louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04381585: Mini Distractor in Vertically Deficient Bone
Official title: Efficacy of Distraction Osteogenesis in Vertically Deficient Anterior Maxillary and Mandibular Bone by Using Mini Distractor With a Submerged Activation Component. A Clinical and Radiographical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Alveolar Bone Loss
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: ADO is a bone regeneration technique, introduced by Chin and Toth in 1996 based in a biological process used for regenerate and consolidate bone between two bone segments obtained after osteotomy.These segments have been gradually separated by the process of distraction. ADO can be performed both horizontally (AHDO) and vertically (AVDO).

Detailed description: Distraction osteogenesis (DO) can be used to regenerate missing hard and soft tissue, Distraction osteogenesis relies on the body's ability to generate bone as two segments of bone are "distracted" apart. The osteotomies are created and the distraction device is placed. Typically, there is a latency phase of one week were a ﬁbrovascular bridge is formed in the osteotomy site. This provides a template to generate new bone as the segments are distracted apart during the activation phase. Once the desired distraction has occurred, the device is left in place for a period of time. Once consolidation (typically 2 to 6 months) has occurred, the distraction device can be removed and implants can be placed. Chiapasco compared GBR to DO and found that both are equally effective in alveolar bone augmentation for implant placement and further stated that the long-term prognosis of vertical bone gain in DO is more predictable.

Eligibility criteria: Inclusion Criteria:

* Acquired alveolar defects (Post extraction, Traumatic avulsion of teeth, Periodontal disease, After tumor resection), congenital alveolar defects, vertically deficient edentulous ridge in maxillary or mandibular anterior region with
* Allen Type A moderate vertical ridge deficiency (3-6mm)

Exclusion Criteria

* Medically compromised patients
* Subjects who underwent radiotherapy or chemotherapy
* Smokers and
* Radiographic presence of less than 5mm of anterior maxillary and mandibular bone height

Primary outcomes:
measure: height of the residual bone
timeFrame: From baseline to 6months.
Secondary outcomes:
measure: Degree of inflammation in gingiva
timeFrame: From baseline to 2-months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Svs Institute of Dental Science
state: Telangana
Study officials:
References:
Clinical trial NCT01123785: A Dose-Escalation Study Designed to Evaluate the Tolerability, Safety, Pharmacokinetics (PK), and Efficacy of Chronic Topical Ocular Application of INO-8875 in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
Official title: A Phase I/II Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics (Efficacy) of Chronic Twice-Daily Topical Monocular Application of INO-8875 Ophthalmic Formulation in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glaucoma
Ocular Hypertension
Keywords: glaucoma
ocular hypertension
adenosine agonist
eye drop
primary open angle glaucoma
Lead sponsor: Inotek Pharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2010-05-14
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
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 how tolerable, safe, and effective it is to give INO-8875 eye drops to adults with glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

1. Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG).
2. Aged 18 to 75 years.
3. Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.

Exclusion Criteria:

1. No significant visual field loss or any new field loss within the past year.
2. Cup-to-disc ratio ≥0.8
3. Central corneal thickness \<500 µm or \>600 µm
4. History of adult asthma or chronic obstructive pulmonary disease
5. A recent (acute) or chronic medical condition that might obfuscate the Subject's study data

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 14 days
Secondary outcomes:
measure: Number of Participants with decreased Intra-ocular pressure
timeFrame: 14 days
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Lugene Eye Institute
state: California
Study officials:
References:
Clinical trial NCT03225456: Oxytocin and Eating
Official title: Exploring the Effects of Oxytocin on Appetite Regulation in Healthy Adult Men
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Weight Gain
Keywords: appetite regulation
obesity
oxytocin
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
name: SingHealth Investigational Medicine Unit
First posted: 2017-07-21
Enrollment: 60
Sex: MALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this protocol, the investigators propose a randomised controlled trial to explore the effects of intra-nasal oxytocin administration on appetite regulation. The investigators will run a cross-over design with 60 healthy adult men.


Eligibility criteria: Inclusion Criteria:

* Gender: Male
* Age: 21-45 years
* Normal weight: Body mass index of 18.5 to 22.9
* Have had a stable weight for the past 3 months (less than 5kg)
* Have regular breakfast meals (≥ 4 times a week of self-reported consumption of a breakfast meal)
* Have habitual sleep of 6.5-8.5 hours
* Have English as first language (or fluent in spoken and written English)

Exclusion Criteria:

* Symptoms / history of any major medical condition, including:

  * Bariatric surgery or surgical obesity treatment
  * Diabetes
  * Cardiovascular disease
  * Thyroid disease
  * Anaemia
  * Psychiatric disorders
  * Eating disorders
* Excessive exercise (running \> 40 km or exercising \> 10 hr in a week)
* Currently on a special diet or trying deliberately to restrict food intake
* Currently on a weight loss program
* Smoking or substance abuse
* Use of medications that can affect weight (e.g., steroids, approved weight-loss drugs)

Primary outcomes:
measure: Taste sensitivity
timeFrame: 2-hour span following oxytocin administration
measure: Taste preference
timeFrame: 2-hour span following oxytocin administration
measure: Value placed upon food
timeFrame: 2-hour span following oxytocin administration
Secondary outcomes:
measure: Subjective ratings of hunger and fullness
timeFrame: 2-hour span following oxytocin administration
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yale-NUS College
Study officials:
References:
Clinical trial NCT01877785: A Study of MHAA4549A to Assess Safety And Pharmacokinetics in Healthy Volunteers
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAA4549A in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This randomized, double-blind, placebo-controlled, single-ascending dose study will assess the safety, tolerability and pharmacokinetics of ascending doses of MHAA4549A in healthy volunteers. Volunteers will be randomized to receive a single dose of MHAA4549A or matching placebo.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Body mass index (BMI) between 18 and 32 kg/m2, inclusive
* Weight 40 to 100 kg
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
* Clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor
* Volunteers agree to use acceptable contraceptive measures

Exclusion Criteria:

* History or clinically significant manifestations of disorders
* History of anaphylaxis, hypersensitivity or drug allergies
* History or presence of an abnormal ECG
* History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit
* History of significant drug abuse within 1 year prior to screening
* Current tobacco smokers
* Positive drug screen at screening or at check-in
* Positive pregnancy test result at screening or Day -1 or breast feeding during the study

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 120 days
Secondary outcomes:
measure: Incidence of anti-therapeutic antibodies
timeFrame: 120 days
measure: Pharmacokinetics: Serum concentration-time profile of MHAA4549A
timeFrame: Pre-dose on day 1 to day 120 post-dose
Other outcomes:
Locations:
city: Quebec
country: Canada
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lim JJ, Deng R, Derby MA, Larouche R, Horn P, Anderson M, Maia M, Carrier S, Pelletier I, Burgess T, Kulkarni P, Newton E, Tavel JA. Two Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Studies To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza A Virus Monoclonal Antibody, MHAA4549A, in Healthy Volunteers. Antimicrob Agents Chemother. 2016 Aug 22;60(9):5437-44. doi: 10.1128/AAC.00607-16. Print 2016 Sep.
Clinical trial NCT06253156: The Effect of Virtual Reality-Based Disaster Education Given to Nursing Students on Disaster Preparedness
Official title: The Effect of Virtual Reality-Based Disaster Education Given to Nursing Students on Disaster Preparedness: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disaster; Personality
Disorder, Mood
Keywords: Disaster
Disaster Preparedness
Psychological Preparedness
Nursing Students
Virtual Reality
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: ZİYAFET UĞURLU
First posted: 2024-02-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is thought that, as a result of the virtual reality-based disaster training given to nursing students, the psychological preparedness of nursing students who will work before, during and after the disaster will increase in disaster preparedness and disaster threat. It is thought that this research will lead to the development of school-based interventions at other universities in similar situations.

The purpose of this research is to increase the level of psychological preparation and awareness of disaster preparedness and disaster threat through virtual reality-based disaster education given to nursing students.


Eligibility criteria: Inclusion Criteria:

* Being a 3rd and 4th year nursing student at the relevant universities where the study will be conducted,
* Not having taken the disaster management course before,
* Not having any health problems related to vision and hearing,
* Not wearing glasses to be able to use virtual reality (VR) glasses

Exclusion Criteria:

* Having any problems with vision or hearing
* Using glasses

Primary outcomes:
measure: DİSASTER PREPARATION
timeFrame: 1-2 mounth
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Başkent University
Study officials:
affiliation: bertugrul@baskent.edu.tr
name: Bekir ERTUĞRUL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03998956: High-density Mapping-guided bOx Isolation and subsTrate Ablation
Official title: Study of High-density Mapping-guided bOx Isolation and subsTrate Ablation for Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Atrial Remodeling
Keywords: catheter ablation
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.


Eligibility criteria: Inclusion Criteria:

* Informed consent signed.
* Age of 18 to 75 years old.
* Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months.
* Willing to have catheter ablation for atrial fibrillation.

Exclusion Criteria:

* Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on.
* Complete atrioventricular block.
* An acute stroke or contradiction of anti-coagulation.
* Hyperthyroidism.
* Having a history of catheter ablation of atrial fibrillation.
* Left atrial appendage thrombosis confirmed by transesophageal echocardiography.
* Pregnancy or lactation.
* Planning for pregnancy in the near future.
* Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal.
* Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.

Primary outcomes:
measure: sinus rhythm maintenance rate
timeFrame: 12 months
Secondary outcomes:
measure: left ventricular ejection fraction
timeFrame: 12 months
measure: Stroke or embolic events
timeFrame: 12 months
measure: Atrial fibrosis
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03549156: Comparison of a Two Ready-to-use Supplementary Foods of Differing Protein Quality for the Treatment of MAM.
Official title: Comparison of a Two Ready-to-use Supplementary Foods of Differing Protein Quality for the Treatment of Moderate Acute Malnutrition in Rural Malawian Children: a Randomised, Investigator-blinded, Clinical Effectiveness Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Moderate Acute Malnutrition, Malnutrition
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Arla Foods
name: Kamuzu University of Health Sciences
name: Project Peanut Butter
First posted: 2018-06-07
Enrollment: 1858
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomised, double-blinded, controlled clinical effectiveness trial of two supplementary foods in the treatment of MAM. The setting will be 21 rural sites in southern Malawi. The participants will be 1800 children 6-59 months old with MAM, defined as mid-upper arm circumference (MUAC) ≥ 11.5 cm and \< 12.5 cm and/or a weight-for-height Z-score (WHZ) between -2 and -3 without bipedal edema. Children will receive approximately 75 kcal/kg/d (314 kJ/kg/d) of one of two RUSFs in two-week rations for outpatient therapy of MAM. The two supplements will be a novel, locally produced peanut/dairy RUSFs, one with a high protein quality (HIPRO RUSF) or one with a standard protein quality, referred to as control RUSF (C-RUSF). The primary outcome measures will be recovery from MAM (achieving MUAC ≥ 12.5 cm and/or WHZ\>-2 by 12 weeks) or failure (death, development of severe acute malnutrition, transfer to hospital for inpatient care, failure to recover from MAM by 12 weeks, default). Secondary outcome measures include rates of weight, height, and mid-upper-arm circumference (MUAC) gain, time to graduation, and adverse effects from the supplementary foods.


Eligibility criteria: Inclusion Criteria:

* MUAC \< 12.5 cm and ≥ 11.5 cm
* without bipedal edema

Exclusion Criteria:

* simultaneously involved in another research trial or supplemental feeding program
* developmentally delayed, have a chronic debilitating illness such as cerebral palsy
* history of peanut or milk allergy

Primary outcomes:
measure: Recovery from Moderate Acute Malnutrition using Mid-Upper Arm Circumference (MUAC) and Weight for Height Z score (WHZ)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Local Feeding Clinics
Study officials:
affiliation: Washington University School of Medicine in St. Louis
name: Mark Manary, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02188056: Observational Prospectif Monocentric Registry of Patients Suffering From VIE
Official title: Observational Prospectif Monocentric Registry of Patients Suffering From VIE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Thromboembolic Disease
Keywords: Venous
Thromboembolic
Pulmonary embolism
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a venous thromboembolic event, hospitalized in the Department of Vascular Diseases and Hypertension, UF 1311 will included in the registry prospectively.

Brief summary: Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For a number of these patients, risk factors have been identified (congenital or acquired thrombophilia, cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of cases, the etiology remains unknown, justifying the need for well-conducted studies to determine other potential risk factors. In addition, the expansion of treatment options with the arrival on the market of new direct oral anticoagulants, allows comparative studies on the effectiveness and frequency of adverse events for each treatment.


Eligibility criteria: Inclusion Criteria:

* diagnosis of venous thromboembolism established by a validated test (venous Doppler ultrasound of the lower limbs, pulmonary angiography, lung scan ventilation / perfusion),
* diagnosis of venous thromboembolism made within 15 days,
* the previous inclusion in the register (outpatient or inpatient)

Exclusion Criteria:

* person doesn't wish to participate in this study

Primary outcomes:
measure: incidence of recurrent thromboembolic
timeFrame: at 1 year post-diagnosis
measure: bleeding complications incidence
timeFrame: at 1 year post-diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Des Maladies Vasculaires - Hta - Nhc
Study officials:
affiliation: Strasbourg University Hospital, France
name: Dominique STEPHAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00790556: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)
Official title: A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of MK8245.

Detailed description: Hypothesis: Multiple doses of MK-8245 are sufficiently safe and well tolerated in patients with Type 2 diabetes based on an assessment of clinical and laboratory adverse experiences (AEs), to permit continued clinical investigation.

Eligibility criteria: Inclusion Criteria:

* Subject has a diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or a single oral anti-hyperglycemic agent
* Subject is willing to follow the weight-maintaining diet and exercise program or equivalent beginning 4 weeks before receiving study drug, throughout the study and until the post study visit
* Subject has been a nonsmoker and/or has not used nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of neoplastic disease (except non-melanomatous skin carcinoma, carcinoma in situ of the cervix, other malignancies successfully treated at least 10 years prior to screening, or malignancies deemed highly unlikely to recur.)
* Subject has a history of Type 1 Diabetes Mellitus and/or history of ketoacidosis
* Subject has a history of contact lens use within approximately the previous 6 months
* Subject has been diagnosed with dry eye syndrome
* Subject has used lipid-lowering therapies in the past 3 months (Subjects on a stable monotherapy dose of statins may be included)
* Subject has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks of starting in the study

Primary outcomes:
measure: Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)
timeFrame: 56 days
measure: Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14
timeFrame: Day 14 of each 14-day Treatment Period
Secondary outcomes:
Other outcomes:
measure: Hepatic Glucose Production (HGP) at Baseline
timeFrame: Baseline
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Nio Y, Hasegawa H, Okamura H, Miyayama Y, Akahori Y, Hijikata M. Liver-specific mono-unsaturated fatty acid synthase-1 inhibitor for anti-hepatitis C treatment. Antiviral Res. 2016 Aug;132:262-7. doi: 10.1016/j.antiviral.2016.07.003. Epub 2016 Jul 5.