bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Probiotics on Stress in Young Adults
Condition: Stress
Study type: Interventional

Summary: 
      The study investigates the effects of probiotics in a young healthy population experiencing
      stress during a stress challenge, i.e. The Trier Social Stress Test (TSST).
    

Detailed description: 
      The study is a prospective, randomized, double-blind, three-arm, placebo-controlled study in
      young adults who are moderately stressed and undergoing a Trier Social Stress Test (TSST),
      comparing probiotics with placebo. The participants will receive either one of the two test
      products or placebo daily for a period of eight weeks.

      At Visit 1, the participants will be dispensed with study product and complete the Cohen's
      Perceived Stress Scale (PSS) and State Trait Anxiety Inventory (STAI) questionnaires. Blood
      samples will be collected for biomarker analysis.

      At Visit 2, participants will undergo a TSST and will complete the PSS and STAI
      questionnaires and Visual Analog Scales (VAS). Saliva and blood samples will be collected for
      biomarker analysis.
    

Intervention name(s): Probiotics; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral capsules; Oral capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Stress; Mental Health
A Comparative Study of the Effect of Ayurvedic Drugs and Metformin in the Management of Diabetes Mellitus (Type II)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Present study entitled "A Comparative Study of the Effect of "Chhinnavahni Kashaya Vati"
      along with "Agnimantha Kwatha" & Metformin in the management of Madhumeha w.s.r. to Diabetes
      mellitus (Type II)" is a small effort to find out an effective remedy for Madhumeha i.e.
      Diabetes Mellitus Type-2
    

Detailed description: 
      Single centered, randomized clinical trial of Chhinnavahni Kashaya Vati along with Agnimantha
      Kwatha was carried out on total of 60 registered patients. They were randomly classified in
      two groups, where in Group-A received Chhinnavahni Kashaya Vati with Agnimantha Kwatha and
      Group-B received Metformin for 12 weeks. Out of these, 12 patients did not complete the full
      course of the treatment.
    

Intervention name(s): Chhinnavahni Kashaya Vati along with Agnimantha Kwatha; Metformin Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Chhinnavahni Kashaya Vati Form : Tablet Dose: 1g TDS (2x500 mg), Before meals Mode of Administration: Oral Anupaan: 20 ml of Agnimantha Kwatha Duration: 3 Months; Drug: Metformin Form: Tablet Dose: 500mg BID/TDS, Before meals Mode of Administration: Oral Anupaan: Plain water Duration: 3 Months
Other intervention name(s): Chhinnavahni Kashaya Vati; Agnimantha Kwatha; Metformin
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Controlled, Parallel Group Trial.
Masking: None (Open Label)
Primary purpose: Treatment
Ragweed Observational Study
Condition: Ragweed Allergy
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      This is an observational to evaluate Total Rhinoconjunctivitis Symptom Score and rescue
      medication usage (as measured by Rescue Medication Score as a Combined Score to inform the
      design of a phase III field study with ToleroMune Ragweed.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with a history of ragweed allergy for at least 2 years and which required
        symptomatic treatment for at least 1 year
      
Keywords: Ragweed allergy
Surgical Approach for Pilonidal Disease
Condition: Pilonidal Disease
Study type: Observational

Summary: 
      In our hospital, between January 2013 and January 2017, those operated with the Modified
      Limberg flap method after the Rhomboid excision due to pilonidal disease, and those operated
      with the un-roofing curettage method will be screened retrospectively. Patients will be
      divided into two groups as Un-roofing curettage group (UC group) and the Modified Limberg
      Flap group (LF group). Operation time, hospital stay time, return to work time, recovery
      time, Time to walk without pain, days, Time to sit on the toilet without pain, days,
      Postoperative VAS and recurrence will be compared between both groups
    

Detailed description: 
      In our hospital, between January 2013 and January 2017, those operated with the Modified
      Limberg flap method after the Rhomboid excision due to pilonidal disease, and those operated
      with the un-roofing curettage method will be screened retrospectively. Patients who are well
      followed up will be included in the study. Demographic features will be recorded. Patients
      will be divided into two groups, the un-roofing curettage group (UC group) and the Modified
      Limberg Flap group (LF group). Surgery time, hospital stay, return to work time, recovery
      time, painless walking time, days, painless sitting time in the toilet, days, postoperative
      VAS, and recurrence will be compared between both groups. In addition, mobilization time,
      days, recovery time, days, exclusion time, days, wound infection, wound distribution will be
      compared between groups. The results will be analyzed with the SPSS statistics program.
      Factors affecting recurrence wound infection, recovery time, hospital stay, operation time,
      early mobilization will be evaluated by univariate and multivariate logistic regression
      analysis.
    

Intervention name(s): Un-roofing curettage method; Modified Limberg Flap Group
Intervention type(s): Procedure; Procedure
Intervention description(s): In this method, the roof of the pilonidal cyst is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis.; In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with Limberg flap after rhomboid excision and un-roofing curettage between January
        2013 and January 2017 in our hospital constitute the study population.
Stimulating Private Sector Malaria Control
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      Preliminary evidence from ongoing research provides strong indications that protecting
      farmers from malaria would be profitable for outgrowing agribusinesses in sub-Saharan Africa.
      The study team invests in experimental research to investigate this conjecture in more
      detail.
    

Detailed description: 
      The study evaluates whether the sourcing of insecticide-treated nets and their distribution
      to smallholder farmers for free would be a profitable investment for a cotton outgrowing
      agribusiness in Zambia.

      The study therefore carries out a major net distribution through the existing distribution
      channels of a cotton outgrowing agribusiness, evaluates the impact of this distribution on
      smallholder cotton yields, and values the profitability implications for the outgrowing
      agribusiness.
    

Intervention name(s): Insecticide-treated net (BASF Incerceptor)
Intervention type(s): Device
Intervention description(s): One per farmer, once during the 2010-2011 season
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Pharmacokinetics Study in Patients With Impaired Hepatic Function
Condition: Patients With Impaired Hepatic Function
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare and evaluate the pharmacokinetics of ASP015K in
      patients with impaired hepatic function and subjects with normal hepatic function.
    


Intervention name(s): ASP015K
Intervention type(s): Drug
Intervention description(s): Oral
Intervention MeSH terms: Peficitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Impaired hepatic function; Pharmacokinetics; ASP015K
Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the chemoprophylactic activity and
      dose-exposure-response relationship of single oral dose of M5717 administered after direct
      intravenous inoculation (DVI) of Plasmodium falciparum sporozoite (PfSPZ) challenge in
      healthy participants.
    


Intervention name(s): M5717; PfSPZ Challenge; Placebo
Intervention type(s): Drug; Biological; Drug
Intervention description(s): Participants will receive single ascending oral dose of M5717 powder in capsule on Day 1 (early liver stage) or on Day 4 (late liver stage).; Participants will receive 3200 units of Plasmodium falciparum sporozoites by DVI.; Participants will receive placebo matched to M5717 on Day 1 (early liver stage) or on Day 4 (late liver stage).
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Healthy Participants; M5717; Malaria; Plasmodium falciparum
Long Term Follow up of Scars Formation and Quality of Life Assessment Study
Condition: Scars Formation; Quality of Life
Study type: Observational

Summary: 
      In previous study (MW2004-011-02), patients with burn wounds had their damaged skin removed
      by either standard of care treatment or by Debrase Gel Dressing (DGD), which is composed of
      enzymes that dissolve the damaged skin selectively (DGD removes only the damaged skin and not
      other parts of the skin).

      The burn wound, like any other wound, heals by the formation of scar at the injured site in
      order to replace the destroyed tissues. Scarring is not a static process, but rather a
      dynamic one, changing over time, especially during the first 24 months post-injury.

      Scars and patients' quality of life from two treatment arms (DGD and SOC) will be compared in
      order to evaluate the long term influence of damaged skin removal and wound care techniques
      on scar formation and maturation.
    


Intervention name(s): Scars assessment & QOL
Intervention type(s): Other
Intervention description(s): Scar assessment and quality of life questionnaires
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients that have previously participated in MW2004-011-02 study
      
Keywords: QOL
A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Condition: Homozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was a Phase III,A two-part (double-blind placebo-controlled/open-label)
      multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in subjects
      with homozygous familial hypercholesterolemia (HoFH).
    

Detailed description: 
      This study had two sequential parts:

        -  Part 1: 6-month double-blind period in which subjects were randomized to receive either
           inclisiran or placebo

        -  Part 2: 18-month open-label follow-up period; placebo-treated subjects from Part 1 were
           transitioned to inclisiran at Day 180 and all subjects who participated in an open-label
           follow-up period of inclisiran only
    

Intervention name(s): Inclisiran Sodium for injection; Placebo; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.; Sterile normal saline (0.9% sodium chloride in water for injection); Sterile normal saline (0.9% sodium chloride in water for injection)
Other intervention name(s): ALN-PCSSC; KJX839; ALN-PCSSC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HoFH
A Study to Characterise the Physiology of Weight Loss and Regain Under Dietary, Behavioural and Pharmacological Interventions in Healthy Obese Subjects
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 1

Summary: 
      Approximately 60 obese, but otherwise healthy, subjects will be assessed in this benchmark
      study to investigate the physiological changes associated with weight loss and regain. The
      aim is to estimate the changes in body composition during and after three interventions (i)
      calorie restricted diet + a marketed anti-obesity drug (sibutramine )(ii) calorie restricted
      diet + sibutramine placebo, and (iii) calorie restricted diet + moderate exercise. The
      interventions will last 12 weeks, after which there is a further 12 week observation period
      during which subjects will return to their normal lifestyle and are expected to regain
      weight. Additionally, a range of biomarkers may be evaluated to determine whether there are
      correlations at early and late time points with weight and fat loss and weight and fat
      regain. The changes in body composition and other biomarkers will be used to determine
      whether mathematical models can be built that predict the weight loss and regain of
      individual subjects. In addition, the usefulness of tools that may aid the physiological
      characterisation of weight loss/regain will be assessed, in particular methods for measuring
      energy expenditure and energy intake such as ambulatory activity meter, Sussex Ingestion
      Pattern Monitor ™ (SIPM), hunger-satiety VAS, indirect calorimetry and, if available, the
      Theranos in-home graphical user interface (GUI) portal. Knowledge of the body composition
      changes resulting from these typical weight loss interventions and predictive markers of
      response would facilitate the design of future studies for novel anti-obesity agents and
      allow earlier, more informed triaging of NCEs.
    


Intervention name(s): sibutramine; sibutramine placebo
Intervention type(s): Drug; Other
Intervention description(s): 10 mg, taken orally once per day for 12 weeks; taken orally once per day for 12 weeks
Intervention MeSH terms: Sibutramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis
Condition: Aphthous Stomatitis
MeSH terms: Stomatitis; Stomatitis, Aphthous
Study type: Interventional

Summary: 
      The aim of the study was to assess the safety, acceptability, and efficacy of product GV-328
      for the treatment of childhood oral aphthous lesion.
    

Detailed description: 
      Prospective study carried out in the Pediatric Dentistry Department of the International
      University of Catalonia. The sample was made up of children between 3 and 13 years old.
      Baseline pain status, functional limitation, edema and lesion diameter were evaluated. The
      treatment lasted 4 days. The parents recorded the intensity of the pain and the number of
      pills provided daily. Statistical significance was accepted with p≤0.05 and a 95% confidence
      interval.

      A total sample of 33 patients, 11 boys (33 %) and 22 girls (67 %) was obtained. The average
      age of the children was 7.8 years (SD: 1.41). Numerical variables referring to pain,
      inflammation and edema presented statistically significant improvements (p-value <0.05).
      Healing efficacy was demonstrated in 13 cases (39 %) and only 3 cases (9 %) reported poor
      taste acceptability.
    

Intervention name(s): GV-328
Intervention type(s): Drug
Intervention description(s): Patients with GV-328 treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aphthous lesion; hyaluronic acid
Acupuncture for Postoperative Nausea, Vomiting and Pain in Children: The Implication of Parental Attitudes
Condition: Postoperative Nausea and Vomiting; Postoperative Pain
MeSH terms: Pain, Postoperative; Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice.
      However, pharmaceutical prophylaxis is only partially effective and can imply unpleasant
      adverse effects. Accordingly, the use of non-pharmacological methods in preventing PONV is
      appropriate. Acupuncture is reported to reduce PONV and pain, and the adverse events are
      minimal.

      The objective of this multicentre, double-blinded, randomized, controlled trial is to
      investigate whether acupuncture can be a supplementary to the ordinary treatment in children
      undergoing tonsillectomy and/or adenoidectomy. In addition, the non-specific effect of
      parental attitudes and expectations on the outcomes will be explored.

      Two hundred and eighty patients will be included and randomized into two groups

        1. Treatment group: acupuncture treatment (approximately 15 to 20 minutes) during
           anaesthesia and standard treatment

        2. Control group: standard treatment

      The primary endpoints in the intervention study are nausea, retching, vomiting and pain
      during 24 hours postoperatively. The effect of acupuncture will be studied with regard to any
      association with possible factors of predisposition to PONV, as well as with other factors
      registered during the study. Adverse events from acupuncture will be registered.

      The objective of the self-report questionnaires is to

        -  investigate parental attitudes and expectations to the acupuncture treatment pre- and
           postoperatively

        -  compare data of the outcomes from the intervention trial with data from the
           questionnaires, in order to find any correlation between parental beliefs, attitudes and
           expectations, and the effect of the acupuncture treatment
    


Intervention name(s): Acupuncture
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Children; Postoperative nausea and vomiting; Postoperative pain; Parental attitudes; Parental expectations
First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NOX-H94
Condition: Anemia; Chronic Diseases; Inflammation
MeSH terms: Inflammation; Chronic Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first clinical trial with NOX-H94. The purpose of this clinical trial is to
      identify a safe and efficacious treatment regimen for the clinical development of NOX-H94 in
      patients with anemia of chronic disease (inflammation).
    

Detailed description: 
      NOX H94 is a pegylated Spiegelmer that specifically binds to human hepcidin, thereby
      antagonizing its role in hemostasis, and is therefore indicated for use in anemia of
      inflammation. Human hepcidin has emerged as the central regulatory molecule of systemic iron
      homeostasis. Hepcidin expression in hepatocytes is regulated by multiple, in particular
      opposing signals, including systemic iron availability, hepatic iron stores, erythropoietic
      activity, hypoxia, and inflammatory states. These different signals are integrated
      transcriptionally. In chronic inflammation, such as occurs in rheumatoid arthritis, chronic
      kidney disease or cancer, elevated hepcidin levels have been measured and may be a key factor
      leading to anemia in these patients.

      NOX-H94 is therefore indicated for treatment of patients with an anemia of inflammation,
      which is characterized by increased intracellular iron stores, increased serum ferritin
      concentrations and reduced sensitivity to treatment with erythropoiesis stimulating agents
      (ESAs), due to the limited availability of serum iron. Antagonism of hepcidin by NOX-H94
      therefore leads to elevated levels of iron and transferrin saturation in the peripheral blood
      and could supply iron for erythropoiesis thereby correcting the anemia.
    

Intervention name(s): NOX-H94; Glucose 5%
Intervention type(s): Drug; Other
Intervention description(s): Dosage form: NOX-H94 25 mg (oligonucleotide basis) Solution for Injection Strength: 14.6 mg NOX-H94 / mL Dose: 0.3 - 4.8 mg/kg single dose Route: IV infusion over 15 minutes / SC administration; Placebo
Other intervention name(s): lexaptepid pegol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: NOX-H94; Hepcidin; Anemia; Inflammation
Efficacy of a New Topical Anesthetic
Condition: Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A new topical anesthetic which contains 5% lidocaine and a disinfection ingredient has been
      developed and is tested in this study (LidoDyn).

      The study examines the efficacy of LidoDyn by comparing it with an already proven anesthetic
      agent (EMLA crème).
    


Intervention name(s): LidoDyn; EMLA creme
Intervention type(s): Drug; Drug
Intervention description(s): Application of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture; Application of 2 gram of EMLA creme to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: children
A Study of LY2828360 in Patients With Osteoarthritic Knee Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of
      LY2828360 in male and female subjects with osteoarthritic knee pain
    


Intervention name(s): LY2828360; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Intervention MeSH terms: CB2 receptor agonist LY2828360
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Osteoarthritis, knee pain, osteoarthritic knee pain