louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05844696: Electrical Neuromodulation for Focal Epilepsy
Official title: Electrical Neuromodulation for Focal Epilepsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Epilepsy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to use electrical neuromodulation on patients with focal epilepsy. The main objective is to assess safety and observe potential therapeutic effects.


Eligibility criteria: Inclusion Criteria:

Part 1

* Age ≥ 20 years old.
* Focal epilepsy patients having received EEG and brain imaging studies and on standard medication.

Part 2

* Age ≥ 20 years old.
* Focal epilepsy patients having received EEG and brain imaging studies and on standard medication for at least 1 year.
* Having received part I intervention.

Exclusion Criteria:

Part 1

* Patients with secondary and progressive macrostructural abnormalities in the brain, such as brain tumors or infectious lesions. This does not include abnormalities directly related to epilepsy, such as mesial temporal sclerosis or focal dysplasia.
* Patients who are unable to undergo brain electrical stimulation, including those with metal in the brain or implanted stimulators/implants.
* Patients with allergies to the sponge material used for stimulation.
* Patients with wounds or infections at the site of sponge application.
* Patients with intellectual disabilities, manic episodes (with a score of greater than 12 on the Young Mania Rating Scale), major physiological illnesses (such as stroke, brain tumors, or heart attacks), or pregnant or breastfeeding women.
* Patients judged by the physician to be unsuitable for the clinical trial due to unstable vital signs or serious internal or external medical conditions.

Part 2

* Patients with secondary and progressive macrostructural abnormalities in the brain, such as brain tumors or infectious lesions. This does not include abnormalities directly related to epilepsy, such as mesial temporal sclerosis or focal dysplasia.
* Patients who could be considered for single focus resection based on the neurologist/neurosurgeon's judgment. However, patients who clearly refuse resection surgery are not subject to this limitation.
* Patients who experience serious adverse events (SAEs) during the part 1 trial.
* Patients who are unable to undergo magnetic resonance imaging (MRI).
* Patients who are planned to receive hyperthermia therapy or transcranial magnetic stimulation.
* Patients judged by the physician to be unsuitable for the clinical trial due to unstable vital signs or serious internal or external medical conditions.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 3 months
Secondary outcomes:
measure: The seizure frequency per month
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06194396: Effect of Chlorhexidine Versus Alcohol on Infections in Neonates
Official title: Effect of Chlorhexidine 2% Versus Alcohol on Healthcare Associated Infections in Neonates: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Infection
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 100
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups 50 neonates / group
Primary purpose: PREVENTION

Brief summary: Chlorhexidine is a local antiseptic that has an important role in the prevention of catheter-associated bloodstream infections. Its application to a newborn's umbilical cord reduces all-cause neonatal mortality.

Detailed description: Skin disinfection by an appropriate antiseptic agent is essential to prevent healthcare-associated infection. Common pathogens responsible for sepsis have been detected in skin microbiota of hospitalized neonates. Such skin inhabitants can cause sepsis and also lead to blood culture contamination resulting in unnecessary antibiotic use. Strict asepsis bundles have been shown to reduce catheter-related blood stream infection (CRBSI) and contamination rates. The choice of appropriate skin disinfectant is, however, based on low-quality evidence, even in adults.

Chlorhexidine gluconate (CHG) is a broad-spectrum antiseptic which is effective against a host of neonatal pathogens. CHG-based products are used frequently in the healthcare setting for peripheral and central venous catheter (CVC) site skin preparation, daily bathing of intensive care unit patients, full-body newborn skin cleansing, umbilical cord care, and Staphylococcus aureus decolonization.

In neonates, CHG used as antiseptic for CVC insertion site preparation and maintenance decreases CVC tip microbial colonization. Trials of full-body skin cleansing and umbilical cord care with CHG in the developing world, which included infants less than 34 weeks gestational age, have demonstrated reduced risk of neonatal mortality. Despite proven efficacy of CHG in neonates, current guidelines acknowledge that no recommendations with regards to CHG antisepsis can be made for infants less than 2 months of age due to incomplete safety data in this population.

Eligibility criteria: Inclusion Criteria:

* Neonates with gestational age 28 weeks or more.
* Neonates needing the insertion of a peripherally inserted central catheter (PICC line) or CVC or umbilical catheter.

Exclusion Criteria:

* Extremely preterm (GA less than 28 weeks).
* Babies who have an allergy to chlorhexidine 2%.

Primary outcomes:
measure: reduction in health care acquired neonatal infection
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
affiliation: Ain Shams University
name: Rania El Farrash
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01831596: Evaluation of a Novel Post-Surgical Dressing
Official title: Evaluation of a Novel Post-Surgical Dressing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post Surgical Wound
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2013-04-15
Enrollment: 59
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 this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device.


Eligibility criteria: Inclusion Criteria:

* Surgically closed incision.
* Subject is 18 years of age or older.
* Subject consents to follow-up per protocol.
* Willing and able to sign informed consent.

Exclusion Criteria:

* Subject is allergic to wound care products used in this study.
* Subject has wounds with exposed blood vessels not suitable for negative pressure therapy.
* Pregnant or pregnancy-suspected subject.
* Subject actively participating in other clinical trials that conflict with the current study.
* Subject is unable or unwilling to comply with protocol requirements.

Primary outcomes:
measure: Frequency of Complaints About Device Use and Operation
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
Study officials:
References:
Clinical trial NCT01724996: Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups
Official title: Usefulness of Chest Wall Tenderness as Bedside Test to Exclude Acute Coronary Syndrome in Different Demographic Groups
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patiens seaking the Emergency room of the University Hospital Zurich because of chest pain

Brief summary: To determine the significance of a simple bedside clinical test (chest wall tenderness) to exclude myocardial ischemia in different demographic groups.

Detailed description: When a patient is presenting with acute chest pain at the ER of the University Hospital of Zurich, the study physician in charge, who is acting simultaneously as one of four attending clinical physicians, is performing the physical examination according to routine clinical practice. The physical examination includes the testing of chest wall tenderness: Palpation of chest wall tenderness in lying 30° elevation of chest position. Flat index with standardized pressure where spontaneous maximum pain is reported (reproducible vs. not reproducible pain vs. no pain). Negative control (right side of chest mid-clavicle intercostal 6/7), reproducible vs. not reproducible pain vs. no pain. The same physician, who is blinded for the final diagnosis at the time of the physical examination, is also recording the patient history including the study interview using the standardized study questionnaire.

Eligibility criteria: Inclusion criteria: All patients over the age of 18 years presenting with the leading symptom of first time or recurrent acute chest pain in the emergency room of the Department of Internal Medicine, University Hospital of Zurich.

Exclusion criteria:

* Missing informed consent.
* Cardiopulmonary unstable patients.
* No self reported chest pain.
* Recent thoracic surgery within1 year, inflammatory joint disease, fibromyalgia, cardiogenic shock.

Primary outcomes:
measure: Chest wall tenderness
timeFrame: From first presententation to omission (6-12 hours)
Secondary outcomes:
measure: Pain description
timeFrame: 6-12 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Internal Medicine
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Internal Medicine
name: Daniel Franzen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grani C, Senn O, Bischof M, Cippa PE, Hauffe T, Zimmerli L, Battegay E, Franzen D. Diagnostic performance of reproducible chest wall tenderness to rule out acute coronary syndrome in acute chest pain: a prospective diagnostic study. BMJ Open. 2015 Jan 28;5(1):e007442. doi: 10.1136/bmjopen-2014-007442.
Clinical trial NCT01860196: Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy
Official title: A Placebo Controlled, Cross-over, Double Blind, Randomized, Clinical Trial to Compare the Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adult Cerebral Palsy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the efficacy and safety of Meditoxin® injection for cervical dystonia in adults with cerebral palsy. It is a placebo controlled, Cross-over, Double blind, Randomized, Clinical trial.


Eligibility criteria: Inclusion Criteria:

* Adult cerebral palsy patients over 20 years old
* Clinically diagnosed for cervical dystonia more than a year ago
* No improvement with antispasmodics for the last month
* Actively participated and gave informed consent

Exclusion Criteria:

* Allergic to the botulinum toxin
* Limited range of motion in cervical spine
* Patients with fever, infection, cancer, uncontrollable seizure
* Generalized neuromuscular junction disease patients
* Pregnant or breast feeding women, or anticipating pregnancy until 12 weeks after the study stopped
* Patients enrolled in other studies
* History of dose change in 4 weeks: antispasmodics, benzodiazepine, anticholinergics
* Botulinum toxin injection history in 6 months
* Previous history of intrathecal baclofen, selective peripheral denervation, deep brain stimulation
* Otherwise clinically non-eligible patients

Primary outcomes:
measure: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
timeFrame: 0, 16, 32 weeks
Secondary outcomes:
measure: Pain in numerical rating scale (NRS)
timeFrame: Every 4 weeks, up to 32 weeks
measure: Japanese Orthopaedic Association (JOA) score
timeFrame: Every 4 weeks, up to 32 weeks
measure: Goal attainment scale
timeFrame: 4, 12, 20, 28 weeks
Other outcomes:
measure: Adverse effect
timeFrame: Every 4 weeks, up to 32 weeks
measure: computed tomography (CT)
timeFrame: 0, 32 weeks
measure: videofluoroscopic swallowing study (VFSS)
timeFrame: 0, 12, 28 weeks
measure: Blood/Urine laboratory tests
timeFrame: 0, 16, 32 weeks
Locations:
Study officials:
References:
Clinical trial NCT02857296: Evaluative Research in the Process of Implementation of an Alternative Device to Hospitalization for People Homeless With Severe Psychiatric Disorders
Official title: Evaluative Research in the Process of Implementation of an Alternative Device to Hospitalization for People Homeless With Severe Psychiatric Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Psychiatric Disorders
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults without home, with severe psychiatric disorders;

Brief summary: The research project aims to analyze the implementation of a new health care system - "alternative device to hospitalization and crisis home for people without home" - whose objective is to provide the homeless and suffering from severe psychiatric disorders adequate care to prevent situations from seeking care or complication of their disease. This device, if it has the administrative and legal structure of the Twin Stop Health Care (LHSS), is based on the original concept of "Soteria House." This will build tools for evaluating the performance of care device by a process evaluation describing and analyzing what activity involves the device, This research seeks to analyze the experimental device in the early stages of its implementation. The observation and analysis of the program period will adjust the management arrangements of the device. The data and conclusions from this research will identify the contributions and benefits of such a device and analyze the difficulties encountered in its implementation.


Eligibility criteria: Inclusion Criteria:

Adults without home with severe psychiatric disorders utilizing the structure, adults who master the French language

Exclusion Criteria:

adults not mastered the French language

Primary outcomes:
measure: socio-anthropological survey
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT00205296: Fitness Training in Children
Official title: Effect of Fitness Training on Insulin Sensitivity and Body Composition in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Low Fitness
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 300
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesize that improvement in cardiovascular fitness is associated with a greater improvement in insulin sensitivity than improvement in body composition (loss of body fat) is associated with insulin sensitivity. Towards that we are randomizing children who are overweight, or children with low fitness levels to exercise intervention 2 or three times per week.


Eligibility criteria: Inclusion Criteria:

* obesity
* low fitness

Exclusion Criteria:

* diagnosis of diabetes
* inability to exercise

Primary outcomes:
measure: maximal VO2 levels
timeFrame: 9 months
Secondary outcomes:
measure: fasting insulin and glucose levels
timeFrame: 9 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Aaron Carrel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01788696: Pilot Study To Assess Effect of Treatment and Adherence in PD Subjects
Official title: Assessment of the Effect of Treatment Pathways, Adherence, and Treatment Efficacy in Parkinson's Disease Subjects Randomized to SPECT Imaging of the Dopamine Transporter (Ioflupane I123 Injection)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: Parkinsonism
Idiopathic Parkinson Disease
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2013-02-11
Enrollment: 20
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: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the impact of imaging the brain as a diagnostic tool in the management of early Parkinson's disease (PD).

Detailed description: The imaging drug used in this study is Ioflupane (123I) Injection, also referred to as DaTscan. DaTscan is FDA approved.

Eligibility criteria: Inclusion Criteria:

* age 18-80;
* diagnosis of idiopathic PD exhibiting at least 2 of 3 cardinal signs (bradykinesia, rigidity and resting tremor);
* maximum duration of previous exposure to anti-parkinsonian therapy being \< 8 weeks;
* ability to signed informed consent;
* willingness and ability to complete medication diary and questionnaires;
* if a female subject of child-bearing potential, the use of an effective method of contraception.

Exclusion Criteria:

* current treatment with anti-parkinsonian medication;
* previous treatment with anti-parkinsonian medication for greater than 8 weeks;
* inability to complete questionnaires;
* unwillingness to complete all questionnaires and medication diary;
* subjects with secondary causes of parkinsonism;
* participant has evidence of clinical significant thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder;
* positive serum/urine pregnancy test at any time during the study period;
* the participant has a history of alcohol, narcotic, or any other drug abuse as defined by the DSM-IV within the past 2 years;
* participation in a concurrent PD trial within 60 days.

Primary outcomes:
measure: Patient adherence to treatment plan
timeFrame: 1 year
Secondary outcomes:
measure: Unified Parkinson Disease Rating Scale (UPDRS)
timeFrame: 1 year
measure: Life Orientation Test - Revised (LOT-R)
timeFrame: 1 year
measure: Marlowe - Crowne Social Desirability Scale (MCSD)
timeFrame: 1 year
measure: Obsessive - Compulsive Inventory (OCI)
timeFrame: 1 year
measure: Expectation of Global Response (EGCR)
timeFrame: 1 year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health Center
state: North Carolina
Study officials:
affiliation: Duke University Health Center
name: Patrick Hickey, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04466696: Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients
Official title: Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: T4 Colorectal Cancer
ERAS
Colon Cancer
Fast Track Protocol
Keywords: colon cancer
ERAS
fast track
t4 colorectal cancer
colorectal cancer
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a clinical diagnosis of stage T4 colorectal cancer who underwent surgical resection between January 2016 to January 2020 at Minimally Invasive Surgery Unit of Tor Vergata University Hospital were prospectively enrolled in the ERAS group and treated with fast track protocol. Postoperative short outcomes were compared to a control group treated with conventional care that underwent surgical resection for T4 colorectal cancer at the same center from January 2010 to December 2015. Data of the control group were collected retrospectively from a prospectively mantained database.

Brief summary: Patients diagnosed with T4 colorectal cancer represent a specific subgroup of colorectal patients, frequently composed of fragile patients whose advanced nature of the disease often requires a multi organ resection by an open surgery approach and frequently leads to higher intra/postoperative complication.Those characteristics makes them to be considered less suitable for ERAS protocol, especially regarding an expected difficult compliance to postoperative items.

The impact of enhanced recovery program on postoperative outcomes in this subset of patients has never been addressed in literature, in fact most of studies either excluded T4 patients due to higher rates of complication or adopted an homogeneous patient sampling analizing all stage colorectal cancer together.

Our aim is to investigate the feasibility of ERAS protocol in T4 colorectal patient, primary outcome was to compare postoperative lenght of stay between T4 colorectal patients treated with ERAS protcol and those treated with standard of care.


Eligibility criteria: Inclusion Criteria:

* colorectal cacer
* hystologic diagnosis of adenocarcinoma of the colon/rectum
* clinically staged T4
* written informed consent to surgery obtained

Exclusion Criteria:

* pregnancy
* failure to perform colonic or rectal resection
* synchronous cancer at time of colorectal cancer diagnosis

Primary outcomes:
measure: Postoperative length of stay
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: