louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04915625: A Prediction Model of 28-day Mortality in Septic Shock
Official title: A Prediction Model of 28-day Mortality in Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Keywords: mortality
Predictive model
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sepsis shock patients admitted to our hospital

Brief summary: This clinical study adopts the design of cohort research, selects the sepsis shock patients admitted to our hospital ICU as the research object, takes the 28-day mortality rate as the outcome index, collects the baseline data of the patient, the severity of the disease, vital signs, the main infection site, the laboratory-related index, the treatment method and other data, screens out the risk factors affecting the sepsis shock 28-day mortality rate and constructs the prediction model accordingly, analyzes the prediction model with the subject's working characteristic curve (ROC). The recognition ability of the model is calculated by the area under the ROC curve (AUC) and the ability of the model to predict 28-day mortality with SOFA and APACHE II.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years of age, gender-neutral;
2. Diagnosed with sepsis shock;
3. ICU survives longer than 48 h;
4. The preservation of clinical data is complete;

Exclusion Criteria:

- Diagnosed with sepsis shock within 6 hours of emergency treatment; Combined with people with autoimmune diseases; 3. Organ transplantation or immunosuppressive treatment; 4. Severe heart, liver and kidney insufficiency; 5. Late stage of malignant tumor; 6. Maternity; 7. Referral or referral to another hospital;

Primary outcomes:
measure: All causes of 28 days mortality
timeFrame: 28 days
Secondary outcomes:
measure: ICU hospitalization time
timeFrame: 2 years
measure: hospitalization mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: ZHIJUN XU, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04922125: Food Structure of Pulses and Satiety
Official title: Impact of Pulse Processing on Feelings of Appetite and Satiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2021-06-10
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A single-blind, randomised crossover design with one arm.
Primary purpose: PREVENTION

Brief summary: Diets containing (whole) pulses have been associated with the potential to increase satiety (and acute food intake). In vitro digestion studies of pulses have shown that (thermal) processing has the potential to modulate macronutrient digestion kinetics. Changes in food (micro)strucutral properties have been identified to retard nutrient release, with a possible effect on appetite sensations. Based on distinct in vitro digestion behaviour, two differently processed pulse meals were chosen to be investigated in humans with the aim to confirm in vitro findings and gain a mechanistic understanding of the influence of structural aspects of pulses on appetite sensations.


Eligibility criteria: Inclusion Criteria:

* BMI (between 18 and 30 kg/m2)
* Healthy men
* Age between 18-45
* Regular breakfast eaters (≥ 4 times a week)
* No allergies

Exclusion Criteria:

* Chronic diseases (diabetes, cardiovascular diseases, or other metabolic diseases that could affect the study)
* Use of daily prescription medicine
* Use of dietary supplements that could affect appetite (used within the last month up to or during the study)
* Smoking or use of any nicotine product (used daily within the last three months up to or during the study)
* Over 10 h of strenuous physical activity per week
* Participation in other clinical studies (participation within the last month up to the study or during the study)
* Food allergies
* Weight change of more than ±3 kg from screening until the trial will be completed
* Inability to comply with the procedures required by the study (including an 8-10 h fast before the trial days).

Primary outcomes:
measure: Self-reported appetite assessment throughout the appetite test days
timeFrame: 2.5 hours
Secondary outcomes:
measure: Secondary Energy Intake (kJ) of ad libitum meal
timeFrame: 30 min
measure: Satiety quotient (SQ)
timeFrame: 30 min
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Food Science/ Section for Food Design and Consumer Behaviour
Study officials:
References:
Clinical trial NCT02449525: Extracorporeal Perfusion of Microvascular Free Flaps
Official title: Extracorporal Perfusion of Free Flaps in the Head and Neck
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perfusion
Complication of Perfusion
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The perfusion of microvascular free flaps is inevitable for completion of reconstruction in the head and neck area. In some patients microvascular anastomosis is impossible because of arteriosclerotic changes, different oncological interventions, and consecutive vessel depletion at the neck. The aim of the project is to establish an innovative system for extracorporeal perfusion of microvascular free flaps after ingrowth of new vessels from the wound bed have taken place. Afterwards, no further perfusion of the vascular pedicle is required for free flaps to survive and provide functional and aesthetic reconstruction.


Eligibility criteria: Inclusion Criteria:

* Vessel depleted neck
* defect in the head and neck area

Exclusion Criteria:

* active oncological disease
* vessels suitable for microvascular anastomosis and reconstruction

Primary outcomes:
measure: Perfusion of Free Flap from wound bed
timeFrame: Two Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Oral and Maxillofacial Surgery, Technische Universität München
Study officials:
affiliation: Technical University of Munich
name: Klaus-Dietrich Wolff, Univ.-Prof.
role: STUDY_DIRECTOR
References:
citation: Fichter AM, Ritschl LM, Rau A, Schwarzer C, von Bomhard A, Wagenpfeil S, Wolff KD, Mucke T. Free flap rescue using an extracorporeal perfusion device. J Craniomaxillofac Surg. 2016 Dec;44(12):1889-1895. doi: 10.1016/j.jcms.2016.09.010. Epub 2016 Sep 23.
citation: Wolff KD, Mucke T, von Bomhard A, Ritschl LM, Schneider J, Humbs M, Fichter AM. Free flap transplantation using an extracorporeal perfusion device: First three cases. J Craniomaxillofac Surg. 2016 Feb;44(2):148-54. doi: 10.1016/j.jcms.2015.11.007. Epub 2015 Dec 1.
Clinical trial NCT04799925: Hyperuricemia and Diabetic Nephropathy
Official title: Effect of Treatment of Hyperuricemia on Progression of Diabetic Nephropathy in Patients With Type II Diabetes Mellitus and Stage III Chronic Kidney Disease.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperuricemia
Diabetic Nephropathies
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-16
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: Patient population will include both males and females above the age of 18 years with T2DM and Diabetic Nephropathy stage 3 CKD (eGFR: 31-59).

Brief summary: The purpose of the study is to detect the effect of treatment of hyperuricemia on eGFR (Estimated Glomerular Filtration Rate) as an objective criterion for assessment of progression of diabetic nephropathy in patients with Type 2 Diabetes Mellitus.

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry.

At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Febuxostat (80 mg, once daily) or Placebo (once daily) in patients with Type 2 Diabetes Mellitus and Stage 3 Chronic Kidney Disease (Estimated Glomerular Filtration Rate 31:59).

Eligibility criteria: Inclusion Criteria:

* Patient population will include both males and females above the age of 18 years with T2DM and Diabetic Nephropathy stage 3 CKD (eGFR: 31-59).

Exclusion Criteria:

* Patients with history of hypothyroidism, alcoholism, urinary tract infections, glomerulonephritis, myeloproliferative disorders and gout "as gout is a common inflammatory arthropathy characterized by painful and swollen joints resulting from precipitating uric acid crystals but hyperuricemia is commonly asymptomatic" or on drugs capable of inducing Hyperuricemia will be excluded from the study.
* Any patient will develop acute kidney injury episode at any time of the study will be excluded from the study.
* Patients with uncontrolled hypertension will be excluded from the study.

Primary outcomes:
measure: Effect of treatment of hyperuricemia on estimated Glomerular Filtration Rate by the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.
timeFrame: 6 months from September 2021 to march 2022.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04464525: Omecamtiv Mecarbil Post-trial Access Study
Official title: Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Chronic Heart Failure With Reduced Ejection Fraction
Lead sponsor: Cytokinetics
Sponsor class: INDUSTRY
First posted: 2020-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to provide access to omecamtiv mecarbil for participants who have completed GALACTIC-HF 20110203.

Detailed description: This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Eligibility criteria: Inclusion Criteria:

* Participant has provided GALACTIC-HF PTA informed consent prior to initiation of any study specific activities/procedures.
* Participant has completed GALACTIC-HF.

Exclusion Criteria:

* Investigational product was permanently discontinued during GALACTIC-HF due to protocol-specified reason.
* Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 days after the last dose of treatment.
* Female participants of childbearing potential unwilling to use 2 acceptable methods of effective contraception during treatment with OM and for an additional 5 days after the last dose of treatment.
* Female participants of childbearing potential with a positive pregnancy test assessed on day 1 by a urine pregnancy test.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* History or evidence of any clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.

Primary outcomes:
measure: Number of participants administered omecamtiv mecarbil during the treatment period
timeFrame: Up to 252 weeks
Secondary outcomes:
Other outcomes:
measure: Participant incidence of serious adverse events and treatment emergent adverse events
timeFrame: Up to 252 weeks
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00387725: Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
Official title: A Randomized, Observer-blinded, Parallel-group, Active-control, Phase ½ Trial Of The Safety, Immunogenicity, And Tolerability Of 20 Mg, 60 Mg, And 200 Mg Of Meningococcal Group B Rlp2086 Vaccine In Healthy Children And Adolescents Aged 8 To 14 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Adolescent
Meningococcal
Safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 127
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria

* Aged 8 to 14 years at the time of enrollment.
* Healthy male or female subjects
* Negative urine pregnancy test for female subjects

Exclusion Criteria:

Exclusion Criteria

* Prior vaccination with a meningococcal B vaccine
* Prior meningococcal disease

Primary outcomes:
measure: Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2
timeFrame: 1 month after Dose 2
measure: Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3
timeFrame: 1 month after Dose 3
measure: Percentage of Participants With at Least One Adverse Event (AE)
timeFrame: Dose 1 up to 1 month after Dose 3
Secondary outcomes:
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Herston
country: Australia
facility: Royal Children's Hospital
state: Queensland
city: Subiaco
country: Australia
facility: Princess Margaret Hospital for Children
state: Western Australia
city: Herston
country: Australia
facility: Sir Albert Sakzewski Virus Research Centre (SASVRC)
city: North Adelaide
country: Australia
facility: Women's & Children's Hospital
city: Subiaco
country: Australia
facility: The Telethon Institute for Child Health Research
city: Westmead
country: Australia
facility: National Centre for Immunisation
city: Woden
country: Australia
facility: Department of Paediatrics and Child Health
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01214525: The Improvement in Uroflow and Postvoid Residual Urine After Urethral Meatotomy in Children With Meatal Stenosis
Official title: The Improvement in Uroflow and Postvoid Residual Urine After Urethral Meatotomy in Children With Meatal Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urethral Meatal Stenosis
Keywords: Meatal stenosis
Meatotomy
Uroflow
Postvoid residual
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-10-05
Enrollment: 25
Sex: MALE
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Toilet trained children, before puberty, scheduled for urethral meatotomy for the treatment of urethral meatal stenosis.

Brief summary: The improvement in uroflow and postvoid residual urine in children after urethral meatotomy for meatal stenosis. The hypothesis is that there is an improvement in both parameters, thus justifying the procedure.

Detailed description: Urethral meatal stenosis is a known complication of circumcision occuring in up to 3% of newborns undergoing circumcision. It is customary to perform a meatotomy in order to prevent bladder outlet obstruction, although bladder outlet obstruction has never been proven and improvement has only been proved in a single, small, retrospective study. Our intention is to evaluate the improvement in objective parameters (uroflow and postvoid residual urine) after urethral meatotomy by measuring these parameter before the procedure, one month after the procedure and one year after the procedure. Symptoms assessment will also be performed.

Eligibility criteria: Inclusion Criteria:

* Toilet trained children
* Before puberty
* No other urologic disease that might affect the measurements
* Primary (first) repair

Exclusion Criteria:

* Children unable to urinate on command
* Children that have started their sexual puberty
* Children with other urologic disease that might affect the study measurements
* Recurrent stenosis after previous repair

Primary outcomes:
measure: Improved maximal urine flow
timeFrame: one month and one year
Secondary outcomes:
measure: Improved (reduced) postvoid residual urine
timeFrame: One month and one year
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Itay A Sternberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meir Medical Center
name: Amos Neheman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: VanderBrink BA, Gitlin J, Palmer LS. Uroflowmetry parameters before and after meatoplasty for primary symptomatic meatal stenosis in children. J Urol. 2008 Jun;179(6):2403-6; discussion 2406. doi: 10.1016/j.juro.2008.01.169. Epub 2008 Apr 23.
Clinical trial NCT03821025: Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction
Official title: Treatment of Malignant Distal Biliary Obstruction - a Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bile Duct Obstruction, Extrahepatic
Cancer of the Pancreas
Cancer of the Bile Duct
Biliary Stricture
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 150
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 randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.


Eligibility criteria: Inclusion Criteria:

* 18years of age or older
* informed consent obtained after oral and written information
* clinical data in accordance with a malignant bile duct obstruction
* imaging evidence: (ultrasonography (US), computed tomography (CT) or magnetic resonance imaging (MRI) shows signs of extrahepatic malignant common bile duct obstruction
* typical ERCP findings of a malignant common bile duct stenosis
* proximal margin of the bile duct stenosis ≥2 cm from the hepatic confluence
* bilirubin \> 50 micromol/L
* radical surgery not deemed possible

Exclusion Criteria:

* patients with active hepatitis or other jaundice-causing hepatic diseases
* informed consent not obtained or patient unable to give informed consent
* patients with no understanding of English, Afrikaans or Xhosa where it is not possible to obtain informed consent
* metastasis with multiple significant intrahepatic stenosis causing blockage of one or more segments of the liver (liver metastasis otherwise not an exclusion criteria)
* the patient is a possible candidate for surgical resection
* suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations)
* the proximal end of the stenosis is \< 2 cm from the hepatic confluence
* previous BII or Roux-en-Y gastric reconstruction
* significant duodenal obstruction making ERCP difficult
* previous bile duct stent

Primary outcomes:
measure: Number of patients without stent failure
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival
timeFrame: 12 months
measure: Stent deployment failure
timeFrame: During procedure
measure: Cost
timeFrame: 12 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
Study officials:
References:
Clinical trial NCT00866125: Hand Function in Patients With Poly- or Dermatomyositis
Official title: Hand Function, Health Related Quality of Life and Activity Performance in Patients With Polymyositis or Dermatomyositis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polymyositis
Dermatomyositis
Keywords: Polymyositis
Dermatomyositis
Grip force
Quality of life
Activity performance
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2009-03-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 50 patients diagnosed with polymyositis or dermatomyositis were identified through the myositis registry at the rheumatology clinic at Karolinska University Hospital, Stockholm, Sweden.

Brief summary: The aim of this study is to investigate the hand function in patients with poly-and dermatomyositis and compare this to healthy individuals and norm values and secondly if hand function correlates to activity performance and health related quality of life.

The study is a cross-sectional study. To assess hand function the investigators will measure grip force with Grippit and arm/hand mobility using EPM-ROM scale. The activity performance will be measured with Myositis Activities Profile and health related quality of life will be assessed with SF-36.

The investigators' hypothesis is that hand function is reduced in comparison to the healthy population and that hand function affects both activity performance and health related quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients with definite or probable polymyositis or dermatomyositis (according to criteria by Bohan and Peter) were included in the study

Exclusion Criteria:

* Other diseases or injuries that could affect arm/hand mobility and grip force for example other rheumatological or neurological disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Ingrid E Lundberg, MD, PhD
role: STUDY_DIRECTOR
References: