louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01339832: An Observational Study of Xeloda (Capecitabine) and Oxaliplatin Prior and Concurrent To Preoperative Pelvic Radiotherapy in Patients With Locally Advanced Rectal Cancer
Official title: Capecitabine and Oxaliplatin Prior and Concurrent to Preoperative Pelvic Radiotherapy in Patients With Locally Advanced Rectal Cancer: A Survival Analysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2011-04-21
Enrollment: 51
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: Colorectal cancer patients having taken part in study ML18280

Brief summary: This observational study is a follow-up study of protocol ML18280. Survival data of patients who took part in and concluded study ML18280 will be collected for up to 5 years after LPLV of ML18270.


Eligibility criteria: Inclusion Criteria:

* Patients who took part in and concluded study ML18280 according to protocol

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Progression-free Survival
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 5 years
measure: Tumor Recurrence Rate (Local and Distant)
timeFrame: Up to 5 years
measure: Type of Adjuvant Chemotherapy
timeFrame: Up to 5 years
measure: Length of Adjuvant Chemotherapy
timeFrame: Up to 5 years
measure: Compliance to Diagnostic Procedures in Surveillance
timeFrame: Up to 5 years
measure: Long Term Side Effects
timeFrame: Up to 5 years
measure: Incidence of Adverse Event (AE) and Serious Adverse Event (SAE)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
city: Chur
country: Switzerland
city: Luzern
country: Switzerland
city: St. Gallen
country: Switzerland
city: Zürich
country: Switzerland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05672732: Assessment of Clinical Trial Experiences of Alzheimer's Disease Patients
Official title: In Depth Observational Clinical Trial Assessing Experiences of Alzheimer's Disease Patients To Determine Trial Attributes Affecting Completion Rates For Specific Demographic Groups
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease
Alzheimer's
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-05
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Alzheimer's Disease patients who are actively considering involvement in an interventional clinical trial, but have not yet completed enrollment and registration.

Brief summary: Taking part in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This study will admit a wide range of data on the clinical trial experience of Alzheimer's Disease patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Alzheimer's Disease patients.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 50 to 80 years of age
* Participant has a diagnosis of Alzheimer's Disease
* Patient has self-identified as planning to enroll in an interventional clinical trial for Alzheimer's Disease

Exclusion Criteria:

* No diagnosis of Alzheimer's Disease confirmed
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form

Primary outcomes:
measure: Rate of patients who decide to enroll in a Alzheimer's Disease Clinical Trial
timeFrame: 3 months
measure: Number of patients who remain in Alzheimer's Disease clinical trial until completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Eratne D, Loi SM, Farrand S, Kelso W, Velakoulis D, Looi JC. Alzheimer's disease: clinical update on epidemiology, pathophysiology and diagnosis. Australas Psychiatry. 2018 Aug;26(4):347-357. doi: 10.1177/1039856218762308. Epub 2018 Apr 3.
citation: Mangialasche F, Solomon A, Winblad B, Mecocci P, Kivipelto M. Alzheimer's disease: clinical trials and drug development. Lancet Neurol. 2010 Jul;9(7):702-16. doi: 10.1016/S1474-4422(10)70119-8.
citation: Rafii MS, Aisen PS. Alzheimer's Disease Clinical Trials: Moving Toward Successful Prevention. CNS Drugs. 2019 Feb;33(2):99-106. doi: 10.1007/s40263-018-0598-1.
Clinical trial NCT04982432: Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa
Official title: Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa (OSIRIS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: UNION therapeutics
First posted: 2021-07-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will be graded and assigned to a severity group (mild, moderate, or severe). All groups will receive the same intervention
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of oral administration of orismilast for treatment of mild, moderate, or severe hidradenitis suppurativa (HS) in adults.


Eligibility criteria: Inclusion Criteria:

1. Male or female adult patients, 18 years of age or older.
2. Have mild to severe HS for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history.
3. Have HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, abdominal, perineal).
4. Has a total inflammatory lesions (AN) count of greater than or equal to 2.
5. Total draining fistula count of less than or equal to 30.
6. A stable analgesic dose for 2 weeks prior to baseline.

Exclusion Criteria:

1. Presence of active skin lesions other than HS that could interfere with the assessment of HS.
2. Receipt of prescription topical therapies for HS within 7 days prior to the baseline visit (Visit 2).
3. Receipt of systemic therapies for HS, within 28 days prior to the baseline visit.
4. Any oral antibiotic within 28 days prior to baseline visit.
5. Receipt of a live vaccine within 14 days prior to screening.
6. Biologic use for indications other than HS within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.
7. Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.

Primary outcomes:
measure: Percent change from Baseline in AN (abscesses and nodules) count at Week 16
timeFrame: Day 1 to Week 16
Secondary outcomes:
measure: Change from Baseline in abscess, nodule, and draining fistula counts at Week 16
timeFrame: Day 1 to Week 16
measure: Change from Baseline in IHS4 value at Week 16
timeFrame: Day 1 to Week 16
measure: Change from Baseline in Patient's Global Assessment of Skin Pain (NRS) at Week 16
timeFrame: Day 1 to Week 16
measure: Change from Baseline in HiSQOL Total Score at Week 16
timeFrame: Change from Baseline in HiSQOL Total Score at Week 16
Other outcomes:
Locations:
Study officials:
affiliation: Zealand University Hospital
name: Gregor Jemec, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02777632: Resistant Bacterial Infections in the Early Post LDLT Period
Official title: Resistant Bacterial Infections in the Early Post LDLT Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplantation Infection
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HCV patients who underwent living donor liver transplantation at Ain Shams Center for Organ Transplantation.

Brief summary: The purpose of this work was to study the incidence, types, risk factors and causative organisms of bacterial infections in HCV Egyptian patients following Liver Transplantation. Moreover, to identify the emerging resistant strains and their proper antimicrobial therapy

Detailed description: This prospective descriptive study has been done at Tropical Medicine department in the period between January 2014 to November 2015.

After the approval of the scientific and ethical committee of Ain Shams University Hospital, Patients with HCV positive end stage liver disease (ESLD) eligible for liver transplantation Ain Shams Center for Organ Transplant (ASCOT); Ain Shams University, (fulfilling the inclusion criteria) were included in the current study. Forty five patients were recruited and each one was followed-up during a period of 3 months following transplantation.

Included patients were divided into 2 groups:

Group 1 included patients who had a postoperative single episode of infection. Group 2 included those patients who had more than 1 episode of postoperative bacterial infection whom were further evaluated for the presence of emerging strains and/or antibiotic resistance.

Eligibility criteria: Inclusion Criteria:

* Egyptian nationality.
* Accepting participation in the current study and signing a written consent form
* Age between 18-60 Years, including males and females.

Exclusion Criteria:

* Patients who refused to be enrolled in the study.
* Patients with other etiologies for end-stage liver disease (HBV, PBC...)
* Patients with preoperative infections, infections within 48 h after transplantation or early post-operative death

Primary outcomes:
measure: Determine the types of early bacterial infections following LDLT, recurrent and resistant infections all were confirmed by cultures.
timeFrame: Within the first 90 days after the operation
measure: Assessment of risk factors for occurrence of recurrent bacterial infections
timeFrame: The first 3 months following LDLT
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine, Ain Shams University
name: Yasmine M Massoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06311032: Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas
Official title: Clinician Decision Making Regarding Surveillance for Low-risk Intraductal Papillary Mucinous Neoplasms of The Pancreas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery Risk Assessment
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Pancreatic Cancer Early Detection (PRECEDE) Consortium is an international, multi-institutional collaborative group of experts to increase survival for pancreatic cancer patients by improving early detection, screening, risk modeling and prevention for those with a heritable risk for pancreatic cancer, through a novel model of collaboration and data sharing.

The PACYFIC group is comprised of Dutch surgeons, gastroenterologists, oncologists, radiologists, radiotherapists, and pathologists. Their common interest is to improve the prognosis of patients with pancreatic cancer, by initiating and performing research, and organizing ongoing training.

Brief summary: The main objective of this study is to determine how physicians make decisions regarding surveillance of Intraductal Papillary Mucinous Neoplasm's (IPMN) of the pancreas.

Detailed description: The study will employ a survey design that poses physicians with a series of three clinical case vignettes. Each vignette describes an IPMN of varying severity, and the physician will be asked determine whether they would continue or discontinue clinical surveillance in each case.

This will be a double-blinded randomized survey study, featuring two arms. Providers will be randomized to either be provided with, or not provided with a risk stratification tool (DART-1) when presented with their clinical case vignettes.

Eligibility criteria: Inclusion Criteria:

* Membership in either the PACYFIC or PRECEDE consortiums
* Physician with expertise in the management of IPMN
* Able and willing to complete survey

Exclusion Criteria:

* Not a member of either the PACYFIC or PRECEDE consortiums
* Not a physician with expertise in the management of IPMN

Primary outcomes:
measure: Number of Decisions to Stop Surveillance Imaging
timeFrame: Day 1
measure: Number of Decisions to Continue Surveillance Imaging
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Greg Sacks, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05880732: Magnesium Sulfate on Postoperative Pain
Official title: The Effect of Preemptive Magnesium Sulfate on Postoperative Pain in Patients Undergoing Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Breast cancer is the most diagnosed type of cancer in women in Turkey and in the world. According to the World Health Organization data, the rate of newly diagnosed breast cancer was reported as 11.6% in 20181. Acute postoperative pain occurs in 40% of patients undergoing surgery for breast cancer2. In the early postoperative period, opioids are commonly used analgesics in the treatment of pain, but they have various side effects such as gastrointestinal, urinary and respiratory symptoms3. Non-opioid analgesics can be used to reduce opioid use and thus limit its side effects. Magnesium sulfate (MgSO4) is an N-Methyl D-Aspartate (NMDA) receptor antagonist that has been used for postoperative analgesia and reducing both the duration and intensity of pain by preventing central sensitization in response to peripheral painful stimulus4-9. The primary aim of this study is to investigate the postoperative analgesic efficacy of MgSO4 in patients who were scheduled for mastectomy with the diagnosis of breast cancer. The secondary aim of our study is to evaluate the changes in perioperative vital signs that may occur due to MgSO4.


Eligibility criteria: Inclusion Criteria:

1. Female breast cancer patients scheduled for mastectomy and modified radical mastectomy
2. 18≥ years and
3. Patients with ASA score I-II

Exclusion Criteria:

1. The patient who refused the study
2. Drug allergy
3. Unregulated diabetes mellitus and hypertension
4. Cardiac failure with \<45% ejection fraction
5. Renal failure (serum creatinine \> 2 mg/dL)
6. Liver failure (blood transaminase values 2 fold higher than normal)
7. Glaucoma
8. Psychiatric or neurological disorders
9. Communication difficulties with patient
10. Calcium channel blockers or narcotic drugs uses before surgery

Primary outcomes:
measure: Postoperative pain was measured and recorded with the Verbal Numeric Rating Scale
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale Univercity Medical School
Study officials:
References:
Clinical trial NCT04897932: Evaluation Trial of Handheld Urinal for Adult Use
Official title: An Evaluation of the Usability and Efficacy of a Prototype Handheld Urinal for Adults Who Suffer From Nocturia, Urge, Frequency, and/or Functional Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Binding Sciences Limited
Sponsor class: INDUSTRY
Collaborators: name: Buckinghamshire Healthcare NHS Trust
First posted: 2021-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Usability and efficacy evaluation of a prototype handheld urinal for adult use

Detailed description: 28 day usability and efficacy evaluation by 154 adults in domestic settings who suffer one or more of nocturia, urge, frequency or functional incontinence.

Eligibility criteria: Inclusion Criteria:

* Suffers from nocturia urge, frequency, or funnctional incontinence

Exclusion Criteria:

* Suffers only from stress UI

Primary outcomes:
measure: Changes in fluid intake
timeFrame: 28 days
measure: Change in incidence of falls associated with urinary toileting
timeFrame: 28 days (3 months reported number of falls based on participant's recollection of incidence during that period)
measure: Change in level of user independence
timeFrame: 28 days
measure: Levels of user confidence
timeFrame: 28 days
measure: Convenience in use
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cropredy
country: United Kingdom
facility: Binding Sciences Limited
state: Oxfordshire
Study officials:
affiliation: Buckinghamshire Healthcare NHS Trust
name: Piers Clifford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05861232: The Effect of Watching Informative Animation on Fear and Anxiety in Children
Official title: THE EFFECT OF INFORMATIVE ANIMATION WATCHING ON ANXIETY AND FEAR DURING INHALATION THERAPY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inhalation Therapy; Complications
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 70
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this project was to determine the effect of showing informative animations to children on anxiety and fear during inhalation therapy. This project is a randomized controlled trial. The population of the study will consist of children aged 7-12 years who apply to the Pediatric Emergency Department of Atatürk University Research Hospital between July 2022 and July 2023. The sample of the study will consist of children and their parents who present to the clinic on the dates determined, who are willing to participate in the study, and meet the inclusion criteria. Probability sampling will be used to select the sample. ''Introductory Information Form'', ''Child Fear Scale'', ''Facial Expression Rating Scale'' and ''Informative Animation'' will be used for data collection.

Detailed description: Type of Study: The study was designed as a randomized controlled experimental study. Place and Time of Research:

The study will be conducted at Atatürk University Research Hospital Pediatric Emergency Department between July 2022 and July 2023.

Population and Sample of the Study: The population of the study will consist of children aged 7-12 years who apply to the Pediatric Emergency Department of Atatürk University Research Hospital between July 2022 and July 2023.

Eligibility criteria: Inclusion Criteria:

* The child is 7-12 years of age
* The family's willingness to participate in the study
* The child's willingness to participate in the study
* The child does not have a chronic disease

Exclusion Criteria:

* The child has a chronic illness
* The child has a neurological or mental impairment
* The child is visually impaired

Primary outcomes:
measure: Child Fear Scale (CFS)
timeFrame: 12 MONTHS
Secondary outcomes:
measure: Facial Expressions Rating Scale
timeFrame: 12 MONTHS
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Faculty of Nursing
state: Center
Study officials:
affiliation: ATATÜRK UNİVERSITY
name: Mukader KAYA, graduate student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03677232: The Living Experience of Hong Kong Chinese Adolescents With CHD.
Official title: The Living Experience of Hong Kong Chinese Adolescents With CHD.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Psychological Well-being
Quality of Life
Adolescent
Chinese
Keywords: Congenital Heart Disease, Hong Kong, Adolescent
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hong Kong Chinese adolescents with CHD, aged 12 to 18, who are able to read and write Chinese, and are attending the outpatient clinic of Department of Pediatric Cardiology.

Brief summary: This study aims to explore the impacts of CHD and its limitations on adolescents and the living experience of adolescents living with CHD.

Hong Kong Chinese adolescents with CHD are having reduced psychological well-being and quality of life than their healthy counterparts. Qualitative study is therefore needed to explore how CHD may impact on the adolescents' psychological well-being and quality of life.

Detailed description: A qualitative study was adopted. Purposive sampling of 30 adolescents with CHD were done. Thematic analysis was used for data analysis. The participants unfold negative impacts of CHD and its treatments, and the challenges they were facing with their relationship with others.

Eligibility criteria: Inclusion Criteria:

* Hong Kong Chinese adolescents
* aged 12 to 18
* able to read and write Chinese
* attending outpatient clinic of Department of Pediatric Cardiology

Exclusion Criteria:

* adolescents with non-structural heart disease
* with developmental delay or comorbid medical conditions

Primary outcomes:
measure: living experience of adolescents with CHD
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: William Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: