louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02911389: Home PT vs FORCE PT
Official title: Unsupervised Home Exercise With and Without a Web-based Recovery Platform as Compared to Traditional Outpatient Physiotherapy After Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2016-09-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to determine if unsupervised, home rehabilitation delivered by a web-based platform or paper manual is a safe and effective alternative to outpatient physical therapy after total knee replacement.


Eligibility criteria: Inclusion Criteria:

1. Any patient undergoing unilateral, primary TKA

Exclusion Criteria:

1. Patients without access to the Internet
2. Patients without access to outpatient PT
3. Revision or conversion TKA
4. Patients discharged to a rehabilitation unit or other form of respite care such as a skilled nursing facility, acute rehabilitation center, convalescent home, long-term care facility or nursing home.

Primary outcomes:
measure: Knee Range of Motion
timeFrame: 1 month post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03410589: Development of a Computerized Adaptive Test (CAT) for Evaluation of Sleep, Fatigue and Quality of Life in Patients With Chronic Pain
Official title: Desenvolvimento de Teste Adaptativo Computadorizado (CAT) Para avaliação do Sono, Fadiga e Qualidade de Vida em Pacientes Com Dor crônica
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic pain

Brief summary: The purpose of this study is to evaluate quality of life, sleep and fadigue in patients with chronic pain using an Item-Response Theory methodology and also generating a Computer Adaptive Testing System


Eligibility criteria: Inclusion Criteria:

be able to read Portuguese be able to write Portuguese being in treatment for chronic pain

Exclusion Criteria:

hearing impairment that impairs ability to respond to tests visual impairment that impairs ability to respond to tests physical impairment that impairs ability to respond to tests cognitive impairment that impairs ability to respond to tests

Primary outcomes:
measure: sleep disorders
timeFrame: Within 1 month before the study start
measure: fatigue
timeFrame: Within 7 days before the study start
measure: measurement quality of live
timeFrame: Within 1 month before the study start
measure: sleep disorders
timeFrame: Within 1 month before the study start
measure: measurement quality of live
timeFrame: Within 1 month before the study start
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das clinicas da FMUSP
state: SP
Study officials:
affiliation: doctor and investigator
name: Daniel C Andrade, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04627389: Orbicularis Oris Z-plasty Modification of Modified Millard Technique and the Esthetic Outcome of Cleft Lip Repair
Official title: Esthetic Outcomes Evaluation of Unilateral Cleft Lip Repaired by Orbicularis Oris Z-plasty Modification of Modified Millard Technique Versus Modified Millard Technique. A Randomized Clinical Trail.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cleft Lip
Keywords: cleft lip
chelioplasty
modified millard
orbicularis oris modification
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the effect of orbicularis oris muscle z-plasty modification of modified Millard technique on the esthetic outcome and length of the repaired lip

Detailed description: forty patients with a unilateral cleft lip will be enrolled in this randomized comparative study. The patients will be divided into two groups, the control (group A) who treated with the modified Millard technique and the study group who repaired by orbicularis oris muscle Zplasty modification of modified Millard technique (group B).

Eligibility criteria: Inclusion Criteria:

* non-syndromic cleft lip patients.
* Primary, unilateral, complete or incomplete cleft lip.
* The patient's age is younger than six months.
* lip repair performed by one craniofacial surgeon

Exclusion Criteria

* syndromic cleft lip.
* Secondary lip treatment (previously operated cases)
* Bilateral cleft lip
* Patients are older than six months. Associated Cardiac anomalies. Any systemic condition

Primary outcomes:
measure: lip legth
timeFrame: immediate postoperative
Secondary outcomes:
measure: Philtral ridge length symmetry index assessment
timeFrame: 6months
measure: Scar width assessment by photograph
timeFrame: 6months
measure: scar width by ultrasound
timeFrame: 6months
measure: scar elascitity
timeFrame: 6months
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
affiliation: Fayoum University
name: shaimaa refahee, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00408889: Prospective Evaluation of Predictors for Organ Failure Following Liver Transplantation
Official title: Prospective Evaluation of Predictors for Organ Failure Following Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Keywords: liver transplantation
organ failure
outcome
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2006-12-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing liver transplantation

Brief summary: Early organ failure occurs frequently and is difficult to predict. The study aims to define a predictive score for early transplant failure.

Detailed description: Patients will be monitored 7 days following liver transplantation, including clinical scores, clinical chemistry, ultrasound findings and indocyaninegreen-clearance.

Eligibility criteria: Inclusion Criteria:

* orthotopic liver transplantation
* age \> 18 years

Exclusion Criteria:

* allergy to indocyangreen

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg
Study officials:
affiliation: Heidelberg University
name: Christoph Eisenbach, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schneider L, Spiegel M, Latanowicz S, Weigand MA, Schmidt J, Werner J, Stremmel W, Eisenbach C. Noninvasive indocyanine green plasma disappearance rate predicts early complications, graft failure or death after liver transplantation. Hepatobiliary Pancreat Dis Int. 2011 Aug;10(4):362-8. doi: 10.1016/s1499-3872(11)60061-1.
Clinical trial NCT04160689: Influence of the Implant Connection on Facial Tissues Maturation
Official title: Influence of the Implant-Abutment Connection on the Ratio Between Height and Thickness of Tissues at the Buccal Implant Zenith: a Perspective Randomised 3d Comparative Analysis on 188 Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bone Loss
Periodontal Bone Loss
Implant Tissue Failure
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The substitution of a tooth with a fixture often induces undesired morphological changes, resulting in a deterioration of the aesthetic appearance. The purpose of this study is to compare the soft tissue behavior next to two different implant connections: 5° (group 1) and 35° hexed (group 2), conical, internal with switching platform design after 12 months of functional provisionalization


Eligibility criteria: Inclusion Criteria:

* Missing teeth
* good oral hygiene
* good systemic health

Exclusion Criteria:

* lactation
* pregnancy
* heavy smoking (more than 20 cigarettes/day)
* severe medical conditions that could affect periodontal health and peri-implant tissue response
* use of drugs correlated to periodontal hypertrophy
* bone volume that required bone augmentation procedures before implant placement as well as soft tissue graft or any kind of peri-implant tissue engineering

Primary outcomes:
measure: height of the peri-implant mucosa (MH)
timeFrame: after 12 months
measure: The width (MT) of the peri-implant mucosa
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Varese
country: Italy
facility: University of Insubria
Study officials:
References:
citation: Farronato D, Pasini PM, Manfredini M, Scognamiglio C, Orsina AA, Farronato M. Influence of the implant-abutment connection on the ratio between height and thickness of tissues at the buccal zenith: a randomized controlled trial on 188 implants placed in 104 patients. BMC Oral Health. 2020 Feb 17;20(1):53. doi: 10.1186/s12903-020-1037-5.
Clinical trial NCT04883489: Pain Classification in Caregivers for Children With Cerebral Palsy
Official title: Clinical Classification of Musculoskeletal Pain in Caregivers for Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Cerebral Palsy
Musculoskeletal Pain
Caregivers
Keywords: chronic pain
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The convenience sampling will implement for this cross-sectional study. Caregivers for children with Cerebral palsy chronic pain who presented at the different Educational and Rehabilitation Center in Kutahya will screen for eligibility by a clinician and will subsequently request to participate in this study.

Brief summary: The care of children with Cerebral Palsy is a process that continues for many years. Individuals who take care of them experience musculoskeletal pain due to the difficulties they experience and face pain that becomes chronic over time. For individuals who take care of children with CP, determining the types of chronic pain is important in order to clarify the classification criteria and for individuals to reach better living standards by tailoring the treatments they will receive. Therefore, the aim of the study is to determine the types of chronic pain in caregivers for children with cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* Having musculoskeletal pain complaints for the last 6 months or more
* experienced musculoskeletal pain or a sensitive disorder (like numbness, tingling, etc.) anywhere in body for which they stated a minimum score of 2 on a numeric pain rating scale
* pain that lasts at least 6 months
* To provide the documented diagnosis of Cerebral palsy of the child in the care of the participants.

Exclusion Criteria:

* Having severe psychological illness
* Having a cognitive dysfunction
* Not participating in the assessment or submitting incomplete answers for questionnaires

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 1 minute
measure: Margolis Pain Diagram
timeFrame: 5 minute
measure: Central Sensitization Inventory
timeFrame: 10 minute
measure: Short Form 36
timeFrame: 10 minute
Secondary outcomes:
measure: Quantitative sensory test
timeFrame: 10 minute
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: KutahyaHSU
Study officials:
References:
Clinical trial NCT06316089: An Intervention to Improve HIV Pre-exposure Prophylaxis Initiation, Adherence and Linkage to Care for Recently Incarcerated Men Who Inject Drugs.
Official title: An Intervention to Improve HIV Pre-exposure Prophylaxis Initiation, Adherence and Linkage to Care for Recently Incarcerated Men Who Inject Drugs.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Substance Use Disorders
Keywords: HIV
Substance Use Disorders
Injection Drug Use
Incarceration
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pre-exposure prophylaxis (PrEP) is effective in preventing HIV infection among people who inject drugs (PWID) yet studies suggest that its use is low among this population which is particularly vulnerable to HIV infection. The criminal justice (CJ) system, at the intersection of increased risk of HIV infection and substance use, presents a unique opportunity to engage PWID in HIV prevention care that incudes PrEP. The study will characterize the facilitators and barriers to PrEP initiation, adherence and linkage to care among male PWID that are experiencing incarceration and develop the "PrEPare-for-Release" intervention to promote PrEP initiation, adherence and linkage to care upon release from incarceration into the community.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Incarcerated at the Rhode Island Department of Corrections
* Identifies as male
* Reports a history of injection drug use
* Meets CDC clinical criteria for PrEP use
* Able to provide written and verbal consent in either English or Spanish

Exclusion Criteria:

* Unable to provide written and/or verbal consent

Primary outcomes:
measure: PrEP initiation
timeFrame: Rapid, within 7 days
Secondary outcomes:
measure: Adherence to PrEP
timeFrame: At least 30 days
measure: Linkage to PrEP care in the community
timeFrame: Within 30 days post-incarceration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01707589: Noninvasive Monitoring of Vital Signs in Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Admission to the NICU and Need for Physiological Monitoring.
Keywords: monitoring
heart rate
respiration rate
temperature
motion
noninvasive
physiologic parameters
NICU
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: the investigators are assessing a non-invasive monitor based on dynamic light scattering that measures pulse rate and respiration rate. The monitor also will be equipped with a temperature sensor and a motion sensor. This monitor will allow multi-parametric measurements in neonates in a simple and noninvasive manner.

Detailed description: Monitoring vital signs in neonates is important. This currently is done with multiple standard clinical monitors. the investigators are developing a very small (coin-sized) sensor that can measure pulse rate, respiratory rate, temperature and body motion. the investigators propose to test our sensor against standard monitoring techniques in neonates in a neonatal ICU (NICU).

The monitor, called ELFI-monitor, is based on dynamic light scattering. A low-power laser beams light into the skin, and the red blood cells in the underlying skin return the light which is recorded in a light sensor. The movement of the red blood cells is affected by the rhythmic cardiac contractility. in this manner, heart rate and rhythm can be assessed. The ELFI monitor also contains an embedded temperature probe and a miniature 3-D motion sensor, allowing capture of additional parameters.

Methods:

the investigators plan to study 100 neonates admitted to the NICU of Meir Hospital Center. These infants are routinely monitored with standard equipment including ECG, oximeter, temperature, and respiratory monitors. the investigators will simultaneously monitor these children with the ELFI monitor, recording pulse rate, cardiac rhythm, respiratory rate, skin temperature and body motion. Recordings will be conducted for a one-hour period on each subject. Data recordings from the ELFI sensor will be compared to the readouts of the conventional monitors used on the patient. It is important to emphasize that the data recordings of the ELFI sensor will not affect clinical decisions in any manner, but will merely be recorded for comparison with conventional sensors.

Eligibility criteria: Inclusion Criteria:

* All neonates admitted the Meir Hospital center NICU
* Parents provide informed consent

Exclusion Criteria:

* Neonates with skin disease

Primary outcomes:
measure: Comparison of data collected from ELFI sensor to standard monitors
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Neonatal department Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Sofia Bauer-rosek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05021289: Guided Imagery on the Perceived Stress Level in High-Risk Pregnancies
Official title: Effect of the Practice of Guided Imagery on the Perceived Stress Level in High-Risk Pregnancies: Randomized Single-Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Risk Pregnancy
Keywords: Guided Imagery
Perceived Stress Level
High-Risk Pregnancies.
Lead sponsor: Munzur University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Designed as a prospective randomized single-blind trial, the research was performed with the participation of a total of 128 women who had high-risk pregnancies and received inpatient treatment on 1 February - 1 May 2021 at the perinatology service of a maternity and children's hospital located in the Anatolian side of Istanbul province of Turkey (64 pregnant women in the experimental group, 64 pregnant women in the control group).
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research was conducted to identify the effect of the practice of Guided Imagery on the perceived stress level in high-risk pregnancies.

Detailed description: Designed as a prospective randomized single-blind trial, the research was performed with the participation of a total of 128 women who had high-risk pregnancies and received inpatient treatment on 1 February - 1 May 2021 at the perinatology service of a maternity and children's hospital located in the Anatolian side of Istanbul province of Turkey (64 pregnant women in the experimental group, 64 pregnant women in the control group).

Eligibility criteria: Inclusion Criteria:• Having a high-risk pregnancy

* Being aged 18 years or above
* Agreeing to participate in the study
* Being literate in Turkish

Exclusion Criteria:

* The pregnant women who voluntarily wanted to leave the research at any stage after being included in the study, could not communicate verbally, had a visual or hearing disorder, and were previously diagnosed with a psychiatric disease were excluded from the research

Primary outcomes:
measure: Perceived Stress Scale.
timeFrame: • The first practice of guided imagery was performed face-to-face with pregnant women. At the end of 20 minutes, the pregnant women's stress levels were reevaluated by using the Perceived Stress Scale.
Secondary outcomes:
Other outcomes:
Locations:
city: Tunceli
country: Turkey
facility: Munzur University
state: Merkez
Study officials:
References:
Clinical trial NCT04460989: Assessment of Patient Satisfaction After Arthroplasty: A Comparative Study by Implant Type
Official title: Evaluation of the Impact of Customization of Total Knee Prostheses on Patient Satisfaction and Functional Outcome of Arthroplasty.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gonarthrosis
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with uni or bilateral primary gonarthrosis

Brief summary: The main objective of this study is to evaluate the benefit of personalized prostheses compared to conventional prostheses on patient satisfaction 24 months after total knee arthroplasty.

Detailed description: Prospective randomized monocentric prospective comparative study carried out as a single blind study on two parallel groups (standard implant or customized implant).

Secondary Objectives: Compare between groups :

* the functional outcome of the arthroplasty
* pain progression
* the evolution of the quality of life
* the conditions of the surgery (duration of surgery, length of hospitalization, blood loss)
* the frequency of adverse events related to arthroplasty

Eligibility criteria: Inclusion Criteria:

* Adult man or woman who has signed consent to participate in the study
* Patient with uni- or bilateral primary gonarthrosis
* For which an indication for total knee arthroplasty has been established

Exclusion Criteria:

* History of knee arthroplasty or osteotomy
* History of knee fracture
* Inflammatory rheumatic disease or any other progressive concomitant disease that may affect the patient's functional prognosis.
* Joint or extra-articular deformities of the lower limb of traumatic origin
* Neurological diseases, stroke sequelae
* Mental disability or any other reason that may hinder the understanding or strict application of the protocol
* Patient not affiliated to the French social security scheme
* Patient under legal protection, guardianship or trusteeship
* Patient already included in another therapeutic study protocol or having participated in another trial within the previous three months
* Arthroplasty actually performed
* Absence of per operative complications in bone (femoral or tibial bone), ligament (rupture or disinsertion of the patellar or quadricipital tendon) or nerve (lesion of the external popliteal sciatica).

Primary outcomes:
measure: IKS self-questionnaire Score at M24
timeFrame: 24 MONTHS
Secondary outcomes:
measure: SF12 score at M24
timeFrame: 24 months
measure: KOOS Score at M24
timeFrame: 24 months
measure: Forgotten Joint Score at M24
timeFrame: 24 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Orthopédique Santy
Study officials:
affiliation: CENTRE ORTHOPÉDIQUE SANTY
name: MICHEL BONNIN, MD
role: PRINCIPAL_INVESTIGATOR
References: