louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01738373: Registry of Patients Treated With Plerixafor (Mozobil®) for Haematopoietic Stem Cell Mobilization Before Autologous Transplantation
Official title: Investigator Centers Will Be All French Hematology Centers Performing Autologous Transplantation and Prescribing Mozobil in Hematopoietic Stem Cell Mobilization Willing to Participate In This Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow / Autologous Transplants
Keywords: autologous stem cell transplantation
lymphoma
multiple myeloma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-11-30
Enrollment: 262
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The selection of the registry's participants will be based on an exhaustive request of all apheresis centers distributed in the French territory.

Brief summary: The aim of this registry is to provide information, in day-to-day practice, on Plerixafor prescription modalities in France, over a 13-month period in order to address the health authorities' request.


Eligibility criteria: Inclusion Criteria:

* Patients treated with Plerixafor for autologous transplantation between November 2011 and November 2012
* Patients who have been informed and who have given their written consent for the access to their medical file

Exclusion Criteria:

* Patients already included in a Plerixafor ongoing clinical trial.

Primary outcomes:
measure: The characteristics of the patients who received treatment
timeFrame: 13 months
measure: Dosage of treatment
timeFrame: 13 months
measure: Number of CD34+ cells collected following treatment
timeFrame: 13 months
measure: Number of patients with the existence of one or more predictive factors of poor mobilisation
timeFrame: 13 months
measure: Duration of treatment
timeFrame: 13 months
measure: Associated treatments
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05022173: Helmet NIV in Acute Respiratory Failure
Official title: Helmet NIV Versus Facemask NIV in Acute Respiratory Failure: A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: non-invasive ventilation
Helmet non-invasive ventilation
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-invasive ventilation (NIV) is a form of respiratory support that has been shown to prevent invasive mechanical ventilation and reduce mortality. This study will investigate the feasibility of performing a larger study examining whether a new modality of NIV, the helmet, is superior to the current face mask in reducing mortality in patients with sudden respiratory failure.


Eligibility criteria: Inclusion Criteria:

* 1) patients who are admitted to the adult ICU
* 2) deemed to require NIV, as per the clinical team, for acute respiratory failure.

Exclusion Criteria:

* 1) with impending cardiac arrest or need for intubation
* 2) Glasgow coma scale \<9
* 3) tracheostomy or upper airway obstruction
* 4) elevated intracranial pressure
* 5) untreated pneumothorax
* 6) who refuse endotracheal intubation (do not intubate order documented)
* 7) facial trauma
* 8) are unable to wear the helmet or facemask
* 9) who use NIV chronically

Primary outcomes:
measure: Consent Rate
timeFrame: 1 year
measure: Recruitment Rate
timeFrame: 1 year
measure: Protocol adherence percentage
timeFrame: 1 year
Secondary outcomes:
measure: Endotracheal intubation
timeFrame: 28 days
measure: ICU mortality
timeFrame: 28 days
measure: Hospital mortality
timeFrame: 60 days
measure: ICU length of stay
timeFrame: Censored at 28 days
measure: Hospital length of stay
timeFrame: Censored at 60 days
measure: Duration of non-invasive ventilation
timeFrame: Censored at 28 days
measure: Duration of invasive ventilation
timeFrame: Censored at 28 days
measure: Adverse events
timeFrame: 28 days
measure: Comfort
timeFrame: 28 days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Science
name: Bram Rochwerg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06361173: Spanish BMT4me Usability & Acceptability
Official title: Spanish BMT4me Usability & Acceptability
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Marrow Transplant
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2024-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit 30 self-identified Spanish speaking primary caregivers of children post-HCT at two institutions.

Brief summary: The objective of this project is to trans-create, conduct user testing of a previously developed and piloted mHealth app, and user acceptability with parents of children in the acute phase post-allogeneic hematopoietic stem cell transplant (HSCT). Nationwide Children's Hospital (NCH) will be the primary data collection site and Columbia University Irving Medical Center will be a secondary site.


Eligibility criteria: Inclusion Criteria:

Eligible caregivers must have children who:

1. Are 0-17 years old
2. Underwent HCT
3. Are planned for discharge prior to day 100 post-transplant

Primary caregivers must:

1. Be Spanish speaking
2. Be ≥18 years old
3. Have a smartphone (iOS or Android) capable of downloading apps

Exclusion Criteria:

(a) Children or caregivers with pre-existing neurodevelopmental disorder/disability or a pervasive developmental disorder will be excluded from this study.

Primary outcomes:
measure: Assess app usability using the System Usability Scale (SUS)
timeFrame: 6/1/24 - 5/1/26
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT01743573: Effects on Physical Fitness, Immunity, and Quality of Life of Yoga Training in Breast Cancer Survivors.
Official title: Effects on Physical Fitness, Immunity, and Quality of Life of Yoga Training in Breast Cancer Survivors.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study wants to prove that Yoga Training can improve physical Fitness, immunity, and quality of Life of in Breast Cancer Survivors. In summary, our findings show potential benefits of yoga for people with cancer in improvements of psychological health. Because of the small number of studies having been conducted and the methodological limitations, the results should be regarded as preliminary and treated with caution. Our preliminary findings also provide practitioners with important information that yoga may be a possible adjunctive therapy for cancer patients to help manage psychological distress and to improve quality of life.


Eligibility criteria: Inclusion Criteria:

* breast cancer with stage1 or stage2, Sedentary life style, no orthopaedic disease and medical disease

Exclusion criteria

* recurrent or metastasis, medical or current psychiatric illness which would make compliance with the study protocol difficult or dangerous, medications which would alter training response

Primary outcomes:
measure: change from baseline immunological factors, cardiorespiratory and muscle fitness, questionnaire for physical activity, fatigue and quality of life at 13th weeks
timeFrame: 13th week
Secondary outcomes:
measure: change from baseline immunological factors, cardiorespiratory and muscle fitness, questionnaire for physical activity, fatigue and quality of life at 25th weeks
timeFrame: 25th week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jau-Yih Tsauo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01404273: Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
Official title: Functional MRI of an Open Trial of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2011-07-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study is being done to examine how meditation and the relaxation response (RR) may change brain activity in attention-deficit/hyperactivity disorder (ADHD).


Eligibility criteria: Inclusion Criteria:

1. Male or female adults (ages 18 - 49).
2. Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by the Diagnostic and Statistics Manual of Mental Disorders (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview.

Exclusion Criteria:

1. Any current, non-ADHD Axis I psychiatric conditions
2. Baseline Beck Depression Inventory (BDI) \> 19.
3. Any clinically significant chronic medical condition.
4. Mental retardation
5. Organic brain disorders
6. Seizures or tics.
7. Pregnant or nursing females.
8. Clinically unstable psychiatric conditions (suicidal behaviors, psychosis).
9. Current or recent (within the past 2 years) substance abuse or dependence.
10. Patients currently or recently (within past 1 month) on psychotropic medication.
11. Subjects with current or prior adequate psychopharmacologic treatment for ADHD.
12. Regular practice of an Relaxation Response-inducing technique within the past year
13. History of claustrophobia or any of the standard contraindications to magnetic resonance imaging (MRI) scanning(metal objects within body).

Primary outcomes:
measure: Change in functional magnetic resonance imaging (fMRI) activation from baseline after a 6-week intervention
timeFrame: 2 sessions, 2 hours each to be conducted before and after the 6-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Benson-Henry Institute, 151 Merrimac St, 4th Floor
state: Massachusetts
Study officials:
affiliation: MGH
name: George Bush, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02974673: Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters
Official title: Ejaculation of Spinal Cord Patient: Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Diseases
Disorder of Ejaculation
Keywords: Spinal Cord Injury
Genito sexuals disorders
Ejaculatory test
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this research is to study the sphincter activity during ejaculation in patients with spinal cord injury in order to detect an ejaculatory dyssynergia. For this purpose, using a catheter the protocol plans to measure the sphincter pressures during ejaculation. Moreover, cardiovascular parameters will be measured continuously during the ejaculatory test.


Eligibility criteria: Inclusion Criteria:

* Patients evaluated by ejaculatory test during their usual care
* Men with spinal cord injury between 18 and 65 years old
* Patients who have given their informed consent
* Patients with social insurance affiliation

Exclusion Criteria:

* Minors
* Patients with justice protection
* Patients over 65 years old

Primary outcomes:
measure: Sphincter urethral pressure measured by electronic microsensors to asses ejaculatory dyssynergia
timeFrame: at inclusion
Secondary outcomes:
measure: Determination of type of ejaculation by bladder catheterization
timeFrame: at inclusion
measure: Sphincter urethral pressure to asses type of ejaculatory dyssynergia
timeFrame: at inclusion
measure: American Spinal Injury Association score
timeFrame: at inclusion
measure: Frequency of ejaculation after stimulation
timeFrame: at inclusion
measure: Amplitude of ejaculation after stimulation
timeFrame: at inclusion
Other outcomes:
Locations:
city: Berck
country: France
facility: Centre Calvé
city: Cerbere
country: France
facility: Centre Bouffard Vercelli
Study officials:
affiliation: Centre Calvé - Berck sur mer
name: Jean Gabriel Previnaire, MD
role: STUDY_DIRECTOR
affiliation: Center Bouffard Vercelli - Cerbère
name: Jean Marc Soler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05822973: Sutures for Treatment of Knee Arthroscopy
Official title: Absorbable Versus Nonabsorbable Sutures for the Treatment of Knee Arthroscopy: A Prospective Comparison of Patient Outcomes and Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroscopy
Suture
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For a knee arthroscopy, two small incisions are made at the level of the joint line on each side of the patellar tendon. Closure of surgical incisions consists of using either nonabsorbable or absorbable sutures. Some surgeons prefer using nonabsorbable sutures due to it being easier to tie, these sutures are less likely to break prematurely, and that they elicit a minimal inflammatory response. On the other hand, some surgeons prefer using absorbable sutures due to the time savings of not having to remove the sutures at a later date and that these sutures decrease patient anxiety and discomfort. The purpose of this study is to prospectively investigate and compare patient's pain, swelling and cosmesis following knee arthroscopy surgery between patients who had their arthroscopy portals closed using resorbable sutures vs. patients who had their portals closed using nonabsorbable sutures.


Eligibility criteria: Inclusion Criteria:

* Patients ages 18 and older undergoing primary knee arthroscopy for diagnostic arthroscopy, removal of a loose body, chondroplasty, or a partial meniscectomy will be included in this analysis

Exclusion Criteria:

* Patients undergoing revision knee arthroscopy as well as patients undergoing ACL reconstruction or meniscal repair surgery will be excluded from this analysis.
* Patients under the age of 18 will be excluded as well.

Primary outcomes:
measure: Postoperative Pain Leveles
timeFrame: 3 months
measure: Patient Satisfaction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04677673: Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients
Official title: Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Gastric Cancer
Chemotherapy Effect
Elderly Patients
Surgery
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 232
Sex: ALL
Minimum age (years): 76
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.

Detailed description: DRAGON SENILE research, Neoadjuvant Chemotherapy plus Surgery versus surgery first for elderly Gastric Cancer patients, is an investigator-initiated; phase II/III, open-label, randomized controlled study. The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.

Eligibility criteria: Inclusion Criteria:

* Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
* Clinical stage: cTNM: stage III
* Performance status: Eastern Cooperative Oncology Group ECOG ≤ 2 (normal to symptomatic but in bed less than half the day)
* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
* Written informed consent

Exclusion Criteria:

* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
* Distant metastases (including retroperitoneal lymph node)
* Locally advanced inoperable disease (Clinical assessment)
* Relapse of gastric cancer
* Malignant secondary disease
* Prior chemo or radiotherapy
* Inclusion in another clinical trial
* Known contraindications or hypersensitivity for planned chemotherapy

Primary outcomes:
measure: Overall Survival
timeFrame: Five years
Secondary outcomes:
measure: Completion rate of planned NAC
timeFrame: Three months
measure: Percentage of Grade 3/4 hematological adverse events
timeFrame: Three months
measure: Pathological response
timeFrame: Four months
measure: Disease-free survival (DFS)
timeFrame: Two years
Other outcomes:
Locations:
Study officials:
affiliation: Ruijin Hospital
name: Zhenggang Zhu
role: STUDY_CHAIR
References:
Clinical trial NCT05679973: Evaluation of the Efficacy of Polybutester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery
Official title: Evaluation of the Efficacy of Polybutester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impacted Third Molar Tooth
Keywords: Polybutester
Polypropylene
Pain
Edema
Trismus
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aimed to evaluate the efficacy of polybutester sutures on postoperative complications in lower impacted third molar surgery.

Detailed description: After extraction of the bilateral lower third molars (35 patients), two different types of sutures were used on each side. Group 1( Polybutester suture) , group 2 (Polypropylene suture). Measurements to evaluate edema, trismus, and pain (using the VAS scale) had been taken pre-procedure and post-procedure( 2nd and 7th day )

Eligibility criteria: Inclusion Criteria:

* Any medication until 2 weeks before the operations,
* Impacted teeth in mesial and horizontal positions and in class 2 and class B according to Pell \& Gregory classification,
* Asymptomatic impacted teeth.
* Coming to control and fill in the given and requested forms,
* Regularly use the given drugs

Exclusion Criteria:

* Systemic disease,
* Smoking,
* Pregnancy or breastfeeding,
* Allergy to the drugs to be used in the study,
* Using any additional medication that may affect the outcome of the study,
* Post-operative alveolitis.

Primary outcomes:
measure: Pain Evaluation
timeFrame: Postoperative 1st day
measure: Pain Evaluation
timeFrame: Postoperative 2nd day
measure: Pain Evaluation
timeFrame: Postoperative 3rd day
measure: Pain Evaluation
timeFrame: Postoperative 5th day
measure: Pain Evaluation
timeFrame: Postoperative 7th day
measure: Edema evaluation using Facial measurement
timeFrame: Preoperative
measure: Edema evaluation using Facial measurement
timeFrame: Postoperative 2nd day
measure: Edema evaluation
timeFrame: Postoperative 7th day
measure: Trismus Evaluation
timeFrame: Preoperative
measure: Trismus evaluation
timeFrame: Postoperative 2nd day
measure: Trismus evaluation
timeFrame: Postoperative 7th day
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yuzuncu Yil University, Faculty of Dentistry
Study officials:
affiliation: Yuzuncu Yıl University
name: Levent Ciğerim, Assoc.Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02407873: Prognostic Impact of Frailty Assessed by Edmondon in Elderly Patient Undergoing Cardiac Surgery
Official title: Prognostic Impact of Frailty Assessed by Edmondon in Elderly Patient Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elective Cardiac Surgery
Keywords: aged of 75 years or more
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 254
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged 75 year and over undergoing elective cardiac surgery

Brief summary: The score on the Edmonton frail scale will be recorded in 250 consecutive patient aged of 75 years or more and undergoing elective cardiac surgery. In those patients the investigators will also record the ITU length of stay, the hospital length of stay, the incidence of complications, the ability to be discharged home and to live independently at postoperative day 30.

The ability of the Edmonton score to predict complication, prolonged hospital and ITU length of stay as well as loss of autonomy at discharge and day 30 will be assessed.


Eligibility criteria: Inclusion Criteria:

* 75 yo and older
* Elective cardiac surgery

Exclusion Criteria:

* Refuse or inability to give consent
* Emergency surgery

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 Days
Secondary outcomes:
measure: Loss of autonomy at discharge (Edmonton score)
timeFrame: 30 Days
measure: Loss of autonomy at day 30 (Edmonton score)
timeFrame: 30 days
measure: Incidence of predefined complications
timeFrame: 30 Days
measure: Length of hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: CHU of Liege
Study officials:
References: