louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05437354: Online Survey: Oncologists' Thoughts Regarding Their Patients
Official title: Oncologists' Thoughts and Expectations Regarding Their Patients. An Online Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncology
Keywords: Oncologists, Survey, Expectations
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any Medical staff in Oncology Field worldwide, with no age limit

Brief summary: Our study is a questionnaire targeting the medical staff in Oncology. It aims at exploring the thoughts and expectations of the medical staff in Oncology regarding their patients management and prognosis worldwide. It also investigates the factors that affect these thoughts and expectations and their effects.

Detailed description: Oncology patients need to trust the medical staff dealing with them. They are expecting knowledge, well communication, competence .. etc. This Questionnaire is for research purpose aiming at exploring the thoughts and expectations of the medical staff in Oncology regarding their patients management and prognosis worldwide. It investigates the factors that affect these thoughts and expectations and their effects. The results of this survey will shed the light on the oncologists' side of their relationship with their patients, which is often ignored or down played.

Eligibility criteria: Inclusion Criteria:

1. Medical/Clinical/Radiation Oncology Physicians
2. Surgical Oncology Physicians
3. Oncology nurses

Exclusion Criteria:

* Medical staff not related to oncology field

Primary outcomes:
measure: What are the most and least important factors the oncologists usually consider when they build their management plan?
timeFrame: Two months
Secondary outcomes:
measure: How often do oncologists inform patients of the detailed management plan? and Why?
timeFrame: Two months
measure: How satisfied do oncologists think most patients are during their management.
timeFrame: Two months
measure: How often are Oncology patients open to their case being discussed in multidisciplinary clinics or being referred to psychiatrists/Nutritionists/palliative care/hospice?
timeFrame: Two months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Riham AbdelAziz, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02436954: Regional Cerebral Oxygen Saturation in Laparoscopic Surgery
Official title: Impact of Neuromuscular Blockade on Cerebral Oxygen Saturation in Laparoscopic Surgery Employ Carbon Dioxide-pneumoperitoneum
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholecyctitis
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2015-05-07
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: While few studies have determined the optimal intra-abdominal CO2 insufflation pressure to achieve optimal surgical condition during LCs with deep-NMB and moderate-NMB in laparoscopic cholecystectomy (LC), previous studies suggested that the use of deep neuromuscular blockade (deep-NMB) can improve surgical condition and reduce the pressure for CO2 insufflation to achieve "optimal surgical space condition".

this difference in the pressure of intra-abdominal CO2 insufflation due to different strategies employing deep-NMB and moderate-NMB for LC may produce possible difference in patient's respiratory pattern and cerebral oxygenation. Although previous study (studies) showed that intra-abdominal CO2 insufflation (10-12 mmHg) decreases cerebral oxy-hemoglobin (HbO2) and total Hb measured by near-infrared spectroscopy (NIRS) during laparoscopic cholecystectomy (LC), few studies have speculated possible impact of different degree of NMB and intra-abdominal CO2 insufflation pressure on patient's cardiorespiratory profile and cerebral oxygenation, so far.

The present study determines and compares the changes CO2 absorption and cerebral oxygenation (cerebral perfusion) after applying CO2 insufflation with different intra-peritoneal pressure 8 vs 12 mmHg during deep-NMB.


Eligibility criteria: Inclusion Criteria:

* cholecystitis
* provision of written informed consent

Exclusion Criteria:

* COPD
* asthma
* low LV ejection fraction

Primary outcomes:
measure: regional cerebral oxygen saturation 1
timeFrame: 1 min
measure: regional cerebral oxygen saturation 2
timeFrame: 2 min
measure: regional cerebral oxygen saturation 3
timeFrame: 3 min
Secondary outcomes:
measure: end-tidal carbon dioxide 1
timeFrame: 1 min
measure: end-tidal carbon dioxide 2
timeFrame: 2 min
measure: end-tidal carbon dioxide 3
timeFrame: 3 min
measure: repiratory rate
timeFrame: 3 min
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03083054: Cellular Immunotherapy for Patients With High Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia
Official title: Cellular Immunotherapy as a Treatment Option for Patients With High Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Myelodysplastic Syndromes
Acute Myeloid Leukemia
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this work is to conduct a clinical study for the development and application of a vaccine with autologous dendritic cells submitted to electroporation with Wilm's tumor 1 (WT1) messenger ribonucleic acid (mRNA), as an adjuvant treatment of high-risk Myelodysplastic Syndromes and Acute Myeloid Leukemia, aiming to delay the progression of the disease or its relapse and increase overall and event-free survival.


Eligibility criteria: Inclusion Criteria:

* Individuals between the ages of 18 and 70
* High-risk myelodysplasia (AREB 1 or AREB 2 subtypes) and Acute Myeloid Leukemia
* Minimum interval of 30 days between the last cycle of chemotherapy (when it occurs) and start of immunotherapy
* Performance status between 0 and 3 on the WHO (World Health Organization)-ECOG (Eastern Cooperative Oncology Group) scale
* Calculated creatinine clearance\> 30 ml / min using the Cockcroft-Gault formula
* Total bilirubin less than or equal to twice the lower limit of the normal range in the institution and aspartate aminotransferase (AST) less than or equal to twice the upper limit of normal
* Absence of blasts in peripheral blood
* Leukocyte count greater than 3000 cells / mm3, hemoglobin greater than 9.0 g / dl and platelets greater than 70,000 platelets / mm3, if possible. (If the patient does not meet these criteria for apheresis, the possibility of transfusion of blood components after leukapheresis will be proposed and the patient should sign a specific term of science on the possibility of transfusion)
* Normal cardiac evaluation
* Negative serologies for hepatitis B and C viruses and HIV
* Written informed consent form signed before entering the study

Exclusion Criteria:

* Does not meet any of the requirements of the inclusion criteria
* Low risk myelodysplasia by IPSS (International Prognostic Scoring System) or WPSS (WHO adapted Prognostic Scoring System) scores
* Individuals with a history of any previous neoplasia, except those with prolonged clinical remission (more than 5 years) of non-melanoma skin cancers and cervical cancer in situ
* Pregnant or lactating women
* Previous immunotherapy or biological therapy

Primary outcomes:
measure: Disease free survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Hematology and Transfusion Medicine Center
state: São Paulo
Study officials:
References:
Clinical trial NCT06365554: On-Premise and Remote Robotic Neurointervention
Official title: Safety and Feasibility of On-Premise and Remote Robotic Neurointervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebrovascular Disease
Lead sponsor: Remedy Robotics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Unity Health Toronto
First posted: 2024-04-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study is a prospective, single arm, single-center study to evaluate the safety and feasibility of the Remedy Robot for on premise and remote robotic Neurointervention.

Detailed description: This is a prospective, single-arm, single-center study to evaluate the safety and effectiveness of the Remedy Robot for patients with a clinical indication for Neurointervention.

Eligibility criteria: Inclusion criteria

* The patient is ≥ 18 years of age
* The Investigator deems the patient appropriate for manual and robotic-assisted Neurointervention.
* The patient or their substitute decision-maker has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

Exclusion criteria:

* Patients currently pregnant or breastfeeding.
* People with any of the following vascular history:
* Known congenital aortopathy, connective tissue disorder or vasculopathy
* Known arterial dissection of any kind
* Bleeding diathesis
* Use of Warfarin, IV Heparin, Clexane, Fondaparinux or any new oral anticoagulants (NOACs) or direct oral anticoagulants (DOACs)

People with any of the following medical history:

* Active malignancy
* Known contrast allergy
* Height \> 190cm

Primary outcomes:
measure: Procedural safety
timeFrame: Measured from the start of the procedure through 24 hours or discharge
measure: Procedural Technical Success
timeFrame: Measured from the start of the procedure through to the completion of the procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05008354: Effect of Pyridoxine on Behavioral Adverse Events of Levetiracetam
Official title: Investigation of Pyridoxine Effect on Behavioral Adverse Events of Levetiracetam in Adult Patients With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Pyridoxine
Behavior Problem
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Mazandaran University of Medical Sciences
First posted: 2021-08-17
Enrollment: 30
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 is a two-arm parallel group randomized double-blind placebo-controlled trial with the aim of Investigating pyridoxine effect on behavioral side effects of levetiracetam in adult patients with epilepsy.


Eligibility criteria: Inclusion Criteria:

* Age≥18 years
* Patients with epilepsy
* Patients who are treated by levetiracetam (Levebel, Cobel darou) in recent month
* Complaint of behavioral problem
* Patient's consent for participation

Exclusion Criteria:

* History of known psychiatric disease
* Pregnancy
* Incidence of psychotic side effects including hallucination, psychosis, suicidal idea or attempt
* Treatment with psychiatric medications
* Alcohol or drug abuse
* Mental retardation to the degree that intervenes comprehension and response to questionnaire

Primary outcomes:
measure: Behavioral side effects
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sari
country: Iran, Islamic Republic of
facility: Bu Ali Sina Hospital
state: Mazandaran
Study officials:
References:
Clinical trial NCT00688454: C-Control: Efficacy and Safety of Therapy With Rosuvastatin in Statin-Naive and in Statin-Switched Patients
Official title: C-Control: Efficacy and Safety of Therapy With Rosuvastatin in Statin-Naive and in Statin-Switched Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesteremia
Keywords: Hyperlipidemia
Rosuvastatin
Efficacy
tolerability
CRESTOR therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 3392
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Statin-naive patients and unsuccessfully treated with other (non rosubastatin) statins patients

Brief summary: The study explores efficacy and safety of the lipid-lowering therapy with CRESTOR in statin-naive patients and in patients with previously unsuccessful statin therapy. This study was designed to investigate the dynamic of the lipid parameters and therapy tolerability during 8-10 weeks treatment with CRESTOR


Eligibility criteria: Inclusion Criteria:

* Patients with hypercholesteremia who was never treated with statins before
* Patient with hypercholesteremia who was treated with a statin (other then rosuvastatin) but because of its adverse effects/insufficient action was switched to therapy with CRESTOR

Exclusion Criteria:

* None

Primary outcomes:
measure: LDL-Cholesterin, HDL-Cholesterin, Triglycerides, Total Cholesterin
timeFrame: 3 visits within 10 weeks
Secondary outcomes:
measure: Tolerability of CRESTOR-therapy
timeFrame: 3 visits within 10 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04462354: Pancreatic Anastomosis After Duodenopancreatectomy
Official title: Pancreatic Anastomosis After Duodenopancreatectomy: Pancreatogastrostomy Versus Blumgart Anastomosis: Prospective, Randomized and Multicentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Anastomotic Leak
Pancreatic Neoplasms
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2020-07-08
Enrollment: 216
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: A national, multicenter, randomized, prospective, parallel group clinical study to evaluate two therapeutic strategies (invaginating pancreatogastric anastomosis versus Blumgart anastomosis).

Detailed description: Background: Postoperative pancreatic fistula is currently the most frequent complications after duodenopancreatectomy. There are currently no RCT comparing two of the most frequently used method of pancreato-enteric anastomosis (invaginating pancreatogastric anastomosis versus Blumgart anastomosis)

Hypothesis: in patients with resectable pancreatic and periampullary tumors, performing a Blumgart (AB) anastomosis for pancreatoenteric reconstruction after duodenopancreatectomy decreases the rate of postoperative pancreatic fistula (PPF) compared to to pancreatogastric anastomosis.

Main goal: To comparatively evaluate the rate of PPF in patients with pancreatic and periampullary tumors undergoing cephalic duodenopancreatectomy after reconstruction with Blumgart anastomosis or pancreatogastric anastomosis.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old.
* Diagnosis of pancreatic and periampullary tumor pathology that requires pancreatoduodenectomy
* Signature of informed consent by the patient or his legal representative

Exclusion Criteria:

* Patients in whom liver metastases or peritoneal carcinomatosis are detected during surgery.
* Patients in whom tumor resection is ultimately not achieved due to intraoperative evidence that the tumor is locally advanced, unresectable.
* Patients with macroscopic residual tumor (R2).
* High risk patients with severe pathology (ASA IV) according to the American Association of Anesthetists.

Primary outcomes:
measure: Postoperative pancreatic fistula rate (PPF)
timeFrame: 3 months
Secondary outcomes:
measure: Bleeding
timeFrame: 3 months
measure: Gastric Emptying Delay (GED)
timeFrame: 3 months
measure: Biliary Fistula
timeFrame: 3 months
measure: Other complications.
timeFrame: 3 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
References:
Clinical trial NCT02231554: Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial
Official title: Effectiveness of Feldenkrais Method Versus a Back School Program in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: low back pain
quality of life
rehabilitation
exercise
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 53
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 purpose of this study study is to determine whether the Feldenkrais method is effective on pain control, functional recovery and quality of life in patients with chronic low back pain by comparing it with a Back School program.


Eligibility criteria: Inclusion Criteria:

* Presence of chronic nonspecific low back pain for at least three months;
* Subjects aged between 18 and 80 years.

Exclusion Criteria:

* Presence of acute low back pain;
* Low back pain due to other causes (vertebral fractures, spondylolisthesis, herniated discs, lumbar canal stenosis);
* CNS and/or PNS disorders;
* Systemic inflammatory disease (eg rheumatoid arthritis);
* Systemic infectious disease;
* Neoplastic disease;
* Previous Surgery;
* Cognitive impairment;
* Pregnancy.

Primary outcomes:
measure: Change of Visual analogue scale (VAS) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: Change of SF-36 Health Survey Questionnaire from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
measure: Change of McGill Pain Questionnaire from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
measure: Change of Waddell Disability Index from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
measure: Change of Multidimensional Assessment of Interoceptive Awarness (MAIA) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Umberto I Hospital
Study officials:
affiliation: Umberto I Hospital, Sapienza University of Rome
name: Vincenzo Maria Saraceni
role: STUDY_DIRECTOR
References:
Clinical trial NCT00680654: Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID
Official title: Interaction Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics of Single Doses of 0.5 and 1 mg of BAY 63-2521 in Patients With PAH and Stable Treatment of Sildenafil 20 mg TID in a Non-randomized, Non-blinded Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension, Pulmonary
Keywords: Pulmonary hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of BAY63-2521 in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg.


Eligibility criteria: Inclusion Criteria:

* Patients with pulmonary hypertension stable for the last 6 weeks
* Treated with Sildenafil 3 × 20 mg
* Undergoing routine invasive diagnostics.

Exclusion Criteria:

* Pre-existing lung disease other than pulmonary arterial hypertension,
* Acute or severe chronic left heart failure,
* Severe coronary artery disease,
* Uncontrolled arterial hypertension;
* Congenital or acquired valvular or myocardial disease except acquired tricuspid valve insufficiency due to pulmonary hypertension,
* Systolic blood pressure \< 100 mmHg, heart rate \< 55 bpm or \>105 bpm, PaO2/FiO2 \< 50 mmHg,
* PaCO2 \> 55 mmHg,
* Severe hepatic insufficiency,
* Severe renal insufficiency,
* Administration of strong CYP3A4 inhibitors or inductors

Primary outcomes:
measure: Impact of a single dose of BAY63-2521 on pharmacodynamic parameters of the pulmonary system, on safety, tolerability and pharmacokinetics.
timeFrame: At baseline, throughout study days 1 and 2
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Löwenstein
country: Germany
state: Baden-Württemberg
city: Gießen
country: Germany
state: Hessen
city: Greifswald
country: Germany
state: Mecklenburg-Vorpommern
city: Dresden
country: Germany
state: Sachsen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01238354: Family & Friends - the Significance of a Significant Other in Treatment
Official title: Conservative Treatment of Obesity at Røros Rehabilitation Centre - A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight Loss
Social support
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2010-11-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study focuses on the difficulties to maintain a weight loss and behavioural change after having been in a institutional intermittent weight loss programme.

We explore if including a member of the family or a close friend in the treatment influences weight loss maintenance after completion of the programme.


Eligibility criteria: Inclusion Criteria:

* Morbid obesity
* 18-50 years of age
* Having a relative or close friend who is willing to participate

Exclusion Criteria:

* Pregnancy
* Serious mental illness
* Severe overeating behaviour
* Significant reduced physical functioning
* Having undergone bariatric surgery earlier
* Serious heart disease

Primary outcomes:
measure: Maintenance of weight loss
timeFrame: 2 years after termination of programme
Secondary outcomes:
Other outcomes:
Locations:
city: Roros
country: Norway
facility: Roros Rehabiliteringssenter
Study officials:
affiliation: Norwegian University of Science and Technology
name: Bård Kulseng, PhD
role: PRINCIPAL_INVESTIGATOR
References: