louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03461991: Correlation Between In-vivo Anatomy of Corneal Dystrophies as Assessed by High- Resolution Optical Coherence Tomography (OCT) Measurement and Histological Examination
Official title: Correlation Between In-vivo Anatomy of Corneal Dystrophies as Assessed by High- Resolution Optical Coherence Tomography (OCT) Measurement and Histological Examination - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Dystrophy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Corneal dystrophies are usually classified histopathologically according to the layer of the cornea that is affected. The International Committee for the Classification of Corneal Dystrophies (IC3D) takes this anatomical classification as referral with summarizing clinical, genetic, and pathological data.

Most of this classification relies on slit lamp findings or histologic specimen, since in-vivo imaging of corneal microstructures has only become available in the recent years. With confocal microscopy it is possible to image corneal microstructures at a high resolution, but this technique is limited by its reduced repeatability and the fact that only a small area can be imaged. By the use of optical coherence tomography (OCT) systems it is possible to overcome these limitations. Commercially available systems, however, only have an axial resolution of about 18 µm which is not sufficient for imaging of all corneal layers.

Recently, a high-resolution optical coherence tomography (OCT) system was developed at the Center for Medical Physics and Biomedical Engineering that enables a resolution of about 1 µm. With this resolution, all corneal structures and several pathologies can be visualized.

In the present study the investigators want to use this OCT system to image corneal dystrophies in patients scheduled for corneal transplantation.


Eligibility criteria: Inclusion Criteria:

* Men and women aged over 18 years
* Presence of corneal dystrophy
* Scheduled for corneal transplantation (PK, ALK, DALK, DSAEK or DMEK)
* No previous corneal surgery in the study eye

Exclusion Criteria:

* Participation in a clinical trial in the previous 3 weeks
* Presence of any abnormalities preventing reliable measurements as judged by the investigator
* Pregnancy, planned pregnancy or lactating

Primary outcomes:
measure: Correlation in measurement of corneal layers in preoperative high-resolution OCT and histological diagnosis of corneal dystrophies of the removed cornea
timeFrame: preoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS)
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
Clinical trial NCT01224080: Use of Adiana Tubal Occlusive Devices in Women With Hydrosalpinx Prior to In Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Women Suffering From Unilateral or Bilateral Tubal Occlusion Due to Hydrosalpinx
Lead sponsor: Reproductive Science Center
Sponsor class: INDUSTRY
First posted: 2010-10-19
Enrollment: 10
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A condition called hydrosalpinx occurs when one or both of the fallopian tubes is blocked with fluid. The fluid can leak into the tube and the uterus. The theory is that the fluid can harm the tubes and uterus making implantation more difficult or harm the embryo.


Eligibility criteria: Inclusion Criteria:

* Are willing to participate in this clinical study
* Are able to comprehend and give informed consent for participation in this study
* Have read, understood and signed an informed consent form
* Have been unable to achieve pregnancy after trying for 1 year or greater and who have unilateral or bilateral hydrosalpinges as evidenced by laparoscopy or ultrasound or HSG
* Have a Day #3 serum FSH\<10, and Day #3 Estradiol\<80
* Recipient women undergoing a ovum donor cycle the donor must have a Day 3 serum FSH \< 10 and Day 3 Estradiol \< 80
* Have an antral follicle count 10 or greater for both ovaries combined, if women using ovum donor (follicle count) will be based on eligible donor
* Have a desire to receive treatment for their HS
* Are willing to undergo a hysterosalpingogram (HSG) 3 months after ADIANA placement to confirm proximal tubal occlusion

Exclusion Criteria:

* Active or recent upper or lower pelvic infection
* Known hypersensitivity to nickel as confirmed by skin test
* Known allergy to contrast media
* Pregnancy or suspected pregnancy
* Delivery or termination of pregnancy less than six weeks prior to Adiana placements
* BMI \> 35
* Abnormal pap smear (CIN2 or greater abnormality) within the past year
* Pelvic malignancy
* Severely retroverted uterus
* Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum
* Abnormal Clomid Challenge Test or abnormal lab values on Day #3 serum FSH and Estradiol
* Antral follicle count less than 10 (both ovaries combined)
* Poor general or gynecologic health
* Inability or refusal to provide informed consent

Primary outcomes:
measure: Evaluate the success rate of proximal tubal occlusion with Adiana inserts in women with hydrosalpinx
timeFrame: 1 Year
Secondary outcomes:
measure: Observe implantation and clinical pregnancy rates post IVF
timeFrame: 1Year
Other outcomes:
Locations:
city: San Ramon
country: United States
facility: Reproductive Science Center
state: California
Study officials:
References:
Clinical trial NCT01233180: Effects of Gua Sha and Thermotherapy on Chronic Neck Pain
Official title: Randomized Controlled Trial Comparing Gua Sha Massage and Thermotherapy for Chronic Neck Pain: Effects on Pain Intensity, Haptic Perception and Body Image.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: neck pain
massage
hyperthermia, induced
touch perception
randomized controlled trial
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 50
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: Gua Sha massage is a traditional chinese medical treatment. It is mostly used in the treatment of the common cold and pain syndromes. Gua Sha involves pressuring the skin by a round-edged instrument until small petechiae appear. This so called "sha", considered as the removal of blood stasis by traditional practitioners, will fade within a few days. Normally, this treatment is not considered as painful, but as relaxing and easing tense muscles.

In this study, the investigators will investigate the effectivity of Gua Sha massage in treating chronic neck pain. The investigators will research effects on subjective pain intensity, neck pain specific disability and haptic perception.


Eligibility criteria: Inclusion Criteria:

* Chronic mechanical neck pain, at least 40 mm on a 100mm visual analog scale.
* Pain for at least 3 months.

Exclusion Criteria:

* radicular symptoms
* congenital spine deformity
* pregnancy
* rheumatic diseases
* oncologic diseases
* other severe psychiatric or somatic comorbidity
* recent invasive or surgical treatment of the spine
* participation in other studies
* skin diseases in the area to be treated

Primary outcomes:
measure: Neck pain intensity (100mm visual analog scale)
timeFrame: Day 4
Secondary outcomes:
measure: Neck disability index (NDI)
timeFrame: Day 4
measure: Haptic perception
timeFrame: Day 4
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
state: Northrhine-Westphalia
Study officials:
References:
Clinical trial NCT02066480: Improved Screening for Osteoporosis
Official title: Improved Screening for Osteoporosis in Women Between 50 and 80 Years Hospitalized in Hospital Departmental Vendee
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 3226
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women between 50 and 80 years hospitalized CHD Vendée

Brief summary: Osteoporosis is a disease characterized by skeletal fragility due to decreased bone mass and deterioration of bone microarchitecture , leading to increased fracture risk for low trauma, such as spinal fractures or femoral neck .

It is estimated that 3 million people are living in France , particularly women , with an incidence that increases with age .

This disease is a major public health issue in terms of morbidity and mortality , costs and risk of recurrence (after a first fracture episode) , including risk factors are identified.

However, although bone densitometry is a reliable diagnostic tool and preventive treatments are at our disposal, screening for osteoporosis is still insufficient .

The objective of our study is to improve the detection of osteoporosis in Hospital Departmental Vendee , using a simple questionnaire seeking risk factors followed by bone densitometry or if risk factors are found. Based on the results , the patient will be sent in rheumatology consultation for implementation of treatment if necessary .

Therefore included women hospitalized in medical services , gynecology, surgery and orthopedics Hospital Departmental Vendee , aged 50 to 80 years. Will not be included women who could answer a simple questionnaire and those previously treated for osteoporosis or have already received a bone density there is less than 3 years old .


Eligibility criteria: Inclusion Criteria:

* Women between 50 and 80 years
* Hospitalized
* In health services, orthopedics, gynecology, surgery
* Able to respond to an easy questionnaire
* Able to give their agreement to participate in the study

Exclusion Criteria:

* Patients with dementia
* Patients can not express
* Patients at end of life
* Patients previously treated for osteoporosis or recent densitometry (BMD) \<3 years
* Patients could not be seen in time by the nurse during their hospitalization
* Patients receiving a measure of legal protection

Primary outcomes:
measure: Number of patients screened at risk for osteoporosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Centre hospitalier départemental Vendée
Study officials:
affiliation: Centre hospitalier départemental Vendée
name: Grégoire CORMIER, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00015080: Naltrexone in Treatment of Cocaine Dependence - 5
Official title: Naltrexone in Treatment of Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Cincinnati MDRU
First posted: 2001-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of naltrexone in the treatment of cocaine dependence as measured by: 1) decreased urine benzoylecgonine (BE) levels, 2) decreased cocaine use by self-report, 3) decreased cocaine craving, and 4) retention in treatment.

Detailed description: Double-blind, placebo controlled study of the safety and efficacy of naltrexone in treating cocaine dependence in a patient sample that initiated the study while in an inpatient setting and were then followed-up for 3 months as outpatients.

Eligibility criteria: Inclusion Criteria:

1. Meet DSM-III-R criteria for cocaine dependency,
2. 18 to 65 years of age,
3. capable of understanding the study,
4. voluntarily signed consent,
5. male or non-pregnant female using approved form of birth control.

Exclusion Criteria:

1. abnormal liver function tests (SGOT, SGPT, or GGT greater than twice the normal values),
2. opioid use within the last 7 days,
3. use of neuroleptics,
4. having a severe acute medical problem,
5. unable to complete psychiatric rating scales, or
6. judged by the investigator to be unlikely to comply with the study protocol

Primary outcomes:
measure: Retention
measure: Cocaine use
measure: Depression
measure: Anxiety
measure: Addiction severity
measure: Global improvement
measure: Psychopathology
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati MDRU
state: Ohio
Study officials:
affiliation: Cincinnati MDRU
name: Eugene Somoza, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Somoza, E., et al. A Double-Blind,Placebo Controlled Clinical Trial of Naltrexone as a Treatment for Cocaine Dependence. NIDA Research Monograph, 1998, 179, p. 295.. None
Clinical trial NCT03374280: Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC
Official title: The Phase Three Trials of Pemetrexed/Cisplatin Intercalating Gefitinib vs Pemetrexed/Cisplatin Treating EGFR Wild NSCLC(Non Squamous Cell Carcinoma)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: non small cell lung cancer
Gefitinib
EGFR negative
Pemetrexed
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 178
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: To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC

Detailed description: In preclinical data, it is identified that pemetrexed combined with erlotinib could achieve good response than pemetrexed because EGFR-TKI (erlotinib) could enhance the sensitivity of pemetrexed. So we design the trial to investigate curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC.

Eligibility criteria: Inclusion Criteria:

1.Histological or cytological diagnosis of small-cll lung cancer histology

2.18 years or older

3.Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2

4.Local stage SCLC without distant metastases

5.After 1st-line chemotherapy (EP or IP) at least 4 cycles

6.After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy

7.CR or PR assessment by RECIST(1.0) before randomized

8.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\^9/L, platelets 100 x 10\^9/L

9.Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases

10.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)

Exclusion Criteria:

1. Mixed non-small cell lung cancer histology
2. Neck and supraclavicular lymph node metastasis
3. Be allergic to temozolomide or intolerable to radiotherapy
4. Any unstable systemic disease
5. Pregnant or lactating women

Primary outcomes:
measure: disease progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: side-effects
timeFrame: 3 years
measure: overall response rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The first affiliated hospital of Guangzhou MC
state: Guangdong
Study officials:
affiliation: the ethics committee of the first affiliated hospital of Guangzhou MC
name: Jiajia Yu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02492880: CoverEdge Algorithm Programming Study
Official title: Study to Characterize the Effects of Programming Features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator System Using the CoverEdge™ Surgical Leads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: stimulation
implantable
pulse generator
back pain
chronic pain
leg pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2015-07-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a prospective, on-label, multi-center, non-randomized, exploratory, single-arm study to characterize the effects of programming features of the Boston Scientific Precision Spectra™ Spinal Cord Stimulator (SCS) System using the CoverEdge™ surgical lead.


Eligibility criteria: Inclusion Criteria:

* Subject implanted, on-label, with a commercially approved Boston Scientific Spectra neurostimulation system and at least one CoverEdge or CoverEdge X surgical lead, per local directions for use (DFU).
* Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
* Subject is 18 years of age or older when written informed consent is obtained.

Exclusion Criteria:

* Subject meets any contraindication in Boston Scientific (BSC) neurostimulation system local DFU.
* Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments.

Primary outcomes:
measure: Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire
timeFrame: minimum 25 days post IPG implant
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Barolat Neuroscience
state: Colorado
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Roshini Jain
role: STUDY_DIRECTOR
References:
Clinical trial NCT00835380: A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069)
Official title: A Phase III Open-Label Study of Immunogenicity, Safety, and Tolerability of 2 Doses of VAQTA™ (Formalin, Inactivated, Alum-Adjuvanted Hepatitis A Vaccine) in Healthy Children 12 to 23 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis A Virus Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will demonstrate the immunogenicity and evaluate the safety/tolerability of the vaccine in Chinese children between 12 and 23 months of age.


Eligibility criteria: Inclusion Criteria:

* Healthy Chinese children 12 to 17 months old at receipt of the first study vaccination

Exclusion Criteria:

* Subject is Hepatitis A virus antibody positive at screening or has a history of Hepatitis A infection
* Subject has a fever 72 hours prior to first injection
* Subject has already been vaccinated for Hepatitis A
* Subject is allergic to aluminum, formaldehyde, sodium borate, latex, or any component of the vaccine
* Subject has received inactivated vaccines within 14 days of screening or live vaccines within 30 days of screening

Primary outcomes:
measure: Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines.
timeFrame: Collect blood sample for HAV antibody testing at Day 0 prior to vaccination, and Month 7 (4 weeks after administration of a 2-dose regimen of vaccines at Month 6)
Secondary outcomes:
measure: Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination
timeFrame: For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00380380: A Study to Assess the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.
Official title: A Randomized, Single-blind, Placebo Controlled, Cross-over Study to Evaluate the Acute Effects of Vildagliptin on Gastric Emptying in Patients With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Vildagliptin, type 2 diabetes, gastric emptying
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-26
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Please note this study is not being conducted in the United States. The purpose of this study is to assess the acute effects of vildagliptin, an unapproved drug, in reducing post-meal glucose levels by delaying gastric emptying.


Eligibility criteria: Inclusion Criteria:

* Must be able to complete a 1-week wash-out of current anti-diabetic medications
* Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose
* Blood glucose criteria must be met
* BMI \<40

Exclusion Criteria:

* History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
* Need for insulin within 3 months or patients on thiazolidinediones
* Significant concommitant disease or complications of diabetes
* Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons
* Abnormal liver function tests as defined by the protocol
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Evaluate the effects of acute effects of vildagliptin on gastric emptying
Secondary outcomes:
measure: Effect on steady state levels of active GLP-1 and GIP
measure: Change in fasting and postprandial glucose levels.
measure: Change in glucagon secretion
measure: Change in postprandial glucose kinetics
measure: Effect on gastric peristalsis
measure: Effect on satiety
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Munich, 81377, Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Vella A, Bock G, Giesler PD, Burton DB, Serra DB, Saylan ML, Dunning BE, Foley JE, Rizza RA, Camilleri M. Effects of dipeptidyl peptidase-4 inhibition on gastrointestinal function, meal appearance, and glucose metabolism in type 2 diabetes. Diabetes. 2007 May;56(5):1475-80. doi: 10.2337/db07-0136. Epub 2007 Feb 15.