bioihbjkbjnl/mcl2 huggingface dataset:
Platelet Rich Plasma Following Hysteroscopic Adhesolysis
Condition: Intra-uterine Adhesions
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      Platelet Rich Plasma Following Hysteroscopic Adhesolysis: A Randomized Clinical Trial
    


Intervention name(s): Platelet Rich Plasma; intra-uterine balloon
Intervention type(s): Procedure; Procedure
Intervention description(s): Platelet Rich Plasma; intra-uterine balloon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Effects of SH T00658ID on Libido
Condition: Contraception; Libido
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering
      from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no
      longer than one year will express the same level of sexual distress when taking SH T00658ID
      compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.
    


Intervention name(s): EV/DNG (Qlaira, BAY86-5027, SH T00658ID); Microgynon; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated SH T00658ID for 28 days per cycle, for 6 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo, encapsulated for blinding purpose; Days 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Six 28-day treatment cycles.; Days 22 to 28: daily oral administration of one encapsulated placebo tablet. Six 28-day treatment cycles.
Intervention MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oral contraceptive; Sexual dysfunction; Libido
Rifampin Drug-Drug Interaction Study With Lurasidone HCl
Condition: Male, Healthy Normal Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The effect of rifampin on the pharmacokinetics of lurasidone
    

Detailed description: 
      by performing an open-label, 2-period, sequential study in healthy subjects. All subjects
      (N=20) will be assigned to the same treatment sequence, 40 mg po dosing.
    

Intervention name(s): Lurasidone HCl
Intervention type(s): Drug
Intervention description(s): 40mg, Single-dose of lurasidone 40 mg (one 40 mg tablet) on Day 1. Daily dosing of rifampin 600 mg (two 300 mg capsules) on Days 1-8. On Day 8, subjects will also receive a single-dose of lurasidone 40 mg (one 40 mg tablet).
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Rifampin DDI with Lurasidone HCl
Combination Chemotherapy With or Without Interleukin-2 and Interferon Alfa in Treating Patients With Metastatic Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill
      melanoma cells. Interferon alfa may interfere with the growth of tumor cells. It is not yet
      known whether combination chemotherapy plus interleukin-2 and interferon alfa is more
      effective than combination chemotherapy alone for metastatic melanoma.

      PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without
      interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that
      cannot be treated by surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Compare response rate, duration of response, and survival rate in patients with
           metastatic malignant melanoma treated with cisplatin, vinblastine, and dacarbazine with
           or without interleukin-2 and interferon alfa-2b.

        -  Determine the toxic effects of these regimens in this patient population.

      OUTLINE: This is a randomized study. Patients are stratified according to performance status
      (0 vs 1), prior interferon (yes vs no), and number of involved sites. Patients are randomized
      to one of two treatment arms.

        -  Arm I: Patients receive cisplatin IV over 30 minutes daily immediately followed by
           vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 60 minutes on day
           1 following vinblastine.

        -  Arm II: Patients receive treatment as in arm I. Patients also receive interleukin 2
           (IL-2) IV continuously on days 1-4 and interferon alfa-2b subcutaneously (SC) daily
           before IL-2 on days 1-4 and after IL-2 on day 5, followed by filgrastim (G-CSF) (SC)
           daily on days 7-16.

      Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or
      unacceptable toxicity.

      Patients are followed at 6 weeks, every 3 months for 18 months, every 6 months for 18 months,
      and then annually for 2 years.

      PROJECTED ACCRUAL: A total of 482 patients will be accrued for this study within 3.5 years.
    

Intervention name(s): aldesleukin; filgrastim; recombinant interferon alfa; cisplatin; dacarbazine; vinblastine
Intervention type(s): Biological; Biological; Biological; Drug; Drug; Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Aldesleukin; Dacarbazine; Vinblastine
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage IV melanoma
Music to Improve Sleep Quality in Adults With Depression and Insomnia
Condition: Insomnia; Depression
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Insomnia is a common sleep disorder for patients with depression. This has a major impact on
      the quality of life for the individual.

      The aim is to investigate, whether music intervention is effective in

        1. improving sleep quality,

        2. reducing symptoms of depression and

        3. improving quality of life

      Participants use a sound pillow and selected music in the The Music Star app at home as a
      sleep aid in 4 weeks.
    

Detailed description: 
      Depression is a common health problem in Denmark with a prevalence for depression of 17-18%.
      Depression has serious personal and social consequence. Sleep disorders are common in
      patients with depression. Resolving sleep disturbances in depression may prevent worsening of
      symptoms and relapse.

      Music listening is widely used as a sleep aid. A study from the Cochrane library shows
      consensus that music may be helpful to improve sleep quality in insomnia. It remains unclear
      if music listening is helpful to patients with depression as it is to a broader population.

      A randomized controlled trial address the use of music as a supplementary treatment to
      improve sleep in depression.
    

Intervention name(s): Music Intervention
Intervention type(s): Other
Intervention description(s): Music intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study design is an explanatory mixed methods design in two parts. The first part is a two-arm parallel group, single center randomized controlled trial (n=120). Experimental group and waitlist control group receive standard treatment according to national guidelines. The experimental group use a sound pillow and The Music Star App at bedtime as a sleep aid in 4 weeks.The second part is an interview study (n=4). Qualitative data from a semi-structured interview on the use of music and sleep are used to discuss findings from the RCT.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: music; depression; sleep disturbances; insomnia; quality of life
Association Between Hypermobility and Chronic Musculoskeletal Pain
Condition: Hypermobility, Joint; Arthralgia; Myofascial Pain Syndromes; Fibromyalgia; Pain Disorder
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Musculoskeletal Pain; Arthralgia; Joint Instability; Somatoform Disorders
Study type: Observational

Summary: 
      Study hypothesis:- Benign joint hyper mobility syndrome which persists into adulthood is a
      special type of benign joint hyper mobility which is more likely to predispose to chronic
      musculoskeletal pain.

      Young Indian adults aged between 25 and 40 years who are blood donors or relatives of
      patients admitted as inpatient or presenting to the out patient department, in Amrita
      Institute of Medical Sciences will be enrolled, after excluding the exclusionary criteria.
      They will be assessed for the presence of chronic musculoskeletal pain using a validated self
      filled questionnaire. The primary investigator who will be blinded to their response will
      examine them for the presence of Benign Joint Hyper mobility Syndrome and for tender points
      suggestive of fibromyalgia.

      Primary Objective:- To determine whether chronic musculoskeletal pain is associated with
      Hypermobility among Indian adults.

      Study design:- Cross sectional survey
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Young Indian adults aged between 25 years and 40 years
      
Keywords: Chronic musculoskeletal pain; Benign joint hypermobility syndrome; Fibromyalgia
Phase I Dose Finding Study for Melatonin in Pediatric Oncology Patients With Relapsed Solid Tumors
Condition: Relapsed Malignant Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate dose escalation of melatonin in pediatric oncology patients with
      relapsed solid tumors. The purpose of this study is to determine the safety of melatonin at a
      dose up to 20 mg daily, as well as to determine the maximum tolerated dose of melatonin.
    


Intervention name(s): Melatonin
Intervention type(s): Drug
Other intervention name(s): SISU Melatonin
Intervention MeSH terms: Melatonin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Comparison Of Outcome Of Treatment OF Topical 15%TCA VS Topical 0.05% Tretinoin In Treatment Of Acanthosis Nigricans
Condition: Acanthosis Nigricans
MeSH terms: Acanthosis Nigricans
Study type: Interventional

Summary: 
      Acanthosis nigricans (AN) is a dermatosis with aesthetic implications and is characterized by
      the focal or diffuse development of a velvety, hyperpigmented cutaneous thickening in
      intertriginous areas. Trichloroacetic acid (TCA), a superficial chemical exfoliative agent
      has shown efficacy in treating acanthosis nigricans. Data from this would help in
      establishing it as a treatment of choice thereby lead to reduction in cost and benefit the
      patient both financially and psychologically.
    

Detailed description: 
      Acanthosis nigricans is common, although exact prevalence depends upon the racial makeup of
      the population studied. Exact pathogenesis is unknown, elevated insulin concentrations result
      in direct and indirect activation of IGF-1 receptors on keratinocytes and fibroblasts,
      leading to proliferation. This hyperpigmentation, which has poorly defined borders, usually
      occurs in skin fold areas symmetrically, such as the back of the neck, axilla and groin, and
      may rarely involve oral mucosa. The lesions may be related to a wide range of benign
      conditions and may occur as a paraneoplastic manifestation of various potentially fatal
      malignancies.
    

Intervention name(s): Topical 15% Trichloroacetic acid
Intervention type(s): Drug
Intervention description(s): Recently trichloroacetic acid (TCA), a superficial chemical exfoliative agent has shown efficacy in treating acanthosis nigricans. Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.
Other intervention name(s): Topical 0.05% Tretinoin
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
Condition: Complication of Urinary Catheter
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 1

Summary: 
      Hypothesis 1: Blood alcohol concentration will be <25 mg/100ml (equivalent to a blood alcohol
      concentration of <0.025%) after a 1 hour urinary catheter ethanol lock.

      Hypothesis 2: Daily urinary catheter ethanol locks will not result in increased hematuria or
      increased urinary white cells.
    

Detailed description: 
      This study involves a confirmatory/refuting approach to the above stated hypothesis. The
      investigators will test this hypothesis by addressing the following aims/objectives:

      Specific Aim 1:

      Quantify blood alcohol levels after a 1 hour 74% ethanol lock in urinary catheters utilized
      in the Pediatric Intensive Care Unit.

      Specific Aim 2:

      Compare cellular components in urinalyses after the introduction of the ethanol locks.

      Potential study subjects will be recruited from the Children's Healthcare of Atlanta -
      Egleston Pediatric Intensive Care Unit. Children that are anticipated to have an indwelling
      urinary catheter for >48 hours will be included. For this pilot study, the investigators will
      enroll 10 patients. Subject ages will range from 6 months to 17 years. Children who are on a
      service other than Critical Care Medicine will have clearance from the primary team prior to
      approaching for enrollment. The consent process will take place prior to or during the
      initial 24 hours of urinary catheter placement.
    

Intervention name(s): Ethanol Lock
Intervention type(s): Drug
Intervention description(s): Ethanol lock, utilizing 74% ethanol, will begin within 24 hours of urinary catheter placement. The lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After the 1 hour dwell time, the clamp will be removed and the alcohol in the lumen of the catheter will be flushed out by the patient's own urine output.
Other intervention name(s): Ethanol; Dehydrated alcohol
Intervention MeSH terms: Ethanol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Ethanol Lock; Alcohol lock; Urinary catheter; Safety
Tiemann Mounted Urodynamic Catheter Technique for Difficult Bladder Catheterization
Condition: URINATION DISORDERS
MeSH terms: Urination Disorders
Study type: Observational

Summary: 
      A report of a technique for insertion a soft urodynamic catheter into the bladder, when
      urethral obstruction causes the catheter to bend and fold over itself at the resistance site.
    

Detailed description: 
      The urodynamic catheter is mounted on a 12F Coudé tip Tiemann catheter, which then carries
      the tip of the urodynamic catheter beyond the obstruction site into the bladder.

      The Tiemann catheter-mounted urodynamic catheter technique can serve as a suitable option to
      insert a urodynamic catheter into the bladder in all male patients in whom it fails due to
      kinking.
    

Intervention name(s): INSERTION OF URETEHRL CATHETER
Intervention type(s): Device
Intervention description(s): USE OF A TIEMANN CATHETER TO INSERT THE URODYNAMIC STUDY CATHETER INTO THE BLADDER
Other intervention name(s): TIEMANN CATHETER
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        MALE PATIENTS 18-80 Y/O WHO UNDERWENT URODYNAMIC STUDY, AND HAD DIFFICULT CATHETERIZATION
      
Keywords: URINARY INCONTINENCE; URODYNAMICS; URINARY RETENTION; URINARY CATHETERIZATION
Depressive Symptoms in Acute Manic Episode
Condition: Bipolar Disorder
MeSH terms: Mania; Bipolar Disorder; Depression
Study type: Observational

Summary: 
      Observational, non-interventional, transversal, multicenter, open label (No treatment is
      involved). The primary objective is to detect the prevalence of depressive symptoms in
      bipolar patients admitted to a psychiatric Unit due to an acute mania episode. Secondary
      objectives include 1) to evaluate, the relationship between depressive symptoms and severity
      of mania; 2) to evaluate, the relationship between depressive symptoms and anxiety; 3) to
      evaluate, the relationship between depressive symptoms and psychotic symptoms; 4) to
      evaluate, the relationship between depressive symptoms and insight; 5) to evaluate, the
      relationship between depressive symptoms and clinical global impression; 6) to evaluate, the
      relationship between depressive symptoms and previous treatment with antipsychotics (whatever
      the antipsychotic was); 7) to evaluate, the relationship between depressive symptoms and
      length of admission; 8) to evaluate factors (demographic, evolution…) which could be involved
      in the presence of depressive symptoms within an acute manic episode; 9) to evaluate, the
      difference on the initial prescription due to the detection of depressive symptoms; 10) to
      evaluate, if exists, differences on the previous psychiatric diagnosis in patients with and
      without depressive symptoms. The primary endpoint is score of the MADRS (Montgomery-Asberg
      Depression Rating Scale) in bipolar patients with acute mania
    


Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        bipolar patients admitted to a psychiatric Unit due to an acute mania episode.
      
Keywords: Acute mania; Bipolar disorder; depressive symptoms; mixed mania
Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The preventive lymphadenectomy is not performed routinely for hepatocellular carcinoma (HCC)
      patients in clinical practice. While many patients suffered the recurrence without the
      evidence of portal or hepatic vascular invasion or multiple loci, it lead to reconsider the
      value of preventive resection of regional lymph node for those patients. Recently, more and
      more studies had found the incidence of lymph node metastasis was higher in autopsy specimen
      than those in operable patients.

      This project is a prospective randomized controlled trial, planning to compare hepatectomy
      with hepatectomy combined lymphadenectomy regarding of the safety and efficacy in HCC
      patients, to reach a further understanding of the role of lymphadenectomy.
    


Intervention name(s): hepatectomy combined with lymphadenectomy; hepatectomy alone
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; hepatectomy; lymphadenectomy; complication; prognosis
PBASE System Idiopathic Rhinitis Clinical Investigation
Condition: Idiopathic Rhinitis
MeSH terms: Rhinitis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the performance of the PBASE system, in terms of the
      efficacy of treatment in patients with idiopathic rhinitis.
    


Intervention name(s): PBASE system 1.1 + CT100 (active treatment); PBASE system 1.1 + CT100 (placebo treatment)
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Using Glucose Sensors to Prevent Hypoglycemia
Condition: Type 1 Diabetes; Hypoglycemia
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Hypoglycemia is the most common complication of Type 1 diabetes particularly in those who
      strive for good glycemic control. In some patients there is a loss of awareness of
      hypoglycaemia so that the first manifestation of hypoglycaemia may be confusion or coma. Such
      a situation may carry risks that the patient may harm him or her self. Medtronic has recently
      developed a continuous glucose sensor that determines the glucose level every 3 minutes using
      a subcutaneous sensor and transmits the information to a remote device (Paradigm RT) that may
      be worn or left close by eg on a bedside table. The device may be programmed to alarm for a
      rapidly falling glucose or for low glucose levels.

      We propose to use this in 16 patients with severe hypoglycemia as evidenced by a high HYPO
      score and see if we can decrease the number of hypoglycemic reactions and document this
      improvement with a better HYPO score.
    

Detailed description: 
      Sixteen patients with Type 1 diabetes (as defined by: onset under the age of 25, lean at time
      of onset, continuous insulin use, and/or history of ketoacidosis and C-peptide negative),
      with a HYPO score over the seventy-fifth percentile (>423), will be approached and offered
      the study.

      The study will be conducted over a three month time-frame. The first month will be a run-in
      period for participants to collect four weeks of glucose readings and information about their
      hypoglycemic events. These records will be used to calculate the baseline modified HYPO
      score. Patients will be screened during the first month for thyroid disease, celiac disease
      and Addison's disease.

      During the second month they will meet with the study nurse for an intensive instruction
      period on the use of the Paradigm RT sensor. They will spend this month practicing to use the
      sensor and confirming they can use it adequately.

      During the final month they will wear the sensor and collect glucose and hypoglycemia records
      for calculation of the final modified HYPO score.

      The end point will be the change from the baseline modified HYPO score to the final four week
      HYPO score and this would be used to identify any improvement.
    

Intervention name(s): Use of glucose sensor (Paradigm Guardian)
Intervention type(s): Device
Intervention description(s): Use glucose sensor to prevent episodes of severe hypoglycemia
Other intervention name(s): Paradigm Guardian glucose sensor
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Hypoglycemia; Glucose sensor
Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Condition: Perennial Allergy to House Dust Mite and/or Cat
MeSH terms: Dust Mite Allergy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or
      cat allergy compared to placebo in adult patients.
    


Intervention name(s): CYT003-QbG10
Intervention type(s): Drug
Intervention description(s): 6 subcutaneous injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment