bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of Melatonin in Sleep Problems of Hemodialysis and Peritoneal Dialysis Patients
Condition: Hemodialysis; Peritoneal Dialysis; Sleep Problems
MeSH terms: Dyssomnias; Parasomnias; Sleep Wake Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Sleep problems can lead to a bad quality of life and a raise of morbidity, also in dialysis
      patients. Sleep problems can be caused by a disturbance of circadian rhythms in our body. For
      a good regulation of these circadian rhythms a uniform external synchronisation is necessary.
      This is the synchronisation of the biological clock of our body by light and other
      influences. In case of a disturbance of the external synchronisation, due to for example naps
      during the day or wake periods at night, internal rhythms can be unlinked. As a result a
      weakened melatonin rhythm and a problematic sleep-wake cycle can be observed. Most dialysis
      patients have sleep problems. Their sleep latency is prolonged. They often take a nap during
      the day and their sleep efficiency is poor. There has only been one study on the melatonin
      rhythm of dialysis patients. The conclusion of this study was that the melatonin rhythm of
      dialysis patients is weakened and disturbed, probably caused by renal insufficiency. In this
      study no link was made between melatonin rhythm and the nature and severity of possible sleep
      problems. In different studies with non-dialysis patients and a disturbed melatonin rhythm,
      exogenous melatonin at the right time leads to a recovery of the normal rhythm and the normal
      biological clock and a better quality of life.

      The aim is to research the endogenous melatonin rhythm and to improve sleep problems of
      hemodialysis patients with a placebo-controlled study with exogenous melatonin. Next to this
      a substudy is performed, in which the effect of the change of daytime to nocturnal in
      hospital hemodialysis on sleep and melatonin is researched.
    


Intervention name(s): Melatonin
Intervention type(s): Drug
Intervention description(s): Melatonin 3 mg once-daily
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis
Condition: Severe Hypertriglyceridemia
MeSH terms: Pancreatitis; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label crossover study. The primary objective of this study is to
      compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid
      (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a
      single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.
    


Intervention name(s): Epanova; Lovaza
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Application Breathing Exercises With Load Inspiratory Postoperative Abdominal Surgery
Condition: Pulmonary Atelectasis; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms
MeSH terms: Pulmonary Atelectasis; Respiratory Tract Diseases
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effects of the use of breathing exercises with
      inspiratory loading on respiratory muscle strength and endurance, lung volumes and capacities
      and thoracoabdominal mobility in patients after bariatric surgery.

      It is believed that the use of inspiratory load may mitigate the negative effects of surgical
      trauma on respiratory muscle dysfunction, preserving respiratory muscle strength, lung
      volumes and diaphragm mobility, thus reducing the risk of pulmonary complications in the
      postoperative period.
    

Detailed description: 
      This is a prospective, randomized and blinded study, where volunteers will be selected
      anthropometric measurements, assessment of lung volumes and capacities, through spirometry,
      thoracoabdominal mobility through the circumference, assessment of inspiratory muscle
      strength and endurance.

      After these evaluations will be done by lottery randomization, where the volunteers will be
      divided into five groups. They are: control, incentive spirometry to flow, the volume
      incentive spirometry, Threshold ™, Power breathe ®, according to their resources to be
      performed during the postoperative period. Each appeal will be held in 6 sets of 15
      repetitions, totaling seven sessions, two in the immediate postoperative period, and five on
      the first postoperative day. At the end of the intervention volunteers will be reassessed.
    

Intervention name(s): incentive spirometry; inspiratory load equipment
Intervention type(s): Procedure; Procedure
Intervention description(s): Incentive spirometry to flow and incentive spirometry to volume; Threshold and Power breathe
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Morbid obesity; bariatric surgery; Respiratory muscle endurance; Respiratory muscle strength; spirometry; physiotherapy
An Investigation of a New Laryngeal Mask Airway LMA Protector
Condition: Airway Morbidity
Study type: Interventional

Summary: 
      Evaluation of LMA Protector
    

Detailed description: 
      This new disposable silicone airway device provides access and functional separation of the
      respiratory and digestive tracts. The airway tube is elliptical in cross section ending at
      the laryngeal opening. The device contains 2 drainage channels (male and female port)
      proximally that continues into a common distal opening posterior to the distal airway cuff
      bowl. The female port allows a gastric tube to be passed into the stomach, whilst a suction
      tube may be attached to the male suction port offering removal of gastric fluid around the
      upper oesophagus sphincter.
    

Intervention name(s): LMA Protector
Intervention type(s): Device
Intervention description(s): Insertion of airway device for airway management during gynaecological procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laryngeal Mask Airway
Celecoxib Combined With Fluorouracil and Leucovorin in Treating Patients With Resected Stage III Adenocarcinoma (Cancer) of the Colon
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Adenocarcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different
      ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the
      growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known
      whether fluorouracil and leucovorin are more effective with or without celecoxib in treating
      resected stage III adenocarcinoma (cancer) of the colon.

      PURPOSE: This randomized phase III trial is studying celecoxib, fluorouracil, and leucovorin
      to see how well they work compared to fluorouracil and leucovorin in treating patients who
      have undergone surgery for stage III colon cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare disease-free survival of patients with curatively resected stage III
           adenocarcinoma of the colon treated with adjuvant fluorouracil and leucovorin calcium
           with or without celecoxib.

      Secondary

        -  Compare the overall survival, the occurrence of new primary colon cancer, and the
           development of new polyps in patients treated with these regimens.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to ≥ 4 tumor-positive lymph nodes (yes vs no), form of adjuvant
      chemotherapy (infusional vs bolus), low-dose aspirin for cardiovascular prophylaxis (yes vs
      no), and participating center. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive fluorouracil and leucovorin calcium IV for up to 6 courses in
           the absence of disease recurrence or unacceptable toxicity. Patients also receive oral
           celecoxib twice daily.

        -  Arm II: Patients receive oral placebo twice daily and fluorouracil and leucovorin
           calcium as in arm I.

      In both arms, treatment with celecoxib or placebo continues for 3 years in the absence of
      disease recurrence or unacceptable toxicity.

      Patients are followed annually for 2 years.

      PROJECTED ACCRUAL: A total of 1,450 patients (725 per treatment arm) will be accrued for this
      study within 2 years.
    

Intervention name(s): celecoxib; fluorouracil; leucovorin calcium; adjuvant therapy
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention MeSH terms: Leucovorin; Celecoxib; Fluorouracil; Calcium; Levoleucovorin
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: adenocarcinoma of the colon; stage III colon cancer
Learning Through Play (LTP) Plus Group Cognitive Behaviour Therapy for Mothers of Young Children (ROSHNI-2)
Condition: Mothers
Study type: Interventional

Summary: 
      The study has both quantitative and qualitative components.

      The objective of the quantitative study is to:

      Determine if supported implementation of the LTP plus programme improves infant development
      compared to standard implementation of the LTP plus programme.

      The objective of the qualitative study is:

      Process evaluation and finding out about implementation challenges (from the perspective of
      the mothers and the people delivering both the LTP plus and the supported implementation
      intervention).
    

Detailed description: 
      In Pakistan, the Learning through Play parenting program was tested initially through a
      cluster randomized study in a rural area of Pakistan. The results of this recently completed
      cluster RCT funded by the Grand Challenges Canada (GCC) showed that LTP Plus works and
      benefits both the mother and the child. More specifically, the results indicate a significant
      reduction in maternal depression.

      Purpose of this cluster RCT is to determine if supported implementation of the LTP plus
      programme improves infant development compared to standard implementation of the LTP plus
      programme. This is an implementation trial comparing two ways of introducing LTP plus. A
      Cluster RCT of culturally adapted intervention LTP Plus will be conducted in the villages of
      Gadap town, Karachi, Pakistan. Total 60 villages will be randomized in two groups LTP plus
      and LTP plus supported implementation. Each cluster will be made of up to 15 mothers.
      Participants will be screened using eligibility checklist. Assessments will be done at
      baseline and after completion of intervention (3-month). All follow ups will be done by
      independent RAs, not involved in delivering intervention sessions.
    

Intervention name(s): LTP Plus
Intervention type(s): Behavioral
Intervention description(s): LTP Plus is comprised of two components; Learning through play (LTP) and Cognitive Behavior Therapy (CBT). The LTP Plus is a low-literacy, sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Thinking Healthy Program (THP) which adopts 'here and now' problem-solving approach. THP uses cognitive behavior therapy (CBT) techniques of active listening, changing negative thinking, and collaboration with the family.
Other intervention name(s): Psycho-social Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Mothers; young children; Implementation; Learning through play Plus; Cognitive Behavior Therapy
Full Plate Diet Study
Condition: Diet Modification
Study type: Interventional

Summary: 
      Comparison between two groups, experimental and control. Experimental will undergo lectures
      on a diet to increase fiber consumption. Blood tests and anthropometric measures will be done
      before and after the 3-months long program. Comparisons will be made pre and post and with
      groups.
    

Detailed description: 
      The Full Plate Diet Clinical Trial is a study that will verify if the three months course is
      sufficient to change diet behavior of the participants. Forty participants will be recruited
      and then randomly assigned to one of two groups (20 in each group): The Experimental group
      will attend one weekly session with instructions on how to increase fiber intake; Control
      group will not have the intervention. The goal of the study is to see if the Full Plate Diet
      program will improve blood measures of metabolic diseases and weight.
    

Intervention name(s): Full Plate Diet
Intervention type(s): Other
Intervention description(s): 12 weekly sessions on how to incorporate more fiber in the diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Control Trial
Masking: None (Open Label)
Primary purpose: Prevention
A Group Study on the Effects of a Short Multi-Domain Cognitive Training in Healthy Elderly Italian People
Condition: Age-related Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Alongside physiological cognitive ageing, nowadays there is an alarming increase in the
      incidence of dementia that requires communities to invest in its prevention. The engagement
      in cognitively stimulating activities and strong social networks have been identified among
      those protective factors promoting successful cognitive ageing. One aspect regarding
      cognitive stimulation concerns the relevance of the frequency of an external intervention.
      For these reasons, the aim of this study was to evaluate the efficacy of a 3-month
      multi-domain cognitive training program, administered once per week in a group of healthy
      elderly aged over 60 years old. Their results obtained on a series of neuropsychological
      tests, both pre- (t0) and post-training (t1), were compared with those of a passive control
      group who did not receive the cognitive training.
    

Detailed description: 
      Participants were assigned to the experimental or control group based on their time of
      application to the program. Both experimental and control group underwent a
      neuropsychological assessment to investigate different cognitive domains, before and after
      (~3 months) the training program. Based on the scores obtained during the preliminary
      neuropsychological assessment, the participants of the experimental training group were
      divided into small subgroups (ranging from 8 to 12 subjects) to further address
      individualization of training (i.e. level of difficulty of the exercises proposed). The
      experimental group attended weekly sessions of the multi-domain cognitive training. Each
      session lasted around one hour and the overall duration of the training was of 3 months, for
      a total of 13 sessions. To promote improvement transfer to everyday life, some of the
      exercises proposed were ecological in their nature, in that, they asked participants to solve
      tasks that recalled everyday situations (such as remembering names or road maps).
      Furthermore, throughout the training, approximately once every two sessions brief
      psycho-educational interventions were provided.
    

Intervention name(s): Multi-domain cognitive training
Intervention type(s): Behavioral
Intervention description(s): Weekly sessions of multi-domain cognitive training, each lasting around one hour for an overall duration of the training of 3 months (13 sessions)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: healthy cognitive ageing; multi-domain cognitive training
A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness (level of pain control) and safety
      of the administration of 2 different dose levels of Extended Release
      Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had
      bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are
      discharged from the hospital.
    


Intervention name(s): Hydrocodone/Acetaminophen Extended Release; Hydrocodone/Acetaminophen Extended Release; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet every 12 hours; 2 tablets every 12 hours; 2 tablets every 12 hours
Other intervention name(s): ABT-712; ABT-712
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Moderate to severe pain following bunionectomy surgery
Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, multi-center, parallel-group Phase I study to evaluate the
      pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC)
      injection of 150 mg/mL or 300 mg/2 mL Depo-Provera CI in the abdomen of women of reproductive
      age with a confirmed ovulatory baseline cycle.
    

Detailed description: 
      This is a randomized, multi-center, parallel-group Phase I study with a primary objective to
      evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single
      subcutaneous (SC) injection of 150mg/mL or 300mg/2mL Depo-Provera CI in the abdomen of women
      of reproductive age with a confirmed ovulatory baseline cycle.

      Secondary study objectives are:

        -  To evaluate and compare the pharmacokinetics (PK) of MPA after a single SC injection of
           150mg/mL or 300mg/2mL of Depo-Provera CI to two injections of Depo-subQ 104 administered
           3 months apart

        -  To evaluate the relationship between serum MPA concentration and suppression of
           ovulation

        -  To evaluate and compare the safety, tolerability and acceptability of a SC injection of
           DMPA of different frequencies, doses and volumes
    

Intervention name(s): DMPA 150; DMPA 300; DMPA 104
Intervention type(s): Drug; Drug; Drug
Intervention description(s): injectable contraceptive; injectable contraceptive; injectable contraceptive
Other intervention name(s): Depo-Provera® CI (150mg/mL, intramuscular); Depo-Provera® CI (300mg/2mL, intramuscular); depo-subQ provera 104® (104mg/0.65mL, sub-cutaneous)
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: depot medroxyprogesterone acetate (DMPA); confidence interval (CI); Subcutaneous (sub-Q); Intrauterine device (IUD); Levonorgestrel (LNG); intrauterine system (IUS)
The Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Prevention of dental caries has taken a great importance in the last decade. The use of
      herbal and natural products became mandatory to avoid the side effects of commercially
      available medications. Aim of the study; the aim was to investigate the anti-cariogenic
      effect of miswak and grape seed extract (GSE).
    

Detailed description: 
      Patients used Miswak sticks, grape seed extract mouth wash and fluoride mouthwash twice daily
      for three month. Saliva samples were collected at base line and after one month and three
      month. Assessment of bacterial count and saliva buffering capacity were performed at base
      line and after one and three month.
    

Intervention name(s): Miswak; Grape Seed Extract Mouthwash; fluoride
Intervention type(s): Other; Other; Other
Intervention description(s): sticks; Mouthwash; mouthwash
Other intervention name(s): silvadora persica; 95% proanthocyanidins; 0.05% sodium fluoride
Intervention MeSH terms: Proanthocyanidin; Grape Seed Extract; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Study to Investigate the Interaction of GSK1292263 With Rosuvastatin and Simvastatin in Healthy Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I, open-label, single-sequence drug interaction study to evaluate the
      effect of repeated doses of GSK1292263 on the pharmacokinetics of rosuvastatin and
      simvastatin in healthy adult subjects. Each subject will receive single doses of simvastatin
      and rosuvastatin on two occasions, once alone and once following administration of repeated
      (BID) doses of GSK1292263.
    


Intervention name(s): Simvastatin; Rosuvastatin; GSK1292263
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Simvastatin 40mg (single dose) on Days 1 and 10.; Rosuvastatin 10mg (single dose) on Days 3 and 12.; GSK1292263 300mg BID Days 6 to 14.
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: GSK1292263, rosuvastatin, simvastatin, pharmacokinetics, drug interaction
Comparative Study of Two Marketed Spherical Soft Contact Lenses
Condition: Refractive Error
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The purpose of this study is to obtain objective and subjective clinical data to compare the
      performance of two soft contact lenses.
    

Detailed description: 
      The study will evaluate the daily wear performance of the Avaira (enfilcon A) spherical lens
      during two weeks of wear compared to Vistakon's Oasys (senofilcon A) spherical lens.
    

Intervention name(s): enfilcon A; senofilcon A
Intervention type(s): Device; Device
Intervention description(s): enfilcon A daily wear soft contact lens; senofilcon A daily wear soft contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment