louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00806468: Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease
Official title: A Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Parkinson Disease
Keywords: nycturia
Parkinson syndrome
desmopressin
Nocturnal polyuria in patients with Parkinson syndrome
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2008-12-10
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will be conducted to study the effect of Desmopressin on the nocturnal micturition frequency in patients with idiopathic Parkinson syndrome.


Eligibility criteria: Inclusion Criteria:

* Male patients with idiopathic Parkinson Syndrome
* 18 to 85 years
* Nocturnal Pollakisuria \> 2 mictions /night (documented in Screening phase )
* Na+ i.S \> 135 mmol/l
* Patient is able to understand all aspects and individual consequences of the clinical trial
* An informed consent signed and dated by the patient is available prior to any study specific treatment
* The study is consistent with the patients´ request for an appropriate treatment

Exclusion Criteria:

* Intake of the following concomitant medication: Carbamazepin, Oxcarbazepine, diuretics (Furosemide, Torasemide), non steroidal antiphlogistics, Loperamide, antidiuretic hormone analoga (besides study medication), drugs for treatment of bladder disfunction, in particular anticholinergics
* Central Diabetes insipidus
* Known heart insufficiency (NYHA Stad. III und IV)
* clinical relevant kidney insufficiency
* Habitual and psychogenic Polydipsia
* Hypersensitivity or allergy against the trial medication or any other ingredient of the trial medication
* Participation in another clinical trial during or within 6 months prior to this clinical trial
* Medical or psychological condition, which might endanger the proper conduction of the clinical trial
* Known drug or alcohol abuse

Primary outcomes:
measure: average nocturnal micturition frequency within the 2 weeks treatment phase each
timeFrame: 6 weeks
Secondary outcomes:
measure: safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Klinikum der Johannes Gutenberg-Universität Mainz, Studienzentrum Neurologie, Langenbeckstr. 1, 55131 Mainz
Study officials:
affiliation: Johannes Gutenberg University Mainz, Department of Neurology
name: Thomas Vogt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00991068: Open-Label Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome
Official title: An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carpal Tunnel Syndrome
Keywords: Pain
Mild to moderate Carpal Tunnel Syndrome
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate carpal tunnel syndrome.

Detailed description: ZARS Pharma, Inc. has developed Synera® (lidocaine 70 mg and tetracaine 70 mg topical patch), a drug delivery patch that utilizes controlled heat to enhance the delivery of a local anesthetic formulation consisting of a eutectic mixture of lidocaine and tetracaine. Synera was approved by the Food and Drug Administration (FDA) on June 23, 2005 and is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodesiccation, and shave biopsy of skin lesions.

The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate CTS.

Eligibility criteria: Inclusion Criteria:

* Pain associated with mild to moderate carpal tunnel syndrome in a single wrist
* Have recent (within 3 months) electrodiagnostic evidence of carpal tunnel syndrome (CTS)

Exclusion Criteria:

* Have bilateral carpal tunnel syndrome
* Have another peripheral neuropathy in the affected limb
* Have had an injection into the carpal tunnel within 8 weeks
* Have had surgical release of the target wrist within previous 6 months
* Have electrodiagnostic evidence of severe CTS

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Pain intensity
timeFrame: Screening/Day 1, Day 8, and Day 15 or early withdrawal
Secondary outcomes:
measure: Pain interference with activities (general, normal work, sleep)
timeFrame: Screening/Day 1, Day 8, and Day 15 or early withdrawal
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: International Clinical Research Institute
state: Kansas
Study officials:
affiliation: International Clinical Research Institute
name: Srinivas Nalamachu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02586168: The Effect of Gemcabene on Insulin Sensitivity in Nondiabetic Subjects
Official title: The Effect of Gemcabene (CI-1027) on Insulin Sensitivity in Nondiabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insulin Sensitivity
Keywords: Insulin Resistance
Lipid Regulator
Lead sponsor: NeuroBo Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-26
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effect of gemcabene on insulin sensitivity as defined by average glucose disposal rate.


Eligibility criteria: Inclusion Criteria:

* Good health, as determined by medical history, physical examination, EKG and clinical laboratory assessments
* Males; and females of non-reproductive potential
* Obesity
* Non-diabetic

Exclusion Criteria:

* Use of any medication considered unacceptable by the clinical investigators during the 14-day period before the start of Day 1. Hormone Replacement Therapy is acceptable.
* Use of a lipid-lowering agent (niacin, fibrates, statin) during the 8 weeks before screening
* Use of any anti-diabetic medications
* Use of any steroid medications
* Donation of any blood or plasma product or participation in another study in the 30 days prior to Day 1
* If female, pregnant, lactating or of childbearing potential; and
* History of significant reaction to any fibrate lipid-lowering agent

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 4 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: 4 weeks
measure: ECG
timeFrame: 4 weeks
measure: Clinical Laboratory - hematology, chemistry
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02370368: Comparison of Videogame Based Dance Training With Agility Ladder Drills on Agility of Volleyball Players
Official title: A Comparison of a Dance Programme Delivered With the XBOX Kinect With Traditional Agility Ladder Drills on Agility Scores of Club Level Volleyball Players of the University of the West Indies, Mona
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Athletes
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will examine the effects of six week dance training, using the Xbox Kinect Just Dance 2014 programme, on the agility scores along with general and hamstring flexibility and extensibility of the hip flexor. The effects of the dance programme will be compared with those of proven agility training techniques (ladder drills).

Detailed description: A randomised clinical trial will be used consisting of 34 (17 in each group) athletes undergoing training. Both groups will undergo one hour of training three times weekly for six weeks, with one group doing dance training (DT) using the Xbox Kinect and the other doing standard training (ST) using traditional ladder drills. Outcomes will be assessed using the Illinois Agility test for agility, sit and reach test for general flexibility, straight leg raise test for hamstring flexibility and the Thomas test for hip flexor extensibility.

Eligibility criteria: Inclusion Criteria:

* To be included in the study persons must be playing volleyball at the University of the West Indies at competitive levels and will be required to give written consent to participate in the study.

Exclusion Criteria:

- 1. Anyone who currently has a musculoskeletal injury of the lower limb that prevents them from performing the respective activities.

2. Anyone involved in a dance programme as this will confound the results of the study.

Primary outcomes:
measure: Change in Agility From Baseline to 6 Weeks
timeFrame: baseline and at 6 weeks
Secondary outcomes:
measure: Change in Hamstring Extensibility From Baseline to 6 Weeks
timeFrame: Baseline and at 6 weeks
measure: Change in Hip Flexor Extensibility From Baseline to 6 Weeks
timeFrame: baseline and at 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06201572: The Value of TOI in Evaluating Renal Function Damage in Hypertensive Emergency Patients
Official title: The Value of Smartphone-based Optical Blood Spectrum Imaging (TOI) in Evaluating Renal Function Damage in Hypertensive Emergency Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypertensive Emergency
Lead sponsor: The Affiliated Hospital of Hangzhou Normal University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized for acute hypertension from January 2022 to December 2024 with onset time \<48 hours and blood pressure measured by standard sphygmomanometer: Systolic blood pressure (SBP)\>180mmHg and/or diastolic blood pressure (DBP)\>120mmHg, age \>18 years old, gender, stable vital signs, good compliance, complete and reliable medical records.

Brief summary: TOI was used to measure heart rate, respiration, blood pressure, heart rate variability and psychological stress. At the same time, the patient's urine protein, creatinine, urea nitrogen and other indicators were detected. According to different renal function, they were divided into observation group and control group, and 100 general inpatients with renal insufficiency were selected as positive control group. The relationship between TOI composite index and renal function in hypertensive emergency patients was compared.

Detailed description: TOI technique was used to measure the heart rate, respiration, blood pressure, heart rate variability, psychological pressure, etc. At the same time, the urine protein, creatinine, urea nitrogen and other results of these patients were measured. According to the different renal function, they were divided into observation group and control group, and 100 ordinary hospitalized patients with renal insufficiency were selected as positive control group. The relationship between TOI composite index and renal function in hypertensive emergency patients was compared. The data management platform provides intelligent management of patients' out-of-hospital follow-up, and the dynamic physiological indicators and psychological assessment data of patients are mastered through the hospital port, so as to provide telemedicine guidance for patients, so as to improve the prognosis of hypertensive emergency patients.

Eligibility criteria: Inclusion Criteria:

* Systolic blood pressure (SBP)\>180mmHg
* Diastolic blood pressure (DBP)\>120mmHg

Exclusion Criteria:

* Severe head and facial skin injury
* Cerebral hemorrhage or severe shock after admission
* Patients who insist on refusing to participate in this clinical tria
* Patients who could not participate in the study for other reasons.

Primary outcomes:
measure: blood pressure
timeFrame: 2023-12-01 to 2024-12-31
measure: creatinine
timeFrame: 2023-12-01 to 2024-12-31
measure: urea nitrogen
timeFrame: 2023-12-01 to 2024-12-31
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03749772: Cognitive Therapy Plus Dietary Intervention for Obesity Treatment
Official title: Effectiveness of a Cognitive Training Therapy for Overweight/Obesity Treatment: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: obesity, cognitive therapy, executive function
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 100
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: TREATMENT

Brief summary: This randomized clinical trial was carried out from January 2017 to December 2017 at the facilities of the Catholic University of Murcia. Written informed consent was required from each patient. The protocols of the present clinical trial follow the CONSORT standards. To measure the impact of cognitive training on weight loss in overweight / obese subjects, a double-blind study (de facto masking) was designed.

Both the participants and the statistical assessors were unaware of the study hypothesis. Participants were unaware of treatments and possible assignments between groups, and only those subjects who were randomly assigned to the cognitive training group were informed that such training was part of dietary therapy.

The principal investigator of the present study (J.J.H.M.) carried out the randomization, with the assistance of the Microsoft Excell program, with the help of a macro designed in Visual Basic® for that purpose.

The randomization divided the subjects into two groups, as they were treated with a hypocaloric diet plus 12 nutrition education sessions (CONTROL group) or a group that were treated with a hypocaloric diet plus 12 sessions of cognitive training (COGNITIVE group).

In order to obtain a similar size in both groups, a randomization in blocks with a 1: 1 allocation ratio was performed.

Cognitive performance measures were performed before and after training. One week before the beginning of the cognitive and dietary intervention, the participants performed a series of cognitive tests. After 12 weeks of both dietary and cognitive intervention, participants were reexamined to measure performance on neurocognitive tests.


Eligibility criteria: Inclusion Criteria:

* Present a BMI\> 27 kg / m2, and want to be part of the study voluntarily

Exclusion Criteria:

* subjects with diabetes mellitus type 2
* subjects with a history of a cardiovascular event (acute myocardial infarction, intermittent claudication, etc.)
* subjects with kidney or liver failure or some other significant pathology (cancer)
* subjects under pharmacological treatment that could affect body weight (corticoids, thyroxine, etc.)
* subjects who were on a diet or had been on a diet at least 6 months before their participation in the study were also excluded.

Primary outcomes:
measure: Total weight loss percentage
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06347172: Deprescribing in Patients Living with Dementia with Caregiver and Provider Nudges
Official title: Deprescribing in Patients Living with Dementia with Caregiver and Provider Nudges
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Dementia
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
name: National Institute on Aging (NIA)
First posted: 2024-04-04
Enrollment: 360
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that outcomes can be feasibly measured and evaluated at scale in a subsequent embedded pragmatic clinical trial (ePCT), and explore representativeness of persons living with dementia and care partners identified.

Detailed description: The PCP nudge will consist of: a 'pre-commitment' EHR nudge triggered when a PCP opens a patient encounter (i.e., prompt to first have a discussion and then later deprescribe) and a brief message within the in-basket prior to upcoming visits including information about their patient. The patient living with dementia (PLWD)/care partner nudge will include an electronic message delivered prior to upcoming visits (in their primary language recorded in the EHR) that includes a recommendation for the PLWD (and care partner, if available) to discuss medications with the PCP at the visit.

Eligibility criteria: Primary care providers will be the primary unit of identification and randomization.

Primary care providers inclusion criteria:

* Providers within Brigham and Women's Hospital primary care practices
* Having prescribed at least one of the high-risk medications of interest

Eligible patients will be identified through this providers within the health care system.

Patient inclusion criteria:

* At least 65 years of age
* Prescribed at least 90 pills of one of the high-risk medications of interest in the last 180 days in the EHR system, which most guidelines consider chronic use, and have a diagnosis of dementia in the EHR.

Primary outcomes:
measure: Composite of the percentage of eligible PCPs or their PLWD/care partners who view or click on information
timeFrame: On or before the primary care provider visit
Secondary outcomes:
measure: Number of nudges that fire as intended: Fidelity
timeFrame: On the primary care provider visit
measure: Discontinuation or prescribed reduction in medication
timeFrame: Within 60 days after the primary care provider visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Brigham
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Julie Lauffenburger, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03259672: Influence of Sevoflurane and Desflurane on Postoperative Sore Throat
Official title: Influence of Sevoflurane and Desflurane on Postoperative Sore Throat
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Arthroplasty
Keywords: intubation
pharyngitis
remifentanil
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 100
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: PREVENTION

Brief summary: This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of sevoflurane or desflurane.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Patients scheduled for general anesthesia with endotracheal intubation

Exclusion Criteria:

* Difficult airway
* Friable teeth
* Rapid sequence induction
* Recent sore throat
* Recent upper respiratory infection
* Asthma
* Chronic obstructive pulmonary disease
* Chronic cough
* Arrhythmia
* Coronary disease
* Heart failure
* Pregnancy
* Allergy to sevoflurane
* Allergy to desflurane
* Fever after halogenated anesthetics
* Jaundice after halogenated anesthetics
* Malignant hyperthremia
* Allergy to remifentanil
* Friable teeth
* History of head and neck surgery
* Multiple intubation attempts
* Regional anesthetic agents
* Gastric tube
* Dexamethasone
* Severe hypovolemia

Primary outcomes:
measure: Number of participants with postoperative sore throat
timeFrame: At 24 hr
Secondary outcomes:
measure: Number of participants with postoperative sore throat
timeFrame: At 0, 2, 4 and 24 hr
measure: Number of participants with postoperative hoarseness
timeFrame: At 0, 2, 4 and 24 hr
measure: Number of participants with postoperative cough
timeFrame: At 0, 2, 4 and 24 hr
measure: Number of participants with postoperative nausea
timeFrame: At 0, 2, 4 and 24 hr
measure: Number of participants with postoperative vomiting
timeFrame: At 0, 2, 4 and 24 hr
measure: Number of participants with additional pain medication
timeFrame: At 0, 2, 4 and 24 hr
measure: Visual analogue scale of postoperative pain
timeFrame: At 0, 2, 4 and 24 hr
measure: Number of participants with shivering
timeFrame: At 0, 2, 4 and 24 hr
measure: Requirements of analgesics
timeFrame: At 0, 2, 4 and 24 hr
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01938872: Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Limb Ischemia
Keywords: critical limb ischemia
drug-eluting balloon
restenosis
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing below-the-knee angioplasty with paclitaxel eluting balloon for critical limb ischemia

Brief summary: to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee angioplasty in terms of restenosis at 12 months


Eligibility criteria: Inclusion Criteria:

* age\>18 years
* angiographic stenosis\>50% or occlusion of one below-knee vessel

Exclusion Criteria:

* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent
* need for amputation

Primary outcomes:
measure: angiographic binary restenosis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Cardiovascular Department, Ospedale S.Donato
state: AR
Study officials:
References: