louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00252200: BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.
Official title: Low Dose Continuous Infusion of BNP (Nesiritide) in the Prevention of Renal Insufficiency Post Cardiopulmonary Bypass Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Kidney Failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Scios, Inc.
First posted: 2005-11-11
Enrollment: 40
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: Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.

Detailed description: This is a randomized, double-blind, placebo controlled study of low dose nesiritide to prevent renal insufficiency after cardiopulmonary bypass surgery. Patients included are those with greater than mild renal insufficiency preoperatively as defined by having a creatinine clearance of less than 50 mL/minute determined by the Cockroft-Gault formula. The infusion of nesiritide (BNP) 0.005 mcg/Kg/minute or placebo begins 1 hour before surgery and runs for 24 hours started after the induction of anesthesia prior to cardiopulmonary bypass.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old, undergoing cardiac surgery requiring cardiopulmonary bypass with baseline creatinine clearance \< 50 ml/min and who are not dialysis dependent.

Exclusion criteria:

* Cardiogenic shock or hypotension with systolic BP \< 90 mmHg.
* Patients with acute or chronic aortic dissection.
* Patients who are enrolled in other studies that have an effect the renal function.

Primary outcomes:
measure: Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula
timeFrame: 72 hours post op
Secondary outcomes:
measure: Number of patients requiring dialysis during the hospitalization
timeFrame: before hospital discharge
measure: Plasma aldosterone levels at 12 hours and 24 hours
timeFrame: 12 hours and 24 hours postoperatively
measure: Total time on ventilator, ICU length of stay, total length of stay in hospital
timeFrame: total length of hospital stay
measure: pre and postoperative diuretic dose used
timeFrame: pre operative and postoperate
measure: Need or absence of need for inotropic support in the 72 hour perioperative period
timeFrame: 72 hours perioperative
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Horng H. Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03825900: Transcranial Direct Current Stimulation and the Interaction Between Chronic Pain and the Intestinal Epithelial Barrier in Patients With Chronic Inflammatory Bowel Diseases (IBD)
Official title: Transkranielle Gleichstromstimulation Und Die Interaktion Zwischen Chronischem Schmerz Und Der Intestinalen Epithelbarriere
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2019-02-01
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the study the investigators aim to test whether transcranial direct current stimulation (tDCS) induced pain reduction is in association with functional changes in the brain measured with magnetic resonance imaging (MRI) and also with a change in permeability of the intestinal epithelial barrier in patients with chronic inflammatory bowel diseases (IBD)

Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases, which is in association with changes in the brain measured via MRI. Additionally, transcranial direct current stimulation and the induced pain reduction influence the permeability of the intestinal epithelial barrier


Eligibility criteria: Inclusion Criteria:

* Inflammatory bowel disease
* Chronic pain (more than 3 months)
* Pain (VAS \> 3/10)

Exclusion Criteria:

* Contraindication to transcranial direct current stimulation
* Contraindications to functional magnetic resonance imaging (fMRI)
* Pregnancy
* Sever internal or psychiatric condition

Primary outcomes:
measure: Functional changes in the brain measured with cerebral MRI
timeFrame: 6 weeks
measure: Structural changes in the brain measured with cerebral MRI
timeFrame: 6 weeks
measure: Functional and/or structural changes in the Intestinal Epithelial Barrier measured with endoscopy of the rectum with sample-taking
timeFrame: 6 weeks
measure: Changes in pain measured with visual analogue scale
timeFrame: 6 weeks
measure: Changes in perception of pain measured with an algometer (pain pressure threshold)
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes in questionnaire "quality of life"
timeFrame: 6 weeks
measure: Changes in functional symptoms using IBS-SSS
timeFrame: 6 weeks
measure: Changes in activity indices using HWI questionnaire or SCCAI questionnaire
timeFrame: 6 weeks
measure: Changes in pain catastrophizing scale questionnaire
timeFrame: 6 weeks
measure: Changes in inflammation biomarker (blood - C-reactive protein)
timeFrame: 6 weeks
measure: Changes in inflammation biomarker (stool - calprotectin)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine
Study officials:
affiliation: Charite University
name: Magdalena S Prüß-Volz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05900700: Digital Youth-Nominated Support Team (YST) Program
Official title: An Open-Label Study of the Feasibility and Usability of a Digital Psychoeducational Social Network Intervention for Suicidal Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Social network
Website
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-06-12
Enrollment: 78
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Electronic Youth-Nominated Support Team (eYST), is experimental. The purpose of this study is to get feedback from users about eYST. Another purpose of this study is to learn how well eYST helps youth.

Detailed description: Assessment data from multiple stakeholders (i.e., youth, parents, and support adults) will be collected at baseline, 4 weeks, 8 weeks, and 12 weeks via self-report and semi-structured interviews.

Eligibility criteria: Inclusion Criteria:

1. Inpatient psychiatric patients who have attempted suicide or have documented Suicide ideation (SI) and a plan to harm themselves at admission.
2. Understand written and spoken English.
3. Own a smartphone or mobile phone.
4. Willing and able to complete enrollment procedures.
5. Parent or guardian and youth able to understand the nature of the study and provide written informed consent and assent for youth
6. Patients who are able to provide at least one verifiable contact for emergency or tracking purposes.

Exclusion Criteria:

1. Patients with active psychosis.
2. Patients experiencing substance withdrawal.
3. Currently enrolled in other treatment studies for the symptoms and behaviors targeted.
4. Patient unwilling or unable to wear a mask during in person study procedures, if mandated due to current COVID/health safety guidelines.
5. Patients who in the judgment of the investigator would have an unfavorable risk or benefit profile with respect to eYST.
6. Any other psychiatric or medical condition or custody arrangement that in the investigators' opinion would preclude informed consent or assent or participation in the trial.

Primary outcomes:
measure: System Usability Scale (SUS) score System Usability Scale (SUS)
timeFrame: Up to week 14
measure: Frequency of use of app
timeFrame: Up to week 12
measure: Duration of use of app
timeFrame: Up to week 12
Secondary outcomes:
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Up to week 14
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Up to week 14
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Up to week 14
measure: Client Satisfaction Questionnaire (CSQ-I)
timeFrame: Up to week 14
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Alejandra Arango
role: PRINCIPAL_INVESTIGATOR
affiliation: Oui Therapeutics, Inc.
name: Patricia Simon
role: STUDY_DIRECTOR
References:
Clinical trial NCT00245700: Adherence of Stalevo, Entacapone and Levodopa
Official title: Study of Adherence of Stalevo, Entacapone and Levodopa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: South Glasgow University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2005-10-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT

Brief summary: To test if combining two antiparkinson drugs into a single tablet improves accuracy of medicine intake by the patient.

To test if patients with Parkinson's disease who take medicines at regular time intervals have smoother symptom control.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Parkinson's disease aged between 18 and 85 years fulfilling UK Brain Bank criteria.
* Current levodopa therapy prescribed on a regular basis three or more times per day but requiring entacapone because of 'wearing off'
* Able to manipulate electronic monitoring bottles and complete questionnaires

Exclusion Criteria:

* Current use of compliance aid such that study participation would be detrimental to patient's adherence
* Pregnancy or breast feeding
* Excess alcohol (over 21 units per week for women and 28 units for men)
* Mini mental state examination of less than 26.
* Severe depression (Geriatric depression score over 20)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
state: Scotland
Study officials:
name: Donald G Grosset, MBChB, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05998200: Safety of Serum for Post-Inflammatory on Hyperpigmentation Skin
Official title: Safety of Serum Containing Alpha Hydroxy Acid (AHA) and Polyglutamate Acid Derivatives for Post-Inflammatory on Hyperpigmentation Skin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Aesthetic
Cosmetic
Post-inflammatory hyperpigmentation (PIH)
Lead sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Sponsor class: INDUSTRY
First posted: 2023-08-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to investigate the safety of serum product containing low dose of alpha hydroxy acid (AHA) i.e. 1% Glycolic acid and Lactic acid and Polyglutamate acid derivatives (PGA) for post-inflammatory hyperpigmentation skin in Malaysia. The study duration is 8 weeks and the skin assessment will be carried out at baseline, week 4 and week 8.The main questions this study aims to answer are:

1. To investigate the safety of serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA for post-inflammatory hyperpigmentation skin among Malaysian.
2. To assess the patient satisfaction after using serum containing low concentration AHA (1% Glycolic acid and Lactic acid) and PGA among Malaysian.


Eligibility criteria: Inclusion Criteria:

* Malaysian from 18 to 40 years old.
* Participants with post-inflammatory hyperpigmentation (PIH).

Exclusion Criteria:

* Participant with known systemic or skin disease and any underlying medical illness
* Pregnant, breastfeeding women or planned pregnancy during the study period.
* Had reported history of dermatologic conditions (i.e. Atopic dermatitis, psoriasis) or known allergies to any ingredients that may be found in the product.
* Had any cosmetic procedures such as Botox, laser and light treatment, facial surgery, chemical peel and any procedures that may improve skin texture 1 month before the study.
* Had history of taking isotretinoin for the past 6 or 12 month and AHA (alpha hydroxyl acids) containing products or any other products for treating hyperpigmentation skin or melasma 1 month prior to study.

Primary outcomes:
measure: Adverse effect after using the serum.
timeFrame: Week 8
Secondary outcomes:
measure: Change in skin moisture level
timeFrame: Baseline, Week 4 and Week 8
measure: Change in skin spot level
timeFrame: Baseline, Week 4 and Week 8
measure: Change in skin pores level
timeFrame: Baseline, Week 4 and Week 8
measure: Change in skin tone level
timeFrame: Baseline, Week 4 and Week 8
measure: Participant satisfaction after using the serum for 8 week.
timeFrame: Week 8
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
state: Selangor
Study officials:
References:
Clinical trial NCT04023500: Supporting Oral Self-care of Patients With Periodontitis Through Motivational Interview
Official title: Supporting Oral Self-care of Patients With Periodontitis Through Brief Motivational Interview
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
Patient Education
Self-Care
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to evaluate the potential additive effect of Motivational Interviewing (MI) on gingival health and self-care. Our hypothesis was that the Motivational Interviewing would result in improved gingival health and self-care compared to prevailing patient education.

Detailed description: The study is designed as a randomized, double-blinded, controlled clinical trial of 6-month duration involving patients with diagnosed periodontitis. The subjects are randomized to intervention or control group using the randomizing list.

For both groups, necessary non-surgical periodontal treatments will be done. In the intervention group The MI-intervention is used as a part of normal dental hygienist appointment and if patient need more than one visit, MI was used in every visit.

In control group prevailing, more professional-centered education is used. Dental hygienist define patients educational needs and give direct instructions how to change behaviour and self-care.

Eligibility criteria: Inclusion Criteria:

* Adults, over 18-year-old
* CPI (Community periodontal index) 3 in at least two sextants and
* Diagnosed parodontitis
* The previous treatment period should have been more than one year ago.

Exclusion Criteria:

* pregnancy (or the planning of pregnancy)
* immunosuppressive illness or a medication,
* hepatitis, HIV, MRSA (methicillin-resistant Staphylococcus aureus)
* a bleeding illness or a anticoagulant (excluding primalan 100-200 mg / a day)
* the labile diabetes
* cytotoxic treatment
* a need for the antibiotic prophylaxis.

Primary outcomes:
measure: Bleeding on probing (BoP)
timeFrame: Up to 6 month
measure: Pocket probing depth (PD)
timeFrame: Up to 6 month
measure: Clinical Attachment Level (CAL)
timeFrame: Up to 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Turku
name: Mirkka Järvinen, MNS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00799500: Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing
Official title: Impact on Prematurity of a First-trimester Screening for Bacterial Vaginosis in Pregnancy Through Weekly Vaginal pH Determination. An Interventional, Community Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Bacterial Vaginosis
Preterm Delivery
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2008-12-01
Enrollment: 1049
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Interventional study to assess the effect of early detection and treatment of bacterial vaginosis in pregnancy on preterm delivery rate.


Eligibility criteria: Inclusion Criteria:

* Pregnant women

Exclusion Criteria:

* Diabetes mellitus (pre-gestational)
* Hypertension (pre-gestational)
* Malformations on ultrasonography at 12 weeks

Primary outcomes:
measure: Preterm delivery rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Catalonia
Study officials:
References:
Clinical trial NCT01522300: Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité Tomos Study- Contribution of Tomosynthesis In Locoregional Pretherapeutic Staging of a Breast Tumor: Multicentricity Search
Official title: Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mammary Tumor
Keywords: Tomosynthesis
breast cancer
specificity
sensitivity
To assess efficacy of Tomosynthesis by evaluating its sensitivity and specificity in detecting the multicentricity of mammary tumor
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor.

Detailed description: The secondaries objectives of the study are:

* Sensitivity and specificity in detecting multifocality of breast tumor
* Sensitivity and specificity of Tomosynthesis in the detection of contralateral tumors
* Predetermination of potential targets for ultrasound

Eligibility criteria: Inclusion Criteria:

* Age\> 18 years.
* Patients with a breast tumor, regardless of the stage and size
* Compulsory affiliation to a social security system.
* Obtaining informed consent in writing, signed and dated.

Exclusion Criteria:

* Patients with cognitive or psychiatric disorders.
* Patient deprived of liberty by a court or administrative.
* Patients with indications against the achievement of MRI, mammography and tomosynthesis
* Pregnant Women

Primary outcomes:
measure: To calculate the sensitivity and specificity of both types of imaging (mammography and Tomosynthesis) with respect to number of tumors multicentric and multifocal identified through MRI.
timeFrame: January 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
Study officials:
References:
Clinical trial NCT01530100: Lower Laser Therapy in Orthognathics Surgery
Official title: Lower Laser Therapy in Orthognathics Surgery - Double Blind Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dentofacial Deformity
Keywords: Edema
Pain
Lower laser therapy
orthognathics surgery
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief summary: This study will examine the use of lower laser therapy to reduce edema and pain in orthognathics surgery.


Eligibility criteria: Inclusion Criteria:

* Dentofacial deformity
* Healthy
* Mandibular surgery
* no medication use

Primary outcomes:
measure: edema, pain and neurosensory disturbancy
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UFG
name: Giovanni Gasperini, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gasperini G, Rodrigues de Siqueira IC, Rezende Costa L. Does low-level laser therapy decrease swelling and pain resulting from orthognathic surgery? Int J Oral Maxillofac Surg. 2014 Jul;43(7):868-73. doi: 10.1016/j.ijom.2014.02.015. Epub 2014 Mar 25.
citation: Gasperini G, de Siqueira IC, Costa LR. Lower-level laser therapy improves neurosensory disorders resulting from bilateral mandibular sagittal split osteotomy: a randomized crossover clinical trial. J Craniomaxillofac Surg. 2014 Jul;42(5):e130-3. doi: 10.1016/j.jcms.2013.07.009. Epub 2013 Sep 4.
Clinical trial NCT06663800: Additional Effects of Ujjayi Pranayama
Official title: Additional Effects of Ujjayi Pranayama on Pulmonary Function in Post Coronary Artery Bypass Graft
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulmonary Function
Coronary Artery Disease
Keywords: Ujjayi Paranyama
Coronary artery bypass grafting
Pulmonary Function
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studying the impact of Ujjayi pranayama on post-Coronary Artery Bypass Grafting (CABG) patients has the potential to positively influence healthcare. This research fosters a patient-centered approach, enhancing cardio respiratory function. Patient education on these practices can empower individuals, actively contributing to their recovery and overall well-being.

Detailed description: . Exercises such as Ujjayi pranayama lower heart rate and benefit high blood pressure sufferers. To determine additional effects of Ujjayi pranayama on pulmonary function in post coronary artery bypass Graft (CABG).

Eligibility criteria: Inclusion Criteria:

* Participants who have 1st post op Day
* Hemodynamically stable \& well oriented patient
* Extubated Patient
* Voluntary based patients
* After approval of surgeon CABG patient were recruited
* Tachypnea

Exclusion Criteria:

* Hemodynamically unstable,
* Uncontrolled Hypertension,
* MSK disease,
* Any previous history of tuberculosis,
* Neurological disease ,
* Acute exacerbation of COAD \& Asthma Attack,
* Any trauma, anxiety or Rib fracture case ,
* During surgery complaint of graft failure ,
* Unwilling to participate ,
* Postural Hypotension.

Primary outcomes:
measure: Borg dyspnea
timeFrame: 5days
measure: PFT
timeFrame: 5days
Secondary outcomes:
measure: Cardiac monitors
timeFrame: 5days
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway general hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Maria Razzaq, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References: