bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Calcium Supplementation on Women in the Curves for Women Program
Condition: Diet Modification
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of dietary calcium supplementation on
      weight loss, bone density, and markers of health and fitness in women participating in the
      Curves exercise and diet program.
    

Detailed description: 
      The Curves International fitness and weight loss program has become a very popular means of
      promoting health and fitness among women. The program involves a 30-minute circuit training
      program and a weight management program involving periods of moderate caloric restriction
      (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600
      calories per day). The program is designed to promote a gradual reduction in body fat while
      increasing strength and muscle mass/tone. Researchers in the Exercise & Sport Nutrition Lab
      at Texas A&M University have conducted an extensive study on the effectiveness and safety of
      the Curves fitness and diet program. Results of this initial study have shown that the
      program promotes weight loss, improves markers of health, and improves fitness. However, we
      feel that the program may be even more effective with some additional nutritional
      interventions. Calcium has been shown to slow bone loss and more recently has been found to
      help promote fat loss. If this is the case, supplementing the diet with calcium may promote
      greater benefits in women participating in the Curves fitness/diet program. The purpose of
      this study is to examine the effect of dietary calcium supplementation on weight loss, bone
      density, and markers of health and fitness in women participating in the Curves exercise and
      diet program.
    

Intervention name(s): Curves Calcium; Calcium Carbonate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU/d of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron).; Calcium (providing 950 mg/d as carbonate); Dextrose placebo
Intervention MeSH terms: Calcium, Dietary; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Calcium Supplementation; Exercise Intervention
Effects of Myofascial Release on Pain, Disability and Electromyography of Erector Spinae in Chronic Low Back Pain
Condition: Low Back Pain; Disability; Motor Activity; Range of Motion
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether myofascial release techniques are effective
      in the improvement of pain, disability and electromyography response of lumbar muscles in
      patients with chronic low back pain.
    


Intervention name(s): myofascial treatment; Placebo
Intervention type(s): Other; Other
Intervention description(s): myofascial release techniques of different muscles implicated in low back pain; A manual sham intervention will be applied to different muscles implicated in low back pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lumbar region; Pain; Fascia; Electromyography; Goniometry
Glycemic Impact of Oatmeal Plus OatWellXF28
Condition: Glycemic Responses
Study type: Interventional

Summary: 
      The objective of this study is to determine the effect on glycemic responses of adding
      various doses of OatWell28XF to Quaker Instant Oatmeal in order to: 1) describe the
      dose-response curve and 2) If possible, identify the minimum level of OatWell28XF which, when
      added to a serving of Quaker Instant Oatmeal, would result in a glycemic response at least
      20% less than that elicited by a β-glucan-free cereal.
    


Intervention name(s): Oatmeal + OatWell28XF; Oatmeal; Hot cereal
Intervention type(s): Other; Other; Other
Intervention description(s): Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety and Pharmacokinetics (PK) Study of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first study in humans with CVT-427 (zolmitriptan inhalation powder) and is
      designed to evaluate the safety, tolerability, and PK of single ascending doses of CVT-427 in
      adult healthy volunteers.
    

Detailed description: 
      Objectives:

        -  To evaluate the overall safety and tolerability of single, inhaled doses of CVT-427
           (zolmitriptan inhalation powder) in healthy adults, with special emphasis on
           cardiopulmonary effects.

        -  To describe the pharmacokinetics (PK) of single, inhaled doses of CVT-427, Zomig®
           Tablet, and Zomig® Nasal Spray in healthy adults.
    

Intervention name(s): zolmitriptan; CVT-427 (zolmitriptan inhalation powder),
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablet and Nasal Spray; Capsules containing zolmitriptan; dose levels equivalent to estimated fine particle dose (i.e., lung-delivered) zolmitriptan.
Other intervention name(s): Zomig®
Intervention MeSH terms: Oxazolidinones; Zolmitriptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine attacks
Natural Dendritic Cell Vaccines in Metastatic Melanoma Patients
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As
      such they are currently used in clinical vaccination protocols in cancer patients, and both
      immunological and clinical responses have been observed. Several subsets of dendritic cells
      have been characterized in the peripheral blood. One such subset is referred to as
      plasmacytoid dendritic cells (PDC), another as myeloid dendritic cells (myDC). To date PDC
      and myDC have not been evaluated for their capability to induce anti-tumor immune responses
      in patients. For this reason the investigators will perform a safety and efficacy study with
      PDC and myDC in stage IV melanoma patients.
    


Intervention name(s): PDC or myDC
Intervention type(s): Biological
Intervention description(s): PDC or myDC; first patient 0.3 * 10E6 PDC; second and third 1 * 10E6 PDC; fourth and fifth 3 * 10E6 PDC.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dendritic Cells
Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to show that the product of the
      new production process has a similar pharmacological profile to the traditional process used
      for the current commercial product Actrapid®.
    


Intervention name(s): human insulin
Intervention type(s): Drug
Intervention description(s): Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Kinesio Taping on Pulmonary Function and Forward Shoulder Posture FSP of Young Adults
Condition: Healthy Young Adults
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effect of kinesio taping on pulmonary function and
      forward shoulder posture in young adults. Limited literature shows an association between
      forward shoulder posture and pulmonary function but the effect of kinesio taping for
      correction of forward shoulder posture and its consequences on pulmonary function is lacking
      in previous studies.
    

Detailed description: 
      Electronic devices and gadgets are mostly used for official and personal needs in this modern
      era. This increased usage leads to poor posture, especially in young adults. The FSP is the
      most common incorrect posture in youngsters. A study on posture correction shows the
      prevalence of rounded shoulders is 84% in the young adult age group of (18 to 24 years). The
      misaligned posture causes changes in anatomical structure leading to many musculoskeletal
      problems. Along with the musculoskeletal system, FSP also decreases chest wall mobility, lung
      capacities, and overall respiratory function. The respiratory muscle's proper functions is
      need to expand the thoracic cavity . The pectoralis muscles function is to elevate the rib
      cage and its tightness leads to lower chest expansion. Rhomboids play a role in stabilizing
      the scapula which helps the serratus muscle in forced inspiration. Weakness of middle and
      lower trapezius muscles causes the inability to straighten the back, thus affecting the
      ability to raise and expand the chest properly. Currently, for posture correction, usually in
      the form of conservative treatments such as stretching and strengthening exercises,
      McKenzie's exercises, Pilates, shoulder support braces, electrical modalities, etc are used
      to correct or reduce FSP. It is a dire need to find out the best physiotherapy approach for
      the correction of forward shoulder posture as well as improvement in pulmonary function that
      is not time-consuming like other exercise interventions. If the effectiveness of kinesio
      taping on pulmonary function is verified it will contribute to future use as the most
      suitable and less time-consuming approach in youngsters with FSP.
    

Intervention name(s): Kinesio Taping; Conventional physiotherapy protocol
Intervention type(s): Other; Other
Intervention description(s): Kinesio Taping will be applied for 6 weeks and it will be changed with new one after every two days; Stretching exercise for pectoralis minor and major:10 sets and 2 sessions per day for 6 weeks.
Strengthening of Rhomboids and Trapezius muscle: 10 sets and 2 sessions per day for 6 weeks.
Deep Breathing: 10 rep and 2 sessions per day for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Forward Shoulder Posture; Pulmonary Function; Kinesio Taping
Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study is to assess the safety and tolerability of
      intravenously (i.v.) administered 186 Rhenium-isotope (186Re)-labelled bivatuzumab and to
      investigate the biodistribution and pharmacokinetics of 186 Re-labelled bivatuzumab in
      patients with non-small cell lung cancer (NSCLC)
    


Intervention name(s): hMAb BIWA 4
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study of TS-143 in Healthy Adult Male Subjects (Single-Dose Administration)
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety, pharmacokinetics and pharmacodynamics when administering a single
      dose of TS-143 to Japanese healthy adult males using a placebo-controlled, double-blind,
      dose-ascending study, in addition to the effects of meals.
    


Intervention name(s): TS-143; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial
Condition: Biopsy-confirmed IgA Nephropathy; Proteinuria Less Than 0.5 g Per Day; Normal Blood Pressure; Serum Creatinine Below 120 Umol/l
MeSH terms: Kidney Diseases; Proteinuria; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 3

Summary: 
      Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in
      the world. The treatment of IgA nephropathy with normal renal function and minimal
      proteinuria is unknown. Since angiotensin-converting enzyme (ACE) inhibitors reduce
      proteinuria and retard the rate of decline of renal function in chronic proteinuric
      nephropathies, including IgA nephropathy. The investigators conduct a randomized control
      study to evaluate the efficacy of ACE inhibitor in the treatment of early IgA nephropathy.
      Sixty patients with biopsy-proven IgA nephropathy and minimal proteinuria are recruited. They
      will be randomized to ramipril for 5 years or no treatment. Blood pressure, proteinuria and
      renal function will be monitored. This study will explore the effects of ACE inhibitor in the
      treatment of early IgA nephropathy, which is a major cause of dialysis-dependent renal
      failure.
    


Intervention name(s): Ramipril
Intervention type(s): Drug
Intervention description(s): 2.5 mg daily
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine,
      montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy
      participants.
    


Intervention name(s): BMS-986196; Caffeine; Montelukast; Flurbiprofen; Omeprazole; Midazolam; Digoxin; Pravastatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Flurbiprofen; Digoxin; Midazolam; Caffeine; Omeprazole; Pravastatin; Montelukast
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BMS-986196
A Study to Assess the Absorption, Metabolism, and Routes of Excretion Following Oral Administration of (14C) Radiolabeled JNJ--42756493 to Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the absorption, metabolism, and excretion of
      JNJ-42756493 in healthy male adult participants after administration of a single oral dose of
      12 milligram (mg) of unlabeled JNJ-42756493 admixed with 14C JNJ-42756493.
    

Detailed description: 
      This is a single--center, open--label (The researchers and participants know the treatment
      the participant is receiving) study. The study consists of 3 parts: Screening (35 days ),
      Open-label Treatment Phase (Day 1 up to Day 14 or 28); and Follow-up (up to 30 days). Total
      duration of the study is approximately 79 to 93 days. Plasma and urine will be collected for
      determination of JNJ-42756493 concentrations. Participants will be primarily evaluated for
      absorption, the metabolic pathways and the excretion of JNJ-42756493. Participants' safety
      will be monitored throughout the study.
    

Intervention name(s): JNJ-42756493
Intervention type(s): Drug
Intervention description(s): Participants will receive a single oral solution at a dose of 12 milligram (mg) of unlabeled JNJ--42756493 admixed with 14C- labeled JNJ--42756493.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy; JNJ-42756493
Efficacy of Neurofeedback Training in Adults With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Neurofeedback training (NFT) has been frequently investigated as an alternative treatment for
      ADHD mainly in children and adolescents. However, randomized double-blind trials that include
      a sham-neurofeedback control group are lacking, as well as studies examining the efficacy of
      NFT in adult ADHD populations. The inclusion of a sham-neurofeedback group is crucial to
      monitor and exclude unspecific effects.

      This study aims to investigate the efficacy of NFT as compared to a sham-feedback condition
      and a cognitive behavioral treatment in adults with persistent ADHD.

      Efficacy is assessed on several outcome parameters, such as symptom severity,
      neuropsychological variables (e.g., attention, memory), and EEG parameters.
    


Intervention name(s): Neurofeedback active; Neurofeedback sham; Metacognitive Training
Intervention type(s): Behavioral; Behavioral; Behavioral
Other intervention name(s): placebo neurofeedback, simulated neurofeedback; cognitive behavioral therapy, group therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD, Neurofeedback, CBT
A Study to Determine Bioequivalence of Isotretinoin in Healthy Male Subjects Under Fed Condition
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, crossover, randomized, single dose, three treatments, three periods
      and six sequences, single dosage, balanced study to determine Bioequivalence of Isotretinoin.
      Bioequivalence will be compared between the reference medication one (T1) vs the test
      medication (T3): (T1 vs T3); and the reference medication two (T2), vs test medication (T3):
      (T2 vs T3). Finally, treatments T1 vs T2 will be compared statistically to determine if they
      are bioequivalent.
    


Intervention name(s): Isotretinoin: Reference Medication 1; Isotretinoin: Reference Medication 2; Isotretinoin: Test Medication
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Isotretinoin reference medication 1 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each); Isotretinoin reference medication 2 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each); Isotretinoin test medication will contain isotretinoin 40 mg (2 capsules of 20 mg each) in the same type of pharmaceutical presentation, containing the same drug but possible to have a different excipients.
Intervention MeSH terms: Isotretinoin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: capsule; Isotretinoin; Bioequivalence
Accuracy of Half-guided Implant Placement
Condition: Partial-edentulism
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present prospective randomized controlled study is to compare the accuracy of
      implant placement performed either with a surgical motor or a torque wrench as part of a
      half-guided surgical protocol after maxillary sinus floor augmentation.
    

Detailed description: 
      Implant insertion with half-guided surgical protocol was utilized by surgical motor
      (machine-driven group) or torque wrench (manual group) in the maxilla. Forty patients were
      randomly divided in two study groups; 20 implants were inserted with a surgical motor and 20
      implants with a torque wrench. After the healing period, accuracy comparison method between
      planned and actual implant positions was performed based on digital intraoral scan. Coronal,
      apical and angular deviation parameters, insertion time and maximum insertion torque was
      evaluated.
    

Intervention name(s): Half-guided implant placement
Intervention type(s): Procedure
Intervention description(s): The surgery was performed under local anaesthesia in both groups, half-guided implant placement was carried out based on randomization.
Other intervention name(s): Guided implant placement
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Forty patients were treated; implant insertion with half-guided surgical protocol was utilized by surgical motor (20 patients, machine-driven group) or torque wrench (20 patients, manual group) in the maxilla.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental implants; computer-assisted surgery; guided surgery; accuracy; machine driven implant insertion; manual implant insertion
Effect of Partial Rib Resection On the Control of Post-thoracotomy Pain
Condition: Pain, Postoperative; Iatrogenic Injury; Post-thoracotomy Pain Syndrome
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of partial rib resection in reducing acute
      post-thoracotomy pain
    

Detailed description: 
      It is known that severe post thoracotomy pain can be reduced by half with some strategies to
      prevent pain development. It was thought that partial rib resection would reduce intercostal
      tension and prevent an uncontrolled fracture. Thus, it is argued that post thoracotomy pain
      can be reduced. Partial rib resection is applied in clinical practice in selected patient
      groups. However, we could not find a clinical study on this subject in the English
      literature. The aim of this study is to determine whether partial rib resection has an effect
      on the control of thoracotomy pain.

      Before the thoracotomy incision, simple randomization will be performed by flipping a coin.

      Routine thoracotomy incision will be performed in the control group. In the intervention
      group, approximately 1 cm segment of the 6th rib will be excised with a rib scissors before
      the thorax retractor was placed.

      Pericostal suture technique will be used in both groups at thoracotomy closure. Demographic
      information of the cases, preoperative respiratory function parameters, body mass index,
      Visual Analogue Scale scores, complications and analgesic doses will be recorded in the Case
      Report Form regularly.
    

Intervention name(s): Partial rib resection
Intervention type(s): Procedure
Intervention description(s): 1 cm partial rib resection during thoracotomy opening
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Clinical data of intervention group and control groups will be compared
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Post thoracotomy pain; Iatrogenic rib fracture; Thoracotomy; Partial rib resection