bioihbjkbjnl/mcl2 huggingface dataset:
Stress and Personality Profiles in IBD
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Main aim is to evaluate the role of stress in the evolution of inflammatory bowel disease
      (IBD) and the quality of life of these patients. A second aim is to establish the existence
      of any psicopathological profile in these patients. We designed a prospective experimental
      study were patients are randomized to receive or not a cognitive-behavior program. Patients
      will be evaluated at 3 and 12 months after the program and study variables will be measured:
      stress level, coping strategies, quality of life, activity of disease and biological
      variables related to IBD.
    


Intervention name(s): Cognitive-behavior interventional program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Effects of High Protein Diet in Obesity, the LOWER Study
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This program is carried out in a dedicated outpatient-clinic in the city of Hengelo for the
      evaluation and treatment of subjects with obesity. The program puts emphasis on intervention
      with appropriate diet and physical exercise, and supports the patients in achieving long-term
      behaviour changes. Interventions which are compared are normal vs high protein/low carb
      diets.
    

Detailed description: 
      Assessment focuses on the effect of the specific diets on weight reduction after 3 months,
      and weight maintenance after 12 months.
    

Intervention name(s): Normal protein energy-restricted; High protein energy-restricted
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Normal protein diet energy restricted; High protein diet, with either low or normal carbohydrate content
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low carbohydrate; high protein diet
Liver Transplantation and Uveal Malignant Melanoma
Condition: Uveal Malignant Melanoma
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      Patients with uveal malignant melanoma with liver metastases have median survival of less
      than 12 months. There is no established treatment showing increased overall survival. The
      study will determine if liver transplantation will result in long term survival in patients
      with liver metastases from uveal malignant melanoma.
    


Intervention name(s): Liver transplantation
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver transplantation; Overall survival
Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers
Condition: Sperm Quality
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the effect of certolizumab pegol (CZP) on
      the quality of sperm obtained from healthy male volunteers.
    

Detailed description: 
      CZP is a PEGylated humanized Fab' fragment with specificity for human tumor necrosis factor
      alpha (TNFα). Evidence suggests that modulation of TNFα signaling may affect male
      spermatogenesis. Therefore, this study will compare semen quality parameters before and after
      a single 400 mg dose of CZP, or matched placebo.
    

Intervention name(s): Certolizumab pegol; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously; 2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously
Other intervention name(s): Cimzia®
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: certolizumab pegol; Cimzia®; healthy male volunteers; sperm
Effects of a Movement Training for Subacromial Pain Syndrome
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome
Study type: Interventional

Summary: 
      Objectives: Evaluate the effects of a rehabilitation program based on movement training on
      symptoms, functional limitations and acromiohumeral distance (AHD) in individuals with SPS.

      Methods: Twenty-five participants with SPS participated in a 6-week program. Outcomes of both
      groups were evaluated at baseline and 6 weeks. Changes in symptoms and functional limitations
      were assessed. Changes in AHD for both groups were assessed using ultrasonographic measures.
    

Detailed description: 
      Background: Multiple factors have been associated with the presence of a subacromial pain
      syndrome (SPS), including deficits in performance of scapular and glenohumeral muscles. Such
      deficits can lead to inadequate kinematics and decreased acromiohumeral distance (AHD).
      Exercises that aim at correcting these deficits, such as movement training, were suggested to
      improve symptoms and functional limitations. To date, few studies have assessed outcomes
      following an intervention focused on movement training.

      Objectives: Evaluate the effects of a rehabilitation program based on movement training on
      symptoms, functional limitations and AHD in individuals with SPS.

      Design: Prospective single group pre-post design. Methods: Twenty-five participants with SPS
      (SPS group) participated in a 6-week program. Twenty asymptomatic volunteers were recruited
      for normative AHD values (control group). Outcomes of both groups were evaluated at baseline
      and 6 weeks, i.e. immediately following intervention for the SPS group. Changes in symptoms
      and functional limitations for SPS group were assessed using the Western Ontario Rotator Cuff
      index (WORC) and Disability of the Arm Shoulder and Hand questionnaire (DASH). Changes in AHD
      for both groups were assessed using ultrasonographic measures.
    

Intervention name(s): Rehabilitation program
Intervention type(s): Other
Intervention description(s): Movement training: To re-educate control of movement, exercises of increasing difficulty in terms of movement plane, range of motion, speed and resistance were performed.
Strengthening: Using extremities weight, free weights or elastic bands, scapulothoracic and scapulohumeral strengthening was performed to increase strength and control of shoulder muscles.
Stretching & Manual Therapy: These modalities, performed only if needed, were aimed at addressing stiffness of posterior and inferior glenohumeral capsule and pectoralis minor.
Patient education: Participants received education regarding posture and body mechanics. They were instructed on preferred shoulder positioning during sleep, activities, work and sports
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shoulder; Rotator cuff; Rehabilitation; Motor control
Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss
Condition: Alopecia; Baldness
MeSH terms: Alopecia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared
      with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern
      hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil
      2% solution which will be provided open-label.
    


Intervention name(s): bimatoprost Formulation A; bimatoprost Formulation B; bimatoprost Formulation C; bimatoprost vehicle solution; minoxidil 2% solution
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.; Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Other intervention name(s): Rogaine®; Regaine®
Intervention MeSH terms: Bimatoprost; Minoxidil; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of ABT-072 in Healthy and Hepatitis C Virus Genotype 1-Infected Adults
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability and pharmacokinetics of ABT-072 in healthy volunteers
      and its anti-viral activity in HCV infected subjects.
    

Detailed description: 
      A blinded, randomized, placebo-controlled trial to study the safety, tolerability, antiviral
      activity and pharmacokinetic profiles of ABT-072 in healthy and HCV genotype-1 infected
      adults.
    

Intervention name(s): ABT-072; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.; Capsule, or powder drug substance from the capsule mixed in an alternative vehicle. For additional information refer to Arm Description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Phase 1
A Study of SANGUINATE for the Treatment of Vaso-occlusive Crisis (VOC) in Adult Sickle Cell Disease Patients
Condition: Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive
      crisis who are admitted to the hospital for treatment.
    

Detailed description: 
      A single-blind, multicenter, randomized, placebo-control study in which 30 Sickle Cell
      disease patients having a vaso-occlusive crisis will either receive SANGUINATE 320
      mg/kg/patient (8 mL/kg/patient) or Normal Saline on Day 1 (Visit 1) and Day 2 (Visit 2)
      infused over 2 hours each day. Patients are to remain in the hospital for up to 7 days but
      can be discharged at any time after receiving the second dose of SANGUINATE, provided their
      vaso-occlusive crisis has resolved and the patient has completed discharge procedures.
      Patients will have a follow-up phone call 7 days after discharge from the hospital to obtain
      safety, concomitant medication and pain assessments.
    

Intervention name(s): SANGUINATE 320 mg/kg; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Two-hour infusion of SANGUINATE on Day 1 and Day 2; Two-hour infusion of Normal Saline and Day 1 and Day 2
Other intervention name(s): pegylated carboxyhemoglobin bovine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sickle Cell; Anemia; VOC; Vaso occlusive crisis
Relative Bioavailability of BI 10773 and Linagliptin in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the relative bioavailability of BI 10773 and of linagliptin after
      concomitant multiple oral administration of 50 mg BI 10773 tablets and 5 mg linagliptin in
      comparison to 50 mg BI 10773 and 5 mg linagliptin given alone.
    


Intervention name(s): BI 10773; Linagliptin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linagliptin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of YVOIRE Volume Versus Perlane in Nasolabial Fold Injection
Condition: Temporary Correction of Wrinkles
Study type: Interventional

Summary: 
      This study was purposed to evaluate the non-inferiority of YVOIRE volume, a hyaluronic acid
      product, in terms of correction of wrinkles and safety in nasolabial fold deep-dermal
      injection, compared to Perlane, the control preparation.
    


Intervention name(s): HA IDF II; Perlane
Intervention type(s): Device; Device
Intervention description(s): Treatment with HA IDF II (YVOIRE volume); Treatment with Perlane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Audit of the Response Time of the Anaesthetic and Surgical Techniques for Crash Caesarean Section
Condition: Pregnancy; Anaesthesia
Study type: Observational

Summary: 
      A decision-to-delivery interval of 30 minutes for category-1 Caesarean section deliveries is
      the standard of practice recommended by clinical guidelines.
    

Detailed description: 
      Our institution established a protocol for category-1 ('crash') CS to expedite deliveries.
      This retrospective audit evaluated all women who underwent category-1 CS in KK Women's and
      Children's Hospital from 2010 to 2013.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women who underwent category one Caesarean section between 2010 to 2013 at KK Women's and
        Children's Hospital, Singapore.
      
Keywords: Caesarean section; Emergency; Anaesthesia
The Effect of Protein Supplementation on Bone Health in Healthy Older Men and Women
Condition: Bone Resorption; Osteoporosis
MeSH terms: Osteoporosis; Bone Resorption
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Women and men consuming a low protein diet may be at risk for bone loss. The purpose of this
      study is to determine whether a daily protein supplement will improve bone health among
      healthy older adults.
    

Detailed description: 
      Dietary protein plays an important role in maintaining balanced calcium levels in the body.
      Protein's impact on skeletal health remains unclear. It is well accepted that increasing
      dietary protein results in greater excretion of calcium through urine. The excreted calcium
      is thought to come in part from bone, which would suggest a negative effect on bone health.
      However, recent studies have found that higher protein intake is, in fact, associated with
      higher bone mineral density and lower rates of bone loss. The purpose of this study is to
      determine if a daily protein supplement will improve bone health and hormonal measures of
      bone metabolism among healthy older men and women who consume low-to-normal levels of dietary
      protein.

      This study will last 18 months. For the duration of the study, participants will be randomly
      assigned to receive either a 40-gram protein supplement or placebo daily. There will be a
      total of nine study visits that will occur at screening, study entry, Month 1.5, and every
      three months thereafter. Dietary records, nutritional counseling, glucose finger stick tests,
      and questionnaires related to falls, physical activity, habits, and study satisfaction will
      occur at all study visits. Blood and urine collection, functional testing, and bone mineral
      density (BMD) testing will occur at selected visits. At Months 0 and 18, half of the
      participants will undergo a quantitative computed tomography (CT) scan to determine bone
      mineral density.
    

Intervention name(s): Whey protein supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 40-g whey protein supplement daily for 18 months; Placebo supplement daily for 18 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dietary protein; Calcium; Parathyroid hormone; Bone markers; Bone mineral density; IGF-1; Urine Calcium
Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage
Condition: Abortion, Habitual
MeSH terms: Abortion, Habitual
Study type: Interventional
Phase: Phase 4

Summary: 
      In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice
      daily), started soon as possible at luteal phase and after a positive pregnancy test and
      continued to 28 weeks of gestation, compared to placebo, ).
    

Detailed description: 
      Progesterone improves secondary outcomes such as gestation at delivery, on-going pregnancy at
      12 weeks, survival at 28 days of neonatal life.

      . Progesterone, compared to placebo, does not incur substantial adverse effects to the mother
      or the neonate.

      Explore differential or subgroup effects of progesterone in prognostic subgroups.

      . Perform an economic evaluation for cost-effectiveness.
    

Intervention name(s): Progesterone; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: recurrent miscarriages; progesterone
Treatment of Periodontitis in Menopausal Patients
Condition: Menopausal Patients; Chronic Periodontitis; Omega 3 Fatty Acids
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this clinical trial is to compare the effectiveness of polyunsaturated fatty
      acids (PUFAs) [omega-3] as an adjunctive treatment to scaling and root planing for menopausal
      women with periodontitis versus scaling and root alone as a non- surgical treatment .

      . The main question it aims to answer is:

      • to investigate the effect of systemic administration of Omega-3 fatty acids in addition to
      SRP on clinical periodontal parameters and GCF levels of osteocalcin and AST in menopausal
      women.

      Participants will given * a soft gelatin capsules containing PUFAs to be consumed directly
      once daily for 12 months along with non-surgical treatment (group2)

      ** a soft gelatin capsules containing olive oil to be consumed directly once daily for 12
      months along with non-surgical treatment (group1)

      Researchers will compare group 1 to group 2 to see if PUFAs has an effect on clinical
      periodontal parameters and GCF levels of osteocalcin and AST in menopausal women. .
    

Detailed description: 
      Menopause is typically accompanied by significant systemic and oral manifestations, including
      hormonal changes and increased susceptibility to periodontal disease, which may involve
      inflammatory biomarkers like aspartate aminotransferase (AST) and Osteocalcin in gingival
      crevicular fluid (GCF). The study aims to evaluate the effectiveness of regular inoculation
      of polyunsaturated fatty acids (PUFAs) as an adjunctive treatment for menopausal women's
      periodontitis.

      Methods: Twenty elderly women with chronic periodontitis were split evenly into two groups by
      random assignment. Patients in group II (the research group) were given soft gelatin capsules
      containing PUFAs to be consumed directly once daily for 12 months, as opposed to the group I
      (the control group), who received soft gelatin capsules containing some olive oil (placebo).
      Scaling and root planning (SRP) were used to address periodontal disease in all cases.

      At baseline, six and twelve months after treatment, clinical indicators and AST and
      Osteocalcin amounts in the GCF will be noted.
    

Intervention name(s): Polyunsaturated Fatty Acids; olive oil
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 1000mg omega-3 fatty acids taken once daily with meals for 12 months; 1000mg olive oil taken once daily with meals for 12 months
Other intervention name(s): omega-3 fatty acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periodontitis, GCF, Osteocalcin.
Computer Assisted Learning (CAL) Module Use for Re-training of Blood Pressure Measurements by Physical Therapy Students
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of a Computer Assisted Learning
      Module for supplemental blood pressure measurement retraining for doctor of physical therapy
      students.
    


Intervention name(s): Computer Assisted Learning (CAL) Module
Intervention type(s): Other
Intervention description(s): The students assigned to Group A will undergo interactive CAL module training by the American Medical Association which outlines how to properly measure blood pressure manually following the American Heart Association guidelines.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study will utilize a randomized crossover design. Students enrolled in this study will undergo traditional blood pressure training. The students will be randomly divided into 2 groups (control and experimental). All students will undergo baseline testing 2 weeks after the class. At 48 hours before the 2 month timepoint, the experimental group will complete a CAL module entitled: "BP Measurement: Student Essentials". The control group will not undergo any retraining activities. All students will retest for accuracy, confidence, and knowledge. At the second 2 month mark, the control group will complete the CAL module and the experimental group will not. All students will retest for accuracy, confidence, and knowledge. All participants, the faculty teaching BP, and outcome assessors will be blinded from knowledge of groups throughout to reduce bias risk.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Physical Therapy; Education; Teaching
A Study of Experimental Mouthwashes
Condition: Gingivitis; Plaque
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of experimental mouthwash
      formulations compared to a hydroalcohol control mouthwash and a positive control mouthwash
      for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a
      twelve-week product usage period.
    


Intervention name(s): Colgate (R) Cavity Protection Toothpaste; Colgate (R) Cello Toothbrush; Prototype 1 Mouthwash; Prototype 2 Mouthwash; Prototype 3 Mouthwash; Listerine (R) Cool Mint (R) Antiseptic Mouthwash; 5% Hydroalcohol Mouthwash
Intervention type(s): Other; Device; Other; Other; Other; Other; Other
Intervention description(s): Participants will use Colgate (R) Cavity Protection Toothpaste for brushing teeth twice daily.; Participants will use Colgate (R) Cello Toothbrush for brushing teeth twice daily.; Participants will use 20 mL of Prototype 1 Mouthwash for 30 seconds after brushing twice daily.; Participants will use 20 mL of Prototype 2 Mouthwash for 30 seconds after brushing twice daily.; Participants will use 20 mL of Prototype 3 Mouthwash for 30 seconds after brushing twice daily.; Participants will use 20 mL of Listerine (R) Cool Mint (R) Antiseptic Mouthwash for 30 seconds after brushing twice daily.; Participants will use 20 mL of 5% Hydroalcohol Mouthwash for 30 seconds after brushing twice daily.
Intervention MeSH terms: Listerine; Anti-Infective Agents, Local; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other