louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03171922: Effects of Internet-based Diet Plus Online Dietary Coach Compared With in Person Clinic Visit Approach on Weight Loss
Official title: Effects of Internet-based Diet Plus Online Dietary Coach Compared With in Person Clinic Visit Approach on Weight Loss in Healthy Obese Women in a Weight-loss Program: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: weight loss
internet-based diet
online dietary coach
clinic visit approach
Diet
Lead sponsor: Novindiet Clinic
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: Tehran University of Medical Sciences
First posted: 2017-05-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy of an internet based diet plus a regular dedicated dietary coach (ID group) versus clinic visit based weight loss program (CD group) on weight loss in obese and overweight female adults.


Eligibility criteria: Inclusion Criteria:

* Must be female
* Must be 18-45 years of age.
* Must have Body mass index (BMI) between 27-35 kg/ m².
* Must be able to have moderate exercise.
* Must be interested to have weight loss.
* Have access to a personal computer and the Internet

Exclusion Criteria:

* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medications that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Smoking
* Menopause
* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Primary outcomes:
measure: Weight
timeFrame: 1year
Secondary outcomes:
measure: Waist circumference
timeFrame: 1year
measure: fasting blood glucoses
timeFrame: 1year
measure: fasting insulin level
timeFrame: 1year
measure: HbA1c
timeFrame: 1year
measure: HOMA-IR
timeFrame: 1year
measure: lipid profiles
timeFrame: 1year
measure: liver function tests
timeFrame: 1year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NovinDiet Clinic
city: Tehrān
country: Iran, Islamic Republic of
facility: NovinDiet Clinic
Study officials:
References:
Clinical trial NCT04921839: Awareness of Operating Room Staff About WHO OR Checklist
Official title: Awareness of Operating Room Staff About WHO OR Checklist
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Safety Issues
Keywords: WHO checklist
WHO OR ckecklist
Lead sponsor: Imam Mohammad ibn Saud Islamic University
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the survey link will be send to operating room staff through hospital administration, participants bio information is never requested. Informed consent was obtained from all those agreeing to complete a survey. This study was exempt from review board approval at authors' institutions.

Brief summary: to understand and analyze awareness of proper timing of when to sing in, time out, and sign out for patients who will be operated in Hail multidisciplinary centers, Saudi Arabia. its role in improving communication in OR, and preventing errors. how frequent not comply and potentials of non compliance. how frequent dose WHO OR check list will cause anxiety in the staff, psychological insult ,potentials to be replaced or adjusted according to each specialty needs.


Eligibility criteria: Inclusion Criteria: operating room staff of hail region hospitals -

Exclusion Criteria: none

-

Primary outcomes:
measure: predictive power of respondent on awareness of WHO OR checklist
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: Central fourth Health Cluster
Study officials:
affiliation: imam mohamamd ibn saud islamic university
name: mohammad alharbi
role: STUDY_CHAIR
References:
Clinical trial NCT06444139: Probiotic Intervention for Occasional Constipation
Official title: A Randomized, Double-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of Probiotics on Gastrointestinal Function in Adults With Occasional Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Function
Occasional Constipation
Keywords: Bowel movements
Gut function
Probiotics
Lead sponsor: Probi AB
Sponsor class: INDUSTRY
First posted: 2024-06-05
Enrollment: 100
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: PREVENTION

Brief summary: The goal of this clinical trial is to study the effect of probiotics on gut function in subjects with occasional constipation. The main question it aim to answer is if intake of probiotics will decrease the transit time. Participants will randomized to either consume probiotics or a placebo product.


Eligibility criteria: Inclusion Criteria:

* Males and females aged 18 - 65 years
* With occasional constipation
* Agrees to maintain current lifestyle habits
* Healthy
* Provided voluntary, written, informed consent to participate in the study

Exclusion Criteria:

* Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
* Allergy, sensitivity, or intolerance to study products or clinical assessment materials
* Chronic constipation
* Current or history of significant diseases or abnormalities of the gastrointestinal tract (examples (include but are not limited to atrophic gastritis, celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease)
* Unstable metabolic disease or chronic diseases
* Unstable hypertension.
* Type I or Type II diabetes, cancer
* Significant cardiovascular event in the past 6 months. History of or current diagnosis with kidney and/or liver diseases
* Self-reported confirmation of current or pre-existing thyroid condition.
* Individuals with an autoimmune disease or are immune compromised
* Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis, blood/bleeding disorders
* Any other condition or lifestyle factor, that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Primary outcomes:
measure: Transit time
timeFrame: Baseline to day 56
Secondary outcomes:
measure: Bowel movements
timeFrame: Baseline to day 28 and day 56
measure: Stool consistency
timeFrame: Baseline to day 28 and day 56
measure: Bloating and flatulence
timeFrame: Baseline to day 28 and day 56
measure: Quality of life
timeFrame: Baseline to day 28 and day 56
measure: Digestive symptoms
timeFrame: Baseline to day 28 and 56
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Science Clinic
state: Ontario
Study officials:
References:
Clinical trial NCT00994539: Dose Proportionality and Food Effect of Morphine Sulfate
Official title: A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Study of the Dose Proportionality of and Effect of Food on Morphine Sulfate Tablets.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Establish the dose proportionality of the 15 mg and 30 mg morphine sulfate tablets and to examine the effect of food on absorption from the 30 mg tablet.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to morphine sulfate or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research
state: Texas
Study officials:
References:
Clinical trial NCT01320839: Effects of an Ankle-Foot Orthosis on Gait While Performing an Attention Demanding Task
Official title: Effects of an Ankle-Foot Orthosis on Gait While Performing an Attention Demanding Task in People With Poststroke Hemiplegia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Gait, Hemiplegic
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who have had a hemiplegic stroke and have an ankle-foot orthosis.

Brief summary: We hypothesize that: (1) gait stability will be increased when wearing an ankle-foot orthosis (plastic brace supporting the foot and ankle); (2) an attention demanding task will decrease gait stability and (3) the improvement in gait stability due to ankle-foot orthosis use will be greater during an attention demanding task.

Detailed description: A quasi-experimental, randomized 2 x 2 factorial within subjects study with the factor of walking condition (2 levels, walking with and without ankle-foot orthotic device) and attention condition (2 levels, walking with and without attention task).

Eligibility criteria: Inclusion Criteria:

* be over the age of 18;
* have the presence of hemiplegia after stroke;
* be wearing an ankle-foot orthosis for at least 6 weeks;
* be able to walk independently and comfortably for a minimum distance of 12 m with or without assistive aids (AFOs, canes and walkers);
* be able to read and understand English, follow verbal instructions and provide verbal answers to questions;
* be able to reach criterion on the attention task (described below)
* be competent to give informed consent as determined by clinical team and noted in the health chart

Exclusion Criteria:

* have history of balance deficits not related to stroke;
* be at high risk of falling during the study;
* suffer from severe aphasia or dementia as determined by health chart and/or initial cognitive screening using the Montreal Cognitive Assessment (MoCA) test.

Primary outcomes:
measure: Velocity
timeFrame: up to one week
Secondary outcomes:
measure: trunk acceleration
timeFrame: up to one week
measure: Step length variability
timeFrame: up to one week
measure: The Berg Balance Scale
timeFrame: up to one week
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Capital Health
state: Nova Scotia
Study officials:
affiliation: CDHA
name: Kim Parker, M.A.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00936039: Effects of Unloading on Muscle Mass
Official title: The Effect of Immobilization on Myocellular Characteristics in Healthy, Young Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immobilization
Physical Inactivity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In the present study, the effects of 3 weeks of unloading on muscle mass and muscle fiber characteristics will be determined. In addition, the effects of 6 weeks of recovery will be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy
* BMI \< 30 kg/m2

Exclusion Criteria:

* Use of medication that may affect haemostasis
* Subjects with (recent) musculoskeletal/orthopaedic disorders known to affect the outcome of the study or that compromise their ability to walk with crutches
* Subjects with metal implants in their lower limbs
* Subjects with known cardiovascular and/or haemostasis disorders
* Subjects with known severe hypertension

Primary outcomes:
measure: muscle mass, muscle fiber size
timeFrame: 1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading
Secondary outcomes:
measure: muscle strength
timeFrame: 1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht UMC
name: Luc JC van Loon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
Clinical trial NCT03292939: Progestrone and Doppler Indices
Official title: The Effect of Vaginal Progestrone on Fetal and Maternal Doppler Indices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Preterm Labor
Keywords: progestrone
doppler indices
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of our study is to assess the effect of vaginal progestrone on fetal and maternal doppler indices

Detailed description: A complete Doppler ﬂow assessment of the maternal and fetal circulation was conducted by an independent investigator blinded to the treatment, before and 48 hours after the ﬁrst administration of 400mg of vaginal progesterone, Voluson E8 (GE Healthcare, Zipf, Austria) ultrasound machine,equipped with a 3.5- MHz curvilinear abdominal transducer with color imaging capabilities, was used in all cases.

Eligibility criteria: Inclusion Criteria:

* Gestational age: 18-33 weeks
* Willing and able to give informed consent
* History of preterm labor (\<34 weeks)
* At risk for preterm labor ( increased amniotic fluid volume)
* Short cervical length (\<25mm) as incidental finding
* Presenting with actual cervical changes ( dilatation and\\or effacement) in current pregnancy

Exclusion Criteria:

* PPROM
* Contraindication to progesterone use
* Diabetic patients, have glucose intolerance
* Multiple pregnancies

Primary outcomes:
measure: change of ultrasound doppler indices.
timeFrame: before and 48 hours after progestrone admistration
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainiy Hospital
Study officials:
References:
Clinical trial NCT01771939: Phacoemulsification and 25 Gauge (25G) Vitrectomy Versus Phacoemulsification Only in Idiopathic Epiretinal Membranes
Official title: Morphologic and Functional Results After Phacoemulsification and 25 Gauge Vitrectomy Versus Phacoemulsification Only in Eyes Affected by Idiopathic Epiretinal Membranes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epiretinal Membrane
Keywords: Idiopathic epiretinal membranes
25-G surgery in idiopathic epiretinal membranes
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 60
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the difference in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, oct retinal thickness and microperimetry in 2 groups of 30 eyes each affected by idiopathic epiretinal membranes that underwent phacoemulsification and 25G pars-plana vitrectomy with internal limiting membrane (ILM) peeling (Group 1) versus phacoemulsification only (Group 2), with a follow-up length up to 5 years.

Detailed description: Idiopathic epiretinal membranes represent a common cause of visual loss in elderly population. Vitrectomy with membrane peeling is nowadays considered the gold standard in the management of such pathology, with very good results either at short-time or at long-time follow up. In case of mild visual impairment due to epiretinal membrane and associated cataract, it is reasonable to treat only the lens pathology (with phacoemulsification and intra-ocular lens (IOL) implantation). In case of symptoms or ophthalmoscopic finding worsening it is always possible to submit patients who only underwent cataract surgery to vitrectomy with membrane peeling. There are, by now, no comparative studies between these two different approaches in medical literature.

Eligibility criteria: Inclusion Criteria:

* Idiopathic epiretinal membranes symptomatic

Exclusion Criteria:

* Absence of ocular symptoms, previous retinal interventions

Primary outcomes:
measure: Visual acuity (using LogMar scale) changes from baseline to pre-defined periods after surgery
timeFrame: within 90,180,360,1360 days after surgery
Secondary outcomes:
measure: Microperimetry parameters and average macular thickness changes
timeFrame: within 90,180,360,1360 days after surgery
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Clinica Oculistica dell'Università, Ospedale Oftalmico
Study officials:
affiliation: Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy 10100
name: Marco Dal Vecchio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy
name: Antonio M. Fea, MD, PhD
role: STUDY_CHAIR
affiliation: Clinica Oculistica dell'Università, Ospedale Oftalmico Turin, Italy
name: Carlo A Lavia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04414839: Comparison of Digital Intubation (Two-finger) and Video Laryngoscopy
Official title: Comparison of Digital Intubation (Two-finger) and Video Laryngoscopy Methods During Nasogastric Tube Insertion in Intubated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubated Patients
Keywords: Digital Laryngoscopy
Endotracheal Tube
Nasogastric Tube (NGT)
Video Laryngoscopy
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Abstract Background: A number of patients referring to the emergency departments (EDs) due to airway obstruction or decreased level of consciousness require the establishment of a definite airway using intubation. On the other hand, performing Nasogastric tube (NGT) insertion is very challenging in anesthetized and intubated patients. And, a conclusive method has not yet been presented in this regard. Hence, the current study aimed at comparing Digital Intubation (two-finger) and Video Laryngoscopy methods during NGT insertion.

Materials and Methods: The present clinical trial was performed on 76 intubated patients that were randomly divided into two groups. Groups A and B underwent Video Laryngoscopy and Digital Intubation (two-finger) methods, respectively. Then, the success rate, the number of attempts to insert NGT, duration of insertion, hemodynamic parameters, and patients' satisfaction level were recorded and examined in this study.


Eligibility criteria: Inclusion Criteria:

* 18-65 year old patients that underwent rapid sequence intubation (RSI) and required NGT insertion

Exclusion Criteria:

* having skull base fracture symptoms
* coagulopathy and hemorrhagic disorders
* maxillofacial traumas leading to the deformity and disturbance in NGT insertion
* diseases and anomalies of the upper respiratory tract
* deviated nasal septum
* nostril stenosis
* esophageal disorders (esophageal stricture, esophageal varices)
* a history of head and neck radiotherapy, and
* patients intubated in and transferred from other centers
* patients with more than two unsuccessful attempts at NGT insertion were excluded from the study.

Primary outcomes:
measure: Success rate
timeFrame: Procedure (The start time was when NGT entered the selected nostril, and the end time was when the measured NGT length was fully entered the stomach.)
Secondary outcomes:
measure: Insertion duration
timeFrame: Procedure (The start time was when NGT entered the selected nostril, and the end time was when the measured NGT length was fully entered the stomach.)
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-Zahra University Hospital
Study officials:
References:
Clinical trial NCT00352339: The New Strategy for Pharmacological Treatment in People With Schizophrenia
Official title: Switch Risperidone to Aripiprazole in Early Stage of Pharmacotherapy of Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Switching
Early stage
Risperidone
Aripirazole
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2006-07-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Switching from Risperidone to Aripiprazole in early stage of pharmacotherapy will demonstrate the same efficacy as compared to risperidone continuation treatment in the treatment of schizophrenia.

Detailed description: It has been thought that D2 Blocking agent is necessary in acute as well as maintenance phase of pharmacological treatment of patients with schizophrenia. However, this classical strategy produces long term adverse events of drug such as TD, osteoporosis and some metabolic syndrome. To overcome these adverse events, new strategy for pharmacological treatment is needed.

Eligibility criteria: Inclusion Criteria:

* Schizophrenia, DSM-IV
* Acute phase

Exclusion Criteria:

* Refractory Schizophrenia
* Substance Abuse
* High risk for suicide

Primary outcomes:
measure: SANS(Scale for the Assessment of Negative Symptoms)
timeFrame: 12 weeks
Secondary outcomes:
measure: SARS(Simpson-Angus Rating Scale)
timeFrame: 12 weeks
measure: Drug Attitude Inventory
timeFrame: 12 weeks
measure: Side effect checklist
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dongrae Hospital
city: Masan
country: Korea, Republic of
facility: Dongseo Hospital
Study officials:
affiliation: Clinical Trial Center, Paik hospital
name: Joo-Cheol Shim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: