louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02933983: Microbiota Upper Respiratory Tract
Official title: Study of the Microbiota and the Potential of Probiotics for Chronic Rhinosinusitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microbiota Upper Respiratory Tract
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 325
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: The study population involves both healthy individuals and CRS patients.

Brief summary: The aim of this study is to investigate whether the microbiota in the upper respiratory tract (URT) (nose, nasopharynx and sinuses) of chronic rhinosinusitis (CRS) patients is disturbed compared to healthy individuals. Therefore, bacterial DNA from swabs, aspirates and tissue will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Special attention will go to microbial species that are overrepresented in the healthy populations as potential health promoting microbes (i.e. probiotics). A better understanding of the URT microbiome might help us to better understand the pathology of CRS and might help to develop new microbiota-based strategies for CRS.


Eligibility criteria: Exclusion Criteria healthy population:

* no use of antibiotics in the past year
* no acute or chronic airway infections
* no cancer
* no autoimmune diseases
* pregnant women

Exclusion Criteria CRS population:

--\> no exclusion criteria

Primary outcomes:
measure: differences in bacterial communities colonizing the upper respiratory tract between healthy individuals and CRS patients measured via Illumina MiSeq
timeFrame: up to 4 years before all samples from both groups are collected and processed
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
citation: De Boeck I, Wittouck S, Martens K, Claes J, Jorissen M, Steelant B, van den Broek MFL, Seys SF, Hellings PW, Vanderveken OM, Lebeer S. Anterior Nares Diversity and Pathobionts Represent Sinus Microbiome in Chronic Rhinosinusitis. mSphere. 2019 Nov 27;4(6):e00532-19. doi: 10.1128/mSphere.00532-19.
Clinical trial NCT01353183: Analysis of the Enteric Nervous System Using Colonic Biopsies
Official title: Analysis of the Enteric Nervous System Using Colonic Biopsies: a Useful Biomarker for the Differential Diagnosis of Parkinsonian Syndromes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Multiple System Atrophy
Progressive Supranuclear Palsy
Keywords: biopsies, enteric nervous system, biomarker
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this project is to develop an original biomarker for Parkinson's disease (PD) and other parkinsonian syndromes (multiple system atrophy and progressive supranuclear palsy) based upon the detection of pathological alpha-synuclein species in routine colonoscopic biopsies.


Eligibility criteria: Inclusion Criteria:

Patients

* Patients aged 50-80 year old, both genders
* Parkinson's disease patients
* Multiple system atrophy patients
* Progressive supranuclear palsy patients
* Controls: patient at risk of colic cancer for whom a colonoscopy is required
* Patients who signed the informed consent

Controls

* Patients aged 50 to 80 year-old for whom a rectosigmoidoscopy or a colonoscopy is required for colorectal screening
* Patients who signed the informed consent
* Health care beneficiary

Exclusion Criteria:

Patients

* Colonic disorder (except non-complicated diverticular disease)
* Other neurological disorder than parkinsonism
* Patients treated with either platelet antiaggregants, anticoagulants or with a known coagulation disorder
* Patients with a cognitive impairment that preclude them from understanding the informed consent
* Patients placed under legal guardianship

Controls

* Neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease or other dementia, amyotrophic lateral sclerosis...
* Functional bowel disorder such as irritable bowel syndrome
* Patients with a cognitive impairment that preclude them from understanding the informed consent

Primary outcomes:
measure: Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry
timeFrame: 3 months
Secondary outcomes:
measure: Presence of alpha-synuclein aggregates in colonic biopsies using 2D electrophoresis
timeFrame: 3 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: DERKINDEREN Pascal, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00193583: Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Refractory and/or Advanced Solid Tumors
Official title: A Phase I Study of Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Patients With Refractory and/or Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this phase I study we will characterize the safety, tolerability, maximum tolerated dose and dose-limiting toxicity of weekly bolus topotecan when administered in combination with two different dosing schedules of carboplatin. We will also evaluate any antitumor activity of these combination regimens.

Detailed description: Upon determination of eligibility, patients will be receive:

* Topotecan + Carboplatin

In order to determine the most appropriate dosing regimen to progress into future phase II trials, two different dosing schedules of topotecan and carboplatin will be utilized (ARM I and ARM II). Patients will be accrued to both treatment arms simultaneously.

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Adult patients at least 18 years old
* Advanced solid tumors refractory to conventional therapy
* ECOG performance status must be 0 or 1
* Patients may have received no more than 3 prior chemotherapy regimens
* Adequate bone marrow, liver and kidney function
* Able to understand the nature of the study and give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Active concurrent infections or serious underlying medical conditions
* Known HIV positivity
* Female patients who are pregnant or lactating
* Received both topotecan and carboplatin

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Maximum tolerated dose
Secondary outcomes:
measure: Dose limiting toxicity
measure: All over response
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Howard A. Burris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06661083: The Effect of Natural Molecules on HPV Infection
Official title: Counteracting HPV Infection with Natural Molecules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV (Human Papillomavirus)-associated
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of the administration of natural molecules in the treatment of HPV infection.


Eligibility criteria: Inclusion Criteria:

* HPV DNA test positivity
* over 18 years

Exclusion Criteria:

* pregnancy
* breastfeeding
* assumption of other products containing EGCG or green tea
* primary immunodepression or pharmacological induced one

Primary outcomes:
measure: HPV DNA test negativity
timeFrame: 6 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Agunco
Study officials:
References:
Clinical trial NCT03531983: Results of Gamma Nail in Trochentric Fractures of the Adults
Official title: Results of Gamma Nail in Trochentric Fractures of the Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trochanteric Fractures
Keywords: gamma nail
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who were admitted to AUH with trochentic fracture and treated by gamma nail

Brief summary: We prospectively reviewed the results of 30 patients who had undergone intramedullary fixation with a gamma nail for femur trochentric fractures in AUH. within 1 year

Detailed description: Hip fractures are considered one of the major health problems in aging societies . These fractures are correlated with increased disability and mortality and a decreased quality of life . Early mobilization of patients with these fractures is essential to improve fracture healing, minimize immediate postsurgical morbidity, and reduce care costs. One essential prerequisite for early mobilization is mechanically stable fracture fixation . Nowadays, most hip fractures are treated by extramedullary or intramedullary implants, which allow a stable fixation in the majority of cases

A dynamic hip screw (DHS) is the most commonly used implant for intertrochanteric fractures . Load bearing in the proximal femur is predominantly through the intact calcar femoral; the lever arm of the laterally placed plate is increased, thus, there is a risk of implant cutout if the calcar is not intact .

Biomechanically, compared with a laterally fixed side plate, an intramedullary device decreases the bending force of the hip joint on the implant by 25-30%. This has advantages especially in elderly patients, in whom the primary treatment goal is immediate full weight-bearing mobilization.

It has been postulated that cephalomedullary nails have an advantage over DHS fixation because of the load-bearing axis being closer to the hip joint fulcrum, and also less blood loss, minimal tissue dissection, shorter operation time, and faster ambulation after surgery . However, other studies have reported that fixation with DHS is better . One of the major drawbacks discovered with the use of the gamma nail is a higher reoperation rate as a result of new fracture around the implant . In this study, we present our results for the treatment of trochentric fractures using a gamma nail in terms of the outcome, drawbacks, and possible complications.

Eligibility criteria: Inclusion Criteria:

* Age (20-70)
* unstable trochentric fractures

Exclusion Criteria:

* pathological fractures due to neoplasia

Primary outcomes:
measure: Number of participants with failure of initial intervention
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00866983: Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil
Official title: A Local, Multi-Centre, Extension, Open Label Access Study, To Provide Sildenafil Therapy For Patients Who Completed A1481244 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil , Prior To Reimbursement And Availability For Patients In Brazil.
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Pulmonary Arterial Hypertension
Keywords: Open label
sildenafil
PAH
Brazil
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to provide sildenafil therapy to patients who completed the A1481244 study for the treatment of PAH, and reside in Brazilian States where Revatio™ is not supplied by Health Secretary, and are judged by the Investigator to derive clinical benefit from continued treatment with Sildenafil. It will be supplied until patient gets access to Sildenafil through Brazilian State Health Secretary from where patient resides.


Eligibility criteria: Inclusion Criteria:

* Subject who completed the A1481244 study and are judged by the Investigator to derive clinical benefit from continuous treatment with Sildenafil 20 mg therapy.
* Subject who resides in a Brazilian State where Sildenafil is not supplied by State Health Secretary.

Exclusion Criteria:

* Pregnant or lactating women.
* Current participation in other studies and during study participation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02033083: Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation
Official title: Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Second Trimester Abortion
Keywords: abortion
cervical dilation
Lead sponsor: Planned Parenthood of Greater New York
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2014-01-10
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective: To study the difference in dilation and evacuation (D\&E) procedure time following overnight cervical preparation with laminaria or Dilapan-S™. The investigators hypothesize procedure time will be less with Dilapan-S™.

Secondary objectives: To compare the use of laminaria and Dilapan-S™ for differences in: (1) initial cervical dilation before D\&E; (2) need for mechanical dilation to accomplish D\&E and ease of dilation if required; (3) number of osmotic dilators placed; (4) ability to complete the D\&E procedure without further cervical preparation; (5) complications; (6) pain and other side effects; (7) patient acceptability; and (8) provider acceptability.

Detailed description: One hundred eighty women were randomized evenly across treatment arms, stratified by gestational age groups of 18 0/7-20 6/7 (n= 91) and 21 0/7-24 0/7 (n=87). The analytic sample N=173 (laminaria=86, Dilapan=87); 2 cases were removed for post-randomization exclusion and 5 for missing data on one or more outcome variables. Demographic information and results for the primary outcome of procedure time are reported below in tabular form in the results section.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Seeking pregnancy termination from 18 0/7 to 24 0/7 weeks of gestation
* Eligible for pregnancy termination at Planned Parenthood of New York City
* Able to give informed consent
* English speaking

Exclusion Criteria:

* • Active bleeding or hemodynamically unstable at enrollment

  * Signs of chorioamnionitis or clinical infection at enrollment
  * Signs of spontaneous labor or cervical insufficiency at enrollment
  * Spontaneous intrauterine fetal demise
  * Allergy to laminaria or Dilapan-S™

Primary outcomes:
measure: D&E Procedure Time
timeFrame: The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Planned Parenthood of New York City
state: New York
Study officials:
affiliation: Planned Parenthood of New York City
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00383383: Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Official title: To Compare the Immunogenicity & Safety of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B, in Pre-Haemodialysis/Haemodialysis Patients (≥15 Years of Age)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-03
Enrollment: 141
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years.


Eligibility criteria: Inclusion Criteria:

* A male or female \> = 15 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject/ from the parents or guardians of the subject.
* Seronegative for anti-HBs antibodies, anti-HBc antibodies \& Hepatitis B Surface antigen (HBsAg).
* If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
* Pre-haemodialysis patient\* or a patient on haemodialysis.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
* Previous vaccination against hepatitis B.
* History of hepatitis B infection.
* Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female
* Clinically abnormal ALT/AST values (\> 3 times normal values)

Primary outcomes:
measure: Anti-HBs seroprotection rates at Month 12.
Secondary outcomes:
measure: Solicited symptoms, unsolicited symptoms and serious adverse events
Other outcomes:
Locations:
city: Hradec
country: Czech Republic
facility: GSK Clinical Trials Call Center
state: Králové
city: Kuala Lumpur
country: Malaysia
facility: GSK Clinical Trials Call Center
city: Malaga
country: Spain
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01700283: Developing Objective Fatigue Indicators in Colorectal Cancer Survivors.
Official title: Developing Objective Fatigue Indicators: Exploring the Relationships Among Fatigue, Muscle Power and Metabolomics Through Fatigue Management and Individualized Exercise Education Program in Colorectal Cancer Survivors.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer、Fatigue、Muscle strength、Metabolomics
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2012-10-04
Enrollment: 306
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aims of this four-year study are to

1. Explore exercise behavior, exercise barriers, and identify the significant factors for exercise behavior in colorectal cancer survivors.
2. Explore the relationships among fatigue, muscle strength, and metabolomics and further examine the possible biomarkers from muscle strength and metabolomics for fatigue.
3. Develop a clinical guidelines of home-based fatigue management and exercise program and test its effect on decreasing fatigue for patients with colorectal cancer after surgery in Taiwan.


Eligibility criteria: Inclusion Criteria:

* Colorectal cancer survivors completed treatment at least 3 months in clinics.
* Aged above 20.

Exclusion Criteria:

* KPS \< 60
* Stage 4
* Bone meta

Primary outcomes:
measure: Developing Objective Fatigue Indicators: Exploring the Relationships Among Fatigue, Muscle Power and Metabolomics Through Fatigue Management and Individualized Exercise Education Program in Colorectal Cancer Survivors
timeFrame: four-year study
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Shiow-Ching Shun, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03616483: The Indiana Myeloma Registry
Official title: Collection of Specimens and Clinical Data to Create A Bio-repository for the Multiple Myeloma Program: The Indiana Myeloma Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Plasma Cell Dyscrasias
Keywords: Multiple myeloma
Monoclonal gammopathy of undetermined significance
Plasmacytoma
Smoldering multiple myeloma
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients disgnosed with one of the following:

1. Monoclonal Gammopathy of Undetermined Significance (MGUS)
2. Smoldering Multiple Myeloma
3. Multiple Myeloma
4. Bony or Soft Tissue Plasmacytoma
5. Primary Amyloidosis

Brief summary: This is a prospective, non-interventional, observational study. The purpose of this study is to collect data and bio-specimens that will support future research


Eligibility criteria: Inclusion Criteria:

1. Male or female patients ≥ 18 years of age at the time of informed consent
2. Has been diagnosed with or is suspected to have one of the following:

   1. Monoclonal Gammopathy of Undetermined Significance (MGUS)
   2. Smoldering Multiple Myeloma
   3. Multiple Myeloma
   4. Bony or Soft Tissue Plasmacytoma
   5. Primary Amyloidosis

Exclusion Criteria:

\< 18 years of age

Have not been diagnosed with one of the following:

Monoclonal Gammopathy of Undetermined Significance (MGUS) b.Smoldering Multiple Myeloma c.Multiple Myeloma d.Bony or Soft Tissue Plasmacytoma e.Primary Amyloidosis

Primary outcomes:
measure: Create a repository
timeFrame: 5 years
Secondary outcomes:
measure: Data collection
timeFrame: 5 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Rafat Abonour, MD
role: PRINCIPAL_INVESTIGATOR
References: