louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02944409: VEGA System® Study in the Total Knee Arthroplasty
Official title: Prospective Non-interventional, Prospective Multicenter Study of VEGA System® Prosthesis in the Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Arthroplasty
Lead sponsor: BBraun Medical SAS
Sponsor class: INDUSTRY
First posted: 2016-10-25
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Person for whom a replacement of knee was planed and for whom the surgeon planed to use VEGA System for the Knee Arthroplasty

Brief summary: This post-market clinical follow-up study intends to investigate long-term functionality of the VEGA System®. The design of the VEGA System® is meant to provide the patient with more knee mobility compared to their pre-operative state.The endpoint is the revision of at least one of the prosthesis components


Eligibility criteria: Inclusion Criteria

1. Patient from 18 to 75 years old
2. Patient is able to comply with follow-up requirements including postoperative self-evaluations.
3. Patient requires a primary knee replacement.
4. Patient has a diagnosis of osteoarthritis
5. Patient has intact collateral ligaments.

Exclusion Criteria

1. Vulnerable patient under legal protection
2. Patients with inflammatory arthritis.
3. Patients that have had a high tibial osteotomy or femoral osteotomy.
4. Pregnancy

Primary outcomes:
measure: Survival rate of the prosthesis at 5 years
timeFrame: needs of revision of at least one of the prosthesis component evaluated 5 years after the knee arthroplasty
Secondary outcomes:
Other outcomes:
Locations:
city: Arras
country: France
facility: Hôpital Privé des Bonnettes-Service de Chirurgie Orthopédique et Traumatologie
city: Paris
country: France
facility: Hôpital Lariboisière- Service de Chirurgie Orthopédique et Traumatologie
Study officials:
References:
Clinical trial NCT01740609: A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers
Official title: A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of Pf-06342674 (RN168) In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
RN168
Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-12-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.


Eligibility criteria: Inclusion Criteria:

* Male subjects and female of non-childbearing potential subjects between the ages of 18 and 55.
* BMI between 18.5 to 32 kg/m2.
* Total body weight ≥40 kg and ≤120 kg.

Exclusion Criteria:

* Previous treatment with an antibody within 6 months prior to Day 1.
* Pregnant or nursing females; females of childbearing potential.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.

Primary outcomes:
measure: Incidence of dose limiting or intolerable treatment related AEs
timeFrame: 60 days
measure: Incidence of treatment emergent AEs
timeFrame: 60 days
measure: Incidence of abnormal laboratory findings
timeFrame: 60 days
measure: Changes from baseline in safety laboratory assessments
timeFrame: 60 days
measure: Abnormal and clinically relevant changes in vital signs, blood pressure, and ECG parameters
timeFrame: 60 days
measure: Incidence of anti-drug-antibodies
timeFrame: 60 days
measure: Severity of treatment emergent AEs
timeFrame: 60 days
measure: Causal relationship of treatment emergent AEs
timeFrame: 60 days
Secondary outcomes:
measure: Area under the Concentration-Time Curve (AUC)
timeFrame: 60 days
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 60 days
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 60 days
measure: PK parameter estimates including T1/2.
timeFrame: 60 days
measure: Systemic Clearance (CL)
timeFrame: 60 days
measure: Apparent Oral Clearance (CL/F)
timeFrame: 60 days
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 60 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04396509: Effects of Type of Delivery Mode and Gestational Age on Maternal Bonding
Official title: Effects of Type of Delivery Mode and Gestational Age on Maternal Bonding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mother-Infant Interaction
Postnatal Depression
Postpartum Anxiety
Keywords: The Maternal Attachment Inventory
Postnatal Depression
Postpartum Anxiety
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Two hundred patients were divided into two groups. 100 women delivered vaginally and another 100 delivered with cesarean section. They were examined three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken.

Brief summary: To evaluate the effects of gestational age and other factors on maternal attachment relationship. There are different results in studies examining the effects of birth type on postpartum depression and mother-infant interaction. The aim of this study was to evaluate factors which affected mother-infant bond (MIB) using maternal attachment inventory (MAI).

Detailed description: The Maternal Attachment Inventory (MAI) measure maternal love attachment (9). Muller tested the MAI questions in two phases; maternal adaptation and maternal attachmentEach item is evaluated by a 4-way to 26-point Likert-type scale ranging from "always" to "never". Always is calculated as (a) = 4 points, often (b) = 3 points, sometimes (c) = 2 points and never (d) = 1 point. The lowest score which could be obtained from the scale that measures maternal emotions and behaviors indicating love is 26, the high score is 104, and a high score indicates a high maternal attachment (12).

Eligibility criteria: Inclusion Criteria:

* natural pregnancy (without any Assisted reproductive technology (ART) method)
* aged 18 to 45 years
* no adverse obstetric history

Exclusion Criteria:

* psychiatric diagnosis
* history of psychiatric drug use
* postpartum blues
* known complications during pregnancy

Primary outcomes:
measure: Compare mother-infant bond (MIB) scores between the vaginal delivery and the C-section (C/S) groups.
timeFrame: 3 months
Secondary outcomes:
measure: evaluate the correlations between the MIB scores and their sociodemographic data.
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT01797809: Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea
Official title: Qlaira® Regulatory Post Marketing Surveillance Study in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-02-25
Enrollment: 757
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Generally healthy women after menarche and before menopause desiring contraception with or without HMB will be recruited who are determined to start Qlaira

Brief summary: The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by KFDA (Korea Food and drug administration)


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent
* Women after menarche and before menopause
* Women requesting contraception or Women diagnosed by a physician as having HMB due to non-organic cause who are also requesting contraception
* Women who are prescribed Qlaira® for the first time, during the study period

Exclusion Criteria:

- All contraindications according to the local marketing authorization have to be considered.

Primary outcomes:
measure: Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Contraceptive Efficacy by Number of unintended pregnancies
timeFrame: From 3 to 6 months
measure: Contraceptive Efficacy by Compliance with Qlaira taking : Administered tablet number/prescribed tablet number
timeFrame: From 3 to 6 months
measure: The relief of heavy menstrual bleeding symptom also will be calculated as an efficacy variable from admission to the study until final visit by subject's assessment
timeFrame: From 3 to 6 months
measure: Number of subjects with improved heavy menstrual bleeding
timeFrame: From 3 to 6 months
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03496909: PhysioTouch for Treatment of Radiation Fibrosis
Official title: The PhysioTouch, A Novel Treatment for Radiation Fibrosis Syndrome in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Radiation Fibrosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A quarter of a million women will develop breast cancer (BC) in this year alone. Many of these women will have side effects as a result of their breast cancer treatment. Radiation Fibrosis Syndrome (RFS) is a common complication from breast cancer treatment that progressively changes tissue and can cause decreased function, pain, and range of motion. The PhysioTouch is a hand held device that can be used to treat RFS and may improve the treatment of fibrotic tissue. This pilot randomized controlled trial aims to determine the efficacy of using the PhysioTouch in addition to current standard of care for treatment of BC-related RFS.


Eligibility criteria: Inclusion Criteria:

* History of radiation therapy for breast cancer
* Clinical or suspected RFS
* Reported functional impairments

Exclusion Criteria:

* Metastatic disease of soft tissue
* History of bilateral radiation therapy
* Previously diagnosed shoulder impairments not related to RFS
* Prior treatment with PhysioTouch
* Current or recent pregnancy
* Current breastfeeding
* Other contraindications to safe and meaningful participation at discretion of study team

Primary outcomes:
measure: Change in self-reported upper extremity function
timeFrame: Baseline to 12 weeks
measure: Change in self-reported pain
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in affected shoulder abduction
timeFrame: Baseline to 12 weeks
measure: Change in affected shoulder flexion
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Michigan Medicine, Department of Physical Medicine & Rehabiliation
name: Katie Rogers, MSOTR-CLT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00404209: Pressurized PPV 23GA Vitrectomy in Complicated Diabetic Tractional Retinal Detachment
Official title: Pressurized Perfluorocarbon Perfused 23 GA Vitrectomy in Complicated Diabetic Retinal Detachment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Retinal Detachment
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2006-11-28
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the feasibility and advantages of using pressurized perfluorocarbon liquid (PCL) perfusion to remove vitreous during suction-cutting 23 GA vitrectomy using a dual, dynamic drive (3D)technology, in complicated retinal detachment surgeries.


Eligibility criteria: Inclusion Criteria:

* Complicated retinal detachment with no more than 6months of evolution

Exclusion Criteria:

* Retinal detachments of more than 6 months of evolution No light perception

Primary outcomes:
measure: Perfluorocarbon liquids consumption
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociación para Evitar la Ceguera en México, Hospital "Luis Sánchez Bulnes"
state: Mexico DF
Study officials:
affiliation: Asociación para Evitar la Ceguera en Mexico, Hospital "Luis Sanchez Bulnes"
name: Hugo Quiroz-Mercado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asociación para Evitar la Ceguera en México
name: Raul Velez-Montoya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00642109: A Comparison of the Retropubic (TVT) With the Transobturator Sling Operation in the Treatment of Female Stress Urinary Incontinence or Stress Dominated Mixed Urinary Incontinence
Official title: A Prospective Randomized Clinical Trial: Comparison of the Retropubic (TVT) With the Transobturator (outside-in T.O.T. Monarc or Inside-out TVT-O) Sling Operation in the Treatment of Female Stress Urinary Incontinence or Stress Dominated Mixed Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2008-03-24
Enrollment: 160
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The midurethral tension-free vaginal tape (a macroporous polypropylene mesh) procedure is a well established technique for treating female stress urinary incontinence in patients with (hyper)mobile urethra. Postoperative continence rates are achieved in up to 95%. Currently, several anatomical approaches are developed and investigated to simplify this minimal invasive technique and make it safer. While the retropubic approach consists of the passage of the needles from under the midurethra up behind the pubic bone through the cavum retzii, the transobturator technique traverses the foramina obturatoria. Intraoperative complications like bladder perforation (in 4%) can be treated conservatively, while postoperative complications like voiding dysfunction (urinary outlet obstruction in up to 16% or urinary retention) are troublesome, impair the quality of life and require occasionally surgical sling release (transection of the sling). The aim of this study is to compare quality of life, postoperative voiding dysfunction, success rates and tape position after retropubic and transobturator sling procedure.

* Trial with surgical intervention


Eligibility criteria: Inclusion criteria:

* Urodynamic stress urinary incontinence or stress dominated mixed urinary incontinence with mobile urethra
* With or without concomitant surgery for pelvic organ prolapse
* With or without hysterectomy

Exclusion criteria:

* No informed consent
* No preoperative urodynamic investigation
* Mixed urinary incontinence with predominant overactive bladder
* Recurrent stress urinary incontinence after sling procedure
* Begin of treatment of overactive bladder less then a month ago or non stable condition
* Pregnancy
* Desires future childbearing
* Concomitant incontinence procedure like intravesikal injection of Botulinumtoxin
* Preoperative postvoid residual urinary volume exceeding 100cc
* Coagulopathies

Primary outcomes:
measure: Urodynamic stress urinary incontinence measurement
timeFrame: December 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich, clinic for gynaecology
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT03368209: Noninvasive Glucose Measurements - Database and Calibration Compilation
Official title: Noninvasive Glucose Measurements - Database and Calibration Compilation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Keywords: Non-invasive glucose monitoring
Lead sponsor: RSP Systems A/S
Sponsor class: INDUSTRY
First posted: 2017-12-11
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open, non-randomized comparison study between device and blood references with diabetic patients
Primary purpose: BASIC_SCIENCE

Brief summary: This study collected spectral raman data from diabetic patients. Data was paired with validated capillary references as well as CGM/FGM readings. Data was used to develop models for glucose prediction.

Detailed description: This trial constitutes three subprotocols: "The OUH protocol", "The Home 1 protocol" and "The Home 2 protocol" The investigation was initiated to collect spectral raman data paired with validated blood references. In the OUH protocol, capillary blood was analysed by ABL 800 Flex blood gas analyzer by Radiometer. In the Home 1 protocol, references were obtained by the finger pricking procedure from HemoCue (Radiometer). In the Home 2 protocol, HemoCue measurements were conducted along with continuous monitoring using Dexcom G4/G5 device (Dexcom) or FreeStyle Libre (Abbott) The data was collected from diabetic patients and Optical Coherence Tomography (OCT) readings were obtained from all subjects.

Eligibility criteria: Inclusion Criteria:

* Subjects with and without diabetes including pregnant women

Exclusion Criteria:

* Subject under 18 years of age
* Subjects not able to understand provided information
* Subjects without measuring sites
* Subjects with rash or wound on measuring sites
* Subjects with stained fingers, such a oil or nicotine
* Subjects not capable of holding arm/hand steadily on probe
* Subjects with thrombosis in arm/hand

Primary outcomes:
measure: Calibration models for device predictive purposes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Endocrinology M, Odense University Hospital
Study officials:
affiliation: Odense University Hospital, Dpt. of Endocrinology M
name: Jan Erik Henriksen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04040309: PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles
Official title: Plasma Rich in Growth Factors Effectiveness for Myofascial Pain Treatment in Masticatory Muscles: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myofascial Pain
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first group of patients will receive 1 ml PRGF 2nd fraction injections into the myofascial trigger point in the masseter muscle.

The second group of patients will receive 1 ml 2% Lidocaine injections into the myofascial trigger point in the masseter muscle.
Primary purpose: TREATMENT

Brief summary: The investigators set up a randomized controlled clinical trial to evaluate the effectiveness of plasma rich in growth factors (PRGF) injections into the masseter muscle trigger points for myofascial pain treatment. The investigators also seek to compare PRGF injections effectiveness with local anesthetic injections.

Dry needling and local anesthetics injections release trigger point by disrupting the membranes of a tout band. However, the injected substance itself does not affect the pathophysiological mechanism of the trigger point.

It is known that the platelets release growth factors who can enhance muscle regeneration processes and moreover reduce chronic pain.

The investigators raised a hypothesis that PRGF injections into the trigger points in masseter muscle can be an effective treatment method for the myofascial pain.


Eligibility criteria: Inclusion Criteria:

* Adult patients.
* Diagnosed myofascial pain syndrome in one side of the masseter muscle (diagnosis is based on diagnostic criteria described by Travell and Simons: 1) palpable taut band, 2) spot tenderness in a taut band, 3) pain recognition.
* Patients have never had injections into their masseter muscle.

Exclusion Criteria:

* Myofascial trigger points in other masticatory muscles.
* Head and neck region inflammations that causes pain.
* Temporomandibular joint pathology which causes pain.
* Trigeminal nerve neuralgia.
* Head and neck region oncological diseases.
* Myofascial trigger points in both sides of masseter muscles.

Primary outcomes:
measure: Pain levels 2 weeks after the procedure: Visual analog scale
timeFrame: Patients pain levels will be measured 2 weeks after the procedure.
measure: Pain levels 4 weeks after the procedure: Visual analog scale
timeFrame: Patients pain levels will be measured 4 weeks after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: LUHS Kaunas clinics Department of Maxillofacial surgery
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Gintaras Januzis, PhD
role: PRINCIPAL_INVESTIGATOR
References: