louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02751541: Human Phototoxicity Test
Official title: Human Phototoxicity Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the phototoxic potential of a topically applied article in human subjects.


Eligibility criteria: Inclusion Criteria:

* Be male or female between the ages of 18 and 60 inclusive;
* Be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* Have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164;
* Be in general good health as determined by the subject's medical history and in the discretion of the investigator.

Exclusion Criteria:

* Have a visible sunburn;
* Have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
* Must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
* Have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products.

Primary outcomes:
measure: Intensity of skin reactions will be evaluated using 5 point grading scale.
timeFrame: Up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06628141: Enhancing Quality of Life in Cancer Patients Through Tailored Nutrition Support: a Comprehensive Approach
Official title: Enhancing Quality of Life in Cancer Patients Through Tailored Nutrition Support: a Comprehensive Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: UOMi Cancer Center
Sponsor class: OTHER
Collaborators: name: Dexeus Clinic Woman
First posted: 2024-10-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to investigate the impact of a dedicated nutritional assistance tool on patients with cancer and to measure its effects on several proposed indicators.


Eligibility criteria: Inclusion Criteria:

* Patients affected by cancer, who decided to participate to the study, signed the informed consent and whose life expectancy is higher than 1 (one) year.

Exclusion Criteria:

* Patients with an eating disorder of psychiatric or psychological origin, diagnosed before cancer treatment.
* Any other exclusion criteria as determined by the oncologist based on the patient's ability to successfully complete the program.

Primary outcomes:
measure: Outcome Measure: Dietary Adherence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: UOMI Cancer Center Clínica Mi Tres Torres
Study officials:
References:
Clinical trial NCT01001741: Pilot Study of Text Message Reminders to Improve HIV Medication Adherence in Botswana
Official title: A Pilot Study of Cellular Phone Text Message Reminders to Improve HIV Medication Adherence at Independence Surgery Clinic Gaborone, Botswana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Antiretrovirals
Adherence
Text messaging
Antiretroviral adherence
Treatment experienced
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 128
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: While medication adherence is critical to successful treatment of HIV, there are few studies of interventions demonstrating improvements in adherence. This may be a particular challenge in the developing world, which has a larger burden of HIV but fewer resources than industrialized countries. The investigators propose a randomized controlled trial of cellular phone text message reminders to improve medication adherence. Our pilot study will be set in a large HIV clinic in Gaborone, Botswana, where Penn researchers have collaborated on research projects in the past. The primary study outcome will be antiretroviral medication adherence.


Eligibility criteria: Inclusion Criteria:

* HIV infected
* 21 years of age or older

Exclusion Criteria:

* Subjects who do not intend to have continuous follow-up care and monthly medication refills at Independence Surgery for at least the next six months

Primary outcomes:
measure: HIV medication adherence
timeFrame: Monthly
Secondary outcomes:
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Independence Surgery
Study officials:
affiliation: University of Pennsylvania
name: Darren Linkin, MD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Harvey Friedman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wharton Business School, UPenn
name: James Thompson, MBA
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Andrew Steenhoff
role: STUDY_DIRECTOR
References:
citation: Reid MJ, Dhar SI, Cary M, Liang P, Thompson J, Gabaitiri L, Steele K, Mayisela S, Dickinson D, Friedman H, Linkin DR, Steenhoff AP. Opinions and attitudes of participants in a randomized controlled trial examining the efficacy of SMS reminders to enhance antiretroviral adherence: a cross-sectional survey. J Acquir Immune Defic Syndr. 2014 Feb 1;65(2):e86-8. doi: 10.1097/QAI.0b013e3182a9c72b. No abstract available.
Clinical trial NCT04445441: An Observational Study to Assess the Protocol for the COVID-19 Treatment in Burkina Faso
Official title: An Observational Study to Assess the Effectiveness of the Standard of Care (Hydroxychloroquine+Azythromicin or Chloroquine+Azythromicin) Recommended by the Ministry of Health for the Treatment of the Coronavirus Infection in Burkina Faso
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
Lead sponsor: Centre Muraz
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Any covid patient over 18 years treated according to standard of care

Brief summary: This is an observational study to evaluate the effectiveness of the combinations Hydroxychloroquine + Azithromycin (HCQ-AZ) and Chloroquine + Azithromycin (CQ-AZ) in the treatment of Coronavirus (Covid-19) infection in Burkina Faso.

Detailed description: All patients who received one of the two combinations will be included in the study and followed-up until the patient is discharged from the hospital. They will be seen daily during the period of their active clinical follow-up at the hospital. At each visit, the medical history since the last visit (including treatments taken), signs and symptoms in progress if any, will be collected. A nasopharyngeal swab will be collected on Day 0, 3, 7 and 14 and then on day 21 if he is still positive in order to assess the evolution of the viral load. However if until the end of the follow-up on D21 the test is still positive, the sampling will be continued until the patient become negative as recommended by the national standard of care for the Covid patients management in Burkina Faso.

In terms of safety, an ECG will be performed on day 0 prior to the treatment administration and this will be repeated on day 7 and day 14 and every week until it normalizes or the patient will be recommended to see a cardiologist to check the normalization of his ECG after discharge from hospital. Adverse events will be recorded including biological parameters (biochemistry and hematology) will be monitored, as well as changes in relevant laboratory parameters.

Eligibility criteria: Inclusion Criteria:

* Any patient over 18 years treated according to the standard of care
* Willing to participate in the study by giving an informed consent

Exclusion Criteria:

* Patients under 18 years of age
* Not willing to participate in the study

Primary outcomes:
measure: Clearance of viral load
timeFrame: 14 days
Secondary outcomes:
measure: Safety of the treatment
timeFrame: 14 days
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: Sourou Sanon University Hospital
city: Ouagadougou
country: Burkina Faso
facility: Tingadogo University Hospital
Study officials:
affiliation: IRSS - URCN
name: Halidou Tinto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01614041: Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder
Official title: Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder: a Multi-center, Randomized, Usual Dose-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-07
Enrollment: 274
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of comparative high dose Tandospirone Citrate in the treatment of patients with generalized anxiety disorder.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Male or female
* Diagnosed with GAD according to DSM-IV
* HAMA score≥17
* Provide with written informed consent
* Agree to be washed-out for two weeks if receiving SSRI, SNRI or NASA.

Exclusion Criteria:

* Serious suicidal tendency
* The score of the sixth item of HAMA ≥3
* The score of HAMD ≥21
* Pregnant or lactating women
* History of allergic or hypersensitivity to tandospirone
* Serious or unstable cardiac, renal, neurologic, cerebrovascular, metabolic, or pulmonary disease
* Secondary anxiety disorders
* Drug or alcohol dependence within 1 year
* Patients currently taking benzodiazepine drugs
* Drivers and dangerous machine operators
* Participated in other clinical studies in the last 30 days
* Patients with clinically significant ECG or laboratory abnormalities
* Patients with a history of epilepsy
* Patients with abnormal TSH concentration

Primary outcomes:
measure: Percentage of patients whose Hamilton Anxiety Scale (HAMA) score change downwards ≥ 50% from baseline to 6 weeks treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: HAMA score changes from baseline to 6 weeks treatment
timeFrame: 6 weeks
measure: Percentage of patients whose HAMA score ≤ 7 after 6 weeks treatment
timeFrame: 6 weeks
measure: HAMA factor score changes after treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
Study officials:
affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Wenyuan Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Q, Zhang H, Lin G, Shi S, Zhang Y, Ji J, Yang L, Yao J, Wu W. Relative Safety and Efficacy of Two Doses of Tandospirone Citrate for Generalized Anxiety Disorder: A Multicenter Randomized Controlled Trial. Neuropsychiatr Dis Treat. 2022 Aug 8;18:1653-1664. doi: 10.2147/NDT.S366048. eCollection 2022.
Clinical trial NCT02297841: Repeated Insult Patch Test of Personal Lubricants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema
Edema
Lead sponsor: Church & Dwight Company, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-21
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Determine the ability of the study material (personal lubricant) to cause sensitization by repeated topical application to the skin of humans under controlled patch test conditions.


Eligibility criteria: Inclusion Criteria:

* In general good health
* Free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events
* Are of any skin type or race, providing the skin pigmentation will allow discernment of erythema
* Complete a medical screening procedure
* Read, understand, and sign an informed consent agreement

Exclusion Criteria:

* Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation
* Are receiving systemic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results
* Have psoriasis and/or active atopic dermatitis/eczema.
* Are females who are pregnant, planning on getting pregnant during the study, or breast-feeding
* Have a known sensitivity for cosmetics, skin care products, topical drugs, or any other type of the products, as related to the material being evaluated

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 24, 48, and 72 hours after patch application
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00798941: ICU Patient and Family Comfort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Thirst
Anxiety
Satisfaction
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Palliative Care Research Center
First posted: 2008-11-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
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 evaluate family-led interventions for Intensive Care Unit (ICU) patients' symptoms (i.e., pain and thirst) that will involve ICU patients' family members in the non-pharmacological management of these symptoms. This family involvement may help to ameliorate not only patients' symptoms but also the families' symptoms and promote family satisfaction with ICU care.


Eligibility criteria: Inclusion Criteria:

* Patient:

  * in ICU for at least 24 hours;
  * adult;
  * able to self-report;
  * pain and thirst greater than 3 on 0-10 numeric rating scale;
  * English-speaking.
* Family member:

  * 18 years or older;
  * visits patient more than other family members;
  * closest person to patient (can be non-biological).

Exclusion Criteria:

* Patient:

  * in ICU for at less than 24 hours;
  * non-adult;
  * unable to self-report;
  * no pain and thirst greater than 3 on 0-10 numeric rating scale;
  * non-English-speaking.
* Family member:

  * younger than 18 years;
  * visits patient less than other family members;
  * not closest person to patient.

Primary outcomes:
measure: patient-reported pain
timeFrame: immediately after intervention
Secondary outcomes:
measure: patient-reported thirst
timeFrame: immediately after intervention
measure: Family-reported anxiety
timeFrame: at end of study
measure: Family-reported satisfaction
timeFrame: end of study
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: U.C. San Francisco
state: California
Study officials:
affiliation: U.C. San Francisco
name: Kathleen A Puntillo, DNSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03449641: PAP Therapy in Patients With Obesity Hypoventilation Syndrome
Official title: PAP Therapy Compliance in Patients With Obesity Hypoventilation Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Hypoventilation Syndrome
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The role of different levels of compliance and long-term effects of positive airway pressure (PAP) therapy on gas exchange, sleepiness, quality of life, depression and death rate in patients with obesity hypoventilation syndrome (OHS).

Detailed description: Various forms of positive airway pressure (PAP) therapy are effective in providing short and long-term benefits in these patients with or without obstructive sleep apnea (OSA). However, there are limited data concerning the impact of long-term effects of PAP therapy on survival and functional status in individuals with obesity hypoventilation syndrome (OHS) and OSA. Therefore we aimed to assess the role of different levels of compliance and long-term effects of PAP on gas exchange, sleepiness, quality of life, depression and death rate in patients with OHS, two year after PAP initiation.

Eligibility criteria: Inclusion Criteria:

* aged between 18 and 80 years
* Obesity hypoventilation syndrome diagnosis (OHS)
* clinically stable for at least 4 weeks prior to the enrolmenT
* above-elementary school education.

Exclusion Criteria:

* refusal to participate
* refusal of PAP therapy
* central sleep apnea syndromes
* restrictive ventilation syndromes
* severe congestive heart failure
* a history of life-threatening arrhythmias
* severe cardiomyopathy
* significant chronic kidney disease
* untreated hypothyroidism
* family or personal history of mental illness
* drug or alcohol abuse
* sedative use
* severe cognitive impairment
* concurrent oncological diseases
* history of narcolepsy or restless legs syndrome.

Primary outcomes:
measure: Effects of positive airway pressure (PAP) therapy on gas exchange
timeFrame: 2 years
Secondary outcomes:
measure: Effects of positive airway pressure (PAP) therapy on sleepiness
timeFrame: 2 years
measure: Effects of positive airway pressure (PAP) therapy on quality of life
timeFrame: 2 years
measure: Effects of positive airway pressure (PAP) therapy on depression
timeFrame: 2 years
measure: Effects of positive airway pressure (PAP) therapy on death rate
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Crete
name: Sophia Schiza, MD, PhD
role: STUDY_CHAIR
References:
citation: Bouloukaki I, Mermigkis C, Michelakis S, Moniaki V, Mauroudi E, Tzanakis N, Schiza SE. The Association Between Adherence to Positive Airway Pressure Therapy and Long-Term Outcomes in Patients With Obesity Hypoventilation Syndrome: A Prospective Observational Study. J Clin Sleep Med. 2018 Sep 15;14(9):1539-1550. doi: 10.5664/jcsm.7332.
Clinical trial NCT02924441: Women's Mammography Study to Improve Comfort During Mammography
Official title: A Study Attempting to Improve the Comfort During Screening Mammography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Mammogram
Pain Management
Lidocaine
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 251
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine in a randomized trial whether it is possible to decrease the discomfort and anxiety of mammography by using the local analgesic lidocaine, or by using calming music in patients receiving a mammogram.

Detailed description: The study is designed to evaluate two methods of reducing pain and anxiety caused by mammography, one of the barriers to the procedure.

Eligibility criteria: Inclusion Criteria:

* Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain.
* Must have two breasts

Exclusion Criteria:

* May not have taken ibuprofen or other pain medication within the Space last 12 hours (ASA 81 mg dose is allowed).
* Must not have a contraindication for using lidocaine: e.g no history of allergic reactions to lidocaine.
* Must not have had history of breast cancer, breast surgery, radiation to the chest wall.
* Must not have broken or irritated skin (as determined by the study nurses).
* May not be lactating or breast feeding

Primary outcomes:
measure: Questionnaire to determine the change (or difference) in pain level before and after mammogram
timeFrame: The questionnaires are completed before and after mammography, on the same day (questionnaire will be completed before leaving the mammography clinic the day of mammography).
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health Cancer Center
state: Texas
Study officials:
affiliation: CTRC @ UTHSCSA
name: Kenneth Kist, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CTRC @ UTHSCSA
name: Virginia Kaklamani, MD
role: STUDY_CHAIR
affiliation: CTRC @ UTHSCSA
name: Pamela Otto, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01376141: Drug Use Investigation for IMIGRAN Tablet
Official title: Drug Use Investigation for IMIGRAN Tablet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 3571
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female Japanese subjects with migraine disorders who were considered appropriate to prescribe sumatriptan tablet according to the prescribing information were eligible for this surveillance study.

Brief summary: The study is designed to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy of sumatriptan tablet, and to discuss the need of special investigation and postmarketing clinical study.

A special focus was placed on the investigation of occurrence of "ischaemic heart disease-like events including arrhythmia, angina pectoris, and myocardial infarction" in the present study.


Eligibility criteria: Inclusion Criteria:

* Subjects with migraine disorders

Exclusion Criteria:

* Subjects with hypersensitivity to sumatriptan
* Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
* Subjects with history of peripheral vascular disorder
* Subjects with history of cerebrovascular disorder or transient ischemic attacks
* Subjects with uncontrolled high-blood pressure
* Subjects with severe hepatic function disorder
* Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist
* Subjects taking monoamine oxidaze inhibitor or use within 2 weeks of discontinuation

Primary outcomes:
measure: The number of incidence of adverse events in subjects with migraine disorders
timeFrame: 2 months
Secondary outcomes:
measure: Occurrence of arrhythmia
timeFrame: 2 months
measure: Occurrence of angina pectoris
timeFrame: 2 months
measure: Occurrence of myocardial infarction
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: