bioihbjkbjnl/mcl2 huggingface dataset:
Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?
Condition: Headache
MeSH terms: Headache Disorders, Secondary; Headache
Study type: Interventional

Summary: 
      It is a common belief that patients with MOH rarely respond of preventative medications
      whilst overusing acute medications. However, no randomized trial has been done previously to
      prove such statement. Based on some clinical experiences, our hypothesis are patients with
      probably MOH may benefit from use of preventive medications better than treatment with abrupt
      withdrawal or no specific treatment.
    

Detailed description: 
      This randomized multi-centre study started January 2004, and patients with probably MOH have
      been included from five different University hospitals in Norway. The last patient was
      included November 9th 2006, final inclusion date was December 31th 2006. At this time a total
      of 64 patients with probable MOH according to the International Classification of Headache
      Disorders, 2nd Edition (2004) were included.

      The included patients were randomized to one out of three possible options:

        1. Abrupt withdrawal of the acute medication(s) they have been overusing. After 3 month:
           use of preventative medication (best choice)in those who need such treatment, 12 month
           follow-up.

        2. Start with preventative medication (best choice) directly without abrupt withdrawal, 12
           month follow-up.

        3. No specific treatment (controls), 5 month follow-up.
    

Intervention name(s): Betablockers or other preventive drugs based on primary headache type
Intervention type(s): Drug
Intervention description(s): Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)
Other intervention name(s): angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin
Intervention MeSH terms: Angiotensin II; Gabapentin; Valproic Acid; Antidepressive Agents; Antidepressive Agents, Tricyclic; Adrenergic beta-Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Medication-overuse headache; preventative medication; controls; follow-up; randomized; abrupt withdrawal
A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom
      scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact
      Scale {GGISIS}) in assessing GI tolerability in adult subjects with RRMS after administration
      of ALKS 8700 or Dimethyl Fumarate (DMF) in Part A, to compare the GI tolerability of ALKS
      8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B, and to Evaluate
      the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B.
    


Intervention name(s): ALKS 8700; Dimethyl Fumarate
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Other intervention name(s): Tecfidera
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RRMS; Multiple Sclerosis; MS; Alkermes; ALKS 8700; Dimethyl Fumarate; DMF; Tecfidera
Investigation of Melatonin and Zolpidem Effect on Postural Instability in Healthy Adult Subjects
Condition: Postural Instability
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomised, double-blind, 3-way crossover, single dose, placebo-controlled study
      investigating the effect on night time awakening body sway of melatonin and zolpidem in
      healthy adult subjects aged of 55 to 64 years.
    


Intervention name(s): Circadin (R) 2 mg; Stilnox (R) 10 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One 2 mg tablet at 23:00; One 10 mg encapsulated tablet at 23:00; One tablet or encapsulated tablet at 23:00
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: melatonin; circadin; zolpidem; body sway; postural instability
Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovascular Accident (CVA)
Condition: Permeable Foramen Ovale; Cerebrovascular Accident
MeSH terms: Stroke
Study type: Observational

Summary: 
      Facing the lack of recommandations of Neurology and cardiology societies, the investigators
      decided in 2002 some Good Medical Practices to define a specific and precise population for
      whom the closure of permeable oval formaen after a first CVA seem to be necessary. Current
      survey of these patients after implantation of a prothesis in interauricular septum is
      defined by a consultation at 1, 3 and 6 months after surgery for a clinical exam and an
      echocardiography. One year after implantation, the investigators systematically realized a
      control by MRI associated to a contrast echography.

      In the aim of evaluating the investigators' medical practice, the investigators decided to do
      an observational study which will permit us to judge of the interest or lack of interest of
      our "Good medical practice" before the publication of prospective and randomised clinical
      studies.
    


Intervention name(s): Data collection
Intervention type(s): Other
Intervention description(s): Collection of characteristics of interauricular septum, characteristics of the CVA, and headache history.
Collection of anamnesis data, surgical past history, especially at the moment of the implement of prothesis, collection of dtat of transthoracic echography, transcranial echodoppler, holter ECG, cerebral MRI.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patient who had an occlusion of POF after CVA, younger than 55 years and without
        thromboembolic events.
A Single Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of MYK-491
Condition: Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 1

Summary: 
      Up to 72 healthy volunteers will be given a single dose of MYK-491 or placebo and be
      monitored for safety and tolerability over a 7 day period.
    

Detailed description: 
      Up to 72 healthy volunteers will be given a single dose of MYK-491 or placebo and be
      monitored for safety and tolerability over a 7 day period. After the 28 day screening period,
      the eligible subject will be admitted to the clinical site and will receive a single dose of
      study drug or placebo. Subjects will be confined to the clinical site for five days (Day -1
      to Day 4) and will return to the clinic on Day 7 for a safety follow-up.
    

Intervention name(s): MYK-491 or placebo
Intervention type(s): Drug
Intervention description(s): Oral suspension
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer
Condition: Colorectal Cancer; Diarrhea
MeSH terms: Colorectal Neoplasms; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs such as octreotide and loperamide hydrochloride use different ways to
      relieve the diarrhea caused by chemotherapy.

      PURPOSE: Randomized phase III trial to compare the effectiveness of octreotide with
      loperamide hydrochloride for the treatment of chemotherapy-related diarrhea in patients who
      have colorectal cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the safety and efficacy of octreotide acetate versus conventional
      therapy with loperamide hydrochloride for chemotherapy related diarrhea in patients with
      advanced colorectal malignancies undergoing chemotherapy with fluorouracil or fluorouracil
      based regimens.

      OUTLINE: This is a prospective, randomized, parallel, open label, multicenter study. Patients
      are stratified by therapy, grade of diarrhea, and prior use of loperamide hydrochloride or
      octreotide acetate. Patients undergo 1 of 3 treatments. Patients receive either low doses of
      octreotide (arm A) or high doses of octreotide (arm B) subcutaneously 3 times daily for 5
      days. Patients in arm C receive oral doses of loperamide following each unformed stool for 5
      days. A diary is completed by patients to record medications and bowel history. Treatment
      continues if diarrhea persists beyond day 5, but will be considered a treatment failure. If
      diarrhea continues to worsen, patients are removed from study. All patients are followed for
      24 days.

      PROJECTED ACCRUAL: This study will accrue a total of 500 patients.
    

Intervention name(s): loperamide hydrochloride; octreotide acetate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Octreotide; Loperamide; Antidiarrheals
Allocation: Randomized
Primary purpose: Supportive Care
Keywords: colon cancer; rectal cancer; diarrhea
Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease
Condition: Stable Atherosclerotic Coronary Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Inflammation
Study type: Interventional

Summary: 
      Atherosclerotic coronary heart disease is a condition thought to involve low-grade
      inflammation. Several reports, clinical and epidemiological, have demonstrated that intake of
      fish oil may be beneficial in attenuating the inflammatory process. Still, however, there are
      lacking data in respect to whether differences in composition of various marine oils may
      influence the inflammatory status differently.

      The hypothesis of the current study is that extract from the antarctic krill (Euphausia
      superba) is better than traditional fish oils when compared head-to-head with balanced
      composition of omega 3 content on inflammatory status.
    


Intervention name(s): Krill; Fish oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Encapsulated oil from the antarctic crustacean Krill; Encapsulated, raffined cod-oil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fish oil; Krill; CAD
Ovarian Hyperstimulation Syndrome and Cabergoline
Condition: Polycystic Ovarian Syndrome; Ovarian Hyperstimulation Syndrome
MeSH terms: Polycystic Ovary Syndrome; Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Interventional

Summary: 
      Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting
      follicular fluid hormone microenvironmentally altering the follicular fluid levels of insulin
      like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and hepatocyte growth
      factor (HGF) levels in women with PCOS and high risk of ovarian hyperstimulation syndrome
      (OHSS).
    

Detailed description: 
      Dopamine agonists have been proposed as a prophylactic treatment for OHSS in women with high
      risk of OHSS, however the possible mechanism of action has not been clearly known. In
      experimental studies, inhibition of vascular endothelial growth factor based pathway was
      proposed as a possible action of mechanism of dopamine agonists. However the role hepatocyte
      growth factor (HGF), insulin like growth factor-I (IGF-I), inhibin B and antimullerian
      hormone (AMH) on cabergoline action in OHSS prevention has not been known.
    

Intervention name(s): Cabergoline
Intervention type(s): Drug
Intervention description(s): Cabergoline tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days
Other intervention name(s): Dostinex
Intervention MeSH terms: Cabergoline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effectiveness of Using Tobacco Free Snuff in Reducing Negative Effects of Smokeless Tobacco Use
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Though spit tobacco is smokeless, it still affects the cardiovascular system and may be
      associated with heart disease, stroke, and high blood pressure. Long-term effects of
      smokeless tobacco (ST) include tooth abrasion, gum recession, mouth disease, loss of bone in
      the jaw, yellowing of teeth, and chronic bad breath. This study will assess the effectiveness
      of using tobacco free snuff in reducing levels of exposure to tobacco and associated
      toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine
      intake.
    

Detailed description: 
      Spit tobacco presents as many health risks to its users as smoking tobacco. Although a
      significant number of ST users recognize the importance of quitting, many either do not want
      to quit or feel it is impossible. For these individuals, tobacco reduction may be an
      important transitional goal, either prior to quitting or as a treatment endpoint. However,
      approaches to help ST users reach this goal have not been studied. This study will assess the
      effectiveness of using tobacco-free snuff in reducing levels of exposure to tobacco and
      associated toxicity, as well as enhancing motivation to either quit or sustain lower levels
      of nicotine intake.

      Participants will be randomly assigned to receive either treatment with tobacco-free snuff or
      treatment without it. All participants will be encouraged to reduce nicotine intake by 50%
      during the first four weeks and by 75% the following four weeks. Participants receiving the
      tobacco-free snuff will be asked to alternate the use of their usual brand of ST with
      tobacco-free snuff in order to achieve the targeted reduction. Participants not receiving the
      tobacco-free snuff will only be informed to try to cut down their tobacco use to the targeted
      reduction. Study visits will occur once weekly during the 8-week treatment period.
      Assessments will include vital signs, physiological measures related to tobacco use, and
      measures of motivation and self-efficacy to quit ST. The number of participants who either do
      not complete treatment, reduce nicotine intake, or quit completely will be assessed at the
      Week 8 study visit and at follow-up visits, which will be held at Weeks 12 and 26.
    

Intervention name(s): Tobacco free snuff
Intervention type(s): Drug
Intervention description(s): Tobacco free snuff
Other intervention name(s): Smokey Mountain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smokeless tobacco, harm reduction
Screening for COVID-19 in Teachers, Childcare Educators, Pupils and Preschoolers
Condition: SARS-CoV-2
Study type: Observational

Summary: 
      The main objectives of this study are

        1. to establish the prevalence of SARS-CoV-2 in schools and kindergartens in the State of
           Mecklenburg-Vorpommern in autumn and winter 2020/2021

        2. to monitor the future spread of the disease by assessing serological responses to
           SARS-CoV-2 in teachers and childcare educators over time
    

Detailed description: 
      Detailed Description:

      This study aims to collect information on teachers and childcare educators as well as on
      pupils and preschoolers in the State of Mecklenburg-Vorpommern

      Over a 5 month period, 5 study visits per participant are planned. At each visit,
      nasal/throat swabs (for PCR testing) will be collected and participants will be asked to fill
      in a questionnaire (asking for SARS-CoV-2 risk factors, perceived risk, and impact of the
      pandemic on their quality of life). In adults, additional blood samples (for SARS-CoV-2
      antibody testing) will be collected at the first and the last study visit. This will help to
      gain a better understanding of viral load and antibody development over time.

      The remaining blood samples will be stored in a repository for future research.

      The study is part of a modular SARS-CoV-2-research programme of the University Medicine
      Greifswald.
    

Intervention name(s): Nasopharyngeal swab; Serum testing
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): SARS-CoV-2 PCR; Anti-SARS-CoV-2 antibody testing (IgA and IgG ELISA)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Teachers and childcare educators as well as pupils and preschoolers
      
Biospecimen description: 
      serum, nasal/throat swabs
    
Keywords: serology; antibody formation; epidemiology
Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery
Condition: Perianal Fistula
MeSH terms: Rectal Fistula; Fistula
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the outcome of anal fistula repair with a
      collagen plug is comparable to that of repair by a mucosal advancement flap.
    

Detailed description: 
      Perianal fistula can occur as a complication to a perianal abscess. A perianal fistula is
      associated with significant morbidity and reduced quality of life. Anal fistulas seldom heal
      spontaneously and may require surgical intervention. The main purpose of the operation will
      be to close the fistula and preserve anal continence. The traditional surgical fistula
      closing techniques often show disappointing results. Today, a collagen plug for fistula
      treatment is commercially available. The mounting of this plug is technically easy and less
      invasive than the traditional closure of the fistula by making a lid of anal mucosa
      (advancement flap). The purpose of this study is to determine whether the outcome of anal
      fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement
      flap, with regard to healing of fistula, anal continence and pain. Plug treatment has so far
      shown promising results, but prospective, randomised controlled trials are needed.
    

Intervention name(s): Anal fistula treatment
Intervention type(s): Procedure
Intervention description(s): A comparison of collagen plug vs advancement flap surgery
Other intervention name(s): Perianal; Lambeau technique; Anal fistula plug; Fistula; Surgical treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of a Patient Navigation System to Reduce Time to Waitlisting for Potential Kidney Transplant Recipients
Condition: End-Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to measure the effect of introducing a patient navigator to
      guide high and moderate risk patients through the pre-waitlisting phases of the kidney
      transplant process. Patients identified as being at high and moderate risk of delay to
      waitlisting will be linked with a patient navigator, who will facilitate their completion of
      pre-waitlisting requirements. We believe that patients who are randomized to a patient
      navigator will be more likely to complete the pre-waitlisting process and will complete the
      process more quickly than high and moderate risk patients who do not receive additional
      assistance from a patient navigator.
    

Detailed description: 
      The investigators plan to implement a newly developed risk assessment tool that uses medical
      and demographic indicators to estimate the probability of waitlisting for all patients
      beginning the transplant process at the Emory Transplant Center. Medical secretaries will
      collect information about patients' medical and demographic characteristics during the
      appointment scheduling phone call. This information will be entered into the REDCap risk
      assessment tool, which will be used to calculate the probability of waitlisting. A previously
      defined cut-off will be used to categorize the risk of delay to waitlisting.

      A random subset of patients identified as being at high and moderate risk of delay to
      waitlisting will be connected with a patient navigator, who will be available not only to
      answer questions, but also to manage clinical information prior to, during, and following
      transplantation. The navigator will work to identify potential barriers and to ensure that
      the most up-to-date clinical information has garnered responses at the nurse and physician
      levels.

      The effect of connecting high and moderate risk patients with a patient navigator on time to
      waitlisting and rate of waitlisting will be analyzed to determine whether such a program is
      an effective means of increasing access to transplant for patients who are likely to face
      financial, racial, and demographic barriers.
    

Intervention name(s): Patient Navigation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Transplantation; Healthcare Disparities; Quality Assurance
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult
      Chinese participants with T2DM who are receiving metformin as background antihyperglycemic
      medication.
    


Intervention name(s): PF-06882961; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD); 3 matching placebo tablets taken twice daily (BID) except Day 1 (QD)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science