louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06558435: Validation of BRACS to European Portuguese
Official title: Translation and Validation of "The Boston Residue and Clearance Scale" to European Portuguese
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deglutition Disorders
Swallowing Disorder
Dysphagia, Oropharyngeal
Keywords: Swallowing Disorders
Dysphagia
Fiberoptic Endoscopic Evaluation of Swallowing
Lead sponsor: Centro Hospitalar de Entre o Douro e Vouga
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neurological or mechanical dysphagia who have undergone a FEES examination and whose test meets the inclusion criteria described above.

Brief summary: The goal of this observational study is to translate and validate the fiberoptic endoscopic evaluation of swallowing scale "The Boston Residue and Clearance Scale - BRACS" to European Portuguese

Detailed description: The Boston Residue and Clearance Scale (BRACS) is a multidimensional scale developed and validated to assess the severity of residues observed during fiberoptic endoscopic evaluation of swallowing (FEES).

It differs from other FEES residue scales, since it considers all aspects related to pharyngolaryngeal residues, specifically, the location, amount and the patient's clearance ability.

The purpose of this study was to translate and cross-culturally adapt the English version of the BRACS into European Portuguese and to investigate the reliability and validity of the translated version of the scale.

Eligibility criteria: Inclusion Criteria:

* FEES recording that allowed good visualisation of the pharynx and larynx.
* FEES recording of patients after head and neck surgery who had anatomical alterations of the structures, but which did not interfere with good visualisation of the residues.
* FEES recording of patients with a tracheostomy or under tube feeding.

Exclusion Criteria:

* FEES recording of patients under 18 years of age.

Primary outcomes:
measure: Reliable and validated European Portuguese version of the BRACS
timeFrame: patients with neurological and/or mechanical oropharyngeal dysphagia evaluated FEES up to 3 months after the first symptomatology
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Maria Da Feira
country: Portugal
facility: Centro Hospitalar de Entre Douro e Vouga
Study officials:
References:
Clinical trial NCT01249235: Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery
Official title: Prospective Randomized Controlled Trial Comparing Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pterygium
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 19
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 if patching the eye or a bandage contact lens along with Tylenol #3 is more effective for pain control following pterygium surgery.


Eligibility criteria: Inclusion Criteria:

* Primary pterygium (no previous surgeries or radiotherapy) requiring excision due to ocular discomfort or disruption in vision
* Size of pterygium greater than 2.5 mm over the cornea (pterygia smaller than this do not result in much postoperative eye pain)
* Ability to understand the nature of the procedure and to complete all measurement requirements
* Adults (age greater than 18)

Exclusion Criteria:

* Ocular surface disease apart from pterygium (such as severe dry eye, corneal disease, scarring from previous infection, radiotherapy, inflammatory diseases or trauma)
* Patients who have had previous ocular surface surgery
* Contraindications to local anesthetics (such as known allergy)
* Pregnancy (as the risk to the fetus with the use of topical antibiotic drops and local anesthetics are not known)
* Patients already on systemic analgesics for any other reason (such as rheumatoid arthritis)
* Allergy to codeine (in order to standardize the systemic analgesic used so that we can compare the effect of bandage contact lens versus 24 hour patching)

Primary outcomes:
measure: Visual Analog Pain Score
timeFrame: 1 week
Secondary outcomes:
measure: Sensitivity to light, tearing, foreign body sensation
timeFrame: 1 week
measure: Postoperative Complications
timeFrame: 1 week
measure: Number of Tylenol #3 tablets required
timeFrame: 1 week
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital, University of Toronto
state: Ontario
Study officials:
affiliation: Toronto Western Hospital, University of Toronto
name: Allan Slomovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00405535: Adjunctive Glycine for Obsessive Compulsive Disorder
Official title: Adjunctive Glycine for Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Keywords: OCD
Obsessive Compulsive Disorder
Glycine
Lead sponsor: Nathan Kline Institute for Psychiatric Research
Sponsor class: OTHER
Collaborators: name: Obsessive Compulsive Foundation
First posted: 2006-11-30
Enrollment: 24
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 purpose of this study is to determine whether individuals with obsessive compulsive disorder who will take a preparation of the amino acid glycine in addition to their current treatment, may experience improvement in their symptoms.

Detailed description: Individuals with obsessive compulsive disorder (OCD) often find inadequate relief, even with the best of currently available treatments. Some evidence suggests the the neurotransmitter glutamate may be a useful target for new treatments for OCD. The amino acid glycine, if given orally in adequate dosages, can have specific effects on one particular glutamate receptor molecule in the brain, that might be helpful with OC symptoms. This randomized, double-blind protocol will have study participants who suffer with OCD take either a glycine preparation or placebo for 12 weeks. Clinical measures (e.g., Y-BOCS, NIMH-OC) will be recorded at each visit to determine whether those taking the glycine experience clinical benefit.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of OCD present for at least 1 year
* Male or female, age 18 to 65
* Stable medication regimen for 12 weeks prior to study entry
* at least moderately severe OC symptoms

Exclusion Criteria:

* Active substance use disorder within the last 6 months
* Comorbid schizophrenia, schizoaffective disorder, bipolar disorder, tic disorder, Tourette Disorder, schizotypal personality disorder
* Hoarding as the principal OCD symptom
* Insulin-dependent diabetes mellitus
* Pregnant or breastfeeding

Primary outcomes:
measure: Y-BOCS (Yale-Brown Obsessive Compulsive Scale)
timeFrame: 12 weeks after baseline
Secondary outcomes:
measure: NIMC-OC scale
timeFrame: 12 weeks after baseline
measure: CGI-Improvement
timeFrame: 12 weeks after baseline
measure: QLS(Quality of Life Scale)
timeFrame: 12 weeks after baseline
measure: Sheehan Disability Scale
timeFrame: 12 weeks after baseline
Other outcomes:
Locations:
city: Orangeburg
country: United States
facility: The Nathan Kline Institute for Psychiatric Research
state: New York
Study officials:
affiliation: Nathan Kline Institute for Psychiatric Research
name: William M Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenberg WM, Benedict MM, Doerfer J, Perrin M, Panek L, Cleveland WL, Javitt DC. Adjunctive glycine in the treatment of obsessive-compulsive disorder in adults. J Psychiatr Res. 2009 Mar;43(6):664-70. doi: 10.1016/j.jpsychires.2008.10.007. Epub 2008 Nov 30.
Clinical trial NCT00363935: Bariatric Dose-ranging Study With Dexmedetomidine
Official title: A Randomized, Double-blind, Controlled Study of Dexmedetomidine (Precedex) Infusion for Improving Control of Acute Autonomic Response During Laparoscopic Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Abdominal Surgery Patients
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2006-08-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: After obtaining informed consent,80 morbidly obese ASA II-III patients undergoing laparoscopic bariatric surgery procedures would be randomly assigned to one of four study groups at UTSWMC at Dallas.Hemodynamic paarameters, recovery times, postoperative pain scores, the need for rescue analgesics and side effects will be recorded.The purpose of this study is to determine the optimal linfusion rate of dexmedetomidine for maintaining cardiovscular stability during general anesthesia.


Eligibility criteria: Inclusion Criteria:

Subjects may be included in the study only if they meet all of the following criteria:

1. Age 18 to 70 years
2. Undergo laparoscopic bariatric surgery requiring general anesthesia
3. Be capable of giving informed consent
4. ASA physical status I-III ( Appendix 1)

Exclusion Criteria:

1. Subjects will be excluded from the study for any of the following reasons:
2. With history of hypertension and allergy to dexmedetomidine
3. Patients who have greater than first degree heart block.
4. Performing major intracavitary surgery procedures
5. Patients who are pregnant or breast-feeding
6. History of alcohol or drug abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The University of Texas Southwestern MedicalCenter at Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center at Dallas
name: Paul White, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04360135: Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy
Official title: Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Post Operative Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is investigating whether administration of acetaminophen the day before surgery improves post operative pain following minimally invasive hysterectomy. Patients will receive either acetaminophen or placebo to take twice per day the day prior to their scheduled surgery. The morning of surgery all participants will receive oral acetaminophen at least 30 minutes prior to surgery. The investigators will examine whether there is a difference in post operative pain between the two groups.


Eligibility criteria: Inclusion Criteria:

* Undergoing minimally invasive hysterectomy for benign indications

Exclusion Criteria:

* acetaminophen allergy
* liver disease
* kidney disease
* consume \>3 alcoholic beverages per day
* weigh \<50 kilograms
* report daily opiate use
* contraindication to acetaminophen
* used acetaminophen within 24 hours of surgery
* undergoing a concomitant pelvic reconstructive procedure

Primary outcomes:
measure: Post-operative opioid use
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Holly Yettaw, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00630435: Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation
Official title: An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of 3 New Formulations of Premarin® /MPA 0.625 mg/2.5 mg Compared With Reference Formulation of Premarin®/MPA in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Menopause
Keywords: Premarin®
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 76
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® \[TM\]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.


Eligibility criteria: Inclusion

1. Healthy postmenopausal women aged 35 to 70.
2. Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg.
3. Nonsmoker or smoker of fewer than 10 cigarettes/day.

Exclusion

1. History or presence of hypertension (\>139 mm Hg systolic or \>89 mm Hg diastolic). Can take up to 2 antihypertensive medications to keep blood pressure under control.
2. History within 1 year of study day 1 of alcohol or drug abuse.
3. Use of any investigational drug within 30 days before study day 1.

Primary outcomes:
measure: Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations
timeFrame: 14 weeks
Secondary outcomes:
measure: No secondary outcome
timeFrame: No time frame
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03823235: Humidified Culture and Live Birth After ICSI
Official title: Humidified Incubator Effect on Live Birth Rate After ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banoon IVF Center
name: Quena IVF Center
name: Amshag IVF Center
First posted: 2019-01-30
Enrollment: 1837
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Humidity for human embryo culture has been raised as essential with advantageous effect on clinical pregnancy and ongoing pregnancy after ICSI compared with a dry incubator. Whether the deleterious effect of dry culture would have an extended effect reaches the live birth rate needs to be examined. This RCT is to examine the effect of dry and humidified culture on live birth rates after ICSI.


Eligibility criteria: Inclusion Criteria:

* Women undergoing a first or second ICSI attempts
* Primary or secondary infertility with a BMI of \< 31 kg/m2
* Duration of infertility of ≥ 18 months and normal baseline ultrasonography
* 18 to 40 years of age
* Tubal factor, male factor, polycystic ovary, unexplained infertility or combined factors
* Tubal factors

Exclusion Criteria:

* Surgically-retrieved, frozen-thawed and pinpoint sperm or globozoospermia
* Thin endometrium
* Uterine anomaly and adhesion
* Adenomyosis
* Submucous myoma
* Endometriosis
* Severe medical condition

Primary outcomes:
measure: Live birth rate
timeFrame: 30 weeks
Secondary outcomes:
measure: Cumulative live birth rate
timeFrame: One year
measure: Ongoing pregnancy rate
timeFrame: 12 weeks of gestation
measure: Cumulative ongoing pregnancy rate
timeFrame: 12 weeks of gestation
measure: Clinical pregnancy rate
timeFrame: 7 weeks of gestation
measure: Cumulative clinical pregnancy rate
timeFrame: 7 weeks of gestation
measure: Implantation rate
timeFrame: 7 weeks of gestation
measure: Cumulative implantation rate
timeFrame: 7 weeks of gestation
measure: Ongoing implantation rate
timeFrame: 12 weeks of gestation
measure: Cumulative ongoing implantation rate
timeFrame: 12 weeks of gestation
measure: Preterm birth rate
timeFrame: 37 weeks
measure: Very preterm birth
timeFrame: 32 weeks
measure: Low birth weight rate
timeFrame: 40 weeks of gestation
measure: Fertilization rate
timeFrame: 6 days of culture
measure: Cleavage rate
timeFrame: 6 days of culture
measure: Rate of high-quality day-3 embryos
timeFrame: 6 days of culture
measure: Blastocyst formation rate
timeFrame: 6 days of culture
measure: Rate of high-quality blastocyst
timeFrame: 6 days of culture
measure: Rate of utilizable blastocyst
timeFrame: 6 days of culture
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Qena
country: Egypt
facility: Qena Fertility Center
city: Sohag
country: Egypt
facility: IbnSina IVF Center
Study officials:
References:
Clinical trial NCT06429735: Precise Robotically IMplanted Brain-Computer InterfacE
Official title: PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tetraplegia/Tetraparesis
Quadriplegia
Cervical Spinal Cord Injury
Amyotrophic Lateral Sclerosis
Quadriplegia/Tetraplegia
Tetraplegic; Paralysis
Keywords: spinal cord injury, ALS, brain computer interface, BCI
Lead sponsor: Neuralink Corp
Sponsor class: INDUSTRY
First posted: 2024-05-28
Enrollment: 5
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.


Eligibility criteria: Inclusion Criteria:

* Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below
* Life expectancy ≥ 12 months.
* Ability to communicate in English
* Presence of a stable caregiver

Exclusion Criteria

* Moderate to high risk for serious perioperative adverse events
* Active implanted devices
* Morbid obesity (Body Mass Index \> 40)
* History of poorly controlled seizures or epilepsy
* History of poorly controlled diabetes
* Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
* Acquired or hereditary immunosuppression
* Use of smoking tobacco or other tobacco products
* Psychiatric or psychological disorder
* Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.
* Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure

Primary outcomes:
measure: Device-Related Adverse Events (AE)
timeFrame: 12 months post-implant
measure: Procedure-Related Adverse Events (AE)
timeFrame: 12 months post-implant
Secondary outcomes:
measure: Device-Related Adverse Events (AE)
timeFrame: Up to 72 months post-implant
measure: Procedure-Related Adverse Events (AE)
timeFrame: Up to 72 months post-implant
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: Barrow Neurological Institute
name: Francisco Ponce, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Jonathan Jagid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05147935: Adding Specialist Palliative Care to Transplantation Pilot Trial
Official title: Adding Specialist Palliative Care to Transplantation Pilot Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: End Stage Liver DIsease
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Specialist palliative care has been shown to be beneficial for patients experiencing serious illness, but has not been studied for patients being evaluated for liver transplantation. The investigators hope in the future to design a multi-center trial of a specialist palliative care intervention to measure the effects of specialist palliative care for patients undergoing liver transplant evaluation. This project represents a pilot to gather needed information to design such a future study.


Eligibility criteria: Inclusion Criteria:

* adult patients (age 18 years or greater) undergoing evaluation for liver transplantation at Vanderbilt University Medical Center

Exclusion Criteria:

1. Patient does not speak English fluently
2. Patient lacks a telephone
3. Patient is a prisoner
4. Patient is deaf
5. Patient currently receives specialist palliative care
6. Patient is not a resident of Tennessee

Primary outcomes:
measure: Acceptability of Intervention
timeFrame: 2 months
measure: Appropriateness of Intervention
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Assistant Professor
name: Myrick C Shinall, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: