louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04808336: Platelet Rich Plasma Injection Versus Surgical Fixation Procedure in Management of Spondylolisthesis grade1.
Official title: Platelet Rich Plasma Injection Versus Surgical Fixation Procedure in Management of Spondylolisthesis grade1.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Spondylolisthesis G1
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spondylolisthesis is a serious health condition that is often treated with surgery or pain-relieving lumbar epidural steroids. Patients with persistent and debilitating symptoms who have failed to respond to conservative treatment should consider surgery.

Objectives: The aim of this study was to compare the therapeutic efficacy of three ultrasound guided PRP injections of the facet joint capsule to surgical procedures in patients with degenerative spondylolisthesis G1 and their effect on neurogenic pain relief and functional improvement over a one-year follow-up period.

Methods:

A one-year prospective randomised comparative clinical trial was performed on 60 patients with degenerative spondylolisthesis G1 who were randomly assigned to one of two groups: Group 1: thirty patients were injected in the facet joint capsule with a series of three ultrasound-guided PRP injections at four-week intervals, and Group 2: thirty patients underwent surgery. They were exposed to clinical neuropsychological testing.They were assessed for pain and function using clinical neurological assessments, VAS (Visual Analogue Scale), FRI (Functional Rating Index), Roland Morris, and ODI.


Eligibility criteria: Inclusion Criteria:

* Patients with degenerative spondylolithesis Grade 1 were diagnosed based on their clinical and radiological image.
* Patients complained of extreme pain and received medical treatment (NSAIDS) without improvement.

Exclusion Criteria:

* Patients with more than two-level pathological lesions and those who had previously
* Patients undergone lumbar surgery,
* HCV, HBV infected patients,
* patients with local abscesses,
* diabetes mellitus,
* malignancy, pregnancy,
* blood disorders (coagulopathy, thrombocytopenia),
* patients who had previously received local injection of steroid within past 3 weeks
* Patients who had undergone lumbar surgery,
* patients with advanced spondylolithesis, disc prolapse,
* inflammatory or musculoskeletal disorders of the spine.

Primary outcomes:
measure: 1-Visual analogue scale. ,
timeFrame: 12 months
measure: 2-The Persian Functional Rating Index (FRI )
timeFrame: 12 months
Secondary outcomes:
measure: Oswestry Disability Index (ODI) for low back pain
timeFrame: 12 months
measure: The Roland-Morris questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Shebien Elkom
country: Egypt
facility: Dalia Saif
Study officials:
References:
Clinical trial NCT04177836: Mindfulness and Romantic Relationship Quality
Official title: Mindfulness and Romantic Relationship Quality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: The Focus of the Study is Romantic Relationship Quality
Keywords: Romantic relationship quality
Mindfulness
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: Carnegie Mellon University
First posted: 2019-11-26
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 2 arms to this intervention - mindfulness and active control.
Primary purpose: BASIC_SCIENCE

Brief summary: The overarching aim of this proposal is to experimentally test whether a mindfulness intervention improves relationship quality. Romantic couples from the community will be randomly assigned to one of two arms: mindfulness vs. active control. Both interventions will be completed on a smart-phone for 14 days using identical intervention activities as our existing published research. After the 14-day period, couples will attend a lab visit and provide relationship quality data.

Detailed description: Romantic couples from the community will be randomly assigned to one of two arms: mindfulness vs. active control. Thus, both partners will either complete the mindfulness intervention (developed to increase attention towards and acceptance of current experiences) or a relaxation-based active treatment comparison intervention (developed to parallel the structure of the mindfulness intervention without the attention towards or acceptance of present experiences). Both interventions will be completed on a smart-phone for 14 days using identical intervention activities as our existing published research, which demonstrated that the mindfulness intervention reduced stress reactivity and improved daily well-being. After the 14-day period, couples will attend a lab visit and provide multi-method relationship quality data.

Eligibility criteria: Inclusion Criteria:

* Couples living together for at least 2 years
* Both partners must be fluent in English
* Both partners cannot already engage in regular systematic mind-body practice (\>2 times per week).
* Both partners must have daily access to an internet-enabled smartphone to complete the intervention

Exclusion Criteria:

-

Primary outcomes:
measure: Changes in Romantic Relationship Quality
timeFrame: Before and after the 2 week intervention
Secondary outcomes:
measure: Changes in Sleep quality
timeFrame: Before and after the 2 week intervention
measure: Changes in Depressive symptoms
timeFrame: Before and after the 2 week intervention
measure: Changes in Blood pressure
timeFrame: Before and after the 2 week intervention
measure: Changes in Life satisfaction
timeFrame: Before and after the 2 week intervention
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
References:
Clinical trial NCT01247636: Home-Exercise vs General Physical Activity: Effect on Health-related Quality of Life
Official title: Effect of Progressive Home-Exercise on Health-related Quality of Life, Balance and Mobility in Older People Discharge From an Outpatient Geriatric Clinic.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Health-Related Quality of Life
Keywords: HLRQ
Elderly
Balance
Mobility
Fear of falling
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2010-11-24
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled trial is to evaluate the effectiveness of an exercised-based programme developed for older people admitted at a geriatric outpatient clinic and to see if a home-exercise program enhances the effect. The outcomes considered is health-related quality of life, balance-self confidence, balance and mobility.

Detailed description: Older people discharge from hospital often have decreased functional and physiological reserve that make them vulnerable of being dependent of others. Research have shown that older people discharge from hospital are vulnerable for functional decline during hospital stay and this decline can persist 6 to 18 months after discharge from hospital.Exercise interventions are proven to have effect on mobility, balance and falls among community-dwelling older people and several studies have shown that deconditioning as a consequence of disuse is reversible with training even in very old individuals. However, few studies have evaluated the effects of physical activity promotion and exercise intervention among elderly recently discharge from a geriatric outpatient clinic.

Eligibility criteria: Inclusion Criteria:

* home-dwelling patients who were admitted at the geriatric clinic.
* Assessed by a doctor to tolerate training
* Able to walk in the corridor for 3 min with or without assistive device

Exclusion Criteria:

* Cognitive disorders mini mental status \< 24

Primary outcomes:
measure: Health-related quality of life
timeFrame: by the time of discharge mean 2 weeks after admission
measure: Health-related quality of life
timeFrame: 3 months
Secondary outcomes:
measure: Functional balance (Berg Balance Scale)
timeFrame: by the time of discharge mean 2 weeks after admission and after 3 months
measure: Functional mobility
timeFrame: by the time of discharge mean 2 weeks after admission, and after 3 months
measure: Functional strength
timeFrame: by the time of discharge mean 2 weeks after admission and after 3 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ulleval University Hospital
Study officials:
affiliation: No afflication
name: Astrid Bergland, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06745336: Clinical Study of CS-001 As a Treatment for Canities (Grey Hair)
Official title: Clinical Study of CS-001 As a Treatment for Canities (Grey Hair)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Canities
Grey Hair
Lead sponsor: Applied Biology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Complex Science
First posted: 2024-12-20
Enrollment: 240
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical Study to Assess the Safety and Efficacy of CS-001 as a treatment for Canities (Grey Hair)

Detailed description: CS-001 is a small molecule that affects lysosomal storage and transfer of melanin from hair follicle melanocytes. In vitro and a small pilot study demonstrated re-pigmentation of grey hair following CS-001 application. The aim of this study is to assess the safety and efficacy of CS-001 as a treatment for grey hair.

Eligibility criteria: Inclusion Criteria:

* Age 30 to 65
* Diagnosed with Grey Hair (Canities)
* Willing and able to apply the treatment as directed, comply with study
* Otherwise healthy
* Able to give informed consent

Exclusion Criteria:

* A medical history that may interfere with study objectives
* Women who are pregnant, lactating, or planning to become pregnant during the study period
* Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
* Subjects who have known allergies to any excipient in CS-001
* Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation
* Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation
* Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation
* Subject is unable to provide consent or make the allotted clinical visits

Primary outcomes:
measure: Greying Severity Score
timeFrame: Week [0,52]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Singal A, Daulatabad D, Grover C. Graying severity score: A useful tool for evaluation of premature canities. Indian Dermatol Online J. 2016 May-Jun;7(3):164-7. doi: 10.4103/2229-5178.182372.
Clinical trial NCT02665936: Effect of Epidural Dexamethasone on Labor Analgesia
Official title: Epidural Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Epidural for Vaginal Delivery Analgesia: A Comparative, Dose Ranging and Safety Evaluation Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Labor
Keywords: epidural analgesia
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to detect whether the addition of epidural dexamethasone will prolong labor analgesia.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I, II
* normal vaginal delivery In early active phase of labor
* singleton cephalic presentation at term

Exclusion Criteria:

* complicated pregnancies
* morbid obesity
* diagnosed fetal abnormalities
* contra-indications to regional anesthesia

Primary outcomes:
measure: Duration of epidural analgesia
timeFrame: an average of 5 months
Secondary outcomes:
measure: Time of onset of sensory block at level T10
timeFrame: an average of 5 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: ahmed i elsakka, m,d,
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: amira r hassan, m,d.
role: STUDY_CHAIR
affiliation: Cairo University
name: nadia y helmy, m.d.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00601536: Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions
Official title: A Single Dose, Two-Period, Two-Treatment Crossover Bioequivalency Study of 300 mg Lithium Carbonate Extended Release Tablets Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fasting conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to lithium, or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Fourteen day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Novum Pharmaceutical Research Services
state: Pennsylvania
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Shirley A Kennedy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04506736: Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery
Official title: Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Surgery
Obese Patients
Keywords: Open lung approach
conventional ventilation
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-08-10
Enrollment: 48
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: HEALTH_SERVICES_RESEARCH

Brief summary: the purpose of this study is to compare open lung approach versus conventional protective ventilation in obese patients undergoing open abdominal surgery

Detailed description: after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 2 groups each one containing 24 patients Group SPV: will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .

Group OLA: The patients will undergo ARM followed by personalized PEEP.

Eligibility criteria: Inclusion Criteria:

* Patient aged between 18 - 65 years
* BMI between 30-40 kg/m²
* ASA I and II,open elective abdominal surgery which is expected to last for more than 2 hours under general anesthesia and planned to be extubated at the end of surgery

Exclusion Criteria:

* Emergency surgery, pregnancy, chronic obstructive pulmonary disease (FEV1 \< 80% of the predicted value)
* active asthma, acute respiratory distress syndrome
* history of pneumothorax, lung cyst, Difficult airway, obstructive sleep apnea,ischemic heart disease, heart failure
* significant arrhythmias and intracranial hypertension. Exposure to radiotherapy and chemotherapy within 2 months before surgery. Advanced Cardiovascular ,liver, renal diseases ischemic heart disease, heart failure, significant arrhythmias and intracranial hypertension

Primary outcomes:
measure: post-operative pulmonary complications
timeFrame: one week postoperative
Secondary outcomes:
measure: heart rate
timeFrame: Baseline (before surgery) and intraoperative
measure: airway pressure
timeFrame: intraoperative
measure: pulmonary complications.
timeFrame: one week postoperative
measure: length of hospital stay,
timeFrame: postoperative up to one month
measure: mean arterial blood pressure
timeFrame: Baseline (before surgery) and intraoperative
measure: ETCO2
timeFrame: Baseline (before surgery) and intraoperative
measure: tidal volume
timeFrame: intraoperative
measure: SpO2
timeFrame: Baseline (before surgery) and intraoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine,Zagazig University
state: Zagazig, Elsharkia,egypt
Study officials:
affiliation: zagazig U
name: Howida A kamal, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT02707536: Influence of Platelet-Rich Fibrin on Post-extraction Alveolar Ridge Healing/Preservation as a Stand-alone or Adjunct to Particulate Graft
Official title: Influence of Platelet-Rich Fibrin on Post-extraction Alveolar Ridge Healing/Preservation as a Stand-alone or Adjunct to Particulate Graft: A Clinical, Radiographic and Histological Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extraction Socket Healing
Alveolar Ridge Preservation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 42
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: The goal of this project is to evaluate the influence of platelet rich fibrin (PRF) in extraction socket healing with or without particulate bone graft. The hypothesis of this study is that PRF will enhance the extraction socket healing and new bone formation when compared to extraction sockets grafted without PRF.


Eligibility criteria: Inclusion Criteria:

* Subjects ≥ 18 years of age
* Hopeless or non-restorable single non-molar tooth per quadrant with adjacent teeth present
* Maximum of two teeth can qualify per patient.
* The buccal plate must be ≥ 1mm in width with a 4-wall configuration.
* Cases requiring minimal sinus grafting (\<3mm)
* Bone grafting limited to the apical portion of the osteotomy site

Exclusion Criteria:

* Exclusion Criteria:
* Untreated periodontal disease, endodontic-periodontal disease and/or caries
* The buccal plate must be ≤ 3mm in width with a 4-wall configuration.
* Patients with uncontrolled or severe systemic disease (Diabetes)
* Patients with medical conditions or taking medication associated with compromised bone healing (Diabetes, Autoimmune Dysfunction, Prolonged Cortisone Therapy, Chemotherapy, or Bisphosphonate Therapy)
* Current Smokers
* Subjects with extensive parafunctional habits (ie; bruxism)
* Subjects who demonstrate inadequate oral hygiene

Primary outcomes:
measure: Change in alveolar ridge width (buccal-lingual)
timeFrame: baseline, 3 months
measure: Change in alveolar ridge height (apical coronal)
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Percentage of vital bone in bone core as assessed histology
timeFrame: 3 months
measure: Percentage of residual bone graft in bone core as assessed histology
timeFrame: 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston School of Dentistry
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sridhar Eswaran, BDS, MS, MSD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03274336: Influence of Audiovisual Aids in the Preanesthetic Interview
Official title: Influence of Audiovisual Aids in the Preanesthetic Interview: A Comparison of the Effect of Face-to-face-interview Versus a Brochure and Video Assisted Interview
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Keywords: patient satisfaction
preanesthesia
movie
brochure
face-to-face interview
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 1172
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: 1000 patients will be asked to fill out a questionnaire about preanesthetic visit right after the interview. On a daily randomization the Groups will be assigned to: Group A = face-to-face interview; Group B = interview plus brochure, Group C= interview plus movie.

Evaluation of patient satisfaction und knowledge transfer will be evaluated with a questionnaire filled out right after the interview with the anesthesist.


Eligibility criteria: Inclusion Criteria:

* voluntary

Exclusion Criteria:

* language Problems
* not able to read or write
* patients does not want to fill out questionnaire

Primary outcomes:
measure: Patient satisfaction on a questionnaire
timeFrame: 15 Minutes
Secondary outcomes:
measure: time
timeFrame: 30 Minutes
Other outcomes:
Locations:
Study officials:
affiliation: Schulthess Klinik
name: Berthold Moser, MD
role: PRINCIPAL_INVESTIGATOR
References: