bioihbjkbjnl/mcl2 huggingface dataset:
The PK/PD Study of A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Single Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel
      Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics,
      Pharmacodynamics with A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects.

      The primary objective of this study is to investigate the safety and tolerability of a range
      of subcutaneous SHR-1222 in healthy subjects. Secondary objectives are to determine the
      pharmacokinetics (PK) and pharmacodynamics(PD) profile of SHR-1222 in healthy subjects
      including assessment of immunogenicity.
    

Detailed description: 
      50 adult healthy subjects with 5 dose groups will be enrolled in the study, including six
      subjects in the lowest dose group, four of whom received the SHR-1209 and two of whom
      received the placebo. The other three groups have 11 subjects in each group, 9 administered
      SHR-1222 and 2 administered placebo. The primary endpoint is the Safety and Tolerability :
      adverse events, vital signs, physical examination, laboratory examination, 12 lead
      electrocardiogram, injection site reactions, etc.
    

Intervention name(s): SHR-1222; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: water injection Route of administration: subcutaneous; Pharmaceutical form: water injection Route of administration: subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Randomized Trial of DHA for Retinitis Pigmentosa Patients Receiving Vitamin A
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to determine whether a nutritional supplement in addition to
      vitamin A will slow the course of retinitis pigmentosa.
    

Detailed description: 
      Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide
      prevalence of approximately 1 in 4,000. Patients typically report night blindness and
      difficulty with midperipheral visual field in adolescence. As the condition progresses, they
      lose far peripheral visual field. Most patients have reductions in central vision by age 50
      to 80 years. Based on electroretinograms (ERGs), the course of the disease can be slowed on
      average among adults on 15,000 IU/day of vitamin A palmitate. While conducting the trial on
      the effects of vitamin A on RP, it became apparent that another substance in the diet could
      be affecting the course of the disease. This prompted the present randomized, controlled
      trial.

      This study is a randomized, controlled, double-masked trial with a planned duration of 5
      years. Patients with the common forms of RP are assigned to either a test or a control group.
      All receive 15,000 IU/day of vitamin A palmitate in addition to either 1200 mg/d of
      docosahexaenoic acid or control capsules. Participants will not know the contents of the
      supplement or the group to which they have been assigned until the end of the trial. The main
      outcome measurement is the total point score on the Humphrey Field Analyzer (HFA). In
      addition, computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured
      annually.
    

Intervention name(s): Vitamin A; Docosahexaenoic acid; Control fatty acid
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 15000 IU/d as retinyl palmitate; 1200 mg/d
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Apioc Toric/Spherical Single Vision Contact Lens
Condition: Refractive Errors
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The Lentechs Apioc-S and Apioc-A contact lenses are made in an FDA-approved contact lens
      material indicated for single-vision and astigmatism. The novel lens design has a lenticular
      portion which is thicker than the optical portion of the lens. When applied to the eye, it is
      oriented in a superior position. Unlike contact lenses currently on the market, this
      innovative design improves lens stability by preventing lens rotation, and may improve tear
      flow behind the lens.
    


Intervention name(s): Apioc-A and Apioc-S Contact Lenses
Intervention type(s): Device
Intervention description(s): Appropriately fit, document and dispense a new spherical and toric contact lens design worn for up to 35 days.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contact lens; soft contact lens
Modulation of Microbial Composition in Ileostomy Patients
Condition: Ileostomy - Stoma
Study type: Interventional

Summary: 
      To determine the small intestinal microbiota response in humans to dietary interventions for
      two consecutive weeks, and to relate this to parameters of intestinal barrier function and
      immune and metabolic responses in blood, as functional outcome parameters of host physiology
    


Intervention name(s): Probiotic 1; Probiotic 2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Fresh fermented dairy drink containing yoghurt ferments; Fresh fermented dairy drink containing probiotic strain; Acidified dairy drink without ferments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: probiotics, microbiota, ileostoma
Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar
Condition: Sexually Transmitted Infections; Schistosoma Haematobium
MeSH terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Schistosomiasis; Schistosomiasis haematobia
Study type: Interventional

Summary: 
      A cross-sectional study of urogenital schistosomiasis and sexually transmitted infections
      (STI) prevalence and associated morbidity in a rural community in Madagascar. Clearance of
      infections and resolution of morbidity were subsequently studied in two phases following
      systematic anti-STI and anti-schistosoma treatment, respectively.
    

Detailed description: 
      The study was conducted in the Schistosoma haematobium high-endemic SIRAMA sugarcane
      plantation near the Ambilobe town in the northern province of Diego Suarez in Madagascar. A
      neighboring low-endemic village, Mataipako, was selected a control village. Participants aged
      15 to 49 years old from SIRAMA were included in the study if positive for S.haematobium egg
      in urine.

      A questionnaire addressing previous medical history and current urogenital symptoms was
      applied. A physical examination, including ultrasonophical (US) examination of urinary tract
      by transabdominal route, was undertaken. A pelvic examination, including transvaginal US was
      performed in women. In men, the prostate and the seminal vesicles were examined by
      transrectal US.

      The following sexually transmitted infections (STI) were systematically assessed:

        -  Neisseria gonorrheae

        -  Chlamydia trachomatis

        -  Mycoplasma genitalium

        -  Trichomonas

        -  Treponema pallidum

        -  Herpes simplex 1 and 2

      After baseline assessment, all participants (and partners) were systematically treated with
      an anti-STI regimen according to the existing guidelines by the Ministry of Health in
      Madagascar.

      Re-assessment by questionnaire, physical examination and sampling for STIs was undertaken 4
      weeks later followed by systematic praziquantel treatment to general community, including
      study participants.

      A final follow-up study following the baseline protocol was conducted 5 months later.
    

Intervention name(s): Treatment with anti-STI and anti-schistosoma regimens
Intervention type(s): Drug
Intervention description(s): Anti-STI regimen: ciprofloxacin 500mg orally, doxycycline 100mg BID orally 7 days and metronidazole 2g orally (cefuroxime im and/or azithromycin alternatively for pregnant and breastfeeding women) Anti-schistosoma regimen: Praziquantel 40mg/kg
Other intervention name(s): Biltricide
Intervention MeSH terms: Praziquantel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Sexually transmitted infections; Urogenital schistosomiasis; Schistosoma haematobium; Reproductive health; Pelvic examination; Ultrasonography; Questionnaire; Madagascar
Single Dose and Multiple Dose Study to Assess Safety and Tolerability of LOU064
Condition: Healthy Volunteers, Atopic Diathesis and Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Disease Susceptibility
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 6-part first-in-human study in up to approximately 184 participants. Parts 1 to 5
      is in health volunteers and part 6 is in subjects with atopic dermatitis.

      The purpose of this first-in-human study is to assess the safety and tolerability and
      pharmacokinetics (PK) of single and multiple doses of LOU064 both as once and twice daily
      oral administration in healthy volunteers and those with atopic diathesis or atopic
      dermatitis. This study will also explore the effect of food intake and different drug
      substance particle sizes on the in vivo disposition of LOU064 in healthy volunteers to guide
      dosing and formulation development for future clinical trials.

      The study is registered on CT.Gov with the initiation of part 6 in patients (FPFV in April
      2019).
    

Detailed description: 
      The study is composed of the following parts:

      Part 1 is a double-blind, placebo-controlled single ascending dose (SAD) escalation study of
      up to 10 cohorts (N = approximately 80) in healthy volunteers Part 2 is a double-blind,
      placebo-controlled multiple ascending dose (MAD) escalation study in up to 6 cohorts in
      healthy volunteers with asymptomatic atopic diathesis with a 12-day treatment period (daily
      dosing) and 4-day follow-up period (N = approximately 48) Part 3 is a single cohort, single
      dose, open-label crossover food effect study (N = approximately 12) in healthy volunteers
      Part 4 is a double-blind, placebo-controlled multiple dose study in up to 2 cohorts of
      healthy volunteers with asymptomatic atopic diathesis with a 12-day treatment period (twice
      daily dosing) and 4-day follow-up period (N = approximately 16) Part 5 is a double-blind,
      single dose, crossover formulation effect study (N = approximately 12) in healthy volunteers
      Part 6 is a double-blind, placebo-controlled multiple dose study in subjects with atopic
      dermatitis with a 4-week treatment period (twice daily dosing of LOU064) and 3-week follow-up
      period in approximately 16 subjects
    

Intervention name(s): LOU064; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LOU064 will be administered as oral capsules in parts 1 to 6.; Matching placebo capsules will be administered in parts 1,2, 4 and 6.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment, So Stated
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out if different doses of Investigational Drug are safe,
      tolerable, and if they have an effect on Mild Cognitive Impairment (MCI).
    

Detailed description: 
      Pre-Clinical experiments indicate the AL-108 compound has neuroprotective, cognitive
      protective and neurotrophic properties; therefore, the compound could be tested in a variety
      of human diseases. Human diseases include Cognitive impairment associated with aging or
      neurodegenerative diseases such as Alzheimer's Disease.

      This clinical trial aims at providing the dose rationale as well as safety and tolerability
      information for AL-108 as evaluated after 12 weeks of intranasal administration in subjects
      with Mild Cognitive Impairment (MCI).

      There are currently no drugs approved for the treatment of MCI nor accepted treatment or
      standard treatment approach.
    

Intervention name(s): AL-108; AL-108; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 mg QD; 15 mg BID; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dementia; Memory; Alzheimers; Cognition; Mind; Aging
Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to
      visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the
      sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic
      procedures.
    

Detailed description: 
      The rationale behind this feasibility study is to show that accessing and visualization of
      the nasal anatomy and paranasal sinuses (Maxillary, Frontal and Sphenoid sinuses) in patients
      suffering from symptoms attributable to sinusitis is feasible; This is an essential step in
      the development of a system that will later allow visualization, sampling, and treatment of
      the sinuses via the natural sinus ostium during the patient's first office visit in a
      minimally invasive manner while enabling treatment by lavage, and minimizing radiation
      exposure, antibiotic use, multiple office visits, and cost.
    

Intervention name(s): 3NT flexible endoscope
Intervention type(s): Device
Intervention description(s): The nasal anatomy will be accessed and viewed with the device during functional endoscopic sinus surgery (FESS) procedure.
Other intervention name(s): Sinusway
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy of Chinese Ocular Exercise on Visual Acuity and Ocular Accommodation in Myopic Teenager
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      To assess whether Chinese ocular exercise is effective in altering distant and near visual
      acuity, ocular accommodation and visual symptoms in myopic teenager, and thus might have the
      possibility of slowing myopia progression in teenager through a weak but long-term effect.
    

Detailed description: 
      Myopia is a public health problem worldwide, especially in some Asian countries like China,
      Singapore, and Japan. Chinese ocular exercise, originating in 1963 with the theory of
      Traditional Chinese Medicine, is a kind of massage on acupuncture points around the eye to
      prevent myopia and alleviate visual fatigue. The exercise has been spread as a community
      ritual and living habit of primary and high school students for nearly half a century.
      However, the prevalence of myopia in Chinese children increased remarkably in recent years.
      Therefore, the efficacy of Chinese ocular exercise on preventing myopia or alleviating visual
      fatigue is widely questioned. Evidence from clinical trials of high level is needed to
      clarify that whether Chinese ocular exercise is effective in slowing and preventing myopia
      progression, or at least in part in easing the symptoms related to myopia and visual fatigue.
    

Intervention name(s): Chinese ocular exercise
Intervention type(s): Other
Intervention description(s): A kind of massage around the acupuncture points around the eye.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Exercise Performance
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a
      stay at moderate altitude on exercise performance of patients with chronic obstructive lung
      disease.
    

Detailed description: 
      Patients with moderate to severe COPD living below 800 m, will be recruited to participate in
      a randomized cross-over field trial evaluating the hypothesis that exercise capacity during a
      2 day sojourn at moderate altitude is improved by nocturnal oxygen therapy via a nasal
      cannula. Outcomes will be assessed during 2 days in Zurich (490 m, low altitude baseline),
      and during 2 days at St. Moritz Salastrains (2048 m).
    

Intervention name(s): oxygen; sham oxygen (room air)
Intervention type(s): Drug; Drug
Intervention description(s): Nocturnal nasal oxygen during stay at 2048 m; Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m
Other intervention name(s): Nocturnal oxygen via nasal cannula, 3 L/min, at 2048 m; Nocturnal nasal room air during stay at 2048 m
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: airway disease; bronchitis; emphysema; lung
A Study of Trimetrexate in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Not Previously Treated for PCP
Condition: Pneumonia, Pneumocystis Carinii; HIV Infections
MeSH terms: Pneumonia; Pneumonia, Pneumocystis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and effectiveness of trimetrexate (TMTX) given at increasing doses
      along with the leucovorin calcium (LCV) for treating Pneumocystis carinii pneumonia (PCP) in
      AIDS patients TMTX is an experimental new drug which is effective for treatment of PCP, but
      has been given to only a few patients. Therefore it is not certain if TMTX is better, the
      same as, or not as effective as conventional drugs against PCP.
    

Detailed description: 
      TMTX is an experimental new drug which is effective for treatment of PCP, but has been given
      to only a few patients. Therefore it is not certain if TMTX is better, the same as, or not as
      effective as conventional drugs against PCP.

      Increasing doses of TMTX are used in combination with LCV as initial treatment for PCP in 50
      AIDS patients. Doses are increased for 21 days on a once daily and then a twice daily basis.
      Dose escalations occur in subsequent groups of patients.
    

Intervention name(s): Trimetrexate glucuronate; Leucovorin calcium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Leucovorin; Trimetrexate; Calcium; Levoleucovorin
Primary purpose: Treatment
Keywords: Trimetrexate; AIDS-Related Opportunistic Infections; Pneumonia, Pneumocystis carinii; Injections, Intravenous; Leucovorin; Dose-Response Relationship, Drug; Drug Therapy, Combination; Folic Acid Antagonists; Administration, Oral; Acquired Immunodeficiency Syndrome; Antineoplastic Agents
Clinical Protocol of Sensitized Acupoint Changes in Knee Osteoarthritis Patients
Condition: Microdialysis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      Based on the research background and the preliminary research basis of the research group, in
      order to answer the material basis and micro-physical environment change characteristics of
      knee osteoarthritis sensitization acupoints and provide scientific basis for in-depth study
      of sensitization of acupoints. This study plans to use knee osteoarthritis as a research
      vehicle, and use microdialysis combined with high performance liquid chromatography to
      analyze the local material basis and key indicators of common sensitization points in knee
      osteoarthritis.
    

Detailed description: 
      This trial is a single-centre, normal controlled, parallel group, clinical trial. The trial
      is an explorative, pilot trial designed to reveal the change of the main material group in
      sensitized acupoints caused by knee osteoarthritis, and provide the key signal substance and
      its changing characteristics of knee osteoarthritis sensitized acupoints.
    

Intervention name(s): microdialysis
Intervention type(s): Device
Intervention description(s): Use microdialysis skill to collect dialyzate at sensitization acupoints
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 32 KOA patients and 32 normal volunteers will be included
      
Biospecimen description: 
      microdialysate of KOA patients' sensitised acupoints
    
Keywords: Knee Osteoarthritis; Sensitized Acupoints; Microdialysis; High performance liquid chromatography（HPLC）
Post Market Clinical Follow Up Study to Collect Additional Data and Imaging
Condition: Pigmentation; Wrinkle
Study type: Interventional

Summary: 
      The intended use of the PicoSure device with focus lens array used in this study is to assess
      images to support additional marketing claims for the treatment of pigmentation and mild to
      moderate wrinkles.
    

Detailed description: 
      Up to 10 subjects will be enrolled at 1 study center. Subjects will attend a
      screening/pretreatment visit which may be performed on the same day as the treatment visit.
      Subjects may receive up to 4 treatments on the face with the PicoSure device.
    

Intervention name(s): RF Non-Invasive Treatment
Intervention type(s): Device
Intervention description(s): Self-controlled single-arm group using the PicoSure device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment