bioihbjkbjnl/mcl2 huggingface dataset:
A Pharmacokinetic Study of Minocycline in Male and Female Volunteers
Condition: Acne
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101
      4% foam product in male and female some of which are with acne
    

Detailed description: 
      This is an open-label, single-center, non-randomized, multiple-administrations study in males
      and females, some of which are with acne.

      Twelve (12) subjects will be enrolled to receive a daily dose of topical FMX-101 minocycline
      (4%) foam for sixteen consecutive days.

      Each subject will undergo screening procedures within 21 days prior to dosing, to assess his
      eligibility to participate in the study, including a dermatological assessment of the acne
      severity and distribution (for subjects with acne).

      On Days 1, 2, 3, 7, 9, 11, 14, 16 and 17 blood will be drawn for PK An End-of Study/Safety
      Follow-up visit will take place on 7-10 days after last dose, which will also include a
      dermatological assessment of response to treatment
    

Intervention name(s): FMX101, Minocycline 4% foam
Intervention type(s): Drug
Intervention description(s): FMX101, Minocycline 4% foam to be applied twice daily for 16 consecutive days
Other intervention name(s): FMX101 antibiotic foam
Intervention MeSH terms: Anti-Bacterial Agents; Minocycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether perampanel alters the response to alcohol
      for heavy drinkers. It is hypothesized that perampanel will reduce the rewarding and
      reinforcing properties of alcohol in the laboratory setting.
    

Detailed description: 
      The main goal of the proposed study is to determine whether the
      alpha-amino-3-hydroxy-5-methyl-4-isoxazoleproprionic acid receptor (AMPA-R) antagonist
      perampanel alters the response to ethanol (i.e., the rewarding and reinforcing effects) using
      a validated laboratory paradigm of intravenous (IV) ethanol infusion. Fifty non-treatment
      seeking heavy drinkers (NTSHDs), N=50, and twenty-five social drinkers (N=25) will undergo
      three test days each: once after receiving a placebo medication, once after receiving
      moderate dose perampanel, and once after receiving a higher dose of perampanel. This
      experiment is the first step in a series of expedient studies that will rapidly determine
      perampanel's potential as a treatment for alcohol dependence. If findings show perampanel
      reduces the rewarding and reinforcing properties of alcohol in the laboratory setting (in
      humans), it would provide a strong rationale for clinical treatment trials with this
      medication. This approach is innovative because it tests a highly novel AMPA-R antagonist for
      the treatment of alcoholism, and uses a state-of-the-art computer assisted IV alcohol pump
      infusion system (called CAIS) to reduce variability in blood alcohol concentrations, thus
      improving the data quality.
    

Intervention name(s): Perampanel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.; Placebo given in place of perampanel during the pre-treatment period and lab session days.
Other intervention name(s): AMPA-R antagonist; anticonvulsant
Intervention MeSH terms: Anticonvulsants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alcoholism; Heavy Drinking; Perampanel
ACT and Virtual Reality for Public Speaking Fear
Condition: Public Speaking Fear
Study type: Interventional

Summary: 
      Investigation of Acceptance and Commitment Therapy (ACT) for the psychological treatment of
      public speaking fear. Two ACT-based treatment delivery modalities (in vivo exposure vs.
      virtual reality) were compared.
    

Detailed description: 
      After being informed about the study, all patients giving written informed consent will be
      assessed to determine eligibility for study entry.

      The clinical trial will include a control group (waiting list).

      Patients who meet eligibility requirements will be assigned to a waiting list, in vivo
      exposure and Virtual Reality.

      Psychological intervention consisted in a 5-session individual face-to-face delivered
      ACT-based treatment.

      The participants will be assessed through self-report instruments and observational
      measurements before and after treatment and at 3 months follow-up.
    

Intervention name(s): ACT; In vivo exposure:; Virtual Reality
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Acceptance and Commitment Therapy methods were focused on promoting Values clarification, Acceptance, Cognitive defusion, Committed action and Flexible attention to the present moment, and included 'The dreamed professional exercise' -variation on '"imagine your funeral" exercise'-, Ship's captain metaphor, Imaginal exposure, Physicalizing exercise, and Watching thoughts as graffiti.; The audience was made up of university students. Every session included a 12 minute oral presentation. Participants were asked to improvise a talk about a new topic (e.g. violence against women, education system in Spain…). Participants had 3 minutes to prepare their speech. Difficulty increased based on each participant's pre assessment (topics and distractors as ringtones, audience whispering...); Virtual reality was delivered through Psious platform distributed in Spain by TEA and through a Virtual Reality equipment that included a Samsung S7 mobile and Samsung Gear VR glasses.
Every session included a 12 minute oral presentation. Participants were asked to improvise a talk about a new topic (e.g. violence against women, education system in Spain…). Participants had 3 minutes to prepare their speech. Difficulty increased based on each participant's pre assessment (topics and distractors as ringtones, audience whispering...)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization assigned participants to 3 arms:
in vivo exposure
virtual reality
waiting list
Masking: Single (Participant)
Primary purpose: Treatment
The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy
Condition: Breast Diseases
MeSH terms: Breast Diseases
Study type: Interventional

Summary: 
      To delineate if the chemical composition (lipid and water) in the presumably normal breast of
      the high risk women is different from those of the low risk group.
    

Detailed description: 
      The researchers would like to investigate and compare the chemical composition in the normal
      breast between high risk women and general population.
    

Intervention name(s): proton magnetic resonance spectroscopy
Intervention type(s): Procedure
Intervention description(s): proton magnetic resonance spectroscopy was performed for the normal breast to evaluate the chemical composition of breast
Other intervention name(s): proton MRS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Breast diseases; magnetic resonance spectroscopy
A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate and compare the pharmacokinetic profile of
      Medroxyprogesterone acetate following subcutaneous administration of 3 different doses of
      TV-46046 and a dose of Depo-subQ Provera in healthy female participants.

      The secondary objectives of the study are to evaluate and compare the safety, local
      tolerability, and acceptability of a subcutaneous injection of 3 different doses of TV-46046
      and a dose of Depo-subQ Provera in healthy female participants.

      The total duration of the study for each participant is expected to be up to 19.5 months.
    


Intervention name(s): TV-46046; Depo-subQ Provera
Intervention type(s): Drug; Drug
Intervention description(s): SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL); SC injection of 104 mg/0.65 mL
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Pharmacokinetics
Pharmacokinetic Interaction Between TRUVADA™ and BILR 355 BS Plus Ritonavir in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the pharmacokinetic effect of BILR 355 + ritonavir® on TRUVADA and TRUVADA
      on BILR 355
    


Intervention name(s): BILR 355 BS; Ritonavir; TRUVADA
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research is to study the safety and effectiveness of bilateral
      stimulation of the anterior nucleus of the thalamus as adjunctive therapy for reducing the
      frequency of seizures in adults diagnosed with epilepsy characterized by partial-onset
      seizures, with or without secondary generalization, that are refractory to antiepileptic
      medications.
    

Detailed description: 
      Medtronic, Inc. is sponsoring an investigational study of the Medtronic DBS Therapy for
      epilepsy, the company's deep brain stimulation (DBS) therapy for patients with refractory
      epilepsy. Epilepsy is a condition that affects 2.3 million Americans, and about one-third of
      these patients are refractory, or continue to experience seizures despite a wide range of
      treatment options.

      The prospective, randomized, double-blind trial uses existing technology to test whether
      bilateral stimulation of the anterior nucleus of the thalamus can safely and effectively
      reduce seizure frequency in patients with epilepsy. It includes enrollment of 157 patients at
      17 sites in the U.S. 110 patients were implanted and monitored for 13 months following
      implant, with long-term follow-up until the device is approved or the study is stopped. 109
      of the 110 implanted subjects were randomized to Active stimulation or Control.

      Patients in the active group, who received neurostimulation, were monitored for a reduction
      in seizure rates compared to the control group, who did not receive neurostimulation during
      the three-month double-blind phase. After the double-blind phase, all patients received
      neurostimulation.

      Candidates for the trial were adults with partial-onset epilepsy for whom at least three
      antiepileptic drugs have proven ineffective. They were to have had an average of six or more
      seizures per month. Candidates continued to receive their epilepsy medications while
      participating in the trial.

      Deep brain stimulation therapy has already received approval in the United States, Europe,
      Canada, and Australia for the treatment of Essential Tremor and Parkinson's disease. Deep
      brain stimulation is not approved in the United States for the treatment of epilepsy.
    

Intervention name(s): Medtronic DBS Therapy for epilepsy; Medtronic DBS Therapy for epilepsy
Intervention type(s): Device; Device
Intervention description(s): Stimulation On; Stimulation Off
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Deep brain stimulation, DBS, SANTE
Effective Dose of Remimazolam for Sedation in Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia
Condition: Remimazolam; Orthopedic Procedures; Sedatives; Anesthesia, Spinal
Study type: Interventional
Phase: Phase 4

Summary: 
      Currently used drugs for monitored general anesthesia include propofol, midazolam, and
      dexmedetomidine. Each drug has diﬀerent advantages and disadvantages. Remimazolam causes a
      relatively small decrease in blood pressure, and it has no injection pain. In addition,
      remimazolam has a very short onset time, and even after the continuous infusion, the onset of
      remimazolam is fast, and even after continuous injection, the eﬀect disappeared very quickly
      due to the short context-sensitive half time. and through continuous infusion, the patient's
      depth of anesthesia can be maintained constant. In addition, the short duration of action and
      the ability to quickly reverse the eﬀect of ﬂumazenil suggest that remimazolam can be used
      eﬀectively under general anesthesia as well as under general anesthesia. Remimazolam can be
      used as a continuous infusion for general anesthesia. However, it has also been reported to
      be used for sedation by continuous infusion or divided intravenous infusion. However, the
      eﬀective infusion dose of remimazolam for supervised general anesthesia without mechanical
      ventilation has not been established.

      In this study, the ED90 of the maintenance dose that maintain loss of consciousness in
      patients when supervised general anesthesia is performed through continuous infusion of
      remimazolam after spinal anesthesia is obtained.
    


Intervention name(s): Remimazolam
Intervention type(s): Drug
Intervention description(s): Remimazolam The starting dose of remimazolam is 1 mg/kg/hr. If sedation does not proceed successfully, increase the infusion rate by 0.2 mg/kg/hr in the next patient. (However, if the infusion rate is less than 0.6mg/kg/hr, the dose is increased by 0.1mg/kg/hr.) If sedation has progressed successfully until the end of surgery, the next patient will use the same dose with a probability of 0.89 or 0.11 It is reduced by 0.2 mg/kg/hr with a probability of (However, if the infusion rate is 0.6mg/kg/hr or less, reduce it by 0.1mg/kg/hr.)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oligopin Supplementation and Bone Turnover Markers and Antioxidant Changes in Postmenopausal Osteopenic Women
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 3

Summary: 
      Osteoporosis fractures impose a significant economic burden on the health system. There is
      evidence that osteoporosis has a high prevalence in Iran (4.8% for men and 7.7% for women),
      and the frequency of osteopenia is 36.8% for men and 39.3% for women in Iran Accordingly, the
      prevention of osteopenia progression towards osteoporosis has been considered as an important
      issue in medicine. Bone is a dynamic tissue that is constantly being remodeled thus the
      equilibrium between bone formation and resorption done by simultaneously regulating
      osteoclasts and osteoblasts is important. Imbalance between bone deposition and resorption
      contributes to reducing bone mineral density and hence increasing the risk of osteoporosis

      Recently, new therapies have been focused on use of medicinal herbs, especially
      phytochemicals. Among phytochemicals, phytonutrients, and especially polyphenols, can act
      both on osteoblast and on osteoclast.

      Pine bark extract (oligopin) is a rich source of polyphenols that exerts strong antioxidant
      and anti-inflammatory activities. It has also beneficial effects on bone turnover based on in
      vitro studies and animal models. Investigators aimed to investigate the effects of oligopin
      on bone turnover markers and plasma and peripheral mononuclear cells oxidative stress in
      postmenopausal women with osteopenia in a double-blind randomized clinical trial.
      Participants are forty four women with osteopenia divided into two groups randomly (22,
      having oligopin, 150 mg, once daily, for 12 weeks). The 2nd group (22 women with osteopenia)
      receives the same amount of the placebo. At the first and the end of the study, blood sample
      are taken to measure in order to peripheral blood mononuclear cells isolation and plasma
      separation. The levels of bone alkaline phosphatase and carboxy terminal collagen type I in
      plasma oxidative stress markers such as total anti-oxidant capacity, malondialdehyde, and
      protein carbonyl were evaluated. Furthermore, oxidative stress will be evaluated in
      peripheral blood mononuclear cells by measurement of expression and activity of magnesium
      superoxide dismutase,catalase and Nuclear factor (erythroid-derived 2)-like 2.
    


Intervention name(s): Oligopin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oligopin ,150 mg ,once daily, 12 week; Placebo,150 mg ,once daily, 12 week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: osteopenia; oligopin; postmenopause; antioxidant; bone
Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int
Condition: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
MeSH terms: Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I trial to determine the maximum tolerated dose/maximum feasible dose
      (MTD/MFD) of a single infusion of FATE-NK100 via intra-peritoneal catheter in women with
      recurrent ovarian, fallopian tube or primary peritoneal cancer meeting one of the following
      minimal prior treatment requirement:

        -  Platinum resistant: may receive FATE-NK100 as 2nd line (as 1st salvage therapy).
           Platinum resistant is defined as disease that has responded to initial chemotherapy but
           demonstrates recurrence within a relatively short period of time (< 6 months) following
           the completion of treatment.

        -  Platinum sensitive: may receive FATE-NK100 as 3rd line therapy (as 2nd salvage therapy).
           Platinum sensitive is defined as the recurrence of active disease in a patient who has
           achieved a documented response to initial platinum-based treatment and has been off
           therapy for an extended period of time (≥ 6 months).
    


Intervention name(s): FATE-NK100; Interleukin-2
Intervention type(s): Biological; Drug
Intervention description(s): FATE-NK100 Infusion (Day 0)
The FATE-NK100 product will be placed in approximately 100 cc of 5% human serum albumin.
Dose Level 1: 1 x 10^7 cells/kg IP
Dose Level 2: >1x10^7 cells/kg to ≤3x10^7 cells/kg
Dose Level 3: Complete FATE-NK100 bag (≥3 x 10^7 to ≤ 10 x 10^7 cells/kg); Interleukin-2 (begin Day 0): 6 million units three times a week for a total of 6 doses. For patients weighing less than 45 kilograms, the IL-2 will be given at 3 million units/m2 three times a week for 6 doses.
The 1st dose will be given immediately (within 30 minutes) after the FATE-NK100 cell infusion on Day 0 as an inpatient. The remaining doses will be given in an outpatient setting.
Other intervention name(s): IL-2
Intervention MeSH terms: Interleukin-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent; Platinum Resistant; Platinum Sensitive
Intradermal Rabies Immunization Using NanoJect: A Comparative Study
Condition: Intradermal (ID) Vaccination Device
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is planned as a single-center, randomized, double-blind placebo-controlled,
      comparative Phase I, first-in-man study to assess the safety and tolerability of the
      NanoJect™ device, and the immunogenicity of the rabies vaccine "Vaccin rabique Pasteur®"
      delivered with the NanoJect™ device by ID route.
    

Detailed description: 
      This study will enroll 66 volunteers randomly assigned to one of the three study arms. Each
      volunteer will receive three injections at each of three vaccination visits. Total study
      duration per volunteer is 2 months.
    

Intervention name(s): NanoJect device (DebioJect™); Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus); Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus); Vaccin rabique Pasteur®; Placebo
Intervention type(s): Device; Device; Device; Drug; Drug
Intervention description(s): The investigational device used in this study is the NanoJect™ device developed by Debiotech company.; The comparator device used for standard ID injections is a classical syringe (1mL BD Luer-Lock™) with a 25G needle (Terumo® Neolus); The comparator device used for standard IM injections is a classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus); Sodium Chloride (NaCl) 0,9%; B. Braun
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of Fish Oil and Vitamin C on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      Combining fish oil and vitamin C supplementation will provide a greater anti-inflammatory
      effect against developing exercise-induced bronchoconstriction (EIB) than either nutritional
      supplement alone.
    

Detailed description: 
      The aim of this study is to extend previous findings that nutritional supplementation or
      dietary modification can ameliorate exercise-induced bronchoconstriction. It has been shown
      in separate studies that fish oil and ascorbic acid (vitamin C) individually protect against
      EIB by improving pulmonary function and reducing airway inflammation. The main aim of this
      study is to determine the comparative and additive effects of fish oil and ascorbic acid
      supplementation on EIB and airway inflammation in asthmatic individuals.
    

Intervention name(s): Fish Oil; Ascorbic Acid; Fish Oil Placebo; Ascorbic Acid Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 10 fish oil (3.2g EPA + 2.0g DHA) capsules per day for 3 weeks; 2 pharmaceutical grade ascorbic acid (1500mg) capsules per day for 3 weeks; 10 placebo fish oil (soy bean oil) capsules per day for 3 weeks; 2 placebo ascorbic acid (sucrose) capsules per day for 3 weeks
Other intervention name(s): Vitamin C; Soy Bean Oil; Table Sugar
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Exercise-Induced Bronchoconstriction; Inflammation; Airway; Fish Oil; Ascorbic Acid