louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01064843: Clinical Evaluation of the Mandibular Mini-Implant Overdenture
Official title: Clinical Evaluation of the Mandibular Mini-Implant Overdenture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stabilization of a Full Lower Denture
Edentulism in Lower Jaw
Lower Denture Made Within Last Few Years
Keywords: Edentulous
Edentulism
Lower denture
Mini dental implant
Imtec MDI
Denture stabilization
Case success rate of overdentures stabilized by MDI
General satisfaction of patients with this treatment
Oral health-related quality of life of these patients
Cost estimates
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: McGill University
name: 3M
First posted: 2010-02-09
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dental implant

Brief summary: Stabilization of existing full lower dentures by means of mini-dental implants (MDI). To test whether 4 mini-implants placed at the front of the lower jaw can stabilize an immediately-modified existing lower denture.

Detailed description: To test whether the percentage of case successes of these lower dentures supported by 4 MDIs is equal to or greater than 95% at 1 year. Success is defined as a denture supported by implants that is functioning in the way it was intended.

Eligibility criteria: Inclusion Criteria:

* Completely edentulous with last tooth extraction 2 years ago or longer.
* Patients requesting implant stabilization of existing lower conventional denture.
* Adequate space in anterior mandible for placement of 4 MDI implants.
* Able to maintain adequate oral hygiene and keep dentures clean.
* Healthy enough to have minor surgical procedures.
* Have adequate understanding of written and spoken English or French.
* Capable of providing written informed consent.

Exclusion Criteria:

* Not enough room in mandibular bone for implant height.
* Has acute or chronic symptoms of parafunctional disorders.
* History of radiotherapy to orofacial region.
* Are or have been taking bisphosphonate IV or other medications (to be evaluated by the researcher).
* Health conditions that may jeopardize treatment (to be evaluated by the researcher).
* Unable or unwilling to return for evaluations or study recalls.

Primary outcomes:
measure: Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term.
timeFrame: 3 years
Secondary outcomes:
measure: Oral health-related quality of life and general satisfaction of patients.
timeFrame: 3 years
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Faculty of Dentistry, McGill University
state: Quebec
Study officials:
affiliation: Professor, Principal Investigator
name: Jocelyne Feine, DDS, MSc, HDR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06132243: Comparative Study on Pharmacokinetics of Two Formulations of Jaktinib in Healthy Adults Under Fasting Conditions
Official title: A Single-dose, Randomized, Open-label, Repeated Cross-over Pharmacokinetic Comparison Study of Two Formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myelofibrosis
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the pharmacokinetic Characteristics of two formulations of Jaktinib Hydrochloride Tablets in Healthy Adult Volunteers


Eligibility criteria: Inclusion Criteria:

* 18≤ age ≤ 45, male or female;
* Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m\^2 (inclusive);
* Informed consent will be signed before the trial, and the content, process and possible adverse reactions of the trial will be fully understood;
* The volunteers should be able to communicate well with the researchers and understand and comply with the requirements of the study.

Exclusion Criteria:

* Participants who were enrolled in a clinical trial or used a study drug within 3 months before administration of the study drug;
* Participants with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years and still clinically relevant according to the investigator;
* Participants with definite diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, metabolic system and other diseases that require medical intervention or are not suitable for clinical trial (such as psychiatric history);
* With positive alcohol breath test;
* Volunteers may not be able to complete the study for other reasons or have other reasons for not participating in the study as judged by the investigator.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) Of Jaktinib and its main metabolite ZG0244
timeFrame: up to 48 hours
measure: Jaktinib and its main metabolite ZG0244 AUC(0-t)
timeFrame: up to 48 hours
measure: Jaktinib and its main metabolite ZG0244 AUC(0-inf)
timeFrame: up to 48 hours
Secondary outcomes:
measure: Jaktinib and its main metabolite ZG0244 Tmax
timeFrame: up to 48 hours
measure: Jaktinib and its main metabolite ZG0244 t1/2
timeFrame: up to 48 hours
measure: Adverse events
timeFrame: Day 1 to Day 12
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Hospital of Changsha
state: Hunan
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT01293643: A Study to Compare the Efficacy and Safety of a Combination of Ketoconazole and Clindamycin Compared to Tetracycline/Amphotericin B Combination Cream for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis (P08077)
Official title: A Phase 3b, Comparative and Randomized Study to Assess the Efficacy and Safety of an Intravaginal Ovule Combination of Ketoconazole and Clindamycin Compared With an Intravaginal Cream Combination of Tetracycline and Amphotericin B for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis, Either Mixed or Isolated
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaginosis, Bacterial
Candidiasis, Vulvovaginal
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-02-10
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to compare the safety and efficacy of the use of a intravaginal ovule containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream containing a combination Tetracycline and Amphotericin B for the treatment of bacterial vaginosis and/or mixed or isolated vaginal candidiasis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of vaginal candidiasis
* No Trichomonas vaginalis or any other protozoa
* No clinical evidences of infection by Neisseria gonorrhoeae, Chlamydia trachomatis, or viral infections

Exclusion Criteria:

* Known sensitivity to the formula components
* Pregnant or nursing patients
* Any gynecological condition contraindicating the use of vaginal ovule or cream.
* Use of any other local or systemic bactericidal, anti-protozoa or antifungal agent within the 2 weeks prior to the study start or during it
* Presence of other sexually transmitted diseases (except from Candidal vaginitis).
* History of recurrent candidiasis (≥4 episodes per year)
* Use of intra-uterine device, spermicides, or diaphragms
* Has metabolic or immune disorder
* Has abnormal uterine bleeding

Primary outcomes:
measure: Percentage of participants that obtain clinical cure
timeFrame: Baseline up to Day 10
measure: Percentage of participants that obtain microbiological cure
timeFrame: Baseline up to Day 10
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00573638: Effects of Xal-Ease on Patient Compliance With Xalatan
Official title: The Effects of the Xal-Ease Delivery Aid Device on Patient Compliance With Xalatan Eye Drops
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
compliance
eye drops
deliver aid
Patients could range anywhere from 40 to 80 years old
Patients must have diagnosis requiring treatment with Xalatan.
Patients will be male or female and from any racial/ethnic background.
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that the Xal-Ease with increase patient compliance with XALATAN


Eligibility criteria: Inclusion Criteria:

* 40 to 80 years old
* Diagnosis warranting treatment with Xalatan eye drops.
* ambulatory and well functioning

Exclusion Criteria:

* non-ambulatory
* less than 40 or greater than 80 years old
* Not using Xalatan eye drops

Primary outcomes:
measure: The primary outcome measure is compliance with the medication XALATAN using and not using the Xal-Ease delivery aid for their glaucoma treatment.
timeFrame: six months
Secondary outcomes:
measure: To determine if any of the other factors mentioned in the survey affect compliance to their medical regimen
timeFrame: six months
measure: To see whether or not the Xal-Ease device helps patients conserve medication. ie - aids in drops not distilled in the eye.
timeFrame: 6 months
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Medical College of Georgia Health Inc
state: Georgia
Study officials:
affiliation: Augusta University
name: Christian D. Nilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03451838: Prediction of Fetal Macrosomia by US
Official title: The Prediction of Fetal Macrosomia by Measurement of Placenta Volume and Thickness in Pregnant Women With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Macrosomia
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
name: National Research Centre, Egypt
First posted: 2018-03-02
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Singleton gestational Gestational age over 16-20 weeks with Intact membrane with Normal umbilical morphology (two arteries and one vein ) with DM in one group and no medical disorders in another group

Brief summary: Fetal macrosomia defined as birth weight above 90th centile ,macrosomia occurs in 42-62%of pregnancy complicated by type 1 diabetes mellitus ,in 30-56% of pregnancy complicated by type 2 diabetes mellitus .

-The delivery of macrosomic infant has potentially severe consequence for both the newborn and mother .Increased birth weight increase the risk in the fetus of shoulder dystocia and premature brachial plexus injury ,and those infant weighing above 4500g are at increased risk for neonatal morbidity ,including the need for assisted ventilation and meconium aspiration .Maternal complication result from operative delivery and include postpartum hemorrhage ,third or fourth degree laceration and postpartum infection .

Detailed description: Estimated fetal body weight is needed especially when head measurement is impossible whenever the fetal head is positioned low in pelvic brim .A convenient method for estimating fetal body weight without head measurement was thus required .

-The human placenta develop with the principal function of providing nutrients and oxygen to the fetus ,adequate fetal growth and subsequent normal birth weight depend on normal placenta .

Eligibility criteria: Inclusion Criteria:

* 1.Singleton gestational 2.Gestational age over 16-20 weeks 3.Intact membrane 4.Normal umbilical morphology (two arteries and one vein )

Exclusion Criteria:

1. The presence of fetal congenital anomaly .
2. Multifetal pregnancy.
3. Maternal chronic disease (hypertension, renal disease ,and pulmonary disease ,etc.)
4. Patient with a diagnosis such as oligohydramnios ,preeclampsia and intrauterine growth retardation .
5. Patient who used cigarette or alcohol during pregnancy.

Primary outcomes:
measure: the number of paticipants who will have babies with macrosomias
timeFrame: within a week from delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy, M.s.c
role: PRINCIPAL_INVESTIGATOR
affiliation: kasraliny hospital- Aljazeerah hospital
name: Ahmed samy, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT01495338: A Comparison of the Safety and Comfort of AC-170
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Normal Ocular Health
Lead sponsor: Aciex Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-20
Enrollment: 60
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 purpose of this study is to evaluate the safety and comfort of AC-170 compared to a placebo.


Eligibility criteria: Inclusion Criteria:

* Able and willing to avoid the use of ocular medications or topical ocular preparations within protocol specific time period.

Exclusion Criteria:

* Known contraindications or sensitivities to the study medication or its components.
* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
* Use of disallowed medications during the period indicated prior to the study enrollment or during the study.

Primary outcomes:
measure: Drop Comfort Score
timeFrame: during 3 minute period
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT00226538: Prediction of Drug Interactions With CYP2C9 Substrates
Official title: Prediction of Potential Drug Interaction With CYP2C9 Substrate by Using Phenytoin Metabolic Ratio as a Marker of Its Activity in-Vivo.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-27
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: CYP2C9, is one of the major drug metabolism enzymes accounting for about 20% of the hepatic cytochrome P450 content and being second only to CYP3A4.

The proposed study will explore different possible drug interactions with CYP2C9 substrates by evaluating the effect of prototype inducers and inhibitors on the phenotypic trait measurement. It is expected that the identification of drugs that might interact with CYP2C9 substrates will be used to rationalize future drug interaction studies designed to evaluate the actual magnitude of effect and its clinical implications. This approach should be particularly useful when applied to those CYP2C9 drugs characterized by a narrow therapeutic index (i.e. warfarin).

This study will consist of three study periods separated from each other by a two weeks washout period. In the course of the study the subjects will receive in a double blind, crossover fashion, rifampin 300 mg. twice daily, diclofenac 50 mg twice daily. and fluconazole 200 mg. twice daily, each for one week. All drugs will be administered as identical looking tablets that will be prepared at the pharmacy of the Hadassah University Hospital and their order of administration will be randomized.On the day prior to, on day 6 of and 7 days following each drug period, the activity of CYP2C9 will be evaluated by the administration of a single phenytoin 300 mg. dose. The subjects will be requested to collect their urine for 24 hours and a single blood sample will be obtained 12 hours post phenytoin intake.


Eligibility criteria: Inclusion Criteria:

* Age range 20-50
* Absence of significant disease states

Exclusion Criteria:

* Known hypersensitivity to one of the drugs used in the study
* Significant disease states
* Regular use of drugs (including birth control pills)

Primary outcomes:
measure: Phenytoin metabolic ratio prior to and following exposure to fluconazole, diclophenac and rifampicin.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoseph Caraco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01210638: Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxymorphone Hydrochloride IR 10 mg Tablets, With a Naltrexone Block, Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-09-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10 mg Tablets under fasting conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to oxymorphone hydrochloride or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Soran Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03453138: Usage of LMA Protector on Patients Who Undergo Laparoscopic Surgery
Official title: The Comparison of Protector LMA and Endotracheal Tube in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia A Randomize Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Mask Airway
Keywords: laryngel mask airway
laparoscopic surgery
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: LMA Protector is a recently developed second generation laryngeal mask several kinds of different laryngeal masks were used for the airway management during laparoscopic surgeries. However there is a lack of knowledge for the use of LMA Protector during laparoscopic surgery .In this study researchers aim to determine the effectivity of LMA Protector and plan to analyse the orofaryngeal cuff pressure and fiberoptic grading scale measurements .

Detailed description: Tracheal intubation may have more complications than laryngeal masks. In this study researchers aim to determine the effectivity of LMA Protector and on the otherside the heamodynamic variables and the complication rates between tracheal ıntubation and laryngeal mask insertion will be compared.

Eligibility criteria: Inclusion Criteria:

* ASA class I-III patients
* Patients undergo laparoscopic surgeries
* Laparoscopic surgeries duration of less than 2 hours

Exclusion Criteria:

* Difficult intubation history
* BMI\>35
* Open cholesistectomies

Primary outcomes:
measure: Ventilatory efficiency pressures for the LMA Protector
timeFrame: Intraoperative
Secondary outcomes:
measure: Feasibility of LMA Protector
timeFrame: Intraoperative
measure: Ease of insertion of LMA Protector
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Derince Research and Training Hospital
Study officials:
affiliation: Derince Research and Training Hospital
name: Mehmet Yılmaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh K, Gurha P. Comparative evaluation of Ambu AuraGain with ProSeal laryngeal mask airway in patients undergoing laparoscopic cholecystectomy. Indian J Anaesth. 2017 Jun;61(6):469-474. doi: 10.4103/ija.IJA_163_17.
citation: Park SY, Rim JC, Kim H, Lee JH, Chung CJ. Comparison of i-gel(R) and LMA Supreme(R) during laparoscopic cholecystectomy. Korean J Anesthesiol. 2015 Oct;68(5):455-61. doi: 10.4097/kjae.2015.68.5.455. Epub 2015 Sep 30.