bioihbjkbjnl/mcl2 huggingface dataset:
Determining Optimal Continuation Treatment Duration for Depressed Children and Adolescents
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study will determine the optimal length of continuation treatment with fluoxetine for
      children and adolescents with major depressive disorder, as well as the factors that may
      contribute to positive response during acute and continuation treatment.
    

Detailed description: 
      Depression is a serious medical illness that affects all ages and populations. However, it
      has only been within the last 10 years that sufficient attention has been devoted to
      researching treatments for depression in children and adolescents. Symptoms of depression in
      this age group vary, but some common signs include pretending to be sick, refusing to go to
      school, clinging to a parent, or worrying that a parent may die. Older children may sulk, get
      into trouble at school, act in a negative or grouchy way, or feel misunderstood. Recent
      studies on selective serotonin reuptake inhibitors (SSRIs), one class of antidepressant
      medications, have shown that SSRIs are effective in reducing depression symptoms. The optimal
      duration of treatment, however, has yet to be established. This study will determine the
      optimal length of continuation treatment with fluoxetine for children and adolescents with
      major depressive disorder, as well as the factors that may contribute to positive response
      during acute and continuation treatment.

      Participants in this study will first attend three study visits over a 2-week period to
      determine eligibility. All eligible individuals will be treated with fluoxetine for 12 weeks.
      Dosages will be determined by the study physician and will be based on clinical response to
      treatment. Study visits will occur weekly for the first 4 weeks and biweekly for the
      remaining 2 months. Depression symptoms, general changes, and adverse reactions will be
      assessed. Participants whose symptoms have improved will be eligible to enter the
      discontinuation phase of the study, which will entail random assignment to either fluoxetine
      or placebo for an additional 24 weeks. Study visits will occur biweekly for 3 months and
      monthly for the remaining 3 months. Depression symptoms and medication side effects will be
      assessed at these visits.
    

Intervention name(s): Fluoxetine
Intervention type(s): Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Major Depressive Disorder
Trial to Assess the Efficacy of Malaria Vaccine PfCS 102
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/IIa double-blind randomized (adjuvant)-controlled trial. 16 volunteers are randomized
      to receive two doses of either 30 µg of PfCS102 formulated in Montanide ISA 720 (verum) or
      ISA 720 alone (control), 60 days apart. Two weeks after the 2nd immunization, 14 volunteers
      are challenged with bites of 5 infected mosquitoes using the NF54 strain of P. falciparum.
      The main outcome will be the length of time between artificial challenge and development of
      blood stage parasitaemia detected by microscopy performed twice a day.
    


Intervention name(s): PfCS102; Montanide ISA 720
Intervention type(s): Biological; Biological
Intervention description(s): Antigen of the sporozoite protein; adjuvant alone
Intervention MeSH terms: Monatide (IMS 3015)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Plasmodium falciparum malaria
Evaluation of the Effect of Rehabilitation Sport After Total Hip Arthroplasty (THA)
Condition: Total Hip Arthroplasty; Osteoarthritis, Hip; Sports Physical Therapy
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      160 patients who received a total hip arthroplasty (THA) were included and randomized to
      receive specific rehabilitation sport (RS) or not (control) in addition to a conventional
      rehabilitation program. Upon completion of the rehabilitation phase 6 weeks, 6 months and 12
      months after surgery sports medical measurements have been performed. Strength abilities of
      the hip muscles were tested with isokinetic dynamometry, postural control with a force
      measuring platform and endurance via lactate measurements.
    

Detailed description: 
      In Germany, rehabilitation sport (RS) is a reimbursed postoperative measure in order to
      support socio-professional reintegration and self-help.

      160 patients who received a primary total hip arthroplasty (THA) were included and randomized
      to receive specific RS or not (control) in addition to a conventional rehabilitation program.
      Upon completion of the rehabilitation phase 6 weeks, 6 months and 12 months after surgery
      sports medical measurements have been performed. Strength abilities of the hip muscles were
      tested with isokinetic dynamometry, postural control with a force measuring platform and
      endurance via lactate measurements. The goal of the study was to prospectively randomized
      evaluate the effect of RS on hip-related muscular strength, endurance and postural stability
      on patients who underwent THA.
    

Intervention name(s): rehabilitation sport
Intervention type(s): Behavioral
Intervention description(s): rehabilitation Sport over 52 weeks after THA, start 6 weeks postoperatively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quantifying the Deterioration of Physical Function in Renal Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Observational

Summary: 
      Patients undergoing haemodialysis present a decrease in physical function, but little is
      known about the rate at which function decreases.

      The purpose of this study is quantifying the nature and degree of functional deterioration
      experienced by stage 5 chronic kidney disease patients during a six month period of
      maintenance haemodialysis therapy.
    


Intervention name(s): Functional Test
Intervention type(s): Other
Intervention description(s): Observation of physical function in hemodialysis patients during a period of 6 months
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with Chronic Kidney Diseases undergoing hemodialysis treatment
A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) Amyloidosis
Condition: Primary Amyloidosis
MeSH terms: Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The treatment with oral melphalan and prednisone has been recommended as standard treatment
      of AL amyloidosis but the results are rather disappointing. Another therapeutic option is
      pulsed high-dose dexamethasone + melphalan (Mel-Dex) with more encouraging results regarding
      the achievement of a faster disease response and higher rates of haematological remission. In
      the last 5 - 10 years, promising treatment outcomes after therapy with high-dose melphalan
      and autologous stem cell support have been reported by several groups but only highly
      selected patients are eligible for this treatment. Lenalidomide has been shown to be
      effective in phase II and III trials in MM patients. Because of the relationship to MM,
      Lenalidomide is a promising therapeutic option also for patients with AL amyloidosis. The
      addition of Lenalidomide to Mel-Dex could improve rate of complete response (CR) and organ
      response in patients not eligible for or refused high-dose chemotherapy.
    


Intervention name(s): Lenalidomide
Intervention type(s): Drug
Intervention description(s): Up to 6 cycles of oral L-Mel-Dex, every 28 days Revlimid® 10 mg daily for 21 days, (add on therapy), Melphalan 0.15 mg/kg/day day 1-4, Dexamethasone 20 mg day 1-4
Other intervention name(s): Revlimid
Intervention MeSH terms: Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AL-Amyloidosis; Lenalidomide
SWOG-9342 Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial
Condition: Breast Cancer; Cardiac Toxicity
MeSH terms: Breast Neoplasms; Cardiotoxicity
Study type: Observational

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: This clinical trial is studying the effect of chemotherapy on heart function in
      treating women who have breast cancer with negative axillary lymph nodes and who are
      undergoing treatment on the SWOG-8897 clinical trial.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the frequency of subclinical congestive heart failure by measuring resting MUGA
           at 5-8 and 10-11 years after randomization in women receiving adjuvant chemotherapy with
           cyclophosphamide, methotrexate, and fluorouracil or cyclophosphamide, doxorubicin, and
           fluorouracil on protocol SWOG-8897.

        -  Estimate the frequency of late cardiac effects (congestive heart failure, cardiac
           ischemic events, and clinical symptoms) in these patients treated with these regimens.

        -  Monitor prospectively the incidence of annual cardiac events between the fifth and tenth
           year after randomization of these patients to these regimens.

      OUTLINE: This is a multicenter study.

      The treating physician completes patient cardiovascular and routine history and physical
      examination questionnaires at baseline and yearly. Patients undergo resting MUGA scans at 5-8
      and 10-11 years after registration on protocol SWOG-8897. The first scan must be performed
      within 3 months prior to enrollment or within 1 month after registration on the current
      study, and the second scan must be done in the tenth year of follow-up and within 3 months
      prior to enrollment or 1 month from the anniversary of registration on the current study.

      PROJECTED ACCRUAL: A total of 420 patients will be accrued for this study. After initial
      accrual is completed, approximately 50 additional patients will be accrued at 10 years.
    

Intervention name(s): management of therapy complications
Intervention type(s): Procedure
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with histologically proven invasive adenocarcinoma of the breast with negative
        axillary lymph nodes
      
Keywords: stage I breast cancer; stage II breast cancer; ductal breast carcinoma; cardiac toxicity
Study of Protein Metabolism in Healthy Older Subjects
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      This is a randomized, double-blinded, crossover study to evaluate muscle protein metabolism
      during fasting and feeding in healthy older subjects.
    


Intervention name(s): Experimental protein powder sachet; Control protein powder sachet
Intervention type(s): Other; Other
Intervention description(s): mixed with 8 oz. water; mixed with 8 oz. water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Efficacy, Safety, and Tolerability Study of RP-G28 in Subjects With Lactose Intolerance
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      RP-G28 is being investigated for treatment of moderate to severe lactose intolerance and its
      potential to improve the tolerance of lactose (dairy products).
    

Detailed description: 
      Lactose intolerance is a common gastrointestinal (GI) disorder that develops in lactose
      maldigesters when consuming lactose or when lactose is added to a previously low-lactose
      diet. Lactose intolerance is characterized by one or more of the cardinal symptoms that
      follow the ingestion of lactose-containing foods. These symptoms include; abdominal pain,
      cramping, bloating, flatulence [gas] and diarrhea. As such, most lactose intolerant
      individuals avoid the ingestion of milk and dairy products, while others substitute
      non-lactose containing products in their diet. Currently, there are no approved treatments
      for this condition.

      Based on the health implications from insufficient calcium intake over a lifetime, including
      increased risk of osteoporosis and hypertension, there is need in the medical community for a
      tolerable and convenient treatment that allows for all levels of milk and dairy product
      consumption in people suffering from mild to severe lactose intolerance.

      Study Objective:

      To access efficacy of two RP-G28 dosing regimes on symptoms related to lactose intolerance
      relative to placebo after 30 days of treatment. The 30 day post-treatment phase will further
      evaluate the treatment's potential to prolong relief from symptoms.

      Study Design:

      The participants will take about 60 days to complete the study. The study consists of 3
      distinct phases: Screening, a 30-day Treatment Phase, and a 30-day Post-Treatment Phase (off
      study treatment observation period). A participant will need to visit the clinical only 6
      times throughout the study.
    

Intervention name(s): RP-G28; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Study drug taken orally; Placebo taken orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lactose maldigestion; Dairy intolerance; Intolerance to milk; Intolerance to dairy; Milk intolerance; GI disorder; Lactose metabolism; GI symptoms after dairy ingestion
Nicotine Metabolism and Little Cigars
Condition: Smoking
Study type: Interventional

Summary: 
      This study examines the effects of smoking little cigars in different groups of smokers. The
      investigators are focusing on differences in how smokers' bodies break down and eliminate
      nicotine from their systems. Some people are fast metabolizers of nicotine, meaning they
      break down and eliminate nicotine from their bodies more quickly. Other people are slower
      metabolizers meaning they break down and eliminate nicotine more slowly. The investigators
      are comparing these two groups of smokers when they switch to smoking cigars instead of
      cigarettes.
    

Detailed description: 
      This study examines the effects of switching from cigarette to little cigar smoking on
      smoking behaviors and toxin exposure in fast and slow nicotine metabolizing smokers. We will
      recruit current smokers (split between slow and rapid nicotine metabolizing smokers) for a
      20-day protocol. Participants will smoke their own brand cigarettes during a baseline 5 day
      period, followed by 15 days smoking little cigars. This study will use a validated,
      phenotypic marker of nicotine metabolism rate that may identify those individuals at greatest
      risk of harm exposure when using little cigars. This study will examine the compensatory
      effects of little cigars on smoking behaviors and toxin exposure among slow and rapid
      nicotine metabolizers.
    

Intervention name(s): Switch to smoking only little cigars
Intervention type(s): Other
Intervention description(s): Participants smoke only little cigars for 15 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: little cigars; cigarettes; smoking
A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies
Condition: Various Advanced Cancer
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and effectiveness of nivolumab alone and
      in combination with ipilimumab in pediatric patients with high grade primary central nervous
      system (CNS) malignancies.
    


Intervention name(s): Nivolumab; Ipilimumab
Intervention type(s): Biological; Biological
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Other intervention name(s): Opdivo, BMS-936558; Yervoy, BMS-734016
Intervention MeSH terms: Nivolumab; Ipilimumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Kinesio Taping on Postural Stability in Young Soccer Players
Condition: Increasing Performance of Healthy Athlete
Study type: Interventional

Summary: 
      The purpose of our study is to investigate the effects of Kinesio Taping application, which
      is applied before the training period, on postural stability in young soccer players.
    


Intervention name(s): Kinesio Taping application
Intervention type(s): Device
Intervention description(s): Therapeutic taping application applied to skin affecting muscle, fascia, circulation, ligaments, tendons and joints.
Other intervention name(s): Kinesio Tex Gold, Kinesio Tex FP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: soccer
Effects Of Ingesting An Energy Bar On Performance And Recovery
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of ingesting a low glycemic whey
      protein energy bar prior, during and following resistance exercise and conditioning on
      performance and recovery.
    

Detailed description: 
      Fit-joy is a commercially available food bar marketed as having a low glycemic index and
      being relatively high in dietary fiber. The fiber contained within this product is
      isomalto-oligosaccharides (IMO) which is a food ingredient with a relative sweetness level
      equal to approximately 60% of sucrose. Chemically, IMO is a mixture of glucose oligomers with
      alpha - (1-6) - linkages. Short and hard exercise produces muscle damage and soreness. The
      Fit-joy bar contains whey protein that previous research in the investigator's lab showed may
      be able to decrease the muscle damaging effects of exercise while also helping with muscle
      growth. The purpose of this study will be to determine if eating a Fit-joy bar before and in
      the middle of a hard weight training workout will promote positive results during the workout
      and 48 hours after the workout.
    

Intervention name(s): Commercially Available Food Bar; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Active; Placebo
Other intervention name(s): Food Bar; Dextrose Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, cross-over administration of supplements with approximately 7-10 days between testing sessions.
Masking: None (Open Label)
Primary purpose: Health Services Research
A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China
Condition: Advanced Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      This is a multi-center, prospective and observational clinical study. Eligible patients will
      accept generalized chemotherapy according to the investigator's assessment. Information
      related to the treatment, including medication, disease condition, expenses, etc. will be
      periodically collected. Follow-up at 2-month intervals will be periodically performed to
      continually collect information about the disease progression, subsequent treatment and
      survival until death or completion of the study.

      Recruited patients will fill out questionnaires about quality of life before initiation of
      treatment, at Cycle 3 and completion of first-line treatment.
    


Intervention name(s): Clinical chemo-drugs
Intervention type(s): Drug
Intervention description(s): Clinical drugs will be selected by the investigator according to recommendations in Chinese and foreign guidelines and depending on clinical experience and the patient's individual conditions, including but not limited to the drugs listed below:
Platinum products: oxaliplatin, cisplatin Fluorouracil products: 5-fluorouracil, capecitabine, TS-1 Taxanes: paclitaxel, docetaxel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with advanced gastric cancer
      
Biospecimen description: 
      the tumor tissue samples were collected to do gene mutation analysis
    
Keywords: Advanced Gastric Cancer; chemotherapy; quality of life; treatment expense; patients accepted first-line chemotherapy
Inspired: Smartphone Videogame-Based Smoking Cessation Intervention
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The investigators are testing a new, smartphone videogame-based intervention for smoking
      cessation.
    

Detailed description: 
      The investigators have developed a novel smartphone videogame, where smokers are required to
      submit breath carbon monoxide samples to demonstrate smoking abstinence, and where they will
      earn game-based rewards contingent on meeting CO goals. Players will be working with teams to
      earn group and social rewards to help advance their game.
    

Intervention name(s): Inspired
Intervention type(s): Behavioral
Intervention description(s): The investigators will be studying the ability of using videogame-based rewards to increase smoking abstinence when they are made contingent on meeting abstinence goals.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group randomization
Masking: Single (Participant)
Primary purpose: Treatment