louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00572208: Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
Official title: Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-12-12
Enrollment: 64
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: In this study we will focus on the postoperative recovery. A successful postoperative recovery should bring the patient to at least to the pre-surgical level. This can probably be achieved by a multimodal approach where at least postoperative pain and PONV are managed.

The surgical injury results in immobilisation which again can result in impaired cardiac, respiratory and musculoskeletal system. Pain relief is a prerequisite for mobilisation and an early return to the pre-surgical level. The preferred drugs for postoperative pain management are opioids. Although opioids are known to be an effective analgesia, they have a series of side effects: nausea, vomiting, constipation, respiratory deficiency, delirium among others.

Gabapentin has been tested for post operative pain. Randomized Clinical Trials have reported a significant better pain scores with Gabapentin in several studies -most of them restricted to the postoperative period in the post-anaesthesia care unit in many different kind of surgeries.

We want to test if Gabapentin can be used instead of opioids for treatment of postoperative pain after heart surgery by median sternotomy.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for elective cardiac surgery with median sternotomy at the department of cardiac surgery, Aarhus University Hospital, Skejby.
2. Patients older than 18 years.

Exclusion Criteria:

1. Patients unable to cooperate.
2. Known allergy for Gabapentin or opioids.
3. Acute pancreatitis
4. History of gastric or peptic ulcer.
5. History of alcohol or drug abuse.
6. Chronic pain or daily intake of analgesics or corticosteroids.
7. Gastrointestinal obstruction
8. Impaired liver function.
9. Impaired kidney function.
10. Previous operation with median sternotomy
11. Pregnant women

Primary outcomes:
measure: Pain
timeFrame: 1 month
measure: Morphine consumption
timeFrame: 1 month
Secondary outcomes:
measure: PONV
timeFrame: 1 month
measure: Medication side effects
timeFrame: 1 month
measure: Hospital stay
timeFrame: 1 month
measure: VAS score and medication 30 days after the operation
timeFrame: 1 month
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
city: Aarhus
country: Denmark
facility: Cardiothoracic and vascular department, Skejby Sygehus
Study officials:
affiliation: Cardiothoracic and Vascular Surgery Department, Aarhus University Hospital, Skejby
name: Vibeke Hjortdal, MD, Dr.sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01501708: Caspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection
Official title: Phase II Study of Caspofungin Based Combined Anti-fungal Therapy for Patients With Proven or Probable Invasive Fungal Infection After Allogeneic Stem Cell Transplantation From HLA-matched Unrelated or HLA-mismatched Related Donors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Leukemia
Transplantation, Hematopoietic Stem Cell
Keywords: caspofungin
IFI
allogeneic hematopoietic stem cell transplantation
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this prospective phase II observational study, we plan to assess the efficacy and tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched unrelated donor or mismatched donor conditioning with ATG containing regimen or present III-IV aGVHD or extensive GVHD undergoing high-dose steroid treatment.

Detailed description: Patients will recieve caspofungin with either voriconazole or amphotericin B as combination therapy for fungal infection

Eligibility criteria: Inclusion Criteria:

* adult patient undergoing allogeneic hematopoietic stem cell transplantation
* age 18-55 years
* with inform consent
* no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
* HLA mismatched related (3\~5/6) or unrelated donors (at least 8/10)
* proven or probable IFI

Exclusion Criteria:

* age less than 18 years or over 56 years
* HLA mismatched related donor
* liver function/renal function damage (over 2 X upper normal range)
* with mental disease

Primary outcomes:
measure: Favorable response rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: 12 weeks, 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Blood & Marrow Transplantation Center, RuiJin Hospital
Study officials:
affiliation: Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
name: Ling Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02156908: D-serine and Cognitive Remediation in Schizophrenia
Official title: D-serine and Cognitive Remediation in Schizophrenia: Open Label Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: cognitive remediation
Lead sponsor: Nathan Kline Institute for Psychiatric Research
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will test the effects of 3 days of D-serine (DSR) on auditory plasticity in a sensory based remediation (SBR) paradigm

Detailed description: We will enroll 8 subjects in an open label, three session pilot in patients will receive three sessions of tone matching SBR.

5 Subjects will receive D-serine (60mg/kg) taken 1x each week during the SBR sessions. Subjects will receive study drug 30 minutes prior to session.

3 subjects received no intervention

Eligibility criteria: Inclusion criteria:

* 18 to 64 years old,
* IQ≥85 and
* estimated Glomerular Filtration Rate (GFR) ≥60. All oral and depot antipsychotics (with the exception of clozapine) are allowable. Patients must be on their antipsychotic medication for 1 month and stable on dose of antipsychotic and adjunctive medications for 2 weeks prior to study entry.

Exclusion criteria:

* history of neurological visual or hearing impairment,
* active suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS),
* current alcohol or drug abuse (\<1 month) or substance dependence (\<4 months). All women of child-bearing potential must have a negative urine pregnancy test at the baseline visit. We require an IQ of ≥85 to ensure that subjects will have a capacity to learn. In our cross-sectional studies, we have observed an IQ≥85 in over 90% of candidates, suggesting that this is not an overly restrictive criterion.

Primary outcomes:
measure: Mismatch Negativity (MMN)
timeFrame: 3 weeks
Secondary outcomes:
measure: Tone Matching Threshold
timeFrame: three weeks
Other outcomes:
Locations:
city: Orangeburg
country: United States
facility: Nathan Kline Institute
state: New York
Study officials:
affiliation: Nathan Kline Institute
name: Joshua T Kantrowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kantrowitz JT, Epstein ML, Beggel O, Rohrig S, Lehrfeld JM, Revheim N, Lehrfeld NP, Reep J, Parker E, Silipo G, Ahissar M, Javitt DC. Neurophysiological mechanisms of cortical plasticity impairments in schizophrenia and modulation by the NMDA receptor agonist D-serine. Brain. 2016 Dec;139(Pt 12):3281-3295. doi: 10.1093/brain/aww262.
Clinical trial NCT02322008: Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice
Official title: Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Ulcerative Colitis
Inflammatory Bowel Disease
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 1035
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1035 patients with CD or UC

Brief summary: Can genetic markers be used to predict anti-TNF response? A cohort was established to identify SNPs associated with anti-TNF therapy in patients with inflammatory bowel disease.


Eligibility criteria: Inclusion Criteria:

* CD or UC, treated with anti-TNF

Exclusion Criteria:

* Missing data

Primary outcomes:
measure: 3-step scale
timeFrame: 22 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bank S, Andersen PS, Burisch J, Pedersen N, Roug S, Galsgaard J, Turino SY, Brodersen JB, Rashid S, Avlund S, Olesen TB, Green A, Hoffmann HJ, Thomsen MK, Thomsen VO, Nexo BA, Vogel U, Andersen V. Effectiveness of anti-tumour necrosis factor-alpha therapy in Danish patients with inflammatory bowel diseases. Dan Med J. 2015 Mar;62(3):A4994.
Clinical trial NCT02817308: Correlation of Serum CA19-9 Levels With Levels in Saliva and Urine of Patients With Ductal Adenocarcinoma of the Pancreas
Official title: Correlation of Serum CA19-9 Levels With Levels in Saliva and Urine of Patients With Ductal Adenocarcinoma of the Pancreas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Pancreatic Ductal
Keywords: Antigen, CA-19-9
Salivas
body fluids
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Ductal adenocarcinoma of the pancreas is the fifth leading cause of cancer related deaths in the European Union. Tumor markers CA19-9 and carcinoembryonic antigen are important components in decision making and follow-up of patients diagnosed with this disease.

These tumor markers were found to be elevated not only in the serum but also in other body fluids in patients with malignant lesions of the parotid gland and the urinary tract. The authors have described in a previews small preliminary study a positive and a strong linear correlation between the levels of CA19-9 in urine and saliva with those presented in the serum of patients with ductal adenocarcinoma of the pancreas. The current study seeks to enlarge the study population to confirm the previous results and standardize the measured levels of CA19-9 in these body fluids.


Eligibility criteria: Inclusion Criteria:

Patients:

* Proven diagnosis of ductal adenocarcinoma of the pancreas
* elevated levels of CA19-9
* possible elevated levels of CEA

Exclusion Criteria:

Controls:

* Previous diagnosis of malignancy

Primary outcomes:
measure: correlation of CA19-9 levels in urine and saliva with those in the serum
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants needed to standardize the measurements in urine and saliva according to those measured in the serum.
timeFrame: 1 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam - health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Offir Ben-Ishay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03586908: PK/PD, Safety and Tolerability of PHP-201 Topical Eye Drop in Korean and Japanese Healthy Subjects
Official title: An Open Label, Multiple-dose, Phase 1 Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PHP-201 Topical Eye Drop in Korean and Japanese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: pH Pharma
Sponsor class: INDUSTRY
First posted: 2018-07-16
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: An open label, multiple-dose, phase 1 clinical trial to evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of PHP-201 topical eye drop in Korean and Japanese healthy subjects

Detailed description: Primary: The evaluation of pharmacokinetic properties of repeating PHP-201 topical eye drop Secondary: The evaluation of pharmacodynamic, safety and tolerability of repeating PHP-201 topical eye drop

Eligibility criteria: Inclusion Criteria:

1. Fully informed about the purpose of the study
2. BMI of 18.0 kg/m² or more and 27.0 kg/m² or less who are between 19 and 50 years of age
3. No congenital or chronic disease and no medically symptomatic findings

Exclusion Criteria:

1. Clinically significant disease history or disease history that may affect the absorption, distribution, metabolism and excretion of the drug, or ophthalmic corneal surgery
2. had BCVA worse than logMAR 0.2(20/30snellen) or IOP \< 10mmHg or \>21mmHg in either eye
3. Abnormalities of clinical examination (SBP, DBP, pulse rate, AST, ALT, Total bilirubin, eGFR and Serum test, ECG)
4. Allergy, drug hypersensitivity and substance abuse
5. Forbidden drug and diet
6. Blood donation and transfusion

Primary outcomes:
measure: Maximum Plasma Concentration [Cmax]
timeFrame: 1week
measure: Time to Cmax[Tmax]
timeFrame: 1week
Secondary outcomes:
measure: Mean Change of Intraocular pressure(IOP)
timeFrame: 1week
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Baek Hospital
state: Busanjin-gu
Study officials:
affiliation: pH Pharma
name: Soojin Kim
role: STUDY_DIRECTOR
References:
Clinical trial NCT00912808: Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease
Official title: A Study of Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: parkinsons disease
falling
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.

Detailed description: This trial is a double-blinded cross-over design comparing donepezil with placebo in 40 subjects with idiopathic Parkinson's disease who report frequent falls or near falls (\>2/week). The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.

Eligibility criteria: Inclusion Criteria:

* Age over 21
* Diagnosis of Parkinson's disease
* Treated with dopaminergic medication for at least 1 year

Exclusion Criteria:

* Must be ambulatory (can use walker or cane)
* No obvious remediable cause of falls
* Falls are on basis of non-CNS etiologies (cardiogenic, orthopedic, peripheral neuropathy, etc)
* Dementia present (MMSE \< 25)
* Not taking cholinergic or anticholinergic medications 10 days prior to screening visit
* No Warfarin use

Primary outcomes:
measure: Fall Frequency Per Day
timeFrame: 6 weeks
Secondary outcomes:
measure: Frequency of Near Falls Per Day
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Kathryn Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04602208: FOCAL HIGH-INTENSITY FOCUSED ULTRASOUND FOR PRIMARY LOCALIZED PROSTATE CANCER: MIDTERM ONCOLOGICAL OUTCOMES
Official title: FOCAL HIGH-INTENSITY FOCUSED ULTRASOUND FOR PRIMARY LOCALIZED PROSTATE CANCER: MIDTERM ONCOLOGICAL OUTCOMES
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 146
Sex: MALE
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: The patients with low or intermediate risk PCa (PSA \<20 ng/ml, Gleason Score 7 or less and clinical stage T2b or less) who received PGA/FT using HIFU

Brief summary: Single-center evaluation of all patients treated for primary localized prostate cancer with focal HIFU from November 2009 to December 2016. To evaluate midterm oncological outcomes of focal HIFU therapy in low an intermediate risk prostate cancer.


Eligibility criteria: Inclusion Criteria:

* • The patients with low or intermediate risk PCa (PSA \<20 ng/ml, Gleason score 7 or less and clinical stage T2b or less) who received PGA/FT using HIFU were included.

Exclusion Criteria:

* Patients who were previously treated with radiotherapy, androgen deprivation therapy (ADT) or other treatment for their prostate cancer were excluded.

Primary outcomes:
measure: Retreatment-free survival (RFS)
timeFrame: May 1, 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Edouard Herriot
Study officials:
References:
Clinical trial NCT01649908: Open Bifurcation Surgery Study
Official title: Evaluation of Cardiac Function in Different Techniques in Infrarenal Aortic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infrarenal Aortic Aneurysm
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Vascutek Ltd.
First posted: 2012-07-25
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with infrarenal aortic aneurysms

Brief summary: Different cross clamping techniques in aortic surgery causes different cardiac stress


Eligibility criteria: Inclusion Criteria:

* AAA \> 5cm

Exclusion Criteria:

* emergency cases

Primary outcomes:
measure: cardiac function with echocardiography
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
Study officials:
References:
Clinical trial NCT02117908: Study of the Application of CPAP to Reduce Complications and Improve Lung Cancer Ablation Radiofrequency Treatment
Official title: Application of CPAP to Reduce Complications and Improve Treatment of Radiofrequency Ablation of Lung Cancer Under Conscious Sedation. A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Lung Cancer
Keywords: prevention
radiofrequency treatment
lung cancer ablation
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2014-04-21
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The project aims to study whether the application of a continuous positive airway pressure (CPAP) of 4 cm water vapor is a safe method in pulmonary radiofrequency intervention (PRF) lung cancer under conscious sedation compared with placebo. And, assess whether CPAP prevents atelectasis formation and consequently reduces the potential complications of PRF and improves procedural success


Eligibility criteria: Inclusion Criteria:

* male and female aged 18 years and older
* Patient with a scheduled intervention for ablation of pulmonary malignant tumor with radiofrequency .
* Patient able to undergo tests and examinations required by the study.

Exclusion Criteria:

* Patients with CPAP intolerance test.
* Patients with progressive disease in which local treatment is not applicable
* Patients with intercurrent process (pleural effusion, pneumonia, ...).
* Patient unable to understand the proceedings.
* Pregnancy or breastfeeding.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: thirty days
Secondary outcomes:
measure: Prevention of atelectasis.
timeFrame: during surgery
measure: Decrease associated complications with PFR. Measurement times: intraoperative, PACU (post-anesthesic care unit), hospital discharge, day 15 and day 30.
timeFrame: thirty days
measure: Treatment success
timeFrame: Measurement time: CT3
measure: Predictors factors of the occurrence of complications during PRA (pulmonary radiofrequency ablation).
timeFrame: thirty days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Hospital Clínic i Provincial de Barcelona
name: Enrique J Carrero Cardenal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: