louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05500053: A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease
Official title: A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genital Herpes
Patient Engagement
Lead sponsor: Rational Vaccines Inc
Sponsor class: INDUSTRY
First posted: 2022-08-12
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with recurrent symptomatic of genital herpes

Brief summary: Determine the baseline characteristics of patients who have recurrent symptomatic genital herpetic disease Determine the acceptance to patients of clinical trial procedures Determine interest in participation in genital herpes vaccine trials


Eligibility criteria: Inclusion Criteria:

* Able to understand and willing to sign the informed consent document.
* Patient confirmation of a diagnosis of HSV-2 infection at least 2 years prior to inclusion. Laboratory confirmation is not required.
* Symptomatic recurrent genital herpetic disease for \>2 years supported by compatible clinical history

Exclusion Criteria:

* Subjects who do not meet the inclusion criteria for the study
* Subjects who are unable to provide legally effective informed consent

Primary outcomes:
measure: Baseline characteristics of patients who have recurrent symptomatic genital herpetic disease
timeFrame: day of questionnaire
measure: Acceptance to patients of clinical trial procedures
timeFrame: day of questionnaire
measure: Interest in participation in genital herpes vaccine trials
timeFrame: day of questionnaire
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Solent NHS Trust
state: UK
Study officials:
affiliation: Solent NHS Trust
name: Rajul Patel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00306553: Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Melanoma
Lead sponsor: Cytos Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2006-03-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine.


Eligibility criteria: Inclusion Criteria:

* Able to provide written informed consent.
* Able and willing to complete all protocol requirements.
* Age: 18 years and older.
* Histological confirmed stage III or IV melanoma.
* At least one confirmed detectable target lesion
* HLA-A\*0201 haplotype
* Expected survival of at least 6 months.
* Full recovery from surgery.
* Able to undergo either CT scan or MRI scan for tumor assessment.
* Wash-out period of 4 weeks after chemotherapy
* All AEs form prior anticancer therapy have resolved to ≤ Grade 1.
* Sexually active males should use adequate contraception throughout the study period and 3 months thereafter.
* Females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine.

Exclusion Criteria:

* Pregnant or nursing.
* Use of an investigational drug within 30 days before enrolment.
* Known or suspected brain metastases.
* Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug
* Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, neurological or bone marrow function disorders
* Serum tests positive for HIV, HBV, HCV.
* Active autoimmune diseases or severe allergies.
* Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
* Abuse of alcohol or other recreational drugs.
* Previous vaccination with a Melan-A analog peptide.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zuerich
country: Switzerland
facility: Dept. of Dermatology, USZ
city: Zuerich
country: Switzerland
facility: Dept. of Oncology, USZ
Study officials:
affiliation: Dept. of Oncology, Univerity Hospital Zuerich, CH
name: Alexander Knuth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03576053: A Mechanistic Evaluation of the Interactions Between Thermoceptive and Pruriceptive Sensory Processing
Official title: En Mekanistisk undersøgelse af Interaktioner Imellem Det Thermoceptive og Det Pruriceptive Sensoriske System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Itch
Thermal Stimulation
Histamine
Cowhage
Serotonine
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this human experimental study is to evaluate the pattern of itch intensity over time in response to strong, short-term heat stimulation in two different models of histamine and cowhage-induced itch. Moreover, the purpose is to evaluate the effect of mild pre-heating of the skin in human experimental models of histamine, cowhage and serotonin. Finally, we want to investigate the effect of short-term intense heat stimulation on previously anesthetized skin.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* Age 18-60 years
* Able to speak and understand English

Exclusion Criteria:

* Suffering from chronic disease
* Pregnancy or lactation
* Prior experience of adverse effects from anaesthetic, specifically Lidocaine
* Drug addiction defined as the use of cannabis, opioids or other drugs - 5 -
* Previous neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
* Current use of medications that may affect the trial
* Active skin diseases
* Active participation in other experiments currently ongoing or within the last 14 days
* Tattoos on volar forearms that will interfere with local skin measurements

Primary outcomes:
measure: eVAS Itch
timeFrame: 10 minutes
measure: Skin temperature
timeFrame: 5 seconds
measure: eVAS Pain
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
state: Nordjylland
Study officials:
affiliation: Aalborg University
name: Daniele Riccio, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04311853: Evidence-Based Nutrition Practice Guidelines of Toolkit and Preliminary Outcomes
Official title: Pilot Study of Type 2 Diabetes Evidence-Based Nutrition Practice Guidelines--Field Test of Toolkit and Preliminary Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Academy of Nutrition and Dietetics
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: practitioners working with patients who have heart failure

Brief summary: The goal of this study is to field test ADA's Type 2 Diabetes Evidence-Based nutrition Practice Guidelines (EBNPG) for Adults in 2008 as a tool for registered dietitians (RDs) for their patients with with type 2 diabetes who have no evidence of organ damage. A six month pilot study will be conducted to determine the feasibility of training RDs in documenting the outcomes of implementing Medical Nutrition Therapy (MNT) using ADA's evidence-based GL for T2D.


Eligibility criteria: Inclusion Criteria:

* over 19 years
* no documented claims for the treatment of TD over the past 7 years
* no MNT claims submitted within the past 12 months
* not under RD care
* able to make visits to the clinic per guidelines

Exclusion Criteria:

* not in end-stage renal disease or renal insufficiency; history of Cardiovascular Disease,Chronic Athrosclerotic Disease, or Myocardial Infection; Chronic Obstructive Pulmonary Disease, untreated depression, severe psychiatric illness; cancer diagnosis in previous two years or on-going radiation or chemotherapy treatment; Congestive Heart Failure.
* pregnant or lactating at time of study
* presence of cognitive limitations that preclude making lifestyle or dietary changes as assessed by the RD during the initial interview

Primary outcomes:
measure: Implementation of new evidence-based nutrition practice guidelines
timeFrame: six months
Secondary outcomes:
measure: Improved health outcomes
timeFrame: six months
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Linda Snetselaar, PhD, RD, LD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academy of Nutrition and Dietetics
name: Esther F Myers, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04032353: Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy
Official title: Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Capsule Endoscopy
Cancer of Stomach
Cancer of Esophagus
Health Policy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of our study was to demonstrate the efficacy and feasibility of the medical consortium for screening upper gastrointestinal cancers with magnetically controlled capsule gastroscopy.

Detailed description: In this study, the investigators designed a propective cohort study to evaluate the the efficacy and feasibility of medical consortium for screening upper gastrointestinal cancers (MCSC) with magnetically controlled capsule gastroscopy (MCCG).

Eligibility criteria: Inclusion Criteria:

* asymptomatic subjects undergong magnetically controlled capsule gastroscopy for health checkup in medical consotium;
* subjects able to give informed consent

Exclusion Criteria:

* suspected or known intestinal stenosis, obstruction, or fistula;
* inoperability of refusal to accept any abdominal surgery;
* dysphagia or gastric paralysis;
* previous history of gastrointestinal disease;
* with pacemaker, implanted-cardiac defibrillator or other implanted electromedical devices;
* need for standard magnetic resonance imaging examination within seven days after swallowing the MCCG, unless the capsule is confirmed to have been excreted;
* other factors that are not suitable for inclusion evaluated by medical stuff

Primary outcomes:
measure: the incidence of upper gastrointestinal cancers, including gastric cancer and esophageal cancer.
timeFrame: 12 months
Secondary outcomes:
measure: tthe focal lesions of upper gastrointestinal tract
timeFrame: 12 months
Other outcomes:
measure: adverse events
timeFrame: 12 months
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT00613353: Sedentary Behavior in Overweight Women
Official title: Sedentary Behavior in Overweight Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedentary Behavior
Overweight
Keywords: Female
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caucasian or African American women between the ages of 18 and 65.

Brief summary: Objective activity data will be collected using accelerometry for a minimum of seven days on 38 adult, female, women recruited from the metabolic Clinic at the University of Mississippi Medical Center. Following objective measurement of activity, participants will complete self-report and objective activity data, as well as the relationship between sedentary activities and food cravings will be examined. It is hypothesized that minutes of sedentary behavior, especially time spent in television viewing, will be significantly correlated with total and specific food cravings.


Eligibility criteria: Inclusion Criteria: Caucasian or African American women between the ages of 18 and 65

Exclusion Criteria: Males and women who are younger than 18 and older than 65

Primary outcomes:
measure: Minutes of sedentary behavior, especially time spent in television viewing, will be significantly correlated with total and specific food cravings
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: The University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: The University of Mississippi Medical Center
name: Jacinda B Roach, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00008853: Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines
Official title: Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infections
Group B Streptococcus
Keywords: Clinical Evaluation
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the safety and favorable immune response to an anti-streptococcal vaccine (a vaccine that treats a common bacterial infection) in healthy non-pregnant women.

Group B Streptococcus (GBS) continues to be the single most frequent cause of life-threatening bacterial infection during the first 2 months of life. Further, GBS pregnancy-related morbidity afflicts more than 50,000 women annually in the US. Therefore, active immunization of women is an appealing strategy for the prevention of GBS disease in pregnant women and their infants during the first 3 months of infant life.

Detailed description: In this study 65 healthy, non-pregnant women will receive a single dose of one of two anti-streptococcal vaccinations. Both types of vaccinations are given in upper arm by injection into the muscle. To assess the vaccine effectiveness, patients have blood drawn and examined at weeks 4, 8 and 26, post-vaccination.

Eligibility criteria: This information currently is not available.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: AIDS Ctr
state: New York
Study officials:
References:
Clinical trial NCT03538353: Patients' Perspectives About a Pain Education Video
Official title: Patients' Perspectives About a Pain Education Video
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 15
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: The overall goal of this single session semi-structured interview project is to explore the validation and contradiction of the preexisting pain beliefs in patients with chronic pain.

Aim 1: After patients watch an educational video, explore occurrences of perceived validation and contradiction and the impact of validation and contradiction on pain beliefs, emotion, and pain.

Aim 2: Obtain patients' recommendations for improving the educational value of the video.

Detailed description: The long-term goal is to reduce disability in patients with chronic pain by improving communication about pain among patients, caregivers, and health care providers (HCPs). The proposed study addresses the long-term goal by conducting a project that investigates the validation and contradiction of patients' preexisting pain beliefs during pain education. Completion of the proposed project will advance the literature on validation and contradiction in patients with chronic pain by (1) focusing on a pain education resource instead of dyadic communication, (2) modifying a measure of validation and contradiction for relevance to an education resource, (3) exploring erroneous perceptions of validation and contradiction, (4) examining the impact of validation and contradiction on pain beliefs, and (5) obtaining patients' recommendations for a popular pain education film. The information gained will be used to improve pain education resources to increase their beneficial effects on pain and disability.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older;
* new patient of the CPMC;
* living independently; and
* self-reported recurrent or persistent pain on most days of the last year.

Exclusion Criteria:

* previously viewed the pain education video used in this project;
* insufficient hearing to communicate with an interviewer; and
* an inability to complete the session within the time allowable.

Primary outcomes:
measure: agreement and disagreement with preexisting beliefs
timeFrame: 1 day
Secondary outcomes:
measure: emotional response to agreement and disagreement with preexisting beliefs
timeFrame: 1 day
measure: pain beliefs
timeFrame: 1 day
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri - Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Erin A Dannecker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02578251: Paracetamol for Intrapartum Analgesia
Official title: Efficacy of Intravenous Paracetamol as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Analgesia, Obstetrical
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 104
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess whether paracetamol is as effective as pethidine for analgesia during the first stage of labor.


Eligibility criteria: Inclusion Criteria:

* Primiparity
* Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes)
* Maternal age between 20-30 years
* Singleton term pregnancy (37-42 weeks of gestation)
* Vertex-presenting fetus

Exclusion Criteria:

* Clinical evidence of cephalopelvic disproportion
* Scarred uterus; previous cesarean section, hysterotomy or myomectomy
* Medical disorders associated with pregnancy, especially gastritis, peptic ulcer, bronchial asthma or renal impairment
* Fetal distress
* Receiving any regional or parenteral analgesia before recruitment in the study
* Known hypersensitivity to the drug family

Primary outcomes:
measure: The efficacy of intravenous paracetamol to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale.
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02343653: The Effect of Resistance Training on Muscle Strength and Nutritional Status in Patients With Liver Cirrhosis
Official title: The Effect of Resistance Training on Muscle Strength and Nutritional Status in Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Keywords: Malnutrition
Muscle mass
Nutrition
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2015-01-22
Enrollment: 39
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 purpose is to investigate the effect of strength training on muscle strength, muscle mass and nutritional status in patients with liver cirrhosis to clarify possible metabolic and inflammatory changes during this intervention. In addition the investigator examine if the intervention is associated with fewer hospital readmission and an improved quality of life.


Eligibility criteria: Inclusion Criteria:

* Cirrhosis, Child Pugh score A and B

Exclusion Criteria:

* Cirrhosis, Child-Pugh score C at inclusion
* Neurological and/or psychiatric disorder
* Pregnancy, breastfeeding
* Patients with malignancy
* Patients with hepatic encephalopathy at inclusion
* Patients with atypical diets, such as vegans

Primary outcomes:
measure: Maximal voluntary muscle strength in knee extensor will be measured by an isokinetic dynamometer and hand strength by hand dynamometer.
timeFrame: 12-14 weeks
Secondary outcomes:
measure: Nutritional status as measured by Triceps skinfold thickness (TSF), mid-upper-arm circumference (MUAC), mid-arm muscle area (MAMA) and hand dynamometer
timeFrame: 12-14 weeks
measure: Readmissions as measured by a follow-up one year after the intervention.
timeFrame: 1-1,5 year
measure: Quality of Life as measured by a standardized questionnaire (SF-36)
timeFrame: 12-14 weeks
measure: Insulin sensitivity as measured by HOMA-IR
timeFrame: 12-14 weeks
measure: Ammonia metabolism as measured by Oral Glutamine Challenge Test
timeFrame: 12-14 weeks
measure: Muscle mass as measured by MRi scan and bioimpedance scan.
timeFrame: 12-14weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Hepatology and Gastroenterology V, Aarhus University Hospital
Study officials:
affiliation: Department of Hepatology and Gastroenterology V, Aarhus University Hospital
name: Niels Kristian Aagaard, Chief phys.
role: STUDY_DIRECTOR
References:
citation: Aamann L, Dam G, Borre M, Drljevic-Nielsen A, Overgaard K, Andersen H, Vilstrup H, Aagaard NK. Resistance Training Increases Muscle Strength and Muscle Size in Patients With Liver Cirrhosis. Clin Gastroenterol Hepatol. 2020 May;18(5):1179-1187.e6. doi: 10.1016/j.cgh.2019.07.058. Epub 2019 Aug 5.