louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06373237: Outcome of Embryos Transferred After Initial Chaotic Results on PGT-A
Official title: Retrospective Observation of Outcomes of Embryos Transferred After Initial Chaotic Results on Preimplantation Genetic Testing for Aneuploidy (PGT-A)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Infertility
Lead sponsor: Inception Fertility Research Institute, LLC
Sponsor class: INDUSTRY
Collaborators: name: Igenomix
First posted: 2024-04-18
Enrollment: 2000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of any age who have conducted PGT-A via Igenomix who have transferred an embryo with an initial chaotic result.

Brief summary: This is a retrospective review of treatment outcomes from fertility clinics in The Prelude Network who have used Igenomix for PGT-A and have transferred embryos with initial chaotic results, regardless if re-biopsy was performed.

Detailed description: Primary objective: to observe the outcomes of embryos transferred with initial "chaotic" results on PGT-A via Igenomix.

Hypothesis: The transfer of chaotic embryos can result in clinical pregnancy, as defined by fetal heartbeat at 6-8 weeks gestation. Furthermore, these transfers may also result in live birth and expand reproductive potential for patients seeking IVF with PGT-A.

Eligibility criteria: Inclusion Criteria:

* Patients that conducted PGT-A via Igenomix who have transferred an embryo with an initial chaotic result.

Exclusion Criteria:

* Patients who had multiple embryo transfer.

Primary outcomes:
measure: Embryo re-biopsy rate
timeFrame: 2 years
measure: Embryo transfer rate
timeFrame: 2 years
measure: Pregnancy rate
timeFrame: 2 years
measure: Live birth rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Inception Fertility LLC
state: Texas
Study officials:
References:
Clinical trial NCT02396537: Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration
Official title: Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration: A Double-blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Children
Midazolam
Lidocaine
Intranasal
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 77
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study was to establish whether premedication with topical lidocaine would reduce the pain associated with IN midazolam administration in children. The study was designed to be a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department.

Detailed description: This was a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department with an annual census of 67,000 patients. Children 6-12 years old for whom IN midazolam was ordered were eligible for enrollment. Patients were randomly assigned an identical intranasal medication (4% Lidocaine or 0.9% saline). Patients were administered the study drug followed by IN midazolam. Patients then assigned a pain score for midazolam administration using the Wong-Baker FACES Pain Rating scale. The primary endpoint of pain score was analyzed with a two-tailed Mann-Whitney U test, with P \< 0.05 considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* Ages 6-12
* Previously healthy
* Attending physician concludes that the patient would benefit from administration of an anxiolysis medication prior to a minor procedure

Exclusion Criteria:

* Moderate to severe asthma or other chronic lung disease
* Co-morbid conditions including cerebral palsy, developmental delay, or other chronic illness deemed by the Attending physician to be unsafe to receive anxiolysis with Versed.
* Any child presenting with a life-threatening condition.

Primary outcomes:
measure: Discomfort With Intranasal Midazolam Administration
timeFrame: immediately after administration of intranasal midazolam
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UAB Department of Pediatrics
name: David Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith D, Cheek H, Denson B, Pruitt CM. Lidocaine Pretreatment Reduces the Discomfort of Intranasal Midazolam Administration: A Randomized, Double-blind, Placebo-controlled Trial. Acad Emerg Med. 2017 Feb;24(2):161-167. doi: 10.1111/acem.13115. Epub 2017 Jan 30.
Clinical trial NCT00913237: To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets
Official title: Randomized, 2-way Crossover Bioavailability Study of Desipramine Hydrochloride 50 mg Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: Antidepressant
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Desipramine Hydrochloride 50 mg tablets.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Biodecision Laboratories
name: Jules Kann, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00766337: Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration
Official title: A Phase 2, Randomized, Masked, Controlled Clinical Study to Assess the Safety and Efficacy of Lucentis® Plus Sirolimus Versus Lucentis® Plus Placebo in Patients With Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Choroidal Neovascularization
Keywords: wet AMD
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
Collaborators: name: MacuSight, Inc.
First posted: 2008-10-03
Enrollment: 62
Sex: ALL
Minimum age (years): 50
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 safety and efficacy of an ocular sirolimus (rapamycin) formulation in combination with Lucentis in patients with sub-foveal choroidal neovascularization secondary to age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration within six months of initial study visit, and may have been treated with up to 3 Lucentis® (ranibizumab) or 3 Avastin® (bevacizumab) injections with the last injection administered at least 4 weeks prior to the initial study visit, or is treatment-naïve
* Visual acuity of 20/40 to 20/200 in the study eye

Exclusion Criteria:

* Any other ocular disease that could compromise vision in the study eye
* Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration

Primary outcomes:
measure: Best-corrected visual acuity by ETDRS
timeFrame: 120 days
Secondary outcomes:
measure: Retinal thickness
timeFrame: 120 days
measure: Safety across treatment groups
timeFrame: Through 2 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
Study officials:
affiliation: MacuSight, Inc.
name: Joel Naor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04381637: Newborn Infant Parasympathetic Evaluation (NIPE) Index After Standardized Tetanic Stimulations Under General Anesthesia
Official title: Newborn Infant Parasympathetic Evaluation (NIPE) Index After Three Standardized Tetanic Stimulations (10, 30 and 60 Miliamps) Performed in a Randomized Sequence Under General Anesthesia in a Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Monitoring
General anesthesia
Analgesia
Pain
Pediatric
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
First posted: 2020-05-11
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The research does not involve the evaluation or comparison of medical strategies.The order of application of the stimuli will be randomized according to a Latin square of order 3.
Primary purpose: DIAGNOSTIC

Brief summary: NIPE monitor is the recently developed pediatric version of the ANI monitor, which is used in adults to monitor analgesia during general anesthesia. In adults, under general anesthesia, ANI decreases after a nociceptive stimulation. The amplitude of this decrease is related to the intensity of the stim. This study aims to investigate if NIPE index decreases in the same manner after stimulations in anesthetized children.


Eligibility criteria: Inclusion Criteria:

* Elective surgery under general anesthesia requiring tracheal intubation and muscle relaxation
* Written informed consent obtained from parents (and from child if appropriate)

Exclusion Criteria:

* Thoracic or cardiac surgery
* Cardiac arrhythmia, Pace maker
* Analgesic medication less than 24 hours before surgery
* Chronic anticholinergic medication
* Contraindication to muscle relaxants or general anesthetics

Primary outcomes:
measure: Variation of NIPE index (∆NIPE)
timeFrame: 3 minutes following tetanic stimulation
Secondary outcomes:
measure: Heart rate Variation (∆HR)
timeFrame: 3 minutes following tetanic stimulation
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Anne LAFFARGUE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lebrun S, Boccara J, Cailliau E, Herbet M, Tavernier B, Constant I, Sabourdin N. Quantitative assessment of a pediatric nociception monitor in children under sevoflurane anesthesia. Reg Anesth Pain Med. 2022 Jun 2:rapm-2022-103547. doi: 10.1136/rapm-2022-103547. Online ahead of print.
Clinical trial NCT00234637: Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor Treatment
Official title: An Open-label Study to Evaluate the Efficacy and Safety of add-on Memantine [5-10 mg b.i.d (10-20 mg/Day)] to Rivastigmine [1.5-6 mg b.i.d. (3-12 mg/Day)] Treatment in Patients With Alzheimer's Disease Who Continued With Rivastigmine Treatment After a Previous Decline While on Donepezil or Galantamine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease,
switch,
rivastigmine,
memantine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-07
Enrollment: 204
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multicenter, open-label study. Following screening and baseline assessments, eligible patients will be switched to rivastigmine and will enter the 16 week run-in rivastigmine treatment phase. After completion of assessments at the end of the run-in phase, patients who were not sufficiently stabilized on rivastigmine alone will receive add-on memantine to their rivastigmine treatment; patients who were stabilized on rivastigmine alone will have completed and be discontinued from the study.


Eligibility criteria: Inclusion Criteria:

* Outpatients who have probable Alzheimer's disease according to the DSMIV criteria
* Patients treated with donepezil (5-10 mg ) or galantamine (16- 24 mg) for at least 6 months
* Patients, in the investigator's clinical judgment, not stabilized on treatment with donepezil or galantamine

Exclusion Criteria:

* Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, active peptic ulcer disease, hypersensitivity to cholinesterase inhibitors or memantine, clinically significant laboratory abnormalities or any patient with a medical condition which would prohibit them from completing the clinical trial

Primary outcomes:
measure: The proportion of responders (cognitive function stable or improved) at the end of phase 2 (vs. end of phase 1).
Secondary outcomes:
measure: Change in cognition at weeks 16 and 28 (end of period 1) compared to baseline
measure: Change in caregiver burden at weeks 16 and 28 (end of period 1) compared to baseline
measure: Change in behavior at weeks 16 and 28 (end of period 1) compared to baseline
measure: Change in executive function at weeks 16 and 28 (end of period 1) compared to baseline
Other outcomes:
Locations:
city: Limoges
country: France
facility: Département de Gérontologie Clinique
state: Cedex
Study officials:
affiliation: Centre Hospitalier Universitaire
name: Thierry Dantoine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05238337: A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200 Following a Single Oral Dose in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Absorption, Metabolism and Excretion in Healthy Volunteers
Lead sponsor: Pyramid Biosciences
Sponsor class: INDUSTRY
First posted: 2022-02-14
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, open-label non-randomized, single dose study in healthy male subjects.

Detailed description: This is a Phase 1, open-label nonrandomized, single dose study in healthy male subjects to determine the absorption, metabolism, and excretion (AME) of \[14C\]-PBI-200

Eligibility criteria: Key Inclusion Criteria:

* Males, of any race, 18 to 65 years of age as of the dosing day.
* Body mass index between 18.0 and 32.0 kg/m2, inclusive.
* Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness.

Key Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).

Primary outcomes:
measure: Total Radioactivity in Urine and Feces
timeFrame: 28 days
measure: Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to infinity [AUC(0-inf)]
timeFrame: 28 days
measure: Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of the last quantifiable concentration [AUC(0-tlast)
timeFrame: 28 days
measure: Maximum Observed Concentration [C(max)]
timeFrame: 28 days
measure: Time to Maximum Concentration [T(max)]
timeFrame: 28 days
measure: Apparent Terminal Elimination Half-life [t(1/2)]
timeFrame: 28 days
measure: Total Radioactivity in Plasma and Whole Blood
timeFrame: 28 days
measure: Ratio for AUC(0-inf) Blood / Plasma
timeFrame: 28 days
measure: Ratio for AUC(0-inf) Plasma PBI-200 / Total Radioactivity
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Labcorp Clinical Research Unit Inc
state: Wisconsin
Study officials:
affiliation: Pyramid Biosciences
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT04809337: Therapeutic Exercises and Stabilization Exercises Given After Manual Therapy
Official title: Comparison of the Effects of Therapeutic Exercises and Stabilization Exercises After Manual Therapy in Patients With Non-Specific Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Non-Specific Chronic Neck Pain
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was conducted to determine and compare the effects of the therapeutic exercises and stabilization exercises given to the patient after the manual therapy session on pain, neck range of motion, daily living activities and quality of life.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-65,
* having neck pain for 3 months or longer,
* was diagnosed with chronic neck pain by a specialist.

Exclusion Criteria:

* People with neurological diseases,
* who had previous surgery in the cervical region,
* who had medulla spinalis tumors,
* vascular pathologies,
* fractures,
* osteoporosis,
* rheumatoid arthritis problems were not included in the study.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 1 minute
measure: Range of motion
timeFrame: 10 minute
Secondary outcomes:
measure: Lateral Scapular Shift Test
timeFrame: 5 minute
measure: Neck Disability Index
timeFrame: 3 minutes
measure: Bournemouth Neck Pain Questionnaire
timeFrame: 5 minutes
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Emine
Study officials:
References:
Clinical trial NCT04475237: Virtual Anatomical Reconstruction of Mandibular Bone Defects Using a Statistical Shape Model
Official title: Virtual Anatomical Reconstruction of Mandibular Bone Defects Using a Statistical Shape Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mandibular Diseases
SSM
Lead sponsor: CADskills
Sponsor class: INDUSTRY
First posted: 2020-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: European adults

Brief summary: Hundred already taken CT-scans (50 male and 50 female) will be anonymized. These scans will be segmented and implemented into a statistical shape model that will be used to predict missing hard tissue of a mandible based on the remaining bone.

Detailed description: Together with the radiology and Craniomaxillofacial (CMF) department, 100 scans will be selected from the database (50 males and 50 females, between 20 and 60 years old). First, they will be anonymized (except the sex and age/date of birth). Afterwards, they will be segmented using Materialise Mimics software. The segmented mandibles will then be used to create a statistical shape model (SSM) using principal component analysis. This model will afterwards be used to predict the mandibular shapes.

Eligibility criteria: Inclusion Criteria:

* Healthy mandibles

Exclusion Criteria:

* Mandibles with major deformities
* Mandibles with obvious problems
* Mandibles that already underwent surgery

Primary outcomes:
measure: A statistical shape model of a mandible
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: CADskills HQ
state: East-Flanders
Study officials:
References:
Clinical trial NCT03125837: Establishment of Airway Database for Surgical Patients
Official title: Study on the Method of Difficult Airway Prediction Based on Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Difficult Airway
Artificial Intelligence
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang University
First posted: 2017-04-24
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients who underwent general anesthesia with endotracheal intubation

Brief summary: Difficult airway is a major reason of anesthesia related injuries with latent life threatening complications. Foresee difficult airway in the preoperative period is vital for the patient's safety. The aim of this study is to develop a computer algorithm that can detect whether the patient is a difficult airway based on photographs form six aspects. This method will be decreased potential complication related to difficult airway and increased patient safety.

Detailed description: Introduction:

The primary purpose of the study is to develop a computer algorithm that can detect whether the patient is a difficult airway based on photographs from six different aspects.

Methods:

This study is divided into two parts. In the first part, we collected the patients' airway assessment score who underwent general anesthesia with endotracheal intubation assessed by an experienced attending anesthesiologists before and after intubation. Evaluation of airway score after tracheal intubation as the gold standard for airway assessment. Digital photographs of the face of each patient in frontal neutral view and in profile neutrals were obtained. Details of the photographs, each corresponding to a facial motion: (1) Frontal, neutral. (2) Frontal, mouth open. (3)Frontal, extreme mouth open and tongue out. (4)Frontal, extreme upper lip bite (5)Profile, neutral. (6) Profile, neutral, maximum head back. The patient's photographs and the airway evaluation score after intubation were input to the computer to train the computer. In the second part, the trained computer was used to evaluate the airway score of the new patient compared with that of the patient after intubation, and calculated the sensitivity.

Eligibility criteria: Inclusion Criteria:

* General anesthesia-induced tracheal intubation in patients who undergoing elective surgical patients

Exclusion Criteria:

* Patients with multiple facial injuries Patients who had undergone head or neck surgery Patients who need emergency operation

Primary outcomes:
measure: the sensitivity of artificial Intelligence to predict difficulty of facemask ventilation and endotracheal intubation
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: