louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01780701: Magnetic Resonance Spectroscopic Imaging Study of Prostatic Fats to Distinguish the Difference Between High and Low Risk Prostate Cancer
Official title: Imaging Prostatic Lipids to Distinguish Aggressive Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate cancer aggressiveness
magnetic resonance imaging
fatty acid synthase
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Portland VA Medical Center
name: Oregon Health and Science University
First posted: 2013-01-31
Enrollment: 66
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all men newly-diagnosed with prostate cancer at the Portland VA and OHSU Urology clinics

Brief summary: A prostate cancer diagnosis starts a list of events that often leads to fast-moving treatment, thought by many to result in vast over-treatment of this disease. So, discovery of different diagnostic methods that allow clinicians to identify slow-growing from potentially fast-growing disease prior to or at the time of prostate biopsy could result in early and suitable treatment for men at greatest risk, while greatly decreasing the number of biopsies, surgical procedures, hormonal and chemotherapeutic treatments, cost, and patient worry, for those with more slow-growing disease.


Eligibility criteria: Inclusion Criteria:

* Prostate cancer diagnosis prior to treatment
* Age 21 years or older
* Signed informed subject consent
* Prostatectomy as planned prostate cancer treatment

Exclusion Criteria:

* Men who do not choose prostatectomy
* Men who have undergone any neoadjuvant therapy
* Men who have cardiac pacemakers or other implanted electronic devices
* Men who have any surgically implanted metal
* Men who have had any surgical procedure that precludes placement of endorectal probe
* Indication of dementia or memory issues listed on problem list
* Men who indicate exposure to ocular metal fragments; confirmed by positive ocular x-ray
* Men who are taking newly-prescribed (within 6 months of enrollment) lipid control medications

Primary outcomes:
measure: Number of participants with increased intraprostatic lipid concentration
timeFrame: Up to 3 years
Secondary outcomes:
measure: Number of participants with increased tumor aggressiveness
timeFrame: Up to 3 years
Other outcomes:
measure: Number of participants with accumulation of lipid intermediates and proteins
timeFrame: Up to 3 years
Locations:
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University Advanced Imaging Research Center
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jackilen Shannon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Jonathan Q Purnell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02341001: Does Text Message Support After Discharge Improve Outcomes Following Bariatric Surgery? A Randomised Trial.
Official title: Does Text Message Support After Discharge Improve Outcomes Following Bariatric Surgery? A Randomised Trial and Sub-study of the BOBS Study (Better Outcomes Following Bariatric Surgery)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Bariatric Surgery Candidate
Keywords: Bariatric surgery
Sleeve gastrectomy
Text messaging
Weight loss
BAROS
Follow-up care
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
Collaborators: name: Health Research Council, New Zealand
First posted: 2015-01-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether text message support after discharge from a bariatric service improves outcomes following bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* All patients who have had a sleeve gastrectomy 18 months ago and are attending the discharge follow-up appointment

Exclusion Criteria:

* Patients who do not have the ability to receive text messages
* Patients who do not understand written English

Primary outcomes:
measure: Percent of excess weight lost
timeFrame: Twelve months
Secondary outcomes:
measure: Bariatric Analysis and Reporting Outcome System (BAROS)
timeFrame: Twelve months
Other outcomes:
measure: Number of re-referrals to the bariatric clinic
timeFrame: Twelve months
measure: Cost comparison
timeFrame: Twelve months
Locations:
city: Auckland
country: New Zealand
facility: Counties Manukau District Health Board
Study officials:
affiliation: University of Auckland, New Zealand
name: Andrew D MacCormick, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Auckland, New Zealand
name: Melanie Lauti, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauti M, Kularatna M, Pillai A, Hill AG, MacCormick AD. A Randomised Trial of Text Message Support for Reducing Weight Regain Following Sleeve Gastrectomy. Obes Surg. 2018 Aug;28(8):2178-2186. doi: 10.1007/s11695-018-3176-1.
Clinical trial NCT02866201: Etiological Diagnosis of Traveler's Diarrhoea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traveler's Diarrhoea
Keywords: Turista
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Traveler's diarrhoea or turista is the most common disease in travelers. It has been reported based on studies in 20 to 60% of travelers, depending among other conditions and travel destinations. Currently, less than 30% of the etiology of diarrhoea is identified by bacteriological v,irological and parasitology traditional techniques. This ignorance of the diarrhoea etiology causes difficulties in the establishment of a specific and rapid management in this extremely common condition and having a significant cost to society. Technological advances in laboratory diagnosis, such as quantitative real-time Polymerase Chain Reaction (PCR), can allow us now to improve the etiological diagnosis of traveler's diarrhoea using simple rectal swabs.

So, the principal objective of this study is to assess the efficacy of a new diagnosis strategy in order to establissh the etiological diagnosis of traveler's diarrhoea. The hypothesis consists in improving the number of patients with a confirmed etiological diagnosis of traveler's diarrhoea by 5%.


Eligibility criteria: Inclusion Criteria:

* Patient leaving for a trip outside France for a period (not exceeding 3 months)
* Patient who get seen by Travel information Service at hospital before departure.
* Adult patients (\> 18 years).
* Patient who freely signed the written informed consent
* Patient affiliated to a social security regime. Exclusion criteria
* Minor patient (\<18 years)
* Pregnant or nursing woman.
* Adult patient under guardianship.
* Patient deprivated with liberty under court order.
* Patient refusing to sign the wrtten consent form

Primary outcomes:
measure: Percentage of patients with a confirmed etiological diagnosis of traveler's diarrhoea
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT06218901: Association of Psychological Distress in Patients With Lung Cancer
Official title: the Association of Psychological Distress in Patients With Advanced Lung Cancer Treated With Immunotherapy or Targeted Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Neoplasms
Psychological Distress
Prognosis Factors
Lifestyle, Healthy
IMMUNOTHERAPY
Targeted Molecular Therapy
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with lung cancer are with the standard treatment and/or are enrolled in the clinical trials.

Brief summary: Psychological distress is a multi-factorial experience of a psychological, social, spiritual, and/or physical nature that may interfere with one's ability to cope effectively with cancer, physical symptoms and treatment. Psychological distress is common and affects the efficacy and prognosis of patients with lung cancer. The systematic anti-tumor therapy may effectively relieve psychological distress including anxiety, depression, and fatigue in patients with advanced lung cancer, the relief of the psychological distress can in turn improve the therapeutic effect.

In summary, this study is to explore the associations of (dynamic) psychological stress with the efficacy and survival of anti-tumor therapy including immunotherapy and targeted therapy for advanced lung cancer patients.


Eligibility criteria: Inclusion Criteria:

* Histologically proven diagnosis of lung cancer
* 18 years of age or older
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Not willing to participate in this clinical trial

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 20 years
measure: Disease control rate (DCR)
timeFrame: 20 years
measure: Progression-free survival (PFS)
timeFrame: 20 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 20 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06432101: Acupuncture Combined With Hydroxychloroquine
Official title: Clinical Efficacy of Acupuncture Combined With Hydroxychloroquine Sulfate Tablets in Improving Oral and Ocular Dryness in Primary Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Sjögren's Syndrome
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To observe the clinical efficacy of acupuncture combined with hydroxychloroquine sulfate tablets on the symptoms of dry mouth and dry eyes in primary Sjögren's syndrome.

Detailed description: Methods: Seventy-two patients with primary Sjögren's syndrome who met the inclusion criteria were randomly divided into the experimental group (36 patients, 3 patients who fell out) and the control group (36 patients, 4 patients who fell out). The control group was treated with oral hydroxychloroquine sulfate tablets alone, 0.2g each time, taken twice a day, 4 weeks for 1 course of treatment, a total of 2 courses of treatment, and the experimental group was treated with acupuncture treatment on the basis of the control group, acupuncture once a day, acupuncture for 5 days and 2 days of rest, 4 weeks for 1 course of treatment, a total of 2 courses of treatment. The changes in the outcome indicators of the two groups before and after treatment were observed, and the main outcome indicators included salivary flow rate (SFR) and Schirmer test. Secondary outcomes included the European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient-Reported Index (ESSPRI), the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), and laboratory measures (ESR, CRP, IgG).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of primary Sjögren's syndrome
* Must be able to receive acupuncture treatment and swallow tablets

Exclusion Criteria:

* Patients with malignant tumors or severe organ function impairment
* Patients who are lactating or pregnant.
* Persons who are participating in clinical trials of other drugs.

Primary outcomes:
measure: Salivary flow rate (Sauf)
timeFrame: 8 weeks
measure: Schirmer test
timeFrame: 8 weeks
Secondary outcomes:
measure: Sjögren's syndrome patient-reported index (ESSPRI)
timeFrame: 8 weeks
measure: EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Harbin
country: China
facility: Senyue Zhang
state: Heilongjiang
Study officials:
affiliation: Heilongjiang University of Chinese Medicine
name: Senyue Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00952601: Pilot Study of the Modified Atkins Diet for Tourette Syndrome
Official title: Pilot Study of the Modified Atkins Diet for Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Tourette Syndrome
Keywords: Tourette
Atkins
Ketosis
Tic
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pharmacotherapy has long been considered the primary approach for tic suppression in Tourette syndrome (TS). Unfortunately, medications are often ineffective and frequently have significant side-effects. This is a pilot therapeutic study using a dietary approach, the modified Atkins diet (MAD). The goal of this study is to establish the safety, tolerability, and efficacy of dietary therapy in patients with TS ("proof of concept") and to determine whether this intervention is worthy of evaluation in large-scale clinical trials. The modified Atkins diet mimics the well established ketogenic diet, but in a less-restrictive dietary manner. Dietary approaches using the MAD/ketogenic diet are currently under investigation for neurological conditions other than epilepsy, including Alzheimer disease, headaches, autism, narcolepsy, brain tumors, traumatic brain injury, Parkinson's disease, and depression.


Eligibility criteria: Inclusion Criteria:

* Ages 12-65 years
* Tourette syndrome (vocal and motor tics for over a year)
* \> 20 score on the Yale Global Tic Severity Scale
* Ability to follow instructions and comply with the dietary changes

Exclusion Criteria:

* Secondary tics
* Underweight (BMI \< 5%)
* Prior use of the Atkins diet for over 2 days
* High cholesterol or triglycerides
* Major depression or anxiety disorder
* Pregnancy
* Substance abuse

Primary outcomes:
measure: Tic frequency
timeFrame: 2 months
Secondary outcomes:
measure: Ketosis
timeFrame: 2 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
References:
citation: Kossoff EH, Dorward JL. The modified Atkins diet. Epilepsia. 2008 Nov;49 Suppl 8:37-41. doi: 10.1111/j.1528-1167.2008.01831.x.
Clinical trial NCT04842201: Single Ascending Dose Study of CM326 in Healthy Volunteers
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CM326 in Adult Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2021-04-13
Enrollment: 44
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: TREATMENT

Brief summary: Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM326 in healthy volunteers.


Eligibility criteria: Key Inclusion Criteria:

* Healthy adult male participant,18 to 65 years of age, inclusive.
* Body Mass Index (BMI) 18 to 26 kg/m2, inclusive.
* History, physical examination, laboratory tests and test related items of inspection were normal or abnormal without clinically insignificant.
* Males must abstain from sex or use highly effective methods of birth control.
* Having given written informed consent prior to undertaking any study-related procedure.

Key Exclusion Criteria:

* Positive for HIV, or Hepatitis B, or C.
* Positive result on urine drug screen.
* Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease).
* With any condition that inappropriate for entry into this study.

Primary outcomes:
measure: Safety of CM326 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
timeFrame: Day 1 through Day 85
Secondary outcomes:
measure: Pharmacokinetics (PK) of CM326
timeFrame: Day 1 through Day 85
measure: Pharmacodynamics of CM326
timeFrame: Day 1 through Day 85
measure: Immunogenicity
timeFrame: Day 1 through Day 85
Other outcomes:
Locations:
city: Zibo
country: China
facility: PKUCare Luzhong Hospital
state: Shandong
Study officials:
affiliation: Peking University Care Luzhong Hospital
name: Jie Hou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06836401: Topical Metronidazole vs Control in Reducing Periodontal Pockets in a Split Mouth Clinical Trial
Official title: Effect of Topical Metronidazole in Reducing Periodontal Probing Depth: A Split Mouth Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontal Disease
Periodontal Inflammation
Keywords: periodontal pocket
periodontal disease
periodontal inflammation
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 20
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: The effect of both the mechanical treatment and the topical metronidazol in reduccing the inflammation and depth of the periodontal pockets were assessed on the first bicuspids.


Eligibility criteria: Inclusion Criteria:

* Periodontal patients with all first premolars suffering from moderate periodontal pockets (\>4mm of probing depth)

Exclusion Criteria:

* No patients received antibiotics nor periodontal treatment in the previous 6 months

Primary outcomes:
measure: Probing depth
timeFrame: Both one month and three months after root scaling
measure: Mieloperoxidase ng/mL
timeFrame: Both one and three months after root scaling
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Dental School of the Faculty of Medicine
Study officials:
affiliation: University of Salamanca
name: Javier Montero, Main Researcher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00682201: Hemodynamic Changes During Normal Pregnancy
Official title: Hemodynamic Changes During Normal Pregnancy: A Prospective Cohort Study of 100 Healthy Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Pregnancy
Blood pressure
Cardiac output
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healty pregnant women scheduled for delivery at the Birth Clinic, Rikshospitalet University Hospital.

Brief summary: Prospective, observational study of the changes in hemodynamic variables such as blood pressure, cardiac output, systemic vascular resistance, and of changes in respiratory variables such as vital capacity, and functional residual volume.A cohort study of 100 healthy pregnant women tested with non-invasive methods during pregnancy and 6 months after delivery.

Detailed description: Healthy pregnant women with the willingness to consent in physiologic tests at 3 different time points during, and one time point after pregnancy. Spirometric tests will be performed with V-MAX, non-invasive measuring of hemodynamics will be measured by Finometer.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who at first admission are healthy

Exclusion Criteria:

* Co-existing diseases who represents decreased physical or psychological function

Primary outcomes:
measure: Pregnancy specific changes in hemodynamic variables
timeFrame: Normal pregnancy time frame
Secondary outcomes:
measure: Respiratory functional changes
timeFrame: Normal pregnancy time frame
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet University Hospital, Division of Anesthesia and Critical Care Medicine
Study officials:
affiliation: Rikshospitalet University Hospital
name: Leiv Arne Rosseland, PhD MD
role: STUDY_DIRECTOR
References: