louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01496950: Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine
Official title: Double-blind Randomized Clinical Trial to Evaluate Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in the Preventive Treatment of Chronic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Migraine
Keywords: migraine
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2011-12-21
Enrollment: 18
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: TREATMENT

Brief summary: The purpose of this study is to determine whether active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive treatment of chronic migraine, compared to placebo repetitive transcranial magnetic stimulation.

Detailed description: Patients with chronic migraine according to the criteria of the International Headache Society will be randomized to either active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex or placebo repetitive transcranial magnetic stimulation, in a total of 23 sessions of treatment (15 sessions in the first month and 8 sessions in the second month of treatment). Outcomes will be evaluated at baseline, after one, two months after treatment, and one month after end of treatment

Eligibility criteria: Inclusion Criteria:

* chronic migraine according to the criteria of the International Headache Society
* no change in prophylactic medication in the past 3 months

Exclusion Criteria:

* other neurological disorders
* bipolar disorder
* alcohol or drug dependence in the past 2 months
* suicidal ideation, psychotic symptoms
* contraindications to transcranial magnetic stimulation (cardiac pacemaker, implanted electronic devices, metal in the skull, skull fractures, history of seizures)
* use of antidepressants in the past 4 weeks
* pregnancy or lack of birth-control method in women of childbearing age

Primary outcomes:
measure: number of days with pain per month
timeFrame: After all treatment sessions (total, 23 sessions within 60 days)
Secondary outcomes:
measure: adverse effects
timeFrame: After all treatment sessions (total, 23 sessions within 60 days)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Israelita de Ensino e Pesquisa Albert Einstein
Study officials:
affiliation: Instituto Israelita de Ensino e Pesquisa Albert Einstein
name: Adriana Conforto, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05450523: Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) Clinical Trial Protocol
Official title: Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Dialysis-associated Peritonitis
Lead sponsor: Qingdao HIGHTOP Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-08
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis.

Brief summary: According to the requirements of the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents", the first registered product (hereinafter referred to as the assessment reagent) - Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) was tested in clinical institutions. ) for clinical validation trials. Prove that the clinical performance of the assessment reagent meets the requirements of the intended use.


Eligibility criteria: Inclusion Criteria:

Patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis. There are no age or gender requirements, and informed consent is required.

Exclusion Criteria:

1. Patients who have been treated with antibiotics for peritonitis before taking the sample.
2. Incomplete information, including: sample ID number, gender, age, department, clinical diagnosis, sample type, and sampling date.
3. The sample size is insufficient.
4. Repeated cases.
5. The samples whose permeate is red in visual inspection.

Primary outcomes:
measure: Assessment reagent test results and clinical reference standard statistics
timeFrame: 8 months
measure: Statistical analysis of non-professional self-testing test
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The first affiliated hosital of Nangchang university
state: Jiangxi
Study officials:
affiliation: The first affiliated hosital of Nangchang university
name: Qinkai Chen, Chief physician
role: STUDY_CHAIR
References:
Clinical trial NCT00160823: Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients
Official title: Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colonoscopy
Keywords: Colon cleansing
Quality
Cost-effectiveness
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: The quality of colon cleansing has a major impact on efficiency and cost of colonoscopy. A hand-out was made to instruct and motivate patients to adequately clean the bowel before colonoscopy.

The aim of the study is to compare adequacy of bowel cleansing in hospitalized patients receiving the hand-out or not on the day before colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Total colonoscopy scheduled during hospital stay in the Hôpital Universitaire de Genève (excluding dependencies);
* Informed consent for inclusion in the study signed by the patient;
* Ability to read and write at least one of the following languages : French, English, Spanish, Portuguese.

Exclusion Criteria:

* Colonoscopy scheduled under general anesthesia;
* Occupation inside the healthcare professions;
* Previous colonoscopy, colostomy or colectomy;
* Megacolon or idiopathic pseudo-obstruction.

Primary outcomes:
measure: Quality of overall colon cleansing
Secondary outcomes:
measure: Quality of cleansing in the ascending colon,
measure: Frequency of inadequate preparation and of failed procedure,
measure: Time to intubate the caecum,
measure: Cost-effectiveness of the self-administered leaflet,
measure: Patient compliance with the self-administered leaflet,
measure: Patient comfort with the colonoscopy.
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Gastroenterology and Hepatology Division, University Hospital of Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Jean-Marc Dumonceau, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03158623: Wound Additives in Primary Total Joint Athroplasty
Official title: The Effects of Platelet-Rich Plasma and Activated Collagen on Wound Healing in Primary Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthroplasty, Replacement
Keywords: total joint arthroplasty
platelet-rich plasma
activated collagen
Lead sponsor: Salt Lake Orthopedic Clinic
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups with identical surgical closures randomized into 2 groups with wound additives and the third group without wound additives.
Primary purpose: TREATMENT

Brief summary: 3 cohorts of total joint patient of 30 members each were randomized to receive PRP or Activated Collegen or no additive were studied for status of the wound at 6 weeks and recorded all complications, infections and reoperations. The three groups were than compared for statistical analysis

Detailed description: Background: Wound healing remains a concern in primary total joint arthroplasty given the risk of deep infections arising from hematomas, wound separations, and superficial infections. If wound additives can prevent these early complications, their universal application would be cost effective. This study examined whether two wound additives, Platelet-Rich Plasma (PRP) and CellerateRX® (activated collagen), would improve postoperative wound healing and reduce complications in primary total joint arthroplasty.

Methods: A prospective, randomized, controlled study using three cohorts with 30 patients each (Group 1: PRP, Group 2: activated collagen, Group 3: control) were examined postoperatively at two and six weeks, at which time the following data were recorded: six wound measurements, total postoperative blood loss, complications of superficial infections, and reoperations.

Eligibility criteria: Inclusion Criteria:

* Osteoathritis of knee and hip

Exclusion Criteria:

* Inflammatory arthritis and hypercoagulable state

Primary outcomes:
measure: Wound Status
timeFrame: 6 weeks post operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04011423: Whole Body Vibration and Unstable Shoes on Balance in Healthy Young People
Official title: Effects of Combined Whole Body Vibration and Unstable Shoes on Balance in Healthy Young People: A Preliminary Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance
Keywords: Unstable Shoes
Whole Body Vibration
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To compare the effect of different type of shoes (unstable or stable) combined with a whole body vibration training on balance.

Design: Randomized controlled trial.

Setting: Laboratory of biomechanics.

Population: Healthy young people.

Detailed description: Background: The use of whole body vibration to train strength and balance has increased in the last years. Last studies have shown that adding an unstable device increased electromyographic activity of the lower limb and the trunk muscles. However, no studies have investigated the effects of wearing unstable shoes during a whole-body vibration training on balance in healthy young people.

Aim: To compare the effects of different type of shoes (unstable \[Intervention group\] or stable \[Control group\]) combined with a 12-weeks whole body vibration training on balance.

Setting: Laboratory of biomechanics.

Eligibility criteria: Inclusion Criteria:

* Body mass index \< 35.

Exclusion Criteria:

* Cardiovascular disease, incapacity to practice a physical activity, musculoskeletal pathologies, neurologic diseases, previous experience with unstable shoes, previous experience with whole-body vibration.

Primary outcomes:
measure: Balance
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Moncada
country: Spain
facility: Universidad CEU Cardenal Herrera
state: Valencia
Study officials:
affiliation: Cardenal Herrera University
name: JF Lisón, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salvador-Coloma P, Arguisuelas MD, Domenech-Fernandez J, Sanchez-Zuriaga D, Amer-Cuenca JJ, Martinez-Gramage J, Montanez-Aguilera FJ, Lison JF. Effects of unstable shoes on trunk muscle activity in patients with chronic low back pain. Gait Posture. 2018 Jul;64:165-168. doi: 10.1016/j.gaitpost.2018.06.025. Epub 2018 Jun 11.
citation: Lison JF, Ortega-Santana B, Anton-Nogues A, Gonzalez-Requena P, Vera-Hervas C, Domenech-Fernandez J, Sanchez-Zuriaga D, Salvador-Coloma P. Effects and underlying mechanisms of unstable shoes on chronic low back pain: a randomized controlled trial. Clin Rehabil. 2018 May;32(5):654-662. doi: 10.1177/0269215517753972. Epub 2018 Jan 14.
Clinical trial NCT02727023: Effect of OMM on Anandamide Levels in Saliva
Official title: Osteopathic Manipulative Lymphatic Pump Technique and Its Effects to the Endocannabinoid System Activity as Measured by AEA Levels Via Mass Spectrometry and Mood Analogue Scale
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anandamide
Endocannabinoids
Keywords: Healthy
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
Collaborators: name: Cold Spring Harbor Laboratory
First posted: 2016-04-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Investigators will be studying the effects of Osteopathic Manipulative Lymphatic Pump Treatment on levels of anandamide in Saliva. A qualitative scale will also be used to measure the canabinomimetic effects of osteopathic treatment.

Detailed description: The Endocannabinoid System is a signaling system composed of: 2 G-Protein coupled receptors (CB1 and CB2), substances acting on the cannabinoid receptors, and the enzymes and proteins involved in regulating endocannabinoids in tissue and at the receptors. The substances acting the cannabinoid receptors CB1 and CB2 are called endocannabinoids. The present study examines the effects of Osteopathic Manipulative Lymphatic Pump Techniques on levels of anandamide, an endocannabinoid, in saliva samples of adult subjects. Based on existing research, the investigators hypothesize that subjects who undergo osteopathic lymphatic treatment will have increased levels of anandamide. Establishing the levels of endocannabinoids in these subjects will allow for a direct measure of the efficacy of the Osteopathic Manipulative Lymphatic techniques. In addition to the quantification of endocannabinoid levels in saliva, a series of 16, 100 mm analog scales will be used to assess the cannabinomimetic effects in the subject pre and post OMM treatment/control and it will be correlated to changes in endocannabinoid levels.

Eligibility criteria: Inclusion Criteria:

* Accepts healthy volunteers.
* Able to read and understand scale for survey.
* BMI (Body Mass Index) TBD- BMI between 18 and 25 kg/m2 Signed informed consent No exercising on the day of or day before the appointment Age 18 and above.

Exclusion Criteria:

* smoker
* Neuropsychiatric disorders
* Autoimmune Disorders
* Unavailable 8AM-12PM
* No Illicit drug use, including exogenous cannabis.

Primary outcomes:
measure: Osteopathic Manipulative Lymphatic Pump Treatment and Its Relationship To Anandamide levels
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: NYITCOM
state: New York
Study officials:
affiliation: NYIT-COM
name: George Cheriyan, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03396523: Losartan and Emotion Processing
Official title: Losartan Effects on the Extinction of Conditioned Fear in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Losartan
Fear extinction
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to investigate the effect of losartan (50mg, single dose) on the extinction of conditioned fear

Detailed description: In a double-blind, between-subject, placebo controlled design the effects of a single dose of losartan (50mg) on fear extinction in healthy male participants will be examined. Participants will initially undergo a Pavlovian fear conditioning procedure, followed by the administration of 50mg losartan or placebo. 90 minutes after treatment subjects will undergo the fear extinction procedure. Neural activity and psychophysiological indices of arousal will be assessed by the simultaneous acquisition of functional magnetic resonance imaging (fMRI) and skin conductance data.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness
* hypertension

Primary outcomes:
measure: Losartan effects on neural activity during fear extinction
timeFrame: 1 hour
Secondary outcomes:
measure: Losartan effects on skin conductance responses during fear extinction
timeFrame: 1 hour
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Benjamin Becker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou F, Geng Y, Xin F, Li J, Feng P, Liu C, Zhao W, Feng T, Guastella AJ, Ebstein RP, Kendrick KM, Becker B. Human Extinction Learning Is Accelerated by an Angiotensin Antagonist via Ventromedial Prefrontal Cortex and Its Connections With Basolateral Amygdala. Biol Psychiatry. 2019 Dec 15;86(12):910-920. doi: 10.1016/j.biopsych.2019.07.007. Epub 2019 Jul 25.
Clinical trial NCT02794623: Tinnitus Suppression for Cochlear Implant Recipients
Official title: Evaluation of Tinnitus Suppression for Cochlear Implant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: cochlear implants
hearing loss
Lead sponsor: The Hearing Cooperative Research Centre
Sponsor class: OTHER
Collaborators: name: Royal Victoria Eye and Ear Hospital
name: Cochlear
First posted: 2016-06-09
Enrollment: 12
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: Tinnitus is the perception of sound in the absence of an external sound. Prevalence in the general population is 10 to 15%, with tinnitus severely impacting quality of life in 1-2 percent of the population. Tinnitus therapy is based on counselling, cognitive and behavioural therapies in combination with sound therapies which mostly rely on masking.

For cochlear implant candidates, the ability to use hearing aids and maskers is limited by the degree of their hearing loss. Reports of tinnitus prevalence in this group range from 67 to 100% with a mean of 80%.

In cochlear implant (CI) recipients, tinnitus suppression primarily occurs during active use of the cochlear implant system. In some CI recipients residual inhibition of tinnitus occurs when the implant is switched off. While the benefits of CI implantation on tinnitus are well documented, there is a group of recipients where tinnitus remains a concern in the implanted ear post-operatively.

The primary aim of this study is to investigate the benefits of using tinnitus masking via a CI sound processor that optimises tinnitus suppression with minimal annoyance to the user. Furthermore a questionnaire will be employed to capture the prevalence, degree and nature of tinnitus in recipients.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Freedom or CI500 series implant
3. At least 3 months experience with the cochlear implant
4. Native speaker in the language used to assess speech perception performance
5. Willingness to participate in and to comply with all requirements of the protocol
6. Self-reported tinnitus in the implanted ear
7. Reside local to investigational site

Exclusion Criteria:

1. Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and test including MRI
2. Additional handicaps that would prevent participations in evaluations
3. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study

Primary outcomes:
measure: Tinnitus Severity Questionnaire
timeFrame: Testing over 6 months
measure: Word recognition scores in quiet
timeFrame: Testing over 6 months
measure: Speech recognition scores in noise
timeFrame: Testing over 6 months
Secondary outcomes:
measure: Degree of handicap as a result of tinnitus
timeFrame: Testing over 6 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The HEARing CRC
state: Victoria
Study officials:
References:
Clinical trial NCT01698723: A Trial of Ribavirin in Patients With ACLF Due to Hepatitis E Virus
Official title: A Double Blind Placebo Controlled Randomized Trial of Ribavirin in Patients With Acute on Chronic Liver Failure Due to Hepatitis E Virus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute on Chronic Hepatic Failure
Liver Failure
Hepatitis E Infection
Keywords: ACLF
HEV
Ribavirin
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The term Acute on chronic liver failure (ACLF) describes a clinical entity characterized by an acute and rapid deterioration of liver function in a patient with previously well-compensated liver disease owing to the effects of a precipitating event. In this condition two insults act simultaneously, one being the preexisting liver injury (chronic liver disease) and the other acute injury which is responsible for the acute decompensation. HEV being a major factor responsible for this clinical entity and has a very high mortality rate. Ribavirin being a safe drug and has been shown to inhibit the replication of HEV, can be an important drug in the treatment of these patients. Therefore the present study is designed to study the impact of Ribavirin in reducing the mortality due to HEV related ACLF.


Eligibility criteria: Inclusion Criteria:

* All ACLF due to HEV
* Consent to participate in trial and collection of blood.

Exclusion Criteria:

* Pregnant and nursing mothers.
* Severe anemia
* Other etiologies of ACLF (eg. Alcohol, drugs, reactivation of hepatitis B and hepatitis C, variceal bleeding, surgical intervention and sepsis)
* Hepatocellular carcinoma (HCC)
* Hepatorenal syndrome (HRS) at admission
* Presence of life threatening cardiovascular, respiratory and neurological disease
* Acquired Immunodeficiency Syndrome
* Patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
* Refusal to provide consent to participate in the study

Primary outcomes:
measure: Improvement in survival
timeFrame: 4 weeks and 12 moths
Secondary outcomes:
measure: Child Score
timeFrame: 4 weeks and 12 months
measure: Viremia
timeFrame: 4 weeks, 3 months
measure: Variceal bleeding
timeFrame: 4 weeks and 12 months
Other outcomes:
Locations:
city: Delhi
country: India
facility: AII India Institute of Medical Sciences
city: Delhi
country: India
facility: All India Institute of Medical Sciences
Study officials:
affiliation: All India Institute of Medical Sciences
name: Subrat K Acharya, DM
role: PRINCIPAL_INVESTIGATOR
References: