louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02543697: Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors
Official title: Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cushing Syndrome
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with tumors in both adrenal glands and slightly elevated cortisol (subclinical Cushings syndrome) are offered to go through an adrenal venous sampling to try to quantify if the overproduction of cortisol is from one adrenal, or from both sides. If it is one-sided, the investigators offer the patient operation.

Detailed description: Adrenal incidentalomas are quite common. About 4 % of the population have adrenal tumors that they are unknown of. Some percentage of this patients produce a little to much cortisol, but not enough to give overt Cushings syndrome. It is shown that slightly elevated cortisol production will give higher blood pressure, higher blood sugar and maybe higher BMI. For another hormone produced in the adrenal glands , aldosterone, we know that even if you have an adrenal tumor on one adrenal, you could have bilateral overproduction of the hormone.In that situations it is no need of an operation of the adrenal with the tumor. When the overproduction is unilateral it is of great value to the patient to operate the adrenal gland, and the symptoms from the hormone excess will disappear. For aldosterone Adrenal venous sampling (AVS) has been used for several years to try to determine if the hormone overproduction is one-sided or to sided. We are in this study using the same principle for cortisol overproduction.

Eligibility criteria: Inclusion Criteria:

* Benign tumors/adenomas in the adrenals and biochemically overproduction of cortisol

Exclusion Criteria:

* Use of steroids ( tablets, inhalations, lotions)

Primary outcomes:
measure: Lateralisation of cortisol overproduction
timeFrame: 2 yeras
Secondary outcomes:
measure: Biochemically and clinically normalising after treatment
timeFrame: 2 years
measure: Verify overproduction of cortisol from the adrenals
timeFrame: 2 yeras
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland Univerity Hospital
name: Grethe Ueland, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ueland GA, Methlie P, Jossang DE, Sagen JV, Viste K, Thordarson HB, Heie A, Grytaas M, Lovas K, Biermann M, Husebye ES. Adrenal Venous Sampling for Assessment of Autonomous Cortisol Secretion. J Clin Endocrinol Metab. 2018 Dec 1;103(12):4553-4560. doi: 10.1210/jc.2018-01198.
Clinical trial NCT02602197: Intravenous Paracetamol Compared Dexketoprofen for Postoperative Analgesia After Septoplasty
Official title: The Efficacy of Intravenous Paracetamol Versus Dexketoprofen for Postoperative Pain Management After Septoplasty: A Prospective Randomized Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: Paracetamol
Dexketoprofen
postoperative pain
septoplasty
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conducted a prospective, randomized, double blind study to compare the effectiveness of intravenous paracetamol and dexketoprofen for preventing pain during first 24 hours postoperative period in adult patient undergoing septoplasty.

Detailed description: Postoperative pain scores as measured by Visual Analog Scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60 minutes and 2th, 4th, 6th, 12th and 24th hours postoperatively.

Eligibility criteria: Inclusion Criteria:

* After patient's inform consent was approved, a total of 70 ASA (American Society of Anesthesiology) physical status I and II adult patients age 18 to 65 undergoing septoplasty were planned include the study.

Exclusion Criteria:

* History of clotting disorders or blood dyscrasias,
* Gastrointestinal ulcer or chronic dyspepsia,
* History of allergy to the study drugs,
* Active bleeding or bleeding disorders.

Primary outcomes:
measure: Change from pain scores until postoperative 24 hours
timeFrame: Pain scores recorded during postoperative 24 hours.
Secondary outcomes:
measure: Cumulative tramadol consumption during postoperative 24 hours.
timeFrame: First postoperative 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03370497: Calcium-protein Co-ingestion and Gut Hormones
Official title: The Acute Effects of Calcium-protein Co-ingestion on Gut Hormone Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, double-blind crossover
Primary purpose: BASIC_SCIENCE

Brief summary: Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Rodent evidence suggests that calcium may potentiate the effects of protein ingestion on gut hormone secretion. Evidence in humans however, is lacking. This study aims to assess whether the addition of calcium to protein ingestion augments postprandial gut hormone availability in humans.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women age between 18-65 yrs.
* Able to consume provided supplement.
* Weight stable for the past 3 month (no change within 3%)

Exclusion Criteria:

* Any previous or current metabolic, cardio-pulmonary or musculoskeletal disease
* Not between the ages of 18-65 years
* A body mass index below 18.5 kg/m2 or above 30 kg/m2 (body mass (kg) divided by your height (m) squared)
* Taking medications that may influence your metabolism
* Plans to change your lifestyle (diet and/or physical activity) during the study period
* Not willing to refrain from alcohol containing drinks or unaccustomed exercise one day before the laboratory sessions.
* Current smoker

Primary outcomes:
measure: Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).
timeFrame: 120 min
Secondary outcomes:
measure: Postprandial plasma GIP area under the curve (mmol/L x 120 min)
timeFrame: 120 min
measure: Postprandial plasma PYY area under the curve (mmol/L x 120 min)
timeFrame: 120 min
measure: Subjective ratings of appetite (au)
timeFrame: 120 min
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Department for Health, University of Bath
Study officials:
References:
citation: Chen YC, Smith HA, Hengist A, Chrzanowski-Smith OJ, Mikkelsen UR, Carroll HA, Betts JA, Thompson D, Saunders J, Gonzalez JT. Co-ingestion of whey protein hydrolysate with milk minerals rich in calcium potently stimulates glucagon-like peptide-1 secretion: an RCT in healthy adults. Eur J Nutr. 2020 Sep;59(6):2449-2462. doi: 10.1007/s00394-019-02092-4. Epub 2019 Sep 17.
Clinical trial NCT01069497: Preventability of Infections in Residents of French Nursing Homes
Official title: Impact of a Multifaceted Intervention on the Preventability of Infections in Residents of French Nursing Homes: Cluster-randomised Controlled Trial (ENLIL Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection Control
Keywords: Infection control
Urinary Tract Infections
Respiratory Tract Infections
Lead sponsor: Observatoire du Risque Infectieux en Gériatrie
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Pierre Fabre Laboratories
name: Gaba Laboratories
First posted: 2010-02-17
Enrollment: 3500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: STUDY HYPOTHESIS : An infection prevention program adapted for the nursing home context can reduce by 5% the number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes.

STUDY DESIGN : The proposal is for an interventional cluster (nursing home) study comprising 2 randomized groups: group 1 (interventional), comprising 25 nursing homes implementing a specific infection prevention program; and group 2 (control), 25 nursing homes continuing to implement their routine prevention measures.


Eligibility criteria: Inclusion Criteria:

* Nursing homes which contain a medical coordinator and at least one nurse and/or nursing auxiliary.
* Nursing Homes located in France (North-West)
* All the residents present or entering the facility during the study period

Exclusion Criteria:

* Nursing homes where a prevention program has already been implemented

Primary outcomes:
measure: Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes
timeFrame: every month
Secondary outcomes:
measure: Number of death
timeFrame: every month
measure: Number of hospitalizations
timeFrame: every month
measure: Number of of prescriptions for antimicrobials
timeFrame: every month
Other outcomes:
Locations:
Study officials:
affiliation: ORIG, EHESP
name: Monique Rothan Tondeur, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chami K, Gavazzi G, Bar-Hen A, Carrat F, de Wazieres B, Lejeune B, Armand N, Rainfray M, Hajjar J, Piette F, Rothan Tondeur M. A short-term, multicomponent infection control program in nursing homes: a cluster randomized controlled trial. J Am Med Dir Assoc. 2012 Jul;13(6):569.e9-17. doi: 10.1016/j.jamda.2012.04.008. Epub 2012 Jun 7.
Clinical trial NCT02339597: Therapy Adherence of APAP Therapy Initiation in Sleep-lab Versus at Home
Official title: Therapy Adherence in Different Settings of Automatic Positive Airway Pressure (APAP) Therapy Initiation in Patients With Obstructive Sleep Apnea (OSA): Comparison Between in Sleep-lab vs. at Home Environment.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Compliance
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: ResMed
First posted: 2015-01-15
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primary hypothesis:

The objective compliance ( # of hours per night of APAP therapy) is higher in patients who get the APAP treatment initiation at home due to the fact that they get better support by telemetric control and the possibility of prompt interventions.

Secondary hypothesis:

Based on the higher support at the home APAP initiation the following parameters will be better in comparison to the standard supply in laboratory:

Objective measures:

* mask leakage
* pressure
* Apnea-Hypopnea-Index (AHI)

Subjective measures:

* quality of life
* sleepiness


Eligibility criteria: Inclusion Criteria:

* written informed consent from patients after verbally and written informing
* Age between 18 and 80 Years
* obstructive sleep apnea syndrome (OSAS) with an AHI \> 15/h and without previous therapy

Exclusion Criteria:

* Intolerance to wear the PAP therapy mask
* sleep breathing disorders (SBD) with central apneas \> 20% and other sleep disorders
* disabilities who prevents the wear of a therapy mask
* initiated PAP therapy
* pre-treatment of OSAS incl. UPPP (uvulo palato pharyngo plasty)
* modified Mallampati Score T3 and T4
* participation on clinical studies 4 weeks before start of the study
* known or acute psychiatric/neurological or psychological disorders, who impairs the compliance to take part of the study.
* chronical or new clinically significant pneumological or cardiovascular disease (exception: effectively therapies of hypertension, cardiac arrhythmia and coronal cardiac disease)
* acute internistic disease
* neuromuscular disease
* condition after Apoplexy
* oncological disease in recent 5 years
* drug/alcohol consumption
* consumption of von psychotropic drugs, hypnotics and other drugs who are able to influence the sleep/wake cycle

Primary outcomes:
measure: Number of usage hours of of positive airway pressure therapy per night
timeFrame: 6 month
Secondary outcomes:
measure: Apnea Hypopnea Index [1 / hour of sleep)
timeFrame: 6 month
Other outcomes:
measure: Quality of Life
timeFrame: 6 month
Locations:
city: Berlin
country: Germany
facility: Charite-Universitaetsmedizin Berlin, Center for Sleep Medicine
Study officials:
References:
Clinical trial NCT05108597: Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy
Official title: Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blood Loss, Surgical
Uterine Myoma
Lead sponsor: Pak Emirates Military Hospital
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A total of 200 women for elective abdominal myomectomy were randomly allocated into two groups.

100 women in experimental group were administered 400ug Misoprostol (2 tablets of Prosotec®) through the rectal route prior to surgery and 100 were in control group, in which no drug was administered.

Detailed description: After getting approval from hospital's ethical committee, patients eligible for the study were recruited in the study according to the selection criteria. Before surgery, after taking informed written consent, patient's detailed history including demographics, parity \& BMI was recorded. Uterine size was assessed by bimanual pelvic examination. Patients undergoing myomectomy were randomly divided into 2 groups using lottery method. In experimental group Misoprostol 400ug was administered per rectally prior to surgery. In control group, no drug was administered.

The surgical procedural elements, the surgeon or surgeons performing the procedure and the use of antibiotics as well as anesthetic agents was standardized to remove any bias. Intraoperative blood loss was recorded by a single trained doctor and calculated using visual scale for the abdominal sponges and chest swabs/gauzes used during surgery and blood collected in suction bottle.

Eligibility criteria: Inclusion Criteria:

1. ASA physical status class I-II
2. Intramural or subserosal fibroids - diagnosed on ultrasound
3. Candidates for elective abdominal myomectomy

Exclusion Criteria:

1. Pre-operative Hemoglobin \< 10 g/dl
2. Patient who received Danazol or GnRH analogues before surgery
3. No other systemic or metabolic disease

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: During the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: PEMH
state: Punjab
Study officials:
affiliation: Resident OBGYN
name: Salma Nisar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02193997: Constipation Fiber Trial
Official title: Double-blind, Placebo-controlled Study to Examine the Effects of Dietary Fiber in Treating Childhood Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation in Children
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines the effects of dietary fiber in the treatment of functional childhood constipation.

Detailed description: This is a 4-week double-blind, placebo-controlled study to examine the effects of dietary fiber in treating functional childhood constipation. The addition of fiber is anticipated to allow children to have more normal stool consistency and frequency.

All participants will be asked to take a snack bar twice daily and will be randomized in a 1:1:1 ratio to fiber 1, fiber 2 or placebo snack bar groups. All participants will be asked to take low-dose Miralax to avoid worsening of constipation in all groups.

Eligibility criteria: Inclusion Criteria:

* 2-16 years of age with functional constipation as defined based on the Rome III criteria

Exclusion Criteria:

* Constipation attributable to organic and anatomic causes or intake of medication
* Children who had previous surgery of the colon or anus
* History of allergy/intolerance to components of snack bar (e.g. celiac disease)

Primary outcomes:
measure: Change in stool frequency
timeFrame: 4 weeks
measure: Change in stool consistency
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Warren Bishop, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02148497: Multi-Colored Placido Disk Viability
Official title: Viability Study of a Multi-Colored Videokeratoscope With Extended Timescale Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Sjogren's Disease
Healthy
Keywords: volunteers
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to show that the multi-colored Placido Disk set-up can get reliable data over long time periods.


Eligibility criteria: Inclusion Criteria:

* Subjects must have clinically diagnosed Dry Eye or Sjörgren's syndrome.
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions that are deemed confounding to the data as determined by the PI)
* Ability to give informed consent
* Willing to spend time for the study; approximately 30 minutes for a visit
* Either gender
* Any racial or ethnic origin

Exclusion Criteria:

* Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s).
* Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to blepharitis and ocular allergy.
* Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract surgery less than one year ago.

Primary outcomes:
measure: Tear film break-up time
timeFrame: up to 3 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Flaum Eye Institute at the University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Geunyoung Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03746197: Interactive Digital Technology to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus
Official title: Interactive Digital Technology (Project EVO) to Assess and Improve Cognitive Dysfunction in Patients With Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lupus Erythematosus, Systemic
Keywords: Lupus
SLE
Cognition
Cognitive Assessment
Videogames
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
name: Akili Interactive Labs, Inc.
First posted: 2018-11-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate whether a short interactive video game device is associated with performance on standard measures of attention and problem solving in patients with systemic lupus erythematosus(SLE). The study is also designed to see if playing the video game for four weeks improves attention and problem solving in patients with SLE.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of SLE

Exclusion Criteria:

* Major neurological problems (head trauma, degenerative vascular or metabolic disorder; neoplasm or toxic exposure) prior to SLE
* Major psychiatric disorder prior to SLE
* Major substance abuse
* Pregnant
* Major motor impairment
* High SLE disease activity
* History of learning disability

Primary outcomes:
measure: Change in mean response time on EVO Monitor
timeFrame: 30 Days
measure: Change in response time variability on EVO Monitor
timeFrame: 30 Days
measure: Change in EVO performance threshold
timeFrame: 30 days
measure: Change in Digit Vigilance Test Scores
timeFrame: 30 Days
measure: Change in Trail Making Test Scores
timeFrame: 30 days
measure: Change in Stroop Test Scores
timeFrame: 30 days
measure: Change in Digit Symbol Substitution Scores
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Natinal Jewish Health
state: Colorado
Study officials:
References:
Clinical trial NCT04453397: Expanded Access for TNB-383B in a Subject With Relapsed/Refractory Multiple Myeloma
Official title: A Single Patient Protocol for TNB-383B, a Bispecific Antibody Targeting BCMA in a Subject With Relapsed/Refractory Multiple Myeloma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Multiple Myeloma
Lead sponsor: TeneoOne Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is a single patient protocol for TNB-383B in a subject with relapsed/refractory multiple myeloma (MM) who is not a candidate for treatment regimens known to provide clinical benefit in MM.


Eligibility criteria: Inclusion Criteria:

* Adequate bone marrow function
* eGFR ≥ 30 mL/min
* Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
* Serum calcium (corrected for albumin) at or below the ULN range

Exclusion Criteria:

* Candidate for treatment regimens known to provide clinical benefit in MM
* Active infection requiring parenteral anti-infective treatment
* Any medical or psychiatric condition which in the opinion of the investigator or Teneobio Medical Monitor places the subject at an unacceptably high risk for toxicities, could interfere with successful or safe delivery of therapy, or could interfere with evaluation of the investigational product or interpretation of subject safety

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
Study officials:
affiliation: Amgen
name: Ben Buelow
role: STUDY_CHAIR
References: