bioihbjkbjnl/mcl2 huggingface dataset:
Behavioral Treatment of Drug Abuse in Severe and Persistent Mental Illness (SPMI) Patients
Condition: Schizophrenia; Mood Disorders; Substance Dependence
MeSH terms: Substance-Related Disorders; Schizophrenia; Mood Disorders
Study type: Interventional

Summary: 
      The main purpose of this study is to determine if the multifaceted treatment for substance
      abuse in dual disordered patients is more effective in reducing drug use than a supportive
      control treatment. The researchers will also determine if adding a case management component
      (Critical Time Intervention; CTI) to the intervention will increase treatment engagement and
      retention.
    

Detailed description: 
      Drug and alcohol abuse by people with severe and persistent mental illness (SPMI) is one of
      the most significant problems facing the public mental health system. We have been conducting
      a project to develop a multifaceted treatment for substance abuse in dual disordered patients
      (Behavioral Treatment for Substance Abuse in Schizophrenia; BTSAS). Results have shown that
      the treatment is well-accepted by patients and has a significant effect on drug use. While
      BTSAS has been effective at retaining subjects and fostering reduced drug use, a major
      problem that occurred was low rates of engagement. The main purpose of this study is to
      determine if BTSAS is more effective in reducing drug use than a supportive control treatment
      and to determine if adding a case management component (Critical Time Intervention; CTI) will
      increase treatment engagement and retention in BTSAS.
    

Intervention name(s): Behavioral Treatment for Substance Abuse in SPMI (BTSAS); Supportive Treatment in Addiction Recovery (STAR); Critical Time Intervention (CTI)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Multifaceted treatment for substance abuse in dual disordered patients which contains 6 components: 1) a urinalysis contingency to enhance motivation to change and increase the salience of goals; 2) structured goal setting to identify realistic, short term goals for decreased substance use; 3) motivational interviewing to enhance motivation to reduce use; 4) social skills and drug refusal skills to enable development of relationships with people who do not use drugs, and to provide success experiences that can increase self-efficacy for change; 5) education about the reasons for substance use and the particular dangers of substance use for people with SPMI; and 6) relapse prevention training that focuses on behavioral skills for coping with urges and dealing with high risk situations and lapses. BTSAS is specifically structured to reduce the load on memory and attention, and minimize demands on higher level cognitive processes.; Manualized substance abuse treatment as usual; Case management component
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treatment; dual diagnosis
Role of Interleukin-1 in Postprandial Fatigue - The Cheesecake Study
Condition: Postprandial Fatigue
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to investigate, if postprandial fatigue symptoms after ingestion of a
      high-fat, high-carbohydrate meal are regulated by Interleukin (IL)-1 and can be prevented by
      inhibition of IL-1 using a single dose injection of a specific IL-1 receptor antagonist.
    


Intervention name(s): Anakinra; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will receive one single subcutaneous injection of 100mg Anakinra during the study, a total of one injection.; Every subject will receive one single subcutaneous injection of Placebo during the study, a total of one injection.
Other intervention name(s): Kineret; Saline
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Fatigue
Effect of Pioglitazone Therapy for Type 2 Diabetes on Vision
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      We are studying patients with diabetes who under proper medical care and administer an
      approved drug. Our interest is if this drug has any sideeffect on vision and if this drug may
      cause swelling of the retina.
    

Detailed description: 
      To evaluate the safety of pioglitazone treatment for diabetes. Recent reports suggest that
      oral glitazone treatment may cause or exacerbate retinal edema. We hypothesized that
      glitazone treatment may cause subclinical edema evidenced by increased retinal thickness. We
      will conduct a double-masked, prospective safety study of 19 subjects undergoing
      placebo-controlled treatment with pioglitazone. Patient treatment consisted of either insulin
      with placebo or insulin with pioglitazone. The main outcome measures are ETDRS visual acuity
      and retinal thickness measured with optical coherence tomography.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male or female patients with type 2 diabetes mellitus on insulin therapy, 30-75 years of
        age with Hgb 1c values between 7.5 - 10% and a BMI of < 40kg/m2. Patients were enrolled if
        they have been on a stable anti-hypertensive and lipid regimen for 90 days prior to study
        randomization.
      
Keywords: diabetes
Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      Currently, the regional anesthetic standard of care for total knee replacement surgery is
      combined spinal/epidural, with or without a femoral nerve block, or FNB. Lasting
      approximately 18 hours, the FNB works by numbing the femoral nerve (and its branches), which
      is the major nerve controlling the knee joint. The femoral nerve also provides movement and
      sensation. While this regional anesthetic technique offers significant postoperative pain
      relief, it is possible that it may cause muscle weakness and increase patients' recovery
      time. Hence there is a need for an alternative technique, one that may help minimize
      postoperative pain as effectively as the FNB, while not causing weakness of the quadriceps
      muscle.

      The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it
      is hypothesized that by "blocking" or anesthetizing the saphenous nerve with local anesthetic
      closer to where it branches off, the area around and below the knee will feel numb. Yet
      unlike with the FNB, the quadriceps muscle itself will still be able to function.

      Patients will be randomized to receive FNB or saphenous nerve block. Quadriceps strength will
      be tested using a dynamometer before surgery (baseline), 6-8 hours following anesthesia
      administration, and on postoperative days 1 and 2. It is hypothesized that patients who
      receive FNB will experience a 50% decrease in quadriceps strength compared to baseline.
    


Intervention name(s): Study Group: Experimental; Control Group
Intervention type(s): Procedure; Procedure
Intervention description(s): The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).; The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
Other intervention name(s): Saphenous (Adductor Canal) Nerve Block; Femoral Nerve Block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Knee Replacement; Regional Anesthesia; Quadriceps; Muscle Strength; Muscle Strength Dynamometer; Quadriceps muscle strength after regional anesthesia for TKA
A Study to Evaluate Safety, Tolerability and Efficacy of Lytixar™ (LTX-109) on Uncomplicated, Gram-positive, Skin Infection
Condition: Gram-positive, Skin Infections; Mild Eczema/Dermatoses; Atopic Dermatitis
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of Lytixar™ applied
      topically to uncomplicated skin infections.

      Three dose levels of Lytixar™ (1%, 2% and 5%) versus placebo will be tested.
    

Detailed description: 
      Treatment of uncomplicated, Gram-positive, skin infection may include application of
      antiseptics and desiccants, but most importantly topical antibiotics. Guidance on the use of
      antimicrobial therapies has been published, poor prescribing practices still exist which
      facilitate the development of bacterial strains resistant to available therapy. The issue of
      antimicrobial resistance is particularly important for Gram-positive cocci such as
      Staphylococcus aureus and Streptococcus pyogenes. Methicillin-resistant Staphylococcus aureus
      (MRSA) has been a problem for many years in the hospital setting, more recently community
      acquired MRSA (CA-MRSA) has emerged posing additional challenges to physicians managing skin
      infection. The medicinal product under development, Lytixar™, is a synthetic antimicrobial
      peptidomimetic agent with a membrane lysing mode of action. Lytixar™ has demonstrated
      activity against several Gram-positive and Gram-negative bacteria in vitro. The compound
      appears to be equally effective against antibiotic-resistant species such as methicillin
      resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococci (VRE) and
      multi-resistant Pseudomonas isolates. The novel membrane lysing mode of action may result in
      a lower propensity to the development of resistance and to date Lytixar™ demonstrates no in
      vitro target-specific cross-resistance with other classes of antibiotics.
    

Intervention name(s): LTX-109
Intervention type(s): Drug
Intervention description(s): Topical administration. 3 times daily. 5 days.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Uncomplicated skin infections; Impetigo; Gram-negative; Diagnosis of uncomplicated, Gram-positive, skin infection. This may include patients with mild eczema/dermatoses such as atopic dermatitis.; Gram-positive organisms which in the opinion of the investigator are causative for infection of the lesion(s),
To Compare lidocaine2%/Clonidine in Combination, With Bupivacaine 0.5 % Alone in Equal Volumes for Combined Sciatic-saphenous Nerve Block in Terms of Selectivity of Blockade
Condition: Bimalleolar Fractures of the Ankle.; Sciatic Nerve Block.; Saphenous Nerve Block.; Post Operative Analgesia Duration.
MeSH terms: Ankle Fractures
Study type: Interventional
Phase: Phase 4

Summary: 
      Clonidine as an adjuvant to local anaesthetics prolongs the postoperative analgesia. It is
      predominantly an alpha 2 agonist, but does have some alpha 1 activity. Clonidine alone
      produces analgesia. When administered centrally its effects are predominantly due to its
      alpha 2 activity. When administered peripherally it prolongs the analgesia through its
      vasoconstrictor effects and by reducing the clearance of local anaesthetic. Another
      possibility is that it prolongs analgesia of peripheral nerve blocks due to a
      hyperpolarisation current .Clonidine has been used successfully both for upper and lower limb
      blocks. Studies of clonidine for lower limb blocks have produced equivocal results . A major
      concern with the lower limb blocks is the risk of falls associated with prolonged motor
      blockade during early mobilisation. Clonidine has been shown to intensify and prolong the
      motor blockade produced by long acting local anaesthetics. Lidocaine when used in combination
      with clonidine can increase the duration of analgesia to 8-18 hrs. Greater doses of clonidine
      are associated with longer analgesia but with more side effects. Clonidine in a dose of 90
      mcg administered with local anaesthetics can produce analgesia for up to 10 hrs with minimal
      side effects. The aim of this study is to compare lidocaine 2% + clonidine 1.5mcg/kg with
      bupivacaine alone in terms of block selectivity for combined sciatic -saphenous nerve block
      in patients under going semi elective foot/ankle procedures.
    


Intervention name(s): Bupivacaine; Lidocaine
Intervention type(s): Drug; Drug
Other intervention name(s): 0.5% bupivacaine, marcaine.; 2% lidocaine + 1.5 mcg/kg clonidine
Intervention MeSH terms: Lidocaine; Clonidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: local anaesthesia; analgesia; bupivacaine; lidocaine; clonidine; sciatic nerve; saphenous nerve
Safety Study on IdeS in Healthy Volounteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in man study to assess safety and tolerability of the IgG cleaving enzyme
      Immunoglobuli G degrading enzyme of streptococcus pyogenes (IdeS).
    

Detailed description: 
      A phase I study (11-HMedIdeS-01, EudraCT no. 2012-000 969-21) first in man single ascending
      dose study in 29 healthy subjects to investigate if IdeS is safe and well tolerated in doses
      up to 0.24 mg/kg body weight (BW).
    

Intervention name(s): IdeS; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: volunteers
Eating Concerns and Compulsivity
Condition: Anorexia Nervosa in Remission; Eating Disorder
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Study type: Interventional

Summary: 
      This study uses a computational task to examine differences in adaptive learning to both
      rewards and punishments between three groups: those who have recovered from anorexia nervosa,
      those who score highly on the EAT-26 (Eating Attitudes Test - 26 item version; an eating
      disorder symptom scale), and healthy controls. This task also allows the examination of pupil
      response (thought to reflect norepinephrine activity) in response to expected and unexpected
      wins and losses.
    

Detailed description: 
      This study involves using a novel computational task (the volatility task, designed by Dr
      Michael Browning) to examine differences in adaptive learning in terms of sensitivity to
      environmental change in those who are in eating disorder 'risk' groups (defined as those with
      a previous diagnosis of AN, and those who score highly in the EAT-26 for eating disorder
      symptoms. This study allows us to investigate whether or not these individuals are able to
      pick up key environmental statistics and adapt their behaviour accordingly. We hypothesise
      that those in eating disorder risk groups will show a deficit in this area, which might begin
      to explain why the cognitive phenotype of 'cognitive inflexibility' is found so commonly in
      these patients. Using pupillometry measures will also allow us to putatively form links
      between this behaviour and the norepinephrine system in these participants, as pupil dilation
      measures are thought to track environmental statistics of this kind. Additionally, this task
      allows us to identify whether there is a particular deficit in tracking and learning about
      positive or negative environmental information. We will be using standard clinical interviews
      and questionnaires to define the groups and to record key variables (e.g. mood information)
      within groups. This study will consist of a single visit, including these interviews and
      questionnaires, the volatility task with pupillometry measures, and the Wisconsin Card Sort
      Task, which we hope to use to demonstrate a baseline difference between groups on cognitive
      flexibility.
    

Intervention name(s): Volatility task
Intervention type(s): Other
Intervention description(s): Participants complete a volatility task, with pupillometry; and a Wisconsin Card Sort Task.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Three parallel groups: those who have recovered from anorexia nervosa; those who worry a lot about eating, shape and weight; and healthy control participants will be included, and all will complete some questionnaires and two tasks.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Computational
Effects of Jeju Red Horsehead Fish-based, High Protein Diet on Satiety and Incretin Hormones in Diabetes Patients
Condition: Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The aim of our study is to investigate the effects of high-protein diet on satiety and
      incretin hormones in patients with diabetes.
    


Intervention name(s): High-protein diet; Standard diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The high-protein diet is made up of 50% carbohydrate, 40% of protein and 10% of fat, providing 480 kcal.
A protein part of the high-protein diet is mostly composed of a grilled Jeju red horsehead fish, a special product of Jeju island in Korea.; The standard diet is made up of 60% carbohydrate, 20% of protein and 20% of fat, providing 480 kcal.
Other intervention name(s): A Jeju red horsehead fish-based meal; A mixed meal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diet; Incretins; Gastrointestinal Hormones; Fish Proteins
A Study to Evaluate the Safety and Tolerability of Using SHR-1210 by Advanced Solid Tumor Subjects
Condition: Solid Tumor; Breast Cancer; Gastrointestinal Cancer
MeSH terms: Gastrointestinal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, non-randomized, dose escalation phase I trial to evaluate safety and
      tolerability of SHR-1210 in patients with advanced solid tumors. The primary objective is to
      assess safety and tolerability of SHR-1210 and identify recommended phase II doses of
      SHR-1210 in patients with advanced solid tumors.
    

Detailed description: 
      This is an open-label, nonrandomized, dose-escalation Phase 1 study to evaluate safety and
      tolerability of SHR-1210 in subjects with advanced Solid Tumors who have failed current
      standard antitumor therapies.

      The safety and tolerability of SHR-1210 will be assessed by ongoing reviews of clinical
      laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical
      examination, electrocardiogram (ECG), and adverse events. Evaluations of immune safety will
      also be conducted (immune-related AEs, or labs of autoimmune sera, inflammatory events, and
      immunogenicity). Safety evaluations (both clinical and laboratory) are performed at baseline,
      before each study treatment, and throughout the study.

      Efficacy will be assessed every 8 weeks. The study consists of 3 periods: screening (up to 14
      days before the first dose), treatment, and follow-up (up to 90 days after the last dose of
      study treatment).
    

Intervention name(s): camrelizumab
Intervention type(s): Biological
Intervention description(s): A fully humanized anti-PD-1 monoclonal immunoglobulin (IgG4 subtype)
Other intervention name(s): SHR-1210
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Safety, Tolerability and Blood Concentrations of Single Doses of AZD3839 in Healthy Volunteers
Condition: Alzheimer's Disease; Safety; Tolerability; Blood Concentration; Healthy Volunteers
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety, tolerability and blood concentration of
      AZD3839 following oral administration of single doses in healthy men and women of
      non-childbearing potential
    


Intervention name(s): AZD3839; AZD3839 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single Oral Dose; Single Oral Dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Phase 1; healthy volunteers; double-blind; placebo-controlled; AZD3839; pharmacokinetics; Alzheimer's Disease
tDCS and Physical Therapy in Stroke
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a painless and noninvasive procedure called
      transcranial direct current stimulation (tDCS) combined with a method of physical therapy
      called constraint-induced movement therapy improves motor function in patients with chronic
      stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning
      tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS
      procedure sessions will be compared to sham (fake) procedure sessions, which is also called
      placebo stimulation. This study is double blind, which means neither the subjects nor
      researchers analyzing motor function will know if participants are receiving real tDCS
      stimulation or placebo. Only the person performing the procedure will know which one
      participants are receiving. Only by comparing the tDCS procedure to a sham (placebo)
      procedure can we understand if the tDCS actually improves motor function.

      We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on
      motor recovery in chronic stroke patients.
    


Intervention name(s): Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy; Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy
Intervention type(s): Device; Device
Intervention description(s): 14 days of constraint induced movement therapy with 10 weekdays of up to 6 hours of training of the affected arm combined with application of tDCS over the primary motor cortex for 40 minutes.; 14 days of constraint induced movement therapy with 10 days of up to 6 hours of training in the affected arm and sham tDCS applied over the primary motor cortex for 40 minutes with active current applied for 30 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Apoplexy; Cerebral Stroke; Cerebrovascular Accident, Acute; Cerebrovascular Apoplexy; Cerebrovascular Stroke; CVA (Cerebrovascular Accident); Stroke; Stroke, Acute; Vascular Accident, Brain