louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00793910: Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy
Official title: Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy: A Randomized, Double-masked, Single Center, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Gabapentin
PRK
pain
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
First posted: 2008-11-19
Enrollment: 106
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of an oral medication called gabapentin in reducing pain after Photorefractive Keratectomy (PRK) eye surgery and to assess the frequency of use of rescue medication interventions, defined as non-steroidal anti-inflammatory (NSAID) eye drops and oral narcotic medication.


Eligibility criteria: Inclusion Criteria:

* Ability to understand and provide informed consent to participate in this study and complete follow-up visits.
* Planned Photorefractive keratectomy (PRK) at the WRAMC Center for Refractive Surgery.
* Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
* Access to transportation to meet follow-up requirements.

Exclusion Criteria:

* Any reason to be excluded for PRK.
* Female subjects who are pregnant, breast feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. \[Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not\].
* Patients with known allergy, sensitivity or inappropriate responsiveness to Gabapentin or any of the medications used in the post-operative course.
* Patients with known depressed renal function.
* Any physical or mental impairment that would preclude participation in any of the examinations.

Primary outcomes:
measure: Level of Pain
timeFrame: 2 hours postoperatively
measure: Level of Pain
timeFrame: day 1 postoperatively
measure: Level of Pain
timeFrame: 3 days postoperatively
measure: Level of Pain
timeFrame: 4 days postoperatively
Secondary outcomes:
measure: Occurence of Use of Rescue Medication
timeFrame: 2 hours to 4 days postoperatively
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
References:
Clinical trial NCT01157910: Bacterial Assessment of Middle Ear Fluid in Children Undergoing Ventilation Tube Placement Surgery
Official title: An Epidemiological and Bacteriological Assessment of Middle Ear Fluid in Children Undergoing Ventilation Tube Placement Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Otitis Media
Age Determined Bacteria
Keywords: Ear infection
Chronic
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-07-07
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children suffering from chronic otitis media who are scheduled for surgery.

Brief summary: Children with chronic otitis media have more resistant bacteria that require surgical intervention to eradicate the infections. The study will evaluate the dominant bacteria and their sensitivities to antibiotics. The information will assist in better treatment plans for children with chronic infections.

The data will also assess the changing patterns in the bacteria colonizing middle ear fluid.

Detailed description: ibid.

Eligibility criteria: Inclusion Criteria:

* All children with chronic ear infections scheduled for surgical interventions

Exclusion Criteria:

* Children who have undergone prior mastoid surgery, or children with oncologic treatments.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe MC,
Study officials:
References:
Clinical trial NCT01326910: Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema
Official title: A Double-Blind, Randomized, Active-Controlled Clinical Trial to Evaluate the Efficacy and Safety of an Over-the-Counter Cream in the Management of Mild to Moderate Atopic Dermatitis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Eczema
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2011-03-31
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This three week study will be conducted to determine the safety and efficacy of an over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.

Detailed description: The objective of this trial is to evaluate the efficacy and safety of an OTC colloidal oatmeal skin protectant cream in children with mild to moderate AD in comparison to that of EpiCeram®

Eligibility criteria: Inclusion Criteria:

* Children ages 6 mo- 18 years
* Any ethnicity
* Diagnosed with atopic dermatitis (AD) per Hanifin-Rajka criteria
* Mild to moderate atopic dermatitis per Rajka-Langeland severity index
* Willing to use only provided cream and body wash for duration of study

Exclusion Criteria:

* Known sensitivity to investigational products
* Pregnant or breastfeeding
* Severe AD per Rajka-Langeland severity index
* AD requiring class I (super potent) or class II or III (potent) topical steroids
* Requires greater than 2.0 g inhaled or intranasal corticosteroids
* Other skin conditions which may interfere with the scoring of AD

Primary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: 3 weeks
Secondary outcomes:
measure: Interim Eczema Area and Severity Index (EASI)
timeFrame: Week 2
measure: Assessment of Itch
timeFrame: through Week 3
measure: Investigator's Global Atopic Dermatitis Assessment (IGADA)
timeFrame: through Week 3
Other outcomes:
Locations:
city: St Petersburg
country: United States
facility: Hilltop Research
state: Florida
city: Miamiville
country: United States
facility: Hilltop Research
state: Ohio
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Qing Li, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Lisante TA, Nunez C, Zhang P. Efficacy and safety of an over-the-counter 1% colloidal oatmeal cream in the management of mild to moderate atopic dermatitis in children: a double-blind, randomized, active-controlled study. J Dermatolog Treat. 2017 Nov;28(7):659-667. doi: 10.1080/09546634.2017.1303569. Epub 2017 Apr 2.
Clinical trial NCT02286310: Effect of Exercise Programs on 3-dimensional Scapular Kinematics, Disability and Pain
Official title: Effect of Exercise Programs on 3-dimensional Scapular Kinematics, Disability and Pain in Subjects With Shoulder Impingement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Impingement Syndrome
Keywords: Exercise
Kinematics
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of exercise program on 3-dimensional scapular kinematics, disability and pain on shoulder impingement with scapular dyskinesia.


Eligibility criteria: Inclusion Criteria:

* Subacromial impingement with scapular dyskinesia

Exclusion Criteria:

* Additional muscular and skeletal or systemic diseases

Primary outcomes:
measure: 3-Dimensional Scapular Kinematics measured by electromagnetic tracking system
timeFrame: Change from Baseline in Angular Data at 1 year
Secondary outcomes:
measure: Pain and Disability Status measured by Shoulder Pain and Disability Index (SPADI)
timeFrame: Change from Baseline in Scor at 1 year
measure: Pain Severity measured by Visual Analogue Scale (in millimeters)
timeFrame: Change from Baseline in Pain Severity at 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Gul Baltaci, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turgut E, Duzgun I, Baltaci G. Effects of Scapular Stabilization Exercise Training on Scapular Kinematics, Disability, and Pain in Subacromial Impingement: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Oct;98(10):1915-1923.e3. doi: 10.1016/j.apmr.2017.05.023. Epub 2017 Jun 24.
Clinical trial NCT00084110: Use of Complementary and Alternative Medicine Among Older Mexican Americans
Official title: Complementary Alternative Medicine
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthritis
Diabetes Mellitus
Fractures
Hypertension
Depression
Urinary Incontinence
Keywords: Aged
Mexican Americans
Complementary Therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-06-08
Enrollment: 3000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to examine complementary and alternative medicine use among older Mexican Americans and to determine how this use influences physical, functional, and mental health.

Detailed description: Alternative medicine has received increasing attention from both the scientific and public communities. While the majority of current alternative medicine use is the result of interest in replacing or augmenting formal medical treatments, several cultures have long-standing traditions of herbal medicine use, particularly among older, more traditional members. Research in this area has been limited primarily to small-scale studies that identify herbal remedies popular in specific cultures. This study observes older Mexican Americans because a substantial proportion of this population continue to utilize traditional herbal remedies in their everyday life.

Eligibility criteria: Inclusion Criteria:

* Mexican American

Exclusion Criteria:

* Unable to complete survey questionnaire

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Jose A. Loera
state: Texas
Study officials:
References:
citation: Loera JA, Black SA, Markides KS, Espino DV, Goodwin JS. The use of herbal medicine by older Mexican Americans. J Gerontol A Biol Sci Med Sci. 2001 Nov;56(11):M714-8. doi: 10.1093/gerona/56.11.m714.
Clinical trial NCT04314310: Effects on Recovery of Postoperative Gastrointestinal Function With Multimodal Analgesia
Official title: Effects on Recovery of Postoperative Gastrointestinal Function With Multimodal Analgesia in Patients Receiving Abdominal and Non-abdominal Surgeries.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastrointestinal Recovery
Keywords: orocecal transmit time, flatus
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: treatment: Tenoxicam; control: placebo
Primary purpose: TREATMENT

Brief summary: breast cancer surgery is associated with a high incidence of persistant postsurgical pain (PPSP). The aim of the study was to evluate the impact of intravenous Tenoxicam on acute and PPSP, analgesic requirements and gastrointestinal recovery in patients undergoing surgery for breast cancer.

Detailed description: thrity patients participated in this randomized, single-blined study. Before and at the postoperative day 1, the bowel function (orocecal transmit time) were measured. Before induction of general anesthesia, patients recieved a bolus of intravenous Tenoxicam or an equal volume of saline (control group). Pain score and opioid consumption were recorded in the postoperative period and then daily for 1 week.

Eligibility criteria: Inclusion Criteria:

* ASA I to II Breast cancer patients Mastectomy or wide local excision + axillary note dissection

Exclusion Criteria:

* Preexisting malignancy Chronic infection Previous pain condition Diabetes Thyroid disorder Severe cardiac, renal or hepatic disease Previous breast surgery Psychiatric illness Neurological disease Contraindication for tenoxicam or morphine use

Primary outcomes:
measure: morphine consumption
timeFrame: until postoperative day7
Secondary outcomes:
measure: orocecal transmit time,
timeFrame: preoperative and postoperative day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01655810: Vitamin D, Cardiovascular Disease, and African Americans
Official title: Vitamin D and Early Markers of Cardiovascular Disease in African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Type 2 Diabetes Mellitus
Cardiovascular Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2012-08-02
Enrollment: 86
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: African-Americans have higher rates of cardiovascular disease morbidity and mortality, as well as vitamin D deficiency. Multiple observational studies have demonstrated an increased risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation between cardiovascular disease and vitamin D levels; however, there is a lack of interventional trials exploring this connection. The objective of this proposal is to address the hypothesis that treatment of vitamin D deficiency in African Americans with type 2 diabetes will improve subclinical markers of cardiovascular disease.

Detailed description: This study will be a double blinded, randomized controlled trial of vitamin D3 supplementation, 4,000 international units per day versus 600 international units per day, for one year to determine the effects on markers of subclinical cardiovascular disease in African Americans with type 2 diabetes and vitamin D deficiency. Outcome assessment will focus on changes in carotid intima-medial thickness (CIMT - ultrasound of the thickness of blood vessels in the neck), as well as markers of systemic inflammation.

Eligibility criteria: Inclusion Criteria:

* African Americans of both genders
* Age 50-70 years
* Type 2 diabetes (A1C \< 9.0%), on stable therapy with oral medications, insulin, or a combination
* 25(OH)D level \< 20 ng/ml
* BP \< 140/90 mmHg; LDL \< 140 mg/dl

Exclusion Criteria:

* Pregnancy
* Cardiovascular disease
* Stage 3 or worse chronic kidney disease
* High urine or serum calcium or history of recurrent kidney stones
* Unstable medical conditions or major systemic diseases such as malignancy

Primary outcomes:
measure: Change from baseline in carotid intima-medial thickness
timeFrame: 0, 6, and 12 months
Secondary outcomes:
measure: Change from baseline in systemic inflammatory markers
timeFrame: 0, 6, and 12 months
measure: Serum calcium
timeFrame: 0, 1, 3, 6, 9, and 12 months
measure: Urinary Calcium
timeFrame: 0, 1, 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Carlos Bernal-Mizrachi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01971710: Advancing Community Level Action for Improving MCH/PMTCT
Official title: Advancing Community Level Action for Improving MCH/PMTCT (ACCLAIM): A Multi-Country Randomized Trial to Evaluate the Effectiveness of Selected Community-Level Interventions on Key MCH/PMTCT Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
AIDS
PMTCT
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Canadian International Development Agency
First posted: 2013-10-29
Enrollment: 187335
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of the ACCLAIM (Advancing Community-Level Action for Improving MCH/PMTCT) project is to increase community demand for, uptake of, and retention in Maternal and Child Health (MCH) and/Prevention of Mother-to-child transmission of HIV (PMTCT) services to improve country progress toward elimination of pediatric HIV/AIDS.

Detailed description: This study will undertake a three-arm randomized trial in Swaziland, Uganda and Zimbabwe. Districts/regions (n=9) with 45 PMTCT-implementing health facilities and their catchment areas (populations 7300-27500), will be randomly allocated to three intervention arms: 1) community leader engagement, 2) community leader engagement with community days, or 3) community leader engagement with community days and male and female community peer groups. The primary study outcome is HIV exposed infants (HEI) returning to the health facility within two months for early infant diagnosis (EID) of HIV. Secondary study outcomes include: gestational age of women attending for first antenatal care, male partners tested for HIV, and HEI receiving nevirapine prophylaxis at birth. Changes in community knowledge, attitudes, practices and beliefs on MCH/PMTCT will be assessed through household surveys.

Eligibility criteria: Inclusion Criteria:

* Must be a member of the community surveyed

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: Proportion of HIV-exposed infants returning to health facility HIV testing
timeFrame: 6-8 weeks after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Mbabane
country: Swaziland
facility: Elizabeth Glaser Pediatric AIDS Foundation
city: Kampala
country: Uganda
facility: Elizabeth Glaser Pediatric AIDS Foundation
city: Harare
country: Zimbabwe
facility: Elizabeth Glaser Pediatric AIDS Foundation
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Godfrey Woelk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woelk GB, Kieffer MP, Walker D, Mpofu D, Machekano R; Project ACCLAIM Study Group. Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial. Trials. 2016 Feb 16;17:88. doi: 10.1186/s13063-016-1202-y.
Clinical trial NCT05918510: Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus
Official title: Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Squamous Cell Carcinoma of the Oropharynx
Carcinomas of Unknown Primary Site
High-risk Human Papillomavirus Infection
Liquid Biopsy
Lymph Node Metastasis
Occult Tumor of the Head and Neck Area
Keywords: Oropharyngeal Tumor
Occult Cancer
HPV Infection
head-neck area
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Istituto Clinico Humanitas
name: Istituto Europeo di Oncologia
name: Azienda Policlinico Umberto I
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: University of Firenze and Siena, Napoli, Italy
name: Weizmann Institute of Science
First posted: 2023-06-26
Enrollment: 142
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: Squamous cell carcinomas of the oropharynx and occult neoplasms with lymph node metastases Cytologically positive laterocervical squamous cell carcinoma treated with TORS or RT or RT/CT

Brief summary: Based on the evidence summarized in the introduction, the clinician hypothesize that the detection of the presence and expression of HPV-DNA, certain miRNAs, and a certain mutational profile in the tissues and biological fluids of these patients, may have important prognostic and diagnostic value not only in HPV-related OPSCCs but also in HPV+ occult T. Accordingly, this study aims to aim to better characterize their potential as biomarkers and to detect the possibility of their their use to implement the sensitivity and specificity of radiological methodologies (PET-CT and MRI), already in use in clinical practice, for monitoring disease progression in this specific subgroup. Finally, by using the collected material to generate organoids and Patient Derived Xenograft (PDX), the study also aims to identify possible new molecular drugs, which could solve the problem of resistance to radiochemotherapy.


Eligibility criteria: Inclusion Criteria:

* Squamous cell carcinomas of the oropharynx and occult neoplasms with lymph node metastases laterocervical cytologically positive for squamous cell carcinoma treated with TORS or RT or RT/CT
* Age \> 18 years
* ECOG performance status \<_ 2
* Ability to follow study procedures and complete questionnaires
* Signature of informed consent

Exclusion Criteria:

* Presence of distant metastases at the time of diagnosis
* Previous cancer of the head and neck district
* Second tumor in therapy or follow-up for less than 5 years

Primary outcomes:
measure: Accouracy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References: