bioihbjkbjnl/mcl2 huggingface dataset:
Modafinil for the Treatment of Alcohol Use Disorders
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      Alcohol use disorder (AUD) is a major cause of morbidity and mortality and more treatments
      are needed, especially pharmacotherapies. There are a variety of efficacious treatments for
      AUD, but effect sizes are small, and vary from study to study. Medications may be more
      effective if particular subgroups of AUD are targeted. Identifying the mechanisms of action
      of a particular medication will help identify the subtypes more likely to respond to therapy.
      Global impulse control is a rational treatment target, and improving it is a likely
      mechanisms by which some medications for AUD work, especially in subtypes of AUD with
      impaired impulse control at baseline. Modafinil is a medication that is FDA approved for the
      treatment of narcolepsy, and is relatively safe and tolerable. There is reason to believe it
      may improve impulse control, and underlying neural circuitry, and may work best to improve
      alcohol use outcomes in AUD with poor impulse control. The overall aim of this study is to
      investigate the effects of modafinil on task performance and the integrity of neural circuits
      mediating response inhibition in treatment-seeking AUD with poor response inhibition, to
      establish target engagement. Secondary aims are to measure whether target engagement mediates
      improvement in alcohol use outcomes, and to utilize machine learning to identify neural and
      behavioral markers which best predict treatment outcomes. Twenty-four individuals with AUD
      and impaired response inhibition will be enrolled in the study, randomized to modafinil or
      placebo, and treated for 6 weeks. Functional magnetic resonance imaging brain scans during a
      response inhibition task and during rest will be obtained at baseline and 2 weeks. Aversive
      stimuli will be included in the response inhibition task to assure that efficacy generalizes
      to several conditions. Diffusion imaging and arterial spin labeling sequences will also be
      obtained. Investigators predict that modafinil will significantly increase brain activity in
      the medial and lateral prefrontal cortex during response inhibition, thereby establishing
      target engagement, and that it will improve alcohol use outcomes. Findings will provide
      information about whether or not a larger R01 trial investigating the efficacy of modafinil
      for individuals with AUD and impaired response inhibition is warranted.
    

Detailed description: 
      see above.
    

Intervention name(s): Modafinil; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Modafinil 300 mg by mouth daily; Placebo
Other intervention name(s): Provigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Impact of Oral Health Literacy on Dental Anxiety and Utilization of Oral Health Services
Condition: Oral Health
Study type: Observational

Summary: 
      Oral Health Literacy is an integral part that should be taken into measures when evaluating
      the oral health status of any population. It has been stated that adults with low oral health
      literacy are more prone to miss their dental appointments and that low levels of oral health
      literacy, and being anxious and fearful of the dentist is a common barrier to the utilization
      of dental services. Unfortunately no previous studies assessed the oral health literacy
      level, dental anxiety and utilization of dental services among the Egyptian population. So
      the aim of the current study is to detect the impact of oral health literacy on level of
      dental anxiety and utilization of dental services among Misr International University (MIU)
      dental patients.
    

Detailed description: 
      The current study is a cross sectional study that includes an interview lead questionnaire
      that will be carried out by second year dental students of the academic years (2018-2019,
      2019- 2020). The questionnaire consists of four sections; a demographic section, a modified
      Arabic Rapid Estimate of Adult Literacy (ARELAD-30) Tool, Arabic Modified Dental Anxiety
      Scale (AMDAS), and Utilization of oral health services questionnaire. Before conducting the
      study, orientation sessions and thorough training of the students will be performed to ensure
      that the students can conduct the interview consistently and efficiently. Students will be
      asked to design educational materials (brochures, leaflets and posters) that aim at improving
      patients' knowledge and awareness regarding oral health and the utilization of oral health
      services. The aim of this study is to detect the impact of oral health literacy on the level
      of dental anxiety and utilization of dental services among dental patients.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Dental patients of both gender, aged from 18-60 years old, who can read.
      
Keywords: Oral health literacy; Dental anxiety; Utilization of oral health services; Dental patients
A Study to Evaluate the Effect of a Potent Cytochrome P450 (CYP) 3A Inhibitor on Ipatasertib
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a single center, open-label, 2-period, fixed-sequence, Phase 1 drug-drug
      interaction study in healthy subjects. The primary purpose of this study is to evaluate the
      effect of itraconazole on the PK of ipatasertib and its primary metabolite (G-037720).
    


Intervention name(s): Ipatasertib; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Ipatasertib 100 mg tablet orally once daily.; Itraconazole 100 mg capsules orally once daily.
Intervention MeSH terms: Itraconazole; Ipatasertib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adjuvant Anti-Recurrence Treatment With Rapamycin on Early-stage HCC
Condition: Hepatocellular Carcinoma; Rapamycin
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with
      overexpression of ASPH after radical surgery using randomized controlled study and provide a
      new anti-recurrence treatment for HCC patients after operation.
    


Intervention name(s): Rapamycin
Intervention type(s): Drug
Intervention description(s): 2mg,po,bid
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aspartate beta hydroxylase; transcatheter arterial chemoembolization
Serum TRAP-5b Levels in Patients With Generalized Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      To compare the effect of non-surgical periodontal therapy with or without systemic
      administration of amoxicillin and metronidazole on the concentration of serum levels of
      TRAP-5b in patients with generalized chronic periodontitis.
    

Detailed description: 
      30 Chronic periodontitis subjects were divided into two groups- group A underwent scaling and
      root planing and group B underwent scaling and root planing with systemic administration of
      amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days.

      Periodontal parameters probing pocket depth and clinical attachment level were measured at
      baseline and at 3rd month. Serum TRAP-5b levels were also measured at baseline, 1 month and
      at 3rd month.
    

Intervention name(s): Scaling and root planing; scaling and root planing along with antibiotic intervention
Intervention type(s): Procedure; Drug
Intervention description(s): subjects underwent full mouth supragingival and subgingival scaling; subjects underwent full mouth supragingival and subgingival scaling along with antibiotic intervention of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days
Other intervention name(s): Non-surgical periodontal therapy; Systemic antibiotics
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A - scaling and root planing Group B - scaling and root planing along with antibiotic intervention of amoxicillin and metronidazole
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Periodontitis; TRAP-5b; Non-surgical periodontal therapy; Systemic antibiotics
Immune Response on Neoadjuvant Therapy in Non-small-cell Lung Cancer (NSCLC)
Condition: Carcinoma, Non-small-cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective is to assess the overall response rate (ORR) after induction therapy with
      docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and
      IIIa. ORR will be determined by the percentage of patients achieving objective response rates
      (CR + PR) according to the RECIST guidelines.
    

Detailed description: 
      Primary objective is to assess the overall response rate (ORR) after induction therapy with
      docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and
      IIIa. ORR will be determined by the percentage of patients achieving objective response rates
      (CR + PR) according to the RECIST guidelines.

      Secondary objective is

        -  To evaluate pathological response determined by histological work up of the surgical
           specimens according to TNM stages.

        -  To evaluate the metabolic response determined by PET analysis.

        -  To assess overall survival (OS) (median survival time and percentage of 1-year
           survival). OS is defined as time elapsed from the date of patient inclusion until
           recorded date of death.

        -  To characterize and quantify toxic effects of the scheduled therapy. Safety profile and
           tolerability will be assessed by recording adverse events, clinically significant
           laboratory abnormalities, physical examination and vital signs. Toxicities will be
           evaluated according to the NCI-CTC Toxicity Criteria and adverse events which are not
           reported in NCI-CTC will be graded as mild, moderate, severe or life-threatening. All
           patients who received any of the scheduled therapy will be included in the overall
           toxicity analysis.

        -  To evaluate the immunological response determined by regulatory T-cells and immune
           activation markers, to define chemoresistance by pharmacogenomic testing.
    

Intervention name(s): Docetaxel; oxaliplatin; cetuximab; surgery
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention description(s): 75mg/m², day 1,22; 40mg/m², d1,2,22,23; 400mg/m² (day1), 250mg/m² (day 8,15,22,29,36); 28 days after end of induction chemotherapy
Other intervention name(s): Taxotere; CDDP; Erbitux
Intervention MeSH terms: Docetaxel; Oxaliplatin; Cetuximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSCLC; non-small-cell lung cancer
Carbetocin Trial: Carbetocin Appropriate Rate Better Equilibrium Between Tonus (TOnus) and CIrculatioN
Condition: Complications; Cesarean Section; Anesthesia; Reaction
Study type: Interventional
Phase: Phase 4

Summary: 
      Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml
      after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood
      transfusion within 24 hours after delivery (World Health Organization, Recommendations for
      the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009).
      Since PPH is more common after caesarean deliveries than after vaginal births and the rate of
      CS is rising over time and will probably continue to rise, the incidence of PPH is expected
      to increase accordingly.

      A meta-analysis has shown that routine administration of an oxytocic agent after caesarean
      delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al., Cochrane
      Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative delivery
      are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the advantage over
      oxytocin of having a longer half-life and therefore reducing the use of additional
      uterotonics. Based on the findings of reduced cardiovascular side-effects with a
      short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J
      Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin
      minimises the cardiovascular side effects without compromising the uterine tone. Therefore,
      we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid
      compared to a bolus application in women undergoing primary or secondary caesarean delivery.
      This prospective, double-blind, randomised controlled non-inferiority trial will take place
      at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be
      inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a
      short-infusion than after a bolus administration (primary safety endpoint).
    


Intervention name(s): Carbetocin Short-infusion; Carbetocin Bolus application
Intervention type(s): Drug; Drug
Intervention description(s): Short-infusion of Carbetocin 100 microgram as compared to bolus application of Carbetocin 100 microgram (double dummy method); Carbetocin 100 microgram given intravenously as a bolus application over about 15 seconds
Intervention MeSH terms: Carbetocin; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Luteal Phase Progesterone in IUI and Gonadotropin Cycles
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study of patients undergoing Controlled Ovarian Hyperstimulation (COH) with
      Gonadotropins and Intrauterine Insemination (IUI) at a Fertility Clinic.

      Infertility is a common problem, and a popular method of therapy is to inject sperm through
      the cervix and into the uterus, a procedure known as IUI. In conjunction with IUI, injectable
      medications (gonadotropins) are used to stimulate the ovaries to produce more than one egg
      per cycle in a process called COH.

      Vaginal progesterone is used for luteal support in in vitro fertilization therapy and has
      been proven to effect pregnancy rates. However, the role of progesterone in COH is still
      unclear. In this study, the investigators want to examine the effect of giving vaginal
      progesterone after COH with IUI on pregnancy rates. The investigators want to study if luteal
      vaginal progesterone results in a higher pregnancy rate compared to no progesterone therapy
      in COH with IUI. At present, fertility centres vary in the use of progesterone after
      insemination, most likely due to the lack of studies on this subject.

      At the Fertility Clinic all patients undergoing COH with injectable medications and IUI,
      regardless of whether they are in the study, have a baseline transvaginal ultrasound and
      blood tests. Patients start the injectable medications for COH until the ovarian follicles
      are large enough, then a medication to release the eggs is given. The IUI is done
      approximately 36 hours later. The day after the IUI, study patients will be given vaginal
      progesterone while the control patients will receive no progesterone. All patients will be
      followed until a pregnancy test is done and a viable foetus is confirmed by ultrasound.
    


Intervention name(s): Progesterone Effervescent Vaginal Tablets
Intervention type(s): Drug
Intervention description(s): Experimental
Other intervention name(s): Endometrin 100 mg twice daily
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: controlled ovarian hyperstimulation; gonadotropins; intrauterine insemination; infertility; luteal progesterone
Evaluation of Antimicrobial Efficacy of Green Tea, Garlic With Lime, Pomegranate Extract and Chlorhexidine Mouth Rinses in a Group of Egyptian Children (In-Vivo Study)
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      the aim of the clinical trial is to evaluate the antimicrobial efficacy of the herbal mouth
      rinses against chlorhexidine mouth rinse.
    

Detailed description: 
      The present study was carried out on 84 children. Children were recruited based on certain
      inclusion criteria after signing a written informed consent by their parents. They were
      divided into 4 groups. Group (I) the children rinsed with Chlorhexidine mouth rinse, the
      child rinsed for 1 minute and plaque samples were collected from the child before and after
      rinsing. Group (II) children rinsed with green tea extract, while group (III) children rinsed
      with garlic with lime extract and group (IV) the children rinsed with pomegranate extract
      mouth rinse with the same procedures. .child satisfaction was measured using 5-point
      pictorial likert scale which is graded from 1 to 5 (1.Excellent.2.Good.3 Average 4.Poor. 5.
      Very poor).

      All the plaque samples were collected and put in sterile test tubes containing thioglycolate
      as a transport media. They transferred to the microbiology laboratory within half an hour
      after rinsing for detection of bacterial counts. These samples were incubated 48-96 hours at
      37°C. Number of bacterial colonies were counted by hand-held digital colony counter.
    

Intervention name(s): Green tea extract mouth rinse; Garlic with lime extract mouth rinse; Pomegranate extract mouth rinse; Chlorhexidine mouth rinse
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): herbal extracts mouth rinse that was prepared in the microbiology laboratory; herbal extracts mouth rinse that was prepared in the microbiology laboratory; herbal extracts mouth rinse that was prepared in the microbiology laboratory; herbal extracts mouth rinse that was prepared in the microbiology laboratory
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the four groups of the mouth rinses were done in parallel with each other
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: herbal mouth rinses; Pomegranate; Caries prevention; Garlic extract; Green tea extract
Effects of Convective Therapies in Dialysis Patients
Condition: Uremia
MeSH terms: Uremia
Study type: Interventional
Phase: Phase 3

Summary: 
      Convective therapies have been proposed for improving chronic dialysis patient outcomes,
      including intradialytic symptomatic hypotension.

      To evaluate the frequency of sessions with intradialytic symptomatic hypotension in different
      types and doses of convective therapies compared with low-flux hemodialysis (HD), the
      investigators performed a multicentre, open-label, randomized controlled trial.
    


Intervention name(s): online pre-dilution hemofiltration; online pre-dilution hemodiafiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): Online pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one; Online pre-dilution hemodiafiltration was performed with a synthetic high-flux membrane with an infusate/blood flow ratio of 0.6 and a dialysate plus infusate rate of 700 ml/min.
Other intervention name(s): online pre-dilution hemofiltration Technique; online pre-dilution hemodiafiltration Technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: blood pressure; cardiovascular instability; symptomatic hypotension; online hemofiltration; online hemodiafiltration
Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy
Condition: Gastric Symptoms; Indicated for Upper GI Endoscopy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot
      be used for the large gastric cavity.This blinded prospective study investigates the accuracy
      of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric
      symptoms and indication for upper GI Endoscopy.
    


Intervention name(s): MCE; Standard gastroscopy
Intervention type(s): Device; Device
Intervention description(s): MCE first, followed by standard gastroscopy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer
Condition: Primary Breast Cancer; Her2 Non-overexpressing
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The planned trial compares an anthracycline-free taxane based regimen versus a modern third
      generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The
      aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to
      a patient, who will only have a modest benefit from this compound. Prior to randomization for
      chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to
      identify patients who should not receive chemotherapy.

      Secondary objectives of this trial will be to compare overall survival and toxicity between
      the two chemotherapy arms, to evaluate survival in the observation arm and to perform
      translational research regarding prognostic and predictive factors.
    


Intervention name(s): Epirubicin; Cyclophosphamide; Docetaxel; Cyclophosphamide; Docetaxel
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 4 cycles, intravenous use, day 1 every three weeks; 4 cycles, intravenous infusion, day 1 every three weeks; 4 cycles, intravenous infusion, day 1 every three weeks after completion of EC-chemotherapy; 6 cycles, intravenous infusion, day 1 every 3 weeks; 6 cycles, intravenous infusion, day one every three weeks
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anthracycline-free; OncotypDX; taxane; Her2 negative breast cancer