louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01249339: In-vivo Extraction of Pb, Cd andTSNA From Swedish Snus
Official title: In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Four Brands of Swedish 'Snus' in Regular Snus Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Smokeless Tobacco
Harm Reduction
Keywords: smokeless tobacco
Nicotine
Cadmium
lead
Tobacco Specific Nitrosamines
Lead sponsor: Contract Research Organization el AB
Sponsor class: INDUSTRY
Collaborators: name: Swedish Match AB
First posted: 2010-11-29
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.

Detailed description: Comparisons:

A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine per portion.

D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg nicotine per portion.

Swedish portion snus will be administered once every hour (4 administrations/brand) and will be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.

Eligibility criteria: Inclusion Criteria:

* Non-smokers, 18 to 50 years of age.
* Habitual use of \> 7 portions snus daily since minimum 1 year.
* Healthy according to the health declaration and interview.
* Written informed consent given.

Exclusion Criteria:

* Concurrent participation in another clinical trial.
* History of allergy.
* History of allergy.

Primary outcomes:
measure: In-vivo extraction of cadmium
timeFrame: 30 minutes' use
Secondary outcomes:
measure: in-vivo extraction of tobacco specific nitrosamines (TSNAs)
timeFrame: 30 minutes' use
measure: In-vivo extraction of lead
timeFrame: 30 minutes' use
measure: In-vivo extraction of nicotine
timeFrame: 30 minutes' use
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: CROel AB
Study officials:
affiliation: Croel AB
name: Erik Lunell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02427139: ANSiStim Study for Active Labor Pain
Official title: Study of ANSiStim for Pain Relief During Active Labor Phase Through Continues Checking of VAS SCORE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Pain
Obstetric Pain
Lead sponsor: DyAnsys, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The specific aim of the study is to do comparison between ANSiStim and Placebo for pain relief in labor. During the treatment, pain relief will be assesed with ANSiStim in active labor through continues checking of VAS SCORE. ANSiStim has been tried in post operative patients with good pain relief .

Detailed description: Pain during labor is caused by contractions of the muscles of the uterus and by pressure on the cervix. This pain can be felt as strong cramping in the abdomen, groin, and back, as well as an achy feeling. Some women experience pain in their sides or thighs as well. Most women have an epidural or spinal during labour or after the birth.

Eligibility criteria: Inclusion Criteria:

* Pregnant Women on an Active Labor

Exclusion Criteria:

* Cardiac Pacemaker or any other implants
* Psoriasis
* Diminish mental capacity

Primary outcomes:
measure: Evidence of Reduced Pain (Pain Scale of 5) in Active Labor Phase after ANSiStim Placement
timeFrame: 48 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Fortis Hospital
state: Karnataka
Study officials:
affiliation: Fortis Hospital - Bangalore
name: Gayathri D Kamath, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01033539: To Demonstrate That Lactobacillus Reuteri ATCC PTA 4659 Survives Passage Through the Gastrointestinal Tract of Humans
Official title: To Demonstrate That Lactobacillus Reuteri ATCC PTA 4659 Survives Passage Through the Gastrointestinal Tract of Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recovery of Lactobacillus Reuteri ATCC PTA 4659
The Safety of Lactobacillus Reuteri ATCC PTA 4659
Keywords: Survive
safety
lactobacillus Reuteri
Lead sponsor: Good Food Practice, Sweden
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effects of a sachet containing Lactobacillus Reuteri ATCC PTA 4659 on the recovery of live Lactobacillus reuteri in fecal samples after 7, 14 and 28 days supplementation as well as 14 days wash out compared to the same sachet without the probiotic bacteria as placebo control.

Detailed description: This study is the first to investigate the relative colonisation of the human GI tract by L Reuteri ATCC PTA 4659. Simple demonstration that they survive passage is the first step in development of potential new probiotics, which is necessary before these strains can be considered for continued testing in probiotic food matrices. The aim of this study will evaluate the safety and tolerability of Lactobacillus Reuteri in healthy adult subjects.

Eligibility criteria: Inclusion Criteria:

* Males and females
* Age 18-65 years
* BMI 19-33
* Hb 120 g/women 130 g/l for men
* Healthy assessed by screening tests and physical examination
* Signed informed consent and bio bank consent

Exclusion Criteria:

* Participation in a clinical study within 90 days prior screening use of antibiotics 2 weeks before baseline
* Pregnant or lactating

Primary outcomes:
measure: Change form baseline to day 28 on treatment in level of live Lactobacillus Reuteri ATC PTA 4659 in faecal material.
timeFrame: Nov 2009-April2010
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Good Food Practice
Study officials:
affiliation: Good Food Practice, Uppsala, Sweden
name: Birgitta E Sundberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02141139: Perioperative Inflammation and Breast Cancer Outcome
Official title: Suppression of Inflammation by Using NSAIDs During Peri-operative Period Can Affect the Prognosis of Breast Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Neoplasms
Keywords: Anti-Inflammatory Agents, Non-Steroidal
Inflammation
Perioperative Period
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-05-19
Enrollment: 1568
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is increasingly recognized the NSAIDS (nonsteroidal antiinflammatory drug) might prevent the several cancers. In breast cancer, the role of NSAIDS (nonsteroidal antiinflammatory drug) has been suggested.However, there was no consistent results. surgery is main cause of inflammation for cancer patients. Therefore, we want to know the association between prevention of perioperative inflammation with NSAIDS and breast cancer outcomes.


Eligibility criteria: Inclusion Criteria:

* Breast cancer patients who took the surgery

Exclusion Criteria:

* underlying medical disease (major heart disease, lung disease, coagulopathy)
* major psychologic disease (major depression, schizophrenia, manic disorder)
* pregnancy
* rheumatic disease patients

Primary outcomes:
measure: disease free survival
timeFrame: 5 years
Secondary outcomes:
measure: overall survival
timeFrame: 5years
Other outcomes:
measure: neutrophil-lymphocyte ratio (NLR), albumin, inflammatory blood lab (CRP)
timeFrame: POD 1-2 weeks (immediate postoperative period)
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT01937039: Johns Hopkins Breast Cancer Program Longitudinal Repository
Official title: Johns Hopkins Breast Cancer Program Longitudinal Repository
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Benign Breast Disease
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2013-09-09
Enrollment: 810
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any man or woman being seen at Johns Hopkins for breast cancer treatment, or for any screening or diagnostic breast procedures (for example: mammograms or biopsies), may join. Individuals without a history of breast cancer, known as "healthy" or "normal" volunteers (meaning they do not have breast cancer) may also join.

Brief summary: The Breast Cancer Program Longitudinal Repository (BCPLR) is being established to fulfill the research mission of the Breast Cancer Program at Johns Hopkins and to serve investigators affiliated with it - to develop a repository of specimens with corresponding characteristics from patients seen in the breast care and cancer clinics.

Detailed description: This research is being done to collect samples for future use that we may learn more about cancer by studying cells in blood and tissue collected from people with breast cancer as well as from volunteers without breast cancer. Our goal is to make these available for research to help to learn how cancer develops and how it may be treated.

Eligibility criteria: Inclusion Criteria:

* Male or female
* 18 years of age or older
* Participants meet one of the following categories: have a known diagnosis of breast cancer receiving a breast cancer evaluation and/or treatment; have benign breast disease receiving a diagnostic procedure and/or evaluation; or, have no known diagnosis of breast disease or abnormality and is undergoing routine screening or diagnostic breast imaging procedures and/or other clinical evaluation.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Repository development
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Antonio C. Wolff, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01495039: Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients
Official title: The Role of Oral Nystatin Prophylaxis in ICU Surgical/Trauma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fungal Prophylaxis
Candida Infection
Critical Illness
Surgery
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2011-12-19
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose. Oral chemoprophylaxis has been advocated to reduce the incidence of Candida colonization and infection. However, Candida prophylaxis in intensive care unit (ICU) is still a matter of debate.

Methods. Randomized, single-center trial studying single drug (nystatin) versus control in surgical ICU patients. Multiple-site testing for fungi were performed in each patient at ICU admission (T0) and subsequently every 3 days (T3, T6, T9...). The primary evaluation criterion was the time course of colonization index (CI) during ICU stay.

Detailed description: Multiple-site testing for fungi included: tracheal secretions, pharingael swab, stomach contents, rectal swab, groin skin fold swab, urine, and blood. These tests will be performed in each patient at ICU admission (T0) and subsequently every 3 days throughout the ICU stay (T3, T6, T9...), as routine in our ICU.The specimens were placed in a dry medium and taken to the Mycology Laboratory. Group assignment was not indicated on specimens, the mycologists were therefore blinded to treatment allocation.

Each specimen was directly microscopically examined and cultured on Sabouraud media.

Eligibility criteria: Inclusion Criteria:

* surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h.

Exclusion Criteria:

* pregnancy,
* proven Candida infection,
* prophylactic or curative antifungal treatment within the last 2 months,
* contraindication to oral drug administration,
* known allergy to nystatin or its derivatives, and prior inclusion in the study

Primary outcomes:
measure: course of the colonization index over time.
timeFrame: AT 15 day from ICU admission
Secondary outcomes:
measure: The secondary evaluation criterion will be the occurrence of a fungal infection during the ICU stay
timeFrame: At 15 day from ICU admission
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Intensive care Unit, Policlinico Hospital Bari
Study officials:
affiliation: University of Bari
name: Francesco Bruno, Professor
role: STUDY_DIRECTOR
affiliation: University of Bari
name: Filomena Puntillo, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giglio M, Caggiano G, Dalfino L, Brienza N, Alicino I, Sgobio A, Favale A, Coretti C, Montagna MT, Bruno F, Puntillo F. Oral nystatin prophylaxis in surgical/trauma ICU patients: a randomised clinical trial. Crit Care. 2012 Dec 12;16(2):R57. doi: 10.1186/cc11300.
Clinical trial NCT04325139: External Validation of a Predictive Model for Bowel Preparation in Patients Undergoing Colonoscopy
Official title: External Validation of a Predictive Model for Bowel Preparation in Patients Undergoing Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Preparation
Colonoscopy
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective study involving eleven tertiary-centers in China.

Brief summary: Bowel preparation is closely lined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies. This study aimed to externally validate the efficiency of a procedure-based model in predicting inadequate bowel preparation


Eligibility criteria: Inclusion Criteria:

* Age≥18
* Patient undergoing colonoscopy

Exclusion Criteria:

* Patients with prior colectomy
* Unable to provide written informed consent

Primary outcomes:
measure: Adequate bowel preparation
timeFrame: 1 hour
Secondary outcomes:
measure: The rate of yellow, clear stool in the last defecation
timeFrame: 1 hour
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Department of Gastroenterology, Hongai Hospital
state: Fujian
city: Xiamen
country: China
facility: Xiang'an hospital of Xiamen University
state: Fujian
city: Qionghai
country: China
facility: Department of Gastroenterology, Qionghai people's hospital
state: Hainan
city: Shijiazhuang
country: China
facility: Department of Gastroenterology, Bethune international peace hospital
state: Hebei
city: Zhengzhou
country: China
facility: Department of Gastroenterology，Zhengzhou Central Hospital
state: Henan
city: Xi'an
country: China
facility: Department of Gastroenterology, Shaanxi Second People's Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shannxi
city: Taiyuan
country: China
facility: Department of Gastroenterology，Shanxi Bethune hospital
state: Shanxi
city: Chengdu
country: China
facility: Department of Gastroenterology，Chengdu third people's hospital
state: Sichuang
city: Shihezi
country: China
facility: Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University
state: Xinjiang
Study officials:
References:
Clinical trial NCT01068639: An Observational Study on Treatment Compliance by Children Treated With Growth Hormone
Official title: IMprove PAtient Compliance sTudy: An Observational, Cross-sectional Study on Children Treated With Growth Hormone in France
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Growth Hormone Disorder
Growth Hormone Deficiency in Children
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-02-15
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children treated for at least one year with growth hormone with any growth hormone product whatever the reason for prescription

Brief summary: This study is conducted in Europe. This observational study aims at evaluating compliance with growth hormone treatment in children and identifying factors influencing compliance.


Eligibility criteria: Inclusion Criteria:

* Child treated for at least one year with growth hormone any growth hormone product
* Followed by the participating paediatrician for at least 1 year.

Exclusion Criteria:

* Refusal to participate
* Child and/or parent unable to give consent or fill out the questionnaires
* Child participating in a therapeutic trial

Primary outcomes:
measure: Average number of injections omitted during the previous month
timeFrame: measured over the past 2 months (retrospective data collection)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06139939: Guided Bone Regeneration for Horizontal Alveolar Ridge Augmentation With Double Layer Technique
Official title: Evaluation of Double Layer Graft Technique for Horizontal Ridge Augmentation With Staged Implant Placement (A Randomized Controlled Clinical Trial With Histological Assessment)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Guided Bone Regeneration
Keywords: sausage technique
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: clinical study with guided bone regeneration for deficient alveolar ridge to restore the defect in width and be able to place implant with two different technique

Detailed description: This study will be conducted to compare the bone formation with double layer graft technique versus standard protocol in GBR for horizontal ridge augmentation with staged implant placement

Primary outcome: Evaluation of alveolar bone width gain clinically and radiographically.

Secondary outcome: Histological analysis of remodeled bone.

Eligibility criteria: Inclusion Criteria:

* 1- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire. (American Society of Anesthesiologists I; ASA I) (Mombelli and Cionca, 2006) 2- Both genders. 3- Age from 20 - 40 years old. 4- Having missing maxillary or mandibular tooth with low or moderate horizontal defect (4-8) according to cologne classification (2013) 5- Presence of sufficient bone height minimum 12 mm that does not require bone grafting or any other ridge augmentation procedure.(Shah and Lum, 2008) 6- Presence of sufficient keratinized mucosa of at least 2 mm.(Bassetti, et al. 2015)

Exclusion Criteria:

* 1- Smokers (Twito and Sade, 2014) 2- Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.

  3- Patients with poor oral hygiene or not willing to perform oral hygiene measures.

  4- Prisoners and handicapped patients. 5- Patients with periodontal or periapical infections.(Tonetti, et al. 1996)

Primary outcomes:
measure: clinical and radiographic outcome
timeFrame: 6 months
Secondary outcomes:
measure: histological analysis of remodeled bone.
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university , faculty of dentistry
Study officials:
References:
Clinical trial NCT01498939: Pharmacokinetics of Insulin Detemir in Healthy Chinese Male Subjects
Official title: A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the 24-hour Pharmacokinetics After Single Dose of Insulin Detemir in Healthy Chinese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetics after a single dose of insulin detemir in healthy Chinese male subjects.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18 and 25 kg/m\^2 (both inclusive)
* Fasting plasma glucose maximum 6 mmol/L
* Non-smoker
* Considered generally healthy upon completion of medical history, physical examination and laboratory assessments, as judged by the Investigator

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Previous participation in this trial. Participation is defined as randomisation
* Receipt of any investigational drug within the last three months prior to this trial
* History of alcohol or drug abuse

Primary outcomes:
measure: Area under the insulin detemir concentration curve
timeFrame: from time zero to 24 hour
Secondary outcomes:
measure: Area under the insulin detemir concentration curve
measure: Maximum serum insulin detemir concentration
measure: Time to maximum serum insulin detemir concentration
measure: Mean residence time (MRT)
measure: Terminal half-life
measure: Insulin detemir clearance
measure: Adverse events
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: