bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility and Preliminary Efficacy of a Reverse Diet as a Novel Weight Loss Maintenance Strategy for Weight-Reduced Adults With Overweight/Obesity
Condition: Overweight and Obesity; Weight Loss Maintenance; Dietary Habits
MeSH terms: Obesity; Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this project is to test, for the first time, a reverse diet in adults with
      current or prior overweight/obesity (Ow/Ob). Weight-reduced adults with current or prior
      Ow/Ob will be randomized to a reverse diet or "standard care" control (CON) intervention for
      12 weeks. Eligible participants will have lost >10% body mass. The reverse diet group will
      receive personalized caloric intake goals, increasing 2-3%/week. The CON group will receive
      standard weight maintenance recommendations with matched contact. At baseline and week 12,
      resting energy expenditure (REE), body mass and composition, subjective appetite, and food
      intake behaviors will be evaluated. In addition to the pre- and post-intervention measures,
      body mass and adherence to reverse diet will be monitored weekly.
    


Intervention name(s): Weight Loss Maintenance (Control vs. Reverse Diet)
Intervention type(s): Behavioral
Intervention description(s): Participants in both groups will receive a 12-week comprehensive, individually delivered behavioral weight loss maintenance intervention, adapted from the Diabetes Prevention Program (DPP) Post-CORE program. This program focuses on utilization of tools and strategies to maintain a healthy lifestyle and prevent weight regain, and is therefore most appropriate for the weight-reduced population we will enroll. While the DPP Post-CORE program includes 15 sessions delivered over 15-months, we will deliver sessions #1-12 and 15 over a 12-week period. Content for sessions 13 and 14 from the DPP Post-CORE curriculum focus specifically on Type 2 Diabetes Mellitus and Heart Disease. The informational handouts will be provided to participants, but not specifically covered in weekly meetings. Groups will differ only in specific caloric prescriptions (described in the Arms section).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: weight loss maintenance; reverse diet; body composition; metabolic rate; dietary adherence; resting energy expenditure; weight loss; weight regain
Effect of Class IV Laser Therapy and Pilates Exercises on Bone Density and Pain in Primary Osteoporosis: A Randomized Controlled Trial
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      the current study was to investigate the effect of class IV laser therapy and Pilates
      exercises on bone density in Osteoporosis.Sixty patients with osteoporosis (T-score values
      below -2.5) in lumbar spine with no evidence of vertebral compression fractures were
      recruited from October 6 University Hospital and Kaser El-aini Hospital, Cairo - Egypt from
      February 2019 to November 2019. Their age ranged from 40 to 60 years old. Patients with a
      history of tumors, ovariectomy, heart disease, renal failure, disc prolapse, or any trauma to
      the back area were excluded from the study
    

Detailed description: 
      They were allocated randomly into three groups: Group A consists of 20 patients received a
      multiwave locked system laser, group B consists of 20 patients received Pilates exercises and
      group C consists of 20 patients received a multiwave locked system laser and Pilates
      exercises. Patients with a history of tumors, ovariectomy, heart disease, renal failure, disc
      prolapse, or any trauma to the back area were excluded from the study. All patients who
      participated in the current study did not intake any medications to accelerate bone density
      like vitamin D or calcium. The randomization method was applied by asking each patient to
      choose a piece of paper that the (A), (B), or (C) letter was written. (A) considered the LLLT
      group, (B) considered the Pilates exercise group, while (C) considered the LLLT and Pilates
      exercises group. Both patients, the examiner, and therapist were blinded from the selection
      process.
    

Intervention name(s): laser therapy; exercise; combination
Intervention type(s): Radiation; Other; Other
Intervention description(s): performed by MLS® Laser Therapy (ASA Srl, Vicenza, Italy). It is designed to synchronize between two modules. One is emitting at 905 nm, with peak optical power = 25 W; each pulse is composed of a pulse train (single pulse width = 100 ns, maximum frequency 90 kHz). The frequency of the pulse trains varied between 1 and 2000 Hz. The other one is emitting at 808 nm in a continuous mode (power 1.1 W) or pulsed mode (pulses repetition rate 1-2000 Hz).; The exercises were applied on a floor mat to achieve a full body workout with 10 repetitions for each exercise and rest for one minute before beginning the next exercise to avoid muscle fatigue as the following.
Modified Hundred
Modified Single Leg Stretch
One Leg Circle
Modified Scissors; laser therapy + Pilates exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Osteoporosis, LLLT, multiwave locked system laser, Physical therapy modalities, DEXA, Pilates exercises
Remifemin Preventing the Climacteric Symptoms in Breast Cancer
Condition: Effect of Drugs; Safety Issues
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      LHRH-a is an important hormone treatment in breast cancer especially in high-risk hormone
      receptor-positive patients or hormone receptor-negative but needing ovarian function
      protecting. The climacteric symptoms caused by LHRH-a are often and prominent, which is a
      common clinical problem.
    

Detailed description: 
      Ovarian function suppression (OFS) or protection has been studied widely in breast cancer. As
      an common drug in clinic, LHRH-a is an important method for OFS in breast cancer especially
      in high-risk hormone receptor-positive patients or hormone receptor-negative but needing
      ovarian function protecting. The climacteric symptoms caused by LHRH-a are often and
      prominent, which is a common clinical problem. Remifemin (cimicifuga racemosa / black cohosh)
      is effective in climacteric symptoms as a hormone replacement treatment, some research
      concluded that it is also safe in breast cancer patients who are postmenopausal or taking
      tamoxifen suffering from climacteric symptoms. While in China, more than 2/3 breast cancer
      patients are pre/peri-menopause, and some part of them should take OFS as an hormone
      treatment. OFS can cause sever climacteric symptoms in a short time. The investigators aim to
      estimate the effect and safety of Remifemin in climacteric symptoms caused by OFS in breast
      cancer.
    

Intervention name(s): Remifemin
Intervention type(s): Drug
Intervention description(s): Remifemin 0.2g po bid*12 weeks at the beginning of the LHRH-a treatment
Other intervention name(s): cimicifuga racemosa; black cohosh
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: remifemin; preventive effect; LHRH-a; breast cancer
Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma
Condition: Pleuropulmonary Blastoma; Recurrent Malignant Peripheral Nerve Sheath Tumor; Recurrent Neuroblastoma; Recurrent Rhabdomyosarcoma; Recurrent Synovial Sarcoma; Wilms Tumor
MeSH terms: Neoplasms; Sarcoma; Neuroblastoma; Rhabdomyosarcoma; Wilms Tumor; Sarcoma, Synovial; Nerve Sheath Neoplasms; Neurofibrosarcoma; Pulmonary Blastoma; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies how well lorvotuzumab mertansine works in treating younger
      patients with Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma,
      malignant peripheral nerve sheath tumor (MPNST), or synovial sarcoma that has returned or
      that does not respond to treatment. Antibody-drug conjugates, such as lorvotuzumab
      mertansine, are created by attaching an antibody (protein used by the body?s immune system to
      fight foreign or diseased cells) to an anti-cancer drug. The antibody is used to recognize
      tumor cells so the anti-cancer drug can kill them.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess the efficacy of IMGN901 (lorvotuzumab mertansine) in Wilms tumor,
      rhabdomyosarcoma, neuroblastoma and other cluster of differentiation (CD)56-expressing tumors
      such as pleuropulmonary blastoma, malignant peripheral nerve sheath tumor (MPNST) and
      synovial sarcoma.

      II. To determine the tolerability of the adult recommended phase 2 dose (RP2D) of IMGN901
      administered as an intravenous infusion, administered on days 1 and 8 of a 21-day cycle, to
      children with refractory Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary
      blastoma, MPNST, or synovial sarcoma.

      III. To define and describe the toxicities of IMGN901 administered on this schedule.

      EXPLORATORY OBJECTIVES:

      I. To correlate tumor response with tumor CD56+ expression. II. To characterize the
      pharmacokinetics of IMGN901 in children with refractory cancer, including an assessment of
      impact on circulating CD56+ peripheral blood cells.

      OUTLINE:

      Patients receive lorvotuzumab mertansine intravenously (IV) over 1-1.5 hours on days 1 and 8.
      Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up for 5 years.
    

Intervention name(s): Laboratory Biomarker Analysis; Lorvotuzumab Mertansine; Pharmacological Study
Intervention type(s): Other; Biological; Other
Intervention description(s): Correlative studies; Given IV; Correlative studies
Other intervention name(s): Anti-Human NCAM-1 Monoclonal Antibody N901; BB-10901; huN901-DM1; IMGN901
Intervention MeSH terms: Maytansine; Lorvotuzumab mertansine; Ado-Trastuzumab Emtansine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2
      doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when
      administered for 12 weeks.
    


Intervention name(s): Etrasimod; Etrasimod; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Etrasimod tablet by mouth, once daily for 12 weeks; Etrasimod tablet by mouth, once daily for 12 weeks; Etrasimod matching placebo tablet by mouth, once daily up to 12 weeks
Other intervention name(s): APD334; APD334
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; APD334; Etrasimod
Vitamin D Treatment to Patients Suffering From Chronic Pain and Vitamin D Hypovitaminosis
Condition: Back Pain; Hypovitaminosis D
MeSH terms: Rickets; Avitaminosis; Vitamin D Deficiency; Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      The objective of this study is to check whether vitamin D will lead to a decrease in pain
      intensity compare to placebo, in patients suffering from chronic pain.
    

Detailed description: 
      Vitamin D is a complex nutrient that functions as a hormone to benefit numerous body tissues.

      Vitamin D is naturally produced by skin exposed to ultraviolet B. Despite the fact that
      Israel is a sunny country, a majority of all patients, and particularly those with pain, have
      inadequate intake of vitamin D.

      Vitamin D therapy is easy for patients to self administer, well tolerated, and very
      economical.

      In this study, we'll check whether vitamin D will lead to a decrease in pain intensity in
      patients suffering from chronic low back pain.
    

Intervention name(s): Vitamin D; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 34,5000 IU vitamin D per week; Placebo
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: back pain; hypovitaminosis D
Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™
      (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide
      HFA-metered-dose inhaler (MDI). The administration of the study medication will be as
      follows: three single doses, separated by a wash-out period. The study will provide further
      data on the safety and tolerability of ciclesonide.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic rhinitis
Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      This study will test the effectiveness of the combination of Naltrexone and Bupropion
      relative to placebo for reducing binge eating in persons with obesity and binge eating
      disorder.
    


Intervention name(s): Naltrexone and bupropion combination; Pill Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Ability of Anesthesiologists Identifying Internal Jugular Vein Bilaterally by Anatomic Landmarks
Condition: Internal Jugular Vein Canulation; Anatomical Landmark
Study type: Observational

Summary: 
      The study is designed to determine anaesthetists ability to locate the right internal jugular
      vein(IJV) and left IJV using a landmark technique. Initially, a questionnaire was completed
      detecting previous user experience. An ultrasound probe, using the midpoint as an 'imaginary
      needle', was placed on the neck of a healthy volunteer and the image recorded. Both
      anaesthetist and volunteer were blinded to the screen until the image was stored.
      Anaesthetists were grouped into senior or junior by the total number of IJV canulation
      experience. The success rate is going to be measured as pass or fail.
    

Detailed description: 
      Anesthesiologists are usually qualified in internal jugular vein canulation by using anatomic
      landmark technique. The anatomy of right IJV and left IJV may differ each other. The
      hypothesis is that the anatomical difference between right and left IJV may give rise to
      false puncture of especially left IJV by using anatomical landmark technique.Although USG is
      available, most of the experienced anesthesiologist does not prefer to use USG for IJV
      canulation due to different reasons.In addition to this anesthesiologists are generally
      preferring right IJV canulation, thus they are inexperienced in left IJV canulation. So
      especially during left IJV canulation,not by anatomical landmark technique but by USG will be
      recommended for anesthesiologists.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        the residents of anesthesiology clinics
      
Keywords: anatomical landmark; internal jugular vein canulation
Correlation Between Cervical Spine Muscle Disorders and the Occurrence of Symptoms of Temporomandibular Joint Dysfunction
Condition: Temporomandibular Joint Disorders
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Muscular Diseases
Study type: Observational

Summary: 
      This study evaluated the correlation between the occurrence of disorders of selected muscles
      of the cervical spine and the occurrence of symptoms of TMJ dysfunction
    

Detailed description: 
      The examination includes personal questionnaire, physical examination and an algometer
      measurement on the upper fibers of the trapezius, levator scapula, sternocleidomastoid and
      rectus capitis posterior major to define pressure sensitivity of neck muscles and define is
      there a correlation between the occurrence of disorders of selected muscles of the cervical
      spine and the occurrence of symptoms of TMJ dysfunction.
    

Intervention name(s): Algometer
Intervention type(s): Device
Intervention description(s): The algometer head was applied to the trigger point of selected muscles at an angle of 90° and, increasing the pressure at a speed of about 100g/s, three measurements were made. Each measurement stoped at the first sensation of pain
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Students from Poland
      
Keywords: TMJ disorders; pressure sensitivity; algometer; young adults; myofascial pain
The Influence of Breathing in Writing
Condition: Mouth Breathing
MeSH terms: Respiratory Aspiration; Mouth Breathing
Study type: Observational

Summary: 
      Purpose: To examine whether nasal breathing influences the perception of sound causing trade
      between hard and soft consonants in the writing of children in school age and the incidence
      of trade.
    

Detailed description: 
      To achieve the above goal explained, it was used:

      Methods: The sample was consisted of 200 children, 100 previously diagnosed with oronasal
      breath (51 females and 49 males) who participated in the study group and 100 nasal breathers
      (54 females and 46 males) which were the control group. 36 words were dictated as minimal
      pairs to be written. Then a story was submitted in sequence of six figures from which the
      subjects produced a text.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        200 children, 100 previously diagnosed with oronasal breath (51 females and 49 males) who
        participated in the study group and 100 nasal breathers (54 females and 46 males) which
        were the control group.
      
Keywords: Respiration; Learning; Speech; Language and Hearing Sciences
Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P02095)
Condition: Mycoses
MeSH terms: Infections; Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH
      56592) under an open label, treatment protocol for subjects with invasive fungal infections:

      A. which are refractory or resistant to standard antifungal therapies; B. for which there are
      currently no effective therapies; C. with a prior history of serious, severe or
      life-threatening toxicities while receiving antifungal therapy; D. with pre-existing organ
      dysfunction which precludes the administration of standard antifungal therapies.
    

Detailed description: 
      The current clinical trial is designed to provide posaconazole (SCH 56592 to subjects with
      invasive fungal infections a) which are refractory or resistant to standard antifungal
      therapies or b) for which there are currently no effective therapies. Subjects with such
      invasive fungal infections cannot be enrolled in controlled, randomized clinical trials.
      Secondly, this clinical trial is also designed to provide posaconazole (SCH 56592) to
      subjects with invasive fungal infections who c) have experienced serious or severe toxicities
      while receiving standard antifungal therapies or d) have pre-existing organ dysfunction such
      as renal dysfunction who require standard antifungal therapy which is precluded because of
      the toxicities associated with such therapy. This clinical trial also serves to allow
      collection of preliminary data regarding the safety and efficacy of posaconazole (SCH 56592)
      against a variety of invasive fungal infections which although serious and life-threatening
      are sufficiently rare so that they cannot be studied in a controlled, randomized clinical
      trial.

      This is an open-label, treatment protocol for a multi-center study of posaconazole (SCH
      56592) 200mg orally four times daily (QID) while hospitalized followed by posaconazole (SCH
      56592) 400mg orally twice daily (BID) on discharge from hospital, in the treatment of
      invasive fungal infections. Approximately 320 subjects have been enrolled at 160 clinical
      study centers in the US and worldwide.
    

Intervention name(s): Posaconazole oral suspension
Intervention type(s): Drug
Intervention MeSH terms: Posaconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aspergillosis, Candidiasis, Cryptococcosis, Phaeohyphomycosis; Invasive Fungal Infections