louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05544032: Expanded Access Program for Axatilimab in Chronic Graft Versus Host Disease (GVHD)
Official title: Expanded Access Program for Axatilimab in Chronic Graft Versus Host Disease (GVHD)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Chronic Graft Vs. Host Disease
Keywords: Chronic Graft Vs. Host Disease
cGVHD
Expanded Access Program
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-09-16
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: To provide axatilimab through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for axatilimab in the treatment of GVHD.


Eligibility criteria: Inclusion Criteria:

* Must be 6 years of age or older.
* Allogeneic HSCT recipients with active cGVHD.
* Has refractory or recurrent active cGVHD despite at least 2 lines of systemic therapy.
* Be willing to avoid pregnancy or fathering children.
* Able to provide written informed consent and/or assent from the patient, parent, or guardian.

Exclusion Criteria:

* Eligible to participate in any actively enrolling axatilimab clinical trial for the treatment of cGVHD.
* History of acute or chronic pancreatitis.
* Has active symptomatic myositis.
* Has known HIV seropositive status.
* Has active, uncontrolled systemic bacterial, fungal, parasitic, or viral infection.
* Has active HBV or HCV.
* Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00841932: Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization
Official title: Retrospective Assessment of the Safety of Performing Fractional Flow Reserve (FFR) of the Myocardium Without Anticoagulation During Diagnostic Cardiac Catheterization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Fractional Flow Reserve
Without anticoagulation
Lead sponsor: Clinyx, LLC
Sponsor class: OTHER
Collaborators: name: Volcano Corporation
First posted: 2009-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent fractional flow reserve (FFR) by Dr. Jonathan Roberts without anticoagulation during diagnostic catheterization were included in this registry.

Brief summary: The purpose of this study is to assess the safety of performing fractional flow reserve (FFR) of the myocardium without using anticoagulation by performing a retrospective review of 100 consecutive patients who have undergone this procedure during diagnostic catheterization.

Detailed description: An experienced interventional cardiologist can perform FFR in a brief period of time. This procedure can safely be performed without anticoagulation, thereby lowering the associated procedural risks by avoiding the bleeding and groin complications that may occur with anticoagulation. Performing FFR without anticoagulation may also decrease facility costs as femoral artery closure can be performed using standard protocols for a diagnostic procedure, instead of standard protocols for an interventional procedure when a patient has been anticoagulated. Performing FFR without anticoagulation does not increase risk of injury to the coronary artery or thrombus in the coronary artery.

Eligibility criteria: Inclusion Criteria:

* Patients with moderate stenosis who underwent FFR without anticoagulation

Exclusion Criteria:

* Therapeutic anticoagulation

Primary outcomes:
measure: Complications related to use of pressure wire
timeFrame: 0-30 days (index procedure)
Secondary outcomes:
measure: Complications due to FFR procedure
timeFrame: 0-30 days (index hospitalization)
Other outcomes:
Locations:
Study officials:
affiliation: Clinyx, LLC
name: Jonathan Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04944732: Evaluation of Diagnostic Criteria for Creutzfeldt Jakob Disease
Official title: Follow up Evaluation of Diagnostic Criteria for Creutzfeldt Jakob Disease (WS / T 562-2017)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Creutzfeldt Jakob Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention, China
First posted: 2021-06-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Creutzfeldt Jakob disease

Brief summary: Clinicians know little about Creutzfeldt Jakob disease, and they are not proficient in the diagnostic criteria of Creutzfeldt Jakob disease, so it is easy to misdiagnose or delay the diagnosis. As a rare central nervous system disease, it is necessary, feasible and practical to evaluate the diagnostic criteria of Creutzfeldt Jakob disease.

Detailed description: To master the clinical application of the diagnosis of Creutzfeldt Jakob disease (WS / T 562-2017) and the problems in the implementation process; The rationality, practicability and operability of the diagnostic criteria were evaluated scientifically; Reduce the misdiagnosis rate; To provide clinical basis and suggestions for further improving the diagnostic criteria. Through consulting the literature of Creutzfeldt Jakob disease, the clinical manifestations, laboratory examination, auxiliary examination and pathological results of Creutzfeldt Jakob disease were analyzed and compared with the current diagnostic criteria; The clinical diagnosis and misdiagnosis of Creutzfeldt Jakob disease were analyzed; To train medical staff at all levels to apply the diagnostic criteria of Creutzfeldt Jakob disease, and to discuss the clinical cases of Creutzfeldt Jakob disease in many hospitals.

Eligibility criteria: Inclusion Criteria:

* Patients with Creutzfeldt Jakob disease

Exclusion Criteria:

* none

Primary outcomes:
measure: Clinical manifestations
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Li Xiaogang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04432532: Neuroendocrine and Adrenal Tumors
Official title: Neuroendocrine and Adrenal Tumors: Biochemical, Histopathologic and Genetic Studies
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Neuroendocrine Tumors
Adrenal Tumor
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed and seeking treatment for neuroendocrine tumors or adrenal tumors

Brief summary: This is a prospective study of rare neuroendocrine and adrenal tumors. Subjects will be enrolled via informed consent, and blood and/or saliva and tissue will be collected. This is designed to work in conjunction with IRB#831990 which is a retrospective protocol. The University of Pennsylvania will be a contributing site with the University of Michigan as the coordinating site for the A5 alliance, a multi-institutional collaborative designed to study neuroendocrine and adrenal tumors.


Eligibility criteria: Inclusion Criteria:

* diagnosed with neuroendocrine and/or an adrenal tumor

Exclusion Criteria:

* pregnant women
* prisoners
* people under the age of 18

Primary outcomes:
measure: Survival
timeFrame: 10 years
Secondary outcomes:
measure: Tumor Recurrence
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04176432: Survival After Emergency Laparotomy in Octogenarians
Official title: Mortality and Complications After Emergency Laparotomy in Patients 80 Years Old or Older
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdomen, Acute
Surgery--Complications
Postoperative Complications
Frailty
Keywords: Emergency surgery
Frailty
Elderly
Postoperative complications
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 106
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to Haukeland University Hospital during 2015-2016

Brief summary: In this single-center retrospective study we wanted to investigate mortality and postoperative complications after emergency laparotomy performed in patients aged 80 years or above.

Detailed description: Methods:

During 2015-2016 106 patients aged 80 years or above underwent emergency laparotomy at Haukeland University Hospital.

Primary outcome was mortality at 30 days. Secondary outcomes were mortality at 90 days, 1 year, postoperative complications and level of care at discharge.

The Medical records were reviewed in detail and mortality and postoperative morbidity were registered. Post-operative complications were defined according to the European Perioperative Clinical Outcome (EPCO) definitions and included if they were Clavien Dindo grade 2 or above.

Eligibility criteria: Inclusion Criteria:

* emergency laparotomy in patients 80 years or above

Exclusion Criteria:

* palliative surgery
* abdominal surgery other than gastrointestinal
* abdominal surgery without midline incision

Primary outcomes:
measure: Number of Deaths within 30 days after emergency laparotomy
timeFrame: From date of emergency laparotomy until 30 days after surgery
Secondary outcomes:
measure: Number of Deaths within 90 days after emergency laparotomy
timeFrame: 90 days after emergency laparotomy
measure: Number of Deaths within 1 year after emergency laparotomy
timeFrame: 1 year after emergency laparotomy
measure: Postoperative complications
timeFrame: Postoperative complications registered in medical records from date of emergency laparotomy until death in hospital or discharge from hospital, whichever came first.
measure: Level of care at discharge
timeFrame: Up to 90 days from date of emergency laparotomy.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01731132: DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.
Official title: DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: HRQoL
IUD
Contraception
SEC-QoL
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 207
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who starts contraception with an IUD.

Brief summary: Knowledge about the impact on quality of life of women initiating IUD in the Spanish population at baseline and after 12 months of use.


Eligibility criteria: Inclusion Criteria:

* 18-49 years old female.
* Women who is visited by a gynecology or primary care physician and starts contraception with an IUD/IUS.
* Women that has not used hormonal contraception in any form in the last 3 months.
* Women who have no problems listening, reading or writing.
* Women who gives their written consent to participate in the study.

Exclusion Criteria:

* Women who have contraindications to use IUDs.
* Women with previous experience with IUDs.
* Women who initiates the use of IUDs for other purposes other than contraception.
* Woman who is participating in a clinical trial at the time of initiating the study.

Primary outcomes:
measure: Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire.
timeFrame: After 12 months
Secondary outcomes:
measure: Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire.
timeFrame: Baseline
Other outcomes:
Locations:
city: Many Locations
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06123832: Study of the Clinical Benefits of Different Formulations of Amphotericin B
Official title: Study of the Clinical Benefits of Different Formulations of Amphotericin B
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Efficacy
Safety
Keywords: Liposomal Amphotericin B for Injection
Amphotericin B Cholesteryl Sulfate Complex for Injection
Amphotericin B for Injection
Safety
Efficacy
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 184
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with documented amphotericin B use discharged from 5 tertiary care hospitals across the country from January 1, 2020 to the present were selected for the study to exclude patients with missing key information for the study and were divided into experimental and control groups for the study.

Brief summary: This project intends to carry out a multi-center retrospective observational real-world study to understand the current status of amphotericin B use by formulation type, compare the differences in safety and efficacy of each formulation in domestic clinical application, provide real-world evidence for clinical drug selection, and provide evidence-based evidence in support of rational clinical drug use.

Detailed description: The researchers selected patients with amphotericin B use records discharged from five tertiary hospitals across the country from January 1, 2020 to the present, extracted data according to the inclusion and exclusion criteria, and divided them into experimental and control groups, in order to understand the current status of amphotericin B use in each preparation type, compare the differences in the safety and efficacy of the various preparations in the domestic clinical application, and provide real-world evidence of the choice of clinical medication.

Eligibility criteria: Inclusion Criteria:

1. Patients discharged from January 1, 2020 to the present;
2. Patients with a record of amphotericin B use.

Exclusion Criteria:

1.Key information missing from patient studies.

Primary outcomes:
measure: Overall Adverse Reaction Rate
timeFrame: Through study completion,up to half a year.
measure: Pathogen clearance rate
timeFrame: Through study completion,up to half a year.
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Rui Yang,MD
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Rui Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06928532: Seated Tai Chi Improves Dynamic Finger Pointing Task and Sitting Balance Control in Subjects With Parkinson's Disease
Official title: Seated Tai Chi Improves Dynamic Finger Pointing Task and Sitting Balance Control in Subjects With Parkinson's Disease: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease and Parkinsonism
Tai Chi
Keywords: Eye-hand coordination
Sitting balance control
Tai Chi
Parkinson's disease
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Hong Kong Metropolitan University
First posted: 2025-04-15
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this prospective study is to investigate the effects of 3 months seated Tai Chi (TC) practice on the eye-hand coordination and sitting balance control of subjects with Parkinson's disease. The main objective it aims to answer are the effects of seated TC training on:

* Shoulder joint range of motion;
* Eye-hand coordination;
* Dynamic sitting balance control; and
* Quality of life in individuals with Parkinson's disease

Researchers compared seated TC training with a control group to see if it improved the aforementioned outcomes.

Participants completed:

* 3-month TC training of 24 sessions in total
* two sessions per week and each session lasted for 1-hour
* went on with their usual physical activities and routines outside the training


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Parkinson's disease (PD)
* Mini-Mental State Examination (MMSE) scored over 24
* Individuals with mobility levels suitable for participation in seated TC

Exclusion Criteria:

-

Primary outcomes:
measure: Shoulder mobility
timeFrame: Immediate after 3-month training period
measure: Eye-Hand Coordination Test
timeFrame: Immediate after 3-month training period
measure: Dynamic sitting balance
timeFrame: Immediate after 3-month training period
measure: Quality of life of Parkinson's disease patients
timeFrame: Immediate after 3-month training period
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Metropolitan University
Study officials:
affiliation: Hong Kong Metropolitan University
name: William Wai Nam Tsang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04384432: Effectiveness of Routine Physical Therapy With and Without Thoracic Mobility Exercises in Chronic Neck Pain
Official title: Effectiveness of Routine Physical Therapy With and Without Thoracic Mobility Exercises in Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: THORACIC MOBILITY EXERCISES
Chronic Neck Pain
Lead sponsor: Government College University Faisalabad
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a limited data available on the effectiveness of thoracic mobility exercises in chronic neck pain and there is a need to determine these exercises in chronic neck pain because chronic neck pain has significant effects on the surrounding muscles of the neck and cervical spine and along with the muscles of shoulder and arm. So the mobility exercises of any region around the neck area can reduce neck pain because these structures are interlinked anatomically and functionally aspects.


Eligibility criteria: Inclusion Criteria:

* 18 years old and over
* A medical diagnosis of chronic cervical pain (more than 3 months of cervical pain evolution)
* Positive flexion rotation test

Exclusion Criteria:

* cervical radiculopathy
* History of Trauma, any Surgery, any Systemic diseases, any Fractures, congenital diseases.
* Dislocation.

Primary outcomes:
measure: Change in Neck Disability Index Questionnaire
timeFrame: 8 week
measure: Visual Analogue Scale
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Suraiya Majeed Trust hospital and Bin Inam clinic
state: Punjab
Study officials:
affiliation: Government College University
name: Awais Bin Inam, MSOMPT
role: STUDY_DIRECTOR
References:
Clinical trial NCT05258032: Structural and Functional Characterization of Rare Ocular Diseases
Official title: Structural and Functional Characterization of Rare Ocular Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinitis Pigmentosa
Stargardt Disease 1
Best Disease
Pattern Dystrophy of Macula
Choroideremia
Keywords: Retinitis pigmentosa
Stargardt's disease 1
Best disease
Pattern Dystrophy of Macula
Choroideremia
Lead sponsor: Barcelona Macula Foundation
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a ROD affecting the posterior segment of the eye

Brief summary: Rare ocular diseases (ROD) are a heterogeneous group of ocular diseases that affect very few people and, generally, for which no tretament is available. An important subgroup of these diseases are inherited retinal degenerations. In this study we focus on understanding the natural history of different ROD that affect the posterior segment.


Eligibility criteria: Inclusion Criteria:

* Male or female 18 years or older with a diagnosis of a ROD affecting the posterior segment
* Patients able to undergo all required ophthalmic exams
* Patients able and willing to sign an informed consent

Exclusion Criteria:

* Patients with other concomitant posterior segment disorders
* Patients taking drugs known to affect the retina and/or optic nerve
* Patients that underwent an intraocular surgery (aside from phacoemulsification with intraocular lens implantation), corneal or glaucoma surgery
* Patients who have participated in the past 12 months or that are currently participating in clinical trials for an ocular disease

Primary outcomes:
measure: Change in best corrected visual acuity
timeFrame: Year 2 as compared to baseline
Secondary outcomes:
measure: Change in mean macular sensitivity
timeFrame: Year 2 as compared to baseline
measure: Change in retinal thickness
timeFrame: Year 2 as compared to baseline
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de la màcula
Study officials:
References: