louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04695782: Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
Official title: Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Rectal Cancer Recurrent
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study design:

A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer.

Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.


Eligibility criteria: Inclusion Criteria:

* • Locally recurrent rectal cancer.

  * Bioptically verified (adenocarcinoma )
  * Available dose plan from primary radiotherapy
  * Previous pelvic RT (\>30Gy EQD2)
  * Evaluated in MDT-conferences (Herlev, Aarhus)
  * Age\>18 years
  * PS 0-2
  * Adequate organ function
  * Informed consent

Exclusion Criteria:

* Non-resectable distant metastases (PET-CT)
* Unable to undergo MRI, PET-CT
* Inability to attend full course radiotherapy and follow up in the out patient clinic.

Primary outcomes:
measure: R0-resection
timeFrame: 5-6 years
measure: 1-year local control
timeFrame: 6-7 years
Secondary outcomes:
measure: Local recurrence
timeFrame: 6-8 years
measure: Disease free survival
timeFrame: 10 years
measure: Overall survival
timeFrame: 10 years
measure: Toxicity
timeFrame: 5-7 years
measure: Patient reported outcomes
timeFrame: 5-7 year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Centre for Particle Therapy
Study officials:
References:
Clinical trial NCT04535882: Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD
Official title: Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Possible Ulcerative Colitis or Crohn's Disease Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: LRG Levels
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In total, a consecutive cohort of 300 patients with possible UC or CD will be enrolled in this study at our hospital.

Brief summary: We attempt to examine the association between serum leucine-rich alpha-2 glycoprotein (LRG) levels and endoscopic activity in patients with possible ulcerative colitis (UC) or Crohn's disease (CD) to determine whether LRG was a predicting marker for UC or CD.

Detailed description: Serum samples were collected from patients, and scores for clinical and endoscopic activity of disease were obtained by reviewing the clinical records of patients. Serum sampling and colonoscopy with histology were performed within 7 days.The disease activity of UC and CD patients was evaluated by the Mayo score and Crohn disease activity index (CDAI), respectively. The Mayo endoscopy score was evaluated. UC patients whose Mayo endoscopy score was 2 or 3 were divided into the active UC group.

CD patients whose CDAI \>150 were divided into the active CD group.

Eligibility criteria: Inclusion Criteria:

* Patients whom possible UC or Crohn disease was suspected

Exclusion Criteria:

* other autoimmune diseases
* acute or chronic renal failure
* chronic heart diseases
* liver cirrhosis
* cancer
* acute or chronic infections
* ischemic colitis
* infectious colitis

Primary outcomes:
measure: Serum LRG measurement
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General Hospital
state: Nagano
Study officials:
References:
Clinical trial NCT05631782: Effects of Shenkang Decoction on Creatinine and Blood Urea Nitrogen in Chronic Renal Failure Hemodialysis Patients
Official title: Effects of Shenkang Decoction on Creatinine and Blood Urea Nitrogen in Chronic Renal Failure Hemodialysis Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Renal Failure
Hemodialysis
Lead sponsor: The First People's Hospital of Zunyi
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 160
Sex: ALL
Minimum age (years): 52
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the clinical effect of Shenkang Decoction in chronic renal failure (CRF) patients with hemodialysis (HD).


Eligibility criteria: Inclusion Criteria:

* The diagnosis of western medicine meets the diagnostic criteria of chronic kidney failure in Internal Medicine
* the diagnosis of TCM meets the diagnostic criteria of the disease in the Guiding Principles for Clinical Research of New Chinese Medicine.
* The patient is over 18 years old,
* can think independently and have civil conduct,
* strictly follow the doctor's advice,
* maintain stable condition and regular HD treatment.

Exclusion Criteria:

* Patients with HD time of no more than three months, severe uncontrolled infection, other malignant diseases, heart, liver, brain, and digestive system dysfunction, mental diseases such as dementia or depression;
* contraindications to HD or contraindications to the study (Shock or systolic blood pressure below 80mm/Hg, severe bleeding or a tendency to bleed, serious infection such as sepsis, or a blood-borne infection, advanced tumor, extremely debilitating or not cooperating with doctor)
* drug allergy, chronic use of glucocorticoids, and immunosuppressants.
* women during pregnancy or lactation.

Primary outcomes:
measure: Renal function index
timeFrame: 8 min
measure: TCM syndrome points
timeFrame: 14 days
measure: Nutritional status index
timeFrame: 14days
measure: Dialysis adequacy judgment index
timeFrame: 14 days
measure: Treatment efficiency
timeFrame: 14 days
measure: General physical examination
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zunyi
country: China
facility: The First People's Hospital of Zunyi
Study officials:
References:
Clinical trial NCT03403582: Raspberries and Postprandial Metabolism
Official title: Raspberries, Postprandial Metabolism and Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Raspberries are high in several phytochemicals, vitamin C and B vitamins and have been shown to be potent antioxidants and anti-inflammatory agents. However, human interventional studies reporting the effects of raspberries in obesity, T2DM and associated oxidative stress and inflammation are limited. Aims, objectives and methods:

Aim 1: To assess the effects of raspberries in postprandial glycemia and lipemia following a high-fat fast-food style meal challenge versus control group Objectives: to execute this aim, the investigators will conduct analyses of serum glucose, insulin and lipids (total cholesterol, LDL-cholesterol, triglycerides, VLDL-cholesterol and HDL-cholesterol) at fasting (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption. The investigators will also calculate homoeostasis model assessment of insulin resistance (HOMA-IR) at these time points using serum glucose and insulin values.

Aim 2: To assess the effects of raspberries in postprandial vascular functions (blood pressure and artery elasticity) and inflammation following a high-fat fast food style meal challenge versus control group

Objectives: to execute this aim, the investigators will measure C-reactive protein (CRP) and the following parameters of vascular function associated with CVD at fasting (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption:

* systolic blood pressure and diastolic blood pressure
* large artery elasticity index and small artery elasticity index
* systemic vascular resistance


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes

Exclusion Criteria:

* not having type 2 diabetes

Primary outcomes:
measure: Postprandial blood glucose
timeFrame: postprandial 4 hours
measure: Postprandial blood lipids
timeFrame: postprandial 4 hours
Secondary outcomes:
measure: Postprandial inflammation
timeFrame: postprandial 4 hours
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Oklahoma State University
state: Oklahoma
Study officials:
References:
Clinical trial NCT01411982: Role of PACAP in Nehprotic Syndrome
Official title: Role of PACAP in Increased Platelet Count and Aggregability in Childhood Nephrotic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrotic Syndrome
Keywords: PACAP (pituitary adenylate cyclase-activating polypeptide)
Nephrotic syndrome
Thrombosis
Platelets
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2011-08-08
Enrollment: 29
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New patients with nephrotic syndrome of patients during a relapse of nephrotic syndrome.

Brief summary: This study will identify the role of PACAP (pituitary adenylate cyclase-activating polypeptide) deficiency in patients with nephrotic syndrome. PACAP is a neuropeptide that has a putative role as an inhibitor of megakaryopoiesis and platelet function. Patients with nephrotic syndrome show decreased PACAP plasma levels, due to urinary loss. We hypothesize that in severe nephrotic syndrome, plasma deficiency of PACAP enhances megakaryopoiesis and causes blood platelet activation, which contribute to the increased rate of thromboembolic disease in these patients.

To test our hypothesis, the role of PACAP deficiency on pro-thrombotic state in patients with nephrotic syndrome will be studied using patient blood and urine samples.


Eligibility criteria: Inclusion Criteria:

* New patient with nephrotic syndrome of patient during relapse of nephrotic syndrome
* Under 16 years old
* Treatment for nephrotic syndrome not yet started by first sample collection

Exclusion Criteria:

* None

Primary outcomes:
measure: PACAP levels in plasma and urine
timeFrame: 3 test moments: at baseline during nephrotic syndrome before start of treatment; 4 weeks after start of remission; 4 weeks after stop of corticosteroid treatment. Estimated total time frame: 5 months
Secondary outcomes:
measure: Platelet count
timeFrame: 3 test moments: at baseline during nephrotic syndrome before start of treatment; 4 weeks after start of remission; 4 weeks after stop of corticosteroid treatment. Estimated total time frame: 5 months
measure: Platelet aggregability
timeFrame: 3 test moments: at baseline during nephrotic syndrome before start of treatment; 4 weeks after start of remission; 4 weeks after stop of corticosteroid treatment. Estimated total time frame: 5 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Pediatrics, UZ Leuven
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT02332382: The Influence of Mother Nutrition on Breast Milk Microbiome
Official title: The Influence of Mother Nutrition on the Composition of Fatty Acid, Oligosacharides and Its Effect on Breast Milk Microbiome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Milk, Composition, Microbiome
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-01-06
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy lactating women

Brief summary: The research subject

Health organizations around the world have determined that breastfeeding is the most critical source of nutrition for newborns in the first weeks and months of their lives. A mother's breast milk contains unique nutritious components and other nonnutritive elements that help promote healthy baby growth and development (1, 2). Recent studies show that a mother's breast milk contains components that vary from each specimen. There are great evidences that maternal and environmental factors have a strong influence on the composition of breast milk. Fatty acids, the second most common component found in breast milk, show extreme sensitivity to maternal nutrition (3, 4).

Latest studies show that breast milk also contains bacterial communities that may have health implications of newborn. The structure of these bacterial communities also varied greatly between subjects (5) .

In the research, we propose to investigate the connection between maternal nutrition, different fatty acids and their role in the growth and development of bacterial populations existing in breast milk.


Eligibility criteria: Inclusion Criteria:Healthy lactating women, breast feeding for the first 3 months after delivery

Exclusion Criteria: No compliance, sickness, drug consumption

-

Primary outcomes:
measure: Change in breast milk composition in relation to nutritional intake
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04474782: Analysis of Defocus Curve of Pre-Presbyopic and Emerging Presbyopic Patients
Official title: Analysis of Defocus Curve of Pre-Presbyopic and Emerging Presbyopic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presbyopia
Lead sponsor: Vance Thompson Vision
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2020-07-17
Enrollment: 45
Sex: ALL
Minimum age (years): 37
Maximum age (years): 48
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A population of 30-60 subjects will be selected for testing. Subjects can be male or female, ages 37-48.

Brief summary: Educating patients on visual performance with presbyopic correcting intraocular lenses is crucial. Understanding the defocus curve of pre-presbyopic and emerging presbyopic crystalline lens will provide eye care provides useful information to better educate patients on visual performance expectations after cataract surgery with a presbyopic correcting intraocular lens. Our objective will be to assess the subjective range of clear vision of a pre-presbyopic and emerging presbyopic patient population utilizing a defocus curve. A comparison of the pre-presbyopic and emerging presbyopic defocus curve to all FDA-approved presbyopic intraocular lenses will be discussed in the manuscript.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide written informed consent on the IRB approved Informed Consent Form
2. 37-48 years of age
3. Phakic

Exclusion Criteria:

1. Previous cataract surgery
2. Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
3. Subjects that are unable to obtain 20/20 BCVA (i.e. amblyopia, etc.)

Primary outcomes:
measure: Change in LogMar visual acuity during vision testing on ETDRS with loose lenses
timeFrame: Screening/enrollment visit
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
Study officials:
References:
Clinical trial NCT03203382: Corneal Nerve Structure in Sjogren's
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sjogren's Syndrome
Vitamin D Deficiency
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 100
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: Suspected or confirmed Sjogren's patients

Brief summary: Patients who are suspected of or diagnosed with Sjogren's disease will be evaluated for ocular symptoms and corneal nerve morphology. We are specifically interested in the relationship between Vitamin D level and aberrations in the morphology of the corneal nerves.

Detailed description: Patients with either suspected or confirmed diagnosis of Sjogren's disease will be recruited to participate. Participation will involve the completion of a brief survey (the OSDI), corneal evaluation with an aesthesiometer, corneal staining with fluorescein and lissamine green, and finally measurement of tear-film breakup time. In addition, participants will have their corneal nerve morphology evaluated with the Heidelberg confocal microscope and finally they will have a blood draw performed to assess vitamin D level.

Eligibility criteria: Inclusion Criteria:

* Suspected or confirmed Sjogren's syndrome
* 18+ years of age

Exclusion Criteria:

* Any condition that in the opinion of the investigator may confound study results or cause concerns for safety

Primary outcomes:
measure: Corneal Nerve Morphology
timeFrame: one time exam
measure: Vitamin D Level
timeFrame: one time exam at baseline, day 1
Secondary outcomes:
measure: vital dye staining
timeFrame: one time exam at baseline, day 1
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Scheie Eye Institute of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Scheie Eye Institute
name: Giacomina Massaro-Giordano
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01128582: Effect of Rozerem on the Perception of GERD Symptoms in Patients With Chronic Insomnia.
Official title: Effect of Rozerem on the Perception of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Chronic Insomnia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Chronic Insomnia
Keywords: GERD
Insomnia
Acid Reflux
Heartburn
Lead sponsor: Southern Arizona VA Health Care System
Sponsor class: FED
First posted: 2010-05-24
Enrollment: 40
Sex: ALL
Maximum age (years): 82
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if administration of Rozerem in comparison to a placebo reduces or eliminates gastroesophageal reflux disease(GERD) symptoms in individuals with both GERD and chronic insomnia.

Detailed description: This is a prospective, randomized, double-blind parallel group study comparing the effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* Stop H2 blockers 72 hrs prior to starting study
* Stop PPI - 3 weeks prior to staring study
* Heartburn 3+ times a week
* Insomnia 3+ times a week for 3 months
* Erosive esophagitis or Abnormal pH test

Exclusion Criteria:

* On PPI or H2 blocker \& not willing to get off
* Normal EGD (upper endoscopy) w/ normal pH test
* Upper Endoscopy(EGD)with erosive esophagitis(EE)- (LA C\&D) LA=Los Angeles criteria. Grades include A-D
* Previous gastrointestinal Surgery
* HX of Diabetes/neuropathy
* HX of seizures
* Known psychological abnormalities(depression,anxiety...)
* Clinically Significant Underlying co morbidity
* Narcotic medications(pain meds)
* Regularly taking sleeping medications (2 week wash-out allowed)
* Taking medications that alter sleep-Psychotropic's, antihistamines, Narcotics and Benzodiazepines Sleep Apnea or other sleep disorders-PLM, RLS etc.

Primary outcomes:
measure: The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology.
timeFrame: 4 week trial
Secondary outcomes:
measure: Improving quality of sleep and quality of life.
timeFrame: 4 week trial period
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona Veterans Health Care System
state: Arizona
Study officials:
affiliation: Southern Arizona Veterans Health Care System-BREFSA
name: Ronnie Fass, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jha LK, Fass R, Gadam R, Maradey-Romero C, Nasrollah L, Hershcovici T, Quan SF, Dickman R. The Effect of Ramelteon on Heartburn Symptoms of Patients With Gastroesophageal Reflux Disease and Chronic Insomnia: A Pilot Study. J Clin Gastroenterol. 2016 Feb;50(2):e19-24. doi: 10.1097/MCG.0000000000000322.
Clinical trial NCT02094482: Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
Official title: Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduction of Initial AHI
Reduction of Initial Snoaring Index
Lead sponsor: Medartis AG
Sponsor class: INDUSTRY
First posted: 2014-03-21
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)

Detailed description: The new OSAS Implant is intended for use in the palate (hard and soft palate/ see picture above) in order to stiffen and stabilize the soft palate, which may reduce the severity of airway obstructions and of snoring in patients suffering from OSA (Obstructive Sleep Apnea). Indications for use of the System include: symptomatic, habitual, social snoring due to palatal flutter or upper airway obstruction primarily caused by the retropalatal obstruction. The System is labeled for use by physicians only.

The primary endpoint is the Apnea-Hypopnea-Index (AHI) in the 90 days follow-up.

Study hypothesis: Reduction of initial AHI ≥20%

Eligibility criteria: Inclusion Criteria:

Study patients must meet all of the following inclusion criteria:

* Socially disturbing snoring with/without obstructive sleep apnea syndrome
* Predominantly retropalatal obstructions established by ApneaGraph ≥60%, sleep nasendoscopy or successful application of the Velumount palatal device
* Findings for predominantly retropalatal obstructions in ENT-examination:
* No tonsils or tonsils grade I - II
* Normal finding of larynx and tongue base
* No lingual tonsil hypertrophy
* ASA (American Society of Anaesthesiology, 1963) criteria I or II
* Body mass index (BMI) \< 33 kg/m2
* Age \> 18 yrs
* Fix bed partner
* Ability to read and understand the patient's information

Exclusion Criteria:

* Previous Pillar implants
* Previous airway surgery other than nasal, adenoid, tonsil or UPPP
* Presence of other sleep disorders
* Psychiatric disorders
* Neurological disorders (e.g. Cerebrovascular injury)
* Dysmorphia of the cranial skeleton
* Pregnancy or breastfeeding
* Known hypersensitivity to nitinol
* Participation in another clinical study

Primary outcomes:
measure: Reduction of initial AHI by ≥20%
timeFrame: 90days
Secondary outcomes:
measure: Reduction of initial snoring index ≥30%
timeFrame: 90days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Kantonsspital Liestal
state: Baselland
Study officials:
affiliation: Kantonsspital Liestal
name: Kurt Tschopp, MD
role: PRINCIPAL_INVESTIGATOR
References: