bioihbjkbjnl/mcl2 huggingface dataset:
Open Label Pilot Study of Perampanel for the Treatment of Alcohol Use Disorder
Condition: Alcohol Disorders
MeSH terms: Alcoholism; Alcohol-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to test the safety, tolerability, and effectiveness of
      the drug Perampanel when used in persons who drink and wish to stop drinking. Perampanel has
      been approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures
      but has not yet been approved to treat alcohol use disorders. For this reason, it is
      considered an investigational drug. Some people in this study will receive Perampanel alone
      and some people will receive Perampanel and Disulfiram, this will be determined by the
      pharmacy.
    

Detailed description: 
      Participants will be asked to take a medication (Perampanel or Perampanel + Disulfiram) every
      day for approximately 8 weeks and have weekly study visits. At these visits, participants
      will be asked questions about their medical history, drinking behavior and life events, have
      bloodwork checked routinely, have regular medication counseling, and perform some computer
      tasks. Throughout the study, there will be regular phone calls from staff. Participants will
      also be asked to use a device called "Soberlink" which is like an at-home breathalyzer test
      to help track progress throughout the study.

      Participants will be randomly assigned (like the flip of a coin) to receive either Perampanel
      alone or Peramanel and Disulfiram.

      Participation in this study will last up to 10 weeks. Approximately 20 individuals will
      participate in this study.

      This study will sequence all or part of participant's DNA. This is a necessary part of the
      study.

      Before starting the study, participants may be referred to an alcohol detoxification program
      (medical treatment of an alcoholic), if clinically indicated.
    

Intervention name(s): Perampanel Tablet; Disulfiram
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups; Disulfiram will be kept at 250mg daily
Intervention MeSH terms: Disulfiram
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 20 subjects with AUD will be randomized 1:1 to one of two groups; perampanel by itself, and perampanel combined with disulfiram.
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Vivatlac Baby on Crying Behavior of Colicky Babies
Condition: Infantile Colic
MeSH terms: Colic
Study type: Interventional
Phase: Phase 2

Summary: 
      Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in
      babies diagnosed for infantile colic.
    

Detailed description: 
      Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria.
      Study design will be open label with two parallel arms (Simethicone and Vivatlac Baby).
      Vivatlac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3
      bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental
      24h paper diaries.
    

Intervention name(s): Simethicone Solution; Vivatlac Baby
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Oral daily treatment for four weeks; Oral daily treatment for four weeks
Other intervention name(s): Simethicone; Multistrain Synbiotic
Intervention MeSH terms: Simethicone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Hepatic Impairment on Aprocitentan Pharmacokinetics
Condition: Hepatic Impairment; Healthy Subjects
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, open-label, single-dose, Phase 1 study, to assess the effect of
      moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of aprocitentan
      (ACT-132577).
    


Intervention name(s): Aprocitentan
Intervention type(s): Drug
Intervention description(s): A single oral dose of 25 mg.
Other intervention name(s): ACT-132577
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Healthy subjects will be matched to subjects with moderate hepatic impairment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Liver Diseases
First-in-human Study With Ascending Single Intra-articular Doses of GZ389988 in Patients With Painful Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the safety and tolerability of ascending single intraarticular doses of GZ389988 in
      patients with painful osteoarthritis (OA) of the knee.

      Secondary Objectives:

      To assess the pharmacokinetic (PK) parameters of ascending single intraarticular doses of
      GZ389988 in patients with painful OA of the knee.

      To obtain preliminary pharmacodynamic evaluation of ascending single intraarticular doses of
      GZ389988 in patients with painful OA of the knee.
    

Detailed description: 
      Screening will be performed within 28 days of dosing. Following the single dose of study
      medication, the study period for each patient will be 84 ± 7 days up to the end-of-study
      visit.

      Total duration for one patient will be up to 17 weeks (up to the end-of-study visit), not
      including the long term observational safety follow-up by phone call for 12 additional weeks.
    

Intervention name(s): placebo; GZ389988
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:solvent for parenteral use
Route of administration: intraarticular; Pharmaceutical form:suspension for injection
Route of administration: intraarticular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Phase Ib)
Condition: Polio
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this phase Ib study is to evaluate the safety of a Sabin Inactivated
      Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in
      infants. 20 adults aged 18~45 years and 20 children aged 4 years were only administered one
      dose of sIPV with high D antigen content. 20 infants aged 2 months (60~90 days) were
      administered three doses of sIPV with high D antigen content, on the month 0, 1, 2 schedule.
      Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination
      to assess the immunogenicity in infants. Adverse events occurring within 30 days after each
      dose were collected to assess the safety.
    

Detailed description: 
      The purpose of this phase Ib study is to evaluate the safety of a Sabin Inactivated
      Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in
      infants. 20 adults aged 18~45 years and 20 children aged 4 years were only administered one
      dose of sIPV with high D antigen content. 20 infants aged 2 months (60~90 days) were
      administered three doses of sIPV with high D antigen content, on the month 0, 1, 2 schedule.
      Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination
      to assess the immunogenicity in infants. Adverse events occurring within 30 days after each
      dose were collected to assess the safety.

      The antigen contents of type I, type II and type III polioviruses in the high-dose Sabin IPV
      were 22 DU, 65 DU and 65 DU. All vaccines were in liquid form, 0.5 ml per dose.
    

Intervention name(s): sIPV
Intervention type(s): Biological
Intervention description(s): The investigational High dosage Sabin IPV was all developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the high dosage Sabin IPV were 22 DU, 65 DU and 65 DU. The vaccine was in liquid form, 0.5 ml per dose.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency
Condition: Urologic Disease
MeSH terms: Renal Insufficiency; Urologic Diseases
Study type: Interventional

Summary: 
      Previous study showed repeated lead chelation therapy significant reduced progressive renal
      insufficiency in patients with chronic renal diseases and high-normal body lead burden in a
      placebo-controlled, randomized, 2-year clinical trial, even factors that influence
      progression, such as blood pressure, the presence or absence of hyperlipidemia, and urinary
      protein excretion were well controlled.Since relative small sample size and short duration of
      follow-up were noted in the previous study, whether repeated lead chelation therapy could
      long-term retard the progression of renal insufficiency remains unknown. Hence, we conducted
      a 51-month placebo-controlled clinical trial to assess the long-term effect of repeated
      chelation in progressive renal insufficiency of patients with high-normal body lead burden.
    


Intervention name(s): calcium disodium EDTA (edetate calcium disodium)
Intervention type(s): Drug
Intervention MeSH terms: Edetic Acid; Calcium; Pentetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Repeated chelation therapy; Progressive renal insufficiency; Body lead burden; Long-term outcome; Glomerular filtration rate
Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)
Condition: Flushing
MeSH terms: Flushing
Study type: Interventional
Phase: Phase 4

Summary: 
      Niacin, or vitamin B3, is known to improve cholesterol disorders and is the most effective
      drug to raise HDL, or the "good cholesterol". The use of niacin has been limited because of a
      peculiar adverse effect referred to as "flushing', which consists of redness, warmth,
      tingling and burning. A recent animal study suggests that flavonoids may prevent flushing due
      to niacin better than drugs like aspirin. The ANTI-FLUSH study is being done to assess
      whether a presently available dietary supplement known as quercetin, which is a flavonoid,
      can reduce the flushing that occurs with niacin. We will also assess whether using quercetin
      to prevent flushing from niacin, can improve how niacin lowers cholesterol.
    

Detailed description: 
      This study involves people between 21 and 75 years. It will be conducted over a period of 8
      weeks, with 4 visits, each separated by 2 weeks. The duration of each visit is 9-10 hours. We
      will test a different dose of quercetin in each visit.
    

Intervention name(s): Quercetin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Quercetin 500, 1000, or 2000 mg PO one time; Placebo PO one time
Other intervention name(s): Isoquercetin
Intervention MeSH terms: Quercetin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Skin; pharmacology; metabolism; lipid
Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
Condition: Leprosy
MeSH terms: Leprosy; Erythema Nodosum
Study type: Interventional
Phase: Phase 2

Summary: 
      Study 2B: Ciclosporin in the management of chronic or recurrent Erythema Nodosum Leprosum
      Aim: To assess the safety, tolerability and efficacy of Ciclosporin in the treatment of
      patients whose ENL is not controlled with standard Prednisolone.

      Objective: A pilot double blind controlled study randomizing patients whose ENL is not
      controlled with standard Prednisolone, and comparing a group treated with Ciclosporin to a
      group treated with additional steroid only.
    

Detailed description: 
      A pilot double blind controlled study randomizing patients whose ENL is not controlled with
      standard Prednisolone, and comparing a group treated with Ciclosporin to a group treated with
      additional steroid only.
    

Intervention name(s): prednisolone; ciclosporin
Intervention type(s): Drug; Drug
Intervention description(s): prednisolone 40mg daily then reducing regimen over 16 weeks; Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
Other intervention name(s): corticosteroids; Cyclosporine; Cyclosporin A
Intervention MeSH terms: Cyclosporine; Prednisolone; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Leprosy; ENL; Erythema Nodosum Leprosum; Prednisolone; Ciclosporin
Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine
Condition: Rapid Sequence Intubation
Study type: Interventional
Phase: Phase 4

Summary: 
      Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs
      of stomach content. It is typically used in acute settings that require acute surgery or in
      prehospital settings, but also in specific risk patients requiring elective surgery. The
      reason for conducting rapid sequence intubation is to minimize the risk of pulmonary
      aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid
      sequence intubation is a procedure with a high risk of complications in itself. The time
      period from induction of anaesthesia to intubation is particularly risky, because the patient
      is apneic. This study addresses this problem by investigating, how quickly spontaneous
      respiration can be reestablished after a rapid sequence intubation when using
      Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended
      to establish a sample size for the full protocol.

      Study hypothesis: The time from correct tube placement to spontaneous respiration is shorter
      when using Rocuronium/Sugammadex compared to Succinylcholine.
    


Intervention name(s): Rocuronium-Sugammadex; Succinylcholine
Intervention type(s): Drug; Drug
Intervention description(s): Rocuronium 1,0 mg/kg is administered iv initially. Upon intubation Sugammadex is administered 16 mg/kg iv.; 1 mg/kg
Other intervention name(s): Esmeron; Bridion; Suxameton; Suxamethon
Intervention MeSH terms: Rocuronium; Succinylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pilot Study of Autologous Ex Vivo Activated NK Cell Infusion in the Treatment of Metastatic Nasopharyngeal Carcinoma
Condition: Metastatic Nasopharyngeal
MeSH terms: Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To demonstrate the feasibility of leukapheresis and ex vivo activation of autologous NK
           cells in patients with metastatic NPC

        2. To demonstrate the safety of low dose systemic IL-2 in combination with escalating doses
           of autologous Ex Vivo Activated NK cells in patients with metastatic NPC

        3. To assess immune measurements such as quantitation of regulatory T cells, EBV specific T
           cells, serum cytokine levels, and NK cell function after treatment with IL-2 and
           autologous Ex Vivo Activated NK cells
    

Detailed description: 
      We are investigating the use of immune cell therapy in metastatic Nasopharyngeal Cancer
      (NPC). Recent small studies have shown that EBV specific cytotoxic T cells can be infused
      into NPC patients with some good clinical effect including tumor responses. We are trying to
      achieve a similar result using a less complex and less costly approach, with Natural Killer
      (NK) cells. NK cells are known to recognize tumor and virally infected cells through a
      variety of mechanisms. Also, NK cells influence the development of antigen-specific T cell
      responses via reciprocal interactions with dendritic cells and the secretion of IFNγ.

      This is a pilot clinical trial to study the feasibility of collecting, manipulating , and
      infusing autologous enriched NK cells activated by short-term incubation in IL-2.
      Leukapheresis units will be collected from eligible patients with NPC. NK cells will be
      selected and activated with IL-2 prior to re-infusion. Patients will receive low dose IL-2
      after infusion of activated NK cells. Post infusion monitoring will include peripheral blood
      T cell subsets, cytokine secretion and serum cytokine levels. The parameters will be
      correlated to clinical observations. If clinical efficacy is shown, our protocol could
      represent a simple way of harnessing the immune system of the patient for treatment of this
      disease. This study will also serve as platform technology development for later trials
      involving manipulating cell therapy products.
    

Intervention name(s): Interleukin, NK cells
Intervention type(s): Drug
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Nicotine on Arousal, Cognition and Social Cognition in Schizophrenic Patients
Condition: Schizophrenia; Cognition Disorders
MeSH terms: Schizophrenia; Cognition Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study in patients with stable schizophrenia will investigate the effect of nicotine on
      arousal, cognitive task and social cognition after acute dose administration.
    

Detailed description: 
      This is a double-blind (neither physician nor patient knows the name of the assigned drug),
      placebo-controlled, randomized (study drug assigned by chance), three-way-crossover trial
      (patients may receive different interventions sequentially during the trial) in patients with
      stable schizophrenia. The three-way-crossover treatment phase will consist of three blinded
      treatment periods separated by a wash out period (the period allowed for the entire
      administered drug to be eliminated from the body) of 2 to 7 days. The study duration for each
      patient will be approximately 8 weeks. Each patient enrolled will be randomized to receive
      Treatment A (1mg nicotine per dosing), Treatment B (2mg nicotine per dosing) or Treatment C
      (placebo) during one of their treatment period. The study drug (nicotine or placebo) will be
      administered three times daily on Day 1 of each treatment phase as a mouth spray, separated 2
      to 3 hours from each other (i.e. 0h; and 2 to 3h; and 4 to 6h post first dosing). Three
      different blocks of cognitive assessments will follow, one after each drug administration.
      Safety evaluations include adverse event monitoring, vital signs and clinical laboratory
      tests. Each patient participating will receive 3 identical study drug administrations per
      dosing day (2 to 3 hours from each other), resulting in an overall dose of 3 mg nicotine
      (Treatment A), 6 mg nicotine (Treatment B) or 0 mg nicotine (Treatment C) per dosing day. By
      the end of the study, after the 3-way crossover, each patient will have received 9 mg
      nicotine via mouth spray.
    

Intervention name(s): A643 (nicotine); A643 (nicotine); placebo
Intervention type(s): Other; Other; Drug
Intervention description(s): 1mg oromucosal nicotine spray- three times daily during each treatment period; 2mg oromucosal nicotine spray- three times daily during each treatment period; placebo - three times daily during each treatment period
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Symptomatic treatment; Cognition; Cognitive deficits; Schizophrenia
Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study will evaluate the safety of an innovative approach expected to be
      disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the
      pancreas. Three doses of the investigational product will be tested in successive cohorts.
      Although safety is the first objective of this study, we will gather efficacy data and
      perform a set of immunological tests to further understand the mechanism of action of this
      new approach in young adults with recent onset type 1 diabetes.
    


Intervention name(s): IMCY-0098; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Small synthetic peptide for SC admin. Solvent: alum hydroxide; Solvent: alum hydroxide
Other intervention name(s): Imotope
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus type 1; Autoimmune disease; Immunotherapy; Diabetes treatment; Residual beta cell function; Adult patients
Integrated Treatment for Cocaine and Mood Disorders - 1
Condition: Cocaine Dependence; Depressive Disorder, Major
MeSH terms: Cocaine-Related Disorders; Depressive Disorder; Mood Disorders; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test whether cognitive behavioral therapy and bupropion
      hydrochloride will help cocaine users, who are depressed, reduce or end their cocaine use and
      improve their mood.
    

Detailed description: 
      The global aim of this study is to evaluate an "integrated" treatment approach for cocaine
      dependent patients with comorbid unipolar depression. It is hypothesized that a
      cognitive-behavioral psychotherapy that targets both disorders, in combination with a
      pharmacotherapy, i.e., bupropion, is expected to provide the best coverage for dual disorders
      and thus maximize treatment outcomes. Specifically, we will conduct a double blind,
      placebo-controlled clinical trial involving the random assignment of participants into one of
      four treatment conditions according to a full 2x2 factorial research design. One independent
      variable will be pharmacotherapy (bupropion versus placebo); the other independent variable
      will be psychotherapy (integrated CBT versus clinical management). The study will enroll 140
      cocaine dependent patients with comorbid major depressive disorder. A secondary objective is
      to further elucidate "primary" and "secondary" paradigms of depressive illness symptoms in
      cocaine-dependent adults and better understand how this distinction influences treatment
      outcome. This will be accomplished by enrolling a subsample of patients with
      substance-induced mood disorder. Taken together, this proposal will examine the feasibility
      and relative efficacy of a novel integrated treatment model for dually-diagnosed patients.
    

Intervention name(s): Bupropion
Intervention type(s): Drug
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cocaine dependence