bioihbjkbjnl/mcl2 huggingface dataset:
Influence on Food Liking of Adding Spices to Replace Dietary Sugar
Condition: Taste Testing
Study type: Interventional

Summary: 
      This study aims to reduce the amount of sugar in a particular food item and add spices to see
      if the food liking of that item rates as high or higher in a post meal survey. Through the
      weekly feeding and testing of the menu items the investigators will determine an opinion of
      the participants. Results of these surveys will determine whether participants enjoy the
      reduced sugar options as much as their full sugar counterparts.
    

Detailed description: 
      The Investigators will determine the overall consumer acceptability of a breakfast meal (tea
      and oatmeal) and a dessert (apple crisp) using a randomized, three-period, within subjects,
      crossover design. The three test conditions will be (1) Full sugar ("FS"), (2) reduced sugar
      (and calorie) with no added spice ("RS") and (3) reduced sugar (and calorie) plus spice
      ("RSS"). The two reduced sugar meals will be matched for calories. Subjects will taste each
      condition of the item on a separate day; tastings will be one week apart.
    

Intervention name(s): apple crisp; tea; oatmeal
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects tasted three items (apple crisp, tea and oatmeal) in a randomized sequence schedule to allow for tasting the three recipes (full sugar recipe, reduced sugar recipe and reduced sugar plus spice recipe) over three weeks. Oatmeal and tea were served together as a breakfast meal and tastings of oatmeal and tea were done over 3 weeks and tastings for apple crisp (served alone) were done over 3 different weeks. Subjects tasted one of the three recipes at each weekly seating.; Subjects tasted three items (apple crisp, tea and oatmeal) in a randomized sequence schedule to allow for tasting the three recipes (full sugar recipe, reduced sugar recipe and reduced sugar plus spice recipe) over three weeks. Oatmeal and tea were served together as a breakfast meal and tastings of oatmeal and tea were done over 3 weeks and tastings for apple crisp (served alone) were done over 3 different weeks. Subjects tasted one of the three recipes at each weekly seating.; Subjects tasted three items (apple crisp, tea and oatmeal) in a randomized sequence schedule to allow for tasting the three recipes (full sugar recipe, reduced sugar recipe and reduced sugar plus spice recipe) over three weeks. Oatmeal and tea were served together as a breakfast meal and tastings of oatmeal and tea were done over 3 weeks and tastings for apple crisp (served alone) were done over 3 different weeks. Subjects tasted one of the three recipes at each weekly seating.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects were asked to taste test 3 versions of test items (in randomized order) and provide a liking score for each (tastings of each recipe were done on separate occasions separated by one week)
Masking: Single (Participant)
Primary purpose: Other
Keywords: Taste Test; Spices; Reduced sugar; Food liking
Use of CBT-I in Individuals With a Concussion
Condition: Concussion, Mild
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      Sleep disturbances have been shown to contribute to poorer recovery from a concussion.
      Furthermore, sleep disturbances have been associated with more frequent and severe
      post-concussion symptoms including headache, vertigo, anxiety, depression, and decreased
      short term memory reducing quality of life and productivity at work or school. Additionally,
      recent research indicates that individuals with a concussion who have poor sleep quality have
      increased levels of Neurofilament light (NfL) and tau biomarkers indicating that there may
      still be axonal damage after weeks or months after the initial concussion injury.
      Post-concussion symptoms have been associated with higher levels of these biomarkers and
      there has been a report of higher levels of NfL and tau years following a concussion event.
      Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia yet
      it remains unclear if this treatment method is effective in improving sleep outcomes,
      reducing concomitant post-concussion symptoms, and biomarkers of neural injury/risk in
      individuals post- concussion. The central hypothesis for this project is treating sleep
      disturbances will yield a clinically relevant reduction in concomitant post-concussion
      symptoms. The objective for the proposed study is to determine if CBT-I will reduce insomnia
      symptoms and improve concomitant post-concussion symptoms in individuals after concussion and
      if symptom improvements are maintained at 6-weeks and 12-weeks after CBT-I intervention.
    


Intervention name(s): cognitive behavioral therapy for insomnia (CBT-I)
Intervention type(s): Behavioral
Intervention description(s): The CBT-I program is a 6-week, 1x/week, one-on-one program. The delivery of CBT-I will be done remotely over a secure teleconference service (Zoom) or phone. Participants will maintain a sleep diary during the course of the program to aid in tailoring the intervention. Each session lasts about 45-60min:
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Dynamic Fluctuation of Donor Microbiota Affects the Prognosis of Fecal Microbiota Transplantation for C. Difficile Infection
Condition: Clostridium Difficile Infection; Fecal Microbiota Transplantation
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Study type: Interventional

Summary: 
      Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and
      extra-intestinal diseases by transplanting the functional microbes in the feces of healthy
      people into the patient's intestine through the upper or lower alimentary tract routes to
      rebuild the patient's intestinal microbiota. Recently, FMT has been widely used in the
      treatment of various gastrointestinal diseases, including but not limit in CDI. In this
      study, we focused on the demonstration of FMT action mechanism in CDI treatment.
    


Intervention name(s): Fecal microbiota transplantation
Intervention type(s): Procedure
Intervention description(s): Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections
Condition: Complicated Intra-abdominal Infections
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the
      treatment of complicated intra-abdominal infections as compared to a comparator group.
    


Intervention name(s): ceftazidime/NXL104 + metronidazole; meropenem
Intervention type(s): Drug; Drug
Intervention description(s): IV TID; IV TID
Other intervention name(s): merrem
Intervention MeSH terms: Metronidazole; Meropenem; Ceftazidime; Avibactam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase I Study of TS-142 in Healthy Participants (Single Doses)
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and pharmacokinetics of single dosing
      of TS-142 to healthy Japanese non-elderly participants in fasting and after meal condition.
    


Intervention name(s): Placebo (fasting); Placebo (feeding); 1 mg of TS-142; 3 mg of TS-142; 10 mg of TS-142 (fasting); 10 mg of TS-142 (feeding); 30 mg of TS-142
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive placebo once in fasting condition; Participants will receive placebo once after meal condition; Participants will receive 1 mg of TS-142 once in fasting condition; Participants will receive 3 mg of TS-142 once in fasting condition; Participants will receive 10 mg of TS-142 once in fasting condition; Participants will receive 10 mg of TS-142 once after meal condition; Participants will receive 30 mg of TS-142 once in fasting condition
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Mobile Phone Game to Prevent HIV Among Young Africans
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      This project will test the feasibility of an electronic game to prevent HIV among African
      preadolescents, delivered via inexpensive Android smart phones. In order to collect
      feasibility data for a future randomized controlled trial, this study involves the
      pilot-testing of the intervention with a sample of young people in Nyanza region, Kenya,
      where 11.4% of young women ages 15-24 are HIV-infected. This feasibility study will be
      carried out with the Kenya Medical Research Institute (KEMRI).
    

Detailed description: 
      This project will test the feasibility of an electronic game for preadolescents, delivered
      via inexpensive Android smart phones. The game is informed by socio-behavioral and
      pedagogical theories, evidence-based practice, and formative research on youth sexual culture
      in sub-Saharan Africa. It is designed to: educate young players, ages 11-14, about sexual
      health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of
      HIV, sexually transmitted infections (STIs), and unintended pregnancy; challenge harmful
      gender norms and HIV stigma; and foster dialogue with parents and caregivers.

      The proposed feasibility test will be conducted in Western Kenya. Sixty preadolescents will
      be enrolled in the trial, 30 in the study arm and 30 in the control arm. The Kenya Medical
      Research Institute (KEMRI) has established community advisory boards (CABs) in Kisumu, which
      will be available to the proposed study.

      Data collection will take place at KEMRI offices, health clinics, or in the meeting room of a
      local community-based organization (CBO). In addition, data on game-play will be
      automatically collected on mobile phones given to preadolescent study participants.
    

Intervention name(s): Tumaini Mobile Phone Game
Intervention type(s): Behavioral
Intervention description(s): Tumaini is a scenario-based role-playing game application, optimized for use on low-cost Android smartphones. Participants will be invited to play the game for at least ten hours over a period of three weeks. The game is designed to: educate players about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs and unintended pregnancy; challenge HIV stigma and harmful gender norms; and promote parent-child dialogue.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV prevention; Preadolescence; Mobile phone game; Feasibility
Tipifarnib and Radiation Therapy in Treating Patients With Unresectable Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary
      for their growth and may make them more sensitive to radiation therapy. Radiation therapy
      uses high-energy x-rays to damage tumor cells. Giving tipifarnib together with radiation
      therapy may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of tipifarnib when
      given together with radiation therapy in treating patients with unresectable locally advanced
      pancreatic cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose and dose-limiting toxic effects of tipifarnib when
           administered with radiotherapy in patients with unresectable locally advanced pancreatic
           cancer.

      Secondary

        -  Determine the 3-month clinical response in patients treated with this regimen.

      OUTLINE: This is a multicenter, dose-escalation study of tipifarnib.

      Patients receive oral tipifarnib once or twice daily on weeks 1-8. Patients also undergo
      concurrent radiotherapy daily, 5 days a week, on weeks 2-8.

      Cohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.

      Patients are followed at 1, 3, and 6 months.

      PROJECTED ACCRUAL: A total of 8-18 patients will be accrued for this study within 12-15
      months.
    

Intervention name(s): tipifarnib; radiation therapy
Intervention type(s): Drug; Radiation
Intervention MeSH terms: Tipifarnib
Primary purpose: Treatment
Keywords: stage II pancreatic cancer; stage III pancreatic cancer; recurrent pancreatic cancer
Combined Therapy for Hepatocellular Carcinoma >3-<5 cm
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The purpose of this study is to compare the safety and efficacy of combined therapy with
      conventional transarterial chemoembolization (cTACE) + microwave ablation (MWA) versus only
      TACE or MWA for treatment of hepatocellular carcinoma (HCC) >3-<5 cm.
    

Detailed description: 
      This study aims to compare the safety and efficacy of combined therapy with conventional
      transarterial chemoembolization (cTACE)+microwave ablation (MWA) versus only TACE or MWA for
      treatment of hepatocellular carcinoma (HCC) >3-<5 cm.

      This randomized controlled trial screened 278 patients with HCC >3-<5 cm. Patients were
      randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93
      underwent combined therapy (Group 3). Patients were followed-up with contrast-enhanced CT or
      MRI. Images were evaluated and compared for treatment response and adverse events based on
      modified response evaluation criteria in solid tumor. Serum alpha-fetoprotein (AFP)
      concentration was measured at baseline and during every follow-up visit.
    

Intervention name(s): Combined therapy; Microwave ablation; Transarterial chemoembolization
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Patients undergoing combined therapy; Patients undergoing Microwave ablation; Patients undergoing Transarterial chemoembolization
Other intervention name(s): Transarterial chemoembolization + Microwave ablation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Combined therapy; hepatocellular carcinoma
Traditional Chinese Medicine for Treatment of Chronic Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether traditional Chinese medicine as
      complementary treatment is safe and effective in the treatment of chronic heart failure.
    

Detailed description: 
      Heart failure (HF) can be defined as an abnormality of cardiac structure or function leading
      to failure of heart to deliver oxygen at a rate commensurate with the requirements of the
      metabolizing tissues, despite normal filling pressures (or only at the expense of increased
      filling pressures). And according to the nature of the clinical presentation, HF is divided
      into acute or chronic HF.

      In 2003, a random sample survey of 15,518 urban or rural residents between 35 and 74 years
      old was made in China: the prevalence rate of heart failure was 0.9%, and according to the
      result, there was about 4,000,000 HF subjects in China.

      In China, the integrative treatment of western and traditional Chinese medicine (TCM) for HF
      is common and has been developed as a treatment model. TCM has been used in China and other
      south and east Asia countries for thousands of years. Syndrome differentiation and treatment
      variation are the basic principles in understanding and treatment of diseases. Investigators
      would like to test the hypothesis that it is efficacy and safety for patients to take TCM
      granules according to syndrome differentiation.

      The specific aims for the study were to evaluate the efficacy and safety of TCM in treating
      chronic heart failure (CHF).
    

Intervention name(s): traditional Chinese medicine; Placebo (gummeline)
Intervention type(s): Drug; Drug
Intervention description(s): 1 bag of drug 2 times per day for 28 days according to syndrome differentiation. For example, the syndrome of one patient is qi deficiency and blood stasis, he will take drugs of qi deficiency and blood stasis each bag 2 times per day for 28days.; Placebo of each syndrome differentiation has the same weight and smell as traditional Chinese medicine of corresponding syndrome differentiation.
1 bag of drug 2 times per day for 28 days according to syndrome differentiation.
For example, the syndrome of one patient is qi deficiency and blood stasis, he will take drugs of qi deficiency and blood stasis each bag 2 times per day for 28 days.
Other intervention name(s): Qi deficiency：huangqi, dangshen; Blood stasis: danshen, chishao,taoren, honghua; Water retention: zexie, zhuling, cheqianzi, tinglizi; Yang deficiency: rougui, zhifuzi; Qi deficiency： gummeline; Blood stasis: gummeline; Water retention: gummeline; Yang deficiency: gummeline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic heart failure; traditional Chinese medicine; syndrome differentiation
Metabolic Syndrome and Fingertip Endothelial Dysfunction
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Life-style intervention with dietetic and exercise therapy is an important fundamental
      approach to patients with metabolic syndrome (MetSyd) which may cause endothelial dysfunction
      leading to cardiovascular events. We investigated whether the life-style modification by
      dietetic and exercise instruction could improve endothelial dysfunction assessed by a new
      non-invasive and automatic device; digital reactive hyperemia peripheral arterial tonometry
      (RH-PAT).
    

Detailed description: 
      Outline of methods RH-PAT was measured in high-risk patients under 70 years old. The MetSyd
      was defined according to guidelines of the National Cholesterol Education Program Third Adult
      Treatment Panel (NCEP - ATP III). We instructed all MetSyd patients about the dietetic and
      exercise therapy according to the Japan Atherosclerosis Society Guidelines for Prevention of
      Atherosclerotic Cardiovascular Diseases. we conducted a questionnaire survey of the
      self-assessment for dietetic and exercise instruction program, respectively.
    

Intervention name(s): Lifestyle instruction
Intervention type(s): Other
Intervention description(s): Instruction dietetic and exercise therapy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assist-Knee: Energy-Harvesting Knee Prosthesis
Condition: Transfemoral Amputation; Artificial Limbs
Study type: Interventional

Summary: 
      The purpose of this research is to validate the Assist-Knee design and function by collecting
      pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when
      using the Assist-Knee to harvest energy and return energy .
    


Intervention name(s): Assist-Knee; Habitual Prosthesis
Intervention type(s): Device; Device
Intervention description(s): Assist-Knee is an experimental lower limb knee prosthesis.; Habitual baseline prosthesis prescribed by participant's clinician.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover clinical trial
Masking: None (Open Label)
Primary purpose: Device Feasibility
Nebulized Midazolam, Dexmedetomidine, and Their Combination in Sedation of Preschoolers Undergoing Dental Treatment
Condition: Dental Anxiety
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and
      their combination as procedural, moderate sedative agents in preschoolers undergoing dental
      treatment.
    

Detailed description: 
      Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry.
      Preschoolers represent a dental behavior management problem and there is always a debate over
      the best behavioral management technique for preschoolers undergoing dental treatment.
      Moderate sedation is considered as an acceptable option.

      Children who need treatment under local anesthesia, for thirty minutes will be included in
      the study. A total of 72 uncooperative pediatric dental patients, of age range 4-6 years,
      will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of
      Dentistry, Alexandria University, Egypt. The participants will be randomly allocated into 3
      groups that will undergo a procedural sedation session via a nebulizer. Children of group I
      will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized
      solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3
      mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.
    

Intervention name(s): Midazolam group (MDZ); Dexmedetomidine group (DEX); Combination of Midazolam and Dexmedetomidine (MDZ/DEX)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland; IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.; Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Nebulized Dexmedetomidine; Nebulized Midazolam; Moderate sedation; Dental procedural sedation; Pediatric dentistry