louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03369158: Pedicle Screw Positioning With MySpine vs Free Hand Technique
Official title: A Prospective Clinical Survey on Accuracy of Pedicle Screws Positioning With MySpine Versus Free Hand Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Deformity
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2017-12-11
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical study in order to evaluate the accuracy of pedicle screw positioning during spine surgery performed with MySpine patient match positioning guide or Free hand technique.

Detailed description: The proposed study seeks to assess the intraoperative accuracy of the Medacta patient-specific MySpine® pedicle screws placement guides in comparison to free-hand technique.

A pre-operative CT scan of the spine is obtained to create a 3-dimensional model of the patient's spine for the MySpine patient group. This model is then used to preoperatively plan the patient's surgery implantation itself, with the same goals of both free-hand and computer assisted techniques. The theoretical advantage of this technique is accurate implant placement without the added surgical time and complexity of the procedure, with lower radiation exposure thanks to less steps of fluoroscopy checks.

The hypothesis for the present study is that the MySpine® technique can place pedicle screws more accurately in comparison to free-hand technique.

The accuracy of the final implant position with respect to the pre-operative planning will be evaluated through CT post-op analysis.

Eligibility criteria: Inclusion Criteria:

* Patients older than 12 years
* patients suffering from coronal or sagittal spinal deformities that will undergo a surgical treatment with a posterior approach and pedicle screws placement
* Patients suitable to undergo spinal stabilization (according to the label indication/contraindications)
* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained when indication to surgery is confirmed.

Exclusion Criteria:

* Patient with congenital spinal deformity (emeverebre, vertebra wedge, vertebrate butterfly, congenital bar, vertebra block)
* Patients with a previous fusion of the spine in the region where screws will be inserted
* Patients with any allergy to the device implanted
* Patients who will be not able to provide their written consent to the study participation
* Patients who are incapable of understanding and wanting

Primary outcomes:
measure: Accuracy of Pedicle Screw Positioning
timeFrame: 1 week after surgery
Secondary outcomes:
measure: Radiological Evaluation of Pedicle Screw Malposition
timeFrame: 1 weeks after surgery
measure: Occurrence of Malposition Side
timeFrame: 1 weeks after surgery
measure: Incidence of Adverse Event
timeFrame: intraoperatively, up to 1 week after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01469858: Perception and Multisensory Integration in Neurological Patients Using fMRI
Official title: Perception and Multisensory Integration in Neurological Patients Using fMRI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Inflammatory Demyelinating Polyradiculoneuropathy
Myasthenia Gravis
Stroke
Anosognosia
Asomatognosia
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective of the study is to explore and map brain areas involved in sensory perception and multisensory integration in patients with central or peripheral neurological damage. The investigators hypothesize for example, that a change (compare to healthy subjects) in the perceptual maps and body representation could be detected and characterize in patients suffering from impairments of peripheral nerve conduction.


Eligibility criteria: Inclusion Criteria:

* diagnosis of the investigated neuronal disease

Exclusion Criteria:

* contraindication for MRI scan
* pregnancy
* refusal to participate in the study

Primary outcomes:
measure: assessing hemodynamic responses by measurement of the Blood-oxygen-level dependence(BOLD)signal
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
citation: Arzy S, Overney LS, Landis T, Blanke O. Neural mechanisms of embodiment: asomatognosia due to premotor cortex damage. Arch Neurol. 2006 Jul;63(7):1022-5. doi: 10.1001/archneur.63.7.1022.
Clinical trial NCT04626258: Fluconazol Versus Medical Honey in the Treatment of Recurrent Vulvovaginal Candidiasis
Official title: A Randomized Controlled Trial to Compare the Efficacy of a Medical Grade Honey Formulation (L-Mesitran®) and Fluconazol (Diflucan®) for the Treatment of Recurrent Vulvovaginal Candidiasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Candidiasis, Vulvovaginal
Recurrent Candidiasis of Vagina
Keywords: Treatment
L-Mesitran
Fluconazol
Vaginal swabs
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 252
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: The purpose of this study is to compare the efficacy of Flucanzol versus L-mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. The investigator will look at vaginal swabs after 1, 6 and 12 months. The investigator included 252 patients.


Eligibility criteria: Inclusion Criteria:

* • Women of at least 18 years old

  * Recurrent vulvovaginal candidiasis (At least 3 episodes of clinical symptoms during the last year)
  * Clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation
  * Capacity to understand, consent, and comply with the trial procedures

Exclusion Criteria:

* Mixed vaginal infections

  * Pregnancy or the intention to become pregnant during the study period
  * Women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion
  * Known allergies for Fluconazole or honey
  * Candida with resistance for Fluconazole

Primary outcomes:
measure: Vaginal swab
timeFrame: 1 month
measure: Vaginal swab
timeFrame: 6 months
measure: Vaginal swab
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life will be termined with questionnaires
timeFrame: 1 month
measure: Quality of life will be termined with questionnaires
timeFrame: 6 months
measure: Quality of life will be termined with questionnaires
timeFrame: 9 months
measure: Quality of life will be termined with questionnaires
timeFrame: 12 months
measure: Side effect of medication will be termined with questionnaires
timeFrame: 1 month
measure: Side effect of medication will be termined with questionnaires
timeFrame: 6 months
measure: Side effect of medication will be termined with questionnaires
timeFrame: 9 months
measure: Side effect of medication will be termined with questionnaires
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03018158: MR Images Variation With or Without Denture Wear
Official title: MR Images Variation With or Without Denture Wear. Motion Artifacts Related With Tongue Movements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnetic Resonance Imaging
Lead sponsor: Nihon University
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.

Detailed description: The magnetic resonance imaging (MRI) is useful to diagnose soft tissue morphology, especially to detect cancer and disk displacement with temporomandibular disorders. The prevalence of tongue cancer may increase with ageing population. A clear MR image is indispensable for clinical diagnosis. However, tongue motion associated with the habitual or swallowing tongue movement may cause artifacts on MRI. This occurrence of motion artifact is speculated to be prominent with the patients without the occlusal support. The objective of this pilot study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.

Eligibility criteria: Inclusion Criteria:

* dentulous
* edentulous classified Eichner' s classfication

Exclusion Criteria:

* involuntary motion occurs during imaging
* absolutely contraindicated or as a rule contraindicated of MRI examination
* subjects have ferromagnetic metals in the oral cavity
* subjects can not swallow naturally

Primary outcomes:
measure: Luminance standard deviation value on MR image
timeFrame: MR Imaging was collected with each condition.Through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Matsudo
country: Japan
facility: Nihon University Hospital
state: Chiba
Study officials:
affiliation: Nihon University
name: Yasuhiko Kawai, DDS MSc PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02231658: Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
Official title: Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Profil Institut für Stoffwechselforschung GmbH
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study will compare lixisenatide and liraglutide in a population of subjects with T2DM not optimally controlled on OADs and / or insulin, which is the target population for these medications.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
* Male or female aged 18-65 years (both inclusive)
* T2DM diagnosis

Exclusion Criteria:

* Contraindications (including known or suspected hypersensitivity) to GLP-1 mimetics
* Use of GLP-1 mimetics or DPP-IV inhibitors
* Clinically relevant dysglycaemia as indicated by HbA1C ≥ 10%

Primary outcomes:
measure: Change from baseline (week -1) in the number of reflux episodes
timeFrame: 24 hours after 10 weeks of treatment
Secondary outcomes:
measure: Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus
timeFrame: After 10 weeks of treatment
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: St. Josef-Hospital, Universitätsklinik
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: St. Josef Hospital Bochum
name: Juris Meier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quast DR, Schenker N, Menge BA, Nauck MA, Kapitza C, Meier JJ. Effects of Lixisenatide Versus Liraglutide (Short- and Long-Acting GLP-1 Receptor Agonists) on Esophageal and Gastric Function in Patients With Type 2 Diabetes. Diabetes Care. 2020 Sep;43(9):2137-2145. doi: 10.2337/dc20-0720. Epub 2020 Jul 9.
Clinical trial NCT03798158: Prevalence and Characterization of Persistent Dyspnea After Hospitalization
Official title: Prevalence and Characterization of Persistent Dyspnea After an Hospitalization for a Respiratory Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyspnea
Pulmonary Disease
Lead sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 150
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: Every consecutive patient admitted to hospitalization for a respiratory cause having a significant dyspnea

Brief summary: The investigators aim to make an overview of persistent dyspnea at the end of an hospitalization for a respiratory disease using an actual tool, the Multidisciplinary Dyspnea Profile questionnaire.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* Able to respond the questionnaire
* Presenting at admission a dyspnea over 3/10 on numerical analogic scale
* Admitted for a respiratory cause

Exclusion Criteria:

* cognitive impairment
* aphasia
* no french-speaking person

Primary outcomes:
measure: Prevalence of persistent dyspnea in the end of an hospitalization for a a respiratory disease
timeFrame: An average of one week, until the end of the hospitalization
Secondary outcomes:
measure: Characterization of persistent dyspnea using MDP
timeFrame: An average of one week, until the end of the hospitalization
measure: Outcome of patients with persistent dyspnea after hospitalization
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: ADOREPS
Study officials:
References:
Clinical trial NCT06149858: Ventral Mesh Hernioplasty : Laparoscopic Versus Open Sublay
Official title: Ventral Mesh Hernioplasty : Laparoscopic Versus Open Sublay
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare between laparoscopic ventral hernia repair and open sublay technique (recurrence ,operative time ,bleeding ,rate of complication and injury , seroma, post operative pain)

Detailed description: A hernia usually happens in abdomen or groin, when one of your organs pushes through the muscle or tissue that contains it. Most hernias eventually will need surgical repair.

sublay mesh repair has the lowest recurrence and surgical site infection in open anterior abdominal hernia repair it is a perfect choice for the repair of ventral abdominal hernia the principles included two main steps: (1) mesh placement deep into the recti muscles and (2) mesh extension beyond the hernia defect.

Laparoscopic ventral hernia repair (LVHR) has established itself as a well-accepted option in the treatment of hernias. Clear benefits have been established regarding the superiority of LVHR in terms of fewer wound infections compared with open repairs. Meticulous technique and appropriate patient selection are critical to obtain the reported results.

• In the laparoscopic technique, a prosthetic mesh is inserted through a trocar into the abdominal cavity and fixed against the abdominal wall. After reducing the hernia contents, the hernia sac is left unresected, and most surgeons do not place additional sutures for closing the hernia orifice. A specific risk of laparoscopic hernia repair lies in freeing adhesions between intestine and abdominal wall, which may result in (sometimes unrecognised) bowel perforation . The mesh should overlap the hernia orifice by at least 5 cm and is anchored to the abdominal wall with tacks, transfascial sutures, or a combination of the two methods. In laparoscopic abdominal hernia repair, mesh placement methods are generally classified into intraperitoneal onlay mesh (IPOM), transabdominal abdominal preperitoneal (TAPP)

Eligibility criteria: Inclusion Criteria:

* All cases of midline ventral hernia fit for surgery

Exclusion Criteria:

1. Surgically unfit cases
2. Complicated hernia (obstructed ,irreducible, strangulated)
3. incisional ,massive ,recurrent hernias

Primary outcomes:
measure: recurrence rate
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: hisham ryad
role: STUDY_DIRECTOR
References:
citation: Issa M, Noureldin K, Elgadi A, Abdelaziz A, Badawi M, Makram M. Evaluation of the Sublay Mesh Repair Outcomes in Different Types of Ventral Hernia. Cureus. 2021 Dec 21;13(12):e20590. doi: 10.7759/cureus.20590. eCollection 2021 Dec.
Clinical trial NCT01753258: Outcomes of Delivery in Patients With Dyspareunia
Official title: Outcomes of Delivery in Patients With Dyspareunia- A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspareunia
Pregnancy
Provoked Vestibulodynia
Pelvic Floor Dysfunction
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 173
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nulliparous women admitted to the Labor and Delivery Department at the Hadassah Medical Center, above the age of 18

Brief summary: The focus of this pilot study is to determine if a woman who experiences pain during sexual intercourse has a higher risk of complications during labor and delivery secondary to pelvic floor dysfunction, anxiety and intolerance towards pelvic examinations. Furthermore, it is unclear whether women with prepartum dyspareunia experience an improvement following vaginal delivery. While physicians may expect that vaginal birth improves dyspareunia due to the stretching effect on pelvic floor, to date, there is insufficient evidence to support this claim. The Investigators plan to prospectively study 200 patients at our Institution, collect information regarding birth and follow them, via questionnaires, regarding their dyspareunia postpartum.


Eligibility criteria: Inclusion Criteria:

1. 200 nulliparous women admitted to the Labor and Delivery Department at the Hadassah Medical Center, above the age of 18.
2. Able and willing to read, understand, and sign the Informed Consent Form and questionnaire.
3. Agree to be contacted in the future to complete telephone questionnaires.

Exclusion Criteria:

1. Induction of labor
2. Placental abruption, placenta previa
3. Malpresentation
4. Non reassuring fetal heart rate upon admission
5. Any other contraindication for vaginal delivery
6. Multifetal pregnancy

Primary outcomes:
measure: Obstetrical outcome of women with a history of dyspareunia
timeFrame: 3 months -1 year
Secondary outcomes:
measure: Rate of alleviation of dyspareunia following vaginal delivery as assessed through patient questionnaires.
timeFrame: 2 years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Ahinoam Lev-Sagie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05927558: Salvage Treatment With Glofitamab in R/R B-NHL: a GIMEMA-FIL Study
Official title: Salvage Treatment With Glofitamab in Patients Affected by Relapsed/Refractory Non-Hodgkin B-cell Lymphoma: a GIMEMA-FIL Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: B-cell Non Hodgkin Lymphoma
Relapse
Refractory Lymphoma
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with refractory/relapsed B-cell non-Hodgkin lymphoma treated in Italy according to the Compassionate Use Program between March 2022 and September 2023

Brief summary: The goal of this observational study is to evaluate the anti-lymphoma activity of glofitamab, administered according to the Compassionate Use Program, in relapsed/refractory B-NHL patients. The main question it aims to answer is the rate of patients in complete response.

Detailed description: This is an observational multicenter study aimed at assessing the anti-lymphoma activity of glofitamab in relapsed/refractory B cell non-Hodgikin lymphoma patients treated according to the Compassionate Use Program in Italy between March 2022 and September 2023. Patients will be observed for a minimum of 12 months after the last glofitamab administration.

Eligibility criteria: Inclusion Criteria:

1. Patients who received glofitamab according to Compassionate Use Program AG42296
2. Age \> 18 years
3. Patients who received at least one dose of glofitamab between March 2022 and September 2023 in the context of the compassionate use program and who completed at least 1 year of observation after last glofitamab administration unless the patient died or was lost to follow up
4. Patients who provided their consent according to local regulation to collect their data for study purposes, dead patients or patients lost to follow up for which any attempt has been made to collect their consent, according to local regulation on data privacy

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of patients in complete response
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ematologia Istituto Nazionale Tumori
Study officials:
References: