bioihbjkbjnl/mcl2 huggingface dataset:
Genetic Modulation of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study the investigators will measure the functional brain activity of adult Attention
      Deficit Hyperactivity Disorder (ADHD) patients, genotyped according to the COMT genotype,
      during a Working Memory Paradigm, before and after a placebo controlled treatment with MPH
      for 6 WEEKS. Within this design, the investigators will be able to evaluate the therapeutic
      effect of MPH treatment on cognitive functions.
    


Intervention name(s): Methylphenidate, non-retard
Intervention type(s): Drug
Intervention description(s): Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition.
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a single-center, randomized, single-blind, investigator-initiated, pharmacological
      study with a parallel design. Patients with ST elevation myocardial infarction undergoing
      primary percutaneous coronary intervention and presenting high platelet reactivity as
      assessed with the Verify Now P2Y12 assay-Accumetrics(Platelet Reactivity Units -PRU≥235) at 2
      hours post-clopidogrel 600mg LD (Day 0), as assessed with the Verify Now P2Y12 assay, will be
      randomized after informed consent, in a 1:1 ratio to the following treatment groups:

      Group Α: Clopidogrel 150mg per day,starting from Day 1 until Day 5 (5 days after
      randomization) Group Β: Prasugrel 60 mg immediate loading (on Day 0) followed by 10mg/day
      starting from Day 1 until Day 5 (5 days after randomization).

      Platelet reactivity assessment will be performed 2 hours after randomization (Day 0), 24 h
      after randomization (Day 1) and on Day 5. Documentation of major adverse cardiac events
      (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and
      serious adverse events (bleeding, other adverse events)will be performed until Day 5.
    


Intervention name(s): Prasugrel; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Prasugrel 60mg immediate loading dose (Day 0)followed by 10mg/day starting from Day 1 until Day 5; Clopidogrel 150mg/d starting from Day 1
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: prasugrel; clopidogrel; primary percutaneous coronary intervention; high platelet reactivity
A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A Clinical Trial of PM01183 in Metastatic Breast Cancer to assess the antitumor activity of
      PM01183 ,to evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts
      response to PM01183 in Metastatic Breast Cancer (MBC) patients, to evaluate the safety
      profile of this PM01183 to analyze the pharmacokinetics (PK) and PK/PD
      (pharmacokinetic/pharmacodynamic) correlations and to evaluate the pharmacogenomic (PGx)
      expression profile in tumor samples.
    

Detailed description: 
      A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected
      Metastatic Breast Cancer to assess the antitumor activity of PM01183 in terms of overall
      response rate (ORR), duration of response (DR),clinical benefit [ORR or stable disease
      lasting over three months (SD > 3 months)], progression free survival (PFS), and one-year
      overall survival (1y-OS) and to evaluate whether the presence of a known germline mutation in
      BRCA 1/2 predicts response to PM01183 in MBC patients, to explore the activity of PM01183 in
      specific breast cancer subpopulations according to hormonal receptor status, HER-2
      overexpression, number and/or type of prior therapies, or according to other available
      histological/molecular classifications, to evaluate the safety profile of this PM01183
      administration schedule [Day 1 every three weeks (q3wk)] in this patient population, to
      analyze the pharmacokinetics (PK) of PM01183 in this patient population, to explore PK/PD
      (pharmacokinetic/ pharmacodynamic) correlations, if applicable and to evaluate the
      pharmacogenomic (PGx) expression profile of selected putative markers potentially predictive
      of response to PM01183, in tissues from tumor samples.
    

Intervention name(s): PM01183
Intervention type(s): Drug
Intervention description(s): PM01183 drug product (DP) is presented as a lyophilized powder for concentrate for solution for infusion with two strengths: 1 mg/vial and 4 mg/vial
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; PM01183; lurbinectedin; Pharma Mar
Digital Home Ovulation Test One Cycle at Home Study
Condition: Pregnancy; Fertility
Study type: Observational

Summary: 
      This study will assess the usability of a Digital Home Ovulation Test when used at home by
      lay-users seeking to conceive.
    

Detailed description: 
      This study will assess the ease of use of a Digital Home Ovulation Test when used by
      lay-users for one cycle in their home environment. The home ovulation test to be used in the
      study is a digital home ovulation test used to detect luteinising hormone (LH) and
      Estrone-3-Glucuronide (E3G) in urine to identify when ovulation is imminent.

      A sample size of 120 volunteers (minimum) will provide adequate information for assessing the
      usability of the home ovulation test. Usability of the test will be assessed through a
      questionnaire completed at the end of the study.

      This observational study will be conducted remotely and volunteers representative of the
      intended user (lay-users) will be recruited.
    

Intervention name(s): Home Ovulation Test
Intervention type(s): Device
Intervention description(s): Digital read home ovulation test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women seeking to conceive
      
Keywords: Trying to Conceive; Digital Home Ovulation Test; Usability
Use of Breath Stacking Technique on Regional Ventilation in Box Chest in Women With Morbid Obesity
Condition: Morbidly Obese
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Objectives: To evaluate the effects of the technique of Breath Stacking (BS) in the
      distribution of ventilation in the chest in women with morbid obesity. Methods: Randomized
      clinical trial, blinded, and controlled with 32 women (BMI ≥ 40kg/m2), separated into two
      groups: control (GC) with n = 16 and 41.94 ± 9.38 years and group Breath Stacking (GBS) , n =
      16 and 40.38 ± 10.16 years. Optoelectronic plethysmography (POE) was used to assess lung
      ventilation. For the BS technique was used to mask the expiratory branch occluded and Wright
      spirometer. GBS held three techniques with an interval of three minutes. The GC used the same
      circuit without the occlusion of the expiratory branch. Results: GBS was found to be higher
      in the contribution of tidal volume (VT) into the chest circumference (p = 0.04) and decrease
      in abdominal compartment (p = 0.03), whereas the CG showed no difference in distribution.
      Spirometric variables: FEV1 (%), FVC (%), FEV1/FVC (%), VC and CI showed no difference before
      and after the technical BS and GBS in the GC. Conclusions: The technique BS altered the
      distribution pattern of regional ventilation, resulting in greater contribution in lung
      volume in the lower rib cage, corresponding to activity of the diaphragm, with redistribution
      of volume between compartments.
    


Intervention name(s): Placebo-BREATH STACKING; BREATH STACKING
Intervention type(s): Other; Other
Intervention description(s): The control group used the same circuit in the intervention group, but without occlusion of the expiratory branch and followed the same protocol to capture the images, ie, basal respiration for five minutes, then three periods of breathing through the mask, the equivalent time the period of technical BS, and five minutes of respiration. The volunteers were instructed to maintain respiration during the period they were using the mask.; In the intervention group used a silicon mask, involving the nose and mouth with two outputs, one containing the Wright spirometer MARK 8 analog output and the other was occluded. It was explained that the mask would only allow the air entering during inspiration, and that should inspire the volunteer gradually filling the lungs with air until you feel that completely filled with an average time of 20 seconds, as shown in figure 1 obtained during the method of BS. The end of the technique would be in two situations: when the volunteer asked for it through a hand gesture, or when prearranged by Wright spirometer, was observed by the researcher that there was no change in the inspired volume.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effects of Prehabilitation in Gastric Cancer Patients With Metabolic Syndrome on Perioperative Outcome
Condition: Stomach Neoplasms; Metabolic Syndrome X
MeSH terms: Stomach Neoplasms; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      A prospective randomised controlled trial to investigate the effects of a pre-operative
      prehabilitation protocol on clinical outcomes of gastric cancer patients with metabolic
      syndrome who undergo laparoscopic radical gastrectomies and to determine the underlying
      mechanisms.
    

Detailed description: 
      To investigate the effects of a pre-operative prehabilitation protocol on clinical outcomes
      of gastric cancer patients with metabolic syndrome who undergo laparoscopic radical
      gastrectomies and to determine the underlying mechanisms.
    

Intervention name(s): pre-operative prehabilitation
Intervention type(s): Behavioral
Intervention description(s): To climb six flights of stairs (approximately 20 meters in height) at least 6 times as a daily routine and adaptive simulated training of restrictive ventilation dysfunction (increased thoracic and decreased abdominal breathing compliance) following abdominal surgery by using a full elastic breathable abdominal bandage.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: gastric neoplasm; metabolic syndrome; prehabilitation; pre-operative exercise; laparoscopic radical gastrectomy
ChemoRT With Adjuvant Chemo in Pancreatic Cancer (TARCEVA)
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To seek preliminary evidence of antitumor activity (progression free survival) of Erlotinib
      in combination with standard adjuvant chemoradiation and chemotherapy in patients with
      resected adenocarcinoma of the pancreas.
    

Detailed description: 
      This study is a phase II trial of erlotinib in combination with chemoradiation in patients
      with stage I/II adenocarcinoma of the pancreas who are candidates for adjuvant
      chemoradiation.

      This study is a phase II trial of erlotinib in combination with chemoradiation in patients
      with resected stage I/II adenocarcinoma of the pancreas who are candidates for adjuvant
      chemoradiation. Eligible patients will receive adjuvant treatment with erlotinib 100 mg plus
      Capecitabine 800 mg/m2 PO BID (5 days on/ 2 days off regimen) and External Beam Radiation
      Therapy (EBRT) at doses of 50.4 Gy in 28 fractions after pancreatectomy (Dosing for
      capecitabine and erlotinib was amended after considering the toxicity profile of the first 6
      patients). Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended
      patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15
      every 28 days plus daily erlotinib 100 mg.

      Eligible patients will receive adjuvant treatment with erlotinib 100 mg plus Capecitabine 800
      mg/m2 PO BID (5 days on/ 2 days off) and External Beam Radiation Therapy (EBRT) to the tumor
      bed plus adjacent lymph nodes at doses of 50.4 Gy in 28 fractions after surgery. For patients
      with close or positive margins after resection, they will be able to receive 54.0 Gy over 30
      fractions. Approximately 4-8 weeks after the conclusion of chemoradiation, it is recommended
      patients will continue treatment with 4 cycles of gemcitabine 1000 mg/m2 days 1, 8, and 15
      every 28 days plus erlotinib 100 mg/daily.
    

Intervention name(s): erlotinib hydrochloride
Intervention type(s): Drug
Intervention description(s): Erlotinib 100 mg PO QD (1 hour prior to Capecitabine) (both given daily without interruption)
Other intervention name(s): Tarceva
Intervention MeSH terms: Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the pancreas; stage I pancreatic cancer; stage II pancreatic cancer
Study on Effects of a Dairy Product Based on Polyphenols and Enriched With Vitamins B6, B9 and B12 on Some Cardiovascular Factor of Risk
Condition: Cardiovascular Risk Factors
Study type: Interventional

Summary: 
      We put forward that polyphenols and vitamins have a cardiovascular prevention effect for
      subject with cardiovascular risk.
    


Intervention name(s): Vitamins B6, B9 and B12 and polyphenols; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Vitamin B 6; Pyridoxal; Pyridoxine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Reduction of cardiovascular factor of risk
Comparison of Exercise and Massage in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The present study was designed to analyse and compare the effects of Pilates exercises and
      connective tissue massage in terms of pain intensity, pain pressure threshold and tolerance,
      anxiety, progress, and health related quality of life in females with fibromyalgia (FM)
    

Detailed description: 
      Treatment of FM is difficult. Conventional treatments do not appear to be managing the
      problem effectively and this has led to other forms of treatment. The aim of treating FM is
      to decrease pain and increase function by means of a multimodal therapeutic strategy, which,
      in most cases, includes pharmacological and non-pharmacological interventions. In the
      literature on non-pharmacological treatment approaches for FM, different managements are
      described, such as exercise, electrotherapy, patient education, self-management programmes,
      massage techniques, cryotherapy, and acupuncture. There are a number of reasons why patients
      choose these complementary and alternative medicine approaches, including dissatisfaction
      with conventional treatments or concerns over the toxicity of drugs. However, there is no
      consensus about which treatment approach is the best.The current randomised controlled trial
      was undertaken as a first pilot study to assess and compare the effectiveness of Pilates
      exercises, an active-group therapy, and connective tissue massage, a passive-personalised
      therapy, in the management of FM in females.
    

Intervention name(s): Pilates exercises; Connective tissue massage
Intervention type(s): Other; Other
Intervention description(s): 15 FM patients participated in the PE programme three times a week during a 4-week period; 21 patients received CTM, three times a week during a 4-week period
Other intervention name(s): No drug name
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pilates Exercises; Connective Tissue Massage
Vitamin D and Disease Activity in Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Observational

Summary: 
      The purpose of this study is to test blood and tissue samples of people with Ulcerative
      Colitis (UC) to see what effects vitamin D may have on the immune system. This research is
      being done because it could lead to the development of new treatment for people with
      inflammatory Bowel Disease (IBD).
    

Detailed description: 
      Patients with UC will be recruited and consented prior to colonoscopy or flexible
      sigmoidoscopy. All patients will be age 18 or older with a known history of UC that has been
      confirmed by biopsy and an extent of disease of at least 20cm proximal to the anus. Clinical
      data will be collected on the patient's age, disease duration, family history of IBD, smoking
      status and history, as well as current medications for IBD through a questionnaire. Data will
      also be collected regarding current vitamin D supplementation (if taking) and dose. Prior to
      the endoscopic procedure, peripheral blood will be drawn into two 10ml red top tubes. At the
      time of endoscopy, five standard size mucosal pinch biopsies will be obtained from 20cm
      proximal to the anus. . A bar-coded unique identifier label will be applied to each sample.
      One biopsy will be placed in formalin. Paraffin samples will be maintained at room
      temperature. Following to the endoscopic procedure, the patient's physician will complete a
      Mayo score based on the patients current symptoms and endoscopic disease severity. Comparison
      will be made between disease activity, serum serum 25 hydroxyvitamin D level, and mucosal
      expression of tight junction proteins as well as proinflammatory cytokines.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): This study is not interventional
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Both female and male participants are being studied
      
Biospecimen description: 
      1. Serum

        2. Colon mucosal RNA

        3. Formalin fixed paraffin embedded colon biopsy
Enhancing Medication-based Analgesia in Humans
Condition: Pain; Cannabis; Opioid Use, Unspecified
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-group, within-subject, double-blind, double-dummy, placebo and
      active-controlled study evaluated whether the FDA-approved cannabinoid dronabinol (Marinol)
      would enhance analgesia, subjective reports, and cognitive performance when compared to the
      FDA-approved opioid hydromorphone (Dilaudid).
    

Detailed description: 
      This was a human laboratory systematic examination of whether adding the FDA-approved
      cannabinoid dronabinol (Marinol; oral) to the FDA-approved opioid hydromorphone (Dilaudid;
      oral) would change the experience of hydromorphone as rated by laboratory measures of pain,
      subjective reports of drug effects, and cognitive performance. Subjects are healthy
      individuals with no history of drug use disorder. Study subjects and staff were completed
      blinded to the study drugs and the class of drugs under investigation and were informed that
      subjects may receive opioids, stimulants, cannabinoids, benzodiazepines, over the counter
      medications, and/or placebo. All participants completed all sessions. Sessions lasted up to
      8-hours and were conducted at least 7 days apart on an outpatient basis. Primary outcomes
      were collected from participants prior to dosing and at several hour periods post-dosing.
    

Intervention name(s): Within-subject test of blinded study medications
Intervention type(s): Drug
Intervention description(s): Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.
Intervention model: Single Group Assignment
Intervention model description: Each participant completed each of the 5 study conditions (identified here as arms).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Clinical Trial, Phase II; Analgesia; Abuse Potential
Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL)
Condition: Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional

Summary: 
      To evaluate the efficacy and safety of Vel-Dex therapy (bortezomib and dexamethasone)
      followed by autologous hematopoietic stem cell transplantation as an initial treatment in
      patients with newly diagnosed AL.
    

Detailed description: 
      Patients will receive two 21-day cycles of induction therapy with vel / dex regimen.
      Bortezomib 1.3mg/m2 on days 1, 4, 8 and 11 will be given by intravenous bolus injection while
      Dexamethasone 40 mg/d will be taken orally on days 1-4. After two cycles of vel / dex
      therapy, the collection of peripheral blood stem cells (PBSC) should be completed within 4
      weeks.Patients will receive ASCT therapy in 8 weeks after collection of PBSC (Recorded as day
      0), while melphalan (day -2) with a dose of 100,140 or 200 mg/m2 (choosing a dose according
      to the degree of risk for patients ) and Vel 1mg/m2 (days -6, -3, +1, +4) will be given. Four
      additional 21-day cycles of Vel treatment (with a dose of 1.6mg/m2 on day 1 and 8 of the
      cycle) will be conducted as consolidation therapy during the recommended 60-90 days after
      HSCT, or after resumption of hematopoietic function ( neutrophil count > 1.5x109/L and
      platelet count> 50x109/L). Later patients won't need maintenance therapy.

      The efficacy criteria are the international standards set with consensus of experts in the
      Tenth International Symposium on Amyloid and Amyloidosis.
    

Intervention name(s): Bortezomib
Intervention type(s): Drug
Intervention description(s): Bortezomib
Other intervention name(s): autologous hematopoietic stem cell transplantation
Intervention MeSH terms: Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hematopoietic stem cell transplantation; amyloidosis; Bortezomib