louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03467620: Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease
Official title: Oral Cannabidiol Capsule Usage as an Adjunct Therapy for Crohn's Disease: a Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Crohn Disease
Inflammatory Bowel Diseases
Cannabis
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 0
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: To date, few studies have assessed the efficacy and safety of Cannabinoids, compounds derived from the Cannabis plant, in patients with Crohn's disease. Our study seeks to pilot a randomized, placebo-controlled trial assessing the efficacy and safety of oral cannabinoids as an adjunct therapy in patients with Crohn's disease.

Detailed description: Crohn's disease is a type of inflammatory disease which can affect any portion of the gastrointestinal tract, from the mouth to the perianal area. Symptoms depend on location of the disease, however, many patients experience some aspect of recurrent abdominal pain, nausea, emesis, and unintentional weight loss. A common and challenging dilemma is how to manage patients who continue to have some degree of symptoms despite a common treatment regimen typically consisting of corticosteroids, thiopurines, methotrexate, or anti-TNF alpha therapies. With the recent wave of medicinal cannabis legalization in many states, many patients have begun using cannabis or commercially available cannabidiol-containing compounds as an adjunct therapy for their symptoms related to chronic inflammation and pain.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* English-speaking
* Ileal and/or ileocolonic involvement as demonstrated by most recent endoscopy
* Short CDAI score \>150
* Have not received oral or intravenous steroids for \>1 month, or with stable dose for \>1 month if currently taking
* Stable dose of AZA for \>1 month, if currently taking
* Stable dose of anti-TNF inhibitor for \>1 month, if currently taking

Exclusion Criteria:

* Pregnant or intend to become pregnant in the next 6 months
* Major abdominal surgery within the past 3 months

Primary outcomes:
measure: CDAI (Clinical Disease Activity Index) score
timeFrame: 12 weeks
measure: Fecal calprotectin
timeFrame: 12 weeks
Secondary outcomes:
measure: Morbidity
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04144582: Sintilimab Combined With Docetaxel for Standard Chemotherapy Failure Non-driver Gene Mutation Metastatic Non-small Cell Lung Cancer
Official title: Multiple-center, Single-arm, Phase II Study on Sintilimab Combined With Docetaxel in Non-driver Gene Mutation Advanced NSCLC Patients Who Had Failed With Double Platinum-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of Sintilimab Combined With Docetaxel in Non-driver Gene Mutation NSCLC patients who failed with double platinum-based chemotherapy


Eligibility criteria: Inclusion Criteria:

* Life expectancy exceeds 3 months
* The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard.

Exclusion Criteria:

* small cell lung cancer or small cell lung cancer
* Currently involved in interventional clinical research or treatment, or have received other research drugs or used research equipment within 4 weeks prior to the first dose;
* Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (eg, CTLA-4, OX-40, CD137);

Primary outcomes:
measure: ORR
timeFrame: Approximately 1 years
Secondary outcomes:
measure: PFS
timeFrame: Approximately 1 years
measure: OS
timeFrame: Approximately 1 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincal Tumor Hospital
state: Hunan
city: Changsha
country: China
facility: Yongchang Z MD
state: Hunan
Study officials:
affiliation: Hunan Province Tumor Hospital
name: Yongchang Z MD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00901082: The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block
Official title: The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
anxiety
intervention
information
relaxation
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2009-05-13
Enrollment: 60
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: SUPPORTIVE_CARE

Brief summary: Patient presenting to chronic pain clinics frequently undergo diagnostic and therapeutic spinal injections as part of their treatment. These procedures can cause significant level of apprehension in patients, which can lead to increased procedural times, increased procedural pain and reluctance to continue with the treatment program. It appears that certain interventions could reduce the anxiety and catastrophization levels and modify pain perception during medical procedures. The investigators therefore sought to evaluate the effect of a single 30 minutes information session which includes relaxation training administered 5 to 6 days before the nerve block procedure on patient's anxiety and catastrophization levels prior to the procedure and pain scores during the procedure, as well as the overall level of satisfaction with care received.


Eligibility criteria: Inclusion Criteria:

* patient scheduled to have a medial branch block
* over 18 years of age

Exclusion Criteria:

* adult able to give their own consent
* patients who had a previous nerve block
* patients who have a major psychiatric illness
* patients who do not understand English or French

Primary outcomes:
measure: Change in the anxiety level prior to the nerve block as per the state trait anxiety questionnaire
timeFrame: 5-7 days (Second visit and Day of block)
Secondary outcomes:
measure: Perceived pain as measured by NRS (numerical rating scale)
timeFrame: Throughout the study (Baseline, day of block and 1 month after)
measure: Unchanged catastrophization level
timeFrame: Baseline and day of block
measure: Satisfaction level of the overall experience
timeFrame: Day after the block
measure: Ease of performing the nerve block
timeFrame: Day of block
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: MUHC, Montreal General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT05353582: Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases
Official title: Preoperative Systemic Therapy With FOLFOXIRI Plus Bevacizumab Followed by Cytoreductive Surgery Versus Upfront Cytoreductive Surgery for Resectable Colorectal Peritoneal Metastases: A Randomized Phase 2 Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Colorectal Neoplasms
Colorectal Cancer
Colorectal Cancer Metastatic
Peritoneal Metastases
Peritoneal Cancer
Peritoneal Neoplasms
Chemotherapy Effect
Cytoreductive Surgery
Hyperthermic Intraperitoneal Chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, parallel-group, phase 2 randomized trial which randomizes patients with isolated resectable colorectal cancer peritoneal metastases to receive preoperative systematic therapy followed by CRS+HIPEC and postoperative chemotherapy or upfront CRS+HIPEC followed by postoperative chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Historically and radiologically confirmed colorectal cancer peritoneal metastasis except for appendical origin;
* Tolerable to scheduled chemotherapy;
* No evidence of extraperitoneal metastases at enrollment;
* Resectable disease determined by radiological and laparoscopy/laparotomy;
* No systematic therapy within 6 months before enrollment;
* Tolerable to cytoreductive surgery.

Exclusion Criteria:

* Without adequate organ function (e.g. :neutrophil countt≤1.5×10\^9/L, or platelets≤75×10\^12/L，or hemoglobin\<90g/L, or aminotransferase、aspartate aminotransferaseAST\<2.5ULN, or total bilirubin\<1.5ULN, or creatinine\<1.5ULN;
* Emergency surgery;
* Recent thromboembolic event or cerebrovascular disease (12 months before enrollment);
* Pregnancy or lactation
* Comorbid with severe physical or mental disease.

Primary outcomes:
measure: Progression free survival
timeFrame: Up to five years after randomization
Secondary outcomes:
measure: Response to preoperative systematic therapy
timeFrame: About 4 months after randomization
measure: Major adverse events of systematic therapy
timeFrame: Up to 8 months after randomization
measure: Overall survival
timeFrame: Up to five years after randomization
measure: Intraoperative peritoneal cancer index
timeFrame: About 4 months after randomization
measure: Complete cytoreductive surgery
timeFrame: About 4 months after randomization
measure: Hospitalization time
timeFrame: About 4 months after randomization
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT04893382: Inflammatory Consequences of Crystalloids in Severely Burned Patients
Official title: Deciphering the Inflammatory Consequences of Crystalloids Used in the Resuscitation of Severely Burned Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burns
Keywords: Resuscitation
Crystalloids
Inflammation
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients admitted to the severely burned unit will be randomized by the research nurse to either received PlasmaLyte or Ringer's Lactate. Research Nurse will then advise the treating team.
Primary purpose: TREATMENT

Brief summary: This is a pilot study, but the investigators will also observe key immunological events with potential significance. The global objective is to study the inflammatory profiles of PlasmaLyte and Ringer's Lactate used in the initial massive fluid resuscitation of severely burned patients. On the long term, the investigators will identify the crystalloid that prevents hyperactivation of macrophages and death of severely burned patients.

Detailed description: The investigators have 4 specific objectives. First, the investigators will compare the activation profiles of macrophages and neutrophils in patients admitted to the severely burned unit with regards to the crystalloids used. Secondly, the investigators will assess the differences in the SOFA scores according to the crystalloids used. Thirdly, the investigators will evaluate the impact of crystalloids in the quality of skin grafts performed on severely burned patients. Lastly, with the help of a patient partner, the investigators will determine the right immunological terminology of the study for a non-scientific population.

Eligibility criteria: Inclusion Criteria:

* admission to the CHUM
* more than 20% of burned area
* first blood withdrawal in the first 24 hours following burn

Exclusion Criteria:

* immunosuppression
* chemotherapy 6 months before admission
* radiotherapy 6 months before admission
* autoimmune diseases
* neoplasia
* pregnancy
* severe infections
* cardiac dysfunctions
* renal dysfunction
* hepatic dysfunctions
* Hepatitis C
* HIV

Primary outcomes:
measure: Change in monocyte phenotype from admission to day 10
timeFrame: Pre-infusion to day 10 post-infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
Study officials:
affiliation: CRCHUM
name: Jean-François Cailhier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02032082: Rule of Carbone Monoxyde in the Ex Vivo Lung Perfusion Reconditionning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurogenic Lung Edema
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Ex vivo lung perfusion (EVLP) is not a new concept and has been widely used to study lung function in small animals. It also has been shown to be a useful technique to evaluate lungs from donation after cardiac death (DCD) (Yeung, Thorac Surg Clin, 2009). It has been recently demonstrated successful application of an acellular EVLP technique in optimalizing lung function ex vivo for an extended period of time. Following 12 h of normothermic EVLP, patients were transplanted and demonstrated immediate life-sustaining function with promising short-term evolution (Aigner, Am J Transplant, 2012; Sanchez, J Heart Lung Transplant, 2012; Cypel, N Engl J Med, 2011).

Lung donation obtained after carbon monoxide intoxication has been recognized as excellent organs because of less general inflammation and less primary graft dysfunction after procedure. In a murine model of brain dead, carbon monoxide inhalation at a low concentration (50 to 500 parts per million (ppm)) exerts significant cytoprotection in several lung injury models via its vasodilatation, anti-inflammatory, and anti-apoptotic properties (Dong, J Heart Lung transplant, 2010). The carbon monoxide inhalation down-regulates pro-inflammatory cytokines (TNF-alpha, IL-6) along with the increase of anti-inflammatory cytokine (IL-10) in recipient serum. The inhalation significantly decreases cell apoptosis in lung grafts, inhibiting mRNA and protein expression of intercellular adhesion molecule-1 (ICAM-1) and caspase-3 in lung grafts (Zhou, Chin Med J, 2008).

Apoptotis and inflammatory processes may, in part, concern alveolar tissue. Research in the field of biomarkers is now opening new perspectives with the development of non-invasive tests allowing for monitoring inflammation and damage in the deep lung. Blood tests (Bernard, Toxicol Appl Pharmacol, 2005) measuring lung-specific proteins (pneumoproteins) such as Clara cell protein (CC16) and surfactant-associated proteins (A, B or D) are now available to evaluate the permeability and/or the cellular integrity of the pulmonary epithelium. These dosages may constitute an interesting way for monitoring the quality of the lung before implantation.


Eligibility criteria: Inclusion Criteria:

Lung Edema

Exclusion Criteria:

Infection Severe Emphysema Tumor

Primary outcomes:
measure: Incidence on Primary Graft Dysfunction
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: CHU Mont-Godinne
state: Namur
Study officials:
References:
Clinical trial NCT06194682: Anterior Cruciate Ligament Study
Official title: "Valutazione Dell'Epidemiologia e Dei Risultati Clinici Nel Trattamento Artroscopico Delle Lesioni Del Legamento Crociato Anteriore"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ACL Injury
ACL
Anterior Cruciate Ligament Rupture
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone and will undergo anterior cruciate ligament reconstruction surgery at the CASCO Team between January 2020 and December 2030. Clinical data, any questionnaires, scores, and radiographic parameters were collected at the same time as the visits and prescribed procedures according to the clinical routine of the department. No additional services will be prescribed by virtue of participation in this study

Brief summary: This retrospective, prospective observational study aims to evaluate the epidemiology and rate of anterior cruciate ligament re- rupture after surgery in patients treated from January 2020 to December 2030 by recording both clinically and radiographically ligament reconstruction.

The primary outcome is the rate of rupture of the anterior cruciate ligament as measured by the Lachmann test in which a positive value for re-rupture is an anterior translation of the tibia greater than 10mm relative to the femur Secondary Objectives: Verify predisposing factors to anterior cruciate ligament injuries (so anatomical factors such as tibial slope, trochlear groove), demographic factors (age, sex, weight, sports played), and the rate of return to sports, quality of life via questionnaires, and arthrosis at the operated knee


Eligibility criteria: Inclusion Criteria:

* - Males and females- attained skeletal maturity
* 18-65 inclusive
* Patients operated on anterior cruciate ligament reconstruction surgery at the Hospital's Casco unit from 2010 to 2030
* Signature informed consent for patients who will be operated on in the prospective phase (from CE approval date to 2030)

Exclusion Criteria:

* failure to reach skeletal maturity

  * Concomitant ligamentous injuries (pcl, mcl, lcl)
  * Neuropsychiatric illness, developmental disorders
  * Pregnant women through self-declaration or breastfeeding
  * Minors

Primary outcomes:
measure: Rerupture rate
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
References:
Clinical trial NCT01270282: Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
Official title: Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinnitus
Lead sponsor: Auris Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-05
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus.


Eligibility criteria: Inclusion Criteria:

* Tinnitus following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotrauma; with onset less than three months ago.

Exclusion Criteria:

* Tinnitus that is not completely maskable
* Fluctuating tinnitus
* Intermittent tinnitus
* Meniere's Disease
* Ongoing acute or chronic otitis media or otitis externa.

Primary outcomes:
measure: The change in tinnitus loudness by magnitude estimation from Baseline to 90 days following the last injection
timeFrame: 90 or 104 days
Secondary outcomes:
measure: Standard audiological evaluations
timeFrame: 90 or 104 days
measure: Questionnaires evaluating the impact of tinnitus
timeFrame: 90 or 104 days
measure: Pharmacokinetic measures
timeFrame: 3 or 14 days
Other outcomes:
Locations:
city: Gainsville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Advanced ENT & Allergy
state: Kentucky
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Edegem
country: Belgium
facility: UZ Antwerp, Department of ENT
city: Gent
country: Belgium
facility: Gent University Hospital, Department of ENT
city: Hasselt
country: Belgium
facility: Virga Jesseziekenhuis Hasselt
city: Braunschweig
country: Germany
facility: HNO Praxis im Schlosscarree
city: Frankfurt am Main
country: Germany
facility: Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
city: Heidelberg
country: Germany
facility: HNO Gemeinschaftspraxis
city: Köln
country: Germany
facility: HNO Praxis
city: Ulm
country: Germany
facility: Bundeswehrkrankenhaus Ulm
city: Rzeszów
country: Poland
facility: NZOZ Laryngologii Wojewodzki Szpital Specjalistyczny
city: Tarnowskie Góry
country: Poland
facility: NZOZ Centrum Medyczne LiMED
city: Warsaw
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Study officials:
References: