bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Healthy Men and Women to Test Whether BI 1358894 Influences the Amount of Bupropion in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the relative bioavailability of a single
      dose of bupropion when given alone (Reference) compared with co-administration (Test) with BI
      1358894 in healthy volunteers.
    


Intervention name(s): Elontril; BI 1358894
Intervention type(s): Drug; Drug
Intervention description(s): Elontril; BI 1358894
Other intervention name(s): Bupropion hydrochloride
Intervention MeSH terms: Bupropion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Loop-tip Cook Medical® Wire Versus Traditional Endoscopic Technique
Condition: Complications of Surgical and Medical Care: General Terms
Study type: Interventional

Summary: 
      The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip
      for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk
      patients.
    

Detailed description: 
      Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be
      associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the
      conventional biliary tree access with contrast injection even if results are conflicting. The
      aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the
      prevention of PEP and biliary tree access, in PEP high-risk patients.

      Type of study: Multicentric, prospective and randomized trial

      Patients: PEP high-risk patients underwent ERCP for benign biliary pathology

      Number of patients: 320 patients (160 for each group)

      Aim:

      Primary end point: The evaluation of the incidence of PEP . Secondary end point: The
      evaluation of CBD percentage cannulation.
    

Intervention name(s): ERCP with loop tip wire; ERCP for cannulation
Intervention type(s): Device; Device
Intervention description(s): Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation; Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: loop; ERCP; cannulation; biliary; wire
Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia
Condition: Alopecia, Androgenetic; Hair Loss/Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      This study investigated the efficacy of adipose derived stem cell conditioned media (ADSC-CM)
      combined with minoxidil for hair regeneration therapy in male AGA.
    

Detailed description: 
      This study was a double-blind, randomized clinical trial (RCT). Two concentrations of ADSC-CM
      were utilized: concentrated and non-concentrated ADSC-CM. The scalp was divided vertically in
      half; one side was injected with 2 ml of ADSC-CM, while the control side received 2 ml of
      NaCl 0,9%. After the injection, patients applied topical 5% minoxidil twice daily. Clinical
      improvements were assessed using photographic evaluation and trichoscan every two weeks.
    

Intervention name(s): Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil; Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil; Placebo and 5% Minoxidil
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): Non-concentrated ADSC-CM is given during week 0, 2, 4, and 6 on the left side of the scalp.
Minoxidil is applied twice using a spray, in the morning and at night.; Intervention is given during week 0, 2, 4, and 6 on the left side of the scalp. Minoxidil is applied twice using a spray, in the morning and at night.; Intervention is given during week 0, 2, 4, and 6 on the right side of the scalp.
Minoxidil is applied twice using a spray, in the morning and at night.
Intervention MeSH terms: Minoxidil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stem cell therapy; Adipose derived stem cell conditioned media; Hair regeneration
1% Alendronate Gel in Treatment of Chronic Periodontitis Among Smokers
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      -  Locally delivered Alendronate (ALN) have potent inhibitory effect on bone and increases
           new bone formation in chronic periodontitis patients

        -  Till date no study has reported the effect of local delivery of ALN in chronic
           periodontitis patients among smokers. Hence the aim of this study is to investigate the
           clinical and radiographic effects of locally delivered ALN as an adjunct to the non
           surgical treatment in smoker chronic periodontitis patients.
    


Intervention name(s): Alendronate; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Identification and Characterization of the Methylation Abnormalities on Whole Genome Among Infertile Men
Condition: Oligospermia
MeSH terms: Oligospermia
Study type: Observational

Summary: 
      This study will analyse the sperm global methylation status of 62 infertile men before
      assisted reproductive techniques. Some of these patients (20%) present hypomethylation of H19
      locus. A global methylation analysis may reveal others imprinting defects.
    

Detailed description: 
      An increase of the abnormalities of the imprint was brought back at the child's stemming from
      assisted reproductive techniques. Now abnormalities of methylation could be implied in
      defects of spermatogenesis and certain abnormalities of development of the male germ cells
      could be due to modifications abnormal epigenetics.

      The objective of this research is to determine the frequency of arisen the abnormalities of
      methylation at the level of the locus H19 in the sperm cells of barren men presenting an
      unexplained oligozoospermia and to determine if these changes are a reflection of
      abnormalities of the profiles of methylation of the whole genome.

      The patients will realize a taking of sperm having signed the consent.
    

Intervention name(s): methylation analyses on spermatozoa from infertile men
Intervention type(s): Other
Intervention description(s): microarray analysis(www.EPIGENOMICS.com)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Men from 18 to 45 years old, presenting an idiopathic oligozoospermia lower than 10 million
        sperm cells / ml and include in a program of medically assisted conception
      
Biospecimen description: 
      Sample of sperm collected by automasturbation
    
Keywords: methylation; micro array; locus H19; male infertility
The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study
Condition: Chronic Pain Syndrome
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      An additional, intermittent bolus application in patients with intrathecal opiate
      administration for chronic pain syndrome may have a positive effect on the effectiveness of
      the treatment. Thus, the effect of an additional, intermittent bolus application in patients
      with intrathecal opiate administration was therefore investigated.

      Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each
      patient was submitted to two treatment periods in randomly chosen order (cross-over design):
      1. standard treatment (continuous opiate administration) and 2. continuous opiate
      administration with intermittent opiate bolus application. Both treatment periods lasted 14
      days. Patients were asked to record pain intensity, side effects and satisfaction with the
      treatment.

      The following hypotheses were tested:

        -  The application of additional opiate boli results in significantly lower pain intensity.

        -  The application of additional opiate boli does not result in a higher rate of adverse
           Events.
    


Intervention name(s): opiate with bolus
Intervention type(s): Drug
Intervention MeSH terms: Opiate Alkaloids
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        individuals with chronic pain syndrome
Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and
      effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean
      Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.
    


Intervention name(s): Esmirtazapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia [USP] name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.; Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.
Other intervention name(s): Org 50081; MK-8265
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy
Condition: Pain
Study type: Interventional

Summary: 
      The aim of this study was to investigate the beneficial effect of bone cement in combination
      with wire cerclage on the stability of the sternum following median sternotomy.

      One half of the patients received only wire cerclage the other both bone cement and wire
      cerclage.
    

Detailed description: 
      The aim of this study was to investigate the beneficial effect of bone cement in combination
      with wire cerclage on the stability of the sternum following median sternotomy.

      It has been shown previously that wire cerclage alone does not provide a stabile
      osteosynthesis following median sternotomy. The hypothesis is that if a stabile
      osteosynthesis can be achieved patient recovery can be hastened and patient discomfort and
      pain reduced.

      One half of the patients received only wire cerclage the other both bone cement and wire
      cerclage.

      The stability of the sternum was evaluated using radiostereometric analysis, PET-CT and
      patient reported outcomes in the form of SF-36 and VAS.
    

Intervention name(s): Kryptonite-bone cement
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: osteogenesis; Positron-Emission Tomography; Radiostereometric analysis
Effects of Late Dinner Against Early Dinner on Weight Loss Healthy Obese Women
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The aim of the present study is to test whether late eating dinner could affect the amount of
      weight loss in healthy obese women in a weight-loss program.
    


Intervention name(s): Early dinner+Diet; Late dinner+Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects are asked to eat dinner meals between 7:00- 7:30 PM in the ED group, while they are on a multidisciplinary weight loss plan for 12 weeks.; Subjects are asked to eat their dinner meal between 10:30-11:00PM, while they are on a multidisciplinary weight loss plan for 12 weeks.
Other intervention name(s): ED; LD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: weight loss; dietary pattern; late dinner; early dinner
Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
Condition: Myopia; Hyperopia; Astigmatism
MeSH terms: Astigmatism; Hyperopia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at
      specific time points over the course of four days. The study was conducted with PureVision
      lenses.
    


Intervention name(s): RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)
Intervention type(s): Device
Intervention description(s): multi-purpose lens care solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Growing Biofilm by an Antiplaque Mouthrinse
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficiency of a new mouthrinse on dental
      plaque deposits.

      The study is carried out on 50 volunteers that are asked to use the mouthrinse without any
      other oral hygiene measure, during 4 days. It is a double bind, cross-over, randomized
      design: the same subjects test the active product and the placebo.
    

Detailed description: 
      The prevention of oral diseases is mainly targeted at the control of dental plaque. While
      tooth brushing is an effective method to remove plaque mechanically, it is not always
      sufficient and chemical antiplaque agents could be helpful. Some of them are used for their
      antibacterial action, the gold standard being chlorhexidine. Despite the great benefit of
      this bactericidal approach, the search continues for active ingredients that could prevent
      dental plaque formation without affecting the biological equilibrium within the oral cavity.

      The aim of this study is to evaluate the efficiency of a mouthrinse, containing red grape
      seed extract and nicométhanol fluorhydrate, in the control of dental plaque deposit in a
      4-days plaque regrowth model.

      The study is a double blind randomized cross-over design, involving 50 healthy volunteers.
      During the treatment periods (4 days) no oral hygiene, measures excepting rinsing with the
      allocated product (active/non active) are permitted.

      On day 1, the subjects receive professional prophylaxis. The mouthrinse is used pure, three
      times per day, after each meal. On day 5, subjects will be scored for disclosed plaque using
      the Quigley Hein index (modified by Turesky).

      After a 2 weeks wash-out period, the subject receives the other product (active/non active)
      and uses it as in the first period.

      On day 5, subjects will be scored again for disclosed plaque
    

Intervention name(s): mouthrinse (Grape Seed Extract + nicomethanol fluorhydrate); mouthrinse containing non-active component
Intervention type(s): Drug; Other
Intervention description(s): Antiplaque mouthrinse containing active component three times a day, during 1 minute, for 4 days; Antiplaque mouthrinse containing non-active component three times a day, during 1 minute, for 4 days
Intervention MeSH terms: Grape Seed Extract
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mouthrinse; grape seed extract; fluor; plaque index
Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS
Condition: Infertility; Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of administration of low dose of human
      chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation
      in infertile women having CC resistant polycystic ovarian syndrome (PCOS).
    

Detailed description: 
      Women will be randomly divided into two groups; CC-HCG group and CC group. Women in the
      CC-HCG group will receive CC (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG
      (200 IU/day SC from day 7 of cycle). Women in the CC group will receive CC alone (150 mg/day
      for 5 consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be
      performed regularly for monitoring of follicular growth (folliculometry); starting from day
      10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one
      follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular
      administration of 10000 IU of HCG and timed intercourse will be advised. If there will be no
      follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued
      and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan
      one week after triggering of oocyte maturation and will be confirmed by assessing the
      midluteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a
      maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle
    

Intervention name(s): Clomiphene citrate and Human chorionic gonadotropin (HCG); Clomiphene citrate
Intervention type(s): Drug; Drug
Intervention description(s): Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle); Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle)
Other intervention name(s): Clomid and Choriomon; Clomid
Intervention MeSH terms: Citric Acid; Sodium Citrate; Clomiphene; Enclomiphene; Zuclomiphene; Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; Clomiphene citrate resistant; HCG
Study to Assess the Effect of OXYJUN on Ejection Fraction and Markers of Cardiovascular Injury
Condition: Cardiac Function in Young Athletes
Study type: Interventional

Summary: 
      Young athletes are usually regarded as a special subgroup of healthy individuals with a
      unique lifestyle who are apparently invulnerable and often capable of extraordinary physical
      achievement. Most athletic disciplines to some extent combine endurance and strength modes of
      physical conditioning. Acute responses to endurance exercise training include substantial
      increases in maximal oxygen uptake, cardiac output, stroke volume, and systolic blood
      pressure in-spite of this, high intensity chronic training such as marathons, very long
      distance bicycle racing etc., can lead to transient acute volume overload of the atria and
      right ventricle, with transient reductions in right ventricular ejection fraction and
      elevations of cardiac biomarkers. Although these biomarkers generally normalize back within
      seven to ten days, these transient changes may sooner or later mark the beginning of
      processes like patchy myocardial fibrosis finally leading to grave chronic heart diseases .

      Inspite of the awareness regarding the cardio vascular risk in the athletes, there have been
      no new advancements in finding an alternate option which can protect the cardio vascular
      system in the athletes.

      Hence in order to address the need of the hour and also to avoid the cardio vascular risk in
      athletes along with improvising the endurance capacity, Enovate Biolife is in the process of
      development of an innovative product "E-OJ-01".

      E-OJ-01 is expected to have beneficial effects on the cardio vascular system of the athletes
      by enhancing ejection fraction which in turn improves cardiac output. This finally is
      hypothysed to increase the maximal oxygen uptake capacity in athletes.
    


Intervention name(s): E-OJ-01 (OXYJUN); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Young athletes; Cardiac endurance; Herbal; Ejection Fraction; Basic Research; Cardiovascular Injury
Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Evaluating the use of Liraglutide in patients with Type 1 Diabetes.
    

Detailed description: 
      This investigation will be a retrospective chart review of in type 1 diabetics who have been
      treated with liraglutide. The study will be conducted at Diabetes-Endocrinology Center of WNY
      at Millard Fillmore Hospital, affiliated to the State University of New York at Buffalo.

      Study Population: 40 patients with type 1 diabetes on treatment with either continuous
      subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more)
      injections of insulin per day on continuous glucose monitoring system (CGMS) will be included
      in the study. These patients with type 1 diabetes have been treated with liraglutide in
      addition to insulin. The investigators would retrospectively review their charts to evaluate
      decreases in fasting, postprandial and the overall mean glucose concentrations.

      The investigators will compare the mean fasting, the mean weekly glucose and the standard
      deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring
      prior to and following one week and 12 weeks of treatment with liraglutide daily. In
      addition, the investigators will compare the time spent at glucose concentrations >150 and
      200mg/dl and <70 and <40 mg/dl. HbA1c levels before and after 12 weeks of treatment with
      liraglutide daily will be compared.
    

Intervention name(s): Liraglutide
Intervention type(s): Drug
Intervention description(s): Liraglutide s/c 0.6mg once daily.
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Type 1 Diabetes Mellitus