bioihbjkbjnl/mcl2 huggingface dataset:
To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo
      Controlled, Three Arm Clinical Study.

      The main objective is to evaluate bioequivalence of Test formulation (Clindamycin Phosphate
      1.2%/Benzoyl peroxide 5% gel) of Cadila Healthcare with Reference formulation (DUAC® Gel of
      Stiefel Laboratories)in the ratio of 2:2:1 of Test drug, Reference drug and Placebo
      respectively.

      Total study duration will be for a period of 78 days which includes treatment duration of 77
      days.

      850 subjects will be enrolled (randomized)as per the inclusion and exclusion criteria
      mentioned in the protocol.
    


Intervention name(s): Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel; DUAC® Gel; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug:-1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days; Drug:-DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days; Drug:-Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
Other intervention name(s): 1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of CHL; DUAC® Gel (of Stiefel Laboratories; Placebo (Vehicle Gel)
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne Vulgaris; DUAC; CADILA; CLIANTHA
An Open-label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will test the safety, tolerability, and pharmacokinetics of escalating doses of
      nusinersen (ISIS 396443) administered into the spinal fluid either two or three times over
      the duration of the trial, in participants with spinal muscular atrophy (SMA).

      Four dose levels will be evaluated sequentially. Each dose level will be studied in a cohort
      of approximately 8 participants, where all participants will receive active drug.
    

Detailed description: 
      This study was conducted and the protocol was registered by Ionis Pharmaceuticals, Inc. In
      August 2016, sponsorship of the trial was transferred to Biogen.
    

Intervention name(s): Nusinersen
Intervention type(s): Drug
Intervention description(s): Single IT injection for each dose
Other intervention name(s): ISIS-SMNRx; ISIS 396443; BIIB058; Spinraza
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Muscular Atrophy; SMA; SMN; SMNRx; ISIS-SMNRx; ISIS 396443
Erythropoietin Therapy for Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized placebo-controlled trial aims to investigate the efficacy and safety of
      erythropoetin for children with cerebral palsy.
    

Detailed description: 
      Cerebral palsy is a disorder of movement and posture resulted from a nonprogressive lesion or
      injury of the immature brain. It is a leading cause of childhood onset disability.

      Many experimental animal studies have revealed that erythropoietin is useful to repair
      neurological injury in brain. The main mechanism of erythropoietin is supposed as follows;

        1. Neuroprotection effect

        2. Angiogenesis

        3. Anti-inflammation.

      On the basis of many experimental studies, erythropoietin is suggested as a therapeutic
      method for cerebral palsy.
    

Intervention name(s): Erythropoietin; Placebo erythropoietin
Intervention type(s): Drug; Drug
Intervention description(s): twice a week for 1 month; twice a week for 1 month
Other intervention name(s): Espogen
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Erythropoietin; Rehabilitation
Preimplantation Genetic Screening in Women Over 35 Year
Condition: In Vitro Fertilization
MeSH terms: Aneuploidy
Study type: Interventional

Summary: 
      In view of insufficient evidence to routinely use Preimplantation Genetic Screening (PGS) to
      improve success rates after IVF, we test the hypothesis that patients with advanced maternal
      age (AMA) have a higher implantation rate (IR) after embryo transfer (ET) of chromosomally
      normal embryos following PGS compared to patients who had an ET without PGS.

      In a randomized controlled trial (RCT) in patients with AMA (≥ 35 years), the clinical IR per
      embryo transferred will be compared after ET on day 5 or 6 between the PGS group (embryo
      biopsy and analysis of chromosomes 13, 16, 18, 21, 22, X and Y) and the control group without
      PGS.
    


Intervention name(s): Preimplantation genetic screening after embryo biopsy
Intervention type(s): Procedure
Intervention description(s): Preimplantation genetic screening after embryo biopsy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: aneuploidies in 7 chromosomes increased with advanced maternal age
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
Condition: Healthy Volunteers
MeSH terms: Alopecia
Study type: Interventional

Summary: 
      The study is aimed to assess the efficacy of a dietary supplement composed of a Wheat Polar
      Lipid Complex (WPLC) in reducing hair loss and improving hair aspect.
    

Detailed description: 
      A double blind, parallel groups, placebo-controlled study is carried out on 60 healthy female
      subjects aged between 18 and 65 years old with all hair type showing diffuse and temporary
      hair shedding with a proportion of hair in telogen phase >15%.

      The study foresees 84 days of products intake. Evaluations of the parameters under study are
      performed at baseline, after 56 and 84 days of products consumption.
    

Intervention name(s): Wheat Polar Lipid Complex; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The study foresees the intake of 2 capsules per day during 84 days; The study foresees the intake of 2 capsules per day during 84 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Kegel Exercise in Nursing Students With Primary Dysmenorrhoea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      In this study, it was aimed to determine the effect of kegel exercise on menstruation
      symptoms, severity of dysmenorrheic symptoms and quality of life in nursing students with
      primary dysmenorrhea. The study was conducted as a single-blind randomized controlled trial.
    

Detailed description: 
      The study was conducted in a single-blind randomized controlled trial with 89 nursing
      students with primary dysmenorrhea. The experimental group was given kegel exercise training
      online, and after the training, a message was sent to remind them to do kegel exercises three
      times a day during the follow-up. No intervention was made in the control group.

      Hypotheses of the Research

        1. VAS total scores in interventions involving kegel exercise training and regular kegel
           exercise are lower than control interval rates (H1).

        2. The total score of the Menstruation Symptom Scale within the participants who
           participated in kegel exercise training and regular kegel exercise was recorded, at
           lower rates than the distribution of control intervals (H1).

        3. The Severity of Dysmenorrheic Symptoms in participants who participated in kegel
           exercise training and regular kegel exercise interventions were lower than the
           distribution of control intervals (H1).

        4. The total scores of the Quality of Life Scale among those who participated in kegel
           exercise training and regular kegel exercises were higher than the proportions of the
           controlled rankings (H1).
    

Intervention name(s): Kegel Exercise
Intervention type(s): Behavioral
Intervention description(s): Before teaching Kegel exercises, it was recommended that the person empty his bladder and wear comfortable clothing.
It was said that the person should extend his legs straight while exercising and not to contract his leg, hip and abdominal muscles and not to hold his breath while the pelvic floor muscles contract.
The relevant muscles were told to contract for 10 seconds and then relax for 10 seconds. The person was also asked to do the exercises during daily activities.
Exercise was implemented regularly 3 times a day (minimum 30-45 exercises) in the morning, noon and evening.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The sample of the study consisted of 89 nursing students with primary dysmenorrhea (45 experimental group and 44 control group)
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: PRIMARY DYSMENORHEA; Kegel exercise; Nursing students; Exercise
Pilates as an Adjuvant Therapy in Parkinson Disease.
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Although Pilates has been proposed as a useful rehabilitation strategy in PD, research on its
      feasibility and potential effects on the motor symptoms and balance with this population is
      scarce. Some works have included Pilates as part of combined exercise session interventions,
      but information concerning their specific effects was not provided. Under these
      circumstances, this study aims at identifying the effects of adding Pilates as part of a
      conventional exercise rehabilitation program on the motor symptoms and static balance of PD
      persons. Participants (n=15) were assigned to a Pilates (PG) or to a conventional exercise
      group (CG) and performed one land-based and one water-based exercise session per week for 14
      weeks. The MDS-UPDRS and a stabilometer were used to assess the impact of the intervention on
      the participant´s motor symptoms and static balance.
    


Intervention name(s): Pilates; Conventional Exercise
Intervention type(s): Other; Other
Intervention description(s): Warm-up exercises included Abdominal and costal breathing and Pelvic Clock. Some exercises included in the main part of the mat session were Arm arcs, Curls up, Femur arcs, Shoulder bridge, Leg circles, among others. The main part of the sitting/standing session included in standing position exercises like Standing on one leg with support, Neck rolls, Side leg lift with support and in sitting position Spine stretch 5", Elbows back with hands behind his head, Heel/knee slides, Shoulder drops, Knee folds, among others. In mat sessions, cooling exercises included in standing position Hamstring stretch and Abdominal Breathing and Rest position and in sitting/standing session Stretching and Abdominal Breathing.; All sessions started with a 15-minute warm-up phase based on walking performance and joint mobility exercises. It was followed by a 35-minute second phase, which included low-impact aerobics (music tempo was set at 120 beats per minute), gross motor coordination tasks and balance activities. The final 5-minute phase focused on gentle stretching exercises.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Parkinson Disease; Neurodegenerative Disorder; Physical Activity; Pilates Method; Stabilometer
Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
Condition: Opioid Overdose
MeSH terms: Opiate Overdose
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to compare the pharmacokinetics (how the body absorbs, breaks down and
      eliminates drug from your body) of nalmefene when given as a single dose intranasally
      (IN;into the nose), as a single dose in each nostril and as two doses in one nostrils; and to
      evaluate the safety and tolerability of nalmefene IN.
    

Detailed description: 
      Open-label, randomized, 3-period, 3-treatment, 6-sequence, ranodmised crossover study in 24
      healthy volunteers. Subjects will be assigned to each of the 6 possible sequences. Each
      subject will receive 3 intranasal (IN) nalmefene doses:

        -  3mg IN dose (one 0.1mL spray of a 30mg/mL solution in one nostril)

        -  6mg IN dose (one 0.1mL spray of a 30mg/mL solution in each nostril)

        -  6mg IN dose (two 0.1mL sprays of a 30mg/mL solution in one nostril) There will be a 6
           day washout period between doses. Screening can occur up to 28 days before admission,
           subjects will then stay in the inpatient facility for 16 days to complete the treatment
           phase of the study and will be discharged following completion of the discharge
           procedures at the end of the last period. Subjects will be called 3 to 5 days after
           discharge to inquire concerning Adverse Events (AEs) and concomitant medications since
           discharge.
    

Intervention name(s): Nalmefene Hydrochloride
Intervention type(s): Drug
Intervention description(s): 3mg nasal spray
Intervention MeSH terms: Nalmefene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics
Efficacy of Motor Control and Diathermy Treatment in Acute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain; Hyperthermia
Study type: Interventional

Summary: 
      Lumbar pain is considered one of the most frequent health problems faced by human populations
      on a global scale.

      This study will be carried out to evaluate the efficiency of motor control treatments
      combined with diathermy in patients diagnosed with acute lower back pain, focusing upon the
      potential for accelerated patient recuperation if both treatments are applied simultaneously
      and jointly.
    


Intervention name(s): microwave diathermy
Intervention type(s): Device
Intervention description(s): Application of microwave diathermy with Monopolar CapacitiveResistive Radiofrequency Therapy (INDIBA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: capacitive resistive diathermy; motor control
Bioavailability in Patient With Psoriasis: Metoject Prefilled Pen
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is conducted to assess the relative bioavailability of MTX administered
      subcutaneously via a prefilled pen (50mg/mL) compared with MTX administered via IM injection
      (25mg/mL).
    


Intervention name(s): Methotrexate
Intervention type(s): Drug
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry
Condition: Sickle Cell Disease; Infant, Newborn, Disease; Drepanocytosis
MeSH terms: Anemia, Sickle Cell; Infant, Newborn, Diseases
Study type: Observational

Summary: 
      Three methods are actually used in newborn screening for sickle cell disease (SCD) in France:
      isoelectric focusing, high performance liquid chromatography and capillary electrophoresis.
      New technologies are currently under development such as Matrix Assisted Laser Desorption
      Ionisation - Time of Flight (MALDI-TOF) and tandem mass spectrometry (MS/MS) using the SpOtOn
      Diagnostics Reagent Kit available in United Kingdom only.

      Zentech company (Liège, Belgium) is developing a package for SCD newborn screening using
      MS/MS technology. The main objective of the present study will be to compare this new
      technique with the technique actually used in the hospital center of Lille (sub-contractor
      for SCD newborn screening of Lyon) and the haemoglobin analysis to test its accuracy
      (sensitivity and specificity).
    


Intervention name(s): SCD newborn screening with the MS/MS method from Zentech
Intervention type(s): Other
Intervention description(s): The analysis of the SCD newborn screening with the MS/MS method from Zentech will be realized after achievement and biological validation of the SCD newborn screening in the usual care pathway. The results will be compared with the method used at the Lille Academic Hospital (CHU Lille) (sub-contractor for SCD newborn screening of Lyon)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Infants with SCD newborn screening conducted in the hospital center of Lyon
A Clinical Study in Healthy Subjects to Evaluate 9MW1911 Injection
Condition: Asthma; COPD; Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, placebo-controlled study, enrolling approximately 38 healthy
      adult subjects (18-65 yrs). The purpose of this study is to evaluate the safety, tolerability
      and PK of single ascending dose of 9MW1911 administered intravenously (IV) in healthy adult
      volunteers. All subjects will be followed up for safety from the time of Informed Consent
      through 113 days post dose.
    


Intervention name(s): 9MW1911 Injection; 9MW1911 Injection Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose intravenously on day 1; Single dose of matching placebo intravenously on day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of a Hydrocolloid Bandage on Pimples
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effectiveness and tolerability of a hydrocolloid
      bandage on pimples when used overnight for one week.
    


Intervention name(s): Study Cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5); Prototype Ultrathin Hydrocolloid Bandage
Intervention type(s): Drug; Device
Intervention description(s): Participants will wash their face with the study cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) for up to 14 days.; Participants will cover their closed and popped pimples in the evening with one or two bandages from Days 0 through 6.
Intervention MeSH terms: Pantothenic Acid; Provitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine whether DAC HYP, when compared to
      placebo, is effective in reducing the rate of relapses between baseline and Week 52. The
      secondary objectives are to determine whether DAC HYP is effective in reducing the number of
      new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2
      hyperintense lesions, reducing the proportion of participants with relapses, and improving
      quality of life.
    


Intervention name(s): BIIB019 (Daclizumab High Yield Process); Placebo
Intervention type(s): Biological; Drug
Intervention description(s): SC injection; Placebo SC injection
Other intervention name(s): DAC HYP; Daclizumab HYP
Intervention MeSH terms: Daclizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MS; multiple sclerosis
Standardized 1µg Adrenocorticotropic Hormone Stimulation Test, and Salivary Cortisol Concentration During the Test
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Study objectives: First, to determine whether intravenous injection of 1 mcg
      adrenocorticotropic hormone (ACTH) through short cannula, in healthy participants, provides
      reliable results of cortisol response, and whether this method would replace the conventional
      technique of injecting ACTH by a needle directly into a peripheral vein. Secondly, to
      determine salivary free cortisol concentration during the test in healthy controls.

      Rationale of study: Intravenous injection of synthetic ACTH1-24 concentration through venous
      short cannula appears to be feasible and simple method. On the other hand, injection of
      ACTH1-24 by a needle directly into peripheral vein, is not infrequently complicated by
      technical problems in subjects with challenging veins. The investigators suppose that, both
      methods would have the same yield in predicting cortisol response.

      Salivary free cortisol test has an evolving importance in assessing the adrenal function.
      This test would be reliable for use in low dose ACTH stimulation (1 mcg) test. The
      investigators will examine the concentration of salivary free cortisol during ACTH
      stimulation test, in order to determine level range in normal controls.
    

Detailed description: 
      The study will include 20 healthy participants of both sexes, aged 18-70 years, that have no
      clinical suspicion of hypoadrenalism, or any active medical condition or treatment that might
      alter blood cortisol levels. Pregnant women and patients whose medical or mental condition
      precludes obtaining informed consent will be excluded.

      In the morning of the first visit, 1 mcg of ACTH1-24 will be injected directly into a
      peripheral vein. Blood and salivary samples will be drawn before injection, and 30 minutes
      after. Salivary cortisol will be drawn also 60 minutes after injection. At least two days
      later, in the morning of the second visit, 1 mcg of ACTH1-24 will be injected through short
      cannula in a peripheral vein, followed by injection of 5 ml of normal saline. Blood and
      salivary samples will be drawn before injection, and 30 minutes after. Salivary cortisol will
      be drawn also 60 minutes after injection. Blood cortisol results and salivary free cortisol
      results will be compared between tests.
    

Intervention name(s): ACTH stimulation test
Intervention type(s): Procedure
Intervention description(s): ACTH stimulation test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic