bioihbjkbjnl/mcl2 huggingface dataset:
Virtual Reality in Motor Performance and Quality of Life in Patients With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Treatment with Nintendo wii is higher to physical therapy conventional in the quality of life
      and motor performance in patients with Parkinson's disease.
    

Detailed description: 
      The aim of this study is to assess if the treatment of rehabilitation with Nintendo wii is
      higher to the conventional in the quality of life and motor performance in patients with
      Parkinson's disease.
    

Intervention name(s): treatment with Nintendo wii.; Physical therapy conventional.
Intervention type(s): Other; Other
Intervention description(s): Participants Will receive treatment with Nintendo Wii over one months. These Patients Will Be subjected to mobilization of stem and stretching. Then Will Be Submitted to Nintendo wii games. Will Be Submitted This group three times a week to a treatment protocol with boxing exercises with wii sports and wii fit; Conventional exercises used with the same goals for the group with wii
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Physical therapy; Virtual Reality; Quality of life; Motor performance
Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration
Condition: Bilateral Middle Ear Effusion
MeSH terms: Otitis Media with Effusion
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with
      bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will
      receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the
      middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The
      study is designed to characterize safety and any procedural issues associated with TTT drug
      administration of OTO-201.
    


Intervention name(s): OTO-201
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone
      propionate and salmeterol was compared with concurrent administration of fluticasone
      propionate and salmeterol. Administration occurred over 14 days and tolerability, PK
      (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.
    


Intervention name(s): fluticasone propionate/salmeterol
Intervention type(s): Drug
Intervention description(s): investigational drug
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma
Contraceptive Counseling Following an Abortion
Condition: Post Abortion Care
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether contraceptive counseling is effective on
      acceptance and use of methods in women following an abortion.
    

Detailed description: 
      Contraceptive counseling is considered an essential component of post abortion care (PAC)
      programmes and it is recommended to prevent unintended pregnancies and unsafe, repeated
      abortions. Indeed, most maternal deaths related to unsafe abortions could be prevented by
      expanding and improving family planning provision.
    

Intervention name(s): Personalized contraceptive counseling
Intervention type(s): Behavioral
Intervention description(s): The intervention comprised a personalized and comprehensive (face-to-face) contraceptive counseling regarding to individual contraceptive history and needs. The counseling intervention was conducted by three trained gynecologists according to standard one day training.
Other intervention name(s): Intervention group; Control group
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ambulatory Care Facilities; abortion care; contraception; counseling; outpatient clinic
Treatment Study Comparing Medium or High Dose Uva-1 Treatment 3x/Week Versus Fluocinonide 0.05% Cream in the Treatment of Morphea.
Condition: Symmetric Limited Morphea
MeSH terms: Scleroderma, Localized
Study type: Interventional

Summary: 
      Compare UVA-1 phototherapy treatment to topical steroid treatment in subjects with morphea.
    


Intervention name(s): Medium Dose UVA-1; High Dose UVA-1
Intervention type(s): Other; Other
Intervention description(s): UVA-1 phototherapy treatment (60 J/cm2) three times per week for 12 weeks.; High dose (120 J/cm2)UVA-1 phototherapy three times per week for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Morphea; Plaque morphea; Localized Scleroderma
Bioequivalency Study of Sertraline Under Fasting Conditions
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline
      Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fasting conditions using a
      single-dose, 2-treatment, 2-period, crossover design.
    


Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Recovery of Bupivacaine or Bupivacaine-Lidocaine Spinal Anesthesia and Infiltration Anesthesia in Herniorrhaphy
Condition: Anesthesia; Inguinal Hernia
MeSH terms: Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is the investigation of whether adding lidocaine to hyperbaric
      bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter
      recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy
      procedures.
    

Detailed description: 
      Consecutive 93 patients undergoing inguinal herniorrhaphy will be recruited with a
      prospective protocol.Spinal anesthesia will be commenced in Group BLS with 2 ml hyperbaric
      bupivacaine (10 mg) + 0.6 ml 1 % lidocaine (6 mg), in Group BS, hyperbaric bupivacaine (10
      mg) + saline in the same volume and Group LIA will have anesthesia with bupivacaine and
      lidocaine for step by step local anesthetic infiltration. Sensorial block will be measured
      with pinprick test, motor block will be tested with Bromage scale. Heart rate, blood pressure
      and peripheral oxygen saturation will be measured every 5 minutes. Time of subarachnoid
      injection, onset of sensorial block (block at L1 dermatome), time to block T10 dermatome,
      maximum block level, time to maximum block and time to two segment regression, T10 regression
      , LI regression and S1 regression of the block will be recorded in group BLS and BS.The onset
      and resolution of the sensorial and motor block will be assessed by anesthetists blinded to
      group allocation. PACU stay and discharge times and VAS pain scores will be recorded in all
      patients. Patients also will be investigated for adverse events (hypotension, bradycardia,
      nausea,PDPH, TNS, urinary retention)and satisfaction regarding the anesthetic method.
    

Intervention name(s): spinal anesthesia; spinal anesthesia; infiltration anesthesia
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): To receive 2 ml heavy bupivacaine + 0,6 ml saline; To receive 2ml bupivacaine +0,6 ml 1% lidocaine for spinal anesthesia.; To receive step by step local infiltration anesthesia as described by the Lichtenstein Institute.
Other intervention name(s): marcaine heavy; marcaine heavy; lidocaine; marcaine; lidocaine
Intervention MeSH terms: Lidocaine; Bupivacaine; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: spinal anesthesia; bupivacaine; lidocaine; local infiltration anesthesia; recovery; duration of anesthesia; outpatient herniorrhaphy
Exploratory Clinical Study to Investigate the Ability of an Experimental Combination Dentifrice to Protect Sensitive Teeth
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity
Study type: Interventional

Summary: 
      This proof of principle (PoP) study will evaluate the ability of an experimental combination
      toothpaste formulation to protect sensitive teeth from dentine hypersensitivity.
    

Detailed description: 
      This will be a PoP, single centre, 8-week, randomised, controlled, examiner blind, parallel
      design, stratified (by maximum Baseline Schiff sensitivity score of the two selected test
      teeth) clinical study in healthy participants with sensitive teeth.
    

Intervention name(s): 3% PVM/MA + 5% KNO3 Combination; 3% PVM/MA only; 5% KNO3 Only; Regular Fluoride
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Toothpaste containing 3% PVM/MA + 5% KNO3 as combination will be used as test product.; Toothpaste containing 3% PVM/MA only will be used as comparator 1 product.; Toothpastes containing 5% KNO3 only will be used as comparator 2 product.; Toothpaste containing regular fluoride will be used as negative control.
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Glucose Levels in Early Pregnancy and Feto-maternal Outcome
Condition: Maternal Diabetes
MeSH terms: Diabetes, Gestational
Study type: Observational

Summary: 
      to find out whether variations in the fasting blood glucose in early pregnancy affect the
      fetomaternal outcome
    

Detailed description: 
      Retrospective study conducted on the records of patients who were seen at Jordan University
      hospital in the period January 2016 to December 2020. All primigravid women with FBS that
      were done in early pregnancy before completed 20 weeks of gestation were included. Exclusion
      criteria were known diabetics, multiple pregnancies, thyroid dysfunction, patients taking
      steroids or any other medications for chronic illness (s) and those with missing data.
      Patients were divided into 2 groups; group had a FBS 80-120 mg/dl and group 2 with FBS less
      than 80 mg/dl. Pregnancy outcomes were then compared between the 2 groups.

      Gestational age was confirmed by early ultra-sound (US) scan before 16 weeks gestation. All
      FBS samples were measured at our laboratory. Investigators collected data regarding patients'
      age, body mass index (BMI), FBS early in pregnancy, any complication in the pregnancy or the
      pregnancy outcome including miscarriage (defined as pregnancy loss before completed 24 weeks
      gestation), preterm delivery (defined as spontaneous vaginal delivery before completed 37
      weeks gestation), gestational age at delivery, polyhydramnios, congenital abnormality (minor
      or major), stillbirth, intra-uterine fetal death (IUFD), neonatal death and mode of delivery.
      For those who underwent cesarean section, the indications were also identified. Fetal outcome
      included birth weight; APGAR score at 1 minute and APGAR score at 5 minutes. The APGAR score
      was determined by the neonatologists who routinely attend deliveries at our hospital.

      Investigators also identified those who were diagnosed to have GDM with any intervention
      (metformin or insulin and their dosages). Diagnosis of GDM was based on a standard 75 gm
      glucose tolerance test (GTT) at 26-28 weeks gestation. A normal FBS level is lower than 95
      mg/dL, one hour lower than 180 mg/dL, two hours lower than 155 mg/dL Three hours after
      drinking the glucose solution, a normal blood glucose level is lower than 140 mg/dL.
    

Intervention name(s): Observation of their fetomaternal outcome
Intervention type(s): Other
Intervention description(s): observe the fetal outcome and maternal outcome
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women in their first pregnancy
A Pilot Study on Effect of SKY on Psychosocial Parameters of Type 2 Diabetic Patients After a 6 Days
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Sudarshan Kriya Yoga intervention has
      effect on the quality of life , anxiety and depression of Type 2 Diabetic Patients.
    

Detailed description: 
      Diabetes is a psychologically and behaviorally demanding disease; therefore psychosocial
      factors are relevant to nearly all aspects of its management. Research findings have
      demonstrated that depression is more common in patients with diabetes than in the general
      population, at least 15 % of patients have clinical depression.Yoga is a mind-body
      alternative therapy which can be used to prevent and treat type 2 diabetes mellitus and
      related complications.

      Sudarshan kriya Yoga is a unique yogic breathing practices which involves several types of
      cyclical breathing patterns, ranging from slow and calming to rapid and stimulating. It is
      recommended for relaxation, stress management, control of psycho physiological states and to
      improve organ function. In this pilot study Investigator recruited 24 type 2 diabetic patient
      and those who consent were provided with 6 days yoga course for a duration of 3 hours and
      trained to practice SKY at home for 12 week. At baseline and after 6 days of SKY,
      questionnaire on anxiety, depression and quality of life were provided to them. Biochemical
      parameters were measured at baseline and after 12 weeks of yoga. Two follow up yoga session
      were provided to the participants. Primary outcome were pre to post intervention change in
      the mental health and quality of life.
    

Intervention name(s): SKY
Intervention type(s): Other
Intervention description(s): Sudarshan Kriya Yoga is a rhythmic breathing exercise with slow and fast breath at a particular pace.It is recommended for stress management as yoga is a mind body control tool. SKY is having effect on multiple organ thus causing the positive effect.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fed Study
Condition: Healthy
Study type: Interventional

Summary: 
      This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg
      delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate is
      equivalent to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy
      Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg of
      Pantoprazole sodium sesquihydrate is equivalent to 40 mg of Pantoprazole) of Wyeth
      Laboratories, USA in healthy, adult, human, male subjects under fed conditions.
    

Detailed description: 
      The study was an open-label, balanced, randomized, two-treatment, two-period, two-sequence,
      single-dose, crossover, bioequivalence under fed conditions

      A washout period of 08 days was enforced between the administrations of study drugs in each
      period. At study check-in, the subjects reported to the clinical site at least 36 hours prior
      to Day 1 dosing and were required to stay for 24 hours after Day 1 dosing. Blood sample
      collections were obtained within 90 minutes prior to dosing (0 hour) and after dose
      administration at periodic interval up to 48.00 hour in each period. A total number of blood
      draws during the study were sixty six (66) and the total volume of blood drawn did not exceed
      324 mL.

      Following an overnight fast of at least 10 hour, a high-fat high-calorie breakfast was served
      to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of
      Pantoprazole delayed release tablet 40 mg of either test or reference formulation was
      administered during each period of the study, along with 240 mL of drinking water at ambient
      temperature under low light condition and under supervision of trained study personnel. Both
      test and reference products were administered to all the study subjects, one in each period.
    

Intervention name(s): Pantoprazole; Pantoprazole
Intervention type(s): Drug; Drug
Intervention description(s): Pantoprazole 40mg Delayed release tablets (Test Product); Protonix® Delayed Release 40 mg tablets (Reference product)
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the
      safety and tolerability of neratinib in healthy subjects and subjects with chronic liver
      disease.
    


Intervention name(s): Neratinib (HKI-272)
Intervention type(s): Drug
Intervention description(s): Neratinib 40-mg oral tablets. SINGLE DOSE of 120-mg (3 x 40-mg tablets)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Entertainment Media to Deliver Educational Messages About Mammography in Saudi Arabia
Condition: Breast Cancer; Behavior
Study type: Interventional

Summary: 
      This clinical trial aims to test if Elissa's Entertainment-Education (EE) song can influence
      Saudi females' intention to perform breast cancer early screening via mammogram.
    

Detailed description: 
      This study will be guided by a scarcely applied theoretical model that integrates the issue
      involvement concept into the Theory of Planned Behavior (TPB) to test the role of issue
      involvement in predicting intention to perform breast cancer early screening via mammogram
      among Saudi females after exposure to EE message.
    

Intervention name(s): You-Tube Video: Elissa's EE song; Active Comparator: Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Watch You-Tube video utilizing Entertainment-Education communication strategy.; Reading materials containing information about early breast cancer screening in the form of infographics. Information is adopted from the Saudi Ministry of Health (MOH).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Mammogram; Prevention
Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules
Condition: Parkinson
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study were to characterize the effects of food on the pharmacokinetics
      (PK) and tolerability of BIA 9-1067 in healthy male subjects.
    

Detailed description: 
      Methodology: Single center, randomized, single dose, open-label, 2-period, 2-sequence,
      crossover study.
    

Intervention name(s): BIA 9-1067
Intervention type(s): Drug
Intervention description(s): A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.
Other intervention name(s): Opicapone, OPC
Intervention MeSH terms: Opicapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opicapone,; Parkinson,; Bial,; BIA 9-1067
A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
Condition: Arthritis; Avascular Necrosis
MeSH terms: Necrosis
Study type: Interventional

Summary: 
      This study compares the posterior approach to the anterolateral approach using the ReCap®
      Total Hip Resurfacing System.
    

Detailed description: 
      Theoretical considerations of RECAP procedures through anterolateral trochanteric osteotomy:

        -  Less bone resection, less complicated revision surgery.

        -  Reduced stress shielding of the femur.

        -  Lower incidence of hip dislocations.

        -  Walking function improved by change in mobilisation regime and operative technique.

        -  Risk of femoral neck fracture is reduced by preoperative measurement of bone density.

        -  Risk of avascular necrosis of the femoral head is reduced with the anterolateral
           approach preserving femoral head blood supply and preventing later failure of the
           implant.
    

Intervention name(s): Anterolateral approach; Posterior approach; ReCap Total Hip Resurfacing; ReCap Total Hip Resurfacing
Intervention type(s): Procedure; Procedure; Device; Device
Intervention description(s): The anterolateral approach is performed with the patient positioned on the side. The blood supply to the femoral neck from the medial circumflex artery is regarded preserved by this surgical method.; The posterior approach is performed with the patient positioned on the side. The medial circumflex artery is cut at the lower border of the short external rotators risking a compromised blood supply to the femoral head.; This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.; This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment