bioihbjkbjnl/mcl2 huggingface dataset:
WD-1603 PK Study in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study to investigate if the extended release formulation of WD-1603 generates
      anticipated plasma concentration profile. The study is an open-label, sequential, 3-way
      crossover study to evaluate if WD-1603 generates anticipated plasma levodopa exposure
      compared to Sinemet IR tablets in healthy subjects. The study comprises of a medical
      Screening visit, three 2-night (3-day) Treatment periods, 2 outpatient visits, and a
      Follow-up visit. Study drug administration in each Treatment period is separated by a washout
      interval of 5 days. The Follow-up visit will occur approximately 7 days (±1) following the
      last study drug administration. The duration of subject participation, including screening,
      is approximately 6 weeks.
    


Intervention name(s): carbidopa-levodopa
Intervention type(s): Drug
Intervention description(s): single dose of WD-1603, BID dose of WD-1603 and Sinemet IR
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rutgers Pilot for PREDICT- Patient LAB Test
Condition: SARS-CoV2 Infection
MeSH terms: Infections; COVID-19
Study type: Interventional

Summary: 
      A pilot study was initiated to assess feasibility of testing asymptomatic dental patients
      presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2
      viral RNA using an FDA approved RT-PCR test for SARS-CoV2- an RNA RT-PCR assay (Accurate
      Diagnostics)
    

Detailed description: 
      Patients with upcoming dental appointments at the Oral Medicine clinic at Rutgers School of
      Dental Medicine were contacted to solicit interest in participating in a pilot study to
      assess feasibility of testing asymptomatic dental patients for SARS CoV 2 infection using an
      RNA RT-PCR assay. Interested subjects completed a previsit survey after confirming their
      interest electronically. Subsequently, they received kit to collect their saliva sample at
      home along with instructions on how to do so. They were directed to drop off their saliva
      samples for testing at the dental clinic and signed the consent form at that time. After
      confirming a negative result, the patients were subsequently triaged over the phone for any
      symptoms and the following day, presented for their dental visit.

      On the day of their visit, they were triaged, completed their dental visit and were surveyed
      to get their feedback on the study procedures and their perceptions of safety.
    

Intervention name(s): Testing for SARS CoV2 RNA
Intervention type(s): Device
Intervention description(s): Device: Testing for SARS CoV2 RNA- lab-based RNA RT-PCR testing
Intervention model: Single Group Assignment
Intervention model description: Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using lab-based RNA RT-PCR testing
Masking: None (Open Label)
Primary purpose: Other
Keywords: Screening; Lab-based testing; Asymptomatic patients; Perception of safety; Feasibility
Pivotal Study to Assess the Safety and Effectiveness of the iTind Device
Condition: Benign Prostate Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as
      compared to control group (catheter only).
    

Detailed description: 
      Medi-Tate i-Temporary Implantable Nitinol Device (iTind) is intended to treat subjects with
      symptomatic BPH.

      A total of 150 subjects with symptomatic BPH will be enrolled into this study, according to
      eligibility criteria.

      Study duration is 12 months and includes 7 visits: screening, screening follow up,
      implantation, retrieval, 6 weeks follow up, 3 months follow up and 12 months follow up.

      iTind Device will be implanted for 5-7 days. Sham will be a routine Foley catheter procedure.
    

Intervention name(s): iTIND; Sham Arm
Intervention type(s): Device; Procedure
Intervention description(s): Temporary Implantable Nitinol Device (iTIND); Foley catheter will be placed and immediately removed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
c9,t11-CLA in Children and Adolescents With Allergic Asthma
Condition: Allergic Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The study was performed to investigate the effects of a dietary intervention with c9,t11-CLA
      on clinical and immunological parameters in children and adolescents with allergic bronchial
      asthma.
    

Detailed description: 
      In-vitro and animal studies strongly suggest that c9,t11-CLA reduces inflammatory processes
      in asthma-models. Aim of this study was to determine possible beneficial effects of orally
      administered c9,t11-CLA in children and adolescents with allergic bronchial asthma.

      Thirty subjects (14 girls, 16 boys, age 6-18 years) were recruited from regular patients in
      the Clinic for Pediatric Allergology of the Friedrich Schiller University Jena. Informed
      consent was obtained from all participants/parents. 29 subjects completed the study.

      The study was designed as a randomized and placebo-controlled study. After a 1-week run-in
      period to ascertain the current state of disease and categorization of allergic sensitization
      by RAST, the participants were randomized and evenly distributed to receive either 3 g/d of
      an esterified CLA preparation free of t10,c12-CLA (75% c9,t11-CLA, 87% purity) or 3 g/d of a
      placebo oil mixed in 100 g portions of milk fat-free yoghurt for 12 weeks. The yoghurt was
      freshly prepared and distributed in frequent intervals.

      At the beginning and at the end of the study, lung function parameters were assessed by whole
      body plethysmography, and venous blood and 24h-urine samples were collected for further
      analyses. Throughout the entire study, the participants daily recorded their peak-flow data
      and kept protocol about their symptoms and drug usage.
    

Intervention name(s): conjugated linoleic acid
Intervention type(s): Dietary Supplement
Intervention description(s): 3 g/d of an esterified CLA preparation free of t10,c12-CLA (75% c9,t11-CLA, 87% purity) or placebo oil mixed in yoghurt for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: c9,t11-CLA; allergic bronchial asthma; children and adolescents
Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients
Condition: Renal Insufficiency; Kidney Diseases; Urologic Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency; Urologic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the effect of renal impairment on the pharmacokinetics,
      safety and tolerability of udenafil in subjects with renal impairment compared to healthy
      subjects.
    


Intervention name(s): Udenafil
Intervention type(s): Drug
Intervention description(s): 100mg Single Oral Dose of
Intervention MeSH terms: Udenafil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Udenafil; DA-8159; renal impairment; healthy volunteers
Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes
Condition: Diabetes; Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon
      counterregulatory response to hypoglycemia in type 1 diabetes.
    

Detailed description: 
      Vildagliptin (50 mg BID) or placebo is given as add-on to insulin treatment for four weeks in
      patients with type 1 diabetes. Then, a hypoglycemic clamp (2.5 mmol/l glucose) is undertaken
      with the determination of glucagon.
    

Intervention name(s): Vildagliptin
Intervention type(s): Drug
Intervention description(s): Vildagliptin (50 mg BID) in four weeks
Other intervention name(s): Galvus
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: DPP-4; GLP-1; Glucagon; Catecholamines; Counterregulation; Type 1 diabetes
Pharmacokinetics and Safety of WAL2014 (Talsaclidine) in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a single
      dose to healthy adult male volunteers in double blind manner.
    


Intervention name(s): Talsaclidine; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Treatment of Latent Tuberculosis Infection With Isoniazid
Condition: Tuberculosis
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to study the effect that treatment of dormant tuberculosis
      infection has on the immunological system.

      We expect to observe an impact over the production of cytokines by peripheral white blood
      cells which may be useful to know if treatment has been effective.
    

Detailed description: 
      As part of on-going studies conducted in the Orizaba Health Jurisdiction in southeastern
      Mexico, household contacts of pulmonary TB patients who recently converted their tuberculin
      test and TST+ve contacts from randomly selected control households with no history of TB
      within the last 2 years (remote contacts) will be enrolled. We assume that these individuals
      are infected with Mycobacterium tuberculosis. Additional confidence that all subjects
      enrolled are latently infected will come from ELISPOT analysis of the response to ESAT-6 and
      CFP-10. We propose to administer INH to 100 TST+ve recent and 100 TST+ve remote contacts for
      6 months. To control for spontaneous fluctuations of biomarker levels, we propose to defer
      therapy by 3 months to half the subjects in each group. Thus, four groups will be defined:

      A. Recently converted contacts receiving isoniazid (5mg per kg up to 300 mg daily for 6
      months) immediately after recruitment.

      B. Recently converted contacts receiving isoniazid (5mg per kg up to 300 mg daily for 6
      months) three months after recruitment.

      C. Remote contacts receiving isoniazid (5mg per kg up to 300 mg daily for 6 months)
      immediately after recruitment.

      D. Remote contacts receiving isoniazid (5mg per kg up to 300 mg daily for 6 months) three
      months after recruitment.

      All contacts will undergo clinical evaluation at enrolment and review. The development of
      active TB will trigger withdrawal and full treatment. Fortnightly clinical review of group B
      during the deferred phase will be undertaken. ELISPOT analysis will be performed on all
      subjects at 0, 1, 4, 13, 26 and 40 weeks in groups A and C, and at 0, 13, 14, 17, 26, 40 and
      54 weeks in groups B and D. A subset of 10 patients per group will be sampled for expression
      analysis at 0, 4, 26 and 40 weeks (groups A and C) and at 0, 13, 17 and 40 weeks in groups B
      and D (160 hybridizations in total).
    

Intervention name(s): Isoniazid; isoniazid
Intervention type(s): Drug; Drug
Intervention description(s): Isoniazid (5mg per kg up to 300 mg daily for 6 months); isoniazid (5mg per kg up to 300 mg daily for 6 months
Other intervention name(s): treatment of latent tuberculosis infection; Treatment of latent tuberculosis infection
Intervention MeSH terms: Isoniazid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Latent tuberculosis; biomarkers; isoniazid; ELISPOT; PPD positive individuals
Endomicroscopy and Crohn´s Disease
Condition: Crohn´s Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      Purpose:

      The main objective of this study is to determine endomicroscopic features of Crohn´s disease.

      Background:

      Crohn´s disease is an inflammatory disease of the intestines that may affect any part of the
      gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. Diagnosis is
      based on several histologic features including transmural pattern of inflammation, crypt
      abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a
      valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an
      "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.

      Scope:

      In patients with Crohn´s disease.
    

Detailed description: 
      Methods:

      Patients underwent colonoscopy for the evaluation of Crohn´s disease. During the endoscopic
      procedure CLE will be performed.

      Procedure:

      The patient underwent colonoscopy. During the procedure the patient will receive intravenous
      fluorescein or topical mucosal staining with acriflavin or cresyl violet, followed by in-vivo
      CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Crohn´s disease.
Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage
Condition: Facial Photodamage
MeSH terms: Facies
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment of actinic damage has included multiple procedures but to date there is limited
      scientific evidence to support the preferential use of one of these therapies according to
      their efficacy, safety and pain tolerance by patients. This study aims to assess the efficacy
      of methyl aminolevulinate + daylight vs placebo + daylight to treat facial photodamage
    


Intervention name(s): Methyl Aminolevulinate (MAL); Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Metvix®; Vehicle
Intervention MeSH terms: Aminolevulinic Acid; Methyl 5-aminolevulinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized-controlled-trial; Methyl-Aminolevulinate; Daylight; Photodynamic-therapy
Asparaginase Encapsulated in Erythrocytes for Patients With ALL and Hypersensitivity to PEG-asparaginase
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Pegylated-asparaginase (PEG-ASP) is an important part of the treatment of childhood acute
      lymphoblastic leukaemia (ALL). Unfortunately 13% of patients develops allergy and further
      treatment is impossible. Furthermore, 6% of patients have developed antibodies (silent
      inactivation) and have no effect of the PEG-ASP treatment. Truncated asparaginase therapy is
      associated with inferior event-free survival outcomes, in particular relapse in central
      nervous system (CNS).

      Eryaspase is a new formulation of asparaginase encapsulated in erythrocytes. The erythrocyte
      membrane protects asparaginase against fast degradation and elimination processes. The
      encapsulation eliminates the direct somatic contact, and it is hypothesized that this
      provides the potential to prolong the activity of the enzyme and reduce toxicities.
    


Intervention name(s): GRASPA
Intervention type(s): Drug
Intervention description(s): Administration of 1-7 doses of 150 IU/kg IV infusion. (every 2 weeks for a maximum of 4 doses and every 6 weeks for maximum 3 doses).
Other intervention name(s): Eryaspase
Intervention MeSH terms: Eryaspase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypersensitivity to PEG-asparaginase
Safety and Pharmacokinetic(PK) Study of GW003 to Metastatic Tumors
Condition: Chemotherapy-induced Neutropenia; Metastatic Tumors
MeSH terms: Neoplasm Metastasis; Neutropenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to access the safety, tolerance and
      Pharmacokinetic/Pharmacodynamic(PK/PD) of single subcutaneous(SC) injection of GW003 in
      patients with metastatic tumors.
    

Detailed description: 
      So far, granulocyte colony stimulating factor (G-CSF) is still currently the only effective
      and security therapy drug for neutropenia caused by cancer chemotherapy. At present, the
      widely used G-CSF products are of such short-acting G-CSF product in China. However, there
      existed some shortcoming about short-acting G-CSF, such as shorter half-life, continuous
      monitoring of the patient's blood neutrophil count and so on.

      Nowadays,long-acting G-CSF product,such as Neulasta®, has become the mainstream of the
      foreign G-CSF market for its superiority of long half-life and absence of monitoring of the
      patient's blood neutrophil count. The new drug Recombinant(Expressed by Pichia pastoris)
      Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I)Fusion Protein(GW003) is a
      long-acting G-CSF.Preclinical studies have shown that GW003 has accelerated neutrophil
      recovery and can shorten the duration of neutropenia symptoms, also reduce its extent,
      therefore minimize the likelihood of serious infections, reflecting a better efficacy and
      more long half-life.

      Phase I was performed as two parts, Ia and Ib. Ia was a sequential dose escalation to observe
      the dose-limiting toxicity(DLT) and Maximum Tolerated Dose of GW003 given subcutaneously to
      patients without receiving chemotherapy,6 dose cohorts(50、150、300、400、500 and 600μg/kg) with
      2-3 subjects in the 50、150μg/kg cohorts and 3-6 subjects（depend on the Dose-limiting
      toxicity） in the 300、400、500 and 600μg/kg cohorts, to evaluate safety and pharmacokinetics
      prior to the Ⅰb.

      Ib proposed two arms (150 and 300μg/kg；n=6-8/arm), and to determine whether to continue to
      increase other dose arm based on the safety and efficacy assessment. Subjects need to receive
      two cycles treatment of AT chemotherapy. In cycle 1, subjects received AT chemotherapy only;
      in cycle 2, subjects were administered subcutaneously GW003 24 hours after chemotherapy
      drugs.
    

Intervention name(s): GW003
Intervention type(s): Biological
Intervention description(s): freeze-dried powder；single SC injection
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of 1L Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-Residue Diet for Bowel Preparation
Condition: Colonoscopy; Colon Polyp; Bowel Preparation Solutions
MeSH terms: Colonic Polyps
Study type: Interventional

Summary: 
      Background 2L polyethylene glycol plus ascorbic acid (PEGA) is known to be as effective as
      standard 4L polyethylene glycol for bowel preparation. However, the volume of this regimen is
      still large. Therefore, the present investigators evaluated the potential of 1L PEGA with
      prepackaged low-residue diet (PLD) for an alternative to 2L PEGA.

      Aim: To evaluate efficacy of 1L PEG with ascorbic acid combined with prepackaged low-residue
      diet as bowel preparation for colonoscopy.

      Methods: The subjects were randomly assigned to either groups. PEGA group received 2L PEGA
      split regimen. PLD group received PLD on the day preceding colonoscopy and 1L PEGA on the
      morning of colonoscopy. One blinded physician performed colonoscopy and evaluated the degree
      of bowel preparation using Boston bowel preparation score (BBPS). A questionnaire regarding
      tolerability and safety were also gathered.
    


Intervention name(s): 1 L PEG with ascorbic acid with prepackaged, low residue diet
Intervention type(s): Procedure
Intervention description(s): Participants who were allocated to the 2 L PEG with ascorbic acid (PEGA) group took 250 ml of PEG with ascorbic acid at 15-min intervals, completing 1 L of the PEG with ascorbic acid protocol at 8:00 PM on the day prior to the procedure. The remaining 1 L of the PEG with ascorbic acid solution was administered in the same manner at 6:00 AM on the day of the procedure. Participants assigned to the 1 L PEG with ascorbic acid with PLD (PLD) group consumed a prepackaged, low residue diet (ZeroCol, Korea Medical Food Inc., Seoul, Korea) which consisted of a breakfast, lunch and dinner, the day prior to colonoscopy. The Participants took 1 L PEG with ascorbic acid solution at 6:00 AM on the day of the colonoscopy in the same way as described above. All of the subjects ingested 500 mL of water for every 1 L of 1 L PEG with ascorbic acid solution consumed. The Participants completed all of the administrations at least 2 hours before the colonoscopy.
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diet
A Study to Learn What Participants Think of Treatment With Betamethasone Plus Loratadine to Treat Their Acute Allergic Rhinitis, Also Known as Hay Fever in Mexico
Condition: Rhinitis, Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      Acute allergic rhinitis is a common allergic reaction to things like pollen or dust. It
      causes inflammation inside the nose, resulting in symptoms similar to the common cold.
      Allergic rhinitis is also known as hay fever.

      In this study, the researchers want to learn what participants think of betamethasone plus
      loratadine as a treatment for their acute allergic rhinitis. These participants will have
      used betamethasone plus loratadine as a treatment for their acute allergic rhinitis within
      the past two months. During the study, participants will complete an online questionnaire
      about their experience with betamethasone plus loratadine.
    


Intervention name(s): Online survey
Intervention type(s): Other
Intervention description(s): Participants will be invited to complete an online questionnaire about their experience of product use.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population are participants who used betamethasone plus loratadine within the
        previous 2 months for the treatment of acute episodes of allergic rhinitis.