louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03335384: Relationship Between PFTs and Pdi in DMD
Official title: The Relationship Between Pulmonary Function Measures and Transdiaphragmatic Measures in Duchenne Muscular Dystrophy Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Fairview Health Services
First posted: 2017-11-07
Enrollment: 0
Sex: MALE
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cross-sectional
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A cross-sectional study to explore the relationship between clinically assessed pulmonary function test (PFT) measures and transdiaphragmatic (Pdi) measures in Duchenne muscular dystrophy (DMD) as well as to explore the relationship between sniff nasal inspiratory pressure (SNIP) and transdiaphragmatic (Pdi) measures in Duchenne muscular dystrophy.

Detailed description: Two small balloons, which are attached to small, flexible tubes, will be put into the esophagus and stomach through your nose. Each balloon is about 2 inches long (deflated) and about the width of a pencil tip. To reduce any discomfort with this procedure, lidocaine gel or spray will be put into the subject's nose and administered to the back of the throat before the balloon. In addition, swallowing water during the procedure will help to reduce any gagging sensation and will assure that the balloon goes into the esophagus. Proper placement of the catheters will be determined using normal tidal breathing against an occluded mouthpiece with a nose clip. Once proper placement is ensured, the catheters will remain in place during your normal PFT maneuvers. Additionally, while the gastric and esophageal balloon catheters are in place, the subject will be asked to perform a maximal sniff maneuver (SNIP) while one nostril is occluded with a plug containing a distal pressure measurement catheter to measure airway pressure. The distal end of the pressure catheter will be connected to a hand held pressure meter to display peak pressure and to provide you visual feedback. This maneuver will be performed 10 times.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Duchenne muscular dystrophy

Exclusion Criteria:

* Inability to follow verbal instructions

Primary outcomes:
measure: Evaluation of Pdi
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of SNIP
timeFrame: 1 year
measure: Evaluation of FVC
timeFrame: 1 year
measure: Evaluation of FEV1
timeFrame: 1 year
measure: Evaluation of FEFmax
timeFrame: 1 year
measure: Evaluation of FEF25-75
timeFrame: 1 year
measure: Evaluation of FEF50
timeFrame: 1 year
measure: Evaluation of MIP
timeFrame: 1 year
measure: Evaluation of MEP
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Eric M Snyder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06489184: The Real World Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China
Official title: This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CLL
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 490
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: Investigators participating in this observational study should include all patients with CLL who initiated treatment with zanubrutinib over the period from July 1st, 2020 to the present, regardless of the treatment status at the time of inclusion. Thus, at the time of enrolment and retrospective data collection, patients may still be on treatment or have stopped treatment for any reason.

Brief summary: This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China


Eligibility criteria: Inclusion Criteria:

* 1. Patients aged ≥18 years old
* 2. Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL \[International Workshop on Chronic Lymphocytic Leukemia\] criteria)；
* 3. Treatment-naïve OR Refractory Recurrence CLL patients who were initiated on Zanubrutinib;
* 4.Prior or current use of Zanubrutinib for ≥3 months
* 5.At least one follow-up was recorded during Zanubrutinib treatment

Exclusion Criteria:

-

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: up to two years
Secondary outcomes:
measure: Overall Survival
timeFrame: up to two years
measure: Time to Next Therapy (TTNT)
timeFrame: up to two years
measure: Adverse Events
timeFrame: up to two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06264284: Emergency (Red Code) Cesarean Section : Maternal and Fetal Prognosis Depending on Anesthetic Modalities in a Level 3 Maternity Ward
Official title: Emergency (Red Code) Cesarean Section : Maternal and Fetal Prognosis Depending on Anesthetic Modalities in a Level 3 Maternity Ward
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Complication
Keywords: c-section, cesarean section, epidural anesthesia, anesthesia complication
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who have undergone an emergency "code red" cesarean from July 19, 2018 to July 19, 2023, at the Nancy CHRU maternity ward

Brief summary: We try to evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome on emergency (Red Code) Cesarean Section.

This study occurred in a Level 3 Maternity Ward.


Eligibility criteria: Inclusion Criteria:

* Pregnant women
* emergency "code red" cesarean section

Exclusion Criteria:

* Any other intervention
* Planned cesarean section

Primary outcomes:
measure: To evaluate whether the type of anesthesia used influences the occurrence of perioperative maternal complications as well as neonatal outcome
timeFrame: From July 19, 2018 to July 19, 2023.
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Stanowski
Study officials:
References:
Clinical trial NCT01727479: Ribose and Sport Performance
Official title: The Effect of Ribose on Performance and Recovery in Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports
Keywords: Peak VO2 consumption
3km time trial
fatigue perception
lactate
time to complete
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Atrium Innovations
First posted: 2012-11-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Investigate the acute effect of ribose supplementation on performance and recovery in athletes.


Eligibility criteria: Inclusion Criteria:

* Men and women
* Training volume \> 7hrs/week
* VO2 max \> 40 and 45 mg/kg/min (for women and men respectively)
* Otherwise healthy individuals

Exclusion Criteria:

* Pregnant or breastfeeding women
* Individuals with endocrine disorders, hypercholesterolemia, cardiovascular diseases, gut diseases, cancer, anemia, hypoglycemia
* Medication for lipids, diabetes, hypertension, inflammation, autoimmune diseases, mood disorders
* Excessive alcohol consumption (more than two drinks by day for men, one for women), smoking, drug use, supplements or natural products consumption during the study

Primary outcomes:
measure: Change in time to complete the third of 3 consecutive 3km time trials on bike
timeFrame: baseline and 1 week
Secondary outcomes:
measure: Performance on the 3 consecutive 3km time trials on bike
timeFrame: baseline and 1 week
Other outcomes:
measure: Fatigue perception after each of the 3 consecutive 3km time trials on bike
timeFrame: baseline and 1 week
measure: Peak Vo2 consumption during each of the 3km time trials on bike
timeFrame: baseline and 1 week
Locations:
city: Québec
country: Canada
facility: Université Laval
state: Quebec
Study officials:
affiliation: Institute on nutraceuticals and functional foods
name: Benoît Lamarche, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03031379: Shortened Preoperative Fasts in ICU
Official title: Feasibility of Shortened Preoperative Fasts in Intubated ICU Patients Undergoing Tracheotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubated ICU Patients
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial assessing the safety and benefits of shortening preoperative fasts on intubated ICU patients undergoing tracheotomy.

Detailed description: Patients undergoing bedside tracheotomy in an ICU are enrolled and randomized into two groups. Arm A receive a standard fast of at least 6 hours. Arm B receive a shortened fast of only 45 minutes, just before the surgery begins. Patients will be monitored for aspiration, pneumonia and our ability to delivery better nutrition as a result of the intervention.

Eligibility criteria: Inclusion Criteria:

* intubated ICU patient undergoing tracheotomy, receiving enteral nutrition, adult, proxy available for consent

Exclusion Criteria:

* pregnant, \<18yo, cannot tolerate enteral feeding

Primary outcomes:
measure: Calories delivered
timeFrame: 72 hours
Secondary outcomes:
measure: Aspiration
timeFrame: 5 days
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
Clinical trial NCT02591979: PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment
Official title: PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment. A Multi-Centre Study to Validate a Sleep Apnea Screening Model in Primary Health Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea Syndrome
Keywords: Sleep Apnea Syndrome
Primary Health Care
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients visited at Primary Care consultations will be included according to a randomization schedule to reach the necessary sample.

Brief summary: The purpose of this study is to develop and validate a work-model in Primary Health Care for identifying patients with Sleep Apnea Syndrome, based on clinical variables and an ambulatory monitoring study.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 to 75 years.

Exclusion Criteria:

* Cognitive impairment or psycho-physical deterioration that impede to perform ambulatory monitoring study.
* Worsened or unstable cardiovascular or cerebrovascular disease.
* Chronic insomnia (\<5h sleep / day).
* Relevant respiratory comorbidity that could interfere with arterial saturation measurements, as moderate to severe chronic obstructive pulmonary disease.
* Neuromuscular disease.
* Refusal to participate in the study.

Primary outcomes:
measure: Apnea/Hypopnea Index
timeFrame: At baseline
measure: Apnea/Hypopnea Index
timeFrame: At 3 months
Secondary outcomes:
measure: Cardiovascular risk factors
timeFrame: At baseline
measure: History of cardiovascular or cerebrovascular disease
timeFrame: At baseline
measure: Lung function tests
timeFrame: At baseline
measure: Self-perceived sleepiness. Epworth Test
timeFrame: At baseline
measure: Self-perceived sleepiness. Epworth Test
timeFrame: At 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study officials:
References:
citation: Penacoba P, Llauger MA, Fortuna AM, Flor X, Sampol G, Pedro-Pijoan AM, Grau N, Santiveri C, Juvanteny J, Aoiz JI, Bayo J, Lloberes P, Mayos M; PASHOS Working Group. A new tool to screen patients with severe obstructive sleep apnea in the primary care setting: a prospective multicenter study. BMC Pulm Med. 2022 Jan 15;22(1):38. doi: 10.1186/s12890-022-01827-0.
citation: Penacoba P, Llauger MA, Fortuna AM, Flor X, Sampol G, Pedro Pijoan AM, Grau N, Santiveri C, Juvanteny J, Aoiz JI, Bayo J, Lloberes P, Mayos M; PASHOS Working Group. Primary care and sleep unit agreement in management decisions for sleep apnea: a prospective study in Spain. J Clin Sleep Med. 2020 Sep 15;16(9):1579-1589. doi: 10.5664/jcsm.8492.
Clinical trial NCT04961879: Dorsal Finger Reconstruction
Official title: Comparative Study to Evaluate the Difference Between Reversed Cross Finger Flap Versus Reversed Island Homo-digital Flap in Distal Dorsal Finger Defect Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Finger Injuries
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: objective of this study is To compare reversed cross finger flap with reversed island homo-digital flap in distal dorsal finger defect reconstruction regarding reliability \& functional and aesthetic outcomes .

comparative study that will be conducted at Plastic surgery department, Sohag university hospital on 30 patients .The population of the study will be patients with distal dorsal digital defects. We will divide the cases into two equal groups: the first are operated with reversed cross-finger flap and the second are operated with reversed island homo-digital flap.


Eligibility criteria: Inclusion Criteria:

* patients with dorsal digital defect distal to distal interphalangeal joint (DIP) joint
* defect size ranged from 1 to 2 cm in width and 1-3 cm in length

Exclusion Criteria:

* chronic heavy smokers,
* traumatic injury to the donor site and perforator .

Primary outcomes:
measure: difference in range of motion between group 1 and group 2
timeFrame: difference in range of motion between group 1 and group 2 will be measured at 4 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT01529879: Assessment of the Effect of an Implant System With a Novel Abutment Attachment Design on Crestal Bone Preservation
Official title: A Prospective Randomized-Controlled Evaluation of an Implant System With a Novel Abutment Attachment Design for the Preservation of Crestal Bone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism
Tooth Disease
Keywords: edentulism
dental implants
clinical study
Nanotite Certain Tapered implant
randomized
crestal bone level
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Integration success rates and the preservation of crestal bone will be higher for the experimental device than for the control implants.

Detailed description: In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by lack of implant mobility and lack of bone loss obtained at various study time points

Eligibility criteria: Inclusion Criteria:

* patients of either sex and older than 18 years of age
* patients needing at least one dental implant to treat partial edentulism
* patients physically able to tolerate surgical and restorative dental procedures
* patients agreeing to all protocol visits

Exclusion Criteria:

* patients with infection or severe inflammation at the intended treatment sites
* patients smoking greater than 10 cigarettes per day
* patients with uncontrolled diabetes mellitus
* patients with uncontrolled metabolic diseases
* patients who received radiation treatment to the head in the past 12 months
* patients needing bone grafting at the intended treatment sites
* patients known to be pregnant at screening visit
* patients with para-functional habits like bruxing and clenching

Primary outcomes:
measure: Cumulative success rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: UNICOC
Study officials:
affiliation: Institucion Universitaria Colegios de Colombia
name: Jorge Arango, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03408379: Impact of Platelet Activation in Intracranial Aneurysm Rupture Risk - PLAQRAN
Official title: Impact of Platelet Activation in Intracranial Aneurysm Rupture Risk - PLAQRAN
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Aneurysms
Ruptured Aneurysm
Keywords: intracranial aneurysms
ruptured aneurysm
platelet activity
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2018-01-24
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients presenting a single or multiple intracranial aneurysm for which an intervention is planned (endovascular treatment or surgery)

Brief summary: Sub arachnoid hemorrhage consecutive to intracranial aneurysm rupture is a devastating disease. Predictors of intracranial aneurysm rupture are limited and focus mainly on size and location. Platelet activation may have a deleterious role on aneurysm rupture. The assumption is that patients with ruptured intracranial aneurysm will present a higher rate of platelet activation compared to patients with non ruptured aneurysms.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 and over
* Patient presenting a single or multiple aneurysm
* Patient presenting an intracranial aneurysm for which an intervention is planned (endovascular treatment or surgery) : elective intervention for an unruptured aneurysm or emergency surgery for a broken aneurysm

Exclusion Criteria:

- Pregnant or breast feeding woman

Primary outcomes:
measure: Proportion of patients with platelet activation
timeFrame: in the 7 days before embolisation
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
References:
Clinical trial NCT04872179: International Registry of Patients With Alpha Thalassemia
Official title: International Prospective Registry of Patients With Alpha Thalassemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alpha-Thalassemia
Alpha Thalassemia Major
Alpha Thalassemia Minor
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 500
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 will be either self-enrolled, or enrolled through their prenatal provider (obstetrician, genetic counselor) or postnatal provider (hematologist, pediatrician).

Brief summary: This is an international prospective registry of patients with Alpha thalassemia to understand the natural history of the disease and the outcomes of fetal therapies, with the overall goal of improving the prenatal management of patients with Alpha thalassemia.

Detailed description: The aim of this registry is to prospectively and retrospectively collect data on patients who are diagnosed with alpha thalassemia major and other alpha thalassemia mutations. Data collected will be used to:

1. Identify patient outcomes of therapies.
2. Improve clinical management of patients with ATM.
3. Improve medical decision making.
4. Improve quality of care.

Eligibility criteria: Inclusion Criteria:

* diagnosis of alpha thalassemia (prenatal or postnatal) with genotype consistent with ATM or BHFS phenotype
* referred to the University of California, San Francisco Fetal Treatment Center for fetal diagnosis, management and/or evaluation for the ongoing in utero stem cell transplantation clinical trial

Exclusion Criteria:

- none

Primary outcomes:
measure: Survival to birth
timeFrame: 6 months
measure: Vineland-3 Adaptive Behavior Scale
timeFrame: 10-15 years
Secondary outcomes:
measure: Gestational age at birth
timeFrame: 6 months
measure: Mechanical ventilation
timeFrame: 1 year
measure: Length of hospitalization
timeFrame: 6 months-1 year
measure: Resolution of hydrops
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Tippi C MacKenzie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kreger EM, Singer ST, Witt RG, Sweeters N, Lianoglou B, Lal A, Mackenzie TC, Vichinsky E. Favorable outcomes after in utero transfusion in fetuses with alpha thalassemia major: a case series and review of the literature. Prenat Diagn. 2016 Dec;36(13):1242-1249. doi: 10.1002/pd.4966. Epub 2016 Dec 7.