louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05170815: Clariance ErYs Registry
Official title: Clariance Registry of ERISMA® and Idys® Devices
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spine Degeneration
Spine Spondylosis Thoracic
Spinal Deformity
Spinal Tumor
Spinal Fracture
Lead sponsor: Clariance
Sponsor class: INDUSTRY
First posted: 2021-12-28
Enrollment: 760
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: Subjects with thoracolumbar disease, and who require spine surgery with Interbody Fusion Device and/or Posterior fixation System

Brief summary: International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF).

The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting.

The primary objective is to demonstrate that the use of the study devices is safe.

The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.


Eligibility criteria: Inclusion Criteria:

* Considered as adult in the respective geography (18 years old or older for France and 21 years old or older for United-States).
* Indicated for treatment with one or more commercially available sponsor spine device included into the study.
* For France only, affiliated with or beneficiary of a social security scheme.

Exclusion Criteria:

* Subjects who are not able to comply with the study procedures based on the judgment of the investigator (e.g., inability to comprehend study related questions, inability to keep scheduled assessment times).
* Subjects who are considered as vulnerable: minor, pregnant woman or people under legal protection (guardianship or curatorship).
* Contraindicated for spine surgery utilizing a commercially available sponsor spine device.

Primary outcomes:
measure: Revision rate
timeFrame: Year 2
Secondary outcomes:
measure: Back & Leg Pain Visual Analog Score (VAS)
timeFrame: Pre-op; Week 9; Month 6; Year 1; Year 2
measure: Oswestry Disability Index (ODI)
timeFrame: Pre-op; Week 9; Month 6; Year 1; Year 2
measure: Self-report multipurpose short-form (SF-12v2®)
timeFrame: Pre-op; Week 9; Month 6; Year 1; Year 2
measure: Subject's Satisfaction
timeFrame: Week 9; Month 6; Year 1; Year 2
measure: Radiological parameter: bony fusion
timeFrame: Week 9; Month 6; Year 1; Year 2
measure: Adverse Events
timeFrame: Through study completion, an average of 2 years
measure: Device Deficiencies
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Santy Orthopedic Center
Study officials:
References:
Clinical trial NCT05012215: Paravertebral Versus Caudal Block in Pediatric PCNL
Official title: Ultrasound Guided Thoracic Paravertebral Block Versus Ultrasound Guided Caudal Epidural Block in Pediatric Patients Undergoing Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Stones
Percutaneous Nephrolithotomy
Keywords: paravertebral block
caudal block
Percutaneous nephrolithotomy
pediatric
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of Ultrasound guided thoracic paravertebral block versus ultrasound guided caudal epidural block in pediatric patients undergoing percutaneous nephrolithotomy

Detailed description: Percutaneous Nephrolithotomy (PCNL) is a commonly performed surgical procedure for complex upper renal tract calculi. Although the skin incision for PCNL appears small, the intensity of intraoperative and postoperative pain is significant owing to soft tissue injury.

Paravertebral block is the technique of injecting local anesthetics in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is used increasingly for intra-operative and post-operative.

Caudal epidural block involves placing a needle through the sacral hiatus to deliver medications into the epidural space. This approach is used widely used for surgical anesthesia and analgesia in pediatric patients.

this work aims to compare the efficacy of Ultrasound guided thoracic paravertebral block versus ultrasound guided caudal epidural block in pediatric patients undergoing percutaneous nephrolithotomy

Eligibility criteria: Inclusion Criteria:

* Patients undergoing percutaneous nephrolithotomy

Exclusion Criteria:

* Coagulation disorders
* Infection at the site of injection
* Allergy to the local anesthetics used
* Spinal cord abnormalities or neurological deficits

Primary outcomes:
measure: Blood pressure during surgery in mmHg
timeFrame: through the surgery, an average of 2 hours
measure: Heart rate (beats/minute)
timeFrame: through the surgery, an average of 2 hours
measure: The concentration of sevoflurane in %
timeFrame: through the surgery, an average of 2 hours
measure: Postoperative pain using FLACC score
timeFrame: up to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT00371215: Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting
Official title: A Phase 2 Study of Recombinant Human Thrombin (rThrombin) Administered Using a Spray Applicator in Subjects Undergoing Autologous Skin Grafting Following Burn or Traumatic Skin Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgical Hemostasis
Keywords: hemostasis
grafting, skin
hemostatics
phase 2
Lead sponsor: ZymoGenetics
Sponsor class: INDUSTRY
First posted: 2006-09-01
Enrollment: 72
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.

Detailed description: This is a Phase 2 multiple site, single-arm, open-label study designed to evaluate the safety of rThrombin in subjects of age 2 to 75 years who are receiving a partial- or full-thickness autologous sheet or mesh grafts following burn or traumatic skin injury. After establishing eligibility, study participants will be treated with topical spray rThrombin at the skin graft recipient site during autologous skin graft surgery. There will be a 1-month follow-up period after the surgery.

Eligibility criteria: Inclusion Criteria:

* Autologous skin grafting with sheet or mesh grafts following burn or traumatic skin injury

Exclusion Criteria:

* Known antibodies or hypersensitivity to thrombin or other coagulation factors

Primary outcomes:
measure: The incidence and severity of adverse events
timeFrame: Up to day 29
Secondary outcomes:
measure: The incidence and grade of clinical laboratory abnormalities
timeFrame: Up to day 29
measure: The incidence of anti-rThrombin product antibodies
timeFrame: Up to day 29
measure: The incidence of hemostasis
timeFrame: Up to 20 minutes
measure: The percentage of graft take
timeFrame: Up to day 29
measure: The incidence of re-grafting
timeFrame: Up to day 29
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard M. Fairbanks Burn Center, Wishard Hospital
state: Indiana
Study officials:
affiliation: ZymoGenetics
name: Allan Alexander, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06908915: Long Pulse 1064 nm Nd:YAG Laser in the Treatment of Erythematotelangiectatic Rosacea and Other Erythematous Telangiectatic Facial Conditions
Official title: Long Pulse 1064 nm Nd:YAG Laser in the Treatment of Erythematotelangiectatic Rosacea and Other Erythematous Telangiectatic Facial Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rosacea, Erythematotelangiectatic
Keywords: Nd:YAG laser
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 32
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical study is to assess the effectiveness of Nd:YAG laser 1064 nm in the long pulse mode in the treatment of signs of rosacea including the erythema of the face and telangiectasia. The used parameter of this laser was of very low energy (spot size: 5mm, fluence: 4.07 J/Cm2, energy: 800 millijoules (mJ) and frequency: 5 Hz. About 2-3 passes performed in each treatment session. Up to four sessions were performed for each patient with 2 weeks interval) and also its was expected to have minimal adverse effects.


Eligibility criteria: Inclusion Criteria:

* Patient with rosacea (erythemato-telangiectatic type)

Exclusion Criteria:

* Other clinical types of rosacea
* Pregnancy and lactation in females
* History of malignancies
* History of photosensitivity
* History of any other modalities of treatment of rosacea over last 6 months

Primary outcomes:
measure: Changes in erythema of face of patients with rosacea been treated by ND:YAG laser 1064 nm long pulse width by using clinician erythema scale (CEA)
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler Medical University
Study officials:
References:
Clinical trial NCT01587885: Comparison of Two Omeprazole-Containing Products for Relief of Frequent Heartburn (MK-0764A-036)
Official title: Protocol PT 11-29: Randomized, Open-label, Cross-over Pilot Study to Evaluate and Compare Two Omeprazole Containing Products for Relief of Frequent Heartburn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heartburn
Keywords: Frequent Heartburn
Omeprazole
Omeprazole, sodium bicarbonate drug combination
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-04-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate a single ingredient product (omeprazole 20 mg) with a combination product capsule (omeprazole 20 mg + sodium bicarbonate 1100 mg) in participants with frequent heartburn.


Eligibility criteria: Inclusion Criteria:

* Females of reproductive potential must demonstrate a negative urine pregnancy test and agree to use an acceptable method of birth control
* Suffer from frequent heartburn
* Refrain from taking non-study medicine or treatment for heartburn for the duration of the study
* Be free of any clinically significant disease that requires a physician's care
* Read and understand English

Exclusion Criteria:

* Any significant medical condition which is a contraindication to the use of omeprazole or sodium bicarbonate
* Known hypersensitivity to the study drugs or any components
* Experiencing any of the following: trouble or pain with swallowing food, vomiting with blood, bloody or black stools
* Participation in another investigational study within 4 weeks prior to the screening visit.

Primary outcomes:
measure: Time-to-onset of Heartburn Relief
timeFrame: Start of treatment until onset of heartburn relief, up to 24 hours
Secondary outcomes:
measure: Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time
timeFrame: Start of treatment until onset of heartburn relief, up to 72 hours
measure: Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire
timeFrame: At end of study (approx. Study Day 40)
measure: Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire
timeFrame: At end of study (approx. Study Day 40)
measure: Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire
timeFrame: At end of study (approx. Study Day 40)
measure: Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire
timeFrame: End of treatment period 1 and end of treatment period 2
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02460185: Role of Maternal Physical Exercise on Spontaneous Labor Onset
Official title: The Role of Maternal Physical Exercise on Spontaneous Labor Onset - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Labour Onset and Length Abnormalities
Lead sponsor: Centro Hospitalar Lisboa Norte
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Evaluate the effects of the practice of maternal physical exercise on the term of pregnancy as a method to enhance spontaneous labor.

Detailed description: At 38 weeks low-risk pregnant women, with singleton cephalic fetus and without previous cesarean delivery, were randomized into 2 groups: a control group without maternal physical exercise practice and a study group with 30 minutes of walking, 3 times a week at 4 Km/h. Induction of labor was performed at 41 weeks

Eligibility criteria: Inclusion Criteria:

* 38 weeks low-risk pregnant women
* singleton cephalic fetus
* without previous cesarean delivery

Exclusion Criteria:

* pathological pregnancy
* twin pregnancy
* previous cesarean section

Primary outcomes:
measure: Rate of labor induction
timeFrame: 41 weeks
Secondary outcomes:
measure: Gestational age on spontaneous labor onset
timeFrame: 5 week
measure: Active stage duration
timeFrame: 1 day
measure: Cesarean section rate
timeFrame: 1 day
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Departamento de Obstetricia, Ginecologia e Medicina da Reprodução
Study officials:
affiliation: Departamento de Obstetricia, Ginecologia e Medicina da Reprodução, Centro Hospitalar Lisboa Norte, Hospital de Santa Maria
name: Isabel Barros Pereira, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pereira IB, Silva R, Ayres-de-Campos D, Clode N. Physical exercise at term for enhancing the spontaneous onset of labor: a randomized clinical trial. J Matern Fetal Neonatal Med. 2022 Feb;35(4):775-779. doi: 10.1080/14767058.2020.1732341. Epub 2020 Mar 29.
Clinical trial NCT04042285: Extracorporeal Shockwave Therapy for Diabetic Foot Wounds
Official title: Extracorporeal Shockwave Therapy for Diabetic Foot Wounds: A Cohort Study Comparing Extracorporeal Shockwave Therapy to Standard Treatment for Diabetic Foot Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Wound
Keywords: Diabetic Foot Wound
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Hull
First posted: 2019-08-01
Enrollment: 24
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: Diabetic patients with a foot wound

Brief summary: Diabetic wounds post digital amputation have poor healing in 30-45% of cases, resulting in 75% of patients undergoing a further amputation within the year, despite best wound management.

Extracorporeal shockwave therapy is a promising safe and non invasive treatment that has been shown to improve healing in chronic ulcers and burns by promoting healing and decreasing risk of infection.

The study will recruit patients on a hospital ward and outpatient departments who have a diabetic foot wound. Participants will be informed about the study, given an patient information sheet and invited to give informed consent.

Consenting participants will undergo shockwave therapy three times in the seven days after their operation, in addition to standard wound care.

Wound measurements, blood perfusion, tissue integrity, quality of life and pain scores will be recorded at baseline, after the third treatment, 4 weeks, 8 weeks and 12 weeks after recruitment to the study.

The study aims to recruit 25 patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetes mellitus
* Open wound of the foot
* ABPI \>0.8
* Age greater than 18 years old
* Able and willing to give written informed consent
* Be able to adhere to protocol and attend all follow up appointments

Exclusion Criteria:

* Pregnancy or breast-feeding
* Current malignancy
* Allergy to materials used in the treatment
* Palliative
* Unable or unwilling to give consent
* Anticoagulation

Primary outcomes:
measure: Wound Volume
timeFrame: 12 weeks
Secondary outcomes:
measure: Pain Questionnaire
timeFrame: 12 weeks
measure: Quality of Life Questionnaires SF-12
timeFrame: 12 weeks
measure: Infection Rate
timeFrame: Recorded at 12 weeks
measure: Minor Amputation Rate
timeFrame: Recorded at 12 weeks
measure: Local Perfusion Rate
timeFrame: 7 days
measure: Tissue Integrity
timeFrame: 7 days
measure: Quality of Life Questionnaire EQ5D3L
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust
Study officials:
affiliation: Academic Vascular Surgery Unit
name: George E Smith, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05762185: Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy
Official title: Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biotherapies
Rheumatology
Rheumatoid Arthritis
Keywords: nurse consultation
biotherapies
Rheumatology
Rheumatoid Arthritis
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Biotherapy present specifics risks that patients must know and learn to manage. A national survey has been carried in this study to evaluate patients safety skills. (wording: " cross study of safety skills of 677 patients treat by biopharmaceuticals for an inflammatory rheumatism). This survey has allowed showcasing patients difficulties in managing their treatment, including for those under subcutaneous biotherapy. More than 60% patients interviewed doesn't know symptoms to bring them to consult and mainly postpone to their injection. The aim of this study is to prove that nursing consultation can allow the patient to become independent in treatment management and thus avoid occurrence of adverse event.


Eligibility criteria: Inclusion Criteria:

* Patient suffering from rheumatoid arthritis followed by Rheumatology consultation of Amiens-Picardie University Hospital
* Patient treated by Subcutaneous Biotherapy for at least 6 months at the time of inclusion
* Major patient
* Patient having signed an informed consent

Exclusion Criteria:

* Minor patient
* Patient with cognitive impairment diagnosed by a physician
* Patient under tutorship or curatorship
* Patient deaf or hard of hearing
* Patient not fluent in the French language (at the decision of the investigator)

Primary outcomes:
measure: Variation of BIOSECURE score between baseline and after nurse consultation
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT03311685: Vaginal Tactile Imaging for the Assessment of Pelvic Organ Prolapse Repair Efficiency
Official title: Vaginal Elasticity Assessment Before and After the Affect of Surgical Repair for Pelvic Organ Prolapse (POP) on Vaginal Elasticity as Measured by Vaginal Tactile Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Female patients with POP will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after surgery for the repair of the POP. Surgical repair will be performed by a single surgeon who will perform either a laparoscopic or vaginal repair.

Detailed description: Patients will be recruited and sign a consent form. The patients included are patients with POP that are candidates for either laparoscopic or vaginal repair.

Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:

* The day of surgery before surgery.
* The day after surgery.
* 3 months post-operational. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Eligibility criteria: Inclusion Criteria:

* Any woman undergoing POP repair

Exclusion Criteria:

* Women above or below the age limit

Primary outcomes:
measure: Vaginal elasticity assessment
timeFrame: Up to 3 months from enrollment
Secondary outcomes:
measure: Comparison of vaginal elasticity between repair methods
timeFrame: Up to 3 months from enrollment
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam healthcare campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References: