louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02598921: Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF
Official title: Determining an Accurate and Cost-effective Strategy for Screening for Uterine Cavity Abnormalities in Women Scheduled for IVF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Assisted reproductive technology
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of the endometrial cavity is an important step in the infertility work-up, particularly if assisted reproductive therapy is planned. The aim is to identify possible endometrial abnormalities that may impair implantation.Undiagnosed endometrial abnormalities are present in 11 to 45% of women scheduled for in vitro fertilization (IVF).Traditionally, two dimensional transvaginal ultrasound (2D TVUS) and hysterosalpingography (HSG) are the basic methods for assessment of the endometrial cavity. However, these imaging modalities have shown high false negative rates among infertile women, a finding that could confine their rule to initial screening rather than definite diagnosis.

Office hysteroscopy (OH) is the gold standard for evaluation of the endometrial cavity. Although the endoscopic approach has been proven to increase pregnancy rate in women who experienced prior implantation failure, evidence on treatment of unsuspected hysteroscopically-diagnosed endometrial lesions, to improve IVF outcome, is still lacking. Nevertheless,clinicians tend to use OH routinely prior to IVF because the psychological and financial burden that infertile couples may experience as a consequence of failed IVF cycle is unjustifiable.Yet, costs and invasiveness of OH counteract its global implementation to all women prior to IVF.


Eligibility criteria: Inclusion Criteria:

* History of primary infertility
* Normal uterine cavity on HSG
* Women were selected for IVF therapy.

Exclusion Criteria:

* Women with known diagnosis of uterine abnormality by office hysteroscopy

Primary outcomes:
measure: Number of patients who have cavitary lesion by three dimensional ultrasound
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT06926621: A Study of Long-term Safety and Efficacy of VX-670 in Participants With Myotonic Dystrophy Type I
Official title: An Open-label Extension Study Evaluating the Long-term Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-670 in Adult Subjects With Myotonic Dystrophy Type I
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Myotonic Dystrophy Type 1 (DM1)
Keywords: DM 1
Myotonic Dystrophy 1
Myotonic Dystrophy Type 1 (DM1)
VX-670
Myotonic Dystrophy
DM
Myotonia
Dystrophy Myotonic
Myotonic Disorders
Steinert Disease
Vertex
Entrada
PMO
ASO
Myotonic Muscular Dystrophy
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Muscular Dystrophies
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2025-04-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the long-term safety and tolerability, efficacy and pharmacokinetics of VX-670 in participants with Myotonic Dystrophy Type I (DM1).


Eligibility criteria: Key Inclusion Criteria:

• Completed study drug treatment in parent study VX23-670-001 (NCT06185764)

Key Exclusion Criteria:

• History of any illness or any clinical condition as pre-specified in the protocol

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Week 108
Secondary outcomes:
measure: Change From Baseline in Splicing Index in Muscle Biopsy at Week 24
timeFrame: Baseline and at Week 24
measure: Maximum Observed Concentration (Cmax) of VX-670 and its Active Component in Plasma
timeFrame: From Day 1 up to Week 96
measure: Area Under the Concentration Versus Time Curve (AUC) of VX-670 and its Active Component in Plasma
timeFrame: From Day 1 up to Week 96
measure: Concentration of VX-670 and its Active Component in Muscle
timeFrame: Baseline and at Week 24
Other outcomes:
Locations:
city: Auchenflower
country: Australia
facility: Wesley Research Institute
city: Melbourne
country: Australia
facility: Neuroscience Clinical Trials Unit, Alfred Brain
city: Montreal
country: Canada
facility: Altasciences Montreal
city: Ottawa
country: Canada
facility: University of Ottawa
Study officials:
References:
Clinical trial NCT04295421: IPACK Block After Total Knee Arthroplasty
Official title: Comparison of Adductor Canal Block and IPACK Block With Adductor Canal Block Alone After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthropathy
Postoperative Pain
Keywords: knee arthoplasty
nerve block
analgesia
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
Collaborators: name: Institut Kassab d'Orthopédie
First posted: 2020-03-04
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adductor canal block (ACB) is a peripheral nerve blockade technique that provides good pain control in patients undergoing total knee arthroplasty (TKA) which however does not relieve posterior knee pain. The recent technique of an ultrasound-guided local anesthetic infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) has shown promising results in providing significant posterior knee analgesia without affecting the motor nerves. The hypothesis was that the combination of ACB + IPACK will provide better pain relief and improve knee function in the immediate postoperative period compared to ACB alone.

Detailed description: This is a prospective, randomized and double blinded study

All patients received :

* Pregabalin 150 mg preoperatively 12 h before the surgery.
* Single-shot spinal anesthesia with 10 to 12 mg of bupivacaine 0.5% and 2.5ug sufentanil patients were randomly allocated to receive:
* Group 1: IPACK + ACB single shoot
* Group 2: contineous ACB For group 1: IPACK was realized after spinal anesthesia with 40 ml ropivacaine 0.2% All patients received ACB in the immediate postoperative period with 20 ml ropivacaine 0.2%

Post operative analgesia included:

* Paracetamol 1g IV every 6 hours
* Diclofenac sodium (50mg) 1 tablet x 2 per day
* Pregabalin 150 mg given orally once daily for a period of 4 weeks.
* PCA morphine (Patient Controlled Analgesia), as a rescue analgesia,
* Continuous ACB catheter for 48H with :

  4 ml per hour 0.2% ropivacaine in group 2 4 ml per hour saline in group 1

Eligibility criteria: Inclusion Criteria:

* primary total knee arthroplasty under spinal anesthesia

Exclusion Criteria:

* Contraindication or refusal to regional anesthesia
* Contraindication to non steroidal anti inflammatory (NSAID's)
* Allergy to opioids
* Allergy to paracetamol
* Creatinine clearance \< 30ml/min
* Weight\<50 kg or \>100kg

Primary outcomes:
measure: Morphine consumption
timeFrame: Day 2
Secondary outcomes:
measure: Pain score at rest
timeFrame: Day 2
measure: Pain score during mouvment
timeFrame: Day 2 [0=no pain ; 10=worste pain]
measure: Ambulation distance
timeFrame: Day 2
measure: Chronic pain
timeFrame: Month 6
measure: functional status
timeFrame: Month 6
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Institut Kassab D'Orthopedie
Study officials:
affiliation: Tunis El Manar University
name: khaireddine Raddaoui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04389021: Virtual Reality Simulation for Intrauterine Device Insertion: A Randomized Clinical Trial
Official title: Clinical Effectiveness of Virtual Reality Simulation in Reducing Discomfort, Anxiety and Pain During Intrauterine Device Insertion: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUD
Keywords: Virtual Reality
IUD
Discomfort
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim of this study is to evaluate the effect of VR on the patients overall experience during the IUD insertion procedure.

Detailed description: A single center, investigator initiated randomized controlled clinical trial. 200 women to be recruited, 100 in the intervention group and 100 in the control group.

The control group will receive the usual treatment (without specific pain management) and the intervention group will receive the usual treatment with VR support.

Endpoints are:

* Objective: successful procedure, need for general anesthesia, presence of syncope and/or vomitus
* Subjective: Pain, procedural cooperation, the degree of difficulty encountered by the physician in performing the treatment, ability to complete VR procedure.

Eligibility criteria: Inclusion Criteria:

* Healthy women who are seeking hormonal intrauterine contraception will be offered participation in the trial if they are 18 years of age or older (minors can be included if a guardians permission has been obtained), are not pregnant, and are willing to follow-up after 6 weeks for a sonographic IUD check.

Exclusion Criteria:

* Epilepsy
* Auditive or visual disabilities
* Invalidating claustrophobia

Primary outcomes:
measure: Patients overall experience of IUD insertion
timeFrame: At insertion
Secondary outcomes:
measure: Pain during insertion
timeFrame: At insertion and 6 weeks later
measure: Discomfort
timeFrame: At insertion and 6 weeks later
measure: Degree of difficulty encountered by the physician
timeFrame: At insertion
measure: Success rate of the procedure
timeFrame: At insertion and 6 weeks later
measure: Patient satisfaction on the longer term
timeFrame: 6 weeks after insertion
measure: Side events
timeFrame: At insertion
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT01473121: Hepatocellular Carcinoma Registry for Turkey (3K Trial)
Official title: Profile of the Hepatocellular Carcinoma Patients in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Registry
Turkey
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 600
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: Patients that are diagnosed with hepatocellular carcinoma in last 3 months

Brief summary: This registry study is national, multi-center, prospective study without any interventions to the treatment strategies and/or decisions of the investigators. It is designed in order to determine the general profile of HCC patients in Turkey. Socio-demographic characteristics, family history, medical history and treatment pattern of HCC patients will be evaluated.


Eligibility criteria: Inclusion Criteria:

* To be diagnosed with hepatocellular carcinoma in last 3 months
* To be older than 18 years old
* To sign informed consent form (ICF)

Exclusion Criteria:

* Patients that does not sign or withdraw informed consent form.
* According to investigator's opinion; existence of any situation/condition that will significantly complicate patient follow up.
* Currently or previously taking part in 3K observational study

Primary outcomes:
measure: Descriptive analysis of HCC risk factors
timeFrame: Baseline
measure: Descriptive analysis of clinical profile of newly diagnosed HCC patients
timeFrame: Baseline
Secondary outcomes:
measure: Number of participants with underlying liver disease and family history
timeFrame: Baseline
measure: Treatment options as applied by doctors to HCC patients
timeFrame: Up to approximately 5 years
measure: Overall survival time since diagnosis
timeFrame: Up to approximately 5 years
measure: Number of participants with adverse events
timeFrame: Up to approximately 5 years
measure: Descriptive analysis of demographic characteristics of HCC patients
timeFrame: Baseline
measure: Descriptive analysis of clinical characteristics of HCC patients
timeFrame: Up to approximately 5 years
measure: Descriptive analysis of tumor properties
timeFrame: Up to approximately 5 years
Other outcomes:
Locations:
city: Multiple Locations
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06527521: Prevalence of Amyloidosis in Trauma Patients
Official title: Prevalence of Amyloidosis in Trauma Patients Using Red Flags Tool
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyloidosis
Keywords: Amyloidosis
Red Flags tool
Traumatology
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 246
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in the waiting list for scheduled trauma surgery

Brief summary: This study aims to determine the frequency of amyloidosis among patients undergoing trauma surgery.


Eligibility criteria: Inclusion Criteria:

* Men and women included in the waiting list for scheduled trauma surgery with at least one of the following criteria defined as red flags: Over 65 years old; Possible family history of amyloidosis, Cardiac pathology: aortic stenosis, presence of left ventricular hypertrophy defined as interventricular septal thickness \> 12mm measured by echocardiography, history of previous brady- or tachyarrhythmias including cardiac conduction blocks, history of syncope or presyncope, pro BNP \> 300 in previous blood tests; History of sensory peripheral neuropathy; History of nephropathy without etiological diagnosis; History of liver disease without a clear cause.
* Ability to cooperate in the necessary evaluations.
* Signed informed consent for inclusion in the study, either by the participant or their legal representative.

Exclusion Criteria:

- Participants previously diagnosed with amyloidosis cannot be included in the study.

Primary outcomes:
measure: Amyloidosis
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Sant Pere De Ribes
country: Spain
facility: Consorci Sanitari Alt Penedes i Garraf-Hospital Sant Camil
state: Barcelona
Study officials:
affiliation: CSAPG
name: Lidia Tikhomirova, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04348721: INTERNATIONAL SURVEY ON COMPLEXITY IN LIVER TRANSPLANTATION
Official title: ASSESSMENT OF COMPLEXITY AND TECHNICAL DIFFICULTIES IN LIVER TRANSPLANTATION: INTERNATIONAL SURVEY OF EXPERTS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplantation
Keywords: complexity
international survey
surgical difficulty
Lead sponsor: Pitié-Salpêtrière Hospital
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: International liver transplant surgeons who had published on liver transplantation

Brief summary: The aim of this study is to perform an online survey to assess the perception of international liver transplant surgeons regarding the complexity and surgical difficulty in liver transplantation and to develop a complexity score and classification.


Eligibility criteria: Inclusion Criteria:

* surgeons in liver transplantation center
* all countries

Exclusion Criteria:

* none

Primary outcomes:
measure: Identify preoperative criteria to evaluate the degree of technical difficulty during a liver transplantation.
timeFrame: five minuts
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié-Salpêtrière Hospital, APHP
Study officials:
References:
citation: Lee MK 4th, Gao F, Strasberg SM. Perceived complexity of various liver resections: results of a survey of experts with development of a complexity score and classification. J Am Coll Surg. 2015 Jan;220(1):64-9. doi: 10.1016/j.jamcollsurg.2014.09.017. Epub 2014 Oct 15.
citation: Lee MK 4th, Gao F, Strasberg SM. Completion of a Liver Surgery Complexity Score and Classification Based on an International Survey of Experts. J Am Coll Surg. 2016 Aug;223(2):332-42. doi: 10.1016/j.jamcollsurg.2016.03.039. Epub 2016 Apr 9.
citation: Manceau G, Benoist S, Panis Y, Rault A, Mathonnet M, Goere D, Tuech JJ, Collet D, Penna C, Karoui M. Elective surgery for tumours of the splenic flexure: a French inter-group (AFC, SFCD, FRENCH, GRECCAR) survey. Tech Coloproctol. 2020 Feb;24(2):191-198. doi: 10.1007/s10151-019-02143-2. Epub 2020 Jan 14.
citation: Reames BN, Blair AB, Krell RW, Groot VP, Gemenetzis G, Padussis JC, Thayer SP, Falconi M, Wolfgang CL, Weiss MJ, Are C, He J. Management of Locally Advanced Pancreatic Cancer: Results of an International Survey of Current Practice. Ann Surg. 2021 Jun 1;273(6):1173-1181. doi: 10.1097/SLA.0000000000003568.
Clinical trial NCT00175721: Trial Comparing Care in Multiple Clinics Versus Care in a Cardiac, Diabetes and Kidney Care Clinic
Official title: Randomized Controlled Trial Comparing Current Care in Multiple Clinics Vs Care in a Novel Cardiac, Diabetes & Kidney Care Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Diseases
Heart Diseases
Diabetes Mellitus
Keywords: Combined Clinic
Chronic Kidney Disease
Diabetes
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the benefits of a combined cardiac, kidney, and diabetes clinic versus multiple clinics.

Hypothesis: Attendance at multiple clinics by one individual patient has multiple problems which may be overcome by the introduction of a combined care clinic.

Detailed description: This is a randomized control trial to compare health care resource utilization, and achievement of stated targets of therapy (BP, Hgb, glucose control, use of preventive medications) as well as patient and health care team satisfaction, and longer term patient outcomes in patients with kidney disease who have either or both diabetes and heart disease, and currently attend either a diabetic or heart function clinic (or both) in addition to a kidney care clinic. In addition, we will also establish and refine the specialized cross-disciplinary care model, within a framework in Vancouver, and evaluate its functioning from the perspectives of allied health and medical professionals.

This is a systematic evaluation of health care delivery methods to a complex group of patients, which will serve as a nidus for ongoing research in both health outcomes research, and biomedical research.

The creation of this multifaceted clinic in an organized manner would permit evaluation of all of the components of it, and also demonstrate the importance of collaboration between disciplines and between public health care initiatives and industry partners, who would fund this clinic infrastructure and research components in the initial phase.

Eligibility criteria: Inclusion Criteria:

* All patients currently attending or who would be eligible to attend 2 or more of the following clinics: cardiac, diabetic or kidney

Exclusion Criteria:

* Those patients currently attending the diabetic, cardiac or kidney clinics who do not have more than one condition (i.e. who have only one of the diagnoses) or who refuse to sign informed consent

Primary outcomes:
measure: Health care utilization and patient/provider satisfaction (5 years)
timeFrame: 5 years
Secondary outcomes:
measure: Patient outcomes (5 years)
timeFrame: 5 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Adeera Levin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06417021: Ergonomics in Ultrasound Procedures
Official title: The Position of the Ultrasound Machine in the Placement of the Central Venous Catheter: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Complication
Competence
Keywords: Central Venous Access
Ultrasound
Ergonomics
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 239
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study will compare two different positions of the ultrasound machine during simulated CVC positioning.

The position of the ultrasound machine will be randomized. Group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis.

Detailed description: We will recruit medical trainees affiliated with the 'Anesthesia and Intensive Care' and 'Emergency Medicine' schools. Data collected for each participant will include: age, gender, specialty school, year of specialization training, expertise in using ultrasound for ultrasound-guided procedures. Once informed consent is obtained, subjects will be divided through simple randomization (a list generated in advance with Excel and subjected to the opaque envelope method) into two groups: A and B. All subjects will be asked to perform CVC placement using the simulator through an 'oblique in-plane' approach. Subjects randomized to group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis.

Eligibility criteria: Inclusion Criteria:

* 'Anesthesia and Intensive Care' and 'Emergency Medicine' residents
* Informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Time to correct CVC position
timeFrame: baseline
Secondary outcomes:
measure: Needle tip visualization
timeFrame: baseline
measure: Complications
timeFrame: baseline
measure: Success of the procedure
timeFrame: 10 minutes from the baseline
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University Hospital of Padova
state: Veneto
Study officials:
References: