bioihbjkbjnl/mcl2 huggingface dataset:
GM1 Ganglioside Effects on Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to examine the short term effects (24 Weeks) of GM1 on
      Parkinson's disease (PD) symptoms, as well as the effects of long-term treatment (120 Weeks)
      with GM1 on disease progression, and to examine the extent to which GM1 treatment influences
      the underlying disease process in PD.
    

Detailed description: 
      The study is designed to further examine the extent to which GM1 ganglioside can improve
      symptoms, delay disease progression, and, perhaps, partially restore damaged brain cells in
      PD patients. GM1 ganglioside is a chemical that is normally found in the brain and is a
      normal part of the outer covering or membrane of nerve cells. This study will compare the
      effectiveness of GM1 to standard PD treatment. In addition to studying clinical measures of
      motor and cognitive functioning, the investigators will use PET (positron emission
      tomography) scanning to image the brain and the dopamine nerve endings in a subgroup of
      patients. Patients with mild to moderate idiopathic PD will be divided into 2 groups. One
      group will receive GM1 for 24 weeks and the other will receive placebo. At the end of this 24
      week period, all patients will enter into a 96 week treatment period in which all patients
      will receive GM1.

      In parallel, a group of standard-of-care patients with mild to moderate PD will be monitored
      over a 1 to 2 year period to assess the natural progression of PD. These patients will
      receive the same clinical evaluations as the treatment group subjects but they will not
      receive the experimental medication.
    

Intervention name(s): GM1 ganglioside; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg twice per day by subcutaneous injection; Twice per day subcutaneous injection, equal volume as active drug
Other intervention name(s): Sygen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease; PD; GM1 Ganglioside; Sygen
E-B-FAHF-2, Multi OIT and Xolair for Food Allergy
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is testing the use of Enhanced-Butanol purified-Food Allergy Herbal
      Formula-2 (E-B-FAHF-2) Chinese herbal therapy in combination with multi-food oral
      immunotherapy (OIT) and Xolair® (Omalizumab) to help children and adults who are allergic to
      foods be able to safely tolerate food allergens. Specifically in this protocol, the food
      allergens are milk, egg, peanut, almond, cashew, hazelnut, walnut, sesame, and/or wheat.
      Omalizumab is considered an investigational drug for the treatment of food allergies in
      children and adults. Investigational means it has not been approved by the Food and Drug
      Administration (FDA) for use in the U.S. The researchers hope to learn whether the addition
      of Chinese herbal therapy (E-B-FAHF-2) can improve the outcome of sustained unresponsiveness
      (which is the ability to consume a food allergen and pass an oral food challenge after being
      off treatment for 3 months) as compared to placebo (i.e. subjects with OIT/Omalizumab +
      herbal vs. OIT/Omalizumab + placebo), and will help adults and children be able to safely
      ingest the foods they are allergic to.
    

Detailed description: 
      Prior studies have shown that this Chinese herbal formulation is safe and well-tolerated in
      food allergic individuals. While oral immunotherapy (OIT) can lead to desensitization, it
      remains uncertain whether this treatment can lead to lasting protection. Therefore, this
      study aims to use the Chinese herbal formula in combination with OIT to determine whether
      sustained protection can be achieved. All subjects will receive multi-allergen OIT, along
      with a 4 month course of omalizumab to provide added safety for the initial dose escalation
      and build up phases. Subjects will be randomized to receive active Chinese herbal formula or
      placebo. Subjects will be treated with OIT for 2 years and then food challenges will be
      performed to assess for desensitization. For those who achieve desensitization, all
      treatments will be discontinued and food challenges will be performed 3 months later to
      assess for sustained unresponsiveness.
    

Intervention name(s): Drug: Chinese Herbal Medication; Drug: Placebo; Drug: Omalizumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsules, 26 month course, starting 2 months pre-OIT.; Placebo capsules that look identical to E-B-FAHF-2 containing corn starch, 26 month course, starting 2 months pre-OIT; 4 months course, starting 2 months pre-OIT through the 2 month build-up phase
Other intervention name(s): E-B-FAFH-2; Placebo Chinese Herb; Xolair®
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Survivor-Sleep Health Information Program
Condition: Sleep Problem; Insomnia; Pediatric Cancer
MeSH terms: Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      The purpose of the study is to learn if an educational program delivered to parents/guardians
      can help improve the sleep of children experiencing sleep problems after completing cancer
      treatment. The name of the intervention is Survivor-SHIP (Sleep Health Information Program).
    

Detailed description: 
      This study will evaluate Survivor-SHIP in a single-arm trial of 20 off-treatment childhood
      cancer survivors (ages 5-12). The intervention is an adapted version of the family-centered
      Sleep Health Program designed at Seattle Children's Hospital. The program offers parents
      information about how to utilize evidence-based strategies for their child's sleep, and has
      demonstrated success in a community-based sample of children with behavioral sleep problems.
      Sessions will focus on providing parents with education about healthy sleep and setting
      targets for modifiable behaviors that can improve their child's sleep health.

      The study will include 3 education sessions taking place over videoconference. Families will
      be asked to track their child's sleep using sleep diaries during the course of the program.
      Prior to, and following the program, families will be asked to complete study questionnaires.
    

Intervention name(s): Survivor-SHIP
Intervention type(s): Behavioral
Intervention description(s): Parent/guardian education about healthy sleep practices to improve their child's sleep health.
Other intervention name(s): Survivor-Sleep Health Information Program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sleep Problem; Insomnia; Pediatric Cancer; Behavioral Intervention
Glucophage® Extended Release (XR) 750 Milligram (mg) Indonesia Bioequivalence (BE) Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess bioequivalence between metformin hydrochloride
      (Glucophage® XR) manufactured in PT Merck Tbk, Indonesia (test drug) and metformin
      hydrochloride (Glucophage® XR) manufactured in Merck Santé, France (comparator drug)
      following single oral dose administration under fasting condition.
    


Intervention name(s): Glucophage XR (Test drug); Glucophage XR (Comparator drug)
Intervention type(s): Drug; Drug
Intervention description(s): Participants received single oral dose of Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) under fasted conditions.; Participants received single oral dose of Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) under fasted conditions.
Other intervention name(s): Metformin hydrochloride; Metformin hydrochloride
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
The Impact of the Glycaemic Index (GI) on Daily Blood Glucose Profiles and Food Intake in Young Chinese Adult Males
Condition: Type 2 Diabetes; Obesity; Prediabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      This study is carried out to find out the inclusion of high and low glycaemic Index (GI)
      foods to daily meals impact on 24 hour blood glucose fluctuations and food intake.
    

Detailed description: 
      The GI is a method of classifying foods based on the food's ability to raise the blood
      glucose level. Low GI foods are recommended as they have a lower impact on blood glucose
      concentrations and also reduce total food intake. There is very little information on how
      eating high and low GI foods affect daily blood glucose concentrations in Asians. Therefore,
      the objective of this study is to observe the effect of eating high and low GI breakfasts and
      snacks on 24 hour blood glucose concentrations and food consumption in Asian males. Healthy,
      normal-weight, Chinese males will be recruited. There will be two sessions (consisting of
      four days for each session) where they will consume either a high or low GI breakfast or
      snack, and a standardized ad libitum lunch buffet. Their glycaemic response will be measured
      using a Continuous Glucose Monitoring System (CGMS) throughout the period. The proposed
      research for the first time demonstrates how the consumption of high and low GI breakfasts
      and snacks affect subsequent energy intake and 24 hour blood glucose profiles in Asians.
      These findings will have significant public health benefits for optimum weight and dietary
      control.
    

Intervention name(s): Rice and bread (high GI); Rice and bread (low GI)
Intervention type(s): Other; Other
Intervention description(s): Rice is a high glycaemic index glutinous rice. Bread is a high glycaemic index white bread.; Rice is a low glycaemic index parboiled basmati rice. Bread is a low glycaemic index multigrain bread.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Oral Remimazolam With and Without Alcohol in Healthy Female Subjects
Condition: Safety Issues
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety
      and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in
      Healthy Female Subjects
    

Detailed description: 
      Evaluating the potential for additive or synergistic effects of alcohol when coadministered
      with remimazolam. Female subjects were selected because they represent the population at
      greatest risk for victimization in drug-facilitated sexual assault. In addition, females have
      a slower ethanol metabolism, therefore, the effects of remimazolam, if coadministered with
      alcohol, may last longer. Hence, this population represents the worst-case scenario in
      evaluating the risk of remimazolam misuse in drug-facilitated assault.
    

Intervention name(s): Remimazolam; Alcohol
Intervention type(s): Drug; Other
Intervention description(s): Remimazolam via oral administration; Alcohol
Other intervention name(s): CNS7056
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: remimazolam
Effect of Steady State Meloxicam on Low Dose Aspirin Induced Inhibition of Platelet Aggregation and Thromboxane Synthesis in Healthy Males and Females
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to investigate the influence of meloxicam on low dose aspirin
      induced inhibition of platelet aggregation and thromboxane B2, when meloxicam is given before
      aspirin.
    


Intervention name(s): Meloxicam; Aspirin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin; Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fit Families Program: Fundamental Motor Skill Intervention in Children With Autism Spectrum Disorders and Their Parents
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The investigators aim to identify the effect of a 12-week fundamental motor skills (FMS)
      (e.g., throwing, catching, running) intervention on the active participation in physical
      recreation activities and a variety of other factors (child behaviors, communication, and
      adaptive skills) and to identify patterns, benefits, constraints, and strategies to active
      participation in physical recreation activities among families of children with autism
      spectrum disorders (ASD) (pre-post) through in-person or via phone interviews with parents
      and children with ASD.
    

Detailed description: 
      Participants will be randomly assigned to one of three protocols: 1) Workshop group, 2)
      Home-based group, and 3) wait-listed home-based group. Participants in all groups will
      receive an activity booklet and physical education-related activity items (e.g., ball, hoop).
      The hypothesis is that both the workshop and home-based groups will improve in all measures
      from pre to post compared to the wait-list control group. The investigators want to determine
      if the differences in the workshop and home-based groups differ significantly or are
      equitable in terms of gains in all areas.

      Note: Due to COVID-19 for the post-test, instead of parents attending the UW-Facilities, they
      will be asked to videotape themselves and their children while performing the test of gross
      motor development (TGMD) activities. For the follow-up test (Fall 2020) we will expect to
      conduct these in person. However, if the situation due to COVID-19 remains the same, the
      investigators will ask families to follow the same procedures (videotape themselves and their
      children).
    

Intervention name(s): 12-week FMS Intervention; Physical Activities & Activity Booklets
Intervention type(s): Other; Behavioral
Intervention description(s): 4 sessions, no more than 3 hours per session covering 1) Sensory Integration, 2) Communication, 3) Aquatic Opportunities, and 4) Physical activity and Sports (during intervention); expected to engage in physical activity at least 3 hours per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
PAC-IC-SAOS Obstructive Sleep Apnea Syndrome and Ventricular Function
Condition: Heart Failure; Arteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion; Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Heart Failure; Arteriosclerosis
Study type: Interventional

Summary: 
      The aim of this clinical trial is to evaluate the effect of obstructive sleep apnea syndrome
      (OSAS) treatment in heart failure patients following coronary artery bypass graft (CABG)
      surgery or other coronary reperfusion.
    

Detailed description: 
      This clinical trial is a double-blind, randomized, placebo-controlled study.

      The first objective is to evaluate the influence of continuous positive airway pressure
      (CPAP) treatment for OSAS on the ventricular function improvement in heart failure patients,
      in comparison with OSA patients treated with sham CPAP. This treatment will be instaurated
      just after the coronary reperfusion surgery

      Secondary objectives :

        -  Evaluation of the effect of CPAP treatment on the endothelial function

        -  Evaluation of the effect of CPAP treatment on systemic inflammation

        -  Evaluation of the effect of CPAP treatment on oxidative stress,

        -  Evaluation of the effect of CPAP treatment on insulin resistance,

      after the coronary reperfusion surgery, in comparison with OSA patients treated with sham
      CPAP and non apneic control patients, with heart failure.

        -  Assessment of the impact of nocturnal desaturation level on the vascular reactivity and
           atherosclerosis of mammary vessels collected during surgery.

        -  Assessment of the impact of nocturnal desaturation level on the oxidative stress,
           inflammation and insulin sensitivity on abdominal and epicardiac adipose tissue
           collected during surgery.
    

Intervention name(s): CPAP treatment; Sham CPAP treatment
Intervention type(s): Procedure; Other
Intervention description(s): This device consists in a nasal continuous positive airway pressure. It will be applied just after CABG and for 3 months for OSA/CPAP patients group.; This device consists in a sham continuous positive airway pressure. It will be applied just after CABG and for 3 months for OSA/sham CPAP patients group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive sleep apneas syndrome; Continuous positive airway pressure treatment; Heart failure; Coronary reperfusion surgery
Optimal Dietary Treatment of Obese Adults
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Recent decades have shown an alarming increase in obesity. Obesity is associated with high
      costs for both the individual and for society. It is therefore important to prevent and treat
      obesity. The investigators believe that if you add a self-help weightloss book and teach
      cooking skills to a standard dietary treatment, then it will result in greater weight loss
      than with dietary treatment alone. However, this has not yet been studied. Since it will
      require more resources, it is important to investigate whether it also works better before
      changing the current treatment.

      Hypothesis: Conventional dietary treatment supplemented with a self-help weightloss book and
      cooking classes are more effective than dietary treatment alone in changes in body weight and
      body composition in obese persons over a period of 12 months. There is no difference if the
      intervention are based on the national dietary guidelines or a relative low-gi and
      high-protein diet.

      Secondary to investigate the impact the interventions have; on diet quality and quantity, on
      markers of metabolic syndrome and on how many subjects complete the study.
    


Intervention name(s): Standard dietary treatment (STD); "Ned i vaegt" (NIV); "Verdens bedste kur" (VBK)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): This group will receive 6 one-on-one sessions with a registered dietitian. Total time spent is 6½ hour. Dietary treatment is based national guidelines and counseling is individualized and tailored to the patient's needs and goals.; This group will receive 3 individual sessions and 3 group sessions. All sessions are with a registered dietitian. Total time spent is 15½ hour. The group sessions consist of 1 hour theory and 2½ hour cooking skills. The whole intervention is based on a danish self-help weightloss book which is based on the national dietary guidelines. Focus is to learn to make "normal" danish dishes in a more healthy way both ingredients, cooking, composition and quantity. They also learn about changing habits, making realistic goals and using their motivation.; This group will receive 3 individual sessions and 3 group sessions. All sessions are with a registered dietitian. Total time spent is 15½ hour. The group sessions consist of 1 hour theory and 2½ hour cooking skills. The whole intervention is based on a danish self-help weightloss book which is based on "new nordic diet" and are a relative low-GI and high-protein diet. Focus is to learn to make new healthy dishes both ingredients, cooking and composition. They also learn about making realistic goals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight loss; Dietary intervention; Self-help book; Cooking; Dietitian; Dietary therapy
Activated Allogeneic Lymphocytes for Induction Graft Versus Tumor Effect in Metastatic Solid Tumors
Condition: Metastatic Breast Cancer; Malignant Melanoma; Renal Cell Cancer; Gastrointestinal Cancer
MeSH terms: Melanoma; Carcinoma, Renal Cell; Gastrointestinal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The present protocol is a phase 2 study designed to investigate the potential application of
      allogeneic cell-mediated immunotherapy in metastatic solid tumors, similarly to the well
      established graft versus leukemia (GVL) effects, in patients with metastatic solid tumors
      resistant to conventional treatment modalities. Patients will be eligible to participate in a
      treatment program based on systemic administration of mismatched lymphocytes activated in
      vitro with rIL-2 (LAK) followed by rIL-2 inoculation in vivo. This treatment is aiming to
      induce an anti-tumor effect mediated by the efficient killing activity of the rIL-2 activated
      cells. Prior to cell infusion patients will receive the conditioning treatment with low dose
      Cyclophosphamide (Cyc) or Fludarabine with 2 injections of low dose alpha interferon. Cell
      therapy will be combined with specific anti-tumor monoclonal antibodies if available for the
      specific disease. Further activation of the anti-tumor activity of alloreactive donor T cells
      and natural killer (NK) cells will be accomplished by in vivo inoculation of rIL-2, aiming
      for enhancing the anti-cancer potential of donor-derived effectors cells. Patients will
      receive one - three cycles of cell therapy, as long as there are no signs of Graft- versus -
      Host - disease (GVHD) and the malignant disease is controlled.
    


Intervention name(s): one - three cycles of cell therapy during 4-6 weeks (3-5x10^7 cells/kg will be given through IV systemically
Intervention type(s): Procedure
Intervention description(s): Patients will be eligible to participate in a treatment program based on systemic administration of mismatched lymphocytes activated in vitro with rIL-2(LAK) followed by rIL-2 inoculation in vivo
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GVL; rIL-2(LAK); GVHD; MST; alloCT; alloBMT