bioihbjkbjnl/mcl2 huggingface dataset:
Acupuncture for Inflammatory Pain and Central Sensitization - A Pilot Study
Condition: Pain; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Acupuncture is used extensively by patients worldwide for a variety of illnesses. While
      research is beginning to show effectiveness in clinical pain, the mechanisms underlying how
      these effects are evoked are poorly understood. Experimental models in healthy human
      volunteers can more closely control the variables of acupuncture needling and begin to
      separate out the relative contribution of specific components of needling and needle
      stimulation. By examining acupuncture's effects on experimental inflammatory models with
      well-characterized physiologic mechanisms, hypotheses can begin to be generated regarding how
      acupuncture produces its clinical effects. We propose to establish a model which could be
      used as a template to examine the individual components contributing to acupuncture's
      clinical effects on inflammation and pain. We hypothesize that acupuncture will have
      analgesic and anti-inflammatory effects on a ultraviolet B induced cutaneous lesion as well
      as a model of heat pain testing which activates central sensitization.

      Twenty healthy human volunteers will participate in a crossover study with active acupuncture
      and sham acupuncture interventions. They will be tested for their minimal erythemal dose
      (MED) to ultraviolet B exposure. An experimental lesion at 3x MED will be administered on the
      lower leg. Background information will be collected which could affect individuals'
      sensitivity to pain such as anxiety and depression, as well as their expectations regarding
      acupuncture treatment.

      The following day they will return for the first experimental day. A measurement with Laser
      Doppler will quantify the inflammation in the ultraviolet B lesion. Heat pain testing will be
      performed using a computer controlled thermode both on and off the ultraviolet B lesion.
      On-lesion testing will be for heat pain threshold. Off-lesion testing will examine temporal
      summation of heat pain.

      Next, a licensed acupuncturist will perform either true electroacupuncture or sham
      electroacupuncture in the region adjacent to the ultraviolet B lesion. Participants are
      blinded to the intervention, as is the examiner collecting data. Afterwards, Laser Doppler
      and heat pain testing will be repeated. The difference between pre-acupuncture and
      post-acupuncture measurements will represent the acupuncture -induced analgesic and
      anti-inflammatory effects.

      Participants will return for another ultraviolet B exposure adjacent to the first, and will
      receive whichever sham or true acupuncture intervention was not performed on the first study
      day.
    


Intervention name(s): Electroacupuncture
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
RAS Quantification in Patients With Aliskiren or Candesartan
Condition: Hypertension; Chronic Kidney Disease; Proteinuria
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria
Study type: Interventional
Phase: Phase 4

Summary: 
      Forced blockade of the renin-angiotensin-system (RAS) by using direct renin inhibition (DRI)
      has long been propagated to effectuate beneficial outcomes. However, recent large clinical
      trials have outlined harmful effects for DRI in combination with other forms of RAS blockade.
      To date, information regarding DRI as RAS-blocking monotherapy is very limited. Furthermore,
      it remains to be elucidated how DRI and angiotensin receptor blockers affect the so-called
      'classical' and 'alternative' RAS molecularly. As components of the 'alternative' RAS (e.g.
      Ang 1-7) have moved into research focus, it would be of importance to determine angiotensin
      regulation with medical RAS blockade.

      In this prospective, single-center randomized trial over 10 weeks, 24 patients with chronic
      kidney disease (CKD) stage III-IV (eGFR 15-59 ml/min) will be randomized to take either
      aliskiren (up to 300 mg per day) or candesartan (up to 16 mg per day) after a two week run-in
      phase where all RAS-blockers are eliminated. The investigators will then employ a novel mass
      spectrometry-based quantification method (after run-in and 10 weeks) to capture the
      concentrations of ten different angiotensin peptides (including angiotensin I and II,
      angiotensin 1-7 and angiotensin 1-5).

      The investigators hypothesize that significant differences exist between angiotensin levels
      in CKD patients with DRI compared to angiotensin receptor blockers. Specifically, the
      investigators expect to determine the regulation of the alternative RAS represented by
      angiotensin 1-7 with proximal versus distal blockade of the system.

      Our data might contribute to a more profound understanding of results from registries and
      clinical trials beyond the clinical effects of RAS blockade. Further, the study's results
      might help to individualize and optimize RAS-blocking therapy strategies in CKD patients.
    


Intervention name(s): RAS blockade discontinuation; Aliskiren; Candesartan
Intervention type(s): Other; Drug; Drug
Intervention description(s): In the initial two weeks of the study, all RAS blockade will be eliminated from the subjects' antihypertensive regimen
Other intervention name(s): Rasilez; Atacand
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: renin-angiotensin-system; RAS blockade
Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome
Condition: Childhood Obstructive Sleep Apnea Syndrome (OSAS)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research is to find out how a nasal spray (fluticasone furoate),
      sometimes given to children with obstructive sleep apnea syndrome (OSAS), works on certain
      cells within a child's adenoids. We hypothesize that intranasal steroids lead to an
      upregulation of T regulatory cells in the adenoid tissues of children with OSAS. This will
      result in a local reduction in inflammation and edema explaining the improvement in OSAS.
    

Detailed description: 
      The objective was to determine the effect of intranasal corticosteroid therapy on
      T-regulatory cells and other inflammatory cytokines in adenoid tissues in children with
      obstructive sleep apnea syndrome.Children were randomized to either no treatment or treatment
      with fluticasone furoate nasal spray, 55 μg/nostril daily, for 2 weeks before
      adenotonsillectomy. Adenoid tissue was obtained at the time of the procedure.
    

Intervention name(s): fluticasone furoate
Intervention type(s): Drug
Intervention description(s): treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy
Other intervention name(s): Veramyst
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Single-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Odanacatib (MK0822) in Healthy Volunteers
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib
      (MK0822) with and without food.
    


Intervention name(s): odanacatib; Comparator: odanacatib (Panel B); Comparator: odanacatib (Panel C); Comparator: odanacatib (Panel D)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): [Intervention Name: odanacatib (Panel A)] Panel A: Odanacatib tablets will be administered to male subjects in rising single doses of 2, 10, 50, 200, or 400 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.; Panel B: Odanacatib tablets will be administered to male subjects in rising single doses of 5, 25 (fasting), 100, 25 (fed), or 600 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period.; Panel C: Odanacatib tablets will be administered to female subjects in rising single doses of 50 or 100 mg over 2 treatment periods. Half of the subjects will receive placebo to odanacatib in one of the 2 treatment periods. There will be at least 7 days between each treatment period.; Panel D: Odanacatib tablets or placebo to odancatib will be administered to male subjects in rising single doses of 100, 200, or 300 mg following a high-fat breakfast over 3 treatment periods. Three of twelve subjects will receive placebo to odanacatib in all 3 treatment periods. There will be at least 10 days between each treatment period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects Multi-Gravitational Suspension-Based Therapy
Condition: Exercise
Study type: Interventional

Summary: 
      Background: Multi-gravitational suspension-based therapy (M-Gravity) is a comprehensive
      discipline based on the principles of non-gravity, which serves to increase the quality of
      life and holistic health of the individual with the rehabilitation content of non-pressure
      inversion therapy.

      Aims: To examine the effects of M-Gravity exercise on posture, physical fitness, quality of
      life, depression, and sleep quality in women without regular exercise habits.

      Methods: This study was designed as a non-randomized controlled trial. This study included 20
      women without regular exercise habits, who participated in the exercise with M-Gravity and 20
      women who did not participate in any exercise program, a total of 40 participants. In this
      study, the investigators planned to evaluate the effects of M-Gravity on women without
      regular exercise habits. The following outcomes were measured: posture with the New York
      Posture Assessment Method, the flexibility of the hamstring and pectoral muscles, time is
      taken to stay in the plank position, depression levels with the Beck Depression Inventory
      scale, sleep quality is performed with the Pittsburgh Sleep Quality Index, and the Nottingham
      Health Profile (NHP) questionnaire to measure the perceived health levels of the subjects.
      The measurement of the contraction force of the deep lumbar muscles is performed with the
      Stabilizer Pressure Biofeedback (Chattanooga Stabilizer). Two evaluations were made before
      and after 4 weeks of exercise.
    


Intervention name(s): Multi-gravitational suspension-based therapy (M-Gravity)
Intervention type(s): Other
Intervention description(s): Multi-gravitational suspension-based therapy (M-Gravity) is a comprehensive discipline based on the principles of non-gravity, which serves to increase the quality of life and holistic health of the individual with the rehabilitation content of non-pressure inversion therapy.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: woman; exercise; posture; physical fitness; quality of life
Does Block Play Improve Language Acquisition: A Randomized Trial
Condition: Healthy
Study type: Interventional

Summary: 
      This is a randomized controlled trial of distributing blocks to children ages 1.5 -2.5 years
      of age to see if language acquisition improves.
    

Detailed description: 
      Children in age group are randomized to get two sets of blocks or not. Outcomes include
      language development assessed using the Macarthur Bates CDI 6 months after enrollment.
    

Intervention name(s): Building Blocks
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
A Nasal Applicator for the Treatment of Trigeminal Neuralgia
Condition: Trigeminal Neuralgia
MeSH terms: Trigeminal Neuralgia; Neuralgia
Study type: Interventional

Summary: 
      The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily
      function and reduces quality of life. The sphenopalatine ganglion, located in the posterior
      part of the middle nasal turbinate, is involved in the pain associated to TN, by blocking the
      sphenopalatine ganglion relieves patients from the symptoms. However, methods currently in
      use to accomplish this are either cumbersome for the patient or invasive regarding the
      puncture of structures.

      The purpose of this study is to evaluate the efficacy of Tx360™, a new nasal applicator
      device, in the treatment of TN. A local anesthetic will be delivered on the ganglion area. We
      are expecting that this new device will provide at least the same pain relief as the
      previously described approaches. However, this nasal applicator is intended to be an easy and
      non invasive method for office use.
    

Detailed description: 
      The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily
      function and reduces quality of life. Pain severity correlates with reduced measures of daily
      functioning, and overall health status.

      The sphenopalatine ganglion, located in the posterior part of the middle nasal turbinate, is
      involved in the pain associated to TN, by blocking the sphenopalatine ganglion relieves
      patients from the symptoms. However, methods currently in use to accomplish this are either
      cumbersome for the patient or invasive regarding the puncture of structures.

      The purpose of this study is to evaluate the efficacy of Tx360™, a new nasal applicator
      device, in the treatment of TN. The Tx360™ is a single use nasal applicator that can reach
      the sphenopalatine ganglion area. It is designed to dispense medications through a flexible
      canula.

      The patients with TN will receive a 0.5 mL spray of local anesthetic on the ganglion area,
      and measure the change in pain intensity and quality of life.

      We are expecting that this new device will provide at least the same pain relief as the
      previously described approaches. However, this nasal applicator is intended to be an easy and
      non invasive method for office use.
    

Intervention name(s): Nasal ganglion block for TN
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pharmacokinetic Study to Compare Sustained Release and Standard Paracetamol Formulations.
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This proof of principle study will evaluate an experimental formulation of paracetamol that
      is being developed for eventual long lasting use. This study is also used for drug safety
      evaluation.
    


Intervention name(s): Paracetamol 500 mg; Paracetamol 1000 mg; Paracetamol 750 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Standard Paracetamol formulation; Paracetamol Sustained Release formulation; Paracetamol Sustained Release formulation
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)
Condition: Diabetes Mellitus, Type 2; Renal Insufficiency
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical trial is designed to provide additional information on the safety and
      tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in
      patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular
      filtration rate (GFR) < 30 mL/min) for a period of 52 weeks.
    


Intervention name(s): vildagliptin; sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): 50mg qd; 25mg qd
Intervention MeSH terms: Sitagliptin Phosphate; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes; vildagliptin
Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl
      estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory
      markers, vascular markers and bone development in overweight adolescent females with
      polycystic ovary syndrome (PCOS).
    

Detailed description: 
      The purpose of this study is to:

      1) to compare effects of treatment with drospirenone/ethinyl estradiol (Yasmin)versus
      rosiglitazone (Avandia) on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal
      hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover.

      OCPs are the first-line therapy for PCOS, however, they do not address the insulin resistance
      or the inflammation. Insulin sensitizers have been used successfully to treat PCOS but
      thiazolidinediones such as rosiglitazone have not been used in adolescents. Therefore we will
      investigate the effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone
      in overweight adolescents with PCOS. We will obtain comprehensive evaluations before and 6
      months after randomization, to the respective treatment arms to determine the differences
      between the 2 treatment modalities.
    

Intervention name(s): rosiglitazone; drospirenone/ethinyl estradiol
Intervention type(s): Drug; Drug
Intervention description(s): 4 mg daily for 6 months; 1 tab (3mg/30mcg) daily for 6 months
Other intervention name(s): Avandia; Yasmin
Intervention MeSH terms: Rosiglitazone; Drospirenone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of the Nutritional Product PTM202 on Acute and Long-Term Recovery From Childhood Diarrheal Disease
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      This trial will assess the impact of the nutritional product PTM202 on childhood diarrhea in
      Guatemalan children. The product is based on cow-milk colostrum and egg. The trial will
      enroll children between the ages of 6 months and 3 years and will assess the impact of the
      study nutrition product on the duration and severity of diarrhea and on weight recovery in
      the 4 weeks following the diarrheal episode. The investigators will be determining the
      etiology of the diarrhea episode to ascertain if the nutritional product works better for
      certain etiologies or has a non-specific benefit.
    

Detailed description: 
      This is a double-blind, randomized control trial of the nutritional product PTM202, which is
      a food product based on cow milk colostrum and eggs from hens that have been immunized
      against human diarrheal pathogens. Children between the ages of 6 months and 3 years will be
      enrolled at two sites in Guatemala who present with acute diarrhea. The study will have two
      strata according to the severity of the diarrhea.

      The study product will be administered over 3 days, and the investigators will assess the
      impact on diarrhea duration and severity, and then follow subjects for 4 weeks to assess the
      impact of the nutritional product on weight gain following the episode, because poor weight
      gain is a major health problem in low-income countries. The investigators will also monitor
      for any adverse events during the trial.

      The duration of participation will be 31 days for all subjects.

      A stool sample will be collected at enrollment to ascertain the etiology of the diarrhea. A
      second sample will be collected at the end of the study to assess changes in pathogens.
    

Intervention name(s): PTM202; Enfamil Puramino
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Administration of study nutritional product once per day for 3 days starting immediately after enrollment; Administration of 30 ml of Enfamil Puramino as placebo once per day for 3 days starting immediately after enrollment
Other intervention name(s): Conforta123
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: colostrum; Immunoglobulin Y (IgY)