louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03405766: Barriers in the Process of Achieving Informed Consent From Critically Ill Patients
Official title: Barriers in the Process of Achieving Informed Consent From Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Ethics
Informed Consent
Study Recruitment
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
name: University of Oslo
First posted: 2018-01-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intensive care unit patients

Brief summary: The study will explore barriers in the process of achieving informed consent from critically ill patients

Detailed description: The barriers will be divided into four major categories:

* Practical barriers
* Medical barriers
* Legal barriers
* Ethical barriers

Eligibility criteria: Inclusion Criteria:

* Patients considered for inclusion in the NORIDES study

Exclusion Criteria:

* None

Primary outcomes:
measure: Study recruitment barriers, Medical
timeFrame: 2018-2022
measure: Study recruitment barriers, Ethical
timeFrame: 2018-2022
Secondary outcomes:
measure: Study recruitment barriers, Practical
timeFrame: 2018-2022
measure: Study recruitment barriers, Legal
timeFrame: 2018-2022
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
citation: Dahlberg J, Eriksen C, Robertsen A, Beitland S. Barriers and challenges in the process of including critically ill patients in clinical studies. Scand J Trauma Resusc Emerg Med. 2020 Jun 8;28(1):51. doi: 10.1186/s13049-020-00732-x.
Clinical trial NCT00794066: Peripheral Arteriopathy Rate In Stroke
Official title: Prevalence of Peripheral Arterial Disease in Acute Ischemic and Hemorrhagic Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Keywords: PAD
Stroke
ICH
prevalence
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2008-11-19
Enrollment: 1500
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: consecutive patients with acute ischemic or hemorhagic stroke.

Brief summary: Purpose:

To assess the prevalence of peripheral arterial disease (PAD) in acute stroke patients.

Interventions:

Assessment of the ankle brachial index using the "boso-ABI-system 100" (www.boso.de).

Design:

Prospective, open, cohort study.

Study size planned:

1500.

Follow-up duration:

3 months.


Eligibility criteria: Inclusion Criteria:

* All consecutive adult patients with acute ischemic or hemorrhagic stroke.

Exclusion Criteria:

* Congestive heart failure.

Primary outcomes:
measure: Functional outcome (modified Rankin Scale)
timeFrame: 3 months
Secondary outcomes:
measure: Prevalence of peripheral arterial disease
timeFrame: during hospital stay
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Neurology, University of Erlangen, Germany
Study officials:
affiliation: Head of the Department of Neurology, University of Erlangen, Germany
name: Stefan Schwab, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04135066: Westlake Nutrition and Brain Health Study
Official title: Westlake Nutrition and Brain Health Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Brain structure and function
Nutrition
Microbiome
Continuous blood glucose monitoring
Lead sponsor: Westlake University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2019-10-22
Enrollment: 1425
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The Westlake Nutrition and Brain Study (WEBRAIN), a sub-study of the Guangzhou Nutrition and Health Study, is a prospective cohort study of residents in Guangzhou city. WEBRAIN aims to explore the links between diet, gut microbiome, and brain health in elderly individuals through comprehensive phenotyping, including continuous blood glucose monitoring for standardized test meals, objective physical activity measurement, and brain magnetic resonance imaging.

Detailed description: The gut-brain axis is implicated in neurodegenerative diseases through various mechanisms, with diet and nutrition linked to both gut and brain health. However, most evidence comes from animal models or small-scale human studies.

The Westlake Nutrition and Brain Study (WEBRAIN) aims to investigate the relationships among diet, gut microbiome, and brain structure and function in a large human cohort through comprehensive phenotyping: 1) objective physical activity measurement using accelerometers over two weeks; 2) continuous blood glucose monitoring for two weeks, including two standardized test meals, alongside traditional dietary assessment via Food Frequency Questionnaires (FFQ) and 24-hour recalls; 3) assessment of cognitive function and brain imaging using the Addenbrooke's Cognitive Examination-Revised (ACE-R) and brain MRI; and 4) gut microbiome profiling analysis using sequencing techniques.

Eligibility criteria: Inclusion Criteria:

Participants from the Guangzhou Nutrition and Health Study, lived in Guangzhou, China, and aged 45 years or older;

Exclusion Criteria:

Metal implants and other contraindications for magnetic resonance imaging scanning

Primary outcomes:
measure: Continuous blood glucose profile over 2 weeks
timeFrame: at enrollment
measure: Brain images
timeFrame: at enrollment
Secondary outcomes:
measure: Cognitive scores
timeFrame: at enrollment
measure: Incidence of Alzheimer's disease (AD)
timeFrame: 6 and 10 years after enrollment
measure: Structure of gut microbiome profile
timeFrame: At enrollment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00801866: Avastin for Post-photocoagulation Macular Edema
Official title: Prevention of Post-photocoagulation Macular Edema by Intravitreal Bevacizumab.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Macular Edema
Keywords: Panretinal Photocoagulation
Macular Edema
Intravitreal Bevacizumab
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2008-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: to evaluate the efficacy of a single intravitreal bevacizumab (IVB) injection, 0.1mL (2.5mg), against panretinal photocoagulation (PRP)-induced macular thickening and visual disturbance in patients with severe nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) and good vision


Eligibility criteria: Inclusion Criteria:

* Patients with Proliferative retinopathy or severe non-proliferative retinopathy
* BCVA of 20/63 or better (56 ETDRS letters
* No history of Macular Edema
* Central Retinal Thickness of 250mics or more

Exclusion Criteria:

* Previous treatment.
* Other ophthalmic diseases. history of Nephropathy, heart diseases and pregnancy
* Media opacities

Primary outcomes:
measure: Best Corrected Visual Acuity
Secondary outcomes:
measure: Central Retinal Thickness.
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Asociación para Evitar la Ceguera en México
state: DF
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Eduarto Torres-Porras, MD
role: STUDY_DIRECTOR
affiliation: Asociación para Evitar la Ceguera en México
name: Octavio Burgos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06562166: Online Adaptive Radiotherapy for Cervical Cancer
Official title: Online Adaptive Radiotherapy (oART) in Radical Radiotherapy for Cervical Cancer - a Multi-center Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: cervical cancer
adaptive radiotherapy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Jiangsu University
name: Zhongnan Hospital
name: Jingzhou First People's Hospital
name: The First Affiliated Hospital of Nanhua University
name: Tongji Hospital
First posted: 2024-08-20
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the clinical efficacy and safety of online adaptive radiotherapy for cervical cancer patients received radical radiotherapy. By comparing with image-guided radiotherapy, the study explores the potential advantages of online adaptive radiotherapy in reducing treatment toxicity and improving local control.


Eligibility criteria: Inclusion Criteria:

1. 18-70 years old;
2. Pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma;
3. 2018 FIGO Stage Ib3, II, and IIIC1
4. Proposed radical pelvic radiotherapy + concurrent sensitizing chemotherapy (platinum-based (cisplatin 30-40mg/m2 or carboplatin alone), starting concurrently in the first week, ≥5 courses)
5. ECOG score 0-2
6. Life expectancy greater than 6 months
7. Ability to remain lying down for more than 30 minutes
8. Patients were fully voluntary and autonomous and co-operated in signing the study informed consent form
9. Complete blood count and basal metabolic indexes within 14 days before enrolment must meet the following requirements: NEUT ≥ 1.5\*109/L, HGB ≥ 60g/L, platelets ≥ 100×109/, blood creatinine \&lt;1.5 mg/dL. AST and ALT are within 2 times the upper limit of normal
10. Must complete baseline assessments and investigations required before treatment before enrolment
11. be eligible for regular follow-up

Exclusion Criteria:

1. Have received radiotherapy or chemotherapy in the past
2. Have undergone radical surgery for cervical cancer
3. Have a previous history of malignant tumor
4. Pregnant or lactating women
5. Presence of other serious co-morbidities such as poorly controlled cardiovascular, urinary, digestive, respiratory, hematological and central nervous system diseases.

Primary outcomes:
measure: Acute non-hematological toxicity
timeFrame: From the start of treatment until 3 months later
Secondary outcomes:
measure: treatment response
timeFrame: 3 months after completion of treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union medical college hospital
Study officials:
References:
Clinical trial NCT06946966: The Effects of Online Mat Pilates and Face-to-Face Equipment-Based Pilates on Pain, Kinesiophobia, and Balance in Individuals With Non-Specific Low Back Pain
Official title: The Effects of Online Mat Pilates and Face-to-Face Equipment-Based Pilates on Pain, Kinesiophobia, and Balance in Individuals With Non-Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: pain
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 57
Sex: FEMALE
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: Non-specific low back pain (NSLBP) is a common musculoskeletal condition that affects a significant portion of the population and often leads to limitations in daily activities, reduced quality of life, and increased levels of kinesiophobi

Detailed description: compare the effects of online mat Pilates and face-to-face equipment-based Pilates on pain, kinesiophobia, and balance in individuals with NSLBP. While both methods emphasize neuromuscular control and alignment, differences in delivery modes and equipment usage may influence outcomes.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 60 years
* Non-specific low back pain for more than 12 weeks
* No clear pathological diagnosis
* Physically and cognitively capable of performing the exercises
* Pain level between 3 and 7 on the Visual Analog Scale (VAS)

Exclusion Criteria:

* Pregnancy
* Spinal surgery in the last 6 months
* Neurological or chronic systemic diseases
* Movement restriction due to severe pain

Primary outcomes:
measure: visual pain scal
timeFrame: 12 weeks
measure: Quebec Back Pain Disability Scale (QBPDS)
timeFrame: 12 weeks
measure: Pressure Algometer
timeFrame: 12 weeks
measure: Y-Balance Test (YBT)
timeFrame: 12 weeks
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahceşehir University Health Center
Study officials:
References:
Clinical trial NCT01919866: Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells
Official title: Haploidentical Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells in Pediatric Patients With Refractory Hematological and Oncological Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Leukemias
Aplastic Anemia
Childhood Solid Tumor
Lead sponsor: University Children's Hospital Tuebingen
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells in combination with a toxicity reduced conditioning regimen or with standard conditioning regimens according to underlying disease.


Eligibility criteria: Inclusion Criteria:

* patients with primary refractory or relapsed disease (including relapse after previous SCT and active disease)
* AML in complete remission of refractory
* MDS RAEB-t/secondary AML
* ALL
* CML
* Non-Hodgkin Lymphoma / Hodgkin Lymphoma
* non malignant diseases (aplastic anemia, thalassemia, SCID)
* relapsed Neuroblastoma
* relapsed soft tissue sarcoma (Rhabdomyosarcoma, Ewing sarcoma, PNET
* soft tissue sarcoma with primary bone metastases or bone marrow
* in whom no matched donor was available,

Exclusion Criteria:

* \< 6 months after previous HSCT
* active cerebral seizure conditions
* massive progression of leukemias or solid tumours before planned trp.
* left ventricular ejection fraction \<25%
* creatinine clearance \<40ml/min before conditioning
* respiratory insufficiency with oxygen demand or DLCO \<30%
* Bilirubin \>4mg/dl, GOT/GPT \>400
* severe infection (HIV, Aspergillosis)
* pregnancy

Primary outcomes:
measure: Engraftment rate and transplant related mortality
timeFrame: 365 days
Secondary outcomes:
measure: Graft versus Host disease and speed of immune reconstitution
timeFrame: 365 days
Other outcomes:
Locations:
city: Graz
country: Austria
facility: University Children's Hospital
city: Halle
country: Germany
facility: University Children's Hospital
city: Hannover
country: Germany
facility: Medizinische Hochschule Zentrum für Kinderheilkunde
city: Jena
country: Germany
facility: University Children's Hospital
city: Tuebingen
country: Germany
facility: University Children's Hospital
Study officials:
affiliation: University Children's Hospital Tuebingen
name: Peter Lang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06039566: NAC Vs Placebo on Opioid Use for Hysterectomy
Official title: A Trial Evaluating the Impact of N-acetylcysteine on Opioid Use in Patients Undergoing a Hysterectomy Procedure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hysterectomy
Keywords: hysterectomy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will enroll females who are ages 18 and older undergoing a laparoscopic or robotic, partial or full hysterectomy. Participants will be randomized to receive IV n-acetylcysteine or placebo during the first 60 minutes of their procedure. At various time points after the procedure patients will be asked to report their pain scores, and any pain medication taken.


Eligibility criteria: Inclusion

* Undergoing elective laparoscopic or robotic, full, or partial hysterectomy procedure
* 18 years of age and older

Exclusion

* Less than 40kg in weight
* Unable to provide written, informed consent
* History of an adverse or anaphylactoid reaction to acetylcysteine
* Active asthma, wheezing, or using inhaled bronchodilators
* Non-English speaking
* Insulin dependent diabetes if D5W is required
* Blood clotting disorders

Primary outcomes:
measure: Opioid Consumption 0-72 hours post-study medication
timeFrame: 0-72 hours after study medication
Secondary outcomes:
measure: Pain Scores
timeFrame: Study medication start to 72 hours post-study medication
Other outcomes:
measure: intraoperative opioid consumption
timeFrame: during the procedure (up to 12 hours)
measure: postoperative anesthesia care unit (PACU) opioid consumption
timeFrame: PACU Arrival until PACU Discharge up to 52 weeks
measure: non-opioid analgesic administration
timeFrame: Anesthesia start until PACU discharge up to 52 weeks
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Sylvia Wilson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03737266: Comparison of Conventional With Sonography Assisted Breast Surgery After Neoadjuvant Chemotherapy
Official title: Sonographically Assisted Versus Conventionally Breast Surgery in Breast Cancer Patients With an Indication for Breast Conserving Surgery After Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Surgery
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 137
Sex: FEMALE
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: Aim of the study is to investigate whether intra-surgical visualisation of malignoma reduces the resection rate in the case of R1 resection compared to the procedure without sonographic visualisation


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years
* Female
* Presurgical validated breast cancer
* Unifocal to multifocal findings
* Palpable and/o non-palpable findings
* Neoadjuvant chemotherapy
* Indication for breast conserving therapy
* General operation ability and anesthesia ability
* Consent to conventional breast conserving breast surgery with wire marking
* Ability and will to follow the study conditions
* Written declaration of consent after clarification

Exclusion Criteria:

* Sonographically not clearly delineate resection areal
* Exclusion criteria for breast conserving therapy
* Simultaneous participation in other interventional trials that interfere with this study at the investigator's discretion

Primary outcomes:
measure: R0 resection rate
timeFrame: 3 years
Secondary outcomes:
measure: Weight of primary resedate
timeFrame: 3 years
measure: Time for cut and sew
timeFrame: During surgery
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department for Women's Health
state: BW
Study officials:
affiliation: Department of Women's Health, University Hospital Tuebingen
name: Markus Hahn, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00150566: Efficacy and Safety of Lanthanum in Controlling Serum Phosphate Levels in Subjects With End Stage Renal Disease Who Require Treatment for High Levels of Phosphate in Their Blood
Official title: A Phase IIIb, Multi-center, Two-Cohort, Randomized Study, With an Open-Label Run-In and a Long-Term Extensions Phase, Assessing an Extended Dose Range of Lanthanum Carbonate in End Stage Renal Disease Subjects Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Failure, Chronic
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test how well higher doses of lanthanum carbonate reduce the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease.


Eligibility criteria: Inclusion Criteria:

* Subjects with ESRD who currently require treatment for hyperphosphatemia
* Women of childbearing potential must have a negative serum beta HCG pregnancy test and must agree to abstain from sexual activity or to use acceptable contraceptives from the time of informed consent throughout the study

Exclusion Criteria:

* Treatment with compounds containing calcium, aluminum or magnesium for use as a phosphate binder
* Hypocalcaemia
* Treatment-naive to any phosphate binder with a serum phosphorus \< 5.5 mg/dL
* Any significant gastrointestinal surgery or gastrointestinal disorders

Primary outcomes:
measure: Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment
timeFrame: 4 & 8 weeks
Secondary outcomes:
measure: Tolerability
timeFrame: 8 weeks
measure: Quality of Life
timeFrame: 8 weeks
measure: Subject/physician satisfaction and preference questionnaires
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Mehrotra R, Martin KJ, Fishbane S, Sprague SM, Zeig S, Anger M; Fosrenol Overview Research Evaluation Study for Early Experience Study Group. Higher strength lanthanum carbonate provides serum phosphorus control with a low tablet burden and is preferred by patients and physicians: a multicenter study. Clin J Am Soc Nephrol. 2008 Sep;3(5):1437-45. doi: 10.2215/CJN.04741107. Epub 2008 Jun 25.