louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06207786: Nasal Iodine Swab Versus Oral Antibiotic to Prevent Surgical Site Infection After Undergoing Mohs Micrographic Surgery
Official title: Efficacy of Intranasal Povidone Iodine Swab Versus Oral Antibiotic Prophylaxis to Prevent Surgical Site Infections in Patients Undergoing Mohs Micrographic Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Skin Cancer
Skin Cancer Face
Malignant Cutaneous Adnexal Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized, open-label, single site clinical trial will be comprised of 2 comparison groups. Treatment arm 1 will be patients undergoing MMS for malignant cutaneous neoplasms receiving nasal povidone-iodine swabs prior to skin reconstruction. Treatment arm 2 will be patients undergoing MMS for malignant cutaneous neoplasms randomized to receive standard of care.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare surgical site infection rates for patients treated with Mohs micrographic surgery after bilateral nasal swab with povidone iodine versus standard treatment including the use of a standardized oral antibiotic prophylaxis protocol.


Eligibility criteria: Inclusion Criteria:

* Non-pregnant, non-lactating/breastfeeding, non-incarcerated, English-speaking persons undergoing Mohs micrographic surgery (MMS) for malignant cutaneous neoplasms and receiving same-day defect repair by the MMS-performing surgeon
* Able to provide written informed consent prior to initiation of any study-specific procedures
* Able to swallow, retain, and absorb oral medications
* All malignant cutaneous neoplasms will be included

Exclusion Criteria:

* On antibiotic treatment or established intolerance or contraindication to povidone-iodine
* Allergy to specific oral antibiotics that are utilized as part of the Mayo Clinic Antibiotic Prophylaxis protocol (cefalexin, azithromycin, clindamycin)
* Requiring oral antibiotic therapy for prophylaxis postoperative infectious endocarditis or hematogenous total joint infection
* Cases where skin reconstruction is performed with non-sterile gloves
* Patients with lesions on the legs, as dilute vinegar soaks are standard practice and this would be a confounder for preventing surgical site infection
* Patients at increased risk for severe infections, including patients on immunosuppressive medications and biologics, patients with a history of HIV infection, chronic lymphocytic leukemia, immunodeficiency syndromes, as well as patients with insulin-dependent diabetes mellitus

Primary outcomes:
measure: Effectiveness of nasal decolonization with povidone-iodine versus a standardized oral antibiotic prophylaxis protocol to prevent surgical site infection (SSI)
timeFrame: 30 days after MMS
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic in Rochester
name: Nahid Y. Vidal, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02480686: Neutrino Regimen for Treatment-experienced HCV GT1 Patients
Official title: Efficacy and Safety of Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C Infection
Lead sponsor: Humanity and Health Research Centre
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
First posted: 2015-06-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV genotype 1b treatment-experienced patients.


Eligibility criteria: Inclusion Criteria:

1. Age equal to or greater than 18 years, with chronic genotype 1b infection;
2. HCV RNA equal to or greater than 10,000 IU/mL at Screening;
3. Cirrhosis determination;
4. Subjects who are treatment-experienced;
5. Screening laboratory values within defined thresholds;
6. Use of highly effective contraception methods if female of childbearing potential or sexually active male.

Exclusion Criteria:

1. HIV or chronic hepatitis B virus (HBV) infection;
2. Contraindications for PEG or RBV therapy;
3. Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
4. Active or recent history (≤ 1 year) of drug or alcohol abuse;
5. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers);
6. Chronic use of systemic immunosuppressive agents;
7. History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

Primary outcomes:
measure: Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
timeFrame: Post treatment Week 12
measure: Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
timeFrame: Baseline up to Week 24
Secondary outcomes:
measure: Change in HCV RNA From Baseline to Week 12
timeFrame: Baseline up to Week 24
measure: Proportion of participants with on-treatment virologic breakthrough and relapse
timeFrame: Baseline up to Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
state: Beijing
city: Hong Kong
country: China
facility: Humanity and Health GI and Liver Centre
state: Hong Kong
Study officials:
affiliation: Humanity and Health GI and Liver Centre
name: George Lau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 302 Hospital
name: Guofeng Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05876286: Sleep and Memory Consolidation in Adults With Attention Deficit Hyperactivity.
Official title: Sleep and Memory Consolidation in Adults With Attention Deficit Hyperactivity.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Sleep
Memory
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Attention Deficit Disorder With Hyperactivity is associated with deficits in cognition and sleep. In healthy adults, memory consolidation processes are related to sleep spindle activity in the sleep electroencephalogram. This association is poorly characterized in adults with attention deficit hyperactivity. In this study, the purpose is to characterize sleep microarchitecture disorders through the analysis of different stage of sleep EEG activity during a polysomnographic examination in adult with mixed Attention Deficit Disorder With Hyperactivity presentation compared to healthy.


Eligibility criteria: Inclusion Criteria for all participants:

* Age from 18 to 45 years old
* Affiliated to the French health care system

Inclusion Criteria for attention deficit hyperactivity disorder patients:

* meeting Diagnostic and Statistical Manual (DSM)-5 criteria for mixed attention deficit hyperactivity disorder presentation without drug treatment for attention deficit hyperactivity disorder.

Exclusion Criteria for all participant:

* People not able to give consent, neurological disease (other than neurodevelopmental disorders; or any other serious disease (cancer, addiction, systemic disease)), untreated sleep apnea, major depression (Beck inventory \> 15), untreated restless leg syndrome; pregnancy in progress or wish to become pregnant during the study or breastfeeding woman, drug treatment including benzodiazepine, neuroleptic or antidepressant before inclusion.

Exclusion Criteria for healthy volunteers:

* Subjective cognitive and/or sleep complaint.

Primary outcomes:
measure: Difference in signal power (db or μV 2) in the sigma frequency bands in N2 sleep
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Toulouse
name: Mélanie PLANTON, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05842486: Hematological Response in Patients With Paroxysmal Nocturnal Hemoglobinuria Treated With Anti-C5 Antibody: an External Control Arm Study for Iptacopan Use in Anti-C5 naïve Patients
Official title: Hematological Response in Patients With Paroxysmal Nocturnal Hemoglobinuria Treated With Anti-C5 Antibody: an External Control Arm Study for Iptacopan Use in Anti-C5 naïve Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Leeds Cancer Centre at St. James's University Hospital
First posted: 2023-05-06
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The real-world cohort consists of patients with diagnosis of paroxysmal nocturnal hemoglobinuria and anemia initiating anti-C5 therapy. Patient data originate from the Hôpital Saint-Louis, France and St. James's University Hospital, Leeds, United Kingdom.

Brief summary: The aim of this non-interventional secondary use of data study is to evaluate hematological response in patients with paroxysmal nocturnal hemoglobinuria and anemia in the 6-month period after initiation of anti-C5 antibody treatment using real-world data obtained from multiple datasets. The results will be used to contextualize results from the APPOINT-PNH (NCT04820530) trial with iptacopan.


Eligibility criteria: Inclusion Criteria:

1. Incident users of anti-C5 antibody treatment (i.e., first use of anti-C5 antibody with no evidence of use prior to that)
2. Confirmed clinical diagnosis of PNH (including PNH clone size \>10% in RBC percent/white blood cell (WBC) percent)
3. Adult patients ≥18 years of age
4. Baseline Hb \<10 g/dL.

Exclusion Criteria:

Patients who met any of the following criteria were not eligible for inclusion.

1. Bone marrow transplantation within one year prior to initiating anti-C5 treatment
2. Hereditary complement deficiency
3. Reticulocyte count \<60x10\^9/L.
4. Pregnancy

Primary outcomes:
measure: Increase from baseline in hemoglobin
timeFrame: between Day 100 and Day 200
Secondary outcomes:
measure: Hemoglobin Response
timeFrame: between Day 100 and Day 200
measure: Transfusion avoidance
timeFrame: Occurrence between Day 15 and Day 200
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP Hôpital Saint Louis
Study officials:
References:
Clinical trial NCT01675986: Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Feeling Anxious
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The insertion of long-lasting intravenous device is done under local anesthesia. Currently, in the investigators hospital, no premedication is given to the patients. However, this procedure occurs in a particular emotional context related to the diagnosis of cancer or malign hemopathies.

Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure can be questionable.

Hydroxyzine is the reference molecule for premedication because of its anxiolytic and anti-histaminic properties A new agent, pregabalin, shares also the same properties

The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on the anxiety score as a premedication during the insertion of long-lasting intravenous device under local anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients aged from 18 to 75 years
* Patient schedules for insertion of long-lasting intravenous device

Exclusion Criteria:

* History of previous insertion of long-lasting intravenous device or central intravenous catheter
* long term treatment of gabapentin or pregabalin
* Hypersensitivity to pregabalin or any of the excipients
* Hypersensitivity to hydroxyzine, one of its metabolites, one of the excipients, another derivative of piperazine, aminophylline or ethylene diamine.
* Patient at risk of glaucoma e
* Patient at risk for urinary retention
* Patient severe respiratory failure
* Patient at the general condition not too corrupted (ASA IV)
* Renal failure with creatinin clearance \< 30 ml / min
* Patient not affiliated to Social Security
* Pregnant or lactating
* Patients in emergency situations
* Inpatient without consent

Primary outcomes:
measure: Efficacy treatment
Secondary outcomes:
measure: Efficacy of pregabaldin
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de POITIERS
Study officials:
affiliation: Poitiers University Hospital
name: Bertrand DEBAENE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02821286: Identification of Anaphylactogenic Antibodies in Peanut Allergy
Official title: Identification of Anaphylactogenic Antibodies in the Blood of Peanut Allergic Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Peanut Allergy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University Children's Hospital, Zurich
First posted: 2016-07-01
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The project population includes patients of at least three years of age with a described history of peanut allergy and/or sensitization to peanut allergens (as evidenced by positive skin prick test or allergen-specific IgE testing).

Brief summary: This project intends the analysis and profiling of specific antibodies against major peanut allergens in peanut allergic individuals and molecular cloning of human antibodies against major peanut allergens.

Detailed description: * Characterization of patient samples reactivity (sera obtained from blood) against major peanut allergens.
* Isolation of antibody-producing B cells.
* Molecular cloning of peanut-specific antibodies from antibody gene sequences obtained from B cells.
* Biophysical and functional characterization of isolated antibodies

Eligibility criteria: Inclusion Criteria:

* Participants have a described clinical history of peanut allergy and/or are sensitized to peanut allergens (as evidenced by positive skin prick test and allergen-specific IgE testing)
* Male and female subjects older than 3 years
* Written informed consent

Exclusion Criteria:

* age below three years
* patients suffering from any disease where blood withdrawals might impact the patients' health status such as known anemia.

Primary outcomes:
measure: Analysis and profiling of specific antibodies against major peanut allergens in samples derived from peanut allergic patients.
timeFrame: June 2016 to May 2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03330886: A Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina
Official title: An Observational Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urothelial Carcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra) that have received the indication for treatment with atezolizumab as per local label (disease progression during or following platinum containing therapy) in the context of routine clinical practice.

Brief summary: The main purpose is to study the safety and effectiveness of atezolizumab in patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical treatment in common clinical practice settings in Argentina.


Eligibility criteria: Inclusion Criteria:

* Signed an informed consent form submitted to the Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT)
* Histologically or cytologically documented locally advanced or metastatic urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra).
* Have received at least one dose of atezolizumab as per local label and clinical practice.

Exclusion Criteria:

* Contraindicated atezolizumab therapy

Primary outcomes:
measure: Percentage of Participants with Adverse Events (AE)
timeFrame: Up to approximately 2 years.
Secondary outcomes:
measure: Percentage of participants with Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR)
timeFrame: Up to approximately 2 years.
measure: Duration of Response (DOR)
timeFrame: Up to approximately 2 years.
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 2 years.
measure: Overall Survival (OS)
timeFrame: Up to approximately 2 years.
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Productos Roche S.A. Quimica e Industrial, División Farmacéutica
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04483986: Does Rectus Re-approximation Cause Adhesion After Cesarean Section?
Official title: The Evaluation of Rectus Re-approximation in Terms of Adhesion After Cesarean Section by Elastography.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstetric Complication
Muscle Injury
Keywords: elastography
rectus muscle re-approximation
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Rectus re-approximation and periton closure are not the obligatory steps during cesarean section. These steps are due to surgeon's preference. However, there is lack of knowledge about the relation of rectus muscle re-approximation and adhesion formation. We are going to study the rectus muscle stiffness by share-wave elastosonography.


Eligibility criteria: Inclusion Criteria:

* Primary cesarean section

Exclusion Criteria:

* Wound infection

Primary outcomes:
measure: Rectus muscle stiffness
timeFrame: 3 months after cesarean section
Secondary outcomes:
measure: Operation time
timeFrame: During operation
measure: Postoperative pain
timeFrame: 3 months after cesarean section
measure: Postoperative bowel function
timeFrame: 3 months after cesarean section
measure: Postoperative bladder function
timeFrame: 3 months after cesarean section
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Sebnem Alanya Tosun
Study officials:
References:
Clinical trial NCT02289586: Interventional Bronchoscopy Under Noninvasive Ventilation
Official title: Interventional Bronchoscopy Under Noninvasive Ventilation for Central Airway Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Noninvasive Positive Pressure Ventilation;
Sedation;
Bronchoscopy；
Interventional；
Central Airway Stenosis
Lead sponsor: Futian People's Hospital
Sponsor class: OTHER
Collaborators: name: Science and Technology Innovation Commission of Shenzhen Municipality
First posted: 2014-11-13
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect and safety of noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis.

With the sedation and analgesia, noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis is safe and effective, carries high satisfaction rate.


Eligibility criteria: Inclusion Criteria:

* (a)patients with central airway stenosis need interventional bronchoscopy. (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;

Exclusion Criteria:

* (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.

Primary outcomes:
measure: The improvement of airway stenosis after the operation
timeFrame: 1 day
measure: The improvement of partial pressure of arterial oxygen (PaO2) after the operation
timeFrame: 1 day
Secondary outcomes:
measure: hospitalization expenses
timeFrame: During the period of hospitalization，an expected average of 4 weeks
measure: hypoxemia during the operation
timeFrame: 1 day
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Futian People's Hospital
state: Guangdong
Study officials:
References: