louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04066842: Vitamin D in Systemic Sclerosis Patients With Periodontitis
Official title: Evaluation Of Vitamin D In Systemic Sclerosis Patients With Periodontitis: A Possible Role In Cardiovascular Disease Risk Progression?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 168
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 42 patients with SSc, 43 patients with CHD, 41 patients with both SSc and CP, and 42 healthy patients were enrolled in the present study

Brief summary: Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of Systemic Sclerosis (SSc) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and SSc and periodontitis in patients with SSc, CP and with CHD.

Furthermore, the objective was to determine if periodontitis and CHD had an impact on serum vitamin D levels.

Detailed description: Using a cross-sectional design, a total of 42 patients with SSc, 43 patients with CHD, 41 patients with both SSc and CP, and 42 healthy patients were enrolled in the present study.

Eligibility criteria: Inclusion Criteria:

* Presence of at least twenty teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Primary outcomes:
measure: Vitamin D levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
affiliation: University of Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00697918: Long Term Effectiveness and Safety Study for RWJ-333369 as Adjunctive Therapy in Korean and Japanese Patients With Partial Onset Seizures
Official title: An Extension Study to Evaluate the Safety and Effectiveness of RWJ-333369 as Adjunctive Therapy in Korean and Japanese Patients With Partial Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seizures
Keywords: Partial onset seizure
Adjunctive therapy
Lead sponsor: SK Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 11
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety of RWJ-333369 at doses between 200-800 mg/day in Korean and Japanese patients who have completed the preceding study (333369-KJ-02).

Detailed description: Despite the introduction of new antiepileptic drugs into overseas clinical settings after 1990's, there still exist those patients who cannot control seizures, and thus the advent of newer antiepileptic drugs is being desired. This is a multicenter, open-label, extension study in patients who have completed the preceding study (333369-KJ-02) and scheduled to continue until the study drug is approved. This study consists of Period 1 (1 year) and Period 2 (only in Japan; planned to continue until the drug is approved Primary objective of this study is to evaluate the long-term safety (Adverse event, Lab test, Electrocardiogram, Vital signs, Pregnancy test, Physician Withdrawal Checklist) of RWJ-333369 at doses between 200-800 mg/day in patients who have completed the preceding study. Secondary objective of this study is to evaluate the long-term effectiveness of RWJ-333369 at doses between 200-800 mg/day in patients who have completed the preceding study. Period 1:RWJ-333369 will be started at 400 mg/day. RWJ-333369 100 mg tablets or 200 mg tablets will be orally administered with noncarbonated water twice daily. The dose will be adjusted between 200 mg/day and 800 mg/day based on effectiveness and tolerance. Period 2: The dose will be adjusted between 200 mg/day and 800 mg/day based on effectiveness and tolerance.

Eligibility criteria: Inclusion Criteria:

* Patients in the preceding study (333369-KJ-02) who have completed Double-Blind Treatment Phase of preceding study

Exclusion Criteria:

* Considered ineligible as study patients by the investigator

Primary outcomes:
measure: Adverse events (subjective/objective findings), blood pressure, pulse rate, body temperature, weight, 12-lead ECG, laboratory tests, pregnancy test. Time measure is 1 year.
timeFrame: For 1 year.
Secondary outcomes:
measure: Percent reduction in partial seizure frequency
timeFrame: For 1 year.
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00103818: An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)
Official title: A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Efficacy Study of MK0928 15 mg and 10 mg in the Treatment of Adult Outpatients With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2005-02-16
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).


Eligibility criteria: Inclusion Criteria:

* Adult outpatients who are between the ages of 18 and 64

Exclusion Criteria:

* Adults who do not have a diagnosis of insomnia (a sleep disorder)

Primary outcomes:
measure: Patient-reported amount of sleep and time to fall asleep at night after 3 months
timeFrame: After 3 months
Secondary outcomes:
measure: Patient-reported awakenings at night
timeFrame: After 3 months
measure: Sleep quality
timeFrame: After 3 months
measure: Functioning after 3 months
timeFrame: After 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Roth T, Lines C, Vandormael K, Ceesay P, Anderson D, Snavely D. Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies. J Clin Sleep Med. 2010 Feb 15;6(1):30-9.
Clinical trial NCT04789018: Enhanced Genetic Awareness and Genetic Evaluation for Men Through Technology, ENGAGEMENT Study
Official title: Enhanced Genetic Awareness and Genetic Evaluation for Men Through Technology ENGAGEMENT Study (Virtual Genetics Board)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-genetic providers who perform prostate cancer (PCA) genetic testing for men in their practices (medical oncologists, radiation oncologists, urologists, primary care providers, mid-level providers)

Brief summary: This study assesses perceived usefulness of a web-based virtual prostate cancer genetics board for providers across academic, community, and veteran affairs settings to discuss prostate cancer genetics cases, precision treatment, and screening recommendation. Information gained from interviews and surveys of participants taking part in the virtual genetics board may lend insights into perceived usefulness, perceived ease of use, acceptability, self-efficacy, genetics knowledge, and barriers/facilitators to implementation to refine the process.

Detailed description: PRIMARY OBJECTIVE:

I. To assess perceived usefulness of a virtual genetics board.

SECONDARY OBJECTIVE:

I. To assess acceptability/feasibility, perceived ease of use, self-efficacy for recommendations, genetics knowledge.

OUTLINE:

Participants complete a survey about genetic knowledge and self efficacy and then attend virtual genetics board. After virtual genetics board meeting, participants complete a second survey about perceived usefulness, ease of use, acceptability, feasibility, self-efficacy and genetic knowledge. Participants may also complete a semi-structured interview after virtual genetics board.

Eligibility criteria: Inclusion Criteria:

• Non-genetic providers who perform PCA genetic testing for men in their practices (medical oncologists, radiation oncologists, urologists, primary care providers, mid-level providers)

Exclusion Criteria:

• Non-medical providers

Primary outcomes:
measure: Mean Likert scaled perceived usefulness scores of the virtual genetics board
timeFrame: After virtual genetics board
Secondary outcomes:
measure: Means or changes in means of Likert scaled acceptability/feasibility
timeFrame: Before and after virtual genetics board
measure: Perceived ease of use
timeFrame: After virtual genetics board
measure: Self-efficacy for recommendations
timeFrame: Before and after virtual genetics board
measure: Change in mean scores on 17 genetics knowledge test questions
timeFrame: Baseline up to post-virtual genetics board
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03132818: Impact of the Assumption in Charge of Medical Aid to the Procreation With Donation of Gametes on the Sexuality of the Couple
Official title: Impact of the Assumption in Charge of Medical Aid to the Procreation With Donation of Gametes on the Sexuality of the Couple
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sexuality
Keywords: Procreation with donation
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing AMP with donation of gametes whose objective is to detect and evaluate the prevalence of sexual disorders

Brief summary: Sexual disorders associated with medical aid for procreation have already been demonstrated in several studies. However, few of them are interested in the problem of patients in charge of donating gametes, and if studied, it is often restricted to donating sperm to a small number of patients. For this reason, it would be interesting to study the impact of the intake and in charge and the treatments of the Medical Aid to the Procreation on this population of patients (including the patients treated in donation of sperm but also Those supported in oocyte donation)


Eligibility criteria: Inclusion Criteria:

* Couple, male and female, meeting the legal criteria for access to medically assisted procreation: a couple, a woman under the age of 43, who can testify to a life together. Then breakdown into 3 inclusion groups:

  * Group 1: Patients undergoing AMP with oocyte donation
  * Group 2: couples supported in AMP with sperm donation
  * Group 3: torque supported in intra torque AMP.

Exclusion Criteria:

* Patients who do not meet the legal criteria for access to the MPA.
* Patients in charge of Medical Assistance for Procreation "Viral Risk"
* Patients undergoing medical aid for procreation for pre-existing sexual dysfunction.
* Patients awaiting embryo reception.

Primary outcomes:
measure: Analysis of anonymous sexual well-being questionnaires: one reserved for men, another reserved for women
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT01328418: Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients
Official title: Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SHOX Gene With Short Stature
Keywords: Lengthening
Lead sponsor: Bilen, Fikri Erkal, M.D.
Sponsor class: INDIV
First posted: 2011-04-04
Enrollment: 22
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether lengthening of both the tibiae and femora in achondroplastic patients is safe and provides reproducible outcome.


Eligibility criteria: Inclusion Criteria:

* Achondroplasia, first lengthening period

Exclusion Criteria:

* Previous lengthening

Primary outcomes:
measure: Paley's functional scoring system
timeFrame: Minimum 2 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medical School
Study officials:
References:
Clinical trial NCT03613818: Efficacy of a Web-Based Alcohol Intervention for High School Students
Official title: Efficacy of a Web-Based Alcohol Intervention for High School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Underage Drinking
Lead sponsor: Boise State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-08-03
Enrollment: 311
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the efficacy of the eCHECKUP TO GO as an intervention to reduce underage drinking and the associated negative consequences among high school seniors. The aim of this project is to provide a brief, low cost intervention that can be easily disseminated as a school-based intervention to address this important public health problem.


Eligibility criteria: Inclusion Criteria:

* Senior enrolled in high school sites

Exclusion Criteria:

* none

Primary outcomes:
measure: Weekly Drinking
timeFrame: Baseline, 1 month follow-up, and 6-month follow up
measure: Peak Drinking Quantity
timeFrame: Baseline, 1 month follow-up, and 6-month follow up
measure: Frequency of Alcohol Use
timeFrame: Baseline, 1 month follow-up, and 6-month follow up
measure: Blood Alcohol Concentration
timeFrame: Baseline, 1 month follow-up, and 6-month follow up
measure: Heavy Episodic Drinking
timeFrame: Baseline, 1 month follow-up, and 6-month follow up
Secondary outcomes:
measure: Alcohol-Related Consequences
timeFrame: Baseline and 6-month follow up
Other outcomes:
Locations:
city: Boise
country: United States
facility: Boise State University
state: Idaho
Study officials:
affiliation: Boise State Univeristy
name: Diana Doumas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doumas DM, Esp S, Turrisi R, Bond L, Flay B. Efficacy of the eCHECKUP TO GO for High School Seniors: Sex Differences in Risk Factors, Protective Behavioral Strategies, and Alcohol Use. J Stud Alcohol Drugs. 2020 Mar;81(2):135-143. doi: 10.15288/jsad.2020.81.135.
citation: Doumas DM, Esp S, Turrisi R, Bond L. A Randomized Controlled Trial of the eCHECKUP to GO for High School Seniors across the Academic Year. Subst Use Misuse. 2021;56(13):1923-1932. doi: 10.1080/10826084.2021.1958862. Epub 2021 Aug 4.
Clinical trial NCT06095518: DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study
Official title: DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extracorporeal Circulation; Complications
Extracorporeal Membrane Oxygenation Complication
Keywords: ECMO
Thrombosis
Haemorrhage
Lead sponsor: Queen Mary Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 50
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring ECMO support

Brief summary: To study the correlation between novel DIC markers and thrombin generation parameters with thrombotic and hemorrhagic complications of patients on ECMO support.


Eligibility criteria: Inclusion Criteria:

* Age ≧ 18; AND
* Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital or Tuen Mun Hospital in Hong Kong; AND
* Require either veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO) support.

Exclusion Criteria:

* Patients who are on central VA-ECMO support; OR
* Patients with missing clinical data; OR
* Patients with pre-existing thromboembolism requiring long term anticoagulation prior to ECMO cannulation; OR
* Post-operative admissions

Primary outcomes:
measure: Composite of thrombotic and hemorrhagic events
timeFrame: From the start of ECMO support to the end of ECMO support (which can be variable, typically around 5 days to 1 week)
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References:
Clinical trial NCT04727918: Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal
Official title: Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Polyps
Keywords: Polypectomy
Cold biopsy forceps
Cold snare polypectomy
Diminutive colorectal polyp
Lead sponsor: French Society of Digestive Endoscopy
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: European guidelines recommend the use of cold snare polypectomy (CSP) for removal of diminutive colorectal polyps (DCP)(5 mm or less). However, for DCP \< 4 mm cold biopsy forceps (CBF) may be optional. Moreover, CBF remains the endoscopist's technique of choice for polyp resection and CSP is associated with a failure of specimen retrieval for histology in up to 6.8% of cases. In this study, the investigators aimed to compare the efficacy of CSP with CBF for removal of DCP in routine colonoscopy


Eligibility criteria: Inclusion Criteria:

* Routine colonoscopy
* Patient older than 18 years
* at least one polyp measuring ≤ 5 mm

Exclusion Criteria:

* inflammatory bowel disease
* polyposis syndrome, pregnancy
* inability to provide informed consent

Primary outcomes:
measure: The primary objective of the study is to compare CBF and CSP in terms of efficacy. The primary end-point is the rate of histological complete resection by anatomopathological examination.
timeFrame: through study completion, an average of 2 years.
Secondary outcomes:
measure: Specimen retrieval rate (% time of polypectomy)
timeFrame: through study completion, an average of 2 years.
measure: Procedure time ( overall time between introduction and removal of colonoscope)
timeFrame: through study completion, an average of 2 years.
measure: Procedure related adverse events will be collected (adverse events : %, number of event for each groupe) during the procedure or during the follow up period (28 days).
timeFrame: All patients will be followed-up until 28 days post-colonoscopy.
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou 20, rue Leblanc
Study officials:
References:
citation: Perrod G, Perez-Cuadrado-Robles E, Coron E, Pioche M, Becq A, Etchepare N, Danan D, Musquer N, Dray X, Laquiere A, Jais B, Broudin C, Benosman H, Cellier C, Rahmi G. Comparison of cold biopsy forceps vs cold snare for diminutive colorectal polyp removal: A multicenter non-inferiority randomized controlled trial. Clin Res Hepatol Gastroenterol. 2022 Mar;46(3):101867. doi: 10.1016/j.clinre.2022.101867. Epub 2022 Jan 14.