bioihbjkbjnl/mcl2 huggingface dataset:
Morbidity in Open Versus Minimally Invasive Esophagectomy
Condition: Esophageal Cancer
Study type: Interventional

Summary: 
      The MIOMIE trial is a prospective randomized controlled study comparing open and laparoscopic
      gastric tube formation in Ivor Lewis esophagectomy. Aim of this trial was to compare the
      minimally invasive approach with the standard open procedure regarding morbidity and
      mortality.
    

Detailed description: 
      Esophageal resection is still associated with considerable morbidity and mortality.
      Standardized preoperative efforts could increase the outcome of these patients. While early
      reports of medical pioneers focused particularly on safety and feasibility, more recent
      studies showed that implementation of minimally invasive esophagectomy (MIE) was widely
      accepted. Since first reports of MIE, different techniques and adjustments have been
      discussed. A recent publication of a large prospective trial in Phase II showed the safety of
      a total minimally invasive approach (video assisted thoracoscopic surgery (VATS) and
      laparoscopy). Surgical technique however is still a subject of debate and the level of
      evidence remains still low. Proving feasibility does not warrant a paradigm shift, as
      experience is an important factor for safety and patient benefit.

      The aim of this study was to evaluate morbidity and mortality of open esophagectomy (OE)
      versus hybrid-MIE in a randomized controlled setting.

      Prior to surgery patients will be randomized either the minimally invasive surgery group
      (laparoscopic gastric tube formation and thoracotomy) or the the open surgery group (open
      gastric tube formation with an open laparotomy approach). Randomizing tool is the
      "randomizer" of the medical university of vienna. (link is attached below)
    

Intervention name(s): minimally invasive esophagectomy; open esophagectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): In the MIE group the laparoscopic procedure was performed for gastric tube formation. The patient was placed in supine position with legs apart. The surgeon stands between the legs using a five-trocar technique. Laparoscopy will be followed by an anterolateral thoracotomy in the fourth intercostal space.; in the open group the gastric mobilization and gastric tube formation will be perfumed with an open surgical approach. Laparotomy will be performed, followed by an anterolateral thoracotomy in the fourth intercostal space.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Minimal-invasive esophagectomy; Esophageal resection; Hybrid esophagectomy
Efficacy of Malaria Vaccines in Kenyan Adults
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      Malaria transmission is falling in some parts of Africa as bed nets and anti-malarials become
      more widely available. However, transmission still persists and it appears that additional
      control measures are required. The leading malaria vaccine candidate in development is RTS,S
      which has efficacy against clinical malaria measured at 30-50% in the field. This partial
      protection might be enhanced by combination with other components. The other vaccination
      approach that has produced repeatable efficacy in humans is the use of viral vectors to
      induce T cell responses. Previous attempts with this vaccine approach have been effective in
      challenge studies in Oxford, but ineffective in the field, probably because of reduced
      immunogenicity.

      Recently, studies in Oxford, Kenya and the Gambia have shown higher levels of immunogenicity
      by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus (modified
      vaccinia Ankara) to deliver the pre-erythrocytic antigen, multiple epitope string with
      thrombospondin- related adhesion protein (ME-TRAP).

      The increase in immunogenicity has lead to sterile protection in 3 out of 14 volunteers and
      partial protection in 5 out of 14 volunteers in challenge studies.

      The investigators propose a Phase 2b study of 120 healthy adult men in Kenya. The
      investigators will assess the efficacy and further evaluate the immunogenicity and safety
      profile of the vaccine regimen. The investigators also intend to assess the correlates of
      efficacy and natural immunity.
    


Intervention name(s): ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation; Rabies vaccine
Intervention type(s): Biological; Biological
Intervention description(s): ChAd63 ME-TRAP: 5 x 10^10vp MVA ME-TRAP: 2 x 10^8 pfu; 2 x 2.5IU Verorab
Other intervention name(s): Verorab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will aim to evaluate the following:

        -  Whether there are any differences in the way the body handles LY2963016 U-200 and
           LY2963016 U-100.

        -  How well-tolerated LY2963016 U-200 is compared with LY2963016 U-100.

        -  How LY2963016 U-200 affects the level of blood sugar in the body compared with LY2963016
           U-100.

      The study will last up to 17 weeks for each participant, including initial screening and
      follow up.
    


Intervention name(s): LY2963016
Intervention type(s): Drug
Intervention description(s): Administered SC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Integrative Medicine for Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      In this study, the effects of a 14-day inpatient treatment in an internal medicine ward for
      integrative medicine on pain, disability, quality of life, satisfaction with life,
      depression, and anxiety will be investigated. Furthermore the influence of potential process
      variables will be evaluated.

      Effects will be measured after completion of the program (2 weeks), and at 6 months follow up
      after start of the program.
    


Intervention name(s): Multimodal integrative medicine inpatient treatment program
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Maternal and Neonatal Benefits of Prophylactic Administration of Vitamin K Before Elective Cesarean Section
Condition: Vitamin K
Study type: Interventional

Summary: 
      Vitamin K deficiency can cause serious risks to pregnant women and their babies that may lead
      to hemorrhage, especially in newborns. We aim to evaluate the efficacy of vitamin k in
      decreasing blood loss during and after elective cesarean section (CS), and to assess the
      neonatal beneficial effects of prophylactic maternal vitamin k administration.
    


Intervention name(s): vitamin k
Intervention type(s): Dietary Supplement
Intervention description(s): patients will take vitamin k 10 mg/ml once daily orally or IM between four and 96 hours before elective cesarean section
Intervention MeSH terms: Vitamin K
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bioavailability Study of Long Chain Omega-3 Fatty Acids From a Gastric Stable Emulsion
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the short term absorption of EPA and DHA from
      triglycerides (TG) released from normal soft gel capsules and from the new patent pending
      vehicle providing a gastric stable emulsion.
    

Detailed description: 
      The present study comprises the design of as well as the effect of pre-emulsification of ω-3
      fatty acids on the bioavailability of docosahexaenoic acid and eicosapentaenoic acid.
      In-vitro studies have shown that long-term steric stabilization of an o/w-emulsion is
      obtained by arresting the oil droplets in a gelatin continuous gel matrix. The emulsion was
      also stable upon dissolution of the gel matrix at physiological conditions in-vitro and is
      hence referred to as a gastric stable emulsion (GSE).

      In the bioavailability study, healthy young students were recruited and presented two
      different single-dose treatments of fish oil containing 5 grams of ω-3 fatty acids; one group
      receiving the fatty acids in traditional soft gel capsules, whereas the other group received
      the fatty acids using the GSE technology. Time resolved (2 - 26 hours) blood plasma analysis
      after intake of this single dose ω-3 fatty acids revealed significantly increased AUC0-26h
      and Cmax of EPA and EPA + DHA when administered as GSE compared to traditional soft gel
      capsules.
    

Intervention name(s): Omega-3 oils from tri-glycerides; Omega-3 oils from marine phospholipids
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Single-dose administration of approximately 5 grams of omega-3 oils from triglycerides; Single-dose administration of approximately 5 grams of omega-3 oils from marine phospholipids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Bioavailability; Eicosapentaenoic acid; Docosahexaenoic acid; Soft gel capsules; Gastric stable emulsion; Omega-3; Tri-glycerides; Marine phospholipids
Nitrate, Chronic Obstructive Pulmonary Disease (COPD) and Exercise
Condition: COPD
Study type: Interventional

Summary: 
      Patients with moderate chronic obstructive pulmonary disease (COPD) typically have reduced
      exercise capacity. This is because their lungs are damaged and because of increased work of
      breathing. In some patients, exercise capacity is reduced to such a level that even simple
      activities of daily living, such as washing and dressing, may impose a challenge.

      Recent findings in healthy young people suggest that increasing the amount of nitrate in our
      diet in the form of beetroot juice can improve the ability to exercise. Studies involving
      cycling have shown that less oxygen is needed to perform the same level of exercise after
      taking more nitrate in the diet. Nitrate (found in abundance in beetroot) is known to be
      converted in the body to nitric oxide (NO), a substance which increases blood flow and may
      affect the energy-producing mechanisms inside muscle cells. A recent exciting finding is that
      such dietary nitrate supplementation appears to reduce the amount of oxygen needed to
      complete moderate intensity exercise (walking) in healthy individuals. It is the purpose of
      this study to see if such effects could be seen in COPD patients. If this is indeed the case,
      then it may suggest that a period of dietary supplementation of a relatively cheap, widely
      available, and natural food product may improve the ability of patients to undergo everyday
      tasks and ultimately improve their quality of life.

      To help investigators understand the effects of dietary nitrate supplementation on the
      ability to exercise in COPD patients, the investigators will recruit 15 people with mild to
      moderate disease. They will complete a series of undemanding exercise tests on three separate
      occasions. On one occasion they will have had a course of nitrate rich beetroot juice leading
      up to the tests, and on the other occasion they will have had a course of beetroot juice with
      the nitrate removed. The investigators will monitor blood pressure, levels of nitrate and
      nitrite in the blood, oxygen uptake and functional capacity during the tests which will allow
      us to assess any effects that may have occurred as a result of increased nitrate intake.
    


Intervention name(s): Beetroot; Beetroot placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): James Whites Drinks beetroot sports shot; James Whites Drinks beetroot sports shot
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Interactive Voice Response (IVR) for Methadone Patients
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Observational

Summary: 
      This study is designed to test whether a telephone call-in program is a feasible way to
      collect mood and drug-related information in individuals enrolled in a methadone maintenance
      program.
    

Detailed description: 
      Participants will complete a baseline interview and a follow-up interview at 5-weeks
      post-baseline. Two-thirds of the participants will be randomized into the telephone call-in
      group, and will be asked to complete daily, 10-minute, telephone interviews. To complete
      these interviews, participants will call into a toll-free telephone interview system with a
      unique and private Study ID number, and answers questions by using the telephone key pad.
      Questions during both the face-to-face interviews and the telephone interviews will assess
      mood, sleep, treatment utilization and drug-related experiences. Participants will be
      compensated for their time.

      Comparison(s): Participants randomized into the telephone component of the study as compared
      to participants in the interview-only component of the study.
    

Intervention name(s): interactive voice response
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals who recently enrolled in methadone maintenance for opioid addiction.
      
Keywords: IVR, methadone; methadone maintenance
The Amenorrhea With Etonogestrel Implant
Condition: Contraception
MeSH terms: Amenorrhea
Study type: Interventional

Summary: 
      The etonogestrel subdermal implant has been available worldwide for more than 15 years. The
      action of etonogestrel subdermal implant is principal via suppression of ovulation, but it
      also has effects on cervical mucus and in some women induces suppression of endometrial
      proliferation. Several studies have confirmed its high efficacy and convenience. The uterine
      bleeding problems and in particular irregular bleeding and amenorrhea are major side effects
      of etonogestrel subdermal implant. A considerable number of patients request early removal
      due to bleeding changes. Amenorrhea occurs in about 22% in etonogestrel subdermal implant
      users. Despite the presence of many studies that reported the prevalence of etonogestrel
      subdermal implant-associated bleeding, little is known about the predictive factors affecting
      menstrual bleeding patterns especially amenorrhea after etonogestrel subdermal implant
      insertion. These predictive factors should be provided prior to the etonogestrel subdermal
      implant insertion which may improve acceptance and continuation of etonogestrel subdermal
      implant.
    


Intervention name(s): Implanon NXT
Intervention type(s): Device
Intervention description(s): women will be subjected to etonogestrel 68 mg implant insertion. Participants will be trained on how to fill the menstrual diary. The menstrual diary includes information about days of bleeding and spotting days.
Other intervention name(s): Etonogestrel subdermal implant
Intervention MeSH terms: Etonogestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Clinical Trial of Transdiagnostic Cognitive-Behavior Therapy for Anxiety Disorders
Condition: Panic Disorder; Agoraphobia; Social Anxiety Disorder; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Panic Disorder; Phobia, Social; Agoraphobia
Study type: Interventional

Summary: 
      Anxiety disorders are the most common mental disorders in community settings, and they are
      associated with significant psychological distress, functional and social impairment.
      Although pharmacological and psychological treatments for anxiety and depression have existed
      for several years now, only a minority of anxiety disorder sufferers are treated according to
      guidelines. Cognitive behavior therapy (CBT) is the most consistently efficacious
      psychological treatment for anxiety disorders, but implementation of CBT in primary care is
      challenging due to limited resources. Recent studies indicate that transdiagnostic group CBT
      for multiple anxiety disorders could be a promising alternative to individual CBT in primary
      care. The aim of the study is to examine the effectiveness of group CBT for anxiety disorders
      as a complement to usual care. The clinical trial will be conducted in three Health and
      Social Services Centers in the province of Québec (i.e. Sherbrooke, Laval and Québec).
      Patients will be French-speaking adults with anxiety disorders, and they will be randomly
      assigned to one of two treatment conditions: a) Transdiagnostic group CBT (12 weekly 2-hour
      sessions), b) usual care. The transdiagnostic group CBT will be offered as a differed
      intervention to participants in the usual care group after the 8-month follow up.
      Participants in both study arms will undergo a baseline clinical evaluation as well as
      outcome assessment interviews at post-treatment, 4, 8, and 12 month follow-up time-points.
      The primary study results will include improvement on a questionnaire on anxiety symptoms.
      Widespread implementation of group CBT could lead to better outcomes for a large number of
      patients living with anxiety.
    


Intervention name(s): Transdiagnostic Cognitive-Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Treatment in the Transdiagnostic CBT condition will consist of 12 weekly 2-hour sessions following the manualized treatment protocol including psychoeducation, cognitive restructuring, exposure and relapse prevention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Panic Disorder; Agoraphobia; Social Anxiety Disorder; Generalized Anxiety Disorder; Cognitive-Behavioral Therapy
Tolerance of Regular Meal Intake With Mycoprotein (TOMMY)
Condition: Gastrointestinal Complication
Study type: Interventional

Summary: 
      This study aims to assess the impact of daily intake of 11 grams of Fermotein™ on
      gastrointestinal complaints and several other health related biomarkers. Furthermore,
      consumer acceptance is investigated. The study has a randomized parallel design. Two
      different treatments will be evaluated e.g. a 18-day intervention with fermotein based meals
      and a 18-day intervention with control meals. At the start and at the end of the
      intervention, a blood sample will be collected. Questionnaires about gut complaints, stool
      consistency and frequency, wellbeing, health complaints or other adverse effects will be
      collected daily during intervention and up to two days after the intervention.
    

Detailed description: 
      Fermotein™ is a mycoprotein, derived from fungi, especially produced for human consumption.
      It is high in protein, high in fiber, low in saturated fat and contains no cholesterol. Its
      functional properties and nutrient content makes them ideal to use as an ingredient for meat
      alternatives and other vegetarian/vegan food products. This study aims to assess the impact
      of frequent intake of 11 grams of Fermotein™ powder (dry) on gastrointestinal complaints and
      several other health related biomarkers.

      The primary objective is to investigate gastro-intestinal complaints during 18 days of
      Fermotein™ consumption. The secondary objective is to assess blood based parameters related
      to general health and consumer acceptance.

      The study has a randomized parallel design. Two different treatments will be evaluated e.g. a
      18-day intervention with Fermotein™ based meals and a 18-day intervention with control meals.
      At the start and at the end of the intervention a blood sample will be collected.
      Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health
      complaints or other adverse effects will be collected daily during intervention and up to two
      days after the intervention.
    

Intervention name(s): Fermotein based meals; Matching control meals with whey protein and wheat bran
Intervention type(s): Other; Other
Intervention description(s): various meal products: bread, soup and an occasional burgers; various meal products: bread, soup and an occasional burgers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fermotein™; Gastrointestinal tolerance
Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Anterior Cruciate Ligament Reconstruction
Condition: Anterior Cruciate Ligament Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      A randomized clinical trial involving 30 individuals submitted to ACL reconstruction will be
      conducted.

      Participants will be randomized into: Group I, submitted to a muscular rehabilitation program
      based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation
      program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation
      protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema
      reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation
      programs based on eccentric isotonic and isokinetic exercise will begin 45 days after ACL
      reconstruction. The programs will last six weeks, with training frequency of two sessions per
      week, separated by a minimum interval of 72 hours.
    


Intervention name(s): Isokinetic eccentric exercises; Isotonic eccentric exercises
Intervention type(s): Other; Other
Intervention description(s): The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality.
45 days after ACL reconstruction, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isokinetic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.; The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality.
45 days after ACL reconstruction, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isotonic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment