louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01890005: Low Dose Aspirin for the Prevention of Preeclampsia
Official title: Low Dose Aspirin Between 13 and 16 Weeks of Pregnancy for the Prevention of Preeclampsia. Double Blind, Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Preeclampsia
Keywords: Preeclampsia
Low dose aspirin
Fetal growth restriction
Neonatal death
Stillbirth
Abruptio placenta
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 476
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. The use of low dose aspirin has been mentioned in several studies with promising results. The investigators decided to evaluate the use of low dose aspirin, starting between 13 and 16 weeks of pregnancy, based on clinical characteristics only to reduce the incidence of preeclampsia.


Eligibility criteria: Inclusion Criteria:

* Gestational age between 13 and 16 weeks of pregnancy
* High risk of preeclampsia, based in clinical risk factors as:

Preeclampsia in a previous pregnancy Mother or sister that developed preeclampsia in a previous pregnancy Diabetes Mellitus (insulin dependant) Chronic Hypertension (with/without proteinuria) Body Mass Index \> 32 Multiple pregnancy Lupus or other autoimmune disorder Chronic Renal Disease.

Exclusion Criteria:

* Blood coagulation disorders of any kind
* Peptic ulcers
* Allergy to aspirin
* Chronic use of anti-inflammatory drugs
* Fetus with mayor anomalies

Primary outcomes:
measure: Prevention of preeclampsia
timeFrame: 6 months
Secondary outcomes:
measure: Prevention of preeclampsia at term
timeFrame: 6 months
measure: Stillbirth
timeFrame: 6 months
measure: Neonatal deaths
timeFrame: 6 months
measure: Neonatal intensive care unit admissions.
timeFrame: 28 days
measure: Abruptio placenta
timeFrame: 6 months
measure: Fetal Growth Restriction
timeFrame: 6 months
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
affiliation: Saint Thomas Maternity Hospital
name: Osvaldo Reyes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Thomas Maternity Hospital
name: Rodrigo Velardee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Thomas Maternity Hospital
name: Ameth Hawkins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Thomas Maternity Hospital
name: Ana Moreno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03226405: Patient Navigation to Improve Patient-Centered Cancer Care
Official title: Patient Navigation to Improve Patient-Centered Cancer Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The MGH Cancer Center's patient navigation (PN) program, utilizes specially trained community-based personnel to improve cancer care in underserved communities by increasing cancer screening and removing barriers to timely care. This program incorporate rigorous evaluation to demonstrate the impact of innovation in healthcare delivery.

Detailed description: This program allow cancer patients from MGH Community Health Centers (CHC) and surrounding communities who experience barriers to accessing care, including poverty, and limited English proficiency, and provide them navigation to receive timely, guideline-concordant treatment at MGH Cancer Center. By offering these vulnerable individuals a patient-centered approach to treatment, The investigators aim to promote patient engagement and increase access throughout the continuum of cancer care.

Eligibility criteria: Inclusion Criteria:

* Adult patients (age 18 and older)
* Newly diagnosed with cancer referred from Massachusetts General Hospital (MGH) community health centers in

  * Revere
  * Chelsea
  * Charlestown
  * surrounding communities referred to receive cancer treatment at the MGH Cancer Center

Exclusion Criteria:

-Patients that primary care providers exclude

Primary outcomes:
measure: Adherence With Cancer Treatment
timeFrame: 2 years
measure: The Time From Cancer Diagnosis To First Oncology Appointment
timeFrame: 2 Years
Secondary outcomes:
measure: Health Related Quality Of Life
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
measure: Proportion Of Patients Enrolled In Clinical Trials
timeFrame: 2 years
measure: Overall Missed Health Care Visits
timeFrame: 2 years
measure: Emergency Department Visits
timeFrame: 2 years
measure: Unplanned Hospitalizations/Readmissions
timeFrame: 2 years
measure: Inpatient Hospitalization Length Of Stay.
timeFrame: 2 years
measure: Patient Satisfaction With Patient Navigation Program (PNP)
timeFrame: 2 years
measure: Patient Engagement In Care
timeFrame: 2 years
measure: Patient's Financial Burden
timeFrame: 2 years
measure: Patient Satisfaction with Cancer Care
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sanja Percac-Lima, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06300905: Clinical Study on Malodor
Official title: Clinical Investigation on Oral Malodor for a New Formula of Stannous Toothpaste as Compared to Colgate Cavity Protection Toothpaste Using Organoleptic Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Malodor
Keywords: Organoleptic method
oral malodor
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2024-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of product use.


Eligibility criteria: Inclusion Criteria:

* Must be male or female 18 to 70 years of age
* Must be in good general health
* Must be in good oral health based on self-assessment
* Must be available during the weeks of this study for all appointment time points
* Should have a minimum of 20 natural uncrowned teeth (excluding third molars)
* Should have a baseline mean oral malodor score greater than or equal to 6.0 and less than or equal to 8.0
* Must give written informed consent
* No known history of allergy to personal care/consumer products or their ingredients

Exclusion Criteria:

* Participation in any other oral clinical studies for the duration of this study
* Full or partial (upper or lower) dentures
* Pregnant or lactating (breast feeding)
* Use of tobacco products
* History of allergy to common toothpaste ingredients
* Use of phenolic flavored products, such as mint flavored candies and chewing gum, the morning of the study and during the sampling periods
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
* Individuals who, due to medical conditions, cannot go without eating or drinking for the post use treatment evaluation time points (6 hrs. + overnight)

Primary outcomes:
measure: Organoleptic Oral Malodor Evaluations
timeFrame: Oral malodor evaluations at baseline & 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Dental Institute of Chengdu
state: Sichuan
Study officials:
affiliation: West China Dental Institute of Chengdu
name: Deyu Hu, DDS,MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05604105: Oral Cancer Awareness in Egypt
Official title: Oral Cancer Awareness Level in Egypt: a Pilot Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Ahram Canadian University
First posted: 2022-11-03
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cross-sectional study aims to quantify the awareness of Egyptian population to oral cancer. The study will be undertaken in the city of 6th of October in Giza governorate. It is a city of population 368,650 inhabitants.

Brief summary: Oral cancer is a fatal disease with high prevalence and poor survival rate. Most oral cancer cases can be detected by the patients themselves. So, when a patient is aware of oral caner, the patient would realize its signs and symptom and seek early medical care; therefore, improving the prognosis.

To our knowledge, the level of awareness of oral cancer has not been investigated in Egyptian population. Therefore, this study is planned to be a pilot study as a first study in Egypt.

Detailed description: Cancer of the oral cavity is considered a global health burden. According to GLOBOCAN report of 2012, the incidence of oral cancer in Egypt was 1,687 per 10,000 per annum; while the mortality was 659 per 10,000 per annum. Statistically, the rates are expected to increase as to reach 2,658 per 10,000 incidence and 1,069 per 10,000 mortality by the year 2030.

Fortunately, 85% of head and neck cancers are visible. Therefore, the patient does not always need to visit a specialist for a special test to check for oral cancer. Instead, if the patients have basic knowledge about oral cancer, its signs and symptoms and its risk factors, they can detect the change themselves.

As a first step to reach this amazing goal, the level of awareness of the general population needs to be detected.

To the best of our knowledge, the awareness of oral cancer has not been assessed in the general population of Egypt before. As awareness of oral cancer is mandatory for dental practitioners, our study targets the general population other than those working in the dentistry field.

Eligibility criteria: Inclusion criteria:

* Adult individuals (Age\>18 years).

Exclusion criteria:

* Dental students or dental practitioners; as awareness of the disease is an integral part of their profession.
* Oral cancer patients: Individuals who experience currently or previously having oral cancer.
* Individuals with mental or communication disabilities.

Primary outcomes:
measure: Level of awareness to oral cancer
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04978805: Progressive Relaxation Exercise on Dyspnea, Pain and Sleep Quality
Official title: The Effect of Progressive Relaxation Exercise on Dyspnea, Pain and Sleep Quality in Lung Cancer Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer patients
Pain
Sleep quality
Progressive Relaxation Exercise
Lead sponsor: Istanbul Sabahattin Zaim University
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an experimental study with pre-test and post-test contro
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned to examine the effect of progressive relaxation exercises applied to lung cancer patients receiving chemotherapy on dyspnea, pain and sleep quality.

Detailed description: It is thought that relaxation exercises reduce respiratory distress and improve sleep quality in lung cancer patients.

Eligibility criteria: Inclusion Criteria:

* Be between the ages of 18-65
* Ability to communicate adequately
* Absence of psychiatric problems
* Those who are determined by the physician that they do not have a physical disability in exercising
* Volunteering to participate in the research
* Individuals who have the ability to use technological tools
* Patients with at least 3 cures

Exclusion Criteria:

* Individuals with phones that do not have voice recording capabilities
* Individuals with phones that do not have the ability to install Whatsapp

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 1. week
measure: Visual Analog Scale
timeFrame: 4. week
measure: Visual Analog Scale
timeFrame: 8. week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1.week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4.week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8.week
measure: Modified Medical Research Council (mMRC)
timeFrame: 1.week
measure: Modified Medical Research Council (mMRC)
timeFrame: 4.week
measure: Modified Medical Research Council (mMRC)
timeFrame: 8.week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zülfünaz
state: State
Study officials:
References:
citation: Borji M, Nourmohammadi H, Otaghi M, Salimi AH, Tarjoman A. Positive Effects of Cognitive Behavioral Therapy on Depression, Anxiety and Stress of Family Caregivers of Patients with Prostate Cancer: A Randomized Clinical Trial. Asian Pac J Cancer Prev. 2017 Dec 28;18(12):3207-3212. doi: 10.22034/APJCP.2017.18.12.3207.
citation: Tsitsi T, Charalambous A, Papastavrou E, Raftopoulos V. Effectiveness of a relaxation intervention (progressive muscle relaxation and guided imagery techniques) to reduce anxiety and improve mood of parents of hospitalized children with malignancies: A randomized controlled trial in Republic of Cyprus and Greece. Eur J Oncol Nurs. 2017 Feb;26:9-18. doi: 10.1016/j.ejon.2016.10.007. Epub 2016 Nov 18.
Clinical trial NCT06098105: Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics
Official title: Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics Undergoing Inguinal Hernia Repair: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic
Ultrasound
Transversus Abdominis Plane Block
Laparoscopic Intraperitoneal Instillation
Pediatrics
Inguinal Hernia Repair
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare laparoscopic -assisted, ultrasound-guided transversus abdominis plane block and laparoscopic intraperitoneal instillation of local anesthetic in pediatrics undergoing inguinal hernia repair.

Detailed description: Inguinal hernia is one of the most common pediatric surgeries. Effective and safe pain management causes fewer side effects and enables faster hospital discharge. It is also important in overcoming chronic pain in the late postoperative period.

Transversus abdominis plane block (TAPB) has emerged as a safe, simple, and inexpensive modality incorporated into many enhanced recovery pathways to achieve narcotic-sparing analgesia after bariatric surgery. TAPB was first performed through the lumbar triangle of Petit in 2001. Since that time, both ultrasound-guided (US) and laparoscopic (LAP) TAPBs have been developed to aid in proper identification of the correct plane and minimize peritoneal penetration.

Eligibility criteria: Inclusion Criteria:

* Age: 2 months to 7 years old
* Both sexes.
* American Society of Anesthesiologists (ASA) I-II.
* Schedule for elective unilateral inguinal hernia repair.

Exclusion Criteria:

* Patients with history of allergy.
* Hepatic and renal failure.
* Previous inguinal surgery.
* Block contraindications (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).

Primary outcomes:
measure: Total postoperative pethidine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Post-operative pain scores
timeFrame: 24 hours postoperatively
measure: Time of first analgesia request.
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT02187705: Micardis® in Patients With Essential Hypertension
Official title: Observation of Therapy With Micardis® (Telmisartan) in Patients With Essential Hypertension in Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 1688
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: The aim of this observational study was to supplement the data on efficacy, safety, and tolerability of telmisartan under daily conditions in hospitals


Eligibility criteria: Inclusion Criteria:

* Patients with essential hypertension
* Minimum age of 18 years

Exclusion Criteria: Not applicable

Primary outcomes:
measure: Changes from baseline in blood pressure
timeFrame: Up to 14 days
measure: Number of patients with adverse events
timeFrame: Up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06248905: Shock Wave Therapy Plus Exercise in GTPS
Official title: Shock Wave Therapy Combined With Strengthening Exercise of Hip Abductor Muscles in the Greater Trochanteric Pain Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Greater Trochanteric Pain Syndrome of Both Lower Limbs
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 80
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 aim of this randomized controlled study is to investigate if the sequential administration of focused shock wave therapy and of a rehabilitation program based on the strengthening of gluteal muscles is more effective than a standard shock wave treatment for greater trochanteric pain syndrome


Eligibility criteria: Inclusion Criteria:

* Unilateral hip pain of four weeks or longer duration
* Pain to palpation in the greater trochanteric area at physical examination
* Pain in hip end-range abduction/rotation/adduction at physical examination
* Gluteal tendinopathy, in absence of full thickness tears at a sonographic examination of the gluteal tendons
* Adult age and written informed consent

Exclusion Criteria:

* No hip osteoarthritis, diagnosed according to Altman's criteria
* No history of knee osteoarthritis
* No history of rheumatologic diseases
* No previous fractures or surgery in the affected limb
* No clinical signs of lumbar radiculopathy at physical examination
* No corticosteroid injections, since the onset of the current pain episode
* No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area)

Primary outcomes:
measure: NRS Pain
timeFrame: 6 months
Secondary outcomes:
measure: EQ5D Quality of life
timeFrame: 12 months
measure: VISA-G Disability
timeFrame: 12 months
measure: Functional capacity (strength of gluteal muscles)
timeFrame: 12 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
References:
Clinical trial NCT01285505: Bioequivalence of a New and a Commercial Alprazolam Sublingual Formulation
Official title: Open-Label, Randomized, Single-Dose, 2-Way Crossover Bioequivalence Study Comparing A New Alprazolam Sublingual Tablet Formulation To An Alprazolam Sublingual Tablet
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: alprazolam
sublingual
bioequivalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study tests the hypothesis that the bioavailability of alprazolam from a new sublingual formulation is the same as that from an existing sublingual formulation.


Eligibility criteria: Inclusion Criteria:

* healthy male or female subjects
* BMI 18 to 26.9
* must give informed consent

Exclusion Criteria:

* clinically significant disease
* narrow angle glaucoma
* positive drug screen

Primary outcomes:
measure: Alprazolam bioavailability as assessed from the area under the concentration-time curve (AUC)
timeFrame: 11 days
measure: Alprazolam bioavailability as assessed by peak concentration (Cmax)
timeFrame: 11 days
Secondary outcomes:
measure: Alprazolam time of maximum concentration (Tmax)
timeFrame: 11 days
measure: Half life of alprazolam
timeFrame: 11 days
measure: Clinically significant safety laboratory tests
timeFrame: 11 days
measure: Clinically significant adverse events
timeFrame: 11 days
measure: Clinically significant vital signs
timeFrame: 11 days
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: