louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00597103: Comparison of Dialysis Therapies on Cognitive Function
Official title: Comparison of Dialysis Therapies on Cognitive Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Chronic Kidney Disease
Keywords: Hemodialysis
Frequent Hemodialysis
Sleep Apnea
Restless Leg Syndrome
Cognitive Function
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2008-01-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with Chronic Kidney Disease (CKD) who require renal replacement therapy and who are currently receiving dialysis.

Brief summary: This study will evaluate the effects of more frequent dialysis on cognitive function including the assessment of sleep apnea and restless legs. Our hypothesis is that more frequent dialysis improves cognitive function and may have important implications on clinical care of ESRD patients and help to emphasize the need for treatments that will allow patients to live "with dialysis" rather than live "for dialysis".


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ESRD
* Age 18 years or greater
* Ability to understand and a willingness to sign an informed consent statement and a Health Insurance Portability and Accountability Act of 1996 (HIPPA) authorization statement.
* Expected survival of at least one year.

Exclusion Criteria:

* Documented non-compliance, defined as missing more than 10% of prescribed treatments during the month prior to the start of the study.

Primary outcomes:
measure: Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis
timeFrame: baseline, 4 months and 12 months
Secondary outcomes:
measure: Longitudinal analysis of cognitive function over time to test the hypothesis that more frequent hemodialysis contributes to delay in cognitive function impairment
timeFrame: baseline, 4 months and 12 months
measure: To test the hypothesis that nightly or daily hemodialysis treatment can ultimately be proven to be cost effective options by preserving cognitive function.
timeFrame: 12 months
measure: Influence of cognitive function on survival.
timeFrame: 12 months
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Satellite Healthcare, Inc
state: California
city: Mountain View
country: United States
facility: WellBound, Inc.
state: California
Study officials:
affiliation: Satellite Healthcare, Inc.
name: Brigitte Schiller-Moran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04711603: A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Official title: A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uremic Pruritus
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-15
Enrollment: 178
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double-blind, Placebo-controlled study to confirm the superiority of MR13A9 to placebo, and followed by extension, open-label treatment to confirm long-term safety of MA13A9 in hemodialysis patients with pruritus.


Eligibility criteria: Inclusion Criteria:

* Patient with Chronic Kidney Disease (CKD) has been on hemodialysis 3 times per week
* Patient receiving treatment for itch
* Patient has a baseline NRS score \> 4

Exclusion Criteria:

* Patient has pruritus cause other than CKD or its complications
* Patients has hepatic cirrhosis
* Patient has a known history of allergic reaction to opiates

Primary outcomes:
measure: Change from baseline in mean itch Numerical Rating Scale (NRS) score at week 4
timeFrame: Up to 58 weeks
Secondary outcomes:
measure: Change from baseline in mean itch NRS score
timeFrame: Up to 58 weeks
measure: Change from baseline in mean itch scores based on the Shiratori severity criteria
timeFrame: Up to 58 weeks
measure: Percentage of subjects with 3-point improvement in mean itch NRS score
timeFrame: Up to 58 weeks
measure: Percentage of subjects with 4-point improvement in mean itch NRS score
timeFrame: Up to 58 weeks
measure: Change from baseline in Skindex-16 score
timeFrame: Week 4, 10, 18, 26, 34, 46, 58
measure: Change from baseline in 5-D itch scale score
timeFrame: Week 4, 10, 18, 26, 34, 46, 58
measure: Percentage of subjects with global symptoms in Patient Global Impression of Change (PGIC)
timeFrame: Week 4, 10, 18, 26, 34, 46, 58
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Research Site
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Yoshitaka Shimizu
role: STUDY_DIRECTOR
References:
Clinical trial NCT02813603: Comparison of 22-gauge and 19-gauge Aspiration Needle During EBUS-TBNA
Official title: Comparison of the Diagnostic Yield Between Various Endobronchial Ultrasound-guided-transbronchial Needles (EBUS-TBN) to Evaluate Suspect Mediastinal and Hilar Lymph Nodes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: EBUS-TBNA
staging
lymph node metastases
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
First posted: 2016-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 Patients with lung cancer and enlarged lymph nodes will be included in this study

Brief summary: Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA concerning the diagnostic yield, the quality and quantity of each biopsy needle without raising the rate of complications.

Detailed description: Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA performed in rigid bronchoscopy for patients with probable lung cancer diagnosis and enlarged mediastinal lymph nodes.

Eligibility criteria: Inclusion Criteria:

* Male or female patients aged over 18
* Patients signed written informed consent
* Mediastinal or hilar enlarged lymph nodes (\>10mm) in short axis radiological or clinical findings likely for lung cancer

Exclusion Criteria:

* Severe impairment of any organs, with do not enable anaesthesia
* Quick \<80%, INR \>1,5, thrombocytes \<50/nl or PTT\>120sec
* Other clinically relevant medical or psychological diseases, which affect the patients judgement or ability to participate in this study.
* Insufficient language ability (spoken and written German)

Primary outcomes:
measure: sample weight
timeFrame: February 2017
Secondary outcomes:
measure: The number of complications like bleeding, infections, pneumothorax and pain
timeFrame: February 2017
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Ruhrlandklinik, University Hospital Essen
state: NRW
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: supervising doctor
name: Kaid Darwiche, PD Dr. med.
role: STUDY_DIRECTOR
References:
citation: Wolters C, Darwiche K, Franzen D, Hager T, Bode-Lesnievska B, Kneuertz PJ, He K, Koenig M, Freitag L, Wei L, Eisenmann S, Taube C, Weinreich G, Oezkan F. A Prospective, Randomized Trial for the Comparison of 19-G and 22-G Endobronchial Ultrasound-Guided Transbronchial Aspiration Needles; Introducing a Novel End Point of Sample Weight Corrected for Blood Content. Clin Lung Cancer. 2019 May;20(3):e265-e273. doi: 10.1016/j.cllc.2019.02.019. Epub 2019 Mar 4.
Clinical trial NCT00417703: Intraocular Pressure Immediately Following Intravitreous Injection of Ranibizumab
Official title: A Prospective Investigation of the Intraocular Pressure Immediately Following Intravitreous Injection of Ranibizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choroidal Neovascularization
Keywords: Intraocular Pressure
Intravitreous Injection
Ranibizumab
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
First posted: 2007-01-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: This study will quantify the intraocular pressure elevation in the immediate time period following intravitreous injection. With more widespread use of intravitreous injections in patients that may require several injections per year, it is important to document the sudden increase in intraocular pressure, including the maximum intraocular pressure and the time required for the intraocular pressure to return to baseline. This data may be useful in stimulating additional studies to evaluate the long term ocular effects of repeated intravitreous injections.

We hypothesize that the intraocular pressure increases significantly following intravitreous injection and then returns to baseline during the initial thirty minutes following ranibizumab injection.

Detailed description: We will assess the trend of intraocular pressure immediately following intravitreal injection of ranibizumab 0.5 mg (0.05 mL) by taking serial intraocular pressure readings every five minutes for thirty minutes after injection. This study is a prospective descriptive data collection consisting of measuring intraocular pressure immediately following intraocular injection, and at 5, 10, 15, 20, 25, and 30 minutes following injection of ranibizumab 0.5 mg.

Eligibility criteria: Inclusion Criteria:

1. Male or Female Patients \>18 years of age
2. Patients will have documented choroidal neovascular membranes on fluorescein angiogram and/or optical coherence tomography
3. Requiring treatment or maintenance therapy for choroidal neovascular membrane
4. Able and willing to provide written informed consent

Exclusion Criteria:

1. History of arterial occlusive disease of the eye.
2. History of advanced glaucoma.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Retina Support Services, Inc
state: Oklahoma
Study officials:
affiliation: Oklahoma State University Medical Center
name: Scott J Westhouse, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01015690: Incidence of Early Pregnancy Loss in Patients With Unexplained Infertility
Official title: Incidence of Early Pregnancy Loss in Patients With Unexplained Infertility Measured by hCG Rise in Urine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: unexplained infertility
hCG
early pregnancy loss
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with unexplained infertility and healthy controls have collected urine samples in the luteal phase of the menstrual cycle for detection of hCG rise and pregnancy

Brief summary: Unexplained fertility could be partly caused by a higher incidence of early pregnancy loss in this group. 65 women with unexplained infertility and 65 healthy controls will collect daily urine samples form the luteal phase. hCG and creatinine levels are measured in order to detect pregnancies and early pregnancy loss.


Eligibility criteria: Inclusion Criteria:

* Unexplained infertility

Exclusion Criteria:

* IVF treatment

Primary outcomes:
measure: incidence of early pregnancy loss
timeFrame: 3 mentrual cycles
Secondary outcomes:
measure: incidence of pregnancies
timeFrame: 3 menstual cycles
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMCUtrecht
Study officials:
affiliation: UMC Utrecht
name: NS Macklon, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01812590: Acute Exercise and Pancreatic Endocrine Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined.


Eligibility criteria: Inclusion Criteria:

* Previous diagnosis with type 2 diabetes, or newly detected in our screening procedures
* Age 30-70 years
* BMI 20-40 kg/m2

Exclusion Criteria:

* Treatment with insulin
* Contraindication to exercise as determined by ECG
* Pregnancy
* Active weight loss in the previous 6 months
* Actively engaged in exercise training programs
* Evidence of chronic pulmonary, cardiovascular, hepatic, renal, or hematological disease

Primary outcomes:
measure: Pancreatic endocrine function
timeFrame: 24-hours following a period of rest/exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT02920190: Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat
Official title: Reduction of Antigen-Lipid-Driven Monoclonal Gammopathies by Targeting Epicardial Fat and Its Lipids Content With Liraglutide: A Glucagon Like Peptide-1 Receptor Analogue (GLP-1RA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Monoclonal Gammopathies
Overweight
Obesity
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to learn about the effect of Liraglutide (Victoza) on the fat of the heart and some fat cells in blood.


Eligibility criteria: Inclusion Criteria:

* BMI ≥27 kg/m2
* At least one overweight/obesity related comorbidity (such as type 2 diabetes, pre-diabetes \[IFG, IGT\], hypertension, dyslipidemia)
* Age \> 18 and \< 70 years old

Exclusion Criteria:

* Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza®
* Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
* Insulin dependent or treated type 2 diabetes
* Current use of other injectable incretins
* History of diabetes ketoacidosis
* Advanced Chronic Kidney Disease, as defined by Glomerular Filtration Rate (GFR) \< 30 mL/min/1.73m2
* Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure
* Clinical or laboratory evidences of chronic active liver diseases
* Acute or chronic infective diseases
* Known or suspected allergy to Liraglutide, excipients, or related products
* Pregnant, breast-feeding or the intention of becoming pregnant
* Females of childbearing potential who are not using adequate contraceptive methods

Primary outcomes:
measure: Change in Epicardial Fat Thickness
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change in serum immunoglobulins
timeFrame: Baseline, 12 months
measure: Change in plasma ceramide levels
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: James Hoffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05396690: Safety and Efficacy of Remimazolam in OPCAB Surgery
Official title: Safety and Efficacy of Remimazolam in Induction and Maintenance of General Anesthesia in OPCAB Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Bypass Surgery
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 94
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Remimazolam is a novel short-acting benzodiazepine drug that acts on the benzodiazepine binding site of gamma-aminobutryic acid (GABA) A receptor, is metabolized by esterase, and has a context-sensitive half-time of about 6-7 minutes. Looking at some previous studies using Remimazolam, the safety and efficacy as a general anesthetic have been sufficiently proven.

In particular, compared to intravenous anesthetic agents such as propofol, the action time of anesthetics is relatively longer, but the frequency of hypotension is low. However, most studies have been conducted on patients of American Society Anesthesiologist (ASA) class I-II, and studies on patients with high severity have not yet been sufficiently secured.

Therefore, this study aims to compare the efficacy and safety of Remimazolam as an anesthetic with Sevoflurane in terms of hemodynamics in patients with high severity undergoing OPCAB surgery.


Eligibility criteria: Inclusion Criteria:

* Adult patients 19 years of age or older to receive OPCAB surgery
* Clinical diagnosis of coronary artery obstructive disease

Exclusion Criteria:

* Ejection fraction \< 35% at preoperative ECHO test
* Mitral regurgitation \> grade 2 at preoperative ECHO test
* Currently using inotropics
* Currently receiving mechanical support

Primary outcomes:
measure: cardiac index (T4)
timeFrame: 5 minutes before operation
measure: cardiac index (T5)
timeFrame: 10 minutes after starting left internal mammary artery dissection
measure: cardiac index (T6)
timeFrame: 10 minutes after starting left anterior descending coronary artery anastomosis
measure: cardiac index (T7)
timeFrame: 10 minutes after starting Y-graft anastomosis of graft vessels
Secondary outcomes:
measure: NE dose
timeFrame: During surgery(from induction of anesthesia to end of surgery)
measure: Incidence of hypotension
timeFrame: During surgery(from induction of anesthesia to end of surgery)
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggido
Study officials:
References:
Clinical trial NCT00252590: Health Focused Motivational Treatment for Alcohol Dependent Veterans
Official title: Health Focused Motivational Treatment for Alcohol Dependent Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Keywords: Psychotherapy motivational intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-11-11
Enrollment: 99
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a health focused motivational intervention will reduce alcohol use for dependent veterans who are receiving outpatient alcohol and drug treatment.

Detailed description: The early months of addiction treatment are a high risk time for relapse. The purpose of this study is to examine whether a health-related intervention delivered in an individual session with a therapist once per month in the initial 4 months of addiction treatment will reduce alcohol use among veterans already enrolled in weekly outpatient treatment group at the VA San Diego Healthcare System. In order to answer this question, study participants will be randomly assigned to one of three study conditions: 1) The Health Motivational condition that receives individual personalized health feedback and motivational activities, 2) the Health Education condition that receives individual education about health problems associated with the heavy alcohol use, and 3) the treatment as usual group that will receive no additional treatment. All participants will be assessed on a monthly basis for 4 months to evaluate alcohol use, drug use, and health status.

Eligibility criteria: Inclusion Criteria:

- Veterans receiving outpatient treatment at the VA San Diego Healthcare System Alcohol and Drug Treatment Program for a diagnosis of Alcohol Dependence

Exclusion Criteria:

* Diagnosis of Bipolar Disorder or Psychotic Disorder.

Primary outcomes:
measure: Percentage of Days Abstinent From Alcohol
timeFrame: 4 months
Secondary outcomes:
measure: Percentage of Days Abstinent From All Substances
timeFrame: 4 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego
name: Susan Tate, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00975390: Muscle Glycogen Synthesis When Caffeine and Protein is Co-Ingested With Carbohydrates
Official title: The Effect of Caffeine or Protein Co-ingestion With Carbohydrate on Post-exercise Muscle Glycogen Synthesis Rate.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Recovery
Keywords: Glycogen
Carbohydrate
Protein
Caffeine
Post exercise muscle glycogen synthesis
Sports nutrition
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-09-11
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to investigate the effect of added protein+leucine or caffeine to 1.2 g/kg/h CHO on the rate of post-exercise muscle glycogen re-synthesis in healthy, recreational athletes.

The investigators hypothesize that both interventions (the addition of caffeine or protein+leucine) will lead to higher glycogen re-synthesis compared to the ingestion of CHO only, and that the co-ingestion of protein and leucine will result in the highest muscle glycogen synthesis rates.


Eligibility criteria: Inclusion Criteria:

* male cyclists
* healthy
* BMI \< 25

Exclusion Criteria:

* female
* use of medication
* non cycling
* BMI \> 25

Primary outcomes:
measure: Muscle glycogen synthesis rates
timeFrame: 6 hours
Secondary outcomes:
measure: Glycogen synthase activity, plasma glucose, insulin, free fatty acids and epinephrine responses
timeFrame: 6 hours
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
References: