louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01763658: Oxidant Status and Effect of Antioxidant in Immune Thrombocytopenia
Official title: Evaluation of Oxidant Status in Patients With Immune Thrombocytopenia (ITP) and the Role of an Adjuvant Antioxidant Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Immune Thrombocytopenia
Keywords: ITP, antioxidant therapy, oxidant status
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oxidative stress occurs as a result of increased activity of free radical-producing enzymes, decreased activity of free radical-removing enzymes, and insufficient levels of antioxidants. The most sensitive molecules to oxidation are lipids. Loss of cell membrane elasticity, increased cell fragility, and a shortened cellular life span results from oxidation of cell membrane lipids.

Detailed description: Free oxygen radicals may have an effect on the structural and functional damage of platelets and plays a role in pathogenesis of thrombocytopenia in both, acute and chronic ITP.

Selenium is an essential mineral found in small amounts in the body. It works as an antioxidant, especially when combined with other antioxidants as vitamin E , A and C. Antioxidants neutralize free radicals and may reduce or even help prevent some of the damage they cause.

aim of this study is to assess oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP) and 6 months later.Another aim of the study is to evaluate effect of antioxidant therapy on bleeding score, platelet count and antioxidant status during 6 months follow-up.

Eligibility criteria: Inclusion Criteria:

* 1. All patients less than 18 years with primary ITP; at initial presentation with platelet count less than 40 x 109/L attended Ain Shams Hematology clinic Children hospital from January 2013 and followed-up for 6 months.

  2. For acute ITP, patients will be newly diagnosed (about one month within the diagnosis).

  3. For chronic (12-24 months) and persistent (3-12 months) ITP patients.

Exclusion Criteria:

1. Patients' platelet count more than 40 x 109/L.; or above 18 years
2. Patients with secondary cause for thrombocytopenia.
3. Patients with any there associated chronic illness affecting oxidant status

Primary outcomes:
measure: oxidant status in ITP
timeFrame: 6 month
Secondary outcomes:
measure: antioxidant therapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: hematology clinic ,pediatrics hospital, Ain Shams University hospital Cairo, Egypt
Study officials:
affiliation: Ain Shams University
name: Mohsen S Elalfy, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06352658: Efficacy of Different Treatments for Obstructive Sleep Apnea
Official title: Efficacy of Different Treatment Modalities for Obstructive Sleep Apnea: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a prospective randomized controlled clinical trial that aimed to evaluate the efficacy of three treatments for obstructive sleep Apnea OSA:

1. Conventionally constructed mandibular advancement device (MAD).
2. Digitally constructed mandibular advancement device (CAD CAM).
3. Uvulopalatopharyngeoplasty (UPPP).


Eligibility criteria: Inclusion Criteria:

* Adequate nasal air flow capacity as determined by qualified otolaryngologist
* Cases showing improvement in airway with mandibular advancement on Acoustic Pharyngometry (AP)
* Patients with the minimum component of dentition to support MDSA.
* Patients with the mandibular protrusive movement of more than 5 mm
* Body mass index (BMI) less than 30 kg/m2

Exclusion Criteria:

* Severe nasal passage obstructions or allergies
* Obesity (BMI greater than 30 kg/m2 )
* Cases with Mallampati score greater than Class 1
* Systemic complications, syndrome, or disease affecting airway
* Severe periodontal disease

Primary outcomes:
measure: Apnea hypopnea index
timeFrame: 4 months
measure: Epwoth sleeplness scale (ESS)
timeFrame: 4 months
measure: Oxygen saturation
timeFrame: 4 months
measure: Snoring index
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University, Egypt
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Mona Sabry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04353258: Research Intervention to Support Healthy Eating and Exercise
Official title: Using Behavioral Economic Strategies to Address Obesity in Economically Disadvantaged Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: weight loss, low income, behavioral economics, contingency management, episodic future thinking, mHealth
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-04-20
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to test the efficacy of a behavioral economics intervention for weight loss in adults from economically disadvantaged backgrounds.


Eligibility criteria: Inclusion Criteria:

* Age between 18-75
* BMI between 25-55kg/m2
* All sexes
* All racial/ethnic groups
* Low SES and/or report qualifying for federal, state or local benefits
* Have a smartphone and willing to use for research purposes

Exclusion Criteria:

* \<18-75\>years of age
* Report being unable to walk 2 blocks without stopping
* Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
* Are pregnant or plan to become pregnant within 1 year
* Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
* Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
* Have diabetes and are on insulin
* Report a medical condition that could jeopardize their safety in a weight loss program with diet and exercise guidelines
* Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)
* Report unable to read and write English

Primary outcomes:
measure: Weight
timeFrame: Baseline, 2 month, 6 month, 12 month, 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: UConn Weight Management Research Lab
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Tricia Leahey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01872858: Efficacy and Safety of Cilostazol in Patients of Vascular Cognitive Impairment-no Dementia (VCIND)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients of vascular cognitive impairment-no dementia (VCIND) in one group is prescribed cilostazol,in the other group is prescribed aspirin. Evaluate both of them in cognitive function, MRI and other sides at given time. The investigators hypothesize that cilostazol is more efficient and safer than aspirin in patients with VCIND.


Eligibility criteria: Inclusion Criteria:

1. Aged between 50-80, both gender；
2. Small vessel disease and associated cognitive impairment, diagnosed as VCIND；
3. Non-specific subjective symptoms (dizziness, somnolence, numbness in limbs) are acceptable.
4. Normal hepatic and renal function.
5. With good compliance.

Exclusion Criteria:

1. Aged above 80 or less than 50.
2. Dementia.
3. Cerebral infarction(\>2cm).
4. Major vascular lesion. (stenosis\>50%).
5. Cardiac cerebral infarction.
6. Intracerebral Hemorrhage.
7. Clinical manifestations cannot attribute to small vessel disease.
8. Major depression or dysfunction in speech, visual ability, hearing or aphasia that would interfere with the cognitive assessment.
9. Severe systematic organic impairment(cardiac, hepatic, renal dysfunction).
10. Thrombocytopenic Purpura.
11. History of hemorrhage in digestive system or surgery in past 3 months.
12. Previously on cilostazol treatment for more than 3 month.
13. Allergic to aspirin or cilostazol.
14. Enrolled in other clinical trials in past 3 months.
15. Lack of informed consent or compliance.
16. Contraindications for MRI scan.

Primary outcomes:
measure: changes in cognitive function
timeFrame: baseline, 3month, 6month, 1year, and 2year
Secondary outcomes:
measure: Number of Participants with Incident cerebral vascular event
timeFrame: 3month, 6month, 1year and 2year
measure: Changes of peripheral inflammatory markers level
timeFrame: baseline, 2year
measure: The progression of cerebral white matter lesion and lacunar infarction
timeFrame: baseline, 3month, 6month, 1year and 2year
measure: changes in MRI-diffused tension image(DTI)
timeFrame: baseline, 2year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Dept. of Neurology, Huashan Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT00446758: Trial of Zinc and HIV Progression in Children
Official title: Trial of Zinc and HIV Progression in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Zinc
HIV
Infants
Children
Morbidity
Child health outcomes
treatment naive
treatment experienced
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
name: Muhimbili University of Health and Allied Sciences
First posted: 2007-03-13
Enrollment: 440
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and improves growth.

Detailed description: The purpose of this study is to examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and improves growth.

Eligibility criteria: Inclusion Criteria:

* HIV Infected Children under 60 months of age presenting at HIV treatment clinics in Dar es Salaam, Tanzania

Exclusion Criteria:

Eligible for ART: CD4 cell counts \< 20% or above pediatric clinical stage of HIV disease 3 according to WHO staging system.

Severe acute malnutrition; Major congenital malformations

Primary outcomes:
measure: Morbidity from respiratory and diarrheal infections, HIV disease progression
timeFrame: every 4 to 6 months until the end of follow-up
Secondary outcomes:
measure: growth in height and weight
timeFrame: every 4 to 6 months until the end of follow-up
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University College of Health Sciences
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Eduardo Villamor, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02802358: Evaluation of Health and Social Interventions Aimed to Old People Discharged From Hospital After a Hip or Wrist Fracture Due to a Fall
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly
Wrist Fracture
Hip Fracture
Keywords: Falls
Functionality
Lead sponsor: Hospital Galdakao-Usansolo
Sponsor class: OTHER_GOV
First posted: 2016-06-16
Enrollment: 1824
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 65 or older with a hip or wrist fracture due to a fall who attended the ED of the participating hospitals

Brief summary: Objectives: To describe social and health care provided to our older patients who have been admitted in the emergency department (ED) after suffering from a hip or wrist fracture due to a fall. To compare among the different hospitals and town halls, the health and social care that participants received. To compare the functional dependency and health related quality of life (HRQoL) presented by the patients immediately and six months after a fall.

Methodology: Prospective Cohort study. One hundred and fifty patients suffering from each type of fracture (hip or wrist) will be recruited consecutively in the Basque Health System's participant hospitals sub-project. Within 3 sub-projects, more than 3000 cases are expected to be collected. Data will be collected from ED and hospital clinical records and by means of questionnaires to measure functional dependency (Barthel and Lawton indexes) and HRQoL (SF-36) requesting information on status before the fall, immediately and six months later. In addition to this, data referred to care provided to the patients by traumatologist, rehabilitation or primary care provider as well as social services in their homes after the index episode will be collected.


Eligibility criteria: Inclusion Criteria:

* Hip or wrist fracture due to an accidental fall.
* Providing informed consent.

Exclusion Criteria:

* Physical or psychological impairments that would prevent patients from properly completing the questionnaires.
* Syncope.
* No acceptance for taking part in the study.

Primary outcomes:
measure: Questionnaires to measure change in the functionality of the elderly
timeFrame: Before and 6 months after the fall
Secondary outcomes:
measure: Questionnaire to measure change in the health-related quality of life of the elderly
timeFrame: Before and 6 months after the fall
measure: Questionnaire to measure change in the performance of activities of daily living
timeFrame: Before and 6 months after the fall
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05637658: The Effect of Aerobic Exercise on Nomophobia and Anxiety
Official title: The Effect of Aerobic Exercise on Nomophobia and Anxiety in Nomophobic University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment
Primary purpose: TREATMENT

Brief summary: It was aimed to examine the effect of aerobic exercise on nomophobia and anxiety in nomophobic university students.

Detailed description: It was aimed to examine the effect of aerobic exercise on nomophobia and anxiety in nomophobic university students. There is no study in the literature examining the relationship between aerobic exercise and nomophobia in young people. Since our study will be the first to investigate the subject, we foresee that it is scientifically important and will shed light on future studies. In addition, national or international publications are planned after the study is completed.

Eligibility criteria: Inclusion Criteria:

* Individuals who scored above 22 points on the Beck anxiety scale and 60 points or higher on the nomophobia scale

Exclusion Criteria:

* any condition that may prevent the participant from exercising

Primary outcomes:
measure: Change from baseline in nomophobia score at four weeks
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Change from baseline in anxiety score at four weeks
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay Üniversitesi
Study officials:
References:
Clinical trial NCT01824758: Effect of Esmolol on Pain Due to Rocuronium
Official title: The Effect of Esmolol on Pain Due to Rocuronium Injection Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Injection Site Irritation
Keywords: esmolol, injection pain, lidocaine, rocuronium
Lead sponsor: Ankara Diskapi Training and Research Hospital
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 90 American society of anesthesiology (ASA) physical status I and II patients undergoing general anesthesia for elective surgery will be included in the study. Patients will be randomized into three groups. Group E will receive esmolol (1 mg/kg), Group IL lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL), followed by a 0.05 mg/kg rocuronium. After intravenous induction with propofol, adequate muscle relaxation for intubation will be received by 0.5 mg/kg rocuronium.

Detailed description: Patients will be observed after injection of rocuronium 0.05mg/kg, then immediately asked if they have pain in the arm. The response are assessed; discomfort, pain, and withdrawal of the hand are recorded and graded using a 4-point scale (none, mild, moderate, or severe). After the intubating dose of rocuronium, withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I and II patients
* Undergoing general anesthesia for elective surgery

Exclusion Criteria:

* Known allergy to esmolol or lidocaine
* Chronic pain
* Pregnancy
* Withdrawal of consent by the patient

Primary outcomes:
measure: The injection pain due to rocuronium
timeFrame: 1 month
Secondary outcomes:
measure: Score on pain due to injection of rocuronium
timeFrame: 1 month
Other outcomes:
measure: To assess patient satisfaction
timeFrame: 1 Month
Locations:
city: Ankara
country: Turkey
facility: Diskapi Teaching and Research Hospital
state: Altindag
Study officials:
affiliation: Diskapi Teaching and Research Hospital
name: Fakelma 05327079113
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01420458: Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012
Official title: A Randomized, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of Two Formulations of BG00012.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: bioequivalence
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2011-08-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.

Detailed description: This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of BG-00012 given in capsule form..

Eligibility criteria: Inclusion Criteria:

* Must give written and informed consent and any authorizations required by local law.
* Males and females 18 - 55 years old inclusive at time of consent.
* Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion Criteria:

* History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
* Known history of or positive test result for Human Immunodeficiency Virus (HIV)
* History of severe allergic or anaphylactic reactions.
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic,metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric and renal or other major disease, as determined by the Investigator.
* Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator, and any screening values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin, or creatinine above the upper limit of normal, or an out of normal range screening value for white blood cells (WBC).
* Current enrollment in any other drug, biologic, or device study.

Primary outcomes:
measure: Area under the plasma concentration curve as a measure of PK.
timeFrame: Participants will be followed during the duration of the study, 4 days. Samples taken at -15mins, 30 mins, 60 mins, 90 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 10 hrs, 12 hrs
Secondary outcomes:
measure: The number of AEs in participants as a measure of safety and tolerability.
timeFrame: Participants will be followed during the time of study - an estimated four days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
Study officials:
References:
Clinical trial NCT02755558: Effects of Energy Density and Portion Size of Milk in Preschool Children
Official title: Effects of Energy Density and Portion Size of Milk in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behaviors
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-04-29
Enrollment: 143
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the investigators varied both the energy density and portion size of milk served with a meal commonly consumed by preschool children. The milk used in this study is commercially available and reflects typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of milk energy density and portion size on preschool children's intake of the milk and the simultaneously served meal. The effect of milk energy density and portion size on children's total energy intake at the meal will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Children must be enrolled in participating childcare centers

Exclusion Criteria:

* Allergy or intolerance to any of the foods or beverages served

Primary outcomes:
measure: Difference between experimental conditions for milk, food, and total intake by weight
timeFrame: once a week for 4 weeks
measure: Difference between experiential conditions for milk, food, and total intake by energy
timeFrame: once a week for 4 weeks
Secondary outcomes:
measure: Meal energy density
timeFrame: once a week for 4 weeks
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Barbara J Rolls
role: PRINCIPAL_INVESTIGATOR
References: