louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03326453: Effect of Mini Implants Supported Over Dentures Versus Conventional Implant After Bone Expansion
Official title: Effect of Mini Implants Supported Over Dentures Versus Conventional Implant After Bone Expansion in Thin Mandibular Ridge on Patient Satisfaction:
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complete Edentulism
Keywords: mini dental implant
overdenture
Patient satisfaction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The better form of ridge will provide using wider implants that can have better abilities to with stand forces and to prevent alveolar bone loss as much as possible. Ridge expansion gained some popularity due to easiness compared to any other procedure that can gain bone. However, this treatment modality needs to be evaluated as compared to Mini Dental Implants (MDIs) over denture in thin mandibular ridge.

In mandibular edentulous patients having thin ridge, does the mini implant supported over denture, compared to the conventional implant supported over denture after bone expansion affect bone height around implants?

Detailed description: PICO

P: Completely edentulous Patients.

I: Mandibular overdenture supported by mini dental implant.

C: Mandibular overdenture supported by conventional implant diameter after bone expansion.

O: outcomes as follows:

Primary Outcome: Patient satisfaction, Questionnaire Visual analog scale (VAS), Measuring unit: Mm. (Geckili et al.

Secondary Outcome: Bone height change, Measuring device: DIGORA® X ray, Measuring unit: Mm.

Eligibility criteria: Inclusion Criteria:

* Completely edentulous patients ranging from age 35 to 75 years
* Angle's Class I skeletal relationship
* Normal facial symmetry
* Cooperative patients
* Adequate inter-arch space not less than 12mm

Exclusion Criteria:

* Temporomandibular disorders
* Uncontrolled diabetes
* Bleeding disorders or anticoagulant therapy
* Flabby tissues or sharp mandibular residual ridge.
* Heavy smokers.
* Patient's with neuromuscular disorders
* Patients on chemotherapy or radiotherapy
* Severe psychiatric disorders
* Angle's class II and III skeletal relationship

Primary outcomes:
measure: patients satisfaction
timeFrame: after six months of over denture insertion
Secondary outcomes:
measure: Bone height change
timeFrame: baseline (T0) initial bone height (millimetres), after six months usage of over denture(T1) bone height (millimetres), then after twelve-months usage of over denture(T2) bone height. 1st period (T1-T0) after 6 months 2nd period (T2-T1) after 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: de Souza RF, Ribeiro AB, Della Vecchia MP, Costa L, Cunha TR, Reis AC, Albuquerque RF Jr. Mini vs. Standard Implants for Mandibular Overdentures: A Randomized Trial. J Dent Res. 2015 Oct;94(10):1376-84. doi: 10.1177/0022034515601959. Epub 2015 Aug 20.
Clinical trial NCT05406453: Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar
Official title: Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar - a Cluster Randomized Controlled Trial to Evaluate Different Community-wide Intervention Strategies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: Whole genome sequencing
cluster randomized controlled trial
Lead sponsor: Institut Pasteur de Madagascar
Sponsor class: OTHER
Collaborators: name: The National Tuberculosis Program, Madagascar
name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
First posted: 2022-06-06
Enrollment: 98362
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: cRCT
Primary purpose: DIAGNOSTIC

Brief summary: Tuberculosis (TB) whole genome sequencing (WGS) allows outbreak identification and disease transmission tracking.

It is hypothesized that prospective WGS-guided epidemiological investigations improve case detection compared to current best practices by adapting contact tracing strategies to local transmission patterns.

A cluster randomized controlled trial (cRCT) will be performed in high TB incidence villages of Haute Matsiatra region in Madagascar. Communities will be randomized in three separate TB control strategies comparing (1) standard of care, (2) the World Health Organization (WHO) recommended best practices and (3) a novel intervention involving TB WGS cluster-guided epidemiological investigations. The incremental value of TB WGS on case notifications and reduction of TB burden will be measured.

Secondary studies will be nested within this cRCT will include:

* A qualitative study which will increase the understanding of the factors facilitating and hindering implementation of WGS-based diagnostics within health systems.
* A cost effectiveness analysis study which will measure the cost effectiveness of newly implemented laboratory methods.

Field and genomic epidemiology data from this project will inform future work on the design of community-level TB elimination strategies in collaboration with Madagascar National TB program


Eligibility criteria: Inclusion Criteria:

* Subjects suspected TB
* subject living in the study area

Exclusion Criteria:

* unable to take a sputum sample

Primary outcomes:
measure: the total number of TB cases detected / 100 000 inhabitants
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vohibato
country: Madagascar
facility: Fokontany Vohibato
Study officials:
affiliation: CHUM
name: Simon Grandjean Lapierre, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03578653: Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2
Official title: Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The full program is focused on identifying and reducing risk factors surrounding falls. Based on previous research, we believe that occupational therapy group classes and adaptive yoga are an ideal pairing to reduce fall risk. The occupational therapy sessions will consist of lecture, group discussion, and activities designed to target biological, behavioral, environmental, and socioeconomic factors that contribute to fall risk specifically for people with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Individuals with a diagnosis of Parkinson's disease OR their care partners
* Individuals who read and understand English
* Individuals who can stand with or without an assistive device
* People who are willing to commit to yoga practice 2x/week for 8 weeks and pay $5/class through Raintree Athletic Club (Scholarships are available if needed!)
* People who are willing to commit to group occupational therapy 2x/week for 8 weeks free of charge
* score of at least 4/6 on the short mini mental status exam

Exclusion Criteria:

* less than 18 years of age

Primary outcomes:
measure: Change in Fall Risk Factor Management
timeFrame: Baseline, Pre-assessment (8-weeks after baseline), and post-assessment (8-weeks after pre-assessment)
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Laura Grimm, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02928653: Beverage Consumption and Fine Motor Control
Official title: The Effect of Low Calorie Sweetener Consumption on Body Weight, Body Composition, Appetite, and Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Keywords: energy intake
energy expenditure
appetite
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study will be to compare the effects of daily consumption of aspartame, rebaudioside a, saccharin, sucralose, and sucrose on body weight and composition in a standardized protocol. The investigators hypothesize that individual low calorie sweeteners (consumed in a beverage) differ from each other in promoting weight loss and decreased fat mass (without energy restriction or dietary guidance) based on their chemical structure.


Eligibility criteria: Inclusion Criteria:

* BMI between 25-40 kg/M2
* Non or rare users of LCS
* Willing to consume large volumes of beverages daily

Exclusion Criteria:

* Weight change \> 3kg in the last year
* Plan to initiate a new diet plan in the next 6 months
* Exhibit eating restraint
* Pregnant/lactating

Primary outcomes:
measure: Body Weight
timeFrame: 12 weeks
measure: Body Composition
timeFrame: 12 weeks
measure: Energy Intake
timeFrame: 12 weeks
measure: Appetite
timeFrame: 12 weeks
measure: Energy Expenditure
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Richard D Mattes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Higgins KA, Mattes RD. A randomized controlled trial contrasting the effects of 4 low-calorie sweeteners and sucrose on body weight in adults with overweight or obesity. Am J Clin Nutr. 2019 May 1;109(5):1288-1301. doi: 10.1093/ajcn/nqy381.
Clinical trial NCT03423953: Comprehensive Nano - Post Market Clinical Follow-Up Study
Official title: Comprehensive Nano Post Market Data Collection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Revision
Correction of Functional Deformity
Keywords: osteoarthritis
avascular necrosis
rheumatoid arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-02-06
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in need of an uncemented shoulder arthroplasty and who meet all of the inclusion and none of the exclusion criteria.

Brief summary: This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.

Detailed description: The Comprehensive® Shoulder System with Nano humeral component is a humeral prosthesis system intended for use in total or hemi shoulder arthroplasty surgery. Total shoulder arthroplasty consists of replacement of the humeral head and glenoid. Hemi-arthroplasty consists of replacement of only the humeral head.

This project is a prospective study including one-hundred and fifty (150) anatomic and hemi cases and 44 reverse shoulders collected from up to ten (10) sites. All potential study subjects will be required to participate in the Informed Consent process.

Eligibility criteria: Inclusion Criteria:

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
* Rheumatoid arthritis
* Revision where other devices or treatments have failed
* Correction of functional deformity.
* Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate
* Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate

Exclusion Criteria:

* Infection
* Sepsis
* osteomyelitis

Primary outcomes:
measure: Survivorship
timeFrame: 10 years
Secondary outcomes:
measure: ASES Score (American Shoulder and Elbow Surgeons)
timeFrame: 10 years
measure: SANE Score (Single Assessment Numeric Evaluation)
timeFrame: 10 years
measure: Constant-Murley Score
timeFrame: 10 years
measure: X-rays evaluated for radiolucencies, osteolysis, migration and subsidence
timeFrame: 10 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Privatklinik Leech
state: Styria
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre
city: Liverpool
country: United Kingdom
facility: University of Liverpool
state: Merseyside
Study officials:
affiliation: Zimmer Biomet
name: Paola Vivoda
role: STUDY_DIRECTOR
References:
Clinical trial NCT05587153: Perfusion Index vs Positional Hemodynamic Changes to Predict Hypotension After Spinal Anaesthesia in Caesarean Section
Official title: Comparative Study Between the Perfusion Index and Positional Haemodynamic Changes for Prediction of Hypotension After Spinal Anaesthesia in Caesarean Section
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Spinal Hypotension
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-10-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women undergoing an elective caesarean section delivery.

Brief summary: Comparative Study between the Perfusion Index and Positional Haemodynamic Changes for Prediction of Hypotension after Spinal Anaesthesia in Caesarean Section

Detailed description: Hypotension following spinal anaesthesia may cause maternal dizziness, nausea, vomiting and fetal acidosis, administration of prophylactic vasopressor agents in pregnant women may cause undesirable effects on the mother and fetus. Perfusion index is the ratio of a pulsatile to a non-pulsatile fraction of blood volume. The increase of the pulsatile fraction manifested during vasodilatation corresponds to a higher PI. So, the patients with a higher PI have a higher risk for post-spinal hypotension. Elevated sympathetic activity before neuraxial anaesthesia was associated with a higher risk for post-spinal hypotension. The significant variability in haemodynamic after the positional change indicates higher sympathetic activity. The high the rise in autonomic activity, the higher the risk for post-spinal hypotension

AIM OF THE WORK:

Prediction of hypotension after spinal anaesthesia in caesarean section either by perfusion index and positional haemodynamic changes

Grouping:

All the recruited patients will be assessed by perfusion index. and by positional haemodynamic changes

Eligibility criteria: Inclusion criteria

* Parturient acceptance.
* American Society of Anesthesiologists (ASA) II
* arturient with be gestational age \>36 weeks and \<41 weeks.
* Body mass index (BMI) ≤35kg/m2
* elective caesarean section delivery

Exclusion criteria

* preeclampsia
* eclampsia,
* gestational diabetes
* Contraindication to regional anaesthesia as allergy, coagulation abnormalities or infection in site of injection.

Primary outcomes:
measure: Prediction of post-spinal hypotension using PI
timeFrame: 6 months
Secondary outcomes:
measure: Prediction of post-spinal hypotension using positional hemodynamic changes
timeFrame: 6 months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of medicine
city: Zagazig
country: Egypt
facility: Ramy
Study officials:
affiliation: Faculty of medicine, Zagazig University Hospitals
name: Naglaa Abdelhaleem, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06265753: Gastrocinemius Function Massage on Lower Extemity Spasticity
Official title: Effects of Gastrocinemius Function Massage on Lower Extemity Spasticity, Spatio- Temporal Gait Variables and Fall Risk ın Patients With Stroke
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Stroke Ischemic
Keywords: Spacticity, Gastrocinemius function massage, stroke, gait
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the study, 2 different groups (experimental and control) will be formed by using randomisation method. In addition to 45 minutes of classical physiotherapy exercises, 10 minutes of gastrocinemius function massage will be applied to the experimental group, while 10 minutes of sham massage and 45 minutes of classical physiotherapy exercises will be applied to the control group. The application will continue 2 days a week for 6 weeks. Spasticity, gait parameters and fall risks of the participants will be evaluated before and after the treatment with the help of various tests.

Translated with www.DeepL.com/Translator (free version)
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate gastrocinemius function massage on physical parameters of stroke patients.

Detailed description: Gastrocinemius function massage is known to relieve pain and increase range of motion. However, its effects on spasticity and physical performance in stroke patients are not fully understood. In this study, we aimed to investigate the effects of gastrocinemius function massage.

Eligibility criteria: Inclusion Criteria:

* having experienced a stroke at least 6 months prior,
* being able to stand independently for at least 1 minute,
* scoring at least 23 on the Standardised Mini-Mental State Examination (SMMSE), indicating no significant cognitive impairment , and
* having lower extremity spasticity rated between 1-3 on the modified Asworth scale
* at least 18 years of age.

Exclusion Criteria:

* comorbidities such as neurological, orthopaedic, metabolic, and rheumatological diseases that could potentially impact soft tissues.
* patients who had received spasticity or other treatments that could affect soft tissues within the past 3 months,
* those with lower extremity injuries, and those with a diagnosis of cancer or who were pregnant.

Primary outcomes:
measure: Spasticity
timeFrame: aproximately 10 miutes
measure: Gait parameters and fall risk
timeFrame: aproximately 5 miutes
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: University Address
state: Muş Alparslan University
Study officials:
References:
Clinical trial NCT04435353: Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19
Official title: Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Distress Syndrome
Hypoxemia
Keywords: Vibroacustic therapy
COVID19
Pneumonia
Lead sponsor: Astana Medical University
Sponsor class: OTHER
First posted: 2020-06-17
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
Intervention model description: Prospective\\retrospective study
Primary purpose: TREATMENT

Brief summary: Vibroacoustic pulmonary therapy in patients with COVID19 is believed to have a positive effect on oxygen status and a decrease in the duration of respiratory failure

Detailed description: This study aims to recruit the required number of patients for statistical identification of the effectiveness of vibroacoustic therapy in patients with COVID 19. Obligatory performance criteria will be presented by the duration of the course of respiratory failure and the duration of mechanical ventilation in the main and control groups. Optional performance criteria will be represented by oximetry values and standardization of laboratory parameters

Eligibility criteria: Inclusion Criteria:

1. adults
2. P/F less 300 torr
3. ARDS by Berlin convention
4. COVID 19 bilateral pneumonia

Exclusion Criteria:

1. children
2. acute brain stroke
3. acute coronary syndrome
4. pulmonary embolism
5. implanted pacemaker

Primary outcomes:
measure: Recovery respiratory fail
timeFrame: 5-7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: Mukatova Irina
state: Nur-Sultan
city: Astana
country: Kazakhstan
facility: Center of pulmonology Astana
Study officials:
References:
Clinical trial NCT02178553: Study of Exparel Versus Epidural for Pain Control After Thoracotomy
Official title: Randomized Non-inferiority Trial of Continuous Thoracic Epidural Analgesia Versus Single Intercostal Nerve Block After Thoracotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain Following Thoracotomy Surgery
Keywords: Thoracotomy
Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Unilateral intercostal nerve blocks provide pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects.

Detailed description: In this study we will study to see if a single set of unilateral intercostal nerve blocks provides pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects. Although the anesthesiologists involved in providing care for patients having thoracotomy incisions at St. Mary's Hospital are experts at placing thoracic epidural catheters, this study will attempt to show that a less technically challenging procedure done by surgeons intra-operatively can provide comparable pain relief.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection or pneumonectomy).

Exclusion Criteria:

* Planned chest wall resection or abdominal incision and/or gastroesophageal surgery;
* Current enrollment in another post-thoracotomy analgesic research protocol; pre-existing pain syndrome (such as fibromyalgia, complex regional pain syndrome or postherpetic neuralgia in a thoracic distribution);
* Daily opioid therapy;
* Current gabapentin or pregabalin therapy;
* Allergy to any study medication; coagulation or infectious issues that would preclude epidural catheter placement;
* Severe psychological disorders or inability to understand the study protocol; -Prisoners or other institutionalized individuals;
* Severe hepatic, renal or cardiovascular disorders.
* Women who are pregnant will not be included in this study.

Primary outcomes:
measure: Pain Scores With Cough on First Postoperative Day
timeFrame: In the morning (8 am) on first postoperative day
measure: Pain Scores With Cough on the Second Postoperative Day
timeFrame: In the morning (8 am) on the second postoperative day
Secondary outcomes:
measure: Pain Scores at Rest in the Morning on the First Postoperative Day
timeFrame: Each morning for two days postoperative
measure: Pain Scores at Rest on the Second Postoperative Day
timeFrame: Each morning for two days postoperative
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: James D Hannon, MD
role: PRINCIPAL_INVESTIGATOR
References: