louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02983695: Cannabinoid Therapy for Pediatric Epilepsy
Official title: Cannabinoid Therapy in Medically Refractory Pediatric Epilepsy - Phase 1: Dosing and Tolerability Study of a Cannabidiol-Rich Whole Plant Extract of Cannabis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Tilray
First posted: 2016-12-06
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 trial to determine the tolerability and optimal dose of CBD rich cannabis extract as an adjunct treatment in children with severe drug resistant epilepsy due to Dravet Syndrome. This is an open label intervention. Study duration is 20 weeks to primary analysis with continued follow-up until 64 weeks completed.


Eligibility criteria: Inclusion Criteria:

* Drug resistant epilepsy due to Dravet syndrome
* Must have clinically apparent seizures
* Must be able to tolerate administration of medication orally or enterally via gastrostomy tube
* Was never on Cannabinoid therapy or have not been treated with Cannabinoid products for at least last 60 days (confirmed by negative urine test for Tetrahydrocannabidiol (THC), only for those who had been treated with CBD).

Exclusion Criteria:

* Co-morbid liver or renal disease
* Without clinically-apparent seizures
* Currently taking any Cannabinoid products.

Primary outcomes:
measure: Establishment of tolerability of TIL-TC150 by measuring the number of participants with adverse events and / or abnormal laboratory values that are related to treatment
timeFrame: 20-64 weeks
measure: Establishment of tolerability of TIL-TC150 by standardised side effects questionnaire -pediatric epilepsy side effects questionnaire (PESQ)
timeFrame: 16-64 weeks
Secondary outcomes:
measure: The impact of therapy on quality of life using the Quality of Life in Childhood Epilepsy (QOLCE) questionnaire
timeFrame: 16-52 weeks
measure: The impact of therapy on everyday behaviours using the Vineland Adaptive Behavior Scales, Second Edition.
timeFrame: 20-64 weeks
measure: change in seizure frequency from baseline
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Blathnaid McCoy, MB BCh BAO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213395: Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Hypercapnic Respiratory Failure
Keywords: Noninvasive ventilation
Acute hypercapnic respiratory failure
Cephalic mask
Facial Mask
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
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: Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are determinant to get an optimal NIV efficacy in parallel with ventilatory comfort.

Facial masks during NIV are associated with deleterious consequences like gas leaks around the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask discomfort. In order to limit these side effects, a cephalic interface has been recently designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit pressure is therefore spread over a larger surface outside the nose area. However, this mask has a high volume that may interfere with NIV efficacy and may also induce claustrophobic sensations.

The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask versus a conventional oronasal mask during AHRF.


Eligibility criteria: Inclusion Criteria:

* Acute hypercapnic respiratory failure
* Indication to noninvasive ventilation

Exclusion Criteria:

* Requirement for endotracheal intubation
* Proven pulmonary embolism
* Present or previous history of ophthalmologic disease

Primary outcomes:
measure: Arterial blood gases
Secondary outcomes:
measure: Respiratory frequency
measure: Severity scores
measure: Ventilatory settings
measure: Patient-ventilator adaptation
measure: Tolerance
measure: Outcome
measure: Complications
Other outcomes:
Locations:
city: Rouen
country: France
facility: Pulmonary & Intensive Care Department - Rouen University Hospital,
Study officials:
affiliation: University Hospital, Rouen
name: Antoine CUVELIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02704195: Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait
Official title: Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson disease
Deep brain stimulation
Freezing of Gait
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in Parkinson's disease

Detailed description: Unilateral modulation of subthalamic stimulation and its impact on freezing of gait in Parkinson's disease will be studied.

In a cross-over, doubleblind, randomized study, a 30% reduction of stimulation intensity of the less impacted side will be compared with chronic treatment with regard to frequency and duration of freezing of gait episodes.

Eligibility criteria: Inclusion Criteria:

Patients affiliated to social security Patient with idiopathic parkinson's disease, with deep brain stimulation since at least one year Freezing of gait Able to give inform consent

Exclusion Criteria:

Patient under guardianship, legal guardianship Psychosis Severe depression Severe cognitive troubles (Mattis \< 130) Other neurologic or medical pathology interfering with gait

Primary outcomes:
measure: improvement of Freezing of gait
timeFrame: 1 month after new stimulation parameters
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Elena Moro, MD
role: STUDY_DIRECTOR
References:
citation: Meoni S, Debu B, Pelissier P, Scelzo E, Castrioto A, Seigneuret E, Chabardes S, Fraix V, Moro E. Asymmetric STN DBS for FOG in Parkinson's disease: A pilot trial. Parkinsonism Relat Disord. 2019 Jun;63:94-99. doi: 10.1016/j.parkreldis.2019.02.032. Epub 2019 Feb 25.
Clinical trial NCT00173095: The Bilirubin Levels in Cerebrospinal Fluid of Spontaneous Subarachnoid Hemorrhage Patients
Official title: The Bilirubin Levels in Cerebrospinal Fluid of Spontaneous Subarachnoid Hemorrhage Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spontaneous Subarachnoid Hemorrhage
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: According to Morgan et. al. (J Neurosurg 101:1026-1029, 2004): bilirubin as a cerebrospinal fluid marker of sentinel subarachnoid hemorrhage: a preliminary report in pigs, we're going to test the hypothesis in the cerebrospinal fluid of spontaneous subarachnoid hemorrhage patients.

Detailed description: According to Morgan et. al. (J Neurosurg 101:1026-1029, 2004): bilirubin as a cerebrospinal fluid marker of sentinel subarachnoid hemorrhage: a preliminary report in pigs, we're going to test the hypothesis in the cerebrospinal fluid of spontaneous subarachnoid hemorrhage patients. We'll collect the serial cerebrospinal fluid in 15-20 spontaneous subarachnoid hemorrhage patients to see the time sequence of changes in bilirubin levels.

Eligibility criteria: Inclusion Criteria:

* spontaneous subarachnoid hemorrhage in less than three days

Exclusion Criteria:

* spontaneous subarachnoid hemorrhage more than three days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Cheng-Mu Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01708395: IBD-OPERA Database, UC Protocol
Official title: IBD-OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Keywords: Ulcerative colitis
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Janssen Services, LLC
First posted: 2012-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults over 18 years of age

Brief summary: The investigators believe that patients with ulcerative colitis are able to report details of their own medical history accurately and record changes in clinical status effectively over time. Using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record.


Eligibility criteria: Inclusion Criteria:

* MD documented diagnosis of ulcerative colitis
* current of past prescription for anti-TNF medication
* at least 18 years of age
* access to medical records to verify information
* 20% of participants will be patients diagnosed within 1 year of inclusion

Exclusion Criteria:

* unwilling or unable to provide informed consent for study participation
* unable to access or use internet
* less than 18 years of age
* diagnosis of crohn's disease or IBD-U
* illiterate or does not possess minimum level of literacy required to complete questionnaire

Primary outcomes:
measure: Validity of patient self reporting
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT00330395: Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)
Official title: A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Candidiasis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-05-26
Enrollment: 16
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants \<3 months of age following treatment with caspofungin at 25 mg/m2. Another purpose is to test the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection).


Eligibility criteria: Inclusion Criteria:

* Neonates and infants \<3 months of age
* Patient has a body weight greater than or equal to 500 grams
* Patient has documented or highly suspected Candida infection

Exclusion Criteria:

* Patient is greater than 3 months of age
* Patient has a body weight of less than 500 grams
* Patient does not meet certain laboratory testing criteria
* Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days
* Patient has documented HIV infection of any stage
* Patient has a history of allergy, hypersensitivity, or serious reaction to caspofungin or another member of the echinocandin class

Primary outcomes:
measure: Pharmacokinetic parameters of drug exposure
Secondary outcomes:
measure: Safety and tolerability
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Saez-Llorens X, Macias M, Maiya P, Pineros J, Jafri HS, Chatterjee A, Ruiz G, Raghavan J, Bradshaw SK, Kartsonis NA, Sun P, Strohmaier KM, Fallon M, Bi S, Stone JA, Chow JW. Pharmacokinetics and safety of caspofungin in neonates and infants less than 3 months of age. Antimicrob Agents Chemother. 2009 Mar;53(3):869-75. doi: 10.1128/AAC.00868-08. Epub 2008 Dec 15.
Clinical trial NCT00057395: A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Solid Malignancies
Official title: A Phase I/II Study of Aroplatin™ in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Esophageal Neoplasms
Hepatocellular Carcinoma
Colorectal Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Neoplasms
Keywords: Esophageal Neoplasms
Esophagus Neoplasm
Esophagus Cancer
Esophageal Cancer
Esophageal Tumors
Esophagus Tumors
Neoplasms, Esophageal
Hepatocellular Carcinoma
Carcinoma, Hepatocellular
Hepatoma
Colorectal Neoplasms
Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumor
Neoplasms, Colorectal
Ovarian Neoplasms
Ovary Neoplasms
Ovary Cancer
Ovary Carcinoma
Ovarian Cancer
Ovarian Carcinoma
Neoplasms, Ovarian
Pancreatic Neoplasms
Pancreatic Cancer
Pancreas Neoplasms
Pancreas Cancer
Neoplasms, Pancreatic
Neoplasms, Pancreas
and other solid tumors
Lead sponsor: Aronex Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2003-04-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.

Detailed description: Primary Objective:

* Determine response rate (RR; complete and partial response \[CR, PR\]) and duration after therapy with Aroplatin™ in patients with advanced solid malignancies.

Secondary Objective:

* Determine the safety and tolerability of Aroplatin

Eligibility criteria: Inclusion Criteria:

* Advanced solid malignancies;
* Amenable to therapy with DACH platinum agents;
* Measurable disease (RECIST criteria);
* ECOG performance score of 0-2;
* Adequate hematopoietic, liver and renal function;
* Adequate cardiac function (maximum of class II, NYHA);
* Women of childbearing potential must have a negative urine or serum pregnancy test;
* Signed written informed consent;
* Subjects must be willing to be followed during the course of treatment/observation and follow-up.

Exclusion Criteria:

* No other active malignancies;
* No prior therapy with oxaliplatin;
* No known brain metastases;
* Active, uncontrolled infection or other serious medical illnesses;
* Not using or have used any investigational therapy during four weeks before start of protocol treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
Study officials:
References:
Clinical trial NCT06236295: Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial
Official title: Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, single-arm, long-term safety and tolerability trial. A total of 300 subjects with chronic kidney disease on hemodialysis are planned to be enrolled.


Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years of age or older
2. Subject understands the study procedures and agrees to participate in thestudy by giving written informed consent.
3. Subject must be receiving regular hemodialysis for at least 12 weeks
4. BMI ≥18 kg/m2 and ≤35 kg/m2
5. iPTH≥ 300pg/ mL

Exclusion Criteria:

1. Subject has received a a history of malignant tumor within 5 years prior to screening
2. Subject has a history of unstable angina, congestive heart failure (NYHA class III or IV), acute myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.
3. Postdialysis systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg
4. Allergy to the investigational drug (SHR6508 injection) and any of its components or excipients
5. Subject has a history of drug use or excessive alcohol use within 6 months prior to screening
6. Female subjects who were pregnant or lactating
7. Other reasons for not participating as deemed by the investigator

Primary outcomes:
measure: Incidence and severity of any adverse events that occurred during the clinical study
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Percent change from baseline in predialysis iPTH during the EAP
timeFrame: through study completion, an average of 1 year
measure: Percent change from baseline in predialysis serum cCa during the EAP
timeFrame: through study completion, an average of 1 year
measure: Percent change from baseline in predialysis serum phosphorus during the EAP
timeFrame: through study completion, an average of 1 year
measure: Percent change from baseline in predialysis calcium-phosphorus product during the EAP
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00638495: Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -
Official title: Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pruritus With Chronic Liver Disease
Lead sponsor: Toray Industries, Inc
Sponsor class: INDUSTRY
First posted: 2008-03-19
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy and safety of TRK-820 are to be evaluated in the treatment of intractable pruritus in patients with Chronic Liver Disease by administering 2.5, 5 and 10 microg of this drug or placebo for 28 days in four groups with a design of randomized, double-blind, parallel-group comparison. In addition, the plasma concentrations of TRK-820 and its primary metabolites are to be determined.


Eligibility criteria: Inclusion Criteria:

* Chronic Liver Disease is present; and the patient's general condition is judged by the physician to be stable with no prospect of an abrupt change in pathophysiology.
* It can be confirmed by either of the following that treatment of pruritus with antihistamines or antiallergics has not been adequately effective in such patients:

Exclusion Criteria:

* Malignant tumors
* Depression, integration dysfunction syndrome (schizophrenia), or dementia
* Hepatic encephalopathy, or hepatic cirrhosis in which ascites or esophageal or gastric aneurysm cannot be controlled
* Alcoholic liver disease
* Atopic dermatitis, chronic urticaria, or other skin disease producing generalized pruritus that is judged by the physician to affect the assessment of pruritus associated with Chronic Liver Disease in this study
* Allergy to opioid drugs
* Drug dependence or alcohol dependence
* Chronic renal failure

Primary outcomes:
measure: Change in VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week])
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Urayasu
country: Japan
facility: Toray Industries, Inc
state: Chiba
Study officials:
References:
Clinical trial NCT02133495: An Outcomes Assessment of the Utility of Belladerm Acellular Dermal Allograft in Ocular Lower Lid Retraction Repair
Official title: Use of Non-Cadaveric Human Acellular Dermal Tissue (BellaDerm®) in Lower Eyelid Retraction Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Eyelid Retraction
Keywords: lower eyelid
retraction
Lead sponsor: SGM Physician Research Consortium
Sponsor class: NETWORK
Collaborators: name: Musculoskeletal Transplant Foundation
First posted: 2014-05-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to Evaluate the efficacy and longevity of a Human-derived, non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the correction of lower eyelid retraction, taking into consideration issues associated with the use of acelular dermis such as contraction and potential regression of repairs.

Detailed description: To Evaluate the efficacy and longevity of a Human-derived, non-cadaveric, acellular dermal implant (BellaDerm) as a posterior spacer graft in the correction of lower eyelid retraction, taking into consideration issues associated with the use of acelular dermis such as contraction and potential regression of repairs.

Eligibility criteria: Inclusion Criteria:

* Lower eyelid retraction, defined as inferior displacement of the lower eyelid margin with inferior scleral show, may be asymptomatic
* May have ocular irritation including foreign body sensation, burning, photophobia and tearing.
* May have aesthetically unsatisfactory eyelid appearance.

Exclusion Criteria:

* Have a condition that would be contraindicated to surgery

Primary outcomes:
measure: Pre and Post operative margin reflex distance 2 MRD 2
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Inferior scleral show
timeFrame: 1 year
Locations:
city: Wayne
country: United States
facility: Morgenstern Center for Orbital and Facial Plastic Surgery
state: Pennsylvania
Study officials:
References: