pain. Because manipulation is the most frequently used treatment of
      musculoskeletal complaints in children, and an increasing number of Danish children see a
      chiropractor, it appears obvious to start the search for evidence by examining the effect of
      this treatment.
    

Detailed description: 
      Parents receive text messages [SMS) on a weekly basis inquiring about the child's
      musculoskeletal pain as well as amount and types of sport during leisure time the past week.
      Following a report of pain, the parents will be interviewed by phone by a member of the
      clinical team, consisting of two licensed physical therapists and two licensed chiropractors,
      for a thorough description of the complaint. Based on this, the interviewer determines
      whether the complaint is negligible or whether the child should be seen by a member of the
      clinical team, in which case the child will be examined at his or her school. At this
      examination, the child will be evaluated for inclusion and exclusion criteria.
    

Intervention name(s): Advice and exercise-based treatment plus joint manipulation; Advice and exercise-based treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): The treatment can consist of advice, activation and exercise and/or manual soft-tissue treatment plus joint manipulation.The areas and frequency of manipulative treatment will be determined by the chiropractor and will consist of high-velocity, low-amplitude manipulation and/or mobilization to the spine and/or the extremities.; The treatment can consist of advice, activation and exercise and/or manual soft-tissue treatment. However, assisted stretching is not allowed as this will approach mobilization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Manipulative treatment; Children; Neck pain; Back pain; Effect; Adolescence; Advise; Exercise
Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria
Condition: Uncomplicated Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate three dose levels of a combination tablet and a
      fixed dose granule formulation of pyronaridine and artesunate (PA) for the treatment of acute
      uncomplicated falciparum malaria in children.
    

Detailed description: 
      This is a Phase II, open-label, sequential-group, dose-escalation, single-centre study to
      study pharmacokinetics, bioavailability comparison of tablets vs. granules, and
      safety/tolerability of PA in paediatric patients with acute symptomatic uncomplicated P.
      falciparum malaria. The study population will include 60 patients, comprising male and female
      children recruited from a single study site located in the endemic region of Gabon.

      Patients will be assigned sequentially to 1 of 4 treatment groups (15 per group): Group A
      (Tablets) PA (48 mg + 16 mg), Group B (Tablets) PA (72 mg + 24 mg), Group C (Tablets) PA (96
      mg + 32 mg), Group D (Granules) PA (60 mg + 20 mg). Oral tablets will be taken once daily for
      3 consecutive days (Days 0, 1 and 2). The dose given to each patient depends on the dosing
      cohort group and the patient's body weight.

      Each patient will attend the study site for screening and baseline procedures, as well as
      receipt of the first dose of study drug on Day 0 (Visit 1, baseline). Patients will be
      hospitalised for the first 72 hours and remain near the study site for the entire duration of
      the study. The patients will return to the study site for all scheduled follow-up visits
      until discharge on Day 42.

      The primary efficacy end point for the study is the incidence of patients with PCR-corrected
      adequate clinical and parasitological response (ACPR) on Day 28. In the case of adverse
      events reported and unresolved at Day 42, patients will be followed up for a further 30 days,
      or until resolution of the event.
    

Intervention name(s): Pyronaridine-Artesunate
Intervention type(s): Drug
Intervention description(s): Once a day for 3 days
Other intervention name(s): Pyramax
Intervention MeSH terms: Artesunate; Pyronaridine; Pyronaridine tetraphosphate, artesunate drug combination
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malaria; P. falciparum; artemisinin based combination therapy (ACT); antimalarial; pyronaridine artesunate (Pyramax)
Cell Therapy by Bone Marrow-derived Mononuclear Cells (BMC) for Large Bone Defect Repair: Phase-I Clinical Trial
Condition: Humerus Fracture Displaced Proximal
MeSH terms: Humeral Fractures
Study type: Interventional
Phase: Phase 1

Summary: 
      In the present phase-I clinical trial we investigate safety and feasibility of an
      augmentation with preoperatively isolated autologous BMC cells seeded onto ß-TCP in
      combination with an angle stable fixation (Philos plate®) for the therapy of proximal humeral
      fractures.
    


Intervention name(s): BMC2012
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: large bone defect, bone marrow-derived mononuclear cells
Telerehabilitation Following Meniscectomy
Condition: Meniscectomy
Study type: Interventional

Summary: 
      Telerehabilitation is a form of tele-treatment in which rehabilitation services are dispensed
      at patients' home utilizing video telecommunication services with real-time synchronous
      exchange of information. Since telerehabilitation was found to be equally effective as
      conventional therapy, it was being practiced even before the COVID times, however it was
      truly valuable during the lockdown. The advantages of telerehabilitation include reducing
      unnecessary travel to the hospital and person to person contact while maintaining social
      distancing. While some of the patients are truly staying at remote areas, others are unable
      to manage travel in the lockdown period. Telemedicine offers the opportunity to deliver
      rehabilitative services in the patients' home, closing geographic, physical, and motivational
      gaps. Punctuality on either side is also assured since the travel times are saved on both the
      ends.

      The purpose of the proposed study is to evaluate telerehabilitation vs in-person
      rehabilitation following Meniscectomy.
    


Intervention name(s): Telerehabilitation Therapy; In-person Rehabilitation Therapy
Intervention type(s): Other; Other
Intervention description(s): Rehabilitation services will be dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information - range of motion exercises for the knee, proprioception and balance training; Range of motion exercises for the knee, proprioception and balance training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Long-term Fasting in Patients With a History of PCI
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Patients in this prospective cohort study were selected if they had a history of PCI more
      than 1 year previously. 405 patients were divided based on their preferences to fasting and
      non fasting and after 1 month of fasting major adverse cardiovascular events were measured
    

Detailed description: 
      Between 18 March 2019 and 18 April 2020, patients seen at Professor Kojuri Cardiovascular
      Clinic in Shiraz, Iran (email:kojurij@yahoo.com, webpage: http://kojuriclinic.com) for their
      annual check-up were selected. We explained the research project to them, and volunteers were
      selected. Patients were assigned to the fasting or non-fasting group according to their
      preference. All volunteers were informed about the details of this research, and provided
      their written informed consent. Patients who declined to participate in the study were
      excluded.

      Patients were instructed how to divide their medication across the two daily meals before
      dawn and after sunset during the month of Ramadan. We informed patients to immediately stop
      fasting and consult the clinic if they experienced any signs of cardiovascular disease,
      including shortness of breath, chest pain, or palpitations. At the end of Ramadan, patients
      were contacted by telephone and asked about their symptoms, including chest pain and dyspnea,
      hospitalization, and MACE. The MACE were defined as acute myocardial infarction,
      hospitalization due to congestive heart failure, new-onset atrial fibrillation, stroke, or
      cardiac arrest [19, 20]. Symptomatic patients were referred to the clinic for cardiovascular
      examination.

      The study was double-blinded. To blind the researchers, the clinic secretary contacted the
      patients and asked them not to specify their group (fasting or non-fasting), and then passed
      the phone to the researcher. We used alphabetical order in each group to blind the
      statisticians. Patients who fasted during Ramadan were designated with the letter X, and
      patients who did not fast during Ramadan were designated with the letter Y.

      For statistical analyses we used IBM SPSS software version 25. We used the chi-squared test
      to compare categorical variables and Student's t-test to compare the mean values of
      continuous variables. The Mann-Whitney U test and Kruskal-Wallis test were used for
      nonparametric variables.
    

Intervention name(s): fasting; not fasting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): more than 12 hour of fasting as ceremony of Ramadan; preferred not to take long term fasting
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: prolonged fasting; percutaneous coronary angioplasty; major adverse cardiac events
Novel Multifocal Soft Contact Lens Study
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      A single site, open label protocol will be used to evaluate the safety and quality of vision
      of a novel soft contact lens. Habitual contact lens wearers will be asked to come to the
      study site for one visit. Ocular health assessments and visual acuity will be completed with
      both the study lens and without.
    


Intervention name(s): Investigational Contact Lens
Intervention type(s): Device
Intervention description(s): A soft contact lens that will be worn only at the study visit.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Zika Virus Infection's Pregnancy Consequences in French Department of America
Condition: Incidence of ZIKV Infection on Fetus During the Pregnancy
MeSH terms: Infections; Zika Virus Infection
Study type: Observational [Patient Registry]

Summary: 
      The Zika (ZIKV) epidemic has spread into the three French Overseas Departments in the
      Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical
      data for the evaluation of potential complications due to having ZIKV infection during
      pregnancy. This study is meant to collect, within usual care practices, clinical and
      paraclinical information which will allow the precise description of the consequences of ZIKV
      infection occurring during pregnancy.
    

Detailed description: 
      This is a prospective observational, non-interventional study that has been integrated into
      the usual standard of care practices. All information and biological samples collected during
      the course of this project will be done through the new medical standard of care which has
      been put in place during the ZIKV epidemic in the DFAs; this new standard of care is a result
      of existing recommendations from medical professionals and/or public health authorities.
      Outside of these recommendations, no invasive procedure will be done simply to satisfy an
      objective of this study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population of this study is women who have been pregnant during the 2016 ZIKV Epidemic
        in the DFAs. Five study arms (hereafter called 'modules') have been defined with various
        inclusion criteria for each module.

        M1: Pregnant women with clinical signs of acute ZIKV infection

        Module 2: Pregnant women for which an abnormality has been detected in the fetus.

        Module 3: Bio-bank of serum, collected once per trimester, from all pregnant women.

        Module 4: Bio-bank of maternal blood and infant cord blood, taken the day of birth in all
        mothers and their babies in the 3 DFAs.

        Module 5: Bio-bank of maternal blood and fetal tissues from women in whom the pregnancy was
        terminated due to miscarriage, abortion on medical grounds, or a fetal death in-utero.
      
Biospecimen description: 
      -  bio-bank of serum from all pregnant women.

        -  bio-bank of maternal blood and infant cord blood

        -  bio-bank of maternal blood and fetal tissues
    
Keywords: asymptomatics; microcephaly; abnormalities
A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated the efficacy and safety of rituximab in patients with active rheumatoid
      arthritis (RA).
    


Intervention name(s): Folate; Methotrexate; Methylprednisolone; Placebo; Rituximab
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): A stable dose, ≥ 5 mg/week given as either a single dose or as a divided weekly dose, orally.; A stable dose of between 10-25 mg/week, oral or parenteral, as prescribed by the treating physician.; Intravenous infusion; Placebo to rituximab intravenous infusion; Intravenous infusion
Other intervention name(s): MabThera®; Rituxan®
Intervention MeSH terms: Methylprednisolone; Rituximab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RA; Rituxan; SERENE
The Utility of Platelet Rich Plasma in Hair Loss
Condition: Androgenetic Alopecia
MeSH terms: Alopecia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Platelet rich plasma (PRP) is an autologous preparation of human plasma with high
      concentration of platelets. Platelets release numerous growth factors, which stimulate cell
      proliferation and differentiation.

      The purpose of this research is to investigate the potential of PRP injection for treatment
      of hair loss. Clinical outcomes will be assessed by noninvasive techniques including
      dermoscopy, multiphoton microscopy, optical coherence tomography, optical Doppler tomography
      and multispectral imaging.
    


Intervention name(s): Platelet rich plasma
Intervention type(s): Procedure
Intervention description(s): Blood drawn from each participant will be spun down to separate platelets. Platelets will be injected into that patient's scalp.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare Active Tymbion Iontophoresis to Sham Tymbion Iontophoresis for Anesthesia of the Tympanic Membrane
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 2

Summary: 
      A prospective, multicenter study to determine if active Tymbion iontophoresis is superior to
      sham Tymbion iontophoresis in providing anesthesia to the tympanic membrane (TM). The study
      will use the Tula iontophoresis systems for healthy adult volunteers in an office setting,
      called Group A of Protocol CPR007003.

      The protocol CPR007003 also includes a Group B study described in a separate Registration
      (NCT03197558).
    

Detailed description: 
      The objective of the study is to determine if active Tymbion iontophoresis is superior to
      sham Tymbion iontophoresis in providing anesthesia to the tympanic membrane. In addition,
      safety will be evaluated by review of the occurrence of adverse events.

      The iontophoresis system (IPS) will be used to facilitate anesthetic delivery to the tympanic
      membrane (TM). The lidocaine-based solution used for local anesthesia of the TM is Tymbion
      (2% lidocaine HCl/ 1:100,000 epinephrine).

      Group A will consist of 40 evaluable healthy adult subjects randomized (1:1) to receive
      unilateral treatment (1 ear) with either active Tymbion iontophoresis or sham Tymbion
      iontophoresis. The sham iontophoresis procedure will be identical to the active Tymbion
      iontophoresis, with the exception that the iontophoresis current will not be activated (ie,
      the same drug solution will be applied to ears in both arms). After the completion of the
      iontophoresis procedure, the tympanic membrane will be tapped with a dull otologic probe to
      test the level of anesthesia. The subject will rate the level of pain using the Visual
      Analogue Scale (VAS) immediately after the tap. Investigators and subjects will be blinded to
      treatment assignment.

      Safety assessments will be done post procedure and at follow as applicable.
    

Intervention name(s): Tymbion Lidocaine/epinephrine solution; Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution
Intervention type(s): Drug; Combination Product
Intervention description(s): The external ear canal will be filled with Tymbion drug solution; The external ear canal will be filled with Tymbion drug solution. The Iontophoresis System (IPS) will be used to deliver current to the Tymbion solution to facilitate drug penetration into the tympanic membrane (TM) tissue to anesthetize (numb) the TM
Other intervention name(s): 2% lidocaine HCl/ 1:100,000 epinephrine; Tymbion; Tula Iontophoresis System; 2% lidocaine HCl/1:100,000 epinephrine; Tymbion
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Pharmaceutical Solutions; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function
Condition: Secondary Hypogonadism
MeSH terms: Renal Insufficiency; Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in
           overweight male subjects with various stages of renal impairment and in volunteers with
           normal renal function.

        -  To compare the safety profile of a single dose of 25 mg Androxal in overweight male
           subjects with various stages of renal impairment and in volunteers with normal renal
           function.
    


Intervention name(s): Androxal 25 mg
Intervention type(s): Drug
Other intervention name(s): enclomiphene citrate
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic