louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03328923: Effects of Seaweed Extract on Mental Performance Following a High-carbohydrate Meal
Official title: Acute Post-prandial Cognitive Effects Following Brown Seaweed Extract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Keywords: post-prandial cognition
brown seaweed
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: innoVactiv Inc.
First posted: 2017-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will receive either 500mg brown seaweed powder (InSea2) or placebo
Primary purpose: OTHER

Brief summary: The current study will explore the impact of seaweed extract on cognitive function following a high-carbohydrate meal at a number of time-points post-consumption.

Detailed description: The current randomised, placebo-controlled, double-blind, parallel groups study will examine the impact of a brown seaweed extract (InSea2) on cognitive function post-prandially in 60 healthy non-elderly adults who self-report post-meal drowsiness. Computerised measures of episodic memory, attention and subjective state will be completed at baseline and for 3 hours following lunch with either seaweed or placebo consumed 30 minutes prior to a carbohydrate-rich meal.

Eligibility criteria: Inclusion Criteria:

* Report post-meal drowsiness

Exclusion Criteria:

Below 18 or above 65 years old at the time of giving consent

* Do not report post-meal drowsiness
* Any pre-existing medical condition/illness
* History of/current head trauma
* History of intestinal tract surgery
* History of/current diagnosis of drug/alcohol abuse
* Currently taking prescription medications (excluding the contraceptive pill)
* Habitual use of dietary/herbal supplements
* Learning difficulties, ADHD (attention deficit hyperactivity disorder), dyslexia
* Frequent migraines that require medication more than once/month.
* Visual impairment that cannot be corrected with glasses or contact lenses
* Smoking
* Excessive use of caffeine (\>500mg per day) from all dietary sources
* Not a native English speaker
* Food intolerances/sensitivities, including seafood/fish allergy
* Pregnancy, seeking to become pregnant, or current lactation
* BMI \<18.5 or \>30 kg/m2
* Any health condition that would prevent fulfilment of the study requirements
* Inability to complete all of the study assessments

Primary outcomes:
measure: Cognitive performance
timeFrame: Change from baseline following acute treatment, measured at 50, 90, 130, 170 and 210 minutes post-dose
Secondary outcomes:
measure: Subjective state
timeFrame: Change from baseline following acute treatment, measured at 50, 90, 130, 170 and 210 minutes post-dose
Other outcomes:
Locations:
Study officials:
affiliation: Northumbria University
name: Crystal Haskell-Ramsay, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01991223: Dexmedetomidine for Catheter-related Bladder Discomfort
Official title: Efficacy of Dexmedetomidine for the Therapy of Catheter-related Bladder Discomfort
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Blood Pressure
Nausea
Vomiting
Arrhythmia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 114
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the efficacy of dexmedetomidine for the prevention of catheter-related bladder discomfort

Detailed description: After transurethral bladder resection, large-sized foley catheter have been used for drainage of urine and residual blood. Because of urinary catheterization, patients usually experiences catheter-related bladder discomfort defined as a burning sensation with an urge to void or discomfort in the supra-pubic region caused by catheter- related bladder irritation.

Dexmedetomidine is an alpha-2 antagonist and used as an analgesic agent. The investigators try to evaluate The efficacy of dexmedetomidine for the treatment of catheter-related bladder discomfort

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for transurethral bladder resection
* ASA I-III

Exclusion Criteria:

* Patient who disagrees to participate this investigation
* Patient with severe cardiovascular disease
* Patient with small-sized foley catheter (less than 18 Fr.)
* Patinets with any urinary tract obstructions
* Patient with hyperactive or neurogenic bladder
* Patients with chronic renal failure
* Patient with morbidly obese
* Patients with neurogenic disorder
* Patient with medications for chronic pain

Primary outcomes:
measure: The number of patients with catheter-related bladder discomfort
timeFrame: at postoperative 1 hour
Secondary outcomes:
measure: Catheter-related bladder discomfort
timeFrame: at postoperative 0, 1, 6, 24 hours
measure: Pain at suprapubic area
timeFrame: at postoperative 0, 1, 6, 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University of Hospital
name: Hee-Pyoung Park
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HC, Lee YH, Jeon YT, Hwang JW, Lim YJ, Park JE, Park HP. The effect of intraoperative dexmedetomidine on postoperative catheter-related bladder discomfort in patients undergoing transurethral bladder tumour resection: A double-blind randomised study. Eur J Anaesthesiol. 2015 Sep;32(9):596-601. doi: 10.1097/EJA.0000000000000196.
Clinical trial NCT04544423: Lumbar Erector Spinae Plane Block in Knee Prosthesis
Official title: Ultrasound-guided Lumbar Erector Spinae Plane Block For Postoperative Analgesia in Knee Prosthesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Block
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Knee prosthesis patients who will be operated under general anesthesia.

Brief summary: To determine the postoperative analgesic efficiency of ultrasound-guided lumbar erector spinae plane block, patients are divided into two groups. Study group received ultrasound-guided lumbar erector spinae plane block, where control had none. Visual analog scale and opioid consumption are recorded.

Detailed description: Erector spinae plane block has successfully been demonstrated to provide an efficient analgesia in patients with rib fracture, open thoracotomy, breast surgery. The present study is aimed to investigate the intraoperative hemodynamic responses, anesthetic and analgesic consumption, and postoperative recovery quality of erector spinae plane block in patients with knee prosthesis. After approval, patients enrolled in the study are divided into two groups by computer-based randomization technique as control and study group. After standard monitorization, anesthesia induction and tracheal intubation, erector spinae plane block is performed to study group and no intervention to control group.

In the intraoperative period, 10 mg / kg paracetamol and 0.05 mg / kg morphine will be used for postoperative analgesia. After surgery, all patients will be given 10 mg/kg paracetamol every 8 hours and will be fitted with a patient-controlled analgesia (PCA) device (Tramadol HCL). PCA device bolus dose will be set to 20 mg, lock time will be set to 10 minutes and the number of buttons per hour will be set as 3.for postoperative analgesia.After surgery, VAS scores of the patients will be evaluated (in the recovery room, 1,3,6,12 and 24 hours, Patients with VAS≥4 will be given 0.03mg / kg morphine as salvage analgesia.After 30 minutes, the patients' VAS will be re-evaluated,If VAS≥4 the same dose will be repeated.

Eligibility criteria: Inclusion Criteria:

Over 18 years of age Planned to knee prosthesis An American Society of Anesthesiologists score of 1,2 or 3

Exclusion Criteria:

Severe cardiovascular disease Psychiatric diseases Rejected to participation Those who have chronic pain

Primary outcomes:
measure: Visual analog scale
timeFrame: one time in postoperative period for one year
Secondary outcomes:
measure: Opioid consumption
timeFrame: During postoperative period for one year
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Gaziosmanpasa University
name: Hakan Tapar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02096523: Use of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder
Official title: Use of Proteomics for the Diagnosis of a Platelet-related Bleeding Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inherited Platelet Disorders
Keywords: inherited platelet disorders
proteome
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 4
Sex: ALL
Minimum age (years): 3
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to identify the platelet defect responsible for the bleeding in families from our inherited platelet disorders Israeli-Palestinian registry. The investigators plan to characterize platelet proteome expression after removing high abundance proteins. The investigators will compare the proteome of sick and healthy members of families with inherited platelet disorders, and identify and validate structural proteins, signaling cascades and biomarkers for detection and diagnosis of unknown platelet disorders. The investigators expect to discover new key findings that allow better understanding of human platelet function and allow better diagnosis and treatment of patients with inherited platelet function disorders.


Eligibility criteria: Inclusion Criteria:

* History of inherited platelet disorders in the family

Exclusion Criteria:

* none

Primary outcomes:
measure: Levels of detectable platelet proteins
timeFrame: 2014-2015 (1 year)
Secondary outcomes:
measure: Changes in protein expression from sick and healthy platelets
timeFrame: 2015-2019 (4 years)
Other outcomes:
measure: Number of proteins that inducate disease
timeFrame: 2017-2019 (2 years)
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT05324423: To Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout
Official title: A Single-center, Open-access Study to Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gout
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single-center, open-access study to evaluate drug interactions between XNW3009, febuxostat, and colchicine in patients with gout


Eligibility criteria: Inclusion Criteria:

* Subject has a body mass index ≥18.0 and ≤32 kg/m2;
* Screening sUA value ≥480μmol/L;
* Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.

Exclusion Criteria:

* Subject known or suspected of being sensitive to the study drugs or its ingredient；sCr\>ULN；
* History of kidney stones or screening kidney stones by B-ultrasound;
* History of malignancy；
* History of xanthinuria；
* Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood
* ALT or AST \> 1.5 x ULN
* Unstable angina, history of symptomatic arrhythmia, or heart failure
* HbAlc\>8%
* eGFR\<60ml/min/1.73m2
* Investigational drug within 3 months of study dosing

Primary outcomes:
measure: Observed maximum concentration at steady state (Cmax,ss)
timeFrame: 100 days
measure: Observed area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
timeFrame: 100 days
Secondary outcomes:
measure: Time to Maximum Serum Concentration (Tmax)
timeFrame: 100 days
measure: Mean Terminal Phase Half-life (t1/2)
timeFrame: 100 days
measure: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
timeFrame: 100 days
measure: Serum or urine Uric Acid Level
timeFrame: 100 days
measure: Serum or urine Creatinine
timeFrame: 100 days
measure: Number of Participants With Clinically Significant Laboratory Test Abnormalities
timeFrame: 100 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Yi Xu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05255523: Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer
Official title: A Single Arm，Multicenter，Real-world Observational Study of Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Breast Cancer
Keywords: pyrotinib;CNS;breast cancer; HER-2 positivity
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effect of pyrotinib

Detailed description: The purpose of this study is to assess the effect of pyrotinib combined with trastuzumab in the maintenance phase delay/reduction of brain metastases after first-line TH(P) therapy for HER-2-positive advanced breast cancer

Eligibility criteria: Inclusion Criteria:

1. age:18-75 years old, female;
2. HER2 positive advanced breast cancer diagnosed by pathology, cytology or radiology, including inoperable breast cancer with stage IV, or recurrent/metastatic breast cancer.HER-2 positivity was confirmed by histopathological test: immunohistochemistry(IHC) results of 3 + or in situ hybridization (ISH) results of amplification of HER2;
3. Disease progression occurs after treatment with trastuzumab (stopping the drug for more than 12 months) or newly diagnosed IV stage breast cancer patients;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
5. Life expectancy greater than or equal to 6 months;
6. The main organs function well, and the inspection indicators meet the following requirements:

1) For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥90×109/L; 2) For results of blood biochemical test ALT and AST≤2×ULN, but≤5×ULN if the transferanse elevation is due to liver metastases； TBIL≤1.5×ULN； Serum creatinine ≤1.5×ULN; 7. The researchers believed that the subjects were preference to benefit; 8. Participants were willing to join in this study, and written informed consent.

Exclusion Criteria:

1. Patients with brain metastases by CT or MRI;
2. More factors affecting of oral drugs (gastrointestinal surgery history, inability to swallow, chronic diarrhea, intestinal obstruction);
3. Study drug and excipient allergy;
4. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
5. Pregnant or lactating female patients;
6. Less than 4 weeks from the last clinical trial;
7. The researchers think inappropriate.

Primary outcomes:
measure: Incidence of first progression with brain metastases
timeFrame: 24 month
Secondary outcomes:
measure: ORR without CNS
timeFrame: 24 month
measure: TTBM
timeFrame: 24 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00583323: Diphenoxylate / Atropine to Decrease FDG Activity During F-18 FDG PET
Official title: Diphenoxylate / Atropine to Decrease Bowel Activity During F-18 FDG PET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2007-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 2-\[18F\]-fluoro-2-deoxyD-glucose positron emission tomography (FDG PET) has proven to be a valuable clinical tool for the staging and surveillance of lymphoma.1-6 Occasionally, lymph nodes in the mesentery and retroperitoneum can be difficult to distinguish from normal bowel activity on PET scans despite three-plane and cine maximal image projection (MIP) imaging. This uncertainty limits the clinical usefulness of PET in some cases of lymphoma.7-8 In addition, bowel activity can also hinder interpretation of PET scans in other types of solid tumors including melanoma and colorectal cancer.6,9,10 Our goal is to determine how well diphenoxylate/atropine 5mg/0.05mg (Lomotil) decreases bowel activity and how this decrease impacts clinical decision-making, specifically for lymphoma staging and surveillance. This is a prospective, randomized, double-blinded study involving 60 patients undergoing PET scans for newly diagnosed or recurrent, untreated lymphoma.


Eligibility criteria: Inclusion Criteria

* Males and females 18 years of age or older
* Subjects pre-scheduled for clinically-indicated PET scan
* Subjects with newly diagnosed or recurrent untreated disease (lymphoma) based on abdominal and/or pelvic adenopathy or masses on CT within 6 months of PET scan Exclusion Criteria
* Allergy to Lomotil (Diphenoxylate hydrochloride, Atropine sulfate)
* Subjects with one or more episodes of diarrhea within 24 hours prior to PET scan
* Women who are breast-feeding
* Subjects with a history of severe liver disease, jaundice, dehydration, or narrow-angle glaucoma

Primary outcomes:
measure: Reduction of bowel activity
timeFrame: 1hour
Secondary outcomes:
measure: Reduction of stomach activity
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05018923: Tetracycline Versus Doxycycline for HP Rescue Therapy
Official title: Bismuth Quadruple Therapy With Tetracycline Versus Doxycycline as Rescue Therapy for Helicobacter Pylori Infection: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled clinical trial will evaluate the efficacy and safety of proton pump inhibitor, bismuth, metronidazole, and either tetracycline or doxycycline for Helicobacter pylori rescue treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori.


Eligibility criteria: Inclusion Criteria:

* Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
* 18-75 years old on the day of signing the ICF.
* Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
* Have failed eradication treatment before.

Exclusion Criteria:

* Have not received Hp eradication treatment.
* Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
* Subjects or guardians refused to participate in the trial.
* Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
* Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment.
* Pregnant or lactating women.
* Active peptic ulcer.
* allergic to drugs used in the trial.
* any other circumstances that are not suitable for recruitment.

Primary outcomes:
measure: Eradication rate of Helicobacter pylori
timeFrame: At least 4 weeks after completion of therapy
Secondary outcomes:
measure: Eradication rate of Helicobacter pylori resistant strains
timeFrame: At least 4 weeks after completion of therapy
measure: Eradication rate of Helicobacter pylori susceptible strains
timeFrame: At least 4 weeks after completion of therapy
Other outcomes:
measure: Adherence rate
timeFrame: 2 weeks during therapy
measure: Frequency of adverse events
timeFrame: 2 weeks during therapy
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Taotao Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01632423: A Study of Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-07-03
Enrollment: 10337
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with open angle glaucoma or ocular hypertension

Brief summary: This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open angle glaucoma or ocular hypertension
* Prescribed Lumigan®

Exclusion Criteria:

* None

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline, 14 Weeks
Secondary outcomes:
measure: Patient Assessment of Tolerability Using a 4-Point Scale
timeFrame: 14 Weeks
measure: Physician Assessment of Tolerability Using a 4-Point Scale
timeFrame: 14 Weeks
measure: Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks
timeFrame: 14 Weeks
measure: Patients Who Will Continue Use of Lumigan® After 14 Weeks
timeFrame: 14 Weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: