bioihbjkbjnl/mcl2 huggingface dataset:
Intranasal SB-705498 in Healthy Volunteers
Condition: Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a First Time in Human (FTIH) study to investigate the safety, tolerability and
      pharmacokinetics (PK) of a) single, escalating and b) twice-daily 14 days repeat doses of
      intranasal SB-705498 in healthy volunteers (HVT). The safety and tolerability of single
      intranasal 498 dosing will be assessed and established before initiating the evaluation of
      repeat intranasal 498 dosing.
    


Intervention name(s): SB-705498; SB-705498; SB-705498; SB-705498; SB-705498; Placebo; SB-705498; SB-705498; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.5mg intranasal SB-705498; 1.5mg intranasal SB-705498; 3mg intranasal SB-705498; 6mg intranasal SB-705498; 12mg intranasal SB-705498; Placebo '498; 6mg intranasal SB-705498 for 14 days bid; 12mg intranasal SB-705498 14 days bid; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Determine How and Why HIV-Infected Subjects on Anti-viral Treatment Develop Lipodystrophy
Condition: HIV Infections; Lipodystrophy
MeSH terms: Lipodystrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      HIV infection is a major global health problem. Survival and quality of life for HIV subjects
      has tremendously improved with the advent of a class of antivirals called protease inhibitors
      and the utilization of highly active combination therapy. However, such therapy has been
      associated with a syndrome called lipodystrophy. This lipodystrophy syndrome causes body
      shape changes; typically thinning and loss of fat from the arms, legs and face, with
      increased fat appearing in the abdomen and neck. There are also metabolic changes which
      occur, and subjects can develop increased triglycerides, increased cholesterol and an
      increased risk for diabetes as indicated by increasing insulin resistance. This study will
      take HIV positive subjects who have not yet started antiviral medications (treatment
      naive)and randomly assign them to one of two treatment arms. These treatment arms will be:
      Sustiva/Zerit/Epivir vs. Viracept/Zerit/Epivir The subjects will be treated and followed for
      two years and have extensive metabolic testing, skinfold thickness measurements, MRI scans
      and other measures to determine if and how they are experiencing changes in metabolism or
      body shape and to discover the mechanism of why this occurs. Understanding the mechanism
      should allow researchers to design interventions for subjects who have lipodystrophy and
      strategies to prevent lipodystrophy from occurring to subjects treated with antivirals in the
      future.
    


Intervention name(s): Nelfinavir mesylate; Stavudine; Lamivudine; Efavirenz
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Lamivudine; Efavirenz; Stavudine; Nelfinavir
Masking: Double
Primary purpose: Diagnostic
Keywords: Lipoproteins; Insulin resistance; Adipose tissue
Toradol (Ketorolac) in Breast Surgery to Reduce Pain & Opioid Use
Condition: Breast Reduction; Breast Reconstruction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate whether perioperative single-dose administration
      of ketorolac (Toradol) can reduce post-operative pain after breast surgery, thereby
      decreasing post-operative opioid use.
    

Detailed description: 
      The investigators will perform a double blinded, prospective randomized trial of
      perioperative ketorolac (Toradol) on breast reduction and breast reconstruction procedures.
      Patients will be randomized into three groups: group 1 will receive a perioperative dose of
      ketorolac (Toradol, 15mg), group 2 will receive ketorolac (Toradol, 30mg), and group 3 will
      be the control and receive a placebo of saline. Patients will be asked to complete a diary or
      log of their average pain and pain medication use to be turned in at a 2 week follow up
      visit.

      The patients, surgeons, anesthesiologist will not know whether the patient received ketorolac
      (Toradol) intraoperatively. Patients' pain will be assessed using pain scores in the
      immediate post-operative period, on post-operative day 1, and at their two-week follow up
      appointment. If patients leave the same day then they will only have two pain score
      assessments; on day of surgery and at their two-week follow up. Additionally, patients will
      be asked to assess their average pain (scale of 1-10 with 1 being no pain and 10 being
      extreme pain) in morning and evenings using a patient diary for the two week post-op period.
      The patient's opioid use will be measured by their opioid use during their hospital stay, as
      well as how many prescription narcotic pills the patient used to manage their pain at home,
      as documented using the patient diary.
    

Intervention name(s): Ketorolac Tromethamine; Saline
Intervention type(s): Drug; Other
Intervention description(s): nonsteroidal anti-inflammatory drug; saline fluid injection
Other intervention name(s): Toradol
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Lime Powder Regimen (LPR) for Prevention of Renal Stone Recurrence
Condition: Urolithiasis
MeSH terms: Urolithiasis; Urinary Calculi; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Lime powder regimen (LPR) is a lime-derived composition enriches with citrate/citric acid and
      potassium. LPR was invented to treat the renal stone patients with high risk of stone
      recurrence after stone removal. LPR should have equal or higher efficacy and lower adverse
      effect than current standard medicine.
    

Detailed description: 
      Lime powder regimen (LPR) is a mixture of lime-derive component with adjuvants containing
      high concentration of citrate, and moderate amount of potassium, magnesium and antioxidants.
      LPR was tested and verified to be very less toxic in cell culture and animal models. The
      clinical trial phase II showed that LPR reduced urinary metabolic abnormalities that enhance
      stone formation, such as hypocitraturia, hypokaliuria and acidified urine. Adverse effect of
      LPR was very low.
    

Intervention name(s): Lime Powder Regimen
Intervention type(s): Drug
Intervention description(s): LPR and placebo were randomly given to subjects for 6 months
Other intervention name(s): LPR supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Urolithiasis; Recurrence; Citrate; Antioxidants; Lime Powder Regimen
Effect of Tulsi (Ocimum Sanctum) on Biochemical Parameters in Young Overweight and Obese Subjects
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to investigate the effect of Tulsi (Ocimum sanctum Linn.) on metabolic and
      biochemical parameters in young overweight and obese subjects. Thirty overweight/obese
      volunteers will be divided into two groups. The first group will receive no intervention. The
      second group will be supplemented with one capsule of Tulsi orally every morning and evening
      in empty stomach for 60 days. The metabolic parameters and liver enzymes will be evaluated
      before and after the intervention.
    

Detailed description: 
      This is a randomized, parallel group, open label pilot study to investigate the effect of
      Tulsi (Ocimum sanctum Linn.) on metabolic and biochemical parameters in young overweight and
      obese subjects. Thirty overweight/obese volunteers will be divided into two groups. The first
      group will receive no intervention. The second group will be supplemented with one capsule of
      Tulsi orally every morning and evening in empty stomach for 60 days. The metabolic parameters
      and liver enzymes will be evaluated before and after the intervention.
    

Intervention name(s): Tulsi(Ocimum sanctum Linn.) capsules
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer
Condition: Breast Cancer; Osteoporosis
MeSH terms: Breast Neoplasms; Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: It is not yet known whether zoledronate is effective in preventing bone loss in
      premenopausal women who are receiving adjuvant chemotherapy after undergoing surgery for
      early stage breast cancer.

      PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in
      preventing bone loss in premenopausal women who are receiving chemotherapy after surgery for
      early stage breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the changes in bone mineral density (BMD) and bone turnover that occur in
           premenopausal women with resected early stage breast cancer during and after 6 months of
           adjuvant chemotherapy.

        -  Determine the factors that predict bone loss during chemotherapy, particularly induction
           of amenorrhea, type of chemotherapeutic regimen, glucocorticoid exposure, and baseline
           BMD, in these patients.

        -  Determine whether zoledronate prevents bone loss in these patients when given during and
           after adjuvant chemotherapy.

        -  Determine the effect of zoledronate on markers of bone turnover in these patients during
           and after adjuvant chemotherapy.

        -  Determine whether the effect on markers of bone turnover predicts response to
           zoledronate in these patients.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to estrogen receptor status (positive vs negative), progesterone
      receptor status (positive vs negative), and adjuvant chemotherapy regimen. Patients are
      randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive zoledronate IV over 15 minutes on day 1.

        -  Arm II: Patients receive placebo IV over 15 minutes on day 1. In both arms, treatment
           repeats every 3 months for up to 4 courses in the absence of disease progression.
           Patients also receive calcium and cholecalciferol (vitamin D) supplements daily.

      Quality of life is assessed at baseline and at 6 and 12 months.

      Patients are followed at 1 year.

      PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): zoledronic acid
Intervention type(s): Drug
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Masking: Double
Primary purpose: Supportive Care
Keywords: osteoporosis; stage I breast cancer; stage II breast cancer
Effects of Integrative Medicine on Infectious Respiratory Diseases Including COVID-19
Condition: Covid19; Influenza A; Respiratory Disease
MeSH terms: COVID-19; Respiratory Tract Diseases; Respiration Disorders
Study type: Observational

Summary: 
      The outbreak of the novel coronavirus SARS-CoV-2 caused a health emergency of international
      proportions when it was declared by the World Health Organization (WHO) in January 2020.
      Since then, the virus has spread internationally and the WHO has classified the outbreak as a
      pandemic. In the context of the increasing reporting of this pandemic and the increasing
      governmental measures to limit or slow down the spread of SARS-CoV-2 by all means, there is
      so far little scientific evidence for the effects of a healthy lifestyle on the disease. The
      aim of this study is to compare the potential of different, possibly protective lifestyles
      using the example of the COVID-19 pandemic. We will conduct an online survey with 3.000
      participants using mobile website technology.
    


Intervention name(s): Cross-sectional survey
Intervention type(s): Other
Intervention description(s): No intervention.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The study is advertised via a website, thus all interested people can participate in this
        survey.
Evaluation of the Change in the DA Ratio, IR and SSI as Parameters of Corneal Biomechanics Post Different LVC Procedures
Condition: Corneal Biomechanics
Study type: Interventional

Summary: 
      In the study, The Investigators will compare the participates' corneal biomechanical
      properties including:

      Deformation Amplitude ratio (Da Ratio) Integrated Radius (IR) Stress strain index (SSI)

      All measurements will be taken before and after 3 months of LVC.
    

Detailed description: 
      Each Participant will undergo preoperative pentacam and corvis scan for his eyes and the 3
      months post operative.

      The participants are divided into 3 groups, one who underwent LASIK, one PRK and one Femto
      LASIK.

      Collected data will before and after surgery will be compared in each arm and then the 3 arms
      will be compared together.
    

Intervention name(s): CORVIS
Intervention type(s): Diagnostic Test
Intervention description(s): Measurement of the DA ratio, IR and SSI before and after for patients under gone LASIK, femto LASIK and PRK using the CORVIS device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CORVIS - Corneal Biomechanics
Application of Auriculotherapy on Nursing Professional Stress Levels
Condition: Stress
MeSH terms: Occupational Stress
Study type: Interventional
Phase: Phase 2

Summary: 
      Objectives: Randomized controlled trial aimed to assess stress levels in nursing staff and
      review the auriculotherapy effectiveness through semi-permanent needles and seeds.
    

Detailed description: 
      Seventy five participants with average and high scores on the Stress Symptoms List (LSS) were
      divided in 3 groups (control, needles and seeds).

      They were evaluated at the baseline, fourth and eighth sessions and 15-day follow-up and
      received 8 sessions through Shenmen, Kidney and Brainstem points.
    

Intervention name(s): auriculotherapy by needles; auriculotherapy by seeds
Intervention type(s): Other; Other
Intervention description(s): The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.; We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.
Other intervention name(s): auricular acupuncture; Auricular acupuncture by seeds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Stress
Safety and Efficacy of Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells (ATIR) in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
Condition: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hematologic Neoplasms; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether ATIR is safe and effective in reducing
      transplant-related mortality and improving overall survival, when infused in patients with a
      hematologic malignancy following a T-cell depleted stem cell graft from a related
      haploidentical donor.
    

Detailed description: 
      Study CR-AIR-007 is an exploratory, open-label, multicenter study. After signing informed
      consent, patients will receive a hematopoietic stem cell transplantation (HSCT) from a
      related, haploidentical donor, followed by infusion with ATIR between 28 and 32 days after
      the HSCT (or later if required by the patient's medical condition). Patients will receive
      ATIR as a single infusion at a dose of 2x10E6 viable T-cells/kg. All patients treated with
      ATIR will be followed up until 12 months after the HSCT. Assessments will be performed at
      weekly visits from the day of ATIR infusion until 8 weeks after ATIR infusion, at monthly
      visits from 3 until 6 months after the HSCT, every 2 months from 6 until 12 months after the
      HSCT, and every 6 months from 12 until 24 months after the HSCT.
    

Intervention name(s): ATIR
Intervention type(s): Biological
Intervention description(s): Donor T-lymphocytes depleted ex vivo of host alloreactive T-cells using photodynamic treatment. Single intravenous infusion with 2x10E6 viable T-cells/kg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Haploidentical stem cell transplantation; Graft-versus-host disease; Immune reconstitution; Alloreactive T-cells; Photodepletion; Photodynamic treatment; TH9402; Transplant-related mortality; Hematologic malignancy
Identification of Gene Biomarkers in Aging Skin
Condition: Hyperpigmentation; Skin Aging
MeSH terms: Hyperpigmentation
Study type: Observational

Summary: 
      This study is a blinded, prospective, single-center, clinical study conducted in Japanese
      female subjects between the ages of 20-75 years. This design uses skin biopsy samples from
      environmentally exposed areas and unexposed (control) areas within the same subjects to
      assess the gene expression profile from three different age groups.
    

Detailed description: 
      The primary objective of the skin aging study is to investigate changes in gene expression
      patterns that occur during the aging process.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asian female subjects between the ages of 20 to 75 years old who are non-smokers with no
        history of prior alcoholism.
      
Biospecimen description: 
      A 4 mm punch biopsy taken from exposed and unexposed skin.
    
Keywords: Skin; Aging; Dermogenomics; Genetic; Biomarker; Dermatology
Treatment of Adults With Growth Hormone Deficiency
Condition: Pituitary Disorders; Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Pituitary Diseases; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate efficacy and safety profile of a new weekly
      administered growth hormone preparation compared with placebo in adults with growth hormone
      deficiency.
    


Intervention name(s): growth hormone
Intervention type(s): Drug
Intervention description(s): subcutaneous injection, once-weekly
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Growth hormone deficiency
Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
Condition: High Triglycerides; Hypercholesterolemia; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
MeSH terms: Hypercholesterolemia; Hypertriglyceridemia; Schizophrenia; Bipolar Disorder; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in
      subjects who have been on an atypical (second-generation) antipsychotic medication. The
      investigators hypotheses are that patients who receive Lovaza will experience a significant
      decrease in triglycerides from baseline. Secondary hypotheses include: Patients will
      experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.
    

Detailed description: 
      This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in
      subjects who have been on an atypical (second generation) antipsychotic medication. Eligible
      subjects include men and women, ages 18-75, who have been taking an atypical antipsychotic
      for at least three months prior to enrollment. Atypical antipsychotics include: clozapine
      (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal), aripiprazole (Abilify),
      ziprasidone (Geodon), quetiapine (Seroquel), paliperidone (Invega), asenapine (Saphris),
      iloperidone (Fanapt), and lurasidone (Latuda). Eligible subjects must also have serum
      triglycerides >200 mg/dl or high cholesterol >250 mg/dl at baseline.
    

Intervention name(s): Lovaza
Intervention type(s): Drug
Intervention description(s): 4 grams per day
Other intervention name(s): Omega 3 Fatty Acids
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
Condition: Gastroesophageal Reflux Disease; Hiatal Hernia
MeSH terms: Gastroesophageal Reflux; Hernia, Hiatal
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the relative merits, safety and effectiveness of
      the EsophyX transoral device in performing an advanced TIF procedure in patients with
      "troublesome symptoms" as defined by the Montreal consensus definition while on PPIs compared
      with sham and placebo controls.
    

Detailed description: 
      Primary Effectiveness Endpoint: A clinically significant reduction in GERD symptoms,
      specifically "Troublesome" regurgitation with or without heartburn assessed by the Reflux
      Disease Questionnaire (RDQ).

      Troublesome symptoms are those which occur a minimum of 2 days a week and are at least
      moderate in severity.

      Secondary Effectiveness Endpoint: The normalization of esophageal acid exposure at 6 months
      and a clinically significant reduction in PPI usage at 12 months.
    

Intervention name(s): TIF Transoral Fundoplication; Sham placebo procedure
Intervention type(s): Device; Other
Intervention description(s): A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions); The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus.
Other intervention name(s): TIF; Sham Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: GERD; Esophagitis; Fundoplication; Anti-reflux surgery; PPI dependent