louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05031546: Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
Official title: Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Uremic Pruritus
Keywords: Hemodialysis
Pruritus
Uremic Pruritus
Dialysis
CR845
Difelikefalin
Chronic Itch
CKD
CKD-associated pruritus
CKD-aP
ESRD (end stage renal disease)
Itch
Itching
KALM
Chronic Kidney Disease
Kidney failure, chronic
Kidney dysfunction
Generalized pruritus
Expanded access
Compassionate use
Lead sponsor: Cara Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients undergoing hemodialysis.

Detailed description: Visits during the expanded access program will consist of a Baseline Visit to confirm eligibility and an End of Treatment visit. Patients will receive IV difelikefalin at a dose of 0.5 mcg/kg after each dialysis session, generally 3 times per week. The End of Treatment visit will be defined as the first dialysis visit following the last dose of IV difelikefalin under the intermediate-size patient population expanded access protocol.

Eligibility criteria: Key Inclusion Criteria:

* Adults ≥ 18 years old;
* Has end-stage renal disease (ESRD) and is currently receiving in-center hemodialysis;
* Has moderate-to-severe pruritus attributed to ESRD which is significantly impacting the patient's quality of life;
* Has no comparable or satisfactory alternative therapy for the treatment of moderate-to-severe pruritus, as determined by the sponsor-investigator.

Key Exclusion Criteria:

* Has severe hepatic impairment (Child-Pugh class C), as the influence of severe hepatic impairment on the pharmacokinetics of difelikefalin has not been evaluated;
* Is pregnant or nursing;
* Has been exposed to any other investigational medication in the past 60 days;
* Present any other reason which may lead to an unfavorable risk-benefit ratio for treatment with difelikefalin, as determined by the sponsor-investigator;
* Has a known or suspected allergy to difelikefalin or any component of the investigational product.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05256446: AMG 701 Expanded Access Program
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-02-25
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access requests for AMG 701 may be considered for adult patients with relapsed and/or refractory multiple myeloma whose disease is in partial response or better after AMG 420 therapy. To request access, use Responsible Party contact information provided in this record.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01430546: Non-interventional Study on Time to Response and Quality of Life in Relapsed/Refractory Multiple Myeloma When Treated With Lenalidomide in Second Line
Official title: Phase IV Study on QoL in Relapsed/Refractory Multiple Myeloma When Treated With Lenalidomide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Relapsed and Refractory Multiple Myeloma
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2011-09-08
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The purpose of this study is to quantify the burden of treatment in relapsed or refractory multiple myeloma in patients receiving lenalidomide after one prior treatment for myeloma.


Eligibility criteria: Inclusion Criteria:

1. Be at least 18 years of age
2. Have a confirmed diagnosis of MM
3. Starting lenalidomide treatment for MM (due to relapsed or refractory disease) after one prior treatment.
4. Have personally signed and dated a legally effective written informed consent form prior to admission to the study.
5. Must be willing and able to understand and comply with the study requirements.

Exclusion Criteria:

1. Individuals who have taken any experimental drugs or participated in a clinical trial within 30 days prior to screening.
2. Individuals with significant psychiatric illness or a clinically significant acute/chronic uncontrolled medical condition that might affect their experience of myeloma symptoms or their ability to describe them.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institute
Study officials:
affiliation: Karolinska University Hospital
name: Hareth Nahi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lund J, Gruber A, Lauri B, Duru AD, Blimark C, Swedin A, Hansson M, Forsberg K, Ahlberg L, Carlsson C, Waage A, Gimsing P, Vangsted AJ, Frolund U, Holmberg E, Gahrton G, Alici E, Hardling M, Mellqvist UH, Nahi H. Lenalidomide versus lenalidomide + dexamethasone prolonged treatment after second-line lenalidomide + dexamethasone induction in multiple myeloma. Cancer Med. 2018 Jun;7(6):2256-2268. doi: 10.1002/cam4.1422. Epub 2018 Apr 19.
Clinical trial NCT00735046: Cognitive Behavioural Therapy of Early Dementia
Official title: Cognitive Behavioural Resource-based Therapy of Early Dementia in the Everyday Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Keywords: Early dementia in Alzheimer's disease (MMSE ≥ 21)
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: University of Leipzig
name: Zentralinstitut für Seelische Gesundheit Mannheim
name: Humboldt-Universität zu Berlin
First posted: 2008-08-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to memory clinics and specialist (psychiatrist, neurologist) offices

Brief summary: A randomized, controlled, parallel-group trial to evaluate the efficacy of a cognitive behavioral therapy for patients with early dementia.

Detailed description: The KORDIAL study is a randomized, controlled, parallel-group trial evaluating the efficacy of a cognitive behavioral therapy for patients at the early stage of Alzheimer's disease. The 3-month experimental intervention consists of 12 individual sessions with regular involvement of carers or other patient proxies. Strategies for improving the patient's coping ability and for enhancing their psychological well-being are combined. The primary outcome criterion is functioning in the everyday context after completion of the intervention and after another 6 months. The control condition will be treatment as usual. The study will be conducted in 5 university outpatient units and in 5 specialist offices.

Eligibility criteria: Inclusion Criteria:

* Mild dementia (MMSE \> 21) in Alzheimer's disease (ICD-10), proxy available

Exclusion Criteria:

* Acute of unstable psychiatric or physical disease, proxy unavailable
* Participation in another trial

Primary outcomes:
measure: Functional ability in the everyday context
timeFrame: Baseline, post treatment, 6 months post treatment
Secondary outcomes:
measure: Quality of life, depression, neuro-psychiatric symptoms
timeFrame: Same as for primary outcome
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Prof. Dr. A. Kurz, Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet Muenchen
state: Bavaria
Study officials:
affiliation: Klinikum rechts der Isar
name: Alexander Kurz, MD
role: STUDY_DIRECTOR
References:
citation: Kliegel M, Eschen A, Thone-Otto AI. Planning and realization of complex intentions in traumatic brain injury and normal aging. Brain Cogn. 2004 Oct;56(1):43-54. doi: 10.1016/j.bandc.2004.05.005.
citation: Werheid K, Thone-Otto AI. [Cognitive training in Alzheimer's dementia]. Nervenarzt. 2006 May;77(5):549-57. doi: 10.1007/s00115-005-1998-2. German.
citation: Kurz A, Pohl C, Ramsenthaler M, Sorg C. Cognitive rehabilitation in patients with mild cognitive impairment. Int J Geriatr Psychiatry. 2009 Feb;24(2):163-8. doi: 10.1002/gps.2086.
Clinical trial NCT06809946: Feasibility of Fluorescence Imaging with Bevacizumab-800CW During Bronchoscopy
Official title: Feasibility of Fluorescence Imaging with Bevaci-zumab-800CW During Bronchoscopy in Patients with a Pulmonary Lesion Considered to Be Malignant
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lung Neoplasms
Pulmonary Neoplasms
Lymph Node Involvement
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: In this feasibility study, bronchoscopy will be combined with fluorescence molecular imaging using the near-infrared fluorescence (NIRF) tracer bevacizumab-800CW for assessment of pulmonary lesions and/or lymph nodes considered to be malignant.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent prior to participation in the study.
2. Age ≥ 18 years.
3. Patient has at least one intrabronchial, near-to-airway located or peripheral pulmonary nodule - with or without pathological lymph nodes - which is considered malignant (independent of its primary origin).
4. Patient is considered fit to undergo a diagnostic and/or therapeutic bronchoscopy (with or without addition of virtual navigation and/or endobronchial ultrasound; including propofol sedation or general anesthesia if either is indicated) to obtain tumor material according to standard care protocols.

Exclusion Criteria:

1. History of infusion reactions to bevacizumab.
2. Medical or psychiatric conditions that compromise the patient's ability to give informed consent.

Primary outcomes:
measure: In vivo fluorescent signal of malignant lesion versus non-tumorous tissue
timeFrame: Assessed directly during the bronchoscopy procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03618446: Predictors Of Mortality After Pelvic Fractures: A Retrospective Cohort Study From A Level-1 Trauma Center In Upper Egypt
Official title: Predictors Of Mortality After Pelvic Fractures: A Retrospective Cohort Study From A Level-1 Trauma Center In Upper Egypt.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Registries
Pelvic Bone Injury
Morality
Keywords: Pelvic fractures
mortality
predictors
trauma registry
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: AO Clinical Investigation and Publishing Documentation
First posted: 2018-08-07
Enrollment: 1188
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1188 patients were considered eligible for analysis. These were further divided into an adult cohort whose age is above 16 years (951 patients) and a pediatric cohort (237 patients).

Brief summary: A retrospective cohort study was carried out for all pelvic fracture patients admitted to Assiut University Trauma Unit (AUTU), a level-1 trauma center. (AUTU) is located in Upper Egypt and provides healthcare to over 30,000 patients per year.

Detailed description: In 2010, a Pelvic Injury Registry was developed to document treatment and outcomes in a standardized manner. All patients admitted to AUTU sign an informed consent to permit using their data for research purposes. Patients' data are prospectively collected and stored in a local database specifically designed for this purpose.

Data collected included age, gender, mechanism of injury, fracture classification, associated injuries, and admission to ICU, the length of hospital stay and presence of abdominopelvic collection as diagnosed by Focused Assessment with Sonography for Trauma (FAST) at admission. The primary outcome measure was in-hospital mortality. Predictors of in-hospital mortality were identified by comparing characters of survivors and non-survivors. Secondary objectives were to analyse the differences between adults and children and to analyse the causes and timing of death.

Eligibility criteria: Inclusion Criteria:

* first-time admissions and patients whose treatment was completed at our hospital
* all pelvic fracture patients admitted to our Trauma Unit.

Exclusion Criteria:

* penetrating injuries
* isolated acetabular fractures
* Patients who were discharged on their own will against the medical advice or whose treatment was continued at another hospital
* re-admitted patients
* Firearm injuries

Primary outcomes:
measure: in-hospital mortality
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Osama Farouk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04246346: Effectiveness of Using Interactive Consulting System to Enhance Informed Choice
Official title: Effectiveness of Using Interactive Consulting System Based on Large Language Model to Enhance Informed Choice of Cataract Patients: a Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age-related Cataract
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 660
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To compare the performance of an interactive chatbot versus senior ophthalmologists for enhancing informed decisions made by cataract patients. The chatbot was built based on large language models, and could generate medical expert-level responses.

Detailed description: Cataract surgery is the only way to treat age-related cataract. For patients at early or moderate stages, cataract surgery is an elective surgery without objective indications. Therefore the patients are uaually not aware whether they should receive the surgery. The number of trained and qualified ophthalmologists are limited in China and lots of patients cannot have detailed consultation with ophthalmologists. As a result, many patients still have doubts about whether they should receive cataract surgery or not. In this study, we aim to assess the effectiveness of an interactive chatbot based on large language models versus senior ophthalmologists to enhance informed decisions made by cataract patients.

Eligibility criteria: Inclusion Criteria:

1. Individuals aged 45-80 years who have been resident in the selected study district for more than six months;
2. A definite diagnosis of age-related cataract;
3. Having not received cataract surgery;
4. Willing to participate the study and provide informed consent.

Exclusion Criteria:

1. Bilateral blindness (presenting distance visual acuity worse than 3/60);
2. Having ocular, hearing or mental disorders precluding reading or telephone interview;
3. Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;
4. Having cataract surgery contraindication.

Primary outcomes:
measure: Informed choice about cataract surgery (the proportion of participants who make an informed choice，which is defined as a good knowledge score and an intention that is consistent with their attitude score)
timeFrame: 2 weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yingfeng Zheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000246: Rapid Benzodiazepine Detoxification Using Flumazenil - 1
Official title: Rapid Benzodiazepine Detoxification Using Flumazenil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance-Related Disorders
Keywords: Substance-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to verify the hypothesis that the benzodiazepine antagonist, flumazenil, will reduce acute benzodiazepine withdrawal.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Benzodiazepine withdrawal severity
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University, Psychiatry
state: Connecticut
Study officials:
affiliation: Yale University
name: Scott Woods, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woods, et al., Soc Neuroscience Abstracts 21: 2098, 1995.
Clinical trial NCT02197546: Acupuncture for Pain During Injection of Local Anaesthetic
Official title: Acupuncture Reduces Pain and Autonomous Distress During Injection of Local Anaesthetic in Children - a Randomised Crossover Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Distress
Satisfaction
Keywords: Injection pain
local anesthesia
acupuncture
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 49
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Stimulation of acupoint LI4 has been shown to result in analgesic effects in patients experiencing acute pain. We aimed to determine whether LI4 acupuncture could reduce pain and distress in children receiving an injection of a local anaesthetic (LA). Children scheduled for dental treatment using local anesthesia as a standard treatment, received bilateral acupuncture at LI4 using indwelling fixed needles. During the treatment, the parents of the patients stimulated the needles by massage. Two different treatment regimes were compared: a standardized LA injection given 5 minutes after acupuncture, and an LA injection without acupuncture. The order of treatment was randomised, with the two treatments performed on different days. Pain intensity during LA injection, assessed by the patient with the Verbal Rating Scale or Faces Pain Scale (0-10), was used as the primary endpoint. Parent- and dentist-assessed pain intensity and agitation, heart rate, and the patients' satisfaction with the received therapy were also recorded.


Eligibility criteria: Inclusion Criteria:

* children with an American Society of Anesthesiologists (ASA) physical status of I or II
* scheduled for at least two dental treatments for caries requiring local anaesthesia

Exclusion Criteria:

* history of analgesic medication, psychiatric disease, or local or systemic infection
* necessity to change their treatment schedule

Primary outcomes:
measure: pain intensity
timeFrame: 3 time points during one day of investigation
Secondary outcomes:
measure: pain intensity assessed by the parents and by physicians
timeFrame: 4 time points during one day of investigation
Other outcomes:
measure: heart rate
timeFrame: 5 time points during one days of investigation
Locations:
city: Greifswald
country: Germany
facility: University Medicine of Greifswald
Study officials:
affiliation: University Medicine of Greifswald
name: Christian Splieth, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04662346: Evaluation of Difficulty Score for Robotic Pancreatoduodenectomy
Official title: Difficulty Scoring System in Robotic Pancreatoduodenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Neoplasm
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Robotic pancreatoduodenectomy is the most complex surgery for a general surgeon and consequently a pancreatic surgeon can aspire to. Due to the close proximity of the pancreas to the large vessels, great skill and experience in the field of pancreatic surgery, robotic surgery and also vascular surgery is essential. The ability to predict the depth of robotic pancreatoduodenectomy in each individual patient would be extremely important, for patient selection and for the implementation of the learning curve. This study aims to provide a difficulty score (DS) for robotic pancreatoduodenectomy to be used to select cases based on the experience and expertise of the surgeon.

Detailed description: Our Robot DIFFICULT Score was developed starting from factors evaluated by surgeons with experience in performing robotic pancreatoduodenectomy in high-volume centers. Based on the univariate and multivariate analysis, the elevated BMI, ASA 3, the need for venous resection and vascular variations in arterial liver supply were considered significant in increasing the degree of "difficulty" in the robotic pancreatoduodenectomy. The Robot ADDICT Score will be calculated in all cases of the International Consortium on Minimally Invasive Pancreatic Surgery (I-MIPS; www.i-mips.com).

Eligibility criteria: Inclusion Criteria:

* pathology of the head of pancreas requiring surgery

Exclusion Criteria:

* pathology of the head of pancreas not requiring surgery

Primary outcomes:
measure: correlation to post-operative complication
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Division of pancreatic surgery
city: Pisa
country: Italy
facility: University of Pisa
Study officials:
affiliation: University of Pisa
name: ugo boggi
role: STUDY_CHAIR
References: