bioihbjkbjnl/mcl2 huggingface dataset:
Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, multi-centre, comparative study in young, healthy, female volunteers
      of reproductive age.

      Primary objective:

      - To investigate the effect of 2 dosages of estetrol combined with P1 or P2, on vaginal
      bleeding patterns (cycle control), in comparison with a combined oral contraceptive
      containing estradiol valerate and dienogest

      Secondary objectives:

        -  To investigate ovulation inhibition

        -  To investigate the effect on SHBG

        -  To assess pregnancy rate

        -  To evaluate subject satisfaction, dysmenorrhoea, acne, and body weight

        -  To investigate return of menstruation after treatment

        -  To evaluate general safety and acceptability
    


Intervention name(s): estetrol, P 1 and placebo tablets; estetrol, P2 and placebo tablets; Estradiol valerate, dienogest and placebo tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 6 treatment cycles each consisting of 28 days of oral administration as follows:
Days 1-24: one estetrol tablet and one P1 tablet per day
Days 25-28: two placebo tablets per day; 6 treatment cycles each consisting of 28 days of oral administration as follows:
Days 1-24: one estetrol tablet and one P2 tablet per day
Days 25-28: two placebo tablets per day; 6 treatment cycles each consisting of 28 days of oral administration as follows:
Days 1-26: one tablet of Estradiol valerate/dienogest per day
Days 26-28: one placebo tablet per day
Intervention MeSH terms: Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes
Condition: Diabetes Mellitus, Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Insulin is a chemical that the body needs in order to use or store sugar. It is made by a
      type of cell called a beta cell which resides in an organ known as the pancreas. Type 1
      diabetes is a disease where the beta cells have been destroyed so that little or no insulin
      is made. Sugar levels rise in the blood as a result. INGAP-Peptide is being tested to attempt
      to create new beta cells in the pancreas, and to restore the ability to produce insulin in
      type 1 diabetic patients.
    


Intervention name(s): INGAP-Peptide; INGAP-Peptide; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1.5 mL, once daily, self-administered SC injection for 90 days; 1.5 mL, once daily, self-administered SC injection for 90 days; 1.5 mL, once daily, self-administered SC injection for 90 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 1 diabetes
Systematic Case Series Investigating Eye Movement Desensitization Reprocessing (EMDR) Efficacy With Childhood Sexual Abuse Survivors
Condition: Trauma, Psychological
MeSH terms: Psychological Trauma
Study type: Interventional

Summary: 
      This study investigates the effectiveness of EMDR for survivors of childhood sexual abuse.
      All participants will undertake a standard course of EMDR via the National Heath Service
      program, alongside a number of questionnaires and a follow-up interview.
    

Detailed description: 
      The aim of this study is to investigate the effectiveness of Eye Movement Desensitisation
      Reprocessing (EMDR) via investigation of the changes in the individual trauma stress response
      on sexually abused adolescents and young adults, aged between 18 and 25 during EMDR
      treatment. The findings of this mixed methods study will explore (a) neuropsychological,
      emotional (namely low self-esteem, anxiety and depression), behavioural functioning and
      quality of life issues via quantitative measures conducted before, during and after treatment
      and (b) client perspectives of such changes through qualitative interviewing (interview guide
      is in Appendix 7) at one month follow-up using Interpretative Phenomenological Analysis
      [IPA]. The study setting will be conducted within the Improving Access to Psychological
      Therapies (IAPT) program framework, established to ensure service users accessing NHS
      treatment are presented with choice in their treatment. Therapy will routinely be delivered
      within GP Surgeries or Health Centres.

      Within this two-fold study, the following key research questions will be considered in
      relation to the effectiveness of EMDR:

        1. Qualitative data will sought to identify; In what ways was EMDR helpful? In what ways
           was EMDR perceived as being unhelpful?

        2. Quantitative data will sought to identify; Are there changes in emotional and
           behavioural functioning (in relation to trauma, anxiety and depressive symptoms)? Are
           there changes in neuropsychological functioning (memory, attention, executive
           functioning)? Are there changes in quality of life issues? Are there changes in
           self-worth?
    

Intervention name(s): Eye Movement Desensitization Reprocessing (EMDR)
Intervention type(s): Behavioral
Intervention description(s): Trauma-Focused Therapy
Intervention model: Single Group Assignment
Intervention model description: Mixed methods study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eye Movement Desensitization Reprocessing; EMDR; childhood sexual abuse; posttraumatic stress disorder; PTSD; adults
Double-Blinded, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Biochemical Activity of Intravenous Cpn10 Administration in Subjects With Mild to Moderate SLE.
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of the study is to evaluate the safety, tolerability, and efficacy of 4
      weeks intravenous treatment with Cpn10 in subjects with mild to moderate active SLE.
    


Intervention name(s): Ala-Cpn10; Placebo
Intervention type(s): Biological; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Usability Study of the Focus Touch™ Conception System: Semen Collection
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a human factors usability study designed to validated usability by obtaining feedback
      in a home use environment regarding ease of use of the Focus Touch™ Conception System
      Conceptacle (when used to collect semen) and the instructions for use. The investigators will
      collect data to demonstrate that the usability requirements of the conception system as
      collection device, as determined by Usability Specification: Focus Touch Conception System,
      ER-000001 have been met. The ability of the device to be used during sexual intercourse
      without discomfort or injury to the female participant's vaginal/cervical tissues shall also
      be taken into account. Participating couples will be asked to use the Focus Touch™ Conception
      System Conceptacle (in condom form), using the Instructions For Use, to collect semen during
      sexual intercourse in a home use environment. This study will involve sexual intercourse
      between monogamous, heterosexual couples who are trying to conceive or are on a non-vaginal
      birth control with which they do not normally use condoms. Participants will be asked to
      complete the study and the questionnaire within 3 days of receiving the study packet. Contact
      information shall be collected, but participants will only be contacted if they fail to
      return the questionnaire within the requested timeframe.
    


Intervention name(s): Cervical cap (Focus Touch™ Conception System)
Intervention type(s): Device
Intervention description(s): Cervical cap
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Cervical cap insemination; Collection condom; Instructions for Use; Safety during intercourse; Acceptability of the cervical cap with condom sheath; slip; break; ease of conversion; adequate sample collection
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10
      mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fasted state.
    

Detailed description: 
      Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in
      the relief of moderate to severe malignant and non-malignant pain.
    

Intervention name(s): Reformulated OXY (oxycodone HCl); Original OxyContin® (OXY) (oxycodone HCl)
Intervention type(s): Drug; Drug
Intervention description(s): Reformulated OXY 10-mg tablet x 1 dose taken without food; Original OxyContin® (OXY) 10-mg tablet x 1 dose taken without food
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy subjects; Opioid
Trebananib in Treating Younger Patients With Relapsed or Refractory Solid Tumors, Including Central Nervous System Tumors
Condition: Central Nervous System Neoplasm; Solid Neoplasm
MeSH terms: Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies the side effects and best dose of trebananib in treating patients
      with solid tumors that has returned after a period of improvement or does not respond to
      treatment, including central nervous system tumors. Trebananib may stop the growth of tumor
      cells by blocking blood flow to the tumor.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate the maximum-tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of
      trebananib (AMG 386) administered as a weekly intravenous infusion to children with recurrent
      or refractory solid tumors.

      II. To determine the tolerability of the solid tumor MTD and/or RP2D of AMG 386 in children
      with central nervous system (CNS) tumors.

      III. To define and describe the toxicities of AMG 386 administered on this schedule.

      IV. To characterize the pharmacokinetics and immunogenicity of AMG 386 in children with
      refractory cancer.

      V. To measure changes in vascular permeability relative to baseline, evaluated by magnetic
      resonance imaging (MRI) perfusion, following AMG 386 administration in pediatric patients
      with CNS tumors.

      SECONDARY OBJECTIVES:

      I. To preliminarily define the antitumor activity of AMG 386 within the confines of a Phase 1
      study.

      II. To measure biologic markers of angiogenesis with potential for correlation with disease
      response.

      OUTLINE: This is a dose-escalation study (part 1) followed by a safety and imaging study
      (part 2).

      Patients receive trebananib intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 22.
      Treatment repeats every 28 days in the absence of disease progression or unacceptable
      toxicity.

      After completion of study treatment, patients are followed up at 30 days and then every 3 to
      6 months for up to 1 year.
    

Intervention name(s): Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Laboratory Biomarker Analysis; Pharmacological Study; Trebananib
Intervention type(s): Procedure; Other; Other; Biological
Intervention description(s): Correlative studies; Correlative studies; Correlative studies; Given IV
Other intervention name(s): DCE MRI; DCE-MRI; DYNAMIC CONTRAST ENHANCED MRI; AMG 386; Angiopoietin 1/2-Neutralizing Peptibody AMG 386
Intervention MeSH terms: Trebananib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Proprioceptive Training With Routine PT on Gross Motor Function in Spastic Quadriplegic CP
Condition: Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      The proprioceptive training with a therapy regime enhances the body's somatosensory input
      that in result changes the body to be more functional in different types of interactions.
      This study is dedicated to finding out how much proprioception training is helpful in gross
      motor function level improvement and enhances functional activities of CP children
    

Detailed description: 
      Proprioception plays an important role in the correct execution of efferent motor performance
      as 70% of cerebral palsy population have deficit in receiving somatosensory signals3.
      Tradition physical therapy exercises including strengthening followed by stretching etc.
      should be reviewed and the therapy must be more oriented to overall individual growth and
      development31. There is a need to push the cerebral palsy population to be exercised with
      proprioceptive stimulation for their maximum participation in the activities of daily life
      including both personal and social aspects. The proprioceptive training with a therapy regime
      enhances the body's somatosensory input that in result changes the body to be more functional
      in different types of interactions. This study is dedicated to finding out how much
      proprioception training is helpful in gross motor function level improvement and enhances
      functional activities of CP children.
    

Intervention name(s): Proprioceptive Training; Routine Physical Therapy
Intervention type(s): Other; Other
Intervention description(s): Proprioceptive Training using increased joint to joint approximation through ankle weights and joint splints.; Neurodevelopmental treatment- age appropriate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: : Spastic Quadriplegia, Cerebral palsy; Proprioceptive training, Somatosensory input
Study of the Efficacy and Tolerance of Light Therapy in Sensitive Skin
Condition: Sensitive Skin
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Light-emitting diode (LED) light therapy is increasingly used successfully and without
      adverse effects in diabetic leg ulcer, chronic low back pain, chronic myofacial pain in the
      neck and in several dermatoses such as acne, Psoriasis, alopecia areata and skin
      rejuvenation. A Korean study conducted in 2013 suggested its effectiveness in patients with
      sensitive skin in connection with rosacea, acne, eczema. The objective of the study is to
      perform a study in subjects with a sensitive skin without associated dermatosis.
    

Detailed description: 
      The objective of the study is to evaluate the efficacy of light-emitting diode therapy in
      subjects with sensitive skin and to assess pain improvement, evaluation of improvement in
      pruritus and evaluation of treatment tolerance.
    

Intervention name(s): LED light
Intervention type(s): Device
Intervention description(s): An exposure to LED light will be carried out twice a week until improvement, maximum 8 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Origin of CEC in Patients After Allo-HSCT
Condition: Graft Versus Host Disease, Acute; Endothelial Dysfunction; Immune Tolerance
MeSH terms: Graft vs Host Disease; Acute Disease
Study type: Observational

Summary: 
      We believe that CEC, besides coming from cells shedding from patient vasculature, could
      partly belong to donor, originating from the cellular graft.
    

Detailed description: 
      In consideration of the fact that the vascular endothelium has been shown to be a target of
      GvHD in early stage and that the count of CEC represent a marker of endothelial damage, we
      want to correlate the presence of donor CEC at engraftment with a putative protective
      function against GVHD manifestations. We will enroll patients affected by hematologic
      disorders undergoing allo-HSCT. At time of engraftment and at + 3 months after allo-HSCT, CEC
      identified and counted by means of the CellSearch system, will be recovered from the counting
      cartridge and further sorted at the single cell level. STR profile of each single CEC
      recovered will be performed in order to define host versus donor origin of each CEC analysed.

      Through the conduct of this study, we expect to upfront identify patients who will or will
      not manifest GvHD. This result will allow definitely different clinical approaches: stringent
      monitoring and early therapeutic intervention, before refractory disease's development, in
      the formers, while, sparing unnecessarily expensive testing or heavier treatment in the
      latters.
    

Intervention name(s): D-CEC counting
Intervention type(s): Diagnostic Test
Intervention description(s): By means of preliminary bulk separation step with the CellSearch system, single CEC will be sorted
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing allo-HSCT for their neoplastic hematologic disorders
      
Biospecimen description: 
      DNA will be obtained from each single CEC
    
Keywords: Circulating Endothelial Cells; Graft versus Host Disease; Neovascularization; Allotransplantation
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
Condition: Human Immunodeficiency Virus Type 1 (HIV-1)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir
      in a fixed-dose combination with cobicistat with that of atazanavir coadministered with
      cobicistat as single agents.
    


Intervention name(s): Atazanavir; Cobicistat; Atazanavir/Cobicistat FDC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300-mg capsule; 150-mg tablet; Atazanavir 300-mg/cobicistat 150-mg FDC tablet
Other intervention name(s): BMS-232632
Intervention MeSH terms: Atazanavir Sulfate; Cobicistat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Safety Study of GSK1995057 Given as Single and Repeat Intravenous Doses in Healthy Subjects.
Condition: Respiratory Disorders
MeSH terms: Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study is to see how safe GSK1995057 is and how well it is tolerated
      after dosing. The study will also investigate how GSK1995057 is taken up, metabolised
      (chemically broken down), distributed through the body and excreted, and what some of the
      effects of the study drug are.
    

Detailed description: 
      This study will be the first investigation of GSK1995057 in humans and is primarily designed
      to investigate safety and tolerability of single and repeat intravenously infused doses. The
      study will enrol healthy male subjects and healthy female subjects of non-child bearing
      potential and will also investigate immunogenicity, GSK1995057 distribution
      (pharmacokinetics), and potential impact on indicators of host immunity and normal
      immunological function. Safety, tolerability, immunogenicity, pharmacokinetic and
      pharmacodynamic data from this trial may facilitate further clinical investigations in
      healthy subjects dosed with GSK1995057 via the inhaled route, and ultimately clinical trials
      in patients with acute lung injury.
    

Intervention name(s): GSK1995057 single dose; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single intravenous dose; Single intravenous dose
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Acute Lung Injury (ALI); Acute Respiratory Distress Syndrome (ARDS)
Zinc Supplementation in Alcoholic Cirrhosis
Condition: Alcoholic Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Alcoholic; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if zinc therapy: (1) strengthens your intestine's
      defensive barrier preventing damaging substances from reaching your liver, (2) decreases
      liver injury (inflammation, oxidative stress, cell death) and scarring, and (3) improves your
      liver-related health. Based on our preliminary animal data and other published reports, we
      expect zinc therapy to achieve all of these goals. Zinc is affordable, available over the
      counter or by prescription, and has an excellent safety profile. Positive results from this
      study will show that zinc is a significant therapy for millions of Americans with alcoholic
      liver disease.
    

Detailed description: 
      Two-thirds of Americans consume alcohol, and an estimated 14 million Americans are
      alcoholics. It has been estimated that 15%-30% of heavy drinkers develop advanced Alcoholic
      liver disease (ALD). The prevalence of ALD in the United States is conservatively estimated
      at 2 million persons. Nearly 50% of liver-related deaths and 30% of hepatocellular carcinomas
      in the US are due to alcoholic cirrhosis. Despite recent advances in our understanding of
      ALD, there is currently no FDA approved medication for any stage of ALD. Zinc sulfate is
      inexpensive, available over the counter, and has an excellent safety profile. If zinc
      positively influences the mechanisms postulated to play a role in human ALD, this affordable
      treatment would become relevant to millions of people worldwide.
    

Intervention name(s): Zinc; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Zinc sulfate 220 mg
Intervention MeSH terms: Zinc; Zinc Sulfate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cirrhosis; alcohol