louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02199444: Effect of Sevelamer on P-cresol Levels in CKD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Kidney Disease Stage 3-5
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly demanded. It has been reported that the phosphate binder sevelamer sequesters p-cresol in vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our study was to evaluate the effect of sevelamer on p-cresol levels in CKD patients.


Eligibility criteria: Inclusion Criteria:

* age \>18 years,
* CKD stage 3-5

Exclusion Criteria:

* Existing or previous treatment within the last 1 year with a phosphate binder;
* hyperphosphatemia (\>5.6 mg/dL);
* hypophosphatemia (\<2.5 mg/dL);
* malnutrition,
* malignant neoplasms,
* current history of gastrointestinal and/or endocrine diseases.

Primary outcomes:
measure: Effect on p-creol levels
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: federico II university, department of nephrology
Study officials:
References:
Clinical trial NCT05503940: Association of Multiple Medications With the Severity of Dyspepsia
Official title: Association of Multiple Medications With the Severity of Dyspepsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyspepsia
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged ≥ 18 years old who met broad criteria of dyspepsia were eligible for our study.

Brief summary: Dyspepsia is a very common gastrointestinal disease. Some medications, were associated with higher frequent incidences of dyspepsia, including non-steroid anti-inflammatory drugs (NSAIDs), Bisphosphonates, Tetracyclines, et al. Multiple medications were suggested to be strongly relate to adverse drug events (ADEs), adverse drug reactions (ADRs), drug-drug interactions, and drug-disease interactions, which may cause gastrointestinal(GI) dysfunction or injury to the GI mucosa. However, it was unclear whether multiple medications was associated with more severe symptoms of dyspepsia and dyspepsia-based score systems.


Eligibility criteria: Inclusion Criteria:

1. aged ≥18 years old
2. Patients who met broad criteria of dyspepsia

Exclusion Criteria:

1. organ failure defined by Marshall standard
2. severe psychiatric illnesses
3. suspected or identified bowel obstruction
4. known malignancy
5. pregnancy or lactation
6. unable to provide consent

Primary outcomes:
measure: The rate of patients with severe dyspepsia judged by patients
timeFrame: 1 day
Secondary outcomes:
measure: Global Overall Symptom score (GOSS)
timeFrame: 1 days
measure: Functional dyspepsia
timeFrame: 1 days
measure: organic upper gastrointestinal (GI) diseases.
timeFrame: 1 day
measure: subtypes of functional dyspepsia
timeFrame: 6 months
measure: Short Form of Nepean Dyspepsia Index (SF-NDI)
timeFrame: 1 day
measure: Hospital anxiety and depression scale
timeFrame: 1 day
measure: Quality of Life scores
timeFrame: 1 day
measure: Number of Participants with other functional gastrointestinal diseases
timeFrame: 1 day
measure: Functional dyspepsia symptom diary (FDSD) score
timeFrame: 1 days
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Xijing 986 Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References:
Clinical trial NCT04977440: High Protein Intake in Critically Ill Ventilated Patients
Official title: High Protein Intake During the Early Phase of Critical Illness Compared With Normal Protein Intake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult mechanically ventilated patients

Brief summary: This prospective interventional randomized control study was conducted on forty patients with respiratory failure; all patients were intubated and mechanically ventilated for at least three days. Twenty patients received high protein intake using whey protein, with daily follow-up of the blood sugar level, serum electrolytes, and chemistry. ICU outcome regarding food intolerance, 30-day mortality, length of MV and ICU-stay was recorded


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Mechanically ventilated patients (for three days or more )

Exclusion Criteria:

* Age \< 18 years old
* Contraindication for enteral nutrition (gut ischemia, obstruction, or perforation)
* Expected intolerance for enteral nutrition (paralytic ileus)
* Inability to start enteral nutrition within 24-hours(i.e. surgery or other interventions)
* Short bowel syndrome
* Hemodynamic instability ( i.e shock state, need for vasopressors )
* Child C liver cirrhosis or acute liver failure
* Dialysis dependency

Primary outcomes:
measure: Effect of high protein intake on glycemic control
timeFrame: up to 7 days
measure: Effect of high protein intake on serum electrolytes
timeFrame: up to 7 days
Secondary outcomes:
measure: Effect of high protein intake on ICU outcome
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Cairo University
name: farouk faris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00456040: Characteristics of Patients With Amyloidosis & Heart Failure Being Evaluated for a Heart Transplant
Official title: Characteristics of Patients With Systemic Amyloidosis and Severe Heart Failure Being Evaluated for a Sequential Cardiac and Autologous Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathy
Keywords: amyloidosis
heart failure
heart transplant
stem cell transplant
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2007-04-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this study is to describe the characteristics of patients with amyloidosis and severe heart failure being evaluated for cardiac and stem cell transplantation.

Detailed description: Systemic amyloidosis is a progressive disease leading to organ failure and death. Treatment has improved survival with stem-cell transplantation. Unfortunately, patients with amyloidosis and severe heart failure are not eligible for stem-cell transplantation.

The average rate of survival for patients with amyloidosis who receive a heart transplant is decreased.

Previous trials have raised the possibility that survival may be increased in patients with amyloidosis, if chemotherapy and stem-cell transplantation is performed after a heart transplant.

We plan to review data of patients with amyloidosis and heart failure who were being evaluated for a heart transplant.

Eligibility criteria: Inclusion Criteria:

* Patients with amyloidosis
* NYHA class III or IV heart failure
* Patients undergoing heart transplant evaluation
* Patients less than 18 years of age

Exclusion Criteria:

* Patients who have unstable pulse and blood pressure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Marc J Semigran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06021340: What To-be-discard Biomaterials From ART Cycles Can Tell us About the Treatment Cycle Outcome?
Official title: What To-be-discard Biomaterials From ART Cycles Can Tell us About the Treatment Cycle Outcome?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IVF
Infertility
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include patients attending the Assisted Reproductive Technolohy (ART) Unit of the Chinese University of Hong Kong for ART treatment.

Brief summary: Various to-be-discard material from IVF treatment cycle will be collect and examined, aiming to identify potential reasons of successful outcome or cycle failure.

Detailed description: Usually around 2/3 of IVF material will be discarded at the end of each treatment cycle, including immature oocytes, abnormal fertilized zygotes, poor grading embryos, spent culture medium, etc. Next generation sequencing will be performed for DNA / RNA analysis including the length and the quantity, RNA-seq will be applied for transcriptome profiling, and protein profile will be investigated in a pool sample. By applying various diagnostic tools against those to-be-discard biomaterials, we aim to identify potential underlying reasons of indicating either for an IVF failure or a successful cycle, and try to develop a non-invasive testing method for embryo quality check; better detection of the embryo implantation potential and eventually further increase the IVF clinical outcome.

Eligibility criteria: Inclusion Criteria:

* Patients attending the Assisted Reproductive Technology (ART) Unit of the Chinese University of Hong Kong for ART treatment.
* Participant able to give voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

* Patient using donor gamete in IVF treatment
* Patient refuses to join and failed to giving consent for any reasons

Primary outcomes:
measure: DNA/RNA sequencing data
timeFrame: Through study completion, around 3 year
measure: Proteomic profile
timeFrame: Through study completion, around 3 year
Secondary outcomes:
measure: Blastocyst formation rate
timeFrame: 5 days after fertilization
measure: Clinical pregnancy rate
timeFrame: Around 5 weeks after embryo transfer
measure: Live birth rate
timeFrame: Around 9 months after embryo transfer
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong and Prince of Wales Hospital
Study officials:
affiliation: CUHK
name: Yiu Leung D Chan, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06200740: Remotely Observed Methadone Evaluation
Official title: Remotely Observed Methadone Evaluation (ROME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: Sonara Health
Sponsor class: INDUSTRY
Collaborators: name: Oregon Health and Science University
name: Stanford University
name: Adapt Oregon
First posted: 2024-01-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Opioid addiction, which affects 16 million individuals worldwide, can be treated using methadone, a proven and effective opioid medication for treating OUD that extends retention in care, reduces mortality, and inhibits illicit drug use. However, methadone treatment is limited to federally certified Opioid Treatment Programs (OTPs), which must meet complex regulatory requirements, and require new patients to take their dose in person six days per week, presenting significant barriers to treatment. To address these barriers, Sonara Heath has developed the Sonara software platform, which will enable OTPs to offer accelerated take-home methadone regimens while maintaining safety and diversion prevention.


Eligibility criteria: Inclusion Criteria:

* Receiving methadone for the treatment of opioid use disorder

Exclusion Criteria:

* Patients with \>13 take-homes
* Patients with positive toxicology results in last 30-60 days
* Patients involved with drug court ineligible for take-homes
* Patients without adequate access to technology
* Patients with \<30 days in treatment
* Patients with mental health instability
* Patients with recent diversion attempts
* Patients using buprenorphine for agonist therapy
* Patients guest dosing at another clinic during trial period

Primary outcomes:
measure: System Usability Scale (SUS)
timeFrame: two weeks
Secondary outcomes:
measure: Acceptability, Appropriateness and Feasibility of Implementation Measures
timeFrame: two weeks
Other outcomes:
Locations:
city: Roseburg
country: United States
facility: Adapt - Roseburg
state: Oregon
Study officials:
References:
Clinical trial NCT02074540: The Influence of Health Beliefs and Uncertainty on Diabetes Type II Patient Compliance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Type II
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetes Type II patients who receive insulin and are hospitalized in the Hillel Yaffe Medical Center in a variety of departments. Patients are both Hebrew and Arabic speaking.

Brief summary: To determine the predicting factors and indicators of compliance with insulin treatment in Diabetes Type II patients.


Eligibility criteria: Inclusion Criteria:

* With complete cognitive abilities
* Independent functioning
* Take insulin

Exclusion Criteria:

* Critically ill patients
* Psychiatric patients

Primary outcomes:
measure: Insulin adherence
timeFrame: Forty minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Jalal Ashkar, MD
role: STUDY_DIRECTOR
affiliation: Hillel Yaffe Medical Center
name: Rinat Majadly, RN, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04428840: Effects of Implementation of a Self-measurement Kiosk in the Emergency Department Waiting Room
Official title: Effects of Implementation of Automated Pre-triage Based on a Self-measurement Kiosk With Questionnaire for Patients in the Emergency Department Waiting Room on Triage Time-stamps and Satisfaction of Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergencies
Keywords: triage
kiosk
early warning score
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 757
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomised in blocks per day regarding use of the kiosk
Primary purpose: DIAGNOSTIC

Brief summary: In this study the participant will be invited to be seated in the self-measurement kiosk after registration in the Emergency department. In this kiosk, the participant will be measuring their own vitals and answering a short questionnaire regarding the reason for presentation. All these results are displayed on a screen for the triage nurse. Based on the results, high-risk patients will be highlighted on the screen, so they may be seen faster.

Detailed description: The questionnaire entails questions which would otherwise be asked by the triage nurse, regarding reason for presentation, fever, pain and and possible allergies. This is done through a touch-screen.

The vital signs and potential alarm symptoms from the (multilingual) questionnaire are being displayed with the pain score on a screen in the triage room and at the nurses desk. An adapted Early Warning Score (aEWS - without respiratory rate) is calculated from the vital signs. Abnormal results are being highlighted and carried up on the screen to the top position. This enables the triage nurse to pick up the sicker participants in the waiting room faster. The measurements are valid, so they do not have to be repeated by the triage nurse.

Users will be contacted afterwards regarding satisfaction of use

Eligibility criteria: Inclusion Criteria:

* all patients presenting ambulatory at the Emergency Department

Exclusion Criteria:

* patients presenting by ambulance / Emergency Medical Services

Primary outcomes:
measure: Triage time-stamp 1
timeFrame: through study completion, average of 1 year
measure: Triage time-stamp 2
timeFrame: through study completion, average of 1 year
Secondary outcomes:
measure: Time to see physician
timeFrame: through study completion, average 1 year
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Spoedgevallendienst
Study officials:
affiliation: UZ Gent
name: Cathelijne Lyphout, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06455540: SUperior Hypogastric Plexus Block During Laparoscopic hysterEctomy (SUBTLE)
Official title: Superior Hypogastric Plexus Block During Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hysterectomy
Keywords: Hysterectomy
Minimally invasive surgery
Quality of recovery
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial sest to assess the efficacy of a superior hypogastric plexus block (SHPB) for quality of recovery after a laparoscopic hysterectomy.


Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* Undergoing laparoscopic hysterectomy for benign indications

Exclusion Criteria:

* Planned procedure that requires dissection of the presacral space
* Allergy to block medication (s)
* Known or suspected malignancy

Primary outcomes:
measure: Quality of recovery
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Postoperative Pain Scores
timeFrame: Up to postoperative day 2
measure: Postoperative Opioid Use
timeFrame: Up to postoperative day 2
measure: The Brief Pain Inventory (BPI)
timeFrame: Up to postoperative day 90
measure: The McGill Pain Questionnaire
timeFrame: Up to postoperative day 90
measure: Incidence of Adverse events
timeFrame: Intraoperative (During block performance)
measure: Length of stay in post-anesthesia care unit (PACU) area
timeFrame: Postoperative day 1
measure: Quality of recovery
timeFrame: Up to postoperative day 2
measure: Postoperative nausea and vomiting
timeFrame: Up to postoperative day 2
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01073540: Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension
Official title: Prospective, Randomized, Open Label, Crossover Study to Compare the Bioavailability Between Optocef Suspension From Bayer (Cephalexin Suspension 250 mg/5 mL) and Equivalent Concentration of Keflex Pediatrico From Eli Lilly (Cephalexin Suspension 125 mg/5mL) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anti-Infective Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Corporación Bonima S.A. de C.V.
First posted: 2010-02-23
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. Treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis

Exclusion Criteria:

* History of illnesses or any organic abnormalities that could affect the results of the study
* History of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs
* Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup

Primary outcomes:
measure: Least square estimator of average maximum plasmatic concentration (log transformed)
timeFrame: After two months
measure: Least square estimator of area under the pharmacokinetic curve (log transformed)
timeFrame: After two months
Secondary outcomes:
measure: Time at which maximum concentration is reached
timeFrame: After two months
measure: Area under the pharmacokinetic curve from time=0 to last blood sample
timeFrame: After two months
measure: Clearance constant of plasmatic concentration of study drug
timeFrame: After two months
measure: Half life of plasmatic concentration of study drug
timeFrame: After two months
measure: Adverse events collection
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Morelia
country: Mexico
state: Michoacán
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: