louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02861326: RELATIONSHIP BETWEEN INITIAL PROBING DEPTH AND CHANGES IN CLINICAL PARAMETERS FOLLOWING NON-SURGICAL PERIODONTAL TREATMENT IN CHRONIC PERIODONTITIS PATIENTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Keywords: chronic periodontitis, dental scaling, periodontal pockets
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 15
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim: The aim of this study was to evaluate the relationship between initial probing depth (IPD) and changes in clinical parameters following non-surgical periodontal treatment (NPT) in chronic periodontitis patients.

Material and Methods: A total of 1672 periodontal pockets having 3 mm≤IPD≤9 mm in 15 chronic periodontitis patients were included. NPT consisting of oral hygiene instructions, scaling and root planing was applied in two sessions. Probing depth (PD), clinical attachment level, gingival recession (GR) were measured before and eight weeks after treatment. Pocket sites were grouped according to their IPD and root number of teeth as single- or multi-rooted.


Eligibility criteria: Inclusion Criteria:

* Systemically healthy,
* Non-smoker,
* Chronic periodontitis diagnosed according to Armitage 1,
* Aged between 35 and 65,
* Not received any periodontal treatment within the last 3 months, • Have horizontal bone loss radiographically,
* Presence at least 20 natural teeth except third molars
* Consent to participate in the study.

Exclusion Criteria:

* Any systemic disease that might interfere with the prognosis of periodontal disease (i.e. diabetes mellitus, HIV infection),
* Smoking,
* Antibiotics, anti-inflammatory drugs or any other medication taken within the previous 6 months that may affect the outcome of the study,
* Any physical limitations or restrictions that might preclude normal oral hygiene procedures.

Primary outcomes:
measure: Probing Depth
timeFrame: 8 week
Secondary outcomes:
measure: Clinical attachment level
timeFrame: 8 week
measure: Gingival recession
timeFrame: 8 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References:
Clinical trial NCT04080726: Efficacy and Safety of HIP1601 Capsule
Official title: A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 40mg and HGP1705 40mg in Patients With Erosive Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erosive Gastroesophageal Reflux Disease
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2019-09-06
Enrollment: 213
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, randomized, double-blind, parallel group study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with erosive gastroesphageal reflux disease.


Eligibility criteria: Inclusion Criteria:

* 19≤ age ≤ 75
* Esophago-Gastro-Duodenoscopy LA classification ≥ grade A
* Patients experienced heartburn or acid regurgitation within 7 days of screening day
* Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

* Has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorder or signs of gastrointestinal bleeding
* Has a severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
* Has a clinically significant renal failure(at screening day, MDRD eGFP ≤ 59 mL/min/1.73m2 or Serum creatinine \>2.0mg/dL)
* Uncontrolled diabetes mellitus
* Before screening EGD, a patient who has taken H2-receptor antagonist or PPI within 2 weeks
* Before screening EGD, a patient who has taken drugs containing following list within 1 weeks : warfarin, anticholinergics for spasmolytic GI, antineoplastic agents, salicylates(except 100mg a day for prevention of cardiovascular disease), steroids, propulsives, sucralfate, NSAIDs, other antacids(e.g. antacids of prostaglandin analogs, antacids of aluminum/magnesium)

Primary outcomes:
measure: Complete healing rate
timeFrame: at 4 weeks or 8 weeks
Secondary outcomes:
measure: Complete healing rate
timeFrame: at 4 weeks
measure: Complete resolution rate of each symptom in GERD
timeFrame: at 4,8 weeks
measure: Proportion of heartburn-free days, acid regurgitation-free days
timeFrame: at 1, 2, 4, 8 weeks
measure: Proportion of heartburn-free nights, acid regurgitation-free nights
timeFrame: at 1, 2, 4, 8 weeks
measure: Time to sustained resolution heartburn, acid regurgitation
timeFrame: at 4 weeks or 8 weeks
measure: Time to sustained resolution of nocturnal heartburn, nocturnal acid regurgitation
timeFrame: at 4 weeks or 8 weeks
measure: Total number of use of relief drugs and average usage per day
timeFrame: at 4 weeks or 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Hunyong Jung, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00773526: A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.
Official title: An Open Label Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO5126766, a Dual Raf and MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-10-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors. In the first part of the study, groups of patients will by sequentially enrolled to receive ascending oral doses of RO5126766 daily for 28 days. The starting dose of 0.1mg will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with selected tumor types will be randomized to receive either the optimal biological dose or the maximum tolerated dose of RO5126766 daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* advanced and/or metastatic cancer not amenable to standard therapy;
* any solid tumor type (Part 1); malignant melanoma, pancreatic cancer or non-small cell lung cancer (Part 2);
* measurable and/or evaluable disease (Part 1), \>=1 measurable lesion (Part 2);
* ECOG performance status 0-1.

Exclusion Criteria:

* prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
* prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study drug;
* known past or present CNS metastases;
* acute or chronic infection.

Primary outcomes:
measure: Maximum tolerated dose (Part 1)
timeFrame: Throughout study
measure: Tumor assessments (Part 2)
timeFrame: Event driven
Secondary outcomes:
measure: AEs and laboratory parameters, ophthalmological examination, pharmacokinetic parameters, pharmacodynamic parameters (Parts 1 and 2).
timeFrame: Throughout study
Other outcomes:
Locations:
city: Villejuif
country: France
city: Barcelona
country: Spain
city: Sutton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02668926: Endocrine and Emotional Effects of Lisdexamfetamine and d-Amphetamine.
Official title: Endocrine and Emotional Effects of Lisdexamfetamine and d- Amphetamine: a Placebo-controlled Study in Healthy Subjects (LisDexStudy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study will compare the acute emotional and endocrine effects of equivalent doses of lisdexamfetamine and amphetamine in healthy subjects. In addition the pharmacokinetics and effects of the amphetamines on aspects of social cognition are investigated.


Eligibility criteria: Inclusion Criteria:

healthy subjects aged 18-45 years

Exclusion Criteria:

1. Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG.
2. Current or previous psychotic or major affective disorder
3. Psychotic or major affective disorder in first-degree relatives
4. Prior illicit drug use (cannabis) more than 5 times or any time within the previous 2 months.
5. Pregnant or nursing women.
6. Participation in another clinical trial (currently or within the last 30 days)
7. Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
8. Tobacco smoking (\>10 cigarettes/day)

Primary outcomes:
measure: Effects of lisdexamphetamine and d-Amphetamine on circulating steroidal hormones
timeFrame: 13 hours
measure: Subjective effects of lisdexamphetamine and d-amphetamine
timeFrame: 13 hours
Secondary outcomes:
measure: Effects of lisdexamphetamine and d-Amphetamine on emotion recognition and empathy
timeFrame: 1h
Other outcomes:
measure: Pharmacokinetics
timeFrame: 13h
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Matthias E Liechti, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Basel
name: Alex Odermatt, Dr.
role: STUDY_CHAIR
References:
citation: Dolder PC, Strajhar P, Vizeli P, Odermatt A, Liechti ME. Acute effects of lisdexamfetamine and D-amphetamine on social cognition and cognitive performance in a placebo-controlled study in healthy subjects. Psychopharmacology (Berl). 2018 May;235(5):1389-1402. doi: 10.1007/s00213-018-4849-0. Epub 2018 Feb 9.
citation: Dolder PC, Strajhar P, Vizeli P, Hammann F, Odermatt A, Liechti ME. Pharmacokinetics and Pharmacodynamics of Lisdexamfetamine Compared with D-Amphetamine in Healthy Subjects. Front Pharmacol. 2017 Sep 7;8:617. doi: 10.3389/fphar.2017.00617. eCollection 2017.
Clinical trial NCT02837926: Comparing Health Services Interventions for the Prevention of HPV-related Cancer
Official title: Work Package 4: HPV Vaccination of Women in Screening Ages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Cancer
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 63
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.

Detailed description: 3000 women aged within the age range of 25-45 years old will be recruited; 250-300 women per country. These women will be identified by means of screening registry lists or screening clinical visits. Eligible women will receive a study questionnaire on the HPV vaccine. Additionally, and independently of participating in the study questionnaire, those who accept will get 3 HPV vaccine doses. Depending on country preferences, either Cervarix® (Glaxosmithkline Biologicals, S.A.) at month 0, 1 and 6 or Gardasil® (Sanofi Pasteur MSD SNC) at month 0, 2 and 6, will be administered.

Safety data and HPV vaccine compliance will be assessed.

A sub study in Spain will also analyze acceptability of HPV vaccination in a sample of women aged 35-40 yrs identified as poor screening attenders.

Two independent informed consent forms will be provided; one for the study questionnaire participation and another for HPV vaccine administration.

Eligibility criteria: Inclusion Criteria:

* women within the age range of 25-45
* attending cervical cancer screening

Exclusion Criteria:

* previous history of HPV vaccine administration

Primary outcomes:
measure: number of vaccinated patients
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT04148326: A Pilot Study to Explore the Role of Gut Flora in Parkinson's Disease
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Parkinson Disease
Parkinsons Disease With Dementia
Parkinson-Dementia Syndrome
Parkinson Disease 2
Parkinson Disease 3
Parkinson Disease 4
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Parkinson's Disease

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Parkinson's Disease.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Parkinson's Disease.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers).
3. Diagnosis of Parkinson's Disease

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Parkinson's Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: One Year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: One year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03162926: A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Official title: An Open-Label Study Evaluating the Safety and Tolerability of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: ViaCyte
Sponsor class: INDUSTRY
First posted: 2017-05-22
Enrollment: 3
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 this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for up to four (4) months.


Eligibility criteria: Inclusion Criteria:

* Men and non-pregnant women of non-childbearing potential
* Diagnosis of T1DM for a minimum of five (5) years
* Stable diabetic treatment
* Willingness to use a continuous glucose meter
* Acceptable candidate for implantation

Exclusion Criteria:

* History of islet cell, kidney, and/or pancreas transplant.
* Two (2) or more severe, unexplained hypoglycemic events within six (6) months of enrollment
* Uncontrolled or untreated thyroid disease or adrenal insufficiency
* Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy
* Non-compliance with current anti-diabetic regimen

Primary outcomes:
measure: Incidence of all adverse events reported for subjects
timeFrame: Thru the Month 4 Visit]
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References:
Clinical trial NCT03971526: Magnetic Resonance Post-contrast Vascular Hyperintensities at 3 T: a Sensitive Sign of Vascular Occlusion in Acute Ischaemic Stroke
Official title: Magnetic Resonance Post-contrast Vascular Hyperintensities at 3 T: a New Highly Sensitive Sign of Vascular Occlusion in Acute Ischaemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischaemic Stroke
Keywords: Cerebrovascular disorders
Magnetic resonance imaging
Neuroimaging
Prognosis
Stroke
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-06-03
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 130 consecutive patients admitted for acute ischaemic stroke with a 3-T MRI performed in the first 12 h of symptom onset.

Brief summary: Magnetic resonance imaging (MRI) is the diagnostic cornerstone for precisely identifying acute ischaemic strokes and locating vascular occlusions.

It was observed that a post-contrast three-dimensional turbo-spin-echo T1weighted sequence showed striking post-contrast vascular hyperintensities (PCVH) in ischaemic territories. The aim is to evaluate the prevalence and the meaning of this finding.

This study included 130 consecutive patients admitted for acute ischaemic stroke with a 3-T MRI performed in the first 12 h of symptom onset from September 2014 through September 2016. Two neuroradiologists blinded to clinical data analysed the first MRI assessments.


Eligibility criteria: Inclusion criteria:

* Patients aged 18 and older at onset of an acute ischaemic stroke
* Availability of at least one pre-therapeutic MRI performed in our centre within 12 h of stroke onset, including a post-contrast 3D TSE T1-weighted sequence.

Exclusion criteria:

* Patients with posterior fossa strokes
* Patients with known intracranial vasculitis or MoyaMoya disease
* Presence of severe MR imaging artefacts preventing correct interpretation

Primary outcomes:
measure: overal survival
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03536026: Localization of Peripheral Pulmonary Lesions: A Pilot Study
Official title: Localization of Peripheral Pulmonary Lesions: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Peripheral Lung Lesions
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. One significant barrier for the bronchoscopic biopsy of peripheral lesions is the ability to reliably locate peripheral lesions in an efficient manner. The majority of the published literature regarding peripheral lesion biopsy has used diagnostic yield as the primary endpoint. Based on this data, it is unclear if non-diagnostic procedures are due to the inability to locate peripheral lesions, or due to the inability to successfully biopsy lesions once located using currently available instruments. This study will evaluate the bronchoscopists' ability to locate peripheral pulmonary lesions by using a conventional chest computed tomography (CT) scan as a reference and a virtual bronchoscopic navigational system, if needed, for the localization of peripheral pulmonary lesions.


Eligibility criteria: Inclusion Criteria:

* Patients with peripheral lung lesions 1-5cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient.
* Are at least 18 years old
* Are able to provide informed consent
* Have CT scans within 30 days suitable for use with the virtual bronchoscopic system

Exclusion Criteria:

* Patients who refuse to participate
* Are less than 18 years of age
* Are pregnant
* Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist
* Are unable to provide informed consent

Primary outcomes:
measure: Localization of peripheral pulmonary lesions as confirmed using radial probe endobronchial ultrasound
timeFrame: At the time of bronchoscopy (day 1)
Secondary outcomes:
measure: Rate of lesion localization using a conventional chest CT as a reference only
timeFrame: At the time of bronchoscopy (day 1)
measure: Rate of lesion localization using virtual bronchoscopic navigation if needed (failed lesion localization using conventional chest CT only)
timeFrame: At the time of bronchoscopy (day 1)
measure: Time to localization of peripheral pulmonary lesions
timeFrame: At the time of bronchoscopy (day 1)
measure: Diagnostic yield of procedures
timeFrame: At the time of bronchoscopy (day 1)
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Alexander Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: