bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Dynorphin 1-13 on Heroin Addiction - 1
Condition: Opioid-Related Disorders; Substance Withdrawal Syndrome
MeSH terms: Opioid-Related Disorders; Substance Withdrawal Syndrome; Heroin Dependence; Behavior, Addictive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of IV dynorphin in humans during acute
      heroin abstinence, in order to determine that dynorphin suppresses acute opiate withdrawal,
      reduces opiate craving, and is safe at doses required to produce the above effects.
    

Detailed description: 
      Randomized double blinded study of the effects of a single IV dose of dynorphin A 1-13 on
      heroin withdrawal in human opiate addicts
    

Intervention name(s): Dynorphin 1 - 13
Intervention type(s): Drug
Intervention MeSH terms: Dynorphins
Masking: Double
Primary purpose: Treatment
Keywords: addiction; opiate; heroin; dynorphin
Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011
Condition: Normal Renal Function; Impaired Renal Function
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the PK and safety profile of LEE011 following a
      single oral dose in adult subjects with various degrees of renal impairment compared to a
      matched group of healthy subjects with normal renal function.
    


Intervention name(s): LEE011
Intervention type(s): Drug
Intervention description(s): 400 mg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anakinra Versus Placebo for the Treatment of Acute MyocarditIS
Condition: Acute Myocarditis
MeSH terms: Myocarditis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There is no specific treatment of acute myocarditis, especially during the inflammatory
      period. Interleukin (IL) is specifically involved during this period and play a role in
      myocardial oedema. ANAKINRA, an IL-1β Blocker, is a new treatment that has never been
      evaluated in myocarditis. The benefit for the patient could be important with a reduction of
      heart failure and ventricular arrhythmias.

      Hypothesis : ANAKINRA in addition to standard therapy for treatment of Acute Myocarditis is
      superior to standard therapy based on an association of beta-blockers and
      Angiotensin-Converting-Enzyme inhibitor (ACE).
    

Detailed description: 
      It is a Double Blind Randomized clinical trial Phase IIb of superiority, enrolling two
      groups: one group treated with the standard of care, defined as the maximum tolerated dosage
      of any beta blockers and ACE, and placebo versus ANAKINRA in addition to the standard of care
      in patients treated for an acute Myocarditis.

      Patients will be randomized to receive ANAKINRA 100 mg/daily or placebo subcutaneously once a
      day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and
      Beta-blocker for 6 months. Randomization 1:1 will be conducted centrally using the electronic
      Case Report Form (eCRF).

      As an exploratory analysis, a second randomization for ACE discontinuation in patients
      without left ventricular dysfunction (LVEF > 50%) at one month post discharge will be
      performed.

      One group will stopped the treatment at one month and the second group will continued the ACE
      for 6 months. This second randomization is in open label.
    

Intervention name(s): ANAKINRA 100 mg/daily subcutaneously; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ANAKINRA 100 mg/daily subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months.; PLACEBO 100 mg/daily subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months.
Other intervention name(s): Kineret
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute Myocarditis; ANAKINRA
Study of Human Epidermal Growth Receptor (HER2) Status Evaluation in Breast Cancer Pathology Samples
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      A multi-center non-interventional, in-vitro trial for evaluation of concordance of the
      results for Human Epidermal Growth Factor Receptor 2 (HER2) expression by the
      Immunohistochemical (IHC) method in pathological samples collected from participants with
      breast cancer.
    

Detailed description: 
      For accurate selection of participants who will be treated with anti-HER2, primary crucial
      thing to do is the right identification of HER2 in breast tumor cells. The advantages and
      disadvantages of IHC and In-Situ Hybridization (ISH) for the detection of HER2 status is
      still disputable. It is generally agreed on that HER2 study should be applied on all invasive
      breast cancer participants. It can be used together with IHC which measures HER2 protein
      expression or ISH which assesses HER2 gene amplification. With regard to IHC, the
      inconsistency of sensitivity and specificity of marketed antibodies, differences in
      interpretation and technical artifacts cause problems in diagnosis on occasion. There is not
      enough study on reasons which cause the consistence and discrepancies between laboratories in
      HER2 detection with IHC method.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Breast tissue samples from female participants with a breast cancer diagnosis
Clinical and Molecular Phenotyping in IBD
Condition: IBD
Study type: Interventional

Summary: 
      Inflammatory bowel disease (IBD) and psoriasis (Ps) are common, chronic, immune- mediated
      barrier diseases with shared inflammatory pathways. Current therapeutic interventions with
      anti-cytokine antibodies (TNF-α, IL-23/IL-12) reflect the intent to disrupt specific pathways
      of inflammatory immunopathology. Individual responses to biological treatment can be thereby
      be exploited in a systems biology approach that employs a targeted mechanism of action (MOA)
      to decipher molecular signatures of therapeutic responses in the context of a distinct
      disease entity. Using a translational approach to investigate clinical and molecular
      phenotypes during therapeutic interference with cytokine signaling and leukocyte trafficking,
      the investigators aim to trace common and unique signatures of drug- and therapy-specific
      responses.

      Patients will undergo endoscopic evaluation of the mucosal surface and gastrointestinal wall
      by conventional HD-colonoscopy, endoscopic ultrasound and confocal laser endomicroscopy prior
      to and during specific therapies with biologicals. In parallel, mucosa samples will be
      obtained to define molecular phenotypes during the course of therapy.
    


Intervention name(s): Infliximab; Vedolizumab
Intervention type(s): Drug; Drug
Intervention description(s): HD-endoscopy, CLE, endoscopic ultrasound after application of TNF alpha antibody; HD-endoscopy, CLE, endoscopic ultrasound after application of Anti-Integrin antibody
Other intervention name(s): Endoscopic assessment after Infliximab; Endoscopic assessment after Vedolizumab
Intervention MeSH terms: Infliximab; Vedolizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Vedolizumab; Infliximab
Emotional Impact of the Way Conducting Cancer Patients to the Surgical Center
Condition: Anxiety Disorders; Depression
MeSH terms: Depression; Anxiety Disorders
Study type: Observational

Summary: 
      Cancer is an extremely aggressive disease, anxiety and depression are consequences some
      patients may develop from diagnosis continuing during treatment. A measures control of the
      cancer is surgery for removal tumor. The surgical procedure is often a difficult experience
      for patients and their relatives, and patients in the preoperative period are often
      psychological symptoms of anxiety and depression. A previous study with the objective
      analyzing patient's emotional repercussion according the type of transport to the surgical
      center reached the following result: patients who go to the surgical center feel more relaxed
      in the preoperative period.

      The primary objective is to analyze emotional repercussion of patient diagnosed with cancer
      classified in Eastern Cooperative Oncology Group (ECOG) Performance Status 0 and 1 according
      type transport to the surgical center.
    

Detailed description: 
      A randomized clinical trial, prospective collection to be performed at the Barretos Cancer
      Hospital, will be include 176 patients, 88 patients being allocated to transport to operating
      room by stretcher on wheels (group 1) and 88 patients being allocated to transport to
      operating room by ambulation (group 2). Patients with indication elective surgery that meet
      the inclusion criteria will be included, and randomized for one of the groups, and may be
      referred by stretcher on wheels to the surgical center (group 1) or referred to the surgical
      center by ambulation (group 2). The Hospital Anxiety and Depression Scale (HAD) and the
      survey developed for the present study Sati-Cir, Evaluation Questionnaire of Satisfaction
      with Healthcare in Surgery, will be the instruments used in data collection. Participants
      will respond both after the course to the surgical center.
    

Intervention name(s): Transport on foot
Intervention type(s): Other
Intervention description(s): Patients go to operating room walking with their families and with their normal clothes
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will be organized including 176 patients sheduled for elective cancer
        surgery at Barretos Cancer Hospital, 88 patients bei ng allocated for transporting to the
        operating room by stretcher on wheels, and 88 patients elective allocated for transporting
        to the operating room by ambulation.
      
Keywords: Anxiety disorders; Depression; Transport to operating room
Drug Use and Sexual Risk Behaviors Among Emerging Adults in the ER
Condition: Drug Use; Sex Behavior
Study type: Interventional

Summary: 
      This project will develop a technology-augmented HIV and substance use risk reduction
      intervention for delivery in the Emergency Department, a medical setting where at-risk
      emerging adults who use drugs and engage in HIV-related risk behaviors are likely to present.
    

Detailed description: 
      Research regarding substance use (including illicit drugs and non-medical use of prescription
      drugs) and HIV-related sexual risk behaviors (HIV SRBs; e.g., inconsistent condom use,
      multiple partners, sex while intoxicated; and prevention of injection drug use) among
      emerging adults (EAs; ages 18-25) has generally focused on alcohol use among college students
      from campus settings; however, substance use and HIV (and other associated Sexually
      Transmitted Infections) disproportionately occur among young people living in urban,
      low-resource communities, particularly individuals of racial minorities. The Emergency
      Department (ED) is a critical venue for accessing at-risk EAs engaging in substance use and
      HIV risk behaviors. Research shows high rates of substance use and HIV SRBs among EA patients
      in the ED, yet no intervention exists for EAs in this setting. The ED may be the only
      opportunity to intervene with these young people because EAs in urban, low-resource settings
      often lack a primary care provider during the transition from pediatric to adult medicine,
      may be un-insured or under-insured, and may not be involved in a traditional college campus
      setting. Further the use of technology (e.g., mobile phones) is relatively ubiquitous among
      this age group, and most prefer technology-based communication (e.g., text messaging or
      instant messaging via apps), therefore interventions for EAs may be enhanced by this type of
      technology. In this phase we will test a tailored intervention for EA patients in the ED
      focusing on reducing substance use and HIV SRBs, which will be enhanced through the use of
      mobile app notifications.
    

Intervention name(s): Brief Intervention
Intervention type(s): Behavioral
Intervention description(s): Intervention for emerging adults (EAs) seeking care in the ED. The intervention will be rooted in motivational interviewing (MI) and will be guided by social cognitive, self-determination, and the trans-theoretical theories. The ED visit presents a "teachable moment" for intervening to promote health behavior, therefore eligible EAs will receive a ~30 minute MI-based session in the ED. In order to capitalize on and potentially extend this moment, participants will receive daily booster notifications delivered through a secure mobile app that they will download to their phone at enrollment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Emerging adults; Drugs; HIV; Risky Sex Behaviors
ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety,
      and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).
    

Detailed description: 
      This protocol is designed to test the safety and efficacy of a drug called Beloranib
      (ZGN-440). It is to be tested for its ability to reduce weight in obese female subjects who
      are of non-childbearing potential. The study will provide information on how much ZGN-440
      gets into the blood, how long it stays in the body, and how it affects other biological
      markers.
    

Intervention name(s): ZGN-440; ZGN-440 sterile diluent
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive ZGN-440 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.; Subjects will receive placebo twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
Other intervention name(s): Beloranib for subcutaneous injection
Intervention MeSH terms: CKD732
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obese; Obesity; Overweight
Evaluation of the Relationship Between Neck Pain and Temporomandibular Disorders in Office Workers
Condition: Neck Pain; Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Neck Pain
Study type: Observational [Patient Registry]

Summary: 
      The current study aimed to explore the associations between neck pain and temporomandibular
      disorders in office workers
    

Detailed description: 
      This is a cross-sectional study. All participants will provide informed consent before
      participating in the study. The study will be conducted in accordance with the Helsinki
      Declaration criteria. Data will be collected using questionnaires, which include information
      on demographic, clinical conditions.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        aged between 18 and 55, working on computer, having neck pain at least three months with or
        without temporomandibular pain
      
Keywords: neck pain; temporomandibular disorder; office workers
Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The study had two objectives. The first main aim was to analyze the effects of tryptophan and
      magnesium-enriched Mediterranean diet on psychological variables (trait anxiety, self-image,
      mood state, eating disorders) and sleep effects in women with fibromyalgia. Our hypothesis,
      based on previous positive effects of tryptophan and magnesium supplementation by separate in
      this population, may improve psychological health and regulate sleep disruptions. The second
      aim was to assess the effectiveness of a manual therapy technique performed with moderate
      digital pressure in fibromyalgia patients on the variables of fatigue, pain, sleep, anxiety
      and mood. It was done to provide an alternative treatment to pharmacological therapies for
      fibromyalgia patients and to provide new evidence on the effects of manual therapy in
      fibromyalgia patients.
    


Intervention name(s): Mediterranean-diet enriched with a higher dose of tryptophan and magnesium; Isocaloric diet; Manual therapy; Placebo therapy
Intervention type(s): Other; Other; Other; Other
Intervention description(s): That gruop eaten at both breakfast and dinner from walnuts (3-5 units), as food with high values of tryptophan and magnesium; That group eaten isocaloric diet plan based on Mediterranean diet.; That group received moderate pressure digital manual therapy.; That group was treated with a US (in off mode) without conductive gel.
Intervention MeSH terms: Tryptophan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: micronutrients; nutrition; therapy; chronic disease
Development of Novel Strategy for Treatment of Anterior Cruciate Ligament (ACL) Injury Using Stem Cell
Condition: Deficiency of Anterior Cruciate Ligament
Study type: Interventional

Summary: 
      Purpose:Development of novel strategy for treatment of anterior cruciate ligament (ACL)
      injury using stem cell.
    

Detailed description: 
      1. Purpose: Development of novel strategy for treatment of anterior cruciate ligament (ACL)
           injury using stem cell.

        2. Subject: Anterior cruciate ligament (ACL) injury 30 patients

             -  ACL reconstruction: 10

             -  ACL reconstruction + Human cord blood derived mesenchymal stem cells and hyaluronic
                acid (Cartistem (TM)): 10

             -  ACL reconstruction + hyaluronic acid: 10

        3. Hypothesis: Human Cord blood derived mesenchymal stem cells can enhance healing between
           bone tunnel and graft in ACL reconstruction.
    

Intervention name(s): Cartistem(TM); hyaluronic acid; ACL reconstruction only
Intervention type(s): Biological; Biological; Procedure
Intervention description(s): ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy.; ACL reconstruction and injection of hyaluronic acid under arthroscopy.; ACL reconstruction only without any injection under arthroscopy
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Positron Emission Tomography (PET) Study to Assess the Degree of Dopamine-2 (D2) Receptor Occupancy in the Human Brain After Single Doses of BL-1020 or Perphenazine in Healthy Male Subjects Using [11C]Raclopride as PET Tracer
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose, open-label, 2-panel (Parts A and B) PET study investigating the degree
      of occupancy of dopamine 2 receptors (D2_RO) in the human brain after single oral doses of
      BL-1020 or Perphenazine (Trilafon®, hereafter called Perphenazine) in healthy male subjects.
      In Part A the D2_RO is investigated for the study compound BL-1020 and in Part B the D2_RO of
      BL-1020 is compared to the D2_RO of Perphenazine, a reference compound.
    


Intervention name(s): BL 1020; Perphenazine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Perphenazine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: receptor oocupancy
Duration Threstholds of Intraoperative Hypotension
Condition: Hypotension
MeSH terms: Hypotension
Study type: Observational

Summary: 
      Intraoperative hypotension is common in non cardiac surgery. longer duration of
      intraoperative hypotension is related with postoperative morbidity and mortality. however,
      with the change of hypotension criteria, the duration threshold also change. the relationship
      of different hypotension criteria and its duration is unclear. This study is to explore the
      their relationship.
    

Detailed description: 
      Intraoperative hypotension is common in non cardiac surgery. longer duration of
      intraoperative hypotension is related with postoperative morbidity and mortality. however,
      with the change of hypotension criteria, the duration threshold also change. the relationship
      of different hypotension criteria and its duration is unclear. This study is to explore the
      relationship between continous difference mean blood pressure criteria and its duration
      thresholds for postoperative major adverse events, which include acute cardiac infarction,
      heart failure, cardiac death, stroke and acute kidney injury.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The analysis set of this study was adults (age ≥ 18 years old) who underwent elective
        non-cardiac surgery from January 1, 2012, to December 31, 2017.
Study to Investigate the Efficacy and Tolerability of AZD1446 in Adult ADHD Patients.
Condition: Adult ADHD
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether 2 weeks of treatment with AZD1446 compared
      to placebo improves ADHD symptoms and is well tolerated.
    


Intervention name(s): AZD1446; AZD1446; AZD1446; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg capsule, oral dose; 80 mg capsule, oral dose; 80 mg capsule, oral dose; Matching capsule, oral dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adult ADHD