bioihbjkbjnl/mcl2 huggingface dataset:
Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost (SIB-IMRT) in the Treatment of Glioblastomas in Adults
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The main goal of this study is to evaluate and to determine the dose of a highly accurate
      irradiation (allowing to increase the dose delivered while restricting the risk of
      complication) in association with temozolomide.
    


Intervention name(s): radiotherapy; temozolomide
Intervention type(s): Radiation; Drug
Intervention description(s): patients will receive from 6 to 7 weeks 5 days a week radiations. The dose of radiation will depend on the level they will be included.; patient will receive whatever the level 7 days a week, temozolomide at the dose of 75mg/m2 during radiotherapy period. They will then follow one month after the end the radiochemotherapy an adjuvant treatment corresponding to a 5 days treatments of temozolomide at the dose of 200mg/m2 every 28 days.
Intervention MeSH terms: Temozolomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IMRT; Radiotherapy escalation dose; glioblastoma; escalation radiotherapy dose
Progressive Weight Loss and Metabolic Health
Condition: Insulin Resistance; Obesity
MeSH terms: Insulin Resistance; Weight Loss
Study type: Interventional

Summary: 
      This study will evaluate the potential beneficial cardiometabolic effect of moderate (5%)
      weight loss and progressive (5%, 10%, and 15%) weight loss in obese adults without diabetes.
      Participants will be randomly assigned to one of 2 groups. Group 1: supervised weight loss
      group (low-calorie diet). Group 2: supervised weight maintenance group (normal diet). Of
      those assigned to group 1, half of the participants will lose 5% of their body weight and the
      other half will lose 5%, 10%, and 15% of their weight over time under the guidance of a
      dietitian. Research testing will be repeated at each time point (5%, 10%, and 15% weight
      loss). In group 2, research testing will be repeated after six months.
    


Intervention name(s): Weight Maintenance; Weight Loss
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects in the weight maintenance arm will maintain a steady body weight (plus or minus 2% of initial body weight) for six months.; Half of the subjects in the weight loss arm will lose 5% of their weight through a low-calorie diet, and half will also lose 10% and 15% body weight.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: obesity; weight loss; insulin resistance
Genetic Determinants of Response to Beta Blockade
Condition: Healthy
Study type: Interventional

Summary: 
      The overall goal of this project is to determine the genetic factors contributing to
      interindividual differences in response to beta-blockade.
    

Detailed description: 
      The Aim is to define the contribution of genetic variation to the interindividual variability
      in response to β-blockade. The rationale for the study is as follows: Beta-blockers prevent
      the activation of β-ARs and thus form the cornerstone of treatment of pathological states
      such as congestive heart failure and coronary artery disease. Functional polymorphisms in
      cardiac beta-receptors have been shown to determine response to β-blocker therapy. A
      physiologic stimulus such as exercise causes sympathetic stimulation and activation of the
      cardiac β-ARs and genotypic differences in response to β-blockers are magnified under states
      of heightened sympathetic activity. Thus, in addition to measuring the response to β-blockers
      at rest, we will also determine the response to β-blockade after sub-maximal exercise on a
      supine bicycle ergometer. Genetic variations that may alter sensitivity to a beta blocker
      will be sought.
    

Intervention name(s): Atenolol (β-blocker)
Intervention type(s): Drug
Intervention description(s): 25 mg tablet
Other intervention name(s): generic atenolol is being used, so not applicable
Intervention MeSH terms: Atenolol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Atenolol; Exercise; Genotype; Healthy volunteers
Improving Sleep to Reduce Risk for Substance Use Disorder
Condition: Substance Use Disorders; Insomnia; Posttraumatic Stress Disorder
MeSH terms: Substance-Related Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Substance use disorders (SUDs) are a prevalent and impairing condition, particularly among
      trauma exposed individuals. The current proposal aims to address the critical need for
      targeted direct SUD prevention in this population by intervening on a novel, malleable risk
      factor for SUD common among trauma-exposed individuals: sleep disturbance. Sleep disturbance
      prospectively predicts the development of SUD and may confer risk for SUD by increasing
      stress reactivity, decreasing decision-making abilities, and ultimately promoting substance
      use to relieve negative affect, a core etiological factor in SUD. However, to our knowledge,
      no experimental studies have determined whether improving sleep leads to reductions in SUD
      risk. As such, the current study will use a randomized controlled trial design to test the
      effects of brief behavioral treatment for insomnia (BBTI) against a waitlist control among a
      sample of trauma-exposed young adults with poor sleep and risk for SUD (N = 60). We aim to
      determine the direct and indirect effects of condition (BBTI vs. waitlist control) on SUD
      symptoms, substance use-related problems, coping motives, and posttraumatic stress symptoms
      through improvements in sleep. Furthermore, we will test direct and indirect effects of
      condition on theoretically proposed mechanisms underlying the association between sleep
      disturbance and SUD risk (i.e., stress reactivity, cravings in response to stress).
    


Intervention name(s): Brief Behavioral Therapy for Insomnia; Repeated Contact
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief Behavioral Therapy for Insomnia; Repeated Contact
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
NET for SGBV Survivors in Eastern DR Congo
Condition: Posttraumatic Stress Disorder; Shame
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Throughout the last 10 years Narrative Exposure Therapy (NET) has evolved as one of the most
      effective, culturally sensitive trauma interventions. In the present study the effectiveness
      of NET delivered by trained health personnel in a sample of survivors of sexual and gender
      based violence (SGBV) who suffer from Posttraumatic Stress Disorder (PTSD) will be assessed.
      Structured baseline, 3 and 6 month follow up interviews will be administered to assess the
      main outcome measures PTSD and shame. The trial will take place in Goma, DR Congo, where SGBV
      and its sequelae has been a major problem.
    

Detailed description: 
      Participants will be recruited through local NGOs and eligible clients randomized to the
      treatment (NET; app. N=100) or treatment-as-usual control (app. N=100) group, respectively.
      At baseline, 3-month and 6-month post-treatment, sociodemographic data, trauma exposure -
      esp. SGBV, PTSD, dissociation, shame, functionality and depression will be assessed in a
      structured interview. The interviews will be conducted by blind Congolese psychological
      interviewers after an intensive 3-weeks training and continuous supervision.
    

Intervention name(s): Narrative Exposure Therapy; Social Support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A local counselors provides social support on demand.
Other intervention name(s): NET
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Shame; Narrative Exposure Therapy; Sexual and gender based violence (SGBV); DR Congo
Minimally Invasive Trocar Placement in Obesity Surgery
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      During surgery for obesity, minimally invasive endoscopy can be performed and can assist the
      surgeon in determining surgical incision sites.
    

Detailed description: 
      Transgastric endoscopic access, without laparoscopic guidance, to the peritoneal cavity can
      be performed safely and guide trocar placement in morbidly obese patients undergoing
      Roux-en-y gastric bypass.
    

Intervention name(s): Transgastric access to the abdomen
Intervention type(s): Procedure
Intervention description(s): Upper endoscopy, gastrotomy created with a needle knife followed by lower endoscopy.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: NOTES; transgastric endoscopy; obesity surgery; Roux-en-Y surgery
Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants
Condition: Infant, Very Low Birth Weight
MeSH terms: Birth Weight
Study type: Interventional

Summary: 
      This study aims to compare the short-term effects on growth and feeding tolerance of a liquid
      high calorie formula added to human milk versus powdered human milk fortifier in small
      preterm infants.
    


Intervention name(s): Similac special care 30; Similac human milk fortifier
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Liquid pre-term formula 30Kcals/oz. used as human milk fortifier.; Powdered human milk fortifier.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Low birth weight; neonates; premature infants; nutrition; human milk fortification; Infant
Adjunctive Neuromuscular Electrical Stimulation for the Rehabilitation of Swallowing
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Neuromuscular Electrical stimulation (NMES) for swallowing has recently been proposed for the
      treatment of dysphagia post stroke and is clinically receiving favor as a treatment modality,
      in the absence of strong research support. This study aims to investigate the effect of NMES
      therapy for dysphagia upon recovery of swallowing function following stroke. The study will
      follow a pilot randomized controlled trial design. Fifty one patients admitted to a sub-acute
      rehabilitation facility will be clinically screened for dysphagia, and randomized into one of
      three groups, NMES, sham NMES or usual care -behavioral swallowing therapy arm. All patients
      will be treated for one hour per day for 3 weeks, and their progress and outcome will be
      monitored. The results will add to the preliminary data on the effectiveness of this form of
      swallowing treatment for patients following stroke, and has the potential to enable more
      efficient allocation of resources to post-acute rehabilitation and thus benefit afforded to
      stroke patients, and the community.
    

Detailed description: 
      This pilot randomized controlled trial (N=51) includes stroke patients admitted to a
      sub-acute rehabilitation facility. Subjects will be clinically screened for dysphagia, and
      randomized into three groups, NMES, sham NMES or usual care -behavioral swallowing therapy
      arm. Following randomization, all subjects will undergo a video-x-ray (modified barium
      swallow) of swallowing to confirm the presence of oropharyngeal dysphagia and provide
      objective data about the nature and degree of dysphagia. All patients will be treated for one
      hour per day for 3 weeks, and their progress and outcome will be recorded. Participants will
      be independently evaluated by a blinded assessor at baseline, post treatment and at 3 months
      following treatment. The primary outcome will be improvement in clinical swallowing ability,
      oral intake level, and body weight. The results will add to the preliminary data on the
      effectiveness of this form of swallowing treatment for patients following stroke.
    

Intervention name(s): swallowing therapy
Intervention type(s): Behavioral
Intervention description(s): Standardized behavioral swallowing intervention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: swallowing, treatment, stroke,rehabilitation
Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for
      Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in
      subsequent efficacy studies.
    


Intervention name(s): CNP520; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo to CNP520 was supplied in capsules.
Other intervention name(s): CNP520 was supplied as capsules in dose strengths of 1 mg, 10 mg, 25 mg and 75 mg.
Intervention MeSH terms: Umibecestat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Alzheimer's Disease,; Amyloid Beta,; cerebrospinal fluid,; beta secretase
Elucidating the Genetic Basis of the Pleuropulmonary Blastoma (PPB) Familial Cancer Syndrome
Condition: Pleuropulmonary Blastoma; Cystic Nephroma; Sertoli-Leydig Cell Tumor of Ovary; Medulloepithelioma; Embryonal Rhabdomyosarcoma of Cervix; Goiter; Sarcoma; Pineoblastoma; Pituitary Tumors; Wilms Tumor
MeSH terms: Rhabdomyosarcoma; Wilms Tumor; Pituitary Neoplasms; Pinealoma; Pulmonary Blastoma; Neuroectodermal Tumors, Primitive; Rhabdomyosarcoma, Embryonal; Leydig Cell Tumor; Sertoli-Leydig Cell Tumor
Study type: Observational

Summary: 
      Pleuropulmonary Blastoma (PPB) is a rare lung tumor which develops in childhood. The
      underlying genetic factors which contribute to the development and progression of PPB are not
      defined. We are working to identify the genetic factors which may contribute to the
      development of this rare tumor.
    

Detailed description: 
      Studies of inherited cancer syndromes have provided unique opportunities to uncover and
      explain important cellular pathways with broad relevance to both sporadic cancers and human
      development. This proposal studies the cancer predisposition syndrome originally described as
      a familial form of pleuropulmonary blastoma (PPB). PPB is a rare, aggressive lung cancer that
      affects young children. Children with PPB and/or their family members are at increased risk
      for a number of rare conditions, including Wilms tumor, rhabdomyosarcoma, brain tumors,
      ovarian tumors and nodular hyperplasia of the thyroid gland. In 2009, we mapped a PPB locus
      and identified germline, loss of function mutations in one copy of DICER1 as the genetic
      basis of this syndrome. DICER1 encodes a protein that performs the final critical step in
      maturation of microRNAs (miRNAs). miRNAs are an important form of gene regulation. The
      syndrome's varied nature is likely attributable to the various roles of miRNAs during
      different developmental and/or functional circumstances. This study focuses on defining the
      full phenotype of this cancer predisposition syndrome including penetrance, expressivity in
      children and adults, pathologic classification of disease and spectrum of predisposing DICER1
      mutations. Improved understanding of the clinical and genetic features of this cancer
      predisposition syndrome is essential to facilitate early diagnosis when the diseases are most
      curable, and to create genetic counseling and educational materials to guide medical care.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Families who have a child or adult with pleuropulmonary blastoma or cystic nephroma are
        invited to participate.
      
Biospecimen description: 
      We are collecting blood samples or saliva samples. When available, we also collect tumor
      samples from prior surgical procedures.
    
Keywords: pleuropulmonary blastoma; PPB; cystic nephroma; DICER1; miRNA
An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and effectiveness of Depakote ER
      (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar
      disorder, manic or mixed type in children and adolescents ages 10-17 years.
    


Intervention name(s): Divalproex Sodium Extended-Release Tablets
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar Disorder Type 1 (manic or mixed type)
Comparison of Bone Mineral Density Changes During Tx With Risperidone or Aripiprazole in Adolescents
Condition: Psychiatry
Study type: Observational

Summary: 
      This study examines if the use of antipsychotic medications might contribute to an
      interruption in bone mineral development and/or a reduction in bone mineral content in
      adolescents.
    

Detailed description: 
      Studies have shown that some antipsychotic medications, including Risperdal, can increase
      prolactin levels in both adult and pediatric populations. Prolactin is a hormone made by the
      central nervous system. The main function of prolactin is to regulate lactation in females.
      However, having too much prolactin over time can interrupt bone mineral accrual and a
      decrease in bone density. Since peak bone mass is reached during adolescents, this is a key
      determinant of a lifetime risk of osteoporosis. On the other hand, there ahve been no reports
      of increased prolactin using Abilify. In fact, in adults Abilify has been shown to normalize
      or even lower prolactin levels. In this study, we will compare the amount of prolactin and
      bone mineral density of adolescents who take Risperdal or Abilify with bone mineral density
      of adolescents who do nto take antipsychotic medications. We will also compare the amount of
      prolactin and bone mineral density of adolescents who take Risperdal with those who take
      Abilify. This study will also help us to learn about the relationship between medications,
      prolactin levels, sex steroids, and bone formation markers in adolescents.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from psychiatry clinic and community resources
      
Keywords: bone mineral content; aripiprazole monotherapy; risperidone monotherapy
Epidural Anesthesia With Chloroprocaine Versus Lidocaine
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Chinese made chloroprocaine has a rapid onset time, effective methodology, can last for a
      short time, provides fast motor recovery and causes no significant side effects.
    

Detailed description: 
      Chloroprocaine hydrochloride is the chloridized local anesthetic of procaine hydrochloride,
      with twice the anesthetic intensity, four to five times the metabolization and half the side
      effect of procaine. The chloroprocaine hydrochloride product made in China has been on sale
      since 2002. To determine the clinical efficacy of low-epidural anesthesia with chloroprocaine
      versus lidocaine, the investigators carried out a prospective, randomized, double-blinded
      multi-centre clinical trial. The results demonstrate that epidural anesthesia using
      chloroprocaine has a more rapid onset time and shorter duration than with lidocaine. It can
      also provide a reliable sensory and motor block in epidural anesthesia, and is thus a more
      attractive alternative than lidocaine for middle and short duration surgical procedures.
    

Intervention name(s): Chloroprocaine; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): 60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 3% chloroprocaine.; 60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 2% lidocaine.
Other intervention name(s): Chloroprocaine Hydrochloride; Lidocaine Hydrochloride
Intervention MeSH terms: Lidocaine; Chloroprocaine; Procaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Epidural anesthesia; Chloroprocaine; Lidocaine
Effect of Dry Needling on Myofascial Trigger Point
Condition: Pain
Study type: Interventional

Summary: 
      Myofascial trigger point is one of the most common causes of musculoskeletal disorders.
      Myofascial trigger point in upper trapezius has been reported as a symptom in patients with
      neck and upper thoracic pain. The purpose of this study was to investigate the prolonged
      effect of dry needling on myofascial trigger point in upper trapezius muscle.
    

Detailed description: 
      Pain intensity and Disability of arm, hand and shoulder (DASH) were collected at base line
      and at the end of treatment sessions, two weeks and three months follow up in both groups.
    

Intervention name(s): Dry Needling
Intervention type(s): Device
Intervention description(s): Dry needling was performed for one week, three times a week.
Other intervention name(s): Western Accupuncture
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dry Needling, Myofascial trigger point, Upper trapezius
Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      The purpose of this study is to: 1) secure basic data of patients with cerebral palsy, 2)
      seek ways to simplify the data for clinical application, 3) progress of hip dislocation,
      presence or absence of hip surgery, and The purpose of this study is to compare differences
      in body development according to severity and nutritional methods.
    


Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        It is difficult to find the basis for calculation because there are no papers that measure
        the body size of children with cerebral palsy and papers that compare with normal children.
        In particular, children with cerebral palsy are rare diseases, and it is difficult to
        recruit a large number of subjects.