louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01220141: Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B
Official title: Prospective Observational Study on NovoSeven® Room Temperature Stable (VII25) in Patients With Haemophilia A or B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-10-13
Enrollment: 51
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male patients with haemophilia A or B with inhibitors treated with room temperature stable NovoSeven® (activated recombinant human factor VII).

Brief summary: This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX
* Treated with room temperature stable NovoSeven®

Primary outcomes:
measure: Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory
timeFrame: after 25 exposure days
Secondary outcomes:
measure: Adverse events reported as potentially related to activated recombinant human factor VII
timeFrame: after 25 exposure days
Other outcomes:
Locations:
city: Prov. de Buenos Aires
country: Argentina
city: Vienna
country: Austria
city: Brussels
country: Belgium
city: Paris La défense cedex
country: France
city: Mainz
country: Germany
city: Budapest
country: Hungary
city: Teheran
country: Iran, Islamic Republic of
city: Dublin 2
country: Ireland
city: Rome
country: Italy
city: Warszawa
country: Poland
city: Paco de Arcos
country: Portugal
city: Bratislava
country: Slovakia
city: Malmö
country: Sweden
city: Crawley
country: United Kingdom
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02568241: Interferon-α After DLI for the Prevention of Relapse
Official title: Interferon α After Prophylactic Donor Lymphocyte Infusion for the Relapse Prevention After Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Leukemia
Keywords: Interferon Alfa-2b
Relapse
Donor lymphocyte infusion
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 42
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aimed to evaluate the efficacy of interferon α after prophylactic donor lymphocyte infusion (DLI) among high-risk acute leukemia patients undergone unmanipulated blood and marrow transplantation. Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for high-risk acute leukemia (AL). However, post-transplant relapse can occur in some patients, and the prognosis of these patients is usually very poor.Prophylactic DLI can decrease the risk of relapse of high-risk AL patients. Interferon α-2b exerts a relatively strong immunomodulatory effect. It can kill AL cells by regulating T-cell and/or natural killer cell functions.Consequently, interferon α-2b may have potential value for high-risk AL patients after transplantation. The study hypothesis: Using interferon α-2b after prophylactic DLI following hematopoietic stem cell transplantation in patients with high-risk AL can further reduce relapse rate and improve leukemia-free survival.

Detailed description: High risk acute leukemia patients (except t(9;22)(q34; q11) cytogenetic abnormalities.) received interferon α-2b after prophylactic DLI at day 30-60 after unmanipulated blood and marrow transplantation. The end points were safety, leukemia-free survival, and immunologic response. Following time is 12 months.

Eligibility criteria: Inclusion Criteria:

* Patients who had high-risk acute leukemia after hematopoietic stem cell transplantation

Exclusion Criteria:

* Patients with t(9;22)(q34; q11) cytogenetic abnormalities;active graft-versus-host disease; active infection; organ failure, or relapse

Primary outcomes:
measure: Leukemia free survival
timeFrame: Participants will be followed for an expected average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Hematology,Beijing
state: Beijing
Study officials:
affiliation: Peking University Institute of Hematology
name: Xiao-Jun HUANG, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04913441: Manual Therapy vs Stretching vs Routine Physical Therapy in Nonspecific Chronic Neck Pain
Official title: Effects of Manual Therapy Versus Stretching Versus Routine Physical Therapy on Pain, ROM, and Functional Disability in Restaurant Chef Workers With Nonspecific Chronic Neck Pain: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck pain
Manual therapy
Stretching exercises
Physical Therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to analyze the effect of Mulligan technique vs stretching techniques and vs routine physical therapy on pain ,range of motion(ROM) and functional disability among restaurant chefs with non-specific chronic pain.

Detailed description: Neck pain (NP) is one of the basic musculoskeletal issues. Neck pain can be due to stress about the musculoskeletal framework because of postural problems and may be related with different causes, such as: - Intervertebral disc herniation, -nerve compression -fracture.

Nonspecific neck pain is a pain located in the lateral and posterior neck that does not show pathognomonic signs and symptoms. When the duration of symptoms is greater than 12 weeks of evolution, it acquires the value of chronicity, being denominated non-specific chronic neck pain (NCNP). It is a common disorder, which generates a great impact and socio-economic cost .

In this study we evaluate the comparison of manual physical therapy vs routine physical therapy vs stretching physical therapy effects among restaurants chefs having non-specific chronic pain.

Eligibility criteria: Inclusion Criteria:

* Neck pain for atleast 3 months having no :

  * Neurological Problem
  * Rheumatological Problem
  * Patient had taken any analgesic medication for neck pain for last 3 months.
  * Non specific neck pain
  * Age 18-60 years

Exclusion Criteria:

* Neck pain due to,

  * Tumors
  * Ankylosings Spondylitis
  * Fracture
  * Dislocation
  * Presence of cord compression
  * Vertebrobasilar artery insufficiency
  * Osteoprosis OR Osteopenia
  * Long term use of anticoagulant or corticosteroid drugs
  * Pain due to any congenital deformity, inflammation or any infection
  * Carcinoma

Primary outcomes:
measure: Visual Analog scale (VAS)
timeFrame: 3 months
measure: Bubble inclinometer
timeFrame: 3 months
Secondary outcomes:
measure: Neck disability Index (NDI)
timeFrame: 3 months
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab Pakistan
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT02270541: Prehospital Study at the Universitair Ziekenhuis Brussel II
Official title: Single-center Clinical Trial Evaluating the Efficacy, Safety, Feasibility, Reliability, and Cost-effectiveness of In-ambulance Telemedicine for Patients With Suspicion of Acute Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Telemedicine
Prehospital
Emergency Medicine
Stroke
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: Vrije Universiteit Brussel
name: Brussels Institute for Research and Innovation (INNOVIRIS)
name: King Baudouin Foundation
First posted: 2014-10-21
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Interventional prospective randomized open blinded end-point (PROBE) single-center clinical trial on the evaluation of the efficacy, safety, feasibility, reliability, and cost-effectiveness of in-ambulance telemedicine for patients with suspicion of acute stroke.

Detailed description: The purpose of PreSSUB II is to evaluate the efficacy, safety, feasibility, reliability and cost-effectiveness of in-ambulance telemedicine during Paramedic Intervention Team transportation of patients with suspicion of acute stroke.

The implementation of expert stroke support in the pre-hospital arena using in-ambulance telemedicine is an innovative approach that opens up new perspectives and allows continuous guidance by a stroke specialist throughout the acute stroke care continuum.

Eligibility criteria: Inclusion Criteria:

* Emergency transportation by the Paramedic Intervention Team of the Universitair Ziekenhuis Brussel
* Age \>= 18 years
* Suspicion of acute stroke with symptom onset \< 12 h or unknown, based on any of the symptoms mentioned in the Belgian manual for medical regulation of pre-hospital care: Hemiparesis, Facial asymmetry, Speech disturbance, Sudden, severe headache, or Confusion.

Exclusion Criteria:

* Patients for whom in-ambulance telemedicine consultation would delay any diagnostic or therapeutic intervention.

Primary outcomes:
measure: Call-to-brain imaging time
timeFrame: within 2 hours
Secondary outcomes:
measure: Medical events during in-ambulance telemedicine
timeFrame: within 2 hours
measure: Recanalisation therapy
timeFrame: upto 8 hours
measure: Clinical outcome
timeFrame: upto 12 months
Other outcomes:
measure: Mortality
timeFrame: upto 100 days
measure: Adverse event
timeFrame: upto 12 months
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Jacques De Keyser, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02911441: Evaluating CBT Delivered by Community Health Workers on Maternal Mental Health and Infant Cognitive Development in Insecure Environments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maternal Anxiety
Maternal Depression
Infant Cognitive Development
Lead sponsor: Heartland Alliance
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 262
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates a cognitive behavioral therapy intervention for mothers with symptoms of anxiety and depression living in insecure environments using a randomized controlled methodology. Key outcomes of interest include maternal mental health and infant cognitive development. The intervention will be delivered by community mental health workers who will be trained to administer 8 to 12 cognitive behavioral therapy sessions.


Eligibility criteria: Inclusion Criteria:

* Women in their third trimester of pregnancy
* Who exhibited symptoms of anxiety and depression

Exclusion Criteria:

* Women who express suicidality

Primary outcomes:
measure: Symptoms of anxiety and depression as measured by Hopkins Symptoms Checklist
timeFrame: 10 months post-birth of their infant
measure: Infant Cognitive Development as measured by Mullen Scales of Early Learning
timeFrame: 10 months post-birth
Secondary outcomes:
Other outcomes:
Locations:
city: Bukavu
country: Congo, The Democratic Republic of the
facility: Heartland Alliance International
state: South Kivu
Study officials:
affiliation: Heartland Alliance International
name: Constantin Kahorha
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05146141: Bent-arm Throw and Tennis Performance
Official title: The Relationship Between Bent-arm Throw and Tennis Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tennis Serve Performance
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 64
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to explore the relaitonship betwenn bent-arm throw and tennis serve performance.

Young players (9-12 years) will be assessed at the beginning of the season and at mid-season to measure the accuracy, the speed and the gesture of tennis serve. During a mid-season, they will have to perform a bent-arm throw warm-up program 5 minutes before each training session to increase their ability to throw.


Eligibility criteria: Inclusion Criteria:

* age between 9 and 12
* playing tennis at least 2 times a week

Exclusion Criteria:

* history of shoulder injury or shoulder pain

Primary outcomes:
measure: Serve velocity
timeFrame: change between the beginning and the end of the season (6 months)
measure: Serve precision
timeFrame: change between the beginning and the end of the season (6 months)
measure: Serve bidimensional movement
timeFrame: change between the beginning and the end of the season (6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Université de Liège
Study officials:
References:
Clinical trial NCT06866041: Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance
Official title: Biological Pathways and Next-Generation Imaging Features Predicting Prostate Cancer Progression in Active Surveillance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low-Risk Prostate Cancer
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 74
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to identify patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance who are at higher risk of upgrading to ISUP Grade Group 2 or higher at confirmatory biopsy one year after diagnosis. Patients with low-risk ISUP GG1 tumors will be selected and undergo:

* PSMA PET with calculation of SUVmax and PRIMARY-Likert score
* Whole Exome Sequencing (WES) analysis on diagnostic prostate biopsies
* Immunohistochemistry on diagnostic prostate biopsies
* Confirmatory biopsy one year after diagnosis, as recommended by international guidelines This prospective, monocentric, single-arm interventional study will assess the predictive accuracy of a multivariable model integrating next-generation imaging and molecular biomarkers to improve risk stratification in active surveillance patients.


Eligibility criteria: Inclusion Criteria:

* Histologically proven low-risk PCa (PSA ≤10 ng/ml; clinical stage ≤T2a, and biopsy ISUP GG 1)
* Non-metastatic status at study inclusion (patient enrollment).
* No prior or concomitant androgen deprivation therapy
* Ability to understand a written informed consent and willingness to sign it.

Exclusion Criteria:

* Unable to tolerate a PSMA-PET scan
* Unwillingness to be managed with AS
* Receipt of neoadjuvant or curative-intent therapies
* Pacemaker
* Inability to obtain the FFPE prostate biopsy specimens from the initial biopsy

Primary outcomes:
measure: Assessment of the Discriminative Ability of a Multivariable Model in Predicting Prostate Cancer Upgrading in Low-Risk Patients Under Active Surveillance"
timeFrame: Baseline diagnostic biopsy and 12 months after diagnosis (when the confirmatory biopsy will be performed)
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT02362841: Assessment of the Evolutions of Transcutaneous CO2 With the Modification of Blood Flow During On-pump Cardiac Surgery
Official title: Assessment of the Evolutions of Transcutaneous CO2 With the Modification of Blood Flow During On-pump Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PtCO2, Extracorporeal Ventilation
Lead sponsor: European Georges Pompidou Hospital
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 41
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: Patients scheduled for cardiac surgery under cardiac arrest and cardiopulmonary bypass were prospectively included in the present observational study conducted at a French teaching hospital.

Brief summary: There are no available criteria for determining the optimal flow rate and mean arterial pressure level in patients under cardiopulmonary bypass (CPB). Transcutaneous carbon dioxide tension (PtCO2) has been proposed for microcirculation monitoring and it could be useful for guiding hemodynamic optimization under CPB. The goal of this exploratory study was to determine the factors that influence PtCO2 variations during CPB.

DESIGN: Cutaneous ear lobe CO2 tension was monitored along with hemodynamic parameters every 10 minutes during CPB, until aortic unclamping. SETTING: French university teaching hospital PARTICIPANTS: Patients scheduled for cardiac surgery requiring CPB were prospectively included.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for cardiac surgery under cardiac arrest and cardiopulmonary bypass were prospectively included in the present observational study conducted at a French teaching hospital.

Exclusion Criteria:

* The exclusion criteria were: age \<18, pregnancy, septic or emergency surgery.

Primary outcomes:
measure: PtCO2
timeFrame: intraoperative value
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03603041: Nutrition, Body Composition, and Sleep
Official title: The Effect of Protein and Omega-3 Fatty Acid Supplementation on Body Composition, Sleep, Cardiometabolic Health and Strength in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Body Composition
Strength
Insulin Sensitivity
Energy Expenditure
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 45
Sex: FEMALE
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the research is to determine if protein and omega-3 fatty acid supplementation improve sleep, improve body composition, and improve markers of metabolic health in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

- Postmenopausal women (12+ months following last reported menstrual cycle)

Exclusion Criteria:

* food allergies
* diet restrictions
* do not habitually eat breakfast
* picky eaters\\regularly consume protein or omega-3 related supplements
* consume omega-3 fatty acid rich fish (tuna, salmon, etc.) greater than two times per month -have any other diet-related conditions that would prevent them from consuming whey protein supplements and/or omega-3 fatty acid supplements
* smoking
* habitual alcohol consumption (\> 4 drinks/week)
* medication impacting appetite or metabolism
* Lipid or blood pressure lowering medication
* Hormone replacement therapy

Primary outcomes:
measure: Sleep Quality
timeFrame: Change in sleep quality from baseline (day 0) to 16 weeks.
Secondary outcomes:
measure: Dietary intake
timeFrame: Change in dietary intake from baseline (day 0) to 16 weeks.
measure: Sleep Quantity
timeFrame: Change in sleep quantity from baseline (day 0) to 16 weeks.
measure: Body composition
timeFrame: On day 1 and day 112 (final day of 16-week intervention) of study.
measure: Resting energy expenditure (REE)
timeFrame: On day 1 and day 112 (final day of 16-week intervention) of study.
measure: Orexin
timeFrame: On day 1 and day 112 (final day of 16-week intervention) of study.
Other outcomes:
measure: Mood
timeFrame: Change in sleep quality from baseline (day 0) to 16 weeks.
measure: Strength
timeFrame: On day 1 and day 112 (final day of 16-week intervention) of study.
measure: Glucose
timeFrame: On day 1 and day 112 (final day of 16-week intervention) of study.
measure: Insulin
timeFrame: On day 1 and day 112 (final day of 16-week intervention) of study.
measure: Blood lipids
timeFrame: On day 1 and day 112 (final day of 16-week intervention) of study.
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Jamie I Baum, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06457841: Black Adult Resilience Study
Official title: Effects of Direct and Vicarious Discrimination on Alcohol and Cannabis Cravings: Virtual Reality Experiment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use
Cannabis Use
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-06-13
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Alcohol and cannabis are the most misused psychoactive substances in the United States, and their misuse among African American young adults has the potential to be especially problematic. The proposed research examines how daily and racial stressors (e.g., racism and discrimination) may lead to alcohol and cannabis use among African American young adults, and what individual and community coping and resources mitigate this causal effect. This research is designed to identify possible targets for culturally responsive prevention and treatment efforts to help prevent and reduce alcohol and cannabis use among African American young adults.


Eligibility criteria: Inclusion Criteria:

* Identify as Black, African American, or Afro-Caribbean
* Proficient in English
* Alcohol and/or cannabis use at least 4 times in past month
* Endorse having used alcohol and/or cannabis to cope

Exclusion Criteria:

* Having participated in similar studies by the research team
* Obtain cut-off scores on measures indicating possible alcohol and/or cannabis use disorder
* In or seeking treatment for alcohol and/or cannabis use disorder

Primary outcomes:
measure: Momentary Alcohol and/or Cannabis Craving
timeFrame: Immediately after the intervention (i.e., within 1 minute)
measure: Duration of Alcohol and Cannabis Intoxication
timeFrame: 48 Hours Post-Intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: P. Priscilla Lui, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: