louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03903341: The Role of the Upper Colliculus in the Idiopathic Blepharospasm
Official title: The Role of the Upper Colliculus in the Idiopathic Blepharospasm : a Pilot Study in Functional MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blepharospasm, Benign Essential
Keywords: Superior colliculus
fMRI
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This pilot study aims at investigating the role of superior colliculus in patients with idiopathic blepharospasm (BSP) de novo, compared to healthy subjects.

Detailed description: The objective of the study is to investigate the function of the superior colliculus (SC) related to visual stimulation by means of fMRI (functional magnetic resonance imaging) in patients with idiopathic BSP compared to healthy subjects. The hypothesis is that SC function is impaired in BSP (role of biomarker of SC).

Eligibility criteria: Inclusion Criteria:

* Non treated idiopathic blepharospasm
* Age: 30- 70 years

Exclusion Criteria:

* Under the following treatments: Botulin toxin, anticholinergic, benzodiazepines, baclofen, beta- and alpha-blockers collyrium
* No MRI Contraindication

Primary outcomes:
measure: Visual pathways fMRI
timeFrame: In a five months period after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
affiliation: CHU Grenoble Alpes
name: Sara Meoni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00724841: A Phase I/II Study of GMX1777 in Combination With Temozolomide for the Treatment of Metastatic Melanoma
Official title: A Multi-Center, Open-Label, Phase I/II Study of GEM1777 in Combination With Temozolomide Administered Every 4 Weeks to Patients With Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Metastatic Melanoma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 1
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: Obatoclax Mesylate (GMX1777) is a water-soluble, intravenously-administered pro-drug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.

Detailed description: GMX1777 will be administered as 3-Hour Infusions in Combination with Temozolomide taken orally for the treatment of Metastatic Melanoma. GMX1777 infusion will be given on either day 1, days 1 and 3, or days 1,3, and 5 every 4 weeks. Temozolomide will be administered on 5 consecutive days every 4 weeks. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed metastatic melanoma
* Up to 1 prior chemotherapy regimen allowed; prior immunotherapy allowed
* Normal organ and marrow function
* Willing to submit to blood sampling for planned PK/PD analyses
* Ability of understand and willingness to sign a written informed consent

Exclusion Criteria:

* No other investigational or commercial agents or therapies
* Prior exposure to GMX1777, GMX1778 or CHS828
* Patients with uncontrolled, intercurrent illness
* Pregnant or breastfeeding women

Primary outcomes:
measure: Determine the recommended Phase II dose of GMX1777 in combination with temozolomide
timeFrame: 2 years
measure: Learn more about the side effects of taking GMX1777 in combination with temozolomide
timeFrame: Within the first 4 weeks
measure: Determine the disease response to treatment with GMX1777 in combination with temozolomide
timeFrame: Within the first 8 weeks
Secondary outcomes:
measure: Learn more about how the body processes GMX1777
timeFrame: Within the fisrt 30 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Gemin X, Inc.
name: Mark Berger, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00549341: PurTox (Botulinum Toxin Type A) for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia
Official title: A Phase I, Single-dose, Double-blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety of PurTox for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia and to Explore Dose-associated Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Spasmodic Torticollis
Keywords: Torticollis
Cervical Dystonia
Lead sponsor: Mentor Worldwide, LLC
Sponsor class: INDUSTRY
First posted: 2007-10-25
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The safety and efficacy of Mentor Purified Toxin, Botulinum Toxin Type A, Purified Neurotoxin, injected intramuscularly into the neck, is being evaluated as a treatment for painful and non-painful spasmodic torticollis/cervical dystonia. It is hypothesized that treatment will decrease symptom severity and will not have any significant side effects.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of torticollis with noticeable symptoms for at least 6 months
* Total TWSTRS score greater or equal to 20, TWSTRS severity score greater than or equal to 10 and TWSTRS Disability score greater than or equal to 3 (must meet all 3 criteria)

Exclusion Criteria:

* Diagnosis of isolated anterocollis
* Concurrent myopathic disease, myotonic dystrophy (or other form of muscular dystrophy), myasthenia gravis
* Currently receiving aminoglycoside antibiotic therapy, curare-like drugs, quinidine, succinylcholine, polymixins, anticholinesterases, magnesium sulfate, or lincosamides
* Any illness that is considered by the Investigator to make the subject an inappropriate candidate
* Cervical spine injury within 18 months or head and neck surgery within 6 months prior to screening
* Pre-existing dysphagia
* History of active autoimmune disease
* Exposure to botulinum toxin based pharmaceutical within 3 months prior to screening
* History of primary non-response or secondary resistance with prior exposure to botulinum based pharmaceuticals
* History of chemotherapy/radiation for malignant disease within 24 months
* Any investigational drug/device during the 30 days prior to screening

Primary outcomes:
measure: Absence of significant drug related adverse effects
timeFrame: Post-injection
Secondary outcomes:
measure: Decrease in symptom severity (TWSTRS)
timeFrame: 30 days post-injection
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Mentor Worldwide, LLC
state: California
Study officials:
affiliation: Mentor Worldwide, LLC
name: Carolyn Austin
role: STUDY_DIRECTOR
References:
Clinical trial NCT00363519: Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus
Official title: MK-0431/ONO-5435 Phase III Clinical Study - Glimepiride add-on Study for Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: MK-0431
ONO-5435
Type 2 diabetes mellitus
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 195
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 purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and glimepiride as monotherapy


Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 diabetes mellitus on diet/exercise therapy and glimepiride as monotherapy

Exclusion Criteria:

* Patients with Type 1 diabetes mellitus

Primary outcomes:
measure: HbA1c
timeFrame: 12 weeks
measure: safety
timeFrame: 52 weeks
measure: tolerability
timeFrame: 52 weeks
Secondary outcomes:
measure: Plasma glucose
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Chubu Region
city: Chugoku
country: Japan
facility: Chugoku Region
city: Hokkaido
country: Japan
facility: Hokkaido Region
city: Kanto
country: Japan
facility: Kanto Region
city: Kinki
country: Japan
facility: Kinki Region
city: Kyushu
country: Japan
facility: Kyushu Region
city: Shikoku
country: Japan
facility: Shikoku Region
city: Tohoku
country: Japan
facility: Tohoku Region
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Mikio Nishii
role: STUDY_DIRECTOR
References:
Clinical trial NCT02442219: A Blood Based Diagnostic Test for Coeliac Disease
Official title: A Blood Based Diagnostic Test for Coeliac Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coeliac Disease
Non Coeliac Gluten Sensitivity
Keywords: gluten
Tetramer
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2015-05-13
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are invited through announcement in media. Eligibility is tested through HLA-test and previous workup with confirmation / exclusion of coeliac disease by reference method (duodenal biopsy).

Brief summary: Persons with coeliac disease treated with a gluten free diet will be asked to give blood for a new diagnostic blood test. In this test investigators will use multimerized HLA bound to different gliadin-peptides (tetramer) and with the help of a flow-cytometer identify (along with other relevant T-cell-markers) gluten specific T-cells. Investigators believe that these cells will be present in persons with coeliac disease regardless of gluten-intake. Investigators will compare their findings with two control groups; Persons on a gluten free diet where celiac disease is excluded (gluten sensitive group) and persons on a gluten containing diet (healthy control group). In the initial and main study investigators will look at HLA DQ2.5 individuals, which comprise \>90% of all persons with coeliac disease.


Eligibility criteria: Inclusion Criteria:

* HLA DQ2.5 positives in primary blinded study (other HLA-types ie DQ8 and DQ2.2 in later unblinded study)
* In gluten free group: Diagnosis must be confirmed by duodenal biopsy done after sufficient time on gluten containing diet and participant must have followed a glutenfree diet since.

Exclusion Criteria:

* Drugs that influence the immune system used last three months
* Infected with Hepatitis B, C or HIV
* Pregnant

Primary outcomes:
measure: Ability of the tetramer test in differentiating persons with coeliac disease from controls by the use of tetramer staining for gluten specific T-cells and flowcytometry
timeFrame: Upto 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University hospital
Study officials:
affiliation: University of Oslo. Oslo University Hospital.
name: Knut EA Ludin, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarna VK, Lundin KEA, Morkrid L, Qiao SW, Sollid LM, Christophersen A. HLA-DQ-Gluten Tetramer Blood Test Accurately Identifies Patients With and Without Celiac Disease in Absence of Gluten Consumption. Gastroenterology. 2018 Mar;154(4):886-896.e6. doi: 10.1053/j.gastro.2017.11.006. Epub 2017 Nov 14.
Clinical trial NCT01094119: A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air
Official title: A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Warming Systems During Surgery
Keywords: heated blanket
heated pad
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2010-03-26
Enrollment: 70
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: SUPPORTIVE_CARE

Brief summary: Recently, a novel posterior heating system has been developed that provides enhanced pressure relief: the Laryngeal Mask Airway (LMA) PerfecTemp. Anactodal experience with this FDA-approved system suggests that the PerfecTemp warmer is effective, even in open abdominal surgery. The investigators therefore propose to test the hypothesis that intraoperative distal esophageal (core) temperatures with PerfecTemp warming are non-inferior to upper-body forced-air warming in patients undergoing open major abdominal surgery under general anesthesia.

Secondary hypotheses include that:

1. intraoperative core temperatures are superior with PerfecTemp than upper-body forced-air warming
2. final intraoperative core temperature is non-inferior with PerfecTemp than upper-body forced-air warming
3. final intraoperative core temperature is superior with PerfecTemp than upper-body forced-air warming.


Eligibility criteria: Inclusion Criteria:

* Body-mass index 20-36 kg/m2
* Age 18-75 yrs
* ASA Physical Status 1-3
* Supine position (with or without lithotomy)

Exclusion Criteria:

* Pre-operative fever
* Serious skin lesions
* And contraindication to either PerfecTemp or forced-air warming

Primary outcomes:
measure: Time Weighted Average Core Temperature
timeFrame: from tracheal intubation to 3 hours after or tracheal extubation
Secondary outcomes:
measure: Proportion of Patients With Temperatures Above 36 Degree
timeFrame: at the end of surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02110719: Decreasing Narcotics in Advanced Pelvic Surgery
Official title: Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Narcotic Use
Pain
Constipation
Nausea
Keywords: narcotic use
pain
constipation
nausea
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In recent years, there has been an emphasis on the creation of "enhanced-recovery", "fast-track" or "multi-modal" pathways to improve perioperative care (1-4). The goal of these programs is to reduce the length of hospital stay, decrease narcotic usage while improving pain control, accelerate post-operative recovery, and expedite return to baseline functional status. Pathways often are developed by a team of surgeons, nurses, pain specialists, anesthesiologists and other support staff. Postoperative components often involve multi-modal analgesia, early return to activity and early return to a regular diet. The goal of this study is to evaluate the efficacy of a multi-modal pain regimen in advanced pelvic surgery with a primary goal of decreasing narcotic usage.


Eligibility criteria: Inclusion Criteria:

* women \>/= 18 years old
* undergoing pelvic organ prolapse or incontinence surgery with the Urogynecology department

Exclusion Criteria:

* males
* \<18 years old
* women unwilling or unable to consent
* same-day-discharge surgery
* history of chronic pain for which they use medications
* current or active history of narcotic abuse
* sleep apnea
* liver or kidney dysfunction
* sulfa allergy

Primary outcomes:
measure: Narcotic use
timeFrame: intraoperative, immediate postoperative and 1 week postoperative
Secondary outcomes:
measure: Pain
timeFrame: postoperative day #1 and postoperative week #1
measure: Nausea
timeFrame: intraoperatively, postoperatively
measure: Constipation
timeFrame: one week postoperatively
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hosptial
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Krista Reagan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00901719: Investigating Systemic and Local Vascular Responses to Apelin in the Context of Renin-angiotensin Upregulation
Official title: Investigating the Interaction of Apelin and Systemic Angiotensin II Peripheral Resistance Vessels and Systemic Haemodynamics in Vivo in Man
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Disease
Heart Failure
Vasodilatation
Keywords: Renin angiotensin system
Apelin
Cardiac output
Vasodilatation
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
name: British Heart Foundation
First posted: 2009-05-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The apelin-APJ system is a relatively new discovery. It has generated interest in part due to it's apparent ability to counteract the renin-angiotensin system, which is frequently overactive in many cardiovascular disease.

Two of the main actions of apelin are to increase the pumping ability of the heart and cause blood vessels to relax. The investigators wish to assess if these actions are altered in the setting of normal renin-angiotensin activation and increased renin-angiotensin activity.


Eligibility criteria: Inclusion Criteria:

* \>18yr

Exclusion Criteria:

* Lack of informed consent
* Age \< 18 years,
* Current involvement in other research studies,
* Systolic blood pressure \>190 mmHg or \<100 mmHg
* Malignant arrhythmias
* Renal or hepatic failure
* Haemodynamically significant aortic stenosis
* Severe or significant co morbidity
* Women of childbearing potential.
* Any regular medication
* Previous history of any cardiovascular disease

Primary outcomes:
measure: Change in cardiac output
timeFrame: 12 months
measure: Change in apelin mediated vasodilatation
timeFrame: 12 months
Secondary outcomes:
measure: Change in systemic haemodynamics
timeFrame: 12 months
measure: Change in relevant neurohumoral hormones
timeFrame: 12 months
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc
Study officials:
References:
citation: Barnes GD, Alam S, Carter G, Pedersen CM, Lee KM, Hubbard TJ, Veitch S, Jeong H, White A, Cruden NL, Huson L, Japp AG, Newby DE. Sustained cardiovascular actions of APJ agonism during renin-angiotensin system activation and in patients with heart failure. Circ Heart Fail. 2013 May;6(3):482-91. doi: 10.1161/CIRCHEARTFAILURE.111.000077. Epub 2013 Mar 21.
Clinical trial NCT03219619: Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla
Official title: Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla: a Randomized Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Observation of Major Duodenal Papilla (MDP)
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2017-07-17
Enrollment: 171
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: DIAGNOSTIC

Brief summary: Examination of major duodenal papilla (MDP) using a side-viewing duodenoscope is a golden standard. However, side-viewing duodenoscope is not available in some endoscopic centers. Cap-assisted esophagogastroduodenoscopy (Ca-EGD) using a transparent cap fitted to the tip of the scope has emerged as an alternative method for the observation of MDP. A recent study showed that complete examination of MDP could be achieved in 97% of patients. The investigators hypothesize that Ca-EGD is non-inferior to duodenoscope for the observation of MDP.

Detailed description: Interim analyses were planned to be performed by the data and safety monitoring board after data collection has been completed for 50% of the enrollment.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years and \< 70 years
* Patients with native MDP who underwent ERCP

Exclusion Criteria:

* Prior surgery in upper GI tract
* Prior history of endoscopic sphincterotomy
* Prior history of MDP treatment
* Known or suspected obstruction of upper GI tract
* Patients in poor condition who may not be suitable for Ca-EGD or duodenoscope
* Pregnancy or lactic women
* Inability to give informed consent

Primary outcomes:
measure: Rate of complete examination of MDP
timeFrame: 5 minutes after intubation of the esophagus
Secondary outcomes:
measure: Endoscopic findings in descending duodenum
timeFrame: 5 minutes after intubation of the esophagus
measure: Overall endoscopic findings
timeFrame: 5 minutes after intubation of the esophagus
measure: MDP examination time
timeFrame: 5 minutes after intubation of the esophagus
measure: MDP examination score
timeFrame: 5 minutes after intubation of the esophagus
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
city: Chongqing
country: China
facility: Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Study officials:
References:
citation: Shi X, Luo H, Ning B, Wang X, Tao Q, Liang S, Zhang R, Chen J, Luo B, Yao S, Pan Y, Guo X, Fan D. Effect of cap-assisted esophagogastroduodenoscopy on examination of the major duodenal papilla: a noninferior, randomized controlled trial. Endoscopy. 2019 May;51(5):427-435. doi: 10.1055/a-0767-6529. Epub 2019 Jan 8.