louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00796601: Maintenance of Efficacy.
Official title: A 6-month, Double-blind, Placebo-controlled, Multi-center, Parallel Group, Maintenance Of Effect Study Of Esreboxetine (Pnu-165442g) Administered Once Daily (qd) In Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: double-blind placebo-controlled maintenance of efficacy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 0
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 hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia
* Pain score greater than or equal to 4 on an 11-point NRS
* FIQ-Total score greater than or equal to 45 points

Exclusion Criteria:

* Other severe pain that may confound assessment or self evaluation of the pain associated with fibromyalgia
* Any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder
* Uncontrolled hypertension Pending Worker's Compensation; Current or recent diagnosis or episode of major depressive disorder, dysthymia and/or uncontrolled depression; Subjects to be at risk of suicide;

Primary outcomes:
measure: Change from baseline to 3 and 6 months in the mean daily pain rating score measured by the 11 point pain intensity Numerical Rating Scale (NRS).
timeFrame: 6 months
measure: Change from baseline to 3 and 6 months in the FIQ-Total score
timeFrame: 6 months
Secondary outcomes:
measure: Pain (including other measures of daily pain and responder analyses);
timeFrame: 6 months
measure: Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36);
timeFrame: 6 months
measure: Global efficacy measures PGIC);
timeFrame: 6 months
measure: Sleep (MOS);
timeFrame: 6 months
measure: Work productivity;
timeFrame: 6 months
measure: Depression (HADS)
timeFrame: 6 months
measure: Safety (vital signs, ECG, laboratory, suicidal ideation)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04933201: Postoperative Music for Orbital Decompression
Official title: Music for Postoperative Pain and Discomfort After Orbital Decompression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Pain
Musth
Keywords: postoperative pain
postoperative discomfort
general anesthesia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of music to the postoperative pain and discomfort after orbital decompression.

Detailed description: To investigate the effect of music to the postoperative pain and discomfort after orbital decompression under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* 16-75 years old
* diagnosed as thyroid eye disease
* bone removal orbital decompression under general anesthesia

Exclusion Criteria:

* any uncontrolled clinical problems
* orbital decompression under local anesthesia
* Reluctance to participate in clinical trials

Primary outcomes:
measure: Pain after orbital decompression
timeFrame: 24 hour after recovery
Secondary outcomes:
measure: Discomfort after orbital decompression
timeFrame: 24 hour after recovery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Huijing Ye
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01432301: Uridine Triacetate as Antidote for Patients at Excess Risk of 5-FU Toxicity Due to Overdosage or Impaired Elimination
Official title: An Open-Label Protocol for the Use of Uridine Triacetate as an Antidote to Treat Patients at Excess Risk of 5-Fluorouracil Toxicity Due to Overdosage or Impaired Elimination
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Toxicity Due to Chemotherapy
Keywords: fluorouracil overdose
fluorouracil toxicity
capecitabine overdose
capecitabine toxicity
Lead sponsor: Wellstat Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-09-12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to provide emergency treatment of adult and pediatric patients:

* Following a fluorouracil or capecitabine overdose regardless of the presence of symptoms or
* Who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous systems, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.

Detailed description: Demographics, baseline disease information, prior disease-directed therapy including fluorouracil or capecitabine, and details of the fluorouracil or capecitabine overexposure (dose, cause, and timing) will be collected. Adverse events information will be collected and recorded. Patients will be followed for 30 days unless the patient expires or resumes chemotherapy within the 30 day period.

Eligibility criteria: Inclusion Criteria:

* The patient received a fluorouracil or capecitabine overdose (regardless of the presence of symptoms) or
* The patient is exhibiting early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration
* Judged by the Investigator to have the initiative and means to be compliant with the protocol
* Able to take oral medications
* Able to start treatment with uridine triacetate within 96 hours after the end of fluorouracil or capecitabine administration
* Provides written informed consent (patient or legally authorized representative)

Exclusion Criteria:

* Has a known allergy to uridine triacetate or any of its excipients
* Unable to have the initiative and means to be compliant with the protocol
* Unable to be compliant with taking oral medications
* More than 96 hours have elapsed since the completion of 5-FU dosing
* Unable to provide written informed consent (patient or legally authorized representative)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04847401: the Relationship Between Helicobacter Pylori Infection and Irritable Bowel Syndrome
Official title: Evaluation of the Relationship Between Helicobacter Pylori Infection and Irritable Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Irritable Bowel Syndrome
Keywords: Helicobacter Pylori
Irritable Bowel Syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: outpatient clinic patients

Brief summary: Evaluating any possible relationship between irritable bowel syndrome occurrence and Helicobacter pylori infection


Eligibility criteria: Inclusion Criteria:

* All patients will be selected according to Rome IV criteria for the diagnosis of IBS, which include:

Recurrent abdominal pain at least 1 day/week in the last 3 months, with two or more of the following criteria:

* Related to defecation
* Associated with a change in frequency of stool
* Associated with a change in form of stool. Criteria achieved for the last 3 months with symptom onset at least 6 months before diagnosis

Exclusion Criteria:

* • Rectal bleeding

  * Anemia
  * Weight loss
  * Onset after 50 years of age
  * Recent antibiotic use
  * Abnormal abdominal examination (organomegaly, lump)
  * Family history of colorectal cancer.
  * Family history of inflammatory bowel disease, or celiac disease.

Primary outcomes:
measure: number of irritable bowel syndrome patients who had H.pylori infection
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06771401: Identification of Biomarkers in Cervical Mucus
Official title: Identification of Diagnostic, Prognostic and Predictive Biomarkers in Cervical Mucus for Reproductive and Gynecological Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Mucus Dysfunction
Infertility, Female
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Cervical mucus is a biological fluid secreted by the endocervical glandular epithelium whose quantitative and qualitative characteristics vary in response to the hormonal stimulus produced by the ovary during the woman's menstrual cycle. As a fertility factor, it performs numerous biological functions: transport, nourishment, defense and capacitation of spermatozoa, defense against pathogens of the female genital tract.

The aim of this research will be to deepen the knowledge of the biochemical characteristics of cervical mucus, in particular to perform characterization by infrared spectroscopy, for the identification of diagnostic, prognostic and predictive biomarkers for disorders affecting the female reproductive system.

A healthy control population and a cohort of patients affected by unexplained infertility will be enrolled for the longitudinal study of the menstrual cycle with ultrasound and hormonal monitoring and serial sampling of cervical mucus.


Eligibility criteria: Inclusion Criteria:

* HEALTHY CONTROL

  * Women of 18-45 years old,
  * Use of the Billings Ovulation Method® for at least three months in the last three years
  * Proven fertility
* STUDY COHORT

  * Women of 18-45 years old,
  * Women affected by unexplained infertility

Exclusion Criteria:

* Virgo women
* Women incapable of understanding and wanting
* Women who have had sexual intercourse in the two days prior to cervical mucus sampling
* Pregnancy, exclusive breastfeeding
* Amenorrhea
* Gynecological hormone ongoing therapies or suspended for less than three months
* Cervico -vaginal infections
* Psychiatric pathologies
* Untreated/decompensated endocrine-metabolic disorders
* Coagulopathies and renal pathologies under dialysis treatment
* Refusal of informed consent
* Previous, current or suspected oncological pathology

Primary outcomes:
measure: Characterization by infrared spectroscopy of cervical mucus
timeFrame: 1 month (3 time points within a menstrual cycle)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06712901: Social Media and Cancer Screening Information
Official title: Social Media and Cancer Screening Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: AmeriSpeak - NORC
First posted: 2024-12-02
Enrollment: 2030
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: NORC/AmeriSpeak will recruit participants who meet the study criteria and invite them to complete a 15-minute survey. Participants will be randomly assigned to one of five conditions, with approximately 400 people in each condition, and will respond to various questions after viewing the study messaging. Once 2,000 participants complete the survey, the data will be de-identified and provided to the study team for analysis.

Detailed description: NORC/AmeriSpeak will put all of the study content into their system. They will send out the opportunity to participate in the study, which should take about 15 minutes, to people in their panel who meet our participation criteria. Participants will be directed to the study information sheet that includes all elements of consent. Participants who agree to participate will start the survey experiment. The survey experiment will randomize participants into one of five conditions: (1) control (no exposure), (2) overall median ranked messages (from the prior study), (3) messages preferred by all participants, (4) messages preferred by Black American participants, and (5) messages preferred by White American participants. Approximately 400 people will complete each condition. After viewing the study stimuli (or no stimuli in the control condition), participants will respond to various outcomes and other variables of interest (see questionnaire draft included). After all 2,000 people have completed the study, the study team will receive a de-identified data file from NORC/AmeriSpeak with all study data and engage in analysis. This study is planned to close the study around that time as the study team completes data analysis and write-up the findings.

Eligibility criteria: Inclusion Criteria:

* Identify as white/Caucasian or Black/African American.

Exclusion Criteria:

* Do not identify as white/Caucasian or Black/African American.
* Previously diagnosed with colorectal cancer
* Non-English speakers

Primary outcomes:
measure: Intentions to adhere to colorectal cancer screening (CRCS) recommendations
timeFrame: 15 minutes
measure: Intentions to adhere test preference indication
timeFrame: 15 minutes
Secondary outcomes:
measure: Likelihood of sharing information via social media
timeFrame: 15 minutes
measure: Information sharing behavior
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Andy King
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute/ University of Utah
name: Andy King, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04764201: The Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers
Official title: A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atrial Fibrillation
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HIP2001 and HGP2001 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* 19 kg/m\^2 ≤ BMI \< 28 kg/m\^2, weight \>60kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<900 mmHg
* agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.

Exclusion Criteria:

* A history of hypersensitivity reactions or clinically significant hypersensitivity reactions
* A history of gastrointestinal diseases or surgery that may affect the absorption of clinical trial drugs
* A history of substance abuse or who test positive for drugs of concern for abuse in the urine drug screening test
* Positive results of serological tests
* Have taken other investigational drugs or bioequivalence drugs within 6 months before the first administration of the investigational drug
* Donated whole blood within 60 days prior to the screening date or donated components within 30 days or received a blood transfusion within 30 days
* Have drank more than 210 g/week of alcohol within 30 days before the screening date
* Have smoked more than 10 bills/day within 30 days before the screening date
* AST, ALT value is more than 2 times the UNL or bilirubin level is more than 1.5 times the UNL, eGFR \< 50 mL/min/1.73m2, Prothrombin (INR) \> 1.31 INR or aPTT \> 39.7 sec
* 12-ECG QTc \>450 ms

Primary outcomes:
measure: AUCt
timeFrame: 0~48 hours
measure: Cmax
timeFrame: 0~48 hours
Secondary outcomes:
measure: AUCinf
timeFrame: 0~48 hours
measure: Tmax
timeFrame: 0~48 hours
measure: t1/2
timeFrame: 0~48 hours
measure: CL/F
timeFrame: 0~48 hours
measure: Vd/F
timeFrame: 0~48 hours
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk University Hospital
Study officials:
affiliation: Jeonbuk University Hospital
name: Mingeul Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03171701: Color Doppler Ultrasonography in Prediction of Arteriovenous Fistula Maturation in Hemodialysis Patients
Official title: Role of Color Doppler Ultrasonography in Prediction of Arteriovenous Fistula Maturation and Its Complications in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arteriovenous Fistula
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be performed at Radiodiagnostic department, Assiut Police Hospital and assiut university hospital on all newly placed arteriovenous fistula for hemodialysis.

Brief summary: The transplant is the definitive treatment of renal insufficiency, in our days. While waiting for it, the arteriovenous fistula surgery is standard procedure.

Detailed description: Ultrasound is the main method of diagnostic imaging, because of its low cost, noninvasive without ionizing radiation associated or iodized contrast.

Vascular procedures and their complications represent a major cause of morbidity hospitalization and cost for patients in hemodialysis .

Many fistulas do not mature appropriately for being used in dialysis. So,The early recognition through the ultrasound examination of problems in the arteriovenous fistula maturation or possible complications that may compromise their viability, offers the opportunity of correction or appropriate treatment .

Criteria for maturation after arteriovenous fistula creation:

* Vein diameter larger than 4 mm remote from the site of fistula.
* Vein located at a depth of \<5 mm from skin surface.

Eligibility criteria: Inclusion Criteria:

* 1) Patients Of Chronic Renal Failure With Newly Placed AVF. 2)Clinically Stable Patients For Assessment Of Maturation Of AVF. 3) Complaints Of Hand Pain Or Numbness Following Creation Of The Access.

Exclusion Criteria:

* 1)Previously Failed AV Fistulas. 2)Deformed Or Scarred Upper Limb.

Primary outcomes:
measure: Role of color Doppler ultrasonography in prediction of arteriovenous fistula maturation and its complications in hemodialysis patients
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Malovrh M. Postoperative assessment of vascular access. J Vasc Access. 2014;15 Suppl 7:S10-4. doi: 10.5301/jva.5000243. Epub 2014 Apr 17.
Clinical trial NCT01763801: Optimization of EKG Method for Long Term Central Venous Catheter Tip Placement
Official title: P-max or P-submax? This is the Question! A Prospective Randomized Search of the Most Reliable ECG Landmark for a Long Term Central Venous Catheter.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vascular Access Complication
Keywords: chemo port
intravenous electrocardiographic guidance
P maximal wave
P submaximal wave
catheter tip
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intravenous electrocardiographic guidance (IVECG) is a safe, reliable and accurate technique to correctly position the catheter tip. The investigators sought to evaluate the superiority of the P-maximal (P-max) wave compared to the P-submaximal (P-submax) wave in obtaining a more correct, safer and longer lasting device placement, with a lower incidence of complications and secondary misplacement.

Detailed description: This prospective randomized trial was designed to observe the placement of long term iv catheters obtained with the IVECG method. Patients were randomised into 2 groups: in group A the catheter tip was placed in correspondence to the P-max, in group B in correspondence to the P-submax. We followed up the tip position by measuring the variation of its distances from the tracheal carina on multiplanar reconstructions of volumetric CT scans taken within a month (T0) and a year (T1) from the port implant.

Eligibility criteria: Inclusion Criteria:

* indication to chemo port insertion
* ability to give informed consent

Exclusion Criteria:

* younger than 18
* inability to give consent
* atrial fibrillation or flutter
* pace-maker or implantable cardioverter-defibrillator

Primary outcomes:
measure: Distance between tracheal carina and distal end of the catheter
timeFrame: up to 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University Hospital Campus BioMedico
Study officials:
affiliation: Campus Bio-Medico University
name: Massimiliano Carassiti, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Campus Bio-Medico University
name: Paola Proscia, Doctor
role: PRINCIPAL_INVESTIGATOR
References: