bioihbjkbjnl/mcl2 huggingface dataset:
Simethicone: Does it Improve Operative Field and Postoperative Pain?
Condition: Simethicone
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Simethicone is an oral anti-foaming agent that reduces bloating, abdominal discomfort, and
      abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract.

      The investigators objective is to evaluate the efficacy and safety of preoperative oral
      simethicone for bowel preparation in gynecological laparoscopies.
    

Detailed description: 
      Introduction: Simethicone is an oral antifoaming agent that reduces bloating, abdominal
      discomfort, and abdominal pain by promoting the clearance of excessive gas along the
      gastrointestinal tract.

      Objective: to evaluate the efficacy and safety of preoperative oral simethicone for bowel
      preparation in gynecological laparoscopies.

      Methods: 100 infertile women will be scheduled for laparoscopy, patients randomized to
      receive either Simethicone (Group I) or placebo tablets (Group II). The primary outcome
      measure will be the overall exposure of the surgical field and pain scoring. Assessment of
      the overall exposure of the surgical field was done using a five-point scale (poor,
      sufficient, medium, good, and excellent). Visual analog score (VAS) will be used for
      assessment of postoperative pain and verbal analog scoring was used for assessment of patient
      satisfaction.
    

Intervention name(s): Simethicone Tab 40 mg; Placebo Tablets
Intervention type(s): Drug; Drug
Intervention description(s): 3 tablets of Simethicone Tab 40 mg (one tablet after each meal) and to fast overnight the day before the operation.; 3 tablets of Placebo Tablets (one tablet after each meal) and to fast overnight the day before the operation.
Other intervention name(s): Disflatyl; Placebo
Intervention MeSH terms: Simethicone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Simethicone; Laparoscopies; Pain
Presence of SARS-CoV-2 (COVID-19) in Semen: Impact on Fertility Preservation in Male Oncological Patients ?
Condition: Sperm Preservation in Oncological Patients; Fertility; Cryopreservation
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining
      fertility preservation for patients requiring immediate oncological treatments exhibiting
      gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from
      cancer patients. This study aims therefore to detect the presence of SARS-CoV-2, specifically
      in the seminal fluid and the spermatozoa fractions of cancer patient semen. The investigators
      will determine if the virus presence in sperm is associated with its presence in the nasal
      swabs, COVID symptoms, specific serological profiles and particular oncological
      pathologies/treatments.
    

Detailed description: 
      To perform this, all patient undergoing oncological fertility preservation will be evaluated
      for COVID-19 symptomatology (fever, cough, headache, myalgia, diarrhea, anosmia,
      pharyngodynia). In addition, a nasopharyngeal swab for SARS-CoV-2 research by RT- qPCR will
      be performed on the day of semen collection. On the same day, serological tests will be
      carried out, and 30 to 50 days after, according to HAS specifications with methods validated
      by the National Reference Center. Seminal fluid and spermatozoa will be separated by density
      gradient centrifugation for a posteriori molecular analysis of SARS-CoV-2 presence.

      Will thus be measured, within the same ejaculate, the concordance between the presence of
      SARS-CoV-2 in the seminal fluid and in the sperm cells fraction.

      The investigators will also determine if the virus presence in the sperm is related with :

        -  (i) the presence of SARS-CoV-2 in the nasal swab;

        -  (ii) patient symptomatology;

        -  (iii) a specific serological profile;

        -  (iv) a particular oncological pathology and / or treatment. The investigators may also
           find out if the presence of the SARS-CoV-2 in semen affects sperm quality.

      This study will be the first one examining the presence of SARS-CoV-2 in semen from cancer
      patients. This will guarantee the safety of fertility preservation procedures during the
      COVID-19 pandemic.
    

Intervention name(s): SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics
Intervention type(s): Diagnostic Test
Intervention description(s): a nasopharyngeal swab for SARS-CoV-2 research by RT- qPCR will be performed on the day of semen collection. On the same day, serological tests will be carried out, and 30 to 50 days after, according to HAS specifications with methods validated by the National Reference Center
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Fertility preservation; Sperm; Cancer; COVID-19; SARS-CoV-2
Safety Study of SPARC1104
Condition: Spasticity
MeSH terms: Muscle Spasticity
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis
    

Detailed description: 
      Safety study of SPARC1104
    

Intervention name(s): SPARC1104 modified dose regimen I; SPARC1104 modified dose regimen II; SPARC1104 modified dose regimen III
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects who exited study CLR_09_21; Subjects who received prior treatment regimen I; Subjects who received no prior treatment regimen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: spasticity
The Effects of Horner's Syndrome Developing After Interscalene Brachial Plexus Block on Autonomic Nervous Activity
Condition: Brachial Plexus Block; Horner Syndrome; Autonomic Imbalance
MeSH terms: Horner Syndrome; Syndrome
Study type: Observational

Summary: 
      This study evaluates the effects of Horner's syndrome on cardiac autonomic nervous activity
      after interscalene brachial plexus block. Cardiac autonomic nervous activity and bilateral
      pupil diameters will be measured in a scotopic light condition, 30 minutes after interscalene
      brachial plexus block under ultrasound guidance and 15 minutes after the subsequent sitting
      position.
    

Detailed description: 
      Stellate ganglia provide sympathetic fibers to the heart. Ipsilateral stellate ganglion block
      accompanied by interscalene brachial plexus block causes Horner's syndrome presenting with
      miosis, ptosis, and anhidrosis. The extent of Horner's syndrome can be represented by the
      difference in pupil diameter between bilateral eyes. Cardiac autonomic nervous activity
      affected by stellate ganglion block can be measured by calculation of heart rate variability
      parameters.
    

Intervention name(s): Interscalene brachial plexus block; 0.75% ropivacaine
Intervention type(s): Procedure; Drug
Intervention description(s): Under ultrasound guidance, the 5th to 7th cervical nerve roots are identified between anterior and middle scalene muscles and subsequently blocked.; Placement of 25 to 30 ml of 0.75% ropivacaine around the 5th to 7th cervical nerve roots
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Tertiary hospital
      
Keywords: Heart rate variability; Mesopic pupil size
Efficacy of the Marine Based Nutritional Supplement Peptidyss® on Sleep and Anxiety
Condition: Sleep Disorder
MeSH terms: Sleep Wake Disorders; Parasomnias
Study type: Interventional

Summary: 
      This interventional, double-blind, randomized, placebo-controlled pilot study aims to
      evaluate the effect of a dietary supplementation of a fish hydrolysate Peptidyss on sleep
      quality and anxiety.
    

Detailed description: 
      A total of 44 healthy participants (n=22 female, n=22 male) aged 35-60 years inclusive are
      included into the study, in a cross-over design. The participants will take both products,
      the fish hydrolysate Peptidyss and the placebo during a period of 4 weeks per product. The
      total duration of the study per participant is 127 days. The study visits are defined as
      Screening Visit and Study Inclusion (V0), Pre-Intervention-1-Visit (V1),
      Post-Intervention-1-Visit (V2), Follow-up-Intervention-1-Visit / Pre-Intervention-2-Visit
      (V3), Post-Intervention-2-Visit (V4) and Follow-up-Intervention-2-Visit (V5). The 4 weeks
      between V2 and V3 will serve as a washout phase between Intervention-1 and Intervention-2. No
      further follow-up visit is planned.

      The primary objective is to evaluate the efficacy of Peptidyss® on sleep quality.

      The secondary objectives are to evaluate the efficacy of Peptidyss® on sleep quality,
      anxiety, perceived stress and quality of life.
    

Intervention name(s): Fish Hydrolysate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The participants take 4 capsules/day of the study product. Two capsules should be consumed orally every morning with breakfast and/or with a glass of (plain, not sparkling) water and not with fruit juice or hot food/drink while ingesting the capsules; and two capsules should be consumed orally every evening with their dinner and/or with a glass of water.
Participants receiving the fish hydrolysate the fourth first weeks will then receive the placebo during another 4 weeks. A wash-out period of 4 weeks is included between each phase of supplementation.; The participants take 4 capsules/day of the study product. Two capsules should be consumed orally every morning with breakfast and/or with a glass of (plain, not sparkling) water and not with fruit juice or hot food/drink while ingesting the capsules; and two capsules should be consumed orally every evening with their dinner and/or with a glass of water.
Participants receiving the Placebo the fourth first weeks will then receive the fish hydrolysate during another 4 weeks. A wash-out period of 4 weeks is included between each phase of supplementation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: sleep disorder; anxiety; stress; fish hydrolysate; food supplement
A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency
Condition: Immunologic Deficiency Syndrome
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the blood level of Gamunex in patients. Patients will take it as an
      injection under the skin or in a vein. The study will compare how safe and tolerable the two
      methods are in the patients. The patients in this study have a defect in their immune system
      from a genetic cause.
    

Detailed description: 
      This is an open-label, single-sequence, multi-center trial with subjects previously diagnosed
      with primary immune deficiency. Subjects will be on IGIV until a steady state is reached at
      which time PK profiling during the IV phase will occur. Subjects will begin SC administration
      1 week following last IV dose and followed for a period of six months. PK profiling in SC
      phase will occur when subject reaches approximate steady-state on SC administration.
    

Intervention name(s): Immune Globulin Intravenous (Human)
Intervention type(s): Biological
Intervention description(s): This trial was an open-label, single-sequence, study. The enrolled subjects received IGIV-C via two routes of administration (IV for 4 -5 weeks and SC for 24 weeks) in order to compare the PK variables, safety and tolerability of SC administration of IGIV-C. Certain subjects required IV IGIV-C dosing during a Run-in Phase (3 - 4 months) for steady-state conditions prior to the IV phase. Subjects received two IV infusions of IGIV (between 200 - 600 mg based on the subject's previous IgG dosing regimen, 3 to 4 weeks apart) until a steady-state was reached at which time PK profiling was performed. Subjects began weekly SC administration (1.37 times the weekly equivalency of each subject's monthly IV dose) 1 week following last IV dose and followed for a period of six months.
Other intervention name(s): Gamunex; Gaminex; Immune globulin intravenous (Human)(IGIV); BAY 41-1000; TAL-05-00004; IGIV-C; IVIG; IGIVnex; NDC-13353-645-71; NDC-13353-646-24; NDC-13353-645-12; NDC-13353-645-15; NDC-13353-645-2
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary immune deficiency
Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease
Condition: Cushing's Disease
MeSH terms: ACTH-Secreting Pituitary Adenoma; Pituitary ACTH Hypersecretion
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to confirm efficacy and safety of osilodrostat for the
      treatment of patients with Cushing's disease who are candidates for medical therapy.
    

Detailed description: 
      The study LCI699C2302 (LINC-4) is a multi-center, randomized, double-blind study to evaluate
      the safety and efficacy of osilodrostat in patients with Cushing's disease.

      Enrolled patients were initially randomized to either osilodrostat or placebo, in a 2:1
      ratio, for a 12-week double-blind period (Period 1). Randomization was stratified by history
      of pituitary radiation. After Week 12, all patients received open-label osilodrostat until
      the end of the Core phase at Week 48 (Period 2).

      After Week 48, patients could join an optional 48 week extension period.
    

Intervention name(s): osilodrostat; osilodrostat Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In the form of filmcoated tablets for oral administration, in the following dose strengths: 1 mg, 5 mg, 10 mg, and 20 mg.; Matching Placebo in the form of filmcoated tablets for oral administration
Other intervention name(s): LCI699
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cushing's disease; LCI699; osilodrostat; Pituitary Gland; Adrenocorticotropic; Hormone; ACTH; UFC
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
Condition: Breakthrough Bleeding
MeSH terms: Metrorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 4-arm study to evaluate and compare bleeding patterns between three different doses
      of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will
      receive physical and gynecological exams, including Pap smear. During the study, all
      participants will be required to complete a diary
    

Detailed description: 
      This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to
      evaluate and compare bleeding patterns in women using one of three different doses of DR-1031
      oral contraceptive with Seasonale oral contraceptive.

      Patients who meet all study entrance criteria will be randomly assigned to one of four
      treatment groups,

      The overall study duration will be approximately 9 months; this will include a screening
      period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of
      approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days after
      completion of study drug.
    

Intervention name(s): DR-1031; Seasonale®; Portia®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.; 84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles.; Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Other intervention name(s): levonorgestrel/ethinyl estradiol; Quartette®; levonorgestrel/ethinyl estradiol; levonorgestrel/ethinyl estradiol
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: oral contraceptives; breakthrough bleeding; spotting
A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia
Condition: Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 2

Summary: 
      Decitabine has been reported to have a clinically significant, often long lasting effect on
      the platelet count in myelodysplastic syndromes(MDS). It is also reported that decitabine
      could increase platelet counts by enhancing megakaryocyte maturation and platelet release.
      Immune thrombocytopenia(ITP) is known as an immune-mediated acquired disease characterized by
      transient or persistent decrease of the platelet count. However, refractory ITP is lacking of
      effective treatments and the efficacy of decitabine in ITP remains poorly understood. Data
      from this study may provide some idea of decitabine in the treatment of ITP.
    

Detailed description: 
      The investigators are undertaking a multicenter, single-arm study of primary ITP adult
      patients from 9 medical centers in China. All the participants are selected to receive
      low-dose of decitabine treatment (given intravenously at a dose of 3.5mg/m2 for 3 days per
      cycle for 3 cycles). Platelet count, bleeding and other symptoms were evaluated before and
      after treatment. Adverse events are also recorded throughout the study.
    

Intervention name(s): Decitabine
Intervention type(s): Drug
Intervention description(s): Decitabine 3.5mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given three cycles.
Intervention MeSH terms: Decitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Decitabine; Immune thrombocytopenia
Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled study that will compare the effect of
      2 different dosage regimens of PCS12852 on gastric emptying time to placebo in both
      idiopathic gastroparesis (IG) and diabetic gastroparesis (DG) patients.
    


Intervention name(s): PCS12852; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PCS12852 oral tablet administered once daily; Placebo comparator oral tablet administered once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Idiopathic Gastroparesis; Diabetic Gastroparesis
Aromatherapy for Anxiety Among Children With Autism Spectrum Disorder
Condition: Anxiety; Autism Spectrum Disorder
MeSH terms: Anxiety Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      This study evaluated the use of bergamot aromatherapy in the treatment of anxiety in a
      medical office setting among children who are diagnosed with an autism spectrum disorder. H
    

Detailed description: 
      Bergamot aromatherapy relieves anxiety in adult populations but has not been tested in a
      pediatric population with autism spectrum disorder. Because autism spectrum disorders often
      include hypersensitivity to sensory experiences, the use of essential oils in this population
      should be evaluated.
    

Intervention name(s): Bergamot Aromatherapy
Intervention type(s): Other
Intervention description(s): Patients in this group inhaled bergamot essential oil for 15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Aromatherapy; Essential Oils; Children
Evaluation of Mineral Absorption in Infants Fed Infant Formula
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to measure calcium absorption in infants fed formula with and
      without prebiotics.
    

Detailed description: 
      Infants will be fed formula and blood drawn and urine collected to measure calcium
      absorption.
    

Intervention name(s): Calcium absorption
Intervention type(s): Procedure
Intervention description(s): formula with or without prebiotics
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Infant; Term
RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury
Condition: Soft Tissue Injuries
MeSH terms: Wounds and Injuries; Soft Tissue Injuries
Study type: Interventional

Summary: 
      The study will investigate whether the impact of PEMF and RF therapies is safe and
      efficacious for the treatment of pain associated with soft tissue injuries as compared to
      treatment with ultrasound, and to show the effects of PEMF and RF therapies on range of
      motion and blood flow associated with soft tissue injuries as compared to ultrasound therapy.
    

Detailed description: 
      This is a randomized, controlled study of the safety and efficacy of a radiofrequency (RF)
      and pulsed electromagnetic fields (PEMF) device compared to ultrasound (US) for the treatment
      of pain associated with soft tissue injuries, and to show the comparative effects on blood
      flow (BF) and range of motion (ROM). Total expected duration of the clinical study is
      approximately 6 months (enrollment period of 4 months and a follow-up period of 3 weeks)
      while individual participation will take three weeks.
    

Intervention name(s): RF and PEMF; Ultrasound
Intervention type(s): Device; Device
Intervention description(s): RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment; Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group receives treatment with RF and PEMF while the second group receives treatment with ultrasound
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: RF/PEMF; Ultrasound