louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00162071: A Phase II Optimization Study of BMS068645 and Sestamibi Planar Imaging
Official title: "A Phase II Open-Label, Non-Randomized, Single-Center Trial to Determine the Optimal Myocardial Perfusion Image Acquisition Time Following BMS068645 Administration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cardiovascular Disease
Ischemic Heart Disease
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of this study is to determine the optimal time for myocardial perfusion imaging with Technetium Tc99m Sestamibi following the administration of BMS068645. The safety of BMS068645 will also be studied.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Have known or suspected heart disease
* Have undergone a clinically indicated SPECT MPI study with adenosine in the last 24 hours to 14 days.
* Weigh between 88 and 250 lbs.

Exclusion Criteria:

* Allergic reaction to Technetium Tc99m Sestamibi or any of its components
* History of asthma or lung disease
* Ingestion of caffeinated substances within 12 hours prior to the study

Primary outcomes:
measure: Measurements of Technetium Tc99m Sestamibi activity will be obtained from various regions of the body at the end of the study to determine optimal imaging times.
Secondary outcomes:
measure: A comparison of adverse events will be conducted at the end of the study to assess safety.
Other outcomes:
Locations:
city: New York
country: United States
facility: Local Institution
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: E Gordon DePuey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01203371: Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS
Official title: PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF NAFTOPIDIL AND TAMSULOSIN TO TREATMENT THE SYMPTOMS OF LOWER URINARY TRACT IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hyperplasia
Keywords: naftopidil
symptoms of lower urinary tract
benign prostate hyperplasia
LUTS
Lead sponsor: Apsen Farmaceutica S.A.
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 0
Sex: MALE
Minimum age (years): 50
Maximum age (years): 90
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 evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia.

Detailed description: Inclusion Criteria:

Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR \> 150mL

Eligibility criteria: Inclusion Criteria:

* Men ≥ 50 years
* Signs and symptoms of BPH
* IPSS of ≥ 10
* Prostate volume of ≥ 20 mL
* PVR \> 150 mL

Exclusion Criteria:

* History of allergy to a AR antagonists
* Treatment with antiandrogen drugs
* Drugs with anticholinergic activity
* Significant history of orthostatic hypotension
* Concomitant neurological diseases
* Known or suspected neurogenic bladder dysfunction
* Carcinoma of the prostate or bladder
* Previous surgery for BPH or bladder neck obstruction
* History of recurrent UTI
* Concomitant active UTI

Primary outcomes:
measure: International Prostate Symptom Score
timeFrame: 2, 4, 8 and 12 weeks
Secondary outcomes:
measure: Adverse Effect
timeFrame: 2, 4, 8 and 12 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da USP
Study officials:
References:
Clinical trial NCT02226471: Serum CTRP3 and RBP4 Levels in Obesity and Hypertension
Official title: Serum CTRP3 and RBP4 Levels in Obesity and Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Hypertension
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We consecutively selected 2100 Chinese subjects from the general population who had undergone medical check-ups at the Southwest Hospital Medical Center at the Third Military Medical University

Brief summary: Insulin resistance is closely correlated with obesity and cardiovascular disease. Adipokines may play important roles in the pathogenesis of obesity, which are a link between obesity and obesity-related disorders.C1q/TNF-related protein-3 (CTRP3) and retinol-binding protein 4 (RBP4) are novel adipokine that modulates the action of insulin in various diseases. This study addressed the relationship between CTRP3, RBP4 and IR in newly diagnosed obesity and essential hypertension.

Detailed description: Serum CTRP3 and RBP4, anthropometric and metabolic parameters were determined in 480 newly diagnosed obesity and essential hypertensive patients not taking anti-obese and antihypertensive medications and 66 normal weight (NW) and normotensive subjects. All subjects were divided into two groups depending on body mass index (BMI), including NW group and obesity group, and then four subgroups were divided according to obesity and hypertension, including NW-normal blood pressure subgroup (NW-NBP), NW-hypertension subgroup (NW-HTN), obese-normal blood pressure subgroup (OB-NBP), obese-hypertension subgroup (OB-HTN).

Eligibility criteria: Inclusion Criteria:

1. Hypertension not taking antihypertensive medications
2. Obesity not taking anti-obese or lipid-lowering medications

Exclusion Criteria:

1. Heart failure;
2. pregnant or lactating
3. diabetes
4. thyroid disease
5. fractures
6. osteoporosis
7. tumors;

Primary outcomes:
measure: CTRP3 and RBP4 levels were measured in obesity and hypertension
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Southwest Hospital, China
name: Deng Wuquan, PHD
role: STUDY_DIRECTOR
References:
citation: Deng W, Li C, Zhang Y, Zhao J, Yang M, Tian M, Li L, Zheng Y, Chen B, Yang G. Serum C1q/TNF-related protein-3 (CTRP3) levels are decreased in obesity and hypertension and are negatively correlated with parameters of insulin resistance. Diabetol Metab Syndr. 2015 Apr 10;7:33. doi: 10.1186/s13098-015-0029-0. eCollection 2015.
Clinical trial NCT04637971: Coaching Intervention in Women At-risk for Common Mental Disorders
Official title: Coaching Intervention to Improve Mental Well-being of Community Women Who Are At-risk for Common Mental Disorders in Hong Kong: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Mental Disorders
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to provide coaching intervention for prevention of developing common mental disorders to 60 at-risk women in Hong Kong.

Detailed description: Participants will be recruited through online screening tool. Eligible subjects with informed consent provided will be randomly assigned to coaching group or self-help tips plus telephone support group.

To test the effectiveness of the coaching intervention, data collection will be conducted on demographics, symptoms and psychosocial aspects at baseline, immediately, 3-month and 12-month post-intervention. A self-reported brief questionnaire will be administered at every intervention as well.

Eligibility criteria: Inclusion Criteria:

* Willing to provide written informed consent
* Able to understand Cantonese and read/write Chinese
* With subsyndromal or minor common mental disorders (CMD) indicated by 10 - 20 of Depression subscale of Depression, Anxiety and Stress Scale (DASS) or 8-14 of Anxiety subscale of DASS

Exclusion Criteria:

* Those mental conditions that require other treatment priorities (e.g., suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders)
* Those medical conditions that severely limit participation, comprehension, or adherence to treatment (e.g., epilepsy, dementia, terminal medical illness)
* Those who are receiving structured psychotherapy or counseling

Primary outcomes:
measure: Changes in depressive symptoms
timeFrame: 6-month post-intervention
measure: Changes in anxiety symptoms
timeFrame: 6-month post-intervention
Secondary outcomes:
measure: Changes in depressive symptoms
timeFrame: Immediate and 3-month post-intervention
measure: Changes in anxiety symptoms
timeFrame: Immediate and 3-month post-intervention
measure: Changes in quality of life
timeFrame: Immediate, 3- and 6-month post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Yi Nam Suen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04028271: Local Anesthesia With Needle-free Injection System
Official title: Comparision of Injection Pain Caused by the 'Comfort in' Injection System Versus a Traditional Syringe for Inferior Alveolar Nerve Block Anaesthesia in Primary Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Anesthesia
Local Anesthesia
Keywords: needle-free injection
pain
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the pain during needle insertion and injection in mandibular molars anesthetized with either traditional syringe (control) or Comfort in System (experimental).


Eligibility criteria: Inclusion Criteria:

* In need of treatment of right and left molar teeth of mandible,

  * Does not have any systemic disorder,
  * High level of communication that can provide logical answers to the questions we ask
  * With parental consent,
  * Volunteers who want to participate in the research
  * 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic

Exclusion Criteria:

* No need for treatment of right and left molar teeth of mandible,
* Has a systemic condition
* Low level of communication that cannot provide reasonable answers to the questions we ask
* Without parental consent
* Do not want to participate voluntarily in the research
* Do not attend a check-in
* Patients not in the 6-12 age group

Primary outcomes:
measure: Wong-Baker Faces Pain Rating Scale (PRS)
timeFrame: 1 year
measure: Face, Legg, Cry, Consolability Scale (FLACC)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Okan University Faculty of Dentistry
Study officials:
References:
Clinical trial NCT01477671: Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children
Official title: Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dengue
Dengue Fever
Dengue Hemorrhagic Fever
Keywords: Dengue
Dengue Fever
Dengue Hemorrhagic Fever
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 667
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants aged between 5 and 10 year-old that are registered in health centers in India.

Brief summary: This is a descriptive prospective community-based seroprevalence study.

Primary objective:

* To determine the prevalence of specific antibodies (immunoglobulin G \[IgG\]) against dengue in healthy 5 to 10 year-old children in India.

Secondary objectives:

* To determine the dengue virus serotype (DeNV-1,2,3 and /or 4) specific to the antibodies in positive (IgG) samples
* To estimate the prevalence of specific antibodies (IgG) against Japanese encephalitis in healthy 5 to 10 year-old children in India.


Eligibility criteria: Inclusion Criteria:

* Aged between 5 and 10 year-old on the day of inclusion
* Healthy child as reported by the parent or legally qualified guardian
* Being registered in selected study site
* Provision of the informed consent form signed by at least one parent or legally qualified guardian
* For children between 8 and 10 years old, provision of the assent form signed.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4
timeFrame: Baseline
Secondary outcomes:
measure: Prevalence of positive serum samples with JEV specific IgG antibodies
timeFrame: Baseline
Other outcomes:
Locations:
city: Kalyani
country: India
state: West Bengali
city: Bangalore
country: India
city: Hyderabad
country: India
city: New Delhi
country: India
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Garg S, Chakravarti A, Singh R, Masthi NR, Goyal RC, Jammy GR, Ganguly E, Sharma N, Singh MM, Ferreira G, Moureau A, Ojha S, Nealon J; DNG10 study group. Dengue serotype-specific seroprevalence among 5- to 10-year-old children in India: a community-based cross-sectional study. Int J Infect Dis. 2017 Jan;54:25-30. doi: 10.1016/j.ijid.2016.10.030. Epub 2016 Nov 4.
citation: Bhavsar A, Tam CC, Garg S, Jammy GR, Taurel AF, Chong SN, Nealon J. Estimated dengue force of infection and burden of primary infections among Indian children. BMC Public Health. 2019 Aug 14;19(1):1116. doi: 10.1186/s12889-019-7432-7.
Clinical trial NCT02481271: Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy
Official title: Effects of Preoperative Relaxation and Intensified Surgery Education on Preoperative Wellbeing and Postoperative Complaints in Patients Undergoing Cholcystectomy - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gall Stones
Keywords: cholecystectomy
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study aims to test the effects of a Preoperative Relaxation intervention and an Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in Patients Undergoing Cholecystectomy.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* 18 years old
* referral for cholecystectomy
* preoperative anxiety at least 4/10 points on a numeric rating scale
* physical and mental capability to participant
* written informed consent

Exclusion Criteria:

* Emergency surgery
* malignoma
* severe comorbidity
* severe psychological disorders
* immunosuppression
* coagulation disorders

Primary outcomes:
measure: preoperative anxiety
timeFrame: day of surgery
measure: postoperative pain intensity
timeFrame: day after the surgery, before meditation
Secondary outcomes:
measure: preoperative anxiety
timeFrame: day of surgery
measure: preoperative anxiety
timeFrame: day of surgery
measure: preoperative anxiety
timeFrame: day of surgery
measure: postoperative disability
timeFrame: day after surgery
measure: postoperative disability
timeFrame: 2 days after surgery
measure: postoperative disability
timeFrame: 10 days after surgery
measure: postoperative fatigue
timeFrame: Day after surgery
measure: postoperative fatigue
timeFrame: 2 days after surgery
measure: postoperative fatigue
timeFrame: 10 days after surgery
measure: postoperative nausea
timeFrame: Day after surgery
measure: postoperative nausea
timeFrame: 2 days after surgery
measure: postoperative nausea
timeFrame: 10 days after surgery
measure: postoperative complications
timeFrame: 10 days after surgery
measure: Satisfaction with care
timeFrame: 10 days after surgery
measure: Satisfaction with interventions
timeFrame: 10 days after surgery
Other outcomes:
measure: course of surgery
timeFrame: day of surgery
Locations:
city: Duisburg
country: Germany
facility: Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen
Study officials:
affiliation: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen
name: Gustav Dobos, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Omlor G, Kiewitz S, Pietschmann S, Roesler S. [Effect of preoperative preoperative visualization therapy on postoperative outcome after inguinal hernia surgery and thyroid resection]. Zentralbl Chir. 2000;125(4):380-5; discussion 385-6. German.
Clinical trial NCT02851771: Improving the Diagnosis of Pneumonia in Emergency Rooms
Official title: Improving the Diagnosis of Pneumonia in Emergency Rooms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 1364
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of pneumonia caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC tests Pneumonia. This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribo Nucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribo Nucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of pneumonia after POC tests.


Eligibility criteria: Inclusion Criteria:

* Patient admitted at hospital for pneumonia requiring, for the emergency physician, a microbiological examination with a "POC pneumonia kit."
* Patient who has freely signed the informed written consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Pregnant woman, parturient or nursing
* Adult major under guardianship
* Patient deprived of liberty under court order
* Patient refusing or unable to sign the informed consent form.

Primary outcomes:
measure: Number of patients in percentage with a confirmed etiological diagnosis of pneumonia
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT01051271: Prophylaxis Against Metoclopramide-Induced Akathisia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Akathisia
Keywords: metoclopramide
akathisia
midazolam
diphenhydramine
metoclopramide induced akathisia
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2010-01-18
Enrollment: 225
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: PREVENTION

Brief summary: ABSTRACT

Study Objective:

To compare the effects of midazolam and diphenhydramine for the prevention of metoclopramide induced akathisia.

Methods:

This randomized, double-blind and controlled trial aimed to investigate co-administered midazolam versus diphenhydramine in the prophylaxis of metoclopramide induced akathisia. Patients 18 through 65 years of age who presented to the ED with primary or secondary complaints of nausea and/or moderate to severe vascular type headache were eligible for this study. Patients were randomized to one of the fallowing three groups: (1) metoclopramide 10 mg + midazolam 1.5 mg (2) metoclopramide 10 mg + diphenhydramine 20 mg (3) metoclopramide 10 mg + placebo. Metoclopramide was administered as a 2 minutes bolus infusion. Midazolam, diphenhydramine and normal saline solution administered as a 15 minutes slow infusion. Whole procedure was observed, akathisia and sedation scores and vital changes were recorded.


Eligibility criteria: Inclusion Criteria:

* Patients 18 through 65 years of age and 50-90 kg of weight who presented to the ED with primary or secondary complaints of nausea and/or moderate to severe vascular type headache were eligible for this study.

Exclusion Criteria:

* Patients who had liver and renal insufficiency
* Electrolyte imbalance
* Acute respiratory symptoms
* Chronic obstructive pulmonary disease
* Blood pressure less than 90/60 mmHg
* Uncooperative individuals
* Pregnant or lactating
* Pre-existing motor disorder
* Restless legs syndrome-parkinson's disease
* Organic brain disorder, (dementia etc.), epilepsy
* Admitted to the ED due to acute psychiatric symptoms
* Deprived mental status
* Advanced hearing loss
* Malnutrition
* Acute asthma attack
* Serious physical illness, especially glaucoma, prostatic hypertrophy, or cardiac disease
* Had a contraindication to anticholinergic medications
* Within 3 days of study entry patients who had taken an antiemetic antihistaminic, antipsychotic, antispasmodic, alpha-blocker, or Ca++2-channel blocker, or within 2 weeks of study entry patients who had taken an antidepressant, barbiturate, benzodiazepine, other sedative/hypnotic, opioid, lithium, or illicit sympathomimetic agent were excluded

Primary outcomes:
measure: akathisia and sedation scores
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: