bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Music Therapy on Psychological Status and Sleep Quality Among Pregnant Women
Condition: Pregnant Women
Study type: Interventional

Summary: 
      There is a strong correlation between sleep disturbance and indications of stress, anxiety,
      and depression. However, in Egypt no research has looked into how better sleep for expectant
      mothers might be achieved by inexpensive, pleasurable, non-invasive music listening.
      Therefore, the aim of this study was to investigate how music listening affects pregnant
      women's psychological status, and sleep quality.
    

Detailed description: 
      This study used a randomized controlled trial (RCT) design and adhered to the Consolidated
      Standards of Reporting Trials (CONSORT) guidelines. The study utilized a simple random
      sampling technique to select participants in proportion to the total number of pregnant women
      in the outpatient Medical National Institute in Damanhur city, Egypt.
    

Intervention name(s): Music Therapy
Intervention type(s): Behavioral
Intervention description(s): Music Therapy intervention will be delivered through instructed participants to empty their bladder and then listen to music for 30 min in a semi-fowler's position with their head and shoulders raised 30° in a quiet and dim environment, listening to the music of symphonic music.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Bioavailability of ABT-333 Within the Gastrointestinal Tract in Healthy Subjects
Condition: Relative Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      This open label, Phase 1 study is to investigate the relative bioavailability of ABT-333 when
      delivered within different sites of the gastrointestinal tract in 12 healthy subjects.
    

Detailed description: 
      Bioavailability of ABT-333 in different areas of the gut
    

Intervention name(s): ABT-333
Intervention type(s): Drug
Intervention description(s): Dose of ABT-333
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: relative bioavailability; healthy volunteers
Study to Evaluate the Pharmacokinetics (PK), Safety, Tolerability of Single-Dose Transdermal Rotigotine in Japanese and Caucasian Healthy Male / Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the Pharmacokinetics (PK) of transdermally delivered Rotigotine in Japanese
      and Caucasian Female and Male Healthy Subjects.
    


Intervention name(s): Rotigotine transdermal patch
Intervention type(s): Drug
Intervention description(s): Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)
Other intervention name(s): Neupro
Intervention MeSH terms: Rotigotine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Rotigotine; Neupro; Japanese; Caucasian; Male; Female; Single dose; Pharmacokinetics
Custom Molded Foot Orthoses Effect on Foot Kinematics and Lower Extremity Electromyography During Walking and Running.
Condition: Lower Extremity Pain of a Mechanical Origin
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effectiveness of two types of in-shoe custom
      made orthotics in altering the motion of the foot and muscle activity of select muscles of
      the lower leg in individuals experiencing lower extremity symptoms of a non traumatic origin.
      We hypothesized that orthotics would decrease the extent of motion of the during walking and
      running when compared to a barefoot condition. The investigators further hypothesized that
      orthotics would decrease the amount of muscle activity seen during walking and running when
      compared to barefoot walking.
    


Intervention name(s): Maximal Arch Subtalar Stabilization; Full Contact Orthosis
Intervention type(s): Device; Device
Intervention description(s): Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover; The Full Contact orthosis is constructed from a 5/32" blue polypropylene with posting material comprised of white polypropylene.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Orthoses; Foot; Kinematics; EMG; Biomechanics
Oral Sildenafil and Intravenous Milrinone on Postoperative Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pulmonary hypertension (PH) is a consequence of an increase in pulmonary vascular resistance
      (PVR), pulmonary blood flow, pulmonary venous pressure, or a combination of these elements.
      Pulmonary arterial hypertension is a frequent complication of congenital heart disease,
      particularly in patients with systemic-to-pulmonary shunts. Persistent exposure o f the
      pulmonary vasculature to increased blood flow and pressure may result in vascular remodeling
      and dysfunction. This leads to increased pulmonary vascular resistance and, ultimately, to
      reversal of the shunt and development of Eisenmenger's syndrome. It may be more appropriate
      to define pulmonary hypertension according to the ratio of MPAP to mean systemic arterial
      pressure (MPAP/MAP) because children may have a low mean systemic blood pressure. MPAP/MAP
      ratio of < 0.25 is normal, a ratio of 0.33-0.5 indicates moderate pulmonary hypertension, and
      a ratio of > 0.5 is indicative of severe pulmonary hypertension
    

Detailed description: 
      30 Patients were randomly allocated in two equal groups; group MS (received intravenous
      milrinone and oral sildenafil) and group M (received only intravenous milrinone). Demographic
      data, patient's clinical data and different intraoperative times were recorded. In 1st
      postoperative 24 hours, we recorded; hemodynamic parameters [mean pulmonary arterial pressure
      (MPAP), mean systemic arterial pressure (MAP), heart rate, central venous pressure]. We
      calculated MPAP/MAP and inotropic score. The incidence of pulmonary hypertensive crisis, side
      effects of studied drugs and complications related to pulmonary artery catheter were
      recorded.
    

Intervention name(s): milrinone; Sildenafil
Intervention type(s): Drug; Drug
Intervention description(s): IV milrinone (0.75 mcg/kg) loading dose over one hour started during re-warming of the patient (before weaning from CPB) and followed by a maintenance dose of 0.75 mcg/kg/minutes till the end of the study.; IV milrinone (0.75 mcg/kg) loading dose over one hour started during re-warming of the patient (before weaning from CPB) and followed by a maintenance dose of 0.75 mcg/kg/minutes till the end of the study. After baseline measurements, sildenafil (1mg/kg) administered in ICU via a nasogastric tube, to be repeated every 4 hours via a nasogastric tube or orally. Sildnafil is presented in tablet form which was dissolved in water to make a concentration of 1 mg/ml.
Other intervention name(s): primacor; viagra
Intervention MeSH terms: Milrinone; Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: pediatric; cardiac; sildenfil; milrinone; pulmonary hypertension
Treatment Effects From Aerobic Endurance Training and Maximal Strength Training in Patients Suffering From Schizophrenia
Condition: Schizophrenia; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Schizophrenia
Study type: Interventional

Summary: 
      This study investigates treatment effects from aerobic endurance training, maximal strength
      training and computer game on aerobic capacity, work efficiency and psychiatric symptoms in
      patients suffering from schizophrenia. The study is a controlled trial. The aim is to
      describe the population in respect to aerobic capacity and muscular strength. Low aerobic
      capacity and muscular strength are important risk factors for cardiovascular disease (CVD).
      The study also aim to evaluate physical and psychiatric effects from physical training.
      Effects from participation in physical training or computer game on symptoms, depression and
      quality of life will be investigated. Data will be collected between October 2005 and August
      2007.
    


Intervention name(s): Aerobic high-intensity interval training (AIT); Computer game training (CG); Maximal strength training
Intervention type(s): Other; Other; Other
Intervention description(s): The AIT group trains 4x4 minute interval training on a treadmill at 85-95 % HRpeak interspersed with 3 minutes of active resting periods at a work load corresponding to 70% HRpeak between each interval. All training sessions are monitored and start with a 6 minute warm-up and end with a 5 minute cool-down period at a work load corresponding to 70% HRpeak. Intervals are performed walking or running on a treadmill with a minimum of 5% inclination, 3 times per week for 8 weeks.; The CG spend the same amount of time (36 minutes), training to improve their ability in the computer game, Tetris. Tetris is a game where small shapes called Tetraminoes fall from the top of the Playfield to the bottom. Players must rotate the Tetraminoes as they fall and fit them together to complete lines. When the player fills an entire line with blocks, that line is removed from the screen. If the player cannot complete lines, the blocks will eventually rise past the top of the screen, and the game ends.; Training starts with a 10 minute warm-up on the treadmill. Maximal strength training is then performed in an inclined leg press machine. The subject lifts 4 maximal repetitions that are repeated 4 times after a 2 minute rest period. Subjects are instructed to lift the weight with an intention of maximal mobilization of force. Training load is increased each time the subject manage to perform 4x4 maximal repetitions. Training is carried out 3 times per week in 8 weeks.
Other intervention name(s): 4x4 interval; Tetris THQ Inc., Xbox, Microsoft; Leg press machine (Technogym); Olympic weights (Eleiko)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Cardiovascular disease; Aerobic capacity; Mortality; Exercise
Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers
Condition: Heart Rate; Blood Pressure
Study type: Observational

Summary: 
      The purpose of this study is to determine the amount of cardiac work as measured by heart
      rate and blood pressure during physical exertion compared to sexual activity.
    

Detailed description: 
      Physical exertion will be measured by a standardized treadmill test. Sexual activity will be
      performed in the study subject's home with his/her spouse or regular partner. Each study
      subject will wear a blood pressure and heart rate monitor at home during their sexual
      activity and will be asked to complete a one page diary upon completion of the activity.
      Normotensive and subject with mild hypertension will be studied to determine if hypertensive
      subjects have a relatively greater increase in their blood pressure during either physical
      exercise or sexual activity.
    

Intervention name(s): Treadmill testing; Ambulatory Blood Pressure and Heart Rate Monitoring
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients will have a exercise stress test using a Bruce protocol during which time heart rates and blood pressures will be monitored and the patient's percieved exertion level monitored and recorded; Patients will wear an ambulatory blood pressure monitor and an heart rate monitor during one sexual encounter.
Other intervention name(s): Quinton treadmill will be used; Space Labs ambulatory BP monitor; Polar heart rate monitor
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men and women over the age of 40 who are sexually active
      
Keywords: Blood Pressure; Heart Rate; Sexual Activity
A Study of Multiple Doses of AbGn-168H by Intravenous Infusion in Patients With Moderate to Severe Chronic Plaque Psoriasis
Condition: Moderate to Severe Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, randomised, double-blind, placebo-controlled, multiple-dose, multi-center
      study of AbGn-168H in subjects with moderate to severe chronic plaque psoriasis. The
      objectives of this study is to investigate efficacy, safety, tolerability, and
      pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients
      with moderate to severe chronic plaque psoriasis.
    


Intervention name(s): AbGn-168H; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): AbGn-168H monoclonal antibody; Placebo of AbGn-168H
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; Dermatology; Monoclonal antibody
Polyunsaturated Fatty Acids (PUFA) Status and Cognitive Function in Healthy Young Adults
Condition: Attention; Memory; Mood; Mental Fatigue
MeSH terms: Mental Fatigue
Study type: Observational

Summary: 
      To date, the relationship between omega-3 polyunsaturated fatty acids (n-3 PUFAs) in
      cognitively intact individuals has only been examined in a limited number of studies; it is
      at present unknown whether supplementation with n-3 PUFAs can improve cognitive function and
      mood in this population. Further to this, it still remains to be established whether a
      relationship exists between peripheral fatty acid status-reflective of dietary n-3 PUFA
      intake-and cognitive function in this population. The current study therefore aims to address
      this issue by exploring the relationship between serum PUFAs and specific cognitive functions
      in a sample of healthy adults. To this end, participants will complete a range of cognitive
      tasks evaluating performance across the domains of attention, memory and executive function.
      Self-report mood assessments will be included as secondary measures.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The sample will be drawn from a student and professional population in the Newcastle upon
        Tyne area in the UK
      
Biospecimen description: 
      Serum
    
Keywords: n-3 PUFAs; Fish oil; Cognitive function; Healthy young adults
Bioequivalence Study of Etoricoxib in Healthy Adult Subjects Under Fasting Condition
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence
      of two different immediate release products each containing Etoricoxib 90 mg, after
      administering a single oral dose, to healthy adult subjects under fasting conditions.
    

Detailed description: 
      Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive
      a single dose of the test product (T) or the reference product (R) at each phase, under
      fasting conditions, with a wash-out period of 14 days.

      Etoricoxib plasma concentration was determined using a validated LC-MS-MS method, followed by
      Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the
      average bioequivalence.
    

Intervention name(s): Etoricoxib 90 mg film coated tablet; Arcoxia 90 mg film coated tablet
Intervention type(s): Drug; Drug
Intervention description(s): an immediate-release tablet containing 90 mg of Etoricoxib; an immediate-release tablet containing 90 mg of Etoricoxib
Other intervention name(s): Test product (T); Reference product (R)
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, single-dose, two-way crossover, open-label, laboratory blind, bioequivalence study
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Bioequivalence; Randomized; Crossover; Etoricoxib
The Effect of Emotion Regulation Training on Anxiety, in College Students in Egypt
Condition: Anxiety; Emotion Regulation
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The important role of Emotion Regulation (ER) in managing stress and anxiety is well
      recognized. Aims: 1) assessing the level of anxiety, and the level of difficulties in emotion
      regulation (DER) among University Students during COVID-19, 2) investigating the effect of
      the emotional regulation training program on the anxiety of University Students during the
      COVID-19. Methods: Part I, students will be assessed for their anxiety, DER, and the general
      impact of COVID-19 on their lives. The students will complete Beck Anxiety Inventory (BAI)
      and Difficulties in Emotion Regulation Scale (DERS). Part II will be a Randomized Control
      Trial (RCT) using a pre-assessment and a post-assessment. A voluntary sample of students will
      randomly assigned to either a group that will receive emotion regulation training or a
      control group. The training program is an adapted version of DBT skills training. The
      training program will include mindfulness, emotion regulation, and problem-solving skills
      through eight 90- min group sessions.
    


Intervention name(s): Emotion Regulation training based on DBT
Intervention type(s): Behavioral
Intervention description(s): trained about emotion regulation and problem solving during eight 90-min group sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: University's students; COVID-19
Study of Adjuvant Radiochemotherapy for Gastric Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In 1991, the South West Oncology Group (SWOG) conducted a randomized study of adjuvant
      chemotherapy (5-fluorouracil and folinic acid) with concurrent radiation (4500 cGy/25
      fractions) versus surgery alone for patients with completely resected gastric carcinoma.

      This landmark study showed the benefit of adjuvant treatment for gastric cancer and radically
      changed the treatment of this disease. However, the resulting standard treatment has severe
      acute toxicity, and despite this advance, 50% of patients still die of gastric cancer. The
      investigators hope to develop a modified protocol using active chemotherapy agents, but with
      reduced acute toxicity. Such an approach could ultimately be studied against the current SWOG
      approach to determine whether or not the addition of cisplatinum improves efficacy.

      Patients who decide to participate in the study will receive a chemotherapy drug called
      5-Fluorouracil (5FU)through an intravenous catheter continuously over 12 weeks. Patients will
      not be admitted to hospital to receive the chemotherapy but will need to wear a waist pack to
      carry a small pump that will deliver the medication. They will however need to make regular
      visits to have their medication bags changed. Patients will also receive Cisplatin
      intravenously every 2 weeks for 4 doses. In addition, patients will also receive radiation to
      their stomach, lymph nodes, and the area where they had their surgery. This study also
      comprise of a questionnaire for us to see how patient's cancer and treatment is affecting
      their quality of life. Patients will have regular follow-up by their physicians.
    


Intervention name(s): cisplatinum combined with infusional fluorouracil (5 FU)
Intervention type(s): Drug
Intervention description(s): Continuous 5FU via intravenous PICC line + 4 doses of Cisplatin every 2 weeks
Intervention MeSH terms: Fluorouracil; Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Telemedicine Evaluation to Standard Evaluation Methods for Pre-Anesthesia Consultation
Condition: ENT Patients Scheduled for Surgery
Study type: Observational

Summary: 
      The purpose of the study is to evaluate different methods of pre-anesthesia consultation,
      with the aim of improving the day of surgery experience for the patient. In this study, we
      will use a telephone consultation, an in-person consultation, and a telemedicine
      consultation, which involves television cameras and monitors that allow live two-way
      communication for the pre-anesthesia consultation. The reason for this study is to evaluate
      the use of telemedicine for the pre-anesthesia consultation. Patients and anesthesiologists
      have been highly satisfied in previous studies using pre-anesthesia telemedicine
      consultation. In this study, we will examine a larger group of patients, as previous studies
      have studied smaller groups of patients.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects scheduled for ENT surgery.
      
Keywords: Pre anesthesia consultation; telemedicine
Minoxidil Response Testing in Males With Androgenetic Alopecia
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Observational

Summary: 
      Topical minoxidil is the most common drug used for the treatment of AGA in men. While topical
      minoxidil exhibits a good safety profile, the efficacy in the overall population remains
      relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair growth,
      minoxidil is typically used twice daily for a period of at least 16 weeks. Due to the
      significant time commitment and low response rate, a diagnostic test to identify
      non-responders prior to initiating therapy would be advantageous.

      Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the
      sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have
      demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked
      hair follicles correlates with minoxidil response in the treatment of AGA and thus can server
      as a predictive biomarker.

      Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify
      non-responders prior to initiating therapy with 5% topical minoxidil foam.

      The primary purpose of this study is to evaluate the clinical validity of the minoxidil
      response in-vitro diagnostic kit.
    


Intervention name(s): 5% minoxidil topical foam
Intervention type(s): Drug
Intervention description(s): 5% minoxidil topical foam
Other intervention name(s): Rogaine 5% minoxidil foam; Regaine 5% minoxidil foam
Intervention MeSH terms: Minoxidil
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males with androgenetic alopecia
      
Biospecimen description: 
      Plucked hair follicles with visible bulbs
    
Keywords: alopecia; androgenetic alopecia; hair loss; minoxidil; 5% minoxidil foam; male pattern hair loss