louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02446782: Efficacy and Safety of Prophylactic Use of an Antibiotic for Medical Thoracoscopy
Official title: A Study to Evaluate the Efficacy and Safety of a Single Dose of an Injectable Antibiotic for the Prophylaxis of Surgical Site and Pleural Space Infection After Medical Thoracoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pleural Effusion
Pleurisy
Empyema
Keywords: thoracoscopy
pleuroscopy
antibiotic prophylaxis
pleural effusion
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2015-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective study to assess the efficacy and safety of a single dose of cefazolin 2g IV for the prophylaxis of surgical site and pleural space infections in patients undergoing medical thoracoscopy.

Detailed description: This is a prospective randomized study to assess the efficacy and safety of a single dose of cefazolin 2g IV for the prophylaxis of surgical site and pleural space infections during medical thoracoscopy.

Consecutive patients who are planned to undergo a medical thoracoscopy (rigid or semirigid) will be enrolled in the study if they satisfy the inclusion and exclusion criteria. One hundred patients will be randomized in 1:1 ratio to receive either of the following: (a) A single dose of intravenous cefazolin 2 gms dissolved in 100 mL of normal saline administered over 10 minutes, between 15 and 30 minutes before the incision, OR (b) 100 mL normal saline administered intravenously over a period of 10 minutes between 15 and 30 minutes before the incision. Thoracoscopy will be performed in the bronchoscopy suite on a spontaneously breathing subject (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions.

Eligibility criteria: Inclusion Criteria:

1. Age ≥12 years
2. Medical thoracoscopy being performed for a pleural effusion for any of the three indications: diagnosis, pleurodesis, or adhesiolysis

Exclusion Criteria:

1. Age ≥80 years
2. Pao2/FIO2\< 300;
3. Hemodynamic instability
4. Myocardial infarction or unstable angina in the last 6 wk
5. Lack of pleural space due to adhesions
6. Uncorrected coagulopathy
7. Failure to provide informed consent
8. Patients already taking any antibiotic due to any reason

Primary outcomes:
measure: Efficacy as assessed by occurrence of wound infection or pleural space infection
timeFrame: 2 months
Secondary outcomes:
measure: Safety as assessed by adverse effects
timeFrame: 7 days
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
References:
Clinical trial NCT03984682: Impact of Joint Crisis Plan
Official title: Impact of Joint Crisis Plan on the Duration of Isolation Measures in Psychiatry.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Keywords: Joint Crisis Plan
Internalized Stigma of Mental Illness (ISMI)
Isolation
physical restraint
Psychiatry
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2019-06-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: For some patients in department psychiatric, isolation measures are put in place. But the measures is not pleasant for the patient or for the care team.

That's why care team are trying to find ways to improve patient care, including asking them how they would like to be treated.

One of the solutions is called the Joint Crisis Plan. A Joint Crisis Plan is a personalized procedure for a patient. It describes the attitude, the care, the measures in case of crisis with the patient and his family. Patients indicate their wishes regarding their care. However, there is no real scientific proof of the effectiveness of this Joint Crisis Plan, especially to reduce isolation measures.

Detailed description: The primary objective of this study is to evaluate efficacy of the Joint Crisis Plan.

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years
* Patients having had at least one isolation, restraint or forced hospitalization measure in the 24 months before inclusion
* Followed by nurses of a mobile team of psychiatry sector Saint Etienne
* Social security affiliation
* Signed informed consent

Exclusion Criteria:

* Patient having already had a Joint Crisis Plan for less than 6 months.
* Patient does not speak French
* Pregnant and lactating women

Primary outcomes:
measure: Duration of isolation
timeFrame: Months: 12
Secondary outcomes:
measure: Perception of constraint
timeFrame: Months: 12
measure: Number of hospitalizations
timeFrame: Months: 12
measure: Number of isolation
timeFrame: Months: 12
measure: Number of physical restraints
timeFrame: Months: 12
measure: Duration of physical restraint
timeFrame: Months: 12
measure: Experience of discrimination and stigmatization
timeFrame: Months: 12
measure: Number of violent events
timeFrame: Months: 12
measure: Number of emergency room visits for psychiatric opinion
timeFrame: Months: 12
measure: Adhesion and feeling of nurses in relation to Joint Crisis Plan
timeFrame: Months: 12
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Yvonne QUENUM, Coordinating nurse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06177782: Accuracy of Tooth Modified Scan Bodies as a Novel Technique
Official title: Accuracy of Tooth Modified Scan Bodies as a Novel Technique for Edentulous Full Arch Implant Supported Dental Prosthesis: A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digital Technology
Dental
Keywords: Jaw relation
Scan body
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2023-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree of trueness of IOS impression for full arch cases.

I

Detailed description: The clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree of trueness of IOS impression for full arch cases. TMSB is a scan body to which different teeth are attached directly as one piece, this may enhance the accuracy level by filling the gabs between ISB as well as acting as a stable artificial AI-easily recognized landmarks thus facilitating the scanning procedure. OS impression utilizing tooth modified scan bodies or conventional scan bodies result in the same degree of trueness as conventional verified splinted open tray impression. To our knowledge, it is the first time in the literature to utilize a novel scan body modified with directly connected teeth as artificial landmarks in vivo.

Eligibility criteria: Inclusion Criteria:

* Participants who had received 4-6 implants in 1 edentulous arch.
* Participants with 1-piece implant-supported complete-arch fixed dental prostheses.
* Systemically free.
* Primary implant stability exceed 72 the day of the definitive impression.

Exclusion Criteria:

* Smoker's.
* Non co-operative patients.

Primary outcomes:
measure: Degree of trueness
timeFrame: Immediately postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbassia
Study officials:
References:
Clinical trial NCT04175782: Enhanced Recovery Protocol in Urogynecologic Surgery
Official title: Comparison of Enhanced Recovery Protocol With Conventional Care in Patients Undergoing Urogynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Cystocele
Rectocele
Pelvic Organ Prolapse
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Enhanced recovery after surgery (ERAS) has been shown to improve postoperative outcomes in a variety of surgical conditions. However, data regarding its role in urogynecologic surgery is limited. This study aimed to investigate the role of the ERAS protocol on postoperative outcomes in patients undergoing urogynecologic surgery.

Detailed description: Enhanced recovery after surgery (ERAS) or in other words "fast-track" protocol roughly purposes to improve patient satisfaction, reduce complications and shorten the hospital stay. Chronic diseases, nutrition, and any volume depletion are corrected prior to surgery and less invasive surgical techniques are utilized to this end The impact of ERAS protocols in decreasing length of stay (LOS), reducing postoperative pain, improving early ambulation and decreasing the rate of potentially serious medical complications have been studied in patients undergoing colorectal, urologic, gastric and pancreatic surgery previously. However, data regarding the role of ERAS protocol in improving postoperative outcomes and postoperative compliance in patients undergoing urogynecological surgery is limited.

The present study purposes to clarify the role of the ERAS protocol on postoperative outcomes in patients undergoing urogynecologic surgery.

Eligibility criteria: Inclusion Criteria:

* Age must be \> 18 years
* Must be scheduled for urogynecologic surgery

Exclusion Criteria:

* Emergency surgery
* Presence of preoperative sepsis
* Presence of advanced liver or kidney disease

Primary outcomes:
measure: Time to ambulation
timeFrame: Up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Please Enter The State Or Province
Study officials:
affiliation: Kanuni Sultan Suleyman Hospital
name: Gulseren Yilmaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04888182: High Protein Diet and Physical Activity in COPD
Official title: The Effect of High Protein Diet in Combination With Physical Activity in the Rehabilitation of Patients With Chronic Obstructive Pulmonary Disease (COPD) at Risk of Malnutrition- a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2021-05-17
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parellel, not blinded
Primary purpose: TREATMENT

Brief summary: COPD outpatients with severe and very severe (grade III-IV) disease at risk of malnutrition commencing rehabilitation (7-10-week physical activity program) were randomized to receive a high protein diet (≥ 25 energy percentage) or standard care.

Detailed description: Peripheral muscle function was measured by 6MWD (6-meter-walk-distance) and handgrip strength; FFM was measured by bioimpedance, mid upper arm circumference, and mid-thigh circumference; quality of life was measured by CAT (????); and dyspnoea was measured by the Medical Research Council dyspnoea scale and Borg scores at baseline and after 12 weeks.

Eligibility criteria: Inclusion Criteria:

* diagnosed COPD stage III or stage IV
* Nutritional risk by screening (NRS-2002)(Kondrup et al, 2002) and/or low-fat free mass (FFMI) (≤ 15% for women and ≤ 16% for men) measured by Bioelectrical Impedance Analysis (BIA)

Exclusion Criteria:

* Terminal phase of COPD
* Lung transplanted patients
* Severe Comorbidities influenzing the end-points (pancreatic insufficiency, severe hepatic failure, inflammatory gastrointestinal disease)

  * Multiple sclerosis
  * Any unwillingness or inability (e.g. not able to make notes of their nutritional intake, come to consultations or manage oral intake)

Primary outcomes:
measure: 6-minute walk test (6MWD)
timeFrame: 7 weeks
measure: hand grip strenght
timeFrame: 7 weeks
Secondary outcomes:
measure: Fat Free Mass (FFM)
timeFrame: 7 weeks
measure: Dyspnoea after 6 minutes walk
timeFrame: 7 weks
measure: Quality of life
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Pulmonary Medicine
Study officials:
affiliation: University of Copenhagen
name: Jens R Andersen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mogelberg N, Tobberup R, Moller G, Godtfredsen NS, Norgaard A, Andersen JR. High-protein diet during pulmonary rehabilitation in patients with chronic obstructive pulmonary disease. Dan Med J. 2022 Oct 11;69(11):A03220185.
Clinical trial NCT05571982: Comparison of the Efficacy of Tidal Volume Breathing and Vital Capacity Breathing During High-flow Nasal Oxygen
Official title: Comparison of the Efficacy of Tidal Volume Breathing and Vital Capacity Breathing During High-flow Nasal Oxygen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the preoxygenation efficacy of tidal volume breathing and vital capacity breathing.


Eligibility criteria: Inclusion Criteria:

-Adult patients 20 years of age or older who are planning to undergo surgery under general anesthesia

Exclusion Criteria:

-basal skull fracture, 2번 - facial anomaly, 3번 - consciousness disorder, 4번 - Risk of aspiration

Primary outcomes:
measure: Oxygen reserve index
timeFrame: for 10 minutes before anesthetic induction. At Day 0.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Hyun Joo Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00312182: Thorough QT Study of Nelfinavir
Official title: Evaluation Of The Effect Of Nelfinavir On QT Intervals At Steady-State After Twice-Daily Administration Of Nelfinavir Tablets To Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess if nelfinavir has any clinically meaninful effect on cardiac function, namely ECG evaluation


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of approximately 18 to 30 kg/m2.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

Primary outcomes:
measure: ECG evaluation
Secondary outcomes:
measure: Pharmacokinetics
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04453982: Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1b
Official title: Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1b
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Breastmilk
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Sinai Health System
First posted: 2020-07-01
Enrollment: 384
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants. When mothers of hospitalized infants are unable to supply their milk, the recommended supplement is human donor milk. The impact of a pandemic on human milk banking is unknown. This study seeks to address this public health issue. Donor milk will be collected from the Rogers Hixon Ontario Human Milk Bank at Sinai Health System in Toronto. Samples will be analyzed for the COVID-19 virus specific nucleic acid and antibody in real-time and results will be immediately disseminated to relevant organizations to inform local, national and international guidelines surrounding donor milk banking to protect the health of infants.


Eligibility criteria: Inclusion Criteria:

- Human milk donor for the Rogers Hixon Ontario Human Milk Bank

Exclusion Criteria:

- None

Primary outcomes:
measure: Prevalence of SARS-CoV-2 in breastmilk
timeFrame: 2 months
measure: Prevalence of SARS-CoV-2 antibody in breastmilk
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sinai Health System
state: Ontario
Study officials:
References:
citation: Ismail S, Unger S, Budylowski P, Poutanen S, Yau Y, Jenkins C, Anwer S, Christie-Holmes N, Kiss A, Mazzulli T, Johnstone J, McGeer A, Whittle W, Parvez B, Gray-Owen SD, Stone D, O'Connor DL. SARS-CoV-2 antibodies and their neutralizing capacity against live virus in human milk after COVID-19 infection and vaccination: prospective cohort studies. Am J Clin Nutr. 2024 Feb;119(2):485-495. doi: 10.1016/j.ajcnut.2023.10.008. Epub 2023 Dec 14.
Clinical trial NCT06925282: Determinants of Rescue Ventilation Requirement in Airway Surgery Under General Anesthesia With THRIVE
Official title: Determinants of Rescue Ventilation Requirement in Airway Surgery Under General Anesthesia With Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Subglottic Stenosis (SGS)
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 80
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: Adult patients scheduled to undergo elective airway surgery under general anesthesia with THRIVE at a single tertiary academic hospital. A total of 80 patients will be prospectively enrolled. All participants will receive standard anesthetic care, and data will be collected during the intraoperative period for analysis of factors associated with the requirement for rescue ventilation.

Brief summary: The anesthesia and surgical procedures from the time the patient enters the operating room to discharge from the recovery room are identical to those used in conventional airway surgeries performed under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE). The time point at which rescue ventilation is required due to a drop in oxygen saturation below 92% during anesthesia will be recorded, and the predictive factors for this event will be investigated.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing elective airway surgery under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE)
* Patients who provide written informed consent

Exclusion Criteria:

* Patients who decline to participate in the study

Primary outcomes:
measure: Time to Rescue Ventilation Due to Hypoxemia During Airway Surgery With THRIVE Under General Anesthesia
timeFrame: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
Secondary outcomes:
measure: Lowest Oxygen Saturation After Initiation of Rescue Ventilation
timeFrame: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
measure: Time to Recovery of SpO₂ to 100% After Rescue Ventilation
timeFrame: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
measure: End-Tidal CO₂ at the Time of Rescue Ventilation
timeFrame: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
measure: Predictive Factors for the Requirement of Rescue Ventilation
timeFrame: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00683982: Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus
Official title: Nitazoxanide vs Probiotics in the Treatment of Acute Rotavirus Diarrhea in Children: A Randomized Single Blind Controlled Trial in Bolivian Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Rotavirus Infection
Keywords: nitazoxanide
Probiotics
Diarrhea
Rotavirus
Children
Lead sponsor: Centro Pediatrico Albina de Patino
Sponsor class: OTHER
First posted: 2008-05-26
Enrollment: 75
Sex: ALL
Minimum age (years): 28
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nitazoxanide has proved an cytoprotective effect against rotavirus infection. How it could be clinically important in time of hospitalization and reduction of duration of diarrhea secondary to rotavirus?

Detailed description: Nitazoxanide has demonstrated a cytoprotective effect against rotavirus, reducing duration time of diarrhea in comparison to placebo in previous studies. In the current study, based in those results, we design a randomized single-blind controlled trial, in order to asses the effectiveness of nitazoxanide and probiotics in comparison with a control group

Eligibility criteria: Inclusion Criteria:

* Positive stool sample for rotavirus test

Exclusion Criteria:

* Severe malnourishment
* Severe dehydration
* History of diarrhea more than 3 days previous hospitalization
* Use of antibiotics, probiotics or nitazoxanide 3 weeks before admission
* Systemic infections
* Severe chronic disease
* Mixed enteric infections besides rotavirus

Primary outcomes:
measure: Duration of diarrhea
timeFrame: Hours
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: hours
Other outcomes:
Locations:
city: Cochabamba
country: Bolivia
facility: Centro Pediatrico Albina Patiño
Study officials:
affiliation: Centro Pediatrico Albina Patiño
name: Carlos N Teran, M.D
role: STUDY_DIRECTOR
References: