bioihbjkbjnl/mcl2 huggingface dataset:
Crossover Trial Determining the Efficacy of Dry Powder Mannitol to Improve Lung Function in Subjects Aged 6-17 Years
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      It is hypothesised that inhaled mannitol 400 mg b.d. will lead to a significant improvement
      in the absolute change in percentage of predicted FEV1 from baseline following eight-weeks of
      trial treatment compared to treatment with inhaled placebo b.d.

      Any improvement in FEV1 is considered clinically meaningful; however, this trial has set a
      threshold of 3% for the purposes of determining an appropriate sample size for statistical
      power whilst retaining trial feasibility in an orphan disease population.
    

Detailed description: 
      Drug Name: Dry powder mannitol for inhalation Phase: 2 Indication: Paediatric and adolescent
      cystic fibrosis Trial Centres: Multicentre Sponsor: Pharmaxis Limited, 20 Rodborough Road,
      Frenchs Forest, NSW 2086 Australia Trial Duration: 27 weeks Number of Subjects: 160 Trial
      Design: Randomised, multicentre, double-blind, placebo-controlled, crossover Primary
      Objective: To determine the effect of eight weeks of twice-daily treatment with inhaled dry
      powder mannitol on lung function (FEV1) in subjects with CF who are aged six to seventeen
      years Dosage and Administration: Trial drug is to be administered via a dry powder inhaler.

        -  Mannitol 400 mg b.d. for 8 weeks followed by a 8-week washout followed by placebo b.d.
           for 8 weeks; or

        -  Placebo b.d. for 8 weeks followed by a 8-week washout followed by mannitol 400 mg b.d.
           for 8 weeks.

      Statistical Methods:

        -  The primary and secondary efficacy analyses will be based upon a modified Grizzle model
           for crossover design. Absolute and relative changes from baseline in percentage of
           predicted FEV1 and FVC will be analysed. The absolute change in percentage of predicted
           lung function (FEV1 and FVC) will be the primary focus. Changes in FEF25-75 will also be
           analysed.

        -  Safety data will be analysed descriptively (listings and summary tables).
    

Intervention name(s): Inhaled Mannitol; Inhaled Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active treatment is inhaled mannitol with a particle size of 3-4 microns; The PLacebo is non respirable mannitol due to the big size particle
Other intervention name(s): Mannitol; IDPM; Dry Powder Mannitol for Inhalation; Bronchitol; Control
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: improving lung function; paediatric and adolescent; FEV1
Effectiveness of Nerve Glide Exercises on Cubital Tunnel Syndrome
Condition: Cubital Tunnel Syndrome
MeSH terms: Cubital Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The objective of this study is to determine if nerve glide exercises in patients with cubital
      tunnel syndrome can improve pain, paraesthesias and reduce the need for future surgery.
      Cubital tunnel syndrome is a common form of peripheral neuropathy caused by compression of
      the ulnar nerve at the elbow. Surgical intervention is typically reserved for those with
      severe symptoms, but many cases can be treated with non-operative measures. This study will
      look at the efficacy of nerve glide exercises in the management of cubital tunnel syndrome.
      70 subjects with cubital tunnel syndrome will be enrolled and randomized into groups
      receiving either standard conservative measures or standard measures in addition to nerve
      glide exercises. Outcomes will be measured 6 months after initiation of treatment with
      questionnaires on clinical symptoms and function to see if there is a difference between the
      two groups.
    


Intervention name(s): Standard Conservative Treatment; Nerve Gliding Exercises
Intervention type(s): Other; Other
Intervention description(s): Range of motion exercises, medication and activity modification.; Taught by occupational therapist. These exercises involve motions of the wrist, arm and neck. Subjects will be instructed to perform exercises regularly following the occupational therapists' protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid Phosphate
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
      of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium
      phosphate salt formulated capsule) after single doses in normal healthy adult subjects and to
      assess the relative bioavailability of TR-701 free acid phosphate powder in capsule
      formulation compared to di-sodium phosphate salt formulated capsule.
    

Detailed description: 
      Subjects will receive the following treatments in a crossover design:

      Treatment A (Reference): One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to
      150 mg TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature
      water;

      Treatment B (Test): One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg
      TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature water;

      Descriptive statistics will be calculated for PK parameters including Cmax, Tmax, AUC0-t, and
      AUC0-inf.
    

Intervention name(s): TR-701 di-sodium phosphate salt; TR-701 free acid phosphate
Intervention type(s): Drug; Drug
Intervention description(s): One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700); One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700)
Intervention MeSH terms: Tedizolid phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation for Non-Hodgkin's Lymphoma (NHL)
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators developed a protocol utilizing once-daily intravenous
      busulfan/melphalan/etoposide regimen as a conditioning for high-dose therapy (HDT) in the
      patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).
    

Detailed description: 
      Treatment:

      busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4
      melphalan 50mg/m2/day i.v. on day -3 and -2
    

Intervention name(s): Busulfan; Melphalan; Etoposide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): busulfan 3.2mg/kg iv on day -8, -7, and -6,; melphalan 50mg/m2/day i.v. on day -3 and -2; etoposide 400 mg/m2 i.v. on day -5 and -4
Other intervention name(s): Busulfex; Alkeran
Intervention MeSH terms: Etoposide; Melphalan; Busulfan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transplantation Conditioning
Comparison of Stretching and MET in Lower Cross Syndrome
Condition: Cross Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      The aim of the study is to compare the effects of stretching exercises & muscle energy
      techniques in the management of lower cross syndrome and to find the effective treatment in
      the lower cross syndrome management.
    

Detailed description: 
      In 2015 the systematic review estimated that prevalence of Chronic low back pain in 24 to 39
      year old individual was 4.2% and the individual between 20 to 59 was 19.6% . The genesis and
      perpetuation of Low back pain (LBP) has many underlying factors among which one is proposed
      by Janda's concept of pelvic crossed syndrome. This condition describes a pattern of tight
      and weak muscles around the pelvis. Marked postural deviation is seen such as increased
      lumber lordosis and depending on this lordosis the muscle involvement can be distinguished.
      The center of the gravity is slightly anterior to S1 or S2, which means pelvis position, is
      key to faulty or good alignment.

      Various studies have been done on muscle imbalance Lower crossed syndrome (LCS) using
      Stretching and Muscle energy Technique (MET). Both have shown superior effects when compared
      to other treatment modalities/techniques. However there is paucity of literature on
      effectiveness of stretching and MET in management of LCS.
    

Intervention name(s): Muscle energy technique; Stretching
Intervention type(s): Other; Other
Intervention description(s): Muscle energy technique for illiopsoas, rectus femoris, erector spinae & hamstrings muscles duration of contraction was 10 sec, rest interval was 5 sec, stretch duration was 30 sec, number of repetition of stretch was 5, number of set was 1, frequency per week was 3; Stretching exercises for illiopsoas, rectus femoris, erector spinae & hamstrings muscles duration of stretch was 15 sec, rest interval was 5 sec, number of repetition was 5, number of set was 1, frequency per week was 3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Muscle energy technique; Lower cross syndrome; stretching
A Clinical Trial of Proximal Composite Restorations
Condition: Class II Caries in Premolars
Study type: Interventional

Summary: 
      Several techniques have been advocated to get good contacts in dental composite restorations
      including interdental separation ring. The investigators study focuses on using separation
      ring with circumferential matrix band instead of a sectional band. Moreover, the
      investigators have attempted to study proximal tightness and proximal contours of composite
      restoration as separate variables
    

Detailed description: 
      A total of 188 premolar teeth with proximal cavity to be assigned on alternate basis in two
      groups. Intervention group teeth received Automatrix band after cavity preparation followed
      by the separation ring using clamp while the control group received Automatrix band alone.

      All teeth to be restored with P-60 composite restorative material(3M-ESPE Dental, USA).
      Outcome (proximal tightness) is determined by a blinded assessor just after the restoration.
    

Intervention name(s): Separation ring; automatrix band
Intervention type(s): Device; Device
Intervention description(s): Separation ring placed along with automatrix band; band placed with a tightening device
Other intervention name(s): BiTine® Separation ring by Palodent, product # 659040); circumferential automatrix band by Dentsply
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: proximal caries, composite restoration, proximal contact
Does Antrum Size Matter in Sleeve Gastrectomy?
Condition: Bariatric Surgery Candidate
Study type: Interventional

Summary: 
      Laparoscopic sleeve gastrectomy (LSG) is currently the most frequent primary bariatric
      procedure performed worldwide. LSG is safe and effective in terms of excess weight loss. It
      is a powerful metabolic operation that activates significant hormonal pathways that lead to
      changes in eating behaviour, glycemic control and intestinal functions. LSG is easier
      regarding its technical aspects and does not need any intestinal anastomosis, begin limited
      to the stomach. The most frequent and sometimes dangerous complications are leaking,
      haemorrhage, splenic injury, sleeve stenosis and gastroesophageal reflux. Despite its
      established efficacy and safety, controversy still exists on optimal operative technique for
      LSG: bougie size, the distance of resection margin from the pylorus, the shape of the section
      at the gastroesophageal junction, staple line reinforcement and intraoperative leak testing
      is among the most controversial issues 11[6]. In literature, different authors have adopted a
      resection distance from the pylorus between 2 and 6-7 cm with various reasons 11[6].
      Resections more distant to the pylorus improve gastric emptying, prevent distal stenosis and
      reduce intraluminal pressure, potentially leading to a lower incidence of fistula and/or
      reflux. On the other hand, resections close to the pylorus would reduce gastric
      distensibility and increase intragastric pressure, potentially increasing satiety with less
      oral intake 11(11,12). The primary aim of this randomized monocentric study is to evaluate
      %EWL at 1 and 2 years follow-up after LSG in two Groups: Group A with a gastric resection
      starting from 2 cm from the pylorus with therefore a wide antrectomy and Group B with a
      gastric resection starting from 6 cm from the pylorus with therefore a small antrectomy.
    


Intervention name(s): Wide antrectomy; Smal antrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 2 cm.; The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 6 cm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Overweight; Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America. The aim of the trial is to
      investigate Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and
      Female Subjects being overweight or with obesity
    


Intervention name(s): NNC9204-0530; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered daily subcutaneously (s.c., under the skin); Administered daily subcutaneously (s.c., under the skin)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Neuromodulatary Efficacy of Transcranial Direct Current Stimulation in Severe Refractory Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Primary Dysmenorrhea (PDM), defined as menstrual pain without discernable organic causes, is
      inexorably common in adolescent women, about 40-90% of women may suffer from it, and 20% of
      them can be severe in the context of being refractory to medication, daily function
      impairment, and having pain of severe degree. Novel therapeutic method is in need for pain
      alleviation for this particular phenotype. It has been reported that PDM females may engage
      motor-cortex based descending pain modulation system in our resting-state functional Magnetic
      Resonance Imaging (rs-fMRI) and thermal pain-activation fMRI studies. Based on the reported
      analgesic efficacy of transcranial Direct Current Stimulation (tDCS) on the motor cortex for
      various experimental painful conditions and clinical pain disorders, it is plausible that
      tDCS can be effective for the severe and medication-refractory PDM patients. This study aim
      to investigate the analgesic efficacy of tDCS in severe PDMs and to elucidate the dynamic
      brain neuroplasticity in the context of experimental pain after tDCS intervention. Thirty
      severe PDMs will be recruited and randomly allocated to either real or sham group in a
      triple-blind manner. Experimental pain electrical stimulation will be performed before and
      after the tDCS intervention. The experimental pain-evoked magnetoencephamographic (MEG) data
      will be correlated with behavioral and psychological measurements. This is the first study in
      the literature investigating the tDCS efficacy for acute pain in severe PDM. The result can
      promise a new possibility for clinical application.
    


Intervention name(s): Active tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): The anode and cathode sponge electrode (51 cm2) will be placed over C3 and FP2 (10-20 system) respectively. 2 mA current will be applied continuously for 20 minutes.; The anode and cathode sponge electrode (51 cm2) will be placed over C3 and FP2 (10-20 system) respectively. 2 mA current will be applied for 30 seconds at the beginning.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: active, sham
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dysmenorrhea; Neuromodulation; Transcranial direct current stimulation; Neuroplasticity; Neuroimaging
Heparin's Influence on ROTEM® Analysis
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      Coagulopathy with transfusion requirements is frequent during cardiac surgery with
      cardiopulmonary Bypass. Rotational thromboelastrometry (ROTEM®) is a viscoelastic whole blood
      point of care test used to assess the patient's coagulation status.

      The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence
      of very high heparin concentrations as seen during cardiopulmonary bypass.
    

Detailed description: 
      The Society of Cardiothoracic surgeons suggest that 50% of patients undergoing cardiac
      surgery have a blood transfusion.

      Several studies indicate an increase in morbidity and mortality related to blood
      transfusions.

      Traditionally, the coagulation tests are performed in the hematology laboratory.

      Rotational thromboelastrometry is a useful method of assessing perioperative coagulation
      function in patients undergoing cardiac surgery.

      The presence of significant amounts of heparin in blood samples during cardiopulmonary bypass
      induces artifactual errors when thromboplastin is used as a reagent. For this reason, whole
      blood coagulation monitoring with ROTEM® has not been feasible during cardiopulmonary bypass
      with heparin anticoagulation. Recently recombinant thromboplastin has come available. It's
      stability is guaranteed by the manufacturer for plasmatic heparin concentrations up to 5UI/l
      .

      Three of the available ROTEM®-tests are EXTEM (activation by recombinant thromboplastin),
      INTEM (activation by elagic acid) and HEPTEM. In the latter, heparinase, added to the INTEM
      reagent, eliminates heparin to reveal underlying coagulopathies.

      The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence
      of very high concentration of heparin and to evaluate whether heparinase could reverse
      heparin's effect on EXTEM and INTEM during cardiopulmonary bypass.

      Arterial blood samples were drawn for analysis after induction of anesthesia (T0),10 minutes
      after the administration of heparin (T1), at unclamping of the aorta (T2) and after heparin
      reversal with protamine (T3). The following tests will be performed: EXTEM, INTEM, HEPTEM and
      a heparinase modified EXTEM. For the latter, recombinant thromboplatin instead of the elagic
      acid is used in the HEPTEM test. Heparin concentrations are measured at T1 and at the end of
      bypass (T2). HEPCON® was used for heparin management.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing coronary artery bypass grafting using cardiopulmonary bypass
      
Biospecimen description: 
      Whole blood
Reducing Hemarthrosis in ACL Reconstruction With BTB Autograft by the Administration of Intravenous TXA
Condition: Anterior Cruciate Ligament Reconstruction
MeSH terms: Hemarthrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the proposed study is to evaluate the effects of administering intravenous
      tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction
      with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and
      post operative pain.
    

Detailed description: 
      The purpose of the proposed study is to evaluate the effects of administering intravenous
      tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction
      with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and
      post operative pain. Patients received the standard arthroscopic ACL reconstruction with a
      BTB autograft and were randomized to either receiving or not receiving two individual doses
      of TXA intra-operatively or receive. The goal of the study is to determine and evaluate the
      effect of intra-operative TXA on post-operative hemarthrosis, pain reduction, and opioid
      consumption.
    

Intervention name(s): Tranexamic Acid
Intervention type(s): Drug
Intervention description(s): One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment