louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05728346: The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization
Official title: A Single-arm Clinical Trial Evaluating the Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization in Patients With Pulp Necrosis of Permanent Teeth
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulp Necroses
Keywords: pulp necrosis
pulp regeneration
Lead sponsor: Fifth Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dental pulp necrosis is one of the most common pathological conditions that results in tooth loss. However, regeneration of functional dental pulp has proved difficult. Therefore, the investigators conduct a single-arm study to evaluate the efficacy and safety of pulp regeneration induced by SHED mixed with hyaluronic acid polymerization in patients with pulp necrosis of permanent teeth.

Detailed description: This study is a single-center, prospective, single-arm study to evaluate the efficacy and safety of pulp regeneration induced by SHED mixed with hyaluronic acid polymerization in patients with pulp necrosis of permanent teeth. This study plans to include 30 subjects from the Department of Stomatology of the Fifth Affiliated Hospital of Guangzhou Medical University. All participants in this study will receive stem cells from human exfoliated deciduous teeth (SHED) mixed with hyaluronic acid polymers after the preparation and disinfection of the root canal of the affected teeth. All participants will undergo screening and baseline visits. After surgery, the participants will be followed up for 2 years.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 45 years
* Patients with pulp necrosis of a single canal permanent tooth due to trauma or caries
* Patients who have signed informed consent

Exclusion Criteria:

* Patients with pulp necrosis caused by severe trauma to the tooth, such as crown root fracture, tooth root fracture, tooth displacement, etc
* Patients with calcification of the apical foramen at the root of the tooth
* History of hereditary disorders of abnormal tooth development
* Dental occlusal trauma, bruxism, malocclusion
* Bad oral habits (sticking out the tongue, biting lips, biting nails, sucking fingers, etc.)
* Presence of uncontrollable pathological processes in the oral cavity (presence of acute advanced diseases in the oral cavity)
* Malnutrition (serum albumin concentration\<2 g/dl)
* Patients with history of other systemic, communicable or hereditary diseases have been diagnosed
* Pregnant, nursing, planning to become pregnant
* The investigators determined that the patient was not suitable for the study

Primary outcomes:
measure: Assessment of pulp vitality
timeFrame: 1、3、6、12、18、24 months
Secondary outcomes:
measure: Blood flow in the root of tooth
timeFrame: 1、3、6、12、18、24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04774146: Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy
Official title: Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PArs Plana Vitrectomy
Retinal Detachment
Silicone Oil Droplets on Intraocular Lens
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 20
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: patients undergoing previous retinal detachment surgery with pars plana vitrectomy with silicone oil tamponade

Brief summary: silicone oil tamponade removal after previous injection of complicated retinal detachment can be achieved with active suction followed by triple air-fluid exchange or prolonged lavage of the vitreous chamber to remove emulsification. Purpose of the study is to compare the amount of silicone oil emulsification droplets within the lavage fluid in case of air exchange and simple lavage to compare which technique removed the highest percentage of emulsion. This is achieved by comparing consecutive samples of lavage fluid

Detailed description: silicone oil tamponade removal after previous injection of complicated retinal detachment can be achieved with active suction followed by triple air-fluid exchange or prolonged lavage of the vitreous chamber to remove emulsification. Purpose of the study is to compare the amount of silicone oil emulsification droplets within the lavage fluid in case of air exchange and simple lavage to compare which technique removed the highest percentage of emulsion. This is achieved by comparing consecutive samples of lavage fluid.

Therefore consecutive patients scheduled to SiO removal with triple air exchange or vitreous chamber lavage are enrolled and 3 samples of intraocular fluid aspirated during the fluid exchange procedure sent to the lab for SiO emulsion count and quantification.

Eligibility criteria: Inclusion Criteria:

* previous silicone oil tamponade after pars plana vitrectomy
* age \>18 years
* Attached retina

Exclusion Criteria:

* unwilling or unable to participate,
* previous multiple eye surgery
* History of Trauma

Primary outcomes:
measure: number of silicone oil emulsification droplets per volume unit
timeFrame: 6 months after primary surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Genova
country: Italy
facility: IRCCS Policlinico San Martino
state: RM
Study officials:
affiliation: IRCCS Policlinico San MArtino
name: Tommaso Rossi
role: STUDY_DIRECTOR
References:
Clinical trial NCT00506246: Efficacy and Safety Study of Two Propofol Formulations
Official title: A Multi-Center, Randomized, Double-Blind, Positive Controlled Study to Evaluate the Efficacy and Safety of Propofol(Propofol®-Lipuro) in Total Intravenous Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: General Anaesthesia
Induction of Anaesthesia
Keywords: anaesthesia
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
Collaborators: name: B. Braun Medical International Trading Company Ltd.
name: Tigermed Consulting Co., Ltd
First posted: 2007-07-25
Enrollment: 220
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: The purpose of the study to compare Propofol-MCT/LCT with LCT in terms of their efficacy and safety during total intravenous anaesthesia

Detailed description: Propofol (chemical substance 2, 6-Diisopropylphenol) is a short-acting intravenous general anaesthetic which is used for induction and maintenance of a general anaesthesia, for long-term sedation of ventilated intensive care patients or for short-term sedation in diagnostic and surgical procedures. As an active substance propofol produces good and readily controlled anaesthesia with smooth and problem-free recovery both in adult patients and in children over 1 month of age. One potential advantage of this formulation is that the MCT/LCT-emulsion reduces pain on injection, a frequently reported adverse reaction with LCT-emulsions of propofol.

Eligibility criteria: Inclusion Criteria:

* Female and male adult patients, and at least 18 and maximal 65 years of age;
* ASA-classification I to II;
* Undergoing an elective surgery, the anaesthesia is expected to last at least 1 hour and no more than 3 hours;
* Will be under total intravenous anaesthesia;
* Willing to give their signed informed consent.

Primary outcomes:
measure: time to loss of eyelash reflex
timeFrame: induction of anaesthesia
measure: doses required for induction of anaesthesia until loss of eyelash reflex
timeFrame: induction of anaesthesia
Secondary outcomes:
measure: patient data/history
timeFrame: during anaesthesia
measure: pre- and concomitant medication
timeFrame: during anaesthesia
measure: anaesthesia relating data
timeFrame: during anaesthesia
measure: recovery data
timeFrame: during anaesthesia
measure: drug safety data (e.g. haemodynamics and clinical outcome)
timeFrame: during anaesthesia
measure: adverse events
timeFrame: during anaesthesia
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pekin Union Medical College Hospital
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiaotong University
city: Shanghai
country: China
facility: Zhongshan Hospital affiliated to Fudan University
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Zhanggang Xue, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02561546: p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
Official title: A Phase II Study to Investigate Preliminary Efficacy Using p53 Gene Therapy for Treatment of Diabetes Concurrent With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HCC
Diabetes
Keywords: concurrent
Lead sponsor: Shenzhen SiBiono GeneTech Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2015-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open-labeled phase II study to investigate preliminary efficacy using p53 gene therapy in treatment of diabetes concurrent with hepatocellular carcinoma (HCC).

Detailed description: It was found in the treatment of HCC using p53 gene therapy that the concurrent diabetes was controlled as well. The objectives of this study are to investigate both anti-diabetic and anti-tumor role of p53 gene therapy. This is an open-labeled, randomized, active-controlled phase 2 study. p53 will be injected via the artery, which supplies blood for the tumor nodules. The study endpoints for anti-diabetic role are fasting plasma glucose (FPG), postprandial glucose (PPG) and glycosylated hemoglobin (A1C) at 30 days after the start of treatment; and for antitumor effect are progression-free survival and overall survival.

Eligibility criteria: Inclusion Criteria:

* histopathologically diagnosed unresectable HCC
* over 18 years old
* with an Eastern Cooperative Oncology Group (ECOG) score of 0-2
* with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C
* with Child-Pugh score A or B; with normal tests of hemogram, blood coagulation, liver and kidney function
* signed the informed consent form.

Exclusion Criteria:

* hypersensitive to study drug
* With an abnormal coagulation condition or bleeding disorder
* infections
* with serious conditions which prevent using the study treatment
* pregnant or lactating

Primary outcomes:
measure: fasting plasma glucose (FPG)
timeFrame: from starting treatment until 60 days
measure: glycosylated hemoglobin (A1C)
timeFrame: from starting treatment until 60 days
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 2 years
measure: progression free survival (PFS)
timeFrame: 2 years
measure: postprandial glucose (PPG)
timeFrame: from starting treatment until 60 days
Other outcomes:
Locations:
city: Dalian
country: China
facility: first affiliated hospital in Dalian University
state: Liaoning
Study officials:
References:
Clinical trial NCT04720846: Categorized PT for Non-arthritic Hip and Groin Pain
Official title: Assessment of a Categorized Physical Therapy Protocol for Non-arthritic Hip and Groin Pain: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Pain
Groin Pain
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is currently limited literature on a categorized physical therapy protocol for management of hip pain. Only a handful of studies have looked at the treatment of osteoarthritis of the hip with a standardized physical therapy treatment, primarily looking at manual therapy versus exercise therapy protocols. However, there are no studies observing the effect of a standardized physical therapy program on patients presenting with non-arthritic hip and groin pain. Based on the gap in the literature, this study will aim to assess the effect of matrix-based standard of care therapy in patients presenting with non-arthritic hip and groin pain.


Eligibility criteria: Inclusion Criteria:

* New patient presenting with non-arthritic hip impingement, hip pain, and groin pain (Tonnis 0-1)
* 18-60 years old

Exclusion Criteria:

* Arthritic hip pain (Tonnis 2+)
* \<18 and \>60 years old
* History of spinal fusion surgery
* History of low back pain with radicular pain
* History of hip arthroscopy
* History of inflammatory conditions, and other concurrent problems interfering with hip therapy (i.e., concurrent back/knee/foot/ankle/shoulder issues)
* Patients currently taking TNF-alpha inhibitors for inflammatory conditions
* History of prior knee osteotomy
* Non-English speakers

Primary outcomes:
measure: iHOT-12 (International Hip Outcome Tool-12)
timeFrame: Up to 6 months
Secondary outcomes:
measure: NRS (numerical rating scale) pain
timeFrame: Up to 6 months
measure: Home exercise completion
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Peter Moley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04079946: The Efficacy Of Complete Mesocolic Excision With Central Vessel Ligation Technique On Lymph Nodes And Safety Margins Compared With Conventional Surgery For Colon Cancer Treatment
Official title: The Efficacy Of Complete Mesocolic Excision With Central Vessel Ligation Technique On Lymph Nodes And Safety Margins Compared With Conventional Surgery For Colon Cancer Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Colon
Keywords: cancer colon
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 40
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: Cancer Colon is one of the major public health problems worldwide. Complete eradication of the tumor with no recurrence or residual masses is a challenge which faces all the surgeons and medical staff all over the world. A lot of techniques were used to ensure 100 % eradication of the tumor and to cure the patients from cancer. Total Mesocolic Excision with Central Vessel Ligation is one of the recent techniques used for colon cancer surgeries. Here in the research the investigators answer the question of how this technique is superior and more beneficial in complete eradication of the tumor than the conventional surgery for colon cancer


Eligibility criteria: Inclusion Criteria:

* • Adult male and female Age of or above 18 years.

  * Tumor localization at the caecum, ascending colon, transverse colon, descending colon, sigmoid colon or rectosigmoid on preoperative endoscopy and radiographic imaging \[barium enema or computed tomography (CT)\]
  * No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease
  * Written informed consent

Exclusion Criteria:

* • Contraindications to major surgery and American Society of Anaesthesiologists (ASA) Physical Status scoring 4 which means extreme systemic disorders which have already become an eminent threat to life regardless of the type of treatment.

  * Infectious disease requiring treatment.
  * Pregnant women
  * Use of systemic steroids.
  * Severe pulmonary emphysema or pulmonary fibrosis

Primary outcomes:
measure: Lymph nodes harvest
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mostafa A. Hassanein, professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Mohamed B. Kotb, profeesor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mahmoud T. Ahmed, lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT02839369: Walking Dynamic Among Children With Brain Damge
Official title: The Effect of Changing Walking Conditions on Walking Dynamic Characteristics Among Children Post a Severe Traumatic Brain Injury, Cerebral Palsy and Typically Developed (TD) Control.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Cerebral Palsy
Keywords: walking performance
Cerebral Palsy, Typically Developed
Lead sponsor: Alyn Pediatric & Adolescent Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 45
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children post Traumatic Brain Injury with Cerebral palsy Typically Developed

Brief summary: The goal of the present study was to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, children with cerebral palsy and typically developed controls.

Detailed description: leisure time physical activity by the Godin and Shephard (G\&S) questionnaire. Balance tests - the Timed Up and Go test (TUG) and functional reach test (FRT). Maximal isometric strength was assessed by using a hand held dynamometer; walking dynamics were recorded by an electronic mat, and the 6 minute walk test, energy expenditure index (EEI) and perceived exertion by the OMNI scale.

Eligibility criteria: Inclusion Criteria:

Post Traumatic Brain Injury

* Post severe closed head injury (Glasgow Coma Scale (GCS) score at admission to emergency room of ≤8
* At least one year post trauma
* Ages 7 to 13 years
* Independent ambulation (foot orthoses permitted)

Children with Cerebral palsy

* GMFCS 1 or 2
* Ages 7 to 13 years
* Able to stand up from a chair independently and maintain standing for more than 5 seconds without falling, without obvious limitation in the passive range of motion of lower extremities.

Typically Developed age and sex controls exclusion criteria:

* Children who could not fulfill simple instructions

Primary outcomes:
measure: step characteristics
timeFrame: 30 minutes
Secondary outcomes:
measure: step time
timeFrame: part of the first assessment
measure: step length
timeFrame: part of the first assessment
measure: gait velocity
timeFrame: part of the first assessment
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Alyn Children's Rehabilitation Hospital
Study officials:
References:
Clinical trial NCT03251469: Single Dose of Tranexamic Acid and Blood Loss, in Elderly Patients With Hip Fracture
Official title: Single Dose of Tranexamic Acid at the Time of Surgery and Blood Loss, in Elderly Patients Undergoing Hip Fracture Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Blood Loss, Surgical
Hip Fractures
Complication, Postoperative
Keywords: tranexamic acid
blood tranfusion
hip fractures
elderly
blood loss
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 200
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the hypothesis that single dose of tranexamic acid (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing and cemented hemiarthroplasty respectively. After application of inclusion and exclusion criteria, patients will be randomized in two groups. Group 1 will include patients that receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that receive normal saline (control group).


Eligibility criteria: Inclusion Criteria:

* Consecutive elderly patients (age \>75 yo) undergoing hip fracture surgery for a stable or unstable intertrochanteric hip fracture with the insertion of a short intramedullary nail (IMN) as well as patients treated surgically with cemented hemiarthroplasty for acute femoral neck (subcapital) hip fracture.

Exclusion Criteria:

* Any contraindication for tranexamic acid
* Multiple fractures
* Requirement for anticoagulant therapy that could not be stopped.
* Ongoing thromboembolic event
* reduced kidney function
* malignancy,
* pathological fracture
* previous operation on the affected hip
* Active coronary artery disease (event in the past 12 months).

Primary outcomes:
measure: number of transfusions of allogeneic RBC from surgery up to day 4
timeFrame: 5 days
measure: total blood loss from surgery to day
timeFrame: 5 days
Secondary outcomes:
measure: incidence of vascular events
timeFrame: 3 months
measure: Incidence of deaths
timeFrame: 3 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 2nd Department of Orthopaedics
state: Attika
Study officials:
References:
Clinical trial NCT05731869: Investigation of the Effect of Epicondylitis Band and Wrist Orthosis
Official title: Investigation of the Effect of Epicondylitis Band and Wrist Orthosis on Extensor Muscle Activity and Upper Extremity Functions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Splints
Keywords: surface electromyography
muscle activation
orthosis
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals

Brief summary: Muscles that are frequently injured in the extensor group are extensor carpi radialis longus, extensor carpi radialis brevis, and extensor digitorum communis. Injury of these muscles is seen as lateral epicondylitis in the clinic. Physiotherapy techniques are frequently applied in the management of diseases related to forearm extensor muscles such as lateral epicondylitis. Various orthoses such as lateral epicondylitis band, wrist orthosis, dynamic extensor brace are used for this. Studies have been conducted on pain, hand function and orthosis satisfaction of different types of lateral epicondylitis orthoses, and the number of studies investigating the effects on muscle activation is insufficient.Therefore, the aim of the study is to examine the effects of different types of orthoses used for the forearm extensor group on extensor muscle activation and upper limb functions.


Eligibility criteria: Inclusion Criteria:

* Between 18-45 years old
* Right upper extremity dominant
* No upper extremity limitation in activities of daily living
* Volunteer individuals

Exclusion Criteria:

* With orthopedic, neurological and rheumatological problems in the upper extremity
* Entrapment neuropathy, TOS, cervical radiculopathy, and cervical disc herniation
* History of upper extremity injury or surgery in the last 6 months

Primary outcomes:
measure: muscle activation
timeFrame: one hour
Secondary outcomes:
measure: hand function
timeFrame: one hour
measure: satisfaction level
timeFrame: one hour
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Mustafa Sarı
state: Ankara
Study officials:
References: