bioihbjkbjnl/mcl2 huggingface dataset:
Safety and PK of Nikkomycin Z in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if nikkomycin Z is safe when administered at
      different dose levels for 14 days. The study will also determine blood levels and urinary
      excretion of nikkomycin Z in relation to dose administered. Healthy patients will be eligible
      to participate and will be allocated to receive nikkomycin Z (various doses) or a placebo.
    

Detailed description: 
      This protocol will serve as a Phase I, randomized, double-blind, placebo controlled,
      multiple-dose study to evaluate the safety, tolerance and pharmacokinetics of nikkomycin Z.
      Nikkomycin Z has previously been studied in a single dose protocol in healthy male subjects.
      This study is designed to run in parallel to protocol VFCE-2007-001 to provide additional
      data on safety and pharmacokinetics. The study will involve a total of 32 subjects (6
      active/2 placebo per group) with a multiple, rising dose strategy.
    

Intervention name(s): nikkomycin Z
Intervention type(s): Drug
Intervention description(s): Multiple rising doses. Doses packaged on a unit dose basis in 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses.
250 mg BID (n=6) vs Placebo capsule BID (n=2), 500 mg BID (n=6) vs Placebo capsule BID (n=2), 750 mg BID (n=6) vs Placebo capsule BID (n=2), 750 mg TID (n=6) vs Placebo capsule TID (n=2) At least 4 subjects complete lower dose before randomization includes next higher dose, thus there are 4 arms for active intervention and corresponding placebos.
Intervention MeSH terms: Nikkomycin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: nikkomycin Z; pharmacokinetics; toxicity
Study of the Effect of Glutamine Supplementation on Chemotherapy Induced Toxicities in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Glutamine, a non essential branched chain amino acid, is most important non toxic nitrogen
      carrier in body. It participates in variety of physiological functions. It is a major fuel
      source of enterocytes and is a substrate for gluconeogenesis in kidney, lymphocytes, and
      monocytes. It is also a nutrient in muscle protein metabolism in response to infection,
      inflammation and muscle trauma. The significance of glutamine to metabolic homeostasis
      becomes evident during periods of stress, when it becomes a conditionally essential amino
      acid. Role of glutamine as protective agent in hepato-biliary dysfunction, in maintaining
      mucosal integrity of the Gastrointestinal tract following its administration in patient with
      major bowel surgery as a supplement and part of TPN in critically ill patients and in
      patients of septicemia, is well established. However the role of glutamine supplementation in
      reducing or preventing chemotherapeutic agents induced toxicity in cancer patients is
      controversial.
    


Intervention name(s): Glutamine; IV Glutamine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2g/kg body weight twice daily in divided doses for 5 days; 50 ml of 20% glutamine IV before chemotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Case Control
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Breast cancer; Chemotherapy; Epirubicin; Glutamine; FEC chemotherapy
A Pharmacokinetic Study of CJ30001 and HKB0701/SLM0807 in Healthy Subject
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose
      combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to
      healthy subjects.
    


Intervention name(s): Period I : HKB0701 and SLM0807, Period II : CJ30001; Period I : CJ30001, Period II : HKB0701 and SLM0807
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Validity and Reliability of Commercially Available Metabolic Carts
Condition: Metabolism and Nutrition Disorder
MeSH terms: Nutrition Disorders
Study type: Observational

Summary: 
      The validity (by alcohol burning and gas infusions) and reliability (day-to-day variability
      in healthy subjects) of six metabolic carts will be compared.
    


Intervention name(s): Assessment of resting energy expenditure
Intervention type(s): Device
Intervention description(s): We will assess the resting metabolic rate and respiratory exchange ratio of twenty healthy adults, with every metabolic cart on two days in the morning. The assessment will last 30 minutes on each metabolic cart, with 15-minute breaks between measurements. The order of the metabolic carts will be randomly selected and replicated the second day.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults
Caverject User Study
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the usability of the system.
    

Detailed description: 
      demonstrate usability
    

Intervention name(s): delivery system
Intervention type(s): Other
Intervention description(s): syringe
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Erectile Dysfunction
Development of Pregnenolone as a Treatment for Depression R61
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      Pregnenolone, an over-the-counter supplement, is a naturally occurring neurosteroid made in
      the adrenal glands and brain. Preclinical research suggests pregnenolone has antidepressant,
      cognitive enhancing, and neuroprotective properties, particularly in women. The following
      hypothesis will be tested in this trial: pregnenolone is associated with improvement in
      depressive symptom severity in women that is associated with changes in the resting state
      functional connectivity (rsFC) and GABA.
    

Detailed description: 
      In this study, 26 adult women meeting criteria for Major Depressive Disorder (MDD) as defined
      in DSM 5, will be randomized to a double-blind, placebo-controlled, crossover phase I
      clinical trial of pregnenolone (i.e. each participant receives 500 mg/d, 800 mg/d
      pregnenolone and placebo in random order). The study will consist of three 7-day treatment
      exposures to each pregnenolone dose with a 14-day washout between each exposure. Baseline
      evaluation will include medical and psychiatric history, psychiatric interview, standard
      laboratory analyses (i.e., blood draw, ECG), and a brief cognitive battery. Neuroimaging will
      be collected after each study drug or placebo administration. Study drug tolerability and
      participant safety will be assessed throughout the study (6 in-clinic visits + a safety
      visit) using structured clinical interviews, self-report questionnaires, and standard
      laboratory analyses.
    

Intervention name(s): Pregnenolone 500 mg; Pregnenolone 800 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pregnenolone 500 mg capsule.; Pregnenolone 800 mg capsule.; Placebo capsule manufactured to mimic pregnenolone capsule.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Depression; Pregnenolone; Women
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone Under Fasting Conditions in Healthy Volunteers
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and bioequivalence of a single oral dose of
      carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa
      combination plus a single oral dose of entacapone under fasting conditions in healthy
      volunteers.
    


Intervention name(s): ELC200 (carbidopa+levodopa+entacapone)
Intervention type(s): Drug
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone; Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; bioavailability; carbidopa; levodopa; entacapone; fasting condition; Healthy volunteers study
A Comparison of Two Instruments for Stabilization of the Cervix During Office Procedures
Condition: Comparing Two Clamps for Mobilization of the Cervix During Common Gynecologic Office Procedures
Study type: Observational

Summary: 
      An Allis clamp causes less pain and bleeding than a single tooth tenaculum when used for
      mobilization of the cervix during common gynecologic office procedures.

      The primary object is to determine the presence of a difference in pain perception between
      the two instruments.

      The secondary objective is to evaluate the differences in the frequency of bleeding, that
      requires treatment, after removal of the instrument and the need to use an alternative
      instruments.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females between the ages of 18 and 89 years undergoing an IUD placement
      
Keywords: cervix; Allis; Tenaculum; gynecology
Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF
Condition: Endometriosis; Infertility
MeSH terms: Infertility; Endometriosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective randomized trial evaluates whether one can predict which infertile women
      with endometriosis who are candidates for in vitro fertilization will benefit from prolonged
      therapy with a GnRH agonist by the determination of the absence of endometrial expression of
      the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which
      all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for
      in vitro fertilization and then undergo randomization to a three month course of a depot
      preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian
      stimulation or standard therapy. prio
    

Detailed description: 
      See summary
    

Intervention name(s): Leuprolide acetate in depot suspension; No intervention
Intervention type(s): Drug; Other
Intervention description(s): Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3
Other intervention name(s): Depot Lupron
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endometriosis,infertility,in vitro fertilization
Supplemented Very Low Protein Diet and the Progression of Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective single center randomized controlled trial with a total duration of 18
      months aiming to evaluate the effectiveness and the safety of a very low protein diet
      supplemented with ketoanalogues of essential aminoacids in reducing the progression of
      chronic kidney disease (CKD) in patients with advanced CKD.
    

Detailed description: 
      All eligible patients who will give informed consent will be screened. Those meeting the
      selection criteria will be enrolled and will enter a 3-month run-in phase during which a
      conventional LPD will be prescribed in all patients.

      At the end of this phase, the subjects still fulfilling all the selection criteria will be
      randomized in a 1:1 ratio to receive the KD or to continue the conventional LPD for a total
      duration of 15 months.

      Nineteen blood and urine samplings are scheduled for each patient, to be drawn monthly. The
      laboratory reports include the nitrogen compounds, calcium-phosphorus metabolism parameters,
      acid-base balance, biochemical nutritional markers, serum C-reactive protein, hemoglobin,
      blood cell count, and biochemical safety parameters (sodium, potassium, liver enzymes, and
      bilirubin).

      The anthropometric measurements and subjective global assessment will be evaluated at
      enrolment, at randomization, and every 3 months thereafter.

      The compliance with the prescribed diet (protein and energy intake) will be assessed monthly
      during the run-in phase, weekly for the first month after randomization, every 4 weeks during
      the next 6 months, and every 3 months thereafter.

      The blood pressure levels, drugs required for the therapy of hypertension, acidosis and
      mineral metabolism disorders, and occurrence of adverse events will be recorded monthly.
    

Intervention name(s): Conventional low protein diet; Very low protein diet supplemented with Ketosteril
Intervention type(s): Behavioral; Dietary Supplement
Other intervention name(s): LPD; Hypoproteic diet; SVLPD, Keto-diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chronic Kidney Disease; Restricted protein diets; Nutritional status
Stroke-induced Immunodepression in Neurorehabilitation
Condition: Stroke; Lymphopenia; Immunosuppression
MeSH terms: Stroke; Lymphopenia
Study type: Observational

Summary: 
      The close interconnection between nervous system and the immune system is well known. Brain
      injuries lead to homeostasis disruption. On the one hand they result in increased brain
      inflammation contributing to tissue repair, at the expense of a possible extension of tissue
      damage. On the other hand, they lead to systemic down-regulation of innate and adaptive
      immunity, determining higher vulnerability to infections, responsible of death and
      comorbidities in the acute and subacute setting.

      Aim of the study was to evaluate the role of immunosuppression in the neurorehabilitation
      pathway in patients with stroke.
    

Detailed description: 
      The perfect balance between nervous and immune system could be severely impaired after brain
      injuries, such as strokes.

      In the acute phase, inflammatory mediators are responsible of central nervous system
      inflammation, associated to tissue repair at the expense of possible secondary brain injury
      or damage expansions.

      In the mean time, activation of hypothalamic-pituitary-adrenal axis and the autonomic nervous
      system determine downregulation of innate and adaptive immunity, with decreased circulating T
      cell count and reduced lymphocytic response. The degree of these changes is linked to the
      severity of brain damage and inevitably lead to higher vulnerability to infections,
      representing a negative prognostic factor in the acute phase.

      Association between immunosuppression and functional outcome in the neurorehabilitation
      setting are missing.

      Aim of this study was to evaluate the role of immunosuppression in the neurorehabilitation
      journey in patients with stroke.

      We analyzed the neutrophil-to-lymphocyte ratio, a useful tool to investigate alterations in
      both the innate and adaptive immune systems. We correlated it to clinical and
      neurorehabilitation scales, investigating disability, functional status, as well as gait
      analysis and occurrence of infectious complications. All outcomes were measured on admission
      in Neurorehabilitation setting and at hospital discharge.
    

Intervention name(s): Neurorehabilitation
Intervention type(s): Other
Intervention description(s): Four to eight weeks motor rehabilitation (500 minutes per week across 6 day per week)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants were selected from a single centre cohort admitted for stroke rehabilitation
        at the Neurorehabilitation Unit of the IRCCS Mondino Foundation (Pavia, Italy).
      
Biospecimen description: 
      Blood samples
    
Keywords: Ischemic stroke; Intracerebral hemorrage; Neurological rehabilitation; Neurorehabilitation; Cerebrovascular disorders; Immunodepression
Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis; Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether TZP-101 is safe in people with diabetes.
      Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic
      patients.
    


Intervention name(s): 5% dextrose in water; TZP-101
Intervention type(s): Drug; Drug
Intervention description(s): 60 ml IV infusion over 30 minutes; 1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg
Other intervention name(s): D5W
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: delayed gastric emptying; symptomatic gastroparesis; diabetes mellitus
Exercise and Health Intervention for Patients With Obsessive Compulsive Disorder (OCD)
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effect of a moderate-intensity aerobic exercise
      intervention for Obsessive Compulsive Disorder (OCD) patients interested in reducing
      symptoms. The investigators expect that this project will contribute much needed knowledge
      about the role that aerobic exercise can play in managing the effects of OCD. If
      moderate-intensity aerobic exercise is efficacious in helping individuals with OCD manage
      obsessions and compulsions, this will establish that aerobic exercise may be a valuable
      adjunct to other OCD treatments such as medication and therapy.
    


Intervention name(s): Aerobic exercise; Health and Wellness
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals.; 12-week health and wellness education control. Weekly sessions about 12 different topics related to OCD, led by an OCD expert.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obsessive Compulsive Disorder; OCD; Exercise; Aerobic Exercise
Glutathione and Its Precursors in HIV-Infected Patients
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to investigate the responses of the serum amyloid A (SAA) pathway to
      dietary supplements of glutamine (Gln) and cysteine (Cys) together with methionine
      (Met)-overloading in HIV+ patients comparatively to healthy controls.
    

Detailed description: 
      Introduction: Among the 4 sulphur-containing amino acids (SAA), only Met and Cys are
      incorporated into proteins, but Hcy and Tau are related to oxidative stress and glutathione
      (GSH), the major intracellular hydro-soluble anti-oxidant agent. HIV+ patients present low
      levels of antioxidant nutrients, including GSH and its precursors.

      Objective: To investigate the responses of the SAA pathway to dietary supplements of Gln and
      Cys together with Met-overloading in HIV+ patients comparatively to healthy controls.

      Methods: Twelve HIV+ (6 males and 6 females, 25-36 yrs old) patients under HAART (one HIV
      protease inhibitor in combination with two nucleoside analogs) for at least one year and 20
      (10M and 10F, 23-28 yrs old) healthy controls were randomly assigned to 7-day diets
      containing either NAC (N-acetylcysteine, 1g/d) or Gln (20g/d), with a 7-day washout period
      with their usual diet (UD). Blood samples were drawn after overnight fast before and after
      (2h and 4h) ingesting the Met (100 mg/kg) overload (Met-OL) with determination of the area
      under the curve (AUC). HPLC plasma analysis of SAA (Met, Hcy, Cys and Tau), GSH and GSSG and
      Ser, Gly, Glu and Gln was carried out at moments before (MO) and after 7-day diets (M1).
      Additionally, at baseline, both groups were assessed for anthropometry (BMI, kg/m2; body fat
      %) and plasma biochemistry (creatinine, urea, γ-glutamyl transpeptidase, glucose,
      triglycerides, cholesterol, uric acid, albumin, folic acid and vitamin B12).The HIV+ group
      (G2) was also characterized by the viral load, CD4+ and CD8+ lymphocytes counts. Statistical
      comparisons were undertaken among diets between groups with p = 0.05.
    

Intervention name(s): Glutathione precursors
Intervention type(s): Dietary Supplement
Intervention description(s): HIV+ patients were assigned to 7 day diets containing either NAC or Gln
Other intervention name(s): Glutamine (L-glutamine); NAC (N-acetyl-L-cysteine)
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Dried Plums for Bone Health in Older Postmenopausal Women
Condition: Bone Diseases, Metabolic
MeSH terms: Bone Diseases; Bone Diseases, Metabolic; Metabolic Diseases
Study type: Interventional

Summary: 
      The objective of the investigators current study was to examine whether 50 g dried plum would
      be as effective as 100 g dried plum in reversing bone loss in osteopenic older postmenopausal
      women.
    

Detailed description: 
      Forty-five randomly assigned into one of three treatment groups: 1) 50g dried plum; 2) 100g
      dried plum; and 3) control (0g dried plum). All groups received 500mg calcium and 400 IU
      vitamin D as a daily supplement. Blood samples were collected at baseline, 3 and 6 months to
      assess biomarkers of bone turnover. Physical activity recall and 3-day food records were
      obtained at baseline, 3 and 6 months to examine physical activity and dietary confounders as
      potential covariates
    

Intervention name(s): Dried Plum
Intervention type(s): Other
Intervention description(s): Three doses of dried plum (0 g, 50 g and 100g) were used as intervention.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Osteoporosis; Dried plum; functional food