louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03330327: Molar Potency Study of HM12470 in Healthy Subjects
Official title: An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12470 and Regular Human Insulin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase 1 study to assess and compare molar potency of HM12470 and regular human insulin in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Females must be non-pregnant and non-lactating
* Males must be surgically sterile or using an acceptable contraceptive method

Exclusion Criteria:

* Participation in an investigational study within 30 days prior to dosing
* Use of new prescription and non-prescription drugs within 3 weeks preceding the first dosing

Primary outcomes:
measure: Blood glucose assessment of HM12470 and regular human insulin (RHI) over the entire dosing period
timeFrame: 1 month
Secondary outcomes:
measure: Cmax of HM12470
timeFrame: 1 month
measure: AUC of HM12470
timeFrame: 1 month
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Hanmi Investigative Site
state: California
Study officials:
References:
Clinical trial NCT02227927: Treatment Use of Domperidone for Gastroparesis
Official title: Treatment Use of Domperidone for Gastroparesis
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: Gastroesophageal Reflux Disease
GERD
Gastroparesis
Keywords: Gastroesophageal Reflux Disease
GERD
Gastroparesis
Domperidone
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2014-08-28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation.

This is a long-term treatment program for prescription of this drug to all patients who, in the investigators' judgement, could benefit from its use.

Detailed description: The Treatment Use of Domperidone program is also available at the Cleveland Clinic Florida/Weston Gastroenterology Department. This is not a "traditional" research study, but an expanded use protocol for patients who may benefit from the drug. Because of this, this study is enrolling patients via invitation only, and as such, all expenses associated with the drug, initiation and follow up of treatment are the responsibility of the patient or the patient's third party payer.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 18 and older
* Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
* Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
* Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

  * increased prolactin levels
  * extrapyramidal side effects
  * breast changes
  * cardiac arrhythmias including QT prolongation and death
  * There is a potential for increased risk of adverse events with the drugs listed in the domperidone protocol addendum.

Exclusion Criteria:

* History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
* Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc\> 450 milliseconds for males, QTc\>470 milliseconds for females).
* Clinically significant electrolyte disorders.
* Gastrointestinal hemorrhage or obstruction
* Presence of a prolactinoma (prolactin-releasing pituitary tumor).
* Pregnant or breast feeding female
* Known allergy to domperidone

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT01622127: Progrip Ventral Study for Sublay Repair
Official title: Efficacy of Self-fixating Mesh in Ventral and Incisional Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Ventral and Incisional Hernia Repair
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2012-06-18
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary ventral and incisional hernia repair.

Brief summary: A novel concept of self-gripping mesh has been developed to achieve secure and long-term posterior wall reinforcement. ProGrip™ mesh is a lightweight (40g/m2) monofilament polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which provide self-gripping properties during the first few months after implantation. The self-fixation of the mesh to the underlying tissues is instantly achieved at application, limiting or avoiding the requirement of sutures (which can penetrate underlying tissues and damage cutaneous nerves), and providing a near tension-¬free repair.

Case series confirmed that Parietex ProGrip™ placed in onlay position allows a safe and painless treatment of incisional hernias and provides secure and efficient fixation mesh. On this basis, larger sizes Parietex ProGrip™ meshes have been developed for larger incisional hernia defect treatment. In order to assess the clinical outcomes following the use of ProGrip™ larger sizes in incisional hernia repair, this mono-center observational study has been initiated.


Eligibility criteria: Inclusion Criteria:

* All patients at participating hospital undergoing incisional hernia repair by using retromuscular placement by open approach.
* Defect size: 5cm ≤ width\*, 10 cm ≤ length ≤ 20 cm

Primary outcomes:
measure: Incidence of peri-operative and post-operative complications using Parietex ProGrip™.
timeFrame: 24 months after surgery
Secondary outcomes:
measure: Description and assessment of the use of Parietex™ ProGrip™ larger sizes meshes at time of surgery
timeFrame: End of surgical procedure
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00522327: Remote Simultaneous Medical Interpreting and Medical Outcomes
Official title: Remote Simultaneous Medical Interpretation: Medical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DIabetes
Keywords: Immigrant
Interpreting
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: The California Endowment
name: The Commonwealth Fund
First posted: 2007-08-29
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: All new patients to the general medicine clinic who were not primarily English speaking were randomized, after consenting, to receieve either remote simultaneous medical interpreting or usual and customary interpreting services. Patient charts were followed for one year after enrollment to assess medical outcomes, including patient satisfaction, diabetes management, lipid management, depression screening and management, vaccine administration.

All Spanish-speaking ER patients were similarly enrolled. They were followed for one ER visit and their knowledge of exit instructions was assessed, as well as their satisfaction with care.


Eligibility criteria: Inclusion Criteria:

* Limited English-speaking
* English-speaking
* New patient in medicine clinic

Primary outcomes:
measure: Adherence with care
timeFrame: one year
Secondary outcomes:
measure: care parameters
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Francesca M Gany, MD., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leng JC, Changrani J, Gany FM. Language discordance and testing for latent tuberculosis infection among recent Asian and Latino immigrants. J Community Health. 2011 Apr;36(2):228-30. doi: 10.1007/s10900-010-9301-2.
citation: Leng JC, Changrani J, Tseng CH, Gany F. Detection of depression with different interpreting methods among Chinese and Latino primary care patients: a randomized controlled trial. J Immigr Minor Health. 2010 Apr;12(2):234-41. doi: 10.1007/s10903-009-9254-7.
citation: Gany F, Leng J, Shapiro E, Abramson D, Motola I, Shield DC, Changrani J. Patient satisfaction with different interpreting methods: a randomized controlled trial. J Gen Intern Med. 2007 Nov;22 Suppl 2(Suppl 2):312-8. doi: 10.1007/s11606-007-0360-8.
Clinical trial NCT02036827: The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy
Official title: The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Pain, Postoperative
Neuromuscular Blocking Agents
Laparoscopy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to investigate whether there is any difference in incidence of shoulder tip pain after laparoscopic cholecystectomy between the groups with moderate neuromuscular block and deep neuromuscular block.

Detailed description: Laparoscopic cholecystectomy has become the gold standard treatment for gall bladder disease. However, 30-50% of patients suffer from shoulder tip pain, which might arise from diaphragm stretch due to pneumoperitoneum.

In the previous pilot study, working intra-abdominal space was increased in the condition of deep neuromuscular blockade. And thus investigators hypothesized that the depth of neuromuscular blockade can affect insufflation pressure and intra-abdominal volume, which result in the severity of diaphragm stretch and postoperative shoulder pain. In addition, the depth of neuromuscular blockade can alter pulmonary compliance.

Eligibility criteria: Inclusion Criteria:

* physical status by American society of Anesthesiology; 1 or 2 patients
* patients with benign gallbladder disease scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

* patient with myasthenia gravis
* allergy to rocuronium or sugammadex
* patient with shoulder pain disease (Ex. rotator cuff tear)
* psychological disease
* patients who cannot understand Korean

Primary outcomes:
measure: Shoulder tip pain
timeFrame: upto postoperative 24 hours
Secondary outcomes:
measure: Postoperative pain
timeFrame: upto postoperative 24 hours
measure: Postoperative nausea and vomiting
timeFrame: upto postoperative 24hours
measure: Intraoperative hemodynamics
timeFrame: upto postoperative 24hours
measure: pulmonary compliance
timeFrame: upto postoperative 24 hours
measure: Satisfaction of the surgeon
timeFrame: upto postoperative 24 hours
measure: Working intrabdominal space
timeFrame: upto postoperative 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam severance hospital
Study officials:
affiliation: Yonsei University
name: Yon Hee Shim, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01312727: Hereditary Tubulointerstitial Nephritis
Official title: Phenotypical and Genetic Characterization of Adult Hereditary Chronic Tubulointerstitial Renal Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephritis, Interstitial
Chronic Renal Failure
Gout
Renal Cysts
Keywords: Tubulointerstitial renal diseases
Hereditary renal diseases
Uromodulin
Renin gene
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2011-03-11
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of this study is to identify families with hereditary chronic tubulointerstitial renal diseases , characterize the phenotype and screen for mutations in known genesis (UMOD, REN, TCF2, NPHP1). Genome wide analysis will be performed in families without mutations identified.

Detailed description: * Inclusion of affected subjects with familial history of chronic renal failure, early gout ,renal cysts in several hospital in France
* Characterization of the phenotype; dosage of the urinary uromodulin in all subjects
* Collect DNA samples
* Screen for UMO mutations first
* Then for REN or TCF2 depending on the phenotype
* Validate the use of the dosage of urinary uromodulin for the diagnosis of UMOD associated disease.
* Identify new genes responsible for hereditary HTIN (Hereditary Tubulointerstitial Nephritis).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* HTIN of unknown cause
* Chronic renal failure defined by a eGFR (estimated Glomerular Filtration Rate) estimated according to MDRD (Modification of the Diet in Renal Disease) \< 60ml / min / 1,73m2.
* At least two siblings affected by gout before 40 years or by chronic renal failure.
* Affiliated or benefiting from a national insurance
* Signature of the enlightened consent.

Exclusion Criteria:

* Endstage renal failure before the age of 18 years in all affected subjects of the family.
* Microscopic or macroscopic persistent hematuria, or proteinuria \> 1gramme / 24hours.
* Other potential cause of TIN (Tubulointerstitial Nephritis): pyelonephritis, drug toxicity.
* High blood pressure known for more than 10 years before the discovery of the renal disease.
* Major cardiovascular before the discovery of the renal disease.
* Chronic auto-immune or infectious disease.
* Polycystic kidney disease with increased of the size of the kidneys

Primary outcomes:
measure: Genotype of HTIN
timeFrame: after 18 months
Secondary outcomes:
measure: Uromodulin dosage in urine
timeFrame: at 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Bertrand Knebelmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03291873: Topography-Guided Customized PRK Versus Q-value Adjusted PRK in Correction of Myopia With or Without Astigmatism
Official title: Topography-Guided Customized PRK (Photorefractive Keratectomy) Versus Q-value Adjusted PRK in Correction of Myopia With or Without Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 104
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: This study will include patients who will undergo PRK in both eyes, for each patient each eye will be randomly allocated to one of 2 procedures:

topography-guided ablation in one eye (group I) and Q-factor customized ablation in the other eye (group II).

Alcon/Wavelight Light Laser Technolo¬gie (GmbH, Erlangen, Germany) will be used for photoablation.

The wavelight Topolyzer (Wavelight AG, Erlan¬gen, Germany)and CSO Sirius scheimpflug camera combined with Placido corneal topography (CSO, Florence,Italy) will be used before and 1, 3 and 6 months after PRK. Refrac¬tive visual outcomes and corneal aberration changes will be compared between the two treatment modalities.


Eligibility criteria: Inclusion Criteria:

* Age more than 18 years
* Myopia with up to -6.5 D with or without astigmatism up to -4.75 D

Exclusion Criteria:

* anterior segment abnormalities (ie, cataracts, corneal scarring)
* basement membrane disease
* history of recurrent corneal erosions
* Schirmer's test less than 5 mm
* established or forme fruste keratoconus
* macular or retinal disease
* current use of immunosuppressive therapy
* autoimmune disease
* pregnancy, and lactation

Primary outcomes:
measure: change in Postoperative spherical equivalent depending on manifest refraction after autorefractometer
timeFrame: 1 , 3 and 6 months postoperative
measure: change in visual acuity using snellen chart
timeFrame: 1 , 3 and 6 months postoperative
measure: change in corneal wavefront aberrations
timeFrame: 1 , 3 and 6 months postoperative
measure: change in Q value anterior at 6mm RMS, RMS of astigmatism, RMS of coma and RMS of spherical aberrations. Strehl ratio : Qvalue,RMS,strehl ratio by CSO Sirius scheimpflug
timeFrame: 1,3 and 6months
measure: change in total RMS
timeFrame: 1,3 and 6months
measure: change in strehl ratio
timeFrame: 1,3 and 6 months
measure: change in Q value
timeFrame: 1,3 and 6 months
Secondary outcomes:
measure: efficacy:ratio of postoperative decimal UDVA to preoperative decimal CDVA
timeFrame: 6 months
measure: contrast sensitivity
timeFrame: 6 months
measure: predictability
timeFrame: 6 months
measure: safety:ratio of mean preoperative decimal CDVA to mean postoperative decimal CDVA
timeFrame: 6 months
measure: stability
timeFrame: 6 months
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Eyecare centre
state: Cairo
city: Giza
country: Egypt
facility: Dar Al Oyun hospital
Study officials:
References:
Clinical trial NCT00698373: Evaluation of Thoracic Tumors With 18F-FMT and 18F-FDG PET-CT A Clinicopathological Study
Official title: Evaluation of Thoracic Tumors With 18F-FMT and 8F-FDG PET-CT: A Clinicopathological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: Fluorine-18-α-methyltyrosine,
Positron emission tomography,
Fluorine-18-fluorodeoxyglucose,
Lung cancer,
Lead sponsor: Gunma University
Sponsor class: OTHER
Collaborators: name: J~pharma
First posted: 2008-06-17
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indeterminate pulmonary nodule suspicious of lung cancer were eligible for this prospective study.

Brief summary: L-\[3-18F\]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for positron emission tomography (PET). The aim of this study was to determine whether PET-CT with 18F-FMT provides additional information for the preoperative diagnostic workup as compared with 18F-FDG PET. Tumor uptake of 18F-FMT was compared with several immunohistochemical markers including L-type amino acid transporter 1 (LAT1).


Eligibility criteria: Inclusion Criteria:

* Patients with indeterminate pulmonary nodule suspicious of lung cancer

Exclusion Criteria:

* Patients with other malignancies and those who had received cancer treatment within the past 5 years were excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01074073: Lithium Drug-Drug Interaction Study With Lurasidone HCl
Official title: A Phase 1, Open-Label, 2-Period, Sequential, Drug-Drug Interaction Study To Determine The Effect Of Lithium 600 Mg BID On The Safety And Pharmacokinetics Of Lurasidone 120 Mg QD In Patients With Schizophrenia Or Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Lithium DDI with Lurasidone HCl
Male/Female, Schizophrenia Patients
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the drug-drug interaction effect between Lithium and Lurasidone HCl.

Detailed description: To compare the steady state pharmacokinetic profile of lurasidone 120 mg QD when administered alone vs. the steady state pharmacokinetic profile of lurasidone 120 mg QD when coadministered with steady state lithium 600 mg BID.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform.
2. Females who participate in this study:

   * are unable to have children-OR-
   * are willing to remain abstinent from Day -5 until 90 days after discharge;
3. Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until 90 days after discharge.
4. Able and agree to remain off of prior antipsychotic medication for the duration of the study.

Exclusion Criteria:

1. Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
2. Positive test results within 30 days prior to the start of the study for:
3. Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration.
4. Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day - 5 to follow-up
5. Use of a monoamine oxidase inhibitor within 21 days prior to Day 1 to Restabilization.
6. Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Culver City
country: United States
facility: CCT/Parexel
state: California
Study officials:
affiliation: CCT/Parexel
name: Marina Bussel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02536573: Study of Total Hip Arthroplasty Using Radlink Surgical Positioning Software
Official title: Prospective, Randomized Study to Evaluate Total Hip Arthroplasty With and Without Radlink Surgical Positioning Software
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Replacement
Keywords: Total hip replacement
Lead sponsor: Anderson Orthopaedic Research Institute
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 200
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: This is a prospective, randomized study of total hip arthroplasty with and without the use of Radlink surgical positioning software. The investigators are interested in discovering whether the use of the Radlink software will provide more accurate acetabular cup position when compared with surgeon estimates based on visual inspection of fluoroscopic images.


Eligibility criteria: Inclusion Criteria:

* Total hip arthroplasty

Exclusion Criteria:

-

Primary outcomes:
measure: Radiographic cup abduction angle
timeFrame: 4 month postoperative
measure: Radiographic cup anteversion angle
timeFrame: 4 month postoperative
Secondary outcomes:
measure: Variance of cup angles measured on x-ray
timeFrame: 4 month postoperative
Other outcomes:
Locations:
Study officials:
affiliation: AORI (Anderson Orthopaedic Research Institute)
name: William G Hamilton, MD
role: PRINCIPAL_INVESTIGATOR
References: