louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01070615: Study to Evaluate Long-Term Tolerability and Safety of Oral Prucalopride in Chronic Constipation
Official title: A Study to Evaluate the Long-Term Tolerability and Safety of Oral Prucalopride Administered to Patients With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Constipation
Lead sponsor: Movetis
Sponsor class: INDUSTRY
First posted: 2010-02-18
Enrollment: 693
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: Objectives: Evaluation of the clinical long-term safety, tolerability, patient satisfaction, pharmacokinetics and pattern of use of oral prucalopride tablets given in doses up to 4 mg once daily to patients with chronic constipation


Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant, non-breast-feeding female outpatients of at least 18 years of age
2. Patient had completed the entire treatment period of the PRU-INT-6 study or the PRU-INT-12 study .

Exclusion Criteria:

1. Patients with impaired renal function
2. Patients with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
3. Females of child-bearing potential without adequate contraceptive protection during the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
Study officials:
affiliation: University Hospital Antwerp, Edegem, Belgium
name: Marc Van Outryve, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camilleri M, Van Outryve MJ, Beyens G, Kerstens R, Robinson P, Vandeplassche L. Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation - follow-up of patients from the pivotal studies. Aliment Pharmacol Ther. 2010 Nov;32(9):1113-23. doi: 10.1111/j.1365-2036.2010.04455.x. Epub 2010 Sep 16.
Clinical trial NCT00135915: Influence of Binge Drinking on Glucose Metabolism in Patients With Type 1 Diabetes - A Pilot Study
Official title: Influence of Binge Drinking on Glucose Metabolism in Patients With Type 1 Diabetes - A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: The Royal Bournemouth Hospital
Sponsor class: OTHER
First posted: 2005-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males or females of at least 18 years of age who were diagnosed with Type 1 diabetes more than 5 years ago.

Brief summary: Although there is no evidence that individuals with type 1 diabetes have a different approach to alcohol compared to the background population, nevertheless, its use does have implications for patients mainly because of the risk of hypoglycaemia unawareness. However, binge drinking has been implicated as a factor in the development of ketoacidosis and is probably under-recognised. The aim of this study is to examine the effect of binge drinking on glucose, insulin, counter-regulatory hormones and other metabolites in patients with type 1 diabetes. It is hoped that data from this project will be used to develop a larger study comparing different treatment regimens for patients using alcohol to reduce the risks of hyperglycaemia as well as hypoglycaemia.

Detailed description: This is a randomised trial involving Type I diabetics who have had Type I diabetes \>5 years. They will be using multiple daily injections of a basal insulin and a rapid acting component.Apart from insulin and oral contraceptive, none will be on regular medication. All will be regular consumers of modest amount of alcohol (Female - less than or equal to 14 units, males - less than or equal to 21 units). Each will participate in 2 studies. Subjects will be randomised either to white wine or an equivalent volume of alcohol-free wine.Outcome measures are the results of the effect of acute ingestion of alcohol on glucose levels and intermediate metabolites in subjects with Type I diabetes.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for \> 5 years
* Use of multiple daily injections of a basal insulin and a rapid acting component
* Regular consumption of modest amounts of alcohol

Exclusion Criteria:

* Type 2 diabetes
* Type I diabetes \< 5 years
* Excessive alcohol consumption
* Unstable diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
Study officials:
affiliation: The Royal Bournemouth Hospital
name: David Kerr, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02187315: Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With IMRT Of Locally Advanced NPC Clinical Study
Official title: Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With Intensity-modulated Radiotherapy In The Treatment Of Locally Advanced Nasopharyngeal Carcinoma PhaseⅡClinical Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Guiyang Medical University
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.


Eligibility criteria: Inclusion Criteria:

1. Pathological diagnosis of early cure Ⅲ - Ⅳ stage of patients with advanced nasopharyngeal carcinoma (according to the 2010 UICC staging criteria, T3-4, N0-3), no evidence of distant metastasis (M0). A measurable tumor lesions;
2. Karnofsky score≥70;
3. Age 18-70 years old, male or female;
4. No major organ dysfunction; Normal bone marrow hematopoietic function (white blood cell ≥4．0×109／L，platelet≥100×109 /L. hemoglobin ≥100g/L)，normal liver function (total bilirubin、alanine aminotransferase、 aspartate aminotransferase ≤1.5 times the upper limit of normal)，normal renal function (creatinine ≤1.5 times the upper limit of normal) electrocardiogram does not affect the normal treatment;
5. To understand this study and sign informed consent form.

Exclusion Criteria:

1. A distant metastasis;
2. Patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study;
3. Pregnancy (confirmed by serum or urine β-HCG test) or between lactation period;
4. Serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.Who had received radiation and chemotherapy.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 5 year
Secondary outcomes:
measure: Number of Participants with curative effect
timeFrame: 1 year
Other outcomes:
Locations:
city: Guiyang
country: China
facility: The Affiliated Hospital of Guiyang Medical College/The Affiliated Cancer Hospital of Guiyang Medical College/Guizhou Cancer Hospital
state: Guizhou
Study officials:
References:
Clinical trial NCT05849415: Periodontal Health and Its Relationship With Psychological Stress
Official title: Correlation Between Periodontal Health, Psychological Stress and Mindfulness Awareness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Stress
Mucositis
Periodontal
Keywords: Periodontal disease
Lead sponsor: D'Albis Dental
Sponsor class: OTHER
Collaborators: name: University of Bari Aldo Moro
First posted: 2023-05-08
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: European people

Brief summary: Studies suggest that chronic exposure to psychological stress can lead to oral health deterioration, alter the immune response, and possibly contribute to increased inflammation, which can impact the physiological healing of periodontal tissues.

People with psychophysiological stress disorders tend to acquire unhealthy habits, leading to less self-care, incorrect nutrition, smoking, alcohol consumption, and reduced physical activity.

This cross-sectional study aims to evaluate the correlation between periodontal health and psychological stress.

Patients between the ages of 35 and 70 will be recruited. Each patient must be visited and a periodontal assessment must be performed, recording the percentage of bleeding on probing and the Periodontal Screening and Recording (PSR). Subsequently, patients will be administered the Sheldon Cohen Perceived Stress Scale (PSS) and the Mindfulness Awareness Attention Scale (MAAS) questionnaires.


Eligibility criteria: Inclusion Criteria:

* Aged \> 18

Exclusion Criteria:

* Pregnancy
* administration of antibiotics in the last 15 days prior to study entry or indications for antibiotic prophylaxis;
* orthodontic appliances
* immunological diseases or use of drugs that can affect oral tissues, (phenytoin, cyclosporine), nifedepine, chronic use of non-steroidal anti-inflammatory drugs);

Primary outcomes:
measure: Periodontal health assessment
timeFrame: 4 month
measure: Sheldon Cohen Perceived Stress Scale (PSS)
timeFrame: 4 month
measure: Mindfulness Awareness Attention Scale (MAAS)
timeFrame: 4 month
Secondary outcomes:
measure: relationship between periodontal health status and psychological tests
timeFrame: 4 month
Other outcomes:
Locations:
city: Mola di Bari
country: Italy
facility: Giuseppe D'Albis
state: Bari
Study officials:
References:
Clinical trial NCT02914015: Continous Quadratus Lumborum Block for Hepatic Surgery With Right Subcostal Incision
Official title: Ultrasound-guided Continous Quadratus Lumborum Block: Effect on Acute Pain and Quality of Recovery After Hepatic Surgery With Right Subcostal Incision
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatectomy
Analgesia
Nerve Block
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This prospective, randomized study, control study aims to compare the analgesic effect, opioids consumption, quality of recovery, length of hospital stay and et al. between unilateral continuous quadratus lumborum block (QLB) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal incision.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo hepatectomy with right J-shape subcostal incision
* Informed consent

Exclusion Criteria:

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)

Primary outcomes:
measure: Cumulative morphine consumption
timeFrame: at 24 postoperative hours
Secondary outcomes:
measure: The pain scores determined by the numeric rating scale (NRS, 0-10)
timeFrame: At 0, 2,4, 8, 12, 24 ,48,72 hours and 7 day after the surgery
measure: Nausea and Vomiting score
timeFrame: At 0, 2,4, 8, 12, 24 and 48 hours after the surgery
measure: Pruritus score
timeFrame: At 0, 2,4, 8, 12, 24 and 48 hours after the surgery
measure: Ambulation time
timeFrame: within the 7 days after surgery
measure: Time of recovery of bowl movement
timeFrame: within the 7 days after surgery
measure: Quality of recovery
timeFrame: 3 days and 7 days after surgery
measure: Patient satisfaction with anesthesia
timeFrame: 48 hours after surgery
measure: Postoperative hospital length of stay
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xulei CUI
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yuguang Huang, MD.
role: STUDY_CHAIR
References:
Clinical trial NCT02209415: EUFURO - EUS-based Follow-Up on R0-resected Patients for Esophageal, Gastric and Pancreatic Cancer
Official title: Endoscopic Ultrasound (EUS) and PET-CT Based Follow-up of Patients Radically Resected for Cancer of the Oesophagus, Stomach or Pancreas.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Stomach Cancer
Pancreatic Cancer
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2014-08-05
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Follow-up after successful operative treatment of cancer in the esophagus, stomach or pancreas in order to detect recurrent disease is a controversial topic.

This is because the methods and the consequence of following these patients is unknown.

Therefore the investigators will randomize these patients in to two groups:

1. One group of patients will be offered visits with a specialist surgeon in a outpatient setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is the current standard at our department.
2. The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same intervals as the first group.


Eligibility criteria: Inclusion Criteria:

* R0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus, stomach or pancreas.

Primary outcomes:
measure: Number of patients eligible for treatment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Center for Surgical Ultrasound, Department of upper surgical gastroenterology
state: Region of Southern Denmark
Study officials:
References:
citation: Bjerring OS, Fristrup CW, Pfeiffer P, Lundell L, Mortensen MB. Phase II randomized clinical trial of endosonography and PET/CT versus clinical assessment only for follow-up after surgery for upper gastrointestinal cancer (EUFURO study). Br J Surg. 2019 Dec;106(13):1761-1768. doi: 10.1002/bjs.11290. Epub 2019 Oct 9.
citation: Bjerring OS, Hess S, Fristrup CW, Hoilund-Carlsen PF, Mortensen MB. The impact of endoscopic ultrasound-guided fine-needle aspiration of lymph nodes on subsequent positron emission tomography/computed tomography imaging: a prospective study. Endoscopy. 2019 Feb;51(2):165-168. doi: 10.1055/a-0647-6824. Epub 2018 Jul 23.
Clinical trial NCT01640015: The Effect of Eating Frequency on Blood Pressure
Official title: The Effect of Number of Eating Episodes Per Day on Blood Pressure. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Blood Pressure
Keywords: Blood pressure
eating episode
eating frequency
insulin sensitivity
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2012-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to identify the effect of meal frequency on blood pressure (BP) levels of individuals.

Detailed description: Migration studies, observational epidemiology and clinical trial data indicate that causes of adverse BP levels are mainly environmental , including lifestyle under which dietary factors play a role. Therefore, lifestyle modification is part of the current American Heart Association recommendations for prevention and control of adverse BP levels.

Although the effects of nutrients and foods on BP have been studied extensively, other dietetic factors such as eating frequency and number of meals in a day have been less thoroughly investigated and warrant further research to explore their possible positive effect on BP.

Eligibility criteria: Inclusion Criteria:

Healthy individuals aged 35-70 years with prehypertension (systolic/diastolic BP 120-139/80-89 mm Hg) BMI 20-30 kg/m2 non-smoking non alcoholic drinkers

Exclusion Criteria:

* Weight change of ≥ 3kg in the preceding 2 months
* Current smokers
* Substance abuse
* Alcohol intake
* Pregnancy
* Diabetes
* Cardiovascular disease
* Cancer
* Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
* Kidney disease
* Liver disease
* Pancreatitis
* Use of medications including: anti inflammatory drugs or steroids, antihypertensive drugs, cholesterol lowering medication, androgens, phenytoin, erythromycin or thyroid hormones.

Primary outcomes:
measure: blood pressure
timeFrame: 2 weeks for 24 hours through blood pressure monitor
Secondary outcomes:
measure: Insulin
timeFrame: measured twice during each phase (2 phases)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Sir John Michael Center - Hammersmith Hospital
Study officials:
References:
Clinical trial NCT04436315: Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder
Official title: Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exergame
Major Neurocognitive Disorder
Long-term Care Facility
Nursing Home
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the feasibility of the intervention and the study design.

Detailed description: This study evaluates the feasibility of the intervention and the study design. Furthermore, it investigates the effects of an exergame training including strength, balance, cognitive and pelvic floor muscle training. The main risk in this study is related to potential accidents/falls during the training (and not mainly to the data acquisition procedures). But as the difficulty of the training game is adaptive, the participants will always be challenged on an appropriate level for their physical condition. Furthermore, before and after the training period, several low risk measurements are conducted. This study contributes to fundamental research investigating how multicomponent exergame training influence physical and cognitive functions.

Eligibility criteria: Inclusion Criteria:

* Aged 60+ years
* Living in residency "de Wingerd" in Leuven (at least two weeks here)
* Being able to straight for minimal 10 minutes without aids
* Visual acuity with correction sufficient to see on a TV screen
* diagnosed with major neurocognitive disorder

Exclusion Criteria:

* Mobility impairments that don't allow to play the exergame
* Any unstable cardiovascular or other health condition which according to the American College of Sports Medicine Standards might lead to unsafe participation (e.g. recent cardiac infarction, uncontrolled diabetes or hypertension)
* Orthopaedic or neurological diseases that prevent exergame training
* Rapidly progressive or terminal illness

Primary outcomes:
measure: Feasibility
timeFrame: 2 years
measure: Motor functions
timeFrame: 2 years
measure: Cognitive functions
timeFrame: 2 years
measure: Mental health
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: De Wingerd
state: Vlaams Brabant
Study officials:
References:
Clinical trial NCT00401115: Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Official title: A Phase 1, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Macular Edema
Diabetic Retinopathy
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
Collaborators: name: MacuSight, Inc.
First posted: 2006-11-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy


Eligibility criteria: Inclusion Criteria include but are not limited to:

* Diagnosed with diabetes mellitus
* Visual acuity of 20/40 to 20/200 in study eye

Exclusion Criteria include but are not limited to:

* Any other ocular disease that could compromise vision in the study eye
* Intraocular surgery of the study eye within 90 days prior to study start
* Capsulotomy of the study eye within 30 days prior to study start

Primary outcomes:
measure: Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope
timeFrame: 12 months
Secondary outcomes:
measure: Visual Acuity
timeFrame: 90 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retina Consultants of Arizona
state: Arizona
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
Study officials:
affiliation: Retina Consultants of Arizona
name: Pravin Dugel, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Retina Associates
name: Wayne Solley, M.D.
role: PRINCIPAL_INVESTIGATOR
References: