louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06016218: Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes
Official title: Effect of Local Application of Platelet-Rich Fibrin Scaffold Loaded With Simvastatin Versus Bone Powder on Peri-Implant Bone Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dental Caries Extending to Pulp
Dental Implant Failed
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 24
Sex: MALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not.

This will be done through:

1. Measuring bone changes around the implant by cone beam
2. Measuring change in bone density around the implants

B- Evaluate the effect of statins on osteoblasts activity and expression of various osteogenic products in vitro.

Detailed description: Twenty four patients requiring rehabilitation by immediate implantation in an extraction socket were recruited for this study. The Patients were divided into three groups (n=8), For the first group; immediately after extraction, PRF alone was added into the extraction socket prior to implant insertion. For the second group, PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion. For the third Group; PRF + Bone powder are inserted into the extraction site before implant insertion. A conebeam CT was used to evaluate the effect on bone changes and bone density around implant sites, for every patient in all implant groups immediately after the surgery and at follow-up time. In vitro experiment: isolation of human Adipose mesenchymal stem cells (hAd-MSCs), characterization and osteogenic differentiation will be done. The cells were divided into two groups one control group and the other statin group. Osteogenic markers were measured in both groups and statistical analysis performed

Eligibility criteria: Inclusion Criteria:

* Badly Broken Down Tooth requiring extraction
* Medically Free
* Any other procedures or surgeries were performed 6 months earlier

Exclusion Criteria:

* patients with systemic diseases affecting bone quality or resorption
* temporomandibular joint dysfunction
* severe attrition or parafunctional habits
* patients undergoing radiotherapy or chemotherapy
* heavy smokers
* vulnerable groups like psychologically unstable patients.

Primary outcomes:
measure: Changes in crestal peri-imlant Bone
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The British University in Egypt
Study officials:
References:
Clinical trial NCT02081118: Glycaemic Control of Monthly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
Official title: A Phase II, 16-week, Double-blind, Placebo-controlled, Parallel-group, Randomised, Multicentre Trial to Assess Effect on Glycaemic Control of Three Doses of HM11260C in Subjects With Inadequately Controlled Type 2 Diabetes Receiving a Stable Dose of Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2014-03-07
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
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 the optimal dose or doses of HM11260C, when administered once a month under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).


Eligibility criteria: Inclusion Criteria:

* Ages eligible for study : 18 years to 74 years
* Genders eligible for study : Male and Female
* Diagnosed with T2DM
* Taking a stable dose of metformin monotherapy
* HbA1c levels of between ≥ 7.0% and ≤ 10.0%
* Females of childbearing potential who are not pregnant and agree to use a reliable method of birth control
* Written informed consent must be obtained

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Diagnosis of type 1 diabetes mellitus
* Uncontrolled diabetes defined as a FPG level of \> 240 mg/dL at screening
* A significant change in body weight in the 3 months before screening
* Any history of GI intolerance
* Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
* Known history of acute or chronic pancreatitis
* A history of alcohol or drug abuse or drug addiction

Primary outcomes:
measure: Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks
timeFrame: Up to day 155
Secondary outcomes:
measure: Fasting plasma glucose levels (FPG)
timeFrame: Up to day 155
measure: 7-point glucose profile
timeFrame: Up to day 155
measure: Serum lipid profile
timeFrame: Up to day 155
measure: Body weight
timeFrame: Up to day 155
measure: Fasting insulin
timeFrame: Up to day 155
measure: C-peptide
timeFrame: Up to day 155
measure: Glucagon
timeFrame: Up to day 155
measure: Glycated albumin
timeFrame: Up to day 155
Other outcomes:
measure: Number of Participants with Adverse Events by HM11260C
timeFrame: Up to day 155
measure: Number of Participants with Immunogenicity by HM11260C
timeFrame: Up to day 155
Locations:
city: Miami
country: United States
facility: Hanmi pharmaceutical
state: Florida
Study officials:
References:
Clinical trial NCT03321318: AK-R215 Pharmacokinetic Study Phase I
Official title: AK-R215 Pharmacokinetic Study Pharmacokinetic Characteristics of AK-R215 in Comparison to Each Component Coadministered in Healthy Adult Male or Menopausal Female Valunteers.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2017-10-25
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of AK-R215

Detailed description: An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the safety and pharmacokinetics characteristics after administration of fixed dose combination or loose combination of AK-R215 in healthy adult male or menopausal female volunteers

Eligibility criteria: Inclusion Criteria:

* BW is above 50kg and BMI is between 18.5 and 30.0
* Subject who agreed and signed on informed consent form prior to the study participation

Exclusion Criteria:

* Presence or history of clinically significant disease
* Treatment history of any drug which might affect IP within 10days
* History of other study drugs within 12weeks

Primary outcomes:
measure: AUC0-t
timeFrame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
measure: Cmax
timeFrame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
Secondary outcomes:
measure: Tmax
timeFrame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
measure: AUCinf,
timeFrame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
measure: T1/2
timeFrame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
Study officials:
References:
Clinical trial NCT03551418: Learning by Repetitive Viewing of Peer Modeling Patient Education Videos by Adults With Down Syndrome
Official title: Learning by Repetitive Viewing of Peer Modeling Patient Education Videos by Adults With Down Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Down Syndrome
Trisomy 21
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The learning of appropriate hand washing technique through repetitive watching of a video depicting an adult with DS washing his hands will be studied.

Detailed description: This study is a next step in evaluating the use of videos depicting a person with DS demonstrating hand washing. The initial study demonstrated improvement in hand washing technique with a verbal explanation of hand washing technique using an Illinois Department of Public Health handout and viewing one of the handwashing videos one time. The study demonstrated a statistical significant difference between learning by viewing the handout and a video of an adult with DS washing his hands vs just viewing the handout.viewing a handout Likely due to small sample size, the study did not demonstrate statistical significance between watching the video of a person with DS washing his hands vs watching the other videos but the trend for the best improvement in handwashing technique was for the group viewing another person with DS demonstrating the handwashing. The hypothesis of this study is that repeated viewing of a video and practicing hand washing will lead to even greater improvement in hand washing technique.

Eligibility criteria: Inclusion criteria

Individuals with:

* DS aged 18 and older
* The ability to use a checklist or to be taught how to use a checklist
* The ability to use a tablet or to be taught how to use a tablet
* Access to an Internet connection

Exclusion criteria

Individuals who:

* Are not yet adults
* Are unwilling to consent and/or assent
* Are unable or unwilling to return the ADSC for the 1 month and 2 months follow up visits
* sensitivity to soap

Primary outcomes:
measure: Appropriate hand washing technique
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Park Ridge
country: United States
facility: Adult Down Syndrome Center / Russell Institute for Research and Innovation
state: Illinois
Study officials:
affiliation: Wake Forest University Health Sciences
name: Brian Chicoine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06966518: Intraoperative Combination of Ketamine and Magnesium Sulfate Infusions on Postoperative Analgesia in Open Rhinoplasty
Official title: Effectiveness of Intraoperative Combination of Ketamine and Magnesium Sulfate Infusions on Postoperative Analgesia in Patients Undergoing Open Rhinoplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraoperative
Ketamine
Magnesium Sulfate
Postoperative Analgesia
Rhinoplasty
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-12
Enrollment: 50
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: The study aims to evaluate the effectiveness of intraoperative combination of ketamine and magnesium sulfate infusions on postoperative analgesia in patients undergoing open rhinoplasty.

Detailed description: Postoperative pain remains one of the most crucial factors affecting patient satisfaction. These symptoms can be distressing for the patient and it may lead to negative psychological implications.

Ketamine is a non-competitive N-Methyl D-Aspartate (NMDA) receptor antagonist that works by blocking the NMDA receptors in the central and peripheral nervous systems.

Magnesium sulfate is also an antagonist for NMDA receptor that has been evaluated in several studies and showed that Mg sulfate decreased consumption of postoperative opioids.

Ketamine and magnesium sulfate have different sites of action on NMDA receptors, so their combination may produce a synergistic effect on NMDA receptors, resulting in more control of postoperative pain and more sparing of consumption of opioids.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I - II.
* Scheduled for rhinoplasty under general anesthesia.

Exclusion Criteria:

* Receiving analgesic or any medications since 48 hours before the surgery.
* Drug addiction.
* Cardiovascular disease.
* Respiratory disease, renal, liver, metabolic and neurological disease.
* Pregnancy or breast feeding.
* Asthma.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Time to the 1st rescue analgesia.
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Heart rate
timeFrame: Till the end of surgery (Up to 2 hours)
measure: Mean arterial pressure
timeFrame: Till the end of surgery (Up to 2 hours)
measure: Degree of patient satisfaction
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events.
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT04664218: Are You in a Poor Country; HIPEC is Still in Reach
Official title: Are You in a Poor Country; HIPEC is Still in Reach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIPEC
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Peritoneal carcinomatosis (PC) is a well-known sequel of multiple abdominal malignancies either arising from the gastro-intestinal tract or of gynaecologic origin. On occurrence, PC is mostly considered as a very bad prognostic sign hence it affects the overall survival with very poor response to systemic chemotherapy.

On introduction of the new concept of combined optimal cytoreduction (CRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC), promising prognosis began to be shown.

A major obstacle which may face application of HIPEC manoeuvre is the cost either of the machine or the disposable kit used in handling the chemotherapy, heating it and delivering it to the patient, hence we established our machine design with its disposable kits making it available for use in poor places.

Detailed description: As aforementioned the use of HIPEC technique offered a promising results in dealing with peritoneal carcinomatosis the high costs seems to be a considerable obstacle in some poor places so we inented a machine with considerably lower costs both in the machine composition and its disposable kit used for every patient we used it for six years in a trial to find any shortage, obstacles or any technical, therapeutic or financial drawbacks compared to the published data of the standard machines

Eligibility criteria: Inclusion Criteria:

* Any patient candidate for HIPEC procedure

Exclusion Criteria:

* Contraindications to HIPEC procedure

Primary outcomes:
measure: Thermal efficiency of the machine
timeFrame: 6 years of the study using the machine
measure: Electrical efficiency of the machine
timeFrame: 6 years of the study using the machine
measure: The manufacturing costs in US dollar
timeFrame: one weak at the start of the trial
measure: The disposable costs in US dollar
timeFrame: 6 years of the study using the machine
Secondary outcomes:
measure: Adverse effects on the patient following HIPEC
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00439413: Selegiline for Smoking Cessation - 1
Official title: Phase 2, Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nicotine Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: VA Office of Research and Development
First posted: 2007-02-23
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is designed to examine the effects of Selegiline Transdermal System and behavioral intervention in smoking cessation as compared to behavioral intervention alone.


Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years of age
* Be in good general health
* Must meet Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for nicotine dependence
* Be currently smoking \> 15 cigarettes/day, and have smoked cigarettes for the past 5 years
* Subjects must be motivated to quite smoking
* If female and of child bearing potential, agrees to use birth control and subject
* Subject must be able to understand and provide written informed consent.

Exclusion

Criteria:

* Please contact site for more information

Primary outcomes:
measure: Quit Rate
timeFrame: Study weeks 6 through 9
Secondary outcomes:
measure: Abstinence
timeFrame: week 14
Other outcomes:
Locations:
city: College Park
country: United States
facility: Department of Public & Community Health
state: Maryland
city: New Brunswick
country: United States
facility: Robert Wood Johnson Med School-Tobacco Dep Program
state: New Jersey
city: Cincinnati
country: United States
facility: Tri-State Tobacco and Alcohol Research Center
state: Ohio
city: Milwaukee
country: United States
facility: Center For Tobacco Research and Intervention
state: Wisconsin
Study officials:
affiliation: VA Medical Center
name: Elbert D Glover, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kahn R, Gorgon L, Jones K, McSherry F, Glover ED, Anthenelli RM, Jackson T, Williams J, Murtaugh C, Montoya I, Yu E, Elkashef A. Selegiline transdermal system (STS) as an aid for smoking cessation. Nicotine Tob Res. 2012 Mar;14(3):377-82. doi: 10.1093/ntr/ntr143. Epub 2011 Aug 16.
Clinical trial NCT03848013: Treatment of Melasma Using Q-switched Nd: YAG Laser and Fractional CO2 Laser Separately and in Combination
Official title: Reatment of Melasma Using Q-switched Nd: YAG Laser and Fractional CO2 Laser Separately and in Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melasma
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * All participants will be divided into 2 groups : Group A \& Group B.
* Group A will be subjected to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser to one side of the face \& fractional co2 laser to the other side of the face with one month interval between sessions.
* Group B will be subjected also to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser to one side of the face \& an additional fractional co2 laser to the other side of the face using the above mentioned parameters with one month interval between sessions.
* Response to treatment will be assessed using the Melanin Index (MI) score, Melasma Area and Severity Index (MASI) score, spectrophotometer ( Derma catch, colorix, Neuchatel, Switzerland ) and a subjective self-assessment method.


Eligibility criteria: Inclusion Criteria:

* melasma patients above 18 years

Exclusion Criteria:

* Pregnancy.
* Usage of chemical peeling 1 month prior to the study.
* Isotretinoin intake 6 months prior to the study.
* Any laser procedure related to melasma lesions 1 month prior to the study.
* Active herpetic lesions.
* Any concurrent active skin disease within the treated area.
* Photosensitive skin conditions such as systemic lupus erythematous.
* History of delayed wound healing.
* Keloid formation.
* Bleeding diathesis.
* Medical conditions such as diabetes mellitus \& autoimmune diseases.

Primary outcomes:
measure: Modified Melasma Area and Severity index change.
timeFrame: 6 months to 1 year
measure: Melanin index change.
timeFrame: 6 months to 1 year
measure: percentage of clinical improvement
timeFrame: 6 months to 1 year
measure: patient satisfaction rate
timeFrame: 6 months to 1 year
Secondary outcomes:
measure: Modified Melasma Area and Severity Index change.
timeFrame: 6 months to 1 year
measure: Melanin index change.
timeFrame: 6 months to 1 year
measure: percentage of clinical improvement
timeFrame: 6 months to 1 year
measure: patient satisfaction rate
timeFrame: 6 months to 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Kasr Al Ainy Hospital Dermatology department
state: El Manial
Study officials:
References:
Clinical trial NCT03004313: Structural and Molecular Neuroplasticity in Migraine
Official title: Structural and Molecular Neuroplasticity in Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: migraine
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to integrate novel MRI techniques with positron emission tomography(PET) for the study of structural and molecular neuroplasticity in the brain of migraineurs, and its clinical association with changes in pain perception and modulation (e.g. allodynia). We will attempt to acquire images of the brain that may, in the future, assist doctors in better understanding how pain is felt and regulated in migraine sufferers.

Detailed description: To investigate interictal opioid receptor (MOR) binding potential (BPND) changes in migraineurs as compared to age/gender-matched healthy controls. To demonstrate that frequency of the headache attacks and severity of cutaneous allodynia levels in migraineurs experienced over multiple attacks are correlated with levels of MOR BPND in specific brain regions. To investigate whether dysfunction of the pain regulatory endogenous opioid system of migraineurs is correlated with changes in the gray matter thickness in cortical areas associated with pain perception and modulation.

Eligibility criteria: Inclusion Criteria:

* Between 18-45 years of age
* Between 1-14 migraine attacks per month or healthy

Exclusion Criteria:

* Cannot be taking daily migraine medication
* Healthy subjects cannot be taking hormonal birth control pills or other medication
* Cannot have chronic pain or a neurologic/psychiatric disorder such as: multiple sclerosis and bipolar disorder.

Primary outcomes:
measure: Level of mu-opioid receptor binding potential in the brain of episodic migraineurs during and outside the headache attack and compared to healthy controls.
timeFrame: 90 min PET scan
Secondary outcomes:
measure: Correlation of migraine attack severity in migraineurs with mu-opioid receptor binding potential
timeFrame: 90 min PET scan
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan - Michigan Center for Oral Health Research
state: Michigan
Study officials:
affiliation: University of Michigan
name: Alexandre DaSilva, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jassar H, Nascimento TD, Kaciroti N, DosSantos MF, Danciu T, Koeppe RA, Smith YR, Bigal ME, Porreca F, Casey KL, Zubieta JK, DaSilva AF. Impact of chronic migraine attacks and their severity on the endogenous mu-opioid neurotransmission in the limbic system. Neuroimage Clin. 2019;23:101905. doi: 10.1016/j.nicl.2019.101905. Epub 2019 Jun 18.