bioihbjkbjnl/mcl2 huggingface dataset:
The Safety and Efficacy Evaluation of Hair Products Containing Probiotics
Condition: Skin Problems
Study type: Interventional
Phase: Phase 2

Summary: 
      Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many
      years, including prevention of skin diseases and improvement of skin conditions. In this
      clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus
      paracasei shampoo on scalp and hair healthcare.
    

Detailed description: 
      To evaluate the safety and efficacy of hair products containing probiotics
    

Intervention name(s): Test group Probiotic Shampoo; Placebo group
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Probiotic Shampoo; Shampoo base
Other intervention name(s): Probiotic Group; Control Group
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Hair health; Scalp health; Probiotics; Scalp microbiota
Investigation of Vascular Relaxing Effects of the Antidiabetic Rosiglitazone.
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The study is designed to test the hypothesis in healthy subjects that the oral antidiabetic
      drug rosiglitazone provides additional vascular relaxing or modulating effects in addition to
      its blood glucose level reducing ability.
    

Detailed description: 
      The aim of the study is to investigate the effect of oral rosiglitazone therapy on the
      vascular responsiveness of different vasoactive compounds (angiotensin II, insulin, histamine
      and glyceroltrinitrate) in healthy subjects. Rosiglitazone will be given orally (4 weeks
      4mg/d, titrated to 8 mg/d for another 4 weeks) as treatment. Every subject will receive
      intravenous stimulation with angiotensin II, histamine, insulin and glyceroltrinitrate before
      and after an 8 weeks treatment interval with rosiglitazone.
    

Intervention name(s): rosiglitazone (drug)
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: vascular reactivity, venodilation
OBE001 Phase 2 Dose-finding Study Versus Placebo in Women Undergoing Embryo Transfer in the Context of IVF-ICSI
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the increase in clinical pregnancy rate
      after administration of a range of single oral doses of OBE001, an oral oxytocin antagonist,
      compared to placebo.
    

Detailed description: 
      The study is a prospective, dose-finding, randomised, parallel group, double-blind,
      placebo-controlled study investigating the efficacy and the safety of the oxytocin receptor
      antagonist OBE001 in 240 women undergoing embryo transfer following IVF or ICSI.

      The four-arm study (OBE001 dose 1, dose 2, dose 3, and placebo) design will allow evaluation
      of a possible dose-dependent pattern of action of OBE001 and, simultaneously, comparison of
      active compound with placebo with regard to both efficacy and safety.
    

Intervention name(s): OBE001 dose 1; OBE001 dose 2; OBE001 dose 3; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): OBE001 dispersible tablets for single oral administration; OBE001 dispersible tablets for single oral administration; OBE001 dispersible tablets for single oral administration; Placebo dispersible tablets for single oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IVF; ICSI
Effectiveness and Safety of Intense Pulsed Light in Patients With Meibomian Gland Dysfunction
Condition: Meibomian Gland Dysfunction (Disorder); Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Meibomian Gland Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      Meibomian gland dysfunction (MGD) is one of the most common causes of dry eye diseases. Over
      the past decade, several treatment options in MGD have been extensively studied including
      warm compression, lid hygiene, ocular lubricants, forceful expression, LipiFlow thermal
      pulsation system, intraductal probing, debridement scaling and intense pulsed light (IPL).
      IPL is a broad spectrum, non-coherent and polychromatic light source with a wavelength
      spectrum of 500-1200 nm. It can be filtered to allow only a range of wavelengths to be
      emitted. Different wavelength makes different depth of tissue to absorb a specific light
      energy. Intense pulsed light (IPL) has been widely used in dermatology as a therapeutic tool
      for removal of hypertrichosis, benign cavernous hemangioma, benign venous malformations,
      telangiectasia, port-wine stain and pigmented lesions. Concurrent ocular surface improvements
      have been observed in patients undergone IPL treatment. Very few prospective clinical trials
      showed that subjective dry eye symptoms decreased and some of the dry eye signs also
      improved. Nonetheless, there is still inconsistency in the efficacy of IPL among these
      studies. Biomarkers, specifically cytokines, in dry eye diseases have been studied to some
      extent. Moreover, the change in ocular surface inflammatory cytokines in patients with MGD
      after IPL treatment is unclear.

      The investigators proposed a prospective randomized double-masked sham-controlled clinical
      trial to investigate the efficacy and safety of intense pulse light in MGD patients.
    


Intervention name(s): Intense Pulsed Light; Standard treatment
Intervention type(s): Device; Combination Product
Intervention description(s): E> Eye (E-SWIN, Paris, France) IPL machine; warm compression, lid scrub and non-preservative ocular lubricants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intense pulsed light; Meibomian gland dysfunction; Dry eye; cytokines
A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
Condition: Ulcerative Colitis (UC); Crohn's Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and
      bleeding from the lining of the rectum and colon (large intestine).Crohn's disease (CD) is a
      long-lasting condition causing inflammation that can affect any part of the gut. CD may cause
      tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever.
      This study will evaluate the effect of repeated infusions of risankizumab on the
      pharmacokinetics of sensitive probe substrates of Cytochrome P450 (CYP) enzymes in
      participants with moderately to severely active UC or CD.

      Risankizumab is an investigational drug being developed to treat trial participants with
      inflammatory diseases such as UC and CD. The study is split into two periods. In Period 1,
      participants will receive single oral doses of CYP sensitive probes and in Period 2,
      participants will receive risankizumab followed by single oral doses of CYP sensitive probes.
      Around 20 adult participants with moderately to severely active CD or UC will be enrolled in
      the study across multiple sites worldwide.

      In Period 1, participants will receive oral doses of CYP sensitive probes on Day 1. In Period
      2, participants will receive risankizumab by intravenous (IV) infusion on Days 1, 29 and 57
      followed by oral CYP sensitive probes on Day 64.

      There may be higher treatment burden for participants in this trial compared to their
      standard of care. Participants will attend regular visits during the course of the study at a
      hospital or clinic. The effect of the treatment will be checked by medical assessments, blood
      tests and checking for side effects.
    


Intervention name(s): Risankizumab; Cytochrome P450 (CYP) Substrates
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) infusion; Tablet: Oral; CYP Substrates: midazolam, caffeine, warfarin, vitamin K, omeprazole and metoprolol
Other intervention name(s): SKYRIZI; ABBV-066
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulcerative Colitis (UC); Crohn's Disease; Risankizumab; SKYRIZI; ABBV-066; Cytochrome P450
Effect of PF-06651600 on the Pharmacokinetics of Oral Contraceptive Steroids
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, 2 way crossover, open-label study of the effect of
      multiple-dose PF 06651600 on single-dose oral contraceptive (OC) pharmacokinetics (PK) in
      healthy female subjects. Subjects will be randomized to 1 of 2 treatment sequences. A total
      of 28 healthy female subjects (14 in each treatment sequence) will be enrolled in the study.
      Each treatment sequence will consist of 2 periods.
    


Intervention name(s): PF-06651600; Ethinyl estradiol (EE) and levonorgestrel(LN)
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg by mouth (PO) once daily (QD); Oral tablet containing 30 ug EE and 150 ug of LN
Other intervention name(s): Oral contraceptives
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Contraceptive Agents; Contraceptives, Oral; Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Human Intervention Study With Calcium Phosphate and Vitamin D
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The study was conducted to investigate the effect of vitamin d3 alone and in combination with
      calcium phosphate on bone metabolism and further physiological parameters in healthy
      subjects. It is postulated that calcium phosphate beneficially influences the bone specific
      action of vitamin d3.
    


Intervention name(s): calcium phosphate; vitamin d; calcium phosphate and vitamin d; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d]; 20 subjects consume for 8 weeks a bread with vitamin d3 [10µg/d]; 20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d] and vitamin d3 (10µg/d]; All participants consume two weeks before intervention a bread without calcium an vitamin d.
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: calcium phosphate; vitamin d3; bone metabolism; human study
Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis
Condition: TTR-mediated Amyloidosis
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a multiple dose, dose escalation study designed to determine the safety,
      tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants
      with transthyretin (TTR) mediated amyloidosis (ATTR).
    


Intervention name(s): Patisiran
Intervention type(s): Drug
Intervention description(s): Participants received a single dose of patisiran as an intravenous (IV) infusion on Day 0 and Day 28 (Q4W). Optional cohorts received an alternative dosing regimen (once every 3 weeks [Q3W]: Day 0 and Day 21) and an alternative premedication regimen.
Other intervention name(s): ALN-TTR02
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RNAi therapeutic
A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and
      preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to
      moderate AD.
    


Intervention name(s): Gantenerumab; Gantenerumab; Gantenerumab; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 75 mg subcutaneous doses every 4 weeks for 24 weeks; 105 mg subcutaneous doses every 4 weeks for 24 weeks; 225 mg subcutaneous doses every 4 weeks for 24 weeks; subcutaneous doses every 4 weeks for 24 weeks
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluating Technology-Based Fall Prevention Interventions
Condition: Falls (Accidents) in Old Age
Study type: Interventional

Summary: 
      Approximately one in three older adults fall annually and it is the primary cause of
      traumatic injury in older adults. While exercise and balance programs have been shown to be
      effective in reducing fall risk, maintaining behavior change is known to be difficult. Thus
      additional interventions need to be validated to add to our current armamentarium to reduce
      falls in older adults. Cognitive training (CT) involves exercises that target specific
      cognitive tasks, such as memory or processing speed. It has been speculated that routinely
      performing such tasks may increase functional ability. Recent work has pointed to an
      increased risk of falls in community-dwelling older adults who have alterations in specific
      cognitive tasks. Thus the purpose of the proposed study is to demonstrate the feasibility and
      to explore the effectiveness of a 16 week CT intervention to reduce risk and incidence of
      fall and improve outcomes up to 1 month post-intervention in a group of community dwelling
      older adults at risk for fall.
    


Intervention name(s): Cognitive Training; Technology-based Education
Intervention type(s): Other; Other
Intervention description(s): Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.; Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Oncolytic Adenovirus, DNX-2401, for Naive Diffuse Intrinsic Pontine Gliomas
Condition: Brainstem Glioma; Neoadjuvant Therapy
MeSH terms: Glioma; Diffuse Intrinsic Pontine Glioma
Study type: Interventional
Phase: Phase 1

Summary: 
      Oncolytic adenovirus for pediatric naive DIPG, to be infused after tumor biopsy through the
      same trajectory in the cerebellar peduncle.
    

Detailed description: 
      Diffuse pontine gliomas (DIPG) are one of the most lethal pediatric tumors. All treatment
      approaches for these tumors have failed, leaving a terrible prospect with median survival
      under one year, and survival at 5 years virtually of zero. Moreover, most of the long term
      survivors suffer from long-term side effects of the aggressive treatment. Thus, new
      therapeutic strategies are required that allow not only for more effective treatments of
      these tumors but also that defer the severe side effects derived from the current therapeutic
      choices. DNX-2401 is an oncolytic virus engineered to replicate specifically in tumor cells
      with an abnormal retinoblastoma (RB) pathway. Moreover, this virus infects cells through
      integrins, which are more abundant in glioma cells. Here we propose a phase I, unicentric,
      non-randomized clinical trial to study the safety and potential efficacy of intratumoral
      administration of DNX-2401 in DIPG. The virus administration will be done after stereotactic
      tumor biopsy, using the same trajectory, after verification of catheter position with
      intraoperative MRI. After 3-4 weeks patients will receive standard radiotherapy and/or
      chemotherapy. The primary objective is to confirm the safety of the target dose known from
      adults trials. Secondary endpoints are overall survival at 12 months (OS12), percentage of
      responses and induced immune response against tumor. The follow up includes close monitoring
      of neurological status, blood tests and brain MRI. If this trial shows evidence of safety and
      efficacy will propel a multicenter clinical trial.
    

Intervention name(s): DNX-2401
Intervention type(s): Biological
Intervention description(s): Brain infusion of the virus through the cerebellar peduncle
Other intervention name(s): Delta-24
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diffuse intrinsic pontine gliomas; Oncolytic adenovirus
To Assess the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Which is the Treatment of COVID-19 in Healthy Volunteers.
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I study is a double-blind, randomized, placebo-controlled study designed to assess
      the safety, tolerability and PK profile of single intramuscular doses of DWRX2003 in healthy
      volunteers.
    


Intervention name(s): DWRX2003, 96mg; DWRX2003, 432mg; DWRX2003, 144mg; DWRX2003, 144mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Drug: Placebo Intramuscularly injection at predefined injection sites; Drug: Placebo Intramuscularly injection at predefined injection sites; Drug: Placebo Intramuscularly injection at predefined injection sites; Drug: Placebo Intramuscularly injection at predefined injection sites
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Anti-Schistosomiasis Vaccine: Sm14 Phase 2b-Sn in School Children
Condition: Schistosomiasis
MeSH terms: Schistosomiasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The clinical trial phase 2b is designed to assess the safety and the specific immune response
      of the active ingredient (protein + adjuvant) in healthy and then in infected school children
      from 8 to 11 years of age with intestinal and/or urinary schistosomiasis, living in the
      Valley of the Senegal River, a highly endemic area for schistosomiasis.
    

Detailed description: 
      A phase 2b trial, self-contained, open-label, controlled, randomized study in three parallel
      arms, two of them formed by groups of healthy or infected school children, both receiving
      three (3) injections at D0, W4 (Week 4), W8; both groups receiving 50 μg Sm14 vaccine
      candidate solution, combined with 2.5μg GLA-SE. The third group is composed by non-vaccinated
      infected school children.

      Sm14: recombinant protein produced in yeast following Good Manufacturing Practices (GMP)
      conditions, presented in vials containing 0.55 ml solution Sm14, 0.4 ml solution is diluted
      with 0.4 ml of GLA (Synthetic Glucopyranosyl lipid A) for intramuscular administration.

      Medical examinations are performed at D0 (before injection, 1 hr and 4 hr after), and a
      safety evaluation at 24 hrs and 48 hrs, after each injection.

      Blood analysis: Liver function tests - renal function tests - blood counts, at W-1 before
      inclusion, and at W9 and W21 during the follow-up.

      Blood samples for immune response analysis at D0, W12 and W21.
    

Intervention name(s): Sm14; GLA-SE solution
Intervention type(s): Biological; Drug
Intervention description(s): Three 0.5 mL intra-muscular injections of the vaccine solution (50μg Sm14) will be administered on D0, W4, W8 (D = day, W = week).; The lot concentration 10μg/mL for injection of 2.5μg GLA-SE/injection.
Other intervention name(s): rSm14; • Glucopyranosyl Lipid A in Stable Emulsion; • Glucopyranosyl Lipid Adjuvant-Stable Emulsion; • Toll-like Receptor 4 Agonist GLA-SE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Schistosomiasis; Recombinant vaccine; rSm14; GLA-SE; Fatty acid-binding protein (FABP); Phase II Clinical Trial; Senegal
Effects of Dry Needling on Spinal Mobility and Trigger Points in Patients With Fibromyalgia Syndrome.
Condition: Fibromyalgia; Back Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This study evaluates the effect of Dry Needling on Spinal Mobility and Trigger Points in
      Patients with Fibromyalgia Syndrome.
    

Detailed description: 
      Dry Needling is a skilled intervention that uses a thin filiform needle to penetrate the skin
      and stimulate underlying myofascial trigger points, muscular, and connective tissues for the
      management of neuromusculoskeletal pain and movement impairments. Dry needling (DN) is a
      technique used to treat dysfunctions in skeletal muscle, fascia, and connective tissue, and,
      diminish persistent peripheral nociceptive input, and reduce or restore impairments of body
      structure and function leading to improved activity and participation.
    

Intervention name(s): Dry Needling; Cross Tape Therapy
Intervention type(s): Device; Other
Intervention description(s): Dry needling is the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, sometimes also known as intramuscular stimulation (IMS). Although dry needling originally utilized only hypodermic needles due to the concern that solid filiform needles had neither the strength or tactile feedback that hypodermic needles provided and that the solid filiform needle could be deflected by "dense contraction knots".; The tape consists of cross bands or strips mesh cross, nonelastic and without any medication, forming a grid-shaped patch. The cross tape will be applied on trigger points.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Paraspinal Muscles; Trigger Points; Randomized Controlled Trial; Mobility Limitation
Long Term Metabolic Safety of Norditropin® Treatment of Small for Gestational Age (SGA) Subjects
Condition: Foetal Growth Problem; Small for Gestational Age
Study type: Observational

Summary: 
      The study is conducted in Europe. The primary aim of this observational study is to compare
      the insulin sensitivity in small for gestational age (SGA) subjects treated with Norditropin®
      with untreated small for gestational age (SGA) subjects and with average for gestational age
      (AGA) subjects.
    


Intervention name(s): somatropin; No treatment given; No treatment given
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SGA previously treated with Norditropin®; Untreated SGA; AGA (Average gestational age)
Other intervention name(s): GHLIQUID
Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        GH treated SGA and controls of non-treated SGA and AGA
      
Biospecimen description: 
      Blood samples