bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Pharmacokinetics of Orally Administered Strontium L-Lactate in Healthy Adults
Condition: Low Bone Density; Osteopenia; Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal
Study type: Interventional

Summary: 
      No clinical trials have evaluated strontium L-lactate (SrLac), the strontium salt of the
      L-enantiomer of lactic acid. Therefore, this clinical study was conducted to obtain general
      safety and pharmacokinetic (PK) information following acute oral intakes of three doses of
      SrLac by healthy adults. The data provided valuable comparisons with the pharmacokinetics of
      other strontium salts that are in clinical use and allowed determination of the dose of SrLac
      that will be useful for the management of bone health.neficial for the treatment of low bone
      density of osteoporosis and osteopenia.
    

Detailed description: 
      Purpose: The aim of this clinical study was to obtain safety and pharmacokinetic information
      following acute oral intakes of three ascending doses of strontium L-lactate by healthy
      adults.

      Subjects and methods: Ten healthy men and women, mean age 43 ± 2 years, ingested one of three
      ascending doses of strontium L-lactate (SrLac) once per week for three weeks in succession.
      Fasting blood collections were performed pre-dose and 1, 2, 3, 4, 5, 6, 8 and 12 hours
      post-dose for determination of serum strontium at each interval.
    

Intervention name(s): Strontium L-lactate
Intervention type(s): Dietary Supplement
Intervention description(s): The Study Product was a highly pure form of SrLac, the strontium salt of L-lactic acid. SrLac was manufactured in compliance with current Good Manufacturing Practices. SrLac was thoroughly tested and met rigorous purity specifications. It was free from contamination by D-lactic acid and trace metals known to harm human health.
Other intervention name(s): SrLac
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: This was an unblinded, sequential, three dose study. The study consisted of one screening visit (Visit 1; day -7) and three test visits (Visits 2, 3, and 4; days 0, 7, and 14) with at least a 6-d washout between test visits.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Bone density; Osteopenia; Osteoporosis; Bone health; Pharmacokinetics
Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the effects of tamoxifen exposure in combination with vorinostat on
      viral reactivation among HIV-1 infected post-menopausal women with virologic suppression on
      antiretroviral therapy (ART), when compared to vorinostat alone.
    

Detailed description: 
      The selective estrogen receptor modulator (SERM) tamoxifen may enhance the ability of the
      histone deacetylase inhibitor (HDACi) vorinostat to reverse HIV-1 latency. This study
      evaluated the safety of tamoxifen therapy combined with vorinostat and the effectiveness of
      this combination on latent virus reactivation in HIV-1 infected post-menopausal women with
      virologic suppression on antiretroviral therapy, when compared to vorinostat alone.

      The study will be conducted in two steps. During Step 1, the study enrolled women with HIV
      into two groups. Arm A received tamoxifen daily for 38 days, plus a single dose of vorinostat
      on Days 35 and 38. Arm B had a 38-day observation period with no tamoxifen, plus a single
      dose of vorinostat on Days 35 and 38. All participants continued to take ART drugs prescribed
      by their doctors. ART drugs were not be provided by the study.

      Study visits during Step 1 occurred at Days 0, 28, 35, 38, 45, and 65. Study visits could
      include physical examinations, blood collection, electrocardiograms, and adherence
      assessments.

      During Step 2, all participants will be followed for 240 additional weeks for annual
      long-term safety follow-up. These visits will be conducted by phone and will collect
      information from participants on vital status and any new cancer diagnoses.

      Step 1 has been completed and this results submission pertains to Step 1. Step 2 follow-up is
      ongoing.
    

Intervention name(s): Tamoxifen; Vorinostat; Antiretroviral drugs
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg orally; 400 mg orally; Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.
Intervention MeSH terms: Tamoxifen; Anti-Retroviral Agents; Vorinostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in
      patients with active, stable plaque psoriasis.
    


Intervention name(s): Ruxolitinib
Intervention type(s): Drug
Intervention description(s): Ruxolitinib 1.5% cream BID for 28 days
Other intervention name(s): INCB018424
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psoriasis
Efficacy of Baclofen in the Treatment of Alcohol Addiction
Condition: Liver Cirrhosis, Alcoholic
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Alcoholic; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Intervention to achieve alcohol abstinence represents the most effective treatment for
      alcoholic patients with liver cirrhosis. However no trials have evaluated the efficacy of
      anti-craving drugs in these patients because of the concern that these medications might
      worsen liver disease. Baclofen is effective to reduce alcohol craving improving abstinence in
      alcohol-dependent patients. It is mainly eliminated by kidney. No hepatic side-effects have
      been reported in treated patients. The present study investigates the efficacy and safety of
      baclofen in achieving and maintaining abstinence in alcoholic cirrhotic patients.
    


Intervention name(s): Baclofen; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Baclofen orally administered for 12 consecutive weeks. For the first 3 days, baclofen administered at a dose of 5 milligrams 3 times per day; subsequently, the daily dose of baclofen will be increased to 10 milligrams 3 times per day.; Placebo will be orally administered for 12 consecutive weeks
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Liver cirrhosis; Alcoholism; Craving
Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting
Condition: Nausea and Vomiting, Postoperative
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Laparoscopic sleeve gastrectomy (LSG) is an emerging treatment modality among the various
      types of surgical approach to obesity (1). The incidence of PONV in obese patients undergoing
      bariatric surgery, who did not receive antiemetic prophylaxis, is high at nearly 70-80 %
      (2,3). Postoperatively, bariatric patients appear to suffer from nausea and vomiting more
      frequently than normal weight or obese patients.
    

Detailed description: 
      Currently, available interventions for PONV prophylaxis, especially as monotherapy, lack
      universal efficacy. Use of combination therapies with different pharmacological basis is
      likely to bring down rates of PONV. (6) Intravenous dexamethasone (8-10mg) reduces the
      incidence of PONV, minimizing activity of phospholipase A2 and blocking the expression of
      cyclooxygenase (COX)2 mRNA that reduce production of prostaglandin and control the release of
      endorphins.

      Aprepitant has demonstrated powerful additive effects when combined with dexamethasone and a
      5-HT3 to prevent both acute and delayed chemotherapy-induced nausea and vomiting (CINV), and
      in the prevention of postoperative nausea and vomiting (PONV) The use of mirtazapine in the
      management of nausea and vomiting has been reported for both treatment and premedication
    

Intervention name(s): Aprepitant and Dexamethasone; Mirtazapine and Dexamethasone; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Aprepitant capsule 80 mg and Dexamethasone 8 mg IVI; Mirtazapine tablet 30 mg and Dexamethasone 8 mg IVI; Dexamethasone 8 mg IVI
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Aprepitant; Mirtazapine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
A Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the safety, tolerability, and pharmacokinetics of single oral
      doses of TS-142 compared to placebo and of a single repeated dose compared to placebo in
      healthy volunteers. This Phase I study is composed of two parts; Part A (Single Ascending
      Dose) and Part B (Repeated Dose). The study employs a randomized, double-blind,
      placebo-controlled, parallel group design to evaluate the single and repeat-dose safety and
      pharmacokinetics of TS-142 in healthy participants.
    


Intervention name(s): TS-142; TS-142 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TS-142 tablets; TS-142 matching placebo tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TS-142
Methylomic Biomarkers for Magnesium Deficiency in the Personalized Prevention of Colorectal Cancer Trial
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Magnesium Deficiency
Study type: Interventional

Summary: 
      Based on the magnesium (Mg) tolerance test, the "gold standard" test of Mg status, more than
      50% US participants had Mg deficiency. Observations suggest that the associations between
      high Mg intake and disease risks may completely differ by the underlying Mg status. Due to
      major limitations, the Mg tolerance test is not used in conventional clinical practice and
      rarely used in research. Instead, serum Mg is used for clinical diagnosis. However, serum Mg
      performs very poorly at identifying those with Mg deficiency. There is a great need to
      develop implementable, sensitive, and specific biomarkers which can be easily used for
      identifying people with Mg deficiency.

      It is known that DNA methylation changes are inducible by environmental exposures, including
      nutrients, and reversible when the exposure disappears. We propose to identify 5-hmC/5-mC
      biomarkers for Mg deficiency by a 4- phase EWAS study in the "Personalized Prevention of
      Colorectal Cancer Trial [PPCCT, R01CA149633; PI, Dai & Yu]" with a total of 240 participants.
      Mg tolerance test will be used as the gold standard. Finally, using newly identified
      biomarkers, we will evaluate if 12-week Mg treatment reduces TRPM7 expression, essential in
      Mg homeostasis and colorectal carcinogenesis, in rectal tissues only among those with Mg
      deficiency.
    


Intervention name(s): Magnesium glycinate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral administration of magnesium glycinate daily for 12 weeks; Oral administration of identical-appearing placebo daily for 12 weeks
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
FreeStyle Libre FGM During Summer Camp for Children With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus; Hypoglycemia; Hyperglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia
Study type: Interventional

Summary: 
      A randomized, double-blinded, single center, parallel design pediatric study, on 45 subjects
      with type 1 diabetes (T1D), aged six to 15 (inclusive) years, measuring sensor time in
      glucose values within range 3.9 - 10 mmol/l (70 - 180 mg/dl) achieved using the FreeStyle
      Libre Flash Glucose Monitoring System (FGM - intervention, Abbott Diabetes Care, California,
      USA) versus Self-Monitoring Blood Glucose (SMBG - control).

      Study duration will be two weeks per subject and two weeks overall, it will take place at
      youth summer camp for children with T1D. Main inclusion criteria include age of six to 15
      (inclusive) years, clinical diagnosis of T1D for at least six months, at least three months
      of current use of insulin pump therapy, HbA1c between 6.3 and 10 % (both inclusive), no other
      chronic medical conditions (beside treated hypothyroidism and celiac disease) and no current
      medications (other than insulin) (detailed list of inclusion and exclusion criteria list can
      be found at section 6).

      The objectives of this clinical investigation is:

      1. to evaluate the efficacy of glucose control using the FreeStyle Libre FGM in children with
      T1D during two weeks of summer camp.
    


Intervention name(s): FreeStyle Libre FGM; SMBG - Blinded Sensor
Intervention type(s): Device; Device
Intervention description(s): Insulin dosing based on FreeStyle Libre FGM system that is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with diabetes mellitus.; Insulin dosing based on SMBG
Other intervention name(s): Intervention - Sensor ON; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Huang Lian (Chinese Herb) in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: The Chinese herb Huang Lian contains ingredients that may slow the growth of
      cancer cells and may be an effective treatment for solid tumors.

      PURPOSE: Phase I trial to study the effectiveness of Huang Lian in treating patients who have
      advanced solid tumors.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of Huang Lian (Chinese herb) in patients with
           advanced solid tumors.

        -  Determine the optimal pharmacologic, molecular, and biologic parameters of this
           treatment regimen in these patients.

        -  Assess the preliminary therapeutic activity of this treatment regimen in this patient
           population.

      OUTLINE: This is a dose-escalation study.

      Patients receive oral Huang Lian (Chinese herb) 4 times daily. Treatment repeats every 21
      days in the absence of disease progression or unacceptable toxicity.

      Cohorts of 1-6 patients receive escalating doses of Huang Lian until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-liming toxicity.

      PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.
    

Intervention name(s): Chinese Herb Huanglian (Coptis chinesis)
Intervention type(s): Drug
Intervention description(s): Patients will receive capsules of the powdered extract of the huanglian root, which will take by mouth 4 times a day (qid).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Early Brain Damage Assessment in Aneurysmal Subarachnoid Haemorrhage in Predicting Cognitive Impairment
Condition: Aneurysmal Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage; Cognitive Dysfunction
Study type: Observational

Summary: 
      the goal of this type of study : observation study is to learn about cerebral edema and
      hematoma in aneurysmal subarachnoid hemorrhage the main questions it aims to answer are
      current clinical practices lack predictive models to identify early structural brain
      abnormalities affecting cognition.
    

Detailed description: 
      the development of a predictive model termed the a-SAH Early Brain Edema/Hematoma Compression
      Neural (Structural Brain) Networks Score System (SEBE-HCNNSS).
    

Intervention name(s): Endovascular coiling, Surgical clipping, Mix
Intervention type(s): Procedure
Intervention description(s): Endovascular coiling, Surgical clipping, Mix
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Han Chinese emergency call
      
Biospecimen description: 
      brain CT& MRI
SIMDiscovery: The Benefits of Utilizing a Simulation Preparation Program for Spinal Fusion Surgery
Condition: Scoliosis Idiopathic Adolescent
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      This is a pilot study aiming to examine preliminary effectiveness of a preparation program
      which includes simulation (SIMDiscovery) in reducing anxiety and increasing feelings of
      preparedness among parents and their children who will undergo spinal fusion surgery.
      SIMDiscovery is an experiential learning preparation program which aims to educate children
      and families about different medical procedures through simulation play.
    


Intervention name(s): SIMDiscovery
Intervention type(s): Behavioral
Intervention description(s): The SIMDiscovery program consists of nine stations that were designed to mirror the different stages of the perioperative process. The stations mirror the different stages of the surgical process and provide patients and their families with education regarding what they can anticipate during each aspect of the intervention.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anxiety; Preparedness; Spinal Fusion
Foot Reflexology in Ocular Hypertensive and Glaucoma Patients
Condition: Ocular Hypertension; Glaucoma
MeSH terms: Glaucoma; Ocular Hypertension
Study type: Interventional

Summary: 
      To determine the effect of foot reflexology in primary open angle glaucoma (POAG) patients
      and the effect of a shoe insert to perform continuous foot reflexology in ocular hypertensive
      (OHTN) patients.
    

Detailed description: 
      This is a prospective pilot study in glaucoma patients and a prospective therapeutic trial in
      ocular hypertensive patients. Patients were recruited from the Temple Ophthalmology
      outpatient clinic. Primary open-angle glaucoma patients were recruited from those about to
      have SLT for additional intraocular pressure (IOP) lowering. OHTN patients were recruited
      from the clinic. The glaucoma patients performed a 5-minute foot massage on a foot massage
      board and the IOP was checked pre-massage, post-massage and 30, 60, 90 and 120 min post
      massage. OHTN patients underwent a one-month drop washout and then performed a 5-minute
      massage using a 3D-printed shoe insert with the identical pressure checks. They then were
      randomly assigned to wear the shoe insert or a sham insert for one day. IOP was checked
      before inserting the insert and at the end of the day. The number of steps was recorded each
      day.
    

Intervention name(s): Massage; Experimental insert; Sham insert
Intervention type(s): Device; Procedure; Procedure
Intervention description(s): Foot reflexology board (JAPAN TSUBO HH-700) with massage focused at the base of the second and third toes; Raised shoe insert, insert used for massage; Flat shoe insert, insert used for massage
Other intervention name(s): JAPAN TSUBO HH-700
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Vitamin D in HIV-Infected Patients on HAART
Condition: Vitamin D Deficiency; HIV
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      This is a research study to look at vitamin D deficiency (low levels) in men and women with
      HIV. As part of your regular medical care, you will be screened for vitamin D deficiency. If
      your levels are low, and you choose to start using vitamin D supplements, the investigators
      would like to take some blood before and after you start using vitamin D to see how this
      affects your levels of HIV, T cells, cholesterol, and other blood levels. The investigators
      will provide you with vitamin D supplements for the first 24 weeks (6 months) of the study.
      If you and your physician decide that you should continue taking vitamin D supplements after
      that time, you will be responsible for purchasing your own vitamin D supplements.
    


Intervention name(s): Vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): 50,000 IU vitamin D3 twice weekly for 5 weeks, followed by 2000 IU daily maintenance supplementation to complete 12 weeks. At the end of the 12-week period, 25(OH)D levels will be checked. If the subject is still deficient, he/she may undergo a second period of supplementation (at the discretion of their provider) to complete a total of 24 weeks. After 24 weeks, we anticipate all subjects will be kept on daily maintenance supplementation by their primary physicians.
Intervention MeSH terms: Vitamin D
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Vitamin D; HAART
Effects of Early Nutrition on Growth
Condition: Infant Newborn
Study type: Interventional

Summary: 
      The primary objective of the study is to compare the growth of infants fed standard infant
      formula with infants fed a reduced calorie and protein formula.
    


Intervention name(s): Human Milk; Investigational infant formula; Milk based standard infant formula
Intervention type(s): Other; Other; Other
Intervention description(s): ad lib; ad lib; ad lib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment