bioihbjkbjnl/mcl2 huggingface dataset:
Effect of SPGB on ICP and Oxygenation of Cerebral Venous Outflow in Craniotomy for Cerebral Tumors.
Condition: Cerebral Tumor
Study type: Interventional

Summary: 
      This study aims to investigate the effect of Sphenopalatine Ganglion Block on ICP and
      arterio- jugular venous oxygen difference (AJVDO2) and jugular bulb oxygen saturation
      (SjVO2). Throughout this study, the efficacy of Sphenopalatine Ganglion Block as scalp block
      in craniotomy operation will be assessed, and the effect of SPGB on cerebral hemostasis
      during craniotomy will be evaluated by monitoring of both ICP, AJVDO2 and SjVO2.
    

Detailed description: 
      This study was performed in the Neurosurgical operating room and included 52 patients
      allocated into two groups: the treatment group (block group) and the control group (non-block
      group). 26 patients enrolled in block group and 26 patients in non-block group.

      Intraoperative ICP monitoring by subdural ICP monitors will be done every 20 minutes in both
      block and non- block groups until craniotomy has been occurred, then at the time of closure
      of the dura . Arterio- jugular venous oxygen difference and Jugular venous bulb oxygen
      saturation changes will be recorded every 20 minutes in block and non- block groups
      throughout time of the surgery till closure of the dura.
    

Intervention name(s): SPGB
Intervention type(s): Procedure
Intervention description(s): Sphenopalatine Ganglion Block using 2% lidocaine in block group. Sphenopalatine Ganglion Block is performed by a hollow culture swab that is connected with a 21-gauge a syringe filled with three ml 2% lidocaine, inserted parallel to the floor of the nose until resistance is felt. The swab is at the posterior pharyngeal wall superior to the middle turbinate. The applicator was kept in the nostril for five to ten mins. The same procedure is done also in the second nostril SPGB using normal saline is performed in the control group
Other intervention name(s): Sphenopalatine ganglion block
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be performed in the Neurosurgical operating room and included 52 patients allocated into two groups: the treatment group (block group) and the control group (non-block group). 26 patients enrolled in block group and 26 patients in non-block group.
Intraoperative ICP monitoring by subdural ICP monitors will be done every 20 minutes in both block and non- block group.
Jugular venous bulb oxygen saturation changes will be recorded every 20 minutes in block and non- block.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SPGB; ICP; CBF; AVDO2
Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)
Condition: Vulvovaginitis; Yeast Infection; Yeast Infection Vaginal; Candidiasis, Vulvovaginal
MeSH terms: Infections; Communicable Diseases; Candidiasis; Candidiasis, Vulvovaginal; Mycoses; Vulvovaginitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy
      of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the
      treatment of moderate to severe VVC.
    

Detailed description: 
      This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy
      of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the
      treatment of moderate to severe VVC.

      Approximately 75 women with moderate to severe VVC will be randomized to 1 of 3 treatment
      groups (200 mg CAMB, 400 mg CAMB, or fluconazole) to achieve approximately 25 subjects in
      each group. The primary objective of this study is to evaluate the safety of 200 mg and 400
      mg doses of oral CAMB for 5 days compared with a single 150 mg dose of oral fluconazole in
      subjects with moderate to severe VVC. The secondary efficacy objectives of this study
      included the clinical cure rate, mycology eradication and responder outcome. Tertiary
      objectives include pharmacokinetics.
    

Intervention name(s): Oral Encochleated Amphotericin B (CAMB); Fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): lipid-crystal nano-particle formulation amphotericin B
Other intervention name(s): MAT2203
Intervention MeSH terms: Fluconazole; Amphotericin B; Liposomal amphotericin B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain (LBP) is one of the most common reasons for seeking medical care and accounts
      for over 3.7 million physician visits/year in the U.S. alone. Ninety percent of adults will
      experience low back pain in their lifetime, 50% will experience recurrent LBP, and 10% will
      develop chronic pain and related disability.

      While there is growing evidence for the clinical effectiveness of alternative and
      complementary therapies to treat low back pain, little is known on the physiologic
      consequences and effects of these treatments. Further, additional data is needed to
      understand how these different treatment techniques effect clinical changes in pain and
      disability. The lack of empirical data hinders acceptance by the wider scientific and
      health-care communities, and it also limits the development of rational strategies for using
      alternative and complementary therapies.
    


Intervention name(s): Manipulation; Mobilization; Laser Therapy
Intervention type(s): Other; Other; Other
Intervention description(s): High velocity short amplitude thrust spinal manipulation applied to the lumbar spine.; Static isometric contractions of the lumbar spine to induce spinal mobilization; Cold laser applied to the paravertebral muscles in the lumbar region
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: low back pain; manipulation; laser therapy; osteopathic; chiropractic; mobilization; muscle energy; physical therapy; muscle; spine; adjustment; rehabilitation
Effects of Different Percentages Body Weight Supported Treadmill Training on Gait, Balance, Quality of Life and Fatigue in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Fatigue; Body Weight
Study type: Interventional

Summary: 
      Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for
      neurologically impaired subjects such as Parkinson's disease (PD). The aim of the study is to
      evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life
      and fatigue in moderate to advanced PD.
    

Detailed description: 
      Body weight supported treadmill training (BWSTT) is an important rehabilitative choice for
      neurologically impaired subjects such as Parkinson's disease (PD). The aim of the study is to
      evaluate the effectiveness of different percentages BWSTT on gait, balance, quality of life
      and fatigue in moderate to advanced PD. Thirty five patients were randomly assigned to one of
      the three groups according to the percentage unweighed: 0% BWSTT, 10% BWSTT and 20% BWSTT.
      All patients participated 30 minutes BWSTT sessions 5 days a week, for 6 weeks. Primary
      outcomes were 6 minute walk test (6MWT), Berg balance scale (BBS), Unified Parkinson's
      Disease Rating Scale (UPDRS); and secondary outcomes were Nottingham health profile (NHP),
      Fatigue Impact Scale (FIS) and Fatigue Severity Scale (FSS) which were performed at the
      beginning and end of the rehabilitation.
    

Intervention name(s): 0% unweighed BWSTT; 10% unweighed BWSTT; 20% unweighed BWSTT
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
After CRP, participants were provided 30 minutes 0% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).; 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
After CRP, participants were provided 30 minutes 10% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).; 30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
After CRP, participants were provided 30 minutes 20% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease; gait; balance; treadmill training; fatigue
Glycemic Response to an Innovative Cookie to Promote Human Health
Condition: Postprandial Glycemic Responses
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether using a coarse wheat fraction in wire-cut
      cookie making induces a lower glycemic response in healthy subjects compared to wheat flour.
    

Detailed description: 
      This study has a double-blind, randomized, cross-over design. During each of the two study
      visits, healthy participants will consume a standard portion of cookies. One cookie
      formulation will present a large amount of coarse wheat fraction, while the other formulation
      will include only wheat flour and will serve as a control. Blood glucose measurements will be
      taken postprandially at regular time points. Gastric emptying rate and oral processing
      behavior will be also object of study.
    

Intervention name(s): Wire-cut cookie
Intervention type(s): Dietary Supplement
Intervention description(s): Investigation of the impact of wheat particle size on the postprandial glycemic response, gastric emptying and oral processing behavior after consumption of wire-cut cookies.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: postprandial glycemic responses; gastric emptying rate; oral processing behavior
The Influence of 5-Aminosalicylates on Thiopurine Metabolite Levels
Condition: Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the influence of different 5-aminosalicylate
      concentrations on the metabolism of azathioprine or 6-mercaptopurine in patients with
      inflammatory bowel disease.
    

Detailed description: 
      Background:

      The concomitant use of 5-aminosalicylates (5ASA) next to azathioprine (AZA) or
      6-mercaptopurine (6MP) in the treatment of inflammatory bowel disease (IBD) may lead to an
      increased effectiveness of therapy as higher levels of the active metabolite of AZA/6MP
      (6-thioguaninenucleotides (6TGNs) are measured.

      Objectives:

      To determine the influence of 5-ASA compounds and its metabolites on the metabolites of
      AZA/6MP (6TGNs + 6-methylmercaptopurine (6MMP).

      Methods:

      Patients with quiescent disease under AZA/6MP therapy are eligible. Patients will receive
      three succeeding regimes (5ASA 2 gram/5ASA 4 gram/ no 5ASA) of 4 weeks next to the standard
      AZA/6MP therapy. At the start and at the end of every regime 5ASA and its major metabolite
      (N-acetyl-5ASA) will be determined in serum next to the measurement of 6TGNs and 6MMP in
      erythrocytes. The safety will monitored by standard laboratory parameters every four weeks.

      Population:

      Patients with IBD in remission and unchanged AZA/6MP dosages for at least 4 weeks.

      Medication:

      5ASA (Pentasa ® granules; Ferring) will be administered orally in dosages of 2 or 4 grams
      daily for a period of 4 weeks.

      Endpoints:

      The rise or decrease in 6TGNs and 6MMP during the different 5ASA regimes. The evaluation of
      the safety of co-administrating 5ASA next to AZA/6MP.

      Risks:

      Side effects of 5ASA use are limited and well known. Some case reports have described the
      potential risk of developing a myelodepression when AZA/6MP and 5ASA are given together due
      to the rise in 6TGNs. However, in daily practice both drugs are administered together
      frequently. The risks of the frequent blood draws are minimal and usually self-limiting
      (haematoma).
    

Intervention name(s): 5-aminosalicylate (Pentasa, Ferring)
Intervention type(s): Drug
Intervention MeSH terms: Mesalamine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Crohn's disease; Ulcerative colitis; Inflammatory bowel disease; azathioprine; 6-mercaptopurine; 5-aminosalicylate; metabolism
The Effect of Yoga and Stabilization Exercises in Individuals With Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Although exercise has been shown to be effective in low back pain in the literature, there is
      no conclusion about which exercise is superior to the other. Although there are studies
      showing positive effects of spinal stabilization exercises and yoga approach on pain level,
      disability level and quality of life in patients with chronic low back pain, studies
      evaluating the effectiveness in many other aspects are insufficient. Therefore, this study
      aimed to investigate the effects of spinal stabilization and yoga exercises on pain,
      functional status, metabolic capacity, kinesophobia and sleep quality in patients with
      chronic low back pain.
    


Intervention name(s): Yoga; Spinal Stabilization Exercise
Intervention type(s): Other; Other
Intervention description(s): Yoga; Spinal Stabilization Exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal stabilization exercise; yoga; low back pain
Study to Compare Bioavailability of GLPG1972 Given as 2 Different Tablet Formulations Versus an Oral Solution
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I, randomized, open-label, cross-over study with 4 single-dose
      treatments of GLPG1972 to compare the bioavailability of the oral wet granulation (WG) tablet
      relative to an oral solution and to the oral direct compression (DC) tablet after single dose
      intake in healthy male subjects and to evaluate the effect of food on the bioavailability of
      the WG oral tablet.
    


Intervention name(s): GLPG1972
Intervention type(s): Drug
Intervention description(s): Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Incidence of Caries in Smoking and Smokeless Tobacco
Condition: DENTAL CARIES
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      The following observational study evaluates incidence of caries in smoking and smokeless
      tobacco based on habit history by clinical examination and DMFT index.
    

Detailed description: 
      Dental caries is an irreversible microbial disease of the calcified tissues of the teeth,
      characterized by demineralization of the inorganic portion and destruction of the organic
      substance of the tooth, which often leads to cavitation. It is a complex and dynamic process
      where a multitude of factors influence and initiate the progression of disease. There are
      practically no geographic areas in the world whose inhabitants do not exhibit some evidence
      of dental caries. It affects persons of both genders in all races, all socioeconomic strata
      and every age group. Likewise, there is strong evidence that tobacco use has numerous
      negative effects on oral health, for example staining of teeth, dental restoration,
      development of oral diseases. A biologically reasonable explanation for an association
      between chewing tobacco use and dental caries may be the presence of higher levels of
      fermentable sugars in chewing tobacco products which can stimulate the growth of carcinogenic
      bacteria. The decreased buffering effect possible lower pH of smokers saliva and higher
      number of lactobacilli and streptococcus mutans group may indicate an increased
      susceptibility to caries in smokers. On the other hand, there are researches which conclude
      that presence of extrinsic tobacco stains appear to provide a protective effect from caries.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients attending Panineeya Institute of Dental Sciences and Research Centre having
        tobacco chewing and smoking habits without fluorosis would be included in the study after
        their informed consent.

        DMFT index is scored for 613 patient of both the genders, visiting OPD of oral medicine and
        radiology after the clinical diagnosis of caries along with radiographs. The clinical
        scores are recorded along with investigations and a proforma would include the habit with
        duration, frequency, area of placement and form of tobacco intake.
      
Keywords: DENTAL CARIES; TOBACCO USERS; SMOKERS; SMOKELESS TOBACCO CHEWERS
The Cardiovascular Effects of Air Pollution: the Role of Nitric Oxide
Condition: Endothelial Dysfunction
Study type: Interventional

Summary: 
      Exposure to air pollution has been linked to increased cardiorespiratory morbidity and
      mortality. The exact component of air pollution that mediates this effect is unknown, but the
      link is strongest for fine combustion derived particulate matter derived from traffic
      sources. Recently, it has been demonstrated that inhalation of diesel exhaust impairs
      vascular vasomotor tone and endogenous fibrinolysis. The mechanism underlying these
      detrimental vascular is unclear, but is thought to be via oxidative stress and altered
      bioavailability of endogenous nitric oxide. In these studies we plan to elucidate the role of
      endogenous nitric oxide (NO) in the adverse vascular responses observed following exposure to
      diesel exhaust.
    


Intervention name(s): Forearm Vascular Study
Intervention type(s): Procedure
Intervention description(s): Forearm venous occlusion plethysmography during intraarterial infusion of L-NMMA (2-8 µmol/min) followed by co-infusion of sodium nitroprusside (90-900 ng/min) as a "nitric oxide clamp". Forearm blood flow then measured during the clamp in response to infused vasodilators acetylcholine (5-20 mg/min), bradykinin (100-1000 pmol/min), verapamil (10-100 µg/min) and sodium nitroprusside (2-8 µg/min).
Other intervention name(s): ACh; SNP; BK
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Nitric Oxide; Nitric Oxide Synthase; Air Pollution; Endothelial Dysfunction; Diesel Exhaust
Online TP (Training Program) on SC (Social Cognition) for Schizophrenia
Condition: Social Cognition
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Randomized controlled trial. Sixty-five participants (83% with schizophrenia or bipolar
      disorder) were recruited from community mental health teams. Fifty-seven met criteria and
      agreed to participate in the study. The conditions of cognitive rehabilitation were assigned
      randomly with support employment CR + IPS (n = 28) and IPS alone (n = 29). Cogpack program
      was used. Two groups were followed at 8 and 12 months after the baseline.
    

Detailed description: 
      This work was developed in the island of Tenerife (Spain) within a public service specialised
      in labour integration of people with disabilities in which an IPS team was set up in 2005.
      The study was carried out in collaboration with the units of community mental health of the
      island. These units carry out the control of people with serious mental illnesses including
      pharmacological treatment and psychosocial programming. All research procedures were approved
      by the Medicine Committee of Canary Health Services.

      The follow-up period for the data collection was set between 2013 and 2014. Employment
      specialists belong to a public institution specialized in work disability.Sixty-five
      participants but only 57 signed written informed consent and completed the baseline. Two
      groups were assigned randomly:one with support employment and cognitive rehabilitation the
      second group with IPS alone
    

Intervention name(s): Cognitive Rehabilitation and Individual Placement and Support
Intervention type(s): Other
Intervention description(s): Cognitive Rehabilitation and Individual Placement and Support
Other intervention name(s): CR and IPS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cognitive rehabilitation with a cognitive training program
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: rehabilitation; schizophrenia; emotional adjustment; theory of mind
Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device.
Condition: Chickenpox
MeSH terms: Chickenpox
Study type: Interventional

Summary: 
      The primary endpoint is the change of the itching score after 3 days of the product use in
      comparison to the basal value.
    


Intervention name(s): Poxclin Coolmousse
Intervention type(s): Device
Intervention description(s): cooling mousse for application in the skin
Intervention model: Single Group Assignment
Intervention model description: To determine the efficacy of PoxClin® CoolMousse in relieving itching associated with chickenpox after 3 days of use (using 5-point scale)
Masking: None (Open Label)
Primary purpose: Treatment