louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02078375: The PRESS RA: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis
Official title: The PRESS RA Study: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: American College of Rheumatology Research and Education Foundation
First posted: 2014-03-05
Enrollment: 23
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will evaluate if the combination of resistance exercise and protein supplementation will increase muscle strength and muscle mass among older individuals with rheumatoid arthritis (RA).

Detailed description: This study proposes a randomized trial to evaluate a tailored 16-week resistance exercise program, in combination with protein supplementation, for older individuals with RA. The exercise protocol in this study is distinctive because it combines dynamic and isometric (static) resistance exercise performed on specialized equipment that can accommodate the range of motion limitations frequently encountered in the older RA population. This study will also begin to evaluate if additional benefit can be achieved with daily protein supplementation

Eligibility criteria: Inclusion Criteria:

* age 60-95 years
* diagnosis of rheumatoid arthritis
* willing to participate in twice weekly exercise sessions

Exclusion Criteria:

* cognitive impairment
* recent heart surgery (within past 12 months)
* severe kidney disease
* use of supplemental oxygen
* presence of pacemaker
* diabetes that requires insulin for management
* allergy to soy or milk

Primary outcomes:
measure: Body composition
timeFrame: after 16 weeks
measure: Muscle strength
timeFrame: after 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Rebecca L. Manno, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04099875: Ultrasonography for Nutritional Assesment in Cirrhotic Patients
Official title: Ultrasonography of Rectus Femoris and Anterior Tibialis Muscles for Nutritional Assesment in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutrition Assessment
Keywords: nutrition,cirrhosis
Lead sponsor: National Liver Institute, Egypt
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cirrhotic patients child A,B

Brief summary: Ultrasonography of Rectus Femoris and Anterior Tibialis muscles for nutritional assesment in cirrhotic patients undergoing major abdominal surgery

Detailed description: in the study, the investigator will use ultrasound to assess the nutritional state of cirrhotic patients after major abdominal surgery,The investigator aim to assess reliability of ultrasound as a bedside,non invasive tool,The investigator will enroll 72 patients for or study which is an observational study

Eligibility criteria: Inclusion Criteria:

* hepatic patients classified as child A, B undergoing major abdominal surgery (liver resection,whipple,Splenectomy,colectomy, Common Bile Duct exploration,By pass surgery)
* 18-60 yrs old
* no past history of nutritional problems,chronic use of drugs,patients with no orthopedic issues such as skeletal fractures or immobilization

Exclusion Criteria:

* Refusal of the patient to share in the study, relevant comorbidities (renal, heart disease or COPD)
* previous immune abnormalities including treatment with corticosteroids
* neuromuscular diseases
* laparoscopic surgery
* patients on parenteral nutrition

Primary outcomes:
measure: Measurement of the diameters of the Rectus Femoris and Anterior Tibialis muscles using the ultrasound in cm and the change of these diameters over the postoperative period till the 7th day to assess nutrition status in cirrhotic patients
timeFrame: perioperative days 1,3,5,7
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: National Liver Institute
state: Menoufia
Study officials:
affiliation: Department of Anesthesia NLI
name: Amany A. Zayd, MBBCH
role: PRINCIPAL_INVESTIGATOR
affiliation: National Liver Institute
name: Eman S. Ibrahim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02194075: Methylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obsessive Compulsive Disorder
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. To test the hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic strategy to improve outcome in OCD.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Met DSM-V criteria
* Y-BOCS ≥ 16
* Course of illness ≥ 1year
* Age range between 18\~40 years old
* Junior high school education level above

Exclusion Criteria:

* Any other psychiatric axis-I or axis-II disorders
* History of epileptic seizures or any other neurological disorder
* Any other clinically relevant abnormalities in their medical history or laboratory examinations; alcohol or drug abuser

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital, Guangdong academy of medical science
state: Guangdong
Study officials:
References:
Clinical trial NCT01623375: A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects
Official title: A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the absolute bioavailability of insulin degludec (IDeg) in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
* Body mass index 18.0-27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the serum insulin degludec concentration-of s.c. administration
timeFrame: From 0 to infinity after single dose
measure: Area under the serum insulin degludec concentration-of i.v. administration
timeFrame: From 0 to infinity after single dose
Secondary outcomes:
measure: Terminal half-life for insulin degludec
timeFrame: From 0 to 30 hours after single dose
measure: Volume of distribution of insulin degludec, estimated during the terminal phase
timeFrame: From 0 to 30 hours after single dose
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02385175: The Accuracy of Tests of Eustachian Tube Function
Official title: The Accuracy of Tests of Eustachian Tube Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eustachian Tube Dysfunction
Keywords: Eustachian tube
test accuracy
clinical test
questionnaire
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with Eustachian tube dysfunction

Brief summary: The Eustachian tube links the middle ear to the back of the nose and is designed to open to allow the pressure in the air-filled middle ear to be equal to external (atmospheric) pressure. In some people this system fails to work properly leading to abnormal pressure in the middle ear, and complications such as middle ear fluid ('glue ear') or damage to the ear drum. The abnormal function of the Eustachian tube is called 'Eustachian tube dysfunction'. An affected person may feel pressure, pain or other symptoms in their ear, and their hearing can be temporarily or permanently reduced.

This study is designed to find out which of a number of simple tests is best at detecting if the Eustachian tube is performing normally. Both patient-completed questionnaires and clinical tests using specialist machines will be compared as a way of diagnosing Eustachian tube dysfunction.

A group of adults aged 18 and above, and children aged 5-17 years with normal ears, and a similar group of people that are already known to have Eustachian tube dysfunction, will both take six different tests and complete four different questionnaires. The differences in the results between the group with ETD and the healthy group will be compared. The results for each test or questionnaire will be compared to see which is best at telling the healthy and Eustachian tube function groups apart, and therefore at diagnosing Eustachian tube dysfunction. The investigators will also look to see if a combination of one or more of the tests or questionnaires is best at diagnosing the disease.

The results of this study hope to provide a test or combination of tests that can be used on a daily basis by ENT doctors. The assessment technique would also be helpful in researching and comparing new treatments for ETD.



Primary outcomes:
measure: Test sensitivity and specificity for assignment of patients to case or control groups
timeFrame: Patients will undertake each assessment once in a single session
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
Study officials:
References:
Clinical trial NCT01142375: Development and Exploration of the Feasibility of Using Locally Synthesized Small Molecule Inhibitors to Treat Human Acute Leukemia Cells
Official title: Development and Exploration of the Feasibility of Using Locally Synthesized Small Molecule Inhibitors to Treat Human Acute Leukemia Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
Keywords: AML
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-06-11
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Leukemia

Brief summary: Acute leukemias are commonly seen in elderly and have no effective therapy. In recent years, small molecule inhibitors have shown a tremendous promise in cancer treatment such as chronic myeloid leukemia and lung cancer. Thus, in this proposal, we intend to use our novel patented "indole" compound to conjugated with hydroxamic acid in histone deacetylases inhibitor, suberoylanilide hydroxamic acid and further modify its structure to generate novel small-molecule anticancer compounds. By screening acute leukemic cell lines, we will look for compounds that have shown potential for future drug development. In our preliminary studies, we have identified a novel compound, MPT0E001, to have marked growth inhibitory activity, induce apoptosis and downregulate c-Myc protein level. We intend to use MPT0E001 as a basis to develop novel compounds and test them in multiple leukemic cell lines and primary leukemia samples (Specific aim 1) and identify the mechanisms for downregulation of c-Myc and other pathways such as NF-kappaB and Akt (Specific aim 2). Once we have identified the lead compounds, we will use murine model to assess the acute toxicity profiles in different dose ranges and examine the effects of blood counts and vital organs. After toxicity study, we will test the lead compounds using in vivo xenogenic murine model using both cell lines and primary leukemia. Using this approach, we hope to develop novel compounds that are able to be used in future leukemic therapy.


Eligibility criteria: Inclusion Criteria:

* Acute Myeloid Leukemia

Exclusion Criteria:

* Hematologic malignancies other than AML

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Hsin-Gjin Eugene Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01433575: A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers
Official title: A Single-center, Open-label, Single Dose, Randomized, Two-way Cross-over Study to Investigate the Pharmacokinetics, Safety, and Tolerability of RO4917838 in Healthy Chinese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-09-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This single-center, open-label, single dose, randomized, two-way cross-over study will evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese volunteers. Subjects will be randomized to receive a single oral dose of either 10 mg or 20 mg RO4917838 and, after a washout period of at least 21 but no more than 35 days, will be re-dosed with the alternative treatment. Anticipated time on study is up to 70 days.


Eligibility criteria: Inclusion Criteria:

* Healthy Chinese male and female volunteers, 18 to 45 years of age inclusive at time of screening
* Healthy status is defined by absence of evidence of any active or chronic disease or disorder following a detailed medical and surgical history and a complete physical examination
* Body mass index (BMI) 19 to 28 kg/m2 inclusive

Exclusion Criteria:

* Pregnant or currently lactating females
* History of any clinically relevant disorder
* Any history of depressive episodes or treatment with antidepressants
* History of drug abuse within the past 2 years or positive results for drugs of abuse at screening or Day -1
* Alcohol dependence or history of this within the past 2 years or positive results for alcohol breath test at screening or Day -1
* Positive for HIV, hepatitis B or hepatitis C infection
* Regular smoker with consumption of more than 10 cigarettes a day or equivalent amount of tobacco
* Participation in a clinical study with an investigational drug or device within the last 3 months prior to dosing
* Medical history of significant drug allergies

Primary outcomes:
measure: Pharmacokinetics: Area under the concentration-time curve (AUC)
timeFrame: 12 days
measure: Pharmacokinetics: Peak plasma concentrations (Cmax)
timeFrame: 12 days
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 4 months
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05899075: Evaluation of Xylitol Wipes as an Oral Hygiene Protocol for Haemophilic Children
Official title: Evaluation of Xylitol Wipes as an Oral Hygiene Protocol for Haemophilic Children: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Haemophilia
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate xylitol wipes as an oral hygiene protocol for haemophilic children


Eligibility criteria: Inclusion Criteria:

* Hemophilic children A or B with No other systemic diseases.
* Aged (6-12 years).
* Co-operative.

Exclusion Criteria:

* Children on long-term antibiotics

Primary outcomes:
measure: dental plaque
timeFrame: One week
Secondary outcomes:
measure: Salivary levels of mutans Streptococcus
timeFrame: One week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AlAzhar U
Study officials:
affiliation: AlAzhar U
name: Hamdy Badreldin
role: STUDY_DIRECTOR
References:
Clinical trial NCT02789475: DP-R212 Pharmacokinetic Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypertension
Hyperlipidemias
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2016-06-03
Enrollment: 38
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of amlodipine and rosuvastatin in healthy adult male subjects.


Eligibility criteria: Inclusion Criteria:

* BMI 18-29
* signed the informed consent form prior to the study participation

Exclusion Criteria:

* Clinically significant disease
* Previously donate whole blood within 60 days or component blood within 14 days
* Clinically significant allergic disease
* Taken IP in other trial within 90 days
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Primary outcomes:
measure: AUCτ,ss of Amlodipine and Rosuvastatin
timeFrame: 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr
measure: Cmax,ss of Amlodipine and Rosuvastatin
timeFrame: 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Jung-gu
country: Korea, Republic of
facility: Inha university hospital
state: Incheon
Study officials:
affiliation: Inha University Hospital
name: Chul woo Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03315975: Flu Vaccine Responses in the Setting of Melanoma Treatment
Official title: Influenza Vaccine Responses in the Setting of Melanoma Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Viral Vaccines
Keywords: Influenza vaccine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. We are conducting a prospective unblinded study of influenza vaccine recipients.

Detailed description: Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. In particular, immune responses following influenza vaccination have not been studied in the setting of advanced melanoma and in the context of various anti-tumor treatments. In this study, we will look at the immune response of subjects receiving vaccination.

Eligibility criteria: Inclusion Criteria:

* adults capable of providing consent
* have a diagnosis of locally advanced or metastatic melanoma

Exclusion Criteria:

* are allergic to influenza vaccination
* have received influenza vaccination within the past 6 months
* require prednisone, methotrexate, or other immunosuppressing medications
* have HIV infection
* have a history of solid organ or bone marrow transplant
* require combination immunotherapy
* are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study

Primary outcomes:
measure: Neutralizing antibody response
timeFrame: 21-42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsyvlania
name: E. John Wherry, PhD
role: PRINCIPAL_INVESTIGATOR
References: