louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03302416: CRF - Nociceptin Receptor Interactions
Official title: In Vivo Imaging of Corticotropin-releasing Factor - Nociceptin Receptor Interactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-10-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Baseline \[C-11\]NOP-1A scan Post-hydrocortisone \[C-11\]NOP-1A scan
Primary purpose: BASIC_SCIENCE

Brief summary: To determine if \[C-11\]NOP-1A receptor binding (VT) can be altered by an intravenous hydrocortisone (cortisol) challenge through CRF-NOP interactions

Detailed description: Examines changes in \[C-11\]NOP-1A pharmacokinetics caused by an intravenous hydrocortisone challenge (1 mg/kg)

Eligibility criteria: Inclusion Criteria:

* Males or females between 18 and 40 years old

Exclusion Criteria:

* Current DSM-5 psychiatric disorders
* Binge drinking as defined in NIAAA criteria in the past month
* Recreational abuse of opiates, sedative-hypnotics, cocaine, amphetamines, MDMA, and PCP, as well as cannabis use
* Currently on any prescription medical or psychotropic medication;
* Current or past severe medical, endocrine, cardiovascular, immunological or neurological illnesses
* Currently pregnant or breast-feeding;
* History of radioactivity exposure via prior nuclear medicine studies or occupational exposure in past twelve months
* Metallic objects in the body that are contraindicated for MRI;
* First-degree relative with psychosis or mood disorders

Primary outcomes:
measure: [C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration
timeFrame: Baseline and 3.5 hours post-hydrocortisone
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
citation: Flanigan M, Tollefson S, Himes ML, Jordan R, Roach K, Stoughton C, Lopresti B, Mason NS, Ciccocioppo R, Narendran R. Acute Elevations in Cortisol Increase the In Vivo Binding of [11C]NOP-1A to Nociceptin Receptors: A Novel Imaging Paradigm to Study the Interaction Between Stress- and Antistress-Regulating Neuropeptides. Biol Psychiatry. 2020 Mar 15;87(6):570-576. doi: 10.1016/j.biopsych.2019.09.013. Epub 2019 Sep 25.
Clinical trial NCT00010816: Herbal Treatment of Hepatitis C in Methadone Maintained Patients
Official title: Herbal Treatment of Hepatitis C in Methadone Maintained Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-02-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Hepatitis C (HCV) is a chronic viral illness leading to progressive liver damage that has emerged as a major public health issue in the United States. While HCV affects all population groups, individuals with a history of intravenous drug use form the largest known risk group. Between 90 and 100 percent of long term intravenous drug use will eventually test positive for HCV, and there is substantial risk that even short term experimentation will result in infection. Studies suggest that HCV will be the major cause of cirrhosis and liver cancer in the next century. Currently, approved therapy includes recombinant interferons, which lead to sustained remission in a minority of patients. However, patients abusing other substances, including alcohol, are not eligible for interferon therapy. The need for investigation into other potential therapies is clear. Current practice patterns in the Far East include the use of traditional herbal remedies for symptomatic chronic viral hepatitis. This study is intended to examine the effect of commonly used herbal remedies for the treatment of symptomatic HCV.


Eligibility criteria: Inclusion Criteria:

* English speaking/reading
* Serum positive for HCV virus by PCR
* Elevated alanine transferase (ALT) within 6 months of the Entry Visit, unattributable to causes other than HCV
* Liver biopsy within 2 years of entry confirming that the histological diagnosis is consistent with chronic HCV
* Laboratory parameters available at the Entry Visit including CBC, differential, and platelet count.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: Jeff Albrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01065116: Artemether-Lumefantrine (AL) Unit Dose Pre-packs Versus Blister Packs
Official title: Effectiveness and Treatment Adherence to Artemether/Lumefantrine Pre-packs Versus Blister Packs in the Treatment of Uncomplicated Malaria in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Keywords: Malaria
Lead sponsor: Malaria Consortium, Uganda
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Uganda
name: Makerere University
First posted: 2010-02-09
Enrollment: 920
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if adherence and effectiveness of AL in the treatment of uncomplicated malaria in children aged under five years using blister packs with pictorial leaflets can be at levels comparable to those with unit dosed age specific pre-packs.

Detailed description: Prompt and adequate treatment of clinical malaria episodes remains one of the key elements of malaria control and this partly depends on patients' compliance to treatment. Uganda adopted Artemether-Lumefantrine (AL) as first line treatment for uncomplicated malaria. This is available at the health facilities in form of 6 dose pre-packs with different doze strengths in different packages. However, concerns about the costs and stock-outs of these packages have been raised and alternative equally efficacious alternatives need to be determined in order to reduce these problems. This study will assess if AL blister-packs can act as alternatives to the unit dose age specific pre-packs in the public sector

Eligibility criteria: Inclusion Criteria:

* Reported history of fever within last 48 hours and or an axillary temperature greater than or equal to 37.50C.
* Weight between 5 kg and 25 kg
* Positive malaria smear results for P. falciparum
* No history of intake of AL in the preceding two weeks
* Able to tolerate oral therapy
* Caregiver has given written informed consent to participate in the study
* If they reside within the designated catchment area of the health facility

Exclusion Criteria:

* Features of life threatening illness including severe malaria

Primary outcomes:
measure: Adherence to Blister-packs versus unit dose pre-packs as measured by pill count and self report.
timeFrame: Day 3
Secondary outcomes:
measure: Parasitological cure rates
timeFrame: Day 28
measure: Clinical cure rates
timeFrame: Days 3
Other outcomes:
Locations:
city: Tororo District
country: Uganda
facility: Mulanda Health centre IV
Study officials:
affiliation: Makerere University Kampala
name: Joaniter I Nankabirwa, MSc CEB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05989516: Surgical Treatment of Hydatid Liver Disease
Official title: Cyst Extraction With Pericyst Reduction and Omentopexy as a Treatment of Choice for Hydatid Liver Disease Caused by E. Granulosus: Retrospective Observational Review of a Single Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydatid Cyst, Hepatic
Lead sponsor: University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 72
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We have analyzed 72 patients diagnosed with liver hydatid disease for a period of 10 years from January 2006 until January 2017 treated surgically by cyst extraction, pericystectomy, and omentopexy.

Brief summary: The goal of this observational study is to show that cyst extraction with pericyst reduction and omentopexy is a suitable treatment for liver hydatid disease caused by E.Granulossus with a low rate of complication and recurrence.


Eligibility criteria: Inclusion Criteria:

* hydatid liver disease

Exclusion Criteria:

* hydatid disease present outside the liver

Primary outcomes:
measure: Post operative complications
timeFrame: one month
Secondary outcomes:
measure: Recurrence rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Skopje
country: North Macedonia
facility: Elena Zafirovikj
Study officials:
affiliation: UHSD St. Naum Ohridski
name: Elena Zafirovikj, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03276416: RAPP-children, Rhinitis & Asthma in Patient Perspective: Development and Validation of a Questionnaire for Quality of Life Evaluation in Children With Asthma and Allergic Rhinitis
Official title: RAPP-children, Rhinitis & Asthma in Patient Perspective: Development and Validation of a Questionnaire for Quality of Life Evaluation in Children With Asthma and Allergic Rhinitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Allergic Rhinitis
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A study population of 150 children with concomitant asthma and allergic rhinitis, aged 6 to 11 years, both males and females, followed-up for one month at the outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).

Brief summary: This observational study aims at developing and validating a simple questionnaire to be routinely applied in the clinical practice, for the evaluation of the quality of life in children with concomitant asthma and allergic rhinitis. The study consists of two phases:

Phase 1: Development of the RAPP-children questionnaire starting from the validated RHINASTHMA-children questionnaire.

Phase 2: Administration and validation of the RAPP-children questionnaire. 150 children with concomitant asthma and allergic rhinitis will be followed-up for one month. Both at baseline and after one month, the RAPP children and several other standardized questionnaires will be administered.


Eligibility criteria: Inclusion Criteria:

* Age between 6 and 11 years
* Concomitant asthma and allergic rhinitis
* Males and Females

Exclusion Criteria:

* Immunological and metabolic systemic disease
* Major malformations of the upper airways
* Active smoker

Primary outcomes:
measure: RAPP-children response patterns
timeFrame: 1 months
Secondary outcomes:
measure: RHINASTHMA-children response patterns
timeFrame: 1 months
measure: C-ACT response patterns
timeFrame: 1 months
measure: VAS response pattern
timeFrame: 1 months
measure: Kiddy-KINDL response patterns
timeFrame: 1 months
measure: Pulmonary function: FEV1
timeFrame: 1 months
measure: Pulmonary function: FVC
timeFrame: 1 months
measure: Pulmonary function: FEF25-75
timeFrame: 1 months
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
state: Sicily
Study officials:
References:
citation: Fasola S, Montalbano L, Ferrante G, Cilluffo G, Malizia V, Baiardini I, Braido F, Viegi G, La Grutta S. RAPP-children: A new tool for assessing quality of life in patients with asthma and rhinitis. Clin Exp Allergy. 2020 Jun;50(6):662-671. doi: 10.1111/cea.13599. Epub 2020 Mar 25.
Clinical trial NCT00959816: A Study to Investigate the Process by Which ABT-614 is Absorbed, Distributed, Metabolized and Eliminated in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Volunteers
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-08-17
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the amount of ABT-614 in the cerebral spinal fluid and blood after administration of a single dose and after administration of daily doses for 14 days in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between 18 and 40 years of age

Exclusion Criteria:

* History of bleeding disorders or deep vein thrombosis (DVT)
* Previous gastrointestinal (GI) surgery or chronic GI disease
* History of spinal surgery
* History of significant, chronic low back pain
* History of frequent headaches

Primary outcomes:
measure: Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse event assessment, physical examination)
timeFrame: One day before dosing through day of last dose and up to 72 hrs post-single dose or up to 14 days post-multiple doses
measure: ABT-614 levels in cerebral spinal fluid
timeFrame: 0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen
measure: ABT-614 levels in blood (plasma)
timeFrame: 0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 22445
state: Texas
Study officials:
References:
Clinical trial NCT05392816: Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein
Official title: Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein in Healthy Females in Fertile Ages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Nutrition, Healthy
Lead sponsor: Chalmers University of Technology
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2022-05-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of this study is to investigate the non-heme iron absorption from single meals of texturized fava bean protein, which has been suggested as a protein source suitable for replacement of meat, compared to the non-heme iron absorption from beef protein and cod protein meals. The study participants are women of fertile ages, which is one of the main groups at risk of developing iron deficiency. Since a dietary shift towards increasingly plant based is being pushed, investigating nutritional effects of such a shift is essential to avoid potential negative effects such as an increase of nutritional deficiencies. The study includes two cross-over single-blinded iron isotope trials in apparent healthy Swedish women of the ages 18-45 years, each of whom served as their own control. Participants will be served matched test meals containing beef and fava bean protein (Study 1), or cod and fava bean protein (Study 2) with radiolabeled non-heme iron 55Fe and 59Fe. Absorption of non-heme iron from test meals will be measured by whole-body counting, and erythrocyte incorporation by liquid scintillation.


Eligibility criteria: Inclusion Criteria:

* Female
* Age 18-45
* Is tolerant to intake of fava bean
* Eats fish and meat
* Feels healthy
* Can eat a breakfast consisting of three potato-based patties

Exclusion Criteria:

* Other sex than female
* Age \<18 and \>45
* Has an ongoing infection
* Is vegetarian
* Is pregnant or lactating
* Takes iron supplements

Primary outcomes:
measure: 59Fe non-heme iron absorption from cod and beef protein meals
timeFrame: 5 weeks
measure: 55Fe non-heme iron absorption from fava bean protein meals.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Chalmers University of Technology, Division of Food Science
Study officials:
affiliation: Chalmers University of Technology
name: Ann-Sofie Sandberg, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05039216: Biobank for Inflammatory Chronic Diseases and Osteoporosis
Official title: Biobank for Inflammatory Chronic Diseases and Osteoporosis of TOULouse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Spondyloarthritis
Osteoporosis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: monocentric observational longitudinal study

Brief summary: The aim of this study is to constitute a biobank for patients followed in the Rheumatology center of Toulouse University Hospital for a chronic inflammatory rheumatism including rheumatoid arthritis (RA), spondyloarthritis(SpA), and psoriatic arthritis (PsA) or a chronic bone disease including osteoporosis in order to identify biomarkers associated with therapeutic response.

Detailed description: Biologic ant targeted synthetic disease modifying anti-rheumatic drugs (bDMARDs and tsDMARDs) have greatly improved the prognosis of chronic inflammatory diseases. To date, many bDMARDs and tsDMARDs targeting different immunologic mechanisms are available to treat RA, SpA or PsA. However, the choice of the treatment and its mechanism of action is based on physician decision and experience. Indeed, predictive clinical and biological factors associated with therapeutic response that could help the physician to make his/her choice are lacking. The aim of BIOTOUL is to collect and store biologic samples in patients with RA, SpA or PsA who begin a new bDMARD or tsDMARD. This biobank will permit to study several biomarkers and assess the association between such markers and response to therapy.

Furthermore, osteoporosis is a chronic disease leading to fractures and disability. Several ant-osteoporotic drugs are now available and biomarker(s) that would help the physician to choose the best therapeutic sequence are lacking. BIOTOUL will also include patients with osteoporosis to identify biomarkers associated with severity and response to anti-osteoporotic treatments.

Eligibility criteria: Inclusion Criteria:

* Chronic inflammatory rheumatism including RA, SpA or PsA or patients with primary or secondary osteoporosis
* With National Health Assurance
* Able to consent to the study

Exclusion Criteria:

* Pregnancy or breastfeeding
* Not able to give a consent
* Severe anemia (Hb\<10g/L)

Primary outcomes:
measure: EULAR response after 3 months
timeFrame: after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Purpan University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Adeline RUYSSEN-WITRAND, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01686516: Synaptic Plasticity Imaging with Diffusion MRI
Official title: Methodological Study of Synaptic Plasticity Imaging with Diffusion MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Aging
Keywords: age
microstructure
diffusion MRI
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2012-09-18
Enrollment: 35
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: population free of any psychological or organic troubles, with no metal inclusions for MRI convenience.

Brief summary: Diffusion MRI employed in functional imaging has the potential to probe directly brain activation instead of blood changes like the BOLD technique. The researchers investigated these rapid synaptic plasticity changes with visual activation followed by BOLD and diffusion functional MRI as well as anatomical (venography, tractography by diffusion) features in young and aged subjects.

Detailed description: This study is devoted to explore brain plasticity by 2 modes of diffusion weighted imaging (DWI) of the brain :

* functional imaging using DWI and BOLD
* anatomical studies using DWI Theses DWI exams use high b-factor to sample tissue microstructure/metabolism. To correlated these DWI changes with anatomical ones, we used anatomical imaging like T1 maps and susceptibility-based maps.

First, the relatively new technique of diffusion functional magnetic Resonance (DfMRI) was explored to obtain activation of brain following visual stimulations. These modality was compared to BOLD and anatomical venography.

The DWI exams for anatomical (tractography) used both high angular resolution directional diffusion encoding (18 directions) and high b-values (as high as b=12 000 s/mm²) to obtain precise knowledge about tissue microstructure.

Study was approved by the National French Institute of Health and by french organism for biomedical studies (AFFSAPS). Study involve 35 subjects, with 5 additional subjects for eventual rejection because of ineligibility criterion, and compare 15 young (20-30 years) to aged healthy people (60-80 years).

Then, anatomical studies are devoted to obtain microstructures information about brain areas that are changed with age, and to validate fully the feasibility of the DfMRI approach.

Eligibility criteria: Inclusion Criteria:

* ages 20-30 years
* 60-80 years

Exclusion Criteria:

* psychological or organic trouble

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Inserm U 825
Study officials:
References: