bioihbjkbjnl/mcl2 huggingface dataset:
Hyperthermia in Fibromyalgia Syndrome
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Hyperthermia; Fever
Study type: Interventional

Summary: 
      This study will examine the effectiveness of water-filtered whole-body hyperthermia during an
      outpatient setting in patients with fibromyalgia.

      The duration of the study is about 3 weeks with two treatment units per week and a passive
      period (follow-up measurement) of 24 weeks after the outpatient setting.
    

Detailed description: 
      A total of about 40 participants over 18 years of age are sought, who will be divided into
      two groups of equal size after inclusion in the study. All participants will receive the same
      amount of water-filtered whole-body hyperthermia within the outpatient setting. One group
      receives the gentle form of GKHT, the other group receives the classic, mild GHKT. All
      abnormalities are documented by the responsible therapists, doctors and nurses. Changes in
      the area of pain and functional limitations as well as the intake of required medication are
      also recorded.

      Before the start and after the completion of the studies, within the clinical stay, blood
      parameters were collected. In order to determine the secondary effectiveness of different
      questionnaire values are also collected. These are also documented after week 12 and after
      week 24, by means of telephone enquiries.
    

Intervention name(s): Hyperthermia Group; Sham-Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The first hyperthermia treatment of the series is carried out for the second aptitude test, directly following the randomisation in the intervention group at the Hospital for Naturopathy and Integrative Medicine in Bamberg. The hyperthermia treatment is then carried out in a cycle of two treatments per week, with at least one day in between, over a period of three weeks, according to the manufacturer's instructions. According to the guidelines, the rectal (possibly vaginal) temperature (as body core temperature), heart rate and oxygen saturation (Sp02) are continuously determined during the hyperthermia treatment. During the treatment, continuous supervision by trained personnel is guaranteed, and a doctor is on call.; The number of treatments is equal to the number of treatments in the intervention group.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment, Sham- and treatmentgroup
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hyperthermia; fibromyalgia syndrome; pain
Acute Effects of Spirulina on Postprandial Glycemic Responses and Arterial Blood Pressure
Condition: Potential Abnormality of Glucose Tolerance; Appetitive Behavior; Blood Pressure
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      This study investigated the effects of three doses of spirulina in glucose beverages on
      postprandial glycemic responses, arterial blood pressure, and subjective satiety.
    

Detailed description: 
      This study aimed to determine the effects of three different doses (4, 6 and 8 g) of
      spirulina in glucose beverages on postprandial glycemic responses, blood pressure, and
      subjective appetite responses in healthy young adults.
    

Intervention name(s): Glucose as reference food; Beverage containing 4g spirulina; Beverage containing 6g spirulina; Beverage containing 8g spirulina
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Thirteen healthy, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50g glucose diluted in 250ml, tested two times, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.; Thirteen healthy, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50g glucose and 4g spirulina diluted in 250ml, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.; Thirteen healthy, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50g glucose and 6g spirulina diluted in 250ml, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.; Thirteen healthy, with BMI between 18 and 29.9 kg/m2 (male: 3, female:10) after 10-14h fast, consumed 50g glucose and 8g spirulina diluted in 250ml, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: blood glucose responses; blood pressure; spirulina; subjective appetite; blood glucose concentrations
Study of Yili Lactoferrin ShuHua Milk in the Improvement of Human Immunization
Condition: Immunization; Human Influenza; Common Cold
MeSH terms: Common Cold; Influenza, Human
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Yili Lactoferrin ShuHua Milk are effective
      in reducing the occurrence of flu symptoms.
    


Intervention name(s): Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml); Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml); Recombined low protein milk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.; Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.; Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Evaluation of a Multimodal Neuroimaging Method for Diagnosis in Parkinsonian Syndromes
Condition: Parkinson's Disease; Multiple System Atrophy
MeSH terms: Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Parkinsonian Disorders; Atrophy
Study type: Interventional

Summary: 
      Based on previous promising results, the next step for the validation of a multimodal MRI
      method in diagnosis and follow up of patients reached by parkinsonian syndromes is (i) to
      test whether the multimodal neuroimaging is able to discriminate at the individual level,
      patients with multiple system atrophy parkinsonism (MSA) and patients with idiopathic
      Parkinson's disease (PD) (ii) to determine whether the method is sensitive to measure changes
      over time for the two diseases, according to imaging, neuropsychological and other clinical
      data. Patients will be compared with healthy controls.
    

Detailed description: 
      30 patients with PD, 30 patients with MSA and 30 healthy controls will be examined in a
      3Tesla MRI.

      The aim of our project is to demonstrate that our multimodal MRI method can discriminate both
      diseases with a similar clinical presentation and monitor the progress of the disease. CIC's
      expertise in recruitment and assessment of patients, and the powers of the INSERM U825 in
      terms of development and processing in neuroimaging guarantee the feasibility of the project
      and its successful completion.
    

Intervention name(s): MRI acquisition; behavioral evaluations
Intervention type(s): Other; Behavioral
Intervention description(s): MRI acquisitions; Evaluations about motor abilities, sleep, cognition and lifestyle
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: differential diagnosis; multimodal MRI; Parkinson's Disease; Multiple System Atrophy
The Efficacy and Safety of PEG-rhG-CSF（Pegylated Recombinant Human Granulocyte Colony Stimulating Factor)in Patients With Breast Cancer Who Were Treated With Intensive Chemotherapy
Condition: Breastcancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients
      with breast cancer who were treated with intensive chemotherapy for prevention of neutrophil
      reduction.
    


Intervention name(s): PEG-rhG-CSF
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
First Time in Human (FTIH) Safety and Pharmacokinetics (PK) Study of GSK3036656 in Healthy Subjects
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK3036656 is being developed by GSK for the treatment of tuberculosis (TB). This is the FTIH
      study for GSK3036656 to evaluate the safety, tolerability and PK of single ascending and
      repeat oral doses of GSK3036656 in healthy adult subjects. The results of this study are
      intended to be used to identify appropriate and well-tolerated doses of GSK3036656 to be used
      in further studies. A food effect assessment will also be undertaken to investigate the
      influence of food on the PK of GSK3036656. The study will be conducted in two parts: Part A
      (single dose) and Part B (repeat dose). Up to two cohorts will be included in Part A. 9
      healthy adult subjects will be included in each cohort. Each cohort will participate in up to
      4 treatment (dosing) periods including a food effect treatment period. During each treatment
      period, GSK3036656 will be administered to 6 subjects and placebo will be administered to 3
      subjects. The starting dose in Part A will be 5 milligrams (mg), and the maximum dose will be
      1500 mg. The two cohorts in Part A will be dosed sequentially (i.e., dosing in Cohort 2
      starts after dosing in Cohort 1 is completed). Initially, there will be a 14 day wash out
      period for individual subjects between each dose level. Study progression to Part B from Part
      A will be based on an acceptable safety, tolerability and PK profile in Part A. Part B will
      comprise up to 4 cohorts (Cohorts 3, 4, 5, and 6) each containing 10 (8 active: 2 placebo)
      healthy adult subjects to examine the safety, tolerability and PK of a repeated daily dose of
      GSK3036656 over a period of up to 14 days. Appropriate doses and dose regimens for Part B
      will be selected based on available safety, tolerability and PK data from Part A and/or any
      preceding repeat dose cohorts from Part B. Dividing the total daily dose into 2 or 3 smaller
      doses may be done in both Part A and Part B. Up to 18 subjects will be enrolled into Part A
      and up to 40 subjects will be enrolled into Part B. The total duration of the study for each
      subject recruited into Part A and Part B will be approximately 12 weeks and 8 weeks,
      respectively.
    


Intervention name(s): GSK3036656; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK3036656 is available as capsules (for oral administration) containing 5 mg, 25 mg or 100 mg of GSK3036656 as free base equivalent.; Placebo is a matching capsule containing Avicel PH (Suitable for Pharmaceutical Use) 102, for oral administration.
Intervention MeSH terms: GSK656
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ascending dose; Pharmacokinetics; GSK3036656; FTIH; Safety
Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children
Condition: Gastrointestinal; Tolerance
Study type: Interventional

Summary: 
      Purpose of this study: assess the maximum tolerated bolus dose of erythritol, delivered in a
      clear beverage, compared with placebo (saccharose) in 4-6 year old children.
    

Detailed description: 
      The study is a randomized placebo-controlled, double-blind cross-over trial designed to
      determine the gastrointestinal (GI) responses and maximum tolerated dose of erythritol in
      young children as a single oral dose in a beverage in-between meals.

      The children were divided into 4 dose groups. In each group of children, only one dose level
      was tested such that each child was exposed to only a single dose level versus placebo. The
      erythritol dose started at 5 grams and was increased by 10 g between each group of children
      only if the preceding dose level was found to have no significant GI tolerance effects. The
      effects on faecal parameters and gastrointestinal complaints were recorded in order to
      determine the threshold dose. After finding a significant difference in tolerance between
      erythritol and placebo in the 25 g dose cohort, a protocol amendment was approved allowing
      the investigators to study a dose of 20 g.

      Test materials were prepared by Cargill, Vilvoorde, Belgium and supplied in bottles
      containing 250 mL of a noncarbonated fruit-flavoured (two flavours: strawberry and orange)
      clear drink sweetened with erythritol at four different dose levels: 5, 15, 20 and 25 g
      (equivalent to 2, 6, 8 and 10% w/v erythritol, respectively). Placebo was supplied in an
      identical manner but prepared with common nutritive carbohydrates (saccharose and
      maltodextrin) and providing an equivalent sweetness to that of the corresponding erythritol
      beverages (i.e.: 1.4, 4.2, 5.6 and 7% w/v).

      In total 185 healthy young children aged 4-6 years were recruited at three clinical
      investigation centres after informed consent of both parents; 184 completed the study.
    

Intervention name(s): Erythritol drink; Placebo drink
Intervention type(s): Other; Other
Intervention MeSH terms: Erythritol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: erythritol; polyol; laxation; gastrointestinal; tolerance; soft drinks; child; diarrhoea
Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      The proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function
      and triggers angiogenesis through induction of local growth factors and endothelial nitric
      oxide synthase. The literature generally confirms that LI-ESWT is safe and cohort studies
      investigating the clinical effects have been encouraging. Meanwhile, randomized trials have
      shown contradictory results. Thus, a randomized trial in 67 PDE5-I responders showed
      statistically greater improvements in the Erectile Function Domain of the International Index
      of Erectile Function (IIEF) with active LI-ESWT treatment compared to a sham treatment
      (p=0.032).
    


Intervention name(s): Li-ESWT
Intervention type(s): Device
Intervention description(s): Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Different Volumes of Erector Spinae Plane Block for Breast Surgery
Condition: Breast Cancer; Breast Neoplasms; Breast Diseases
MeSH terms: Breast Neoplasms; Breast Diseases
Study type: Interventional

Summary: 
      Postoperative pain is an important issue in female patients underwent breast surgery.
      Postoperative effective pain treatment provides early mobilization and shorter hospital stay.
      The US-guided erector spina plane block (ESPB) may be used for postoperative pain treatment
      following breast surgery. It is a relatively novel interfascial block that was defined by
      Forero et al. It has been reported that ESPB provides effective analgesia management for
      several breast surgeries.
    

Detailed description: 
      Various methods may be performed to reduce the use of systemic opioids and for effective pain
      treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided
      interfascial plane blocks have been used increasingly due to the advantages of ultrasound in
      anesthesia practice.

      The US-guided erector spina plane block (ESPB) provides thoracic analgesia at T5 level and
      abdominal analgesia at T7-9 level. ESPB contains a local anesthetic injection into the deep
      fascia of erector spinae. Visualization of sonoanatomy is easy, and the spread of local
      anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs
      in several dermatomes with cephalad-caudad way. In the literature, it has been reported that
      ESP block provides effective analgesia after several surgeries such as open heart surgery,
      breast surgery, thoracoscopic and abdominal operations.

      The aim of this study is to compare the efficacy of the different volumes of US-guided ESPB
      for postoperative analgesia after mastectomy and axillary dissection surgery. The primary aim
      is to compare postoperative opioid consumption, and the secondary aim is to evaluate pain
      scores (VAS), and adverse effects related with opioids (allergic reaction, nausea, vomiting).
    

Intervention name(s): Bupivacaine + Fentanyl
Intervention type(s): Drug
Intervention description(s): Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
Intervention MeSH terms: Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two models for this study. The first group is 30 ml volume ESPB group. The second one is 20 ml volume ESPB group
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mastectomy and axillary dissection surgery; Postoperative pain management; Erector Spinae Plane Block
A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess 1) the effect of multiple doses of itraconazole (CYP3A4
      inhibitor), rifampin (CYP3A4 inducer), and esomeprazole (pH modifier) on the pharmacokinetics
      of a single oral dose of ABI-H2158, and 2) the effect of steady-state oral ABI-H2158 on the
      pharmacokinetics of midazolam (sedative) and levonorgestrel/ethinyl estradiol (active oral
      contraceptive) in healthy adult participants.
    


Intervention name(s): ABI-H2158; Itraconazole; Rifampin; Midazolam; Ethinyl Estradiol / Levonorgestrel; Esomeprazole; Placebo matching oral contraceptive
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ABI-H2158 tablets; Itraconazole capsules; Rifampin capsules; Midazolam syrup; Ethinyl Estradiol / Levonorgestrel tablets; Esomeprazole capsules; Placebo matching Ethinyl Estradiol / Levonorgestrel tablets
Intervention MeSH terms: Itraconazole; Rifampin; Midazolam; Esomeprazole; Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Contraceptive Agents; Contraceptives, Oral; Estradiol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP
Condition: Gingivitis; Periodontitis
MeSH terms: Gingivitis; Periodontitis; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      90-day, self-controlled, longitudinal, non-blinded clinical trial which will measure changes
      in clinical parameters in participants with gingivitis and Stage I or II periodontitis who
      apply ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse.
    

Detailed description: 
      The study will be conducted with 60 medically healthy participants between ages 18 to 75
      years with gingival or periodontitis (Stage I or II) who are receiving routine preventive
      care and/or periodontal maintenance.

      Subjects will brush with ClōSYS® Sensitive Fluoride Toothpaste twice daily and rinse with
      ClōSYS® Sensitive Rinse twice daily after brushing.

      The primary response variables will be the Subjects' scores on the Plaque Index (PI),
      Gingival Index (GI) and the number of sites with bleeding upon probing (BOP). Probing depths
      and clinical attachment level will be assessed at baseline and 3 months. Adverse events will
      also be assessed and documented at each visit. In addition, Subjects will keep a usage diary
      documenting their daily use of the toothpaste and oral rinse and any comments or observations
      regarding usage or adverse events.
    

Intervention name(s): ClōSYS® Sensitive Fluoride Toothpaste; ClōSYS® Sensitive Rinse
Intervention type(s): Drug; Other
Intervention description(s): ClōSYS® Sensitive Fluoride Toothpaste is an over-the-counter drug product containing 0.12% stabilized chlorine dioxide (sodium chlorite in an aqueous solution) and 0.13% w/v fluoride ion.; ClōSYS® Sensitive Rinse is a cosmetic product containing 0.1% stabilized chlorine dioxide.
Intervention MeSH terms: Fluorides
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gingivitis or periodontitis (Stage I or II)