louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03611023: Study of the Touch® Trapezo-metacarpal Prosthesis
Official title: Multicentric Observational Study of the Touch® Trapezo-metacarpal Prosthesis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Complications Due to Internal Joint Prosthesis
Thumb Osteoarthritis
Lead sponsor: Groupe Concepteur Touch
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with the Touch® prosthesis by one of the three investigating surgeons

Brief summary: Prospective observational study of implanted patients with a new orthopaedic implant: the Touch trapezo-metacarpal prosthesis

Detailed description: Prospective observational study of implanted patients with a new orthopaedic implant: the Touch double mobility trapezo-metacarpal prosthesis, 15 years follow up.

Eligibility criteria: Inclusion Criteria:

• Patients implanted with the Touch® prosthesis by one of the three investigating surgeons

Exclusion Criteria:

* Patient not in capacity to understand the study
* Patient not in capacity to consent to the study

Primary outcomes:
measure: Implant Survival at 3 years
timeFrame: 3 Years
measure: Implant Survival at 5 years
timeFrame: 5 Years
measure: Implant Survival at 10 years
timeFrame: 10 Years
measure: Implant Survival at 15 years
timeFrame: 15 Years
Secondary outcomes:
measure: Functional Outcome at 3 years
timeFrame: 3 Years
measure: Functional Outcome at 5 years
timeFrame: 5 Years
measure: Functional Outcome at 10 years
timeFrame: 10 Years
measure: Functional Outcome at 15 years
timeFrame: 15 Years
Other outcomes:
Locations:
city: Saint-Chamond
country: France
facility: Hopital du Gier
Study officials:
References:
Clinical trial NCT03642223: Central and Peripheral Adiposity and Iron Absorption
Official title: Relation Btw Adiposity, Inflammation & Iron Absorption:Comparison Btw Central & Peripheral Adiposity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adiposity
Iron-deficiency
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: American University of Beirut Medical Center
First posted: 2018-08-22
Enrollment: 121
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Adiposity is a state of sub-clinical inflammation, thus hepcidin is increased in adiposity, often leading to iron deficiency in this population group. Central adiposity is generally considered having a greater negative effect on health compared to peripheral adiposity. Whether this can be also seen in hepcidin and thereby in iron absorption is uncertain.


Eligibility criteria: Inclusion Criteria:

* either normal-weight (BMI 18-25kg/m2) or overweight/obese (BMI 28-50kg/m2) with either central or peripheral fat deposits based on DEXA

Exclusion Criteria:

* Iron Supplement or antibiotic intake within 2 weeks before study start
* diagnosed chronic disease or gastrointestinal disorders
* regular use of medication (except contraceptives)
* pregnancy
* lactation
* smoking
* blood donation or surgery within the last 4 months.

Primary outcomes:
measure: Fractional and total iron absorption
timeFrame: 14days after the administration of the test meal
Secondary outcomes:
measure: Serum Hepcidin
timeFrame: at baseline
measure: Serum ferritin
timeFrame: at baseline
measure: Serum TfR
timeFrame: at baseline
measure: Serum CRP
timeFrame: at baseline
measure: Serum AGP
timeFrame: at baseline
measure: Serum IL-6
timeFrame: at baseline
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut
Study officials:
References:
citation: El-Helou N, El-Mallah C, Wehbe N, Bissani N, Stoffel N, Herter-Aeberli I, Zimmermann M, Obeid O. A test to measure oral iron absorption and glucose tolerance simultaneously in 18 to 55 year old premenopausal women. Clin Nutr ESPEN. 2021 Dec;46:325-329. doi: 10.1016/j.clnesp.2021.09.737. Epub 2021 Sep 29.
Clinical trial NCT00211523: Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne
Official title: Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of MBI 226 2.5% and 5.0% Acne Solutions Applied Topically for 6 Weeks to Subjects With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Acne
Propionibacterium Acnes
Keywords: acne
acne vulgaris
MBI 226
Propionibacterium acnes
lesion counts
lesions
inflammatory
non-inflammatory
topical
Lead sponsor: BioWest Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 75
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the safety and efficacy of MBI 226 2.5% and 5.0% Acne Solutions, applied topically for six weeks, in the treatment of acne.


Eligibility criteria: Inclusion Criteria:

* Males and females, ages 13 and up, exhibiting high levels of facial P. acnes
* Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria:

* Acne conglobata, acne fulminans, or secondary acne (chlorine, drug-induced acne, etc.)
* Active facial cysts

Primary outcomes:
measure: - percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment
Secondary outcomes:
measure: - percent change in lesion counts after ~2 and ~4 weeks
measure: - Global Severity Assessment
Other outcomes:
Locations:
Study officials:
affiliation: BioWest Therapeutics Inc
name: Jim Pankovich
role: STUDY_DIRECTOR
References:
Clinical trial NCT05190523: Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Biliary Cholangitis
Keywords: ASC42
primary biliary cholangitis
PBC
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2022-01-13
Enrollment: 98
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 study is a phase II, multicenter, randomized, double-blind, placebo-controlled, seamless adaptive design clinical study, aiming to evaluate the safety and effectiveness of three doses of ASC42 matched placebo in subjects with primary biliary cholangitis.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤75 years old at screening.
* Definite or probable PBC diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors:

  1. Biochemical evidence of cholestasis based on ALP elevation.
  2. Presence of AMA, or other PBC-specific autoantibodies, including sp100 or gp210, if AMA is negative.
  3. Liver biopsy consistent with PBC.
* Screening ALP ≥ 1.67× ULN
* Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0.

Exclusion Criteria:

* ALT or AST \> 5× ULN; ALP \>10× ULN
* History or presence of other concomitant liver diseases
* Child-Pugh grade B or C

Primary outcomes:
measure: Percentage changes of alkaline phosphatase (ALP) compared with baseline.
timeFrame: Day85
Secondary outcomes:
measure: Percentage changes and absolute changes of alkaline phosphatase (ALP) compared with baseline.
timeFrame: Day15\29\57\85
measure: Percentage changes and absolute changes of serum γ-glutamyltransferase (GGT), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) compared with baseline.
timeFrame: Day15\29\57\85
measure: Incidence of treatment-emergent adverse events, serious adverse events and adverse events of special interests.
timeFrame: Day15\29\57\85
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT03585023: Infections and Pregnancy Loss: Correlation Between Abortion and Silent Infections.
Official title: Silent Intracellular Infections and Early Pregnancy Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Loss
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who underwent revision of uterine cavity for spontaneous abortion or voluntary termination of pregnancy

Brief summary: Correlation between the presence of intracellular viruses/bacteria and the incidence of miscarriage during the first trimester of pregnancy.

Detailed description: In this study we will analyse chorionic villi derived from abortion during the first trimester of pregnancy (spontaneous abortion vs voluntary pregnancy interruption), in order to correlate the presence of infective viruses/bacteria and the incidence of miscarriage.

The first objective of this project will be to find the viral DNA of HPV, BK and JC polyomaviruses and bacterial DNA of Chlamydia trachomatis, Ureaplasma parvum, Ureaplasma urealyticum, Mycoplasma hominis in the aborted tissues collected from spontaneous abortions, and to compare the prevalence of these DNAs to those derived from elective specimens.

Acronyms:

DNA: deoxyribonucleic acid HPV: human papillomavirus PCR: polymerase chain reaction HPyV: human polyomavirus PBMC: peripheral blood mononucleated cell BKV: BK polyomavirus JCV: JC polyomavirus

Eligibility criteria: I.Inclusion and exclusion criteria

Inclusion criteria:

* age of the patients range from 18 to 42 years old;
* gestational age ranging in the first 12 weeks.

Exclusion criteria:

* medical history or laboratory tests positive for sexually transmitted diseases (HIV, HBV, HCV, LUE) during the last year;
* Congenital or Acquired Immunodeficiency diseases, or immunosuppressive therapies during the last year;
* Therapeutic abortion (voluntary interruption of pregnancy, law 194 art 6 comma b)
* well known causes responsable for spontaneous abortions such as genetic, severe uterine or hormonal abnormalities and use of teratogenic drugs.

Primary outcomes:
measure: Individuation of DNA of intracellular agents (viral und bacterial) in chorionic tissue und blood sample.
timeFrame: December 2014 - April 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03421223: Digital Signals in Chronic Pain (DiSCover Project)
Official title: Digital Signals in Chronic Pain (DiSCover Project)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Evidation Health
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 10161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit virtually and individuals can participate remotely.

Brief summary: The DiSCover Project is a 1-year longitudinal case-control observational study. In this study, the investigators plan to collect different types of data including self-reported health outcomes and quality of life data, behavioral data from activity trackers and health and fitness apps, data from lab tests, genetic data, and environmental data. One of the goals of this study is to develop digital biomarkers for chronic pain severity, flare ups and quality of life.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Resides in the United States
* Case Inclusion Criteria: Self-reported diagnosis of chronic pain and experiences moderate chronic pain as assessed by scoring at least 4 on the Numeric Pain Rating Scale
* Control Inclusion Criteria: Self-reported not having chronic pain

Exclusion Criteria:

* Less than 18 years old
* Is not able to read or understand English

Primary outcomes:
measure: Self-reported chronic pain severity measured by BPI-SF
timeFrame: 1 year
measure: Quality of Life Scale for Pain
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Evidation Health
state: California
Study officials:
affiliation: Evidation Health
name: Jessie L Juusola, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01272323: Cat-PAD Follow on Study
Official title: An Optional 1 Year Follow up Study to Evaluate the Continued Efficacy of Cat-PAD in Cat Allergic Subjects Following Challenge to Cat Allergen in an Environmental Exposure Chamber
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cat Allergy
Rhinoconjunctivitis
Keywords: Cat allergy
Rhinoconjunctivitis
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Cetero Research, San Antonio
name: Adiga Life Sciences, Inc.
First posted: 2011-01-07
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject previously randomised in study CP005 and completed all dosing visits and the PTC

Brief summary: Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma.

The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who completed all dosing visits in study CP005 approximately one year after the start of treatment.

Detailed description: Subjects who completed all dosing visits and the post treatment challenge (PTC) in study CP005 will be invited to attend the Screening Visit for CP005A. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.

Eligibility criteria: Inclusion Criteria

* Previously randomised in study CP005, completed all treatment visits and the Post Treatment Challenge (PTC).

Exclusion Criteria

* "Partly controlled" and "uncontrolled" asthma
* History of anaphylaxis to cat allergen
* FEV1 of less than 70% of predicted
* Subjects who cannot tolerate baseline challenge in the EEC
* Treatment with beta-blockers,Alpha-adrenoceptor blockers, Tranquillizers or psychoactive drugs
* A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)

Primary outcomes:
measure: Total Rhinoconjunctivitis Symptom Score
timeFrame: 50-54 weeks after the start of treatment in CP005
Secondary outcomes:
measure: Total Symptom scores for ocular and nasal symptoms
timeFrame: 50-54 weeks after the start of treatment in CP005
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Cetero Research
state: Ontario
Study officials:
affiliation: Cetero Research, San Antonio
name: Peter Couroux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02716623: The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer
Official title: The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Diabetes Mellitus
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2016-03-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
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 learn if bladder cancer patients can follow a diet and exercise program during treatment and whether the program will improve results of their treatment.

Detailed description: This study will examine the effects of a carbohydrate restricted (CR) diet in bladder cancer patients with diabetes. The goal of this pilot study is to determine if the CR diet and exercise routine are feasible for this patient population to follow.

Participants in this study will receive meals tailored to their specific needs. A registered dietitian will work with them to establish guidelines for the meals and to follow their progress throughout the study.

Participants will be asked to be in this study for up to 12 months. A participant will be asked to make a total of 16 in-person visits over the course of 12 months.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of non-muscle-invasive bladder cancer
* Have completed Transurethral Resection of Bladder Tumor (TURBT) procedure
* Diagnosis of diabetes or pre-diabetes, or use diabetic medication, or show signs of diabetes which would prompt a diabetic screening

Exclusion Criteria:

* Evidence of muscle-invasion or metastatic disease
* BMI less than 18.5 and/or score in the "severe malnourished" category of the patient generated subjective global assessment (PGSGA)
* Unable to complete the exercise regimen or deemed a fall risk
* Participating in a research study involving any form of treatment intervention

Primary outcomes:
measure: Participant compliance with study specific CR diet
timeFrame: 12 months
Secondary outcomes:
measure: Presence of Tumor M2-PK
timeFrame: 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Eugene Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02057523: Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
Official title: Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Proteinuria
Transplant Glomerulopathy
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2014-02-07
Enrollment: 2
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: TREATMENT

Brief summary: The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Kidney transplant recipients with confirmed transplant glomerulopathy on kidney biopsy.
* Failed standard therapy (\>25% reduction in proteinuria) including maximum use of an ACE inhibitor, ARB, or aldosterone blocker with a goal blood pressure less than 130/80 and optimization of their immunosuppression

Exclusion Criteria:

* Diabetes

Primary outcomes:
measure: 50% Reduction in Proteinuria or Proteinuria < 150mg/Day
timeFrame: 6 months
Secondary outcomes:
measure: 25% Improvement in the MDRD eGFR
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Sanjeev Akkina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00944723: Impact of Mass Zinc Fortification Programs on Plasma Zinc Concentration
Official title: Evaluation of the Use of Plasma Zinc Concentration for Assessing the Impact of Targeted and Mass Zinc Fortification Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Zinc Deficiency
Keywords: zinc fortification
zinc supplementation
plasma zinc concentration
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Helen Keller International
name: Cheikh Anta Diop University, Senegal
name: Global Alliance for Improved Nutrition
First posted: 2009-07-23
Enrollment: 132
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of mass zinc fortification programs.

Detailed description: The objectives of the present study are to determine whether plasma zinc concentration changes in response to additional zinc consumption, as provided by zinc-fortified cereal-based complementary foods fed to adult men (fortified at a level consistent with currently proposed levels). The following specific steps will be completed:

1. Zinc-fortified breads prepared from zinc-fortified wheat flour will be developed with assistance from experts in food technology.
2. A four-week feeding trial will be implemented to assess the change in plasma zinc concentration among young adult men who receive: a) bread fortified with a moderate amount of zinc and a liquid vitamin preparation between meals; b) bread fortified with a large amount zinc and a liquid vitamin preparation between meals; c) non-zinc-fortified bread and a liquid vitamin preparation between meals \[negative control group\]; and d) non-zinc-fortified bread and a zinc-containing liquid vitamin preparation between meals \[positive control group\].

Eligibility criteria: Inclusion Criteria:

* apparently healthy males

Exclusion Criteria:

* Hemoglobin \<80 g/L

Primary outcomes:
measure: Plasma zinc concentration
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Dakar
country: Senegal
facility: Helen Keller International
Study officials:
affiliation: University of California, Davis
name: Kenneth H Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aaron GJ, Ba Lo N, Hess SY, Guiro AT, Wade S, Brown KH. Plasma zinc concentration increases within 2 weeks in healthy Senegalese men given liquid supplemental zinc, but not zinc-fortified wheat bread. J Nutr. 2011 Jul;141(7):1369-74. doi: 10.3945/jn.110.136952. Epub 2011 May 11.