louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04998318: 1:1 Comparison of the Pocket Colposcope in Kenya
Official title: Compare the Performance of the Pocket Colposcope to VIA/VILI for Triage of HPV+ Women in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
HPV Infection
HIV Infections
Keywords: cervical cancer screening, Pap smear, Colposcopy
Pap smear
colposcopy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
First posted: 2021-08-10
Enrollment: 434
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500 unique patients globally in Duke and non-Duke protocols to date. 400 women who are HPV-positive and planned to undergo treatment at 6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be randomized 1:1 to either standard-of-care visual inspection or colposcopy with the Pocket Colposcope

Detailed description: Women randomized to the standard-of-care arm will undergo VIA followed by Visual Inspection with Lugol's Iodine (VILI). Women randomized to the Pocket Colposcope arm will undergo Pocket-Assisted VIA (PA-VIA), green light imaging, and VILI using the Pocket Colposcope. Women in both arms will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. The locations of the biopsies will be based on provider impression. After their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. Those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure.

Eligibility criteria: Inclusion Criteria:

1. Age \> 25 years old and \< 65 years old
2. Sex: Female
3. Positive HPV test within past 6 months
4. HIV+ women

Exclusion Criteria:

1. Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)
2. Women with a negative HPV test
3. Patients incapable of giving informed consent
4. Women with a history of cervical cancer
5. Pelvic exam concerning for cervical cancer or cervical infection

Primary outcomes:
measure: Percentage of lesions identified by the pocket colposcope
timeFrame: Baseline
measure: Percentage of lesions identified by the visual inspection
timeFrame: Baseline
Secondary outcomes:
measure: Percentage of Provider who identified possible obstacles as measured by surveys
timeFrame: baseline
measure: Percentage of participants who identified possible obstacles as measured by surveys
timeFrame: baseline
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: Duke University
name: Megan Huchko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05089318: Evaluation of Flexofytol® PLUS in Hand Joint Chronic Dyscomfort.
Official title: Curcuminoids and Boswellia Serrata Extracts Combination Decreases Hand Joint Discomfort : Results From a Belgian Real-Life Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hand Joint Discomfort
Keywords: Hand joint pain
curcumin
boswellia serrata
support to standard treatment
Lead sponsor: Tilman S.A.
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 239
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults above 45 years with chronic hand joint discomfort

Brief summary: The purpose of this study is to evaluate the effect of curcuminoids and Boswellia serrata extracts combination (Flexofytol PLUS) in support to standard treatments during a 12-weeks period on hand pain on people with chronic hand joint discomfort.


Eligibility criteria: Inclusion Criteria:

* Older dan 45 years old,
* With hand joint chronic discomfort,
* Regularly uses of paracetamol or NSAIDs to manage pain,
* Painful symptoms must have been present for more than 6 months,
* The patient assesses their pain on a visual pain scale and must be greater than 4 out of 10 over the last 48 hours.

Exclusion Criteria:

* Related to previous and associated treatments:

  * Corticosteroids injection in the 3 previous months, whatever the joint concerned,
  * Use of Slow-acting drugs for OA and/or dietary supplements taken within less than 6 months prior to the study (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy or homeopathy for hand joint discomfort..),
  * Anticoagulant (coumarinic) treatment and heparin,
  * General corticotherapy in the 3 previous months,
  * Contraindication to paracetamol, curcumin, boswellia and NSAID's.
* Related to associated pathologies:

  * Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),
  * The patient has rheumatoid arthritis or gout,
  * The patient has a bile obstruction.
* Related to patient:

  * Pregnant or breastfeeding women.

Primary outcomes:
measure: Pain using a Numerical Rating Scale (NRS)
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boncelles
country: Belgium
facility: Yves Henrotin
state: Liège
city: Boncelles
country: Belgium
facility: Yves Henrotin
Study officials:
affiliation: Tilman S.A.
name: Yvan Dierckxsens
role: STUDY_DIRECTOR
References:
Clinical trial NCT05214118: Bringing Education Through Technology, Empathic Listening, and Research
Official title: Project BETTER: Bringing Education Through Technology, Empathic Listening, and Research - A Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test a new educational technology-based program and brochure as a supplement to prenatal education from providers. The program provides education about common challenges that pregnant and parenting women receiving medication for Opioid Use Disorder (OUD) often face. Specifically, it addresses the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.


Eligibility criteria: Inclusion Criteria:

1. Female
2. ≥18 years of age
3. Meet criteria for Opioid Use Disorder
4. Currently receiving MOUD pharmacotherapy (including buprenorphine, buprenorphine/naloxone, or methadone)
5. Pregnant (\<34 weeks EGA)
6. Initial in-person visit at OB MOTIVATE clinic for the current pregnancy ≤10 weeks ago

Exclusion Criteria:

1. Considering/planning adoption
2. Present with a serious cognitive/psychiatric impairment
3. Existing language barriers making true informed consent impossible

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: Within 2 weeks of completing the intervention
measure: Acceptability of the intervention
timeFrame: Within 2 weeks of completing the intervention
Secondary outcomes:
measure: Change in perceived competence
timeFrame: Baseline to within 2 weeks of completing the intervention, up to 5 weeks
measure: Change in parental competence
timeFrame: Baseline to within 2 weeks of completing the intervention, up to 5 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Caitlin E Martin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01108718: Study of Mattress Type in Fibromyalgia
Official title: Study of Mattress Type in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Mattress
Tempur-Pedic
Fibromyalgia
Sleep patterns
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2010-04-22
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine if a new mattress relieves the symptoms of fibromyalgia and improves sleep, and if this is the case, whether one type of mattress is better than the other in doing so.

Detailed description: The various stages of sleep will be monitored via polysomnography(PSG) and scored to indicate the degree to which they reflect a normal sleep pattern. Changes in the severity of fibromyalgia symptoms will be assessed by tender point exam and study questionnaires administered at 2 month intervals.

Eligibility criteria: Inclusion Criteria:

* Female subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia -- that is they have both wide spread pain and more than 10 of the 18 tender points
* 18 years of age or older
* Has to be on stable medications and followed by one physician

Exclusion Criteria:

* Subjects with the existence of an undiagnosed sleep disorder - namely obstructive sleep apnea or periodic leg movement syndrome
* Pregnancy

Primary outcomes:
measure: Mattress Preference of Fibromyalgia Patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pain and Fatigue Study Center - Beth Israel Medical Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Benjamin Natelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03925818: Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication
Official title: Twice-a-day PPI, Tetracycline, Metronidazolequadruple Therapy With Pylera® or Lactobacillus Reuteri for Treatment naïve or for Retreatment of H. Pylori: Two Randomized Pilot Studies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Lactobacillus reuteri; Bismuth; Helicobacter pylori;
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 99
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: This study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection.

Detailed description: Bismuth, metronidazole and tetracycline yielded high cure rates for H. pylori infection. Earlier studies suggested that the bismuth quadruple therapy may be effective when given twice-a-day rather than q.i.d. and that b.i.d. therapy was associated with fewer side effects. The addition of the probiotic Lactobacillus reuteri (Gastrus®) to Lactobacillus reuteri (Gastrus®) that has been shown to increase the cure rates by 10-14%. In another study bismuth supplementation with L. reuteri DSM 17938, in a modified low dose quadruple therapy provided good eradication rates (93.3%; 95% CI : 85-99%) in clinical practice.

Eligibility criteria: Inclusion Criteria:

- Positive for H. pylori infection

Exclusion Criteria:

* Presence of malignancy
* Pregnancy or lactation
* Clinically significant diseases
* History of drug or alcohol abuse
* Allergy to pantoprazole or to any component of regimens used in the study
* Use of anti-secretory drugs, antibiotics or probiotics 4 weeks preceding the enrollment.

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: 30-40 days after the end of treatment
Secondary outcomes:
measure: Compliance and side effects evaluation
timeFrame: 30-40 days
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: Clinica Medica, Dipartimento di Medicina Clinica e Sperimentale
state: SS
Study officials:
affiliation: Università degli Studi di Sassari
name: MARIA P Dore, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01931618: Testing the Efficacy of an Online Alcohol Intervention in a Workplace Setting
Official title: Digital Therapy: Evaluation of the Fully Automated Alcohol Intervention "Balance".
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hazardous Drinking
Harmful Drinking
Keywords: alcohol
online intervention
hazardous drinking
harmful drinking
early intervention
behavior change intervention
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2013-08-29
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test - in a workplace setting - if an online multi-session alcohol intervention improves treatment effect over and above a single session screening with feedback.

Hypothesis: automated online multi-session follow-up improves the effect on alcohol consumption over and above a single session screening

Detailed description: Setting: Online study among Norwegian employees.

Participants: At-risk drinkers among employees in a select group of norwegian workplaces is recruited through an e-mail to their job e-mail account, and advertisements on the intranet of their organization.

Design: Randomized controlled trial (RCT). Subjects in both conditions receives a single session screening procedure including individualized normative feedback. The control group receives an online booklet about the effects of alcohol. The treatment group receives the multi session follow up program "Balance".

Eligibility criteria: Inclusion Criteria:

* hazardous or harmful drinking (i.e., a FAST-score of 3 or more)

Exclusion Criteria:

* underage (\<18)
* not provided a valid e-mail address
* not provided a valid (Norwegian) mobile phone number

Primary outcomes:
measure: The number of standard alcohol units consumed during the previous seven days
timeFrame: Measured six months after enrollment/baseline
Secondary outcomes:
measure: Sick leave during last week
timeFrame: Assessed at six months post baseline
measure: Negative consequences of alcohol consumption
timeFrame: Assessed at six months post baseline
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: The Norwegian Centre for Addiction Research, University of Oslo
Study officials:
affiliation: The Norwegian Centre for Addiction Research, University of Oslo
name: Håvar Brendryen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brendryen H, Johansen A, Nesvag S, Kok G, Duckert F. Constructing a Theory- and Evidence-Based Treatment Rationale for Complex eHealth Interventions: Development of an Online Alcohol Intervention Using an Intervention Mapping Approach. JMIR Res Protoc. 2013 Jan 23;2(1):e6. doi: 10.2196/resprot.2371.
citation: Brendryen H, Johansen A, Duckert F, Nesvag S. A Pilot Randomized Controlled Trial of an Internet-Based Alcohol Intervention in a Workplace Setting. Int J Behav Med. 2017 Oct;24(5):768-777. doi: 10.1007/s12529-017-9665-0.
Clinical trial NCT01477918: Prevalence of Metabolic Syndrome in Patients With Schizophrenia in Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Metabolic Syndrome
Keywords: prevalence
Korea
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include all patients that met the following criteria:

1. Diagnosis of schizophrenia according to DSM-IV-TR
2. Age between 18-65 years

To obtain the representative results for the prevalence of the MetS in schizophrenic patients stratified age and gender, we plan to evaluate about one thousand patients in twenty nationwide centers.

1. 20 centers were selected to provide the representative results of prevalence of the MetS
2. 50 patients in each center were consecutively enrolled

Brief summary: The aim of this study is to examine the prevalence of the Metabolic syndrome(MetS) in Korean patients with schizophrenia.

Primary objective:

• To investigate the prevalence of the MetS in Korean patients with schizophrenia

Secondary objectives:

• To compare the prevalence of the MetS among 3 groups according to antipsychotics: typical antipsychotic monotherapy group, atypical antipsychotic monotherapy group, 2 or more antipsychotics group (polypharmacy)


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia according to DSM-IV-TR
* Age between 18-65 years

Primary outcomes:
measure: prevalence of metabolic syndrome (MetS)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
Study officials:
References:
Clinical trial NCT01123018: Screening for Memory Studies
Official title: Screening for Memory Studies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Memory Loss
Memory Deficits
Dementia
Keywords: Memory Loss
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2010-05-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: healthy older adults with memory concerns

Brief summary: We hope to recruit participants into various clinical trials and research projects.

Detailed description: The purpose of this protocol is to advertise, recruit, and do a preliminary screen for various clinical trials. Anonymous information collected will be entered in a database available to researchers connected with the Stanford/VA Aging Clinical Research Center, located at VA Palo Alto Health Care System, Palo Alto Division.

Eligibility criteria: Inclusion Criteria:

* Age 55 or over.

Exclusion Criteria:

* Major psychiatric problems.
* Major medical problems.
* Aversion to test-taking.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: Stanford University
name: J. Wesson Ashford Jr., MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashford JW, Borson S. Primary care screening for dementia and mild cognitive impairment. JAMA. 2008 Mar 12;299(10):1132-3; author reply 1133-4. doi: 10.1001/jama.299.10.1132-b. No abstract available.
Clinical trial NCT00567918: Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis
Official title: Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratoconjunctivitis
Conjunctivitis
Keywords: Keratoconjunctivitis
Vernal keratoconjunctivitis
FK506
Tacrolimus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis

Detailed description: To give a chance of continuous use of 0.1% FK506 ophthalmic suspension to patients with vernal keratoconjunctivitis who were enrolled in the FJ-506D-AC09 study, long-term safety and efficacy were evaluated. Primary efficacy endpoint was the mean change from the baseline (before the treatment) in total score for objective clinical signs.

Eligibility criteria: Inclusion Criteria:

* Vernal keratoconjunctivitis patients who were enrolled in the FJ-506D-AC09 study
* Patients who wish to receive continuous administration of FK506 ophthalmic suspension

Exclusion Criteria:

* Subjects who needed prohibited concomitant therapy at the initiation of the study
* Subjects who needed to wear contact lenses during treatment period on a testing eye
* Subjects with complicating an eye infection

Primary outcomes:
measure: Safety
timeFrame: length of study
Secondary outcomes:
measure: The mean change from the baseline (before the treatment) in total score for objective clinical signs
timeFrame: length of study
measure: Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign
timeFrame: Length of study
measure: Subjective symptom score (Visual Analog Scale)
timeFrame: Length of study
measure: The improvement rate
timeFrame: Length of study
Other outcomes:
Locations:
city: Ehime
country: Japan
city: Hokkaido
country: Japan
city: Kagoshima
country: Japan
city: Kochi
country: Japan
city: Miyazaki
country: Japan
city: Osaka
country: Japan
city: Tochigi
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References: