bioihbjkbjnl/mcl2 huggingface dataset:
Third Trimester 3D Printed Models Versus 3D Ultrasound Effects on Maternal-Fetal Attachment
Condition: Maternal-Fetal Relations
Study type: Interventional

Summary: 
      This study will invite healthy women with singleton pregnancies and normal 20 week
      ultrasounds to participate in the study that will involve completing a demographic
      questionnaire and measure of attachment, a 3D ultrasound, being randomized to receive a 3D
      printed model of the fetal face or not, and completing the attachment measure again.
    


Intervention name(s): 3D printed model; Placebo
Intervention type(s): Other; Other
Intervention description(s): Same as previously reported in arm descriptions; nothing other than the ultrasound
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: 3D ultrasound only or 3D ultrasound and printed model of fetal face
Masking: None (Open Label)
Primary purpose: Health Services Research
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo
      and nitrazepam as a comparative drug.
    


Intervention name(s): zolpidem MR; nitrazepam; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Other intervention name(s): FK199B
Intervention MeSH terms: Nitrazepam; Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; schizophrenia; manic-depressive psychosis; zolpidem
A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer
Condition: HER2-negative Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, open-label, parallel-group, pre-surgical study aimed to investigate the
      biological effects, safety, tolerability, and pharmacokinetics (PK) of different doses of
      oral AZD9833 in post-menopausal women with primary breast cancer
    

Detailed description: 
      The study will be conducted in approximately 20 study centers across 3 countries and will be
      conducted in three stages (stage 1, stage 2 and stage 3). After the screening visit and
      confirmation of eligibility, evaluable participants will be enrolled across treatment groups.
      In stage 1, up to 24 evaluable participants across two treatment groups will be enrolled. A
      Safety and Data Monitoring Committee will convene to review stage 1 data and decide whether
      further treatment groups are required in stage 2. Stage 2 will include participants across up
      to 3 treatment groups. Stage 3 will include two treatment groups:

      Stage 1 Group 1: AZD9833 Dose A once daily Group 2: AZD9833 Dose B once daily

      Stage 2 Group 1: AZD9833 Dose A once daily Group 2: AZD9833 Dose B once daily Group 3:
      AZD9833 Dose C once daily

      Stage 3 Group 1: AZD9833 Dose A once daily Group 2: AZD9833 Dose B once daily

      Adverse events and concomitant medications information will be collected throughout the
      study. Thereafter there will be 28-day follow-up visit after discontinuation of study
      treatment
    

Intervention name(s): AZD9833
Intervention type(s): Drug
Intervention description(s): AZD9833 tablets will be administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomised, open-label, parallel-group study. The study is divided into three stages as follows:
Stage 1: In this stage post-menopausal participants will be randomised in 2 cohorts in 1:1 ratio to receive AZD9833 with 12 evaluable participants in each cohort.
Stage 2: In this stage post-menopausal participants may be randomised in up to 3 cohorts, which may include up to 3 doses of AZD9833.
Stage 3 : In this stage post-menopausal participants may be randomised in up to 2 cohorts in 1:1 ratio, which may include up to 2 doses of AZD9833.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; Breast carcinoma; Estrogen-Receptor-positive breast cancer; HER2-negative breast cancer
Lofexidine for Opiate Withdrawal - 1
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate lofexidine for opiate withdrawal.
    

Detailed description: 
      An 11 day inpatient placebo-controlled, double-blind study of 96 opiate dependent, treatment
      seeking individuals randomized to 2 medication groups: lofexidine and placebo to be conducted
      in inpatient units at 3 treatment sites.
    

Intervention name(s): Lofexidine
Intervention type(s): Drug
Intervention MeSH terms: Lofexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: opiate dependence
TEAMcare for Diabetes in Mental Health Centers
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This proposal aims to demonstrate the feasibility and acceptability of adapting TEAMcare for
      patients with schizophrenia. The aim of this innovative mental health center-based team
      intervention is to improve diabetes, cardiovascular and psychiatric outcomes among patients
      with poorly controlled type 2 diabetes. The study will be conducted in two phases over the
      2-year grant period.

      Phase 1. Development of the adapted TEAMcare intervention and training of team members.

      Phase 2. During year 2, we will implement the intervention on the caseload of 40 outpatients
      at Harborview Mental Health Services with schizophrenia and poorly controlled type 2
      diabetes. The intervention involves the management of subjects' diabetes, hypertension, and
      hyperlipidemia by a CMHC diabetes team for 6 months (advanced nurse specialist on-site at
      supervised in weekly meetings by a psychiatrist and a UW Diabetes Center endocrinologist).

      The primary aim of this pilot research grant is to evaluate the feasibility of implementing
      this complex intervention, in order to guide the design of a larger scale efficacy study
      (R01). Both process and outcome measures will be evaluated at baseline, and at 3- and 6-month
      follow-up visits for the 40 subjects enrolled in this feasibility trial.
    


Intervention name(s): TEAMcare treatment of diabetes
Intervention type(s): Other
Intervention description(s): TEAMcare is an evidence-based collaborative care approach to the treatment of diabetes and psychiatric illness. It involves structured visits with a study nurse to monitor psychiatric symptoms, control of medical disease, and self-care activities. The nurses use motivational coaching to help patients solve problems and set goals for improved self-care and medication adherence. Medications for diabetes, hypertension, and hyperlipidemia are monitored and therapy intensified based on treat-to-target guidelines. All of these process and outcome measures are tracked in a registry designed for the study, and the nurses receive weekly supervision with a psychiatrist, an endocrinologist and a psychologist in order to review new cases and to track progress. Once a patient achieves targeted levels for relevant measures, the patient and the nurse develop a maintenance plan.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MD Auralia (HA Filler) in Treatment of Nasolabial Wrinkles
Condition: Nasolabial Fold, Hypoplastic
Study type: Interventional

Summary: 
      Auralya® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of
      reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.

      To evaluate the overall safety of the medical device and performance of Auralya® dermal
      filler in terms of absolute change of WSRS score (Wrinkle Severity Rating Scale) assessed by
      Investigator at 8 and 12 weeks after the initiation of treatment, compared to Baseline Visit
      (day 0).
    

Detailed description: 
      Minimally invasive procedures (injectable dermal fillers) are among the techniques preferred
      by an increasing number of specialists in Aesthetics due to their clinical performance
      regarding volume restoration, and favourable safety profile.

      During January - March 2018, it was performed a review of the scientific literature to find
      similar investigations to determine the minimal clinical significant difference between
      Baseline and a period of 30 days after the end the treatment.

      In a similar dermal filler study, Takanobu Mashiko et al used a 5-grade WSRS and showed that,
      at 4 weeks after treatment, they achieved a 1.7 ± 0.5 (mean ± SD) improvement between those
      visits.

      Considering the exploratory nature of this study and the fact that this investigation is
      first in-human, we choose to take a 0.5 WSRS decrease, at 90 days from the treatment start,
      as a minimal clinically significant difference. The standard deviation considered for the
      sample size calculation was set at 0.8 WSRS points.

      By using a one-sided Wilcoxon Signed-rank test (matched pairs), a significance level of 0.05
      and a power of 0.95 (probability of finding an effect when there is one), we calculated a
      total sample size of 31 subjects.
    

Intervention name(s): Auralya
Intervention type(s): Device
Intervention description(s): Hyaluronic Acid-Dermal Filler
Intervention model: Single Group Assignment
Intervention model description: This trial is open label, multi-center, non-randomized single group.
Masking: None (Open Label)
Primary purpose: Other
DHA and X-Linked Retinitis Pigmentosa
Condition: Retinitis Pigmentosa; X-linked Genetic Diseases
MeSH terms: Retinitis; Retinitis Pigmentosa; Genetic Diseases, Inborn; Genetic Diseases, X-Linked
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose:

      Retinitis pigmentosa (RP) is characterized by progressive loss of visual function due to
      specific genetic mutations. This trial is focused on patients with one of the most severe
      forms of the disease, X-linked inherited RP (XLRP). This disease is characterized by early
      onset (typically loss of night vision as a child) followed by loss of peripheral vision as a
      teenager and young adult. There is no male-to-male transmission of the disease in the family.

      There is no cure for RP and treatment options are limited. Two clinical trials have not found
      a benefit from nutritional supplementation with the long-chain polyunsaturated fatty acid,
      docosahexaenoic acid (DHA), at low daily doses although there is evidence that it slows
      disease progression in certain instances. In this clinical trial, we propose that a high dose
      nutritional DHA supplement will slow the loss of visual function and preserve usable vision
      in patients with XLRP.

      This study is a 4-year placebo-controlled randomized clinical trial meaning that patients
      have a 50-50 chance of receiving placebo or experimental treatment. A total of 66 patients
      will be enrolled; 33 will receive placebo and 33 will receive the treatment. Entry criteria
      include diagnosis of XLRP by an ophthalmologist, age 7 to 32 years, male, sufficient visual
      function such that disease progression can be followed for the entire duration of the trial,
      and a willingness to visit the testing site (Dallas, TX) once a year.

      Annual visual function testing includes ETDRS visual acuity, full-field and multifocal
      electroretinography (ERG), static peripheral visual fields, and fundus photography. Cone ERG
      function is the primary outcome measure.

      Funding Source - FDA, Foundation Fighting Blindness, DSM Nutritionals
    

Detailed description: 
      Location & Contact Information:

      Retina Foundation of the Southwest, 9600 N. Central Expressway, Suite 200, Dallas, TX 75231
      Contact: Dr. D. Hoffman (dhoffman@retinafoundation.org) or Dr. D. Birch
      (dbirch@retinafoundation.org).
    

Intervention name(s): docosahexaenoic acid OR corn/soy oil placebo
Intervention type(s): Drug
Intervention description(s): daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial
Other intervention name(s): DHA; omega-3 fatty acid; OR RANDOMIZED TO corn/soy oil placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: retina; electroretinography; clinical trial; docosahexaenoic acid; omega-3 fatty acid; x-linked inheritance
COPD on Primary Care Treatment (COOPT)
Condition: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Bronchitis, Chronic
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Chronic Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this family practice based study is to determine the long-term treatment effects
      of two drugs that are presumed to modify the course and progression of chronic obstructive
      pulmonary disease (COPD), oral N-acetylcysteine and inhaled corticosteroids.
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD) is a disorder characterised by symptoms and
      abnormal tests of expiratory flow that do not change markedly over periods of several months
      observation. COPD includes chronic bronchitis and emphysema. It is not fully clear which
      medication is the most efficacious in the long-term treatment of COPD. In contrast to asthma,
      the efficacy and therefore the precise role of inhaled corticosteroids is less clear in the
      treatment of patients with COPD. The same applies to another (much less investigated)
      possibility in the treatment of COPD, the anti-oxidant agent N-acetylcysteine.
      N-acetylcysteine is used as a mucolytic agent in a variety of clinical conditions, such as
      acute and chronic bronchitis and cystic fibrosis. The aim of this study, which is performed
      in family practices, is to determine the 3-year treatment effects and cost-effectiveness of
      oral N-acetylcysteine versus an inhaled corticosteroid (fluticason propionate) in modifying
      the course and progression of COPD.

      Comparisons: N-acetylcysteine (oral, 600 mg o.d.) and fluticason propionate (dry powder
      inhalation, 500 mcg b.i.d.) are compared with placebo
    

Intervention name(s): N-acetylcysteine; fluticasone propionate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluticasone; Xhance; Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trial; Family Practice; Respiratory Function Tests; Health Status
Effect of Selected Types of Breathing Exercises on Different Outcome Measures in Covid-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Coronavirus disease 2019 (COVID-19) infection leads to significant respiratory that have
      negative impact on function and quality of life (QoL). Breathing exercises are effective and
      important in patients with COVID-19.
    

Detailed description: 
      Coronavirus disease 2019 (COVID-19) infection leads to significant respiratory symptoms that
      have negative impact on function and quality of life (QoL). Breathing exercises are effective
      and important in patients with COVID-19.

      This study aimed to evaluate the effect of Buteyko breathing versus Bhastrika Pranayama on
      different outcome measures in COVID-19 Patients.

      Sixty patients of both genders with age range from 40-50 years old were recruited from El
      Khankah Centeral Hospital with positive nasopharyngeal swab samples and presence of
      ground-glass opacification in their chest computed tomography scan (CT-scan). Patients were
      assigned randomly into two groups A & B and took their medications. Group A received
      traditional physical therapy program (mobility exercises and Postural drainage) with
      Bhastrika Pranayama breathing exercise. Group B received traditional physical therapy program
      with Buteyko breathing exercise. Patients were assessed by Modified Borg Dyspnea Scale (MBS),
      blood samples (levels of CRP and d-dimer), six-minute walk test (6MWT), Pittsburgh Sleep
      Quality Index (PSQI), 36-Item Short-Form Health Survey (SF-36) Questionnaire.
    

Intervention name(s): breathing exercise
Intervention type(s): Other
Intervention description(s): Buteyko breathing technique developed to control hyperventilation and anxiety which leads to shortness of breath. It uses series of exercises to teach patients to breathe less deeply and less rapidly /Bhastrika "Bellow Breathing" is diaphragmatic breathing - deep breathing involving the diaphragm rather than the accessory muscles. Regulated pranayama exercises require inhalation, maintaining isometric contraction of respiratory muscles and forceful expiration. These techniques will strengthen respiratory muscles
Other intervention name(s): Bhastrika pranayama . Buteyko breathing exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sixty patients of both genders with age range from 40-50 years old will be recruited from El Khankah Centeral Hospital with positive nasopharyngeal swab samples and presence of ground-glass opacification in their chest computed tomography scan (CT-scan) will be assigned randomly into two groups A & B and take their medications.
Masking: None (Open Label)
Primary purpose: Prevention
Combined and Isolated Effects of Sleep Deprivation and Alcohol Intake on Exercise Performance in Humans.
Condition: Alcohol Intake; Sleep Deprivation
MeSH terms: Sleep Deprivation; Alcohol Drinking
Study type: Interventional

Summary: 
      Although the effects of acute alcohol intake and sleep deprivation on exercise performance
      lacks evidence in the literature, in many situations, they occur simultaneously. Once the
      alcohol affects physiological processes, the processes that occur during sleep can be
      impaired, such as: suppression of GH release, action of neurotransmitters and neuromodulators
      in the CNS, changes in the proportion of sleep stages and may lead to suppression of REM
      sleep. These changes promote a significant functional impairment such as a reduction in
      alertness and modification in reaction time, which affects the performance of any activity of
      daily and professional life. However, the combined effects on the physical performance
      variables, such as aerobic and neuromuscular performance lack of evidence in the literature.
    

Detailed description: 
      Ten subjects were randomized in four situations after familiarization and control situation:
      (1) alcohol intake combined with sleep normal; (2) alcohol intake combined with sleep
      deprivation; (3) placebo intake combined with sleep normal and (4) placebo intake combined
      with sleep deprivation.
    

Intervention name(s): Alcohol intake; Sleep deprivation
Intervention type(s): Other; Other
Intervention description(s): The subjects will be drink beer (with or without alcohol) before sleep intervention (normal sleep and sleep deprivation).; One night of sleep deprivation or one night of normal sleep.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
A Trial of Patients With a Charles Bonnet Syndrome
Condition: Prevalence, Psychiatrist Intervention
MeSH terms: Charles Bonnet Syndrome
Study type: Interventional

Summary: 
      Charles Bonnet Syndrome (CBS) is defined by the occurence of visual hallucinations (VH) in
      the absence of any mental disorder. Elderly patients with reduced visual acuity due to
      ophthalmic diseases are most affected. Conditions are often associated with the syndrome of
      age-related macular degeneration, cataract or glaucoma. Existing data on the syndrome's
      prevalence in Europe reveal diverse results. Aim of this study was to assess the prevalence
      of CBS in patients with low visual acuity and to evaluate, if an additional therapeutic
      interview with and treatment by a psychiatrist is beneficial.
    

Detailed description: 
      Patients with a visual acuity of 0.5 LogMAR or less in the better eye were screened for CBS.
      Instruments used were an interview asking for details of the hallucinations, a mental test
      and a scale concerning quality of life. Patients with CBS were randomized by minimization in
      two groups: in group 1, a patient-doctor interview by an ophthalmologist was performed and in
      group 2 an interview and if needed, a therapy by a psychiatrist. At the 3-months follow up,
      the psychological strain of patients was recorded again.
    

Intervention name(s): interview
Intervention type(s): Other
Intervention description(s): control group: interview, study group: explanation and exploration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Randomized control trial; Charles Bonnet syndrome; visual hallucinations; age related macular degeneration; patient education