bioihbjkbjnl/mcl2 huggingface dataset:
Family Intervention for Mental Illness and Substance Abuse
Condition: Schizophrenia; Bipolar Disorder; Substance-related Disorders
MeSH terms: Substance-Related Disorders; Schizophrenia; Bipolar Disorder
Study type: Interventional

Summary: 
      This study will evaluate a family intervention program for individuals with bipolar disorder,
      schizophrenia, or schizoaffective disorder and co-occurring substance use disorders.
    

Detailed description: 
      Substance use disorder (SUD) in persons with severe mental illness may worsen the course of
      psychiatric illness. The loss of family support for individuals with mental illness is a
      major contributing factor to housing instability, homelessness, and other problems. Despite
      progress toward integrating mental health and substance abuse services, interventions that
      improve the course of mental illness while helping the families of the mentally ill are not
      currently available. Enhancing skills for coping with mental illness may be an effective
      strategy for treating SUD, decreasing caregiver burden, and improving the long-term outcomes
      for people with mental illness.

      Patients and their families are randomly assigned to either the Family Intervention for Dual
      Diagnosis (FIDD) program or family psychoeducation. The FIDD program lasts for up to 3 years
      and includes both single and multiple-family group formats. The family psychoeducation
      program consists of 6 weekly sessions. Routine assessments are conducted on all patients, and
      relatives are evaluated on a wide range of outcomes, including substance abuse,
      hospitalizations, psychiatric symptoms, legal problems, aggression, housing and homelessness,
      family burden, social support, and quality of life. To determine the effectiveness of the
      FIDD program, knowledge of mental illness and problem-solving skills are assessed in the
      families following treatment.
    

Intervention name(s): Family Intervention for Dual Diagnosis; Family psychoeducation program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The family intervention for dual diagnosis program lasts for up to 3 years and includes both single and multiple-family group formats.; The family psychoeducation program consists of 6 weekly sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychotic Disorders; Schizoaffective Disorder; Substance Abuse
A Study of LNK01001 Capsule in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study was to evaluate the safety and efficacy of multiple doses of
      LNK01001 monotherapy versus placebo in the treatment of adults with active Ankylosing
      Spondylitis
    

Detailed description: 
      This study includes two periods. In Period 1, Participants who meet eligibility criteria will
      be randomized in a 1:1:1 ratio to receive a twice daily oral LNK01001 Dose A or LNK01001 Dose
      B or a matching placebo for 12 weeks. Participants who receive a placebo in Period 1 will be
      re-randomized at Week 13 in a 1:1 ratio to receive a twice daily oral LNK01001 Dose A or
      LNK01001 Dose B for 12 weeks (period 2). Those participants, based on the ASAS40 response,
      who receive LNK01001 (Dose A or Dose B) in Period 1 may switch to receive a different
      treatment dose for 12 weeks (period 2).
    

Intervention name(s): LNK01001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules for oral use; Capsules for oral use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in
      participants with moderate to severe ulcerative colitis (UC).
    


Intervention name(s): BMS-986165; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified Dose on Specified Days; Specified Dose on Specified Days
Other intervention name(s): Deucravacitinib
Intervention MeSH terms: Deucravacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy, safety, bleeding pattern of low dose LNG
      (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for
      use by women 18 to 40 years of age. In addition, pharmacokinetic assessments will be
      performed.
    


Intervention name(s): Levonorgestrel IUS (LCS, BAY86-5028)
Intervention type(s): Drug
Intervention description(s): In Vitro release rate: 12µg LNG/24h
Intervention MeSH terms: Levonorgestrel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Contraception; Intrauterine contraception system
A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind,
      placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with
      Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011.

      Part B is a randomized, two-dose, open-label dose expansion study to evaluate GS-6624 in
      subjects with IPF and is currently enrolling.
    

Detailed description: 
      The primary objective of this study is to characterize the safety, tolerability, and PK of
      GS-6624 after multiple IV administrations in patients with IPF. The secondary objectives are
      to evaluate the formation of anti-GS-6624 antibodies and to measure the effects of GS-6624 on
      FVC, DLCO, and SGRQ score. A total of 48 patients will be enrolled. In the double-blind phase
      (Part A), a total of 18 patients were enrolled at 3 dose levels. Part A was completed in
      October 2011.

      In Part B, 30 patients will be enrolled at 2 dose levels. Part B is open-label and is
      currently enrolling.
    

Intervention name(s): GS-6624
Intervention type(s): Drug
Intervention description(s): Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period.
Other intervention name(s): AB0024
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fibrosis; Pulmonary Fibrosis; Lung Diseases; Interstitial
Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      To demonstrate effectiveness of hybrid fractional laser for the treatment of poor skin
      quality on the decolletage, back of the hands and lower legs
    


Intervention name(s): Hybrid Fractional Laser
Intervention type(s): Device
Intervention description(s): Hybrid Fractional Laser Device
Other intervention name(s): HALO
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Forced-air Warming and Circulating-water Mattress in Preventing Heat Loss During Vascular Surgery
Condition: Hypothermia; Vascular Surgery; Forced-air Warming Mattress; Circulating-water Mattress
MeSH terms: Hypothermia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a custom-made forced-air warming mattress
      can prevent heat loss in patients undergoing vascular surgery better than a circulating-water
      mattress
    

Detailed description: 
      A reusable, custom-made forced-air warming mattress was made of a light to medium weight
      water resistant canvas, sewn like mattress with 2 arms placed underneath the patient. An open
      hole at proximal part of one arm was designed to attach with a hose of warm air delivery
      device. Small holes (2-3 mm2), 5 inches apart were punched on the upper surface of this
      mattress around the patient except for the area underneath the patient that the holes were 9
      inches apart. The weight of the patient will obstruct the air flow and prevent direct blowing
      of warm air onto the underside of patients. There is a special appendage connected to the
      upper part of mattress which can connect warm air to cover the patient's chest. There is a
      special appendage connected to the upper part of mattress which can convect warm air to cover
      the patient's chest. The mattress is 97 inches x 97 inches, with 2 arms of 25 inches x 16
      inches and a special appendage of 45 inches x 12 inches for covering the chest with warm air
      delivery. This size is proper for patient of 170 cm. height. In order to reuse it, the
      mattress can be washed, dried and sterilized by gas or autoclaved for more than 50 times. A
      sterile sheet well enhance the sterile environment of the operating field.
    

Intervention name(s): warming device (a reusable, custom-made forced- air warming mattress)
Intervention type(s): Device
Intervention description(s): 2=forced-air warming mattress
1=circulating-water mattress
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypothermia; Vascular surgery; Forced-air warming mattress; Circulating-water mattress
Tramadol to Reduce Opioid Withdrawal Symptoms
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Individuals with opioid addiction often experience serious withdrawal symptoms that may make
      relapse unavoidable. Tramadol, a medication that is currently used to treat pain caused by
      chronic conditions such as cancer or joint pain, may also be effective at reducing opioid
      withdrawal symptoms. This study will evaluate the effectiveness of tramadol at reducing
      withdrawal symptoms in individuals addicted to opioid drugs.
    

Detailed description: 
      Opioid withdrawal symptoms are a major contributing factor for why opioid treatment programs
      often fail. Individuals with severe opioid withdrawal symptoms may experience shaking, muscle
      and bone pain, nausea, depression, anxiety, and drug craving. Tramadol is a medication that
      is currently used to treat moderate to severe pain in individuals with cancer, joint pain, or
      pain resulting from surgery. Because of its pharmacological profile, tramadol may also be
      useful in treating opioid withdrawal. Further research is needed to confirm the benefits of
      tramadol for opioid addicts. The purpose of this study is to evaluate the effectiveness of
      tramadol at reducing opioid withdrawal symptoms in opioid-dependent individuals.

      This 6-week inpatient study will enroll opioid-dependent individuals. Participants will be
      required to reside at the research clinic for the entire study. All participants will receive
      morphine maintenance treatment on a daily basis. Twice a week participants will take part in
      experimental challenge sessions in which they will be randomly assigned to receive varying
      doses of tramadol, naloxone, morphine, or placebo. These sessions will assess the ability of
      tramadol to suppress opioid withdrawal symptoms. Participants will complete performance tasks
      to measure psychomotor and cognitive functioning. Heart rate and blood pressure will be
      monitored throughout the experimental sessions. A specialized camera will also be used to
      assess pupillary response of the eyes. Questionnaires and self-reports will be completed to
      assess medication effects and withdrawal symptoms. Following the end of the study, all
      participants will be offered outpatient drug abuse treatment.
    

Intervention name(s): Tramadol; Naloxone; Morphine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Morphine; Tramadol; Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Opiate Addiction; Opiate Dependence
Investigation of Memantine in the Treatment of Memory, Concentration or Attention Problems
Condition: Memory Disorder; Retention Disorder, Cognitive; Subjective Cognitive Impairment; Memory, Concentration or Attention Problems
MeSH terms: Memory Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, memantine will be tested in a new indication: in the treatment of subjective
      memory, concentration, or attention problems (subjective cognitive impairment) in the absence
      of dementia.
    


Intervention name(s): Memantine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will receive memantine 10mg tablets once daily; Each subject will receive matching placebo tablets once daily
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intraocular Bevacizumab (Avastin) for Rubeosis Iridis
Condition: Glaucoma; Rubeosis Iridis
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      Bevacizumab (Avastin®, Roche, Rio de Janeiro, Brazil) is an anti-VEGF recombinant humanized
      monoclonal IgG1 antibody used to treat colorectal cancers. Bevacizumab may have a role in
      treating ocular disorders involving fibrovascular proliferation. To determine whether
      intraocular bevacizumab decreases rubeosis iridis in patients with neovascular glaucoma.
    


Intervention name(s): bevacizumab
Intervention type(s): Drug
Intervention description(s): 1.25mg/month
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bevacizumab; rubeosis iridis; glaucoma
Optimal Approach for Analysis of Case-Control Genetic Association Studies
Condition: Lung Diseases; Asthma
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      The purpose of this study is to examine the effectiveness of approaches to correct for the
      effects of population stratification on case-control genetic association studies.
    

Detailed description: 
      BACKGROUND:

      In racially admixed populations, genetic associations may be confounded by population
      stratification. To control for population stratification, statistical methods that use marker
      genotype data to infer population structure have been proposed as an alternative to
      family-based tests of association. However, there are limited empirical data on how these
      methods perform in real populations. This study will use well characterized populations of
      Mexican and Puerto Rican asthmatics, their parents, and control subjects recruited from the
      same sites to examine the effectiveness of approaches to correct for the effects of
      population stratification on case-control genetic association studies.

      DESIGN NARRATIVE:

      This study has three specific aims: 1) To test and compare methods of detecting and
      correcting for population stratification, the study will genotype a total of 100 ancestral
      informative markers (AIMs) for 400 asthma cases and an equal number of control subjects.
      These AIMs will then be used with three statistical methods developed to detect and correct
      for population stratification. The number and characteristics of markers required to correct
      false positive associations between AIMs, asthma, and asthma quantitative traits will be
      evaluated and compared; 2) To compare the power of genomically adjusted case-control studies
      to the Transmission Disequilibrium Test (TDT). An allele from each of the 100 AIMs will be
      considered as a risk factor for a simulated "phenotype." The association between phenotypes
      and each AIM will be tested with the TDT and with a case-control analysis after adjustment
      for stratification to compare the false negative rates for these study designs. 3) To use the
      results from aim 1 and 2 to define an optimal approach for analysis and interpretation of
      case-control association studies in these populations and apply this approach to analyze the
      association between asthma and a series of candidate genes. The results of these studies
      should provide important insights into optimal methods to control for population
      stratification in case-control association studies, thereby facilitating the inclusion of
      admixed populations in future genetic studies of complex diseases such as asthma.
    

Observational model: Family-Based
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Family-based cross sectional analysis
      
Biospecimen description: 
      Retrospective genetic analysis of DNA; samples collected between 1998-2001
RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula
Condition: Complication of Hemodialysis; Vascular Access Complication
MeSH terms: Fistula
Study type: Interventional

Summary: 
      A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus
      standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in 150 patients
      with haemodialysis access stenoses.
    

Detailed description: 
      Prospective multicenter randomized (1:1) Investigator Sponsored Trial, in which 150
      consecutive patients candidates for percutaneous intervention of haemodialysis access will be
      randomly assigned to one of two study arms:

        1. Treatment Arm: paclitaxel drug-eluting balloon (DEB) dilatation using the APERTO-balloon

        2. Control Arm: standard percutaneous transluminal angioplasty (PTA).

      The aim is to evaluate the safety and efficacy of paclitaxel drug-eluting balloon (DEB) for
      the reduction of restenosis in haemodialysis shunts compared to standard percutaneous
      transluminal angioplasty (PTA).
    

Intervention name(s): DEB, drug eluting balloon; standard PTA
Intervention type(s): Device; Device
Intervention description(s): Percutaneous angioplasty performed with a DEB - drug eluting balloon; Percutaneous angioplasty performed with a standard balloon
Other intervention name(s): Paclitaxel eluting balloon; POBA
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: drug eluting balloon; percutaneous balloon angioplasty
Previous Injury History and Performance of Male Elite Ice Hockey Players
Condition: Wounds and Injuries; Sports Physical Therapy
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      BACKGROUND: In ice hockey, skating is a combination of speed, power, and balance.
      OBJECTIVE:The aim of this study is to examine the relationship between previous injury
      history and on-ice and off-ice performance of elite male ice hockey players.

      METHODS: This study was designed as prospective cross-sectional study. Fifty elite men's ice
      hokey players included (n=50, mean age 23y 8mo, SD 5y 3mo). Off-ice performance measures were
      30 m Sprint Test, Broad Jump Test, Push-up Test, Hexagon Agility Test, Plank Test. The 2
      on-ice tests were 30m On-ice Sprint Test and Cornering "S" Turn Agility Test.The athletes'
      history of injury were including previous injury site, type, number and the mechanism of
      injury. RESULTS: In push up test, there was a significant difference in those who had left
      hand and right knee injuries and, athletes who had dislocation were found to be statistically
      significant (p <0.05). According to cornering s turn agility test results, athletes who had
      puck injury were found to be statistically significant (p <0.05). In 30m sprint and hexagon
      agility test results, athletes who had overuse injury were found to be statistically
      significant (p <0.05). There was a significant correlation between on-ice 30m sprint and
      cornering s turn agility tests with broad jump test and also with off-ice push-up and plank
      tests (p<0.05). CONCLUSIONS: As a result of the performance tests, push up test might be a
      distinctive test in determining the performance of the athletes after injury. Also on-ice
      tests had a correlation with off-ice plank test which is the indicator of core muscle
      strength.
    

Detailed description: 
      We believe that the current performance and performance deficiencies of the athletes
      determined and existing training programs will be arranged to eliminate performance
      deficiencies. We wanted to raise awareness about whether there is a general deficiency in ice
      hockey performance caused by past injuries and which exercises should be included in the
      training program in order to overcome performance deficiencies.
    

Intervention name(s): Applying on-ice and off-ice performance tests
Intervention type(s): Diagnostic Test
Intervention description(s): The subjects were given a written description of study procedures and potential risks.The athletes'history of injury including previous injury site, type, number, date, surgical status, time to return to the field after the injury and the mechanism of injury were recorded. The subjects completed off-ice performance measures followed by on-ice testing with time allotted for warm-up before both the off-ice and on-ice testing.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: hockey; performance testing; muscular strength and endurance; wounds and injuries