bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a Dietary Fibre Supplementation of a Low Calorie Diet on Appetite and Body Weight
Condition: Appetite Suppression; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      This 18 week, randomized, double blind, placebo controlled trial will examine the effects of
      thick dietary fibre (PGX) supplementation of a low calorie diet (LCD) on appetite, weight
      loss, body composition, and compliance in overweight and moderately obese female.

      The investigators believe that 15 grams/day PGX supplementation of a low calorie diet over a
      14-weeks period will elicit a better appetite score (e.g. reduced hunger) compared to the
      rice flour supplementation of the LCD.
    


Intervention name(s): PolyGlycopleX (PGX); Rice flour
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The full dose of the study intervention is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.; The full dose of the placebo comparator is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: viscous; fibre; polysaccharide; appetite; hunger; satiety; weight management
Monitor the Incidence of Congenital Malformations in Infants of Women Who Have Been Treated With Ganirelix (Orgalutran®)(Study 38644)(P05966)(COMPLETED)
Condition: Pregnancy; Neonates
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      The primary purpose of this study is to collect data on the incidence of congenital
      malformations in infants of women with an ongoing pregnancy after controlled ovarian
      stimulation with recombinant follicle stimulating hormone /ganirelix followed by in vitro
      fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI), and to compare this
      incidence with that of a group of women who used a long protocol with a gonadotropin
      releasing hormone agonist as historical controls.
    


Intervention name(s): ganirelix; GnRH agonist
Intervention type(s): Drug; Drug
Intervention description(s): Daily 0.25 mg ganirelix administered to prevent premature LH surges during COS in order to achieve a pregnancy; Long protocol of GnRH agonist administered to prevent premature LH surges during COS in order to achieve a pregnancy
Other intervention name(s): Orgalutran; Org 37462
Intervention MeSH terms: Ganirelix
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Single site study; A total of approximately 2000 infants born after IVF or ICSI: app. 1000
        infants born after ongoing pregnancies resulting from COH including Puregon/Orgalutran
        treatment followed by IVF or ICSI and app. 1000 infants born after treatment with a long
        agonist protocol followed by IVF or ICSI as controls.
      
Keywords: Neonatal outcome; Congenital malformations; In-Vitro fertilization; Controlled ovarian stimulation; Follow-up
Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging
Condition: Photoaging; Hyperpigmentation; Rhytides
MeSH terms: Hyperpigmentation; Skin Diseases
Study type: Interventional

Summary: 
      Recent research has reported that the maple leaf extract exhibits anti-aging effects by
      inhibiting elastase activity, thereby preventing the breakdown of elastin and interfering
      with the formation of wrinkles. Red maple leaf extract contains phenolic compounds known as
      glucitol-core-containing gallotannins (GCGs) which help reduce the appearance of wrinkles and
      may decrease skin inflammation, dark spots and pigmentation. The objective of this study is
      to examine the effects of topical Maplifa on the cosmetic appearance of facial lines, redness
      and skin tone.
    


Intervention name(s): 1% red maple leaf extract in cream base; 5% red maple leaf extract; vehicle
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): 1% red maple leaf extract is combined in a cream base; 5% red maple leaf extract is combined in a cream base; vehicle cream base only
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy females ages 30-70 with Fitzpatrick skin type I-IV
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: maple leaf extract; skincare; photoaging; hyperpigmentation
Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer
Condition: Rectal Cancer; Locally Advanced Rectal Cancer; Hyperthermia; Hyperthermic Radiochemotherapy; Hyperthermic Chemoradiotherapy; Deep Regional Hyperthermia
MeSH terms: Rectal Neoplasms; Hyperthermia; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The current trial is evaluating the impact of deep regional hyperthermia on the pathological
      complete response rate in locally advanced rectal cancer in the context of preoperative 5FU
      based radiochemotherapy.
    


Intervention name(s): Deep regional hyperthermia; Radiotherapy; Chemotherapy (5-Fluorouracil)
Intervention type(s): Other; Radiation; Drug
Intervention description(s): Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.; Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.; 5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.
Intervention MeSH terms: Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rectal Cancer; Hyperthermia; Radiochemotherapy; Chemoradiotherapy; Deep regional hyperthermia; pathologic complete response; Regression Grade; Locally advanced rectal cancer; complete response
Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use
Condition: Weight Change
MeSH terms: Body Weight; Body Weight Changes
Study type: Observational

Summary: 
      The purpose of this study is to learn if women gain weight using progestin-only methods of
      contraception and if so, how much. The investigators will look at users of two progestin-only
      methods: the levonorgestrel-containing intrauterine contraceptive (LNG-IUC) and the
      etonorgestrel (ENG) subdermal implant, and compare these users' weight change to that of
      users of a non-hormonal method, the copper intrauterine device.

      The primary hypothesis is that ENG implant and LNG-IUC users' weight and body composition
      will increase more than the copper-IUD users. The investigators will collect body composition
      data using dual-energy x-ray absorptiometry (DEXA), and collect information about diet and
      activity using validated questionnaires.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants who are starting an IUD or implant through their provider could be eligible.
Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus; Dyslipidemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to establish the safety of ezetimibe/simvastatin and simvastatin
      in adolescents with Type 1 Diabetes and to determine the amount of decrease in
      LDL-cholesterol.The study hypothesizes that simvastatin and ezetimibe/simvastatin will be
      safe in adolescents with Type 1 Diabetes and will lower LDL-cholesterol at 6 months.
    

Detailed description: 
      Cardiovascular disease is the leading cause of death in people with type 1 diabetes mellitus
      (T1DM) and since atherosclerosis begins in childhood, data to inform clinicians as to
      appropriate dyslipidemia treatment in this high-risk population are of great public health
      importance. In this trial of lipid-lowering medications (Zocor [simvastatin], a statin,
      compared to Vytorin [ezetimibe/simvastatin], a combination of a statin and Zetia, a
      medication that blocks cholesterol absorption) will be performed in patients ages 12-18 years
      with LDL ≥ 130 mg/dl, consistent with current ADA guidelines. The study hypothesizes that
      Zocor and Vytorin will be safe in adolescents with T1DM and will lower LDL-cholesterol at 6
      months compared to baseline. In a two-arm design, Vytorin will lower LDL-c more than
      monotherapy with Zocor.
    

Intervention name(s): Simvastatin; Ezetimibe/Simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): simvastatin 20 mg daily; Ezetimibe (10mg)/Simvastatin (20mg)
Other intervention name(s): Zocor; Vytorin
Intervention MeSH terms: Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 1 Diabetes Mellitus; dyslipidemia; adolescents
High Risk Factor, Clinical Feature, and Follow up of Neonatal Arrhythmia
Condition: Neonatal Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Observational

Summary: 
      This study included 189 newborns (77 male,112 female) diagnosed with arrhythmia in the NICU
      of Children's Hospital of Chongqing Medical University, China, from January 2015 through
      December 2019. To investigate the high-risk factors, clinical manifestations, and clinical
      outcomes of neonatal arrhythmia.
    

Detailed description: 
      The incidence of neonatal arrhythmia is 3.94‰(189/47911), and the mortality of neonatal
      arrhythmia is 0.21‰(10/47911) within 1 year after birth.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        neonates
Renal Sympathetic Denervation in Mild Refractory Hypertension
Condition: Refractory Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the benefit of renal sympathetic denervation in
      patients with mild refractory hypertension
    


Intervention name(s): Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA); Sham procedure
Intervention type(s): Device; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Integrated Eye Tracking and Neural Monitoring for TBI: Optimization
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      Traumatic brain injury (TBI) is one of the most frequent injuries affecting service members.
      Unfortunately, current neurocognitive assessment tools are unable to reliably detect mild TBI
      more than a few days post- injury. Therefore, development of advanced systems for assessment
      and diagnosis of TBI are a top priority within Department of Defense. This project aims to
      evaluate a combined electroencephalography (EEG) and eye tracking system capable of assessing
      compromised cognitive function stemming from TBI, with the goal of enhancing operational
      readiness and aiding in diagnosis, improving health care and rehabilitation for affected
      military personnel.
    

Detailed description: 
      This study (N=100) will be a correlational study to assess cognitive function in healthy
      controls, individuals with mild TBI, and individuals with moderate-to-severe TBI.

      In general, participants will provide demographic information, medical history, and details
      of their head injury. Participants will also complete a brief neuropsychological assessment
      to obtain an index of cognitive ability, along with the Fusion Test with eye tracking and
      linked EEG. MRI data may also be obtained.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Male and female service members with or without traumatic brain injury (TBI).
      
Keywords: Traumatic brain injury, eye tracking, EEG, cognition
Staccato Zaleplon Single Dose Pharmacokinetics
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the safety, tolerability and pharmacokinetics of
      zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers
    


Intervention name(s): Inhaled placebo; Inhaled Zaleplon 0.5 mg; Inhaled Zaleplon 1 mg; Inhaled Zaleplon 2 mg; Inhaled Zaleplon 4 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Inhaled Staccato Placebo; Inhaled Staccato Zaleplon 0.5 mg; Inhaled Staccato Zaleplon 1 mg; Inhaled Staccato Zaleplon 2 mg; Inhaled Staccato Zaleplon 4 mg
Other intervention name(s): Staccato Placebo; Staccato Zaleplon 0.5 mg; Staccato Zaleplon 1 mg; Staccato Zaleplon 2 mg; Staccato Zaleplon 4 mg
Intervention MeSH terms: Zaleplon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy adult volunteers
Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      This trial consists of two linked substudies.

      Substudy 1: Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness
      Study

      Substudy 2: Activating Messages for Enhancing Primary Care Practice (AMEP2): Toxicity Study

      The purpose of the Effectiveness Study is to assess the comparative effectiveness of three
      multimedia educational interventions (a targeted educational video, a tailored interactive
      multimedia computer program, and an "attention control") for increasing the likelihood that
      primary care patients with significant depressive symptoms will seek appropriate care (n =
      510). The primary study outcomes are provision of minimally acceptable initial care,
      reductions in depression-related stigma, and improvement in depression symptoms. (See Process
      of Care and Patient Outcomes in Primary Outcome Measure section.)

      The purpose of the Toxicity Study is to assess the potential benefits (reduced stigma) and
      harms (inappropriate prescribing) associated with three multimedia depression educational
      interventions when administered to patients with few or no depressive symptoms (n = 308). The
      primary outcomes relating to this outcome are reducing depression-related stigma and reducing
      unnecessary prescribing. (See Toxicity in Primary Outcome Measure section.)

      Both studies will look at the secondary outcome measure of patient requests for depression
      treatment.
    

Detailed description: 
      This project is an investigator-initiated study involving two sequential phases and is funded
      by the National Institute of Mental Health. Phase I included the use of marketing research
      (i.e. focus groups, adaptive conjoint analysis, and other survey methods) to produce two
      clinic-based interventions: a public service announcement (PSA) and interactive multimedia
      computer program (IMCP). The two clinic-based interventions are intended to include messages
      that will activate patients to talk with their physicians about specific health concerns
      (depression) and/or any depressive symptoms they've been experiencing. In Phase II (as
      described in this registration protocol), those interventions will undergo assessment in a
      randomized controlled effectiveness trial (RCT) in primary care settings in Sacramento and
      San Francisco.
    

Intervention name(s): Public Service Announcement; Interactive Multi-Media Computer Program; Sleep Hygiene Video
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Evaluation of the Effect of the Gap Between Bone and Implant Surface on the Implants Stability
Condition: Missing Teeth
MeSH terms: Tooth Loss; Anodontia
Study type: Interventional

Summary: 
      This study aims to evaluate the changes in the stability of implants of the same macro-design
      placed with particle grafting in the fresh extraction socket, without grafting and placed in
      healed implant sites.
    


Intervention name(s): Dental implant
Intervention type(s): Device
Intervention description(s): Dental implant placement
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dental implant, primary stability, immediate placement
Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease; Dyspnea
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
Study type: Observational

Summary: 
      For patients admitted to the medical ward, it is usually difficult to predict if their
      clinical condition will deteriorate, however subtle changes in vital signs are usually
      present 8 to 24 hours before a life-threatening event such as respiratory failure leading to
      ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations
      can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7
      clinical vital parameter monitoring systems offer a unique possibility to identify clinical
      deterioration before patients progress beyond the point-of-no-return, where adverse events
      are inevitable. The WARD-COPD project aims to determine the number and duration of
      cardiopulmonary micro events during the first 4 days after hospital admission with Acute
      Exacerbation of COPD. We will also test the server installation, develop a database of core
      data and assess the frequency of artefacts and failure to capture the continuous monitoring
      signal.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients admitted to hospital for Acute Exacerbation of COPD.
      
Keywords: Wireless monitoring; Continuous monitoring; Vital parameters; Clinical deterioration
A Study of a Values-Based Intervention to Promote Weight Loss
Condition: Obesity; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      More than 160 million American adults are overweight or obese. Existing weight loss
      interventions from self-help to gold standard behavioral treatments, while often effective,
      do not sufficiently maintain motivation to adhere to dietary goals in the face of powerful
      biological and environmental influences to consume highly palatable foods. Clarification and
      awareness of values, a staple of acceptance-based treatments drawn from Acceptance and
      Commitment Therapy, are thought to enhance autonomous motivation to engage in behaviors
      consistent with one's personal life values (e.g., health) in the presence of countervailing
      forces (e.g., hunger, deprivation). However, the independent efficacy of values clarification
      and awareness in facilitating weight control has never been tested. This pilot study seeks to
      investigate the feasibility and acceptability of a series of three weight loss workshops
      (based off the gold standard) infused with values clarification and awareness techniques to
      promote weight control. Participants will be asked to follow a reduced-calorie dietary
      prescription while holding their values in mind in moments of dietary decision-making over
      the course of one month. The primary aims of this study are to: 1) develop the series of
      values-infused workshops, using participant feedback to iterate and improve the treatment
      manual; and 2) evaluate treatment acceptability. Secondary aims are: 1) to evaluate whether
      clinically meaningful changes in measures of values clarification and values awareness occur;
      2) to evaluate whether the intervention will lead participants to experience clinically
      meaningful changes in values-congruent weight control behaviors; 3) to evaluate whether the
      intervention will lead participants to experience clinically meaningful changes in weight;
      and 4) to evaluate theorized mechanisms of action in the intervention.
    


Intervention name(s): Values-Based Behavioral Treatment
Intervention type(s): Behavioral
Intervention description(s): The values-based behavioral treatment will consist of a series of three, once-weekly weight loss workshops infused with techniques to elicit values clarification and awareness in moments of dietary decision-making, and to enhance autonomous motivation for behavior change.
Intervention model: Single Group Assignment
Intervention model description: All participants are enrolled into a single condition, consisting of a series of three, once-weekly values-infused weight loss workshops.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Weight Loss; Behavioral treatment; Values; Values-based behavior change; Autonomous motivation; Acceptance and Commitment Therapy
Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether chiropractic manipulation or medical
      therapy is effective in the treatment of chronic neck pain.
    

Detailed description: 
      Neck pain is a common complaint, approximately 10% of the population have neck pain. Many
      modalities are used to treat neck pain, but no therapy has been found to be clearly superior.
      We conducted a randomized controlled study of chiropractic manipulation versus medical
      therapy for chronic neck pain.

      Subjects (n=70) with neck pain for more than 3 months but with no evidence of radiculopathy
      or myelopathy were randomized. Both groups were instructed to do neck exercises and use heat
      daily. The chiropractic group received 12 standardized manipulations over 6 weeks. Nurses saw
      the medical group on the same visit schedule and received acetaminophen 1,000 milligrams four
      times a day as needed. Blinded observer performed all measurements. The primary outcome
      measure was the Neck Disability Index (NDI). Secondary measures were pain via a visual
      analogue scale, global via Medical Outcome Study Short Form and range of motion via Cybex
      electronic inclinometer.
    

Intervention name(s): Chiropractic manipulation; acetaminophen
Intervention type(s): Procedure; Drug
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Neck Pain; Chiropractic manipulation; Randomized controlled trial