bioihbjkbjnl/mcl2 huggingface dataset:
Faecal Microbiota Transplantation in Patients With Microscopic Colitis
Condition: Microscopic Colitis
MeSH terms: Colitis; Colitis, Microscopic
Study type: Interventional

Summary: 
      Microscopic colitis (MC) is a disease with chronic inflammation of the colon that is mostly
      diagnosed in middle-aged or elderly women. Patients suffer from chronic watery diarrhoea,
      abdominal pain and weight loss. The aetiology of MC is still unknown but it is hypothesized
      that MC is caused by a deregulated immune response to a luminal agent in predisposed
      individuals, and an important role of the intestinal microbiota is suggested.

      In the current proof-of-concept study, the effect of faecal microbiota transfer (FMT) in 10
      MC patients will be evaluated. FMT consists in the infusion of suspended stool from a healthy
      donor into the intestine of a patient with the aim to restore a disturbed intestinal
      microbiota.
    

Detailed description: 
      This will be an intervention pilot study with a 12-week and an optional 6-months follow-up
      period. It will be investigated if the infusion of suspended stool from healthy donors
      improves the symptoms of MC patients by restoring their disturbed intestinal microbiota. This
      procedure is known as faecal microbiota transplantation (FMT).

      MC patients (n=10) will be randomised to receive FMT using stool from one of two healthy
      donors.

      At baseline, blood samples and mucosal biopsies will be obtained from the descending colon.
      In addition, faecal samples will be collected and patients will complete symptom
      questionnaires. The first FMT will be administered by colonoscopy, FMT 2-3 by enemas. Faecal
      samples will be collected and questionnaires will be completed at different time points
      during the study. The patients will be followed-up at 6 weeks, 8 weeks, 12 weeks and 6 months
      after receiving FMT 1, however, the follow-up after 6 months will be optional. Additional
      biopsies from the descending colon and blood samples will be collected 6 weeks after the
      first FMT.
    

Intervention name(s): Faecal microbiota transfer (FMT)
Intervention type(s): Other
Intervention description(s): Suspended stool from a healthy donor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bolus of Saline in Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a non-randomized, Phase 2 clinical trial designed to assess optical cerebral
      blood flow (CBF) response to bolus normal saline. Subjects will have had an ischemic stroke
      within 96 hours of enrollment. The study intervention will be a one hour monitoring session.
      There will be a 15 minute baseline measurement period, followed by intravenous administration
      of 500cc of 0.9% NaCl over 30 minutes, and finally 15 minutes of monitoring post-bolus. All
      study measurements will cease after 1 hour. Subjects will be followed during their
      hospitalization for 7 days or until discharge, whichever is sooner, to monitor for adverse
      events and to collect clinical information.
    


Intervention name(s): Normal saline
Intervention type(s): Other
Intervention description(s): intravenous administration of 500cc of 0.9% NaCl over 30 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Acute Effect of Hypericum Perforatum on Short-Term Memory in Healthy Adults
Condition: Subclinical Anxious Adults; Nootropic Potential of Hypericum and Alprazolam; Healthy Adults
Study type: Interventional
Phase: Phase 4

Summary: 
      Rationale Over-the-counter drugs containing hypericum perforatum (H. perforatum), have been
      argued to improve memory and sustained attention. So far, these claims have not been
      supported in human studies. However, previous studies used rather high dosages, and little is
      known about the acute effect of small dosages.

      Objective We evaluated whether an acute treatment with Remotiv 500 and Remotiv 250 (500 or
      250 mg of H. perforatum quantified to either 1 or 0.5 mg of hypericin) improved memory,
      sustained attention, as well as mood and state anxiety in healthy adults.

      Method A single dosage, randomized, double blind, placebo-controlled trial was conducted with
      82 student participants (33 women). Each participant received placebo in one session and one
      of two dosages in the other session. Order of the sessions and dosage conditions were
      randomized between subjects. Participants completed a battery of tasks assessing short-term
      memory capacity and sustained attention.
    


Intervention name(s): Hypericum perforatum extract
Intervention type(s): Drug
Intervention description(s): 250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of a New Growing-up Milk on Growth and Nutrient Adequacy in Children With Picky-eating Behaviors
Condition: Picky Eating Behaviors
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study was to compare the change in z-scores for growth during a
      120-day study period in children with picky eating behaviors who were randomly assigned to
      receive nutrition counseling only (control group) or nutrition counseling plus an oral
      milk-based nutritional supplement (study group). The secondary objectives of the study were
      to compare the following between the control and study groups: a) dietary macro- and
      micro-nutrient intakes; b) quantitative ultrasound bone measurements of radius and tibia; and
      c) incidence of common illnesses (diarrhea, upper and lower respiratory tract). The safety
      objective of the study was to compare the frequency of adverse events (AE) among the control
      group and study group subjects.
    


Intervention name(s): nutrition counseling plus oral milk-based nutritional supplement; nutritional counseling
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Study group subjects were instructed to consume at least 2 servings (230 mL per serving) of an oral milk-based nutritional supplement daily, in addition to their regular diet, for a total of 120 (±3) days.; nutritional counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Children with picky-eating behaviors; Children aged 2.5 - 5 years; reported by caregivers; with weight-for-height z-scores ≤ 25th percentile at enrollment
Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The aim of this study is to compare the clinical performance of the Biofinity Toric
      (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of
      daily wear.
    

Detailed description: 
      Single masked, open label, randomized, bilateral, crossover study design comparing comfilcon
      A against lotrafilcon B lenses over 1 month of daily wear for each study lens. Each subject
      will be randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B)
      for one month of daily wear before repeating the schedule for the second pair without a
      washout period.
    

Intervention name(s): comfilcon A; lotrafilcon B
Intervention type(s): Device; Device
Intervention description(s): test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B); test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
Other intervention name(s): Biofinity Toric; Air Optix
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Hamstrings Strengthening in Proffesional Athlets
Condition: Exercise; Hamstring Injury
Study type: Interventional

Summary: 
      Athelts that meet the inclusion criteria will be randomized into two groups. The experimental
      group will receive an 8-week (3 days per week) specificl protocol based on hamstring
      strengthening (isometric, concentric and excentric exercises), and the control group will not
      receive any additional exercise. The aim of the study is to investigate the changes in hip
      and knee muscle strength, in the extensibility of cuadriceps, hamstrings and hip abductors,
      in the physical functions and in the final marks.
    


Intervention name(s): hamstring strengthening
Intervention type(s): Other
Intervention description(s): A progressive and individualized hamstring strengthening protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; therapeutics; prevention
Patient-centered Outcomes During Using Self-ligating Brackets With or Without Piezocision vs Traditional Brackets
Condition: Crowding, Tooth
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The different types of brackets (e.g., self-ligating and conventional brackets), and the
      various acceleration methods (e.g., corticotomy) cause varying degrees of pain and
      discomfort. This study will assess pain, discomfort, and other patient-centered outcomes in
      adults with severe crowding on the upper jaw requiring two first premolars extraction.

      There are three groups:

      The first group (control group): the patients in this group will be treated using
      conventional brackets alone.

      The second group (Experimental group): the patients in this group will be treated using
      self-ligating brackets alone.

      The third group (Experimental group): the patients in this group will be treated using
      self-ligating brackets associated with flapless corticotomy.
    

Detailed description: 
      Pain associated with orthodontic treatment is one of the undesirable complications, which
      negatively affects the patient's cooperation. Pain may occur due to the pressure on the
      periodontal ligaments induced by orthodontic forces. The perception of pain is affected by
      many factors related to the patient, such as age, gender and any previous treatment
      experiences, which are negatively or positively reflected on the patient's cooperation. As
      for the factors related to the type of orthodontic treatment provided, the pain and
      discomfort are proportional to the brackets system used and the forces applied, especially in
      the leveling and alignment stage. The amount of tooth movement is directly affected by the
      friction between the brackets and the wires used. The physical properties of the wire and
      brackets used and the dimensions of the applied wires, in addition to the type of ligation
      play a significant role in the amount of friction generated.
    

Intervention name(s): Traditional braces; Self-ligating braces; Self-ligating braces + piezocision
Intervention type(s): Device; Device; Procedure
Intervention description(s): MBT 0.022 perception traditional braces will be used without any acceleration method.; MBT 0.022 perception Self-ligating braces will be used without any acceleration method.; Flapless corticotomy will be applied for the upper anterior teeth.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Self-Ligating Brackets; Flapless corticotomy; Severe crowding; Leveling; Aligning
Nutritional Support in Pressure Ulcer Patients
Condition: Pressure Ulcers
MeSH terms: Pressure Ulcer; Ulcer
Study type: Interventional

Summary: 
      Pressure ulcers are frequently associated with malnutrition. Previous studies have reported
      that nutritional support can improve the healing rate of pressure ulcers but no attention has
      been clearly given to the nutritional status of the patient treated. Moreover, other
      investigators have suggested the additional healing power of some nutrients. Unfortunately,
      previous results have been unpowered by small sample size, poor monitoring of compliance to
      treatments and the confounding effect of other nutrients. The investigators aimed to test the
      effect and additional benefits of several micronutrients delivered through oral nutritional
      support on the healing rate of pressure ulcers in malnourished patients.
    


Intervention name(s): Enriched nutrition formula; Control formula
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): oral formula enriched in arginine, zinc and antioxidant oligoelements; Isonitrogenous isocaloric oral formula
Other intervention name(s): Cubitan (NUTRICIA Italia)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pressure ulcers; Healing; Malnutrition; Nutritional support; Micronutrients
Focus of a Running Schedule and Risk of Running Injuries
Condition: Running Related Injuries
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Running is a natural part of human locomotion and humans have been running for million of
      years. In modern society, running has become a popular way of exercise and is undertaken by
      many people worldwide, possibly because it provides a cheap and easily accessible form of
      exercise, and the positive effects of running on health and fitness are well known.
      Unfortunately, running is also associated with a high risk of injury.

      The purpose of this project is to investigate how a running schedule which focuses either on
      running distance or running speed influence the overall risk of injury and the types of
      injury sustained in recreational runners.
    

Detailed description: 
      Trails directed at investigating differences in injury risk in relation to the focus of the
      running schedule have been conducted without any firm conclusions. People engaged in
      recreational running or choosing running as a new and active lifestyle needs guidance on
      which running schedules minimize the injury risk, aiding their chance of an active lifestyle
      and possibly reversing the increase in people developing a lifestyle disease. To develop
      running schedules minimizing the risk of injury, an understanding of the mechanisms that the
      different training variables impose on the human body is necessary. The existing literature
      on running intensity and the development of injuries show conflicting result. More studies
      are necessary to ascertain if there is a relationship between the intensity of running. In
      such studies, it is important to include other training variables in the analysis and to
      quantify running exposure using an objective method of measuring the relative intensity and
      absolute volume.
    

Intervention name(s): An 8 week preconditioning period; 16 week training period
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Receipt of a weekly running schedule through an online training diary.; Receipt of a weekly running schedule through an online training diary.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Overuse injury; Running related injury; Running pattern
Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
Condition: Pancreatic Cancer; Lymphadenopathy; Gastrointestinal Stromal Tumor
MeSH terms: Gastrointestinal Stromal Tumors; Lymphadenopathy
Study type: Interventional

Summary: 
      Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving
      the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate
      - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has
      traditionally been done with fine needle aspirate where a needle is inserted into the tumor
      and potentially malignant cells are extracted for microscopic analysis. More recently, a
      needle that allows a tissue biopsy for histologic analysis has been FDA approved.

      The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide
      excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges
      from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring
      histology for diagnosis. However, there is currently only limited data from prospective
      studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a
      randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to
      EUS-FNB.
    

Detailed description: 
      Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving
      the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate
      - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has
      traditionally been done with fine needle aspirate where a needle is inserted into the tumor
      and potentially malignant cells are extracted for microscopic analysis. More recently, a
      needle that allows a tissue biopsy for histologic analysis has been FDA approved.

      We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140
      patients with the primary outcome being diagnostic yield. Each patient will be randomized to
      FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will
      crossover to the other arm.
    

Intervention name(s): Fine needle aspiration; Fine needle biopsy
Intervention type(s): Device; Device
Intervention description(s): Fine needle aspiration; FNB
Other intervention name(s): Echo Tip FNA Needle; Echo Tip Procore
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: EUS; FNA; FNB
Influence of Stabilization Splint Thickness on The Temporomandibular Disorders
Condition: Temporomandibular Disorder; Temporomandibular Joint Disorders; Orofacial Pain
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Facial Pain
Study type: Interventional

Summary: 
      The aim of the study is assessing the effect of the stabilization splint (SS) thickness on
      the temporomandibular disorder's and their symptoms; such as muscle or temporomandibular
      joint (TMJ) pain, TMJ sounds, and limitation of mouth opening.
    

Detailed description: 
      Participants are selected from patients who applied to the clinic with the complaint of
      temporomandibular disorders (TMDs). Symptoms are evaluated with RDC/TMD forms. Regarding the
      treatment plan, patients are divided into two groups; 2 mm-thick splint group (2 mm-TSG) and
      4 mm-thick splint group (4 mm-TSG). They used SS's at night for 8 hours, and they were
      recalled on 1st, 2nd, 3rd, and 6th months after splint insertion. Their symptoms and splints
      are checked.
    

Intervention name(s): stabilization splint
Intervention type(s): Other
Intervention description(s): Stabilization splint is an appliance which applied to upper or lower jaw and regulating the occlusal forces in the temporomandibular joint that can cause disorders, also preventing excessive contraction of the masticatory muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stabilization splint; temporomandibular disorders; RDC/TMD; temporomandibular joint; orofacial pain
Phase III Study of Coagulation FVIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors
Condition: Hemophilia A With Inhibitors; Hemophilia B With Inhibitors
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate
      dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the
      treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor
      VIII/IX
    

Detailed description: 
      This was a global, multicenter, Phase III, prospective, open-label, randomized, crossover
      study. After obtaining informed consent and performance of screening procedures, patients who
      met all inclusion and exclusion criteria were randomized to one of two treatment regimens as
      follows:

        -  75 µg/kg treatment regimen

        -  225 µg/kg treatment regimen

      For each treatment regimen there were two phases:

        -  Phase A (Initial phase)

        -  Phase B (Treatment phase)

      The assigned treatment regimen was the dose administered in Phase A and was the starting dose
      in Phase B.
    

Intervention name(s): Coagulation Factor VIIa (Recombinant)
Intervention type(s): Biological
Intervention description(s): A cross over design to assess the efficacy of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of RBT-1 in Healthy Volunteers and Subjects With Stage 3-4 Chronic Kidney Disease
Condition: Acute Kidney Injury
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, single-center, dose-escalating study to evaluate the safety,
      tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-1 in healthy volunteers and
      in subjects with Stage 3-4 CKD.
    


Intervention name(s): RBT-1
Intervention type(s): Drug
Intervention description(s): intravenous administration
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention