bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Intravenous Infusions of Gut Hormones on Appetite and Metabolism.
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of intravenous infusion of two
      gastrointestinal hormones, PYY3-36 and GLP-1, alone and in combination, on appetite in
      healthy obese men. The investigators hypothesize that an intravenous infusion of each hormone
      alone will decrease food intake at a buffet meal and decrease appetite, and that in
      combination, there will be a greater decrease in food intake and appetite compared to each
      hormone alone.
    


Intervention name(s): PYY 3-36; GLP-1; saline infusion
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.8 pmol/kg/min x 3 hours; 1.0 pmol/kg/min x 3 hours; saline infusion x 3 hours
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; energy expenditure; incretins; appetite regulation; GLP-1; PYY; ad libitum energy intake
Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT
Condition: Hematological Malignancies
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary goal of the study is to determine the incidence and severity of acute Graft
      versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor
      Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the
      combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will
      determine the safety of this combination in the first six months post transplant.

      Secondary goals include determining the time to recovery of white blood cells and platelets
      (engraftment), determining the occurrence of opportunistic infections, defined as infection
      that occurs in people with weakened immune systems and caused by organisms that do not
      normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral
      infections), estimating the incidence of chronic GVHD at two years and the overall and
      disease free survival at two years.

      Immune response will be assessed by means of immuno-correlative studies both prior to and at
      various points after transplant.
    


Intervention name(s): Tacrolimus and Thymoglobulin
Intervention type(s): Drug
Intervention description(s): Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or "transplant." Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours.
Other intervention name(s): PROGRAF®
Intervention MeSH terms: Tacrolimus; Thymoglobulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ● Non-Hodgkin lymphoma,; ● Hodgkin disease,; ● Acute Myelogenous or Acute Lymphocytic Leukemia; ● Myelodysplastic Syndromes,; ● Chronic Myelogenous Leukemia; ● Multiple Myeloma; ● Chronic Lymphocytic Leukemia; ● Myelofibrosis and other myeloproliferative disorders;
Platelet Concentrate in Achilles Tendon Repair
Condition: Achilles Tendon Rupture; Soft Tissue Injury; Tendon Injury
MeSH terms: Wounds and Injuries; Rupture; Tendon Injuries; Soft Tissue Injuries
Study type: Interventional

Summary: 
      People operated for a rupture of the Achilles tendon receive a concentrate of their own
      platelets injected into the operated area. The study is randomized and single-blinded, with
      20 treated patients and 20 controls, who get no injection. The primary endpoint is a
      mechanical property of the tendon after 12 weeks (modulus of elasticity), as measured by a
      special type of radiography. This radiography uses 0.8 mm metal markers, which are injected
      into the tendon. The tendon is mechanically loaded during radiography and its strain can be
      measured as increased distance between the markers. Other mechanical variables at 6, 12 and
      52 weeks are secondary variables, as well as a validated patient-administrated questionaire
      at 1 year.
    


Intervention name(s): Autologous platelets; no injection
Intervention type(s): Biological; Biological
Intervention description(s): Local injection 10mL, about 2.5 x 10E10 platelets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: platelets tendon ligament
Efficacy and Safety Study of Udenafil Tablets in Erectile Dysfunction.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, double blind, placebo controlled, multicentric, clinical study will assess
      the efficacy and safety of Udenafil (100 mg) tablets in patients suffering from erectile
      dysfunction(ED).
    


Intervention name(s): Udenafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo-control; Placebo
Intervention MeSH terms: Udenafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Studying the Effects of Phentermine on Eating Behavior
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this study is to determine whether one week of phentermine compared to placebo
      administration results in changes in food intake during a laboratory meal.
    

Detailed description: 
      This study aims to explore whether short-term measures of eating behavior can be related to
      later, longer-term weight loss. In a double-blind, randomized fashion, participants will be
      asked to take study medication for three weeks: one week of phentermine and two weeks of
      placebo. At the end of the first and third weeks, participants will be asked to participate
      in a range of eating behavior studies. Following this three-week, double-blind phase,
      participants will be offered 6 months of open treatment for weight loss.
    

Intervention name(s): Phentermine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo.; Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration.
Other intervention name(s): adipex; ionamin; sugar pill
Intervention MeSH terms: Phentermine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome
Condition: Diarrhea-predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to test the efficacy and safety of a traditional Chinese
      medication Tong-Xie-Yao-Fang for patients with diarrhea-predominant irritable bowel Syndrome
      (IBS-D).
    

Detailed description: 
      Participants: The sample size of this trial is 118, to test an odds ratio of 3.5 at a
      significance of 0.05 and power of 0.8.

      Intervention: Tong-Xie-Yao-Fang versus placebo Data collection: Standard operation procedure
      will be developed for how to interviewing the participants, how to use the IBS diary, how to
      enter the data into the electronic case report forms.
    

Intervention name(s): Tong-Xie-Yao-Fang; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.; The placebo is the same as Tong-Xie-Yao-Fang in appearance.
Other intervention name(s): Tongxieyaofang
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Yakult Ingestion in Residents and Staffs at Indonesian Elderly Houses
Condition: Healthy
Study type: Interventional

Summary: 
      A study to investigate the effect of Yakult® containing L. casei Shirota on the intestinal
      microbiota, intestinal environment, and stool frequency in healthy adult and elderly subjects
      in Indonesia. The clinical phase of this study was conducted for 26 weeks in three different
      elderly houses. The subjects were grouped into two categories: probiotic and placebo group,
      according whether the subjects consumed product or placebo samples. Fecal sampling were taken
      three times during the study.
    

Detailed description: 
      The study investigates the ingestion effect of a commercialized probiotic milk drink,
      Yakult®, for residents and staffs at Indonesian elderly houses (age limit: 18 - 95 years
      old). The study will be conducted as a double blind, placebo controlled parallel comparison
      study. There will be 26 weeks used for the study, comprised of: A 2-week baseline assessment
      period, and 24-week probiotic or placebo intake period.

      From 112 subjects, the participants will be grouped into two: probiotic and placebo group.
      Those in probiotic group will consume Yakult® (Fermented milk drink containing over 6.5×10^9
      CFUs of L. casei Shirota/65 ml), while placebo group will consume the placebo product (taste,
      appearance, component, and number of calories are the same as Yakult®, non-fermented milk
      product). The treatment intake will be done for 24 weeks (182 days).

      During the study, the participants are expected to fill questionnaire of frequency of bowel
      movements and Chinese Constipation Questionnaire to obtain the defecation frequency (Bristol
      Stool score) and abdominal symptom scores. Fecal samples will be collected three times: on
      the last day of the baseline period (day 14±1), 12 weeks (day 98±1) after intake period,
      after the 24-weeks intake period (day 182±1). Afterwards, the obtained fecal samples will be
      further analyzed for its microbial composition, level of short-chain fatty acids and
      putrefactive compounds.
    

Intervention name(s): Yakult®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fermented milk drink containing over 6.5×10^9 CFUs of L. casei Shirota/65 ml; Taste, appearance, component, and number of calories are the same as Yakult®, non-fermented milk product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: probiotic; elderly subject; intestinal microbiota
The Effect of Palliative Care Training on Symptom Management and Quality of Life in Chronic Heart Failure
Condition: Heart Failure; End of Life
MeSH terms: Heart Failure; Death
Study type: Interventional

Summary: 
      Palliative care is of great importance because of poor quality of life and high mortality
      risk in advanced heart failure. This study was planned as a randomized controlled trial to
      determine the effect of palliative care training on symptom management, rehospitalization,
      and quality of life among patients with heart failure.
    

Detailed description: 
      Patients were informed about the research and written informed consent was obtained. Data
      were collected by face-to-face interviews within two days before discharge. Patient
      information form and scales were applied to Patients in the intervention and control groups.
      Patients in the intervention group were received education after filling the forms. The
      training was given one by one at the hospital. One or two relatives of patients were included
      in the training. The patient was comfortably seated, and the room door was closed, face to
      face interaction was conducted. The patient and his/her relatives were allowed to ask
      questions during the training. The patient in the intervention group received at least 45
      minutes of data collection from a case because of detailed training. It took about 15 minutes
      to collect data from a patient in the control group. In some patients, the training program
      was divided to be clearer. The patients were traced by telephone at the first, third, and
      sixth months after discharge. The investigator's phone number was presented to the patients
      and they were told that they could call at any time. Continuous communication was ensured by
      giving the educator's phone number to the patients. The training was repeated by contacting
      the phone. The intervention group was retrained about symptoms they experienced during their
      telephone interview. The training was given to the experimental group as planned. No
      modifications/changes were made to the intervention during the study. Special notes were
      taken for each patient. The effect of the education given on the quality of life and symptom
      management was evaluated with questionnaires. The intervention was adhered to as planned.
    

Intervention name(s): palliative care educatiom
Intervention type(s): Behavioral
Intervention description(s): The patients in the intervention group were presented palliative care training in addition to their usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The control group took usual care and the intervention group took both usual care and palliative care.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: heart failure; palliative care; rehospitalization; symptom burden; quality of life
Temporal Relationship in Recovery of Muscular Pain and Functional Variables in an Experimental Muscular Pain Model in Hamstrings
Condition: Pain, Muscle
MeSH terms: Myalgia
Study type: Observational [Patient Registry]

Summary: 
      Basal measurements are taken in relation to the study variables. Immediately subjects perform
      eccentric exercise on right hamstrings to develop delayed onset muscle soreness (DOMS).

      Measurements of the study variables are taken in the same conditions 48, 96 and 168 hours
      after the exercise to study the evolution of the variables while recovering from DOMS.
    

Detailed description: 
      Basal measurements are taken in relation to the study variables.

      The variables are:

        -  pressure pain thresholds

        -  electromyography values

        -  static and dynamic plantar pressure measurement

        -  active knee extensibility

        -  maximal strength of knee flexors

        -  thermography

        -  scales of pain perception

      Immediately subjects perform eccentric exercise on right hamstrings to develop DOMS (delay
      onset muscle soreness).

      Measurements of the study variables are taken in the same conditions 48, 96 and 168 hours
      after the exercise to study the evolution of the variables while recovering from DOMS.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Non sedentary healthy men
      
Keywords: DOMS; Healthy subjects; Pressure pain thresholds; Active Knee Extension test; Maximal strength; Electromyography; Plantar pressure measurement; Gait analysis
Ultrasound-guided Percutaneous Electrolysis in Female Soccer With Soleus Injury
Condition: Injury;Sports
MeSH terms: Athletic Injuries
Study type: Interventional

Summary: 
      This study evaluates if the physiotherapy treatment based on combination of therapeutic
      exercise program and ultrasound-guided PNE on chronic soleous injuries may cause changes in
      pain, dorsal flexion of the ankle and muscle fatigue in female dance
    


Intervention name(s): Invasive treatment and exercise therapy
Intervention type(s): Other
Intervention description(s): The subjects of experimental group will perform therapeutic exercise program and they will be receive Percutaneous Electrolysis therapy and the subjects of experimental group will perform the same exercise program and they will be receive only needling puncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      To study the effect of oxytocin on face processing and response inhibition in autistic adults
      by fMRI.
    

Detailed description: 
      Autism is a developmental disorder affecting approximately 60/10,000 individuals. It is
      characterized by social and language deficits and repetitive behaviors/restricted interests.
      Functional imaging is becoming a very useful tool in trying to understand the neurobiology of
      autism. Oxytocin is a hormone produced by the brain to assist with labor and lactation.
      Recent evidence suggests that it may be involved in social attachment and in repetitive
      behaviors. In this project, we will study how oxytocin changes the way the brain of autistic
      adults processes faces, and deals with response inhibition (the ability to interrupt ongoing
      responses should they prove ineffective or interfering with attaining a goal). There is
      currently no functional imaging data assessing the effect of oxytocin on the brain. We will
      explore the activation patterns in response to oxytocin across circuits involved in social
      cognition (face fusiform area) and response inhibition (caudate, orbitofrontal and
      dorsolateral cortex) by administering a specific fMRI task activating those circuits before
      and during an oxytocin infusion. We will also explore the effect of oxytocin in these areas
      by administering specific cognitive testing not associated with fMRI before and during
      oxytocin infusion.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 international units = 1 cc, IV over 4 hours; Normal Saline, IV over 4 hours
Other intervention name(s): Pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness of a Psycho-educational Group (PEG) Intervention on Supportive Care and Survivorship Issues in Early-stage Breast Cancer Survivors Who Have Received Systemic Treatment
Condition: Breast Cancer; Cancer; Anxiety; Cognitive Dysfunction
MeSH terms: Breast Neoplasms; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      As cancer mortality rates improve in Asia, there is an increasing focus on patient-reported
      outcomes and survivorship issues. In view of the numerous medication and psychosocial issues
      that are commonly faced by early-stage breast cancer survivors, it deems important to develop
      and conduct specific interventional programs to mitigate these problems. In the literature,
      it is well recognized that psychosocial interventions are effective to manage emotional
      distress and quality of life, with the evidence clearly clustered in studies on female
      patients with breast cancer. One meta-analysis suggested that psycho-oncologic interventions
      including individual psychotherapy, group psychotherapy, psychoeducation, relaxing training
      can produce positive effects on emotional distress, anxiety and depression, and
      health-related QOL.

      The investigators hypothesize that a significant reduction in anxiety, improvement of
      cognition and improvement of health-related quality of life among those who receive
      psycho-education, in comparison to those in the usual care. Hence, this randomized trial is
      designed to assess the effectiveness of a psycho-educational group (PEG) intervention on
      supportive care and survivorship issues, which include anxiety, depression, cognitive
      function, toxicities management of cancer- or treatment- related physical symptoms, and
      health-related quality of life in early-stage breast cancer patients.
    


Intervention name(s): Psychoeducation group; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): On the basis of previous studies that evaluated PEG interventions for women with breast cancer, a structured program based on the Cognitive Behavioral Therapy (CBT) principles was developed. Patients in the PEG group will be involved in three sessions of psychoeducation. The PEG program is designed to cover the various aspects outlined by the IOM on quality cancer survivorship.; Usual Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease
Condition: Thyroid Associated Ophthalmopathies; Thyroid-Associated Ophthalmopathy
MeSH terms: Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to investigate the efficacy, safety, and tolerability
      of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months,
      in comparison to placebo, in the treatment of participants suffering from active TED.

      "Funding Source - FDA OOPD"
    


Intervention name(s): teprotumumab; normal saline
Intervention type(s): Drug; Drug
Other intervention name(s): RV 001; HZN-001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thyroid Eye Disease, Graves Orbitopathy, Thyroid Associated; Ophthalmopathy