louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01854515: Comparison of Efficacy of Nebulizing Budesonide and Intravenous Dexamethasone Before Extubation on Prevention of Post-extubation Complications in Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Sounds
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study was aimed at investigating the efficacy of nebulizing Budesonide sin comparison with intravenous Dexamethasone before extubation in prevention of post-extubation complications amongst patients admitted in intensive care unit.

In this double-blind randomized clinical trial study, 90 patients (age between 18 to 65) who are intubated (at least for 48 hours) and now are ready for extubation will be enrolled in the study after obtaining a written informed consent from their parents or guardians.

The investigators divide our patients randomly into two equal groups.

-In the budesonide group patients underwent a therapy with nebulizing Budesonide at a dose of 1 mg diluted in 4 cc of sterile water for 20 minutes, one hour preceding extubation. After extubation patients received nebulizing budesonide via oxygen mask at the same dose every 12 hours for 48 h.i In dexamethasone group intravenous dexamethasone was administered to patient at a dose of 0.15 mg/kg before extubation. After extubation, the administration of intravenous Dexamethasone continued at the same dose every 12 h. for 48 h.

Another anesthesiologist who is unaware about kind of medication, will evaluate the patients for severity of stridor. We will record the vital sings and grade of stridor every 6 hour. Respiratory rate (RR), heart rate (HR), blood pressure (BP) and oxygen saturation (SPO2) were recorded for each patient immediately before aerosol administration (time 0) and at 30 and 60 min; and 2,4,8,12,24,36 and 48 hrs. After extubation then the presence of stridor (heard with the aid of stethoscope) was recorded within 48 hr of extubation


Eligibility criteria: Inclusion Criteria:

1. Patients' age 18-65 years old
2. Intubated for more than 48 hours after surgery
3. Met the weaning criteria defined as respiratory rate \< 30 breaths / min, negative tidal volume \> 5 ml/kg ideal body weight, and shallow index (respiratory rate/tidal volume) \< 105 breaths / min/L

Exclusion Criteria:

1. Any history of corticosteroid therapy in previous week
2. Nasal or throat disease / surgery
3. Pulmonary airway disease
4. Gastrointestinal bleeding

Primary outcomes:
measure: post extubation stridor
timeFrame: After extubation until 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Alzahra University Hospital
Study officials:
References:
Clinical trial NCT02407015: The Effect of 3D Autostereoscopic Video-game Play on the Visual Fatigue in Children
Official title: A Randomised Control Trial to Evaluate the Effect of 3D Autostereoscopic Video-game Play on the Total Horizontal Fusional Vergence Amplitudes of 7 to 11 Year Old Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Fatigue
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 41
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to examine the specific effect that 3D game play has on the control of the eyes horizontal movements. It will examine the youngest group of consumers this technology is marketed to, 7 to 11-year-olds and no children under 7 years of age will be recruited to this study as per Nintendo's hardware guidelines, which recommends that children under 7 years of age not play in 3D mode. It will examine the effect of playing in 3D for 30 minutes on horizontal fusional amplitudes compared with a control group playing in 2D for 30 minutes.

Detailed description: This study will be a prospective blind randomised control trial. The participants will be randomised into one study group, with participants playing a game in 3D; and a control group, with participants playing the same game in 2D. The study is blind due to the use of an independent assessor, reducing testing bias by ensuring that the tester does not know the randomisation results. The known dependant variables are the total horizontal fusional amplitudes at 1/3m and 6m and the independent variable is the use of 2D or 3D game play.

Eligibility criteria: Inclusion Criteria:

* Male and female 7 to 11-year-olds with no prior history of binocular vision / ocular motility dysfunction.

Exclusion Criteria:

* Corrected visual acuity of less than 0.000 tested with SLT at 3m.

  * Interocular visual acuity difference of 0.100 (tested with SLT) or greater, which could indicate the presence of Amblyopia.
  * The presence of any manifest deviation (Tropia).
  * Presence of any ocular motility dysfunction, which affects primary position.
  * Reduced binocular convergence of 10 centimetres or less.
  * Stereoacuity of less than 170" (this may indicate the presence of a microtropia or other undiagnosed pathology).
  * Any prior or existing medical history of epilepsy or seizures.
  * Any prior or existing medical history of repetitive strain injury.

Primary outcomes:
measure: Change in horizontal fusional amplitude
timeFrame: Immediately following gameplay
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS trust
state: Cambridgeshire
Study officials:
affiliation: University of Sheffield
name: Louisa A Haine, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06178315: EUS-guided Celiac Plexus Block vs. Sham in Chronic Pancreatitis
Official title: Randomized Trial of EUS-guided Celiac Plexus Block vs. Sham for Palliation of Pain in Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pancreatitis
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 94
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 aim of this randomized trial is to assess the efficacy of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.

Detailed description: Chronic pancreatitis is a complex fibroinflammatory disease arising from numerous etiological factors and a variety of clinical manifestations. Abdominal pain is the most debilitating complication and can result in significant morbidity and impact on quality of life. Endoscopic ultrasonography (EUS) has been increasingly utilized for celiac plexus block (EUS-CPB), whereby a steroid in combination with a local anesthetic agent are injected into the celiac plexus within the abdominal cavity. The aim of this randomized trial is to assess the efficacy of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Abdominal pain of at least 3 months duration and a VAS score ≥ 3, with or without the use of narcotic analgesics.
* Diagnosis of chronic pancreatitis on EUS examination, with ≥ 5 features on EUS.
* No other cause of abdominal pain

Exclusion Criteria:

* Age \< 18 years.
* History of prior EUS-CPB.
* Use of anticoagulants that cannot be discontinued for the procedure.
* Clinically significant allergy to bupivacaine or triamcinolone.
* Unable to obtain consent for the procedure from either the patient or LAR.
* Intrauterine pregnancy.

Primary outcomes:
measure: Rate of adequate pain relief
timeFrame: 1 month
Secondary outcomes:
measure: Technical success
timeFrame: Immediately after procedure
measure: Pain scores measured using Visual Analog Scale.
timeFrame: 3 months
measure: Pain scores measured using the Comprehensive Pain Assessment Tool-Short Form.
timeFrame: 3 months
measure: Quality of life assessment
timeFrame: 3 months
measure: Opioid analgesic use
timeFrame: 3 months
measure: Procedure-related adverse events
timeFrame: 3 months
measure: Disease-related adverse events
timeFrame: 3 months
measure: Hospital admissions for management of chronic pancreatitis.
timeFrame: 3 months
measure: Length of hospitalization in any patient hospitalized
timeFrame: 3 months
measure: Rate of cross-over to EUS-CPB in patients initially assigned to the sham group.
timeFrame: 3 months
measure: Rate of need for any additional endoscopic, surgical or radiological intervention for chronic pancreatitis.
timeFrame: 3 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
References:
Clinical trial NCT02724215: Effect of Sleep Apnea on Blood Pressure Control and Outcome Early After Subarachnoid Hemorrhage
Official title: Effect of Sleep Apnea on Blood Pressure Control and Outcome Early After Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subarachnoid Hemorrhage
Sleep Apnea
Keywords: Subarachnoid hemorrhage
Sleep Apnea
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Subarachnoid Hemorrhage admitted to a University Hospital

Brief summary: In this observational study patients with subarachnoid hemorrhage (SAH) will be screened for sleep apnea (SA) to investigate if SA is associated with impaired blood pressure control and worse clinical outcome early after SAH.

Detailed description: Patients admitted with non-traumatic SAH will be consented and screened for sleep apnea within 48 hours after hospital admission. Blood pressure and clinical outcome will be monitored throughout ICU treatment and hospital stay, respectively. Diagnosis of sleep apnea will be confirmed on follow-up 3-6 month after SAH by sleep apnea screening (portable cardiorespiratory monitoring and out-of-center polysomnography, respectively).

Eligibility criteria: Inclusion Criteria:

* Subarachnoid Hemorrhage (Hunt \& Hess 1 to 4)
* \> 18 years of age
* Ability to consent for study of healthcare proxy able to confirm patient will to participate

Exclusion Criteria:

* Stoke within 3 month prior to admission
* Intubation prior or within 24 hours after admission
* no healthcare proxy

Primary outcomes:
measure: Time to blood pressure target
timeFrame: Within 10 Days of hospital admission with subarachnoid hemorrhage
measure: Medication needed to achieve blood pressure target
timeFrame: Within 10 Days of hospital admission with subarachnoid hemorrhage
Secondary outcomes:
measure: Change in modified ranking scale (mRS) from baseline to discharge and follow-up visit, respectively.
timeFrame: 3 to 6 Month after SAH
measure: Change in NIH stroke scale score (NIHSS) from admission to discharge and follow-up visit, respectively.
timeFrame: 3 to 6 Month after SAH
measure: Barthel Index at discharge at follow-up visit, respectively.
timeFrame: 3 to 6 Month after SAH
Other outcomes:
measure: Incidence of Sleep Apnea in Patients with Subarachnoid Hemorrhage
timeFrame: 6 Month after SAH
Locations:
city: Bonn
country: Germany
facility: Department of Neurology and Department of Neurosurgery
Study officials:
affiliation: Vice Chair of Department of Neurosurgery
name: Erdem Gueresir, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Physician
name: Sebastian Zaremba, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaremba S, Albus L, Vatter H, Klockgether T, Guresir E. Poor blood pressure control following subarachnoid hemorrhage in patients with sleep apnea. Sleep Breath. 2021 Jun;25(2):777-785. doi: 10.1007/s11325-020-02184-0. Epub 2020 Sep 14.
Clinical trial NCT01309815: Existential Issues in Elderly People With Cancer
Official title: Existential Issues in Elderly People With Cancer in an Early Palliative Phase- a Phenomenological Hermeneutic Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: neoplasms
existentialism
existential concerns
Meaning making
early palliative phase
elderly
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
First posted: 2011-03-07
Enrollment: 21
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients from 70 years and older, receiving palliative treatment and care in Innlandet Hospital Trust

Brief summary: The purpose is to describe, interpret and provide a detailed understanding of what it means to be elderly people with cancer who receive treatment in specialized health care. Focus is especially put on the content and expression of existential issues and the importance of spirituality for the patient´s life story and medical story.

Detailed description: Existential and spiritual issues in elderly people with cancer are scarcely investigated with respect to the content and importance of these aspects to this patient group in terms of living with their disease and benefit from specialist health treatment and care. The present study is an independent doctoral study that also has an initial function for an intended multidisciplinary research project with the working title "Aged people with cancer".

Eligibility criteria: Inclusion Criteria:

* Patients with cancer from the age 70 and older receiving palliative treatment in specialized health care

Exclusion Criteria:

* Terminal patients
* Patients considered as too sick for the interview session
* Patients with lack of consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brumunddal
country: Norway
facility: Innlandet Hospital Trust
Study officials:
affiliation: Innlandet Hospital Trust, Centre for Psychology of Religion
name: Lars J Danbolt, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03987815: Neoadjuvant Nivolumab for Operable Esophageal Carcinoma
Official title: Neoadjuvant Nivolumab for Operable Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2019-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm phase II study, in which maximum 3 cycles of nivolumab (240 mg fixed dose every 2 weeks) is administered for T2- or T3-node negative esophageal squamous cell carcinoma, before curative operation.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed esophageal squamous cell carcinoma
2. Clinical stage T2N0 (invasion to muscularis propria) or T3N0 (invasion to adventitia)
3. ECOG performance 0 or 1
4. Age 19 years or older

Exclusion Criteria:

1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer
2. Ineligibility or contraindication for esophagectomy
3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
5. Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.

Primary outcomes:
measure: Major pathologic response
timeFrame: 2 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 2 months
measure: Positron Emission Tomography (PET)-CT response
timeFrame: 2 months
measure: Progression-free survival (PFS)
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jong-Mu Sun
Study officials:
affiliation: Samsung Medical Center
name: Jong-Mu Sun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03393715: Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes
Official title: Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Hypertension
Keywords: Diabetes
Hypertension
Perindopril
chronobiology
Africa
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Yaounde 1
First posted: 2018-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: open label randomised controlled trial with crossover of perindopril administered in the morning versus evening on blood pressure control
Primary purpose: TREATMENT

Brief summary: We assessed the influence of time of administration of ACE inhibitors on circadian blood pressure control in sub Saharan type 2 diabetes patients with stage 1 hypertension over 56 days as first line treatment.

Detailed description: Background: Renin-angiotensin system antagonists represent the mainstay of blood pressure (BP) lowering treatment options in people with diabetes. ACE inhibitors have a long half-life and offer the advantage of a single daily dose, usually empirically taken in the morning.

Objective: We assessed the influence of time of administration of ACE inhibitors on circadian BP control in type 2 diabetes (T2D) patients with stage 1 hypertension.

Methods: Twenty T2D patients (9 being women) with a mean age of 58.7 years, diagnosed with stage 1 of hypertension and naive to BP lowering medications, were included. They were randomly allocated to receive perindopril 10 mg/day as a monotherapy either in the morning or in the evening for 28 days, with crossover without washout period on day 29th and additional 28 days follow-up. A 24-hour ambulatory BP monitoring (ABPM) was performed at baseline, days 28 and 56.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Grade 1 hypertension
* Informed consent

Exclusion Criteria:

* estimated creatinine clearance≤ 60ml/min
* White coat hypertension after initial 24 hour ABPM
* Previous antihypertensive treatment
* Pregnant women
* Individuals working during the night
* Hyperkalemia

Primary outcomes:
measure: 24-hour blood pressure profile
timeFrame: 56 days
Secondary outcomes:
measure: Night time blood pressure dip
timeFrame: 56 days
Other outcomes:
Locations:
Study officials:
affiliation: Yaounde Central Hospital
name: Eugène Sobngwi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04995315: Pyruvate Kinase Deficiency Global Longitudinal Registry Substudy of Protocol AG348-C-008
Official title: Pyruvate Kinase Deficiency Global Longitudinal Registry Substudy of Protocol AG348-C-008: Cognition in Participants With Pyruvate Kinase Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pyruvate Kinase Deficiency
Keywords: Glycolytic enzymopathy
Congenital Nonspherocytic hemolytic anemia (CNSA)
PKD
Lead sponsor: Agios Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 13
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: Participants with PK deficiency will be enrolled in at least 3 sites also participating in Study AG348-C-008. If any participants are unable to complete the Day 0 CBB assessments, additional participants may be enrolled.

Brief summary: This is a substudy of Study AG348-C-008, an observational, longitudinal, multicenter, global registry that aims to better understand the longitudinal clinical implications of pyruvate kinase deficiency (PK deficiency). The primary purpose of this study is to describe the cognition of participants with PK deficiency, as objectively measured by the Cogstate Brief Battery (CBB).


Eligibility criteria: Inclusion Criteria:

* Participant must be ≥18 years of age;
* Participant must be enrolled in Study AG348-C-008.

Primary outcomes:
measure: Change Over Time in Cogstate Brief Battery (CBB) Scores
timeFrame: Day 0, Day 90
Secondary outcomes:
measure: CBB Scores of Participants as Compared to the Scores of Age-Matched Controls
timeFrame: Day 0, Day 90
measure: Percentage of Participants With Blood Transfusions Affecting Cognition, as Assessed by the Investigator
timeFrame: Day 90
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Milan
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
Study officials:
affiliation: Agios Pharmaceuticals, Inc.
name: Medical Affairs
role: STUDY_CHAIR
References:
Clinical trial NCT00427115: Multimodal Intervention in Allogeneic Stem Cell Transplantation
Official title: Pilot Study of an Exercise an Psycho-Educational Intervention During Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allogeneic Stem Cell Transplantation
Leukemia
Keywords: Patients undergoing allogeneic stem cell transplantations
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-01-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: To evaluate the feasibility and safety of a 4-6 weeks exercise - psycho-educational intervention in patients undergoing allogeneic stem cell transplantation (allo-HCST). The intervention included structured and supervised exercise, relaxation and psycho-educational components. It was hypothesized that the intervention would minimize loss of physical capacity during hospitalization.


Eligibility criteria: Inclusion Criteria:

* 18-65 yrs
* patients undergoing allogeneic stem cell transplantation

Exclusion Criteria:

* recent cardiovascular or pulmonary disease
* abnormal EKG
* psychiatric disorder
* motor function, musculoskeletal or neurological disturbances
* bony metastasis

Primary outcomes:
measure: Physical capacity VO2 max, muscle strength (1RM, Isometric), stair test
timeFrame: Baseline, post
Secondary outcomes:
measure: quality of life indices
timeFrame: baseline, post, 3 and 6 months
measure: FACT-An, EORTC, HADS, Mini-Mac, Symptom Assessment form
timeFrame: baseline, post, 3 and 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
Study officials:
affiliation: Copenhagen University Hospital, Denmark
name: Mary E Jarden, MSN PhD stud
role: PRINCIPAL_INVESTIGATOR
affiliation: Copehagen University, Faculty of Health Sciences, Denmark
name: Lis Adamsen, ProfessorPhD
role: STUDY_CHAIR
References: