louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00810459: Trilogy Comparison Study - Pediatrics
Official title: Trilogy Comparison Study - Pediatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 6
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study (Part II) will be to compare the performance of the Trilogy device and a conventional ventilator (participant's current device). Both devices will be set to the participants' current mode and prescription settings.

Detailed description: A. Primary Hypothesis and end-point In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable level of gas exchange (measured as partial pressure of carbon dioxide (CO2) in arterial, venous or capillary blood)and peripheral capillary oxygen saturation, (SpO2) levels during various modes of ventilation.

B. Secondary Hypothesis and end-points In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable breathing pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and subjective measures of breathing comfort (measured by modified Borg dyspnea scale).

Eligibility criteria: Inclusion Criteria:

1. Age \> 1years of age; \< 18 years of age
2. Greater than 5 kg
3. Considered clinically stable, with low flow oxygen requirements less than 15 LPM (or FIO2 less than 60 %) and PEEP no greater than 10 cm H2O
4. Requiring mechanical ventilation through nasal/facial mask, tracheostomy or endotracheal tube (ET Tube)

Exclusion Criteria:

1. Clinically unstable, i.e.,

   1. Acute Respiratory Failure
   2. Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents)
   3. Uncontrolled cardiac ischemia or arrhythmias
   4. or as otherwise determined inappropriate for the study as determined by the investigator
2. Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
3. Pregnancy

Primary outcomes:
measure: Comparable Level of Gas Exchange (Measured as Partial Pressure of Carbon Dioxide (CO2) in Arterial, Venous or Capillary Blood)
timeFrame: After one hour of ventilator use
measure: Comparable Level of Gas Exchange for Peripheral Capillary Oxygen Saturation (SpO^2)
timeFrame: After one hour of ventilator use
Secondary outcomes:
measure: Heart Rate
timeFrame: 60 minutes
measure: Minute Ventilation
timeFrame: 60 minutes
measure: Tidal Volume
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Steven Mink, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05017259: Calorie Restriction Diets on Weight Reduction, Post weigh-in Recovery and Exercise Performance in Athletes
Official title: The Metabolomic Exploration of Low-carbohydrate and Calorie Restriction Diet on Weight Reduction, Post weigh-in Recovery and Exercise Performance in Taekwondo Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Reducing
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Low-carbohydrate diets are often used as weight-loss strategies by obese individuals and athletes. This diet has effects on oxidizing fat and suppressing appetite. But short term evidences are still few. In combat sports such as taekwondo, athletes prefer rapid weight loss to achieve a desired weight category. The purpose of this study was to investigate the impact of the low carbohydrate diet combined with strict calorie restriction on body composition and exercise performance in taekwondo athletes.

Detailed description: This study used a randomized cross-over design. Each participant completed a low carbohydrate and a high carbohydrate trial in a random order, separated by a 30-day wash-out period. Each trial comprised of a 7-day weight loss period, followed by an 18-hr recovery period. The purpose of this study was to investigate the effect of 7-day caloric restriction with low- or high-carbohydrate diet, combined with an 18-hr recovery period, on body weight loss and taekwondo-specific performance.

Eligibility criteria: Inclusion Criteria:

* Must have at least 6 years of Taekwondo training experience
* Must have participated in domestic or international competitions

Exclusion Criteria:

* Smoking
* Cardiovascular disease
* Diabetes
* Hypertension
* Any medication in the past 3 months

Primary outcomes:
measure: Body weight in kilograms assessed by air-displacement plethysmography (Bod Pod)
timeFrame: 1 min
measure: Body fat mass in kilograms assessed by air-displacement plethysmography (Bod Pod)
timeFrame: 1 min
measure: Lean body mass in kilograms assessed by air-displacement plethysmography (Bod Pod)
timeFrame: 1 min
Secondary outcomes:
measure: Taekwondo-specific reaction time in seconds assessed by Electromyography (EMG) signals
timeFrame: 1 min
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Taiwan University of Sport
Study officials:
affiliation: Assistant professor
name: Chin Hsu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00989859: Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants
Official title: A Pilot Study Using Photo-plethysmographic (PPG) Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development
Keywords: monitoring
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2009-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infant

Brief summary: The researchers want to determine if ambient light, plethysmographic , can monitor reliably heart rate, respiration rate and oxygen saturation in infant patients in a hospital setting.

Detailed description: The plethysmographic signal is typically strong on children. This provides a reliable heart rate monitor. However, to measure oxygen saturation, a quantitative value of the strength at two wavelength regions (green and red) is required. It is also not known if the normal ambient light is spectrally appropriate to analyze the video signals for oxygenation. With the current prototype of our system, we can monitor heart rate reliably and estimate oxygen saturation in adults, using normal artificial light or daylight, entering through a window. Heart rate and oxygen saturation will be extracted from the plethysmographic signal off the cheek, forehead or hand while the respiration rate may be retrieved from the plethysmographic signal off the chest area.

Eligibility criteria: Inclusion Criteria:

* infant in NICU at CHOC hospital

Exclusion Criteria:

* non-infant

Primary outcomes:
measure: ambient light, PPG can monitor reliably heart rate, respiration rate and oxygen saturation (SpO2)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: CHOC
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Stuart Nelson, MD
role: STUDY_DIRECTOR
affiliation: Beckman Laser Institute University of California Irvine
name: William Verkruysse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04837859: Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma
Official title: Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Classical Hodgkin Lymphoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the trial is to establish an individualized first-line treatment incorporating checkpoint inhibition for early-stage unfavorable cHL, which is effective and well tolerated.

Detailed description: Programmed cell death protein-1 (PD-1) blockade is highly effective and well tolerated in relapsed or refractory cHL and has also demonstrated efficacy in the first-line treatment of cHL in combination with doxorubicin, vinblastine, and dacarbazine (AVD) in the phase II GHSG NIVAHL trial. A relevant proportion of patients achieved an early metabolic complete remission (CR) with anti-PD-1 monotherapy and might not require standard chemo- or radiotherapy. Limiting therapy-associated short- and long-term side effects of these conventional treatments including impaired quality of life, second primary malignancies or organ damage is of utmost importance in the predominantly young cHL patients. This trial will hence further reduce treatment intensity and provide a chemo- and radiotherapy-free therapy to optimally responding patients.

Eligibility criteria: Inclusion Criteria:

* Age 18-60 for the main trial cohort
* Age ≥ 61 years and eligible for AVD as determined by CIRS-G score and investigator for the exploratory cohort
* First diagnosis of treatment-naïve cHL
* Early-stage unfavorable disease (i.e. stage IA, IB and IIA with risk factors a-d, stage IIB with risk factors c-d):

  1. large mediastinal mass
  2. extranodal lesion(s)
  3. elevated erythrocyte sedimentation rate
  4. ≥ 3 nodal areas

     Exclusion Criteria:
* Presence of nodular-lymphocyte predominant Hodgkin lymphoma, grey-zone lymphoma and/or central nervous system involvement of lymphoma

Primary outcomes:
measure: Progression Free Survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: 1st Department of Medicine, Cologne University Hospital
Study officials:
affiliation: 1st Department of Medicine, Cologne Universit Hospital
name: Paul Broeckelmann, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06330259: Does the AMH Concentration Depend on the Menstrual Cycle?
Official title: Ist Die Konzentration Des Anti-Müllerschen Hormons (AMH) abhängig Vom Menstruationszyklus?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reproductive Sterility
Keywords: natural menstrual cycle
AMH
3D ultrasound
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2024-03-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy female women with regular menstrual cycles.

Brief summary: During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH (anti-Muellerian Hormone) will be measured in the serum.

Detailed description: During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH will be measured in the serum. Half of the serum samples will immediately be subjected to hormone analysis whereas the other half will be stored frozen at -80 °C. After conclusion of the study the frozen samples will be subjected to re-measurment again a reference laboratory. The aim is to study the stability of the AMH Elecsys Assay under both conditions. The participants will be health women aged between 18 and 40 years. They will be grouped into a younger and an older group. They will be observed during one menstrual cycle, then they will remain unobserved during a second menstrual cycle, and then again they will be observed during a third menstrual cycle.

Eligibility criteria: Inclusion Criteria:

* regular menstrual cycles, between 24 and 32 d.
* body mass index between 24 and 32 kg/m2
* no HIV, no Hepatitis B and C
* no smoking

Exclusion Criteria:

* intake of reproductive hormones, including birth control pill
* pregnancy or breastfeeding
* infertility
* polycystic ovary syndrome

Primary outcomes:
measure: AMH Elecsys Assay
timeFrame: 3 months
Secondary outcomes:
measure: Effect of handling of the serum on measured AMH concentrations
timeFrame: 3 months
measure: 3D ultrasound of both ovaries
timeFrame: 3 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Christian De Geyter
Study officials:
affiliation: University of Basel
name: Christian De Geyter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04618159: Does Helipyl Eradicate
Official title: Does Helipyl Eradicate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Eradication
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: helipyl is given to patients with non symptomatic helicobacter pylori infection
Primary purpose: DIAGNOSTIC

Brief summary: Helipyl is on the market; actually it is a post-biotic because it is a killed Lactobacillus reuteri DSMZ 17648. The aim is to demonstrate (or not) that this product eradicates helicobacter, which it claims to do.

Detailed description: This is a pilot project. There is quite limited literature on this product and Helicobacter pylori eradication. My personal opinion is that the literature and guidelines are contradictory. The European guideline is that Helicobacter pylori should not be corrected unless there are "serious" symptoms . On the other hand, Helicobacter is a carcinogen. Quite often, parents ask us, children's gastroenterologists, to screen their children for Helicobacter because they are symptomatic and are being eradicated, and know that Helicobacter is contagious. This creates a difficult situation: not answering the question is not an option according to the parents' opinion. Going into the question and eradicating "classic" is against all guidelines.

Hence this pilot project: 10 complaints-free carriers of Helicobacter pylori (\> 5 years) will be treated with Helipyl for one month (product supplied by the company). Beforehand, at the end of the treatment and a month after stopping of the treatment, we do a C13 breath test.

Eligibility criteria: Inclusion Criteria:

* \>5 and \<18 years
* male and female
* asymptomatic helicobacter pylori

Exclusion Criteria:

* helicobacter pylori infection with symptoms
* \<5 years

Primary outcomes:
measure: to evaluate the C13 breathtest
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
state: Brussel Hoofdstedelijk Gewest
Study officials:
References:
Clinical trial NCT04590859: Penile Blood Flow Characteristics Following Caudal or Penile Block
Official title: Penile Blood Flow Characteristics Following Caudal or Penile Block
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Aim of This Study is to Measure Blood Flow Before and After a Block
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 25
Sex: MALE
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: males undergoing circumcision using penile or caudal

Brief summary: Pediatric urologic surgery is generally accompanied by use of a caudal or penile block for analgesia. A caudal block is performed by injecting local anesthetic in the low epidural space while a penile block is performed by injecting local anesthetic above the pubic symphysis. Local anesthetic in the epidural space is known to caudal vasodilation interiorly. It is unknown as to whether this vasodilation results in alteration in flow to the penile tissue and potentially changes tissue characteristics. The aim of this study is to measure blood ultrasound velocity in the dorsal penile artery and vein before and after a block.

Detailed description: Pediatric urologic surgery is generally accompanied by use of a caudal or penile block for analgesia. A caudal block is performed by injecting local anesthetic in the low epidural space while a penile block is performed by injecting local anesthetic above the pubic symphysis. Local anesthetic in the epidural space is known to caudal vasodilation interiorly. It is unknown as to whether this vasodilation results in alteration in flow to the penile tissue and potentially changes tissue characteristics. The aim of this study is to measure blood ultrasound velocity in the dorsal penile artery and vein before and after a block.

Eligibility criteria: Inclusion Criteria:

* Children ages \<7 years undergoing circumcision at TCH Penile or Caudal block to be performed at discretion of anesthesiology/Urology providers
* ASA classification1,2
* use of laryngeal mask airway

Exclusion Criteria:

* Previous cardiac surgery
* Antihypertensive medication
* requirement for intravenous anesthetic
* ASA classification non 1,2
* parental refusal of participation parental refusal of block
* patients requiring intubation

Primary outcomes:
measure: penile blood flow
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas childrens Hospital
state: Texas
Study officials:
References:
Clinical trial NCT04157959: The Drug-Drug Interaction of SHR4640 and Febuxostat in Patients With Hyperuricemia
Official title: A Phase I, Single-Center, Open-Label Study to Evaluate Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat in Patients With Hyperuricemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hyperuricemia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-11-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640 and Febuxostat interaction in patients with Hyperuricemia.


Eligibility criteria: Inclusion Criteria:

1. Subject has a body mass index ≥18 and ≤30 kg/m2;
2. Screening sUA value ≥8mg/dl;
3. Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.

Exclusion Criteria:

1. Subject known or suspected of being sensitive to the study drugs or its ingredient；
2. ALT、AST、TBIL\>ULN;
3. History of kidney stones or screening kidney stones by B-ultrasound；
4. History of malignancy；
5. History of xanthinuria；
6. Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood。

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma
timeFrame: Day1 to Day 14
measure: Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma
timeFrame: Day1 to Day 14
Secondary outcomes:
measure: Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma
timeFrame: Day1 to Day 14
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events
timeFrame: Clinical significant changes from Day-21 up to Day 29
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of QingDao University
state: Shan Dong
Study officials:
References:
Clinical trial NCT00480259: Hyperproteic Nutrition:Correlation of BUN to Nitrogen Balance
Official title: Hyperproteic Nutrition; Correlation of BUN to Nitrogen Balance and Associated Infection Rates With Bimodal Protein Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Feeding
Keywords: blood urea nitrogen
nitrogen balance
nutrition
intensive care
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2007-05-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to determine if the following are true. When protein requirements exceed metabolic requirements, blood urea nitrogen(BUN) levels will rise. Elevated BUN levels in the absence of renal failure, hepatic failure, or GI bleeding, will be correlated with improved nitrogen balance and inversely correlated with infection rates, days of mechanical ventilation, ICU days, and total hospital days.

Detailed description: The purpose of this study is threefold. First, to determine if a correlation exists between BUN and nitrogen balance in the context of hyperproteic nutrition administration. Creatinine clearance will also be followed to determine if there is any harmful effect to the kidney secondary to an elevated BUN. Secondly, to determine if there is a difference in hospital acquired infection rate, ventilator days, ICU days, and hospital stay between the current nutrition standard at Penn State Hershey Medical Center and a hyperproteic nutrition protocol. Thirdly, to determine the accuracy of at least three calculated creatinine clearance formulae when compared to a measured creatinine clearance.

Eligibility criteria: Inclusion Criteria:

* Greater then or equal to 18 years of age and patient in Intensive Care Unit
* Receiving enteral nutrition, with expected duration of at least 5 days
* Blood urea nitrogen and creatinine clearance are part of routine blood work
* Indwelling urinary catheter in place

Exclusion Criteria:

* Renal or hepatic failure
* Current or history(past 6 mos) of GI bleeding
* Serum creatinine on day of screening of equal to or greater then 1.5 mg/dl
* Creatinine Clearance on day of screening of equal to or less then 30ml/min
* Hypovolemia resulting in increased BUN
* Septic shock
* Blood urea nitrogen on day of screening equal to or greater then 30mg/dl

Primary outcomes:
measure: Increase in BUN
timeFrame: Unable to document -incomplete information and investigator no longer at institution; no records available
Secondary outcomes:
measure: Decrease in infection rate, ventilator days, ICU stay and hospital dys
timeFrame: Unable to document -incomplete information and investigator no longer at institution; no records available
Other outcomes:
Locations:
Study officials:
affiliation: Penn State University, College of Medicine, Dept of Anesthesiology
name: John K Stene, MD
role: PRINCIPAL_INVESTIGATOR
References: