louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04078477: Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care
Official title: Prevention of Pressure Ulcer by Lateral Tilt Bed in Neurocritical Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pressure Ulcer
Keywords: Pressure Ulcer
Neurocritical Care
Acute Brain Disease
Unconsciousness
Preventive Strategy
Lead sponsor: Regional Hospital Liberec
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
First posted: 2019-09-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention: parallel assignment. Blind for statisticians: statisticians from a different institution will only know type A or B randomization.
Primary purpose: PREVENTION

Brief summary: Patient positioning is an essential part of a preventive strategy for neurocritical care patients.

The aim of the study will be to determine whether the positioning of the bed is the same or better compared to the positioning of the patient's bed in the presence of pressure ulcer.

Detailed description: In the monocentric, intervention, prospective, randomized study, we will investigate incidence of pressure ulcer in 300 adult consecutive patients admitted to our Neurointensive Care Unit (NICU). All patients will suffer from acute primary brain disease and will be unconscious with artificial pulmonary ventilation.

Eligibility criteria: Inclusion Criteria:

* Primary brain disease
* Hospitalization in JIP neurocenter
* Age\> 18 years
* Unconsciousness
* Artificial pulmonary ventilation

Exclusion Criteria:

* Intracranial hypertension
* Decubitus on the skin upon admission

Primary outcomes:
measure: Incidence of pressure ulcer
timeFrame: Through study completion, on average every 24 weeks.
Secondary outcomes:
measure: Prolonging the stay in the NICU
timeFrame: Through study completion, on average every 24 weeks.
measure: Cost effectiveness of patient´s NICU stay
timeFrame: Through study completion, on average every 24 weeks.
Other outcomes:
Locations:
city: Liberec
country: Czechia
facility: Regional Hospital Liberec
Study officials:
affiliation: Department for Science and Reseach
name: Vendula Machackova, MSc., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05663177: Almonertinib Plus Metronomic Oral Vinorelbine
Official title: Almonertinib Plus Metronomic Oral Vinorelbine Beyond Limited Progression on Third-generation TKI in EGFR-mutant Advanced NSCLC，an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: EGFR
NSCLC
Third-generation TKI
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-12-23
Enrollment: 40
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: EGFR-mutant advanced NSCLC, disease progression on the third-generation TKI

Brief summary: To evaluate the efficacy of continuing osimertinib in conjunction with metronomic oral vinorelbine after limited progression on osimertinib, to provide clinical experience on the treatment strategy for these patients.

Detailed description: This study is a clinical observation study. The patients who comfirm the criteria will be treated with Almonertinib plus metronomic oral vinorelbine. The patients will be followed up until the tumor progressed, and the efficacy (PFS, ORR, DCR) of tumor therapy were evaluated.

Drug administration regimen: Ametinib 110mg once a day; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.

Eligibility criteria: Inclusion Criteria:

* Non-small cell lung cancer diagnosed by histopathology or cytology;
* Previous molecular pathology was EGFR sensitive mutation;
* Stage IV;
* ECOG score 0-2;
* Prior to receiving the third generation of EGFR-TKI targeted therapy, and TKI targeted therapy showed limited progress;
* According to RECIST1.1 standards, there are measurable or evaluable lesions
* The patient has fully understood this study and voluntarily signed a written informed consent form;
* The estimated survival time is more than 3 months.

Exclusion Criteria:

* Histological or cytological confirmation of small cell lung cancer or squamous cell carcinoma at the first diagnosis;
* The progression of the third generation EGFR-TKI suggests histological transformation.

Primary outcomes:
measure: PFS
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes:
measure: ORR
timeFrame: up to 12 months
measure: DCR
timeFrame: up to 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01170377: Effect of Valproate on Propofol
Official title: The Effect of Valproate on the Required Dose of Propofol for Sedation in Patients With Mental Retardation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Retardation
Keywords: Intravenous sedation
Dental treatment
Mental retardation
Antiepileptic drug
Valproate
Propofol
Lead sponsor: Okayama University
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with mental reterdation

Brief summary: The aim of this study is to evaluate the effect of valproate on the required dose of propofol for sedation in patients with mental retardation.

Detailed description: The intravenous sedation with propofol is very useful for patients with mental retardation and challenging behavior. However, it is very difficult to titrate the dose of propofol for maintaining the adequate sedation depth because of the difficulty of verbal communication with them. Most of them have a epilepsy and take antiepileptic drugs. Antiepileptic drugs are thought to influence on the effect of anesthetics. Valproate is reported to inhibit the metabolism of propofol. Therefore, we divide the patients into two groups : patients receiving valproate (valproate group), patients receiving no antiepileptic drugs (control group), and compare the required dose of propofol and the recovery time.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 16 or over
2. American Society of Anesthesiologists (ASA) physical status 1 or 2
3. The treatment of dental caries, endodontics, periodontics and prosthesis were planed
4. Participants had moderate or severe Mental Retardation, and were not completely cooperated with dental treatment

Exclusion Criteria:

1. Patients could communicate and cooperate with dental treatment, but used dental sedation for decrease of the anxiety and the fear about dental treatment or another reasons
2. Patients needed premedication and inhalational anesthetics
3. Patients had uncontrolled or sever medical condition

Primary outcomes:
measure: The dose of anesthesia agent
timeFrame: 1 day
measure: The recovery time of eyelash reflex
timeFrame: 1 day
measure: The recovery time of eye opening
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Okayama
country: Japan
facility: Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Study officials:
affiliation: Department of Dental Anesthesiology and Special Care Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
name: Minako Ishii, D.D.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01507077: ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity
Official title: ZGN-440 (Beloranib for Subcutaneous Injection), A Novel Methionine Aminopeptidase 2 Inhibitor for Treatment of Obesity: A Randomized Double-Blind Placebo Controlled Dose Escalation Phase 1b Trial to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Initial Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obese
Obesity
Overweight
Lead sponsor: Zafgen, Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-10
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety, and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).

Detailed description: This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-440). It is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing potential. The study will provide information on how much ZGN-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.

Eligibility criteria: Inclusion Criteria:

* Obese but otherwise healthy females
* Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months)
* BMI ≥ 30 and ≤ 45 kg/m2
* Stable body weight during the past 2 months

Exclusion Criteria:

* Use of weight loss agents in the past month
* History of eating disorder
* History of type 1 or type 2 diabetes mellitus
* Current smokers

Primary outcomes:
measure: Demonstrate safe doses of ZGN-440 for reduction of body weight in obese female volunteers.
timeFrame: Approximately 4 weeks
Secondary outcomes:
measure: Incidence, severity and dose-relationship of adverse events as well as changes in physical examinations, ECGs, vital signs and/or laboratory evaluations as a measure of safety and tolerability.
timeFrame: Approximately 4 weeks
measure: Peak plasma concentration of ZGN-440 to assess relationship to weight loss.
timeFrame: Approximately 4 weeks
measure: Elimination half-life of ZGN-440 to assess relationship to weight loss.
timeFrame: Approximately 4 weeks
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Q-Pharm Clinics, Royal Brisbane and Women's Hospital
state: Queensland
Study officials:
affiliation: Q-Pharm Clinics, Royal Brisbane and Women's Hospital
name: J K Marjason, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02397577: Reference Values for Gastric Emptying
Official title: Normal Values for Gastric Emptying in a 13C-octanoate Breath Test Using a Solid Test Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Gastric Emptying
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2015-03-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Healthy volunteers will ingest a 13C-octaoate containing test meal and 13C in expiratory air will be followed. Normal values will be calculated data of these tests.

Detailed description: This is a clinical study for establishing reference values in a 13C-octanoate breath test and a 13C-sodium acetate breath test. Healthy volunteers (n=75) will eat a solid test meal of scrambled eggs and toast containing 13C-octanoate. 13C-content of exhaled air will be measured at baseline and followed for the next 4 hours. One week later, the healthy volunteers (n=75) will drink a standardized nutritional shake (Ensure Plus Vanille, Abbott) containing 13C-sodium acetate. 13C-content of exhaled air will be measured at baseline and for the next 4 hours. Estimated gastric emptying time will be calculated using established algorithms.

Eligibility criteria: Inclusion Criteria:

* Subjects free of relevant abdominal complaints
* Written informed consent

Exclusion Criteria:

* Age under 18
* Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders)
* Known diabetes mellitus, scleroderma, neurological impairment or other major current disease
* Subjects unable to stop medication that alters gut function for 1 week prior to the study, including anticholinergics, calcium canal inhibitors, beta blocker, prokinetics, proton-pump inhibitors, DDV-IV-Inhibitors, Inkretin-mimetica, non-steroidal anti-inflammatory drugs, macrolid antibiotics
* Pregnancy beyond week 12 (no pregnancy test will be performed)
* Involvement in any other clinical trial during the course of this trial, nor within a period of 14 days prior to its beginning or 14 days after its completion
* Known allergy or intolerance against hen egg protein or gluten

Primary outcomes:
measure: Half gastric emptying time t50 according to Ghoos et al. (t50_Ghoos)
timeFrame: 4 hours after test meal
Secondary outcomes:
measure: t50 according to Bluck & Coward (t50_Bluck)
timeFrame: 4 hours after test meal
measure: t50 according to Wagner & Nelson (t50_WN)
timeFrame: 4 hours after test meal
measure: Gastric emptying coefficient (GEC)
timeFrame: 4 hours after test meal
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Division of Gastroenterology, University Hospital Zurich
Study officials:
References:
Clinical trial NCT02957877: LMWH Infusion as Anticoagulation for Home HD
Official title: Low-molecular Heparin Infusion as Anticoagulation for Nocturnal Home Hemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Endstage Renal Disease
Keywords: Anticoagulation
Anti-Xa activity
Low-molecular weight heparin
Unfractionated heparin
Lead sponsor: Alice Ho Miu Ling Nethersole Hospital
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There is a lack of data in the literature about the use of low-molecular weight heparin (LMWH) as anticoagulation for nocturnal home hemodialysis (NHHD). This study aims to evaluate the efficacy and safety of LMWH, administered by infusion method, as compared to unfractionated heparin as anticoagulation for NHHD treatment.

Detailed description: Low-molecular weight heparin (LMWH) and unfractionated heparin (UFH) are established systemic anticoagulants for the patients who receive conventional thrice-weekly hemodialysis in absence of significant bleeding risk. For the patients who undergo nocturnal home hemodialysis (NHHD), LMWH is seldom utilized because of the need of an additional bolus injection during a long dialysis treatment, which is impractical as the patients are sleeping during hemodialysis. Moreover, there is a potential risk of LMWH accumulation due to its longer half-life. As there is a paucity of data in the literature on the use of LMWH for NHHD treatment, this trial is conducted to assess the safety and efficacy of LMWH, administered by infusion method, in this particular group of dialysis patients.

Eligibility criteria: Inclusion Criteria:

* Prevalent NHHD patients who have received \>1 year dialysis with unfractionated heparin as anticoagulant
* Age \>= 18
* Informed consent available

Exclusion Criteria:

* History of intolerance to LMWHs during HD
* Receiving warfarin or other oral anticoagulant
* Pregnant patients

Primary outcomes:
measure: Prothrombin time
timeFrame: Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis
measure: Activated partial thromboplastin time
timeFrame: Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis
measure: Anti-Xa level
timeFrame: Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis; 24 hours after administration of LMWH
measure: Dialyser urea and creatinine clearances
timeFrame: At 15 mins after starting hemodialysis and 15 mins before the end of hemodialysis
measure: Dialyser thrombus score
timeFrame: At the end of hemodialysis (8th hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
Study officials:
affiliation: Alice Ho Miu Ling Nethersole Hospital
name: Steve Siu-Man Wong, MBChB, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01364077: Ivabradine in Hemodialysed Patients With Increased Heart Rate
Official title: Efficacy and Safety of Ivabradine in Hemodialysed Patients With Increased Heart Rate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: High Heart Rate
Keywords: Heart rate
Dialysis
ESRD
ivabradine
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 100
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 significant association between resting heart rate (HR) and both all-cause mortality and cardiovascular mortality has been demonstrated in numerous epidemiologic studies for both the general population and for patients with cardiovascular disease.

Cardiac disease is the leading cause of death among hemodialysis (HD) patients a recent study reported that the 48-hr mean HR is an independent predictor of cardiovascular events in normotensive hemodialysis patients.

Ivabradine, a pure HR lowering agent,acting on If current inhibition has proven beneficial antianginal effects and mortality reduction linked to HR reduction in ischemic patients.

Aim:

To evaluate the safety and efficacy of ivabradine in normotensive hemodialysed patients with increased pre-dialysis HR (\> 80 bpm)


Eligibility criteria: Inclusion Criteria:

* Dialysis patients
* Sinus rhythm
* Pre-dialytic Heart rate \> 80 bpm

Exclusion Criteria:

* Atrial fibrillation/atrial flutter
* Heart failure
* Valvular disease

Primary outcomes:
measure: Heart rate
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients that experienced hypotension
timeFrame: 1 year
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Chair of Cardiology
Study officials:
affiliation: Second Univesity of Naples
name: Gennaro Cice, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00149877: Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
Official title: Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Constipation
Keywords: Chronic constipation, tegaserod
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients with CC.


Eligibility criteria: Inclusion Criteria:

* Male and females of at least 18 years of age
* A 12-month history of constipation (defined as \< three spontaneous bowel movements per week and ≥1 of the following symptoms \>25% of the time: hard stools, sensation of incomplete evacuation and straining)

Exclusion Criteria:

* Patients with cancer, inflammatory bowel disease or other structural bowel disease
* Patients who participated in a prior tegaserod study
* Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.
Secondary outcomes:
measure: Number of csbm during 8 weeks of treatment.
measure: Daily assessment of bowel habits:frequency, form, straining, feeling of complete evacuation.
measure: Daily patients' assessment: bowel habits, constipation, distention/bloating, abdominal discomfort pain.
measure: Laxative use.
measure: Safety and tolerability.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Basel
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT06545877: REKOVELLE PEN for S.C. Injection General Drug Use Survey (Controlled Ovarian Stimulation in Assisted Reproductive Technologies)
Official title: REKOVELLE® PEN S.C. Injection 12μg/36μg/72μg for Controlled Ovarian Stimulation in Assisted Reproductive Technologies - General Drug Use-results Survey
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are undergoing assisted reproduction (ART) such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

Brief summary: This survey targets controlled ovarian stimulation with this drug for the development of multiple oocytes in women undergoing assisted reproduction (ART) such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).


Eligibility criteria: Inclusion Criteria:

* Participants who received the REKOVELLE in controlled ovarian stimulation in assisted reproductive technologies and have consented to participate in the survey.

Exclusion Criteria:

* No exclusion criteria because data are collected under conditions of use in daily practice.

Primary outcomes:
measure: Adverse Events
timeFrame: From initiation of the administration, in case of embryo transfer is not performed, until 1 week after oocyte collection, and in case embryo transfer is performed, 6 weeks after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Omitama
country: Japan
facility: Ferring Investigational Site
state: Ibaraki
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
Clinical trial NCT04694677: Safety of Tranexamic Acid in Reducing Blood Loss Myomectomy.
Official title: Safety of Tranexamic Acid Versus Misoprostol in Reducing Blood Loss in Myomectomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myoma
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2021-01-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Uterine leiomyomas (fibroids) are the most common benign tumors among women . Fibroids are found in approximately 15% to 30% of women in the reproductive age group

Detailed description: Although most of them are asymptomatic, 20-50% of fibroids may cause problems such as heavy menstrual bleeding, anemia, pelvic pain, pressure symptoms from extrinsic compression of the colorectal and urinary tract, infertility, and recurrent pregnancy losses, where surgical intervention is often indicated

Eligibility criteria: Inclusion Criteria:

* women with myomas

Exclusion Criteria:

* with with malignant lesions

Primary outcomes:
measure: the number of women who will have less blood loss
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algezeera hospitaland National Research Centre ,Egypt
name: Mahmoud Alalfy
role: STUDY_DIRECTOR
References: