louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00005434: Opioid Compromise in Hypertension--Modulating Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To confirm the preliminary findings of age, race, and hypertension chronicity effects on opioid and cardiovascular responses to stress and to determine the opioid mechanisms mediating these effects using an opioid receptor blockade strategy.

Detailed description: BACKGROUND:

Opioids exert depressor effects on cardiovascular responses through sympathetic nervous system inhibition. Research suggests that opioid inhibition of sympathetic activity may be compromised in hypertension. Preliminary studies by the Principal Investigator suggest that the nature of this compromise may be influenced by age and race. Additionally, literature suggests that hypertension chronicity may modulate opioid sympathoinhibitory actions. The receptor mechanisms mediating the observed modulating effects of age, race, and hypertension chronicity on opioidergic inhibition and regulation of blood pressure remained to be determined.

DESIGN NARRATIVE:

Two double-blind, placebo-controlled cross-over studies were conducted to evaluate the effects of naltrexone hydrochloride, an oral opiate antagonist, on adrenergically-mediated cardiovascular responses in older and younger, Black and White normotensives and hypertensives with varying lengths of hypertension duration. Cardiovascular and opioid responses were measured in response to a stressor combined with either placebo or naltrexone pretreatment. Results from these studies assisted in (a) elucidating opioidergic mechanisms underlying the increased rates of hypertension morbidity and mortality among Blacks and the elderly, and (b) ultimately optimized the design of pharmacological interventions for the prevention and treatment of hypertension.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Svetkey LP, Timmons PZ, Emovon O, Anderson NB, Preis L, Chen YT. Association of hypertension with beta2- and alpha2c10-adrenergic receptor genotype. Hypertension. 1996 Jun;27(6):1210-5. doi: 10.1161/01.hyp.27.6.1210.
Clinical trial NCT00041834: Geographic Modeling of Traffic and Asthma Rates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: childhood asthma
traffic
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-07-22
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: This study surveys the parents/guardians about symptoms and diagnosis of asthma in kindergarten and first-grade students in 13 schools around the city of Anchorage, Alaska. Traffic information is also measured and entered in geographical information mapping system with student's home and school locations. The study will assess whether students living in high traffic areas have greater risk of diagnosis of asthma.

Detailed description: Survey was distributed through the schools. Parents/guardians were asked about indoor exposures such as environmental tobacco smoke, insects, mold, woodstoves, as well as demographic information about the child and housing type, income,also biologic information about parental asthma. Questions included symptoms of respiratory illness as well as wheezing and medication use. Civil engineering department measured traffic on local roadways and gathered traffic information from state and municipal sources regarding traffic on arterioles and major traffic arteries. All information was entered into geographical information system (GIS) including the closest cross-streets to the child's home and the school location. Traffic exposure variables are being developed for each child and will be added to the database on indoor exposures. A regression model will be used to determine the significance of traffic exposure in receiving a diagnosis of asthma for children five to seven years of age.


Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05555134: INHALATION CHAMBER MANAGEMENT IN PEDIATRICS: EFFICACY OF AN EDUCATIONAL INTERVENTION IN PATIENTS DIAGNOSED WITH BRONCHOSPASM AND THEIR FAMILY CAREGIVERS.
Official title: INHALATION CHAMBER MANAGEMENT IN PEDIATRICS: EFFICACY OF AN EDUCATIONAL INTERVENTION IN PATIENTS DIAGNOSED WITH BRONCHOSPASM AND THEIR FAMILY CAREGIVERS.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bronchospasm
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 121
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Several studies show that unnecessary and frequent visits to the emergency department for bronchospasm care are associated with inadequate management of inhalers and poor education on the approach to respiratory distress. Main objective: To determine the degree of frequentation to the pediatric emergency department for bronchospasm at 1, 3 and 6 months after the educational intervention. Design: Randomized controlled clinical trial with two groups: EXPERIMENTAL will receive the educational intervention, along with usual care, and CONTROL will receive usual care. Subjects: pediatric patients (2-15 years) diagnosed with bronchospasm; in home treatment with inhalation chambers; and their parents. Emergency Department recruitment. Follow-up at home


Eligibility criteria: Inclusion Criteria:

* Patients between 2-15 years of age attending the Pediatric Emergency Department of the Hospital Universitario Puerta de Hierro Majadahonda (HUPHM) with a mild, moderate or severe bronchospasm crisis and who have used the inhalation chambers on at least one occasion; with autonomy in the use of the inhalation chambers at home

Exclusion Criteria:

* Not understanding Spanish

Primary outcomes:
measure: degree of frequentation to the emergency department
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Belén de la Rosa
state: Madrid
Study officials:
References:
Clinical trial NCT03698734: Evening Primrose Oil Efficacy in Second Trimester Abortion
Official title: Effect of Adding Evening Primrose Oil to Misoprostol in Second Trimester Abortion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Missed Abortion
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: efficacy of evening primrose oil in shortening the duration of induction in 2nd trimesteric missed abortion


Eligibility criteria: Inclusion Criteria:

* Primiparous women

Exclusion Criteria:

* Previous uterine incision( Cs, myomectomy,)
* Contraindications to medical or surgical uterine evacuations (eg, hemodynamically unstable, coagulopathy)
* Evidence of intra-uterine infection
* Rupture of fetal membranes.
* Intrauterine device in place.
* Allergy to prostaglandins or EPO

Primary outcomes:
measure: duration of medical induction of abortion
timeFrame: up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university maternity hospital
state: Abbassya
Study officials:
References:
Clinical trial NCT00778934: In-Home Use Study to Evaluate Use of an Intimate Health Product in Females
Official title: A Single-blind, Multi-center, In-home Use Study to Evaluate Sexual Enhancement Effects of Product PD-F-5394 in Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coitus
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the effects of an intimate health product on sexual experience in females.

Detailed description: Study to evaluate consumer perceptions of a cosmetic intimate health product on sexual experience in females, using a validated psychometric questionnaire.

Eligibility criteria: Inclusion Criteria:

* Normal, healthy females \>18 years of age
* In committed heterosexual relationship for \>6months
* Of adequate sexual functioning
* On acceptable method of birth control

Exclusion Criteria:

* Pregnant or breastfeeding
* Allergy to product ingredients
* Irritation or infection in genital area
* Unstable or uncontrolled medical condition

Primary outcomes:
measure: To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses
timeFrame: End of study (3 weeks after baseline visit)
Secondary outcomes:
measure: Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.
timeFrame: throughout duration of the study (+ 30 days for spontaneously reported SAEs)
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Center of Marital and Sexual Health of South Florida
state: Florida
city: Beachwood
country: United States
facility: Center for Marital and Sexual Health, Inc.
state: Ohio
Study officials:
affiliation: J&J CPPW
name: Rita Wanser
role: STUDY_DIRECTOR
References:
Clinical trial NCT02073734: Effects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP
Official title: Effects of Preoperative Dexamethasone on Postoperative Quality of Recovery Following Vaginal Reconstructive Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pelvic Organ Prolapse
PONV
Keywords: pelvic organ prolapse surgery
dexamethasone
postoperative nausea and vomiting
peroperative administration
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.

Detailed description: This is a randomized controlled trial involving single administration of 8 mg Dexamethasone per IV preoperatively among women undergoing vaginal reconstructive surgery for pelvic organ prolapse.

Eligibility criteria: Inclusion Criteria:

* Women aged 18-81 years old who are scheduled to undergo a major vaginal reconstructive surgery, including hysterectomy with or without hysterectomy

Exclusion Criteria:

* Daily use of steroids or antiemetic agents such as Zofran, Reglan, Compazine and Phenargan within one month of surgery
* Regional anesthesia for surgical procedure
* Chronic pain requiring opioid treatment daily
* History of allergy to the study medication
* Severe renal and liver disease
* Pregnancy
* Non English speaking
* Psychiatric disorder that will preclude completion of questionnaires
* Minor surgery that does not involve overnight admission
* Surgery that does not involve hysterectomy or vaginal intraperitoneal apical suspension
* Hypersensitivity reaction to steroids
* Evidence of systemic fungal infection
* Evidence of any systemic infection
* Uncontrolled diabetes

Primary outcomes:
measure: The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40).
timeFrame: up to 20-24 hours after surgery
Secondary outcomes:
measure: To determine if dexamethasone has positive impact on other clinical recovery variables such as nausea, vomiting and pain.
timeFrame: 20-24 hours after surgery
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Triheath
state: Ohio
Study officials:
affiliation: TriHealth Good Samaritan Hospital
name: Rachel N Pauls, MD
role: STUDY_DIRECTOR
affiliation: TriHeath Good Samaritan Hospital
name: Rachel N Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pauls RN, Crisp CC, Oakley SH, Westermann LB, Mazloomdoost D, Kleeman SD, Ghodsi V, Estanol MV. Effects of dexamethasone on quality of recovery following vaginal surgery: a randomized trial. Am J Obstet Gynecol. 2015 Nov;213(5):718.e1-7. doi: 10.1016/j.ajog.2015.05.061. Epub 2015 May 29.
Clinical trial NCT03290534: Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
Official title: Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lung Cancer
Lung Cancer Stage I
Lung Cancer Stage II
Keywords: wedge resection
sublobar resection
brachytherapy
CivaSheet
Pd-103
CivaTech Oncology
lung cancer
lung
Lead sponsor: CivaTech Oncology
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 40
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: This is a feasibility study to determine the usefulness of a brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit lung cancer patients by reducing the radiation dose to critical structures, such as the heart wall, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.


Eligibility criteria: Inclusion Criteria:

* Subject signed inform consent
* Suspected or proven non-small cell lung cancer (NSCLC) in the upper lobes of the left or right lung
* Pre-operative criteria
* Lung nodule suspicious for NSCLC
* Mass ≤ 7 cm in maximum diameter by CT scan of the chest and upper abdomen
* Clinical stage I or Clinical stage II
* Not pregnant or nursing
* Negative pregnancy test in premenopausal women
* Fertile patients must use effective contraception
* More than 5 years since prior invasive malignancy unless non melanoma skin cancer or in-situ cancer

Exclusion Criteria:

-

Primary outcomes:
measure: Local Control Rate at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Freedom from regional or distant recurrence
timeFrame: 1 year
measure: Time to recurrence
timeFrame: 1 year
measure: Toxicity graded on CTCAE 4.0 Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
References:
Clinical trial NCT06647134: A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy
Official title: A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthritis
Polymyalgia Rheumatica
Immune Checkpoint Inhibitors
Keywords: arthritis
polymyalgia rheumatica
immune related adverse events
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

Brief summary: To understand the severity and nature of participants experiences during irAEs following immune checkpoint inhibitor immunotherapy.

Detailed description: 1. To understand the severity and nature of participants experiences during rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, including their functional impact
2. To explore domains relevant to participants experiencing rheumatic immune-related adverse events following immune checkpoint inhibitor immunotherapy, and attitudes to domains identified from the literature

Eligibility criteria: Inclusion Criteria

The criteria are:

* Patients aged 18 years and above
* English (conversational level) speaking, with the ability to give informed consent
* Patients with a rheumatologist clinician diagnosis of inflammatory arthritis irAE or PMR irAE following ICI therapy

Exclusion Criteria

* Acutely life-threatening or worsening cancer
* Hearing impairment functionally limiting participation in verbal interview

Primary outcomes:
measure: Safety and Adverse Events (AEs).
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Y. Jeff Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03690934: Treatment of Transsphicteric Fistula-in-ano by Method of Laser Thermoobliteration(FiLaC™).
Official title: Randomized Conrtolled Study: Fistula Laser Closure (FiLaC™) vs Monopolar Coagulation for Treatment of Complex Anal Fistulae.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fistula
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2018-10-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled, parallel study to compare the results of treatment for patients with transsphincteric fistulas-in-ano.

Detailed description: We are planning to eroll 120 patients in this study,the duration of the stady be 3 years. Each of two groups will include 60 people. Pationts in the first group will be assigned to get treatment of the fistula-in-ano by laser thermo-obliteration (FiLAC™), patietns of the second group will forego monopolar coagulation of the fistulas tract with suturing the internal fistulas opening.

Eligibility criteria: Inclusion Criteria:

1. Informed consent to the study;
2. Patients with high transsphincteric fistula (\>1/3), suprasphincteric fistula whithout abscesses;
3. The presence of a formed fistulous tract \> 2 cm in length.

Exclusion Criteria:

1. Suprasphincteric fistula with abscesses or infiltrates;
2. Extrasphincteric fistula;
3. Length of fistula tract \< 2 cm;
4. The presence of sever scars in the region of internal fistula opening, wide fistula opening \> 5 mm;
5. Crohn's fistulae

Primary outcomes:
measure: Rate of healing
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology
Study officials:
References:
Clinical trial NCT06985134: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh
Official title: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh
Condition ...Moderate to Severe Axial Spondyloarthopathy
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the present study was conducted to determine the comparative efficacy and safety of thalidomide and SSZ in moderate to severe cases of ankylosing spondylitis in Bangladesh.


Eligibility criteria: Inclusion Criteria:

* The present study included patients aged \>18 years with inflammatory low back pain fulfilling the Modified New York criteria for moderate to severe ankylosing spondylitis. The criteria include radiographic sacroiliitis (at least grade II bilaterally or grade III unilaterally) along with clinical signs, such as inflammatory back pain for at least 3 months' duration, limitation of lumbar spine in sagittal and frontal planes, or chest expansion decreased relative to normal values for age and sex

Exclusion Criteria:

* Exclusion criteria were non-inflammatory back pain or back pain due to inflammatory causes other than AS, failure to confirm a washout period of four weeks, those, those who were on DMARDs, allergy to thalidomide, sulphasalazine, and NSAIDs, known to have kidney diseases or cardiac disease, active peptic ulcer disease, and pregnancy.

Primary outcomes:
measure: BASDAI
timeFrame: Outcome 1: "Bath Ankylosing Spondylitis Disease Activity index(BASDAI) pain score at baseline"; Outcome 2: " "Bath Ankylosing Spondylitis Disease Activity index(BASDAI) pain score at week 12""
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bsmmu
state: Shahbag
Study officials:
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: ISLAM
role: STUDY_DIRECTOR
References: