bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine the safety and efficacy of two vaginal
      doses of Proellex® administered for up to 2 courses of treatment (18 weeks each), each
      separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine
      fibroids.
    


Intervention name(s): Placebo; Telapristone Acetate
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.; Telapristone acetate, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Other intervention name(s): Proellex®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: uterine fibroids; leiomyoma; fibroid tumor; fibroma
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
Condition: Opioid Overdose
MeSH terms: Drug Overdose; Opiate Overdose
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a Phase 1, single-center, open-label, randomized cross-over study to
      evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone
      hydrochloride intranasally.
    

Detailed description: 
      Based on the intended AP003 product presentation there will be two devices in each carton
      allowing for administration of a total of 16 mg. This study is designed for subjects to
      receive naloxone therapy either through the AP003 device or through the currently approved
      NARCAN® nasal spray (4 mg) device (per label), reference therapy. After administration of the
      therapy patients will be followed by a 48-hour washout period before treatment crossover. Key
      study parameters include safety and PK. Safety evaluations will include but not limited to
      complete and system directed physical examinations (including signs of nasal irritation such
      as erythema, edema, and erosion), administration of a Brief Smell Identification Test
      (B-SIT), assessments of vital signs, 12 lead electrocardiogram (ECG), continuous cardiac
      telemetry monitoring (CCT) , clinical laboratory tests (e.g., hematology, chemistry,
      urinalysis, pregnancy test), and evaluation of adverse events.
    

Intervention name(s): 16 mg naloxone AP003; 8 mg naloxone NARCAN Nasal Spray
Intervention type(s): Combination Product; Combination Product
Intervention description(s): 4 doses of 4 mg each (total: 16 mg) of naloxone through the AP003 device; 2 doses of 4 mg each (total: 8 mg) of the naloxone through the NARCAN Nasal Spray device
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NARCAN; Opioid Overdose; Naloxone; Intranasal
Weight Loss Impact on Male Fertility
Condition: Obesity; Sub Fertility, Male; Metabolic Syndrome
MeSH terms: Infertility; Infertility, Male; Metabolic Syndrome; Weight Loss
Study type: Interventional

Summary: 
      This is a prospective non-randomized unicentric clinical trial, characterized by the
      inclusion of obese (BMI> 35) male with subfertility (sperm count showing low sperm counts and
      / or motility and / or morphology and / or DNA fragmentation). Patients selected at the
      endocrinology obesity HC-FMUSP outpatient will be submitted to very low calorie diet (VLCK)
      for 6 months, being reassessed clinically and laboratorially monthly.
    


Intervention name(s): Very Low Carb Ketogenic Diet
Intervention type(s): Dietary Supplement
Intervention description(s): Patients will be submitted to very low-calorie ketogenic dietary intervention (VLCK) according to the recommendations of the Pronokal® Method program including lifestyle and physical activity guidelines. The ketogenic stage (phase 1-3) consists of a VLCD diet (600-800 kcal / d), with low carbohydrate intake and lipids. The amount of high biological value proteins ranges from 0.8 to 1.2 g / kg of body weight / day. This first stage (ketogenic) is maintained until the patient reaches the goal of reducing the target weight by 80% to be reduced, being variable in time, according to the response of each patient. After this period, it evolved to a non-ketogenic stage, initiating the hypocaloric diet (800 to 1500 Kcal), with progressive introduction of other food groups, reducing weight more slowly. The maintenance stage consists of a balanced diet, ranging from 1500 to 2000 Kcal.
Intervention model: Single Group Assignment
Intervention model description: Prospective, unicentre, single group
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954
Condition: Hepatic Impairment; Healthy Volunteers
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of varying degrees of hepatic function on
      the single dose PK of IV TAK-954.
    

Detailed description: 
      The drug being tested in this study is called TAK-954. This study will evaluate the safety
      and tolerability of single intravenous doses of TAK-954 in participants with varying degrees
      of hepatic function.

      The study will enroll approximately up to 32 participants. Participants will be enrolled in
      one of the 4 treatment groups based on their degree of hepatic impairment which will be
      determined based on Child-Pugh Score as follow:

        -  Group 1 TAK-954 0.2 mg: Mild Hepatic Impairment (Child Pugh Class A)

        -  Group 2 TAK-954 0.2 mg: Moderate Hepatic Impairment (Child Pugh Class B)

        -  Group 3 TAK-954 0.2 mg: Severe Hepatic Impairment (Child Pugh Class C)

        -  Group 4 TAK-954 0.2 mg: Healthy Participants

      The Child-Pugh classification will assess the severity of 5 hepatic parameters (total serum
      bilirubin, serum albumin, prothrombin time, ascites and encephalopathy grade) on a scale of 1
      (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe)
      where higher score indicates more severity.

      All participants will receive a single dose of TAK-954 0.2 mg on Day 1.

      This study may have a full study design, where Group 1 to Group 4 will enroll approximately 8
      participants in each group or a reduced study design, where no participants will be enrolled
      in Group 1 and approximately 8 participants will be enrolled in Group 2 to Group 4.

      This multi-center trial will be conducted in Czech Republic and Slovakia. The overall time to
      participate in this study is approximately 7 weeks. Participants will remain confined to the
      clinic for 4 days, with 2 further out-patient visits, and will make a final visit to the
      clinic 10-14 days after receiving their last dose of TAK-954 for a follow-up assessment.
    

Intervention name(s): TAK-954
Intervention type(s): Drug
Intervention description(s): TAK-954 intravenous infusion.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Healing Touch During Chemotherapy Infusions for Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      To study if Healing Touch is effective during chemotherapy treatment for breast cancer
    

Detailed description: 
      To study the effectiveness of Healing Touch provided during chemotherapy infusions on the
      experience of women undergoing treatment for breast cancer. Healing Touch (HT) is a gentle,
      non-invasive form of energy-balancing work that promotes relaxation and can help manage the
      side effects of chemotherapy.
    

Intervention name(s): Healing Touch; Standard care; guided relaxation
Intervention type(s): Procedure; Other; Procedure
Intervention description(s): every other week (during their infusion); Adriamycin, cyclophosphamide, and paclitaxel administered as standard of care
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Three Capsaicin Dermal Liquid Formulations on Epidermal Nerve Fiber Immunostaining and Sensory Function
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate potential changes in epidermal nerve fiber
      immunostaining (ENFI) and sensory nerve function in healthy normal volunteers following
      single applications of three different investigational topical Capsaicin Dermal Liquids (10%
      w/v trans capsaicin), and a comparable control (propylene glycol). In addition, the pain and
      tolerability of the application of each formulation will also be assessed. Data from this
      clinical study may be used to select a formulation for further clinical evaluation.
    

Detailed description: 
      This is a randomized, controlled, single-blind, single-center, Phase 1 study in twenty normal
      healthy volunteers. Each subject will have a single 15 minute exposure to each of three
      topical Capsaicin Dermal Liquids and the control. Each application site, located on the
      distal and proximal anterior medial thigh areas, will be 5.0 × 5.0 cm in size. The volume
      applied will be 15 mcL per cm2 and hence the total volume applied will be 375 mcL.

      At baseline and prior to skin punch biopsy at Day 7, QST of the four application sites for
      warming and cooling detection thresholds, and assessment of mechanical (sharp pain) sensation
      and tactile thresholds, will be performed and evaluated. This will be repeated at each of the
      four application sites on Day 7 and the Termination Visit.
    

Intervention name(s): Capsaicin Dermal Liquid
Intervention type(s): Drug
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Analgesics; Capsaicin
Managerial Database II
Condition: HIV
Study type: Observational

Summary: 
      This study will collect information on health status and risk behaviors, as well as basic
      demographic and biomedical information for a group of HIV positive adolescents receiving care
      at the ATN sites.
    

Detailed description: 
      The proposed study is a cross sectional study intended to be conducted at each of the 15
      Adolescent Medicine Trials Units (AMTUs) participating in the ATN and to enroll all
      participating patients followed at each site. This approach will allow for the examination of
      the broad spectrum of youth participating in the ATN, including those newly entered into
      care.

      Psychosocial and risk-taking behavioral data will be collected using Audio Compute-Assisted
      Self-Interview (ACASI); biomedical information will be collected through medical chart
      abstraction.
    

Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): Participants will have biomedical information extracted from their medical chart, will complete the ACASI questionnaire and have a face-to-face post-ACASI debriefing interview administered. Participants who do not have a documented HIV-1 viral load and/or CD4+ T-cells count from within the previous six months will also have venipuncture performed to obtain a blood sample for these tests to be performed.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All HIV-infected adolescents and young adults engaged in care at the 15 sites and their
        affiliates who are between 12 and 24 years of age, inclusive, are aware of their HIV status
        and understand written and/or verbal English will be included in the master list from which
        the study sample will be derived.
      
Keywords: Medication adherence; Substance use; Sexual risk behaviors
Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome?
Condition: Prader-Willi Syndrome; Growth Hormone Deficiency
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to estimate the sensibility at the growth hormone in vivo at the
      children presenting a Prader-Willi syndrome (SPW) in comparison with children presenting a
      deficit in growth hormone (GHD).
    

Detailed description: 
      Estimate the sensibility at the growth hormone in vivo at the children presenting a
      Prader-Willi syndrome (SPW) in comparison with children presenting a deficit in growth
      hormone (GHD) by the measure of the circulating rates of IGF-I under treatment.
    

Intervention name(s): Growth hormone (Genotonorm® or Omnitrope®); DEXA, blood tests, H.G.P.O, osseous age.; biopsy
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): drug : the treatment will be begun in progressive dose by beginning by ¼ of the dose the first week, then ½ of the dose the second week, then 3/4 of the dose the third week and total dose the fourth week.; SPW, GHD, SPW-B :
blood tests : centralized dosage H.G.P.O : adjusted to children's age.; Biopsy : Cutaneous and fat tissue biopsy.
Intervention MeSH terms: Hormones
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prader-Willi Syndrome; Growth Hormone Deficiency
Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 1

Summary: 
      A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing
      progestin and estrogen.
    

Detailed description: 
      A pharmacokinetic (PK) drug interaction study of erenumab and an oral contraceptive
      containing progestin and estrogen. All participants will receive an oral contraceptive
      containing progestin and estrogen throughout the duration of the study. Participants will
      also receive a single dose of erenumab, administered by a healthcare provider in cycle 3.
      Serial PK samples will be collected at specified time points to characterize the PK of the
      oral contraceptive progestin and estrogen components with and without the presence of
      erenumab.

      The study consists of three 28-day cycles and a follow-up period. The first 28 day cycle is
      an acclimation period when participants initiate oral contraception (Cycle 1). During Cycle 2
      and 3 the PK of ethinyl estradiol (EE) and active metabolites of norgestimate (ie,
      norelgestromin [NGMN] and norgestrel [NG]) will be characterized following the last active
      dose of oral contraceptive in each cycle (cycle day 21). Erenumab will be given in cycle 3
      (cycle day 10); 24-hour PK characterization of norgestimate and EE metabolites will occur 11
      days after administration of erenumab, which will maximize the potential for detecting a
      drug-drug interaction.
    

Intervention name(s): Erenumab; Ethynil Estradiol/Norgestimate Oral Contraceptive
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of erenumab administered in the abdomen.; Ethynil estradiol (EE)/norgestimate combination oral contraceptive is a 28-tablet cycle in which 1 oral tablet is taken daily; each containing 0.250 mg norgestimate and 0.035 mg EE for 21 days, after which a tablet only containing inert ingredients is taken for last 7 days of the 28 day cycle.
Other intervention name(s): AMG-334; Aimovig™; Ortho-Cyclen®
Intervention MeSH terms: Erenumab; Norgestimate; Contraceptive Agents; Contraceptives, Oral; Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Implant Pharmacokinetic and Pharmacodynamic Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, pharmacokinetic and pharmacodynamic study in healthy volunteers.
      Twenty four subjects will be enrolled in the study and will be assigned to receive either a
      16 mg afamelanotide bioresorbable implant from the current manufacturing process or a 16 mg
      afamelanotide bioresorbable implant from the optimized manufacturing process. Implants will
      be administered subcutaneously.

      The following procedures will be conducted throughout the study:

        -  Collection of blood samples for analysis of afamelanotide concentrations

        -  Measurement of skin reflectance for estimation of melanin density, and luminance (L*),
           blue/yellow colour hue (b*)

        -  Safety monitoring
    

Detailed description: 
      The objective of the proposed study is to confirm that the pharmacokinetic and
      pharmacodynamic properties of implants eluting 16 mg of afamelanotide produced by this final
      optimized manufacturing process are essentially the same as those of implants manufactured
      with the same formulation that have been used in earlier clinical studies

      The study will involve the use of an implant, which comes in the form of a small rod to be
      administered under the skin.

      For this study, afamelanotide has been formulated as a controlled release depot injection
      (implant). This means that the afamelanotide will be released slowly into the body over a few
      days. Once inserted, the implant will remain in the body after afamelanotide has been
      released and will slowly dissolve.
    

Intervention name(s): Afamelanotide Group 1; Afamelanotide Group 2
Intervention type(s): Drug; Drug
Intervention description(s): One 16 mg bioresorbable afamelanotide implant (Group 1) from the previous manufacturing process.; One 16 mg bioresorbable afamelanotide implant (Group 2) from the optimized final manufacturing process.
Other intervention name(s): afamelanotide; afamelanotide
Intervention MeSH terms: Afamelanotide; alpha-MSH
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were assigned to receive either a 16 mg bioresorbable afamelanotide implant from the previous manufacturing process or a 16 mg bioresorbable afamelanotide implant from the optimized final manufacturing process.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Afamelanotide; Nontherapeutic Human Experimentation in healthy volunteers
Taking Into Account the Patient/Parent Preference in the Galenic Choice in Atopic Dermatitis. Feasibility and Impact on Treatment Adherence
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      Atopic dermatitis is a chronic inflammatory skin disease often occurring in childhood.

      The treatment consists in making daily local treatment with topical steroid on inflammatory
      lesions and emollient on the whole body. However, approximately 70% of patients do not adhere
      to therapy.

      Studies have shown that this treatment failure is caused by the complexity of the treatment,
      the time required for its implementation, the cost of treatment, the dosage of the products,
      fear of side effects or misunderstanding about the chronicity of these diseases inflammatory
      conditions of the skin.

      This study aims to evaluate the consideration of patient preference in the choice of
      excipient used for the topical treatment of eczema.
    

Detailed description: 
      Day 0 :

        -  Inclusion, collecting non-opposition

        -  Presentation of the samples: 4 products presented in the same packaging (pump bottle 200
           ml) and ranked in order of their fat content:

        -  Cold Cream: 88%

        -  Modified Cerat Galen (national formulary): 66%

        -  Cold Cream Fluid: 32%

        -  Ointment: 21% The 4 products are all equally effective and suited in the treatment of
           atopic dermatitis.

      The patient choose the cream it will apply from 4 presented. A total of two bottles will be
      given to the patient. A bottle containing only the emollient applied to dry areas and another
      bottle in which 30% will be added Diprosone (topical steroid) to be applied on areas of
      eczema).

        -  Remitting the questionnaires

        -  Severity scoring of atopic dermatitis (SCORAD)

      Day 30:

        -  Remitting the questionnaires

        -  Treatments delivery for 2 months

        -  SCORAD / PO SCORAD

        -  Treatment weighing

      Day 90:

        -  SCORAD / PO-SCORAD

        -  Treatments weighing

        -  Remitting the final questionnaire
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Multicenter prospective nonrandomized uncontrolled open-label study
      
Keywords: Atopic dermatitis, Feasibility, Adherence to treatment
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia
Condition: Homozygous Familial Hypercholesterolemia (HoFH)
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to establish the efficacy, safety and tolerability of
      rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, multi-center, cross-over study of the
      efficacy, safety and tolerability rosuvastatin in children and adolescents (aged 6 to <18
      years) with homozygous familial hypercholesterolemia (HoFH). The study is designed to assess
      the efficacy of rosuvastatin 20 mg compared to placebo on lipids, lipoproteins and
      apolipoproteins in pediatric patients with HoFH. The outcome measures to be assessed include
      low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C),
      total cholesterol (TC), triglycerides, non-HDL-C, LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C,
      apolipoprotein B (ApoB), apolipoprotein A 1 (ApoA-1) and ApoB/ApoA-1 following 6 weeks of
      treatment with rosuvastatin 20 mg or placebo. Pharmacokinetic data of the trough plasma
      exposure of rosuvastatin will also be assessed in these pediatric patients with HoFH.
    

Intervention name(s): Rosuvastatin 20mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active drug will be taken taken orally, QD, either in the morning or in the evening; Will be taken taken orally, QD, either in the morning or in the evening
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: LDL-C; HoFH; Hyperlipidemia