louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02734641: Does Increase in Appetite After Iron Treatment Induced by Ghrelin Hormone
Official title: Does Increase in Appetite After Iron Treatment Induced by Ghrelin Hormone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 111
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: Patients register to intravenous (IV) iron therapy due to iron deficiency anemia that wasn't responded to oral treatment or wasn't tolerable due to side effects and healthy volunteer.

Brief summary: The purpose of this study is to examine whether iron therapy in patients with intravenous iron deficiency anemia causes an increase in appetite. And whether this increase is mediated by the hormone ghrelin.

Detailed description: Prior to Iron treatment Investigator will sample subject blood for: counting blood, iron sector indices, renal function, electrolytes, and measure the level of ghrelin fasting plasma. In addition, the patient will fill a structured questionnaire that examines appetite levels. participants will be asked to answer a structured questionnaire which will include information on demographics, clinical data (fever, allergies, weight, height) and comorbidities. Additional data on laboratory tests, comorbidities, medication and regular blood and urine cultures results will be taken from the medical file. Iron treatment will be given according to local standard procedure . At the end of the treatment ghrelin levels and questionaire will be retaken .

iron deficiency anemia is defined: hemoglobin \<12 gr / dl in women and Hb \<13 gr / dl in men with ferritin \<15 ng / ml.

Eligibility criteria: Inclusion Criteria:

* Iron deficiency anemia that wasn't responded to oral treatment or wasn't tolerable due to side effects
* sign and dated informed consent form.

Exclusion Criteria:

* chronic inflammatory disease.
* chronic renal failure
* active cancer.
* active Infectious disease.
* non iron deficiency anemia.
* pregnancy.

Primary outcomes:
measure: Ghrelin levels after treatment with Intravenous Iron
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek medical center
Study officials:
affiliation: HaEmek Medical Center, Israel
name: mazen Elias, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04399941: Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
Official title: Role of Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Keywords: intravenous ultrasound (IVUS)
central venous stenosis (CVS)
hemodialysis
dialysis access malfunction
fistulogram
stenosis
virtual histology (VH-IVUS) software
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hemodialysis represents a life line of patients with end stage renal disease, who are commonly maintained on hemodialysis through catheters. Prolonged exposure to these catheters eventually damages the walls of veins, which results in stenosis at the local site. This condition is called central venous stenosis (CVS) and affects number of patients on hemodialysis in the United States and can compromise the dialysis efficacy. The current diagnostic modality for CVS is venography, which has several limitations. This study proposes to examine intravenous ultrasound (IVUS) as a potentially superior modality, which will provide additional information.


Eligibility criteria: Inclusion Criteria:

* ESRD (end stage renal disease) patients at BMC (Boston Medical Center)
* Receiving hemodialysis
* Has a dialysis access malfunction
* Undergoing a diagnostic fistulogram for the dialysis access malfunction

Exclusion Criteria:

* None

Primary outcomes:
measure: Extent of stenosis
timeFrame: 18 months
measure: Length of lesions
timeFrame: 18 months
measure: Morphology of lesion
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Vipul Chitalia, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06243341: The Impact of MACA Supplementation on Basketball-related Performance
Official title: The Impact of Lepidium Meyenii (MACA) Supplementation on Basketball-related Performance and Anti-fatigue Ability: a Double Blind Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports
Keywords: Lepidium meyenii
Basketball Jump Shooting Accuracy Test
Repeated Sprint Ability Test
blood lactate clearance rate
ergogenic aids
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: a double blind crossover study
Primary purpose: BASIC_SCIENCE

Brief summary: In this randomized crossover study, ten elite healthy male basketball players were included. Following a 17:00 PM training routine, participants completed a two-week supplementation with 2000 mg of MACA or placebo. After supplementation, participants underwent a Basketball Jump Shooting Accuracy Test and Repeated Sprint Ability Test.

Detailed description: Supplementation with Lepidium meyenii (MACA) has been shown in animal studies to increase blood lactate clearance and rapid lactate removal, which may be effective in reducing fatigue during intermittent exercise. However, no studies have investigated the effects of MACA supplementation on interval exercise and basketball performance. We hypothesized that MACA supplementation could reduce fatigue and improve performance in elite healthy male basketball players. This study aimed to determine the effectiveness of MACA compared to placebo on overall basketball performance.

Eligibility criteria: Inclusion Criteria:

* (i) healthy male adults, those individuals who are free of pain, insomnia, or other injuries recently, without any medication used in recent 2 months,
* (ii) basketball players competing in a Taiwan university basketball association for more than two years.

Exclusion Criteria:

* (i) were below 20 years old,
* (ii) did not have won at least eighth place in national-level basketball competitions,
* (iii) were with cardiovascular diseases or any disease that made subjects feel ill.

Primary outcomes:
measure: Countermovement jump test
timeFrame: immediately after 2 weeks intervention
Secondary outcomes:
measure: Basketball Jump Shooting Accuracy Test
timeFrame: immediately after 2 weeks intervention
measure: Repeated Sprint Ability Test
timeFrame: immediately after 2 weeks intervention
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Taiwan University of Sport
Study officials:
affiliation: Sport Science Research Center
name: Che-Hsiu Chen, PhD
role: STUDY_DIRECTOR
References:
citation: Stone M, Ibarra A, Roller M, Zangara A, Stevenson E. A pilot investigation into the effect of maca supplementation on physical activity and sexual desire in sportsmen. J Ethnopharmacol. 2009 Dec 10;126(3):574-6. doi: 10.1016/j.jep.2009.09.012. Epub 2009 Sep 23.
Clinical trial NCT00081341: Cognition, Steroids, and Imaging in Cushings Disease
Official title: Cognition, Steroids, and Imaging in Cushings Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cushing Syndrome
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2004-04-12
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: This study investigates the effects of the glucocorticoid hormone cortisol on brain structure and function. Patients with Cushing's disease are studied before and after treatment. Brain imaging and neuropsychologic tests are used to study changes in the hippocampus and thinking and learning functions as well as mood during the period of elevated cortisol. At several intervals after treatment, these are reexamined to study the degree of reversibility of the abnormalities. The contribution of cortisol as well as testosterone and estrogen to dysfunction and recovery is studied. Since elevated cortisol and dysregulation of its secretory system occurs in a significant proportion of the aged and in Alzheimers Disease and Major Depressive Disorder, these studies will help advance knowledge of the role of cortisol in these conditions.


Eligibility criteria: Inclusion criteria:

* patients with suspected Cushing's syndrome with clinical findings suggestive of Cushing's syndrome and positive screening tests (urinary free cortisol and low dose overnight dexamethasone suppression test).

Exclusion criteria: none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: General Clinical Research Center, University of Michigan Health System
state: Michigan
Study officials:
References:
Clinical trial NCT01299441: Endotracheal Cardiac Output Monitor (ECOM) for Patients Undergoing Liver Transplantation
Official title: Noninvasive ECOM Monitoring of Hemodynamic Parameters During Liver Transplantation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Transplantation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: CONMED Corporation
First posted: 2011-02-18
Enrollment: 40
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: PROBABILITY_SAMPLE
Study population: Patients undergoing liver transplantation

Brief summary: The purpose of this study is to determine whether the endotracheal cardiac output monitor (ECOM) is accurate and predictive in liver failure patients with hyperdynamic circulatory changes.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing liver transplantation surgery

Exclusion Criteria:

* Patients who are anticipated to remain intubated postoperatively for greater than 24 hours.

Primary outcomes:
measure: endotracheal cardiac output monitor (ECOM), a non-invasive cardiac output monitor, is accurate and predictive
timeFrame: Less than 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Timothy Shine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00398541: Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients (0954A-322)
Official title: Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-11-10
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the antihypertensive and neuroprotective effects of Hyzaar(R) in elderly subjects in comparison with Natrilix(TM).


Eligibility criteria: Inclusion Criteria:

* ACEi or ARB naive or not taking ACEi or ARB concurrently for at least one month before the run-in period
* Be able to carry out his or her own daily activity
* - Be at least 50 years old at inclusion in the study Be diagnosed with mild to moderate hypertension, treated or untreated
* Literate
* Not taking any cognitive-enhanced agent at baseline
* Present with a memory complain ( spontaneous or informed by caregiver)

Exclusion Criteria:

* Congestive heart failure with NYHA class \>2
* Renal failure or renal insufficiency with serum creatinine \>1.4mg/dl
* chronic severe liver disease with abnormal GPT and GOT \>2 times of upper normal limits
* Diagnosed with major depression when entering the study
* Foreign language as his or her mother tongue so that the test results will not be reliable
* History of stroke or transient ischemic attack (stroke is defined as focal neurological sign progressing stepwise)
* Hypersensitive to the active ingredient and any other component of losartan potassium and indapamide tablets
* Major hearing loss/deafness and/or major visual impairment/blindness preventing from performing the tests
* Myocardial infarction within the past 6 months
* Single functioning kidney
* Anuria

Primary outcomes:
measure: Neuropsychological tests and blood pressure after treatment of 12 weeks
timeFrame: after treatment of 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06301841: An Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care
Official title: Prospective Randomized Clinical Trial Assessing the Value of an Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: To Reduce Duration of Antibiotics Exposure in Patients With COPD Hospitalized in Intensive Care Unit With Pneumonia
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 64
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: Investigators propose to conduct a multicenter, prospective, randomized, controlled, assessing the interests of an antibiotic protocol guided by the combined use of serum procalcitonin (PCT) and a broad-panel respiratory multiplex PCR (mPCR) to reduce duration of antibiotics exposure in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) with pneumonia. The primary endpoint is the number of antibiotic-days for the treatment of pneumonia.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Documented or suspected clinically COPD according to the criteria of GOLD
* Community-acquired pneumonia defined as the presence of a radiological (i.e., chest X-ray or CTscan) infiltrates consistent with an infectious site and associated with one or more of the following items: dyspnea, cough, sputum, fever above 38 ° C, chest pain, localized crackles with or without signs of pleural effusion, higher leukocytosis at 10,000 / mm³ or leukopenia below 4000 / mm³
* Admitted to the hospital for less than 48 hours
* ICU Admission
* Informed Consent signed by the patient or his representative

Exclusion Criteria:

* Patient immunocompromised including congenital immunodeficiency, haematologic malignancy, immunosuppressive drugs (including anticancer chemotherapy and post-transplantation therapies), neutropenia neutrophil count below 500 / mm³ secondary to chemotherapy, corticosteroids greater than 0.5 mg / kg / day for more than 10 days, HIV infection
* Therapeutic limitation Existence
* Minor patient or under guardianship or custody
* Pregnant woman
* Refusal to participate in the study
* The inclusion of the subject in another biomedical research protocol in progress or for less than 30 day
* Patients treated with antibiotics before ICU referral are no excluded.

Primary outcomes:
measure: Duration of antibiotic therapy
timeFrame: from ICU admission to day 28 or hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Medical Intensive Care Unit, CHU Caen
Study officials:
affiliation: CHU de Caen Normandie, Médecine Intensive et Réanimation Médicale, 14000 CAEN, France
name: cedric daubin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06391541: mTLIP vs. ITP Blocks in Lumbar Disc Surgery
Official title: Comparison of the Effects of Modified Thoracolumbar Interfacial Plan Block (mTLIP) and Intertransverse Process Block in Lumbar Disc Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lumbar Disc Herniation
Pain, Postoperative
Regional Aneshesia
Keywords: postoperative pain
opioid consumption
Pain management
nerve blocks
QoR-15
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: to compare ultrasonography (USG)-guided intertransverse process block and modified thoracolumbar interfascial plan (mTLIP) block in the treatment of postoperative pain in patients undergoing lumbar disc herniation surgery under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* ASA I-II-III risk group
* Patients whose consent was obtained with an informed consent form
* Patients who will undergo lumbar disc herniation surgery

Exclusion Criteria:

* Patients who refused to participate in the study
* Allergic to local anesthetics
* Patients with coagulopathy
* Infection at the site of intervention
* Patients under 18 years of age
* Patients with ASA score IV and above
* Chronic pain disorders
* Those with neurological or neuromuscular disease
* Patients with psychiatric problems
* Patients with a history of opioid use
* Chronic use of NSAIDs
* Those contraindicated for regional anesthesia
* Patients with a history of opioid use
* Chronic analgesic use

Primary outcomes:
measure: postoperative opioid consumption
timeFrame: up to 24 hours after surgery
Secondary outcomes:
measure: pain scores
timeFrame: up to 24 hours after surgery
measure: incidence of nausea and vomiting
timeFrame: up to 24 hours after surgery
measure: Quality of Recovery-15 scale
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University medicine faculty
state: Kozlu
Study officials:
References:
Clinical trial NCT04185441: Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia
Official title: National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Erectile Dysfunction
Benign Prostatic Hyperplasia
Keywords: Erectile Dysfunction
Benign Prostatic Hyperplasia
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2019-12-04
Enrollment: 262
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Tanzânia association in adults with erectile dysfunction associated with Benign Prostatic Hyperplasia.


Eligibility criteria: Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Male participants aged 18 years or more;
* Sexually active participants with a defined partner who have averaged 1 attempt at sexual intercourse per week in the past month;
* Diagnosis of Benign Prostatic Hyperplasia;
* Diagnosis of erectile dysfunction;
* Patients with score between 6 and 25 points in the erectile function questionnaire;
* IPSS (International Prostate Symptom Score) greater or equal to 8 points;

Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* History of alcohol and/or substance abuse within 2 years;
* Diagnosis of other diseases or conditions in the urinary tract, including but not limited to: cancer, neurogenic bladder; urinary incontinence, recurrent infection, urethral stricture, bacterial prostatitis;
* Clinical evidence of prostate cancer;
* Hypogonadism or absent sexual desire;
* Severe psychiatric or psychosocial disorders;
* Primary erectile dysfunction;
* Polyneuropathy, neurodegenerative diseases, trauma or spinal cord injuries, central nervous system tumors or other conditions that may affect erections;
* Anatomical penile deformation that can significantly impair erection, including but not limited to: angulation, cavernous fibrosis, Peyronie's disease.

Primary outcomes:
measure: Change from baseline in erectile function questionnaire.
timeFrame: 8 weeks
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study.
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa
state: São Paulo
Study officials:
References:
Clinical trial NCT05759741: Alterations of Gut Microbiome, Function, and Its Intervention After Defunctioning Ileostomy
Official title: Alterations of Gut Microbiome, Function, and Its Intervention After Total Mesorectal Excision With Defunctioning Ileostomy for Mid-low Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Ileostomy - Stoma
Rectal Cancer
Microbial Disease
Intestinal Functional Disorder
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group was given probiotics: 4 tablets of MIYAIRI 588, inserted into the distal ileostomy, once a week. The control group was not given drugs, only monthly outpatient follow-up of the anastomosis stoma.
Primary purpose: TREATMENT

Brief summary: This study focused on the alterations of gut microbiome and function during defunctioning ileostomy, and observed the effects of probiotic intervention on intestinal microbiome and function. The investigators looked forward to find the specific intestinal maladjusted flora from this work, which could provide a new scheme for the subsequent treatment of the damaged intestinal function and the reduction of the incidence of postoperative complication.


Eligibility criteria: Inclusion Criteria:

1. Patients with primary rectal cancer received total mesolectal resection combined with defunctioning ileostomy.
2. Patients voluntarily sign informed consent.

Exclusion Criteria:

1. Disease progression or death after surgery.
2. Patients with inflammatory bowl disease.
3. Patients need to be on antibiotics/other probiotics for a long time.

Primary outcomes:
measure: Wexner incontinence score
timeFrame: 1 year
Secondary outcomes:
measure: fecal incontinence quality-of-life scale
timeFrame: 1 year
measure: Rate of postoperative complications
timeFrame: 1 month after operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan hospital
Study officials:
References: