louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01899456: Impact of Sympathetic Renal Denervation- a Study in Patients After Renal Transplantation
Official title: A Randomized Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation in Patients After Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Chronic Kidney Disease
Renal Transplantation
Sympathetic Activity
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 18
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 study is aiming to document the safety and effectiveness of renal denervation in patients after renal transplantation with hypertension. Catheter-based renal denervation will be performed using CE marked, percutaneous Symplicity catheter.


Eligibility criteria: Inclusion Criteria:

* Patient after renal transplantation (\> 6 month) without resection of native kidneys
* systolic blood pressure \>=150 mmHg
* on 3 or more antihypertensive medications
* Individual is 18 years of age
* Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.

Exclusion Criteria:

* secondary causes and a white coat hypertension
* renal artery abnormalities
* eGFR \< 30mL/min (MDRD)
* angina
* severe Aortic valve stenosis
* Individual is pregnant, nursing or planning to be pregnant
* other

Primary outcomes:
measure: Safety and efficacy of renal denervation in patients after renal transplantation
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Effect of renal denervation in patients after renal transplantation on different organ systems.
timeFrame: Baseline to 6 month
Other outcomes:
Locations:
city: Munich
country: Germany
facility: 1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München
Study officials:
affiliation: 1. Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Unversität München
name: Simon Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schneider S, Promny D, Sinnecker D, Byrne RA, Muller A, Dommasch M, Wildenauer A, Schmidt G, Heemann U, Laugwitz KL, Baumann M. Impact of sympathetic renal denervation: a randomized study in patients after renal transplantation (ISAR-denerve). Nephrol Dial Transplant. 2015 Nov;30(11):1928-36. doi: 10.1093/ndt/gfv311. Epub 2015 Sep 1.
Clinical trial NCT06017856: Physical Exercise and Nutrition in Functional Gastrointestinal Disorders in Obese Children
Official title: The Impact of Physical Exercise and Nutrition on Functional Gastrointestinal Disorders in Obese Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Functional Gastrointestinal Disorders
Obesity, Childhood
Keywords: obese
overweight
abdominal pain
diarrhea
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obese and overweight subjects patricipating in the life style modification program as well as healhy controls of normal weight

Brief summary: A prospective observational case-control study evaluating the effect of a weight loss intervention program on functional gastrointestinal disorders among overweight and obese children.

Detailed description: The investigators intend to conduct a prospective observational case-control study of overweight and obese children, aged 6-18 years, followed in the child health and sport center at Meir medical center, Kfar-Saba, Israel.

Overweight and obese subjects, defined as body mass index (BMI) percentile ≥85%, will be offered to participate. Healthy subjects with normal BMI percentile from other pediatric outpatient clinics as well as relatives and friends of physicians from the pediatric division will be enrolled and serve as the control group.

Study visits will be at enrollment and after 3 and 6 months of participation in the intervention program. During the visits the investigators will collect anthropometric measurements (height, weight, BMI, total body fat). Participants (age 10y and above) or their parents (age 6-10y) will fill a validated questionnaire for diagnosis of FGID based on ROME IV criteria. The investigators will also collect data from exercise capability testing and quality of life questionnaires performed regularly (and irrespective of this study) during the intervention program.

The investigators will then compare between subjects who succeeded to those who failed in losing at least 5% of their initial body weight as well as to healthy controls with normal BMI percentile.

Eligibility criteria: Inclusion Criteria:

* obese / overweight children participating in the life style modification program at the child sport and health center

Exclusion Criteria:

* other known chronic non-functional gastrointestinal conditions (e.g. Celiac disease, inflammatory bowel disease)

Primary outcomes:
measure: Diagnosis of functional gastrointestinal disorder
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Eyal Zifman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03316456: Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction
Official title: The Role of Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-Induced Gut Barrier Damage
Acute Leukemia
Keywords: AL
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute leukemia population at the University of Minnesota

Brief summary: This is an observational study to collect stool, blood, and urine from acute leukemia patients undergoing induction chemotherapy in order to generate preliminary data regarding the association between microbiota and chemotherapy-induced gut barrier damage. This study consists of inpatient collections of blood, urine, and stool while the patients are undergoing inpatient induction therapy. Patients will not be scheduled for any additional procedures or testing beyond what is required for clinical care.


Eligibility criteria: Inclusion Criteria:

* Adults (ages 18 - 99 years) undergoing inpatient induction chemotherapy for newly diagnosed or relapsed acute leukemia (myeloid or lymphoblastic).
* Any induction regimen (standard or experimental) with planned \~4 weeks of inpatient stay
* Able to provide written voluntary consent before performance of any study related procedure.

Primary outcomes:
measure: Variation of Gut Microbiota Composition and Diversity
timeFrame: Three times weekly until day 28 of chemotherapy.
Secondary outcomes:
measure: Variation of Gut Barrier Integrity
timeFrame: Three times weekly until day 28 of chemotherapy
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center at University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Armin Rashidi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rashidi A, Ebadi M, Rehman TU, Elhusseini H, Halaweish HF, Kaiser T, Holtan SG, Khoruts A, Weisdorf DJ, Staley C. Lasting shift in the gut microbiota in patients with acute myeloid leukemia. Blood Adv. 2022 Jun 14;6(11):3451-3457. doi: 10.1182/bloodadvances.2021006783.
citation: Rashidi A, Ebadi M, Rehman TU, Elhusseini H, Nalluri H, Kaiser T, Ramamoorthy S, Holtan SG, Khoruts A, Weisdorf DJ, Staley C. Altered microbiota-host metabolic cross talk preceding neutropenic fever in patients with acute leukemia. Blood Adv. 2021 Oct 26;5(20):3937-3950. doi: 10.1182/bloodadvances.2021004973.
Clinical trial NCT05963256: Prediction Model for TOF
Official title: Investigation for Development of Predictive Model for Train of Four (TOF)% for Neurophysiological Monitoring During Neuroanesthesia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurophysiologic Monitoring
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 20
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: Patient undergoing neurosurgery

Brief summary: This study was aimed to investigate a prediction model for predicting train-of-four (TOF) 50% in patients undergoing neurosurgery.


Eligibility criteria: Inclusion Criteria:

* patient undergoing neurosurgery
* scheduled for intra-operative neurophysiological monitoring
* American Society of Anesthesiologists physical class I, II, III

Exclusion Criteria:

* unable to monitor train-of-four
* decline to participate in the study

Primary outcomes:
measure: Train-of-four (TOF) ratio
timeFrame: 30 minutes after reaching the TOF plateau
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eunah Cho
Study officials:
affiliation: KangbukSamsung Hospital
name: Eunah Cho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01951456: Resistance Training as an Aid to Smoking Cessation Treatment
Official title: Resistance Training as an Aid to Smoking Cessation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Smoking cessation
resistance training
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2013-09-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether resistance training can aid smoking cessation.


Eligibility criteria: Inclusion Criteria:

Age 18 or older, smoke five or more cigarettes a day for at least the past 12 months

Exclusion Criteria:

Participating in any type of exercise for \>60 minutes/week over the past 3 months, current smokeless tobacco use, participation in an ongoing effort to quit smoking, current or planned pregnancy, any serious medical condition that would make exercise unsafe

Primary outcomes:
measure: Smoking cessation
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Cortisol
timeFrame: 3, 6, 12 months
measure: Mood
timeFrame: 3, 6, 12 months
measure: Cigarette cravings
timeFrame: 3, 6, 12 months
measure: Abstinence self-efficacy
timeFrame: 3, 6, 12 months
measure: Sleep
timeFrame: 3, 6, 12 months
measure: Body composition
timeFrame: 3, 6, 12 months
measure: Body weight
timeFrame: 3, 6, 12 months
measure: Lung function
timeFrame: 3, 6, 12 months
measure: Blood pressure
timeFrame: 3, 6, 12 months
measure: Cholesterol profile
timeFrame: 3, 6, 12 months
measure: Glycosylated hemoglobin
timeFrame: 3, 6, 12 months
measure: Muscular strength
timeFrame: 3, 6, 12 months
measure: Aerobic fitness
timeFrame: 3, 6, 12 months
measure: Smoking cessation
timeFrame: Change from baseline to 6 months
measure: Smoking cessation
timeFrame: Change from baseline to 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
References:
Clinical trial NCT00000256: Reinforcing Effects of Brief Exposures to Nitrous Oxide - 8
Official title: Reinforcing Effects of Brief Exposures to Nitrous Oxide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: nitrous oxide
reinforcer
subjective effects
healthy volunteer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 11
Sex: ALL
Minimum age (years): 22
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine reinforcing effects of brief exposures to nitrous oxide in healthy volunteers.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Choice of nitrous oxide vs placebo
timeFrame: After 1.5 min of inhalation each of nitrous oxide then placebo
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zacny JP, Klafta JM, Coalson DW, Marks S, Young CJ, Klock PA, Toledano AY, Jordan N, Apfelbaum JL. The reinforcing effects of brief exposures to nitrous oxide in healthy volunteers. Drug Alcohol Depend. 1996 Nov;42(3):197-200. doi: 10.1016/s0376-8716(96)01281-1.
Clinical trial NCT03497156: Bariatric Surgery and Pharmacokinetics of Lercanidipine
Official title: Bariatric Surgery and Pharmacokinetics Lercanidipine: BAR-MEDS Lercanidipine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Lercanidipine
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-04-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on lercanidipine are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: lercanidipine concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00425256: Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sexual Arousal Disorder
Lead sponsor: Palatin Technologies, Inc
Sponsor class: INDUSTRY
Collaborators: name: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
First posted: 2007-01-22
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This 8 week at home study is designed to explore efficacy endpoints and evaluate the safety of intranasal Bremelanotide in women with Female Sexual Arousal Disorder. Efficacy will be assessed vs. a parallel placebo group.


Eligibility criteria: Inclusion Criteria:

* Post menopausal and in general good health
* In a stable relationship with a male partner for at least 6 months
* Willing to attempt sexual activity once a week with your partner

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center, LLC
state: Arizona
city: LaJolla
country: United States
facility: University of California, Department of Family and Preventative Medicine
state: California
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: New London
country: United States
facility: Coastal Connecticut Research
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Ft. Myers
country: United States
facility: Clinical Study Center
state: Florida
city: West Palm Beach
country: United States
facility: Center For Marital and Sexual Health of South Florida
state: Florida
city: Fort Wayne
country: United States
facility: Northeast Indiana Research
state: Indiana
city: Baltimore
country: United States
facility: Center for Sexual Medicine at Sheppard Pratt
state: Maryland
city: Hackensack
country: United States
facility: Advanced Biomedical Research, Inc
state: New Jersey
city: Purchase
country: United States
facility: The Center for Female Sexuality
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Gynecologic Associates
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Medford
country: United States
facility: Medford Women's Clinic, LLP
state: Oregon
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: West Reading
country: United States
facility: Advanced Clinical Therapies, Inc.
state: Pennsylvania
city: Houston
country: United States
facility: Accelovance
state: Texas
city: Seattle
country: United States
facility: Women's Clinical Research Center
state: Washington
Study officials:
References:
Clinical trial NCT00845156: Alpha Lipoic Acid and Insulin Resistance
Official title: Alpha Lipoic Acid and Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: Diabetes
Insulin resistance
healthy controls
anti oxidants
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects will be screened with a 2 hour oral glucose tolerance test. After this screening visit, their insulin resistance will be measured. Subjects will then be given either alpha lipoic acid (antioxidant) or placebo for 6 weeks. The insulin resistance test will be repeated after the 6 weeks. We believe these studies will confirm the beneficial effect of alpha lipoic acid on insulin sensitivity.

Detailed description: We propose to perform a placebo-controlled study of Alpha Lipoic Acid (LA) administration in a cohort of non-obese, non-diabetic, insulin resistant subjects. The insulin sensitivity of 180 subjects will be initially estimated by measuring fasting glucose and insulin levels (homeostasis model assessment) and oral glucose tolerance test (OGTT). The 60 most insulin resistant subjects will then be randomized to 6 weeks of therapy with either 600 mg three times a day of LA or placebo. To quantitate the ALA-induced improvements, euglycemic hyperinsulinemic clamps to evaluate insulin sensitivity, OGTT using deuterated glucose to evaluate glycolytic glucose disposal, and muscle biopsies to evaluate insulin signaling pathways, will be performed before and after treatment. We believe these studies will (1) confirm the beneficial effect of CR-ALA on insulin sensitivity; (2) further our understanding of the molecular mechanisms of LA action; and (3) because these insulin resistant subjects are at risk for the development of type 2 diabetes, the Metabolic Syndrome, and coronary artery disease (CAD), a demonstration of the beneficial effects of LA on insulin action could ultimately have important public health consequences.

Eligibility criteria: Inclusion Criteria:

* Healthy, not exercising regularly

Exclusion Criteria:

* Diabetes, Impaired glucose tolerance, Heart disease, Liver disease, HIV, abnormal TSH results, other abnormal lab values

Primary outcomes:
measure: Insulin Resistance
timeFrame: 0 months and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Umesh Masharani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Martha Kennedy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213356: Study of the Nervous Control of the Anal Sphincter
Official title: Evoked Responses of External Anal Sphincter After Cortical and Lombo-sacral Magnetic Stimulations
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Spinal Cord Injuries
Keywords: spinal cord injuries - anal sphincter - evoked potentials
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy volunteers patients with spinal lesion patients with cauda equina syndrome

Brief summary: Anal incontinence and constipation are frequently observed in patients with neurological disease. The purpose of this study is to evaluate the neurological control of the anal sphincter in healthy subjects, patients with neurological disease by a new electrophysiological technique. This technique consists in recordings of anal sphincter responses after magnetic stimulations of the cortex and the sacral nerves.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* patients with spinal lesion
* patients with cauda equina syndrome

Exclusion Criteria:

* pregnant women
* pacemaker or other metallic material implanted
* epileptic patients
* organic colorectal disease
* obese patients
* previous neurological surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: University hospital of Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Anne-Marie LEROI, PHD
role: PRINCIPAL_INVESTIGATOR
References: