louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06141928: Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty
Official title: Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Hip Arthroplasty
Functional Recovery
Lead sponsor: Clinic for Orthopedics Lovran
Sponsor class: OTHER
Collaborators: name: Special Hospital for Orthopedics Biograd na Moru
First posted: 2023-11-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to determine differences in functional recovery after total hip arthroplasty between a group of patients operated on using a direct lateral approach, an anterolateral minimally invasive approach, and a posterior approach to the hip joint.

Arthroplasty is the most commonly performed surgical procedure in orthopedics and is also considered the gold standard for treating the final stage of osteoarthritis. There are several different approaches, but there are still conflicting studies that talk about the benefits of a particular approach. There is an insufficient number of scientific, prospective studies that monitor the basic functional and rehabilitation parameters, which are also indicators of the success of the performed procedure.


Eligibility criteria: Inclusion Criteria:

* hip osteoarthritis

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Functional recovery after total hip arthroplasty / Range of motion
timeFrame: 2 years
measure: Functional recovery after total hip arthroplasty / Walking speed
timeFrame: 2 years
measure: Functional recovery after total hip arthroplasty / Harris Hip Score
timeFrame: 2 years
measure: Functional recovery after total hip arthroplasty / Hip abductors strength
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lovran
country: Croatia
facility: Clinic for Orthopeadics and Traumatology Lovran
state: Primorsko-Goranska
Study officials:
affiliation: Clinic OL
name: Antea Buterin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232128: Protocol for Radiofrequency Ablation of Pulmonary Neoplasms
Official title: Protocol for Radiofrequency Ablation of Pulmonary Neoplasms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Neoplasms
Lead sponsor: Oncology Specialties, Alabama
Sponsor class: OTHER
First posted: 2005-10-04
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research trial involves the development of a new treatment for lung tumors. It is for patients whose tumor cannot be surgically removed, have refused surgery, or the tumor has not responded well to other forms of treatment. This treatment uses a needle probe to deliver energy into the lung tumor. This probe is placed utilizing a CT scan image. The energy heats the tumor causing tumor cell death.


Eligibility criteria: Inclusion Criteria: The patients enrolled in this study should be judged to have sufficient survival to benefit from control of local disease and include at least one of the following:

1. unresectable primary or metastatic lung tumors
2. may benefit from multiple modalities of therapy
3. chemotherapeutic or radiation oncologic options have been exhausted

Exclusion Criteria:

1. co-existing morbidities that preclude the use of surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Comprehensive Cancer Institute
state: Alabama
Study officials:
affiliation: Comprehensive Cancer Institute
name: Marshall T. Schreeder, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04123028: The Association Between Blood Eosinophilsp in Thai COPD Patients: A Prospective Study
Official title: The Association Between Blood Eosinophils and Clinical Outcomes of Chronic Obstructive Pulmonary Disease Patients: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Copd
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 145
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thai COPD patients in out-patient department

Brief summary: The association of blood eosinophil as a biomarker for eosinophilic Thai COPD patients, such as COPD exacerbation, hospital admission, lung functions and mortlity.

Detailed description: The prospective one year study in Thai COPD patients for the clinical outcomes of COPD compare between eosinophilic and non-eosinophilic which determine by blood eosinophil counts equal or more than 300 cells/microliters. The primary outcomes was COPD exacerbation, the secondary outcomes were lung function, dyspnea and quality of life.

Eligibility criteria: Inclusion Criteria:

* diagnosis of COPD by GOLD criteria

Exclusion Criteria:

1. high blood eosinophil from known causes such as systemic corticosteroid use, malignancy, parasitic infection
2. Patients who had previous acute exacerbation within 30-day before study entry
3. Patients who had previous systemic corticosteroids used within 30-day before study entry

Primary outcomes:
measure: Acute worsening of respiratory symptoms
timeFrame: 1 year
Secondary outcomes:
measure: Physiological outcomes
timeFrame: 1 year
measure: health related quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Songkhla
country: Thailand
facility: Faculty of Medicine, Prince of Songkla university
Study officials:
affiliation: Prince of Songkla University
name: Kanung Saejiam, MS
role: STUDY_DIRECTOR
References:
citation: Bafadhel M, Pavord ID, Russell REK. Eosinophils in COPD: just another biomarker? Lancet Respir Med. 2017 Sep;5(9):747-759. doi: 10.1016/S2213-2600(17)30217-5. Epub 2017 Jun 7.
citation: Juthong S, Kaenmuang P. Association between blood eosinophils with exacerbation and patient-reported outcomes in chronic obstructive pulmonary disease patients in an endemic area for parasitic infections: a prospective study. J Thorac Dis. 2020 Sep;12(9):4868-4876. doi: 10.21037/jtd-19-4101.
Clinical trial NCT01767428: Pharmacokinetic Study to Compare Two Formulations of Paracetamol
Official title: A Pharmacokinetic Study to Evaluate the Rate and Extent of Absorption of Paracetamol From Two Formulations in an Indian Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fever
Headache Disorders
Pain
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-01-14
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers aged 18-55yrs willing to give written informed consent for the study
* BMI must be within the range 18.5 - 24.9 kg/m\^2
* Participant with a minimum weight of 50 kg

Exclusion Criteria:

* Participant with current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure)
* Participant with known or suspected intolerance or hypersensitivity to the study materials
* Participant who are vegetarian
* Participant smoking more than five cigarettes a day

Primary outcomes:
measure: AUC (0-inf)
timeFrame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.
measure: Cmax
timeFrame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.
measure: AUC (0-t)
timeFrame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.
Secondary outcomes:
measure: Tmax
timeFrame: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00372528: An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures
Official title: An Open-Label, Multi-Center, Add-On Study Of Pregabalin (LYRICA) In Subjects With Refractory Partial Seizures Who Have Completed Studies 1008-010, 1008-035, 1008-114 Or 1008-164
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Epilepsy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this trial is to allow continued access to pregabalin to Canadian subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114 and 1008-164 and to continue to study the long term safety of pregabalin administered as adjunctive therapy at dosages from 150 mg/day to 600 mg/day in Canadian subjects with refractory partial seizures.


Eligibility criteria: Inclusion Criteria:

* Must have completed Pfizer open-label studies 1008-010; 1008-035; 1008-114 or 1008-164 and wishes to continue receiving open-label pregabalin
* Must have responded favorably to pregabalin in Pfizer open-label study 1008-010, 1008-035, 1008-114 or 1008-164 and in the clinical opinion of the investigator continued treatment with pregabalin is in the the patient's best medical interest

Exclusion Criteria:

* Is pregnant or is considering becoming pregnant during the course of the study
* Experienced a serious adverse event during open-label Pfizer study 1008-010, 1008-035, 1008-114 or 1008-164

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Year 5 and follow-up (30 days after last dose)
Secondary outcomes:
measure: Mean Number of Seizures
timeFrame: Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01872728: Facial Block for Outpatient Rhinoplasty Analgesia
Official title: Efficacy of Facial Block for Outpatient Rhinoplasty Analgesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Outpatient Rhinoplasty
Keywords: facial block
levobupivacaine
regional anesthesia
rhinoplasty
outpatient
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-06-07
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: A bilateral facial block (infraorbital and infratrochlear) will be performed immediately after intubation in patients undergoing outpatient rhinoplasty with 2.5% levobupivacaine (intervention group) or saline as control. Intravenous saline or morphine will be administered at the end of surgery in intervention or control groups, respectively. In case of pain in post-anesthesia care unit (numerical pain score \>3 on a 0-10 scale), both groups will receive intravenous morphine titration. The total perioperative morphine consumption (intraoperative and in post-anesthesia care unit) will be compared between groups. Pain intensity, presence of nausea/vomiting and patient's satisfaction will be compared between groups.


Eligibility criteria: Inclusion Criteria:

* Outpatient rhinoplasty
* American Society of Anesthesiologists (ASA) classification I-II
* Affiliated to Social Security
* Written informed consent

Exclusion Criteria:

* Allergy to levobupivacaine
* Incapacity to give consent
* Chronic pain

Primary outcomes:
measure: Total morphine consumption during the perioperative period (operating theater and post-anesthesia care unit)
timeFrame: J0
Secondary outcomes:
measure: Pain intensity in post-anesthesia care unit
timeFrame: J0 (At arrival in post-operative care unit)
measure: Postoperative nausea and vomiting
timeFrame: J1 (At day 1 after surgery)
measure: Patient satisfaction at day 1
timeFrame: J1 (At day 1 after surgery)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
Study officials:
References:
Clinical trial NCT04416828: Medical Imaging in the Diagnosis of Ganglion Cysts of the Hand
Official title: Medical Imaging in the Diagnosis of Ganglion Cysts of the Hand
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ganglion Cyst of Both Hands
Keywords: Portable ultrasound
Diagnostics
Mobile ultrasound
Hand held ultrasound
Wireless ultrasound
Lead sponsor: Waldfriede Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 90
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: Ninety male and female patients with ganglion cyst of the wrist or hand planned for surgery will be recruited at the hand surgery outpatient clinic of the Waldfriede Hospital Berlin. Patients will be diagnosed with ganglion cyst of the hand/wrist by an experienced hand surgeon using clinical and MRI data.

Brief summary: The aim of this study is to investigate if inexpensive, readily available and portable wireless ultrasound devices can detect ganglion cysts of the wrist and hand in compare to a cart-based ultrasound device before surgery.


Eligibility criteria: Inclusion Criteria:

* Flexor tendon sheath ganglion cyst
* Dorsal ganglion cyst
* Palmar ganglion cyst
* Male and female patients minimum age 18 years
* MRI of the affected area

Exclusion Criteria:

* Pregnancy, lactation
* Malignant disease
* Insufficient mental possibility of cooperation
* Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study

Primary outcomes:
measure: Size and location of ganglion cysts of the wrist and hand
timeFrame: Baseline (pre-surgery)
Secondary outcomes:
measure: MRI measure of size and location of ganglion cysts of the wrist and hand
timeFrame: Baseline (pre-surgery)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Waldfriede Hospital
Study officials:
affiliation: Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
name: Martin Lautenbach, MD
role: STUDY_CHAIR
affiliation: Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
name: Markus Bock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00814528: Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses
Official title: Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Actinic Keratosis
Keywords: actinic keratosis
skin lesions
5-ALA
AK
Blu-Light
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2008-12-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the treatment of skin growths called actinic keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil (5-FU).


Eligibility criteria: Inclusion Criteria:

* 18-95 years old
* Diagnosied with actinic keratoses.

Exclusion Criteria:

* Patients who have had Isotretinoin therapy less that 1 year prior to screening.
* Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).
* History of porphyria

Primary outcomes:
measure: Actinic keratosis /incomplete therapy and reoccurence
timeFrame: 18 months
Secondary outcomes:
measure: Erythema
timeFrame: 2 weeks post therapy
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Maria Tsoukas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02221128: PerClot to Control Bleeding in Endoscopic Sinus Surgery
Official title: A Post Market Surveillance Study Evaluating the Safety and Effectiveness of PerClot to Control Mild Bleeding in Subjects Undergoing Endoscopic Sinus Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinusitis
Lead sponsor: CryoLife Europa
Sponsor class: INDUSTRY
Collaborators: name: CryoLife, Inc.
First posted: 2014-08-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing Endoscopic Sinus Surgery

Brief summary: A prospective, single centre, single arm study designed to collect clinical data on PerClot when used in subjects undergoing endoscopic sinus surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects having Endoscopic Sinus Surgery
* Subjects who will have PerClot used as a haemostatic agent
* Subjects willing and able to give consent
* Subjects over 18 years old

Exclusion Criteria:

* Subjects unable or unwilling to give consent for their data to be collected

Primary outcomes:
measure: Number of subjects who achieve of haemostasis after the application of PerClot
timeFrame: intraoperatively
Secondary outcomes:
measure: Number of subjects who require the use of alternative methods to achieve haemostasis after the application of PerClot
timeFrame: intraoperatively
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: David Roberts
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00780728: Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial Hypertension
Official title: Addition of Sildenafil to Bosentan Monotherapy in Patients With Pulmonary Arterial Hypertension (PAH)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hypertension, Pulmonary
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-10-28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This study will examine the effects of add-on sildenafil to bosentan monotherapy in patients with Pulmonary Arterial Hypertension. Patients on bosentan monotherapy will be followed every 6 months to assess if they have met the pre-defined treatment goals. If a patient fails to achieve these treatment goals or fails to maintain them, sildenafil will be added to their existing bosentan monotherapy. Patients will be assessed 6 months after start of combination therapy for changes in 6MWT, Borg dyspnea scale, WHO functional class, quality of life.


Eligibility criteria: Inclusion \& Exclusion Criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01849328: Testing Spectrosense EVA System for Detection of Breast Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Rauscher, Gregory E., M.D. PA
Sponsor class: INDIV
First posted: 2013-05-08
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with breast cancer, biopsy confirmed, ages above 18. vs. Healthy women without breast cancer.

Brief summary: Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the Spectrosense EVA system, which is combination of a gas chromatography (GC) and software algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the best discrimination between Breast Cancer sick population and healthy population. The gold standard for identifying sick/healthy population is biopsy proven breast cancer.


Eligibility criteria: Breast Cancer group:

Inclusion Criteria:

* Age from 18 years old
* Breast cancer positive biopsy
* Before any treatment
* Signed Informed Patient Consent

Exclusion Criteria:

* Age under 18 years old
* Neoadjovant treatment
* Post surgery for breast cancer
* A history of any other cancer type, except skin cancer that is not melanoma

Healthy group:

Inclusion Criteria:

* Healthy women
* No history of Breast cancer
* Signed Informed Patient Consent

Exclusion Criteria:

* History of Breast cancer
* Breast cancer background in the family
* A history of any other cancer type, except skin cancer that is not melanoma

Primary outcomes:
measure: Obtaining a set or sets of VOC bio-markers that will provide the best discrimination between Breast Cancer sick population and healthy population. breast cancer.
timeFrame: Upon enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
Study officials:
References: