louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01322087: Does the Access to Small Delicious Dishes, Have a Positive Effect on Nutritional Intake in Patients at Nutritional Risk?
Official title: Does the Access to Small Delicious Dishes, 24 Hours a Day, Have a Positive Effect on Nutritional Intake in Patients at Nutritional Risk?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Nutrition
new energy dense food concept
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Rationale:

The objective of this study was to investigate whether a new energy dense food concept, on order 24 hours a day, would lead to a minimum 75% intake of nutritional needs in patients at nutritional risk. The investigators target was for 70% of patients to reach 75% of their energy and protein requirements.

Methods:

An intervention study was conducted with inclusion of 40 patients at nutritional risk, according to the NRS-2002 criteria. The food concept consisted of 36 small delicious dishes. Patients could choose food from both the new concept and the ordinary patient buffet. The investigators monitored patients' nutritional requirements and daily nutritional intake.


Eligibility criteria: Inclusion Criteria:

* patients at nutritional risk, according to the NRS-2002 criteria.
* patient must be able to understand the information and be able to give a written inform consent
* well-functioning gastrointestinal tract
* Anticipated length of hospitalization \> 5 days
* Should understand and speak danish

Exclusion Criteria:

* Terminal patients
* patients with dysphagia
* patient with food allergy or intolerance
* patients who only receives enteral or parenteral nutrition

Primary outcomes:
measure: Change in energy and protein intake compared to the historical control group
timeFrame: 3 to 7 days recording of dietary intake
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Copenhagen University Hospital at Herlev
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Tina Munk, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06028087: Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment
Official title: Real-World Mapping Antithrombotic Regimens in Multiple Myeloma Patients on Treatment (The MAMMOTH Study of the GIMEMA Working Party on Hemostasis and Thrombosis)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Diagnosis
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 736
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: Adult patients with a newly diagnosis of symptomatic Multiple myeloma treated at the Italian haematological Centers of the GIMEMA network. Patients will be enrolled prior to any treatment for MM.

Brief summary: The goal of this observational study is to learn about antithrombotic regimens in Multiple myeloma patients. The main question it aims to answer is the efficacy of different types of thromboprophylaxis (antiplatelet agents, heparins, oral anticoagulants) in preventing venous thromboembolism (VTE).

Detailed description: This is an observational prospective cohort study aimed at assessing the efficacy of different types of thromboprophylaxis in MM patients; the setting is the GIMEMA network of the Italian haematological Centers.

The observation time for each patient will be of 3 years from the start of the active treatment for MM. Patients will remain in the study regardless of the stage of disease, type of treatment (induction, transplantation, maintenance), type of antithrombotic prophylaxis, occurrence of thrombosis.

Four cohorts will be identified: cohort 1 will include patients without thromboprophylaxis, cohort 2 will include patients receiving antiplatelet agents, cohort 3 will include patients receiving heparins, and cohort 4 will include patients receiving oral anticoagulants.

Eligibility criteria: Inclusion Criteria:

1. Age equal to or greater than 18 years of age.
2. New diagnosis of symptomatic MM according to the CRAB or the SLIM criteria of the International Myeloma Working Group
3. First active treatment for MM started after recruitment in the study
4. Signed informed consent

Exclusion Criteria:

1. Patients having had thrombosis within 6 months before diagnosis of MM
2. Patients with need of combined antithrombotic regimens (i.e. VKA or DOAC or LMWK and one or two antiplatelet drugs)
3. Ongoing first active treatment for MM initiated before the starting of the study.

Primary outcomes:
measure: Rate of venous thromboembolism according to different thromboprophylaxis strategies
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS UOC Servizio e DH di Ematologia
Study officials:
affiliation: Università Cattolica, Fondazione Policlinico A. Gemelli IRCCS, Roma
name: Valerio De Stefano
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00392587: A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)
Official title: A Randomised, Double-blind, Placebo-controlled Parallel Study to Assess the Safety, Tolerability,Pharmacodynamics and Steady State Pharmacokinetics of Repeated Doses of GW856553 in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Pharmacodynamics
Pharmacokinetics
Tolerability
COPD
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
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 assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days.


Eligibility criteria: Inclusion criteria:

* Women of childbearing potential
* Established history of COPD
* Cigarette smoking history greater than 10 pack years
* FEV1 between 40 and 80% of predicted normal for height, age and sex.

Exclusion criteria:

* Morbidly obese patients (body mass index \>40)
* Hospitalisation or treatment for worsening of COPD in past 6 weeks
* History of increased liver function tests
* hypersensitivity to salbutamol or ipratropium bromide
* Blood pressure \> 155/95

Primary outcomes:
measure: Measurements of adverse events, changes in heart rate, blood pressure, blood tests, heart function and lung function throughout the 14 day study. Exacerbations of COPD over the 14 day study.
timeFrame: 14 days
Secondary outcomes:
measure: Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing.
timeFrame: after 7 and 14 days of dosing
measure: Concentration of the drug in the blood after 1, 3, 7, 10 and 14 days of dosing.
timeFrame: after 1, 3, 7, 10 and 14 days of dosing
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Grosshansdorf
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Yang S, Lukey P, Beerahee M, Hoke F. Population pharmacokinetics of losmapimod in healthy subjects and patients with rheumatoid arthritis and chronic obstructive pulmonary diseases. Clin Pharmacokinet. 2013 Mar;52(3):187-98. doi: 10.1007/s40262-012-0025-6.
Clinical trial NCT04917887: Long-Term Follow-up Protocol
Official title: A Prospective, Observational, Long-Term Follow-Up (LTFU) Study to Evaluate the Long-Term Safety of the Krystal Biotech, Inc. Gene Therapy Backbone Products Using HSV-1 Backbone
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dystrophic Epidermolysis Bullosa
Recessive Dystrophic Epidermolysis Bullosa
Dominant Dystrophic Epidermolysis Bullosa
Lead sponsor: Krystal Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who received at least one treatment of gene therapy from a Krystal Biotech, Inc. sponsored study, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of a prior parent treatment protocol. However, if a participant enrolls in a different Sponsor gene therapy trial during the LTFU phase this participant will be dropped out from the study.

Brief summary: The main objective of this prospective, observational, long-term follow-up (LTFU) study is to evaluate the long-term safety profile of the gene therapy products evaluated by Krystal Biotech, Inc. which have a shared backbone of HSV-1, in participants who received at least one dose of investigational product (IP).

Detailed description: Due to the guidelines for gene therapy for vectors which may undergo latency/ reactivation, Krystal Biotech, Inc. has established a Long-Term Follow-up Protocol which will identify and mitigate the long-term risks to the participants receiving their gene therapy products and capture delayed adverse events in participants, annually, for 5-years following the last study visit. Additionally, it will allow the Sponsor to further understand the persistence of the gene therapy products used in their parent treatment protocols.

Eligibility criteria: Inclusion Criteria:

* All adult and pediatric participants who received at least one gene therapy treatment in a previous Krystal Biotech, Inc. sponsored study, and have discontinued or completed the parent treatment protocol (which do not have the LTFU embedded into the parent protocol), as applicable.
* Consent/Assent must be obtained by the participants (and, parental/legal representative, when applicable) prior to any study-related data being collected.
* Participant is willing and able to adhere to the protocol requirements.

Exclusion Criteria:

* Participants who enroll into a non-Krystal Biotech, Inc. interventional gene therapy clinical trial will be excluded from the study.

Primary outcomes:
measure: Serious Adverse Events (AE)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rancho Santa Margarita
country: United States
facility: Mission Dermatology Center
state: California
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Coral Gables
country: United States
facility: Pediatric Skin Research
state: Florida
Study officials:
References:
Clinical trial NCT00577187: Placement of CS/LV Pacing Leads With EnSite NavX Guidance
Official title: Placement of Coronary Sinus/Left Ventricular Leads With EnSite NavX Guidance
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-12-20
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study utilizes the 3D mapping capabilities of the EnSite NavX mapping system to help guide the placement of the left ventricular lead during cardiovascular resynchronization therapy implant procedures with the goal of reducing fluoroscopic exposure and procedure time.


Eligibility criteria: Inclusion Criteria:

* Patients schedule to undergo CRT implant (per established guidelines)

Exclusion Criteria:

* Standard exclusions to CRT implant procedures

Primary outcomes:
measure: Fluoroscopy and procedure time
timeFrame: Procedural
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Christopher C Erickson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02390687: Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients
Official title: Evaluation of the Efficacy of Probiotics in Chronic Periodontitis Patients-A Randomized Placebo Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Periodontitis
Lead sponsor: Next Gen Pharma India Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: KVG Medical College and Hospital
First posted: 2015-03-17
Enrollment: 31
Sex: ALL
Minimum age (years): 35
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontitis is an infectious inflammatory disease. Bacteria modulate the inflammatory response and alter the diversity of periodontal disease. In recent years, various host-response modulation therapies have been developed to block the pathways responsible for periodontal tissue breakdown.

There have been significant changes with respect to the effectiveness of, and attitudes towards conventional antimicrobial therapy to combat disease. With the threat of widespread antibiotic resistance rendering many antibiotics useless against important diseases, there is an increased necessity not only to minimise antibiotic use and develop novel non-antibiotic-based treatments, but also to raise the profile of disease prevention. One approach that has gained interest over recent years is the use of probiotic bacteria for oral applications. The rationale for their use in oral health care stems from the increase in evidence that supports their claims for benefit for a range of diseases. Lactobacilli play an important role in the maintenance of health by stimulating the natural immunity as well as by contributing to the balance of the microflora, by interacting with the other members of the flora. The application of health promoting bacteria for therapeutic purposes, is one of the strongest emerging fields. Time has come to shift the paradigm of the treatment from specific bacteria elimination to alteration of the bacterial ecology by using probiotics.

So the purpose of this study is to discover a more promising approach for the treatment of chronic periodontitis .


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed chronic generalized periodontitis
* Need of phase 1 therapy
* Pocket probing depth (PPD) of ≥ 5 mm \< 7 mm at two and/or more sites
* Patients with no history of allergies to the drugs to be used

Exclusion Criteria:

* Patients on antibiotics within 3 month prior to study
* Patients with any systemic diseases
* Patients with history of any periodontal therapy within 6 months to trial

Primary outcomes:
measure: Improvement in Periodontal Clinical indices
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in bone pattern
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kurunjibhag, Sullia (D.K.)
country: India
facility: Department of Periodontics, K.V.G. College & Hospital,
state: Karnataka
Study officials:
affiliation: KVG Medical College & Hospital
name: Mudnoor M Dayakar, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00141687: Early External Cephalic Version (ECV) 2 Trial
Official title: Early External Cephalic Version 2 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breech Presentation
Keywords: External cephalic version
Cesarean section
pregnancy
labour
Breech pregnancy
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: University of British Columbia
First posted: 2005-09-01
Enrollment: 1543
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: For women with a fetus in breech presentation, does early ECV (at 34 0/7 up to 35 weeks and 6/7 days) versus delayed ECV (not before 37 weeks and 0/7 days) increase or decrease the likelihood of cesarean section (CS)?

Detailed description: Primary Outcomes: Rate of Caesarean section

Secondary Outcomes: Rate of preterm birth

Other Outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, serious fetal complications, maternal death or serious maternal morbidity, non-cephalic presentation at birth, women's views, and health care costs.

The Data Coordination for this study is being carried out at the Maternal, Infant Reproductive Health Research Unit at Sunnybrook and Women's College Health Sciences Centre.

Eligibility criteria: Inclusion Criteria:

1. Women with any breech presentation
2. A live singleton fetus
3. Gestational age of 33 weeks 0 days to 35 weeks 6 days

Exclusion Criteria:

1. Contraindications to ECV (e.g. fetal heart rate abnormalities, abruptio placenta, major life-threatening fetal anomalies, uterine anomalies, hyper-extended fetal head, rupture of membranes, severe oligohydramnios, severe polyhydramnios)
2. Contraindications to early ECV (e.g. increased risk of preterm labour \[such as past history of preterm labour in this or previous pregnancies\], increased risk of abruptio placenta \[such as maternal hypertension\])
3. Contraindications to labour or vaginal delivery (e.g. placenta previa, previous classical CS)
4. Women planning delivery by CS if the fetus turns to cephalic
5. Women planning a vaginal delivery if the fetus remains breech
6. Women at increased risk of unstable lie (eg. grand multiparity)
7. Previous participation in EECV2 Trial

Primary outcomes:
measure: Rate of cesarean section
timeFrame: Information not available
Secondary outcomes:
measure: Rate of pre-term births. Other outcomes: admission to neonatal intensive care unit ≥ 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, or others.
timeFrame: Information not available
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Dr. Eileen Hutton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00765687: Screening Non Small Cell Lung Cancer With Bone Metastasis and Efficacy and Safety Research of Receiving Bisphosphonates
Official title: A Multi-center Observational Clinical Study of Screening of Non-small-cell Lung Cancer With Bone Metastasis and Efficacy and Safety of Those Receiving Bisphosphonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-small Cell Lung Cancer
Bone Metastases
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2008-10-03
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A multicenter Prospective Study to assess the screening methods, parameter of NTX and the efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in patients of non-small cell cancer with bone metastasis in china.


Eligibility criteria: Inclusion Criteria:

1. Age \>18, either sex
2. Histologically confirmed non-small cell cancer
3. One bone metastasis at least confirmed by image(X ray,CT or others)
4. Without receiving zoledronic acid
5. Life expectancy \> 6 M
6. ECOG \<= 2
7. Signed ICF

Exclusion Criteria:

1. Women who are pregnant or in lactation
2. Patients with hyperostosis
3. with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
4. Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
5. Severe co-morbidity of any type that may interfere with assessment of the patient for the study -

Primary outcomes:
measure: Skeleton-related event
timeFrame: 24 months
Secondary outcomes:
measure: overall survival
timeFrame: 24 months
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: SunYat-senU
state: Guangdong
Study officials:
affiliation: Cancer Center of Sun Yat-Sen University (CCSU)
name: Zhang Li, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04214587: Biological Investigation of Explanted Endobronchial Lung Valves Study
Official title: Biological Investigation of Explanted Endobronchial Lung Valves Study - Investigation of the Mechanism of Action of Tissue-device Interactions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Emphysema or COPD
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Severe emphysema patients routinely scheduled for bronchoscopic lung volume reduction with one-way endobronchial valves

Brief summary: Rationale:

COPD is a severe, often progressive and currently incurable lung disease which affects both the upper airways (chronic bronchitis) as well as the lower airways (emphysema). In advanced stages of the disease air-trapping severely reduces the ability to breathe and subsequently the quality of life. A highly effective treatment for restoring lung mechanical functionality of these patients is the introduction of bronchoscopic lung volume reduction (BLVR), e.g. implanting small silicone/nitinol valves (EBV) inside the airways to reduce air-trapping. Although successfully investigated in a selected group of severe COPD patients, the effectiveness of the treatment can sometimes be short-lived due to fibrotic and granulation responses and tissue-material interactions.

Objective:

The main objective of this study is to study and understand the underlying biological principles of granulation and fibrotic responses limiting the effectiveness and longevity of BELVR treatment with EBVs, this to investigate the mechanism of action of tissue-device interactions.


Eligibility criteria: Inclusion Criteria:

* Elidgible for EBV treatment

Exclusion Criteria:

* Anticoagulation which cannot be stopped prior to the procedure

Primary outcomes:
measure: the % of the 150 patients that will develop a need for rebronchoscopy after 18 months
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: UMC-Groningen/NL
name: Dirk-Jan Slebos, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: