louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04616131: Evaluating the Response to Neoadjuvant Chemotherapy With Circulating Tumor DNA in Pancreatic Cancer
Official title: Evaluating the Response to Neoadjuvant Chemotherapy With Circulating Tumor DNA in Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreas Cancer
Lead sponsor: Central DuPage Hospital
Sponsor class: OTHER
Collaborators: name: Elsa U. Pardee Foundation
First posted: 2020-11-04
Enrollment: 60
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: Male or female individuals age 18 and over planning to receive chemotherapy for pancreatic cancer that has not spread outside of the pancreas and nearby lymph nodes.

Brief summary: For patients who have been diagnosed with pancreatic cancer that has not spread outside of the pancreas and nearby lymph nodes. The purpose of this research study is to understand if we are able to detect pancreatic cancer DNA in the blood stream before, during, and after treatment.

Detailed description: Cancer DNA in the blood stream is called circulating tumor DNA or ctDNA. The presence or absence of pancreatic cancer ctDNA in the blood stream may help clinicians to better understand pancreatic cancer behavior in response to specific treatments, like chemotherapy and surgery. Understanding how treatment alters the ctDNA can help future patients diagnosed with pancreatic cancer. The presence or absence of ctDNA or the clearance of ctDNA after treatment may help to guide further treatment decisions for cancer patients after surgery.

Eligibility criteria: Inclusion Criteria:

* Biopsy or cytology proven adenocarcinoma of the pancreas
* No clinical evidence of metastatic disease on imaging
* Age 18 or older
* Receiving chemotherapy for non-metastatic pancreatic cancer

Exclusion Criteria:

* Biopsy proven metastatic disease

Primary outcomes:
measure: Number of patients with circulating tumor DNA (ctDNA) levels as not detectable in their blood compared to number of patients with ctDNA detected.
timeFrame: 3 months
Secondary outcomes:
measure: Investigators will look for statistically significant correlations of ctDNA blood levels with clinical treatment responses of tumor grades, CA 19-9 units/milliliter blood level, and radiologic response by RECIST categories of complete response.
timeFrame: 12 months
Other outcomes:
Locations:
city: DeKalb
country: United States
facility: Northwestern Medicine Cancer Center Kishwaukee
state: Illinois
city: Geneva
country: United States
facility: Northwestern Medicine Cancer Center Delnor
state: Illinois
city: Warrenville
country: United States
facility: Northwestern Medicine Cancer Center Warrenville
state: Illinois
Study officials:
affiliation: Northwestern Medicine Central DuPage Hospital
name: Akhil Chawla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00753831: Efficacy of Aurosling in Frontalis Sling Suspension Surgery
Official title: Randomized, Double Blind, Active Controlled Study of the Efficacy, Surgical Outcome and Complications of Silicone Rod Sling in Frontalis Sling Suspension Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ptosis, Eyelid
Keywords: Blepharoptosis
Ophthalmoplegia
Blepharospasm
Lead sponsor: Aurolab
Sponsor class: OTHER
First posted: 2008-09-17
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To Study the Efficacy of Aurosling as a suspension material in Frontalis suspension surgery in ptosis

Detailed description: Silicon rod is an effective and safe material used in frontalis suspension in treating ptosis with poor levator function.The elasticity and ease of adjustment of silicon rod are ideal characteristics for suspension material used to treat severe ptosis in patients with poor bells phenomenon. In the present study , we attend to study the efficacy of aurosling silicon material as a suspension material for frontalis sling surgery

Eligibility criteria: Inclusion Criteria:

* Congenital Ptosis
* Severe Ptosis (MRD\<0)
* Poor levator function (\<4mm by Berke's method)
* Myogenic Ptosis (Myasthenia gravis)
* Chronic progressive external ophthalmoplegia
* Neurogenic Ptosis (Third cranial palsy)
* Blepharospasm
* Ptosis caused by trauma

Exclusion Criteria:

* Acquired Ptosis
* Horners syndrome
* Blepharochalasis/Dermatochalasis
* Mechanical Ptosis
* Mild or Moderate Ptosis (MRD 1\>1)
* Good or fair levator function (\>4 mm by Berke's method)
* Previous Ptosis surgery
* Ptosis associated syndromes/Other anomalies including
* Marcus Gunn jaw winking syndrome
* Blepharophimosis syndrome
* Dry eye syndromes
* Corneal anesthesia
* Medical/Pediatric/Anesthesia condition contraindicating to surgery or anesthesia
* Nystagmus where adequate measurements could not be done
* Uncorrected vertical squint of any sort

Primary outcomes:
measure: Ptosis Correction
timeFrame: 15th day, 90th day postoperatively
Secondary outcomes:
measure: Adverse Events
timeFrame: 15th day, 90th day postoperatively
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
Study officials:
affiliation: Aravind Eye Hospital, Madurai
name: Usha Kim, DO, Dip NB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02066831: Diabetes Coaching Study
Official title: Diabetes Coaching Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
Collaborators: name: German Institute for Telemedicine and Health Promotion
First posted: 2014-02-20
Enrollment: 202
Sex: ALL
Minimum age (years): 25
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to compare the effect of telemedical coaching versus telemedical control on HbA1c, weight, BMI, blood pressure, blood lipids, medication, nutrition, physical activity and quality of life in type 2 diabetes patients with poor glycaemic control.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus
* hemoglobin A1c (HbA1c) \>7.5%
* at leat two different antidiabetic drugs
* body mass index \>27kg/m2

Exclusion Criteria:

* acute infections
* diagnosed chronic diseases other than type 2 diabetes and hypertension, e.g. cancer, chronic obstructive pulmonary disease (COPD), asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, (macro-) nephropathy, kidney insufficiency with glomerular filtration rate (eGFR) \< 30ml / min / 1.73 m2
* acute chemotherapy or chronic cortisol treatment
* smoking cessation for less than 3 months and or planned smoking cessation during study
* known intolerance of any ingredient of Almased (especially soy protein)
* pregnancy or breast feeding, lack of contraception (women)
* other study participation in the last 6 months prior to study start

Primary outcomes:
measure: HbA1c
timeFrame: 12 months
Secondary outcomes:
measure: weight
timeFrame: 12 months
measure: antidiabetic medication
timeFrame: 12 months
measure: Cardiovascular risk parameters (blood pressure, blood lipids)
timeFrame: 12 months
measure: physical activity (step count)
timeFrame: 12 months
measure: nutrition
timeFrame: 12 months
measure: quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: West-German Center of Diabetes and Health
Study officials:
affiliation: West German Center of Diabetes and Health
name: Stephan Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kempf K, Altpeter B, Berger J, Reuss O, Fuchs M, Schneider M, Gartner B, Niedermeier K, Martin S. Efficacy of the Telemedical Lifestyle intervention Program TeLiPro in Advanced Stages of Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Jul;40(7):863-871. doi: 10.2337/dc17-0303. Epub 2017 May 12.
Clinical trial NCT00153231: Posterior IVS Versus Sacrospinous Suspension in Vaginal Vault Prolapse Repair
Official title: Clinical Evaluation of Morbidity and Efficacy of Posterior IVS (Infracoccygeal Sacropexy), in Comparison to the Standard Sacrospinous Suspension in the Surgical Treatment of Vaginal Vault Prolapse by the Vaginal Route.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaginal Prolapse
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Hypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and functional results of an innovative posterior tape in vaginal prolapse repair by vaginal route, in comparison to the sacrospinous suspension.

Study design, materials and methods This study involves 5 centres in French Public Hospital. Patients will be randomly allocated to be operated by a sacrospinous suspension or by an posterior IVSTM (Tyco Healthcare, France). Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up, as well as a validated questionnaire on sexual problems. The difference on early post-operative pain should be 30% (40% for the sacrospinous suspension and 10% for the posterior IVS). Then the estimated number of patient is 40 in each arm.


Eligibility criteria: Inclusion Criteria:

* Age more than 18
* Vaginal vault prolapse of grade 2 or more (POP-Q system)
* Symptomatic prolapse

Exclusion Criteria:

* Patient unable to read French language
* Cystocele without vaginal vault prolapse
* Vaginal vault prolapse of grade 1
* Associated rectal prolapse
* Rectal inflammatory disease (Crohn, RCH).

Primary outcomes:
measure: Early post-operative pain evaluated by a visual analogic pain the next day after the operation.
Secondary outcomes:
measure: - Peri-operative morbidity
measure: - Patient satisfaction
measure: - Quality of life
measure: - Post-operative sexuality
measure: - Anatomical cure rate on vaginal vault support
Other outcomes:
Locations:
city: Nimes
country: France
facility: Hôpital Carémeau
Study officials:
affiliation: Hôpital Carémeau, Nimes, France
name: Renaud de Tayrac, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01769131: A Comparison of Two Instruments for Stabilization of the Cervix During Office Procedures
Official title: A Comparison of Two Instruments for Stabilization of the Cervix During Office Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Comparing Two Clamps for Mobilization of the Cervix During Common Gynecologic Office Procedures
Keywords: cervix
Allis
Tenaculum
gynecology
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2013-01-16
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females between the ages of 18 and 89 years undergoing an IUD placement

Brief summary: An Allis clamp causes less pain and bleeding than a single tooth tenaculum when used for mobilization of the cervix during common gynecologic office procedures.

The primary object is to determine the presence of a difference in pain perception between the two instruments.

The secondary objective is to evaluate the differences in the frequency of bleeding, that requires treatment, after removal of the instrument and the need to use an alternative instruments.


Eligibility criteria: Inclusion Criteria:

* Female
* Between 18 and 89 years of age
* Undergoing an IUD placement

Exclusion Criteria:

* IUD placement within the last 6 months
* Active cervical or pelvic infection
* pregnant
* Patient taking coagulation medications

Primary outcomes:
measure: A comparison of two instruments for stabilization of the cervix during office procedures
timeFrame: 1 year
Secondary outcomes:
measure: A comparison of two instruments for stabilization of the cervix during office procedures
timeFrame: 1 year
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
References:
Clinical trial NCT02285231: Anti-hyperglycemic Effect of Short-term Arginyl-fructose Supplementation in Subjects With Pre-diabetes and Newly Diagnosed Type 2 Diabetes: Randomized, Double-blinded, Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Keywords: Anti-hyperglycemic effect
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this double-blind, placebo-controlled study, subjects with prediabetes and type 2 diabetes were randomly assigned to the placebo control group or the test (Arginyl-fructose: AF) group. We determined fasting serum levels of glucose, hemoglobin A1c (HbA1c), insulin, and free fatty acids (FFAs), were measured by 2-h oral glucose tolerance tests (OGTTs) at baseline and after the 6-week intervention.


Eligibility criteria: Inclusion Criteria:

- All subjects are with prediabetes (IFG or IGT) or newly diagnosed type 2 DM (T2DM) no taking medicine. IFG was defined as fasting glucose between 100 and 125 mg/dL and IGT was defined as 2-h OGTTs glucose levels 140-199 mg/dL. Newly diagnosed type 2 diabetes was defined as fasting glucose ≥126 mg/dL or 2-h OGTTs level ≥ 200 mg/dL.

Exclusion Criteria:

- Exclusion criteria included 1) glucose lowering medications or insulin injections; 2) abnormal liver or renal function; 3) chronic stomach and intestines disease; 4) chronic alcoholism; 5) pregnancy or intending to become pregnant during time of study. 6) complications; 7) an occupation that could be dangerous if hypoglycemia should occur.

Primary outcomes:
measure: 2-h oral glucose tolerance tests (OGTTs
timeFrame: 6 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Park SE, Kim OH, Kwak JH, Lee KH, Kwon YI, Chung KH, Lee JH. Antihyperglycemic effect of short-term arginyl-fructose supplementation in subjects with prediabetes and newly diagnosed type 2 diabetes: randomized, double-blinded, placebo-controlled trial. Trials. 2015 Nov 14;16:521. doi: 10.1186/s13063-015-1036-z.
Clinical trial NCT03097731: Epidemiological Screening of IL10RA Mutation Rate in China
Official title: Epidemiological Screening of p.R101W and p.T179T IL10RA Mutation Rates in Henan Province, China
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Digestive System Disease
Keywords: interleukin-10
inflammatory bowel disease
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 24
Maximum age (years): 28
Standard ages: CHILD
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the study period, all newborns in the selected hospital were included.

Brief summary: The presentation of IBD in early childhood is uncommon and the monogenetic defects, especially IL-10 signaling pathway play a key role in very early onset inflammatory bowel disease (VEO-IBD). IL-10 or IL-10R deficiency associated VEO-IBD is considered a rare disorder. To date, there were about 60 cases were reported all over the word. But in our Chinese VEO-IBD Collaboration Group, 42 patients with biallelic mutations affecting IL10R genes were identified from 93 VEO-IBD patients, and the mutation sites are highly concentrated, including 83.9% (26/31) with p.R101W and 55% p.T179T (17/31) mutation, and the proportion of patients from Henan( A province of China) is higher. So we speculate that IL-10RA mutation may not be very rare, and the frequency of heterozygote subjects might be higher than suspected.

Detailed description: 1. The mutation rates of p.R101W and p.T179T IL10RA in Henan newborn.
2. Is there any clinical symptoms in children with IL-10RA-deficient? and the onset of the symptoms.
3. Whether the intestinal permeability is normal in heterozygote subjects.

Eligibility criteria: Inclusion Criteria:

* In the study period, all newborns in the selected hospita

Exclusion Criteria:

* Children whose guardian refused to participate in the study

Primary outcomes:
measure: The mutation rate of IL-10RA in chinese
timeFrame: From birth to 3 years old
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan university
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Ying Huang, MD and PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00305331: Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease
Official title: Phase II Clinical Trial of Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson's Disease
Peripheral Edema
Keywords: Parkinson's disease
Domperidone
Peripheral edema
Pramipexole
Ropinirole
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2006-03-21
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The dopamine agonists, pramipexole (Mirapex) and ropinirole (Requip), are drugs that are used to treat symptoms of Parkinson's disease. However, these drugs can induce bothersome leg swelling or edema in about 20 percent of patients. The cause of this edema is unknown but may be secondary to stimulation of peripheral dopamine receptors in the kidney or blood vessels. We hypothesise that a peripherally acting dopamine receptor antagonist, will reduce edema in PD patients. This study will assess the effect of the peripheral acting dopamine D2 receptor antagonist, domperidone as a potential treatment for dopamine agonist-induced leg swelling.

Detailed description: The study is a phase II, randomised double-blind, placebo-controlled, cross-over trial. There are four periods: recruitment and randomisation; treatment period one (4 weeks); washout (1 week); and finally treatment period two (4 weeks). Patients will be randomly assigned domperidone 20 mg tid in treatment period one followed by placebo tid in treatment period two, or placebo tid in treatment period one followed by domperidone 20 mg tid in treatment period two.

Eligibility criteria: Inclusion Criteria:

* Idiopathic PD
* On a stable medication regimen for at least one month with leg edema occurring after the start of pramipexole or ropinirole and the absence of other possible reasons for discontinuation of pramipexole or ropinirole treatment (e.g. other adverse effects).

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Women of child bearing age not using a reliable method of contraception
* Coronary disease, abnormal QT interval on electrocardiogram (EKG)
* Diabetes mellitus
* Hepatic disease
* Alcohol abuse
* Renal disease
* Edema of one leg only
* Presence of other conditions possibly causing leg edema

Primary outcomes:
measure: left foot volume measured by water displacement
Secondary outcomes:
measure: subjective reporting of leg oedema; UPDRS, CGI and adverse events
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Movement Disorders Clinic, Toronto Western Hospital, 399, Bathurst St
state: Ontario
Study officials:
affiliation: Toronto Western Hospital, UHN
name: Susan H Fox
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00905931: Lycopene Following Aneurysmal Subarachnoid Haemorrhage
Official title: Acute Oral Lycopene Therapy on Cerebral Autoregulation and Delayed Ischaemic Deficits Following Aneurysmal Subarachnoid Haemorrhage (LASH): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Subarachnoid Hemorrhage
Aneurysm
Keywords: Aneurysmal subarachnoid hemorrhage (aSAH)
Cerebral vasospasm
impaired cerebral autoregulation
transient hyperaemic response test
delayed ischaemic neurological deficits
Lead sponsor: University of Cambridge
Sponsor class: OTHER
Collaborators: name: Cambridge Theranostics Ltd
First posted: 2009-05-21
Enrollment: 124
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study the investigators wish to explore the potential neuroprotective effects of acute oral supplementation of lycopene, a natural anti-oxidant derived from tomatoes, on cerebral vasospasm and autoregulation, and examine whether any improvements translate into a reduction of biochemical markers of vascular injury and inflammation a decrease in the prevalence of secondary strokes following subarachnoid haemorrhage.


Eligibility criteria: Inclusion Criteria:

* Age: \> 18 years old,
* Confirmed aneurysmal subarachnoid hemorrhage (aSAH),
* Time from ictus \< 96 hours

Exclusion Criteria:

* Age: \< 18 years old,
* Non-aneurysmal SAH,
* Time from ictus \> 96 hours,
* Severe carotid atherosclerotic disease (≥70%)
* High-dose statin therapy (\>80 mg/day fluvastatin; \>40 mg/day simvastatin; \>40 mg/day pravastatin; \>10 mg/day atorvastatin; \>10 mg/day rosuvastatin 28),
* Allergy or hypersensitivity to tomatoes and tomato products and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin)

Primary outcomes:
measure: Incidence of vasospasm
timeFrame: Daily for 21 days
measure: Duration of impaired autoregulation measured with transcranial Doppler
timeFrame: Daily for 21 days
Secondary outcomes:
measure: Level of biochemical markers of vascular injury: LDL, oxy-LDL, CRP, circulating endothelial cells, endothelial progenitor cells
timeFrame: Days: 0, 3, 6, 12, 14, 21
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
Study officials:
affiliation: Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Addenbrooke's Hospital, Hills Road, CB2 0QQ Cambridge, UK
name: Peter J Kirkpatrick, FRCS(SN)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verghese M, Sunkara R, Shackelford L, Walker LT. Lycopene and cardiovascular diseases. In Preedy VR, Watson RR Ed. Lycopene: nutritional, medicinal and therapeutic properties. Science Publishers, New Hampshire, USA 2008.