bioihbjkbjnl/mcl2 huggingface dataset:
Core Strengthening for DRA in Postpartum Women
Condition: Diastasis Recti; Postpartum; Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      This study will prospectively measure the effectiveness of a core strengthening program on
      reducing the inter-rectus distance (IRD) and abdominal wall muscle contraction in postpartum
      women with diastasis rectus abdominus (DRA). Additionally, this study will aim to investigate
      and clarify the association between IRD and low back pain.
    

Detailed description: 
      DRA is a separation of the abdominal wall muscles that commonly occurs during pregnancy and
      is caused by the stretching of the linea alba to accommodate a growing fetus. Separation of
      core muscles is thought to be factor in postpartum low back pain, stress urinary
      incontinence, and core strength, as well as being cosmetically undesirable. This study will
      evaluate the effect of a core strengthening program on shortening the IRD and improving the
      connectivity and strength of abdominal wall muscles in postpartum women with a DRA. It will
      also investigate the relationship between IRD and low back pain.
    

Intervention name(s): Core Muscle Strength Training
Intervention type(s): Other
Intervention description(s): Targeted weekly workouts consisting of low-impact aerobic exercises and resistance exercises designed to address muscle imbalance common in women who exhibit DRA and to prompt automatic core engagement while performing compound, multi-joint movements.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety Study of Tetrathiomolybdate in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the safety of the administration of a copper chelating agent,
      tetrathiomolybdate, for patients with idiopathic pulmonary fibrosis that have failed previous
      treatment. The primary endpoint for this study is safety with secondary endpoints including
      change in pulmonary function, exercise capacity, and quality of life.
    


Intervention name(s): Tetrathiomolybdate
Intervention type(s): Drug
Intervention MeSH terms: Tetrathiomolybdate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Honey in Idiopathic Dilated Cardiomyopathy
Condition: Idiopathic Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Background: Honey, as a natural product produced by honey bees, has anti-oxidant,
      anti-microbial, anti-inflammatory and immunomodulator properties. A few reports suggest that
      honey might have positive effects on cardiovascular diseases.

      Methods: This was a randomized controlled study, which was carried out on 50 children, aged 2
      to 12 years, suffering from idiopathic dilated cardiomyopathy (IDC). Patients were randomly
      assigned into two equal groups: the honey group and the control group. In the honey group,
      honey was provided in a dose of 1.2g/kg/day for three months in addition to the traditional
      treatment of IDC. The patients in the control group received only their standard treatment,
      without honey. The main outcome measure was the percent change in the ejection fraction (EF)
      and the fraction shortening (FS) shown in echocardiography.
    

Detailed description: 
      Background: Honey, as a natural product produced by honey bees, has anti-oxidant,
      anti-microbial, anti-inflammatory and immunomodulator properties. A few reports suggest that
      honey might have positive effects on cardiovascular diseases.

      Methods: This was a randomized controlled study, which was carried out on 50 children, aged 2
      to 12 years, suffering from idiopathic dilated cardiomyopathy (IDC). Patients were randomly
      assigned into two equal groups: the honey group and the control group. In the honey group,
      honey was provided in a dose of 1.2g/kg/day for three months in addition to the traditional
      treatment of IDC. The patients in the control group received only their standard treatment,
      without honey. The main outcome measure was the percent change in the ejection fraction (EF)
      and the fraction shortening (FS) shown in echocardiography. Patients in each group were
      subjected to history taking, clinical examination and investigations, including ECG and
      echocardiography at baseline and end of the study. Patients continued their standard
      treatment during the study. The honey used in the study was subjected to physicochemical
      analysis before use, and it was kept in closed containers away from light until the time of
      administration.
    

Intervention name(s): honey
Intervention type(s): Dietary Supplement
Intervention description(s): Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessing Body Posture and Postural Balance Among Young Adults With Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of the study is to assess the relationship between body posture and dynamic
      balance in adults with childhood-onset asthma and compare them to a non-asthmatic control
      group matched for gender, age, weight, and height.
    

Detailed description: 
      Participants will sign a consent form and provide personal information such as gender, age,
      weight, and height for calculating BMI, pulmonary function test, and respiratory muscle
      strength test, as well as their asthmatic/clinical history. After collecting demographic
      information and obtaining consent from participants, they will be asked to remove their
      T-shirts and stand in the usual relaxed standing position facing the opposite side of the
      machine's window. When the machine is properly positioned, it will take photographs. which
      will then be converted into three-dimensional images on the computer for further analysis.
      When the participant is fully dressed and ready, the second test will be performed using the
      Biodex balance machine. The parameters and testing mode to begin the dynamic balance test
      will be entered into the machine, and the procedure will begin. The participants will be
      thanked for their participation and contribution to our study
    

Intervention name(s): 3D/4D spine and posture analysis "DIERS FORMETRIC 4D" ,The Biodex Balance System SD-
Intervention type(s): Other
Intervention description(s): 3D/4D spine and posture analysis "DIERS FORMETRIC 4D" for postural analysis assessment
,The Biodex Balance System SD- for balance assessment
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        bronchial asthma -18 years above health group ( non bronchial asthma )
      
Keywords: body Posture; dynamic Balance; Biodex Balance System; DIERS FORMETRIC 4D posture analysis
A Pharmacokinetics, Pharmacodynamics and Safety Study of Warfarin in Combination With Tamiflu (Oseltamivir)
Condition: Drug Therapy, Combination
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, randomized, 2-period crossover study, to evaluate the
      pharmacokinetics, pharmacodynamics, safety and tolerability of warfarin in combination with
      Tamiflu (oseltamivir) in participants stabilized on warfarin. Participants will be randomized
      to receive either their warfarin followed oseltamivir and warfarin, or by oseltamivir and
      warfarin followed by warfarin. The treatment periods will be separated by a washout period of
      at least 4 days. Participants will continue receiving warfarin once daily at a prescribed
      usual dose throughout the study.
    


Intervention name(s): Oseltamivir; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): Oseltamivir 75 mg orally, twice daily for 4 days and once on Day 5.; Warfarin once daily, at a dose determined through titration by participants' usual hematologist.
Other intervention name(s): Tamiflu®
Intervention MeSH terms: Oseltamivir; Warfarin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery
Condition: Gastric Bypass Surgery; Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut
      peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric
      bypass surgery (GBP).
    

Detailed description: 
      The main goal is to study the effect of meal number, size and texture on metabolism and
      incretin levels after GBP. Patients will be studied before GBP (T0) and 12-15 months after
      GBP (T1). At T0 and T1, patients will come for 2 study days for 8 hours: On one study day, a
      single meal will be served, on the second study day, three small isocaloric meals, with the
      order of the conditions randomly assigned. The total amount of calories and the overall
      nutrient composition will be equivalent between conditions. The meals will be either all
      solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or
      liquid test meals.

      Gastric emptying will be measured by the acetaminophen test.
    

Intervention name(s): Liquid Meal; Solid Meal
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bariatric; Gastric Bypass; Gastric Banding,; Incretins; glucagon-like peptide-1(GLP-1); gastric inhibitory peptide (GIP)
Safety and Efficacy of Intranasal Application of GX-03 as a Treatment and Prevention for COVID-19.
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2b clinical trial to evaluate the safety and efficacy of intranasal application of
      GX-03 as a treatment and prevention for COVID-19.
    

Detailed description: 
      Phase 2b clinical trial to evaluate the safety and efficacy of intranasal application of
      GX-03 as a treatment and prevention for COVID-19. Patients hospitalized with a diagnosis of
      mild to moderate COVID-19 will be evaluated for a period of five days. Participating health
      care providers will be evaluated for a period of ten days. Swab samples will be collected
      from the right and left anterior nostrils at the beginning of the study, as well as three
      times per day in the treatment arm for five days. Swab samples will be collected from the
      right and left anterior nostrils at the beginning and end of the prevention arm. Samples will
      be subjected to biomolecular tests and viral cultures to assess positivity and disease
      progression. Safety will be evaluated through standard measures of erythema and edema in the
      nasal mucosa.
    

Intervention name(s): GX-03; Petrolatum ointment
Intervention type(s): Drug; Drug
Intervention description(s): Same dosage used in Bactroban Nasal studies.; Viscous ointment similar in form to study drug.
Other intervention name(s): Hexagen Antimicrobial; Placebo
Intervention MeSH terms: Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two part study with four total arms. Parts: Health care providers and CV-19 infected patients. Arms: Interventional and placebo in each of the two groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Study to Assess the Pharmacokinetics, Safety, and Tolerability of ACT-129968 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To explore the pharmacokinetics (PK) of a single dose of two different formulations of
      ACT-129968, i.e., tablet versus capsule and to evaluate the safety and tolerability of a
      single dose of two different formulations of ACT-129968, i.e., tablet versus capsule.
    

Detailed description: 
      A total of 10 female and 10 male healthy subjects will be enrolled and will attend two
      treatment periods, separated by a 7-9 day washout. Over these two periods, two formulations
      of ACT-129968 (Treatment A: two capsules, 250 mg each; Treatment B: one tablet, 500 mg) will
      be administered in the sequence A/B or B/A to 10 subjects (5 females and 5 males) per
      sequence as determined by randomization.
    

Intervention name(s): ACT-129968 500 mg tablet; ACT-129968 250 mg capsule
Intervention type(s): Drug; Drug
Intervention description(s): ACT-129968, a tetrahydropyridoindole derivative, is a chemoattractant receptor homologous molecule expressed on T helper 2 cells (CRTH2) antagonist; ACT-129968, a tetrahydropyridoindole derivative, is a chemoattractant receptor homologous molecule expressed on T helper 2 cells (CRTH2) antagonist
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; Tolerability; Safety; ACT-129968
Yttrium-90 Anti CD66 Monoclonal Antibody in Childhood Relapsed/Refractory Leukaemia
Condition: Acute Myeloblastic Leukemia; Acute Lymphoblastic Leukemia; Juvenile Myelomonocytic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Juvenile
Study type: Interventional
Phase: Phase 1

Summary: 
      The radio-labeled anti-CD66 monoclonal antibody (with 111In for dosimetry and 90Y for
      therapy) will be administered in the T11 North room, UCLH, while the reduced intensity
      conditioning regimen and the allogeneic hematopoietic stem cell transplant will be performed
      in 2 centers, according to the age of the patient: A) patients aged < 13 years will be
      transplanted at the Bone Marrow Transplantation Department, Great Ormond Street Hospital
      (GOSH), and B) patients aged 13-18 years will be transplanted at the Bone Marrow
      Transplantation Department, University College London Hospitals (UCLH).
    


Intervention name(s): Yttrium-90 labelled monoclonal antibody against CD66
Intervention type(s): Other
Other intervention name(s): Radioimmunotherapy
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Intervention model description: 3+3 Dose escalation study, patient will receive 111In-labelled anti-CD66 MoAb (dosimetry) and 90Yttrium-labelled anti-CD66 MoAb (for therapy)
Masking: None (Open Label)
Primary purpose: Treatment
Health Care Analysis on Myocardial Revascularization in Patients With Chronic Coronary Heart Disease (CHD)
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      Myocardial infarction and chronic coronary heart disease (cCHD) are the most frequent causes
      of death in Germany. Treatment options include widening of the narrowed / blocked coronary
      vessel via catheter and stent or bypass surgery in which the narrowed vessel sites are
      bridged. The "German National Disease Management Guideline on cCHD" helps doctors to decide
      which treatment is most appropriate for the severity of vascular damage and possible
      concomitant diseases of the patient. Nevertheless, there are other factors determining
      treatment decision. For example, the equipment or preferences of the hospital or department
      in which patients are admitted, play a role in the decision.

      The aim of the REVASK project is to investigate whether and to what extent the collaboration
      of cardiology and heart surgery specialists in so-called "heart teams" influences the
      decision on therapy.

      For this purpose, doctors and patients will be interviewed about how the treatment decision
      was made and how satisfied both sides are with the outcome of the treatment and the decision.
      In addition, claims data from several German health insurance companies (Techniker, BARMER,
      Betriebs- und Innungskrankenkassen) will be analyzed. Treatment data, which is documented as
      usual by the treating medical staff and passed on to the health insurance companies for
      accounting purposes, is used. Furthermore, treatment data recorded in the registers of the
      professional societies is analyzed.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        outpatient cardiology practices, hospitals with a cardiology department and hospitals with
        a cardiology and heart surgery department (n=20) in Germany
      
Keywords: Chronic coronary heart disease; myocardial revascularization; heart team; decision making; cardiology; heart surgery
Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump
Condition: Diabetes Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The current study focuses on terms of use of Insulin Aspart, fast analogue of human insulin
      and commonly used in the treatment of type 1 diabetes, where it obtained the marketing
      authorization for this indication. In the patient who have an insulin pump, insulin Aspart is
      given daily like a pre-prandial bolus (just before the meal). However, many patients perform
      their bolus after the meal. However this insulin administration modality is not clearly
      studied in the literature.
    

Detailed description: 
      The functional insulin therapy is a method for adjusting insulin doses which tends to mimic
      the physiology, especially when food intake with proportional dose calculation to the amount
      of carbohydrates ingested by the use of ratios. This method of adaptation, increasingly used
      in France, is an extension in the use of subcutaneous insulin pump with a more precise
      determination of bolus doses with meals, and use of aids dose calculations (assistant wizard
      for instance). In practice every day, some patients perform their bolus immediately after
      eating, not just before, allowing them to know exactly the amount of ingested carbohydrates
      and not the one provided in advance.

      This study is very interesting because it allows to compare the injection of an analogous
      bolus of fast insulin before and after the meal.
    

Intervention name(s): Insulin Aspart
Intervention type(s): Drug
Intervention description(s): Injection of Insulin Aspart before or after meals
Other intervention name(s): Bolus
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Risk Factors for Postpartum Psychosis
Condition: Postpartum Period; Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Observational

Summary: 
      A range of psychological disorders occur in women in the postpartum period. These include
      "the blues", which occurs in the first days after birth and which is very common and
      self-limiting; severe psychoses often associated with mania or bipolar illness, occurring in
      the first weeks after birth; and mild to moderate depression, occurring weeks to months after
      birth. Studies have been done focused on postpartum psychosis using a retrospective
      investigation, which gave only a limited material on the prevalence of psychological
      disorders in postpartum women. The investigators hypothesized that different pathways to
      psychosis function as the risk factors which may be overlapped, truly independent, mediating,
      or moderating, in new mothers who are at high risk and/or during the early period of
      delivery. In addition, the investigators purposed that the temporal sequence of biological,
      social and demographic variables are also the potential factors contributing to the
      development of postpartum psychosis.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Parturients undergoing spontaneous or induced labor or cesarean delivery
      
Keywords: Labor; Psychology; Postpartum Psychology
A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy
Condition: Muscle Weakness | Patient; Pain
MeSH terms: Muscle Weakness
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients undergoing arthroscopic hip surgery have been shown to have significant
      post-operative pain that may delay discharge, recovery, and early mobilisation. A
      pre-operative regional anesthesia technique, the fascia iliaca block may be an effective
      method for acute post-operative analgesia.

      This is a prospective, randomized controlled study of the preoperative fascia iliaca block
      for patients undergoing hip arthroscopy.

      The enrolled patients will be randomized to receive either a fascia iliaca block with the
      local anesthetic ropivacaine or to have a sham block. All patients will receive a general
      anesthetic for the hip arthroscopy.
    

Detailed description: 
      Arthroscopic hip surgery is used to diagnose and treat interior joint pathology. Although
      minimally invasive in nature, patients have considerable amount of pain postoperatively,
      leading to prolonged recovery room stay and increased opiate requirements. The investigators
      performed a retrospective chart review in patients who underwent hip arthroscopy at the UCSF
      Orthopedic Institute. 89% of the patients had pain immediate after surgery requiring opioid
      therapy. Regional anesthesia has previously been shown to reduce discomfort after hip
      arthroscopy. However, there is currently no safe, well-established ultrasound guided regional
      anesthesia technique for arthroscopic hip surgery. The fascia iliaca block has shown to
      decrease acute pain related with hip fractures, as well as pain related with knee
      arthroplasty. The ultrasound guided fascia iliaca block is easy to perform and has an
      excellent safety record. The investigators believe that the ultrasound guided fascia iliaca
      block improves pain control in patients undergoing arthroscopic hip surgery.

      Patients will receive a sham block group or a fascia iliaca block, performed in the
      preoperative area.

      Pain scores and measurement of quadriceps strength will be assessed preoperatively and
      postoperatively. The patient will receive a pain diary consisting of pain scores, pain
      medication consumption, and a brief pain inventory. Within 48 hours postoperatively, an
      anesthesiologist will call the patient and review the patient's pain scores, pain medication
      consumption and brief pain inventory.
    

Intervention name(s): Peripheral Nerve Block; Sham Block
Intervention type(s): Drug; Drug
Intervention description(s): Regional Anesthesia by Local Anesthetic Injection; Sham Block by saline injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment