bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Rotation-advancement and Straight-line Surgical Approaches in Repairing Unilateral Cleft Lip Defect
Condition: Unilateral Cleft Lip
MeSH terms: Cleft Lip
Study type: Interventional

Summary: 
      compare different effects of Rotation-advancement based on the Millard technique and
      Straight-line based on Fisher modification as surgical approaches in repairing lip defect of
      unilateral cleft lip patients.
    

Detailed description: 
      Twelve participants with unilateral cleft lip equally divided into two groups. Both groups
      were photographed preoperative and postoperative. The Control group treated using
      (Rotation-advancement) based on the Millard technique; and the test group treated using
      (Straight-line) technique based on Fisher modification.
    

Intervention name(s): Advancement-rotation approach based on Millard' for repairing lip defect.; Straight-line approach
Intervention type(s): Procedure; Procedure
Intervention description(s): patients were treated using Millard technique is the downward rotation of the medial part of the flap, and lateral advancement of the flap to close and fill the defect. if more lip height is needed; "cut- as- you-go" by adding a back-cut incision at the end of his rotation incision down toward the philtral ridge of non-clefted side. Moreover; C-flap is used to close nasal sill.; patients were treated using Straight-Line design based on Fisher modification. C-shaped flap extend from the proposed nasal sill to the origin of philtral column of medial flap as a straight incision to the planned top of the cupid's bow. In addition, to the previous mentioned incision, small inlate incision is needed to length the cleft side on the medial flap.
On the other hand, on the lateral flap; two connected triangular incisions are used; one on the vermillion border at Noordhoff's point. And the other one just above the cutaneous margin to improve aesthetic outcome and diminish formed scar.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Total-Body Irradiation Plus Stem Cell Transplantation And White Blood Cell Infusion in Treating Older Patients With Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem
      cell transplantation may be able to replace immune cells that were destroyed by radiation
      therapy used to kill tumor cells. Infusions of donor white blood cells may decrease the
      body's rejection of the transplanted peripheral stem cells.

      PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy, peripheral
      stem cell transplantation, and donor white blood cell infusions in treating older patients
      who have acute myeloid leukemia.
    

Detailed description: 
      OBJECTIVES: I. Determine whether mixed or full donor chimerism can be safely established in
      older patients with acute myeloid leukemia (AML) treated with nonmyeloablative conditioning
      comprised of low dose total body irradiation, followed by allogeneic peripheral blood stem
      cell transplantation, followed by unrelated donor lymphocyte infusion (DLI). II. Determine
      whether mixed chimerism can be safely converted to full donor chimerism in patients treated
      with DLI. III. Determine the potential efficacy of this regimen in AML patients who are in
      first remission.

      OUTLINE: Conditioning: Patients undergo low dose total body irradiation followed by infusion
      of allogeneic peripheral blood stem cells (PBSC) on day 0. Donor lymphocyte infusions:
      Nonmobilized donor lymphocytes are harvested from the same HLA identical related donor on day
      95 after PBSC transplantation. Eligible patients with mixed chimerism and no graft versus
      host disease (GVHD) receive the first donor lymphocyte infusion (DLI) on the same day that
      donor lymphocytes are collected. Patients who continue to have mixed chimerism and no GVHD
      receive the second DLI at a higher dose level on day 65 after the first DLI. Patients are
      followed weekly until day 90, and then monthly thereafter.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
    

Intervention name(s): therapeutic allogeneic lymphocytes; peripheral blood stem cell transplantation; radiation therapy
Intervention type(s): Biological; Procedure; Radiation
Primary purpose: Treatment
Keywords: adult acute myeloid leukemia in remission; adult acute erythroid leukemia (M6); adult acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute megakaryoblastic leukemia (M7); adult acute monocytic leukemia (M5b)
Dose Proportionality and Food Effect of Morphine Sulfate
Condition: Pain
Study type: Interventional

Summary: 
      Establish the dose proportionality of the 15 mg and 30 mg morphine sulfate tablets and to
      examine the effect of food on absorption from the 30 mg tablet.
    


Intervention name(s): morphine sulfate
Intervention type(s): Drug
Intervention description(s): morphine sulfate 15 mg and 30 mg tablets
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Wearable Lower Extremity Exoskeleton to Promote Walking in Persons With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether a wearable robotic exoskeleton can help
      people with multiple sclerosis (MS) to walk again.
    

Detailed description: 
      Loss of the ability to walk is one of the significant problems in persons with multiple
      sclerosis (MS). This limitation prevents the person from having an active and meaningful life
      at home and in the community. Also, more energy is needed to walk, which can cause fatigue
      and further leads to a non-active life style and poor quality of life. Unfortunately, walking
      training is often not available for this population because of the severity and progress of
      the disease; therefore, a new strategy is needed to help people with MS to walk again. A new
      technology, the wearable robotic exoskeleton, has been developed to help persons with spinal
      cord injuries stand up and walk. The robotic legs are powered by batteries and controlled by
      motors. This study will investigate the use of a wearable robotic exoskeleton to help persons
      with MS to walk. Participants will receive trainings (5 days per week for 3 weeks) to walk
      with the robotic exoskeleton (EKSO, EKSO Bionics, Richmond, CA). During the training, a
      physical therapist will teach the participant how to maintain balance, sit to stand, stand to
      sit, and walk with the wearable robotic exoskeleton. The hypothesis is that persons with MS
      will be able to use a robotic exoskeleton to walk better and with less energy costs.
    

Intervention name(s): Ekso® (Wearable lower limb exoskeleton)
Intervention type(s): Device
Intervention description(s): The wearable lower limb exoskeleton is a powered, robotic lower limb exoskeleton with actuated hips and knees. A control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Multiple Sclerosis; Ambulation; Rehabilitation; Wearable Robotic Devices
Talking Card for Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The research goal is to explore the use and effects of a custom-recordable audio discharge
      instruction card (Talking Card) in the pediatric health care setting. This study will address
      a primary, experimental research question: can pediatric asthma control be improved through
      the distribution of a custom-recorded audio asthma instruction card to parents at the health
      provider's office? Secondary, descriptive objectives will be to evaluate feasibility of
      Talking Card delivery and to collect and summarize parental reactions to the design and use
      of the audio discharge instruction card.

      The specific aims of this study are:

        1. To compare the change in mean Childhood Asthma Control Test (C-ACT) scores for children
           aged 4 through 11 years with uncontrolled asthma receiving a custom-recorded asthma
           instruction card to the change in mean C-ACT scores for those receiving usual care.

        2. To measure the use and impressions of a custom-recordable audio asthma discharge
           instruction card among primary caregivers of children with uncontrolled asthma through
           quantitative and qualitative survey questions.

      The investigators hypothesize that:

      1) Asthma control in children 4 through 11 years of age with uncontrolled asthma, as measured
      by the C-ACT, will improve to a greater extent among those receiving a custom-recordable
      audio discharge instruction card than among those receiving usual care.
    


Intervention name(s): Taking Card
Intervention type(s): Other
Intervention description(s): Recordable greeting card-style discharge instruction card
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Asthma; Health Literacy
MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate biosimilarity between test product MabionCD20® and
      the reference product - MabThera® (rituximab) and to demonstrate comparative safety and
      tolerability of a single course of treatment of MabionCD20® and MabThera® in patients with
      moderate to severe active rheumatoid arthritis.
    

Detailed description: 
      Subjects who meet the criteria for participation in this study receive 2 intravenous
      infusions of MabionCD20® or MabThera® with two weeks interval in combination with
      methotrexate and folic acid. After the treatment period, patients are followed for 24 weeks,
      in order to continue checking safety. Therefore, the total study lasts 48 weeks. There is a
      possibility to repeat treatment after 6 months of the first infusions if subject meets the
      retreatment criteria.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Autoimmune Diseases; Rituximab; Immune System Diseases; Joint Diseases; Rheumatic Diseases
The Relationship Between Body Composition and Physical Fitness in Young Male Basketball Players
Condition: Sports Physical Therapy
Study type: Observational

Summary: 
      In this study, it is aimed to investigate the relationship between body composition, aerobic
      capacity, trunk muscle endurance and muscle strength in young male basketball players.

      The study will take place at a local basketball academy. Young male athletes between the ages
      of 10-24 and enrolled in a basketball academy will be included in the study. Participants who
      have been involved in basketball for less than a year, and those who have injuries that
      prevent participation in the study will be excluded.
    

Detailed description: 
      Individual development differences in young people can have an impact on physical fitness
      components such as aerobic capacity, trunk muscle endurance and muscle strength required for
      basketball. At the same time, differences in these components can have effects on each other.

      There is a complex relationship between anthropometric changes during growth and physical
      fitness because many differences can occur during the physiological development of players.
      In this context, differences in growth rate and development in young basketball players are
      complex factors that affect game performance and player success. Characteristics such as body
      height, body weight, skeletal muscle ratio and body fat are among the basic anthropometric
      components of a basketball player, and these components are considered to be important
      indicators of a player's game performance.
    

Intervention name(s): OMRON BF511 Body Composition Monitor
Intervention type(s): Other
Intervention description(s): The OMRON BF511 Body Composition Monitor is a digital scale and participants' body compositions will be evaluated with this device. The aerobic capacities of the participants will be evaluated with the Multi-Stage 20 m Shuttle Run Test and the maximum oxygen consumption levels will be calculated with the help of the formula with the data obtained from this test. The trunk extensor muscle endurance of the participants will be evaluated with the Biering-Sorensen Test and the trunk flexor endurance will be evaluated with the Kraus-Weber Test. Participants' M. Quadriceps, M. Hamstring, M. Biceps Brachii and M. Triceps Brachii muscle strengths will be evaluated with MicroFET® 2 hand dynamometer.
Other intervention name(s): Multi-Stage 20 m Shuttle Run Test; Biering-Sorensen Test and Kraus-Weber Test; MicroFET® 2 hand dynamometer
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young male basketball players enrolled in a local basketball academy
      
Keywords: Basketball; Body Composition; Aerobic Capacity; Muscle Endurance; Muscle Strenght
Probiotics in Primary Care
Condition: Antibiotic Side Effect
Study type: Interventional

Summary: 
      Antibiotics are lifesaving medicines and generally safe, yet unwanted side effects are
      common. While destroying illness-causing 'bad' bacteria, antibiotics can upset the protective
      'good' bacteria in the body. This research will test if taking a probiotic with prescribed
      antibiotics will decrease the chance of having bothersome antibiotic-associated side effects.
    

Detailed description: 
      Objectives Several studies have demonstrated that probiotics can be helpful in preventing
      antibiotic-associated diarrhoea in hospitalized patients. However, the extent to which
      probiotics may benefit healthy adults taking a course of antibiotics has not been
      investigated in primary care. Furthermore, patient willingness to take a probiotic supplement
      concomitantly with antibiotics has not been explored. We aimed to conduct an exploratory
      study using probiotics in adults requiring an acute course of antibiotic therapy.

      Methods Patients prescribed antibiotics for treatment of acute infections in an outpatient
      family practice setting were randomized to receive either a probiotic or placebo
      concurrently. Patients completed adherence diaries and daily symptom checklists to assess
      gastrointestinal and vaginal (women) symptoms and collect information about adherence.
    

Intervention name(s): Probiotic
Intervention type(s): Dietary Supplement
Intervention description(s): Probiotic capsule, 2 capsules twice daily
Other intervention name(s): Florajen 3
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Comparison of Treatment Modalities in Poor Responders Undergoing IVF
Condition: Poor Responders
Study type: Interventional

Summary: 
      The accurate identification and efficient management of poor responders remains one of the
      most enigmatic challenges in assisted reproductive technology (ART). The investigators study
      will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who
      poor responders.
    


Intervention name(s): Letrozole; human menopausal gonadotropin (hMG)
Intervention type(s): Drug; Drug
Other intervention name(s): Femara
Intervention MeSH terms: Letrozole; Menotropins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Poor responders; letrozole; human menopausal gonadotropin
Efficacy/Safety of HA Inhalation Solution for Hereditary Emphysema in Patients With Alpha-1 Antitrypsin Deficiency
Condition: Emphysema; Alpha 1-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency; Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of administering repeated
      doses of Hyaluronic Acid Inhalation Solution to subjects with Emphysema that have
      Alpha-1-Antitrypsin deficiency
    

Detailed description: 
      The study primarily aims to establish desmosine and isodesmosine concentrations in plasma,
      sputum and urine measured as markers of elastin degradation systemically in the lung and also
      markers of inflammation and fibrinogen. Assessment of vital signs, lab tests, carbon monoxide
      diffusing capacity, oxygen saturation, pulmonary function tests, ECGs, physical exams and
      adverse events.
    

Intervention name(s): Hyaluronic Acid Inhalation Solution; Placebo Inhalation Solution
Intervention type(s): Drug; Drug
Intervention description(s): twice a day 3 mL of 0.03% Hyaluronic Acid Inhalation Solution; Twice a day 3 ml of placebo inhalation solution
Other intervention name(s): active inhalation solution
Intervention MeSH terms: Pharmaceutical Solutions; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Emphysema; COPD; Alpha-1 Antitrypsin Deficiency
Evaluation of Low Level Laser Therapy in Primary Tooth Pulpotomy Treatment
Condition: Pulpotomy
Study type: Interventional

Summary: 
      In our study, it was aimed to compare the long-term effectiveness of diode laser and low
      level laser therapy and primary tooth amputation treatments using calcium hydroxide (LLLT+CH)
      in primary second molars with deep dentinal caries. Ninety patients ( 42 Gırl, 48 Boy) aged
      6-9 years with deep dentin caries in the mandibular second molar were included in the study.
      The patients were randomly selected according to the treatment to be applied and divided into
      two groups as the diode laser group (N=45) and the LLLT+CH group (N=45). The patients were
      called for control appointments at the 1st, 3rd, 6th and 12th months after the treatment, and
      both clinical and radiographic follow-ups were performed. Chi-square and Fisher's Exact tests
      were used to compare categorical variables according to groups in statistical analysis, and
      p<0.05 was considered significant. When the study results at the end of 12 months were
      evaluated, the diode laser group had a clinical success rate of 95.6%, and a success rate of
      93.3% radiologically; The LLLT+CH group had a success rate of 97.7% clinically and 90.9%
      radiologically. There was no statistically significant difference between the success rates
      of the groups (p>0.05). According to the clinical and radiographic results of our study, it
      was determined that diode laser and LLLT+CH amputations showed similar success rates in
      primary second molars with deep dentin caries. It has been seen that both methods can be used
      safely in primary tooth amputations. It is thought that clinical and histological studies and
      studies examining the effectiveness of dental laser applications in primary tooth amputation
      treatment are needed.
    


Intervention name(s): diode lazer; low level diode laser
Intervention type(s): Device; Device
Intervention description(s): diode laser was applied during the pulpotomy procedure; Low-dose diode laser was applied during the pulpotomy procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The principal objective of this study is to compare migration patterns between the Attune and
      Attune S+ PS knee systems using model-based RSA over the first 2 post-operative years.
      Secondary objectives include; comparison of 2-year migration values against published
      thresholds for adequate short-term fixation, quantify changes in functional and health status
      of subjects following surgery and compare between study groups, and assess occurrences of
      complications following surgery.
    

Detailed description: 
      This is a multi-centre, randomized controlled trial of patients undergoing
      posterior-stabilized total knee arthroplasty. In this study, the investigators propose to
      randomize 50 subjects to receive either the standard Attune PS TKA (n=25) or the enhanced
      fixation Attune S+ PS TKA (n=25) and follow them for a period of 2 years post-operatively.
      The primary outcome of the study will be stability of fixation of the tibial baseplate as
      measured by model-based RSA. Secondary outcomes will be to determine the functionality of
      patients after surgery using self-reported questionnaires.
    

Intervention name(s): ATTUNE PS Knee; ATTUNE S+ PS Knee
Intervention type(s): Device; Device
Intervention description(s): The ATTUNE PS Knee is the standard implants.; The ATTUNE S+ PS Knee is the enhanced fixation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To evaluate the effect of oral administration of herbarium mixture Guazuma ulmifolia (GU) and
      Tecoma stans (TS) on metabolic profile in type 2 diabetic patients.
    

Detailed description: 
      A randomized, double blind, placebo controlled, clinical trial was carried out 40 type 2
      diabetic patients independently of their basal hypoglycemic treatment. At beginning and at
      end of the study, BMI, waist circumference, a metabolic profile (fasting glucose, HbA1c,
      lipids and biosecurity profile), were measured. The patients were randomly assigned to
      receive the herbarium mixture (GU/TS) 1 g before each meal, or placebo for a period of 90
      days. All patients received therapy medical nutrition.
    

Intervention name(s): Guazuma Ulmifolia plus Tecoma Stans; Calcinaned magnesia
Intervention type(s): Drug; Drug
Intervention description(s): Guazuma ulmifolia (313.6 mg) -Tecoma stans (86.4 mg) = 400 mg per capsule; Calcined magnesia 400 mg per capsule
Other intervention name(s): GUATECO; Placebo
Intervention MeSH terms: Magnesium Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two study groups were formed that were randomly assigned with the closed envelope technique to the corresponding group. Group Placebo vs. Guazuma ulmifolia plusTecoma stans
Masking: Double (Participant, Investigator)
Primary purpose: Treatment