bioihbjkbjnl/mcl2 huggingface dataset:
GRIB Forsoeget-2004
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      The difficulties in loosing weight may not stem from lack og knowledge about nutrition, as
      implied by the standard treatment but from difficulties in following the advice. The
      hypothesis is, that revealing and addressing these difficulties psychotherapeutically may be
      more efficient in obtaining weight reduction. The effect of psychological group treatment of
      severely overweight children and their parents is compared with traditional nutritional
      information. In other words: Which is better: back-up or enlightenment?
    

Detailed description: 
      At on-set the children get a medical examination, blood-tests, measurement of height, weight,
      skin-fold, waist and hip. Children and parents fill out questionnaires on social and
      educational background as well as motivation and expectations to the treatment. All Children
      are thereafter randomised into two groups:multi-disciplinary group intervention versus
      traditional information. The randomisation is stratified according to gender and degree of
      overweight (135%-145% and >145%) supposing that the degree of overweight may mirror the
      difficulties in loosing weight. The experimental intervention consists of one lecture of
      general nutrition, weekly psychological group sessions for the children followed by physical
      exercise, and separate bi-monthly group sessions for the parents. After six months children
      and parents go to separate group sessions once a month for six months. The control group is
      offered nutritional advice once with a brief follow-up after one month. The height and weight
      of the children is measured every month, and the fat % is measured with DEXA-scanning at
      on-set, after six months, and after twelve months
    

Intervention name(s): multi-disciplinary group intervention; traditional information
Intervention type(s): Behavioral; Other
Intervention description(s): children:weekley session in 6 months, monthly sessions for 6 months parents: bi-monthly sessions for 6 months, monthly sessions for 6 months; 1 session of nutritional advise for parents and child and 1 follow-up after one month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; children; psychological intervention
Dose-finding Study for Vitamin K2 in Human Volunteers
Condition: Vitamin K-status
Study type: Interventional

Summary: 
      Earlier studies have shown that high vitamin K-intake leads to improved bone and vascular
      health by increased carboxylation of Gla-proteins in these tissues. From all K-vitamins,
      Menaquinone-7 (MK7) has been identified as the most effective cofactor for the carboxylation
      reaction of Gla-proteins such as osteocalcin and matrix-gla protein. The question remains
      which dosage of MK7 leads to optimal carboxylation levels of these proteins.

      The primary objective of this double-blind randomized intervention study is to establish the
      optimal dose of MK7 for carboxylation of the vitamin K-dependent proteins osteocalcin in bone
      and matrix-gla protein in the vessel wall. The optimal dose will be the concentration at
      which osteocalcin and matrix-gla protein are > 90% in the active (=carboxylated) form.
    

Detailed description: 
      This study is a double-blind randomized intervention study. In total 42 healthy volunteers
      (men and women) between 18 and 45 years will be recruited among the Maastricht University
      community (coworkers/students) and randomized into one of the following groups:

      Placebo, 10 mcg MK7, 20 mcg MK7, 45 mcg MK7, 90 mcg MK7, 180 mcg MK7, 360 mcg MK7.

      Each group will consist of 6 volunteers with approximately equal numbers of men and women (3
      men / 3 women). A double-blind design of the study is chosen to avoid the occurrence of bias
      during the study. The randomization procedure will be performed by an investigator who is not
      involved in the coordination of the study and will generate specific randomization codes for
      each subject. After randomization, the volunteers consume the indicated amount of capsules
      once daily with either breakfast of dinner during a period of 12 weeks.

      During the first week, blood samples of the volunteers will be collected at day 0, 1, 3 and 7
      to study immediate effects on carboxylation of OC and MGP. After the first week, blood
      samples will be drawn every first day of week 2, 4, 6, 8, 10, and 12.
    

Intervention name(s): Placebo; MK7
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Menaquinone-7
Intervention MeSH terms: Menaquinone 7
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: vitamin K2; dosis-response; osteocalcin; matrix-gla protein
Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection
Condition: HIV-1 Infection
MeSH terms: Infections; Communicable Diseases; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of a
      combination of the broadly neutralizing antibodies (bNAbs) teropavimab (formerly GS-5423) and
      zinlirvimab (formerly GS-2872) in combination with the HIV capsid inhibitor lenacapavir
      (LEN).
    


Intervention name(s): Oral Lenacapavir; Subcutaneous Lenacapavir; Teropavimab; Zinlirvimab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets administered without regard to food; Administered in the abdomen via subcutaneous injections; Administered intravenously; Administered intravenously
Other intervention name(s): GS-6207; GS-6207; 3BNC117-LS; GS-5423; 10-1074-LS; GS-2872
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Role of the Gut Microbiome on Lean Mass and Physical Function in Older Adults
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Observational

Summary: 
      The investigators recently published significant associations between circulating gut
      bacteria-related metabolites with lean and skeletal muscle mass and with measures of physical
      function in older adults, evidence that suggests a role for gut bacteria on the maintenance
      of these outcomes. To date, studies aimed at identification of associations between gut
      bacteria with lean mass or with specific measures of physical function have yet to be
      reported. Accordingly, the over-arching hypothesis is that gut bacteria are associated with,
      and are causatively involved in mechanisms that underlie the maintenance of lean mass and
      physical function in older adults. Results obtained from the proposed study are intended as
      the basis for future studies aimed at targeted modulation of the gut microflora, which may be
      a novel and innovative means for improving lean mass and physical function, and for
      addressing the public health priority of healthy aging in older adults.
    

Detailed description: 
      In older adults (70+ years), reduced lean body mass and physical function are associated with
      increased disability, hospitalization, morbidity and mortality. Because older adults are the
      fastest growing global subpopulation, identification of mechanisms that underlie the
      maintenance of lean mass and physical function will be important for addressing the public
      health priority of healthy aging.

      Gut bacteria may be involved in mechanisms that underlie the maintenance of lean mass and
      physical function. In support of this hypothesis, in multiple publications the investigators
      recently reported significant associations between circulating gut bacteria-related
      metabolites with these outcomes in older adults. Accordingly, the overarching study
      hypothesis is that is gut bacteria are associated with, and are causatively involved in
      mechanisms that underlie the maintenance of lean mass and physical function in older adults.
      To test this hypothesis, the investigators propose to: characterize the association between
      fecal bacteria with lean mass and physical function (AIM 1), test the causative role of gut
      bacteria on the maintenance of lean mass and physical function by colonizing germ-free mice
      with fecal bacteria from older adults (AIM 2), and examine potential mechanisms that link gut
      bacteria with these outcomes by identifying associations between gut bacteria and serum
      metabolites with lean mass and physical function (AIM 3).
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Older adults (70-85y), BMI < 35 kg/m2
      
Biospecimen description: 
      Feces, Serum
    
Keywords: microbiome, metabolome, aging, lean mass, physical function
Using Affective Differences to Predict Response to Behavioral Treatment for Major Depressive Disorder
Condition: Depression
MeSH terms: Depressive Disorder
Study type: Observational

Summary: 
      This study will determine how people with depression differ from healthy people in brain
      activity and interpreting emotions, both before and after receiving a psychotherapy
      treatment.
    

Detailed description: 
      Major depressive disorder is a serious form of depression that may be treated with
      psychotherapy. However, up to 40% of adults with depression do not show reduced symptoms when
      treated with cognitive therapy or behavioral activation (BA), two common forms of
      psychotherapy. Certain indicators are generally linked with a successful outcome of
      psychotherapy-demographic and clinical characteristics, comorbidity, and treatment
      adherence-but no factors reliably predict outcomes of psychotherapy in individuals. This
      study will test whether two characteristics related to the way people process emotions,
      affective asymmetry and affective reactivity, can predict whether people with depression will
      improve with BA therapy.

      Both depressed and healthy participants will be recruited for this study. Participation in
      this study will last 31 weeks. All participants will complete baseline assessments at Weeks 1
      and 2. Depressed participants will then begin receiving 16 weekly sessions of BA therapy. All
      participants will be assessed again after 8, 16, 17, and 28 weeks. Assessments will include
      the following: a urine toxicology screening; interviews on mental and physical health, family
      and childhood experiences, and current mood and functioning; computer tasks; recordings of
      electroencephalography (EEG) activity; recordings of reaction to a startle probe; recordings
      of electromyography (EMG) activity; recordings of electrodermal activity (EDA); and
      measurement of blood pressure.
    

Intervention name(s): Behavioral Activation
Intervention type(s): Behavioral
Intervention description(s): Behavioral Activation included up to 16 weekly 50 minute psychotherapy sessions using BA (Addis & Martell, 2004; Martell et al., 2001, 2010). Techniques included functional analyses to identify the antecedent and consequential aspects of low mood, and interventions such as monitoring daily activities, assessing pleasure/satisfaction and competence achieved via activities, assigning tasks that induce mastery or pleasure, and reducing skill deficits. Clinicians included postdoctoral fellows in clinical psychology (n = 2) or licensed clinical psychologists (n = 2).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants are drawn from the general population through on-line advertisements for the
        study.
      
Keywords: Major Depressive Disorder, EEG, Negativity bias
Telematic Dance Intervention on Quality of Life of Older
Condition: Aging Well
Study type: Interventional

Summary: 
      The aim of this study is to analyse the effectiveness of a telematic dance intervention on
      the quality of life of older people.

      This project is a controlled, randomized clinical trial. 54 people (Intervention Group, n=27;
      Control Group, n=27) between the ages of 60-80 will participate in the study.

      Intervention Group participants will perform a 3-month telematic dance program based on
      choreographic work. The participants shall be measured 3 times, at baseline,
      post-intervention, and at 6-month post-intervention follow-up. Aside from the quality of
      life, variables of balance, risk of falling, number of falls, level of physical activity,
      mood, functionality, comorbidity, and quadriceps strength will also be measured.
    


Intervention name(s): Telematic dance program
Intervention type(s): Behavioral
Intervention description(s): Telematic dance program
The dance program will consist of 24 sessions distributed twice a week for a total period of 3 months. Each session will include:
A) Warm up: It will consist of analytical and global movements of increasing intensity and stretching exercises. It will also involve body awareness and motor control exercises.
B) Choreography part: the participants must follow and learn the choreographies. Intensity ranges shall vary between low and moderate. (3-4 in Borg's Modified Scale (0-10)).
C) Cool down: It will consist of global movements of decreasing intensity, stretching, breathing, and relaxing exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: older; dance; muscle strenght; quality of life
Plant-Based Meat vs Animal "Red" Meat Trial
Condition: Inflammatory Response
Study type: Interventional

Summary: 
      To assess the changes in the circulating levels of TMAO after 1-week of beef or plant-based
      burger diet.
    

Detailed description: 
      Single-center, randomized, single-blinded cross-over trial including healthy adult
      participants (N=40, omnivores, aged between 25 and 65 years, and with a body mass index (BMI)
      between 20 and 40 kg/m2 (see participation criteria below). Participants will be randomized
      to either red meat (cow burger) or plant "meat" (plant-based burger). The primary outcome
      will be the within-group change in the TMAO levels.
    

Intervention name(s): Red meat patties group; Plant-based patties group
Intervention type(s): Other; Other
Intervention description(s): 1. Baseline Visit: day -7 before randomization
Clinical history
Refrain from seafood, eggs, fish or meat, for 7-day ("washout") prior to Day 1. 2. Day 1 Randomization
Randomization to 1 of 2 interventions: plant-based or meat burgers
6 days-worth of burgers will be delivered to the participant's house 3. Day 1-6:
The participant will be asked to eat a specific randomized diet for 6 days 5. Days 7
Physical exam (weight, BP, HR)
Food questionnaire
Blood draw: Circulating TMAO, Total, LDL, and HDL cholesterol, Creatinine, High-sensitivity c-reactive protein
Urine Collection - TMAO 6. Day 7-14: Washout 7. Day 14: Patties delivery 8. Day 14-20: Assigned diet for 6 days 9. Days 20: Same as day 7; Same as above
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-center, randomized, single-blinded cross-over trial including healthy adult participants (N=40, omnivores, aged between 25 and 65 years, and with a body mass index (BMI) between 20 and 40 kg/m2 (see participation criteria below). Following one week of a meat, egg, and seafood free diet ('washout'), participants will be randomized to either red meat (cow burger) or plant meat (plant-based burger) for one week. Following this, participants will under go another week of diet washout and will then be crossed over to the other meat burger for one week. The primary outcome will be the within-group change in the TMAO levels.
Masking: Single (Participant)
Primary purpose: Other
Keywords: TMAO; Red meat; Plant-base nutrition; Cardiovascular diseases
Custom Pack in Spine Surgery
Condition: Bone Diseases; Spine Cancer; Spine Osteoarthritis
MeSH terms: Spondylitis; Bone Diseases; Osteoarthritis, Spine; Spondylarthritis
Study type: Interventional

Summary: 
      Recent evidence suggests the efficacy of "custom pack" procedure on the operators reduction
      time and on the contamination risk due to the opening of many sterile packs. Nevertheless
      ,the studies available are sponsored by the industry and their results are very few. The aim
      of this study is to evaluate the correlation and reliability of spine surgery "custom pack"
      efficacy in adult patients obtained in the reduction of surgery time, relative risks, and
      materials wasted compared with the standard surgical field procedure practice .
    


Intervention name(s): custom pack; standard care
Intervention type(s): Other; Other
Intervention description(s): Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.; The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Nucleus Basalis Deep Brain Stimulation for Thinking & Memory Problems in Parkinson's.
Condition: Dementia in Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      We will perform a pilot study to evaluate the effectiveness of human NBM DBS at improving
      cognitive deficits in PD patients referred and eligible for conventional DBS treatment for
      coexisting motor impairments. Six patients with PD with both motor fluctuations and cognitive
      impairments (including but not restricted to deficits in attention and working memory) will
      have bilateral electrodes implanted to ensure that superficial contacts lie in the
      conventional motor GPi target, while the deepest electrical contacts lie in the NBM- (see
      figure 1). We will place electrodes using our conventional image guided, stereotactic
      frame-based procedure currently used in patients at NHNN. Patients will be randomised into 2
      groups in a crossover trial design to have 3 month periods of NBM stimulation switched on or
      switched off separated by a 1 month washout period, following which the patient will cross
      over to have the opposite condition for a further 3 months- see timeline. At the end of the
      crossover period, all patients will be invited for continued follow up with stimulation
      switched on and will have neuropsychological evaluations at 6 monthly intervals. Patients
      will be given the option of receiving additional conventional stimulation to the motor GPi,
      through the higher contacts of each electrode, at the end of the crossover period.
    


Intervention name(s): NBM DBS
Intervention type(s): Device
Intervention description(s): Deep Brain Stimulation targeting the Nucleus Basalis of Meynert
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      This two site study will evaluate the safety and effectiveness of laparoscopic truncal
      vagotomy for the treatment of obesity with baseline study and 18 month post op follow up.
    

Detailed description: 
      30 morbidly obese patients evenly enrolled at The University of California San Francisco and
      at the University of Rochester will be selected for study on a voluntary basis. They will
      have a BMI of >35 with at least one obesity related comorbidity or a BMI between 40 and 45.
      Subjects will undergo specific tests of vagal function and baseline metabolic evaluation at
      baseline.

      Thereafter they will undergo a laparoscopic truncal vagotomy. Over 18 months, post operative
      tests of adequate vagotomy, weight loss, change in body composition and metabolism will be
      studied.
    

Intervention name(s): Laparoscopic Truncal Vagotomy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children
Condition: Cystic Fibrosis; Healthy
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      This study compares the lung clearance index (LCI) in cystic fibrosis and healthy children
      obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each
      participants will perform the test (LCI) in duplicate on each device.
    

Detailed description: 
      Using nitrogen as the inert gas, there are currently two commercially available devices that
      offer the possibility to measure the LCI. However, comparison between them are lacking. The 2
      MBWN2 devices are the "EasyOne Pro Lab" (ndd Medical Technologies, Zürich, Switzerland) and
      the "Exhalyzer D" (Eco Medics AG, Duernten, Switzerland).
    

Intervention name(s): Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"
Intervention type(s): Device
Intervention description(s): Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        CF : primary care clinic HC : community sample
      
Keywords: Lung Clearance Index; Cystic Fibrosis; Multiple Breath Nitrogen Washout