louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03184415: Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients With Gastritis
Official title: A Multi-Center, Randomized, Parallel, Double-Blind, Phase III Clinical Trial to Compare the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy With DWC20155 or DWC20156 Monotherapy in Patients With Gastritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastritis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2017-06-12
Enrollment: 230
Sex: ALL
Minimum age (years): 19
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 evaludate the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients with Gastritis


Eligibility criteria: Inclusion Criteria:

* Male of female of at least 19 years old
* Patients diagnosed with acute or chronic gastritis by gastroscopy
* Patients with one or more erosions found by gastroscopy

Exclusion Criteria:

* Patients with peptic ulcer and gastroesophageal reflux disease
* Patients with previous gastrointestinal surgery
* Patients with history of gastrointestinal cancer

Primary outcomes:
measure: Improvement rates of stomach erosions by the endoscopy
timeFrame: At 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Daewoong pharmatceutical
Study officials:
References:
Clinical trial NCT03683615: Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures
Official title: Resorbable Polymer Plates in Repair of Blowout Orbital Floor Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Traumatic Orbital Deformity
Keywords: Resorbable, blow out fractures
Lead sponsor: Minia University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2018-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is a prospective study to evaluate the use of resorbable plates for the repair of blow out orbital floor fractures over a follow up period of one year at both cosmetic and functional levels.


Eligibility criteria: Inclusion Criteria:

* Class I, II blowout floor fracture.
* Presented within 2 weeks of trauma.
* Have muscle or soft tissue distortion with clinically significant diplopia, enophthalmos or restrictive strabismus.

Exclusion Criteria:

* Comminuted orbital fractures involving the rim.
* Associated globe injuries.
* Delayed presentation.

Primary outcomes:
measure: anatomical reduction of the fracture
timeFrame: one month
Secondary outcomes:
measure: improvement of symptoms
timeFrame: 6 to 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00507715: Study of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk
Official title: Clinical Trial to Study the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease, Idiopathic
Keywords: Parkinson's Disease, Idiopathic
l-dopa levels
plantago ovata husk
Lead sponsor: Rottapharm Spain
Sponsor class: INDUSTRY
First posted: 2007-07-26
Enrollment: 18
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the effect of the association levodopa/carbidopa with plantago ovata husk in Parkinson´s disease patients of recent diagnostic, that are being treated with levodopa/carbidopa.

Detailed description: Although the treatment with l-dopa is the election treatment for Parkinson´s disease, a high number of patients develop motor complications, including, fluctuations and dyscinesia after some years of treatment.

The origin of the fluctuations is not well established, but it could be attributed, al least partially, a pharmacokinetics factors. So that, it could improve the answer and reduce the adverse reaction if we reach more stable levels of L-dopa in the circulation. The first experimental studies in animals showed that Plantago ovata husk has an influence in the pharmacokinetics parameters of L-dopa, obtaining more stable levels.

Eligibility criteria: Inclusion Criteria:

* Patients with diagnostic of idiopathic Parkinson disease, with well controlled symptomatology with administration of l-dopa/carbidopa.
* At least 3 months of treatment continued of levodopa.
* Patients that give the their consent to participate in the study.

Exclusion Criteria:

* Patients with diagnostic of idiopathic Parkinson disease, with bad controlled symptomatology with administration of l-dopa/carbidopa.
* Patients with allergic predisposition to Plantago ovata husk or other contraindications for its use.

Primary outcomes:
measure: To study how the fiber Plantago ovata husk modifies the pharmacokinetics parameters of the absorption and elimination of L-dopa.
timeFrame: 14 days
Secondary outcomes:
measure: To evaluate if the treatment with Plantago ovata husk modifies the biochemical parameters as total cholesterol, HDL y LDL, glycaemia, etc.
timeFrame: 14 days
Other outcomes:
Locations:
city: Leon
country: Spain
facility: Hospital de León
state: León
Study officials:
affiliation: Departamento de Ciencias Biomédicas de la Facultad de Veterinaria de la Universidad de León, León (Spain)
name: Sierra Matilde, Ph, phD
role: STUDY_CHAIR
affiliation: Hospital de León, León (Spain)
name: Carriedo Demetrio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00328315: Cardiac SPECT With Rotating Slant Hole Collimator
Official title: Myocardial Perfusion SPECT Using a Rotating Multi-segment Slant-hole Collimator
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Diseases
Chest Pain
Keywords: Myocardial Perfusion SPECT
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2006-05-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and Females 18-80 who are scheduled for a clinical Cardiac Stress Test

Brief summary: The goal is to conduct a clinical pilot study to evaluate the use of a rotating multi-segment slant-hole collimator in the detection of myocardial defects.

Detailed description: Myocardial perfusion SPECT is recognized as an effective clinical diagnostic imaging technique in the assessment of myocardial perfusion and coronary artery diseases. It is the most important clinical application of SPECT imaging techniques.

The goal is to conduct a clinical pilot study to evaluate the use of rotating multi-segment slant-hole (RMSSH) SPECT in the detection of myocardial defects especially in very sick patients in the nuclear medicine clinics, emergence room, and intensive care units. Comparison of the clinical utilities of the cardiac RMSSH SPECT technique with conventional cardiac planar and SPECT with parallel-hole collimation will also allow us to evaluate the potential application of the technique to a wider patient population.

The objective of this study is to test the hypothesis that quantitative 99mTc myocardial perfusion RMSSH SPECT provides similar diagnostic accuracy in patients with cardiac diseases as conventional SPECT imaging techniques.

Eligibility criteria: Inclusion Criteria:

* Males and Females 18-80 who are scheduled for a clinical Cardiac Stress Test

Exclusion Criteria:

* Pregnant Women and Children

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Benjamin Tsui, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00224315: Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial
Official title: Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia, Schizoaffective Disorder
Keywords: Schizophrenia,
schizoaffective disorder,
treatment resistancy
clozapine,
ziprasidone
risperidone
combination
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.

Detailed description: Partial response of schizophrenic psychoses to a monotherapy with clozapine is a frequent problem of clinical psychiatry. Current problems are treatment resistant positive and/or negative symptoms, as well as side effects. Therefore, different strategies of augmentations have been applied. Based on successful experiences in case reports and results of other work groups, we aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.

Eligibility criteria: Inclusion Criteria:

* Treatment resistant schizophrenic or schizoaffective disorder under therapy with clozapine,
* Age between 18 and 70,
* Informed consent

Exclusion Criteria:

* No informed consent,
* Intolerance with respect to ziprasidone or risperidone,
* Contraindications with respect to these substances,
* Gravidity or missing anticonceptive safety
* Substance dependance (excluded nicotin)

Primary outcomes:
measure: PANSS, SANS, HAMD, GAF, CGI, QTc
Secondary outcomes:
measure: Body weight, EPMS, Akathisia,Prolactin, blood pressure, heart rate
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Institute of Mental Health, Department of Psychiatry,
state: BW
Study officials:
affiliation: Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany
name: Mathias Zink, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01703715: Hydration and Outcome in Older Patients
Official title: Hydration and Outcome in Older Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dehydration
Keywords: Hydration
Elderly patients
Age 65 years and over
Admitted acutely to medical admissions ward
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted acutely to medical wards who are aged 65 years and over.

Brief summary: Dehydration is recognised as a major issue in healthcare. Recovery after illness, extended length of stay, pressure sores and slow tissue recovery can all be impacted by dehydration. One of the biggest problems for many people with regard to getting a drink is easy, independent access - if they can't reach the jug/cup without a struggle then they often will go thirsty and potentially become dehydrated.

The purpose of this study is to investigate the impact of dehydration on outcome in patients 65 years and over. Furthermore we aim to assess the impact of providing easy, 24 hour, independently accessible fluids on reducing dehydration as well as improving patient experience.

We hypothesise that patients who are dehydration will take longer to recover from illness and stay in hospital for longer periods.


Eligibility criteria: Inclusion Criteria:

1. - All patients of 65 years and over that are admitted acutely to medical wards
2. - Ward staff who have been working in the clinical area for the duration of the trial (The Hydrant part of the study).

Exclusion Criteria:

1. - Patients who are moribund
2. - Patients who are doubly incontinent
3. - Patients on the end of life pathway
4. - Patients with terminal illness with a known life expectancy less than 3 months

Primary outcomes:
measure: Serum Osmolality
timeFrame: At admission and 48hrs post admission to hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Queens Medical Centre
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Dileep N Lobo, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05984615: Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients
Official title: Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BRAF Positive Metastatic Melanoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-08-09
Enrollment: 1961
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: This was a retrospective, noninterventional cohort study

Brief summary: This was a retrospective real-world evidence cohort study.


Eligibility criteria: Inclusion criteria:

* Diagnosis of melanoma (The International Classification of Diseases, 9th Revision \[ICD-9\] 172.x \& 10th revision \[ICD-10\] C43 or D03x).
* Pathologic stage IV at initial diagnosis on or after 01 January 2011.
* First-line treatment with IO monotherapy or combination therapy (nivolumab, pembrolizumab, ipilimumab + nivolumab) or TT combination therapy (dabrafenib + trametinib, vemurafenib+cobimetinib, encorafenib+binimetinib) on or after 01 January 2014.
* Evidence of a BRAF test.
* Evidence of a BRAF-positive result prior to or up to 30 days after first-line (1L) therapy initiation.
* At least 18 years of age at the time of initiation of 1L treatment.

Exclusion criteria:

* Documented receipt of a clinical trial treatment for cancer at any time on or after 01 January 2014.
* Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment.

Primary outcomes:
measure: Mean age
timeFrame: Baseline
measure: Number of male patients
timeFrame: Baseline
measure: Race
timeFrame: Baseline
measure: Mean Charlson comorbidity index (CCI) score
timeFrame: Baseline
measure: Eastern Cooperative Oncology Group performance status (ECOG PS)
timeFrame: Baseline
measure: Number of patients with study-related biomarkers
timeFrame: Baseline
measure: Number of metastatic sites
timeFrame: Baseline
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 6 months and 1, 1.5, and 2 years
measure: Overall survival (OS)
timeFrame: 6 months and 1, 1.5, and 2 years
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05476315: Emergency Surgery During Covid Compared to Emergency Surgery During Pre-covid Period
Official title: Is Emergency Surgery Back to Pre-covid-19 Era? Our Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Surgery
COVID-19
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 356
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Our cohort-study was conducted by analyzing four groups of patients admitted to the Department of Medical and Surgical Sciences of the Hospital of Foggia, Apulia southern part of Italy :

* group 1: people admitted during the no-covid period from March 09th, 2019 to May 09th, 2019;
* group 2: people admitted from March 09th, 2020 to May 09th, 2020;
* group 3: people admitted from March 09th, 2021 to May 09th, 2021
* group 4: people admitted from March 09th, 2022 to May 09th, 2022

Brief summary: The aim of this study is to analyze the trend of hospitalizations and how emergency operations have qualitatively and quantitatively changed in our Department of Medical and Surgical Sciences of the Foggia Hospital from 2019 (pre-covid era) to date.


Eligibility criteria: Inclusion Criteria:

* Patients underwent emergency surgery from March 2019 to May 2022

Exclusion Criteria:

* Patients underwent elective surgery

Primary outcomes:
measure: Is emergency surgery back to pre-covid-19 era?
timeFrame: From March 2019 to May 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: University of Foggia
Study officials:
affiliation: University of Foggia
name: Giovanna Pavone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03421015: Genetic Analysis of Prostate Cancer to Identify Predictive Markers of Disease Relapse or Metastatic Evolution
Official title: Genomic Analysis in Localized or Locally Advanced Prostate Cancer. Identification of Biomarkers Predictive of Biochemical or Metastatic Recurrence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Neoplasms
Keywords: localized prostate cancer
prostatectomy
biomarkers
metastatic recurrence
genomic
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: New York Presbyterian Hospital
First posted: 2018-02-05
Enrollment: 84
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: Patients managed by radical prostatectomy for prostate cancer

Brief summary: Developing a genetic study on localized or locally advanced prostate cancer. The aim of the study is to identify genomic alteration predictive of metastatic recurrence in the context of primary heterogeneity, by using the next generation sequencing (NGS) techniques.

Identifying such biomarkers may be useful to detect a higher relapse risk, and thus lower the mortality rate.


Eligibility criteria: Inclusion Criteria:

* Patients managed by radical prostatectomy for prostate cancer between 2000 and 2016.
* Follow up \> 6 years
* Negative pre surgical extension assessment
* Prognostic Grade Groups (OGG) III-IV-V
* Biochemical recurrence defined by 2 consecutive PSA rises ≥ 0,2 ng/mL
* Metastasis positive imaging

Exclusion Criteria:

* Neoadjuvant therapy
* Follow up \< 6 years
* Prognostic Grade Groups (PGG) I-II
* Biochemical recurrence with metastasis negative imaging

Primary outcomes:
measure: The genetic alteration frequencies of TMPRSS2-ERG gene fusion
timeFrame: Baseline
Secondary outcomes:
measure: Frequency of amplification of proto-oncogenes (MYC, AR, PIK3CA),
timeFrame: Baseline
measure: Frequency of mutations or deletions of tumor suppressor genes (PTEN, TP53, NKX3-1),
timeFrame: Baseline
measure: Frequency of point mutations modifying protein function (SPOP)
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHRU
Study officials:
affiliation: University Hospital, Lille
name: Arnauld Villers, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04935515: C Reactive Protein in Home Quarantined Coronavirus Disease 2019 (COVID -19) Patients.
Official title: C Reactive Protein Based Early Intervention for Home Quarantined COVID -19 Patients to Avoid Complications and Hospitalization.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID -19
Keywords: COVID -19;
Home quarantine;
C-Reactive Protein (CRP);
D-Dimer,
Early Intervention prior to onset of hypoxia
Lead sponsor: UR Anoop Research Group
Sponsor class: OTHER
Collaborators: name: UR Anoop Research Group
First posted: 2021-06-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: During the peak of the second COVID -19 wave, the hospitals were over-crowded. Many COVID -19 positive patients had to stay at home and reach out to their family physicians for guidance. Medical follow-up for these patients was a daunting challenge. As in - patient hospital facilities were not readily accessible due to over crowding, early objective tests to identify home quarantined patients prone to deterioration and timely medical intervention to avoid hospitalization were required.

Based on early assessment of inflammatory markers like CRP and clinical signs like persistent high-grade fever, need-based early medical intervention was initiated in home quarantined COVID -19 patients prior to the onset of hypoxia, in order to avoid complications and hospitalization

Detailed description: 25 home quarantined COVID -19 patients who contacted online for medical guidance underwent clinical and biochemical evaluation. Radiological evaluation was done only if indicated.

Based on early objective biochemical tests like elevated CRP and clinical signs like persistent high-grade fever on the third or fourth day after onset of symptoms, early medical treatment was initiated prior to onset of hypoxia.

All the 25 patients recovered without any complications and did not require hospitalization.

Eligibility criteria: Inclusion Criteria:

1. COVID -19 positive patients under home quarantine
2. Patients consulting online on the 3rd or 4th day after the onset of symptoms.
3. Patients with oxygen saturation 94% and above.

Exclusion Criteria:

1. Patients consulting online on or after 5th day of onset of symptoms.
2. Patients with oxygen saturation less than 94% during the initial presentation.
3. Systemic disease known to increase CRP levels.

Primary outcomes:
measure: Number of home quarantined COVID -19 positive patients requiring admission in a hospital for hypoxia.
timeFrame: Two weeks from the onset of symptoms.
Secondary outcomes:
measure: Number of home quarantined COVID -19 patients developing thromboembolic complications
timeFrame: Four weeks from the time of initial presentation
Other outcomes:
Locations:
city: Puducherry
country: India
facility: ONLINE
Study officials:
affiliation: UR Anoop Research Group
name: MANIMARANE ARJUNAN, MD,DM-CARDIO
role: PRINCIPAL_INVESTIGATOR
References: