bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Stress Levels and Depressive and Anxiety Symptoms in Patients With COPD
Condition: COPD; Anxiety State; Stress; Depressive Symptoms; Mood Disorders
MeSH terms: Anxiety Disorders; Depression; Mood Disorders
Study type: Observational

Summary: 
      The aim of the study was to assess the levels of depression, anxiety and stress in patients
      with COPD qualified for In-hospital pulmonary rehabilitation program
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD), manifested by coughing, shortness of breath,
      sputum production, wheezing and reduced physical performance, is one of the most frequently
      diagnosed lung diseases. Anxiety and depression have been found to increase the number of
      acute exacerbations and hospitalizations (thus reducing quality of life), weight, appetite,
      sleep disorders, fatigue or loss of energy, lack of concentration, pessimism about the future
      and suicidality. Anxiety has been estimated to occur in 21-96% and depression in 27-79% of
      patients with COPD, values that are higher than for the general population or other chronic
      diseases. Pulmonary rehabilitation leads to the improvement to the physical capacity and
      overall fitness of the patients with COPD allowing restoration of independence in daily
      functioning. Psychological support is required in order to reduce the negative psychological
      symptoms related to both the pulmonary disease itself and the comorbidities. In the presented
      study, the aim was to assess the prevalence of levels of depression, anxiety and stress in
      patients with COPD qualified for In-hospital pulmonary rehabilitation program.

      The program includes the following elements:

      Three weeks of pulmonary rehabilitation conducted in an outpatient care facility:

        -  5- time a week for 30 minutes a specific respiratory exercises- relaxation exercises for
           breathing muscles, exercises to increase breathing, prolonged exhalation exercise, chest
           percussion

        -  5- time a week for 20-30 min training on a cycle ergometer

        -  5- time a week for 30 minutes a fitness and respiratory exercises - coordination and
           balance exercises, stretching exercises

        -  relaxation training by Schultz. The technique involves the daily practice of sessions
           that last around 15 minutes. During each session, the practitioner repeats a set of
           visualisations that induce a state of relaxation.
    

Intervention name(s): Pulmonary rehabilitation
Intervention type(s): Behavioral
Intervention description(s): Patients qualified for rehabilitation were assessed for stress levels as well as symptoms of anxiety and depression before rehabilitation began
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with chronic obstructive pulmonary disease
      
Keywords: pulmonary rehabilitation; depression; anxiety; stress
A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to assess the biological potency of the In-House Reference Preparation (IHRP)
      of peanut allergens extract by a quantitative Skin Prick Test (SPT) method in peanut-allergic
      subjects.
    


Intervention name(s): DBV712 IHRP
Intervention type(s): Drug
Intervention description(s): DBV712 Solution for Skin Prick Test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: EPIT; Epicutaneous; Immunotherapy; Viaskin
A Study in Healthy Japanese Men to Test How Well Different Doses of BI 764198 Are Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety and tolerability of BI 764198 in
      healthy male subjects following oral administration of single dose and multiple rising doses
      per day over 14 days.

      Secondary objectives are the exploration of pharmacokinetics (PK) of BI 764198 after single
      and multiple oral dosing.
    


Intervention name(s): BI 764198; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 764198; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This trial consists of a single dose part and a multiple rising dose (MRD) part. The first dose group is conducted in the single dose part and the second dose group onwards are conducted in the MRD part.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To evaluate the efficacy of the association Lantus (once-a-day, od) Apidra (thrice-a-day,
      tid) in terms of change HbA1c from baseline to end of study (week 24), in patients with Type
      1 Diabetes Mellitus (T1DM).

      Secondary Objectives:

      To evaluate:

        -  The change of hemoglobin A1c (HbA1c) from baseline to week 12

        -  The percentage of patients with HbA1c < 7% at week 12 and week 24

        -  The FBG and the 7-point self monitoring of blood glucose (SMBG) at baseline, week 12 and
           week 24

        -  The daily dose for both insulin glulisine insulin glargine at baseline, week 12 and week
           24

        -  The incidence of symptomatic hypoglycemias

        -  Adverse events
    

Detailed description: 
      After a two-week run-in period patients will enter a six-month treatment period.

      Estimated study duration per patient : 26 weeks (including a 2-week run-in period).
    

Intervention name(s): INSULIN GLARGINE; INSULIN GLULISINE
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day at bedtime; Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: three times a day, preferably just before the meal
Other intervention name(s): Lantus SoloStar; Apidra SoloStar
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bone Marrow Mononuclear Cell and Hyperbaric Oxygen Therapy in Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      There were evidences that the non-immune mediated inflammatory pathways of cell damage
      occurred in vitro in human islets upon hyperglycemia in type 2 diabetes mellitus. Autologous
      stem cell therapies were an emerging set of therapies that showed promise with a low side
      effect profile. we hypothesized that infusion of mononuclear cells from buffy coat obtained
      from bone marrow might provide multiple signals for regeneration and inflammation-induced
      lesion recovery of local tissues, of which the effect might be maximized by intra-arterial
      pancreatic infusion through angiography and combination with hyperbaric oxygen therapy.

      This trail includes a foregoing sub-trial that investigate the feasibility and safety of a
      novel method for massive bone marrow collection. The traditional BM collecting procedure is
      unfavorable because it yields minor bone marrow. Studies have shown that physiological
      exercise can increase bone marrow blood flow, which might facilitate BM collection.

      We plan to include a total of 60 patients with type 2 diabetes and randomly assign them to
      either a control group or an exercise group (n =30 each). The patients in the exercise group
      exercised 30 minutes before the operation. All patients underwent routine surgical care. The
      collected BM volume, operation time, collecting speed , puncture times and pain scores during
      the operation were recorded. Bone marrow samples were tested for CD34+ flow cytometry and
      whole blood cell count.
    


Intervention name(s): BM-MNC+HOT; BM-MNC; HOT; SMT
Intervention type(s): Drug; Drug; Device; Drug
Intervention description(s): Autologous Bone Marrow Mononuclear cell Infusion Combined With Hyperbaric Oxygen Therapy; Autologous Bone Marrow Mononuclear cell Infusion; Hyperbaric Oxygen Therapy; hypoglycemic drugs or exogenous insulin
Other intervention name(s): stand medical therapy (enhanced hemoglucose monitor, health and diet counseling and insulin injection)
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes mellitus; bone marrow mononuclear cell; hyperbaric oxygen therapy
Yellow Pea Protein and Fibre and Short Term Food Intake
Condition: Obesity; Type II Diabetes Mellitus; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      It is hypothesized that yellow pea protein and fiber will reduce short-term food intake,
      subjective appetite and glycemic response.
    

Detailed description: 
      A within-subject, randomized study was conducted. Each subject returned 5 times, 1 week
      apart, and received 1 of the 5 treatments per week. The 5 treatments were tomato soup with 10
      or 20 g of isolated yellow pea fibre or protein, or a control soup with no added pea
      fractions. Food intake was measured at an ad libitum pizza meal served 30 minutes after
      treatment. Satiety and blood glucose (via finger prick) were measured throughout the
      treatment period.
    

Intervention name(s): yellow pea protein; yellow pea fiber; Control Tomato Soup
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Served in a tomato soup; Served in a tomato soup; Served in a tomato soup
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Obesity; Food intake regulation; blood glucose regulation; protein; fiber; pulses; yellow peas
Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers Without Charcoal Block
Condition: Asthma; Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide
      HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers without charcoal
      block.
    

Detailed description: 
      A pivotal, single-dose, randomized, open-label, two-period, two-sequence, two-treatment,
      crossover, comparative bioavailability study for test drug Synflutide HFA 250/25 Inhaler and
      reference drug SeretideTM 250 EvohalerTM in healthy volunteers without charcoal block. Fifty
      healthy, male and female volunteers, 20-65 years of age, with a body mass index (BMI) within
      18.0-30.0 kg/m2, inclusive, will be enrolled. A single dose of 4 puffs (eq. to fluticasone
      propionate 1000μg+salmeterol 100μg from valve) in each study period. Plasma samples will be
      assayed for fluticasone propionate and salmeterol using a validated analytical method
      according to the principles of Good Laboratory Practice.
    

Intervention name(s): Fluticasone propionate; Salmeterol (as xinafoate)
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled corticosteroid, pMDI; Long Acting Beta-agonist (LABA), pMDI
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Myofascial Massage in the Treatment of Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effectiveness of an approach that combines
      massage therapy with elements of neurocognitive rehabilitation such as motor imagery and the
      words of the physiotherapist compared to a traditional massage therapy in reducing pain in
      patients with chronic low back pain (CLBP) and to evaluate if and how the pain reduction is
      linked to the interoceptive awareness and which is the patient's ability to relax through the
      measurement of the hearth rate variability (HRV).
    


Intervention name(s): Massage therapy; Neurocognitive rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Massage therapy as a treatment option to induce a relaxation and a reduction of pain and stress in patients affected by chronic low back pain.; Provided through the association of motor imagery and the words of the physiotherapist with the aim of increasing the effectiveness of massage in reducing pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Low back pain; interoceptive awareness; motor imagery; massage
Assessing Patient Response to Therapeutic Exercise Based on Clinical Prediction Rule (CPR) for Spinal Manipulation
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether patients who meet the criteria of the
      clinical prediction rule for spinal manipulation may respond more favorably to repeated
      exercises according to a direction of preference (what makes the symptoms decrease). The
      investigators do not know which of these two commonly-used treatments (manipulation or
      specific exercise) is better to treat low back pain.
    

Detailed description: 
      With the trends in health care focusing on treatment effectiveness, it is important for
      physical therapists to select the most appropriate intervention according to patient
      classification. Physical therapy interventions for management of LBP include therapeutic
      exercises and spinal manipulation.

      The purpose of this study is to determine whether patients who fit the Clinical Prediction
      Rule (CPR) for spinal manipulation may respond instead to exercise according to repeated
      lumbar movements in the direction of preference.

      The subjects for this study will be comprised of individuals referred for treatment of low
      back pain and data will be collected by physical therapists with certification in MDT who had
      experience treating patients through the use of spinal manipulation. Patient functional
      questionnaires and impairment measures will be used to analyze the patient's perceived level
      of function and outcome.

      Following the completion of an informed consent, subjects will undergo a physical therapy
      examination by a licensed physical therapist. Patients will be included in the study if they
      meet the CPR for spinal manipulation as describe in earlier research 6,11. Following the
      examination, all qualified subjects will be randomly assigned to either the (1) spinal
      manipulation group or (2) the McKenzie (MDT) group and will receive treatment in accordance
      with their assigned group. The assessment tools administered at the initial examination will
      be readministered for follow-up analysis.
    

Intervention name(s): MDT (McKenzie Method); Spinal thrust manipulation
Intervention type(s): Procedure; Procedure
Intervention description(s): Subjects who perform exercises in their direction of preference.; Subjects who receive spinal thrust manipulation as an intervention.
Other intervention name(s): functional outcomes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: McKenzie; thrust manipulation; clinical prediction rule
A Study to Assess Bioavailability and Pharmacokinetics of CAT- 354
Condition: Asthma; Healthy
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous
      administration compared with intravenous administration.
    

Detailed description: 
      To compare the bioavailability and pharmacokinetics of CAT-354 following subcutaneous
      administration of 150 milligram (mg) and 300 mg compared with 150 mg given intravenously.
    

Intervention name(s): CAT-354 150 mg (intravenous); CAT-354 150 mg (subcutaneous); CAT-354 300 mg (subcutaneous)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.; A single dose of CAT-354 150 mg injection subcutaneously on Day 0.; A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Other intervention name(s): Tralokinumab; Tralokinumab; Tralokinumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; CAT-354; Tralokinumab; Healthy
Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The goal of this study is to determine what effect Cetaphil® Restoraderm® system has on
      babies' skin versus Johnson & Johnson baby lotion and skin cleanser.
    

Detailed description: 
      Subjects will randomly be divided into a group using Cetaphil® Restoraderm® system or a group
      using Johnson & Johnson baby lotion and skin cleanser . At 3, 6, and 12 months non-invasive
      measurements of barrier function will be used to test the babies' skin. The procedures are as
      follows:

        -  Transepidermal loss (TEWL - measures the water loss from the skin)

        -  Skin electrical capacitance (measures how much water stays in the top layer of skin)

        -  Skin pH (measures level of pH)

        -  Skin microbiome analysis (skin swabs to check genetic code of skin bacteria)

        -  Lipidomic and natural moisturizing factor analysis (measures lipids (oils) in the top
           layer of skin)

      Both groups will be reminded to follow the instructions about general good skin care of
      infants. Subjects will be asked if they agree to provide a saliva sample. If yes, a saliva
      sample will be collected from the inside of the infant's cheek at the 6 month visit and will
      be shipped to the laboratory of Dr. Irwin McLean at the University of Dundee, where it will
      be tested for gene defects in the skin barrier that might trigger the development of eczema.
      Defects in the gene called filaggrin have been shown to increase the risk of developing
      eczema. The samples will be identified by a code to protect your infant's identity. The
      saliva samples will be stored only for this study, and then the sample will be destroyed.
    

Intervention name(s): Cetaphil Restoraderm; Standard of Care
Intervention type(s): Other; Other
Intervention description(s): Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.; Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser.
Other intervention name(s): Johnson&Johnson
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: atopic dermatitis; skin care
Monday is Fasting Day - Non-Randomized Trial on Intermittent Fasting
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The aim of this pilot study is to evaluate the effects of one regular fasting day per week
      over a total period of 8 weeks compared to a normal-eating habits among healthy volunteers.
    

Detailed description: 
      Participants in the intervention group receive an initial group training for fasting. Then
      all participants will observe one fixed fasting day per week (monday) over a total period of
      eight weeks.

      Participants in the control group receive an initial group training for healthy diet
      according to current German guidelines (DGE). Moreover, they will receive the same offer as
      in the intervention group at the end of the 8-week study period. Until then the control group
      participants follow a regular healthy diet.
    

Intervention name(s): Fasting / Caloric Restriction; Healthy Diet
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fasting; Caloric Restriction; Focus is to observe effects of fasting in healthy volunteers.
Effects of Lee Silverman Voice Treatment BIG on Dynamic Balance in Parkinson's Patients
Condition: Parkinson Disease; Motor Disorders; Balance; Distorted
MeSH terms: Parkinson Disease; Motor Disorders
Study type: Interventional

Summary: 
      To determine the effects of Lee Silverman Voice Treatment BIG on dynamic balance in
      Parkinson's patients
    

Detailed description: 
      This study will be conducted to compare the effects of Lee Silverman Voice Treatment BIG and
      conventional physiotherapy on dynamic balance in patients of PD. Patients will be recruited
      according to inclusion criteria and data will be collected from Riphah rehabilitation center,
      National Hospital Lahore. Dynamic gait index will be used as data collection tool to test
      dynamic balance of patients. Patients will be allocated to intervention groups by
      randomization. After approval from ethical committee, data collection will be started and
      informed consent will be taken from all patients.
    

Intervention name(s): Lee Silverman Voice Treatment BIG; conventional treatment
Intervention type(s): Other; Other
Intervention description(s): Patients assigned to experimental group will get Lee Silverman Voice Treatment BIG along with conventional treatment.; patients in this group will get conventional treatment program encompassing set of exercises such as complex motor sequences, stretching, dual tasking, mental imagery and core stability.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: total 26 participants will be randomly assigned to experimental group (Lee Silverman Voice Treatment BIG along with conventional therapy) and control group( conventional treatment)
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson Disease; Balance; Distorted; Motor Disorders