louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01365546: Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery
Official title: Prospective, Open-Label, Multi-Center, Phase III CLinical Study to Investigate the Efficacy and Safety of Human Factor VWF/FVIII Concentrate (Wilate) in Subjects With Inherited Von Willebrand Disease Who Undergo Surgical Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevent Bleeding in Major Surgery
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with congenital VWD (von Willebrand Disease)
* Require therapy with a VWF (von Willebrand Factor) product to treat any major surgical procedure

Exclusion Criteria:

* Known coagulation disorder other than VWD
* Known history of, or suspected VWF or FVIII inhibitors
* Subjects with hepatic liver disease
* Known or suspected hypersensitivity or previous evidence of severe side effects to wilate or other VWF/FVIII concentrates
* Pregnant women in the first 20 weeks of gestation

Primary outcomes:
measure: Overall Hemostatic Efficacy (Success or Failure) of Wilate, Based on the Intra-operative Assessment of the Surgeon and the Post-operative Assessment by the Investigator Using a 4-point Ordinal Efficacy Scale.
timeFrame: 30 Days
Secondary outcomes:
measure: Assessment of Intra-operative Hemostatic Efficacy
timeFrame: 1 Day
measure: Post-operative Efficacy Assessment
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Hemophilia and Thrombosis Center
state: Indiana
city: Chapel Hill
country: United States
facility: UNC-CH Comprehensive Hemophilia Center
state: North Carolina
city: Milwaukee
country: United States
facility: Blood Center of Wisconsin
state: Wisconsin
city: Sofia
country: Bulgaria
facility: SHAT Joan Pavel
city: Vellore
country: India
facility: Christian Medical College
state: Tamil Nadu
city: Pune
country: India
facility: Sahyadri Specialty Hospital
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Milano
country: Italy
facility: Granda Ospedale Maggiore Policlinico
city: Vicenza
country: Italy
facility: ULSS6 Vicenza Ematologia
city: Muscat
country: Oman
facility: Sultan Quaboos University Hospital
city: Warsaw
country: Poland
facility: Instytut Hematologii i Transfuzjologii
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Timisoara
country: Romania
facility: Louis Turcanu Childrens Emergency Hospital
city: Johannesburg
country: South Africa
facility: Hemophilia Comprehensive Care Center
city: Izmir
country: Turkey
facility: Ege University
Study officials:
References:
Clinical trial NCT06471946: VA Conditioning Regimen Allo-HSCT for Elderly Higher-risk MDS
Official title: Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT for Elderly Patients With Higher-risk Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Higher-risk Myelodysplastic Syndromes
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 54
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this phase 1/2 trial is to test the safety and efficacy of Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT in treating patients with higher-risk MDS.

Detailed description: The investigators will evaluate 2 year overall survival(OS) after transplantation in patients with higher-risk MDS. Progression free survival (PFS), incidence of acute GVHD, non-relapse mortality (NRM), graft-versus-host disease (GVHD)-free relapse-free survival(GRFS), and incidence of chronic GVHD at 1 and 2 years after transplantation will be counted.

Eligibility criteria: Inclusion Criteria:

* The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
* The patient is willing and able to adhere to the study visit schedule and other protocol requirements.
* The patient should be diagnosed with higher risk MDS according to the standard criteria of the World Health Organization (WHO).

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.

Primary outcomes:
measure: Overall Survival
timeFrame: 3 year
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 3 year
measure: Incidence of acute GVHD and chronic GVHD
timeFrame: 3 year
measure: Non-relapse mortality (NRM)
timeFrame: 3 year
measure: Graft-versus-host disease (GVHD)-free relapse-free survival(GRFS)
timeFrame: 3 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
Study officials:
affiliation: Navy General Hospital, Beijing
name: Liren Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02521246: Efficacy and Safety of Candesartan Associated With Chlorthalidone Versus Losartan Associated With Hydrochlorothiazide (Hyzaar®) in Essential Hypertension Control
Official title: Efficacy and Safety Evaluation of the New Association on Fixed Dose of Candesartan Cilexetil + Chlorthalidone (16mg + 12.5mg and 16mg + 25mg) Compared With HYZAAR® in Hypertension Control
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Essential Arterial Hypertension
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 0
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.


Eligibility criteria: Inclusion Criteria:

* Signed Consent of the patient;
* Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who are being treated with monotherapy.

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator opinion can not participate in the study;
* Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;
* Morbid obesity or immunocompromised patients;
* Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;
* Participants who do not have the two upper limbs;
* Participants with important electrocardiographic changes;
* Creatinine clearance - less than 60 mL / min;
* History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months;
* Microalbuminuria urine sample greater than 30 mg/g;
* Patients with history of hypersensitivity to any of the formula compounds;
* Pregnancy or risk of pregnancy and lactation patients;
* Participation in clinical trial in the year prior to this study;

Primary outcomes:
measure: Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal
timeFrame: 60 days
Secondary outcomes:
measure: Safety will be evaluated by the adverse events occurrences.
timeFrame: 9 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05854446: Delphi Study on Myofascial Pain Syndrome Challenges in Turkey: Patient Journey, Burden, Diagnosis & Treatment Needs.
Official title: Navigating the Challenges of Myofascial Pain Syndrome in Turkey: A Delphi Methodology Study on Patient Journey, Disease Burden, and Unmet Diagnosis and Treatment Needs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myofascial Pain Syndrome
Keywords: Disease burden
Delphi methodology
Patient journey
Myofascial Pain Syndrome
Quality of life
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A panel of 20 experts from diverse backgrounds in healthcare and pain management.

Brief summary: Myofascial pain syndrome is a chronic pain disorder that affects many people in Turkey. This research study aims to explore the challenges faced by patients with myofascial pain syndrome in Turkey, including the disease burden, patient journey, and unmet diagnosis and treatment needs. The study will utilize the Delphi methodology, which involves gathering input from a panel of experts over multiple rounds to achieve consensus on the topic. The results of this study will shed light on the current state of myofascial pain syndrome management in Turkey and provide insights into the areas where improvements can be made.

Detailed description: The study will use a Delphi methodology to investigate the challenges faced by patients with myofascial pain syndrome in Turkey. A panel of 20 experts with diverse backgrounds in healthcare and pain management will be selected. The study will be conducted in three rounds, with the first round consisting of open-ended questions to identify key themes related to the disease burden, patient journey, and unmet needs. In the second round, experts will rate the importance of each theme, and in the third round, they will review the results of the previous round and provide additional feedback. Data will be analyzed using content analysis and descriptive statistics to identify the areas of consensus and divergence among the experts.

Eligibility criteria: Inclusion Criteria:

* Being an expert on healthcare.
* Giving consent.

Exclusion Criteria:

* Not giving consent.
* Any disorder or condition that may negatively affect reading, comprehension, and form filling.

Primary outcomes:
measure: Identification of areas of agreement and disagreement among experts.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04008446: Effect of Vitamin B12 on the Development of Sepsis, in Culture Positive Patients
Official title: Effect of Vitamin B12 on the Development of Sepsis, in Culture Positive Patients : an Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who present to the ED with suspicion of infection, and for whom microbiological cultures are indicated,can to be enrolled into the study

Brief summary: This is an prospective observational study assessing the effect of vitamin B12 on the odds of developing sepsis in patients with infection confirmed by a positive culture result.

The hypothesis is that patients with infection confirmed by positive cultures who develop sepsis have lower vitamin B12 levels than patients infection, confirmed by positive cultures, who do not develop sepsis.


Eligibility criteria: Inclusion Criteria:

* Adults (≥18 years old)
* Infection, confirmed by a positive culture result
* Signed informed consent.

Exclusion Criteria:

* Pregnancy and/or breast feeding
* Inability to follow the procedures of the study, due to language problems, psychological disorders, social conditions or dementia

Primary outcomes:
measure: Holotranscobalamin (HTC) levels
timeFrame: 6 days
Secondary outcomes:
measure: Vitamin B12 levels
timeFrame: 6 days
measure: Methylmalonic acid (MMA) levels
timeFrame: 6 days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
References:
Clinical trial NCT04450446: Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves
Official title: Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Hemorrhage
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patients with spontaneous cerebral hemorrhage and mechanical valves from 2015 to 2020 in the second affiliated hospital of Zhejiang university medical college.

Brief summary: The investigators retrospectively reviewed the electronic medical records of the patients with spontaneous cerebral hemorrhage and mechanical valves from 2015 to 2020 in the second affiliated hospital of Zhejiang university medical college. Medical documents and patient data were reviewed, including patient age, gender, type of mechanical heart valve, replacement time, replacement site, underlying disease, anticoagulant drugs at admission, type of cerebral hemorrhage, treatment mode, time without anticoagulant, length of stay, mortality, etc


Eligibility criteria: Inclusion Criteria:

* patients with spontaneous cerebral hemorrhage and mechanical valves

Exclusion Criteria:

* age\<18y
* pregnant patients
* death in 24 hours without anticoagulant

Primary outcomes:
measure: survival and death patients after follow-up investigation for 60 months
timeFrame: 2015-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital,School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: second affiliated hospital,school of medicine, zhejiang university,china
name: libin li, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03175146: A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely
Official title: Stereotactic Body RadioTherapy (SBRT) for Oligo-metastatic Colo-rectal Cancer With Bio-marker Evaluation for Early Progression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Neoplasms
Neoplasm Metastasis
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study will evaluate if "curative intent" SBRT can provide high response rates and clinically meaningful cancer control with acceptable toxicity specifically in patient with metastatic colorectal cancer (mCRC) who do not have surgical options and are no longer responding to systemic therapy

Detailed description: SBRT for Oligo-metastatic Colorectal cancer

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed Colo-rectal Cancer
* 1-3 Liver metastasis measurable on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
* Surgically resected primary disease
* Technically/medically inoperable or patient declined surgery
* Progression or Stability after at least 1 Line of chemotherapy
* Adequate marrow function: Hb \> 80g/L, Platelets \> 100 x 109/L, White blood cell \> 2 x 109/L
* Eastern Cooperative Oncology Group (ECOG) status 0-2
* Age \> 18 years
* Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

* Prior liver radiation, or radiation in close proximity to planned treatment sites
* Prior invasive malignancy
* Severe, active co-morbidity
* Active hepatitis or Child Pugh Score B (9) or worse
* Pregnant or nursing women
* Extra hepatic disease: Any Bone/Any Brain, 2 or more Lung metastasis
* Life expectancy \< 6 mo from any cause
* Concurrent chemotherapy
* Response to prior chemotherapy with minimal measurable disease in liver

Primary outcomes:
measure: Response rate within the treated liver lesion
timeFrame: 6 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: Up to 5 years
measure: Toxicity
timeFrame: From date of randomization up to 5 years
measure: Quality of Life
timeFrame: From date of Randomization to Death or Progression or 5 years whichever comes first.
measure: Median survival
timeFrame: From date of randomization upto 5 years
measure: Overall survival
timeFrame: From date of randomization upto 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Tom Baker Cancer Centre
name: Richie Sinha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02054546: TIMP-2 and IGFBP7 for the Prediction of the Cardiac Surgery Associated Acute Kidney Injury
Official title: Novel Biomarkers (TIMP-2 and IGFBP7) of Tubular Renal Cell Damage for the Prediction of the Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) - A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 110
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: adults with planned cardiac surgery and cardiopulmonary bypass

Brief summary: The purpose of this study is to analyze the new biomarkers (TIMP-2 and IGFBP-7) of tubular renal cell damage for the prediction of the Cardiac Surgery Associated acute kidney injury.


Eligibility criteria: Inclusion Criteria:

* planned cardiac surgery

Exclusion Criteria:

* renal dialysis
* minors
* emergency
* no cardiopulmonary bypass

Primary outcomes:
measure: AKI-stadium 1 (KDIGO)
timeFrame: 30 days
Secondary outcomes:
measure: all cause mortality
timeFrame: 30 days
Other outcomes:
measure: AKI Stadium 2-3 (KDIGO)
timeFrame: 30 days
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jens Fassl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03977246: Effect of Open-placebo Intervention on Cycling Performance
Official title: The Effect of an Open-placebo Intervention on Cycling Time-trial Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Performance
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of an open-label placebo intervention on cycling time-trial performance.

Detailed description: This study investigated the effect of open-placebo on cycling time-trial (TT) performance. Twenty-eight trained female cyclists completed a 1-km cycling TT following a control session or an open-placebo intervention. The intervention consisted of an individual presentation, provided by a medic, in which the concept of open-placebo was explained to the participant, before she ingested two red and white capsules containing flour; 15 min later, they performed the TT. In the control session, the participant sat quietly for 20 min.

Eligibility criteria: Inclusion Criteria:

* Females aged between 18 and 45 years old;
* A minimum of one-year training experience in cycling.

Exclusion Criteria:

* Smokers
* Chronic disease
* Prior or current use of steroids
* Use of creatine in the last 6 months
* Use of beta-alanine in the last 6 months

Primary outcomes:
measure: Exercise performance
timeFrame: 20-min following open-placebo intervention
Secondary outcomes:
measure: Blood lactate
timeFrame: Immediately post-exercise
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
city: Sao Paulo
country: Brazil
facility: School of Physical Education and Sport - USP
Study officials:
affiliation: University of Sao Paulo
name: Bruno Gualano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04105946: Opioid Free Anesthesia in ENT Surgery
Official title: Opioid Free Anesthesia Versus Conventional Total Intravenous Anesthesia for ENT Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Endoscopic Sinus Surgery
Keywords: FESS
Opioid Free Anesthesia
Opioid Consumption
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Opioid Free Anesthesia (OFA) - which has been applied mainly in bariatric surgery - has begun to receive more and more attention and to obtain fanatical supporters versus conventional anesthesia. The advantages of this type of anesthesia are mainly achieved by the action and effect of the various drugs that compose it.

Functional Endoscopic Sinus Surgery is performed in cases where sinusitis or its complications are difficult to treat with medication. With special cameras and endoscopes, the narrow anatomical regions of the sinus can be depicted and precisely surgically approached. Usually surgery is conducted under general anesthesia. According to the literature, total intravenous anesthesia should be used for sinus surgery to achieve blood pressure control as well as controlled hypotension to prevent intraoperative bleeding. Most of the studies agree that the best type of anesthesia for this type of surgery is total intravenous anesthesia. When it comes to Opioid Free Anesthesia in FESS, there are not many studies, except of some studies that don't use solely Opioid Free Anesthesia but some of the drugs that consist it.

Patients scheduled for elective Functional Endoscopic Sinus Surgery will be randomised in two groups. One receiving OFA and one receiving TIVA.


Eligibility criteria: Inclusion Criteria:

* Patients 18 - 75 years old
* Elective FESS

Exclusion Criteria:

1. Patients \< 18 or \>75 years of age
2. Patients who can't read of speak the Greek language
3. Patients with psychiatric disorders
4. Patients with atrioventricular block in ECG
5. Patients with musculoskeletal disorders
6. Patients with coronary artery disease
7. Patients uncapable of giving informed consent

Primary outcomes:
measure: Pain management
timeFrame: 48 hours
measure: Intraoperative bleeding in the surgical field
timeFrame: intraoperatively
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 48 hours
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Univeristy of Thessaly
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Elena Arnaoutoglou, MD, PhD
role: STUDY_CHAIR
affiliation: University of Thessaly
name: Ioannis Chatzioannou, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital of Larissa
name: Dimitra Papaspirou, MD
role: PRINCIPAL_INVESTIGATOR
References: