louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04584918: An Open Label Study to Assess the Effect of Euryco-10® Oral Dietary Supplement in Senior Men
Official title: An Open Label Study to Assess the Effect of Euryco-10® Oral Dietary Supplement on Total Testosterone, Sex Drive and Energy Level in Senior Men
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Aging
Lead sponsor: Innovus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 12
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: To evaluate the effect and support the tolerance of orally ingested formulation containing Eurycoma longifolia dietary supplement (Euryco-10) on a cohort of senior men.

Detailed description: This is a single-center, single arm, open label study in senior men. This study will investigate the effect and tolerance of oral ingestion of Euryco-10. Subjects meeting all inclusion and none of the exclusion criteria will be enrolled and provided with study dietary supplement. Subjects will be instructed to take 2 capsules per day for 35 days. Administration and any adverse events will be recorded in the subject diary. At each clinic visit (Day 0, Day 21 and Day 35) the Subject will complete the AMS Questionnaire.

Eligibility criteria: Inclusion Criteria:

Male ≥ 55 years of age

Exclusion Criteria:

Severe lower urinary tract symptoms.

Current use of any herbal and/or nutritional supplements that can interfere with testosterone.

A history of cancer except melanoma skin cancer.

Currently receiving treatment with cancer chemotherapy or antiandrogens.

Chronic use of systemic glucocorticoids (use within \>14 days up to the 3months prior to screening); use of non-testosterone anabolic steroids within12 months prior to screening.

History of frequent opioid use \>1 time/week during any week within 30 days prior to screening.

Have a history of known angina.

Have a history of severe liver disease or clinical evidence of hepatic impairment at screening.

Untreated severe obstructive sleep apnea.

Allergies to any of the ingredients in Euryco-10® or BioPerine.

Any condition which would interfere with the subject's ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results

Primary outcomes:
measure: Change in serum total testosterone concentration compared to baseline
timeFrame: Day 0, Day 21 and Day 35
Secondary outcomes:
measure: Change in Q 9 of the AMS Questionnaire
timeFrame: Day 0, Day 21 and Day 35
measure: Change in Q17 of the AMS Questionnaire
timeFrame: Day 0, Day 21 and Day 35
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
Study officials:
References:
Clinical trial NCT00188318: Hardwins - Squamous Cell Carcinoma Head & Neck (Surgery/RT)
Official title: A Phase II Study of Hyperfractionated Accelerated Radiotherapy Delivered With Integrated Neck Surgery for Node-positive Cases in Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Squamous Cell
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-09-16
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is examining the effects of increasing the dose of radiation given to treat head and neck cancer. Radiation doses to the primary cancer are higher than usually given; lymph glands of the neck will also be treated at a lower dose. Surgery on the lymph glands my be necessary in the future. Radiation treatments given in small fractions twice a day allows a higher dose to be delivered than if the treatment was given once a day. This study will enroll patients at three sequential increasing dose levels. Approximately 40 patients will be enrolled at each dose level.


Eligibility criteria: Inclusion Criteria:

* Histologically proven squamous cell carcinoma
* Larynx \& pharynx (except Nasopharyngeal carcinoma)
* Stage III \& IV, but any stage hypopharynx
* Informed Consent

Exclusion Criteria:

-

Primary outcomes:
measure: Toxicities as per CTCAE
timeFrame: 1 yr
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: John Waldron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05000918: Functional Food Application of Okara Protein Hydrolysate (OPH)- for Anti-exercise-fatigue
Official title: Functional Food Application of Okara Protein Hydrolysate (OPH)- for Anti-exercise-fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: National Taichung University of Education
First posted: 2021-08-11
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the anti-exercise-fatigue effects of okara protein hydrolysate (OPH) in men

Detailed description: Each subject must undergo a cardiopulmonary capacity test to assess the maximum oxygen uptake 1 week before the intervention (day 1), and then eat the test food for 4 weeks (day 8 to day 35). Before and after the intervention (the 8th and 35th day), posture measurement, diet questionnaire survey and endurance exercise ability test were carried out. The trial period was 35 days. The subjects will take blood samples before, during, after, and 30 minutes and 60 minutes after the end of the two endurance exercise tests. During the whole period of participating in the program, blood will be collected 10 times, each with a blood volume of 15 mL. Gas is collected during the period and within 1 hour after exercise. Gas is collected every 15 minutes and 1 minute at a time. Analyze his exercise time, oxygen intake and blood biochemical value.

Eligibility criteria: Inclusion Criteria:

* The subject is a male and aged 20-40.
* The subject has a usual exercise habit (exercising 2 times or more per week) and did not participate in professional sports competitions or professional sports training during the study period.
* No smoking or drinking habits.
* No food allergies and the liver function is normal.
* No cardiovascular diseases or other chronic diseases, and no serious illnesses requiring hospitalization during the study period.
* The subject can understand the test process described in the consent form and the possible potential risks and benefits, and can sign the consent form.
* The subject can accept dietary control during the trial period.

Exclusion Criteria:

* Those who have taken nutritional supplements containing branched-chain amino acids.
* Those who cannot complete the endurance exercise ability test.
* Those who are diagnosed with kidney disease, heart disease, or cancer and are still under active treatment.
* Have used other drugs, whose pharmacological effects may affect fatigue.
* Subjects who have systemic infections and require systemic antibiotics.

Primary outcomes:
measure: Change the metabolic substances level after intervention
timeFrame: 8th day, 35th day
Secondary outcomes:
measure: Change the exercise time after intervention
timeFrame: 8th day, 35th day
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
state: South
Study officials:
References:
Clinical trial NCT01765218: Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
Official title: Topiramate as an Adjuvant to Therapeutic Hypothermia for Infants With Hypoxic Ischemic Encephalopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hypoxic Ischemic Encephalopathy
Keywords: Hypoxic ischemic encephalopathy
HIE
Perinatal depression
Whole body cooling
Therapeutic hypothermia
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 34
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.

Detailed description: Hypoxic ischemic encephalopathy (HIE) is a devastating and unexpected disease in newborns that affects 1.5-2.6 per 1000 live births. Hypoxic ischemic encephalopathy has a mortality rate of up to 30% and survivors are at significant risk for adverse long-term outcomes, including seizures, cerebral palsy, and developmental delay. The investigators propose a randomized controlled study comparing therapeutic hypothermia alone, or therapeutic hypothermia combined with topiramate. The investigators hypothesize that adjuvant therapy with topiramate will reduce short term severity of HIE including seizures (the primary outcome), a composite HIE severity score, and reduce the time of normalization of the amplitude integrated EEG (aEEG). The investigators further hypothesize, that it will improve longer term outcomes such as developmental outcome. The primary hypothesis is that seizures before hospital discharge (or before 4 weeks post-natal age (which ever is earlier)) will be significantly reduced in the topiramate group compared to the control group

Eligibility criteria: Inclusion Criteria:

In order to be eligible for cooling the baby must meet all three of the following sets of criteria

1. Be near term (typically ≥34wks gestation) and be aged \< 6h old
2. Have signs of early perinatal depression (EITHER 10 minute Apgar score \< 5, OR pH \< 7.00 within 60mins of age, OR Base Excess \< -12 within 60mins of age, OR need respiratory support at 10min of age due to respiratory depression)
3. Have signs of moderate or severe encephalopathy based on either clinical examination or on amplitude integrated aEEG assessment

Exclusion Criteria:

1. Known congenital myopathy
2. Known congenital neuropathy

Primary outcomes:
measure: Number of Patients With Seizures
timeFrame: At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier)
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: UC Davis
name: Kristin R Hoffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00769418: Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Multiple Oral Dose Study, to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0822 in Healthy Male and Postmenopausal Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-09
Enrollment: 62
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: TREATMENT

Brief summary: This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).


Eligibility criteria: Inclusion Criteria:

* Subject is a male between the ages of 18 and 45 or a female less than or equal to 70 years of age
* Females must be past menopause
* Subject is a nonsmoker
* Subject is willing to avoid excessive alcohol consumption during the study and is willing to avoid alcohol entirely for 24 hours prior to drug administration and during PK sampling
* Subject is willing to refrain from consuming grapefruit or grapefruit juice

Exclusion Criteria:

* Subject has a history of multiple/severe allergies to drugs or food
* Subject has donated blood within 4 weeks of starting the study
* Subject has a history of metabolic bone disease, urolithiasis, or bisphosphonate treatment
* Subject has any infections or any condition leading to immune problems, including HIV
* Subject regularly uses illegal drugs
* Subject consumes more than 3 alcoholic beverages per day
* Subject drinks 4 or more caffeinated beverages per day
* Subject uses any prescription or nonprescription medications

Primary outcomes:
measure: Safety and tolerability of multiple oral doses of MK0822
timeFrame: After 14 days of treatment for men and 21 days for women
Secondary outcomes:
measure: PK profile of MK0822
timeFrame: predose and at selected time intervals postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Stoch SA, Zajic S, Stone J, Miller DL, Van Dyck K, Gutierrez MJ, De Decker M, Liu L, Liu Q, Scott BB, Panebianco D, Jin B, Duong LT, Gottesdiener K, Wagner JA. Effect of the cathepsin K inhibitor odanacatib on bone resorption biomarkers in healthy postmenopausal women: two double-blind, randomized, placebo-controlled phase I studies. Clin Pharmacol Ther. 2009 Aug;86(2):175-82. doi: 10.1038/clpt.2009.60. Epub 2009 May 6.
Clinical trial NCT00306618: Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma
Official title: A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy of Panzem Nanocrystal Colloidal Dispersion Administered Orally to Patients With Recurrent Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Glioblastoma Multiforme
Lead sponsor: CASI Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-03-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme (GBM)


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of a 1st or 2nd recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma).
* 18 years or older
* An interval of at least 2 weeks between prior surgical resection or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks)
* Karnofsky performance score equal to or greater than 70%
* Hematocrit greater than 29%, absolute neutrophil count greater than 1,500 cells/micro liters, platelets greater than 100,000 cells/ micro liters
* Serum creatinine less than 1.5 X upper limit of normal (ULN), serum SGOT less than 2.5 X ULN; and bilirubin less than 1.5 times ULN
* Signed informed consent form and authorization for use and disclosure of protected health information approved by the IRB prior to patient entry
* Agree to use effective contraceptive methods

Exclusion Criteria:

* Current, active systemic bleeding or excessive risk of bleeding
* Be pregnant or lactating; not employing effective birth control
* Concurrent severe and/or uncontrolled medical disease
* Impairment of gastrointestinal (GI) function/disease
* Requirement for therapy with coumadin (warfarin sodium)
* Patient is less than 5 years free of another primary malignancy
* Patients unwilling to or unable to comply with the protocol
* Grade 2 or greater peripheral sensory neuropathy

Primary outcomes:
measure: 6 month progression free survival and median overall survival
timeFrame: time of progression; survival
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: The Brain Tumor Center, Duke University Medical Center
state: North Carolina
Study officials:
affiliation: The Brain Center at Duke, Duke University Medical Center
name: David A. Reardon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06775418: Comparison Between Ultrasound Guided Erector Spinae Plane Block and Dexmedotomidine in Lumber Spine Surgeries.
Official title: Comparison Between Ultrasound Guided Erector Spinae Plane Block and Dexmedotomidine in Lumber Spine Surgeries.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Analgesia, Postoperative
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ultrasound (US) guided Erector spinae plane block (ESPB) as a new trunchal fascial plane block technique was proposed in 2016. US guided ESPB has aroused the interest of many nerve block experts. The goal of this study is to evaluate the effect of US guided ESPB versus (VS) intravenous Dexmedotomidine on postoperative analgesia and intra operative hemodynamic parameters in lumbar spine surgeries.

The aim of this study is to compare the efficacy of ESPB to intravenous Dexmedetomidine in patients who are undergoing elective lumber spine surgeries regarding the effect on postoperative analgesia and intra operative hemodynamic parameters.

Detailed description: The use of US guided ESPB in lumbar spine surgery has not been extensively studied in clinical research. Although there is limited research available, some studies have highlighted differences in the mechanism and effectiveness of the block in different regions of the erector spinae muscle. Some scholars question the practicability of US guided ESPB in lumbar surgery. This suggests that further investigation is needed to understand the practicality and potential benefits of using ultrasound-guided ESPB in lumbar spine surgery.

Dexmedetomidine, a highly selective α₂ receptor agonist, has a sympatholytic, sedative, amnestic and opioid sparing effect. It does not cause respiratory depression and can therefore be used as an adjuvant in certain clinical settings .

Eligibility criteria: Inclusion Criteria:

* ASA I and II patients. aged 18 to 50 years. 70 to 80 kg.

Exclusion Criteria:

* patients under 18 years of age.

  * History of Allergic reactions to study drugs.
  * Opioid or analgesic abuse, and chronic treatment with opioids, or nonsteroidal anti-inflammatory drugs.
  * History of bleeding tendency or coagulopathy

Primary outcomes:
measure: (VAS) during the 1st 24 hours
timeFrame: 24 HOURS
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT02506218: Optimizing Meal and Snack Timing to Promote Health
Official title: Optimizing Meal and Snack Timing to Promote Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will be conducted using standardized techniques to collect blood samples via an acute, randomized, cross-over design. Subjects will be provided all of their meals the day prior to testing and participate in 3 testing days with a minimum of 1 week break between testing days and a maximum time commitment of 7 weeks. A trained phlebotomist will place a catheter and collect blood samples from an antecubital vein using sterile techniques.


Eligibility criteria: Inclusion Criteria:

25-39 years old

* BMI between 22-37 kg/m2
* Weight stable (± 4.5 kg) for the previous 3 months
* Not currently (or within the past 6 months) following a vigorous exercise regimen or weight loss program
* No acute illness
* Not smoking
* Not diabetic
* Not pregnant or planning pregnancy in the next 3 months
* Lactose tolerant
* Willing to limit purposeful activity for 48 hours prior to each testing day
* Willing to consume study foods and beverages.

Exclusion Criteria:

* \<25 or \>39 years old, BMI \<22 or \>37 kg/m2
* Currently (or within the past 6 months) following a vigorous exercise regimen greater than -3 - 45 minute exercise sessions per week
* Currently following a weight loss program where subject has lost greater than 4.5 kg
* Acute illness
* Smoking
* Diabetic
* Pregnant or planning pregnancy in the next 3 months
* Lactose intolerant
* Unwilling to consume study foods and beverages
* Peri and post-menopausal women.

Primary outcomes:
measure: Plasma amino acid concentration
timeFrame: 7 weeks
Secondary outcomes:
measure: Blood glucose concentration
timeFrame: 7 weeks
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
Clinical trial NCT04985318: Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of aTTP
Official title: Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)- REACT-2020
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acquired Thrombotic Thrombocytopenic Purpura
Keywords: aTTP
caplacizumab
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female subjects with confirmed diagnosis of an acute episode of aquired thrombotic thrombocytopenic purpura, who have been treated with one dose of caplacizumab.

Brief summary: The objective of this national, prospective, multi-centre observational study is to describe the prescription rational and practice in Germany, confirm the efficacy of caplacizumab in a real-world setting, and identify predicting factors in iTTP-patients with regard to persistent autoimmune activity, therapy guidance and risk of complications. The rational is to develop new treatment algorithms that optimize overall patient outcome and reduce treatment cost.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of an acute episode of acquired thrombotic thrombocytopenic purpura
* Treatment with at least one single dose of caplacizumab (10 mg i.v. or s.c.)
* Male or female patients ≥ 18 years of age
* signed written informed consent

Exclusion Criteria:

* Hereditary thrombotic thrombocytopenic purpura
* disability to give informed consent

Primary outcomes:
measure: Treatment of aTTP with caplacizumab
timeFrame: Enrollment
Secondary outcomes:
measure: Stabilization of thrombocyte
timeFrame: Enrollment
measure: Normalization of LDH
timeFrame: Enrollment
measure: Normalization of haptoglobin
timeFrame: Enrollment
measure: Risk factors for complications
timeFrame: Enrollment
measure: Risk factors for adverse outcomes
timeFrame: Enrollment
measure: Risk factors for persistent autoimmune activity
timeFrame: Enrollment
measure: Parameters for therapy guidance
timeFrame: Enrollment
measure: Effect of caplacizumab on adjunct treatments with PEX
timeFrame: Enrollment
measure: Effect of caplacizumab on adjunct treatments
timeFrame: Enrollment
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
affiliation: Department II of Internal Medicine, University of Cologne
name: Linus Völker, MD
role: PRINCIPAL_INVESTIGATOR
References: