bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety and Efficacy of Artemisinin- a Herbal Supplement on COVID-19 Subjects
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be an open label, prospective, multi-center, comparative, interventional study to
      evaluate safety and efficacy of Artemisinin 500 mg in subjects with mild to moderate
      COVID-19. Initially subjects having mild to moderate COVID-19 will be screened as per
      predefined eligibility criteria for the study. Eligible 120 subjects will be enrolled to
      receive treatment with Artemisinin and SOC (Standard of Care as per CLINICAL MANAGEMENT
      PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate
      General of Health Services (EMR Division)) or SOC. Subjects will be randomized in 2:1 ratio.
      Group 1 will have 80 subjects and Group 2 will have 40 subjects.
    

Detailed description: 
      The study will involve screening (Day 1), treatment period of up to maximum 28 days till end
      of study. The investigator shall make every effort to follow the schedule of study
      assessments and procedures. A window period of 1 day will be allowed for assessments post
      randomization. Screening Upon obtaining the written informed consent the subjects will be
      screened to confirm the eligibility for participating in this study. If RT PCR result is
      available for the subject then screening and baseline (randomization) activity will be on the
      same day. As per the Investigator discretion, the subjects meeting the criteria will be
      hospitalized for the first cycle of treatment Treatment period Subjects will receive
      investigational product and SOC after randomization as per protocol. Subject's compliance
      with the study treatment regimen of Artemisinin one (1) capsule a day for five (5) days, will
      be assessed during treatment period. Subjects receiving at least one dose of study treatment
      will be included in the safety analysis. Efficacy analysis will be conducted in completers
      (subjects who have completed at least 5 consecutive days of dosing in either arm) The first
      cycle of the study drug treatment will be given in the hospital, for which the subjects have
      to be hospitalized till Day 5, unless prolongation of hospital stay is necessary as per the
      investigator. On day 14, telephonic follow up is done for subjects discharged after Day 5.
      For Day 28 visit all subjects will visit the hospital to complete the End of Study
      activities.
    

Intervention name(s): Artemisinin; Dexamethasone
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): a herbal supplement; corticosteroids
Intervention MeSH terms: Artemisinins; Artemisinin; Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 to 1 ratio
Masking: None (Open Label)
Primary purpose: Treatment
Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 2

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the
      uterus or womb). This infection may go away by itself, but if it does not go away (this is
      called persistent infection), it can lead in women over a long period of time to cancer of
      the cervix. This study will evaluate the efficacy in prevention of persistent HPV-16 or
      HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK
      Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 -
      25 years of age at study start. Approximately 1000 study subjects will either receive the HPV
      vaccine or a control vaccine (Hepatitis A vaccine) administered intramuscularly according to
      a 0-1-6 month schedule.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      The Protocol Posting has been updated to reflect changes as a consequence of an amendment to
      the protocol. Sections impacted are Official Title of the study and Intervention name.
    

Intervention name(s): HPV-16/18 vaccine (Cervarix™); Aimmugen™
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HPV Vaccine Efficacy
Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin
Condition: Schizophrenia; Celiac Disease
MeSH terms: Celiac Disease; Schizophrenia
Study type: Observational

Summary: 
      The purpose of this protocol is to collect serum zonulin levels in people with schizophrenia.
      This one time visit will collect zonulin levels, antibodies to gliadin (tissue
      transglutaminase and antigliadin antibodies) and other information that may relate to
      increased intracellular tight junction permeability as it related to the immune and stress
      system and the immune association with kynurenic acid pathway 50. Data will be collected for
      use in future grant applications and published reports.
    


Intervention name(s): Blood Draw
Intervention type(s): Procedure
Intervention description(s): One time blood draw
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with schizophrenia will be recruited by MPRC through their patient recruiting
        network including the Treatment Research Program and the Outpatient Research Program and
        affiliated sites. Patient with schizophrenia may also be recruited through the NIDA
        screening protocol process. (UMB approved IRB protocol HP-00043664)
      
Biospecimen description: 
      Laboratory Measures:

      Zonulin and gliadin antibodies will be sent to the lab of Dr. Alessio Fasano for assay.

      Genetic and Biochemical analysis will be sent for analysis and storage of blood sample at the
      Maryland Psychiatric Research Center Neurogenetics laboratory under the direction of Dr.
      Ikwunga Wonodi. Analysis will include kynurenic acid metabolites, inflammatory markers from
      Peripheral Blood Mononuclear Cells (PBMC) and future genetic analysis including but not
      limited to human leukocyte antigen (HLA) haplotypes (DQ2 and DQ8).

      Cytokines will be analyzed by the Cytokine Core Laboratory at the University of Maryland
      using Luminex Technology.

      Other standard laboratories will be done by Lab Corp or other contract laboratory.
Bunionectomy Study (0000-063)
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      We are interested in whether bunionectomy can be used as a model to study the treatment of
      acute pain. It has been used to study the effect of Non-Steroidal Anti-inflammatory (NSAIDS)
      medications (such as ibuprofen) and other pain relieving drugs. We are interested to know if
      this model is useful to study other drugs for the treatment of acute pain. The other drugs
      being tested in this study are pregabalin and naproxen sodium. These drugs are approved for
      use by the Food and Drug Administration (FDA). This study is designed to test whether these
      two drugs are effective in treating pain after a bunionectomy.
    


Intervention name(s): pregabalin; naproxen sodium; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will be randomized just prior to surgery to 1 of 3 study treatments: pregabalin (300 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.; Patients will be randomized just prior to surgery to 1 of 3 study treatments: naproxen sodium (550 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium will be dosed starting 12 hours following T=0 and every 12 hours until 36 hours following T=0.; Patients will be randomized just prior to surgery to 1 of 3 study treatments: placebo treatment will be administered approximately 1 hour prior to surgery. Postoperatively, placebo will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
Other intervention name(s): naproxen
Intervention MeSH terms: Naproxen; Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Primary, unilateral, first metatarsal bunionectomy with osteotomy
Electrical Muscle Stimulation on Muscle Mass, Strength, and Body Composition
Condition: Electrical Muscle Stimulation; Exercise; Resistance Training
Study type: Interventional

Summary: 
      In recent years, electrical muscle stimulation (EMS) devices have been developed as a
      complementary training technique that is novel, attractive, and time-saving for physical
      fitness and rehabilitation. While it is known that EMS training can improve muscle mass and
      strength, most studies have focused on the elderly or specific patient populations. The aim
      of this study was to investigate the effects of frequency-specific EMS combined with
      resistance exercise training for 8 weeks on muscle mass, strength, power, body composition,
      and parameters related to exercise fatigue. Additionally, we aimed to evaluate the
      feasibility and safety of EMS as an exercise aid to improve body composition. We recruited 14
      male and 14 female subjects who were randomly assigned to two groups with gender parity (7
      male and 7 female/group): (1) no EMS group and (2) daily EMS group. Blood biochemical routine
      analysis was performed every 4 weeks from pre-intervention to post-intervention, and body
      composition, muscle strength, and explosive power were evaluated 8 weeks before and after the
      intervention. We also performed an exercise challenge analysis of fatigue biochemical
      indicators after 8 weeks of intervention.
    


Intervention name(s): electrical muscle stimulation
Intervention type(s): Device
Intervention description(s): The electric muscle stimulator (EMS) used in this study was from Funcare (Funcare Co., Ltd, Taichung, Taiwan). EMS electrodes were attached to the biceps of both hands, the abdomen, and the quadriceps of both legs sequentially. Each part was stimulated once a day for 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Autologous Mitochondrial Transfer in ICSI to Improve Oocyte and Embryo Quality in IVF Patients. Pilot Study
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The principle objective is to improve embryo quality through autologous micro-injection of
      mitochondria isolated from Ovarian stem cells into the oocytes themselves, as a complementary
      ICSI technique in patients with low embryo quality in previous IVF cycles and in those who
      did not bear children.

      This improvement in embryo quality will be determined through on-going pregnancy rate after
      treatment and/or improvement in embryo quality according to morphological
      (ASEBIR-"Association for the study of Biology in Reproductive Science), morphokinetic
      criteria and in Preimplantation Genetic Screening.

      Using an adaptive design, retrieved oocytes of approximately 60 patients will be randomized
      in the first part of the study to two treatment groups; standard ICSI procedure without
      mitochondrial supplementation and ICSI with autologous mitochondrial supplementation.
      Following an interim analysis of outcomes, an additional 130 patients may be added, for a
      total of 190 patients.
    


Intervention name(s): Autologous mitochondria with ICSI; STANDARD ICSI PROCEDURE
Intervention type(s): Other; Other
Intervention description(s): Autologous mitochondria during the intracytoplasmic sperm injection (ICSI) process will be added to this randomized group of oocytes.; STANDARD ICSI PROCEDURE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effect of Acetazolamide on Lung Water Content by Ultrasound in Patients With Respiratory Disease at Altitude
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on lung
      water content by ultrasound at acute altitude exposure in patients with Chronic Obstructive
      Pulmonary Disease (COPD).
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect
      of acetazolamide (375 mg per day) vs. placebo on lung water content by ultrasound in
      lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants
      living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the
      Tuja Ashu high altitude clinic (3100 m), and stay there for 2 days. Acetazolamide 375mg/day
      (or placebo) will be administered 24 hours before departure at 760 m and during the stay at
      altitude. Outcomes will be assessed during the stay at 3100 m.
    

Intervention name(s): ACETAZOLAMIDE oral capsule; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3100m; Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3100m
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention; acetazolamide; obstructive airway disease; lung water
A Video-Based HCV Curriculum for Drug Users
Condition: Hepatitis C; Opiate Dependence
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Opioid-Related Disorders
Study type: Interventional

Summary: 
      The investigators hypothesize that a well-designed hepatitis C (HCV)video education
      curriculum for high-risk drug users will show measurable benefits in improving HCV testing,
      hepatitis A and B vaccinations, and HCV knowledge, attitudes, and motivations toward
      transmission behavior change. The investigators will use a 4-part modular video series
      designed for at-risk drug users, and in this 12 week study will assess its impact on
      testing/vaccinations as well as knowledge, attitudes, and motivations in methadone-maintained
      drug users as compared to a usual-care intervention.
    

Detailed description: 
      Injection drug users are at high risk for contracting hepatitis C (HCV). Very few
      culturally-specific educational tools have been developed to improve outcomes in this
      population. We hypothesize that measurable improvements in HCV testing, hepatitis A and B
      vaccinations, and testable knowledge, attitudes, and motivations may be elicited by such a
      curriculum.

      In this study, we will investigate the impact of a 4-module short video educational series on
      these measures in in-treatment drug users maintained on methadone. Subjects will be enrolled
      in 3 sequential cohorts of 150 each: usual care, a 4 weekly sequential video cohort, and a
      single-session intervention in which the 4 videos are viewed at once. Subjects will undergo
      written testing for knowledge, attitudes about transmission behaviors, and motivations toward
      behavior change before the intervention, 4 weeks after the intervention, and 12 weeks after
      the intervention. Additionally, we will measure and compare the rates of HCV testing and
      HAV/HBV vaccinations before and at the 12-week time point in all cohorts.
    

Intervention name(s): Hepatitis C educational video; Video
Intervention type(s): Behavioral; Other
Intervention description(s): Prevention education video about hepatitis C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: hepatitis C; heroin; populations at risk; testing; vaccination
Study to Investigate the Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic Soft Tissue Sarcoma
Condition: Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1 open-label study to study the safety and activity of aldoxorubicin with
      ifosfamide/mesna in subjects with metastatic, advanced, unresectable soft tissue sarcoma.
    


Intervention name(s): aldoxorubicin; aldoxorubicin; aldoxorubicin; ifosfamide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): administered at 170 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days; administered at 250 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days; administered 350 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
Other intervention name(s): INNO-206; INNO-206; INNO-206
Intervention MeSH terms: Ifosfamide; Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: soft tissue sarcoma; aldoxorubicin; ifosfamide; mesna; phase 1; INNO-206
A Two-part Study in Edoxaban-treated Healthy Subjects to Establish a Punch Biopsy Bleeding Model and to Evaluate the Effect of a 4-factor Prothrombin Complex Concentrate on Anticoagulation
Condition: Bleeding
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study consists of 2 parts. Part 1 will be an open-label, randomized, 2
      treatment, 2-way crossover study. Part 2 will be a double-blind (Sponsor unblinded),
      randomized, placebo controlled, sequential descending prothrombin complex concentrate dose, 2
      sequence, 2 period crossover study. In both parts of the study, the assessor of BD and BV
      will remain blinded. In Part 2 of the study, both the subject and the clinic staff involved
      in study conduct will be blinded (with the exception of the pharmacist or nurse who prepares
      the blinded individual treatments from open-label supplies). The study programmer and
      statistician will also be blinded to treatment assignment. The Sponsor will remain unblinded
      for both parts of the study.
    


Intervention name(s): 60mg edoxaban; 180mg edoxaban; 50 IU/kg Beriplex P/N; 25 IU/kg Beriplex P/N; 10 IU/kg Beriplex P/N
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Edoxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: punch biopsy
A Single Dose Study To Test Two Pediatric Forms Of Ritlecitinib Compared With Adult Ritlecitinib In Healthy Adults
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I, single dose study to test two forms of pediatric ritlecitinib compared to adult
      ritlecitinib in healthy adults aged 18-55 years old. Approximately 12 adults will participate
      for approximately 2.5 months.
    


Intervention name(s): ritlecitinib; ritlecitinib; ritlecitinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30 mg intact adult capsule; 10 mg pediatric capsule; 30 mg spray congealed beads
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole
      administered alone & in combination with Multi MatriX system (MMX®) formulation of
      mesalazine/mesalazine (Lialda®; Mesavancol®; Mezavant®) (MMX Mesalazine/mesalamine).
    


Intervention name(s): sulfamethoxazole + MMX placebo; Sulfamethoxazole + MMX Mesalazine/mesalamine
Intervention type(s): Drug; Drug
Intervention description(s): 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX Mesalazine/mesalamine placebo once daily (QD) orally for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX Mesalazine/mesalamine placebo orally on Day 4.; 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4
Other intervention name(s): Lialda
Intervention MeSH terms: Sulfamethoxazole; Mesalamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Impact of Experienced Endoscopy Nurse Participation on Polyp and Adenoma Detection During Colonoscopy
Condition: Polyp; Adenoma
MeSH terms: Adenoma; Polyps
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether experienced endoscopy nurse participation
      during screening colonoscopy could increase polyp and adenoma detection rate.
    


Intervention name(s): Colonoscopist only; Experienced Endoscopy Nurse Participation
Intervention type(s): Procedure; Procedure
Intervention description(s): Only Colonosopist Observe during Colonoscopy (single observer); Experienced Endoscopy Nurse Participation Observation during Colonoscopy (Both endoscopist and endoscopic nurse observe)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nurse; Colonoscopy; Polyp; Adenoma;