louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01047371: Why in Hospital - Factors Determining Time to Discharge Readiness After Arthroplasty Surgery
Official title: Why in Hospital - Factors Determining Time to Discharge Readiness After Arthroplasty Surgery: An Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Nausea
Vomiting
Dizzyness
Fatigue
Organizational Concerns
Ect.
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2010-01-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients scheduled for total hip or knee arthroplasty

Brief summary: The purpose of this study is to evaluate patient related factors determining length of stay in hospital after arthroplasty surgery.

Detailed description: To evaluate why the patient is in hospital after surgery, when predefined discharge criteria are met, which patient related clinical problems hinder fulfilling of the discharge criteria, and to evaluate actual length of stay in hospital.

All consecutive patients scheduled for total hip or knee arthroplasty are included in the trial.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for total hip or knee arthroplasty

Exclusion Criteria:

* Age under 18 years

Primary outcomes:
measure: Patient related factors determining length of stay in hospital
timeFrame: Daily (average 2 days)
Secondary outcomes:
measure: Length of stay in hospital
timeFrame: At discharge (average 2 days)
measure: Time till fulfilling of predefined discharge criteria
timeFrame: At discharge (average 2 days)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidovre
Study officials:
affiliation: Hvidovre University Hospital
name: Henrik Husted, MD
role: STUDY_DIRECTOR
affiliation: Hvidovre University Hospital
name: Troels H. Lunn, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07000071: Non-invasive Secondary Respiratory Support in Late Preterm and Term Infants
Official title: Non-invasive Secondary Respiratory Support in Late Preterm and Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonates
Respiratory Distress
Non- Invasive Ventilation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present work is to compare between various modes of non-invasive respiratory support (including NCPAP, NIPPV, and NHFOV) as secondary respiratory support modes in late preterm and term neonates as regards the need for reintubation. Additionally, the study aims at comparing between the three modes concerning the associated morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* The gestational age (GA) is between 34 and 41 weeks.
* Extubation from invasive mechanical ventilation initiated due to RD, irrespective to the cause of RD.
* Respiratory distress is assessed based on clinical manifestations (tachypnea, nasal flaring, intercostal retractions, diminished air entry, and or grunting)

Exclusion Criteria:

* Major congenital anomalies.
* Major cardiac diseases.
* Presence of cardiovascular instability (sepsis, severe dehydration, severe anemia).
* Neurologically insulted neonates who are unable to take adequate spontaneous breathing.

Primary outcomes:
measure: Failure rate
timeFrame: 72 hours after weaning
Secondary outcomes:
measure: duration of non-invasive ventilation
timeFrame: first 72 hours after weaning from mechanical ventillation
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Marwa Mohamed Farag
Study officials:
References:
Clinical trial NCT01686971: The Needs of Cancer Survivors
Official title: The Needs of Cancer Survivors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Needs and Demands of Oncology Patients
Breast Cancer Patients.
Colon Cancer Patients.
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oncology patients at the end of theier treatment. The patients will consist from 2 most common cancer diseases:Breast cancer and colon cancer.

Brief summary: A questionaire for cancer patients without an active treatment in order to evaluate their needs and/or demands.

Detailed description: Cancer patients on finishing therapy will be interviewed by a registered nurse by a approved questionaire asking about his /her feeling needs and demands.

Efforts to help them will be trid

It is well known from studies that survivors have unmet medical and non-medical needs that are not met, this includes physical, emotional and practical issues. The purpose of this study is to study them and investigate the methods how to alleviate them.

All patients with breast and colon cancer that are refered to the Rambam Oncology center will be investigated.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with two common cancers (breast, colon) that have completed the treatment (chemotherapy, radiotherapy)
* Male and Female patients 18-80 years old.

Exclusion Criteria:

* Patients with active disease.
* Recipients of care that matches the criteria of hospice care.
* Patients with a diagnosis of dementia or other cognitive failure
* Patients who do not speak Hebrew

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam MC
Study officials:
affiliation: Rambam MC
name: Eliezer Robinson, Proffesor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06357871: Role of Renal Biopsy in the Suspicion of Nephrotoxicity of Immunotherapy (Checkpoint Inhibitors) in Solid Cancer
Official title: Role of Renal Biopsy in the Suspicion of Nephrotoxicity of Immunotherapy (Checkpoint Inhibitors) in Solid Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chemotherapeutic Toxicity
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University Hospital, Strasbourg, France
name: CHU de Reims
name: Centre Hospitalier Régional Metz-Thionville
name: European Georges Pompidou Hospital
First posted: 2024-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include all patients hospitalized for kidney biopsy in the context of acute renal failure with CPI treatment.

Brief summary: Checkpoint inhibitors represent a new class of widely used immunotherapy, however with immune-mediated adverse effects, with renal damage estimated at 1.4% and 4.9% depending on the series.

Acute tubulointerstitial nephritis (ATNI) represents the most common type of damage, although there are other types of damage, associated or not with NTIA.

We aim to establish a probability score for the presence of histological NTIA lesions in a patient treated with CPI who presents with acute renal failure in order to guide the nephrologist and oncologist in their management in the event of AKI at the CPI, and determine the usefulness of a PBR to guide the suspension/resumption of immunotherapy +/- associated corticosteroid therapy; avoiding a PBR exposing to a high iatrogenic risk and sometimes impossible.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old Diagnosis of solid cancer treated by immunotherapy such as checkpoint inhibitor, associated or not with chemotherapy Renal failure having benefited from a renal biopsy

Exclusion Criteria:

* None

Primary outcomes:
measure: Estimation using a multivariate model of the factors associated with the histological presence of NTIA vs NTA lesions in a patient treated with CPI
timeFrame: between January 2020 and December 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: CHRU de Nancy
name: Adrien Flahault, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02834871: Integration of the Cervical Proprioceptive Signals in Patients With Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Dystonia
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the cervical muscular force control , taking into account the proprioceptive signals, in patients with and without cervical dystonia.


Eligibility criteria: Inclusion criteria:

* patients presenting focal or segmental cervical dystonia diagnosed by a neurologist expert in the diseases with abnormal movements
* having signed a consent for study participation

No Inclusion Criteria:

Neurological affection other than cervical dystonia (typical or atypical parkinsonism, other ...)

* Severe pain, trauma or disease of the cervical spine known or suspected other than cervical dystonia requiring treatment in the last 6 months
* Ongoing neuroleptic treatment
* Pregnancy or breastfeeding
* Lack of insurance coverage

For patients, are added the following no inclusion criteria are added:

* Trembling cervical dystonia
* Injection of botulinum toxin in the past three months

Primary outcomes:
measure: Measuring (in Newton) of the muscular force exerted by extending movements of the cervical spine in static and dynamic condition
timeFrame: two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmique Adolphe de Rothschild
Study officials:
References:
citation: Carment L, Maier MA, Sangla S, Guiraud V, Mesure S, Vidailhet M, Lindberg PG, Bleton JP. Does dystonic muscle activity affect sense of effort in cervical dystonia? PLoS One. 2017 Feb 13;12(2):e0172019. doi: 10.1371/journal.pone.0172019. eCollection 2017.
Clinical trial NCT02884271: Cardiopulmonary Resuscitation in Operating Room
Official title: Intraoperative Cardiac Arrest: Incidence and Outcome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intraoperative Cardiac Arrest
Keywords: CPR
cardiac arrest
operating room
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 7
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: This study will include all patients who develop cardiac arrest in the operating room (including preoperative waiting area and postoperative recovery unit) Dokuz Eylul University Hospital.

Brief summary: In the last ten years patient safety during routine surgical interventions has increased; however as there is an increase in the number of specialized surgical interventions and high risk patients like elderly and emergency patients, the incidence of perioperative cardiac arrest has not reduced but remains fixed. The incidence of perioperative cardiac arrest varies from 4.3-34.6 for each 10,000 procedures. However as in a lot of other countries exact data are lacking also for Turkey. With this study the investigators want to start collecting data about intraoperative cardiac arrest in Turkey, starting at their institution The aim is to evaluate the incidence and outcome in the study. Secondary aim is to assess the causes of cardiac arrest in the operating room.

Detailed description: Patient information will be collected on a form entitled "Data collection form" including all medications and interventions during cardiopulmonary resuscitation and routine daily used anesthesia registration form.

Eligibility criteria: Inclusion Criteria:

* All patients who develop cardiac arrest in the operating room

Exclusion Criteria:

* Absence of informed consent
* Patients arriving into the operating room with ongoing CPR

Primary outcomes:
measure: incidence of intraoperative cardiac arrest
timeFrame: baseline
measure: neurologic outcome of patients according to Cerebral performance category scale
timeFrame: until six months after return of spontaneous circulation
Secondary outcomes:
measure: causes of intraoperative cardiac arrest among participants/patients
timeFrame: baseline
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
Study officials:
affiliation: Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
name: Bahar Kuvaki, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02357771: Probiotic Lozenge Reduce Streptococcus Mutans in Plaque in Orthodontic Bracket Patients
Official title: Topical Application of Probiotic Lozenge to Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malocclusion
Keywords: misalignment of the two dental arches
mal-align teeth
Lead sponsor: Next Gen Pharma India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peoples University, Bhanpur, Bhopal
First posted: 2015-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Advances in orthodontics have improved the quality of appliances and treatment protocols, raising the standard of patient care. However, enamel demineralization is still a problem associated with orthodontic treatment, leading to the formation of white spot lesions; this is a grave concern to orthodontists and patients.

The overall prevalence of white spot lesions among orthodontic patients has been reported to be between 4.9% and 84%.1 When basic oral hygiene is poor, orthodontic appliances create areas of plaque stagnation, especially around brackets, bands, wires, and other attachments. Levels of acidogenic bacteria, present in the plaque, notably Streptococcus mutans (S mutans), are higher in orthodontic patients than in non-orthodontic patients.

This causes demineralization around the brackets and leads to white spot lesions. They are most prevalent around the cervical region of bands in the posterior region, whereas in the anterior region, the lateral incisors in both arches, followed by the canines, are most commonly affected.


Eligibility criteria: Inclusion Criteria:

* Orthodontic treatment with the straight wire appliance (MBT, 0.022-in slot; 3M Unitek, Monro- via, Calif).
* Complete permanent dentition (excluding third molars).
* No chewing gum or mouthwash used in the last week and during the study.
* Habit of brushing twice daily with fluoride toothpaste.

Exclusion Criteria:

* Patient with poor periodontal condition.
* Patient with known medical condition e.g. subacute bacterial endocarditis, diabetes, valvular disease, anemia etc.

Primary outcomes:
measure: Changes in the levels of streptococcus Mutans in the plaque around orthodontic brackets.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bhopal
country: India
facility: Department of Orthodontics & Dentofacial Orthopaedics, People College Of Dental Sciences & Research Centre, Bhanpur
state: Madhya Pradesh
Study officials:
affiliation: Peoples College of Dental Sciences & Research Centre, Bhanpur, Bhopal, Madya Pradesh
name: Upendra Jain, M. Orth.
role: STUDY_CHAIR
References:
Clinical trial NCT00997971: Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein
Official title: Phase 3 Safety Study of a Partially Hydrolyzed Rice Protein Formula in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth
Allergy
Keywords: Hydrolysed rice protein formula
Cow's milk protein allergy
Infant formula
Gastrointestinal tolerance
Lead sponsor: Sodilac
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 86
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice protein infant formula.

Detailed description: This objective will result in the study of non-inferiority of the experimental formula in terms of variation of weight compared with growth curves after 3 to 6 months of exclusive regime with the experimental formula.

Parents provide informed written consent.

4 visits are forecasted in pediatric surgeries: V1(inclusion), V2 (2 months), V3 (4 months) and V4 (6 months). The last visit corresponds to the beginning of the food diversification decided by the pediatrician. Ideally it takes place at 6 months. If the food diversification starts at 4 months, then V3 and V4 constitute the same last visit.

Eligibility criteria: Inclusion Criteria:

* Term health infants with gestational age ranging from 37 to 42 weeks
* Infants less than 1 month old
* Non breastfed children at the inclusion
* Growth parameter normal
* Apgar score \> 5 to 7 minutes
* Change in the formula because of digestive troubles (colics, gas, regurgitation) or risks of allergy
* Absence of metabolic, nervous or digestive troubles
* Absence of digestive haemorrhage, apnea or dizzy turn

Exclusion Criteria:

* Partial breastfed children
* Infants presenting a cow's milk protein allergy
* Infants currently participating in another trial
* Infants presenting an organic disease involving medicinal or surgical treatment

Primary outcomes:
measure: Growth parameters
timeFrame: 2nd, 4th and 6th months
Secondary outcomes:
measure: Clinical Tolerance
timeFrame: 3 days before the 2nd and 6th months
measure: Atopic diseases (eczema atopic, asthma)
timeFrame: 2nd and 6th months
Other outcomes:
Locations:
city: Aix les bains
country: France
city: Asnieres
country: France
city: Besancon
country: France
city: Boulogne Billancourt
country: France
city: Caen
country: France
city: Ecully
country: France
city: Lyon
country: France
city: Meaux
country: France
city: St Priest en Jarez
country: France
Study officials:
affiliation: Hôpital d'enfants Armand Trousseau
name: Jean-Philippe Girardet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03860571: Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers
Official title: A Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Normal Healthy Volunteers
Lead sponsor: NImmune Biopharma
Sponsor class: INDUSTRY
First posted: 2019-03-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Primary purpose: TREATMENT

Brief summary: Study type: Interventional Description of intervention(s) / exposure

For single ascending dose, five dose target ranges of BT-11 (depending on body weight the doses in each cohort will be 5.9 - 7.7 mg/kg; 18.9 - 25.0 mg/kg; 44.3 - 50.0 mg/kg; 68.5 - 75 mg/kg and 94.2 - 100.0 mg/kg) will be evaluated, based on subject's weight on Day 1.

For multiple ascending dose (once daily for 7 days), three dose target ranges of BT-11 (depending on body weight the doses in each cohort will be 5.9 - 7.7 mg/kg; 44.3 - 50.0 mg/kg; and 94.2 - 100.0 mg/kg) will be evaluated, based on subject's weight on Day 1.

White tablets containing 500 mg BT-11 or matching placebo tablets will be dispensed.

Single ascending dose duration of administration will be once. For multiple ascending dose it will be up to 7 days.

The mode administration will be oral tablet. Compliance and adherence to the intervention will be performed based on the tablet return, tablet not consumed by the subject.

The safety monitoring committee will evaluate safety at conclusion of single ascending cohort 2 prior to the commencement of dosing for the multiple ascending dose.


Eligibility criteria: Key Inclusion Criteria:

1. Healthy male and female volunteers aged 18 to 65 years, inclusive.
2. Body weight 65 - 85 kg.
3. Volunteer has read, confirmed understanding of, and signed the written informed consent form after the nature of the study and all essential elements of the informed consent document have been fully explained and all of the Volunteer's questions have been answered to his or her satisfaction, prior to initiation of any study procedures.

Key Exclusion Criteria:

1. Any clinically significant abnormality identified in the screening history, physical examination (including Vital Signs), laboratory testing, or electrocardiographic testing. Repeat testing of vital signs to confirm the value is allowed. Up to two repeat tests are permitted to confirm eligibility.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: up to 14 days
Secondary outcomes:
measure: PK
timeFrame: 24 hours
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Site
state: Virginia
Study officials:
References: