louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00805116: Marine Oils and Arthritis
Official title: Whale Oil Versus Cod Liver Oil in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: National Institute of Nutrition and Seafood Research, Norway
Sponsor class: OTHER_GOV
First posted: 2008-12-09
Enrollment: 7
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: NSAIDS are associated with adverse GI effects and COX-2 inhibitors have cardiovascular risk. Long-term oral supplementation with fish oil reduce e.g. joint pain in rheumatoid arthritis (R.A) patients, with reduced need for NSAIDS, in addition to being cardioprotective. The aim is to investigate if 4 month supplementation of 15 ml/day of whale blubber oil compared with cod liver oil reduce the intensity of joint pain in patients with R.A (primary outcome). Patients are assessed at inclusion and after study (4 months) during routine polyclinical visit. Patients are called for interview after 6 and 12 weeks. Secondary outcomes are e.g. morning stiffness, quality of life and functional level

Detailed description: Not relevant

Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis patients according to American College of Rheumatology criteria (with active disease and in remission). Intensity of joint pain last week (30 mm or more on 100 mm Visual analogue scale). Stable use of DMARDS and no corticosteroid injections last 4 weeks before study and during study.

Exclusion Criteria:

* Non-Norwegian speaking/reading or not understanding study design or non-compliance. Pregnant/lactating women. Bleeder disease, known HIV or hepatitis, medication with Marevan (blood thinner). Not willing or possible to stop taking regular omega-3 supplements during study.

Primary outcomes:
measure: To detect a difference in 10 mm on visual analogue scale (intensity of joint pain last week) between the two treatment groups
timeFrame: At study end (4 months)
Secondary outcomes:
measure: To detect a group difference in morning stiffness last week in minutes (720 min = 12 hours are limit for duration of morning stiffness recorded)
timeFrame: Study end (4 months)
measure: To detect a difference between groups in quality of life using SF-36
timeFrame: Study end (4 months)
measure: To see a group difference in functional level using MHAQ
timeFrame: Study end (4 months)
Other outcomes:
Locations:
Study officials:
affiliation: NIFES
name: Livar Frøyland, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00898716: Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan
Official title: Phase 1 Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-05-12
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807 when administered orally on a once daily schedule in subjects with solid tumors.


Eligibility criteria: Inclusion Criteria:

* Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group performance 0-1

Exclusion Criteria:

* Any disorder with dysregulation of glucose homeostasis
* Dumping syndrome
* History of glucose intolerance

Primary outcomes:
measure: To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days
timeFrame: Within the first 28 days
Secondary outcomes:
measure: To assess the safety and tolerability
timeFrame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
measure: To establish recommended Phase 2 dose of BMS-754807 when administered orally on a once daily schedule
timeFrame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
measure: To assess the metabolic effect on blood glucose
timeFrame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
measure: To assess the pharmacokinetics of BMS-754807 administered orally on a once daily schedule
timeFrame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
measure: To assess any preliminary evidence of anti-tumor activity
timeFrame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
measure: To explore potential biomarkers of biological response
timeFrame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks
Other outcomes:
Locations:
city: Chuo-Ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06308016: Study of the Risk of Pharyngocutaneous Fistula in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification.
Official title: Study of the Risk of Pharyngocutaneous Fistula (PCF) in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification (Fistula-score)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Laryngeal Cancer
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For the present study, data relating to patients who, in a manner, will be analyzed retrospectively consecutive, I meet the following criteria.

All patients underwent procedures and/or diagnostic-therapeutic procedures, as well as tests and assessments as required by guidelines and/or conventional clinical management

Brief summary: Multicenter retrospective study of a cohort of patients affected by laryngeal carcinoma and subjected to total laryngectomy surgery at the centers participating in the reference period and responding to inclusion criteria.

Detailed description: Evaluate the relative weight of each factor pre-operative risk, in order to build a score (fistula-score) to be able to stratify before surgery surgical total laryngectomy patients in low-risk and high-risk PCF pharyngocutaneous fistula.

Analyze and process data relating to a total of approximately 500 patients underwent, consecutively, total laryngectomy for malignant neoplasm of the larynx

The results obtained from the present study will allow patients to be stratified into low and high risk for PCF to undergo total laryngectomy, so as to reduce this surgical complication

Eligibility criteria: Inclusion Criteria:

Patients undergoing LT surgery with direct closure of the pharynx in case of:

* naïve laryngeal neoplasm (cT1-T3 and cT4a without extension to the esophagus or hypopharynx or oropharynx);
* recurrence of laryngeal neoplasm in a patient who has undergone previous surgical treatment (CO2 laser limited within the larynx or OPHL);
* recurrence of laryngeal neoplasm after RT or Ch-RT treatment;
* lack of functionality of the larynx induced by (Ch-)RT treatment;
* Availability of data according to the assessments that will have to be made, including a FU period of 2 months.

Exclusion Criteria:

* Use of flap, pedicled / free, on-lay / in-lay at the same time as LT surgery. Patients previously subjected to trans-oral surgery of the hypopharynx and/or oropharynx.

Primary outcomes:
measure: Identification of risk factors
timeFrame: 12 months
Secondary outcomes:
measure: Stratify patients
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
affiliation: IRCCS "Regina Elena" National Cancer Institute
name: Raul Pellini, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02063516: Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal
Official title: Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal - A Perspective, Randomized，Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Efficacy of Oropharyngeal Seal Pressure
Keywords: Airway Cuff
Guardian
Proseal
Cuff Pressure
laryngeal Mask Airway
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and Proseal LMA) and to observe any associated complications.

Detailed description: Condition:

The study focuses on the comparison of the ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement between the Guardian LMA and the LMA Proseal in paralyzed, anesthetized patients.

Device: Guardian Laryngeal Mask Device: LMA Proseal

Study Type:

Interventional

Study Design:

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)

Eligibility criteria: Inclusion Criteria:• Ambulatory patients scheduled to undergo knee arthroscopy, transurethral resection of bladder tumor, hand, gynecological and general surgical under a short general paralysed anesthesia of less than 2 hours (American Society of Anesthesiologists physical status I-II)

* 18 to 65 years of age
* Mallampati score less than 3
* thyromental distance more than 6.5 cm
* mouth opening more than \>2.5 cm
* a body mass index less than 35 kg/m2;

Exclusion Criteria:

* Body weight 50 Kg
* Pregnancy
* Difficult airway
* Recent history of upper respiratory tract infection and sore throats
* A history of esophageal reflux disease
* ENT surgery
* Laparoscopic surgery
* Inability to understand the Study Information Sheet and provide a written consent to take part in the study.

Primary outcomes:
measure: Oropharyngeal Seal Pressure
timeFrame: 5 min
Secondary outcomes:
measure: Anatomic Position
timeFrame: 5 min
Other outcomes:
measure: Amount of Air Added to Keep Cuff Pressure 60cmH20.
timeFrame: 30 minutes, 60 minutes, 90 minutes and 120 minutes
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References:
citation: Pajiyar AK, Wen Z, Wang H, Ma L, Miao L, Wang G. Comparisons of clinical performance of Guardian laryngeal mask with laryngeal mask airway ProSeal. BMC Anesthesiol. 2015 May 1;15:69. doi: 10.1186/s12871-015-0039-3.
Clinical trial NCT01815216: Effect of Gastric Bypass Surgery on Brain Responses
Official title: The Effects of Bariatric Surgery on Impulsivity and Attentional Bias to Food Cues
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Obesity
Hormone Responses
Cognitive Health
Keywords: Bariatric surgery
Cognition
Satiety hormones
Brain networks
Inhibitory control
Food intake
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2013-03-20
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: After obesity surgery gastric bypass (GBP) patients usually lose more than 50% of its former preponderance in relative short time (\~ 2 years). But knowledge of the underlying biological mechanisms of decline in body weight is still inadequate.

This project intends to examine patients' background activity in the brain (i.e. "the resting state activity") and brain volume using MRI both before and one year after surgery.

Detailed description: We will also investigate whether hormonal changes in response to food intake after obesity surgery is associated with patients' impulsive control when exposed to pictures of food in the MRI.

Eligibility criteria: Inclusion Criteria:

* female
* right-handed
* scheduled for bariatric surgery in the Academic Hospital of Uppsala, Sweden

Exclusion Criteria:

* undergone more than one bariatric surgery
* suffer from mental disorders (depression, phobias, etc.) that can not be controlled with treatment.

Primary outcomes:
measure: Change in background activity in the brain (resting state activity) after bariatric surgery
timeFrame: 1 year
Secondary outcomes:
measure: Change in response inhibition after bariatric surgery
timeFrame: 1 year
Other outcomes:
measure: Change in memory-function after bariatric surgery ("concentration")
timeFrame: 1 year
Locations:
city: Uppsala
country: Sweden
facility: Academic Hospital
Study officials:
affiliation: Academic Hospital Uppsala
name: Magnus Sundbom, MD
role: STUDY_DIRECTOR
affiliation: Uppsala University
name: Christian Benedict, PhD
role: STUDY_DIRECTOR
affiliation: Uppsala University
name: Pleunie Hogenkamp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06800924: Posture and Spinal Mobility in Anorexia Nervosa
Official title: Analysis of Posture and Spinal Mobility in Women Suffering From Anorexia Nervosa
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
Spinal mobility
Posture
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects admitted to the study will be recruited at the beginning of hospitalization in the Division of Eating and Nutrition Disorders (END), Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy. Thirty women suffering from anorexia nervosa clinically diagnosed based on the DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders 5; American Psychiatric Association, 2013), aged ≥ 18 years, will be studied.

As a control group, 30 normal-weight adult women (age: ≥ 18 years; BMI: 18.5-24.9 kg/m2) will be recruited from the medical/nursing and research staff.

Brief summary: The primary objective of the study is to compare the results of the postural and mobility analysis obtained with the use of the Idiag M360 instrument in adult women with anorexia nervosa and in a control group represented by age-matched normal-weight women.

Secondary objectives will be to correlate the results obtained from previous postural analyses with anthropometric parameters, the duration and onset of the disease, and the presence/date of onset of secondary amenorrhea.


Eligibility criteria: Anorexia Nervosa:

Inclusion Criteria:

* Female sex
* Age 18 years and older
* Anorexia nervosa clinically diagnosed based on the DSM-5 criteria
* Hospitalized in the Division of Eating and Nutrition Disorders (END), Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy

Exclusion Criteria:

* Absence of signed informed consent
* Musculoskeletal or neurological conditions (leg length discrepancy, spinal deformities, and physical disabilities caused by surgery)
* Treatment with anti-inflammatory drugs

Normal Weight:

Inclusion Criteria:

* Female sex
* Age 18 years and older
* BMI: 18.5-24.9 kg/m2
* Recruited from the medical/nursing and research staff

Exclusion Criteria:

* Absence of signed informed consent
* Musculoskeletal or neurological conditions (leg length discrepancy, spinal deformities, and physical disabilities caused by surgery)
* Treatment with anti-inflammatory drugs

Primary outcomes:
measure: Lateral flexion
timeFrame: Baseline
measure: Lumbar flexion
timeFrame: Baseline
measure: Lumbar extension
timeFrame: Baseline
measure: Thoracic extension
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano IRCCS, Site Piancavallo
state: Verbania
Study officials:
References:
Clinical trial NCT03755024: WHO Fetal Growth Charts
Official title: Implementation of WHO Fetal Growth Charts in Assiut,Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Growth Complications
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women attending Antenatal care clinic of Women's Health Hospital, Faculty of Medicine, Assiut university.

Brief summary: Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood. Ultrasound estimation of fetal weight before birth is today very widely used in clinical practice, and, while essential for the identification and management of high-risk pregnancies,the current reference ranges used worldwide are largely based on single populations from a few high-income countries and are therefore of uncertain general applicability.

Detailed description: Against this background, WHO made it a high priority to provide fetal growth charts for estimated fetal weight and common ultrasound biometric measurements intended for worldwide use. WHO study was conducted in 10 countries including Egypt (Assiut).The study showed that fetal growth differs significantly between countries. Growth was to a small extent influenced by maternal age, height, weight, and parity, and by fetal sex. The study suggested that these WHO charts for growth are more suitable for international use than those commonly applied today. However, the differences between countries, with maternal factors, and with fetal sex mean that these growth charts may need to be adjusted for local clinical use to increase their diagnostic and predictive performance. In our setting, we are using the charts built in the ultrasound machines based on studies done in western countries. So, it is prudent now to implement the WHO fetal growth charts in our setting

Eligibility criteria: Inclusion Criteria:

* They have body-mass index between 18-30;
* They have a singleton pregnancy;
* Their gestational age at entry is between 8+0 to 12+6 weeks based on last menstrual period.
* They have no history of health, environmental or economic constraints likely to impede fetal growth; need for long-term medication (including fertility treatment); smoking currently or in the previous 6 months; recurrent miscarriage; and any previous baby delivered pre-term (\<37 weeks) or with a birth weight \<2,500g b. Exclusion criteria:
* Multiple pregnancy
* Congenital fetal malformation (cardiac, cerebral, renal malformations, etc.)

Primary outcomes:
measure: Proportion of fetuses with abnormal fetal growth diagnosed using WHO fetal charts
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00447824: Pain Detection and Interception in Neonates
Official title: Pain Detection and Interception in Neonates During Blood Sampling
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Detection
Pain Intervention
Keywords: Pain
Neonates
NIDCAP
Venous
Capillary
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Helse sor
First posted: 2007-03-15
Enrollment: 160
Sex: ALL
Minimum age (years): 31
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis:

1. May the introduction of NIDCAP during blood sample reduced pain in neonates during blood sample
2. Compare the effect of venous and capillary blood sample method

Detailed description: introducing the: Newborn Individualized Developmental Care and Assessment Program

Eligibility criteria: Inclusion Criteria:

* Born gestation age 31-36

Exclusion Criteria:

* Infection, respiratory distress

Primary outcomes:
measure: value of Premature Infant Pain Profile
measure: Heart rate
measure: Saturation
measure: Skin conductance changes
Secondary outcomes:
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital SSHF
state: Vest Agder
Study officials:
name: Knut G Hernes, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT05097924: Gastrointestinal Tolerability of a Partially Hydrolyzed Ready-to-feed Infant Formula in Healthy Newborns
Official title: Gastrointestinal Tolerability of a Partially Hydrolyzed, Whey-based, Ready-to-feed Infant Formula in Healthy Newborns During the Birth Hospitalization Period: a Post-market Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Nutritional Physiological Phenomena
Infant Formula
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-10-28
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn infants

Brief summary: Gastrointestinal tolerability of a partially hydrolyzed, whey-based, ready-to-feed infant formula in healthy newborns during the birth hospitalization period: a post-market study


Eligibility criteria: Inclusion Criteria:

* Written informed consent has been obtained from both parents or a legally acceptable representative (LAR).
* Full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2500 g and ≤ 4500 g.
* Parent(s) must have independently elected, before enrollment, to formula feed.
* Infant age ≤ 24 hours after birth.
* Child's parents / LAR are of legal age of consent, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol.

Exclusion Criteria:

* Infant is exclusively breastfed.
* Evidence of significant cardiac, respiratory, endocrine, hematologic, gastrointestinal, or other systemic diseases, infections, or disorders.
* Infant has other condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study.
* Conditions that require infant feedings other than those specified in the protocol.
* Infant is currently participating in another interventional clinical trial that impacts study outcomes.

Primary outcomes:
measure: Parent-reported individual gastrointestinal (GI) symptoms and GI-related behaviors
timeFrame: Daily through study completion (age 2 to 5 days)
measure: Parent-reported individual GI- and feeding-related behaviors
timeFrame: At study completion (age 2 to 5 days)
measure: Number of infants with specific GI characteristics
timeFrame: Daily through study completion (age 2 to 5 days)
measure: Number of feeds per day
timeFrame: Daily through study completion (age 2 to 5 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Dr Sulaiman Al Habib Hospital
Study officials:
References: