bioihbjkbjnl/mcl2 huggingface dataset:
Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers
Condition: COVID-19; SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Double blind, Multi-Centre study to evaluate the safety, reactogenicity, tolerability, and
      immunogenicity of three investigational vaccine groups and one placebo group in healthy
      volunteers who receive two intramuscular doses of BBV152 vaccine formulations and placebo. A
      total sample size of 755 healthy volunteers, with 375 and 380 volunteers in phase 1 and 2
      studies, respectively.

      A protocol amendment was made to evaluate a boosting regimen at the 6-month interval in the
      Phase 2 trial. At 6 months post-dose 2, participants who received the 6ug Algel-IMDG
      allocation were randomized equally to receive a third dose of BBV152 (6ug Algel-IMDG) or
      placebo.
    

Detailed description: 
      Phase 1 study

      The study is designed to evaluate the safety, reactogenicity, tolerability, and
      immunogenicity of Four arms of healthy volunteers who receive two intramuscular doses of
      BBV152 vaccine formulations or Placebo. A total no of 375 subjects will be enrolled in 4:1
      ratio.

      This study will be conducted in a dose escalatory manner with a two-dose regimen fourteen
      days apart.

      Phase 2 study

      The study is designed to evaluate the safety, reactogenicity, tolerability, and
      immunogenicity of two arms of healthy volunteers who will receive two intramuscular doses of
      BBV152 vaccine formulations (BBV152-A & BBV152-B) in a 1:1 ratio with dosage schedule on Day
      0 and Day 28.

      A protocol amendment was made to evaluate a boosting regimen at the 6-month interval in the
      Phase 2 trial. At 6 months post-dose 2, participants who received the 6ug Algel-IMDG
      allocation were randomized equally to receive a third dose of BBV152 (6ug Algel-IMDG) or
      placebo. The investigator, participant and Sponsor were blinded to the allocation.
    

Intervention name(s): BBV152A - Phase I; BBV152B - Phase I; BBV152C - Phase I; Placebo - Phase I; BBV152A - Phase II; BBV152B - Phase II
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14; 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14; 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14; 0.5 ml of the Placebo will be administered intramuscularly twice at Day 0 and Day 14; 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28; 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: BBV152; COVID-19 vaccine; inactivated vaccine
Evaluation of Intranasal Naltrexone and Naloxone
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be to determine the pharmacokinetics of naltrexone and naloxone when
      administered via intranasal separately and in combination in healthy volunteers.
    


Intervention name(s): Naltrexone; Naloxone; Naltrexol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intranasal spray; Intranasal spray; Intranasal spray
Other intervention name(s): Vivitrol; Narcan
Intervention MeSH terms: Naltrexone; Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      Wireless Capsule Endoscopy has been the most reliable diagnostic standard for small bowel
      Crohn's disease. Endoscopic healing is an important endpoint to measure response to
      treatment.
    


Intervention name(s): certolizumab pegol
Intervention type(s): Drug
Intervention description(s): 400mg subcutaneous injections at week 0, week 2, week 4, then every 4 weeks thereafter
Other intervention name(s): Cimzia
Intervention MeSH terms: Certolizumab Pegol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's; Inflammatory Bowel Disease
Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the proposed study is to evaluate the bioavailability of CHF6001 after
      inhaled administration and to characterize the mass balance and route of elimination of
      CHF6001 in human along with its relevant metabolites.
    

Detailed description: 
      This clinical trial is a single centre Phase I study, with a single dose, non-randomized,
      open-label, uncontrolled design.

      A total of 8 subjects will be included in the study.

      It will aim to assess the absolute bioavailability, the mass balance and routes of
      elimination of CHF6001 in male healthy volunteers, using [14C]-radiolabelled drug substance
      administered as an intravenous (IV) infusion concomitantly to an inhaled non-radiolabelled
      dose.

      Standard safety assessments will be conducted during the Study, including safety blood and
      urine laboratory tests, vital signs, physical examinations, ECGs and observations of any
      adverse events. Blood, urine and feces samples will be also collected for PK analysis.
    

Intervention name(s): CHF6001
Intervention type(s): Drug
Intervention description(s): 4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of [14C]-labelled CHF6001
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Osteoporosis Disease Management Demonstration Project (0000-037)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of disease management interventions on bone
      mineral density (BMD) screening rates and osteoporosis treatment rates in women age 65 years
      or older.
    


Intervention name(s): Disease Management Assessment
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
Condition: Thyroid Neoplasm; Goiter
MeSH terms: Thyroid Neoplasms; Postoperative Complications
Study type: Interventional

Summary: 
      Primary Objectives

        -  To compare the amount of post-operative wound drainage between the group of patients in
           which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™
           placebo is utilized (Arm B).

        -  To compare the length of time to drain removal between Arm A and Arm B. Secondary
           objectives

        -  To compare the incident or rates of seroma, hematoma, and post-operative edema between
           the two groups.

        -  To compare the reported pain experienced in each group at selected time points using a
           standard numerical rating scale (NRS).

        -  To compare the length of hospital stay between the two groups of patients.
    


Intervention name(s): EVICEL
Intervention type(s): Drug
Intervention description(s): EVICEL
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized placebo-controlled double-blind trial.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: EVICEL, Fibrin Sealant, Thyroidectomy
Sleep Disturbance in Chronic Rhinitis
Condition: Sleep Disturbance
MeSH terms: Rhinitis; Dyssomnias; Parasomnias
Study type: Observational

Summary: 
      The aim of this study is to evaluate the characteristic of sleep disturbance in allergic and
      non-allergic rhinitis in Dr. Cipto Mangunkusumo Hospital, Jakarta. A cross sectional analytic
      descriptive study with consecutive sampling was performed. A total of 22 chronic rhinitis
      patients, consisted of 11 allergic and 11 non-allergic rhinitis were evaluated of their sleep
      disturbance's characteristics.
    

Detailed description: 
      At first, all recruited subjects were evaluated for total nasal symptom scores (TNSS) and
      nasal obstruction symptoms evaluation scores (NOSE). Sleep disorder was assessed using
      Epworth Sleepiness Scale (ESS), Pittsburg Sleep Quality Index (PSQI) questionnaires, and
      polysomnography (PSG). Both the allergic and non-allergic rhinitis groups will be compared in
      terms of their sleep disturbance characteristics (from comparing ESS, PSQI, and PSG results).
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Allergic and non-allergic rhinitis patients
      
Keywords: allergic; nasal congestion; daytime sleepiness; polysomnography
Cost- Effectiveness of a Face-to-Face Rehabilitation Program vs an Telemedicine Program in Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Perform a cost-utility analysis in patients with chronic low back pain through
      electroanalgesia treatment and exercises administered by telemedicine program versus
      face-to-face program
    

Detailed description: 
      A double blind clinical trial will be developed in a sample of 80 subjects with chronic low
      back pain. Patients will receive 3 weekly sessions of electroanalgesia and an exercise
      program for 8 weeks, for a total of 24 sessions. The aim is to analyze the cost-
      effectiveness of a face-to- face rehabilitation program vs a telemedicine program on
      disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar
      mobility in flexion and muscular electrical activity.
    

Intervention name(s): Face-to-Face Rehabilitation program; Telemedicine program
Intervention type(s): Other; Other
Intervention description(s): In each hospital, two trained therapists will carry out a face-to-face rehabilitation program consisting of electroanalgesia and an exercise program that follows the Mckenzie method. The physiotherapists place the electrodes in the patients, for this they use 5x9 cm electrodes, which they place at the bilateral paravertebral level, in the patients who present with radicular pain, the electrodes will be placed in the path of the affected nerve. The duration will be sufficient to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal periarticular components of the spine.; It consists in an e-Health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study protocol for a double blinded two-arm randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back pain; Electroanalgesia; McKenzie Method; Telemedicine; Study protocol for a Randomized clinical trial
COMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy
Condition: Diabetes; Endocrine, Nutritional and Metabolic Diseases (E00-E89)
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The purpose of this research study is to collect information about a new treatment for Type 2
      Diabetes Mellitus (T2DM), using a medical device called the Metabolic Neuromodulation System
      which is intended to help regulate blood glucose levels in patients whose (T2DM) is not well
      controlled despite treatment with multiple medications. The medical device delivers low-level
      radiofrequency energy through the wall of the blood vessel to the liver to disrupt the nerves
      that lead to the liver. Previous research has shown that disrupting these nerves may lead to
      a lowering of blood sugar levels.
    

Detailed description: 
      Prospective, First-in-Human (FIH), multi-center, non-randomized trial to evaluate the initial
      safety and performance of hepatic sympathetic denervation to aid in glycemic control.
    

Intervention name(s): Metabolic Neuromodulation System (MNS)
Intervention type(s): Device
Intervention description(s): Prospective, First-in-Human (FIH), multi-center, non-randomized trial to evaluate the initial safety and performance of hepatic sympathetic denervation to aid in glycemic control.
Other intervention name(s): Hepatic sympathetic denervation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes
A Study to Assess the Efficacy of Rucaparib in Metastatic Breast Cancer Patients With a BRCAness Genomic Signature
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of a PARP inhibitor, rucaparib, in
      progressing breast cancer patients and who are carrying a BCRAness profile defined by genomic
      signature or BRCA 1 or 2 somatic mutation, without known BRCA 1 or 2 germline mutation.
    

Detailed description: 
      This is a single arm, open-label, multicentric, phase II trial, with a Simon two-stage
      design, assessing the efficacy of a PARP inhibitor, rucaparib, in 41 progressing breast
      cancer patients with at least one line of chemotherapy at the metastatic setting., and who
      are carrying a BRCAness profile defined by Clovis genomic signature or a BRCA1 or 2 somatic
      mutation, without known BRCA1 or 2 germline mutation.
    

Intervention name(s): rucaparib
Intervention type(s): Drug
Intervention description(s): 600 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops.
Intervention MeSH terms: Rucaparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Viral Load on Intrahepatic Recurrence in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC)
Condition: Carcinoma, Hepatocellular; Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Carcinoma; Carcinoma, Hepatocellular; Hepatitis; Recurrence
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of serum hepatitis B virus (HBV) DNA
      level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs)
      related with HBV.
    

Detailed description: 
      Prospective cohort study

      Survival

        -  Overall survival rate

        -  Disease free survival rate

      Recurrence

        -  Cumulative recurrence rate
    

Intervention name(s): PEIT; RFTA
Intervention type(s): Procedure; Procedure
Intervention description(s): Percutaneous Ethanol Injection Therapy; Radiofrequency Thermal Ablation
Other intervention name(s): PEI, local ablation therapy; RFA, local ablation therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HBV DNA; HCC; recurrence; PEIT; RFTA
Bioequivalence Study to Compare Diclofenac Potassium Coated Tablet Versus Cataflam® 50 Coated Tablet
Condition: Non-steroidal Anti-inflammatory (NSAID); Analgesic; Antipyretic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Randomized, four-way, four-period, fully-replicated, single oral dose, open-label, crossover,
      bioequivalence study to compare Diclofenac Potassium coated tablet (50 mg Diclofenac
      Potassium) versus Cataflam® 50 coated tablet (50 mg Diclofenac Potassium), in healthy
      subjects under fasting condition
    


Intervention name(s): Diclofenac Potassium coated tablet (50 mg Diclofenac Potassium); Cataflam® 50 coated tablet
Intervention type(s): Drug; Drug
Intervention description(s): One Diclofenac tablet was administered orally.; One Diclofenac tablet was administered orally.
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine
Condition: Migraine, With or Without Aura
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50
      and 100 mg) compared to placebo for the acute treatment of a single migraine attack.
    


Intervention name(s): Ubrogepant; Placebo-matching Ubrogepant
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.; Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese Patients
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of ISIS-FGFR4RX.
    


Intervention name(s): ISIS-FGFR4RX; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ISIS-FGFR4RX administered subcutaneously; Placebo administered subcutaneously
Other intervention name(s): ISIS 463588
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Energy Expenditure
Biomarkers to Predict Time to Plasma HIV RNA Rebound
Condition: HIV-1 Infection
Study type: Observational

Summary: 
      The purpose of this study is to collect information about what happens when people pause, or
      temporarily stop taking, ART, and to collect blood samples from these people at frequent
      intervals. We will also study the safety of pausing ART under close observation.
    


Intervention name(s): Antiretroviral treatment pause
Intervention type(s): Drug
Intervention description(s): Antiretroviral treatment pause
Intervention MeSH terms: Anti-Retroviral Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected men and women ≥18 to ≤70 years of age, maintained on suppressive ART for a
        minimum of 2 years with CD4+ count ≥500 cells/mm3 and nadir CD4+ count ≥200 cells/mm3.
A Study of Tranexamic Acid (XP12B) in Women With Heavy Menstrual Bleeding
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a multicenter, open-label extension study for subjects completing either of 2
      pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment
      phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3 g
      administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation.
      After the last treatment period, a follow-up phone call occurred approximately 30 days (range
      25 to 35 days) after the last dose of study drug.
    


Intervention name(s): Tranexamic acid
Intervention type(s): Drug
Intervention description(s): Tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation for 9 menstrual periods.
Other intervention name(s): XP12B; Lysteda
Intervention MeSH terms: Tranexamic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menorrhagia; Heavy Menstrual Bleeding; Lysteda
Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to assess the safety and tolerability of a 180μg/ml TID
      dose regimen of recombinant human nerve growth factor (rhNGF) eye drop solution administered
      over 8 weeks versus a vehicle control in patients with progressive primary open-angle
      glaucoma despite IOP control.

      The secondary objectives are to measure the changes in BCDVA, visual field, ERG and
      structural changes in ganglion cell layer and nerve fiber layer thickness measured by optical
      coherence tomography. The secondary outcomes will be examined at 1, 4 and 8 weeks of therapy,
      and at 4 and 24 weeks after cessation of therapy (Week 12 visit and Week 32 visit), and will
      include functional assessments to investigate evidence of a persistent biological effect
      after discontinuation of the study treatment.
    

Detailed description: 
      This is an 8 Week phase Ib, monocentric, randomized, double-masked, vehicle controlled,
      parallel groups, study with a 24 Week follow-up period to evaluate the safety and potential
      efficacy of a 180 μg/ml recombinant human nerve growth factor (rhNGF) eye drops solution
      versus vehicle in 60 study participants with chronic primary open angle glaucoma.

      Participants may qualify with either progressive optic neuropathy despite maximal current
      therapy (i.e. IOP reduction), or with stabilized IOP but diminished vision (central or
      peripheral).

      Participants with a qualifying eye will be randomized 2:1 to topical recombinant human nerve
      growth factor (rhNGF) therapy or vehicle placebo control. Examinations for safety and
      efficacy will occur one week following initiation of therapy, and at 4, 8, 12 and 32 weeks.

      All participants in either arm will be followed clinically at 4 weeks after cessation of
      therapy.
    

Intervention name(s): rhNGF; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Recombinant Human Nerve Growth Factor 180μg/ml (one 35 μl drop equals to 6.30 μg of rhNGF) reconstituted solution three times a day (TID) for 8 weeks of treatment.; Ophthalmic Placebo solution of the same composition as the test product with the exception of rhNGF reconstituted solution times a day (TID) for 8 weeks of treatment.
Other intervention name(s): cenegermin; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment