louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05502744: Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy.
Official title: Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy: A Prospective Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholecystitis, Acute
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of study is compare outcome of patients undergoing early laparoscopic cholecystectomy within 72 hours from the begging of symptoms to those of patients managed conservatively and operated late after 6-8weeks after the inflammatory reaction has subsided.

Detailed description: Acute cholecystitis is considered one of the most common acute surgical problems. It includes typical symptoms of pain in right hypochondrium, fever, increased leucocytes count and abdominal US used to confirm this clinical diagnosis. Laparoscopic cholecystectomy (LC) is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent laparoscopic cholecystectomy and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective laparoscopic cholecystectomy . Emergency laparoscopic cholecystectomy has advantage of a decreased hospital stay and avoids the risk of emergency admission for non-resolved or recurrent symptoms, which is associated with an increase in morbidity, pain and delayed return to work. Also, some trials showed increased morbidity with elective laparoscopic cholecystectomy mostly due to biliary disease while patients await surgery. Comparative studies are deficient in evaluation of outcomes of emergency cholecystectomy and elective cholecystectomy in acute cholecystitis. So the interest of our study is to compare between the emergency laparoscopic cholecystectomy and elective laparoscopic cholecystectomy regarding the feasibility and the safety of the first.

Eligibility criteria: Inclusion Criteria:

1. age less than 70 years.
2. fit for surgery.

Exclusion Criteria:

1. patients with co-existent common bile duct stones based on imaging and biochemical criteria.
2. Patients with Pancreatitis .
3. Patients with previous upper abdominal surgery.
4. Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g.Chronic Pulmonary Disease, significant Cardiac Disease)

Primary outcomes:
measure: Incidence of intraoperative complications in urgent versus elective lap cholecystostomy.
timeFrame: Intraoperative time
Secondary outcomes:
measure: Incidence of postoperative complications in urgent versus elective lap cholecystectomy.
timeFrame: 6 months.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06411444: Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance
Official title: Effectiveness of Kidney Shaped Versus Grape Design Nasal Stents in Conjunction With Nasoalveolar Molding Appliance on Nasolabial Esthetics in Infants With Complete Unilateral Cleft Lip and Palate: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cleft Lip
Cleft Lip and Palate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 28
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare 2 different designs of nasal stents in conjunction with nasoalveolar molding appliance regarding the changes in nose and lip esthetics in infants with cleft lip and palate.


Eligibility criteria: Inclusion Criteria:

* Complete unilateral cleft lip and palate.
* younger than 30 day old

Exclusion Criteria:

* Syndromic patients.
* older than 30 days old.

Primary outcomes:
measure: Nase and lip esthetics
timeFrame: Photos are planned to be taken before starting the treatment and right after finishing it.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT06337344: Neurophysiological Effects of Mind-body Exercise in Healthy Adults
Official title: Enhanced Executive Functioning After Single-session Mind-body Practice is Associated With Changes in Prefrontal Hemodynamics: a 3-armed Randomized Controlled Functional Near Infra-red Spectroscopy (fNIRS) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: mind-body practice
Qigong
Neurophysiology
Functional Near Infra-red Spectroscopy
fNIRS
Executive Function
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is some clinical evidence showing that Baduanjin (BDJ) practice, a type of mind-body based physical exercise, can improve executive function (EF). However, the neurophysiological changes associated with improved cognitive function remain elusive. Therefore, this study aims to carry out randomised controlled trial to explore how the single-session BDJ practice affect the function of prefrontal cortex(PFC) and also the EF of healthy adults, measure by fNIRS and verbal fluency test accordingly. A total of 60 healthy adults (based on power analysis 80% (β= 0.20) chance (α = 0.05, two-tailed)), aged 18 to 40 year old, without any physical, neurological, and neuropsychiatric disorder, classified as right-handed by Edinburgh Handedness Inventory, also with normal intelligence as verified by the Test of Nonverbal Intelligence will be recruited and randomly assigned to treatment(i.e. BDJ), active control(i.e, exercise), and passive control(i.e. video viewing) group. The investigator anticipate that this single-session BDJ practice will result in - (1) enhancing executive functioning , and (2) changes in functional brain activation pattern in PFC in adults. The result will give a spotlight to neurophysiological treatment effect of single-session Baduanjin on healthy adults, in developing intervention for improving executive functioning of adults.


Eligibility criteria: Inclusion Criteria:

* Right-handed adults with normal intelligence (i.e. intelligence quotient ≥ 80), and without any physical, neuropsychiatric, and neurological disorders

Exclusion Criteria:

* Current positive history of head injury, seizure, stroke, other central nervous system diseases, other comorbid psychiatric illness, or reports of strong suicidal ideation.

Primary outcomes:
measure: Change in cognitive function as assessed by verbal fluency task (VFT)
timeFrame: 17 min after baseline
measure: Hemodynamic changes as assessed by fNIRS
timeFrame: Baseline, during the 12-min intervention(immediate after baseline), immediate post-assessment(12 min after baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Kowloon
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Hector Tsang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04493944: Edible Seaweeds and Health: Quality Biomarkers to Support Consumer Acceptance
Official title: Edible Seaweeds and Health: Quality Biomarkers to Support Consumer Acceptance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Habits
Self Efficacy
Keywords: Seaweeds, Food skills, Self Efficacy
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Quebec Maritime Network (Odyssee Saint-Laurent)
First posted: 2020-07-30
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Seaweeds have been part of the diet of Asian countries for thousands of years, but consumption by Quebecers remains unfamiliar. Because of their rich nutrients content and unique bioactive compounds, seaweeds have a great dietary potential. The overall objective of the project is to determine the potential for sustainable local exploitation of St. Lawrence seaweeds by assessing their quality under growing conditions and following processing, and to use them as a basis for culinary innovations for both industry and consumers. Our specific objectives are as follows:

1. To assess the impact of environmental factors on the specific profile of biomarkers of nutritional quality and health potential of harvested or cultivated seaweed;
2. To determine the impact of processing on the profile of biomarkers of nutritional quality and health potential of harvested and cultivated seaweed;
3. To study changes in dietary attitudes and behaviours through a culinary workshop promoting the acceptance of seaweeds and their appropriation as an ingredient by consumers.

The application for ethical approval and this trial registration applies only to Specific Objective 3.

Detailed description: For recruitment purposes, adults interested in cooking and consuming Quebec seaweeds will be randomly assigned to an experimental group (n=16 x 3 groups, ingredients, recipes and a culinary workshop) or a control group (n=16 x 3 groups, ingredients and recipes). Online questionnaires will be administered via the secure platform of INAF (FANI) at the beginning and the end of the study.

Eligibility criteria: Inclusion Criteria:

* be interested in cooking and consuming Quebec seaweeds in various forms
* be available to fill out online questionnaires and perhaps participate in a culinary workshop in Quebec City

Exclusion Criteria:

* have allergies and dietary restrictions

Primary outcomes:
measure: Cooking and food-preparation practices with seaweeds
timeFrame: 2 months
measure: Consumption of seaweeds
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec city
country: Canada
facility: Institue of Nutrition and Functional Foods (INAF)
state: Quebec
Study officials:
affiliation: co-investigator, responsible for Specific Objective 3
name: Veronique Provencher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05697744: Evaluation of Vidiac Scores of Obese and Morbid Obese Patients Intubated by Videolaryngoscopy
Official title: Evaluation of Vidiac Scores of Obese and Morbid Obese Patients Intubated by Videolaryngoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vidiac Score
Videolaryngoscopy
Obesity, Morbid
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients to be operated under general anesthesia and endotracheal intubation

Brief summary: The aim of the study was to observe the vidiac score values of only patients with obesity as a risk factor for difficult intubation. Secondly, it was aimed to evaluate the number of intubation attempts and intubation time, vidiac scores between obese and morbid obese patients and to reveal the differences, if any.


Eligibility criteria: Inclusion Criteria:

* All obese and morbidly obese patients to be operated under general anesthesia and endotracheal intubation

Exclusion Criteria:

1. under 18 years old
2. The patient's refusal
3. Difficult airway story before
4. Congenital or previous airway anatomical disorder
5. Patients who have undergone airway surgery
6. Patients with a mass in the head and neck region
7. Body mass ındex \< 30 kg/m2

Primary outcomes:
measure: vidiac score
timeFrame: during entubation
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Aysun Postacı, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01431144: Implant Placement With Simultaneous Gum Grafting
Official title: The Effect of Implant Placement and Simultaneous Soft Tissue Augmentation in the Esthetic Zone Using Either Connective Tissue Autograft or Acellular Dermal Matrix Allograft on Peri-implant Hard and Soft Tissue Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous
Keywords: soft tissue thickness
dental implant
soft tissue recession
implant exposure
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: BioHorizons, Inc.
First posted: 2011-09-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a comparison of implant placed and simultaneously grafted with either autogenous connective tissue or a connective tissue allograft. The objective is to determine the change in soft tissue thickness and determine if a better result is obtained with the autograft or the allograft. The hypothesis is that there will be no difference in soft tissue thickness over the implant between the autograft and the allograft technique.


Eligibility criteria: Inclusion Criteria:

* One edentulous site bordered by 2 teeth needing a dental implant

Exclusion Criteria:

* Systemic diseases that affect the periodontium
* Previous head and neck radiation
* Smoking more that 1/2 pack per day
* Requires prophylactic antibiotics
* Allergy to meds used in study
* Previous chemotherapy
* Pregnancy

Primary outcomes:
measure: Soft Tissue Thickness Over the Implant
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Graduate Periodontics Clinic, School of Dentistry, University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Henry Greenwell, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01771744: Revisional Versus Primary Roux-en-Y Gastric Bypass: a Case Matched Analysis
Official title: Revisional Versus Primary Roux-en-Y Gastric Bypass: a Case Matched Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of Revisional Surgery for Failed Gastric Banding
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: morbidly obese patients

Brief summary: This study compared revisional malabsorptive laparoscopic very very long limb gastric bypass (VVLL RYGB) with primary VVLL RYGB and tested the hypothesis that one staged revisional laparoscopic VVLL RYGB is a safe and effective procedure after failed restrictive gastric banding.


Eligibility criteria: Inclusion Criteria:

* Primary Gastric Bypass according to SMOB (Swiss group for the study of morbid obesity) Guidelines
* Revisional Gastric Bypass after failed Gastric Banding

Exclusion Criteria:

* According to SMOB Criteria

Primary outcomes:
measure: weight loss
timeFrame: 2 years
Secondary outcomes:
measure: Complication rate
timeFrame: early (30 days) and late (> 30 days)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05101044: Open Trial to Improve Retention in Care for Persons With HIV Who Use Substances
Official title: Improving Retention in Care for Persons With HIV Who Use Substances by Increasing Acceptance and Reducing Stigma (Open Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Hiv
Keywords: Acceptance and commitment therapy
Acceptance-based behavioral therapy
Behavioral intervention
Acceptability and feasibility
Stigma
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-11-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An uncontrolled open trial approach will be used in which all participants receive the ABBT intervention.
Primary purpose: TREATMENT

Brief summary: The open trial will examine the feasibility and acceptability of a brief, empirically-supported acceptance-based behavioral therapy intervention to promote retention in care for out-of-care people with HIV who use substances.

Detailed description: The proposed study will adapt a brief, 2-session acceptance-based behavioral therapy (ABBT) intervention to help people with HIV (PWH) who use substances tolerate fears of stigmatization, increase acceptance of HIV status and substance use problems, and increase engagement in care. By conducting an open trial with 15 adults recruited from an HIV primary medical care clinic, the study will focus on the feasibility of recruiting out-of-care PWH and determine the acceptability of the refined ABBT protocol.

Eligibility criteria: Inclusion Criteria:

1. HIV+
2. Meet DSM-5 criteria for one or more of the following substance use disorders, at any severity level: cocaine, methamphetamine, and/or opioid
3. ≥18 years old
4. Poorly retained in care, defined as no attended medical appointment in the past 9 months
5. Able to speak and read English at a level sufficient to complete the study procedures
6. Have telephone access

Exclusion Criteria:

(a) Patients who are cognitively impaired, which will be determined by chart review during screening

Primary outcomes:
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 1 month
Secondary outcomes:
measure: Participant Retention Rate Across Intervention Sessions
timeFrame: Baseline and 1 month
measure: Participant Retention Rate for Follow Up Assessments
timeFrame: Baseline and 1 month
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Ethan Moitra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05630144: Deprescribing for Older Adults After Hospital Discharge in Home Health Care
Official title: Deprescribing for Older Adults After Hospital Discharge in Home Health Care - A Pilot Feasibility Study of the HomeMed Deprescribing Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Polypharmacy
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-11-29
Enrollment: 5
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the feasibility of providing a medication optimization program to improve patient health outcomes during the transition from hospital to home. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of future hospitalizations.


Eligibility criteria: Patient Inclusion Criteria:

* 65 years of age and older
* currently hospitalized or having been hospitalized in the previous 2 weeks
* having a discharge disposition of home with a referral to receive HHC services from URMHC, or currently receiving HHC services from URMHC
* taking more than 10 regular medications daily
* having a primary care provider who is in the URMC system
* Ability to self-consent
* English-speaking

Patient Exclusion Criteria:

* end-of-life prognosis in the following 6 months
* currently receiving hospice care, end-of-life care, or palliative care
* conditions that impact the receipt of the intervention, such as severe cognitive impairment that interferes with the subject's ability to communicate with interventionists;
* substantial difficulties in hearing, vision, and verbal expression that disable the participant from communicating effectively while receiving the HomeMed intervention

Primary outcomes:
measure: mean time spent on intervention
timeFrame: 3 months
measure: number of participants who complete a post intervention survey about feasibility
timeFrame: 3 months
measure: Percentage of participants undergoing deprescribing
timeFrame: 3 months
measure: Percentage of intervention adherence indicators checked
timeFrame: 3 months
measure: Percentage of patients who improve in ability to do things that are important before and after intervention
timeFrame: 3 months
measure: Total number of medications used per participant
timeFrame: 3 months
measure: Percentage of patients who report a reduction in medication burden
timeFrame: 3 months
measure: Percentage of participants who report a reduction in medication side effect
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT02654444: Semi-Quantification of Her2/Neu Protein Expression in Formalin Fixed, Paraffin-Embedded Normal and Neoplastic Tissue
Official title: Concordance Study of Her2 Expression Level in Breast Cancer Tissues
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Immunohistochemical (IHC)
Her2/Neu
Breast cancer
Lead sponsor: Applied Spectral Imaging Ltd.
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 3
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women having breast cancer

Brief summary: The purpose of the study is the identification and quantification of protein expression level in breast cancer tissues.

The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying her2 immunohistochemical (IHC) stained samples.

Detailed description: The anti Her2/neu Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the Human Epithelial growth factor receptor (Her2/neu) expression in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Her-2 test is indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the Her-2 kit provides the antibodies that offer direct visualization and semi-quantification of the HER2 protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.

Eligibility criteria: Inclusion Criteria:

* Women having breast cancer aged 21 and up
* Borders of tumor nuclei are distinguishable
* Nuclei should have good integrity
* Background should not contain particles that interfere with the analysis

Exclusion Criteria:

* Slides that cannot be analyzed manually by Pathologist

Primary outcomes:
measure: IVD study of HER2 IHC samples: Accuracy of analysis
timeFrame: 1 Day
measure: IVD study of HER2 IHC samples: Repeatability & Reproducibility of analysis
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: