bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts
Condition: Anogenital Warts; Condylomata Acuminata; Human Papillomavirus Infection
MeSH terms: Warts; Papillomavirus Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the safety, tolerability and efficacy of the
      topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human
      papillomavirus (HPV).
    

Detailed description: 
      Genital warts (GW; also called condylomas or condylomata acuminata) are lesions caused by
      infection of Human papillomavirus (HPV)(specifically HPV-6 or HPV-11 types, found in > 95% of
      lesions). GW are sexually transmitted and affect about 1% of the sexually active population.
      GW represent a distressful condition for social and sexual life, especially in the cases of
      external condylomas. No HPV-specific antiviral treatment exists to date, and all existing
      therapies (either surgical or drug) have limited efficacy, with a significant level of GW
      recurrences and are associated with local skin reactions. AP611074 is a synthetic new
      chemical entity that is a potent and selective inhibitor of the interaction between two viral
      proteins from HPV6 and HPV11, an interaction that is a necessary step for HPV DNA replication
      and thus viral production. AP611074 is the "first in class" specific HPV antiviral described
      to treat condyloma caused by HPV infection.
    

Intervention name(s): AP611074; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo gel manufactured to appear identical to AP611074 5% gel
Other intervention name(s): HPV antiviral; Anticondyloma drug
Intervention MeSH terms: Antiviral Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Genital warts; Anogenital warts; HPV; Human papillomavirus; Antiviral
Prevention in Volleyball Players
Condition: Prevention
Study type: Interventional

Summary: 
      The objective of this study is to assess the interest and the efficiency of a warm-up
      prevention program on the prevalence of shoulder injuries in amateur volleyball players.

      Around ten teams will be included in the study. They will be divided into two groups (blind):
      an intervention group and a control group.

      A warm-up prevention program will implemented in the teams of intervention group. This
      program will have to be followed twice a week, at the beginning of the training session.

      In both groups, shoulder injuries will be registered each month by an online questionnaire.
    

Detailed description: 
      Around ten teams will be recruted among the clubs in the Province of Liege. They will be
      divided into two groups (blind): an intervention group and a control group.

      Each month, both groups will be asked to fill in a form with the potential injuries they
      experienced during the past month.

        -  Intervention group :

      All the teams included in the intervention group will be asked to follow a warm-up prevention
      program (about 15 minutes) at least twice a week, at the beginning of the training session.

      At the beginning of the season, one experimenter will go to the different clubs in order to
      present the program, to explain the exercises and to correct the players while doint the
      exercises.

      During the season, the same experimenter will go to the clubs at regular intervals to make
      sure that the players are well doing the program and to assess the compliance.

      - Control group :

      The objective of the control group is to estimate the prevalence of shoulder injuries in a
      group without any prevention implementation. The players of this group will jus have to
      answer the monthly questionnaire about the potential injuries they experienced during the
      previous month.
    

Intervention name(s): Prevention exercises
Intervention type(s): Other
Intervention description(s): Participants will have to follow a warm-up prevention program (15 minutes) twice a week
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: prevention, shoulder, exercises, volleyball
Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.
Condition: Intubating Video Stylet
Study type: Interventional

Summary: 
      the video stylet (VS), it is considered one of the newer devices in this category. It is a
      portable device with liquid crystal-display module screen for visualization of vocal cords.
      It is considered an alternative to the flexible fiberoptic endoscope especially in the
      developing countries where the device cost is the main limiting factor. It has many benefits
      such as being light weight, easy to clean, durable, chargeable, less expensive and reusable.
      However newer video stylet devices have not been formally evaluated for tracheal intubation
      in case of laterally positioned patients.
    

Detailed description: 
      Following approval from Ethics and Research Committee of Theodor Bilharz Research Institute,
      the study protocol will be explained to the patients after taking their consent.

      Upon arrival to the operating room, a 20 G cannula will be sited intravenously and infusion
      of Ringer's solution will be started. Intravenous midazolam in a dose of 0.05 mg/ Kg will be
      given. Then, a five-lead electrocardiogram (GE-Datex Ohmeda 5 lead ECG cable), a pulse
      oximeter (GE- Datex Ohmeda adult finger spO2 sensor) and a non-invasive blood pressure
      monitor (GE-Datex Ohmeda NIBP cuff, adult double tube with bag) will be attached to the
      patient.
    

Intervention name(s): video stylet; fiberoptic
Intervention type(s): Device; Device
Intervention description(s): trachea will be intubated using laryngoscopic assisted video stylet device in lateral position; intubation will be done using fiberoptic device by the same anesthesiologist in lateral position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
An Exploratory Study of PQ Grass 27600 SU
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      PQGrass309 is aimed at exploring the expected average treatment effect of PQ Grass 27600 SU
      cumulative dose on symptom and medication score in a field setting. The study will enrol
      adult subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis (SAR) induced by
      grass pollen exposure.
    

Detailed description: 
      PQGrass309 is a randomised, double-blind, placebo-controlled exploratory study to explore the
      efficacy and safety of PQ Grass 27600 SU in subjects with seasonal allergic rhinitis and/or
      rhinoconjunctivitis (SAR) induced by grass pollen exposure. The study is expected to be
      conducted in the United States (US) and the European Union (EU). The study will enrol enough
      subjects to allow treatment of approximately 150 subjects.

      The aim of this exploratory field study is to explore amongst others the following:

        -  The efficacy and safety (up to 6 months following treatment) of a cumulative dose of
           27600 standardised units (SU) of PQ Grass in the treatment of grass pollen allergy.

        -  The expected average treatment effect on combined symptom and medication score.
    

Intervention name(s): PQ Grass; Placebo Option 1; Placebo Option 2
Intervention type(s): Biological; Drug; Drug
Intervention description(s): Suspension for injection; Suspension for injection; Solution for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PQ Grass; Seasonal Allergic Rhinitis or Rhinoconjunctivitis
Efficiency and Safety of Water Birth
Condition: Water Birth
Study type: Interventional

Summary: 
      Water birth are not risks factors for newborns.
    

Detailed description: 
      Investigators will study medical records of woman who have water birth and evaluate different
      parameters. Study lasts from February 2020 till April 2021. The questionnaire contain
      information about woman's expectations of labour Number of participant is approximately 500.
    

Intervention name(s): Delivery in water
Intervention type(s): Behavioral
Intervention description(s): Participants delivery in water
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: water birth
Effects of Synvisc on Cartilage in Knee Osteoarthritis (OA)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative used to treat knee
      osteoarthritis (OA). Animal studies have shown that Synvisc can have favorable effects on
      cartilage when injected into joints. This study attempts to evaluate the effects of Synvisc
      when injected into knees of patients with knee OA by means of a specialized MRI technology
      (dGEMRIC).
    

Detailed description: 
      Hylan G-F 20 (Synvisc) is an FDA-approved hyaluronate derivative which is administered by
      injection into osteoarthritic joints for the treatment of osteoarthritis. Preclinical
      investigations have demonstrated that Hylan G-F 20 can favorably affect chondrocyte
      metabolism and recent clinical studies [Ann Rheum Dis. 2004 May;63(5):478-82; Osteoarthritis
      Cartilage. 2005 Mar;13(3):216-24] provide support for a disease-modifying effect of Hylan G-F
      20 therapy. This study will utilize dGEMRIC imaging of patients with knee OA to assess the
      effects of Hylan G-F 20 therapy on cartilage in vivo over time. Delayed Gadolinium Enhanced
      MRI of the Cartilage (dGEMRIC) permits a quantitative assessment of GAG distribution within
      intact cartilage in vivo. Since dGEMRIC is noninvasive, the technique may be useful to
      non-invasively monitor the influence of various treatments on hyaline cartilage.
    

Intervention name(s): Synvisc
Intervention type(s): Device
Intervention description(s): intra-articular, 3 weekly injections
Other intervention name(s): hyaluronan
Intervention MeSH terms: Hylan; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: knee osteoarthritis, synvisc, hyaluronan, dGEMRIC,cartilage
Investigation of Topical SB705498 on Healthy Volunteers
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      A two part, randomized, double-blind, placebo controlled study to investigate the effects of
      topical doses of SB705498 in healthy volunteers.
    

Detailed description: 
      This study is a two part, randomized, double-blind, placebo controlled study to investigate
      the effects of topical doses of SB705498 on capsaicin, histamine, and cowhage responses in
      healthy volunteers. Part A has been designed to establish whether the topical formulation is
      capable of delivering SB705498 to the proposed site of action, and to select an appropriate
      dose for Part B. Part B will examine the effects of SB705498 on pruritus initiated by a
      histaminergic and a non-histaminergic pathway, using two different challenge agents;
      histamine and cowhage. This may provide important information about the role of TRPV1 in
      pruritus and the therapeutic potential of SB705498.
    

Intervention name(s): SB705498; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1%, 3% and 5% (w/w) of SB705498 will be used in part A of the study. One dose will then be selected based on criteria explained in the protocol for use in Part B of the study.; Placebo to match SB705498 will be used in both Part A and Part B of the study.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pruritus; TRPV1; Cowhage; Atopic Dermatitis; Capsaicin; Itch; Histamine; healthy volunteers; SB705498; Clinical
A Study to Evaluate the Safety and Tolerability of Cendakimab in Chinese Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the drug levels, safety, and tolerability of
      cendakimab in healthy male and female Chinese participants.
    


Intervention name(s): Cendakimab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Other intervention name(s): CC-93538, BMS-986355, RPC4046
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy; Chinese; Cendakimab
Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease
Condition: Prediabetes; Coronary Artery Disease; Insulin Resistance; Glucose Intolerance
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Insulin Resistance; Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 3

Summary: 
      Objectives:

      The investigators examined whether rosiglitazone, a thiazolidinedione (TZD), is beneficial
      for pre-diabetes mellitus (DM) adults with documented coronary artery disease (CAD).

      Background:

      Microvascular and macrovascular complications are common in type 2 DM. There is no evidence
      about the effects of TZDs, synthetic peroxisome proliferator-activated receptor (PPAR)-γ
      activators (insulin sensitizers and adipose transcriptional regulation and anti-inflammatory
      process activators) on pre-DM patients with documented CAD.
    

Detailed description: 
      Materials and Methods:

      This is a randomized, double-blind, placebo-controlled study, patients will be randomly
      assigned to the TZD group and to the placebo group with a 6-month treatment period.

      Biomarkers will also examined before and 6 months post-treatment during the trial.

      The primary end-points will be the diagnosis of major cardiovascular events: myocardial
      infarction, overt heart failure, and surgery or coronary intervention for CAD.
    

Intervention name(s): placebo tablet; rosiglitazone (4 mg)/day
Intervention type(s): Drug; Drug
Intervention description(s): placebo tablet for 6 months; rosiglitazone (4 mg)/day for 6 months
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: prediabetes; coronary artery disease; insulin resistance; glucose intolerance
The Optimization of Procedural Pain Control in Intensive Care Unit (ICU) Patients
Condition: Critical Illness
MeSH terms: Critical Illness; Pain, Procedural
Study type: Interventional

Summary: 
      The purpose of this study is to determine the influence of morphine 2,5 mg or morphine 7,5 mg
      iv during a painful and unavoidable intervention in critically ill patients.
    

Detailed description: 
      In 2006, in the Intensive Care Unit (ICU) of the St. Antonius Hospital an analgesia
      improvement program has been implemented. This program consisted of training of ICU nurses
      and intensivists using a hospital based standardized pain protocol, and systematic pain
      measurements in rest, rated by the patient himself whenever possible or otherwise by the
      attending nurse. This program has resulted in a reduction of severe pain levels (NRS≥4) in
      ICU patients in rest from 41% to 22%. In order to further reduce this percentage, a pain
      titration protocol is introduced in 2007. As no attention has yet been paid to
      intervention-related pain levels in these patients, in this prospective study pain control
      will be studied using different analgesic dosages of morphine iv (2,5 mg vs 7,5 mg) around
      unavoidable painful interventions within a pain titration protocol for pain control in rest.
    

Intervention name(s): morphine
Intervention type(s): Drug
Intervention description(s): patients receive 7,5 mg morphine iv 30 minutes before intervention (turning of the patient), the day after admission in the ICU. before, during and after, the patient will be asked to rate the pain using the NRS
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pain; Intensive Care Unit; morphine; pKpD; numerical rating scale; critically ill patients
Single-dose, Two-way Crossover Bioequivalence of Lamotrigine in Healthy Male Volunteers Under Fasting Conditions
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the bioequivalence of lamotrigine from Lamotrigin Desitin 100 mg tablets and
      Lamictal 100 mg Tablet.
    

Detailed description: 
      In the pivotal study bioequivalence of Lamotrigin Desitin 100 mg tablets and Lamictal 100 mg
      tablet in healthy, male volunteers should be proven.

      The drug products were studied using a crossover design with 24 healthy, non-smoking, male
      volunteers being administered an oral dose of 1 × 100 mg tablet under fasting conditions.
    

Intervention name(s): Lamotrigine 100 MG
Intervention type(s): Drug
Intervention description(s): tablets
Other intervention name(s): Lamotrigin Desitin 100 mg
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of High Fat Diet on the Pharmacokinetics of AD16 Tablets in Healthy Chinese Adult Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was a single-center, randomized, open-access, two-crossover, single-dose study
      design with 16 subjects to evaluate the pharmacokinetics of a high-fat diet on a single dose
      of oral AD16 tablets in healthy Chinese adults and the safety of a single dose of oral AD16
      tablets in healthy Chinese adults.

      Compared with fasting administration, a high-fat diet reduced the rate of AD16 tablet
      absorption in healthy adult subjects and had no effect on overall exposure to AD16.

      The elimination and distribution characteristics of AD16 in vivo were similar under the
      conditions of feeding and fasting administration.

      A single dose of AD16 tablets after fasting and high fat diet showed good safety.
    


Intervention name(s): high-fat diet group（AD16 20mg）; fasted group（AD16 20mg）
Intervention type(s): Other; Other
Intervention description(s): AD16 was administered with 240 mL water 30 minutes after the subjects ate a high-fat, high-calorie food.; Subjects took AD16 on an empty stomach and fasted within 4 hours after taking the drug.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immediate and Delayed Effects of Kinesio Taping on the Neuromuscular Performance
Condition: Neuromuscular Performance, Balance and Function
Study type: Interventional

Summary: 
      The purpose of this study is analyze the immediate and late effects of the application of KT
      in neuromuscular performance of the quadriceps in postural balance and function of the lower
      limb of healthy subjects.
    

Detailed description: 
      Sixty volunteers, females will be recruited and randomly divided into 3 groups with 20
      members each: control group (CG) - 10 minutes at rest; placebo group (PG) - Kinesio Taping
      (KT) without application of tension in the vastus lateralis (VL), vastus (VM) and rectus
      femoris (RF); and Kinesio Taping group (KTG) - application of KT with tension in VL, VM and
      RF. All volunteers will be evaluated for their distance from the single and triple hop test,
      postural balance (baropodometry), the joint position sense (JPS), the knee extensor torque
      (concentric and eccentric assessment at 60 °/s) and electromyographic activity of the VL
      muscle in five distinct stages: the first before the intervention (AV1), the second
      immediately after (AV2) and the following three 24h (AV3), 48 (AV4) after the intervention
      protocol. Soon after the AV4, KT will be removed after 24 hours and take place the last
      review (AV5).
    

Intervention name(s): Functional elastic tape; placebo Functional elastic tape
Intervention type(s): Other; Other
Intervention description(s): application of KT with tension in the vastos medialis, rectus femoris and vastus lateralis muscles; application of KT without tension in the vastos medialis, rectus femoris and vastus lateralis muscles
Other intervention name(s): Kinesio Taping; placebo Kinesio Taping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Electromyography; Baropodometry; Torque
Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Condition: Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR
    

Detailed description: 
      This is a phase II, multi-center, single-arm, global study of MEDI4736 monotherapy in
      patients with PD-L1 positive recurrent or metastatic Squamous Cell Carcinoma of the Head and
      Neck (SCCHN), who have progressed during or after treatment with only 1 systemic palliative
      regimen for recurrent or metastatic disease that must have contained a platinum agent.
    

Intervention name(s): MEDI4736
Intervention type(s): Drug
Intervention description(s): MEDI4736 monotherapy
Intervention MeSH terms: Durvalumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and neck cancer; SCCHN