bioihbjkbjnl/mcl2 huggingface dataset:
L-Arginine and Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether the treatment with L-arginine leads to an
      improvement of erectile dysfunction in patients with erectile dysfunction.
    

Detailed description: 
      Erectile dysfunction (ED) is a common medical disorder often affecting the aging male. Nitric
      oxide (NO) is a physiological signal essential to penile erection. NO synthase (NOS)
      catalyzes the production of NO from L-arginine. ADMA, a competitive inhibitor of NO synthase
      increases with age and many disorders that reduce NO in the erectile tissue are commonly
      associated with ED. Although new pharmacological strategies have been identified for medical
      treatment of ED, patients often seek alternative therapies for cost or side effect reasons.

      The aim of the present study is to determine the efficacy of orally administered L-arginine
      on ED not caused by established organic disease.
    

Intervention name(s): L-arginine; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: nitrate; nitric oxide; asymmetric dimethylarginine; blood pressure; NOS; IIEF
Osteopathy and Prevention of Gastrointestinal Side Effects in Women Treated for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Adjuvant chemotherapy with the protocol 3 cure of 5-FU + Epirubicine + Cyclophosphamide
      (FEC100) and 3 cure of Taxotere is a standard treatment in the management of patients with
      breast cancer and in adjuvant situation.

      The efficacy of 3 FEC100 and 3 Taxotere protocol in adjuvant situation for women treated for
      breast cancer is associated with several invalidating side effects for the quality of life of
      patients. 92% of women treated will present gastrointestinal toxicities of any grade. 11%
      will present nausea and vomiting of grade 3-4. Current treatments to prevent these
      gastrointestinal toxicities include Emend from Day 1 to Day 3 in association with setrons at
      Day 1 and corticosteroids from Day 1 to Day 3. Despite the marked improvement in
      gastrointestinal toxicities with preventive treatments, 83% of patients would use
      alternatives medicine: homeopathy, herbal medicine, acupuncture, hypnotherapy and / or
      osteopathy.

      Osteopathy is a method of care and unconventional therapeutic approach. In France, the
      professional title of osteopath is recognized. It aims to prevent and treat functional
      disorders, especially those related to adverse effects of treatment. In oncology, this
      discipline may have additional support for the patient by limiting the mechanical and
      physical constraints of sensitive areas to the toxicity of the treatment. In the case of
      gastrointestinal toxicities of myofascial and musculoskeletal techniques are used in
      abdominal areas to relieve symptoms. The investigators hypothesis is that osteopathy could
      have an interest in the management of gastrointestinal toxicities related to chemotherapy in
      women with breast cancer and in adjuvant treatment situation.
    


Intervention name(s): osteopathic technique; Placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): Osteopathe will perform continuous pressure on the middle ribs in order to reduce the mechanical stress of the anatomical elements related to liver; patients will have a relaxing osteopathic technique. A non therapeutic abdominal technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Tübingen High Altitude Ophthalmology Study
Condition: Altitude; Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      Tuebingen High Altitude Ophthalmology Study to investigate the effects of high altitude on
      retinal structure and function as well as anterior chamber in regard to acute mountain
      sickness.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy volunteers
A Healthy Female and Male Volunteers Aspirin Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between
      Esomeprazole and Aspirin after multiple dose administration.
    

Detailed description: 
      A Phase I, open-label, randomized, two way crossover pharmacokinetic study comparing the
      bioavailability of acetylsalicylic acid (ASA) after 5 days repeated once daily administration
      of a fixed dose combination capsule of ASA 81 mg/esomeprazole 20 mg and ASA 80 mg (European
      aspirin reference product).
    

Intervention name(s): Capsule ASA 81mg/esomeprazole 20mg; Acetylsalicylzuur Apotex Cardio
Intervention type(s): Drug; Drug
Intervention description(s): Multiple doses administered on Day 1 to 5; Multiple doses administered on Day 1 to 5
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Acetyl Salicylic Acid; Bioavailability; Healthy Volunteers
Three Year Follow up of a Randomised Controlled Trial (RCT) of an Intervention for Tobacco Dependence Among Those With a Psychotic Illness
Condition: Psychotic Disorder; Behavior, Addictive
MeSH terms: Tobacco Use Disorder; Mental Disorders; Psychotic Disorders; Behavior, Addictive
Study type: Observational

Summary: 
      This is a three year follow up of a previous study where researchers at UNSW and UNewc asked
      smokers with serious mental health problems to participate in a 12-month study, to assess
      whether intervention could assist people experiencing mental illness reduce their tobacco
      smoking.
    

Detailed description: 
      Between 2001 and 2003, the School of Public Health and Community Medicine at the University
      of New South Wales carried out a large study with the Centre for Mental Health Studies at the
      University of Newcastle. The project asked people with serious mental health problems, who
      also smoked cigarettes, to participate in a 12-month study, which involved completing several
      questionnaires/other assessments over that time with a member of the research team. Around
      half of the participants in this study also received treatment for their smoking from the
      research team. This treatment involved weekly therapy with one member of the research team,
      and covered the relationship between smoking and mental illness, teaching people to cope with
      desires to smoke, how to recognise and avoid high risk situations for smoking, and how to
      plan alternative ways of coping with those situations where smoking usually occurred. In
      addition, nicotine patches were also available to assist people who made the decision to
      reduce their smoking. This study hoped to learn whether this new treatment could assist
      people experiencing mental illness reduce their tobacco smoking.

      After three years, previous participants were invited to participate in another follow-up
      assessment to check-in with their current situation, their mental health and levels of
      smoking.
A Comparison of the Bioavailability of OZ439 When Delivered Directly to the Small Intestine, or Via the Oral Route
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the bioavailability of nanoparticulate OZ439
      delivered to the proximal small bowel (PSB) via the Enterion™ capsule relative to oral OZ439
      suspension (current "powder in bottle" [PIB]) and oral nanoparticulate OZ439.

      The study will also characterise the plasma concentration time profile of OZ439 when
      delivered via Enterion capsule to the PSB in comparison with OZ439 PIB formulation delivered
      orally and nanoparticulate OZ439 delivered orally Safety and tolerability of OZ439
      formulations will be determined following delivery to the PSB and administered orally
    

Detailed description: 
      Previous clinical studies with OZ439 have shown variable PK and a food effect. One hypothesis
      is that this may be related to a 'common ion effect' leading to precipitation of the drug as
      a less soluble hydrochloride salt in the stomach, resulting in variable absorption of the
      drug. This study is designed to investigate the possibility of improving the PK profile by
      delivering the drug directly to the PSB, thereby bypassing the stomach. The study will
      compare a previously dosed PIB formulation with oral delivery of a nanoparticulate as a
      caplet formulation. The same caplet formulation containing nanoparticulate will be
      administered to the PSB via the Enterion capsule.
    

Intervention name(s): OZ439 120mg PIB; 120 mg OZ439 caplet; 120mg OZ439 caplet via Enterion capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 120mg dose (as free base) of OZ439 as a solution made up from powder in bottle (PIB); 120 mg (as free base) of OZ439 immediate-release (IR) caplet formulation containing nanoparticulate, administered directly via the oral route; 120 mg OZ439 (as free base) in an immediate release (IR) caplet formulation containing nanoparticulate,administered orally via the Enterion capsule and delivered directly to the proximal small bowel (PSB)
Other intervention name(s): Regimen A; Regimen B; Regimen C
Intervention MeSH terms: Artefenomel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability
Relationship of Preoperative Parathyroid Hormone (PTH) and Ex-Vivo Gamma Counts in Minimally Invasive Parathyroidectomy
Condition: Parathyroid Disease
MeSH terms: Parathyroid Diseases
Study type: Observational

Summary: 
      The intent for this study is to do a retrospective chart review of all patients who have
      undergone minimally invasive parathyroidectomy for primary hyperthyroidism. All data
      collected will be recorded under assigned identification numbers that will have no
      association with medical record or hospital numbers. Identifying characteristics will include
      age and sex. Anonymity will be upheld. The patient/family will not be contacted directly. All
      information will be obtained from the medical chart. Demographics, location, preoperative PTH
      levels and intraoperative Ex-Vivo gamma counts, co-morbid conditions, and the outcome based
      on the hospital notes will be obtained from patients' charts and will be transferred to a
      secure database. It is our hypothesis that there is a linear relationship between immediate
      preoperative parathyroid hormone (PTH) levels and Ex-Vivo gamma counts and the aim of this
      study is to better describe this relationship.
    


Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        An estimated 200 patient charts will be reviewed.
Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy
Condition: Early Stage Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the use of intra-operative Magnetic Resonance
      Imaging (MRI) and Mass Spectrometry (MS) during breast conserving surgery, and to determine
      if these tests are capable of accurately predicting the presence or absence of breast tumor
      in surgical specimens at the margins.
    

Detailed description: 
      This research study is a Phase II clinical trial investigating the use of intra-operative MRI
      and MS in breast cancer surgery. Phase II clinical trials test the safety and effectiveness
      of an investigational intervention to learn whether the intervention works in treating a
      specific disease. "Investigational" means that the intervention is being studied.

      Prior research has shown that intraoperative MRI and MS are two types of tests that are
      feasible to use during cancer surgery and may be able to guide therapy. In this study, we are
      evaluating the accuracy of intra-operative MRI and MS in determining whether or not all
      cancer tissue was removed during breast surgery.
    

Intervention name(s): Intra-operative Magnetic Resonance Imaging (MRI); Mass Spectrometer Analysis of Tissue Sample
Intervention type(s): Procedure; Other
Intervention description(s): Analysis of Tissue Sample
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Early Stage Breast Cancer; Breast Conserving Surgery; Breast Cancer Stage I; Breast Cancer Stage II
Efficacy and Safety of Nasal Spray Solution Containing Human IgG1 Anti-COVID-19 Antibody Cocktail
Condition: SARS CoV 2 Infection; SARS-CoV-2 Acute Respiratory Disease
MeSH terms: COVID-19; Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional

Summary: 
      Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody
      cocktail is a medical device innovated to provide the dual-action physical barrier on nasal
      mucosa that aids the natural defence in which the mucus layer is fortified by a steric
      barrier-forming agent HPMC and invading viral particles of all major SARS-CoV-2 VOCs,
      including Delta and Omicron, are locally trapped and blocked from entering the cells by the
      highly-specific human IgG1 anti-SARS-CoV-2 monoclonal antibody cocktail.
    

Detailed description: 
      The transmission of SARS-CoV-2 through inhalation results in the nasal cavity and nasopharynx
      being the primary entry point of the virus and containing the highest viral load in the body
      during the virus incubation period. Recently, the administration of vaccines and agents via a
      nasal route has gained a lot of momentum because it takes advantage of the direct delivery of
      an agent to the site of primary infection. The local defence system, especially
      antibody-mediated immunity at the nasal epithelium, is crucial for COVID-19 prevention.
      However, people who responded to the vaccination against COVID-19 typically maintain
      sufficient local antibody levels in the nasal cavity for only a short period; hence a
      repeated boosting strategy is required to control the rate of SARS-CoV-2 breakthrough
      infection. In addition, the new VOCs such as Omicron are known to escape vaccine immunity;
      therefore, an innovative approach is needed in this unprecedented situation

      Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody
      cocktail is a medical device innovated to provide the dual-action physical barrier on nasal
      mucosa that aids the natural defence in which the mucus layer is fortified by a steric
      barrier-forming agent HPMC and invading viral particles of all major SARS-CoV-2 VOCs,
      including Delta and Omicron, are locally trapped and blocked from entering the cells by the
      highly-specific human IgG1 anti-SARS-CoV-2 monoclonal antibody cocktail.
    

Intervention name(s): Human IgG1 anti-SARS-CoV-2 antibody cocktail; Placebo
Intervention type(s): Device; Device
Intervention description(s): Hypromellose-based nasal spray solution containing human IgG1 anti-SARS-CoV-2 antibody cocktail; Normal saline
Intervention MeSH terms: Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Tolerability and safety of the study product will be evaluated when given 3 times a day for 7 days in 36 healthy volunteers.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: SARS-CoV-2; SARS-CoV-2 inhibition; Nasal Spray; Anti-SARS-CoV-2; Antibody Cocktail
Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Clinical research of Yang Yin Fu Zheng therapy in HBV associated hepatocellular carcinoma
      basing on immune microenviroment.The purpose of this study is to observe the efficacy of
      routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC.
    


Intervention name(s): Yang Yin Fu Zheng therapy; Routine medical care
Intervention type(s): Drug; Drug
Intervention description(s): Yang Yin Fu Zheng is a Chinese herbal compound.; Routine medical care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Classification and Assessment of Mental Health Performance Using Schematics
Condition: Suicide Ideation; Suicidal Intention; Suicide and Depression
MeSH terms: Suicide
Study type: Observational

Summary: 
      This is an open enrollment study to collect data for the optimization of smartphone-based
      algorithms for the early detection of mental health and suicidal risk in a student
      population. Approximately 2000 students, ages 8-23, will be recruited by therapists across 30
      schools and mental health centers.
    


Intervention name(s): MHSAFE app
Intervention type(s): Device
Intervention description(s): App to detect presence of mental state
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Thirty sites across Southwest Ohio will be recruited, including schools (using the
        school-based therapists), community mental health centers, and colleges/universities
        (counseling centers). Approximately 150 therapists across 30 sites will be recruited to
        enroll students from their current caseloads.
A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      Part 1: An open label, dose and age escalation phase to evaluate the safety and
      immunogenicity of VXA-CoV2-1.1-S with a repeat-dose vaccination schedule in healthy adults
      aged 18 - 75 years old that are either vaccine naive or have received prior vaccination with
      an mRNA (messenger ribonucleic acid) vaccine for the prevention of COVID-19.

      Part 2: This phase will assess the efficacy of prophylactic VXA-CoV2-1.1-S against confirmed
      COVID-19 occurring from 7 days after second dose with a repeat-dose vaccination schedule in
      healthy adults compared to placebo. Safety and immunogenicity of VXA-CoV2-1.1-S will also be
      evaluated in this phase.
    

Detailed description: 
      Part 1: This is an open-label, dose-ranging phase of the study to determine the safety and
      immunogenicity of an orally administered adenoviral-vector based vaccine (VXA-COV2-1.1-S)
      expressing a SARS-CoV-2 antigen and dsRNA adjuvant. Post screening activities, healthy adult
      volunteers, either naïve or prior vaccinated with an mRNA COVID-19 vaccine, aged 18 - 55 yrs
      old, and then 56 - 75 yrs old, will be enrolled into the study in 8 subgroups. Participants
      will receive either a low or a high dose of an oral tableted vaccine at Days 1 and Day 29.
      The total study period will last ~ 2 months during the active phase, with a total 12 month
      safety follow-up period post last vaccination. Safety, reactogenicity and immunogenicity
      assessments will be performed at set times during the study active and follow-up periods.
      Subjects will be monitored for symptoms of COVID-19 throughout the duration of the study
      follow-up period. An independent data monitoring committee (IDMC) will provide safety
      oversight through the duration of the trial. Safety and immunogenicity data will inform on
      the dose selection for Part 2.

      Part 2: This will be a placebo-controlled phase with the vaccine dose level selected from
      Part 1. Subjects will receive two doses of vaccine or placebo at Days 1 and 29. Subjects will
      be followed as in Part 1 for safety and immunogenicity. They will also be followed for 6
      months for efficacy.
    

Intervention name(s): VXA-CoV2-1.1-S; Placebo Tablets
Intervention type(s): Drug; Other
Intervention description(s): COVID-19 (SARS-CoV-2) E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with dsRNA Adjuvant Oral Tablet Vaccine; Placebo tablets matching the active vaccine tablets
Other intervention name(s): Oral Tableted Ad5 COVID-19 Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Open-label dose and age escalation lead in phase in naive and prior vaccinated subjects, followed by a multi-center, placebo-controlled efficacy phase.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: oral vaccine; SARS-CoV-2; tablet vaccine
Phase 1 PK Study to Assess Safety, PK, Tolerability of HM15912 in Subjects With Renal Impairment and Normal Renal Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of
      HM15912 in Subjects with Renal Impairment and Matched Control Subjects with Normal Renal
      Function
    


Intervention name(s): HM15912
Intervention type(s): Drug
Intervention description(s): Drug: HM15912 Active 0.5mg/kg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Determine the Safety of AV-1, an Antibody Being Developed for Treatment of Dengue, in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      AV-1 is a human monoclonal antibody (mAb) being investigated as a potential therapy for
      dengue, a mosquito-borne viral disease with extensive global public health impact. Globally,
      over 2 billion people are thought to be at risk of infection from the dengue virus and there
      are an estimated 390 million infections each year. Current treatment options for dengue are
      limited to supportive care, so a safe and effective treatment would provide substantial
      public health benefits. AV-1 has not previously been tested in humans. This study aims to
      determine the safety of AV-1 in healthy adult volunteers, when administered as a single IV
      infusion. The results of the study are based on the clinical study report and statistical
      analysis plan.
    


Intervention name(s): AV-1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose, administered by IV infusion (volume: 250 mL); 0.9% sterile saline. Administered by IV infusion (volume: 250 mL)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Healthy volunteers; Monoclonal antibody; AV-1; Safety; Dengue