louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01748864: Evaluation of the Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers
Official title: A Single-Center Phase I Clinical Study to Evaluate The Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Volunteers
Lead sponsor: Endocyte
Sponsor class: INDUSTRY
First posted: 2012-12-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A Phase 1, single-center, open-label, single arm, baseline-controlled (for safety) study in normal volunteers. Study will determine biodistribution and excretion of the radioactive drug substance and evaluate the safety and tolerability of 99mTC-Etarfolatide in normal volunteers.


Eligibility criteria: Inclusion Criteria:

* Subject must be 18 years of age or older.
* Subject must not have any major health problems as deemed by principal investigator.
* Subject must provide informed consent prior to enrollment.

Exclusion Criteria:

* Subject is pregnant or breast-feeding.
* Subject is simultaneously participating in another investigative drug or device study.
* Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this study.
* Subject has a known history of chronic abuse of drugs or alcohol or tests positive in pre-study urine drug abuse screen.
* Subject is currently taking folic acid supplements and cannot stop taking the supplements for a period of 8 days (7 days prior to the study and one day after last imaging procedure).
* Subject's physical condition unsuitable for radionuclide imaging.
* Subject has been administered another radiopharmaceutical that would interfere with the assessment of the biodistribution of 99mTc-etarfolatide.

Primary outcomes:
measure: Distribution of Radioactive Drug Substance
timeFrame: 24 hours
Secondary outcomes:
measure: Safety of 99mTc-Etarfolatide in Normal Volunteers
timeFrame: 4 days post-injection of EC20
measure: Tolerability of 99mTc-Etarfolatide in Normal Volunteers
timeFrame: 4 days
Other outcomes:
measure: Quality of SPECT images of Normal Volunteers with or without injection of Folic Acid
timeFrame: 24 hours
Locations:
city: Hallendale
country: United States
facility: MD Clinical
state: Florida
city: Lafayette
country: United States
facility: Horizon Oncology
state: Indiana
Study officials:
affiliation: Horizon Oncology Research, Inc.
name: Wael Harb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MD Clinical
name: Beth Safirstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00108264: Tumor RNA Transfected Dendritic Cell Vaccines
Official title: Tumor RNA Transfected Dendritic Cell Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Prostatic Neoplasms
Neoplasm Metastasis
Immunotherapy
Active
Dendritic Cells
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-04-15
Sex: MALE
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to use dendritic cells transfected with amplified RNA from autologous tumor cells to develop a vaccine strategy for the treatment of prostate cancer in patients with disseminated disease.

Detailed description: The specific aims are: 1) to evaluate, in a phase I clinical trial, the safety of vaccinating patients with dendritic cells transfected with RNA from autologous cancer cells; 2) to analyze the T cell responses induced by the treatment; and 3) to improve the efficacy of the treatment by developing methods to increase the induction of CD4+T cell responses.

Eligibility criteria: Inclusion Criteria:

* Patients with a histologically confirmed diagnosis of metastatic prostate cancer stages D1 - D3 are eligible for this study.
* They must not have a history of autoimmune disease, serious intercurrent chronic or acute illness, pulmonary disease, active hepatitis, serologic evidence for HIV, or be receiving corticosteroid or immunosuppressive therapy.

Exclusion Criteria:

* Patients will be excluded from the study if they have received chemotherapy or other forms of immunotherapy in the 6 weeks prior to study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT06953921: Correlation Between Serum Albumin Level and Severity of Hepatic Encephalopathy in Patients With Chronic Liver Disease in Sohag University Hospital
Official title: Correlation Between Serum Albumin Level and Severity of Hepatic Encephalopathy in Patients With Chronic Liver Disease in Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatic Encephalopathy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: sample size calculation will be performed based on anticipated incidence rates of HE and variability in serum albumin levels, aiming for a study population of 100patients to achieve adequate statistical power.

Brief summary: assess the correlation between serum albumin levels and the severity of hepatic encephalopathy in patients with chronic liver disease.

assess the impact of albumin level on clinical course and outcomes of HE.

Detailed description: sample size calculation will be performed based on anticipated incidence rates of HE and variability in serum albumin levels, aiming for a study population of 100-150 patients to achieve adequate statistical power.

- All patients included in the study will be subjected to : Glasgow Coma Scale (GCS) score. Clinical Assessment: Baseline evaluation of patients to confirm chronic liver disease diagnosis and determine clinical characteristics.

History of prior episodes of HE, presence of ascites, variceal bleeding, and other complications of chronic liver disease .

Age, gender, etiology of cirrhosis (e.g., viral hepatitis, alcohol), comorbid conditions (e.g., diabetes, hypertension)

* Laboratory investigation :

Serum albumin level AST ALT Total bilirubin and direct CBC Serum creatinine Proth time and concetntration

Eligibility criteria: Inclusion Criteria:

* patients aged \>18 years.
* Confirmed chronic liver disease (by imaging ,
* liver function tests , and clinical history).
* Diagnosed with hepatic encephalopathy based on clinical criteria.
* Patients able to provide informed consent.

Exclusion Criteria:

* Patients age less than 18 years old
* Acute liver failure.
* Chronic renal failure on dialysis.
* Pregnant women.
* Patients with active malignancy.

Primary outcomes:
measure: assess the correlation between serum albumin levels and the severity of hepatic encephalopathy in patients with chronic liver disease.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospital
Study officials:
References:
Clinical trial NCT04497064: Breakfast Knowledge, Beliefs, and Habits of Exercising Adults
Official title: Breakfast Knowledge, Beliefs, and Habits of Exercising Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: anyone with a valid Ohio University email address or who saw the advertisement on social media who was older than 18 and participates in structured exercise

Brief summary: This study is being done to determine typical breakfast consumption habits in various populations of exercisers. Participants will be asked a series of questions pertaining to their participation in regular exercise, their current breakfast consumption, food preferences, meal timing, and general knowledge of sports nutrition and pre-exercise breakfast consumption.

Detailed description: Participants will complete a one-time survey regarding breakfast habits and beliefs and sports nutrition knowledge, as well as the type, frequency, and intensity of exercise engaged in on a weekly basis.

Eligibility criteria: Inclusion Criteria:

* 18+ years old
* regular exerciser

Exclusion Criteria:

* younger than 18 years old
* do not regularly exercise

Primary outcomes:
measure: breakfast composition
timeFrame: Day 1
measure: breakfast habits
timeFrame: Day 1
measure: breakfast beliefs
timeFrame: Day 1
measure: sports nutrition knowledge
timeFrame: Day 1
measure: exercise habits
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University Exercise Physiology Lab
state: Ohio
Study officials:
References:
Clinical trial NCT06435364: Cervical Manual Therapy and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain
Official title: Investigation of the Effect of Instrument Supported Cervical Manual Therapy Methods and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Syndrome
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 40
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: People with chronic neck pain are becoming more and more common in society every day.

Detailed description: In chronic neck pain investigations, it is generally reported that all people experience neck pain once in my life and more than half of the developed societies experience this problem. It has been stated that 48% of these continue as chronic neck pain, which significantly affects the quality of life due to the postponement of treatment due to its cost.

Eligibility criteria: Inclusion criteria for volunteers and/or study participants;

* Presence of neck pain for at least three months
* Non-specific neck pain
* To have signed the voluntary consent form

Exclusion criteria for volunteers and/or participants;

* Having undergone surgery for the cervical region
* Rehabilitation of the neck area at least three months prior to treatment
* Traumatic medulla spinalis injury
* Neurological deficit
* Rheumatological disease
* Structural spinal disorders

Primary outcomes:
measure: Heart rate variability
timeFrame: 4 weeks
measure: Neck disability index:
timeFrame: 4 weeks
measure: Joint Range of Motion
timeFrame: 4 weeks
measure: The visual analogue scale (VAS)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahçehir University
Study officials:
References:
Clinical trial NCT06008964: The Effect of Aromatherapy Applied After Cesarean Section on Pain Intensity and Comfort Level
Official title: Determination of the Effect of Aromatherapy Using Lavender and Ylang Ylang Essential Oils on Pain Severity and Comfort Level After Cesarean Section: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Keywords: Aromatherapy
pain
ceserean
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
Collaborators: name: Şerife İrem DÖNER
name: Merve YAZAR
name: JULE ERİÇ HORASANLI
First posted: 2023-08-24
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Today, many complementary therapies such as acupuncture, reflexology, homeopathy, hypnotherapy, music and aromatherapy are tried in addition to medical methods to reduce pain and anxiety. Aromatherapy is a therapy method in which essential oils are used to protect and improve physical and psychological health. Oils can be applied directly to a single person or indirectly to people in a room by inhalation . In direct application without steam, essential oils can be applied by inhalation by dripping onto a cotton ball . It is stated that lavender aromatherapy, one of the most commonly used aromatherapies, has analgesic, antiseptic, sedative, antispasmodic and healing properties Ylang Ylang aromatherapy is stated analgesic, anti-inflammatory, antimicrobial, antiemetic,anti-tarral, carminative, sedative, antiseptic, spasmolytic properties. In the studies conducted, anxiety, labor pain, labor duration, and psychological effects of aromatherapy were examined, but no study was found in which lavender and chamomile essential oils were used and the effects of pain and comfort level were examined. The aim of this study is to determine the effect of lavender and Ylang Ylang essential oils in relieving pain and increasing comfort after cesarean section.


Eligibility criteria: Inclusion Criteria:

* 18-49 years old,
* women who have had a cesarean section

Exclusion Criteria:

* epilepsy,
* migraine,
* chronic headache,
* asthma,
* women who are allergic to fragrance sensitivities to aromatic oils

Primary outcomes:
measure: pain related to cesarean section
timeFrame: post operative 4-8-12 hours
Secondary outcomes:
measure: comfort related to cesarean section
timeFrame: post operative 4-8-12 hours
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
Study officials:
affiliation: serifeiremdoner@gmail.com
name: şerife irem döner
role: STUDY_CHAIR
affiliation: merve.yazar@karatay.edu.tr
name: Merve Yazar
role: STUDY_CHAIR
References:
Clinical trial NCT00373802: The Use of Nasal Phenylephrine in Infants With Bronchiolitis
Official title: A Randomized, Double-Blinded Placebo Control Trial of Nasal Phenylephrine in Infants With Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchiolitis
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Drops of either saline or phenylephrine are placed in the nose of infants less than 12 months of age to determine if it helps them to breathe easier.


Eligibility criteria: Inclusion Criteria:

* Age 4 weeks to 12 months; admitting diagnosis of bronchiolitis; admitted to hospital's bronchiolitis pathway, admitted during weekdays, need for nasal suctioning.

Exclusion Criteria:

* Congenital heart disease, history of hypertension, previous wheezing, prior use of inhaled corticosteroids, gestational age at birth of \<34 weeks.

Primary outcomes:
measure: Respiratory Distress Assessment Index at 5 minutes, 60 minutes, and 180 minutes.
Secondary outcomes:
measure: Respiratory rate, oxygen saturation and use of supplemental oxygen at 5, 60, and 180 minutes.
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Medical Center of Akron
name: Rachel Konda-Sundheim, MD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01807702: 13C-Pyruvate Breath Test
Official title: 13C-Pyruvate Breath Test Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: dichloroacetate
pyruvate
lactate
pyruvate dehydrogenase
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the test is to measure an enzyme called pyruvate. Subjects will fast for 12 hours and then undergo a breath test, have blood drawn, and cells from the inside of the mouth collected over a 12 hour period. The tests will be repeated at least a week later and subjects receive a dose of dichloroacetate (DCA)

Detailed description: Subjects will be screened with a history and physical and have baseline laboratory values drawn to assure that the subject is healthy.Subjects will fast for 12 hours before the test. The next day they will receive a dose of 25mg of pyruvate dissolved in 80ml of Crystal Light. The pyruvate used in this study will be prepared with a nonradioactive form of carbon, called a stable isotope. It poses no hazard to the subject's health. About 50 mls of blood will be drawn over a 120 minute time period from an IV catheter placed in the arm. Subjects will also be asked to exhale into a plastic tube about 12 times in 120 minutes to collect 13C carbon dioxide (13CO2). Cells from inside of the mouth will be collected by subjects swishing a tablespoon of mouth wash for one minute and then spitting it into a sterile plastic tube. At least one week following the first admission subjects will return to repeat the above procedure and receive 25mg of dichloroacetate (DCA) one hour before receiving the pyruvate. Then the same samples will be collected. Subjects have the option of doing the tests 4 times receiving the DCA on the last visit.

Eligibility criteria: Inclusion Criteria:- healthy volunteers

* normal history,
* normal physical
* normal baseline laboratory data.

Exclusion Criteria:

* Any illness
* Chronic health condition
* Use of street drugs
* Taking medication
* Abnormal labs Abnormal physical exam -

Primary outcomes:
measure: Effect of dichloroacetate on pyruvate dehydrogenase and 13C02 production.
timeFrame: Baseline to one year
Secondary outcomes:
measure: Blood Lactate levels and 13CO2 Response to DCA
timeFrame: Baseline to one year
measure: Conversion of 13C pyruvate to 13C pyruvate
timeFrame: Baseline to One Year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Peter W. Stacpoole, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01124721: Effects of Cognitive Training on Academic Task Performance in Attention Deficit Hyperactivity Disorder (ADHD)
Official title: Pilot Testing of Cognitive Training on Academic Task Performance in Children With Attention-deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Attention
Keywords: Cognitive training
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2010-05-17
Enrollment: 26
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Impaired WM is a central deficit in ADHD. A computerized training program, Cogmed, has been shown to increase WM capacity in children with ADHD. It is not known whether the training improves behavior associated with classroom learning, such as remaining on-task and inhibiting off- task behavior. The aim of this study is to utilize ecologically valid measures to investigate training's effect on observable ADHD behavior in conjunction with more standard measures. Subjects will be randomly assigned to a Cogmed versus an active "placebo" condition in which the tasks do not increase in difficulty level in a double-blinded fashion. The effects of the active Cogmed versus placebo computer training will be compared on measures in children with ADHD.


Eligibility criteria: Inclusion Criteria:

1. Age range 7-14
2. At least average academic and intellectual functioning via parent report.
3. Must have ADHD (by parent report of previous diagnosis or per telephone screening checklist - to be confirmed via interview and ratings)
4. Attentional, hyperactive or impulsive symptoms that interfere with functioning.

Exclusion Criteria:

1. Diagnosis of severe mental illness for example, psychotic, bipolar or major depressive disorder, (by history)
2. Mental retardation (by history)
3. English is not the primary language
4. Family does not have a computer

Primary outcomes:
measure: Restricted Academic Situations Task
timeFrame: 6 weeks
measure: Working memory measures
timeFrame: 6 weeks
measure: Rating scales
timeFrame: 6 weeks
Secondary outcomes:
measure: Fluency and attention measures
timeFrame: 6 weeks
measure: Self-control and executive functioning measures
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UCaliforniaDavis MIND Institute
state: California
Study officials:
affiliation: University of California, Davis
name: Julie Schweitzer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04355221: Pulsed Radiofrequency in Trigeminal Neuralgia
Official title: Pulsed Radiofrequency in Treatment of Classic Trigeminal Neuralgia (Prolonged Duration Versus Higher Voltage)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia
Keywords: pulsed radiofrequency
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 60
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: The current study investigated the efficacy of pulsed radiofrequency in pain reduction in TN patients and compared the efficacy and the impact on the quality of life of the standard technique with a prolonged duration technique and a higher voltage one.

Entire enrolled patients were diagnosed as classic TN according to the international headache society classification (IHS, 2013) and underwent brain MRI and MRA to exclude secondary causes. Patients were randomly divided into three groups, Group A patients underwent PRF using the standard settings, group B patients underwent PRF with prolonged duration and Group C patients underwent PRF with higher voltage. VAS and pain amplitude reduction were recorded before the intervention and 1 hour, 1 day, 1week, 1 month, 6 months and 1year after it. Quality of life was assessed before and 1 year after the intervention.


Eligibility criteria: Inclusion Criteria:

* Patients are diagnosed as classic TN according to the international headache society classification of headache disorders
* Visual analogue scale (VAS) for pain of at least 4 or more.
* Pain is refractory to medical treatment (for at least 3 months with three drugs including carbamazepine with optimum dosage) or patients who developed intolerable side effects from medications.

Exclusion Criteria:

* Symptomatic (secondary) TN: which is causes by structural lesion other than neurovascular compression such as multiple sclerosis, tumors, stroke or trauma according to the international headache society classification (IHS, 2013).

Local infection at the site of the needle puncture. Bleeding tendency or coagulopathy. Previous treatment with invasive treatments such as radiofrequency thermo coagulation, destructive chemical injection, gamma knife treatment, percutaneous balloon micro-compression or microvascular decompression.

Major mental or psychiatric disorders. History of drug abuse.

Primary outcomes:
measure: Pain amplitude reduction
timeFrame: 1 year
Secondary outcomes:
measure: RAND 36-Item Health Survey
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: