louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00755144: A Randomized Control Trial to Assess Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Implant Designs
Official title: A Prospective Randomized Study on Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Arthroplasty Implant Designs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Biomet U.K. Ltd.
First posted: 2008-09-18
Enrollment: 200
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective Randomised Control Trial to compare the Early Clinical and Functional Outcome of the ROCC and LCS total knee arthroplasty implant designs.

Detailed description: This study compares two similar designs of cementless rotating bearing total condylar knee replacements. The study will be conducted at a single clinical unit with a senior orthopaedic surgeon implanting all devices.Their performances will be assessed by clinical scores and comprehensive function outcome documentation undertaken by qualified physiotherapists. The persons undertaking the assessments will be blinded to which implants the patients have.

Eligibility criteria: Inclusion Criteria:

* Patients suitable for cementless knee replacement
* Patients skeletally mature and under 80 years of age at pre-operative clinic
* Patients presenting with osteoarthritis of the knee
* Patients must be ambulatory at time of pre-operative clinic
* Patients must be able to understand instructions and be will to return for follow-up

Exclusion Criteria:

* Previous knee surgery (except arthroscopic/open menisectomy)
* Patients with inflammatory arthritis
* Patients with significant medical co-morbidity - ASA IV
* Disorders causing abnormal gait or significant pain
* Patients unable to consent
* Severe visual impairment

Primary outcomes:
measure: American Knee Society Score
timeFrame: Preoperative, 8weeks, 1 year
Secondary outcomes:
measure: WOMAC
timeFrame: preoperative, 8 weeks, 1 year
measure: VAS Pain
timeFrame: Preoperative, 4weeks, 8weeks, 3months, 1 year
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Musgrave Park Hospital
Study officials:
References:
Clinical trial NCT05955144: Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones
Official title: Clinical Validation of the Screening Tool Picterus Jaundice Pro to Assess Neonatal Jaundice Using Different Types of Smartphones
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Jaundice
Lead sponsor: Picterus AS
Sponsor class: INDUSTRY
First posted: 2023-07-21
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.

Detailed description: The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.

Picterus JP bilirubin estimates from a Samsung S7 will be compared with three smartphones with different camera types and a TcB measurement The clinical outcomes will be compared to our camera validation systems. Skin color measurements using a spectrophotometer will be used for technical optimization of the camera validation system

Eligibility criteria: Inclusion Criteria:

* Infants born with gestational age \> 37 weeks.
* Birth weight ≥ 2500 grams
* Age 1 - 14 days

Exclusion Criteria:

* Infants showing signs of inborn disease.
* Infants with skin rash or other skin disease that affects the skin where measurements are performed.
* Infants transferred to the pediatric ward for medical treatment.
* Infants that have received phototherapy in the last 24 hours

Primary outcomes:
measure: jaundice screening
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olav Hospital
Study officials:
References:
Clinical trial NCT06906744: Quantitative Assessment of Signal Loss in Cardiotocography Using External Recording
Official title: Quantitative Assessment of Signal Loss in Cardiotocography Using External Recording
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Maternal Heart Rate
Keywords: Maternal heart rate recording
Cardiotocography
Neonatal morbidity
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female (≥ 18 years old) with gestational age at delivery \>36 weeks

Brief summary: Signal loss in cardiotocography (CTG) recordings is numerous and frequent, whether due to artifacts in signal acquisition or confusion over inadvertent maternal heart rate recording, with various negative consequences for neonatal morbidity and unnecessary obstetric interventions. Data on this issue are 10 to 15 years old. CTG remains the primary method for assessing fetal well-being during labor, almost systematically.


Eligibility criteria: Inclusion Criteria:

* Adult female (≥ 18 years old)
* Patient treated at a hospital between February 1, 2024 and February 28, 2024
* Having undergone cardiotocography in the labor and delivery room
* Gestational age at delivery \>36 weeks

Exclusion Criteria:

* Patient who has expressed opposition to the use of medical record data
* Patient without CTG
* Gestational age at delivery \<36 weeks

Primary outcomes:
measure: Percentage of signal loss during fetal heart rate (FHR) recording during labor.
timeFrame: during labor
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gynécologie-Obstétrique CMCO - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT05632744: Evaluation of CG-100 Intraluminal Bypass Device
Official title: Evaluation of CG-100 Intraluminal Bypass Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Colospan Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-01
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of CG-100 Intraluminal Bypass device


Eligibility criteria: Inclusion Criteria (pre-operative):

1. Willing to comply with protocol-specified follow-up evaluations
2. 22-75 (inclusive) years of age at screening
3. Diagnosed with colorectal cancer
4. Has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent

Primary outcomes:
measure: Safety of the CG-100 Intraluminal Bypass Device
timeFrame: 10 days
Secondary outcomes:
measure: Safety of the CG-100 Intraluminal Bypass Device
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Reẖovot
country: Israel
facility: Soroka Medical Center
Study officials:
References:
Clinical trial NCT00600444: PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port
Official title: Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: permanent venous access
chemotherapy
parenteral nutrition
Patients with a benign and/or malignant diseases which demand a safe and permanent venous access, e.g. for chemotherapy and/or parenteral nutrition
benign diseases
malignant diseases
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2008-01-25
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports.


Eligibility criteria: Inclusion Criteria:

* Age equal or greater than 18 years
* Patients scheduled for primary elective implantation of TIAP

Exclusion Criteria:

* Participation in another clinical trial which could interfere with the primary endpoint of this study
* Lack of compliance
* Impaired mental state or language problem
* Patients with known allergy to contrast agent

Primary outcomes:
measure: Primary success rate of the randomized intervention
timeFrame: Assessed on the day of surgery (day 0)
Secondary outcomes:
measure: Peri-/postoperative complication rate for the randomized intervention
timeFrame: Assessed after 90 day post operation
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
state: Baden Würtemberg
Study officials:
affiliation: University of Heidelberg, Department of General, Visceral and Transplantation Surgery
name: Markus W Büchler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knebel P, Lopez-Benitez R, Fischer L, Radeleff BA, Stampfl U, Bruckner T, Hennes R, Kieser M, Kauczor HU, Buchler MW, Seiler CM. Insertion of totally implantable venous access devices: an expertise-based, randomized, controlled trial (NCT00600444). Ann Surg. 2011 Jun;253(6):1111-7. doi: 10.1097/SLA.0b013e318214ba21.
citation: Knebel P, Fischer L, Cremonese E, Lopez-Benitez R, Stampfl U, Radeleff B, Kauczor HU, Buchler MW, Seiler CM. Protocol of an expertise based randomized trial comparing surgical Venae Sectio versus radiological puncture of Vena Subclavia for insertion of Totally Implantable Access Port in oncological patients. Trials. 2008 Oct 24;9:60. doi: 10.1186/1745-6215-9-60.
Clinical trial NCT00695240: Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair
Official title: Post-Operative Pain Control Using Direct Continuous Bupivacaine Infusion After Pelvic Organ Prolapse Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Post-Operative Pain
Pelvic Organ Prolapse
Keywords: Continuous bupivacaine infusion
Analgesia
Lead sponsor: St. Luke's Hospital, Kansas City, Missouri
Sponsor class: OTHER
First posted: 2008-06-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective randomized controlled study will determine the efficacy of continuous local anesthesia at decreasing pain scores compared to patient controlled analgesia for pelvic organ prolapse procedures including posterior colporrhaphy and sacrospinous ligament fixation.

Detailed description: Direct post-operative analgesia can be administered via a direct continuous analgesia pumps providing local anesthetic into a dissected area. To date, no studies have been conducted to evaluate pain control or infection with vaginal placement of catheters for pelvic organ prolapse surgery. To help pelvic surgeons assess the relative benefit of continuous local infusion of topical anesthetic following sacrospinous ligament fixation versus PCA pump, we compared pain scores, narcotic, anti-pruritic and anti-emetic drug usage, and wound complications.

Eligibility criteria: Inclusion Criteria:

* Female patients greater than 18 years of age
* Undergoing posterior colporrhaphy at Saint Lukes Hospital, Kansas City, MO.

Exclusion Criteria:

* Patients with chronic pain conditions requiring daily narcotics were excluded

Primary outcomes:
measure: The primary outcome was a difference in the Wisconsin Brief Pain Inventory and Visual Acuity Score after treatment with the direct continuous analgesia device compared to PCA alone.
timeFrame: Each day post-operatively
Secondary outcomes:
measure: Secondary outcome was differences in the amount of narcotics, NSAIDS, antiemetics, time to return of bladder function, and complications between the study groups.
timeFrame: Each day post-operatively
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
Study officials:
affiliation: St. Luke's Hospital
name: Tyler M Muffly, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00439140: Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-02-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.

Detailed description: Botulinum toxin Type A 300U has been discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) will receive botulinum toxin Type A 200U instead.

Eligibility criteria: Inclusion Criteria:

* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
* Inadequate response to anticholinergic medication used to treat overactive bladder.
* Neurological respiratory impairment and abnormal pulmonary function test results

Exclusion Criteria:

* History or evidence of pelvic or urologic abnormality
* Previous or current diagnosis of bladder or prostate cancer
* Symptomatic or untreated urinary tract infection at time of enrollment

Primary outcomes:
measure: Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Baseline, Week 6
measure: Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline, Week 6
measure: Change From Baseline in FEV1/FVC Ratio
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change From Baseline in the Number of Urinary Incontinence Episodes
timeFrame: Baseline, Week 6
measure: Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP)
timeFrame: Baseline, Week 6
measure: Change From Baseline in Maximum Cystometric Capacity (MCC)
timeFrame: Baseline, Week 6
Other outcomes:
measure: Number of Participants With at Least a 15% Decrease From Baseline in FVC
timeFrame: Baseline, Weeks 2, 6 and 12
measure: Number of Participants With at Least a 20% Decrease From Baseline in FVC
timeFrame: Baseline, Weeks 2, 6 and 12
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
city: Herston
country: Australia
state: Queensland
city: Victoria
country: Canada
state: British Columbia
city: Chennai
country: India
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06195644: Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
Official title: Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cortical Excitability
Multiple Sclerosis
Keywords: Galvanic Vestibular Stimulation
Hand Dexterity
Multiple Sclerosis
Transcranial magnetic Stimulation
Cortical excitability
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate the following:

1. The impact of implementing GVS in MS rehabilitation on cortical excitability.
2. The influence of GVS on upper limb function in patients diagnosed with MS. Patients will be randomly assigned to a control group (Conventional Physical Therapy program = CPT) and a study group (Galvanic Vestibular Stimulation = GVS in addition to the conventional program) subsequently. CPT will perform moderate intensity aerobic training (arm ergometer) and task oriented hand manipulation training, while GVS will receive Galvanic Vestibular Stimulation will be added to the conventional physical Therapy program.


Eligibility criteria: Inclusion Criteria:

1. Patients with ataxic RRMS type of both genders will be recruited. The last MS relapse occurred at least 3 months prior to the study.
2. Patients' age will range from 20 to 45 years old.
3. Ambulant Patients who meet the level less than or equal to 5 on EDSS will be recruited.
4. Patients' score on Mini Mental State Examination should be \> 26.
5. Mild or no spasticity (grade 1 or 1+) according to Modified Ashworth Scale.
6. All patients must at least hold Primary stage certificate of education from one of the Egyptian educational authorities.
7. All patients can independently sign consent form

Exclusion Criteria:

* Patients will be excluded if they have:

  1. Moderate to severe auditory or visual or cognitive impairment.
  2. Coexistence of other neurological diagnoses of Central or Peripheral Nervous system (e.g. cerebrovascular stroke, vestibulopathy or polyneuropathy).
  3. History of any problems that hinder conduction of aerobic training or magnetic stimulation (e.g. deep venous thrombosis, shunts and pacemakers).

Primary outcomes:
measure: Cortical changes
timeFrame: 15 minutes
measure: Upper Limb motor dexterity
timeFrame: 15-20 minutes
Secondary outcomes:
measure: Advanced dexterity (Handwriting analysis) by MovAlyzeR® software
timeFrame: 15-20 minutes
measure: Balance
timeFrame: 15-20 minutes
measure: Fatigue
timeFrame: 15-20 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT00406744: Efficacy of Retreatments With Intravitreal Bevacizumab
Official title: Evaluation of Efficacy of Intravitreal Bevacizumab Retreatments
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Age Related Macular Degeneration
Choroidal Neovascularization
Keywords: neovascularization
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2006-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Choroidal neovascularization is a leading cause of visual loss in people older than 60 years and for its treatment there had been performed multicentric studies with Lucentis (Ranibizumab) with a significant improval of visual acuity. In our institution we evaluated efficacy of bevacizumab in several pathologies but we dont know what would be the results if we use the same dose several times. Our purpose was to determine the efficacy of bevacizumab for improve or stabilize visual acuity with two or more intravitreal inyections of bevacizumab.


Eligibility criteria: Inclusion Criteria:

* \* Any visual acuity

  * OCT: Central foveal thickness greater than 300 u or with evidence of subretinal fluid.
  * Active angiogram leakage

Exclusion Criteria:

* \* Basal Inflammatory disease

  * Endoftalmitis history
  * Lesions bigger than 5400 u or with scarring greater than 50% of lesion.

Primary outcomes:
measure: Best corrected visual acuity, OCT foveal thickness and fluorescein angiogram
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico DF
country: Mexico
facility: Asociacion para Evitar la Ceguera en Mexico
state: DF
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Veronica Kon-Jara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03754244: A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics
Official title: A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the pharmacokinetic characteristics of TQ-B3456 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility criteria: Inclusion Criteria:

- progressive or metastatic non-small cell lung cancer that diagnosed Pathologically or cytologically diagnosed patients who have received EGFR tyrosine kinase inhibitor monotherapy (e.g., gefetinib, erlotinib, ecotinib, afatinib) for disease progression EGFR T790M mutation was confirmed ECOG PS≤1 Adequate blood cell counts, kidney function and liver function Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

Patients with non-small-cell lung cancer who have received osimertinib or other raw materials or preparations for EGFRT790M mutant drugs Hypertension (systolic BP ≥140 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication; Hepatitis B virus patients with active replication (DNA\> 500 cps / mL), hepatitis C; Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history

-

Primary outcomes:
measure: Dose-Limiting Toxicities（DLT）
timeFrame: Baseline up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: No. 241 Huaihai West Road, Xuhui District, Shanghai
state: Shanghai
Study officials:
References: