louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01977261: High Tibial Osteotomy for Osteoarthritis of the Knee
Official title: High Tibial Osteotomy for Osteoarthritis of the Knee: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 92
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: TREATMENT

Brief summary: A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.

Detailed description: A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.

The primary outcome measure was the achievement of an overcorrection of valgus of 4°. Secondary outcome measures were the severity of pain (visual analogue scale), knee function (Hospital for Special Surgery score), and walking distance.

Eligibility criteria: Inclusion Criteria:

* Radiological OA, medial joint pain and varus malalignment

Exclusion Criteria:

* Symptomatic OA of the lateral compartment, rheumatoid arthritis, ROM \<100, collateral ligament laxity, history of fracture of previous open operation of the lower limb and a flexion contracture \> 10 degrees.

Primary outcomes:
measure: The achievement of an overcorrection of valgus of 4°.
timeFrame: one year
Secondary outcomes:
measure: Severity of pain
timeFrame: one year
measure: Knee function
timeFrame: one year
measure: Walking distance
timeFrame: one year
Other outcomes:
measure: Number of participants with adverse events
timeFrame: one year
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
Study officials:
References:
Clinical trial NCT01163461: Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia
Official title: Real Word Effects in Phonological Treatment for Word Retrieval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-07-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a behavioral speech therapy trial for individuals who have suffered a stroke on the left side of the brain and have difficulty speaking. The name of this disorder is called 'aphasia'. Individuals who participate in this study will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).

Detailed description: The study design was a single group (n=26) with repeated testing (3 times) pre- and post-treatment. All participants received the same treatment protocol (described in detail in Appendix A and in Minkina et al. (under review)). In order to control for improvement in language function related to passage of time, and for the effect of repeated exposure to outcome measures, individuals were randomly assigned to one of two conditions: delayed treatment or immediate treatment (Figure 2). Participants who were randomized to the delayed group received repeated testing three times before and three times after a six-week delay. During the delay phase they were permitted to participate in usual speech-language care (e.g., conversation groups and individual therapy).

Standardized assessments and outcome measures (described in detail below) were administered prior to the start of treatment (for both immediate and delayed groups), at the end of the delay phase (delayed group only), immediately after treatment termination, and at three months post-treatment.

Eligibility criteria: Inclusion Criteria:

* left hemisphere stroke
* monolingual English speaking
* right handed
* presence of aphasia

Exclusion Criteria:

* preexisting neurological condition

Primary outcomes:
measure: Speech Production
timeFrame: Baseline to one week post treatment termination and three months post treatment termination
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Diane L. Kendall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kendall DL, Hunting Pompon R, Brookshire CE, Minkina I, Bislick L. An analysis of aphasic naming errors as an indicator of improved linguistic processing following phonomotor treatment. Am J Speech Lang Pathol. 2013 May;22(2):S240-9. doi: 10.1044/1058-0360(2012/12-0078).
Clinical trial NCT01267461: Evaluation of the Proliferative Activities of Insulin Analogues in Primary Human Tumor Cells
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Endometrial Cancer
Colon Cancer
Keywords: To asses the biological actions of insulin analogs in primary tumor cells
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2010-12-28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT

Brief summary: Recently the general medical literature has become aware that the use of certain long-acting insulin analogues could potentially increase cancer risk.During the last few years the investigators group generated information of both scientific and clinical relevance on the proliferative and anti-apoptotic actions of insulin analogues. The goal of this project is to evaluate the hypothesis that the proliferative and signalling activities elicited by insulin analogues may have a impact on tumor behavior. In this study the investigators will asses the biological actions of insulin analogs in primary tumor cells of endometrial and colon cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with Endometrial and Colon Cancer

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03964961: Effect of Functional Massage in Neuromuscular Response.
Official title: Effect of Functional Massage in Gastrocnemious Muscles Neuromuscular Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuromuscular Diseases
Keywords: functional massage
conventional massage
neuromuscular response
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares the effects of two types of massage: a conventional massage and a functional massage, in the neuromuscular response of the gastrocnemious muscles.


Eligibility criteria: Exclusion Criteria:

* Muscle injury in the last two months
* To not understand the study orders
* Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol

Primary outcomes:
measure: Delay time change
timeFrame: 2 minutes before the intervention, and 8 minutes after the intervention
measure: Contraction time change
timeFrame: 2 minutes before the intervention, and 8 minutes after the intervention
measure: Sustain time change
timeFrame: 2 minutes before the intervention, and 8 minutes after the intervention
measure: Relaxation time change
timeFrame: 2 minutes before the intervention, and 8 minutes after the intervention
measure: Maximal displacement change
timeFrame: 2 minutes before the intervention, and 8 minutes after the intervention
measure: Stiffness change
timeFrame: 5 minute before the intervention, and 5 minute after the intervention
measure: Elasticity change
timeFrame: 5 minute before the intervention, and 5 minute after the intervention
measure: Relaxation change
timeFrame: 5 minute before the intervention, and 5 minute after the intervention
Secondary outcomes:
measure: Gastrocnemious strength change
timeFrame: 8 minutes before the intervention, and 2 minutes after the intervention
measure: Passive ankle dorsiflexion change
timeFrame: 6 minutes before the intervention, and 4 minutes after the intervention
measure: Jump height change
timeFrame: 10 minutes before the intervention, and 1 minute after the intervention
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References:
Clinical trial NCT06537661: Effect of Virtual Reality on TMD Following Maxillofacial Surgery
Official title: VIRTUAL REALITY and TEMPOROMANDIBULAR DISORDER FOLLOWING MAXILLOFACIAL SURGERY
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Temporomandibular Disorder
Keywords: VR
TMD
Maxillofacial surgery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 2
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixty eight patients who have TMJ pain and ROM restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ).

Will be randomly divided into two equal groups ( group A, group B ). Their ages range from 20 - 35 years.

The Purpose of the study is to evaluate the therapeutic efficacy of VR in decreasing pain and improve ROM for Patients after maxillofacial surgery.

Detailed description: Sixty eight patients who have TMJ pain and ROM restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ).

Will be randomly divided into two equal groups ( group A, group B ). Their ages range from 20 - 35 years.

The VR glasses which were the source of visual and auditory feedback, were connected by Bluetooth to a mobile phone and all the videos of selected tasks (tasks of Active mobility exercises and isometric contraction exercises, massage exercises) were turned on. Active mobility exercises (jaw opening 6 times of 30 s; lateralization 10 times of 5 s; protrusion 10 times Of 5 s).

* Self-massage masticatory Muscles, After each session.
* Isometric contraction exercises The Purpose of the study is to evaluate the therapeutic efficacy of VR in decreasing pain and improve ROM for Patients after maxillofacial surgery.

Eligibility criteria: Inclusion Criteria:

* The subject selection will be according to the following criteria:

  * Patients after Arthrocentesis .
  * Patients after Temporomandibular joint condylar discopexy.
  * Age ranges between 30 - 45 years.
  * All patients will have informed consent .Exclusion Criteria:
* • Surgery That conducted on the temporomandibular joint (meniscectomy, arthroscopy, etc.).

  * oral surgery (e.g., surgery for impaction of the third molar), as well as patients with concomitant systemic or neurological conditions.

Primary outcomes:
measure: Measure pain
timeFrame: 6weeks
Secondary outcomes:
measure: Maximum mouth opnening (MMO )
timeFrame: 6weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Nehal mohamed
city: Giza
country: Egypt
facility: Nehal mohamed
Study officials:
References:
Clinical trial NCT06241261: Arresting Early Childhood Caries With a Silver Diamine Fluoride Gel
Official title: Randomised Clinical Trial to Arrest Early Childhood Caries With a Silver Diamine Fluoride Gel
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Early Childhood Caries
Keywords: Silver Diamine Fluoride
Caries
Arrest
Gel
Children
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 630
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to determine whether the efficacy of a 38% silver diamine fluoride (SDF) gel is non-inferior to a 38% SDF solution for arresting carious lesions in preschool children when applied at half-yearly intervals over a 30-month period.

Detailed description: Aim: Silver diamine fluoride (SDF) is typically available as a 38% aqueous solution, which is runny and difficult to apply. A 38% SDF gel has been introduced but it has not been tested clinically. The objective is to determine whether the efficacy of a 38% SDF gel is non-inferior to a 38% SDF solution for arresting carious lesions in preschool children.

Methods / Design: This non-inferiority randomised clinical trial will recruit 630 3- to 4-year-old children to receive either SDF gel or SDF solution on their carious lesions every 6 months. The primary outcome is the proportion of active carious tooth surfaces that arrest at the 30-month follow-up. The same examiner will conduct all examinations at the kindergartens over 30 months. The examiner, the children, and the children's parents will be blinded to treatments. The parents will be surveyed on their child's oral health-related behaviours and socioeconomic background to allow adjustment for effect modification.

Significance: If the result is as anticipated, SDF gel will prolong contact of SDF with the carious lesion to promote remineralisation. As SDF gel is cost-effective, simple, non-invasive, and non-aerosol-generating, it can be widely recommended for caries control.

Eligibility criteria: Inclusion Criteria:

* generally healthy, have at least one tooth with cavitated dentine carious lesion

Exclusion Criteria:

* uncooperative and difficult to manage, with severe forms of hypoplasia of fluorosis or other oral diseases, wearing orthodontic devices or under dental treatment, have major systemic diseases, or are on long-term medication

Primary outcomes:
measure: The hardness of cavity on tooth by probing
timeFrame: The follow-up oral examinations will be conducted every 6 months for 30 months totally
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Chun Hung Chu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03183661: A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial
Official title: Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn Disease
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject is enrolled who are injected ALLO-ASC-CD intravenous infusion in phase 1 clinical trial of ALLO-ASC-CD-101.

Brief summary: This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.

Detailed description: This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.

ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore their immunomodulatory effects are significant for treating immune-related disease, such as crohn's disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease.

Eligibility criteria: Inclusion Criteria:

1. Subjects who are injected with ALLO-ASC-CD in phase 1 clinical trial of ALLO-ASC-CD-101.
2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Subjects who are considered not suitable for the study by the principal investigator.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Yonsei University
name: Jae Hee Cheon, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Joo Sung Kim, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Young Ho Kim, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03502161: Clinical Evaluation of the QuantiFERON CMV Assay
Official title: Clinical Evaluation of the QuantiFERON CMV Assay
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: CMV
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CMV D+/R- SOT recipients older than 18 that are receiving 3-6 months of antiviral prophylaxis and can provide Informed Consent.

Brief summary: Validate the use of the device in the clinical setting for assessing the risk of CMV Infection in SOT recipients after the completion of antiviral prophylaxis.


Eligibility criteria: Inclusion Criteria:

* Adult CMV D+/R- liver, kidney, heart, pancreas, lung, intestinal, or combined transplant recipients that are 18 years of age or older.
* Scheduled to receive between 3 to 6 months of antiviral prophylaxis
* Provide Informed Consent

Exclusion Criteria:

* Subjects less than 18 years old
* Scheduled to receive longer than 6 months or shorter than 3 months of prophylaxis
* Unable to provide Informed Consent

Primary outcomes:
measure: Change in time to CMV Infection between sub-groups of QF-CMV assay classifications.
timeFrame: At time of prophylaxis termination, +1 month from termination, +2 months from termination
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References:
citation: Tolkoff-Rubin N, Rubin R. The impact of cytomegalovirus infection on graft function and patient outcome. Graft 1999; 2:S101-3.
citation: Singh N. Preemptive therapy versus universal prophylaxis with ganciclovir for cytomegalovirus in solid organ transplant recipients. Clin Infect Dis. 2001 Mar 1;32(5):742-51. doi: 10.1086/319225. Epub 2001 Feb 20.
Clinical trial NCT06194383: Treatment of Hyperpyrexia and in the Pediatric Emergency Department (FEVER_ED)
Official title: Optimization of the Treatment of Hyperpyrexia and Associated Symptoms in the Pediatric Emergency Department (FEVER_ED)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fever
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients (aged between 6 months 0 and 20 years), with fever (T \&gt; 38°C) with/without associated symptoms, treated with standard antipyretic drugs orally (paracetamol, ibuprofen or paracetamol/ibuprofen combination)

Brief summary: Fever represents the main cause of admission to the emergency room in older people pediatric. It occurs in the presence of a wide range of pathologies, from infectious forms (the most common, viral or bacterial) up to more complex and/or systemic forms (such as inflammatory or neoplastic ones). The drugs currently indicated for the management of fever in children are: paracetamol and ibuprofen. There are no recent studies conducted in pediatric population, who have demonstrated the greater effectiveness of therapy with paracetamol or ibuprofen, The objective of our study is, therefore, to identify which therapy is most appropriate for controlling body temperature e of associated symptoms in pediatric patients arriving in the emergency room with fever.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients (aged between 6 months 0 and 20 years)
* fever (T \&gt; 38°C) with/without associated symptoms, treated with standard antipyretic drugs orally (paracetamol, ibuprofen or paracetamol/ibuprofen combination)
* who have expressed their consent to participate in the study.

Exclusion Criteria:

* age \&lt;6 months or \&gt;20 years;
* patients who did not express consent to participate in the study

Primary outcomes:
measure: Response to the treatment as evaluation of associated symptoms
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
References: