louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01894828: Nutritional Supplementation in Patients With no Signs of Malnutrition
Official title: The Effect of Nutritional Supplementation in Cancer Patients With no Clinical Signs of Malnutrition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Primary Neoplasm
Secondary Neoplasm
Abdominal Neoplasm
Keywords: Nutritional support
Gastrointestinal cancer
Malnutrition
Lead sponsor: MedSource Polska
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study was to assess the effect of nutritional supplementation on nutritional status and postoperational complications in cancer patients with no clinical signs of malnutrition

Detailed description: In previous psychological studies our team found high level psychological stress in over 60% of cancer patients. This may cause numerous problems including anorexia, which together with biological disturbances can initiate cancer related catabolism even when it can not yet be seen. In this study we want to answer the question if oral nutritional supplementation can help the patient overcome the catabolism in its initial phase and improve nutritional status, which would result in reduced number of postoperational complications

Eligibility criteria: Inclusion Criteria:

* Primary or secondary resectable gastrointestinal and abdominal malignancy
* No signs of malnutrition at qualification for surgery
* General performance \>70 Karnofsky scale
* Informed consent

Exclusion Criteria:

* history of radio or chemotherapy
* signs of mechanical ileus
* other major gastrointestinal diseases
* type 1 diabetes
* autoimmunological diseases requiring systemic steroids
* signs of infection
* renal and/or liver failure

Primary outcomes:
measure: Improvement of nutritional status
timeFrame: After 14 days
Secondary outcomes:
measure: Reducing number of complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Department of Surgical Oncology Medical University of Gdańsk
state: Pomorskie
Study officials:
affiliation: Department of Surgical Oncology Medical University of Gdańsk
name: Paweł Kabata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgical Oncology Medical University of Gdańsk
name: Tomasz Jastrzębski, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02798328: Direct Oral Anticoagulant Assay Detection & Classification Study for the TEG 6S System
Official title: Direct Oral Anticoagulant Assay Detection & Classification Study for the TEG 6S System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DOAC Eligible Subjects
Lead sponsor: Haemonetics Corporation
Sponsor class: INDUSTRY
First posted: 2016-06-14
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: DOAC Eligible Subjects

Brief summary: Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and classify the presence of DOAC drugs in a subject.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* DOAC administered for a minimum of 7 days

Exclusion Criteria:

* Genetic Bleeding disorders. Known or subsequently discovered inherited defects of coagulation (e.g. hemophilia or Von Willebrand disease)
* Not known when last two DOAC doses were administered prior to blood draw
* DOAC first administered (or resumed after temporary cessation) less than 7 days prior to blood draw
* DOAC dosage outside of manufacturer's recommended range (e.g. study subject with renal impairment and supratherapeutic dose)
* Heparin or LMWH administered within 7 days prior to blood draw
* On any medications known to affect coagulation status and listed below
* Bruising, wounds or scarring in the area of venipuncture

List of medications known to affect coagulation status

1. Vitamin K Antagonists \[VKAs\] Warfarin Phenprocoumon Acenocoumarol Tecarfarin \[ATI-5923\] Phenindione Anisindione Elinogrel Vorapaxar Atopaxar
2. Heparin and Heparins Unfractionated Heparin \[UFH\] LMWH Fondaparinux Idraparinux Danaparoid
3. Vasopressin Analogues DDAVP
4. Direct Thrombin \[IIa\] Inhibitors Hirudin Lepirudin Bivalirudin Argatroban
5. Defibrinating Agents Ancrod

Primary outcomes:
measure: Presence / Absence of DOAC Drug
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: South Bend
country: United States
facility: Memorial Hospital South Bend
state: Indiana
city: Duluth
country: United States
facility: Essentia Institute of Rural Health
state: Minnesota
city: Spartanburg
country: United States
facility: Spartanburg Regional Healthcare System
state: South Carolina
city: Falls Church
country: United States
facility: Inova Health Care Services
state: Virginia
Study officials:
References:
Clinical trial NCT02933528: Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS
Official title: An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS in Patients With Moderate to Severe Scalp Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2016-10-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment with DSXS .

Detailed description: Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis. Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant, non-lactating females 18 years of age or older.
* IRE-approved, signed informed consent form that meets all criteria of current FDA regulations.

Exclusion Criteria:

* Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.

Primary outcomes:
measure: Proportion of Patients in the Study With HPA Axis Suppression
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Taro Pharmaceuticals USA, Inc.
state: New York
Study officials:
affiliation: http://www.novumprs.com/contact
name: Novum Pharmaceutical Research Services
role: STUDY_CHAIR
References:
Clinical trial NCT05334628: The Effect of ESPB on Intraoperative Hemodynamics in VATS
Official title: The Effect of Erector Spinae Plane Block on Intraoperative Hemodynamics in Video-Assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Video-Assisted Thoracoscopic Surgery
Erector Spinae Plane Block
Mean Arterial Pressure
Heart Rate
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Video-assisted thoracic surgery (VATS) is frequently applied in thoracic surgery operations. VATS has become the standard procedure in minor and major lung surgeries. In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Thoracic paravertebral block (TPVB), erector spinae plane block (ESPB), and serratus anterior plane block (SAPB) are also among the regional anesthesia techniques frequently used in thoracic surgery.

General anesthesia (GA) is the main method of anesthesia for thoracic surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as TPVB, ESPB, and SAPB, more stable hemodynamics is expected by providing preemptive analgesia in patients. As a result of all these; In this study, we aimed to compare the intraoperative hemodynamic changes of patients who underwent preoperative ESPB in patients who will undergo VATS resection under GA with those who underwent postoperative ESPB.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-40 kg/m2
* Patients undergoing elective video assisted thoracoscopic surgery

Exclusion Criteria:

* Advanced cancer
* History of chronic analgesic therapy
* History of local anesthetic allergy
* Infection in the intervention area
* Patients with bleeding disorders

Primary outcomes:
measure: Mean arterial pressure
timeFrame: Perioperative period
measure: Heart rate
timeFrame: Perioperative period
Secondary outcomes:
measure: Pain scores
timeFrame: First 24 hours after surgery
Other outcomes:
Locations:
city: Keçiören
country: Turkey
facility: Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
state: Ankara
city: Çankaya
country: Turkey
facility: Ankara City Hospital
state: Ankara
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Nilgün Zengin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04171128: Procalcitonin Role in Influenza Patients With Regard to Morbidity, Mortality and Antibiotic Use
Official title: Procalcitonin Role in Influenza Patients With Regard to Morbidity, Mortality and Antibiotic Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: procalcitonin
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: seasonal influenza patients, adult population

Brief summary: The investigators intend to observe the inflammatory marker procalcitonin (PCT) in comparison with patient variables on morbidity, mortality and antibiotic treatment.

The overall aim is to observe if a low PCT value can have potential in reducing unessesary antibiotic use in seasonal influenza patients.

Detailed description: This is an observational study of the clinical utility of early PCT measurements in seasonal influenza, with particular attention to PCT's predictive value for prognosis and bacterial respiratory superinfection. The aim is to evaluate PCT as a supplementary aid in the standard clinical evaluation of influenza patients. Patients may be included if a positive influenza test is reported within 48 hours after an initial clinical suspicion of influenza, and the hospital stay is lasting more than one day. The investigators have included 74 patients from the second half of the 2018-19 influenza season and will continue to include patients from the complete 2019-20 season.

Primary endpoints: Mortality (in-hospital and within 30 days post-discharge), bacterial respiratory tract superinfection.

Secondary endpoints: Intensive care unit stay, the proportion of patients on antibiotic use and total antibiotic use in doses and LOT ("length-of-treatment").

Eligibility criteria: Inclusion Criteria:

* patient admitted to the hospital with positive influenza test

Exclusion Criteria:

* none

Primary outcomes:
measure: mortality
timeFrame: 30 days
Secondary outcomes:
measure: antibiotic use
timeFrame: up to one year
Other outcomes:
Locations:
city: Sarpsborg
country: Norway
facility: Ostfold Hospital Trust
state: Ostfold
city: Sarpsborg
country: Norway
facility: Ostfold Hospital trust
state: Viken
Study officials:
affiliation: Ostfold hospital trust, Kalnes
name: Ingrid christensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02226328: Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl-sedation for Flexible Bronchoscopy: A Randomized, Single Blind, Controlled Study of Satisfaction and Safety.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Flexible Bronchoscopy
Sedation
Satisfaction
Safety
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 128
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: Flexible bronchoscopy almost always requires sedation to be successful. In order to increase the availability of propofol for sedation, non-anaesthesiologist administered propofol sedation has been suggested as an alternative to traditional midazolam/opioid sedation or the general anaesthesia provided by anaesthesiologists.

Hypothesis: Patients undergoing flexible bronchoscopy prefers non-anaesthesiologist administered sedation with propofol as opposed to non-anaesthesiologist administered sedation with midazolam and fentanyl.

Propofol sedation is as safe as midazolam and fentanyl sedation.


Eligibility criteria: Inclusion Criteria:

1. Elective flexible bronchoscopy.
2. Willing to be randomised
3. Provide written informed consent

Exclusion Criteria:

1. Allergy to contents administered
2. pregnant or nursing
3. \<18 years of age
4. Not able to complete questionnaire
5. Acute condition
6. severe COPD
7. \> ASA II
8. Sleep apnea
9. Risk of aspiration
10. Previously difficulty with anesthesia
11. Difficult airway

Primary outcomes:
measure: Satisfaction with sedation
timeFrame: At discharge, on average 30 minutes after procedure termination.
Secondary outcomes:
measure: Number of adverse events as a surrogate marker of safety.
timeFrame: During procedure. On average 20 minutes.
Other outcomes:
measure: Patient comfort
timeFrame: Per-operatively, on average 20 minutes
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
affiliation: University of Copenhagen at Gentofte Hospital
name: Paul F Clementsen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00346528: Safety of NGOIS Compared to BSS Plus in Pediatric Patients
Official title: Safety of NGOIS Compared to BSS Plus in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-06-30
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared to BSS Plus for use during cataract surgery in Pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Cataract present.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* As per age requirements.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon for Trial Locations
state: Texas
Study officials:
affiliation: Medical Monitor
name: Stephen Lane
role: STUDY_DIRECTOR
References:
Clinical trial NCT01589328: Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB
Official title: Randomized Controlled Trials for the Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Biliary Tract Cancer
Cancer Pain
Depression
Keywords: pancreatic cancer
biliary tract cancer
cancer pain
depression
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2012-05-01
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Effect of Early management on PAin and DEpression in patients with PancreatoBiliary Cancer, EPADE-PB

Purpose

To determine whether early palliative care integrated with usual oncologic care with automated symptom monitoring can improve depression and pain in patients with cancer


Eligibility criteria: Inclusion Criteria:

* Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No
* Pathologic confirmed locally advanced or metastatic pancreatic cancer or biliary tract cancer
* within 8 weeks after diagnosis
* cancer-related pain (Brief Pain Inventory \[BPI\] worst pain score \>3), depression (Center for Epidemiological Studies-Depression Scale \[CES-D\] \>16) or both
* Karnofsky Performance Rating Scale ≥50%

Exclusion Criteria:

* Opioid intolerance
* History of drug or alcohol abuse
* Impaired sensory or cognitive function
* Pregnant or lactating woman
* Women of child bearing potential not using a contraceptive method
* Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential

Primary outcomes:
measure: Reduction in pain score
timeFrame: at baseline, 1 month, and every 3 months, up to 1 year
measure: Reduction in depression score
timeFrame: at baseline, 1 month, and every 3 months, up to 1 year
Secondary outcomes:
measure: Quality of life
timeFrame: at baseline, 1 month, and every 3 months, up to 1 year
measure: Overall survival
timeFrame: at baseline, 1 month, and every 3 months, up to 1 year
Other outcomes:
Locations:
city: Goyang, 410-769
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00035828: A Blinded Study Comparing the Safety and Efficacy of a Fully Human Anti-IL8 Monoclonal Antibody (ABX-IL8) to Placebo in Patients With Chronic Bronchitis and COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Bronchitis, Chronic
Keywords: COPD
Chronic bronchitis
Chronic obstructive pulmonary disease
Shortness of breath
Dyspnea
Bronchitis
Lead sponsor: Abgenix
Sponsor class: INDUSTRY
First posted: 2002-05-07
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if ABX-IL8 will improve shortness of breath.

Detailed description: Chronic Obstructive Pulmonary Disease (COPD) is defined as a disease state characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema. The airflow obstruction is generally progressive, may be accompanied by airway hyper-reactivity, and may be partially reversible. Inflammation in the lungs is triggered by exposure to inhaled toxic substances that can lead to tissue damage, mucous secretion, airways narrowing and tissue destruction.

Interleukin-8 (IL-8) plays a major role in elevating sputum in patients with COPD and may contribute to tissue destruction. Therefore, the highly specific antibody to IL-8 (such as ABX-IL8) may help to reduce mucous production and tissue destruction.

Eligibility criteria: Inclusion Criteria:

* \> 50 years old
* \> 20 pack-year of smoking
* Diagnosed with COPD and chronic bronchitis

Exclusion Criteria:

* Patients with bronchiectasis, cystic fibrosis, tuberculosis, asthma, alpha-1 antitrypsin deficiency, CHF
* Require oxygen therapy
* Uncontrolled hypertension
* HIV or Hepatitis
* Recent history of COPD exacerbation
* Patients with cancer
* Recent history of infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Abgenix
state: California
Study officials:
References:
Clinical trial NCT01584128: Oxidized Regenerated Cellulose to Decrease Vaginal Cuff Complications
Official title: Use of Structured Non-woven Absorbable Hemostat (or Oxidized Regenerated Cellulose) to Decrease Vaginal Cuff Dehiscence Rate in Laparoscopic Hysterectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Cuff Complications
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 101
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women, age 20-80, undergoing laparoscopic hysterectomy

Brief summary: The goal of the investigators study is to determine whether the use of oxidized regenerated cellulose reduces the risk of vaginal cuff cellulitis, pelvic abscess, or vaginal cuff dehiscence in patients undergoing laparoscopic hysterectomy. The investigators hypothesize that the use of oxidized regenerated cellulose will reduce the risk of vaginal cuff cellulitis, pelvic abscess, and vaginal cuff dehiscence in patients undergoing laparoscopic hysterectomy.

Detailed description: Structured non-woven absorbable hemostat (or oxidized regenerated cellulose) was designed and marketed for its hemostatic properties. It is used in our practice to achieve hemostasis at the site of the vaginal cuff closure during laparoscopic hysterectomy. While the hemostatic properties of oxidized regenerated cellulose are well known and documented, there is newer research to suggest that oxidized regenerated cellulose may have antimicrobial activity. One In vitro study investigated the antimicrobial activity of oxidized regenerated cellulose products against multiple antibiotic resistant microorganisms and found that the antimicrobial affect of the oxidized regenerated cellulose products was significantly greater than that of the controls. There are a limited number of studies investigating the antimicrobial activity of oxidized regenerated cellulose products in vivo (and none in gynecologic surgery).

Eligibility criteria: Inclusion Criteria:

* female, ages 20-80, undergoing laparoscopic hysterectomy

Exclusion Criteria:

* malignant indications for hysterectomy

Primary outcomes:
measure: Incidence of vaginal cuff complications
timeFrame: postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Hershey Medical Center
name: Carrie A Hossler, MD
role: PRINCIPAL_INVESTIGATOR
References: