louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03579186: OKS for Gait Instability
Official title: Optokinetic Stimulation for the Treatment of Gait Abnormalities
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gait, Unsteady
Vestibular Disorder
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients undergoing a clinical gait assessment will be recruited for this study. Those that consent to participate will complete their clinical gait assessment as part of their normal evaluation. Subjects will then complete a gait assessment while wearing experiencing optokinetic stimulation. The investigators will compare baseline gait and postural control before and during OKS stimulation.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Specific aim: To determine whether optokinetic stimulation can improve gait abnormalities.

Hypothesis: Optokinetic stimulation stimulates the vestibular system and can improve vestibular induced gait disorders.

Detailed description: This is a pilot study designed to determine whether or not the optokinetic stimulation improves gait in patients with gait abnormalities, specifically vestibular induced gait disorders. The study population will consist of patients already receiving a gait assessment through the Brain Fit Club (BFC) at Beth Israel Deaconess Medical Center. This gait assessment involves walking and posture evaluations. Patients will complete a gait assessment as part of their normal BFC evaluation. Those who consent to participate in the study will then complete a gait assessment while receiving optokinetic stimulation. The investigators will compare baseline gait and postural control before and during OKS stimulation.

Eligibility criteria: Inclusion criteria:

* Receiving a gait assessment through the BFC
* Ages 21-75

Exclusion criteria:

* Left hemiparesis
* Requires a cane or walker
* Documented evidence of falls or instability to the left
* Reduced vision
* Moderate or severe dementia

Primary outcomes:
measure: Gait - (measured using a wireless 3D accelerometer)
timeFrame: After 5 minutes of OKS
measure: Posture - (measured using a stationary force platform)
timeFrame: After 5 minutes of OKS
Secondary outcomes:
measure: Speed
timeFrame: After 5 minutes of OKS
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT01230086: Trop-Shock DFT-testing Versus None
Official title: hs Troponin Release in Relation to Different ICD-Implantation Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Defibrillation Testing - ICD Therapy Optimisation
Keywords: ICD
DFT-testing
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2010-10-28
Enrollment: 195
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Implantation of a cardioverter defibrillator (ICD) is the treatment of choice for primary and secondary prevention of sudden cardiac death. Traditionally, intraoperative testing for sensing and defibrillation capabilities of the ICD system is performed. Modern implantation strategies suggest a non-testing approach because net-benefit of a testing versus a non-testing strategy is questionable and because arrhythmia induction and defibrillation may cause micro damage to the heart.

The study aims to investigate the contribution of different steps in the ICD implantation procedure (implantation of the lead, shock delivery and induced ventricular fibrillation) with respect to their potential damage to the heart measured by high sensitivity (HS) TroponinT.


Eligibility criteria: Inclusion Criteria:

* ICD-Implantation in patients with coronary artery disease or dilative cardiomyopathy

Exclusion Criteria:

* Atrial fibrillation with inappropriate anticoagulation

Primary outcomes:
measure: Influence of different ICD-implantation strategies on release of high sensitivity Troponin
timeFrame: 6 hours
Secondary outcomes:
measure: Influence of different ICD-implantation strategies on BNP release
timeFrame: 6 hours
Other outcomes:
Locations:
city: München
country: Germany
facility: Technische Universität München
state: Bavaria
Study officials:
References:
citation: Semmler V, Biermann J, Haller B, Jilek C, Sarafoff N, Lennerz C, Vrazic H, Zrenner B, Asbach S, Kolb C. ICD Shock, Not Ventricular Fibrillation, Causes Elevation of High Sensitive Troponin T after Defibrillation Threshold Testing--The Prospective, Randomized, Multicentre TropShock-Trial. PLoS One. 2015 Jul 24;10(7):e0131570. doi: 10.1371/journal.pone.0131570. eCollection 2015.
Clinical trial NCT02389686: Intra-operative Radiotherapy For Breast Cancer Women After NSM
Official title: Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer After Nipple-sparing Mastectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Keywords: Ductal carcinoma in situ （DCIS）
Nipple-sparing mastectomy (NSM)
Intraoperative radiotherapy (IORT)
INTRABEAM
Lead sponsor: Guangdong Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 110
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to assess the value of the INTRABEAM system for breast cancer.

Detailed description: Despite the advancement and increasing use of nipple-sparing mastectomy (NSM) is still carried out in a portion of breast cancer patients. However, the role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC). Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to broaden the application of the INTRABEAM system for breast cancer, investigating the feasibility of INTRABEAM IORT in NSM with breast reconstruction.

Eligibility criteria: Inclusion Criteria:

* Tumor diameter ≤3 cm
* Tumor from the papilla\>2cm
* Low grade ductal carcinoma in situ
* Candidate for breast-conserving surgery
* Must have undergone lumpectomy with negative margins or minimal margin involvement
* Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection
* No evidence of metastatic disease
* Informed consent

Exclusion Criteria:

* No informed consent
* Tumor size \> 3 cm
* Tumor from the papilla≤2cm
* Intermediate or high grade ductal carcinoma in situ
* Invasive carcinoma
* No indication for a boost

Primary outcomes:
measure: Ipsilateral breast tumor recurrence rate after surgery within five years
timeFrame: Within 5 years after surgery
Secondary outcomes:
measure: Disease free survival after surgery within five years
timeFrame: Within 5 years after surgery
measure: Overall survival after surgery within ten years
timeFrame: Within ten years after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Academy of Medical Sciences
state: Guangdong
Study officials:
affiliation: Guangdong Academy of Medical Sciences
name: Liao Ning, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04181086: Pattern and Management of Intracranial Cavernoma
Official title: Pattern and Management of Intracranial Cavernoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Management of Intracranial Cavernous Hemangioma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: all patients with confirmed diagnosis of intracranial cavernoma with MRI and will undergo surgery

Brief summary: Intracranial cavernous vascular malformations are variously known as cavernous angiomas, cavernous hemangiomas, or, more simply, cavernomas. Cavernomas are congenital low flow vascular lesions. It composed of irregular sinusoidal vascular channels, lacking smooth muscle, and elastic fibers. They lack feeding arteries or draining veins and contain no neural tissue. The first description of an intracranial cavernoma was given by Virchow, in 1863. For over a century, it was considered to be an extremely rare malformation, usually found at autopsy, and exceptionally diagnosed during life. The prevalence of cerebral cavernous malformations (CCM) is estimated to be 0.4-0.9%.


Eligibility criteria: Inclusion Criteria:

* All patients presented with intracranial cavernomas (single or multiple, superficial or deep, supratentorial or infratentorial)
* Denovo or recurrent patients.

Exclusion Criteria:

* None

Primary outcomes:
measure: clinical outcome
timeFrame: one month post operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00979186: A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance
Official title: A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cholecystectomy
Keywords: transgastric cholecystectomy
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2009-09-17
Enrollment: 0
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 study will document being able to successfully perform transgastric cholecystectomy (laparoscopic visualization) using a small collection of study surgical tools.


Eligibility criteria: Inclusion Criteria:

Men and women will be enrolled in this study who:

* Are willing to give consent and comply with evaluation and treatment schedule, able to understand and complete study questionnaires;
* At least 18 years of age;
* Have a clinical diagnosis of gallbladder disease indicated for cholecystectomy;
* ASA Classification I or II (Appendix II); and
* Have a negative serum pregnancy test (for women of childbearing potential);
* Have the study procedure attempted.

Exclusion Criteria:

* BMI \> 35;
* Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);
* Suspicion of gallbladder cancer, tumor, polyps, or mass;
* Acute cholecystitis or acute pancreatitis;
* Presence of common bile duct stones;
* History of open abdominal surgery;
* Evidence of abdominal abscess or mass;
* Diffuse peritonitis;
* Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy;
* Clinical diagnosis of sepsis;
* History of peritoneal trauma;
* Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial;
* Planned concurrent surgical procedure;
* Prior or planned major surgical procedure within 30 days before or after study procedure;
* Previous diagnosis of intra-abdominal adhesions;
* Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
* Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox; or
* Any condition which precludes compliance with the study (Investigator discretion).

Primary outcomes:
measure: Proportion of procedures completed
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Department of Surgery, UCSD
state: California
Study officials:
References:
Clinical trial NCT04006886: Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC)
Official title: Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) - a Pilot-Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduction of Intestinal Inflammatory Activity
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel
name: Johannes Gutenberg University Mainz
First posted: 2019-07-05
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Gluten is a protein found in wheat and other cereals as barley and rye. It triggers an inflammatory reaction in the small-bowel of genetically predisposed persons. Alpha-amylase/trypsin inhibitors (ATIs) of wheat seem to be the responsible trigger of this intestinal Inflammation.

Intestinal inflammation is connected to other extra-intestinal autoimmune inflammations like PSC (as f.ex. the association of PSC with inflammatory bowel disease proves).

Hypothesis: Avoidance of ATIs through a gluten-free diet will reduce intestinal inflammation and thus also the the inflammatory activity in the liver.

Proof of hypothesis:

* Pilot study with n=20 patients with PSC
* Explorative, open-label, mono-centric study
* Inclusion criteria: age 18-65, diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.


Eligibility criteria: Inclusion Criteria:

* diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.

Exclusion Criteria:

* patients with coeliac disease or wheat allergy
* patients with active colitis
* patients already on gluten-free diet
* liver transplanted patients
* patients also diagnosed with autoimmune hepatites (PSC-AIH overlap)
* coloscopy within 2 months before study
* Endoscopic retrograde cholangiopancreatography (ERCP) within 3 months before study
* antibiotics within 3 month before study

Primary outcomes:
measure: Reduction of intestinal inflammatory activity
timeFrame: 2 months
Secondary outcomes:
measure: Inflammatory activity of the liver
timeFrame: 2 months
measure: Reduction of inflammatory cells/markers in the blood
timeFrame: 2 months
measure: Quality of life
timeFrame: 2 months
measure: Change of symptoms with change of diet.
timeFrame: 2 months
measure: Changes in patients microbiota
timeFrame: 2 months (5 months with follow-up)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References:
Clinical trial NCT06929286: A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)
Official title: COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-Muscle Invasive Bladder Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 125
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of different FDA-approved/NCCN-recommended drug treatments for NMIBC. In particular, the FDA-approved drug nadofaragene firadenovec will be compared to usual care with other NCCN-recommended standard treatments for NMIBC (gemcitabine with or without docetaxel, mitomycin, re-treatment with BCG, or pembrolizumab).


Eligibility criteria: Inclusion Criteria:

* 21 years of age or older
* Being treated for high-grade NMIBC (Tis, Ta, or T1) with one of the participating treating urologists at MSK
* One or more prior induction course of BCG at any point in time and judgment by the treating urologist that BCG has failed

  °Any amount of maintenance BCG is allowed
* In the previous 12 months, receipt of at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment

  °An intravesical agent can include BCG or any other NMIBC treatment
* In the opinion of the treating urologist, there is no contraindication to treatment with nadofaragene firadenovec (i.e. hypersensitivity to IFNa, severe immunosuppression) and there is uncertainty over whether nadofaragene is better than "best usual care"

Exclusion Criteria:

* Opting for treatment with radical cystectomy
* Currently enrolled in a clinical trial of an experimental therapy for NMIBC
* Prior exposure to nadofaragene firadenovec

Primary outcomes:
measure: high-grade recurrence-free survival
timeFrame: up to 24 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: up to 24 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Eugene Pietzak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03567486: Predictive Factors of Visual Recovery After Paraoptic Tumors Removal
Official title: Paraoptic Tumors : Study of the Radiological, Ophthalmological and Intraoperative Predictive Factors of Visual Recovery After Neurosurgical Removal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculum Sellae Meningioma
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2018-06-25
Enrollment: 99
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: tuberculum sellae meningioma

Brief summary: Paraoptic tumors - including mostly sellar meningiomas, pituitary gland adenomas and craniopharyngiomas - classically affect the visual function. Some preoperative factors, determined on retrospective studies, are known to constitute bad prognostic factors, such as duration of symptoms and retinal nerve fiber layer thinning on OCT. We propose to perform a single center prospective study in which detailed preoperative ophthalmological and radiological criteria will be collected before surgery. Intraoperative information will be noted as well. All these data will be statistically examined regarding the postoperative visual recovery at 3, 6 and 12 months


Eligibility criteria: Inclusion Criteria:

* tuberculum sellae meningioma surgical indication

Exclusion Criteria:

* surgical contra indication MRI contra indication optical disease

Primary outcomes:
measure: variation of Visual field
timeFrame: between before surgery and 6 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT04413786: Oxytocin's Effects on Face Attentional Processing
Official title: The Modulatory Effect of Oxytocin on Attentional Processing of Emotional Faces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: oxytocin
emotional faces
attention
N2pc
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate whether intranasal oxytocin (24IU) treatment has a regulatory effect on attentional processing of emotional faces.

Detailed description: In a placebo-controlled double-blind between-subject design experiment, investigators plan to investigate the effect of oxytocin treatment on attentional processing of emotional faces. Subjects complete questionnaires in Chinese versions before treatment administration, including the Beck Depression Inventory, Autism Spectrum Quotient , Trait Anxiety Inventory, Toronto Alexithymia Scale, Multidimentional Assessment of Interoceptive Awareness. This experiment consists of two tasks including Emotional Face Cue-target Task and Visual Search Task. In the first task, subjects need to make a response to judge the position of target after a cue-target is presented. In the second task, subjects are asked to search the target "U" or inverted "U" placed on the nose of emotional/neutral faces and make an choices based on their oorientation. During these phases, subjects' response accuracy, response time and electrophysiological activity (ERP) are recorded.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders.

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness

Primary outcomes:
measure: Response time in reponse to different emotional face targets.
timeFrame: 1 hour
measure: N2pc
timeFrame: 1 hour
Secondary outcomes:
measure: Response accuracy in response to different emotional face targets.
timeFrame: 1 hour
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of life science and technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology
name: Shuxia Yao, Doctor
role: STUDY_DIRECTOR
References: