louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06475014: Application of Knee Measurements on 3D CT in TKR
Official title: Application of Knee Measurements on 3D Computed Tomography in Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Knee Disease
Lead sponsor: Vinmec Healthcare System
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with severe osteoarthritis of the knee who underwent primary TKA

Brief summary: A 3D Computed Tomographic Study of Vietnamese Knee Morphology for Total knee Replacement

Detailed description: There were controversies and inconsistent results regarding the effectiveness of PSI.

However, most authors used PSI from commercial manufacturers. From our view, the surgeon's involvement in PSI planning and design can affect the PSI's accuracy. Some other benefits of in-hospital PSI included the use of any type of implant without depending on the manufacturer's software system, faster and cheaper. Therefore, we conducted this study to evaluate the effect of in-hospital PSI in which the surgeons take part in the manufacturing job.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of knee osteoarthritis, grade III, IV
* Underwent total knee replacement using patient-specific intrumentation
* With pre and post-operative whole limb CT-Scanners

Exclusion Criteria:

* Paticipants with valgus knee deformity,
* A history of hip arthroplasty,
* Large bone defect that required augments.

Primary outcomes:
measure: Radiology outcome
timeFrame: 30/06/2023
measure: Clinical outcome, self-administered questionnaire
timeFrame: 30/06/2024
measure: Clinical outcome, by surgeon's evaluating
timeFrame: 30/06/2024
Secondary outcomes:
Other outcomes:
measure: AP-ML dimesion
timeFrame: 30/06/2023
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec Times City Hospital
state: Hai Ba Trung
Study officials:
affiliation: Hanoi Medical University
name: Duong Dinh Toan, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT06902714: Effects of Oral Tranexamic Acid on Short Term Postoperative Outcomes Following Total Shoulder Arthroplasty
Official title: Evaluating the Effects of Oral Tranexamic Acid on Short Term Postoperative Outcomes Following Total Shoulder Arthroplasty: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Shoulder Arthroplasty
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to evaluate the short-term clinical outcomes of patients undergoing total shoulder arthroplasty who receive an extended postoperative course of oral tranexamic acid


Eligibility criteria: Inclusion Criteria:

* Skeletally mature patients (ages 18-79) undergoing primary total shoulder arthroplasty

Exclusion Criteria:

* Patients with Cancer, venous thromboembolism, stroke, heart disease, pregnant or nursing, allergic to TXA, current tobacco use, anticoagulants other than aspirin.

Primary outcomes:
measure: VAS
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Walter Smith
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01303614: Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice
Official title: Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysterosalpingography Practice: a Prospective Randomized Double Blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gynecological Pathology
Keywords: hysterosalpingography
prilocaine
local anaesthetic
pain relief
gynecological pathology
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysterosalpingography diagnostic practice.


Eligibility criteria: Inclusion Criteria:

* patients that must perform a hysterosalpingography
* acceptance to participate in the study signed informed consent

Exclusion Criteria:

* hypersensitivity or allergy to anesthetics
* refusal of the patient
* patients under age 18 years old and pregnant
* unbearable pain that involves other analgesic measures

Primary outcomes:
measure: pain reduction in the performance of hysterosalpingography
timeFrame: after hysterosalpingography and a month later
Secondary outcomes:
measure: sense of discomfort experience during the procedure
timeFrame: a month after hysterosalpingography
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Baldomero Arnau Rivera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnau B, Jovell E, Romero M, Gonzalez M, Esteba L, Garcia A. Lidocaine-prilocaine cream as analgesia for hysterosalpingography: a randomized, double blinded, controlled study. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:216-9. doi: 10.1016/j.ejogrb.2014.09.035. Epub 2014 Sep 30.
Clinical trial NCT00992914: Pilot Study of Stellate Ganglion Injection to Provide Relief From Hot Flushes
Official title: Pilot Study of Stellate Ganglion Injection With Anesthetic as a Method to Provide Relief From Hot Flushes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Menopause
Keywords: Hot flushes (vasomotor symptoms)
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-10-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to determine whether stellate ganglion injection with local anesthetic (the study procedure) can reduce the number and severity of hot flashes in women who have hot flashes.

Hot flashes can have a significant impact on daily living, disrupt sleep, and lead to fatigue and irritability during the day. Hot flashes are the most common reason that women seek hormonal therapy. However, for many women, including breast cancer survivors, this is rarely an option, and these women seek alternatives to hormonal therapy to treat hot flashes.

The study procedure has been in clinical use for more than fifty years in treating certain disease states and chronic pain. The study procedure has not been used to relieve hot flashes and the use of the study procedure with local anesthetic for the reduction of hot flushes is considered experimental.


Eligibility criteria: Inclusion Criteria:

* Women surgically or naturally menopausal,
* Experiencing moderate to severe hot flushes, AND
* Elect to undergo stellate ganglion block procedure.

Exclusion Criteria:

* Subjects who are currently sick,
* Subjects have acute infections or cardiac compromise,
* Subjects who have local infections of the anterior neck region, severe
* Subjects who have pulmonary disease,
* Subjects who are anticoagulated,
* Subjects who are on hormone therapy,
* Subjects who have a blood clotting disorder,
* Subjects who have an American Society of Anesthesiologists (ASA) physical status score of 3 or higher (severe systemic disease, not incapacitating),
* Subjects who have allergic reactions to local anesthetics and/or contrast dyes,
* Subjects who have past or present diagnosis of psychosis,
* Subjects who have current diagnosis of depression, OR
* Subjects who have current substance or alcohol abuse.

Primary outcomes:
measure: Reduction of hot flushes.
timeFrame: 6 months
Secondary outcomes:
measure: To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function.
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Lee P Shulman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04190914: Different Treatment Modality in Necrotic Primary Molars
Official title: Clinical and Radiographic Evaluation of Triple Antibiotic Paste and Calcium Hydroxide With Iodoform as Intra-canal Medications in Regenerative Treatment of Necrotic Primary Teeth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Teeth
Dental Pulp Regeneration
Keywords: triple antibiotic paste
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 54
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Necrotic primary molars in preschool children will be treated with the regeneration concept to provide a healthy biological environment within the root canal system and regression in clinical signs and symptoms which are the primary outcomes of regeneration treatment.

Detailed description: A convenient sample of preschool children have a necrotic primary second molar randomly allocated to one of the 3 study groups which are: group A (control) treated by the conventional treatment ( pulpectomy followed by stainless steel crown SSC), group B: treated by regeneration using triple antibiotic paste followed by SSC), group 3:(treated by regeneration using calcium hydroxide with iodoform(metapex) followed by SSC.

the 3 groups were evaluated at baseline, 6 months and 12 months for clinical and radiographic success.

Eligibility criteria: Inclusion Criteria:

* A child with one or more necrotic primary teeth
* Presence of abscess/fistula
* Sensitivity to percussion
* Presence of maximum grade 2 mobility ( Not more than 1 mm)
* Increases of the dental lamina dura
* cooperative patients

Exclusion Criteria:

* Medically compromised children
* Patient allergic to any of the used materials
* Presence of pathologic root resorption (internal-external) or more than 1/3 of the apical root.
* Presence of vitality in the canals
* Presence of grade 3 mobility
* Non-restorable teeth

Primary outcomes:
measure: number of patients treated in the 3 groups and have a clinical success according to the checklist absence of pain, pain on percussion, mobility, clinical abscess or fistula
timeFrame: 12 months
measure: number of patients treated in the 3 groups and have a radio graphic success according to the checklist absence of radiolucency, internal or external root resorption
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry- Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Dina D Abd-Elmoneam, masters
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02502214: Feasibility Study of Preimplantation Genetic Diagnosis for Single-gene Disorders
Official title: Feasibility Study of Preimplantation Genetic Diagnosis for Single-gene Disorders by Using Nextgeneration Sequencing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preimplantation Diagnosis
Keywords: Preimplantation Genetic Diagnosis
PGD
Next-Generation Sequencing
NGS
Single-Gene disorders
Cystic Fibrosis
CFTR
Single-cell analysis
PCR
SNP
Whole Genome Amplification
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Preimplantation Diagnosis (DPI) may be offered to couples at risk of transmitting a serious genetic disease to their offspring

Brief summary: Preimplantation Genetic Diagnosis (PGD) for monogenic diseases is usually performed by multiplex PCR combining polymorphic microsatellites familial analysis and, where possible, couple-specific mutation detection. Single-cell multiplex PCR developments are costly and time-consuming. We propose to test and clinically validate a targeted next-generation sequencing approach for the PGD for cystic fibrosis. This technique would allow a PGD for probably almost every couple asking for it in our centre, without a previous couple-specific development (but only a preliminary familial analysis). It will be based on haplotyping using a large number of SNPs and mutation detection. A clinical validation will be performed by reanalysing non-transferable embryos obtained after PGD for cystic fibrosis, with couple's informed consent. Concordance of the results between PGD and reanalysis by NGS will be achieved and if validated, this technique may be applied to future PGD for cystic fibrosis in our centre. The same technique may then be applied for other PGD indications for which a set-up is often needed.


Eligibility criteria: Inclusion Criteria:

* Age\> or = 18 years
* Couples at risk of transmitting cystic fibrosis
* asking for a PGD in Strasbourg
* DNA samples available at the laboratory for:

  * The couple
  * A related with CFTR status known
  * Having signed an informed consent

Exclusion Criteria:

* Inability to give informed consent (understanding difficulties...)

Primary outcomes:
measure: Monogenic diseases
timeFrame: for the duration of hospital stay, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Laboratoire de Diagnostic préimplantatoire Site du CMCO
Study officials:
References:
Clinical trial NCT01436214: Dose-Escalation and Safety Study of APC-100 for the Treatment of Prostate Cancer
Official title: Phase 1/2a, Open-Label, Dose-Escalation and Safety Study of APC-100 [Pentamethylchromanol, 2,2,5,7,8-Pentamethyl-6] in Men With Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Lead sponsor: Adamis Pharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2011-09-19
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a phase 1/2a, open label, dose escalation and safety study of APC-100 (2,2,5,7,8-Pentamethyl-6-chromanol) in men with advanced prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with histopathologically proven adenocarcinoma of the prostate
* Patients must have progressive disease
* Patients must have had prior treatment with bilateral orchiectomy or androgen deprivation therapy with an LHRH-blocker with evidence of treatment failure

Exclusion Criteria:

* Patients treated with other secondary hormonal therapies
* Patients with prior chemotherapy given for castrate-resistant prostate cancer
* Patients with prior radiation therapy completed less than 4 weeks prior enrollment
* Patients with prior investigational therapies within 4 weeks before treatment with APC-100
* Evidence of active second malignancy

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) and recommended Phase 2a Dose
timeFrame: Within 12 weeks following treatment
Secondary outcomes:
measure: Plasma Pharmacokinetics (PK) profile of APC-100
timeFrame: Pre-Dose, Cycle 1:Day 1, Cycle 2:Day 2,Pre-Dose on Day 1 of each additional cycle
measure: Assess number, types, and severity of toxicity and adverse events
timeFrame: 12 weeks
measure: Assess preliminary evidence of anti-tumor activity through PSA response
timeFrame: pre-study, Cycle 1: Day 1 (unless prestudy was performed within 7 days of study entry), Cycle 2: Day 1, End of Treatment
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: Wayne State University
name: Elisabeth I Heath, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Jeremy Cetnar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04582214: Oscillation and Lung Expansion Therapy in Patients With COVID-19
Official title: A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized With COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Oscillation and Lung Expansion
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
Collaborators: name: Emory University
name: Northwestern University
First posted: 2020-10-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The active treatment group will consist of patients who are treated OLE therapy while on heated high-flow oxygen therapy. Results from subjects in the active treatment group will be compared to retrospectively collected results from patients treated with standard care with no OLE therapy.
Primary purpose: TREATMENT

Brief summary: A Pilot Study of the Use of Oscillation and Lung Expansion (OLE) Therapy in Patients Hospitalized with COVID-19

Detailed description: This is a randomized prospective open-label cohort study in patients with COVID-19 to evaluate the impact of Oscillation and Lung Expansion (OLE) therapy using The MetaNeb® System on the hospital length of stay in patients hospitalized and receiving heated high-flow oxygen therapy for COVID-19 infection. The active treatment group will consist of patients who are treated OLE therapy while on heated high-flow oxygen therapy .

Results from subjects in the active treatment group will be compared to results from patients treated with standard care with no OLE therapy.

Eligibility criteria: Inclusion Criteria:

* Adult patient (\> 18 years of age)
* Tested positive or person under investigation (PUI) for COVID-19 infection
* Currently require heated high-flow oxygen therapy to maintain SaO2 \> 90 %
* Signed informed consent (phone consent)
* Heated high-flow oxygen initiated within the past 72 hours

Exclusion Criteria:

* Serious medical condition that, in the investigator's judgment, precludes the patient's safe participation in the study
* Pressure related risk for pneumothorax
* Patient inability or unwillingness to tolerate OLE therapy
* Staff unavailable or unable to deliver therapy
* Current requirement for mechanical ventilation or expected requirement for mechanical ventilation within the next 12 hours

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: Time frame begins when the patient is first started on heated high-flow oxygen therapy and ends when they are ready for discharge from the hospital. Expected time is a a few days but not expected to exceed 3 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT04086914: Fascia Iliaca Compartment Blocks for Pain Control in Hip Fractures
Official title: Fascia Iliaca Compartment Blocks to Improve Preoperative Pain Control in Elderly Hip Fractures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Hip Fractures
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is comparing the use of a peripheral nerve block and standard opioid pain medications in pain control in hip fractures prior to surgery. A peripheral nerve block is a procedure that injects numbing medicine around a nerve to help decrease the pain, motion, and sensation around the painful site temporarily. The purpose of this study is to evaluate if peripheral nerve blocks are more effective for pain control than just standard opioid pain medication while decreasing the amount of side effects from opioid medication.


Eligibility criteria: Inclusion Criteria:

* Aged 50 or older, low energy hip fracture, acute hip fracture

Exclusion Criteria:

* On anticoagulants, hardware present near injection site, preexisting nerve injury.

Primary outcomes:
measure: Mean Baseline Pain score on Visual analogue scale at initial encounter
timeFrame: 0-60 minutes
measure: Mean Change from baseline pain score on the visual analogue scale
timeFrame: 3-8 hours after initial encounter
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
Clinical trial NCT03618914: Anemia and Inflammation
Official title: Interactive Effects of Iron Status and Inflammation on Serum Hepcidin and Erythrocyte Iron Incorporation in Young Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Deficiency Anemia
Inflammation
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Ibn Tofail University-CNESTEN
First posted: 2018-08-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young women with or without iron-deficiency anemia

Brief summary: During inflammation hepcidin concentrations are increased, leading to a decrease in iron absorption. In iron deficiency anemia hepcidin is suppressed due to the activation of erythropoiesis. Whether inflammation or anemia has the stronger effect on hepcidin is uncertain.


Eligibility criteria: Inclusion Criteria:

* BMI \<27.5kg/m2
* body weight \<70kg
* either non-anemic (Hb\>12.5g/dl) or anemic (Hb between 8-12 g/dl and ferritin \<15ng/ml)

Exclusion Criteria:

* pregnant or lactating
* chronic disease
* smoking
* inflammation defined as CRP\<5mg/L; AGP\<1g/L

Primary outcomes:
measure: Fractional and total iron absorption
timeFrame: 14 days after the second baseline test meal administration
measure: Fractional and total iron absorption
timeFrame: 14 days after the test meal administered 24 hours after vaccination
Secondary outcomes:
measure: Serum hepcidin
timeFrame: up to 36 hours
measure: Serum Interleukin 6
timeFrame: up to 36 hours
measure: Serum ferritin
timeFrame: up to 36 hours
measure: Serum transferrin
timeFrame: up to 36 hours
measure: Serum CRP
timeFrame: up to 36 hours
measure: Serum AGP
timeFrame: up to 36 hours
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: Ibn Tofail University-CNESTEN
Study officials:
References: