louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01218360: Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)
Official title: Observational Study on Disease Severity, Evaluation Tools and the Long Term Impact of Each Treatment Strategy in the Daily Clinical Practice in Patients With Moderate to Severe Active Crohn's Disease (Protocol P06484)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Keywords: Crohn's disease
standard-of-care
Crohn Disease
Active Crohn's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-10-11
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with diagnosed active Crohn's Disease who are inadequately controlled with their current therapy

Brief summary: This is an observational study to determine the prevalence of moderate to severe Crohn's disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a standard clinical practice.


Eligibility criteria: Inclusion Criteria

1. Must have a diagnosis of active Crohn's Disease irrespective of severity,
2. Must be inadequately controlled with their current therapy and for whom physician

   decides to switch treatment.
3. Must be between 18 and 65 years of age, of either sex,
4. Must demonstrate willingness to participate in the study by signing the written informed consent.

Exclusion Criteria

* No specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial

Primary outcomes:
measure: Percentage of Crohn's disease participants among the study population with a Crohn's Disease Activity Index (CDAI) score of 220-450 at the enrollment to the study.
timeFrame: Week 0
measure: Record of treatment strategy followed
timeFrame: Week 0 to 2 years
measure: Change in the CDAI score during the observational period
timeFrame: Week 0 to 2 years
Secondary outcomes:
measure: Number of surgeries and hospitalizations during the observational period
timeFrame: Week 0 to 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02780960: Human Papillomavirus (HPV) Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia
Official title: HPV Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Intra-epithelial Neoplasia Grade 1 or Worse
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 127
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the performance of HPV self-sampling (self-HPV) in detecting residual/recurrent disease in women treated by loop electro-surgical excision (LEEP) for CIN1+.

Detailed description: The HPV test is an efficient method to assess the long-term risk of residual/recurrent disease in women treated for cervical intraepithelial neoplasia grade 1 or worse (CIN1+).

Women treated by LEEP for CIN1+ will be invited to participate. Follow-up visits will be performed at 6 months and 12 months after treatment and will include cytology, colposcopy when indicated and HPV testing. Two weeks before each follow-up visit at the colposcopy clinic, a home-based Self-HPV will be organized. A sample of 168 women will be included. Agreement between the two methods (Dr-HPV vs. S-HPV) will be measured using the kappa statistic (κ).

the investigators expect to find that Self-HPV may be an accurate method to predict residual and recurrent disease in women previously treated by LEEP.

Eligibility criteria: Inclusion Criteria:

* attending colposcopy clinic
* biopsy-proven CIN1+ lesion
* understands study procedures and accepts voluntarily to participate by signing the informed consent form

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Number of patients with CIN
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Genève
country: Switzerland
facility: Geneva University Hospital
Study officials:
References:
citation: Viviano M, Vassilakos P, Meyer-Hamme U, Grangier L, Emery SL, Malinverno MU, Petignat P. HPV self-sampling in the follow-up of women after treatment of cervical intra-epithelial neoplasia: A prospective study in a high-income country. Prev Med Rep. 2021 Sep 20;24:101564. doi: 10.1016/j.pmedr.2021.101564. eCollection 2021 Dec.
Clinical trial NCT00925860: Non-Positive Pressure Ventilation in Hypoxemic Patients
Official title: Non-Positive Pressure Ventilation in Hypoxemic Patients. A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Respiratory Failure
Lead sponsor: Hospital Provincial de Castellon
Sponsor class: OTHER
First posted: 2009-06-22
Enrollment: 64
Sex: ALL
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: The study is aimed to assess the possible benefit of non-positive pressure mechanical support in front of conventional ventilation in patients admitted to the intensive care unit (ICU) because of pure hypoxemic respiratory failure.

Detailed description: Pure hypoxemic patients admitted to intensive care unit in a teaching hospital have been randomized to be treated by conventional ventilatory support or non-positive mechanical ventilation support. Those patients who did not benefit from the experimental non-positive ventilatory support, were intubated and conventionally mechanically ventilated and discarded for analysis. The primary outcome was mortality rate in both groups, and secondary outcomes were length of stay, improvement of oxygenation, and reduced complications rates.

Eligibility criteria: Inclusion Criteria:

* dyspnea with respiratory rates higher than 35 p.m.
* pO2 \< 65 mmHg
* paO2/FiO2 \< 250

Exclusion Criteria:

* respiratory or cardiac arrest
* gastrointestinal bleeding
* hemodynamic instability
* face surgery
* upper airway obstruction
* inability for active cooperation
* need for airway protection
* exacerbation of COPD
* decrease of conscious level
* acute pulmonary cardiogenic oedema

Primary outcomes:
measure: mortality rates
timeFrame: patient hospital discharge
Secondary outcomes:
measure: oxygenation improve
timeFrame: patient hospital discharge
measure: diminishing of tracheal intubation incidence
timeFrame: patient hospital discharge
measure: ICU and Post ICU hospital length of stay
timeFrame: patient hospital discharge
Other outcomes:
Locations:
city: Castello
country: Spain
facility: Intensive Care Department - General Hospital
Study officials:
affiliation: INTENSIVE CARE DEPARTMENT, HOSPITAL GENERAL DE CASTELLO
name: Alberto Belenguer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00159276: GR Defect in Sputum Cells in COPD
Official title: GR Defect in Sputum Cells in COPD
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: To investigate a possible mechanism of the GR defect in patients with severe COPD by studying the effect of dexamethasone (Dex) on GR-GRE binding, expression of inflammatory and anti-inflammatory factors such as IL-6, IL-8, MKP-1, GILZ, SLPI production in sputum cells


Eligibility criteria: Inclusion Criteria:

* Patients with moderate (stage II, GOLD) COPD or subjects who are healthy smokers or subjects who are non-smokers.
* Written informed consent

Exclusion Criteria:

* Current upper respiratory tract infections
* Any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study
* Subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
Study officials:
affiliation: Imperial College London
name: Sergei A Kharitonov, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01257776: Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients
Official title: Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Critical Limb Ischemia (CLI)
Diabetes
Keywords: Critical Limb Ischemia (CLI)
Diabetes
Mesenchymal Stem Cells
Regenerative Therapy
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Iniciativa Andaluza en Terapias Avanzadas
First posted: 2010-12-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose.

The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs (CLI) and without possibility of revascularization, from whom results can clinically be evaluable, of whom, 20 patients will be included in the experimental group (10 for each dose level) and 10 in the control group.

In each of the two dose levels to be used in the study, 15 patients will be included, who will be randomized to the experimental group or the control group according to a distribution 2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level, we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose tissue) and 5 patients in the control group (conventional treatment)


Eligibility criteria: Inclusion Criteria:

* Diabetes, type 1 or 2
* Critical Limb Ischemia (Rutherford Becker Class II,III or IV)of at least one limb.
* No options for target limb revascularization.

Exclusion Criteria:

* Cancer antecedent in the last two years
* Current limb infection or limb gangrene

Primary outcomes:
measure: Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis)
timeFrame: 6 months
measure: Major adverse event (death, target limb amputation)
timeFrame: 1 month, 6 months, 12 months
Secondary outcomes:
measure: Ankle Brachial Index
timeFrame: 1 month, 6 months, 12 months
measure: University of Texas Classification at target limb
timeFrame: 1 month, 6 months, 12 months
Other outcomes:
Locations:
city: Seville
country: Spain
facility: University Hospital Virgen Macarena
city: Seville
country: Spain
facility: CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine)
Study officials:
affiliation: University Hospital Virgen Macarena. Seville.Spain
name: Rafael J Ruiz-Salmeron, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Virgen Macarena. Seville.Spain
name: Antonio De la Cuesta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01572376: Autologous Bone Marrow Stem Cells in Pressure Ulcer Treatment
Official title: Treatment of Pressure Ulcers With Autologous Bone Marrow Stem Cells in Spinal Cord Injury Patients.Phase I/II Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type IV Pressure Ulcers
Chronic Wounds
Spinal Cord Injury
Keywords: Pressure ulcers
Chronic wounds
Spinal cord injury patients
Bone marrow
Mononuclear
Debridement
Lead sponsor: Hospital Universitario Central de Asturias
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine the safety and feasibility of an autologous mononuclear stem cells infusion in pressure ulcers of paraplegic patients; and moreover, to evaluate the efficacy of the treatment.

Detailed description: Taking into account the encouraging results obtained in the treatment of non-healing chronic wounds using bone marrow cells Given that treatment strategies for pressure ulcers can be both costly and complex, in this study we examine the possibility of improving pressure ulcer healing using stem cell therapy.

Eligibility criteria: Inclusion Criteria:

* Type IV ulcer pressures of more than 4 months topical treatment without response
* No option for conventional surgery
* Age range of 18-75 years old

Exclusion Criteria:

* Patients out of inclusion age range
* Patients with evidences of mental illness
* Patients with evidences of previous alcohol or drugs dependencies
* Pregnant women
* Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma

Primary outcomes:
measure: Absence of adverse effects during timeframe as infections or complications related with the intervention.
timeFrame: Six months
Secondary outcomes:
measure: Improvement and closure of the pressure ulcer
timeFrame: One year
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
Study officials:
References:
citation: Sarasua JG, Lopez SP, Viejo MA, Basterrechea MP, Rodriguez AF, Gutierrez AF, Gala JG, Menendez YM, Augusto DE, Arias AP, Hernandez JO. Treatment of pressure ulcers with autologous bone marrow nuclear cells in patients with spinal cord injury. J Spinal Cord Med. 2011;34(3):301-7. doi: 10.1179/2045772311Y.0000000010.
Clinical trial NCT05714176: Comparative Study Between Oral Liposomal Iron,Iron Supported Lactoferrin and IV Iron Dextran in CKD Children
Official title: Comparative Clinical Study to Evaluate the Efficacy and Safety of Oral Liposomal Iron, Oral Iron Supported Lactoferrin and IV Iron Dextran in Children With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: CKD - Chronic Kidney Disease
Lead sponsor: Menoufia University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2023-02-06
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, parallel study that will be conducted on pediatric patients with CKD.

Detailed description: The study will be conducted on 90 pediatric patients with CKD who will be divided into 3 groups: Group l: 30 pediatric patients who will receive oral liposomal iron 30 mg/day for 12 weeks. Group 2: 30 pediatric patients who will receive oral iron supported iron 1 mg+ lactoferrin 100 mg/day for 12 weeks. Group 3: 30 pediatric patients who will receive IV iron dextran 50 mg/3 times weekly for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* A) Pediatrics ≤18 year old male and female patients. B) Pediatrics with CKD stages 3-5.

Exclusion Criteria:

* A) CKD patients' ≥18 year old. B) Active bleeding C) Malignancy D) Anemia due to any disease other than CKD E) Blood Transfusions

Primary outcomes:
measure: Hemoglobin measure
timeFrame: 3 months
Secondary outcomes:
measure: Biomarkers measure
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Tanta University
name: Sahar K Hagazy, PhD
role: STUDY_CHAIR
affiliation: Menoufia University
name: Mohamed SH Al-Haron
role: STUDY_CHAIR
References:
citation: Amanullah F, Malik AA, Zaidi Z. Chronic kidney disease causes and outcomes in children: Perspective from a LMIC setting. PLoS One. 2022 Jun 8;17(6):e0269632. doi: 10.1371/journal.pone.0269632. eCollection 2022.
citation: Ammirati AL. Chronic Kidney Disease. Rev Assoc Med Bras (1992). 2020 Jan 13;66Suppl 1(Suppl 1):s03-s09. doi: 10.1590/1806-9282.66.S1.3.
citation: Ueda N, Takasawa K. Role of Hepcidin-25 in Chronic Kidney Disease: Anemia and Beyond. Curr Med Chem. 2017;24(14):1417-1452. doi: 10.2174/0929867324666170316120538.
citation: Moscheo C, Licciardello M, Samperi P, La Spina M, Di Cataldo A, Russo G. New Insights into Iron Deficiency Anemia in Children: A Practical Review. Metabolites. 2022 Mar 25;12(4):289. doi: 10.3390/metabo12040289.
citation: Wojtaszek E, Glogowski T, Malyszko J. Iron and Chronic Kidney Disease: Still a Challenge. Front Med (Lausanne). 2020 Dec 18;7:565135. doi: 10.3389/fmed.2020.565135. eCollection 2020.
Clinical trial NCT03366376: Hippocampus-sparing WBRT and Simultaneous Integrated Boost for Multiple Brain Metastases From NSCLC
Official title: A Phase II Multi-institutional Study of Hippocampus-sparing Whole Brain Radiotherapy and Simultaneous Integrated Boost for Multiple Brain Metastases From Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Brain Metastases
Keywords: hippocampus
radiotherapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Korean Radiation Oncology Group
First posted: 2017-12-08
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates hippocampus-sparing whole-brain radiotherapy with simultaneous integrated boost for patients with multiple brain metastases from non-small cell lung cancer. The primary endpoint is intracranial progression free survival, and secondary endpoints are verbal neurocognitive function, overall survival, adverse events according to CTCAE v4.03, and quality of life.


Eligibility criteria: Inclusion Criteria:

* Pathologically proven diagnosis of primary non-small cell lung cancer
* 3 or more measurable brain metastasis ≥3 mm outside a 5-mm margin around either hippocampus on gadolinium contrast enhanced MRI within 14 days prior to registration
* KPS ≥70
* Age ≥55 years
* Informed consent prior to study entry

Exclusion Criteria:

* Patients with leptomeningeal metastases
* ≥3 organ sites of extracranial metastases (including lung-to-lung metastases) within 3 months
* Contraindication to MRI such as implanted metal devices or foreign bodies
* Prior radiation therapy (including SRS) to the brain

Primary outcomes:
measure: Intracranial progression free survival
timeFrame: until 12 months
Secondary outcomes:
measure: Verbal neurocognitive function (Seoul Verbal Learning Test-Elderly, SVLT-E)
timeFrame: 3,6,12 months
measure: Overall survival
timeFrame: until 12 months
measure: Adverse events
timeFrame: 3,6,12 months
measure: Quality of life
timeFrame: 3,6,12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT03731676: Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty
Official title: Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients were randomly assigned to a fixed bearing or rotating platform of two prostheses. A subsequent study (the one retrospectively registering the original study) asked these patients a series of questions from published questionnaires to assess long term outcomes.


Eligibility criteria: Inclusion Criteria:

1. Osteoarthritis
2. Rheumatoid or other inflammatory arthritis
3. Post-traumatic arthritis
4. Juvenile rheumatoid arthritis
5. Avascular necrosis

Exclusion Criteria:

1. History of recent/active joint sepsis
2. Charcot neuropathy
3. Psycho-social disorders that would limit rehabilitation
4. Metabolic disorders of calcified tissues, such as Paget's disease
5. Joint replacement due to autoimmune disorders
6. Skeletal immaturity
7. Ligamentous laxity requiring a constrained prosthesis

Primary outcomes:
measure: Change in Functional Status over time
timeFrame: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
measure: Change in Osteoarthritis Status over time
timeFrame: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
measure: Change in Overall Health Status over time
timeFrame: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Secondary outcomes:
measure: Change in Satisfaction of Knee over time
timeFrame: Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20.
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Dr. William Hopkinson
state: Illinois
Study officials:
References: