louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00240045: The Use of Drugs to Improve Kidney Function in Patients With Liver and Kidney Dysfunction
Official title: The Use of Midodrine, Octreotide and Albumin in Refractory Ascites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Hepatorenal Syndrome
Refractory Ascites
Keywords: Hepatorenal syndrome
Refractory ascites
Midodrine
Octreotide
Albumin
Cirrhosis
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2005-10-17
Enrollment: 9
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome are mediated in part by diminished circulatory volume and that treatment with midodrine, octreotide and albumin can improve renal and patient outcomes by restoring effective circulating volume and systemic perfusion.

Our primary objective is to assess change in creatinine clearance using inulin. We will enroll 15 patients with Type 2 hepatorenal syndrome or refractory ascites once inclusion and exclusion criteria are satisfied. They will be treated for 1 month with octreotide LAR, albumin and midodrine. Renal, serum and neurohormonal parameters will be measured before, during, and after initiation of drug and compared.


Eligibility criteria: Inclusion Criteria:

* Cirrhosis (biopsy or compatible clinical (ascites, varices), laboratory (low albumin, elevated bilirubin, elevated INR) and radiologic data (nodular appearing liver on ultrasound)).

Type 2 hepatorenal syndrome and/or refractory ascites

Exclusion Criteria:

* Secondary causes of renal dysfunction (proteinuria \>500 mg/day, active urinary sediment, abnormal renal ultrasound, nephrotoxic medications) Bacterial infection (positive blood, urine or ascites cultures) within the past 2 weeks Gastrointestinal hemorrhage or encephalopathy within the past 2 weeks Age \<18 Transvenous intrahepatic portosystemic stent shunt (TIPS) Hepatocellular carcinoma beyond the Milan criteria

Primary outcomes:
measure: Improvement in renal function (creatinine)
timeFrame: one month
Secondary outcomes:
measure: Ascites control
timeFrame: one month
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Vincent Bain, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01702545: Determination of Drugs and Their Metabolites in Hospitalized Patients
Official title: Determination of Drugs and Their Metabolites in Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoplasms
Lead sponsor: Klinikum Nürnberg
Sponsor class: OTHER
First posted: 2012-10-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients

Brief summary: The current state of knowledge on the concentration of drugs and their metabolites in the individual human body is not satisfying concerning the question about behavior of drugs in the human body, taking into account individual patient factors such as age, weight and organ dysfunctions.

This projects deals with the question of drug levels in the blood of hospitalized patients.

The aim of this study is to extend the knowledge about the behavior of drugs in the human body significantly, for the safety and benefit of future patients. This also includes to establish a relationship between drug levels in patients and the desired and undesired effects of a drug.

As a result, the future perspective is to find the optimal dose for the individual patient by measuring the blood concentration of a drug.

Detailed description: The primary goal of the study is to gain an overview of the plasma concentrations of relevant drugs which occur in different patient populations and to what extent they are consistent with those concentrations described in the literature.

If the expectation is confirmed, that a significant heterogeneity in the plasma concentrations of these patients exists, the investigators will try to find influencing factors for this circumstance on the basis of routine clinical parameters (height, weight, renal function, concomitant medications, etc.).

Ultimately, this project will identify substances with a high interindividual variability in plasma levels, where drug monitoring might be suggested.

Eligibility criteria: Inclusion Criteria:

* legal capacity

Exclusion Criteria:

* severe anemia

Primary outcomes:
measure: Plasma concentrations [ng/mL] of various drugs at different timepoints
timeFrame: up to five years
Secondary outcomes:
Other outcomes:
Locations:
city: Nürnberg
country: Germany
facility: Dept. of Internal Medicine V, Klinikum Nürnberg Nord
state: Bavaria
Study officials:
affiliation: Paracelsus Medical University Klinikum Nuremberg, Germany
name: Martin Wilhelm, Prof Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT02507245: Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD)
Official title: Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD): Lung Function Parameters Assessment; Quality of Life Assessment; Stress Parenting Assessment (Pneumo GHD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Deficiency
Keywords: GHD
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 48
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 48 children affected by GH deficiency , recruited in the outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.

Brief summary: The aim of this study is to assess the developmental patterns of lung function in children affected by growth hormone deficiency after one year of GH therapy.The assessment by specific questionnaires of quality of life and of parental stress index.Parameters will be evaluated at the time of the diagnosis and after 12 months of GH therapy.

Detailed description: Observational longitudinal study in children affected by idiopathic growth hormone deficiency (GHD): lung function parameters assessment; quality of life assessment; stress parenting assessment (Pneumo GHD). The aim of this study is to assess the developmental patterns of lung function in children affected by growth hormone deficiency after one year of GH therapy.The assessment by specific questionnaires of quality of life and of parental stress index.Parameters will be evaluated at the time of the diagnosis and after 12 months of GH therapy.

Eligibility criteria: Inclusion Criteria:

* GH deficiency

Exclusion Criteria:

* Respiratory infections 4 weeks before the recruitment
* Children with autoimmune diseases
* Therapy with drugs able to modify the lung function

Primary outcomes:
measure: Assessment of the developmental patterns of lung function before and after GH by spirometry
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03579745: Evaluation of Profile Changes and Torque Control in Dental Bimaxillary Proclination Cases Using Lingual Lever Arm Mechanics vs Conventional Lingual Orthodontic Mechanics A Randomized Controlled Trial
Official title: Evaluation of Profile Changes and Torque Control in Dental Bimaxillary Proclination Cases Using Lingual Lever Arm Mechanics vs Conventional Lingual Orthodontic Mechanics A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bimaxillary Proclination
Keywords: lingual orthodontics
Lever arm
En masse retraction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the profile changes and torque control using lingual lever arm vs conventional lingual mechanics. Half of the patients will receive lever arms and the other half will receive conventional lingual orthodontics.

Detailed description: Conventional lingual orthodontic biomechanics leads to torque loss during en masse retraction of the anterior segment in the bimaxillary proclination cases treated by first premolar extraction. Torque loss affects the final outcome of the treatment negatively.

Adding a lever arm to the lingual wire will transmit the point of force application at or apical to the center of rotation which will reduce or eliminate toqrue loss during anterior segment retraction.

Eligibility criteria: Inclusion Criteria:

* Male or female adult patients with age range 18-30 yrs old.
* Class I bimaxillary dentoalveolar proclination.
* Full permanent dentition.
* Good oral hygiene.
* Maximum anchorage is required.
* Healthy bone around the first molars is needed.

Exclusion Criteria:

.Systemic disease.

* Severe crowding.
* Extracted or missing upper permanent tooth/teeth (except for third molars).
* Signs, symptoms or previous history of temporomandibular disorders (TMD).
* Previous orthodontic treatment.

Primary outcomes:
measure: Nasolabial angle
timeFrame: 12 months
measure: Profile convexity reduction
timeFrame: 12 months
Secondary outcomes:
measure: Torque control
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Amr Abuelezz, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01595945: Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate
Official title: Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate in Obese Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: Caloric restriction
Obesity
Gastric bypass
Resting metabolic rate
Lead sponsor: KiloCoach e.U.
Sponsor class: OTHER
Collaborators: name: Hospital Barmherzige Schwestern Vienna
First posted: 2012-05-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Studies in overweight and obese subjects show a decline in resting metabolic rate (RMR) even after moderate caloric restriction. Yet the onset and course of such a metabolic adaption is still unclear. Lower resting metabolic rates were also reported after gastric banding bariatric surgery but have not yet been investigated in subjects after gastric bypass. The purpose of this study is to investigate the consequences on resting metabolic rate in subjects with obesity after moderate caloric restriction or gastric bypass.


Eligibility criteria: Inclusion Criteria:

* BMI ≥30 kg/m2

Exclusion Criteria:

* Marked weight reduction in the last 2 years (\>5% of initial body weight)
* Recent extreme fasting (during the last month)
* Manifest eating disorders (assignment to a specialist for eating disorders)
* Severe psychiatric disorders requiring treatment
* Pregnancy, lactation

Primary outcomes:
measure: Resting metabolic rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Body composition (muscle mass, fat mass)
timeFrame: 24 weeks
measure: Body Mass Index
timeFrame: 24 weeks
measure: Caloric restriction
timeFrame: 24 weeks
measure: Weight loss
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hospital Barmherzige Schwestern Vienna
city: Vienna
country: Austria
facility: KiloCoach e.U.
Study officials:
affiliation: KiloCoach e.U.
name: Rosa Aspalter, MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05663645: Navigating Health Insurance Selection for IVF Benefits
Official title: Navigating Health Insurance Selection for in Vitro Fertilization (IVF) Benefits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: infertility
IVF
health insurance
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effectiveness of an educational intervention on health insurance literacy and utilization of in vitro fertilization (IVF) insurance benefits. The investigators hypothesize that the intervention is acceptable and satisfactory and will result in increased health insurance literacy and utilization of IVF benefits.


Eligibility criteria: Inclusion Criteria:

* Employees eligible for health insurance coverage
* Reproductive aged (18 to 50 years)
* Intention to grow their family in the next year
* Primary language English or Spanish

Exclusion Criteria:

* None

Primary outcomes:
measure: Health Insurance Literacy Measure
timeFrame: 10 months after receipt of the intervention
Secondary outcomes:
measure: Health Insurance Literacy Measure
timeFrame: 1 month after receipt of the intervention
measure: Utilization of IVF services
timeFrame: 10 months after receipt of the intervention
measure: Insurance coverage
timeFrame: 10 months after receipt of the intervention
measure: Out of pocket expenses
timeFrame: 10 months after receipt of the intervention
measure: Financial hardship
timeFrame: 10 months after receipt of the intervention
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: H. Irene Su, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04289545: Postprandial Effects of Functional Bread
Official title: Postprandial Effects of Functional Bread
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates whether bread with added galactomannan, a soluble fiber, can reduce the postprandial glucose response in healthy overweight adults.

Detailed description: This single-blind crossover-designed study wants to investigate the postprandial effect of functional bread in healthy overweight adults. Therefore, four types of bread, consumed by the participants, have added galactomannan in different amounts and viscosities, and one bread is the control bread.

The participants arrive after an overnight fast and before the consumption of bread, a fasting blood sample is taken.

After the ingestion, blood samples are taken at specific times. The area under the curve of the postprandial glucose is expected to differ between the functional breads.

Eligibility criteria: Inclusion Criteria:

* healthy, overweight adults (BMI between 25 and 30 kg/m2)

Exclusion Criteria:

* Known diagnosis of diabetes mellitus type 2
* HbA1c at screening ≥ 48 mmol/mol
* Other chronic diseases (heart disease, cancer) within the last 3 years
* Pregnancy and lactation
* Known drug or alcohol abuse
* Unwilling to follow the study requirements

Primary outcomes:
measure: area under the curve of postprandial glucose
timeFrame: 180 minutes
Secondary outcomes:
measure: area under the curve postprandial insulin
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen, Research Unit for Health Surveys
Study officials:
affiliation: University of Bergen
name: Jutta Dierkes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00981045: Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function
Official title: Randomized Evaluation of Efficacy and Safety of Ferric Carboxymaltose in Patients With Iron Deficiency Anemia and Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency Anemia
Impaired Renal Function
Keywords: IDA
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-22
Enrollment: 2561
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: The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects \> or = to 18 years of age.
* Chronically impaired renal function.
* Screening visit central laboratory hemoglobin \< or = to 11.5 g/dL.
* Screening ferritin \< or = to 100 ng/mL or \< or = to 300 when transferrin saturation (TSAT) is \< or = to 30%.
* If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks prior to randomization.

Exclusion Criteria:

* Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or Venofer.
* Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
* Requires dialysis for treatment of chronic kidney disease OR is being considered for initiation of dialysis during the time period of this trial.
* No evidence of iron deficiency.
* Any non-viral infection.
* AST or ALT at screening as determined by central labs greater than 1.5 times the upper limit of normal.
* Known positive hepatitis with evidence of active disease.
* Received an investigational drug within 30 days of screening.
* Alcohol or drug abuse within the past 6 months.
* Hemochromatosis or other iron storage disorders.
* Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG Performance Status greater than 1.
* Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
* Pregnant or sexually-active female subjects who are not willing to use an acceptable form of contraception.

Primary outcomes:
measure: Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.
timeFrame: Day 56
measure: Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.
timeFrame: Day 120
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals, Inc.
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04292145: Effectiveness of Relaxation Techniques
Official title: Efficacy of an Application as a Relaxation Technique
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress, Psychological
Keywords: breathe
breathing
relax
relaxation
respiration
stress
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of the two groups as they enter the study.
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to assess the validity of a relaxation app. This will be accomplished by obtaining self-report measures about mood and respiratory symptoms. We hypothesize that self-report in the relaxation app condition will be different from that of the relaxation only condition.


Eligibility criteria: Inclusion Criteria:

* Student enrolled in SMU
* Speaks English

Exclusion Criteria:

* Must have an Apple Watch to use during time of participation in the study

Primary outcomes:
measure: Sensations Questionnaire
timeFrame: at study completion, up to 2 years
measure: Positive and Negative Affect Schedule
timeFrame: at study completion, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
affiliation: Southern Methodist University
name: Richard Y Kim, BA
role: PRINCIPAL_INVESTIGATOR
References: