bioihbjkbjnl/mcl2 huggingface dataset:
The Cosmetic Effect of Mineral Clay Masks
Condition: Rhytides
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the cosmetic effects of commercially available mineral
      clay masks over a 4-week period. Changes in skin pigmentation, shine, wrinkles, and texture
      will be assessed.

      A second aim of the study is to assess the safety and tolerability of mineral clay masks by
      assessing redness and participant feedback.
    


Intervention name(s): Clay mask
Intervention type(s): Other
Intervention description(s): Clay mask powders- French green, Rhassul and bentonite
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Clinical Trial to Evaluate the Effect of an Oral Probiotic on the Vaginal Flora
Condition: Vaginal Flora
Study type: Interventional

Summary: 
      Clinical trial to evaluate the effect of a probiotic containing Lactobacillus Crispatus on
      the vaginal flora
    


Intervention name(s): Probiotic containing Lactobacillus Crispatus
Intervention type(s): Dietary Supplement
Intervention description(s): 1 tablet / day of probiotic (275 mg of live probiotic lactic ferments: 10 Mld L. fermentum (SGL 10), 10 Mld L. gasseri, 10 Mld L. casei, 10 Mld L. acidophilus, 10 Mld L. crispatus) during 2 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaginal Flora; Oral Probiotics
Comparative Safety, Tolerability, Pharmacokinetic Study of AVT02 (100MG/ML) and Humira (100MG/ML) in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Adalimumab is an immunosuppressive drug that belongs to the family of anti-TNF agents. It
      contains a monoclonal antibody produced by biotechnology. It is designed to bind to tumor
      necrosis factor (TNF), a substance that is involved in several auto-immune processes. By
      binding to TNF, adalimumab blocks its activity, reducing the severity of various chronic
      inflammatory diseases including Rheumatoid Arthritis, Plaque Psoriasis and others.

      Often, the high cost of biologic products may preclude access to the treatment to a big
      portion of the population worldwide. A biosimilar product that provides comparable safety and
      efficacy at more affordable cost would fulfill a broader medical need.

      Humira has been available on the market for several years. Recently, a higher concentration
      (100 mg/mL) formulation has been introduced in major markets. Alvotech is developing AVT02,
      that is a proposed biosimilar of adalimumab containing high concentration (100 mg/mL) of
      active ingredient.

      The objective of this clinical trial is to assess the similarity of AVT02 (100 mg/mL) with
      Humira (100 mg/mL), in terms of tolerability, safety (including immunogenicity) and compare
      the pharmacokinetics in healthy volunteers.
    


Intervention name(s): Adalimumab 100 MG/ML [Humira]; AVT02 100MG/ML
Intervention type(s): Drug; Drug
Intervention description(s): prefilled syringe at a concentration of 100MG/ML and delivering 40MG of adalimumab, as a single dose on day 1 day 1; prefilled syringe at a concentration of 100MG/ML delivering 40MG of AVT02, as a single dose on day 1 day 1
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single Centre, Randomised, Single-Blind, Pilot Study
Masking: Single (Participant)
Primary purpose: Treatment
Treatment of Cervical Syndrome With Physium Therapy
Condition: Cervical Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      This study aim to investigate the effects of physium therapy for improving pressure pain
      thresholds (PPTs), range of motion,Neck Disability Index, the multidimensional health related
      quality of life (SF-12) and the multidimensional health related quality of life and pain in
      patients with mechanical neck pain (NP).
    

Detailed description: 
      Fifty-four participants with NP will randomly allocated to either an physium therapy (five
      sessions) or a physical therapy (PT) groups (ten sessions) during two weeks. Multimodal PT
      program included: ultrasound therapy (US), transcutaneous electric nerve stimulation (TENS)
      and massage. Visual Analogue Scale (VAS), Neck Disability Index ( NDI), range of motion and
      (CROM), Questionnaire SF-12 and PPTs in sub-occipital and upper trapezius muscles were
      measured at baseline, at the end of treatment and at 1 month follow-up. T-tests and a
      repeated-measures multivariate analysis of variance (RM-MANOVA) were used for VAS, CROM and
      PPTs, respectively.
    

Intervention name(s): Physiotherapy treatment with physium device.; Conventional physiotherapy treatmen
Intervention type(s): Procedure; Procedure
Intervention description(s): This group will treated five times with the analgesic program of physium therapy. Each maneuver was performed once per session by slow and progressive. The whole procedure lasted no more than 45 minutes.; The PT group will treated during two weeks (ten days/week) with ultrasound therapy (US), transcutaneous electric nerve stimulation (TENS) and massage, in this order. Ultrasound will applied in pulse mode at an intensity of 1 megahertz for 10 minutes in the sub-occipital region and the vicinity of the trapezius muscles. TENS will applied with a pulse duration of 250 microseconds at a frequency of 80 Hertz for 20 minutes in the sub-occipital region and the trapezoids. Deep massage was applied at a slow speed for 20 minutes using sliding neutral creams. Massage therapy included gliding and kneading techniques applied over trapezius (upper, lower and middle fibers), splenius capitis and levator scapulae muscles with a therapeutic intention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Neck Pain; Physical Therapy Modalities; Massage; Manual Therapy
Erectus Nerve Block for Lumbar Spine Surgery
Condition: Spine Surgery; Pain Relief; Morphine; AdverseEvent
Study type: Interventional
Phase: Phase 3

Summary: 
      : Spine surgery induced severe postoperative pain. Several techniques as intravenous
      multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the
      first postoperative days. Regional anesthesia using the erectus nerve block is a simple
      infiltration across lamina of the vertebra: Ultrasound-guided posterior ramus of spinal nerve
      block for anesthesia and analgesia in lumbar spinal surgery This study compared erector nerve
      block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine
      surgery. The investigators hypothesized that eructor nerve block induced a large block from
      L1 to L5 that induced posterior nerve roots block anesthesia. This block reduced pain after
      surgery.
    


Intervention name(s): Local administration of ropivacaine; Local administration of placebo (saline solution)
Intervention type(s): Drug; Drug
Intervention description(s): Erector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery; injection of saline solution in addition with conventional anesthesia for spine surgery
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Osteopenia With Melatonin
Condition: Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional

Summary: 
      The aim of the study is to assess the effect of melatonin treatment in patients with
      osteopenia on BMD, muscle function, quality of life and calcium homeostasis.
    

Detailed description: 
      Background: Melatonin is known for its regulation of circadian rhythm. The production falls
      with age, which explains why elderly may have disturbed sleep patterns. Laboratory study and
      animal experimental studies suggests that melatonin also may protect against bone loss
      through increased osteoblast- and inhibited osteoclast activity. However, so far human
      studies have not been performed.

      Design and patients: Double blinded randomised controlled study. Eighty post-menopausal women
      (aged 55-75) with osteopenia are randomized to receive 1mg, 3mg or placebo (daily - at night
      time) for 12 months.

      Methods and results: Effects of melatonin on BMD, bone- structure and mass will be assessed
      through DXA-scans, pQCT, and QCT. Quality of life, sleep, and activity level will be assessed
      though questionnaires. Calcium homeostasis will be analyzed through blood and urines samples.
      As safety parameters, balance and muscle function will also be performed.

      Conclusion: Expected improvements in BMD, quality of life and sleep.
    

Intervention name(s): Melatonin
Intervention type(s): Drug
Intervention description(s): 1 or 3 mg of melatonin PO each night for 12 months
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Low-intensity Laser and Photodynamic Therapy on Infected Dentin of Permanent Teeth With MIH
Condition: Molar Incisor Hypomineralization
MeSH terms: Molar Hypomineralization
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this research was to evaluate the clinical effect of photodynamic therapy on
      dentin infected by caries lesion in permanent teeth with Molar Incisor Hypomineralization
      (MIH). The study was composed of Groups (1 and 2). The methodology was based on the selection
      of patients from 6 to 12 years of age with permanent molar teeth, randomly divided. The
      selected teeth had deep dentin caries lesions on the occlusal surface, and sensitivity,
      indicated for clinical restorative treatment. Photodynamic therapy was applied with the use
      of low-intensity laser in permanent teeth selected for the treatment of infected dentin in
      G1. In this group, antimicrobial photodynamic therapy (aPDT) and atraumatic restorative
      treatment (ART) were made. In G2, only ART was performed. The teeth were restored with high
      viscosity glass ionomer cement. All patients had clinical and radiographic follow-up with a
      time interval of 6 and 12 months. Data were submitted to descriptive statistical analysis.
      For the evaluation of the association of categorical variables like age and gender, the
      Chi-square test and Fisher's exact test were used. To analyze the correlation between the
      continuous variables, the Pearson correlation test was applied. ANOVA and Kruskal-Wallis were
      applied for the analysis of dentin density in the radiographic images scanned and the
      microbiological results for colony forming units.
    


Intervention name(s): aPDT; ART
Intervention type(s): Radiation; Procedure
Intervention description(s): For the aPDT the PapacarieMblue (Fórmula e Ação) was used. It was left for 5 minutes in the cavity. The carious tissue was removed and the application of the PapacarieMblue was repeated. The tissue was then irradiated in a single spot with a red laser, of wavelength of 660 nm, for 300 s, with the energy of 500mJ. These parameters were also applied in the vestibular root of the teeth, to try and prevent sensitivity.; Removal of infected dentin with a curette only, followed by cavity cleaning and restoration with glass ionomer cement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Single-Dose Study of Black Cohosh and Red Clover
Condition: Menopause
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense
      (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose
      of one botanical preparation. The observation period will be one week. Drug toxicity,
      absorption, distribution, metabolism and elimination data will be collected, and dosages to
      be utilized in a Phase II clinical trial will be determined.
    

Detailed description: 
      This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense
      (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose
      of one botanical preparation. The observation period will be one week. Drug toxicity,
      absorption, distribution, metabolism and elimination data will be collected, and dosages to
      be utilized in a Phase II clinical trial will be determined. The Phase II trial will examine
      the efficacies of red clover and black cohosh for the reduction of menopausal symptoms in
      healthy menopausal women. The study will be randomized, double-blinded, and
      placebo-controlled. Study duration will be one year.
    

Intervention name(s): Cimicifuga racemosa; Trifolium pratense
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: menopause; hot flashes; botanicals
10 Prescriptions an Hour. Group Treatment and Physical Activity Referral in a Primary Health Care Setting
Condition: Type 2 Diabetes; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of group treatment including physical
      activity referral (PAR) on level of physical activity and quality of life in patients
      diagnosed with type 2 diabetes and/or hypertension in a primary health care setting
    

Detailed description: 
      A sedentary lifestyle and low levels of physical activity in populations are major health
      problems today and contribute substantially to poor health and diseases such as type 2
      diabetes and hypertension. An increased and systematic effort to increase physical activity
      in the Swedish population in general, and in patients with type 2 diabetes/hypertension in
      particular, is important. Written prescriptions of physical activity with follow-up (i.e.,
      PAR), is a cost-efficient way to increase physical activity in individuals.

      The aim of this trial is to study whether physical activity is increased by a group method
      involving PARs in patients with hypertension and/or type 2 diabetes compared with a control
      group that receives usual care in the same primary care setting. Follow-up will be performed
      at 6 and 12 months.

      This trial is being conducted to determine whether it is possible to offer PARs to more
      patients in a way that requires less effort and resources. The intervention in this study
      requires 10 minutes of a health care worker's time per patient during a 6-month period. Each
      patient requires 100 minutes with an instructor who oversees the group intervention.

      Group treatment is given 3 weeks after baseline and at 6 months. Follow-up at 12 months
      involves data collection, but no intervention.

      An empowerment process, with the 5-A-model as framework, will be used in the clinical
      intervention.

      All participants will be required to fill in questionnaires and wear an ActiGraph GTM1/GTM3
      for 7 days at baseline and at 6 and 12 months.
    

Intervention name(s): Group treatment and PAR
Intervention type(s): Behavioral
Intervention description(s): Group treatment (8-12 patients per group) involving an empowerment-based process and the 5-A model and including PAR. Two group sessions, 6 months apart. The estimated total time for both group sessions together is 100 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Group treatment; Physical activity referral; Type 2 diabetes; Hypertension
The Effect of Warm Local Anesthetic Solution on Epidural Anesthesia
Condition: Cesarean Section
Study type: Observational

Summary: 
      The investigators are going to compare the onset and duration of nerve blockage with the use
      of pre-warmed (38°C) and room temperature (20°C) local anesthetic solutions (ropivacaine and
      fentanyl) on epidural anesthesia for cesarean section, and compare the incidence of
      complications such as hypotension, nausea and vomiting.
    

Detailed description: 
      Spinal anesthesia has a shorter time to onset than epidural anesthesia, and the amount of
      local anesthetic administered is lower than that of epidural anesthesia, resulting in less
      systemic toxicity and superior block effect.

      However, there are disadvantage that it is difficult to control the block height and the
      incidence of hypotension is high.

      On the other hand, epidural anesthesia has the advantages of less sudden hypotension due to
      slow autonomic blockade, but it has a disadvantage that sensory nerve and motor nerve block
      time is delayed compared to spinal anesthesia.

      The degree of nerve block for cesarean section surgery requires a high level of anesthesia
      above the T6 level, so the frequency of hypotension is high due to rapid sympathetic block
      after spinal anesthesia.

      In this respect, hemodynamically stable epidural anesthesia is preferred when performing
      anesthesia for cesarean section.

      The investigators are going to compare the onset and duration of nerve blockage with the use
      of pre-warmed (38°C) and room temperature (20°C) local anesthetic solutions (ropivacaine and
      fentanyl) on epidural anesthesia for cesarean section, and compare the incidence of
      complications such as hypotension, nausea and vomiting.
    

Intervention name(s): Temperature
Intervention type(s): Other
Intervention description(s): temperature of drug
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Among the pregnant women who were administered cesarean section in this study, those who
        agreed to participate in this study.
      
Keywords: pre-warmed epiural anesthetics; epidural anesthesia
Effect of Beta-Glucan on Cholesterol Lowering
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The primary aim of this study is to determine whether the cholesterol-lowering efficacy of
      barley b- glucan varied as function of molecular weight (MW) and the total daily amount
      consumed. Our second aim is to investigate the mechanism responsible for the action,
      specifically, whether β-glucan lowers circulating cholesterol concentration via inhibiting
      cholesterol absorption and synthesis. Thirdly, we aim to determine if any gene-diet
      interactions are associated with cholesterol lowering by barley β-glucan. In addition, we aim
      to investigate the alteration of the gut microbiota after β-glucan consumption and the
      correlation between the altered gut microbiota and cardiovascular disease risk factors.
    

Detailed description: 
      This study consists of four dietary phases which are separated by >28 days wash-out period.
      During the treatment phase, participants will be provided with all meals for the 35 day
      period. Breakfast meals will be consumed under the supervision of the research staff and
      lunch, dinner and snacks will be provided to take home in take-out packaging. While subjects
      are on the wash-out period they will return to their normal diet. The meals are on a 7 day
      rotating schedule that reflect an average Canadian diet. Changes in blood lipids, body
      weight, and waist circumference will be measured during each treatment phase. Cholesterol
      absorption and synthesis will be examined by stable isotope method. Single nucleotide
      polymorphisms (SNPs), rs3808607 of gene CYP7A1and rs429358 and rs7412 will be determined
      byTaqMan® SNP Genotyping assay following the manufacturer's protocol. Fecal samples will be
      collected at the end of each intervention phase and will be subjected to Illumina sequencing
      of 16S rRNA genes.
    

Intervention name(s): Control; 3g LMW beta-glucan; 5g LMW beta-glucan; 3g HMW beta-glucan
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Minimal beta-glucan; 3grams beta-glucan; 5 grams beta-glucan; 3 grams of high molecular weight beta-glucan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Beta-Glucan; Barley; Molecular Weight; Viscosity; Cholesterol; Stable isotope; Gene-nutrient interaction; Gut microbiota
Acquisition of Normative Data for Musculoskeletal Ultrasound in Children
Condition: Normative Data Study of Joints of Healthy Children
Study type: Observational

Summary: 
      The primary objective is to establish normative data for Canadian children for the shoulder,
      elbow, wrist, finger, hip, knee, ankle and toe joint including the relevant tendons
      surrounding the joint.
    

Detailed description: 
      The respective joints will be assessed through ultrasonography and data will be collected and
      analyzed
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy children will be recruited via invitation by investigators
Effects of Mechanical Versus Manual Traction in the Management of Low Back Pain.
Condition: Low Back Pain; Low Back Pain, Mechanical; Disc Degeneration; Disc Prolapse; Disc Prolapse With Radiculopathy; Lumbar Radiculopathy
MeSH terms: Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Radiculopathy; Back Pain; Low Back Pain; Prolapse
Study type: Interventional

Summary: 
      This study compared the effects of mechanical and manual traction on pain, disability and
      lumbar spinal curvature in patients with discogenic low back pain
    


Intervention name(s): Hot Pack; Manual Traction; Mechanical Traction; Joint Mobilization; TENS
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Superficial Heating; Manual Traction for 10 minutes; Mechanical Traction for 10 minutes; 3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions; TENS for 10 minutes with hot pack
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment