louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03595319: Median Sevoflurane Concentration for Hypotension Between Young and Elderlypatients: Adaptive Clinical Trial
Official title: Comparison of Median Alveolar Sevoflurane Concentration for Hypotension Between Young and Elderly Patients: Adaptive Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypotension
Keywords: Hypotension
Sevoflurane
Elderly
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Adaptive up and down methodology. Anesthesia will be induced using etomidate, rocuronium and remifentanil. After intubation and mechanical ventilation, a high fresh gas flow and variable vaporizer target concentration will be used to stabilize the patient's target end tidal sevoflurane in less than two minutes.

Each patient's target end tidal sevoflurane is determined by the concentration used in the previous patient of the same group and by the incidence of hypotension. If the previous patient suffered hypotension, next patient's target concentration will drop. If there was no hypotension, next patient's target concentration will rise. The first patient on each group will be 2%. Target end tidal will vary 0.4% until the first crossover, then drop to 0.2% until the second crossover and will vary 0.1% thereafter.
Primary purpose: BASIC_SCIENCE

Brief summary: Two arms: elder group, young group. Dixon's up and down adaptive methodology for ED50. Executed after Anesthesia induction for 10min without touching the patient after starting mechanical ventilation.

Detailed description: This adaptive clinical trial will vary target end tidal sevoflurane by 0.4, then by 0.2 and by 0.1 thereafter in order to minimize sample size.

Eligibility criteria: Inclusion Criteria:

* Understands experiment, is voluntary, signs informed consent;
* Does not take medication that influences arterial pressure;
* Normotensive.

Exclusion Criteria:

* Received any medication that influences arterial pressure before experiment;

Primary outcomes:
measure: Hypotension incidence related to sevoflurane
timeFrame: During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Secondary outcomes:
measure: Systolic hypotension
timeFrame: During the first 10 minutes after end tidal sevoflurane concentration stabilizes
measure: Diastolic hypotension
timeFrame: During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital Universitário de Brasilia
state: Distrito Federal
Study officials:
affiliation: University of Brasilia
name: Gabriel MN Guimarães, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02528019: Metabolic and Cardiovascular Effects of Dipeptidyl Peptidase-4 (DPP-4) or Sodium-glucose Co-transporter Type 2 (SGLT2) Inhibitors
Official title: Effects of the DPP-4 or SGLT2 Inhibitors on the Metabolic Cardiovascular Systems in Patients With Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Effects of the DPP-4 Inhibitors or SGLT2 Inhibitors on the Protective Actions for Diabetic Complications
Lead sponsor: Kurume University
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inhibition of dipeptidyl peptidase-4 (DPP-4) or sodium-glucose co-transporter type 2 (SGLT2) has been proposed as a therapeutic target for type 2 diabetes. However, how DPP-4 inhibitors or SGLT2 inhibitors exert protective actions for diabetic complications in addition to their glucose-lowering effects remains unknown.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 2 diabetic patients
* Must be able to swallow tablets
* never received DPP-4 inhibitors or SGLT2 inhibitors

Exclusion Criteria:

* uncontrolled diabetes (fasting plasma glucose\>200 mg/dL)
* receiving insulin therapy
* hepatic disorders (2.5 fold or greater increases in aspartate transaminase or alanine transaminase levels above the upper limits of normal)
* inflammatory disorders
* neoplastic disorders
* recent (\<3months) acute coronary syndrome and stroke
* any acute infection

Primary outcomes:
measure: Effects of treatment on the nominal change in arterial stiffness from baseline after 6 months of treatment as measured by cardio-ankle vascular index
timeFrame: 6 months of treatment
Secondary outcomes:
measure: Change from baseline in subcutaneous and visceral fat volume
timeFrame: 6 months of treatment
measure: Change from baseline in lipid profile including malondialdehyde-modified low-density lipoprotein and remnant-like particle cholesterol
timeFrame: 6 months of treatment
measure: Change from baseline in circulating inflammatory markers
timeFrame: 6 months of treatment
Other outcomes:
Locations:
city: Kurume city
country: Japan
facility: Kurume University Hospital
Study officials:
affiliation: Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine
name: Nobuhiro Tahara, MD, PhD
role: STUDY_CHAIR
References:
citation: Bekki M, Tahara N, Tahara A, Igata S, Honda A, Sugiyama Y, Nakamura T, Sun J, Kumashiro Y, Matsui T, Fukumoto Y, Yamagishi SI. Switching Dipeptidyl Peptidase-4 Inhibitors to Tofogliflozin, a Selective Inhibitor of Sodium-Glucose Cotransporter 2 Improve Arterial Stiffness Evaluated by Cardio-Ankle Vascular Index in Patients with Type 2 Diabetes: A Pilot Study. Curr Vasc Pharmacol. 2019;17(4):411-420. doi: 10.2174/1570161116666180515154555.
Clinical trial NCT01239719: Randomized Study for Effectiveness and Safety Evaluation of Dexamethasone 0.5 mg + Fumarate Clemastine 1 mg Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Allergy
Dermatitis
Keywords: Allergic dermatitis
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to prove the efficacy of the dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in reducing the signs and symptoms of allergic dermatitis.


Eligibility criteria: Inclusion Criteria:

* Patients who sign the IC in two ways, agreeing with all study procedures
* Patients aged above 18 years of any ethnicity, class or social group, female or male
* Patients with acute, subacute or chronic dermatoses, of inflammatory and / or allergic origin, to which it is recommended the use of drugs under investigation, such as:

  * atopic dermatitis
  * prurigo
  * primary contact dermatitis or allergic hives
  * drug eruption
  * allergic vasculitis
  * dyshidrosis, Note: The above clinical conditions are diagnosed from clinical examination.

Exclusion Criteria:

* Patients being treated with antibiotics
* Participation in clinical trials in the 12 months preceding the investigation
* Current treatment with immunosuppressants (eg, cyclosporine or methotrexate)
* Current treatment with phototherapy (UVA, UVB, PUVA and lasers)
* Use of systemic corticosteroids in the visit to include or 15 days preceding the survey
* Topical treatments at the site of lesions in the 15 days preceding the survey
* Presence of any skin condition
* Presence of secondary infections at the site of treatment, diagnosed clinically;
* Presence of other eczematous diseases, such as nummular eczema, neurodermatitis, seborrheic dermatitis, psoriasis, scabies, and Buckley's syndrome
* Pregnant or lactating women
* Chronic alcoholism
* Patients with a history of hypersensitivity to any component of the products under investigation.
* Any finding of clinical observation (clinical history or physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study.
* Allergic Dermatosis mild or, acording to the investigator criteria, is not justified systemic treatment.

Primary outcomes:
measure: Evaluate, through clinical examinations, the effectiveness of the combination tablet with 0.5 mg of dexamethasone and clemastine 1 mg, compared with 0.5 mg tablet of dexamethasone in improving the signs and symptoms associated with allergic dermatitis.
timeFrame: 14 days of treatment.
Secondary outcomes:
measure: Evaluation of the efficacy.
timeFrame: 14 days of treatment.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04579419: Injection Site Pain Botulinum Toxin Reconstituted in NS With and Without Sodium Bicarbonate
Official title: Injection Site Pain, Onset and Duration of Action of Botulinum Toxin Reconstituted in Normal Saline With and Without Sodium Bicarbonate; A Prospective, Single Center, Randomized, Double-Blind Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wrinkle
Lead sponsor: King Abdulaziz Medical City
Sponsor class: OTHER_GOV
First posted: 2020-10-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to investigate the effects of botulinum toxin type A injections diluted with the mixture of sodium bicarbonate (SB) and normal saline (NS) on pain reduction, onset of action and duration of action.

This is a prospective, randomized, double-blind clinical study, which included 30 female patients (age\>25). The patients were randomized to receive botulinum toxin (BT) injections diluted with NS and SB on one side of the face and saline control injections on the other side. Pain severity was assessed using visual analogue scale. The onset and duration of action were recorded according to the patients' subjective opinions after 1 week and 3 months, respectively. The study was approved with an IRB (Institutional Review Board) number of RC19/371.


Eligibility criteria: Inclusion Criteria:

* Any female patient who is in good health and has moderate dynamic forehead and glabellar wrinkles.

Exclusion Criteria:

* • Patients \<25 years old

  * Presence of neuromuscular disease or intake of drugs affecting muscle tone.
  * Any active infection in the treatment area.
  * Patients receiving anticoagulation or had a diagnosis of bleeding disorders.
  * Any patient who had undergone the following treatments to the forehead area in the past 6 months: botulinum toxin injections, ablative laser procedures, radiofrequency device treatments, ultrasound device treatments, or medium to deep chemical peels.
  * Any patient who had temporary soft-tissue augmentation material to the forehead area in the past 12 months, semi permanent soft-tissue augmentation material in the past 2 years, or permanent soft-tissue augmentation material at any point in the past.
  * Any patient with prior facial cosmetic surgical procedures such as eyebrow-lifts, blepharoplasties, and rhytidectomies.

Primary outcomes:
measure: Injection site pain
timeFrame: Immediately after the injections
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City
Study officials:
References:
Clinical trial NCT02908919: Impact of Time Intervals of Preparation on Quality and Tolerance of the Bowel Preparation
Official title: Impact of Time Intervals on Quality and Tolerance of the Bowel Preparation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bowel Preparation
Colonoscopy
Keywords: Colonoscopy
Picosulfate sodium
Polyethylene glycol
Magnesium citrate
Ascorbic acid
SPMC (solution picosulfate + magnesium citrate)
PEGA (Polyethylene glycol + ascorbic acid)
Lead sponsor: Faculty Hospital Kralovske Vinohrady
Sponsor class: OTHER_GOV
Collaborators: name: Nemocnice T.Bati, Zlin
name: Brno University Hospital
name: University Hospital, Motol
First posted: 2016-09-21
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine optimal time intervals for preparation before colonoscopy using different formulas.

Detailed description: Different formulas are used for bowel preparation before colonoscopy. Present guidelines are based on conventional polyethylene glycol. Their validity for other preparations were not evaluated. Relationship between length of preparation, interval to colonoscopy and bowel preparation quality, tolerance are assessed.

Eligibility criteria: Inclusion Criteria:

- subjects referred to diagnostic or therapeutic colonoscopy.

Exclusion Criteria:

* ileus
* known or suspected bowel obstruction
* active bowel inflammation
* pregnancy
* any presence of serious medical conditions ( esp. cardiac, renal, liver diseases)
* history of prior colonic or rectal surgery
* inability to obtain valid data from

Primary outcomes:
measure: Quality of bowel preparation according to time intervals of bowel preparation
timeFrame: One day
Secondary outcomes:
measure: Tolerance of bowel preparation according to time intervals of bowel preparation
timeFrame: One day
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Faculty Hospital Kralovske Vinohrady
city: Zlin
country: Czech Republic
facility: Nemocnice T.Bati
Study officials:
affiliation: Faculty Hospital Kralovske Vinohrady, Prague
name: Jan Matous, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02630719: Timolol Eye Drops in the Treatment of Acute Migraine Headache
Official title: Timolol Eye Drops in the Treatment of Acute Migraine Headache
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Migraine
Keywords: headache
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
Collaborators: name: Truman Medical Center
First posted: 2015-12-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine whether timolol eye drops are effective in alleviating acute migraine headaches. Subjects will be randomized to receive either timolol eye drops or placebo (tears) to use as a migraine abortive medication.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of migraine headache

Exclusion Criteria

* Non-migraine headache
* Use of systemic beta-blocker
* Medical history of hypotension, bradycardia, syncope or other significant cardiovascular disease
* Medical history of difficulty breathing, asthma or chronic obstructive pulmonary disease or other pulmonary disease
* Medical history of glaucoma, ocular hypertension or hypotony, punctual stenosis, current use of other ophthalmic medications
* Previous adverse reaction to timolol or other beta-blockers
* Inability to self-administer eye drop due to physical or cognitive disorders
* Currently pregnant or breastfeeding
* Pregnant in the past year
* Non-english speaker

Primary outcomes:
measure: Timolol Eye Drops in the Treatment of Acute Migraine Headache
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Truman Medical Center
state: Missouri
Study officials:
affiliation: UMKC
name: Sean Gratton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cossack M, Nabrinsky E, Turner H, Abraham A, Gratton S. Timolol Eyedrops in the Treatment of Acute Migraine Attacks: A Randomized Crossover Study. JAMA Neurol. 2018 Aug 1;75(8):1024-1025. doi: 10.1001/jamaneurol.2018.0970.
Clinical trial NCT00804219: Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination
Official title: Characterization of Humoral and Cellular Immunity of Low and High-responders After TBE Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tick-borne Encephalitis
Keywords: low responsiveness after vaccination
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-12-08
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The phenomenon of no- and low-responsiveness has been described after applications of different vaccines (e.g. hepatitis B, TBE) and is concerning about 2-10% of the vaccinees.

The aim of this project is to investigate the humoral and cellular immune responses of low-responders after TBE vaccination in order to find parameters regarding immunoregulation against TBE. It is of interest if non-responsiveness is a general immunological deficit of a distinct patient group or if it is a antigen-specific phenomenon.


Eligibility criteria: Inclusion Criteria:

* Adults (≥18 years) of both sexes without upper age limit
* Willingness to sign written informed consent form
* Basic vaccination plus one booster (minimum) of TBE-vaccine,

Exclusion Criteria:

* Age: \< 18 years
* Pregnancy or breast feeding
* Prior TBE infection
* Planned surgery within 2 weeks before/after any scheduled rabies vaccination during the entire study
* Concomitant medication: systemic cortisone, immune suppressive therapy 4 weeks before or planned medication during the study
* History of autoimmune disease
* Drug addiction
* Plasma donators
* Administration of other vaccines 4 weeks before/after day 0
* Administration of immunoglobulins 6 weeks prior to any vaccination or blood donation during the entire study period
* Specific Immune Therapy (Hypo-/Desensibilization) within 14 days before and after the 2 study vaccination doses.
* History of any malignant disease 5 years prior to the study entry
* Any contraindication for the administration of the TBE- or influenza vaccine according to the manufactures information.

Primary outcomes:
measure: cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination
timeFrame: 7 days after TBE-booster plus influenza vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Institute of Specific Prophylaxis and Tropical Medicine
Study officials:
affiliation: Institute of Specific Prophylaxis and Tropical Medicine
name: Ursula Wiedermann-Schmidt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00659919: Treatment of Neuroleptic Induced Acute Akathisia With Trazodone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: BeerYaakov Mental Health Center
Sponsor class: OTHER_GOV
First posted: 2008-04-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Administration of trazodone for the treatment of neuroleptic induced acute akathisia in a cross-over fashion of 6 days duration. 3 days of placebo and 3 days of trazodone.


Eligibility criteria: Inclusion Criteria:

* Patients with akathisia according to DSM-IV criteria at least mild akathisia.

Exclusion Criteria:

* Change of pharmacologic regimen 7 days prior to study entry
* Significant systemic disease
* The presence of chronic akathisia
* Patients unable to cooperate

Primary outcomes:
measure: Barnes Akathisia rating scale, Positive and Negative syndrome scale, Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Clinical Global Impression, Scale for the Assessment of Negative Symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yaacov
country: Israel
facility: Beer Yaakov MHC
Study officials:
References:
Clinical trial NCT04137419: Probiotics as Adjunct to Nonsurgical Periodontal Treatment
Official title: Probiotics as Adjunct to Nonsurgical Periodontal Treatment, Double Blinded Randomized Controled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: Periodontitis
Probiotic
Non-surgical therapy
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ProlacSan probiotic lozenges and gels contain L. plantarum and L. brevis strains with proven in vitro antimicrobial activity against P. gingivalis. In our study we aim to investigate proposed benefit of ProlacSan as adjunct to conventional initial periodontal treatment in a group (n = 40) of Grade III and IV periodontitis patients. Patients will be randomized in two groups receiving either probiotic (n = 20) or placebo (n = 20) after completion of nonsurgical treatment within 7 days. Before treatment and after three months, standard periodontal parameters will be measured by masked examiner and plaque samples harvested for cultivation of 9 most relevant periodontal pathogens. One lozenge per day of probiotic/placebo will be used during 3 months healing period. Primary outcome measures will be the number of persisting sites per patient that need additional surgical treatment defined as sites with probing depth \> 4 mm and bleeding on probing.


Eligibility criteria: Inclusion Criteria:

* periodontitis stage III or IV
* at least 20 teeth for evaluation
* besides solitary crowns, no other prosthodontic tooth replacements
* good systemic health
* smoking less than 10 cig/day

Exclusion Criteria:

* periodontal treatment lass than 1 year before inclusion
* antibiotic therapy in the last 6 months
* chronic systemic diseases with the impact on periodontium or healing process
* medication with the impact on periodontium or healing process

Primary outcomes:
measure: Residual diseased site number
timeFrame: 3 months
measure: Gingival bleeding index
timeFrame: 3 months
Secondary outcomes:
measure: Probing pocket depth reduction
timeFrame: 3 months
measure: Recession
timeFrame: 3 months
measure: Bleeding on probing
timeFrame: 3 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Dental Clinic
Study officials:
affiliation: Assist. prof.
name: Rok Gašperšič, PhD
role: PRINCIPAL_INVESTIGATOR
References: