bioihbjkbjnl/mcl2 huggingface dataset:
Growth Hormone Treatment of Women With Turner Syndrome
Condition: Turner Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Syndrome
Study type: Interventional

Summary: 
      Growth hormone treatment is used in girls with Turner syndrome to increase final height. The
      aim of this study is to evaluate the effect of growth hormone treatment on body composition
      and heart function in adult women with Turner syndrome. The hypothesis is that the fat mass
      will decrease and lean body mass will increase. There is only very limited documentation of
      the effect on the heart in this study population.
    

Detailed description: 
      This study is a randomised, double-blinded, controlled clinical trial to evaluate the effect
      of growth hormone (GH) treatment on adult women with Turner syndrome. The endpoints will be
      changes in body composition and heart function evaluated by echocardiography (ECHO) and
      positron emission tomography (PET).

      Phase one: 6 months of GH or placebo treatment. Phase two: "open label" all participants are
      treated with GH for 12 months. At baseline, healthy controls will be examined, but will not
      receive any treatment
    

Intervention name(s): Growth Hormone; Placebo; Healthy controls
Intervention type(s): Drug; Drug; Other
Intervention description(s): 1.25 mg, 6 months; Equivalent to 1.25 mg, 6 months; Healthy controls
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Turner syndrome; growth hormone treatment; positron emission tomography; heart
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Subjects With Osteoarthritis Knee Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a sequential, randomized, double-blind, placebo controlled, multiple dose, dose
      escalation study in subjects with OA knee pain (n=32; 8/cohort). In each cohort, subjects
      will be randomized 3:1 to receive SC AMG 403 or placebo once every 4 weeks for a total of 4
      doses (Q28D x 4).
    


Intervention name(s): AMG 403; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AMG 403 for the treatment of subjects with osteoarthritis; contains no active drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
UC-961 (Cirmtuzumab) in Relapsed or Refractory Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the safety of the investigational agent,
      cirmtuzumab. Cirmtuzumab is a monoclonal antibody drug designed to attach to a protein,
      called ROR1, on the surface of chronic lymphocytic leukemia (CLL) cells to block cell growth
      and survival. ROR1 is rarely expressed on healthy cells so the idea is to preferentially get
      rid of the cancer cells. Although there is evidence in laboratory animals that cirmtuzumab
      can decrease the number of CLL cells, the investigators do not know if this will work in
      humans. This drug will be given to humans for the first time in this study. Therefore, the
      goal of this study is to see if cirmtuzumab is safe and tolerated in study participants.
    

Detailed description: 
      This is a first in human, open-label single institution, Phase I dose escalation study of in
      patients with relapsed or refractory CLL. Treatment cycle (14 days) will consist of
      cirmtuzumab administered intravenously on a bi-weekly (every two weeks) schedule for a total
      of 4 doses. Eight dose cohorts (of 3 to 6 patients in size) plus an expansion cohort of 6
      patients are planned. In the first 4 dose cohorts, there is intra-patient dose escalation to
      monitor for acute toxicities, such as tumor lysis syndrome.

      A cycle may be repeated every 14 days if the patient has at least stable disease by clinical
      examination (or interim response assessment) and has again met hematologic, renal, and
      hepatic laboratory parameters as defined in the eligibility section, and is without ongoing
      Grade 3 non-hematologic or Grade 4 hematologic toxicities attributable to cirmtuzumab. The
      total duration of study drug administration is 4 cycles. Each cycle consists of clinical and
      laboratory evaluation on Day 1 and safety assessments on Days 3 and 8.
    

Intervention name(s): cirmtuzumab
Intervention type(s): Drug
Other intervention name(s): UC-961
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cancer; CLL
Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Dyssomnias; Parasomnias; Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the effectiveness of Lunesta on cancer patients who have received chemotherapy and
      who require patient controlled analgesia (PCA), specifically to assess whether Lunesta will:

        -  improve sleep thereby decreasing need for opiates via PCA

        -  improve sleep thereby decreasing pain by self report

        -  improve sleep thereby decreasing fatigue by self report
    

Detailed description: 
      Pain and fatigue are the most common symptom complaints of cancer patients. Although dramatic
      improvements have come about in recognizing and treating cancer related pain, less progress
      has been made in treating fatigue. Interventions to improve sleep may offer benefit in terms
      of pain and fatigue.

      One of the less commonly recognized side effects of opiate use is sleep disruption.

      Experimentally-induced sleep disruption lowers the threshold for detection of painful
      stimuli. Thus, although opiates are obviously helpful for pain, they do so at certain
      "costs": they increase next day fatigue, constipation, and have other side effects; they
      disrupt sleep which further increases next day fatigue; and finally, by virtue of their sleep
      disruptive properties, they lower the threshold for pain stimuli.

      Cancer patients requiring chemotherapy commonly require PCA because of oral mucositis. The
      objective of this study is to assess whether opiate usage may be reduced and complaints of
      fatigue and pain be lessened if patients had better sleep.
    

Intervention name(s): Eszopiclone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): eszopiclone 2 to 3 mg po at bedtime; placebo 2 to 3 mg po at bedtime
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pain; fatigue; sleep; bone marrow transplant; cancer
Real-world Evidence Study on the Performance and Safety of Halova Ovules
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Study type: Observational

Summary: 
      An open-label, multicentric, non-randomized, single-arm, pilot, interventional clinical
      investigation to confirm the tolerability and performance of the medical device Halova in
      lubrication of the vagina and vaginal atrophy treatment.
    

Detailed description: 
      The primary objective of this investigation is to evaluate the therapeutic performance and
      tolerability of Halova ovules in treating vaginal atrophy and restoring the natural
      lubrication of the vaginal mucosa.

      The secondary objective of this clinical investigation are to evaluate the performance of the
      medical device by clinical examination, and the degree of patient satisfaction related to the
      intended use (Likert scale).
    

Intervention name(s): Halova
Intervention type(s): Device
Intervention description(s): Halova is a class I medical device formulated as vaginal ovules and intended for intravaginal administration in order to promote and/or accelerate the hydration, healing, re-epithelialization and/or soothing of injured, atrophic or irritated vaginal mucosa. The ovules melt evenly in the vaginal mucosa forming a cream with a moisturizing and calming effect that support the restoration of the vaginal epithelium.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult women, with atrophic vaginitis caused by estrogen hormone deficiency or vaginal
        dryness as a result of contraceptive treatment or other disorders.
      
Keywords: Dyspareunia; Dysuria; Vaginal lubrication
Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy
Condition: Knee Injury
MeSH terms: Knee Injuries
Study type: Interventional

Summary: 
      Purpose of this study is to investigate the pain outcomes and satisfaction of pain relief for
      pediatric patients receiving needleless jet-injected (J-Tip) lidocaine prior to regional
      anesthesia with femoral and/or sciatic nerve block and general anesthesia for arthroscopic
      knee surgery compared to femoral nerve block and/or sciatic nerve block with needle injected
      lidocaine prior to regional and general anesthesia.
    

Detailed description: 
      The J-tip device has not been reported for use prior to regional block anesthesia prior to
      femoral or sciatic nerve blocks. The use of the J-tip device for lidocaine introduction prior
      to femoral or sciatic blocks at Arnold Palmer Medical Center has been up to the discretion of
      the anesthesiologist. It has been anecdotally reported at our institution to have equal or
      better pain relief for the regional nerve blocks as needle introduction of lidocaine.

      This study seeks to evaluate the difference in pain from local anesthetic infiltration with
      J-tip needleless injection device compared to needle injection by use of Visual Analog
      Scales.

        -  To evaluate efficacy of femoral nerve block after J-tip device lidocaine injection post
           operatively by use of Visual Analog Scales.

        -  To assess patient and parent satisfaction with J-tip device use by satisfaction
           questionnaire.

        -  To assess changes in post operative pain medication amounts with J-tip device use.
    

Intervention name(s): J-Tip; Syringe and 25 gauge needle
Intervention type(s): Device; Device
Intervention description(s): After sterile preparation, the J-tip injector will be placed on the skin at the selected site of the regional block needle introduction. Firm pressure will be placed with the J-tip injector on the site for the chosen block, the safety ring slid down, the trigger pressed and the tip held firmly on the skin for three seconds. One quarter of a milliliter of one percent lidocaine will be injected with the characteristic "pop" and "hissing" sounds inherent to the J-tip injector.; The same initial timeout and sterile prep procedure will be followed for the use of local syringe and 25 gauge needle injection of 1% lidocaine ninety seconds prior to introduction of the regional block needle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Patient Perspective on Remote Monitoring of Cardiovascular Implantable Electronic Devices
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      A relatively new and promising development in the area of cardiovascular implantable
      electronic device therapy is remote patient monitoring (RPM). RPM systems can interrogate the
      device automatically and send the data from the patients' home to the physician, thereby
      reducing in-clinic follow-ups.

      The purpose of this study is to evaluate the effect of RPM + in-clinic follow-up versus
      in-clinic follow-up only on patient-reported health status and device-acceptance after
      implantation with an implantable cardioverter defibrillator (ICD) or cardiac
      resynchronization defibrillator (CRT-D).

      Secondary objectives are (1) to identify subgroups of patients who prefer RPM over in-clinic
      visits or vice versa due to specific clinical and psychological factors and (2) To
      investigate the cost-effectiveness of RPM + in-clinic follow-up compared to in-clinic
      follow-up only.
    


Intervention name(s): Remote patient monitoring; In-Clinic check-ups
Intervention type(s): Device; Other
Intervention description(s): Remote monitoring of ICD and heart failure data; Calender-based In-Clinic ICD check-up
Other intervention name(s): Boston Scientific LATITUDE system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: implantable defibrillators; remote patient monitoring; patient-reported outcomes; cost-effectiveness
Cholesterol Metabolism in Heterozygous Phytosterolemia
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to examine the effect of plant sterols on cholesterol absorption
      and synthesis in people with heterozygous phytosterolemia.
    

Detailed description: 
      A plant sterol supplementation study will be conducted in individuals who are heterozygous
      for phytosterolemia compared to non-carriers. The study will use a double-blind, randomised,
      crossover, placebo-controlled design in which participants will consume 2 treatments
      including 1.6 g of plant sterol pills and a placebo pill, each for 4 weeks. A 4 week washout
      period will separate the two treatment periods. Plant sterol concentrations will be measured
      by gas liquid chromatography and absorption will be measured by the ratio of campesterol to
      lathosterol in plasma. Cholesterol absorption and synthesis will be measured by dual stable
      isotope technique, involving simultaneous administration of 13C-cholesterol and deuterium
      oxide, respectively.
    

Intervention name(s): phytosterol ester
Intervention type(s): Dietary Supplement
Intervention description(s): 1.6 g phytosterols/day for 29 days
Other intervention name(s): Phytocell Phytosterols, NPN#: 80012048
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for
      three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS
      related complex (ARC).
    


Intervention name(s): Zidovudine; AS-101
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zidovudine
Primary purpose: Treatment
Keywords: Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; ammonium trichloro(dioxoethylene-O,O'-)tellurute; Zidovudine
sTep dOWn Inhalers in the reAl woRlD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      To establish the feasibility of stopping inhaled steroids and switching or maintaining dual
      bronchodilation in one visit - in the real world, for people with COPD.
    

Detailed description: 
      COPD patients prescribed a combination of any inhaled corticosteroid (ICS), long acting beta
      agonist (LABA) and long acting muscarinic antagonist (LAMA) will be switched to a single
      LABA/LAMA combination inhaler, stopping their ICS. They will be followed up for 12 months.

      Participants are shown the four currently available LABA/LAMA combination inhalers and
      instructed on their use. The clinical specialist will use standard prompts in an effort to
      demonstrate the inhalers in an unbiased way. The participants will choose: Ultibro®
      (Breezhaler device) or Duaklir® (Genuair device) or Anoro® (Ellipta device) or Spiolto®
      (Respimat device) and they will be prescribed the inhaler of their choice provided they can
      demonstrate effective use.

      Patients will be reviewed 4, 12, 26 and at 52 weeks after switching with clinical outcomes
      measured at these points. As this is a real-world open study the patients and GPs are
      instructed that treatments can be changed at any point as clinically indicated, including
      restarting an ICS.
    

Intervention name(s): Any LABA/LAMA
Intervention type(s): Drug
Intervention description(s): Following consent, patients will be taken off their current ICS/LABA/LAMA combination inhalers and shown 4 single inhaler LABA/LAMA devices and asked to choose a preferred device to use, provided they can demonstrate effective use.
Other intervention name(s): Long acting beta agonist; Long acting muscarinic antagonist
Intervention MeSH terms: Muscarinic Antagonists
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD
Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses
      of CTP-692 in healthy volunteers.
    


Intervention name(s): CTP-692; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; Single oral dose
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Constipation Fiber Trial
Condition: Functional Constipation in Children
MeSH terms: Constipation
Study type: Interventional

Summary: 
      This study examines the effects of dietary fiber in the treatment of functional childhood
      constipation.
    

Detailed description: 
      This is a 4-week double-blind, placebo-controlled study to examine the effects of dietary
      fiber in treating functional childhood constipation. The addition of fiber is anticipated to
      allow children to have more normal stool consistency and frequency.

      All participants will be asked to take a snack bar twice daily and will be randomized in a
      1:1:1 ratio to fiber 1, fiber 2 or placebo snack bar groups. All participants will be asked
      to take low-dose Miralax to avoid worsening of constipation in all groups.
    

Intervention name(s): Fiber; Fiber; Placebo
Intervention type(s): Other; Other; Other
Other intervention name(s): Single fiber type; Blend of fiber types
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pilot Study to Evaluate the Safety and Efficacy of 5-ALA-SFC in Type II Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this pilot study is to assess the safety and preliminary efficacy of 5-ALA - SFC
      at doses up to 200 mg per day in subjects with type II diabetes.
    

Detailed description: 
      The primary objective is to assess the safety of 5-ALA - SFC at doses up to 200 mg per day in
      subjects with type II diabetes mellitus. Safety will be assessed by the incidence of adverse
      events and clinically significant laboratory results.

      The secondary objective is to assess the efficacy of 5-ALA-SFC at doses up to 200 mg per day
      on glycemic control in subjects with type II diabetes mellitus. Efficacy measures will
      include fasting plasma glucose level, HbA1c level, lipid profile, and body weight.
    

Intervention name(s): 5-ALA-SFC; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study product will be in the form of white-opaque capsules for oral administration, containing either 50, 75, or 100 mg of active 5-ALA - SFC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Disaster Preparedness Among Families Caring for Children With Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      The primary aim of the survey is to ascertain the emergency preparedness among our families
      with diabetes mellitus and to obtain a percentage of unprepared to the ones who are prepared.
      The secondary aim is to demonstrate the relationship between disaster preparedness and
      factors like socio-economic status, parent's marital status, ethnicity and those who had
      prior experience of a disaster to those who have not experienced a disaster.
    

Detailed description: 
      This is a cross-sectional study. The subjects are the parent/parents/legal guardian, who will
      be coming to the clinic for their routine appointment for diabetes management. During the
      time in which the subject is waiting for the doctor or after their check-up, a research team
      member will approach the family and ask for their permission to administer the survey. The
      survey consists of a series of questions designed to ascertain the awareness towards
      emergency preparedness among families. After they have completed the questionnaire they would
      be given and/or mailed handouts to enhance their awareness towards disaster preparedness.

      Potential Benefits:

      This study will help to increase awareness regarding disaster preparedness among the surveyed
      families. Subjects and families will gain valuable information about caring for diabetes in
      the event of a disaster.

      The potential benefit to the society is that through this study we can ascertain the primary
      caregiver's awareness of disaster preparedness in regard to a family member with a chronic
      illness. We will suggest measures to improve their competency towards dealing with disasters.
      We will be providing educational literature to the primary care givers in the form of
      handouts at the end of the survey.
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The target populations for our study are the families attending the Diabetes/ Endocrine
        Clinic at Texas Children Hospital.