bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Knee-osteoarthritis (OA) is a common and disabling problem, that represents a global health
      issue since none of the current therapies are truly disease modifying. The use of mesenchymal
      stem cells (MSCs) in OA-preclinical models has been associated with a reduction in cartilage
      degradation, the attenuation of bone sclerosis and an effective anti-inflammatory response.
      Investigators have designed a randomized phase I/II placebo controlled trial of UC-MSCs in
      knee OA. Outcomes will be evaluated at 12 months, comparing monodosis versus double
      intra-articular injection, re-randomized at 6 months.
    


Intervention name(s): umbilical-cord mesenchymal stromal cells; Hyaluronic Acid
Intervention type(s): Biological; Drug
Intervention description(s): Intra-articular knee injection of UC-MSC 20x10e6 at 0 and 6 months; Intra-articular knee injection of Hyaluronic Acid (3ml) at 0 and 6 months
Other intervention name(s): UC-MSCs; Durolane
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intraaortic Balloon Pump in Cardiogenic Shock II
Condition: Myocardial Infarction; Shock, Cardiogenic
MeSH terms: Myocardial Infarction; Shock, Cardiogenic; Infarction; Shock
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients in cardiogenic shock complicating acute myocardial infarction (AMI) are referred to
      a tertiary care center for percutaneous coronary intervention (PCI) of the infarct related
      artery in this multicenter, ran-domized clinical trial. After checking in- and exclusion
      criteria computerized randomization is performed to either PCI plus intraaortic balloon pump
      (IABP) insertion and medical treatment or PCI plus medical treatment only. Intensive care
      treatment is performed according to standard care including hemodynamic monitoring using a
      pulmonary artery catheter for optimal volume status adaptation and inotropic drug
      administration.

      The IABP will be weaned after hemodynamic stabilization. Primary outcome measure will be
      30-day mortality. The secondary outcome measures such as hemody-namic, laboratory and
      clinical parameters will serve as surrogate for prognosis of the patients.
    


Intervention name(s): Intraaortic balloon pump
Intervention type(s): Device
Intervention description(s): intraaortic balloon pump from Datascope/Maquet or Arrow/Teleflex will be used
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myocardial infarction; cardiogenic shock; percutaneous coronary intervention; intraaortic balloon counterpulsation; Acute myocardial infarction - cardiogenic shock
Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers
Condition: Blood Glucose
Study type: Interventional

Summary: 
      Prospective, open, mono-center, randomized, two part study with 4-way cross-over design in
      each study part.

      The objective of the study is to investigate blood glucose levels after oral intake of
      defined amounts of lactulose.
    


Intervention name(s): Lactulose crystals 10 g; Lactulose crystals 20 g; Lactulose liquid 10 g; Lactulose liquid 20 g; Oral glucose 20 g; Still water
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.; White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.; Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.; Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.; White crystalline powder used as food ingredient. To standardise for 20 g glucose, 22 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.; Still water will be used. Water from the same source will be also used to dissolve investigational and control products.
Other intervention name(s): glucose monohydrate
Intervention MeSH terms: Methamphetamine; Lactulose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Blood glucose level; Oral intake; Lactulose; Healthy volunteers
Salbutamol, Pharmacogenetics and Breathing Mechanics
Condition: Bronchoconstriction; Inhaled Salbutamol; Cycling Performance
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 4

Summary: 
      Athletes using asthma medications called β2-agonists win a disproportionately high number of
      medals at Olympic Games. Due to a large variety in the genes that affect how individuals
      respond to β2-agonists, the investigators will look at variations in the genetic response to
      these medications by dividing athletes into high-responders and low-responders. The
      investigators will then compare athletic performance after the inhalation of β2-agonists to
      placebo. Furthermore, the investigators will analyze the effect of β2-agonists on breathing
      mechanics. Due to differences in their anatomy females may decrease the energy needed for
      breathing during high-intensity exercise to a greater extent compared to male athletes after
      the inhalation of β2-agonists.
    


Intervention name(s): Salbutamol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 60 minutes prior to the start of a 10km cycling time trial on a bike ergometer, subjects will inhale either 400ug of salbutamol 1600ug of salbutamol or 400ug of placebo in a randomly assigned manner in a single dose.
Other intervention name(s): ventolin
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: exercise-induced bronchoconstriction (EIB); inhaled salbutamol; performance enhancing; cycling
Transplantation of Autologous Peripheral Blood Mononuclear Cells for Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      To assess the safety of peripheral blood mononuclear cell transplantation into the
      subarachnoid space for the treatment of amyotrophic lateral sclerosis.
    

Detailed description: 
      Amyotrophic lateral sclerosis (ALS) is a rapidly evolving, fatal neurodegenerative disease
      resulting from the degeneration of cortical, bulbar and spinal motor neurons. The disease
      progresses inexorably to death, usually because by failure of respiratory function, with a
      median duration of 3 years.

      Recent clinical trials using various types of stem cells, including mesenchymal stromal
      cells, neural stem cells, and peripheral blood mononuclear cells (PBMCs), represent promising
      strategies for stem cell-based treatment in ALS. It has been demonstrated that the
      inflammation and neuronal death were reduced in ALS patients after bone marrow
      transplantation. In addition, the incidence of immune response was decreased by autologous
      transplantation of bone marrow cells in ALS patients. PBMCs are multi-potent stem cells that
      are very attractive for a cell therapy approach in ALS because of their plasticity and
      ability to provide the host tissue with growth factors or modulate the host immune system.
      PBMCs were used clinically and few adverse effects were attributed to their administration.
      Early clinical investigations indicated that the transplantation of autologous PBMCs into the
      dura is feasible in ALS patients; however, one study was limited to three patients and the
      other recruited eight patients. There are still many questions regarding the intrathecal
      transplantation of PBMCs for ALS. Therefore, a retrospective study was performed to assess
      further the safety and efficacy of the procedure and to test the impact of a cell therapy
      approach in ALS patients.

      Statistical analysis Data, expressed as the mean ± SD, were analyzed using SPSS version 17.0
      for Windows (SPSS Inc., Chicago, IL, USA). Statistical analyses were performed by paired
      sample t-test. A value of P < 0.05 was considered statistically significant.
    

Intervention name(s): PBMC autotransplantation
Intervention type(s): Biological
Intervention description(s): Fourteen amyotrophic lateral sclerosis (ALS) patients are received peripheral blood mononuclear cell (PBMC) autotransplantation.
Intervention model: Single Group Assignment
Intervention model description: 14 patients conducted at the First Affiliated Hospital of Dalian Medical University, China were eligible if they had definite or probable sporadic amyotrophic lateral sclerosis (ALS).
Masking: None (Open Label)
Primary purpose: Treatment
CHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial
Condition: Transient Hypertension, Pregnancy
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional

Summary: 
      Prior to undertaking CHIPS which will be a large and difficult trial, we believe we need to
      first determine whether clinicians will comply with the interventions of 'less tight' and
      'tight' control of dBP, and whether the interventions will result in differences in mean dBP
      between groups. A pilot will also allow us to confirm the ability of centres to identify
      eligible women and the willingness of women to join CHIPS.
    

Detailed description: 
      To determine whether 'less tight' control of mild-moderate non-proteinuric maternal
      hypertension, aiming for a diastolic blood pressure (dBP) of 100mmHg, can decrease the risks
      of adverse perinatal outcome without increasing maternal risk compared with 'tight' control,
      aiming for a dBP of 85mmHg.
    

Intervention name(s): Randomized to either a 'less tight' group or a 'tight' group
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; blood pressure; pregnancy
A DEXA Clinical Study to Evaluate the Osteointegrative Potential of Trabecular Titanium™
Condition: Primary Total Hip Replacement
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to evaluate the osteointegrative potential of the
      Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD)
      around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months
      after surgery.
    


Intervention name(s): Delta TT acetabular cup
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Safety and How the Body Affects a Drug (CNTO 1959) in Healthy Volunteers and in Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and how the body affects a drug (CNTO
      1959) in healthy volunteers and in patients with psoriasis.
    

Detailed description: 
      CNTO 1959 is an experimental drug. In this study, CNTO 1959 will be tested to see if it may
      be useful in treating psoriasis. This disease causes inflammation of skin and nails. This is
      a Randomized (study drug assigned by chance), Double-blind (neither physician nor patient
      knows the name of the assigned drug), Placebo-controlled study of the experimental drug CNTO
      1959 in both healthy patients as well as patients with psoriasis. This study will compare the
      effects (both good and bad) of CNTO 1959 to those of placebo. The purpose of this study is to
      evaluate the safety and potential side effects of CNTO 1959 given to healthy volunteers and
      patients with moderate to severe psoriasis. In addition, the investigators will measure how
      much study drug is in the blood following a dose of CNTO 1959, and determine if the body
      makes antibodies to it. (An antibody is a protein made by the body in response to a foreign
      substance). Safety assessments will be performed throughout the study and include obtaining
      and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and
      severity of adverse events. This is the first time that CNTO 1959 will be studied in humans.
      There will be 2 parts to this study. The first part of this study will involve healthy
      volunteers, and the second part of the study will involve patients with psoriasis. About 47
      healthy volunteers and 24 patients with moderate to severe psoriasis will take part in the
      study. Enrollment for the healthy volunteer part is closed as of 23SEP09. CNTO 1959 will be
      administered as either an intravenous (IV) infusion or subcutaneous (SC) injection. Duration
      of participation may be up to 28 weeks.
    

Intervention name(s): CNTO 1959; Placebo
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: CNTO 1959; Healthy Volunteers; Psoriasis
Evaluating the Comparative Pharmacokinetics of Nicotine After Administration Via JUUL or Tobacco Cigarettes
Condition: Nicotine Administration & Dosage; E-cigarettes; Vaping; E-Liquid; Tobacco Smoking
Study type: Interventional

Summary: 
      This is an observational, crossover design that will examine the pharmacokinetics and
      pharmacodynamics of impact of smoking tobacco cigarettes or vaping the JUUL electronic
      cigarette.
    

Detailed description: 
      The goal of this study is to better understand the pharmacokinetic and pharmacodynamics
      responses produced by the JUUL e-cigarette, compared to tobacco cigarettes, in e-cigarette
      and tobacco cigarette smokers.

      Specific Aim #1- To categorize the nicotine pharmacokinetic (PK) profile (maximum plasma
      concentration; time to maximum plasma concentration and area under the concentration-time
      curve) and compare when using the JUUL e-cigarette vs. a tobacco cigarette in a standardized
      manner.

      Specific Aim #2- To categorize the nicotine PK profile (maximum plasma concentration; time to
      maximum plasma concentration and area under the concentration-time curve(AUC)) and compare
      when using the JUUL e-cigarette vs a tobacco cigarette when using the product ad libitum.

      Specific Aim #3- To evaluate various outcomes following JUUL e-cigarette or tobacco cigarette
      use, both with standardized and ad lib use including: heart rate, plasma catecholamines,
      pulmonary function testing.

      Specific Aim #4- To evaluate and compare the effects on craving, reward and satisfaction when
      using the JUUL e-cigarette vs. tobacco cigarette.
    

Intervention name(s): JUUL; Tobacco
Intervention type(s): Other; Other
Intervention description(s): Electronic Cigarette; Tobacco Cigarette
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Mifamurtide (L-MTP-PE) for High-Risk Osteosarcoma
Condition: Osteosarcoma
MeSH terms: Osteosarcoma
Study type: Observational

Summary: 
      The purpose of this study was to collect information regarding the safety and tolerability of
      mifamurtide (liposomal muramyl tripeptide phosphatidyl ethanolamine; L-MTP-PE).
    

Detailed description: 
      The drug being tested in this study is called mifamurtide (L-MTP-PE; liposomal muramyl
      tripeptide phosphatidyl ethanolamine). Mifamurtide is being used to treat people with
      osteosarcoma, a form of cancer.

      This was a patient-access study that looked at adverse events, disease progression, and
      overall survival in study participants.

      The study enrolled 205 patients, of whom 204 were treated with mifamurtide intravenously at a
      dose of 2 mg/m2 twice weekly (at least 3 days apart) for 12 weeks, and then weekly for an
      additional 24 weeks, for a total of 48 doses in 36 weeks (following surgery for primary or
      metastatic disease).

      This study was conducted in the United States. Participants could receive treatment for up to
      9 months. This study was previously mis-categorized as an interventional study.
    

Intervention name(s): Mifamurtide (L-MTP-PE)
Intervention type(s): Drug
Intervention description(s): Solution for intravenous infusion
Other intervention name(s): Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine
Intervention MeSH terms: Mifamurtide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Had diagnosis of high grade osteosarcoma with relapsed or recurrent disease, locally or
        metastatic, with disease not completely resectable or who were unable to complete
        recommended chemotherapy due to toxicity: relapse, recurrence local or metastatic; unable
        to have standard surgical resection; abbreviated chemotherapy regimen secondary to
        toxicity.
      
Keywords: Drug Therapy
Can Oxytocin Enhance the Placebo Effect?
Condition: Oxytocin Effect on Memory Performance During Phase 1; Oxytocin Effect on Memory Performance During Phase 2; Oxytocin Effect on Memory Performance During Phase 3; Oxytocin Effect on Memory Performance During Phase 4
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study aimed to investigate whether oxytocin (OXT) had effect on placebo effect.
    

Detailed description: 
      The current study included three phases to investigate oxytocin effect on placebo effect:

        1. In a double-blind, between-subject, placebo controlled design study to investigate the
           intranasal OXT (24IU) treatment in 66 healthy male subjects using working memory task.

        2. In a single-blind(subjects were informed that the treatment was oxytocin),
           between-subject, placebo controlled design study to investigate the intranasal OXT
           (24IU) treatment in 53 healthy male subjects using working memory task.They were
           informed that oxytocin would increase memory perfomance by a female experimenter.

        3. In a single-blind(subjects were informed that the treatment was oxytocin),
           between-subject, placebo controlled design study to investigate the intranasal OXT
           (24IU) treatment in 53 healthy male subjects using working memory task. But the subjects
           were told that oxytocin would decrease the performance by the same female experimenter.

        4. In a single-blind(subjects were informed that the treatment was oxytocin),
           between-subject, placebo controlled design study to investigate the intranasal OXT
           (24IU) treatment in 52 healthy male subjects using working memory task. The subjects
           were told that oxytocin would increase the performance by a male experimenter.

      Memory performance was included as dependant factor. All subjects completed a range of
      questionnaires measuring personality and affective traits and levels of anxiety: State-Trait
      Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Interpersonal Trust Scale(ITS).
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Placebo effect; Working memory
Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the number of men who have suppression of sperm production when using a daily
      regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel applied transdermally.
    


Intervention name(s): Testosterone; Nestorone®; Nestorone®; Nestorone®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.; Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.; Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.; Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Intervention MeSH terms: ST 1435; Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Contraception; Male Contraception; Suppression of Sperm Production