bioihbjkbjnl/mcl2 huggingface dataset:
Outcomes After Epigastric Hernia Repair in Women.
Condition: Epigastric Hernia
MeSH terms: Hernia; Hernia, Abdominal
Study type: Observational [Patient Registry]

Summary: 
      Nationwide cohort study on women undergoing epigastric hernia repair
    

Detailed description: 
      Women have the highest prevalence of epigastric hernia repair. Outcomes after epigastric
      hernia repair are rarely reported independently, although pathology and surgical techniques
      may be different than for other primary ventral hernias.

      The aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in
      women on a nationwide basis.

      Methods Nationwide cohort study from the Danish Hernia Database. Complete data from women
      undergoing elective epigastric hernia repair during a 12-year period (2007-2018) was
      extracted. A 100% follow-up was obtained by combining data from the National Civil Register.
      The primary outcome was operation for recurrence, secondary outcomes were readmission and
      operation for complications. Outcomes for open sutured repair, open mesh repair mesh, and
      laparoscopic repairs were compared.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        females in Denmark undergoing epigastric hernia repair
The Effect of a Probiotic Intervention in Healthy Subjects and Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The study was performed to investigate the effects of a probiotic supplementation containing
      Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 and Bifidobacterium animalis
      subsp. lactis DGCC 420 (B. lactis 420) on clinical, immunological and faecal parameters in
      healthy volunteers and in patients with atopic dermatitis (AD).
    

Detailed description: 
      Recent studies suggest that oral bacteriotheraphy with probiotic bacteria might be useful to
      alleviate atopic dermatitis in infants. There are few indications about the effect of
      probiotics in the management of atopic dermatitis in adults.

      As a precondition for participating in this study, the subjects were provided information in
      writing and verbally about the details of the study. Informed consent was obtained from all
      volunteers. Before the beginning of the study, all participants were subject to a medical
      examination in the Clinic for Dermatology and Dermatologic Allergology of the Friedrich
      Schiller University Jena. The AD was diagnosed according to the atopy-score of Diepgen.
      Severity of eczema was evaluated by using the SCORAD score. A skin prick test was performed
      for the exclusion of type 1 sensitivity to cow's milk.

      The study was designed as a placebo-controlled and cross-over study. After a 3-week run-in
      period the 30 participants (15 healthy subjects and 15 patients with AD) were randomized to
      receive either 200 ml/d of a probiotic drink containing L. paracasei Lpc-37, L. acidophilus
      74-2 and B. lactis 420 or 200 ml/d of a placebo drink for 8 weeks. After a 2-week washout
      period the intervention was crossed between the groups and the respective products were
      consumed for another 8 weeks followed by a 2-week washout period. Venous blood and fresh
      stool samples were collected before the beginning and at the end of each period. In AD
      patients the Scoring of atopic dermatitis (SCORAD) was assessed by the same physician every 4
      weeks and 2 weeks after the wash-out period, respectively.
    

Intervention name(s): probiotics
Intervention type(s): Dietary Supplement
Intervention description(s): Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 Bifidobacterium animalis subsp. lactis DGCC 420
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: probiotics; atopic dermatitis; immune system; human; Lactobacillus; Bifidobacterium; healthy subjects
Effect of Riociguat on Bone Metabolism
Condition: Pharmacology, Clinical
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days,
      on bone metabolism.
    

Detailed description: 
      Clinical pharmacology
    

Intervention name(s): Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Riociguat administered in a dose of 2.5 mg (single tablet), thrice daily, over 14 days.; Placebo administered as a single tablet, thrice daily, over 14 days.
Intervention MeSH terms: Riociguat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bone Metabolism
Effect of Increasing Time Spent Outdoors on Myopia Prevention in School-Aged Children in Northeast China
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to develop a school-based intervention aimed at prevent the
      onset and development of myopia among school aged children by increasing time spent outdoors
      in northeast China.
    

Detailed description: 
      The purpose of this study is to develop a school-based intervention aimed at prevent the
      onset and development of myopia among school aged children by increasing time spent outdoors
      among elementary and secondary school students in northeast China. It is expected that the
      results will provide evidences for policy-makers and school healthcare providers for their
      school children myopia prevention.
    

Intervention name(s): increasing time spent outdoors
Intervention type(s): Behavioral
Intervention description(s): The intervention group undertook interventions by increasing time spent outdoors. The interventions composed of performing two additional recess program lasting 30 minutes outside the classroom that encouraged children to go outside for outdoor activities during recess in both the morning and afternoon during school days within a intervention period of 1 school year.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vision, Ocular; Physical activity; Schoolchildren; Intervention Studies
Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and
      tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive
      Disorder (MDD).
    


Intervention name(s): Placebo; Vortioxetine (Lu AA21004); Venlafaxine XL
Intervention type(s): Drug; Drug; Drug
Intervention description(s): capsules, daily, orally; encapsulated tablets, daily, orally; capsules, daily, orally
Other intervention name(s): Brintellix; Effexor®
Intervention MeSH terms: Vortioxetine; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major depressive disorder; Placebo-controlled; Active reference; Multicenter study; Randomised study; Acute treatment
Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion
      and tolerance.
    

Detailed description: 
      Lactose intolerance is a common gastrointestinal (GI) disorder that develops in lactose
      maldigesters when consuming too much lactose or when lactose is added to a previously
      low-lactose diet. Lactose intolerance is characterized by one or more of the cardinal
      symptoms that follow the ingestion of lactose-containing foods. These symptoms include;
      abdominal pain/cramps, bloating, flatulence [gas] and diarrhea. As such, most lactose
      intolerant individuals avoid the ingestion of milk and dairy products, while others
      substitute non-lactose containing products in their diet.

      Based on the health implications from insufficient calcium intake over a lifetime, including
      increased risk of osteoporosis and hypertension, there is need in the medical community for a
      tolerable and convenient treatment that allows for all levels of milk and dairy product
      consumption in people suffering from mild to severe lactose intolerance. This study will
      evaluate a treatment that provides a simplified dosing regimen as well as the potential for
      extended relief from symptoms following a limited therapy regimen.
    

Intervention name(s): RP-G28 or placebo; RP-G28 or placebo
Intervention type(s): Drug; Drug
Intervention description(s): Qualified subjects randomized to daily dosing with RP-G28 or placebo; Daily dosing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lactose maldigestion; dairy intolerance; intolerance to milk; intolerance to dairy; milk intolerance; GI disorder; lactose metabolism; GI symptoms after dairy ingestion
Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel
      Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical
      Gel (Clindamycin- Benzoyl Peroxide Gel).
    


Intervention name(s): Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo); Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Applied to the entire face twice daily for 10 weeks; Applied to the entire face twice daily for 10 weeks; Placebo
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Drug-Drug Interaction Study of AG120 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-Label, 2-Period, Fixed Sequence Study to Determine the Effect of Multiple Oral Doses
      of Itraconazole on the Single Dose Pharmacokinetics of AG 120 in Healthy Adult Subjects.
      Period 1 consists of a single oral dose of AG-120 will be administered at Hour 0 followed by
      PK sampling for 504 hours (21 days). In Period 2, multiple oral doses of itraconazole will be
      administered once daily (QD) for 18 consecutive days with a single oral dose of AG-120
      coadministered at Hour 0 on Day 1. PK sampling for AG-120 will be taken for 504 hours (21
      days) following AG-120 dosing on Day 1.
    


Intervention name(s): AG120; Itraconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative
      Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys
      laboratories with Zyrtec 10 mg of Pfizer labs in Healthy Adult Human Male Subjects Under Fed
      Conditions.
    

Detailed description: 
      Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Cross
      Over, and Comparative Oral Bioavailability study in healthy, adult, human, male subjects
      under Fed Conditions.
    

Intervention name(s): Cetirizine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Cetirizine Hydrochloride Tablets 10 mg
Other intervention name(s): Zyrtec Tablets 10 mg
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lifestyle, Eating, and Activity Patterns
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this research is to test the effect of manipulating eating frequency on hunger
      and the reinforcing value of food in 50 overweight/obese adults participating in a 6-month
      behavioral weight loss intervention.
    

Detailed description: 
      Previous observational and experimental research suggests that increased eating frequency is
      related to lower weight, body mass index (BMI)and body fatness. It is proposed that eating
      frequently during the day reduces overall energy consumed by preventing the development of
      excessive hunger. As elevated hunger increases the reinforcing value of food, and greater
      intake occurs when the reinforcing value of food increases, eating frequently during the day
      may be a dietary strategy that can aid with reducing energy intake and improving weight loss
      during a behavioral weight control program. Therefore, the purpose of this proposed research
      is to test the effect of manipulating eating frequency on hunger and the reinforcing value of
      food in 50 overweight/obese adults participating in a 6-month behavioral weight loss
      intervention. Participants will be randomized to 1 of 2 conditions: 1) a condition in which
      participants will be given an eating frequency prescription to eat every 2 to 3 hours
      (Grazing); or 2) a condition in which participants will be given an eating frequency
      prescription of eating 3 meals per day (Three Meals). Both conditions will receive an
      identical dietary prescription, a low-calorie (1200 to 1500 kcals/d), low-fat (≤ 30% kcals
      from fat) diet and an identical physical activity goal of 200 minutes of moderate-intense
      physical activity per week. Additionally, both conditions will receive an identical
      state-of-the-art, 6-month, behavioral weight loss program.
    

Intervention name(s): Behavioral weight loss intervention
Intervention type(s): Behavioral
Intervention description(s): both conditions will receive an identical dietary prescription, low-calorie and less than 30% calories from fat and an identical physical activity goal of 200 minutes of moderate-intense physical activity per week during a 6 month behavioral weight loss program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intervention studies; feeding behavior; eating frequency; weight loss; dietary intake
ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure
Condition: Nerve Block; Analgesia; Pectus Excavatum
MeSH terms: Funnel Chest
Study type: Interventional

Summary: 
      This is a prospective randomized double-blind non-inferiority trial designed to test the
      hypothesis that erector spinae plane block (ESPB) is non-inferior to thoracic paravertebral
      block (TPVB) in postoperative pain control after pectus excavatum repair.
    


Intervention name(s): ESPB group; TPVB group
Intervention type(s): Procedure; Procedure
Intervention description(s): A 21-gauge 100-mm needle will be inserted into the fascial layer beneath the iliocostalis, longissimus, and spinalis muscles. A bolus of 0.25% ropivacaine 0.5 ml/kg will be injected into the fascial layer. Contralateral ESPB will be performed similarly.; A 21-gauge 100-mm insulated needle will be inserted into the paravertebral space via an in-plane parasagittal approach. After perforating the costotransverse ligament, 0.25% ropivacaine 0.5 ml/kg will be injected. Anterior movement of the pleura indicated the appropriate spread of the local anesthetics in the paravertebral space. The process will be repeated on the contralateral side.
Other intervention name(s): Erector spinae plane block; Thoracic paravertebral block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Antagonistic Interaction CB1-paracetamol
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of an possible inhibiting effect of Rimonabant on the analgesic effect of
      Paracetamol in healthy volunteers
    

Detailed description: 
      Double Blind, cross-over, randomized and controlled versus placebo, study in healthy
      volunteers.
    

Intervention name(s): Rimonabant and Paracetamol and placebo
Intervention type(s): Drug
Intervention description(s): evaluation of an possible inhibiting effect of rimonabant on the analgesic effect of paracetamol in healthy volunteers
Intervention MeSH terms: Acetaminophen; Rimonabant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pain,; analgesia; Healthy volunteers
Effectiveness of a School-based Tobacco Prevention Program for Middle School Students in Saudi Arabia
Condition: Tobacco Use
Study type: Interventional

Summary: 
      This study evaluated a school-based tobacco program, "Dentists Fighting Nicotine Dependence
      (DFND)", to prevent the initiation of tobacco use among middle school students in Saudi
      Arabia using a social competences/social influence approaches.
    

Detailed description: 
      A quasi-experimental controlled trial design was utilized. Eight middle schools were selected
      from the regional education registry; four allocated to treatment arm and four to control
      arm.

      A total of 28 seventh grade classes were included in the study; 14 served as treatment and 14
      as control arms. All students present in these classes on the initial visit were invited to
      take part in the study [Treatment=379; Control=255].

      The treatment arm received the new tobacco prevention program (DFND) whereas the control arm
      received only the regular tobacco prevention program administered by the Department of
      Education. DFND was delivered by trained health educators over 5 weeks, two sessions per
      week. Two follow up surveys were administered; at one week and at two years
      post-intervention. Study outcomes were current tobacco use, knowledge about tobacco, attitude
      toward not using tobacco, and perceived behavioral control (PBC) of tobacco use. Covariates
      included sex, parent education, academic performance, absenteeism, student allowance, and
      religiosity.
    

Intervention name(s): DFND Program
Intervention type(s): Behavioral
Intervention description(s): The DFND program consisted primarily of a 10-session curriculum, each session lasting about an hour. The curriculum was comprehensive and incorporated information about tobacco and its adverse health effects, social influences, and social competence skills.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: A quasi-experimental, controlled trial design was utilized to evaluate the effectiveness of a school-based tobacco program, "Dentists Fighting Nicotine Dependence (DFND)", to prevent the initiation of tobacco use among middle school students (grades 7-9) in Jeddah, Saudi Arabia.
Eight middle schools were selected from the regional education registry; four allocated to treatment arm (n=379) and four to control arm (n=255). The treatment arm received the new tobacco prevention program (DFND) whereas the control arm received only the regular tobacco prevention program administered by the Department of Education. DFND was delivered by trained health educators over 5 weeks, two sessions per week.
Masking: None (Open Label)
Primary purpose: Prevention
Influencing Factors on Training Efficacy in Healthy Adults
Condition: Health Status; Maximal and Submaximal Parameters of Physical Performance
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to investigate the effects of carbohydrate intake on training
      efficacy and health parameters of an endurance training program in healthy adults.
    

Detailed description: 
      Carbohydrate availability in endurance exercise seems to attenuate exercise-induced
      perturbations of cellular homeostasis and consequently diminishes the stimulus for training
      adaptation. Therefore, a negative relationship with exercise efficacy seems plausible.
      However, experimental evidence is rare and far from conclusive. Therefore, the present study
      aims to test the influence of carbohydrate intake on the efficacy of a typical preventive
      training program.
    

Intervention name(s): Endurance Training
Intervention type(s): Behavioral
Other intervention name(s): 4 sessions a week at 70 percent heart rate reserve
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention; Exercise; Health; Endurance
Relative Bioavailability Study of Nadolol (1 x 80 mg) Tablets Under Fasting Conditions
Condition: High Blood Pressure; Migraine Headaches; Chest Pain
MeSH terms: Migraine Disorders; Hypertension; Headache; Chest Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the relative bioavailability of Nadolol (1 x 80
      mg) tablets under fasting conditions.
    


Intervention name(s): Nadolol (1 x 80 mg) Tablets (Invamed, Inc); Corgard (1 x 80 mg) Tablets (Bristol Laboratories)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nadolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed Product
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a single-masked, two-arm, parallel-group, randomized-controlled, dispensing clinical
      trial to evaluate the visual performance.
    


Intervention name(s): senofilcon A C3; Dailies Total 1 Multifocal Contact Lenses
Intervention type(s): Device; Device
Intervention description(s): TEST Lens; CONTROL Lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Glutaminergic Agents for Cocaine Abuse - 5
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate glutaminergic agents for cocaine abuse.
    


Intervention name(s): Nimodipine
Intervention type(s): Drug
Intervention MeSH terms: Nimodipine
Primary purpose: Treatment
Keywords: cocaine