louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03020810: Dupilumab Compassionate Use Study
Official title: Dupilumab Compassionate Use Study
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Asthma
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-01-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is a single patient expanded access, compassionate and non-emergency use study that provides patients with severe asthma, who do not qualify for ongoing clinical trials with dupilumab, access to this investigational treatment.

Detailed description: This study is being undertaken to determine whether dupilumab has efficacy in extremely severe asthma, and to allow a very severe asthma patient, who has been tried on nearly every immunosuppressive drug, early access to a potentially effective therapy.

The patient will continue in the study indefinitely. Safety will be evaluated and serious adverse events will be reported.

Eligibility criteria: Inclusion Criteria:

* Sever systemic corticosteroid dependent asthma for more than 5 years

Exclusion Criteria:

* Disease other than asthma
* Circulation eosinophils more than 1500/ul
* Current smoker or more than 10 pack years

This is a single-patient study. The University of Pittsburgh site is not enrolling new patients.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04658810: Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CMV) Seroconversion During Pregnancy,
Official title: Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CMV) Seroconversion During Pregnancy, Without Ultrasound Signs or With Non-serious Ultrasound Signs of Maternal-fetal CMV Infection.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mothers
Cytomegalovirus Infections
Pregnancy Related
Keywords: CMV
Pregnancy
PTSD
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Assessment of post-traumatic stress disorder using the Perinatal Post-traumatic Stress Disorder)

Brief summary: Reports of maternal seroconversion to CMV during pregnancy can be extremely stressful. This virus is little known to the general public and searching for information on the Internet quickly leads to a consultation of a site mentioning the risk of severe psychomotor retardation in the event of prenatal cytomegalovirus infection.

The psychological repercussions in the event of prenatal CMV infection with criteria of severity, leading or not to a request for IMG, is undeniable, but no study has investigated the consequences of seroconversion to CMV without transmission of the virus to the patient fetus, or in the case of transmission without criteria of seriousness, on the patient's experience during and after her pregnancy. Such a study would, if necessary, improve the care and support of these future mothers


Eligibility criteria: Inclusion Criteria:

* Adults
* Referred to the 3 DAN centers with maternal seroconversion to CMV during their pregnancy, confirmed, with or without confirmed prenatal transmission.
* Presence of ultrasound signs without criteria of seriousness if the materno-fetal infection is proven.
* Support between January 1, 2008 and December 31, 2020.
* No opposition from patient

Exclusion Criteria:

* Reversed or anteconceptional CMV seroconversion
* Concomitant infection with another infectious agent and suspected cross-reaction
* Multiple pregnancy
* Ultrasound and / or MRI severity criteria
* Medical termination of pregnancy
* Fetal death in utero
* Birth \<32 weeks and / or birth weight \<1500 grams (birth criteria in maternity level IIA)
* Intercurrent event that may be the cause of an abnormality in psychomotor development
* Patients protected by justice

Primary outcomes:
measure: PTSD evaluation
timeFrame: Through study completion, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Gynécologie Obstétrique, Hôpital Mère Enfant
city: Pierre-Bénite
country: France
facility: Service de Gynécologie Obstétrique, Hôpital Lyon Sud
Study officials:
affiliation: service de Gynécologie-Obstétrique, Hôpital de la Croix Rousse
name: Alexis Fichez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01441310: Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer
Official title: Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Gastric cancer
Sentinel node navigation surgery
Dual method
Recurrence
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2011-09-27
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer sentinel node mapping.

The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections.

Detailed description: Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early gastric cancer.

Laparoscopic SNNS:

1. ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative endoscopy
2. Sentinel node basin identification and dissection
3. Sentinel nodes picking in back table
4. Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry for cytokeratin)
5. If the sentinel node biopsy by frozen section is negative, limited gastrectomy will be performed or if positive, radical D2 gastrectomy will be performed.

Sample size: 100 cases

Study duration: 5 years( 2year enrollment, 3 year follow-up)

Eligibility criteria: Inclusion Criteria:

* Age 20-80
* Informed consent
* No other malignancies
* cT1N0 stage gastric cancers \< 4cm
* no allergic history of isotope

Exclusion Criteria:

* Patients eligible for endoscopic submucosal dissection(ESD) with absolute indication

Primary outcomes:
measure: 3 Year disease free survival
timeFrame: Postoperative 3 year
Secondary outcomes:
measure: Sentinel node detection rate, occurrence of complication ,Qualtity of life and remnant stomach function evaluation.
timeFrame: postoperative 1, 3, 6, 12 month
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyung-Ho Kim, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02216812: Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures?
Official title: Does Vitamin C Reduce Finger Stiffness After Distal Radius Fractures? A Placebo Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Finger Stiffness
Distal Radius Fracture
Keywords: Finger stiffness
Range of motion
Distal radius fracture
Vitamin C
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 134
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: The reported prevalence of disproportionate pain and disability among patients recovering from a fracture of the distal radius varies widely. Literature reports numbers between 1% and 37%, perhaps in part because it is poorly defined, known by so many different names, subjective, and unverifiable.

The investigators are interested in the effect of vitamin C after distal radius fractures on objective measurement of finger motion, patient reported outcome measures, and pain intensity, instead of the previously used, subjective and imprecise criteria for complex regional pain syndrome.

Patients presenting to the Hand and Orthopaedic Trauma Services of MGH with a distal radius fracture will be asked to participate in this clinical trial. Patient will be randomly assigned to take either placebo or vitamin C 500 mg until full finger motion is attained as regarded by the treating physician at follow-up or for 6 weeks.

The investigators hypothesize no difference in finger stiffness at 6 weeks measured by distance to palmar crease of the index through little finger between patients taking vitamin C or placebo after a distal radius fracture. Additionally, the investigators assess finger stiffness by range of motion and stiffness of the thumb, and difference in PROMIS upper extremity function and pain score both measured at six months.


Eligibility criteria: Inclusion Criteria:

* All adult (age 18 or greater) patients presenting to the Hand and Orthopaedic Trauma Services of the Massachusetts General Hospital (MGH) within two weeks of a fracture of the distal radius, either operatively or nonoperatively treated

Exclusion Criteria:

* Patients with severe kidney failure, known allergy for vitamin C or pregnancy
* Multiple fractures, except for ulna fractures

Primary outcomes:
measure: Distance to Palmar Crease Index Through Small Finger
timeFrame: Day 1 (baseline), 6 weeks
Secondary outcomes:
measure: Active Flexion Index Through Small Finger
timeFrame: Day 1 (baseline), 6 weeks
measure: Thumb Motion
timeFrame: Day 1 (baseline), 6 weeks
measure: PROMIS Upper Extremity - CAT
timeFrame: Day 1 (baseline), 6 weeks, 6 months
measure: 0-10 Ordinal Pain Score
timeFrame: Day 1 (baseline), 6 weeks, 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Neal Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02102412: First in Man Aer-O-Scope
Official title: A Single-center Study to Evaluate the Safety & Performance of the Aer-O-Scope for Traveling Through the Colon in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Screening Colonoscopy for Low Risk Subjects
Keywords: crc
colonoscopy
colon cancer
Lead sponsor: GI View Ltd.
Sponsor class: INDUSTRY
First posted: 2014-04-02
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: A single center study intended to evaluate the Aer-O-Scope Colonoscope System.

Detailed description: A clinical study in Zagreb Croatia, intended to evaluate the Aer-O-Scope Colonoscope System. The study includes 120 subjects and has the following endpoints:

Evaluation of the Aer-O-Scope advancement, imaging and retraction throughout the Colon.

Safety: No occurrence of any device related major adverse event (for details see section 9.5)

Efficacy:

1. Advancement of device towards the ceacum and retraction
2. Visualization of the colon mucosa by the traveling imaging device
3. Procedure duration
4. Handling and operation (assessment by operator)

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between 18 and 65 years of age.
* Sign informed consent.

Exclusion Criteria:

* Subjects with any known GI related symptoms complaints or GI diseases.
* Subjects with cancer or other life threatening diseases or conditions.
* Pregnant women.
* Subjects who underwent any abdominal surgery.
* Morbid Obesity (BMI \> 40).
* Drug abuse or alcoholism.
* Bed-ridden subject.
* Inadequate communication with the subject.
* Subjects under custodial care.
* Participation in any clinical study within the last 30 days.
* Subjects with known cardiovascular and pulmonary diseases.

Primary outcomes:
measure: Ability to traverse the colon using the aer-o-scope
timeFrame: under 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Rebro Hospital
Study officials:
affiliation: Chief Gastro, Zagreb
name: Boris Vucelic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02037412: Impact of Ticagrelor on the Endothelial Healing Following Drug-eluting Stent Implantation in the Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Acute Myocardial Infarction
Unstable Angina (Intermediate Coronary Syndrome)
Keywords: Ticagrelor
strut coverage
DES
ACS
OCT
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 148
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that ticagrelor may enhance endothelial healing after DES implantation by increasing adenosine concentrations by the inhibition of adenosine uptake into erythrocytes, compared to clopidogrel. Thus, the investigators will evaluate the extent of endothelialization (stent strut coverage) and neointimal hyperplasia (neointimal thickness) 3 months after DES implantation by optical coherence tomography (OCT)


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 20 years old
* Patients who are hospitalized and expected to undergo PCI for acute coronary syndrome, including acute myocardial infarction and unstable angina.

Exclusion Criteria:

* Age \> 80 years
* Cardiogenic shock or unstable patients
* Increased risk of bleeding, anemia, thrombocytopenia
* A need for oral anticoagulation therapy
* Pregnant women or women with potential childbearing
* Life expectancy \< 1 year

Primary outcomes:
measure: Stent re-endothelialization
timeFrame: Three months after stent implantation
measure: Neointimal hyperplasia
timeFrame: Three months after stent implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: Patil SB, Jackman LE, Francis SE, Judge HM, Nylander S, Storey RF. Ticagrelor effectively and reversibly blocks murine platelet P2Y12-mediated thrombosis and demonstrates a requirement for sustained P2Y12 inhibition to prevent subsequent neointima. Arterioscler Thromb Vasc Biol. 2010 Dec;30(12):2385-91. doi: 10.1161/ATVBAHA.110.210732. Epub 2010 Nov 11.
citation: Kim JS, Fan C, Choi D, Jang IK, Lee JM, Kim TH, Park SM, Paik SI, Ko YG, Hong MK, Jang Y, Chung N. Different patterns of neointimal coverage between acute coronary syndrome and stable angina after various types of drug-eluting stents implantation; 9-month follow-up optical coherence tomography study. Int J Cardiol. 2011 Feb 3;146(3):341-6. doi: 10.1016/j.ijcard.2009.07.012. Epub 2009 Aug 25.
Clinical trial NCT01127412: Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial
Official title: Early Obesity Intervention Program Within GECKO Drenthe; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Physical Activity
Keywords: overweight
physical activity
infancy
body composition
motor development
motor activity
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2010-05-20
Enrollment: 228
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate whether stimulating physical activity during the first year of life influences growth and body composition, and stimulates motor activity and motor development


Eligibility criteria: Inclusion Criteria:

* date of birth (December 2006-February 2008)
* area of living (around Meppel and Hoogeveen in the province of Drenthe, one of the Northern provinces of the Netherlands)

Exclusion Criteria:

* Children under care of child physiotherapists will be excluded from the program

Primary outcomes:
measure: Growth
timeFrame: Regularly during the first year of life, at 2.5 years of age
measure: Body composition
timeFrame: Regularly during the first year of life, at 2.5 years of age
Secondary outcomes:
measure: Motor activity
timeFrame: At the age of 5 months, 8 months and 2.5 years of age
measure: Motor development
timeFrame: At the age of 5 months, 8 months and 2.5 years of age
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04021212: Pituitary Adenoma and Serum Lipid
Official title: Effects of Pituitary Adenoma Resection on Serum Lipid Level
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pituitary Adenoma 1, Acth-Secreting
Keywords: Pituitary
Pituitary Adenoma
Serum Lipid Levels
Resection
Recurrence
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2019-07-16
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with pituitary adenomas and underwent an endoscopic transsphenoidal approach at the Shandong Provincial Hospital affiliated with Shandong University. All adenomas were resected by transsphenoidal surgery and identified by histological diagnoses.

Brief summary: Pituitary adenomas are usually benign monoclonal neoplasms caused by a mixture of pituicyte alterations together with a changed endocrine and paracrine regulatory milieu. Thus, it can cause serious health problems such as abnormal target organ function, pain, disability and even death. In clinical practice, we found many patients with pituitary adenomas are usually accompanied by hyperlipidemia, which is the main cause of cardiovascular diseases. However, it has been unclear if there is an association between pituitary adenomas and serum lipid profile. In the present study, we aim to focus on the patients with pituitary adenomas and their lipid profile before and after operation including first occurrence and recurrence.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with pituitary adenomas
2. All adenomas were resected by transsphenoidal surgery and identified by histological diagnoses.

Exclusion Criteria:

1. Missing vital data, such as age, gender, serum lipid profile, pathology reports;
2. Complications or conditions that affect pituitary status and lipid metabolism, such as pregnancy, malignant adenomas or severe hepatic or renal dysfunction and
3. Use of any medication that affects the pituitary or lipid metabolism, including statins, fibrates, thyroid hormones, anti-thyroid drugs, iodine, amiodarone, alemtuzumab, lithium, tyrosine kinase inhibitors, interferon, estrogens, androgens,glucocorticoids, nonsteroidal anti-inflammatory drugs, antiepileptic drugs, rifampicin, furosemide, heparin or β-adrenoceptor blockers in the past 3 months.

Primary outcomes:
measure: Change in serum lipid levels
timeFrame: Measured at pre-operative and 6 months after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Jiajun Zhao
role: STUDY_CHAIR
References:
Clinical trial NCT01120912: Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients
Official title: A Single Center, Non-randomized, Single Blind, Placebo Controlled, Single Dose Study of the Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients - Phase 1 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Keywords: oral insulin
Lead sponsor: Oshadi Drug Administration
Sponsor class: INDUSTRY
First posted: 2010-05-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will be a non-randomized, open label, single dose, single blind, placebo control, single center, single arm study in Type I diabetes patients. The study will include single dose administration for the evaluation of single dose acute toxicity, pharmacokinetics and activity.


Eligibility criteria: Inclusion Criteria:

* Stable type I diabetes mellitus.
* Male/female 18 years old and up.
* Glucose level is treated only by s.c basal/bolus insulin injection (not by insulin pump) at least 48 hours prior to study initiation.
* Patients must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.
* Patients must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation.

Exclusion Criteria:

* Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
* Patients with positive HIV serology or positive HBsAg at screening.
* History or evidence of any active liver disease.
* C-peptide \> 3 mg/ml (fasting).
* Hba1c\<10.
* eGFR\>60.
* Female patients who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
* Inability to give written informed consent.
* History of alcohol or drug abuse within 6 months of screening.
* Patients who have a positive urine drug screen for substances of abuse (benzodiazepine, THC, opiates, amphetamines, cocaine) at the screening.
* Mental disorders.
* Patients with poor venous access.
* Significant swallowing disorders.
* Digestive disorders.
* Small bowel surgery.
* Mall absorption disorders.

Primary outcomes:
measure: Adverse events occurrence
timeFrame: one month
Secondary outcomes:
measure: Evaluate the glucose lowering effect of Oshadi Oral Insulin
timeFrame: 12 hours following administration
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Assaf Harofe Medical Center
state: Beer-Yaakov
Study officials:
affiliation: Oshadi Drug Administration
name: Hanna Levy, Dr.
role: STUDY_DIRECTOR
References: