louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06307106: Various Strategies to Reduce Acute Post Hemorrhoidectomy Pain: A Comparative Study
Official title: Various Strategies to Reduce Acute Post Hemorrhoidectomy Pain: A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Post Operative Pain
Keywords: hemorrhoidectomy
acute pain
corticosteroids
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-03-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Since post hemorrhoidectomy pain is a severe and common post operative symptom so there is a need to find a suitable method for reducing this pain, up to our knowledge, this the first study in ZUH to compare between ketrolac, light Marcaine, corticosteroids and diclofenac sodium injection at surgical site for relieve of post operative pain. This is a randomized controlled comparative prospective clinical trial.


Eligibility criteria: Inclusion Criteria:

* both sex.
* age from 18 to 60.

Exclusion Criteria:

* patient refusal.
* patients with associated ano-rectal diseases such as fissures, fistulas, ano-proctitis, recurrent or thrombosed hemorrhoids and ano-rectal malignancy.
* patients with liver cell failure. patients unfit for surgery according to American Society of Anesthesiologists.

Primary outcomes:
measure: age
timeFrame: within 2 days before operation
measure: sex
timeFrame: within 2 days before operation
measure: number of hemorrhoids
timeFrame: within 2 days before operation and intra-operatively
measure: degree of hemorroids
timeFrame: within 2 days before operation and intra-operatively
measure: post operative pain
timeFrame: 1st, 2nd 3rd, 7th, 14th days post-operatively
measure: ambulation
timeFrame: from 1st to 3rd day post-operatively
measure: return to work
timeFrame: from one day to one month post-operatively
measure: patient satisfaction
timeFrame: from one day to one month post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
Study officials:
affiliation: faculty of medicine Zagazig University
name: Reham Zakaria, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01549106: IPI-145 Single Ascending, Multiple Ascending, Food Effect and Drug-Drug-Interaction Study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food and Ketoconazole on the Pharmacokinetics of IPI-145 When Administered to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: SecuraBio
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-145 after single and repeat oral administration, and to evaluate the effects of food and ketoconazole on the plasma pharmacokinetics of IPI-145.


Eligibility criteria: Inclusion Criteria:

1. Gender : male or female
2. Age : 18-55 years, inclusive
3. Body Mass Index (BMI) : 18.0-30.0 kg/m2
4. Medical history without major pathology
5. For males only: Willingness to use adequate contraception from the time of dosing and not donate sperm until 3 months after the follow-up visit
6. Females who have a negative pregnancy test at screening and on each admission, and are of non-childbearing potential. Females of non-childbearing potential are defined as women who are surgically sterile or post-menopausal (defined as at least 1 year post cessation of menses and follicular stimulating hormone (FSH) \>23.0 mIU/mL)
7. Willing and able to sign the written Informed Consent Form (ICF)

Exclusion Criteria:

1. Previous participation in the current study
2. Evidence of clinically relevant pathology
3. History of relevant drug and/or food allergies
4. Part 4 only: Known or suspected adverse reaction or contraindication to the imidazole class of drugs

Primary outcomes:
measure: Safety and tolerability assessments consisting of adverse events, vital signs, 12-lead ECG, clinical laboratory tests and physical examinations will be performed following IPI-145 single and repeat oral administration in healthy subjects
timeFrame: 8 months
measure: Plasma concentrations of IPI-145 and metabolites
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
facility: PRA International
Study officials:
affiliation: Verastem, Inc.
name: Hagop Youssoufian, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01269606: Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes
Official title: A Trial Comparing the Pharmacokinetic Properties of Insulin Aspart With Fast-acting Insulin Human Following Intravenous Infusion or Intramuscular Injection in Japanese Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-01-04
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at which rate the body eliminates the substance from the body) of insulin aspart with fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection in Japanese subjects with type 1 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Treated with multiple daily insulin injections for at least 12 months
* Current daily basal insulin requirement above or equal to 0.3 U/kg/day
* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0%
* Body Mass Index (BMI) 18.0-28.0 kg/m\^2

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start (screening)
* Surgery or trauma with significant blood loss (more than 500 mL) within 3 months prior to trial start (screening)
* Subject who smokes more than 10 cigarettes or the equivalent per day
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Clearance at steady state (CLss) for IV treatment group
timeFrame: from 180 min to 240 min
measure: Area under the curve (AUC) for IM treatment group
timeFrame: from 0 to 480 min after intramuscular injection
Secondary outcomes:
measure: Area under the curve (AUC) for IM treatment group
timeFrame: from 0 minutes to infinite time after intramuscular injection
measure: Steady state concentration (Css) for IV treatment group
timeFrame: from 180 min to 240 min
measure: Hypoglycaemic episodes
timeFrame: from screening (visit 1) to follow-up visit (2-21 days after last trial product administration)
measure: Adverse Events (AEs)
timeFrame: from first trial related activity to follow-up visit (2-21 days after last trial product administration)
Other outcomes:
Locations:
city: Fukuoka
country: Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02248506: Epidemiological Study About the Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis
Official title: Epidemiological Study About the Clinical and Microbiological Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Candidiasis, Vulvovaginal
Keywords: Candidiasis
Lead sponsor: Instituto Palacios
Sponsor class: OTHER
Collaborators: name: Gynea Laboratorios SA
First posted: 2014-09-25
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis.


Eligibility criteria: Inclusion Criteria:

* Sexually active women between 18 and 50 years
* Patients attending to the gynecologist with acute vulvovaginal candidiasis.
* Patients requiring standard treatment with clotrimazole 500 single dose and that the decision to prescribe this treatment is prior to inclusion in the study.
* Women who agree to participate in the study and has signed the informed consent sheet.

Exclusion Criteria:

* Use of any medication that may interfere significantly with study assessments.
* Pregnant or breastfeeding
* Women with signs of other genital infection
* Within 3 months after childbirth or abortion
* Patients that is expected not to attend follow-up visits

Primary outcomes:
measure: Vaginal swab test
timeFrame: Baseline
measure: Vaginal swab test
timeFrame: month 2
measure: Vaginal swab test
timeFrame: month 3
measure: Vaginal swab test
timeFrame: month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Palacios
Study officials:
References:
Clinical trial NCT03730506: Assessment of the Accuracy of Surgical Guide Designed From Digital Impression, Dental Model Scanning Using CBCT and Desktop Scanner in Computer Guided Implantology:
Official title: Assessment of the Accuracy of Surgical Guide Designed From Digital Impression, Dental Model Scanning Using CBCT and Desktop Scanner in Computer Guided Implantology: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Computer Guided Implant
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of the Accuracy of Surgical Guide Designed from Digital Impression, Dental Model Scanning using CBCT and Desktop Scanner in Computer Guided Implantology:

Randomized Clinical Trial.

Detailed description: Research question:

In computer guided Implantology, are surgical stents designed from scan of dental model by CBCT and from digital impression as accurate as surgical stents designed from desktop scanner?

Statement of the problem:

The role digital dentistry is improved in computer guided implantology especially with development of computer guided implant software, desktop scanner and intra oral scanner development and CBCT machines.

Intra-oral scanner, desktop scanner and CBCT scanner can be used in creation of 3D digital model that can be used with computer guided implant in fabrication of the surgical stent.

And the question, is the accuracy of surgical guide will be affected when designed by one of these different modalities?

Rationale for conducting the research:

Digital 3D dentoginival details are very important in computer guided implantology and designing of surgical stent.nowadays there are many methods to obtain this soft tissue replica as CBCT,desktop scanner and intra oral scanner.this study is conducted to asses the effect of different method of soft tissue digitization on the accuracy of surgical template used in computer guided implantology.

Eligibility criteria: Inclusion Criteria:

* partially edentulous patient.
* Patients with bucco-lingual bone thickness more than 6 mm allowing flapless implant placement.

Exclusion Criteria:

* Completely edentulous patient or Free end saddle edentulous area.
* Patients needing graft or sinus lifting with implant placement.
* Patients with thin ridges.
* Patients with systemic disease that may affect bone quality.
* Patients with poor oral hygiene and active periodontal diseases.
* Patient with limited mouth opening

Primary outcomes:
measure: Evaluation of angular deviation of virtual implants and actual implant position by 3rd party software in degrees
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05202899: Effect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy
Official title: Effect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Brain Tumors
Keywords: sugammadex、awake craniotomy
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of sugammadex for reversal of rocuronium-induced neuromuscular block on Perioperative Management of awake Craniotomy


Eligibility criteria: Inclusion Criteria:

* Age: 18-45 years old body mass index (BMI)≥ 18.5-23.9 kg/m2, ASA grade I \~II.

Exclusion Criteria:

* Suffering from a mental illness or preoperative communication disorder, patients with claustrophobia, breathing, circulation, neuromuscular system and kidney, and other important viscera function disorder, pregnant or lactating women, a history of malignant hyperthermia, the history of drug allergy in the process of general anesthesia and recent may not used to the interaction between rocuronium, vecuronium bromide reacts drugs (such as aminoglycoside antibiotics, Anticonvulsant, magnesium).

Primary outcomes:
measure: awake time
timeFrame: 10-30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Military Region General Hospital, Department of Anesthesiology
state: Guangdong
Study officials:
References:
Clinical trial NCT03563599: A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)
Official title: An Open-label Randomized Study to Evaluate the Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203) in Treatment-naïve Patients With Newly Diagnosed Drug-sensitive Sputum Smear-positive Pulmonary Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB
Lead sponsor: Qurient Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).


Eligibility criteria: Inclusion Criteria:

1. A new episode of pulmonary TB determined by testing at the study appointed laboratory: Mycobacterium tuberculosis positive and rifampicin and isoniazid sensitive on a rapid molecular test
2. A chest X-ray taken no more than 14 days before Screening which in the opinion of the Investigator is consistent with TB
3. Sputum smear positive on direct microscopy for acid-fast bacilli on at least 1 pre-treatment sputum sample
4. Ability to produce an adequate volume of sputum as determined by an approximately 16-hour overnight sample collection
5. Be of non-childbearing potential or using effective methods of birth control, as defined in the protocol

Exclusion Criteria:

1. The patient is mentally or legally incapacitated at Screening
2. Any condition or circumstance, in the opinion of the Investigator, which may make the patient unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the patient's safety
3. Clinically significant evidence of extra-thoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the Investigator
4. The patient has been infected with hepatitis B or C virus as confirmed by tests for hepatitis B core antibodies, hepatitis B surface antigens, and the hepatitis C virus antibodies
5. The patient with history of allergic reaction to isoniazid, rifampicin, pyrazinamide, ethambutol or related substances (eg, tosylate), as confirmed by the clinical judgement of the Investigator

Primary outcomes:
measure: The EBA (early bactericidal activity) of telacebec (Q203)
timeFrame: Days 0 to 14 post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: TASK Applied Science
city: Cape Town
country: South Africa
facility: UCT Lung Institute
Study officials:
References:
Clinical trial NCT04719299: Smartphone Application in Reducing Dental Anxiety
Official title: Effectiveness of Smartphone Application in Reducing Anxiety During Pediatric Dental Procedures: a Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: evaluating the effectiveness of smartphone applications (Tell-Play-Do) (TPD) in reduction of preoperative anxiety in children undergoing restorative treatment, as measured by heart rate and Venham's Picture Test.

Detailed description: A total of at least 78 patients aged from 6-8 years will be included. All participants will be divided equally into two groups. Study group TPD using smartphone application and Control group (Tell-Show-Do) (TSD) using traditional behavior management technique.

Dental anxiety using Venham's Picture Test and heart rate using pulse oximeter will be assessed during dental treatment

Eligibility criteria: Inclusion Criteria:

* School-age children aged from 6-8 years.
* Presence of carious primary molars without pulpal involvement.
* Parents have the ability to write, read and willingness to participate in the study.
* First dental visit to the clinic.
* Normal healthy children.

Exclusion Criteria:

* Children with previous dental experience.
* Medically compromised children.
* Children with special needs (physical or mental).

Primary outcomes:
measure: Change in dental anxiety scores
timeFrame: Baseline and immediate post operative
measure: Change in heart rate
timeFrame: Baseline and immediate post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT05568199: Udall Project 1 Aim 4
Official title: Udall Project 1 Aim 4
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinsons Disease
Deep Brain Stimulation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants are identified by clinicians and trained research personnel through the movement disorder clinic. Patients are identified during the University of Minnesota DBS surgery candidacy evaluation process.

Brief summary: By defining the strength and direction of connectivity patterns at rest and during movement across the basal ganglia-thalamocortical (BGTC) network we will characterize the role of individual circuits in motor performance and cognitive function, paving the way for future development of optimization algorithms for DBS that take advantage of this understanding.


Eligibility criteria: Inclusion Criteria:

* Implanted with a DBS system
* Existing 7T imagery (either done as standard-of-care or done as part of Noam Harel's study, IRB #1210M22183)
* Diagnosed with idiopathic Parkinson's Disease
* Minimum age 21 years

Exclusion Criteria:

* Other significant neurological disorder, as determined by PI
* Diagnosis of dementia
* Pregnant

Primary outcomes:
measure: Motor association with pathway activation patterns
timeFrame: 6 months post surgery
measure: Cognitive outcome 1 association with pathway activation pattern
timeFrame: 6 months post surgery
measure: Cognitive outcome 2 association with pathway activation pattern
timeFrame: 6 months post surgery
measure: Cognitive outcome 3 association with pathway activation pattern
timeFrame: 6 months post surgery
measure: Cognitive outcome 4 association with pathway activation pattern
timeFrame: 6 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jerrold Vitek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: