louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05791266: Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil
Official title: Safety of Sticker Pad Containing Essential Oil Containing Lavender and Ylang-ylang Oil Attached to the Collar for Decrease Blood Pressure in Healthy Volunteer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 56
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: OTHER

Brief summary: The aims of the study were to evaluate safety of sticker pads containing lavender and ylang ylang oil in healthy volunteers.

Detailed description: The lavender and ylang ylang oil pad was attached to the shirts of healthy volunteers for 2 hours. The outcomes were evaluated before, during and 30 minutes after removal of the pad. Adverse reactions, irritation score, and quality of life were assessed. Blood pressure and pulse rate were also measured

Eligibility criteria: Inclusion Criteria:

* age 18 to 60 years
* no allergic history of lavender and ylang ylang oil
* no dermatological diseases, immunocompromised diseases, seizures, asthma, or respiratory diseases.

Exclusion Criteria:

* an unstable condition of other diseases
* olfactory problems
* pregnancy
* lactation

Primary outcomes:
measure: Adverse reactions of the respiratory tract, skin, eye, and central nervous system
timeFrame: 2 hours
Secondary outcomes:
measure: Irritation of eye, respiratory, other neurological, and toxicity reaction
timeFrame: 2 hours
measure: Systolic blood pressure
timeFrame: 2 hours
measure: Diastolic blood pressure
timeFrame: 2 hours
measure: Pulse rate
timeFrame: 2 hours
measure: Rhinoconjunctivitis quality of life questionnaire
timeFrame: 2 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
Study officials:
affiliation: Chulalongkorn University
name: Pornanong Aramwit
role: STUDY_DIRECTOR
References:
Clinical trial NCT04655066: Evaluation of the Subjectively Perceived Pelvic Floor Function in Patients With Gynecological Tumors and Breast Cancer Under Systemic Tumor Therapy Using a Validated Questionnaire
Official title: PANTHERA-Studie "Pelvic Floor Disorders in Patients Under ANtineoplastic THERApy"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Floor Disorders
Lead sponsor: St. Josefs-Hospital Wiesbaden GmbH
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gynecological tumors and breast cancer under systemic tumor therapy

Brief summary: The multimodal therapy of gynecological malignancies and breast cancer often leads to an impairment of the pelvic floor function. This has a major impact on the quality of life of cancer patients. The aim of the study is to record and analyze the potential subjective impairment of the bladder, bowel and sexual function under systemic tumor therapy as well as possible influencing factors by means of validated disease-specific questionnaires. to find possible starting points for the prevention and treatment of the symptoms.


Eligibility criteria: Inclusion Criteria:

* Breastcancer under tumor therapy
* Gynecological carcinoma under tumor therapy

Exclusion Criteria:

* none

Primary outcomes:
measure: Primary Endpoint
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: 12 months
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital Wiesbaden GmbH
Study officials:
References:
Clinical trial NCT05163366: Oral Morphine Versus Ketamine in Pain Management
Official title: Oral Morphine Versus Rectal Ketamine in Pain Management During Burns Wound Dressing Changes in Paediatric Population at Mbarara Regional Referral Hospital: An Open Label Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Procedural
Lead sponsor: Mbarara University of Science and Technology
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Rectal ketamine versus oral morphine in pain management in paediatric wound and burns
Primary purpose: TREATMENT

Brief summary: The study will mainly focus on procedural pain management using oral morphine versus rectal ketamine during paediatric burn and wound dressing at Mbarara Regional Referral Hospital.

Detailed description: Subjects will be randomly assigned to one of the two treatment groups A and B. Guardians of patients who are scheduled for burn wound care will sign written consent pre- operatively about procedural pain management. Group A will receive rectal ketamine while those in Group B will receive only traditional standard of care protocols.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients between 6 months and 6-years old scheduled for a minimum of one procedure for burn wound dressing at the pediatric unit at Mbarara Regional Referral Hospital

Exclusion Criteria:

* Children with rectal or anal pathology,
* Refusal to assent to participate or parental or guardian refusal to consent in the study
* Children who require mechanical ventilation or already intubated in Intensive care unit
* Those allergic to Ketamine or its constituents

Primary outcomes:
measure: PAIN SCORES ON ORAL MORPHINE VERSUS KETAMINE ARM
timeFrame: 4 hours
measure: DIFFERENCE IN THE INCIDENCE OF ADVERSE EFFECTS IN ORAL MORPHINE VERSUS KETAMINE ARM
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara Regional Referral Hospital
city: Mbarara
country: Uganda
facility: Mbarara Regional Referral Hospital
Study officials:
affiliation: Mbarara University of Science and Technology
name: ALICE G. ATAI, MbChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03852966: Better Sleep in Psychiatric Care - ADHD Pilot Study
Official title: Better Sleep in Psychiatric Care - ADHD. A Pragmatic Within-group Pilot Study to Develop and Evaluate Effects and Feasibility of a CBT-based Manual for Treating Sleep Problems in Adult Patients With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder
Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2019-02-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pragmatic, within-group pilot study
Primary purpose: TREATMENT

Brief summary: Comorbidities, including sleep problems, are common in adult Attention Deficit Hyperactivity Disorder (ADHD). Treatment of choice for insomnia is cognitive behavioral therapy (CBT-i), but evidence is lacking for CBT-i in patients with ADHD and sleep problems.

The purpose of this study was to investigate if patients at a specialist clinic for ADHD benefit from a group delivered CBT-i treatment; whether insomnia severity improves following this treatment.

This pragmatic within-group pilot study with a pre to post and three-month follow-up design was set at a specialist psychiatric out-patient clinic for adult ADHD.

As an adjunct to care-as-usual at the clinic, a CBT-i-based group treatment targeting sleep problems prevalent in the ADHD-population, designed for patients with executive difficulties, was offered as 10 weekly 90-minute group sessions and scheduled telephone support.

All outcome measures were subjectively reported by participants. Data analyzed with dependent t-tests according to intent-to-treat.


Eligibility criteria: Inclusion Criteria:

* being a patient at the clinic (i.e. having a diagnosis of AD(H)D)
* self-reported sleep problems
* returning pre-treatment questionnaires and signed consent form

Exclusion Criteria:

* none

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline to 10 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: Change from baseline to 24 weeks
Secondary outcomes:
measure: Adult ADHD Self-Report Scale (ASRS)
timeFrame: Change from baseline to 10 weeks
measure: Adult ADHD Self-Report Scale (ASRS)
timeFrame: Change from baseline to 24 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of ADHD, Northern Stockholm Psychiatry
Study officials:
affiliation: Karolinska Institutet
name: Susanna Jernelöv, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jernelov S, Larsson Y, Llenas M, Nasri B, Kaldo V. Effects and clinical feasibility of a behavioral treatment for sleep problems in adult attention deficit hyperactivity disorder (ADHD): a pragmatic within-group pilot evaluation. BMC Psychiatry. 2019 Jul 24;19(1):226. doi: 10.1186/s12888-019-2216-2.
Clinical trial NCT05623566: Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
Official title: Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Jaundice, Neonatal
Lead sponsor: Picterus AS
Sponsor class: INDUSTRY
Collaborators: name: RSIA Kendangsaru Surabaya
name: Universitas Airlangga
First posted: 2022-11-21
Enrollment: 284
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya.

Detailed description: A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Airlangga University hospital and RSIA Kendangsari MERR in Surabaya.

This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in Indonesian newborns. The Picterus Calibration Card was placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP was used to collect digital images.

Eligibility criteria: Inclusion Criteria:

* Infants born with gestational age \>31
* Birth weight ≥ 1500g
* Age 0 - ≤14 days
* Consent obtained from the parents

Exclusion Criteria:

* Infants born with congenital abnormalities;
* Infants respiratory support;
* Infants suffering from a condition that may alter the skin tissue circulatory system, such as sepsis and heart failure;
* Infants who have received phototherapy in the last 24 hours.

Primary outcomes:
measure: Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
timeFrame: 5-10 minutes
Secondary outcomes:
measure: Correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn
timeFrame: 1-2 minutes
measure: correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns
timeFrame: 5-10 minutes
measure: Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns
timeFrame: 5-10 minutes
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Airlangga University hospital
state: East Java
city: Surabaya
country: Indonesia
facility: RSIA Kendangsari MERR
state: East Java
city: Surabaya
country: Indonesia
facility: Dr. Soetomo General Hospital
state: East Java
Study officials:
References:
Clinical trial NCT04540666: VR Sedation in Third Molar Surgery
Official title: Sedation Sparing Effect of Virtual Reality in Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: Anaesthesia for dental surgery
Sedation for dental surgery
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Anaesthesia or sedation for dental surgery is Challenging. Over-sedation, leading to upper airway obstruction, desaturation and apnoea, is very common. On the other hand, it is also very common that inadequate sedative drugs were given, leading to under-sedation with unsatisfactory experience during operation. Therefore, it is good if some other methods are provided for sedation, avoiding side effects associated with sedative drugs.

Detailed description: Immersive virtual reality (VR) is a form of distraction therapy and is believed to create an immersive experience that can restrict the mind from pain and anxiety and has been shown to be superior to simple distraction in reducing pain.

Eligibility criteria: Inclusion Criteria:

* Unilateral impacted lower third molar that requires surgical removal
* Depth of impaction within 8mm as measured by Winter's line.
* Cantonese speaking

Exclusion Criteria:

* ASA \> III
* BMI \> 35
* Known Obstructive Sleep Apnoea
* Patients with known or potential difficult airway
* Chronic use of sedatives and opioid
* Alcohol or drug abuse
* Visual and hearing impairments
* Claustrophobia
* Cognitive impairment
* History of seizure

Primary outcomes:
measure: Intraoperative propofol dose
timeFrame: From the start of anaesthesia to the end of anaesthesia, up to 2 hours after the start of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References:
Clinical trial NCT00040066: Development of Human Laboratory Study Model of Cocaine Relapse Prevention. - 1
Official title: Development of Human Laboratory Study Model of Cocaine Relapse Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2002-06-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the development of human laboratory study model of cocaine relapse prevention.

Detailed description: The primary objective of this study will be to develop experimental procedures and parameters demonstrating arousal and craving responses to cocaine-related environmental cues as a model for future testing of the relapse prevention medication treatment of cocaine addiction.

Eligibility criteria: Inclusion Criteria:

* Cocaine dependent, non treatment seeking individuals

Exclusion Criteria:

Please contact site directly for details.

Primary outcomes:
measure: Cocaine craving
measure: Cocaine related high
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Integrated Substance Abuse Program
state: California
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: John Roache, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01944566: Microbial Community Transplantation on the Armpit.
Official title: Microbial Community Transplantation on the Armpit in Order to Reduce the Malodour Generation on Armpit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy, Bad Odour From Armpit
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2013-09-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The malodour generation of a person's armpit is caused by the bacteria thriving on that armpit. In order to alter or reduce once bad body odour, the living microbial community on the armpit of a non-malodorous person will be transmitted (or up scaled and transmitted) to the armpit of a malodorous person. The odour is evaluated by a trained smelling panel, the bacteria living on the armpit is examined by means of molecular techniques. The microbial transplantation and its follow-up happens under the supervision of a medical doctor.


Eligibility criteria: Inclusion Criteria:

* bad armpit odour

Primary outcomes:
measure: Reduction of bad odour of the armpit.
timeFrame: 24 evaluations in approximately 10 weeks.
measure: Molecular characterisation of the bacterial community after microbial transplantation.
timeFrame: 24 evaluations in approximately 10 weeks.
Secondary outcomes:
measure: Reduction of bad odour of the armpit over a longer period.
timeFrame: after 4 months
measure: Reduction of bad odour of the armpit over a longer period.
timeFrame: after 6 months
measure: Molecular characterisation of the bacterial community after microbial transplantation.
timeFrame: after 4 months
measure: Molecular characterisation of the bacterial community after microbial transplantation.
timeFrame: After 6 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Nico Boon, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01824966: Signet Ring Cell Carcinoma in Esophageal Adenocarcinoma
Official title: Signet Ring Cells in Esophageal and GE Junction Carcinomas Have a More Aggressive Biological Behavior
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenocarcinoma
Esophageal Cancer
Keywords: Esophagectomy
Signet Ring Cells
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From our prospectively built database we retrieved all adenocarcinoma from 1990 till 2009 who underwent primary surgery with R0 resection. Seven hundred seventy-nine patients were included for further analysis. Pathology reports mentioning signet ring cells (n = 82) were reviewed by our pathologist and, after confirmation, tumors were classified into two groups according to WHO criteria (\>50% SRC or \<50% SRC). The remaining 697 ADC patients served as control group.

Brief summary: There has been much controversy surrounding the biologic behavior and prognosis of esophageal signet ring cell (SRCs) containing carcinomas. To clarify the biologic behavior of SRCs, the investigators compared the clinicopathologic features and prognosis of SRCs with other adenocarcinomas (ADC) of the esophagus and gastroesophageal junction (GEJ).

Detailed description: Adenocarcinoma (ADC) of the esophagus and gastroesophageal junction (GEJ) is an aggressive neoplasm and has a poor prognosis. Surgical based treatment has been the treatment of choice for localized esophageal adenocarcinoma.

Signet-ring cell carcinoma is a unique histologic subtype of adenocarcinoma characterized by abundant intracellular mucin accumulation and a compressed nucleus displaced toward one extremity of the cell (the so-called signet-ring cell (SRC)). According to the World Health Organisation (WHO), a true signet-ring cell carcinoma (SRCca) is defined as an adenocarcinoma in which the predominant component (more than 50% of the tumor) consists of isolated or small groups of SRC in the stroma. If the tumor contains less than 50% of those cells, it is generally considered as an adenocarcinoma (ADC).

Eligibility criteria: Inclusion Criteria:

- Adenocarcinoma R0 resection Primary surgery

Exclusion Criteria:

- Other histology R1 or R2 resection Neoadjuvant therapy

Primary outcomes:
measure: Cancer specific 5 year survival in SRCC
timeFrame: from surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven; Dept. of Thoracic Surgery
Study officials:
affiliation: University Hospital Leuven; Dept. of Thoracic Surgery
name: Philippe Nafteux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06185166: State of Play of Non-tuberculous Mycobacteria in Alsace
Official title: State of Play of Non-tuberculous Mycobacteria in Alsace: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Tuberculous Mycobacteria
Keywords: Non-Tuberculous Mycobacteria
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subject (≥ 18 years old) in whom a biological sample is culture positive for a non-tuberculous mycobacterium

Brief summary: Non-tuberculous mycobacteriosis (NTM) are infectious diseases caused by mycobacteria that are not part of the Tuberculosis complex. More than 190 species have been identified to date.

As an environmental reservoir, it most often affects the lungs, skin and soft tissues, lymph nodes, but it can affect all organs. Varying in virulence depending on the species, most infections do not cause illness.

There is currently no coordinated care pathway for this pathology in Alsace. The means necessary to set up such a structure requires knowing the importance of the disease.

Detailed description: The aim of the study is to determine the incidence of non-tuberculous mycobacterial infections in the ALSACE region, the proportion of cases in which the infection causes illness, and its evolution over time.

Eligibility criteria: Inclusion Criteria:

* Adult subject (≥ 18 years old)
* in whom a biological sample is culture positive for a non-tuberculous mycobacterium
* born in France and domiciled in Alsace (i.e. whose home postal code begins with 67 or 68)
* not opposing the reuse of its data for scientific research purposes

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* not domiciled in Alsace
* Born abroad
* Isolation of a mycobacterium from the Tuberculosis complex and Mycobacterium gordonae

Primary outcomes:
measure: Retrospective description of non-tuberculous mycobacteria in Alsace
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pneumologie - CHU de Strasbourg - France
Study officials:
References: