louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05008068: Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes
Official title: Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Platelet-rich Fibrin
Simvastatin
Keywords: Platelet-rich fibrin
Simvastatin
Bone loss
Peri-implant Bone Changes
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 8
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy.
Primary purpose: SCREENING

Brief summary: ACKGROUND: Simvastatin (SIM), a pharmacological drug used for hypercholesterolemia, has been found to have pleotropic effects on bones. Simvastatin together with the appropriate carrier may decrease bone loss around implants.

PURPOSE: To compare the long term effects of autologous PRF alone, and PRF loaded with SIM on peri-implant bone changes and implant stability in patients undergoing implant rehabilitation.

MATERIALS AND METHODS: A randomized controlled split-mouth studyincluding 8 males between the ages of 45-60 years. Each patient received two implants, one on each side of the arch. One side was treated with PRF alone and the other side with PRF +Simvastatin, at the time of Osteotomy. A cone-beam CT was used to evaluate bone changes around the insertion of implant sites atthree, six, and twelve months postoperatively. The secondary outcome included measuring implant stability using Ostell device at baseline and 3 months post insertion. To compare groups at different time periods, data was examined using a two-way (ANOVA) analysis.


Eligibility criteria: Inclusion Criteria:

* patients with a partially edentulous mandible indicated for rehabilitation with implant prostheses,
* any extractions, or surgeries performed at least six months earlier.

Exclusion Criteria:

* patients with systemic diseases affecting bone quality or resorption
* temporomandibular joint dysfunction,
* severe attrition or parafunctional habits,
* patients undergoing radiotherapy or chemotherapy,
* heavy smokers,
* vulnerable groups such as psychologically unstable patients

Primary outcomes:
measure: The measurement of bone thickness
timeFrame: After 3 months of the osteotomy and application of Simvastatin
measure: The measurement of bone thickness
timeFrame: After 6 months of the osteotomy and application of Simvastatin
measure: The measurement of bone thickness
timeFrame: After 12 months of the osteotomy and application of Simvastatin
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The British University in EGYPT
Study officials:
References:
Clinical trial NCT04874168: The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery:
Official title: The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery: (A Randomized Controlled Double-blinded Clinical Trial )
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 210
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare bilateral ultrasound-guided TAP block with single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia

Detailed description: This double-blind, randomized controlled trial aimed to compare bilateral ultrasound-guided TAP block to single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia. This will be done by measuring VAS (visual analogue score) for pain after ceserian section at2, 4, 6, 12, 24 hours .

Eligibility criteria: Inclusion Criteria:

* Women undergoing cesarean section under spinal anesthesia
* Aged ≥19 years and \> 40 years .
* Gestational age ≥ 37 Weeks .
* Informed Consent From the Patient .

Exclusion Criteria:

* Body mass index (BMI) ≥40 kg/m2 ..
* History of recent opioid exposure .
* Hypersensitivity to any of the drugs used in the study .
* Significant cardiovascular, renal, or hepatic disease.

Primary outcomes:
measure: The degree of pain at rest ;
timeFrame: From 2 hours to 24 hours postoperatively
Secondary outcomes:
measure: The time to the first postoperative opioid dose
timeFrame: at 2, 4, 6, and 12 hours.
Other outcomes:
measure: The degree of pain on movement (hip flexion and coughing)
timeFrame: From 2 hours to 24 hours postoperatively
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Alabbasia
Study officials:
affiliation: Ain Shams University
name: Ahmed G Elnajar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05763368: Evaluation of Proprioception in Patients With Total Hip Replacement
Official title: Evaluation of Proprioception in Patients With Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coxarthrosis; Primary
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Disturbances of balance and postural stability are frequent in patients with coxarthrosis due to the damage to the mechanoreceptors, characteristic of arthritic degeneration, and muscular hypotrophy of the affected limb.

The aim of the study is to evaluate with adequate instrumentation the alterations of proprioception and postural control in patients with hip osteoarthrosis and the effectiveness of joint reconstruction in improving any deficit.


Eligibility criteria: Inclusion Criteria:

* Primary Osteoarthrosis
* BMI \< 35 kg/m\^2
* Able to stand in monopodalic support without aids / support

Exclusion Criteria:

* History of previous hip or knee replacement
* Orthopedic trauma within the previous 6 months
* Pathologies that can interfere with balance: neurological (of the central nervous system, neuropathies, movement disorders), vestibular, visual, cognitive disability, consumption of alcohol / drugs / psychoactive drugs in the 24 hours prior to the test

Primary outcomes:
measure: Change from baseline postural stability and proprioception
timeFrame: At baseline, 3 months, 6 months, and 12 months from surgery
measure: Change from baseline postural stability and proprioception
timeFrame: At baseline, 3 months, 6 months, and 12 months from surgery
Secondary outcomes:
measure: Clinical improvements
timeFrame: At baseline, 3 months, 6 months, and 12 months from surgery
measure: Clinical improvements
timeFrame: At baseline, 3 months, 6 months, and 12 months from surgery
measure: Patient satisfaction
timeFrame: At baseline, 3 months, 6 months, and 12 months from surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS-Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT06730568: Effect of Different Non-surgical Treatment Approaches of Peri-implantitis
Official title: Effect of Different Non-surgical Treatment Approaches of Peri-implantitis: a Multi-arm Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Inflammation
Peri-Implantitis and Peri-implant Mucositis
Non-surgical Treatment
Lead sponsor: Yeditepe University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2024-12-12
Enrollment: 26
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: Peri-implantitis is a biofilm-associated pathological condition characterized by inflammation within the peri-implant mucosa, which leads to the progressive loss of the surrounding supporting bone tissue. The primary goal of managing peri-implantitis is to control the peri-implant biofilm and resolve inflammation. Nonsurgical treatment of peri-implantitis by submarginal mechanical instrumentation alone typically provides clinical improvements, particularly in non-advanced cases. However, to ensure surface decontamination and enhance treatment outcomes, alternative or adjunctive methods, such as systemic/local antibiotics, antiseptics, lasers, and air-abrasion systems, have been proposed.

Therefore, the null hypothesis (H0) of the present study is that no statistically significant difference would be detected in clinical inflammation signs among patients diagnosed with early-stage peri-implantitis after undergoing one of the following treatments: nonsurgical mechanical instrumentation alone, mechanical instrumentation plus chlorhexidine (CHX), mechanical instrumentation plus gaseous ozone, mechanical instrumentation plus glycine air polishing, or glycine air polishing alone.


Eligibility criteria: Inclusion Criteria:

* the presence of at least one titanium implant with clinical and radiographic signs of initial to moderate peri-implantitis
* single-unit or partial restorations without overhangings
* absence of occlusal overload
* the presence of at least 2 mm of keratinized attached peri-implant mucosa
* periodontally healthy participants with a good level of oral hygiene

Exclusion Criteria:

* the presence of implant mobility
* systemic diseases (i.e. diabetes (HbA1c \<7), osteoporosis, bisphosphonate medication) which could affect the outcome of treatment
* smoking
* placement, and prosthetic loading of implants within the past year

Primary outcomes:
measure: Probable Pocket Depth
timeFrame: Baseline, 3 months, and 6 months after treatment
Secondary outcomes:
measure: Bleeding on Probing
timeFrame: Baseline, 3 months, and 6 months after treatment
measure: Plaque Index
timeFrame: Baseline, 3 months, and 6 months after treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Dentistry Faculty
Study officials:
References:
Clinical trial NCT04672668: Correlation Between the Volume Flow of the CFA After Angioplasty of Critical Ischemic Limb and Wound Healing
Official title: Correlation Between the Volume Flow of the CFA After Angioplasty of Critical Ischemic Limb and Wound Healing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wound Heal, Duplex Volume Flow
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-12-17
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with threatened limbs, having angioplasty .

Brief summary: in our study we are examining the volume flow of the common femoral artery before and after angigraphy of a critical ischemic limb, as a predictor for wound healing after the treatment

Detailed description: All patients with threatened limbs, that was decided upon to have angioplasty will be asked to sign consent form to participate in this study.

Before having the angioplasty, all participants will be examined with ultrasound duplex to determent their common femoral artery volume flow. Day after the angioplasty, they will be reexamined (this is the usual practice) to detriment the new volume flow in the CFA.

The participents examinations in the outpatient clinics will be documented and time for healing will be recorded.

Eligibility criteria: Inclusion Criteria:

* All patients with threatened limbs, that was decided upon to have angioplasty .

Exclusion Criteria:

* those who are not willing to sign a consent form to participate in this study

Primary outcomes:
measure: wound healing
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Health Center
Study officials:
affiliation: sheba health center
name: moshe halak, dr
role: STUDY_CHAIR
References:
Clinical trial NCT02158572: Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System
Official title: A Single-arm, Open-label, Multicenter Phase 3 Study of the Contraceptive Efficacy, Safety and Tolerability of the AG200-15 Transdermal Contraceptive Delivery System (TCDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: prevention of pregnancy
Lead sponsor: Agile Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-06-09
Enrollment: 2032
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.

Detailed description: AG200-15 is used in a 4-week (28-day) treatment cycle: a patch is applied and replaced every 7 days for 3 consecutive weeks, followed by a 1-week "patch-free" period.

Eligibility criteria: Inclusion Criteria:

* Healthy, sexually active woman at risk for pregnancy seeking to use hormonal contraception for at least 1 year
* Ability to demonstrate willingness to participate and adhere to study protocol

Exclusion Criteria:

* Known or suspected pregnancy
* Lactating women
* Anticipates use of condoms or any other form of back-up contraception during the study
* History of dermal sensitivity to medicated patches (nicotine) or to bandages, surgical tape, etc.
* Has a contraindication to combined estrogen-progestin contraceptive use
* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
* Smoker who is 35 years old or over

Primary outcomes:
measure: Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset.
timeFrame: 1 year
Secondary outcomes:
measure: Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 25 kg/m2, ITT Dataset
timeFrame: 1 year
measure: Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 25 and < 30 kg/m2, ITT Dataset
timeFrame: 1 year
measure: Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 30 kg/m2, ITT Dataset
timeFrame: 1 year
Other outcomes:
measure: Self-reported Skin Irritation at Application Site
timeFrame: 1 year
measure: Self-reported Skin Itching at Application Site
timeFrame: 1 year
measure: Self-reported Patch Adhesion
timeFrame: 1 year
measure: Cycle Control
timeFrame: 1 year
Locations:
Study officials:
affiliation: Agile Therapeutics
name: Elizabeth Garner, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Nelson AL, Kaunitz AM, Kroll R, Simon JA, Poindexter AN, Castano PM, Ackerman RT, Flood L, Chiodo JA 3rd, Garner EI; SECURE Investigators. Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results. Contraception. 2021 Mar;103(3):137-143. doi: 10.1016/j.contraception.2020.11.011. Epub 2020 Nov 28.
Clinical trial NCT03771872: Virtual Prism Adaptation Therapy on Hemispatial Neglect
Official title: Effects of Virtual Prism Adaptation Therapy in Stroke Patients With Hemispatial Neglect
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Recovery of Function
Rehabilitation
Perceptual Disorders
Virtual Reality Exposure Therapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Bundang Rusk Rehabilitation Specialty Hospital
First posted: 2018-12-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of virtual prism adaptation therapy on hemispatial neglect in chronic stroke patients. This study is the randomized, double-blind, sham-controlled, cross-over design. Total 10 patients will be allocated randomly to either real virtual prism adaptation therapy or sham therapy with the wash-out period of more than 2 weeks. Two sessions (20min/session) per day, for 5days (total 10 sessions) will be provided. Behavioral outcomes will be measured before and after completing a total of 10 sessions therapy.


Eligibility criteria: Inclusion Criteria:

* 3 months after stroke onset
* 2 or more tests indicative of hemispatial neglect in following 3 tests: 1)line bisection test, 2)Albert's test, 3)Drawing test.
* Ability to recognize the target object, hand trajectory in the immersive virtual reality
* 16 points or more in the Korean version of mini-mental state examination

Exclusion Criteria:

* Previous stroke or traumatic brain injury history
* Can not cooperate during the therapy, due to delirium or aphasia
* Unstable medical conditions
* Severe psychiatric symptoms that interfere with the therapy participation (e.g. severe depression, agitation, psychotic symptoms)
* Pregnancy
* Can not maintain sitting posture

Primary outcomes:
measure: Behavioral Inattention Test (BIT) Score
timeFrame: Change from Baseline at 5 days
Secondary outcomes:
measure: BIT Conventional subtest score (BITC)
timeFrame: Change from Baseline at 5 days
measure: BIT Behavioral subtest score (BITB)
timeFrame: Change from Baseline at 5 days
measure: Comb and Razor Test
timeFrame: Change from Baseline at 5 days
measure: Catherine Bergego Scale (CBS)
timeFrame: Change from baseline at 5 days
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Bundang Rusk Rehabilitation Specialty Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT04785872: Neuman Systems Model and Infertility Stress
Official title: EFFECT OF NEUMAN SYSTEMS MODEL BASED NURSING APPROACH ON STRESS AND COPING WITH STRESS FOR WOMEN RECEIVED INTRAUTERIN INSEMINATION TREATMENT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Intrauterine Insemination
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 62
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, it is aimed to determine the effect of Neuman Systems Model based nursing approach on stress an coping with stress for women received intrauterine insemination (IUI) treatment. The study has been planned as a single blind experimental study in pretest-posttest design with randomized control. Sample group is going to be chosen from women who have taken IUI treatment in Ankara University Fertility Diagnosis, Treatment, Research and Application Center. Sample size of the study has been determined as 72 such that intervention=36 and control=36. While gathering data, personal information form, The COMPI Fertility Problem Stress Scales and The COMPI Coping Strategy Scales are going to be used. In the scope of the study, four interviews with women in intervention group are going to be done during IUI treatment.


Eligibility criteria: Inclusion Criteria:

1. Getting a diagnosis of primary infertility
2. Volunteering to participate in the study
3. Being over the age of 18
4. Taking IUI treatment
5. Not being diagnosed with a chronic disease
6. Not being diagnosed with a psychiatric illness
7. Do not have a problem that can interfere with written and verbal communication.

Exclusion Criteria:

1. To want to leave the study,
2. Cancellation of treatment.

Primary outcomes:
measure: The COMPI Fertility Problem Stress Scale
timeFrame: Immediately after intrauterine insemination procedure
measure: The COMPI Coping Strategy Scale
timeFrame: Immediately after intrauterine insemination procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Fertility Diagnosis, Treatment, Research and Application Center
Study officials:
affiliation: Ankara University Nursing Faculty
name: Menekşe N Aker, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05983172: Multi-omics Approach of Risk Stratification for Patients With de Novo Acute Myeloid Leukemia
Official title: Multi-omics Approach of Risk Stratification for Patients With de Novo Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid leukemia
Machine learning
Artificial intelligence
Risk stratification
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with acute myeloid leukemia

Brief summary: The investigators will use machine learning to identify features on bone marrow smears and select features that are related to gene mutations, gene expression, or prognosis. The investigators will then use genome-wide transcriptomic profiling to investigate gene expression that is associated with patients' outcomes. The investigators will design a next-generation sequencing panel with unique molecular index and assess its feasibility and robustness in detecting measurable residual disease and optimize the panel/platform/bioinformatic pipeline. Finally, The investigators will use machine learning to integrate bone marrow smear features, gene mutations, gene expression, and measurable residual disease to construct a comprehensive risk assessment system that is based on multi-omics data. The investigators believe that such a platform will help physicians to design the most appropriate treatment strategies for individual patients, not only advancing the concept of precision medicine but also improving patients' prognoses.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with acute myeloid leukemia at the National Taiwan University Hospital
2. Ever enrolled in 201802021RINC、202109078RINB、201709072RINC

Exclusion Criteria:

Nil

Primary outcomes:
measure: Overall survival
timeFrame: From date of diagnosis until the date of death from any cause, assessed up to 30 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Xavier Cheng-Hong Tsai, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: