louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01850810: Evaluation of a Nutritional Product for People With Type 2 Diabetes
Official title: Evaluation of a Nutritional Product for People With Type 2 Diabetes (T2DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2013-05-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this trial is to evaluate a nutritional product for people with Diabetes.


Eligibility criteria: Inclusion Criteria:

* Subjects will be eligible for the study if they meet all of the following inclusion criteria:

  1. Diagnosis of Type 2 Diabetes.
  2. Age between 18 and 75 years.
  3. HbA1c \> 6.0 but ≤ 8.5
  4. If female and of childbearing potential , subject is non-pregnant, non- lactating, at least 6 weeks postpartum and agrees to practice birth control throughout study duration.
  5. BMI is \> 18.5 kg/m2 and \< 40.0 kg/m2.
  6. Chronic medication dosage must be stable for at least two months prior to Screening Visit.
  7. Subject states that they are a habitual consumer of a morning meal.

Exclusion Criteria:

* Subjects will be excluded from the study if they meet any of the following criteria:

  1. Use of exogenous insulin or GLP-1 agonists for glucose control.
  2. Diagnosis of Type 1 diabetes.
  3. History of diabetic ketoacidosis.
  4. Current infection (requiring medication or hospitalization), has received corticosteroid treatment in the last 3 months, or has had surgery or received antibiotics in the last 3 weeks.
  5. Active malignancy.
  6. Significant cardiovascular event \< 12 weeks prior to study entry.
  7. End stage organ failure or status post organ transplant.
  8. Active metabolic, hepatic, or gastrointestinal disease.
  9. Chronic, contagious, infectious disease.
  10. Currently taking herbals, dietary supplements, or medications (other than antihyperglycemic medications) that could profoundly affect blood glucose.
  11. History of fainting or other adverse reactions in response to blood collection.
  12. Clotting or bleeding disorders.
  13. Allergy or intolerance to study product ingredient.

Primary outcomes:
measure: Hunger
timeFrame: Treatment Visit Week 1 and Treatment Visit Week 2
Secondary outcomes:
measure: Fullness
timeFrame: Treatment Visit Week 1 and Treatment Visit Week 2
measure: Desire to Eat
timeFrame: Treatment Visit Week 1 and Treatment Visit Week 2
measure: Prospective Consumption
timeFrame: Treatment Visit Week 1 and Treatment Visit Week 2
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Amy Devitt-Maicher, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06420310: Pesticides and Parkinson´s Disease
Official title: Prevalence of Preclinical and Prodromal Parkinson´s Disease in Subjects Exposed to Pesticides
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pesticide-Induced Parkinsonism
Lead sponsor: Hospital Universitario de Burgos
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 260
Sex: ALL
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects not diagnosed with PD living in Burgos region

Brief summary: The aim of this project is to study whether people exposed to pesticides have a higher risk of developing PD. We will perform an epidemiological study determining the presence of pesticides in urine and comparing signs traditionally associated with PD in early forms.

Detailed description: Within different risk factors, pesticide exposure increases the risk of developing Parkinson's disease (PD) through epigenetic mechanisms by modifying the expression of genes related to PD and secondary mitochondrial dysfunction.We will conduct a cross-sectional prevalence study with cases (exposed to pesticides) and controls (not exposed to pesticides), randomly selecting 130 individuals in each group. Pesticide exposure will be determined through questionnaires.We will study the prevalence of preclinical and prodromal PD based on pesticide exposure, stratified by age and gender in the exposed, and non-exposed groups. Preclinical and prodromal PD will be assessed using: biological biomarkers and prodromal PD signs. Multivariate analyses will be employed to determine the risk of presenting early PD, adjusting for different clinical covariates. The results of this study will allow us to understand the early mechanisms associated with neurodegeneration and pesticides exposure.

Eligibility criteria: Inclusion Criteria:

* Farmers exposed to pesticides for cases
* No work exposure to pesticides for controls

Exclusion Criteria:

* Subjects without signed consent form
* Neurological significant conditions

Primary outcomes:
measure: Prodromal PD
timeFrame: over the last year
Secondary outcomes:
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
Study officials:
References:
Clinical trial NCT02597010: A 2 Week, Crossover Trial of Dietary Nitrate in HTN
Official title: Dietary Nitrate for Resistant Hypertension: A Randomized, Placebo-controlled, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: University College Dublin
name: Connolly Hospital Blanchardstown
First posted: 2015-11-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations including newly diagnosed, untreated hypertensives. The additional effect in hypertensives on blood pressure lowering medications is uncertain.

Detailed description: Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations including newly diagnosed, untreated hypertensives. The additional effect in hypertensives on blood pressure lowering medications is uncertain.

The investigators hypothesize that chronic nitrate consumption might decrease blood pressure in hypertensives who are suboptimally controlled on at least one blood pressure medication compared to a placebo beetroot juice.

This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint ambulatory blood pressure will be assessed in conjunction with demographics and blood draw. After baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 7 consecutive days when assessments will be repeated followed by 7 days of placebo and endpoint assessments or the converse.

Eligibility criteria: Inclusion Criteria:

* Clinically stable,
* Uncontrolled hypertension

Exclusion Criteria:

* Pulmonary hypertension
* Active CVD
* Taking vasodilators
* Diabetes mellitus

Primary outcomes:
measure: Change in day ambulatory blood pressure
timeFrame: Day 1, day 15, day 29
Secondary outcomes:
measure: Change in plasma nitrate
timeFrame: Day 1, day 15, day 29
measure: Change in 24h ambulatory blood pressure
timeFrame: Day 1, day 15, day 29
measure: Change in night ambulatory blood pressure
timeFrame: Day 1, day 15, day 29
measure: Change in cardiac biomarkers
timeFrame: Day 1, day 15, day 29
measure: Change in plasma nitrite
timeFrame: Day 1, day 15, day 29
measure: Change in inflammatory biomarkers.
timeFrame: Day 1, day 15, day 29
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04645810: A Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence
Official title: A Pilot Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
HDR
Keywords: Brachytherapy
Prostate Cancer
High-Dose-Rate (HDR)
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn more about what effects the use of high-dose-rate (HDR) brachytherapy on prostate cancer recurrence, seen by AXUMIN PET scan, has on prostate cancer.

Detailed description: In this study the investigator would like to better understand the use of high-dose rate (HDR) brachytherapy to target only recurrent prostate cancer that can be seen by AXUMIN PET scan. The use of HDR brachytherapy for prostate cancer is not new, but it is a more recent advancement to use it to treat only what can be seen instead of the whole prostate.

Eligibility criteria: Inclusion Criteria:

History of histologically confirmed, clinically localized adenocarcinoma of the prostate treated with external beam radiation, brachytherapy, or combination of external beam radiation and brachytherapy, with curative intent completed at least 24 months ago F-18 fluciclovine (AXUMIN) PET scan within 90 days prior to registration demonstrating recurrent lesion within the prostate gland Biopsy confirmation of disease recurrence within the prostate gland Age ≥ 18 KPS ≥ 70% Suitable candidate for brachytherapy based on established criteria IPSS score \<16 No pelvic arch interference No Rectal fistula/fissure Fit for general or spinal anesthesia No history of urethral stricture Ability to understand, and willingness to sign the written informed consent

Exclusion Criteria:

Evidence of metastatic or nodal disease outside of the prostate gland on AXUMIN PET scan within 90 days prior to enrollment Patient unable to have MRI Patients with neuroendocrine or small cell carcinoma of the prostate TURP within 6 months prior to enrollment History of Crohn's disease, ulcerative colitis, or known radiation proctitis Inability to understand spoken and written English

Primary outcomes:
measure: Number of patients with prostate-specific antigen (PSA) levels rising of 2ng/ml or above
timeFrame: 6 Months
measure: Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
timeFrame: 6 Months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 6 Months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester Wilmot Cancer Center
name: Hong Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03293810: Glybera Registry, Lipoprotein Lipase Deficient (LPLD) Patients
Official title: Glybera Registry, Long-term Safety and Efficacy Follow-up in Lipoprotein Lipase Deficient (LPLD) Patients Treated With Alipogene Tiparvovec (GLYBERA®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lipoprotein Lipase Deficiency
Familial Hyperlipoproteinemia Type 1
Familial Hyperchylomicronemia
Lead sponsor: UniQure Biopharma B.V.
Sponsor class: INDUSTRY
First posted: 2017-09-26
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with GLYBERA®, either during their participation in a clinical trial or in the commercial setting till October 25th, 2017

Brief summary: Lipoprotein lipase deficiency (LPLD) is a rare autosomal recessive disorder, characterized by loss-of function mutations in the LPL gene, leading to the inability to produce functionally active lipoprotein lipase (LPL). LPL is the key enzyme in the metabolism of triglyceride (TG)-rich lipoproteins (chylomicrons (CM) and very low-density lipoproteins (VLDL)). LPLD results in extremely high concentrations of circulating TG-rich lipoproteins.

No drug therapy for LPLD is currently available. Clinical management of LPLD patients consists of severe dietary fat restriction and the use of medium-chain triglycerides to substitute for normal dietary fats.

Alipogene tiparvovec (Glybera®) received marketing authorisation from the European commission on 25 October 2012. Glybera® aims to correct lipoprotein lipase deficiency sufficiently to decrease the morbidity and lower the risk of inherent complications of LPLD, in adult patients genetically diagnosed with LPLD.

The Glybera Registry is designed to collect the long-term safety and efficacy data of GLYBERA®

Detailed description: All patients treated with GLYBERA®, in a clinical trial and when GLYBERA® was commercially available who are currently participating in the LPLD Registry (Long term follow up of safety and efficacy in LPLD), will be asked to continue their participation in this Glybera Registry to collect long-term safety and efficacy data.

Eligibility criteria: Inclusion Criteria:

* All patients treated with GLYBERA®, either during their participation in a clinical trial or in the commercial setting till October 25th, 2017 (= expiration date of Marketing Authorization of GLYBERA®), and
* Who are currently participating in the LPLD Registry

Exclusion Criteria:

* None

Primary outcomes:
measure: Long-term collection of Safety and Efficacy of GLYBERA®, as measured by collection of Adverse Events, Immunological responses and information on Pancreatitis-events
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Interdisciplinary Metabolism Center, Lipid Out-Patient-Clinic, Lipid Apheresis, Charité, University of Berlin
Study officials:
affiliation: Universitaria Policlinico Paolo Giaccone, Palermo
name: Maurizio Averna, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT04781010: Characterization and Outcome of Children With Leukodystrophy: An Observational Study at Sohag University Hospital
Official title: Characterization and Outcome of Children With Leukodystrophy: An Observational Study at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Children With Leukodystrophy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include children with leukodystrophy diagnosed and followed-up at the pediatric neurology clinic of Sohag University Hospital during the period of the study.

Brief summary: Leukodystrophies are heterogeneous genetic disorders characterized by the selective involvement of white matter in the central nervous system (CNS) (1, 2). Inherited leukodystrophies are diseases of the myelin, including abnormal myelin development, hypomyelination, or degeneration of myelin (3, 4).

Most of these disorders fall into one of three categories; lysosomal storage diseases, peroxisomal disorders, and diseases caused by mitochondrial dysfunction and each leukodystrophy has distinctive clinical, biochemical, pathologic, and radiologic features (5).


Eligibility criteria: Inclusion Criteria:

* The patients fulfilling all the following criteria will be included:

  1. Age ≤ 18 years.
  2. The presence of typical clinical, biochemical, and neuroimaging features of leukodystrophies.

Exclusion Criteria:

* 1- Children who have coexistent genetic disorders. 2- Children who have cerebral malformations. 3- History of perinatal asphyxia. 4- History of head trauma or intracranial hemorrhage. 5- Acquired CNS myelin disorders, such as multiple sclerosis and related acquired demyelinating processes, infectious and post-infectious white matter damage, toxic injuries and non-genetic vascular insults.

Primary outcomes:
measure: White matter changes in MRI
timeFrame: 2 years
measure: Biochemical changes
timeFrame: 2 years
Secondary outcomes:
measure: Electrophysiological changes
timeFrame: 2 years
measure: Tandem mass spectrometry (MS/MS) finding
timeFrame: 2 years
measure: Urinary organic acid analysis
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
citation: Parikh S, Bernard G, Leventer RJ, van der Knaap MS, van Hove J, Pizzino A, McNeill NH, Helman G, Simons C, Schmidt JL, Rizzo WB, Patterson MC, Taft RJ, Vanderver A; GLIA Consortium. A clinical approach to the diagnosis of patients with leukodystrophies and genetic leukoencephelopathies. Mol Genet Metab. 2015 Apr;114(4):501-515. doi: 10.1016/j.ymgme.2014.12.434. Epub 2014 Dec 29.
citation: Berger J, Moser HW, Forss-Petter S. Leukodystrophies: recent developments in genetics, molecular biology, pathogenesis and treatment. Curr Opin Neurol. 2001 Jun;14(3):305-12. doi: 10.1097/00019052-200106000-00007.
Clinical trial NCT06859710: THC and CBD: a Controlled Human Study Probing a Harm Reduction Strategy
Official title: Interactions Between Delta-9-THC and CBD: a Controlled Human Drug-administration Study Probing a Harm Reduction Strategy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Abuse, Drug
Pain
Keywords: Cannabis
THC
CBD
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to assess the impact of CBD on the effects of THC.

Detailed description: Some evidence indicates that cannabidiol (CBD), a non-intoxicating cannabis component, might mitigate certain effects of THC. This study will examine possible roles for CBD in modulating THC's adverse and analgesic effects.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant and non-lactating females aged 21-55 years
* Report cannabis use 1-7 days per week over the month prior to screening
* Not currently seeking treatment for their cannabis use
* History of inhaled cannabis use
* Have a Body Mass Index from 18.5 - 34 kg/m2
* Able to perform all study procedures
* Must be using a contraceptive (hormonal or barrier methods)

Exclusion Criteria:

* Meeting DSM-V criteria for severe Cannabis Use disorder (CUD) or any substance use disorder other than nicotine, caffeine, mild or moderate CUD
* Evidence of severe psychiatric illness (e.g. mood or anxiety disorder with functional impairment or suicide risk, schizophrenia) judged by the study physician (and PI) to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.
* Report using other illicit drugs in the prior 4 weeks
* Current pain
* Pregnancy
* Currently enrolled in another research protocol
* Not using a contraceptive method (hormonal or barrier methods)
* Insensitivity to the cold water stimulus of the Cold Pressor Test
* Any disorders that might make cannabis administration hazardous as determined by evaluation physician after review of all medical assessments along with medical history.
* Not able to speak and read English

Primary outcomes:
measure: Subject-rated drug effects of abuse liability
timeFrame: 3 hours
measure: Analgesia as measured using the Cold Pressor Test
timeFrame: 3 hours
measure: Behavioral task performance as assessed by the DRUID App Score
timeFrame: 3 hours
measure: Pharmacokinetics of THC
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: Ziva Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03305510: Vitamin D Deficiency of Couples and Infertility
Official title: Prospective Cohort Study About Vitamin D Deficiency of Couples and Infertility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Infertility
Couples
In-vitro Fertilization
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 1500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non-interventional, single-center cohort study and measured 25(OH) D plasma levels prior to ovarian stimulation in couples who underwent IVF/ICSI.

Brief summary: Between March 2016 and March 2017, we performed a large retrospective, non-interventional, single-center cohort study and measured 25(OH)D3 plasma levels prior to ovarian stimulation in couples who underwent IVF/ICSI.And we analysed the correlation of vitamin D status and reproductive capacity .

Detailed description: Before conducting ovarian stimulation, all couples must conduct preoperative routine examination such as routine blood test, blood group examination and infectious disease examination. We collected 2ml remaining blood from the examination by use of sodium heparin, which then conducted 1,25(OH)2D3 assay by liquid chromatography-tandem mass spectrometry.

All patients underwent a standardized ovarian stimulation regimen, oocyte retrieval, and fertilization, followed by a planned fresh or frozen embryo transfer.Normal fertilization rate was defined as the presence of two pronuclei (2PN) at the time of fertilization assessment, 16-19 h after ICSI or conventional insemination. The percentage of top quality embryos was defined as the percentage of top quality embryos among the total number of 2PN embryos. Blastocyst forming rate was calculated as number of formed blastocysts devided by number of cultured blastocysts.

Eligibility criteria: Inclusion Criteria:

* couples who underwent IVF/ICSI.

Exclusion Criteria:

* sperm or egg donation, PGD or PGS,TESA or PESA, ovum frozen ,no oocyte for fertilization.

Primary outcomes:
measure: fertilization rate
timeFrame: the time of fertilization assessment, 16-19 hours after ICSI or conventional insemination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Hospital
name: Kun Qian, Doctor
role: STUDY_CHAIR
References:
citation: Jiang L, Yang J, Song J, Hu Y, Qian K. Normal fertilisation rates and serum 25-OHD levels among couples undergoing in-vitro fertilisation: a prospective cohort study. BMC Pregnancy Childbirth. 2020 Jun 5;20(1):346. doi: 10.1186/s12884-020-02959-z.