louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02721095: Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl
Official title: Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl for Correction of Hypokalemia in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypokalemia
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2016-03-28
Enrollment: 84
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: evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia

Detailed description: Hypokalemia is frequently encountered in hospitalized patients. Intravenous (IV) potassium repletion with saline is preferred used for initial therapy. However, administration of normal saline (0.9%NaCl) usually provokes sodium and potassium diuresis, thus, it might delay reversal of the hypokalemia.

Object of this study : to evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia.

Eligibility criteria: Inclusion Criteria:

* Serum K+ 2.5-3.49 mmol/L
* No life threatening condition from hypokalemia

Exclusion Criteria:

* Pregnancy
* Volume overload, heart failure
* Hypotension
* Acute kidney injury
* Dysnatremia
* K+ shift
* Salt wasting nephropathy

Primary outcomes:
measure: Number of participants with normal serum K as assessed by serum electrolyte
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Phramonkutklao Hospital
Study officials:
affiliation: Instituitional review board royal thai army medical department
name: Yaowana Thanapat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00512395: Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections
Official title: Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: laparoscopic colorectal surgery
epidural analgesia
pain score
postoperative ileus
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Triemli Hospital
First posted: 2007-08-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epidural anaesthesia in open surgery is a effective method for analgesia and has a positive effect on postoperative resolution of ileus. In laparoscopic surgery, the role of epidural surgery is not established. This prospective observational trial evaluates the effect of epidural analgesia in patients undergoing elective, laparoscopic colorectal surgery.

Detailed description: All patients with elective, laparoscopic colorectal resection between November 2004 and January 2007 were included in the trial. The decision for epidural analgesia was made by the anaesthetist and the patient. Contraindications were previous back surgery, coagulopathy, severe spondylarthrosis and refusal by the patient as contraindications.

Primary outcome was subjective feeling postoperatively, assessed with a VAS for pain and cramps and amount of analgesics used. Secondary outcomes were duration of postoperative bowel dismotility (first flatus, first defecation, first solid food intake) and general and specific morbidity.

Eligibility criteria: Inclusion Criteria:

* elective laparoscopic colorectal resection

Exclusion Criteria:

* emergency surgery
* preoperatively planned stoma formation

Primary outcomes:
measure: pain (VAS), cramps (VAS) and quantity of analgesics
timeFrame: 8 days
Secondary outcomes:
measure: duration of postoperative ileus morbidity
timeFrame: 6 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Triemli Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Urs Zingg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00144495: A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy
Official title: A Multicenter, Open-Label Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy Induced Anemia
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Cancer patients

Exclusion Criteria:

* a history of myocardial, cerebral or pulmonary infarction
* severe hypertension beyond control by drugs

Primary outcomes:
measure: The increase in Hb concentration
timeFrame: Day 28th or later
Secondary outcomes:
measure: Changes in QOL scores
timeFrame: 84 days
Other outcomes:
Locations:
Study officials:
affiliation: Chugai Pharmaceutical
name: Yoshiharu Ishikura
role: STUDY_DIRECTOR
References:
Clinical trial NCT02380495: "Studio NaVA" - National Study on Quality of Life in Adolescents Affected by Allergic Rhinitis With or Without Asthma
Official title: Studio NaVA - Studio Nazionale Sulla Qualità Della Vita in Adolescenti Con Rinite Allergica Con e Senza Asma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Asthma
Keywords: Adolescents
Respiratory Pathology
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 1200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * 600 adolescents with allergic rhinitis with/without asthma, from 14 to 17 years age, recruited from Pediatricians of the Italian territory
* 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology (patient family)

Brief summary: "Studio Nava" is a National Study aiming to assess allergic rhinitis and asthma outcomes on Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. "Studio Nava" also proposes the innovative use of a web platform ("http://nava.ibim.cnr.it/") that contains all standardized tools (medical-healthcare web form, ACT, Asthma control test; PSQI, Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for adolescents; Rhinasthma; VAS scale), that will be available for the doctors after the registration to the web platform. Downloaded questionnaires will be delivered to case-patient, asking him/her to fill them during the waiting time of the visit.


Eligibility criteria: Inclusion Criteria:

* Clinical cases n°: 600 adolescents affected by allergic rhinitis with/without asthma, from 14 to 17 years age.
* Controls n°: 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology.

Exclusion Criteria:

* Subjects that have not allergic rhinitis with/without asthma diagnosis or are \<14 years old or \>17 years old

Primary outcomes:
measure: Assessment of the allergic rhinitis impact on quality of life
timeFrame: 2 weeks
Secondary outcomes:
measure: The impact of AR and asthma on quality of sleep
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
state: Sicily
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology, IBIM
Study officials:
References:
Clinical trial NCT00648895: A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients
Official title: Effect of Nebivolol on Forearm Vasodilation, Nitric Oxide Bioavailability, and Oxidative Stress in Patients With Stage 1/2 Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
Blood pressure
Nebivolol
Bystolic (TM)
Metoprolol ER (TM)
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other biomarkers.


Eligibility criteria: Inclusion Criteria:

* Male or female, ambulatory outpatients 18-79 years old at screening
* Minimum 2-year history of Stage I/II hypertension
* Qualifying blood pressure criteria for study entry and for randomization
* Willing to adhere to the dietary compliance and undergo protocol procedures
* Have a lifestyle that will permit him/her to attend all evaluations, including those conducted on consecutive days

Exclusion Criteria:

* Have any form of secondary hypertension
* Have clinically significant respiratory or cardiovascular disease
* Presence/history of coronary artery disease or peripheral vascular disease
* Have diabetes mellitus, Type I or II
* Have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker

Primary outcomes:
measure: Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).
timeFrame: Before treatment and after 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Forest Investigative Site
state: Texas
Study officials:
affiliation: Forest Research Institute, Inc., a Subsidiary of Forest Laboratories, Inc.
name: Tatjana Lukic, MD., M.Sc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03129295: Phase II Proof of Concept Study in Uncomplicated UTI
Official title: A Randomized, Double-Blind, Placebo-Controlled, MultiCenter Study of the Efficacy and Safety of MPC-SHRC for the Relief of Symptoms Associated With Uncomplicated Urinary Tract Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Urinary Tract Infections
Lead sponsor: Mission Pharmacal
Sponsor class: INDUSTRY
First posted: 2017-04-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections.


Eligibility criteria: Inclusion Criteria:

* Non-pregnant, nonlactating woman with moderate to severe symptoms of urinary tract infection
* On adequate birth control
* Normal ECG

Exclusion Criteria:

* Participated in any other trial within 30 days of visit 1
* Known or suspected allergy to investigational drug
* Narrow angle glaucoma
* Recovering from chicken pox or flu-like symptoms
* History of peptic ulcer, gastrointestinal bleeding, gastrointestinal surgery, or gastrointestinal dysfunction which could interfere with drug absorption
* Taken any drugs for within past 24 hours for symptoms associated with uncomplicated urinary tract infections
* Currently taking prohibited drugs
* Taken an antibiotic within 7 days of Visit 1
* Are ineligible to receive an antibiotic
* History of urinary retention
* History of interstitial cystitis
* History of impaired renal function
* History of impaired hepatic function
* Diagnosis or suspicion of complicated urinary tract infection or systemic infection
* History of substance abuse

Primary outcomes:
measure: Change from baseline on assessment instrument
timeFrame: 6 hours after the first dose of study drug
Secondary outcomes:
measure: Change from baseline on assessment instruments
timeFrame: Three hour intervals after first dose of study drug
measure: Change from baseline on Pain Scale
timeFrame: Three hour intervals after first dose of study drug
Other outcomes:
Locations:
city: Jeffersonville
country: United States
facility: First Urology PSC
state: Indiana
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Lawrenceville
country: United States
facility: Lawrence OB/GYN Clinical Research, LLC
state: New Jersey
city: Plainsboro
country: United States
facility: Women's Health Research Center
state: New Jersey
Study officials:
affiliation: Hurley Consulting Associates Ltd.
name: Margaret E. Hurley, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03116581: Altruistic Decisions
Official title: Study on the Parameters That Influence Perceptual Decisions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Keywords: Perceptual Decision
Social Cognition
Motivation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study aimed to understand how payoffs for others influence perceptual decision making. The research consists in testing how varying monetary payoffs for another modify the perceptual decision making processes. The use of drift diffusion models on a random dots task enable the characterization of the decision parameter(s) that are modulated when a decision is made to win payoffs for others as compared to decisions for self-benefits. Once the parameter revealed through behavioral experiment, neuroimaging is applied to find the neural correlates of the effects of taking others into account in the decision making process.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 35
* Right-handed
* French
* Normal vision or corrected by contact lenses

Exclusion Criteria:

* Contraindications to the MEG examination
* Presence of a perceptual disorder (vision) or motor impairing the capacity to carry out the tasks requested (including dyschromatopsia and achromatopsia).
* Taking of medical treatment in progress (excluding contraceptive pill).
* Known neurological or psychiatric history or disorders.
* Participants in an exclusion period for any other research.
* Participants who do not benefit from social protection.
* Participants refusing to be informed of the results of the medical examination.
* Participants who refuse to be informed of the possible detection of an anomaly.
* Participants with MRI contraindications

Primary outcomes:
measure: Modulation of the decisional parameter by the payoff conditions
timeFrame: 1 hour
measure: Modulation of the decisional parameter by the beneficiary conditions
timeFrame: 1 hour
Secondary outcomes:
measure: Event-Related potentials
timeFrame: 1 hour
measure: Time-frequency brain responses
timeFrame: 1 hour
measure: BOLD
timeFrame: 1 hour
Other outcomes:
Locations:
city: Bron
country: France
facility: CH le Vinatier
Study officials:
affiliation: CH le Vinatier
name: Caroline DEMILY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02248181: Post Marketing Surveillance Study of Sifrol® in Patients With Idiopathic Parkinson's Disease
Official title: Post Marketing Surveillance Study of Sifrol® - Monotherapy in Patients With Idiopathic Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 442
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Idiopathic PD patients recruited at office-based neurologists, psychiatrists or physicians in special neurological clinics

Brief summary: Study to document pramipexole dosing during monotherapy, occurrence of fluctuations and dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms, assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and L-Dopa when given concomitantly.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of early stage idiopathic Parkinson's Disease
* No pre-treatment with any dopaminergic treatment (de novo patients), or Pre-treatment with L-Dopa at doses of \< 200 mg/d

Exclusion Criteria:

* Treating physicians are asked to consider the regulation described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole

Primary outcomes:
measure: Change in dosing details of Pramipexole
timeFrame: up to 21 months
measure: Occurrence and clinical course of Parkinson Disease (PD) motor symptoms
timeFrame: up to 21 months
Secondary outcomes:
measure: Assessment of Kinetic Tremor
timeFrame: up to 21 months
measure: Change in dosing details of L-Dopa
timeFrame: up to 21 months
measure: Global Assessment of tolerability by investigator on 4-point scale
timeFrame: after 21 months
measure: Global assessment of efficacy by investigator on a 4-point scale
timeFrame: after 21 months
measure: Number of patients with adverse drug reactions
timeFrame: up to 21 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01100281: Prefrontal Cortex and Abstract Thinking
Official title: Neuropsychological and Anatomical Study of Concept Formation in Frontal Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abstract Thinking
Concept Formation
Keywords: prefrontal cortex
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2010-04-08
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3 groups including : PSP, FTD, AD

Brief summary: The capacity of concept formation is not well understood, even if a link is supposed with the functioning of the frontal lobes.

Our aim is to better understand the cognitive mechanisms underlying this function and to try to correlate the performance with atrophy of the frontal lobe in neurodegenerative diseases involving this region (frontotemporal lobar degeneration and progressive supranuclear palsy).


Eligibility criteria: Inclusion Criteria:

* informed consent signed
* MMSE\> 20
* No contra indication to MRI

Exclusion Criteria:

* MMSE\<20

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Inserm U 975
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Richard Levy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00510081: An Evaluation of an Injectable Material for Correction of Wrinkles
Official title: An Open Label Evaluation of the Safety and Efficacy of Calcium Hydroxylapatite (Radiesse®) Injection in the Correction of Jowl-Associated Chin Notches
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Jowls
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2007-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the effectiveness of a filler in improving wrinkles.

Detailed description: The primary objective of this study is to determine whether focal injection of calcium hydroxylapatite (Radiesse®), an injectable biodegradable filler, into jowl-induced chin notches can result in safe, aesthetically pleasing, and long-lasting correction of these.

Eligibility criteria: Inclusion Criteria:

* Age 40-65
* Have wrinkles
* The subjects are in good health.
* The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

* Subjects who have received within the past 3 months or are planning to receive in the next 6 months, botulinum toxin injections for correction of wrinkles.
* Subjects who have received within the past one year any soft tissue augmentation material into the chin and experimental area (defined as any area on the face below the lower lip vermilion, excluding the lateral lip marionette line up to 1 cm below this level).
* Subjects with prior history of nodule formation or hypersensitivity reactions to lidocaine or medium-term augmentation materials, including hyaluronic acid derivatives, poly-L-lactic acid, and calcium hydroxylapatite.
* Subjects who are currently using anticoagulation therapy.
* Subjects who have a history of bleeding disorders.
* Subjects who are unable to understand the protocol or to give informed consent.
* Subjects with mental illness.

Primary outcomes:
measure: Correction of wrinkles
timeFrame: 1 week
Secondary outcomes:
measure: Development of adverse events
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University, Feinberg School of Medicine, Department of Dermatology
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: