louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06910345: Effect of Melatonin Patches on Sleep in Urological Surgery
Official title: Effect of Melatonin Patches on Sleep Quality in Patients Undergoing Urological Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urological Surgery
Keywords: transdermal melatonin,
urological surgery
sleep quality
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing urological surgery may experience a decrease in sleep quality due to many factors such as hospitalization, different environment, pain, stress and anesthesia. After surgery, melatonin secretion decreases and circadian rhythm becomes irregular in patients. This problem can lead to sleep disorders in patients. Melatonin is an important hormone that regulates both sleep and circadian rhythms. The aim of this study is to observe the effect of a melatonin skin patch designed to produce melatonin in a way that ensures a stable increase in melatonin levels in the blood, on patients undergoing urological surgery.

Detailed description: The purpose of this study was to observe the effect of a melatonin skin patch designed to produce melatonin, which would provide a stable increase in blood melatonin levels, on patients undergoing urological surgery. The patients were applied a melatonin patch before surgery. The other group received routine nursing care.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone planned urological surgery,

  * Those who receive melatonin patch therapy,
  * Those who are between the ages of 18-70,
  * Those whose hemodynamic conditions are stable will be included.

Exclusion Criteria:

* •Patients who used different sleeping pills/hypnotics during the study period,

  * Patients with delirium/psychiatric illness,
  * Patients with hearing and speech problems will not be included.

Primary outcomes:
measure: sleep quality
timeFrame: The Richards-Campbell Sleep Scale will be completed at 20:00 the evening before surgery and at 06:00 the morning of surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Atlas University
Study officials:
References:
citation: Aeschbach D, Lockyer BJ, Dijk DJ, Lockley SW, Nuwayser ES, Nichols LD, Czeisler CA. Use of transdermal melatonin delivery to improve sleep maintenance during daytime. Clin Pharmacol Ther. 2009 Oct;86(4):378-82. doi: 10.1038/clpt.2009.109. Epub 2009 Jul 15.
Clinical trial NCT04307745: Primary Prevention Habits for the Shoulder: Survey of the Sportsman's Entourage
Official title: Primary Prevention Habits for the Shoulder: Survey of the Sportsman's Entourage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Prevention
Shoulder
Questionnaire and Survey
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be physiotherapist, doctor, trainer and physical trainer who are one contact with athletes (upper limb athletes).

Brief summary: Purpose: To provide an update on the implementation of prevention among overhead athletes by their entourage.

Materiel and method: This study will be conducted by the means of a questionnaire. The target population consisted of doctors, trainers, physical trainer and physiotherapist.

The questionnaire will be validated by experts in each categorie and published on an online survey website


Eligibility criteria: Inclusion Criteria:

* Professions: physiotherapist, doctor, trainer or physical trainer

Exclusion Criteria:

* Other professions

Primary outcomes:
measure: Primary prevention of the shoulder
timeFrame: The questionnaire will last 15 minutes at most
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
Study officials:
affiliation: ULiège
name: Amandine Gofflot
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01945645: Ready to Act - Health Education in People With Hyperglycaemia
Official title: Ready to Act. A Health Education Programme for People With Screen-detected Hyperglycaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Behavior
Keywords: Prevention
Screening
Type 2 diabetes
Action Competence
Family practice
Health Services Research
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 509
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A pre-randomized study in primary health care was designed to investigate health education in a subpopulation extracted from general practitioners (GPs) in one Danish county in the treatment arm of the ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care) study, DK. The overall objective of the 'Ready to Act' health education programme was to support the participants' competences in daily life and act appropriately with respect to their dysglycaemic condition. The achievement of action competence involved four learning objectives: intrinsic motivation, informed decision-making, action experience and social involvement. The programme was delivered in primary care settings (health centre or GP surgeries) by nurses, dieticians, physiotherapists and GPs.


Eligibility criteria: Inclusion Criteria:

* age 40-69 years at the time of screening and diagnosed with screen-detected T2D, IGT or IFG (according to WHO criteria).

Exclusion Criteria:

* women who were pregnant or lactating, those with a psychotic illness or an illness with a prognosis of less than one year.

Primary outcomes:
measure: Modelled cardiovascular disease risk
timeFrame: 3 years after intervention, dec 2010
Secondary outcomes:
measure: Glycated hemoglobin
timeFrame: 3 years after intervention, dec 2010
measure: se-cholesterol
timeFrame: 3 years after intervention, dec 2010
measure: Patient Activation
timeFrame: One year and three year (2006, 2007, 2010)
measure: Blood pressure
timeFrame: 3 years after intervention, dec 2010
measure: Physical activity
timeFrame: 3 years after intervention, dec 2010
measure: Smoking
timeFrame: 3 years after intervention, 2010
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Public health
Study officials:
affiliation: Aarhus university, Department of Public health
name: Helle Terkildsen Maindal, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04548245: Markers of Executive Attention Development in Preschoolers
Official title: Markers of Executive Attention Development in Preschoolers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Deficit Disorder
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 70
Sex: ALL
Minimum age (years): 48
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preschool children born preterm vs term

Brief summary: This project aims to identify precursors of executive attention that can serve as early markers of ADD.


Eligibility criteria: Inclusion Criteria:

* Normal schooling
* Parental consent

Exclusion Criteria:

- Psychotropic drug

Primary outcomes:
measure: Amplitude in µV of EEG changes relative to baseline when expected stimulus is omitted in a tactile stimulation sequence
timeFrame: at 4 years old
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Comete U1075 Inserm Unicaen
Study officials:
References:
Clinical trial NCT01073345: Portal Venous Hemodynamic Changes After Hepatectomy
Official title: Portal Venous Hemodynamic Changes After Hepatectomy and the Incidence of Postoperative Ascites
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ascites
Hepatectomy
Keywords: Patients undergoing elective hepatic resection
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated at a University Hospital

Brief summary: The aim of this study is to investigate the pathophysiological mechanisms underlying the formation of posthepatectomy ascites with a focus on the significance of changes in portal venous hemodynamics after hepatic resection. By evaluation of other factors that may be involved in the formation of ascites this study may help to show to what extent the increase of portal venous pressure contributes to ascites formation. Detailed knowledge about pathogenetic factors concerning the formation of postoperative ascites might help preventing protracted hospital stay and further inconveniences to the patient.

Detailed description: The mechanisms underlying the development of large-volume ascites after hepatectomy remain poorly understood. While studies on animal models suggest an increase of portal venous pressure after hepatectomy that may in turn favor the transudation of fluid into the peritoneal cavity further factors may be critically involved in the postoperative formation of ascites. These factors may include a drop in serum protein levels (and colloid osmotic pressure), a transient impairment in renal function and a surgery-induced capillary leakage. However, a better knowledge of the pathophysiology represents the prerequisite for efficient treatment.

In the present study the impact of changes in hepatic hemodynamics after hepatectomy on development of ascites will be investigated. Enrolled patients will receive measurement of portal venous flow and pressure as well as hepatic artery flow before and after hepatic resection. Associations of changes in these parameters with development of postoperative ascites and further postoperative complications will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective hepatic resection
* Age equal or greater than 18 years
* Informed consent

Exclusion Criteria:

* Evidence of ascites or hypalbuminemia preoperatively
* Renal insufficiency
* Expected lack of compliance
* Impaired mental state or language problems

Primary outcomes:
measure: Postoperative ascites
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of General, Visceral and Transplantation Surgery
Study officials:
References:
Clinical trial NCT02886845: Genotyping 2 SNPs in Chinese Breast Cancers
Official title: Study of Two Single Nucleotide Polymorphisms in Chinese Breast Cancers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: rs185670819 and rs183489969
Keywords: SNP,Breast Neoplasms
Lead sponsor: The First Affiliated Hospital of the Fourth Military Medical University
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Woman aged superior to 18 years old
* Inform consent signed
* Woman with breast cancer that have been diagnosed in clinic

Exclusion Criteria

* No inform consent signed
* Patient under guardianship, curatorship
* Psychosocial disorder

Brief summary: The purpose of this study is to determine the frequency of two Single Nucleotide Polymorphisms (SNPs) by sanger-sequencing in Breast Cancers and healthy controls .

Detailed description: Since the 1990s breast cancers incidence of china has increased more than twice as fast as global rates. Chinese patients are responsible for 12.2% of all newly diagnosed breast cancers and 9.6% of all deaths to world breast cancers. Breast cancer is now the second frequently diagnosed cancer and is the leading cause of cancer-related death in Chinese women.

Two of the most prevalent breast cancer susceptibility genes are BRCA1and BRCA2. However，because of population based Genetic heterogeneity, the frequency of BRCA1/BRCA2 mutation is not as high in Caucasian population as in China. Anyway, the mean age at diagnosis of breast cancer in China is almost 10 years younger and more cases are diagnosed before 40 than those in Caucasians. Therefore, it is believed that there are certain specific susceptibility loci in Chinese breast cancers.

In preliminary experiments, investigators found two germline mutations may associate with Chinese breast cancers.

The purpose of the study is to determine the frequency of two germline mutations by sanger-sequencing in a larger sample of Chinese breast cancers

Eligibility criteria: Inclusion Criteria:

* Woman aged superior to 18 years old Inform consent signed Woman without breast cancer and family history of cancer

Exclusion Criteria:

* No inform consent signed Patient under guardianship, curatorship Psychosocial disorder

Primary outcomes:
measure: Genotyping of 2 SNPs ( rs185670819 and rs183489969) in Chinese breast cancer patients and age-matched healthy control women .
timeFrame: January of 2019
Secondary outcomes:
measure: Both of the 2 SNPs' minor allele frequency or affected ratio shows statistically significant differences between case and control groups
timeFrame: June of 2019
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: The First Affiliated Hospital of Fourth Military Medical University
name: hongping song, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02356445: Use of Immunosuppressive Therapy for Sarcoidosis
Official title: Outcome of Use of Cytotoxic Drugs for Inflammatory Lung Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcoidosis
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with sarcoidosis treated

Brief summary: Retrospective review of the outcome of use of immunosuppressive drugs in treatment of sarcoidosis

Detailed description: Patients receiving one or more cytotoxic or other immunosuppressive drug will be observed

Eligibility criteria: Inclusion Criteria:

Any patient treated for sarcoidosis

Exclusion Criteria:

* None

Primary outcomes:
measure: Clinical Outcome
timeFrame: 2 years
Secondary outcomes:
measure: Toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Robert P Baughman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baughman RP, Kotzin J, Lower EE. The Value of a Patient Global Assessment in Management of Sarcoidosis. Lung. 2021 Aug;199(4):357-362. doi: 10.1007/s00408-021-00455-5. Epub 2021 Jul 13.
citation: Zhou Y, Lower EE, Li HP, Costea A, Attari M, Baughman RP. Cardiac Sarcoidosis: The Impact of Age and Implanted Devices on Survival. Chest. 2017 Jan;151(1):139-148. doi: 10.1016/j.chest.2016.08.1457. Epub 2016 Sep 8.
Clinical trial NCT04826445: USE OF 18FDG PET-CT TO PREDICT THE RESPONSE OF MANDIBULAR OSTEORADIONECROSIS TO THE PENTOCLO PROTOCOL WITH DOCUMENTED ANTIBIOTHERAPY
Official title: USE OF 18FDG PET-CT TO PREDICT THE RESPONSE OF MANDIBULAR OSTEORADIONECROSIS TO THE PENTOCLO PROTOCOL WITH DOCUMENTED ANTIBIOTHERAPY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mandibular Osteoradionecrosis
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with mandibular osteoradionecrosis treated in the PENTOCLO protocol

Brief summary: This study is created in order to refine and reduce the duration between the medical and surgical therapeutic sequences (when the surgery is necessary) in these fragile patients knowing that conventional radiological changes can only be observed with a delay comprised between 3 and 6 months starting from observed clinical changes.


Eligibility criteria: Inclusion Criteria:

1. Patients with symptomatic osteoradionecrosis with a PENTOCLO protocol indication (decided in a multi-disciplinary staff).
2. Patient should understand to any protocol-specific procedures performed. Patient who did not object to participate after being informed of the study. Patient should be able and willing to comply with study visits and procedures as per protocol.
3. Patients must be affiliated to a social security system or beneficiary of the same.
4. Patients must be over 18 years old (legal age).

Exclusion Criteria:

1. Excluded forms of the disease: mandibular osteoradionecrosis complicated by mandibular fracture and / or hyperalgesic (resistant to analgesic treatment of stage III).
2. Contraindications specific to the treatment under study (allergy to one of the PENTOCLO treatments, contraindication to 18FDG PET-CT).
3. Associated pathology that contra-indicate on of the PENTOCLO treatment.
4. Pregnant woman, declaring likely to be pregnant or breastfeeding. Chilbearing age women must declare not being pregnant and use effective contraception.
5. Impossibility to submit to the medical follow-up of the test for geographical, social or psychological reasons.
6. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or unable to express its opposition to participating in the study.

Primary outcomes:
measure: diagnosis performance of 18-FDG PET-CT
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References:
Clinical trial NCT05937945: Studying Patient Experiences in Osteoporosis Clinical Trials
Official title: Uncovering Osteoporosis Clinical Trials: Firsthand Patient Insights Into Clinical Trial Experiences
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoporosis
Keywords: osteoporosis
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Osteoporosis patients who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Clinical trials for osteoporosis are designed to assess the safety and effectiveness of novel osteoporosis treatments. These trials play a crucial role in establishing whether these new treatments outperform existing options and provide substantial evidence to support their adoption within the wider population.

The primary aim of this particular study is to investigate the experiences of individuals diagnosed with osteoporosis who participate in a distinct clinical trial involving a medical intervention. The focus will be on closely monitoring the rates of trial completion and withdrawal among these participants.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with osteoporosis
* Patient has self-identified as planning to enroll in an observational clinical trial
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Pregnant or nursing patients
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form

Primary outcomes:
measure: Number of patients who decide to join in an osteoporosis clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in osteoporosis clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Liu C, Liu N, Xia Y, Zhao Z, Xiao T, Li H. Osteoporosis and sarcopenia-related traits: A bi-directional Mendelian randomization study. Front Endocrinol (Lausanne). 2022 Sep 14;13:975647. doi: 10.3389/fendo.2022.975647. eCollection 2022.
citation: Bell A, Kendler DL, Khan AA, Shapiro C M M, Morisset A, Leung JP, Reiner M, Colgan SM, Slatkovska L, Packalen M. A retrospective observational study of osteoporosis management after a fragility fracture in primary care. Arch Osteoporos. 2022 May 6;17(1):75. doi: 10.1007/s11657-022-01110-z.
citation: Amer M, Noor S, Kashif SM, Nazir SUR, Ghazanfar T, Yousaf S. Evaluation of Disease Related Knowledge in Patients of Osteoporosis: An Observational Study. Altern Ther Health Med. 2021 Jun;27(S1):97-103.
Clinical trial NCT01252745: Efficacy of an Intranasal Testosterone Product
Official title: An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadism
Lead sponsor: Acerus Pharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism


Eligibility criteria: Inclusion Criteria:

* Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes) testosterone levels \>100 ng/dl and ≤ 300 ng/dL.
* Normal Otolaryngological nasal endoscopy examination.
* Normal prostate examination (no palpable prostatic mass), and serum PSA ≤ 4.0 ng/mL.

Exclusion Criteria:

* Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex hormones
* Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12 months
* History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or sinus surgery.
* History of nasal disorders (e.g. polyposis, recurrent epistaxis ( \> 1 nose bleed per month, abuse of nasal decongestants) or sleep apnea.

Primary outcomes:
measure: Cmax of Serum Testosterone
timeFrame: 24 hours
measure: Cavg of Serum Testosterone
timeFrame: 24 hours
measure: AUC0-t of Serum Testosterone
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Quality of Life Medical and Research Center
state: Arizona
city: Miami
country: United States
facility: Pharmax Research Clinic Inc.
state: Florida
city: Shreveport
country: United States
facility: Regional Urology LLC
state: Louisiana
Study officials:
References: