louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03020862: Beetroot Juice - Effects on Performance in Chronic Obstructive Pulmonary Disease Patients
Official title: Beetroot Juice - Effects on Performance in Chronic Obstructive Pulmonary Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Moderate
Keywords: Dietary nitrate
Physical performance
Blood pressure
Nitrite
Exercise
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose is to evaluate exercise performance in patients with Chronic Obstructive Pulmonary Disease (COPD) after supplementing with higher doses of dietary NO3-, compared to previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity level.

Detailed description: The purpose is to evaluate exercise performance in patients with Chronic Obstructive Pulmonary Disease (COPD) using the 6-minute walk test (6MWT) after supplementing with higher doses of dietary NO3- compared to previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity level.

Eligibility criteria: Inclusion Criteria:

* Moderate-severe Chronics Obstructive Pulmonary Disease (COPD) (FEV1 \<80% of predicted).

Exclusion Criteria:

* Smoking,
* failure to complete physical testing,
* on-going participation in rehabilitation programs,
* pacemaker or use of nicotine products,
* oxygen mask,
* beta blockers,
* antibacterial mouthwash,
* chewing gum or stomach-neutralizing medicine during the intervention.

Primary outcomes:
measure: Physical performance on 6-min walk test (6MWT)
timeFrame: 6 minutes
Secondary outcomes:
measure: Blood Pressure
timeFrame: At baseline and 150 minutes after consumption of beverages
measure: Plasma Nitrite concentration
timeFrame: Baseline, 150 and 210 minutes after consumption of beverages
measure: Oxygen consumption during submaximal cycling
timeFrame: Two trials of 6 minutes duration (10 min break between trials)
measure: Physical activity level
timeFrame: Six days
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Sport Science, Department of Public Health, Aarhus University
Study officials:
affiliation: Aarhus University, Department for Public Health, Section for Sport Sciene
name: Mette Hansen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01559662: Effect of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery
Official title: A Prospective Randomized Controlled Trial of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery in Patients Managed With Early Enteral Feeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Ileus
Keywords: chewing gum
ileus
gastrointestinal function
colorectal surgery
abdominal surgery
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Purpose of this study is to evaluate the effect of gum chewing on recovery of gastrointestinal function in patient undergoing major colorectal surgery. The investigators hypothesize that patients who chew gum after major colorectal surgery will have faster recovery of gastrointestinal function.


Eligibility criteria: Inclusion Criteria:

* Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form
* American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
* Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy

Exclusion Criteria:

* Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
* American Society of Anesthesiologists (ASA) Class IV or V;
* History of abdominal carcinomatosis
* History of radiation enteritis
* Children \< 18 or adults \> 85 years of age

Primary outcomes:
measure: Time (in hours) to tolerating a low residue diet
timeFrame: 30 day postoperative period
Secondary outcomes:
measure: Time (in hours) to passage of flatus
timeFrame: 30 day postoperative period
measure: Time (hours) to first bowel movement
timeFrame: 30 day postoperative period
measure: Daily Appetite Assessment
timeFrame: Postoperative day 1 - 7
measure: Daily pain assessment
timeFrame: Postoperative day 1 - 7
measure: Daily nausea assessment
timeFrame: Postoperative day 1 - 7
measure: Major or Minor Medical and Surgical Complications
timeFrame: 30 day postoperative period
measure: Length of postoperative hospitalization in days
timeFrame: Duration of postoperative hospitalization (expected average of 5 days)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Phillip Fleshner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04860362: Pilot Randomized Control Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1
Official title: Effectiveness of a Telehealth Group for Improving Peer Relationships for Adolescents With Neurofibromatosis Type 1
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurofibromatosis 1
Social Skills
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: NF Midwest
name: NF Northeast
First posted: 2021-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a pilot randomized control trial of the UCLA PEERS protocol delivered via Telehealth with teens with neurofibromatosis type 1 whose parents report that they have difficulty making and keeping friends.


Eligibility criteria: Inclusion Criteria:

* Physician diagnosis of neurofibromatosis type 1
* Age 12-17
* Main language spoken in the home is English
* Reliable internet access
* Current functional impairment in peer relationships
* Teen is interested and motivated to participate

Exclusion Criteria:

* Main language spoken in the home is not English
* Cognitive or developmental difficulties that affect reading comprehension or understanding of treatment material
* Significant behavioral concerns
* Other comorbid medical conditions
* Major surgery in past 6 months
* Prior social skills group treatment within past 6 months
* Prior participation in PEERS

Primary outcomes:
measure: Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
timeFrame: within 4 weeks of PEERS completion
measure: Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)
timeFrame: within four weeks of PEERS completion
measure: Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
timeFrame: 16 weeks following PEERS completion
measure: Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Parent
timeFrame: within four weeks of PEERS completion for treatment group
Secondary outcomes:
measure: Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)
timeFrame: within 4 weeks following PEERS completion
measure: Social Responsiveness Scale -2 (SRS-2; Constantino, 2005)
timeFrame: 16 weeks following PEERS completion
measure: Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen
timeFrame: within 4 weeks of PEERS completion
measure: Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) Teen
timeFrame: 16 weeks following PEERS completion
Other outcomes:
measure: Peds QL (Varni et al, 2002) Parent
timeFrame: within 4 weeks of PEERS completion
measure: Peds QL (Varni et al, 2002) Teen
timeFrame: within 4 weeks of PEERS completion
Locations:
city: Milwaukee
country: United States
facility: University of Wisconsin-Milwaukee
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Bonnie Klein-Tasman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02148562: Assessment of Hepatitis B Virus Intra-host Population and Host-specific Immune Marker Diversity
Official title: Assessment of Hepatitis B Virus Intra-host Population and Host-specific Immune Marker Diversity With Next-generation Sequencing: From Chronic Infection to End-stage Liver Disease and Liver Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Hepatitis B, Chronic
End Stage Liver Disease
Carcinoma, Hepatocellular
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2014-05-28
Enrollment: 274
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver disease related to Hepatitis B in a pre-advanced (chronic infection) and advanced stage (end-stage liver diseases) treated at the Hepatology Department of University Hospital of Leuven

Brief summary: In this project proposal, the investigators will investigate the genetic alterations of Hepatitis B Virus (HBV) strains circulating in Belgian patients who developed end stage liver disease. Additionally, the investigators will compare and link these data sets with three genetic factors involved in immune system response.

Detailed description: This project proposes to identify and characterize the genetic alterations associated with intra-host evolution of HBV from a chronically infection status to an end-stage liver disease status.

Eligibility criteria: Inclusion Criteria:

Study group:

* Clinical diagnosis of advanced liver disease related to chronic Hepatitis B infection (cirrhosis, hepatocellular carcinoma,..)
* Availability of serum samples

Control group:

* Clinical diagnosis of liver disease related to chronic Hepatitis B infection in a pre-advanced stage
* Matched demographic and geographic characteristics to study group
* Availability of serum samples

Exclusion Criteria:

* Liver disease caused by other hepato-tropic viruses
* Patients with auto-immune diseases

Primary outcomes:
measure: genetic variants of Hepatitis B
timeFrame: 6 months
Secondary outcomes:
measure: genetic variation in host-specific immune markers
timeFrame: at day of enrollment
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven campus Gasthuisberg
state: Flemish Brabant
Study officials:
affiliation: UZ Leuven campus Gasthuisberg, Herestraat 49. 3000 Leuven, Belgium
name: MahmoudReza Pourkarim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06285162: Analgesia Nociception Index to Explore Autonomic Nervous System in Patients With Continuous Renal Replacement Therapy
Official title: Analgesia Nociception Index and Autonomic Nervous System Exploration During Continuous Renal Replacement Therapy in Intensive Care Patients.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Critically Ill
Renal Replacement Therapy
Keywords: Analgesia Nociception Index
R-R interval
autonomic nervous system
haemodynamic
fluid removal
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 30
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: Critically ill patients with continuous renal replacement therapy, fluid overload and haemodynamically stable.

Brief summary: The Analgesia Nociception Index (ANI) reflects the balance between sympathetic and parasympathetic tone. It is based on a specific interpretation of the R-R interval variation. During fluid removal by net ultrafiltration in patients with fluid overload and continuous renal replacement therapy, some data suggest that haemodynamic variation could be induced by the autonomic nervous system. The study aims to investigate ANI variations in this context and their association with the haemodynamic variations observed.


Eligibility criteria: Inclusion Criteria:

* Continuous renal replacement therapy in intensive care unit
* Initiation of net ultrafiltration according to the protocol of the department or to EARLYDRY study (NCT 05817539) (3 criteria required):

  * Fluid overload \> 5% or peripheral oedema
  * Noradrenaline equivalent \<0.5μg/kg/min
  * No peripheral hypoperfusion
* Invasive blood pressure monitoring
* Central venous line in superior vena cava territory
* Regular sinus rhythm
* Patient awake or Richmond Agitation and Sedation Scale \> -3

Exclusion Criteria:

* Ongoing administration of inotropes
* Ongoing administration of beta blockers
* Current administration of alpha-2 agonists
* History of dysautonomia
* Pregnant or breast-feeding woman
* Mechanical circulatory assistance
* Opposition to participate
* Adults under legal protection
* Persons deprived of their liberty by judicial or administrative decision

Primary outcomes:
measure: Percentage of changes in ANI.
timeFrame: 6 hours after initiation of net ultrafiltration
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel
Study officials:
affiliation: Département d'anesthésie-réanimation, Hôpital cardiologique Louis Pradel, HCL
name: Martin RUSTE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02311062: Compatibility of Different Injury Prevention Exercises in Athletes
Official title: Effects of Two Different Injury Prevention Resistance Exercise Protocols on the Hamstring Torque-Angle Relationship: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury Prevention
Keywords: training, soccer, eccentric, lengthening, unstable, squatting
Lead sponsor: University of Greenwich
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This investigation is aimed to examine the effects of two different exercise-oriented protocols on the knee torque-angle relationship of the knee flexors.

Thirty two young soccer players were be randomly assigned to three groups: hamstring-eccentric (ECC, n=11), unstable-squatting (UNS, n=11) or control (C, n=10). The ECC and UNS groups performed eighteen sessions over 6 weeks of an injury prevention protocol, using only 3 hamstring-eccentric or unstable-squatting exercises. The angle-torque relationship was measured before and after the training intervention. Voluntary isometric torque was recorded at six test angles, with participants prone (35º-100º; 0º on full extension).

Detailed description: This study utilized a three parallel-groups randomized controlled design, where 3 between-participant conditions, ECC, UNS and C, were tested. Once considered eligible for the study, all participants were familiarized with the testing procedures. Participants attended the laboratory for a pre-training test session, where body mass, height and muscle functional parameters were recorded. Two days after their pre-test, participants including in ECC or UNS started a 6 weeks (18 sessions) training program while the control group did not perform any type of resistance training.

Nevertheless, during the 6 weeks intervention period all three groups continued with their normal recreationally physical activity consisting in 2 to 3 sessions per week of soccer training or friendly matches. Two days after the end of the intervention period muscle function was re-tested.

Eligibility criteria: Inclusion Criteria:

* males, recreationally trained football players
* Read and sign the informed consent

Exclusion Criteria:

* Participants that has undertaken a lower body resistance-training program in the preceding 6 months,
* Reported a previous lower limb injury

Primary outcomes:
measure: knee torque-angle
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06034262: Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint Osteoarthritis
Official title: Evaluation of the Treatment of Symptomatic Proximal InterPhalangeal (PIP) Joint Osteoarthritis with a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Osteoarthritis Hand
Keywords: Proximal InterPhalangeal Joint (PIPJ)
OsteoArthritis (OA)
Lead sponsor: TBF Genie Tissulaire
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this open, prospective, multicenter trial is to evaluate the use of a sterile, devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition in the treatment of PIP joint osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Male or female; age between 18 and 75 years.
* Patient with symptomatic PIPJ OA.
* Patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention.
* Patient with a QuickDash score \> 33 points (converted to 50%).
* Patient with pain, at rest, in the PIPJ ≥ 4/10 on a VAS.
* Patient who received the study information and provided consent.
* Member or beneficiary of a national health insurance plan.

Exclusion Criteria:

* Pregnant or breastfeeding woman; woman without effective contraception.
* Patient with signs of neuropathy with functional disorders such as hyperesthesia.
* Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia.
* Person confined by a judicial or administrative decision.
* Adult subjected to legal protection measures or unable to provide his/her consent.

Primary outcomes:
measure: Change in the symptomatology related to the PIPJ OA
timeFrame: 12 months
Secondary outcomes:
measure: Absence of toxicity
timeFrame: Through study completion (12 months)
measure: Change in pain related to PIPJ OA
timeFrame: 1 month, 3 months, 6 months, 12 months
measure: Change in the treated finger mobility
timeFrame: 3 months, 6 months, 12 months
measure: No apparent joint space anomaly
timeFrame: 12 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Lyon
country: France
facility: Institut Chirurgical de la Main et du Membre Supérieur
city: Nantes
country: France
facility: Centre de la Main - Clinique Jules Verne
Study officials:
References:
Clinical trial NCT03343262: Mechanisms Underlying the Regulation of Impaired Glucose Tolerance by Auricular Concha Electro-acupuncture
Official title: Mechanisms Underlying the Regulation of Impaired Glucose Tolerance by Auricular Concha Electro-acupuncture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Impaired Glucose Tolerance
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 158
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Impaired Glucose Tolerance (IGT) is an abnormal metabolic state following glucose metabolic steady state but prior to diabetes. IGT is an important stage during the progression of diabetes, with an underlying mechanism of insulin resistance and pancreatic β cell dysfunction. IGT is one of the diseases that shows significant beneficial response to acupuncture treatment. Original findings from the investigators'laboratory show that transcutaneous auricular vagus nerve stimulation (taVNS) which is innervated by vagus nerve, would enhance the activity of pancreatic β cells, promote the secretion of insulin, upregulate the expression of insulin receptors in central as well as peripheral tissues, thus to improve glycometabolism. In this study, the investigators would further illuminate the mechanism of taVNS at "yidan-pi" auricular acupoints on the regulation of glucose metabolism, its improvement of the IGT state in rat model, as well as its regulation effect on insulin receptor expression and insulin resistance, and systematically illustrate the clinical effective of this treatment on IGT, with emphasize on its influence on the concentrations of glucose and HbA1c, and thus provide an effective proposal for clinical acupuncture.


Eligibility criteria: Inclusion Criteria:

* ages between 20 and 70
* fasting plasma-glucose(FPG) less than 7 mmol/L, or 2h p-glucose 7.8-11.1 mmol/L
* anti-diabetic medication of any kind
* able to provide informed consent

Exclusion Criteria:

* comorbidities that would prohibit participation in study procedures, including cardiovascular disease, hematological system disease or psychosis
* females of childbearing potential who were pregnant, breast-feeding
* infection within the 1 month
* known or suspected abuse of alcohol or narcotics

Primary outcomes:
measure: FPG
timeFrame: Baseline and 6 week, 12 weeks
measure: OGGT
timeFrame: Baseline and 6 week, 12 weeks
Secondary outcomes:
measure: BMI
timeFrame: Baseline and 12 weeks
measure: A1C
timeFrame: Baseline and 6 week,baseline and 12 weeks
Other outcomes:
measure: pulse
timeFrame: Baseline and 12 weeks
measure: respiration
timeFrame: Baseline and 12 weeks
measure: blood pressure
timeFrame: Baseline and 12 weeks
measure: body temperature
timeFrame: Baseline and 12 weeks
Locations:
Study officials:
affiliation: Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
name: Peijing Rong, doctor
role: STUDY_DIRECTOR
References: