louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00474799: Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine)
Official title: An Open Label, Randomized, Single Center, Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine) in Opioid naïve, Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Javelin Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-05-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to characterize the repeat dosing plasma profile, extent of accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and morphine-6-glucuronide during administration of MNS075 in two different, clinically-relevant dosing schedules.

Detailed description: This study is an open label, randomized, two-treatment, two-period, two-sequence, single-center, crossover study comparing the pharmacokinetics, safety and tolerability of MNS075 (intranasal morphine) at doses of 7.5 mg self-administered q1h for 7 hours (8 doses) and 15 mg self-administered q3h for 9 hours (4 doses).

Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers 18 years of age or older

Exclusion Criteria:

* History of alcohol, drug addiction, or substance abuse.
* Known to or suspected to be currently abusing alcohol or drugs.
* Allergy or hypersensitivity to shellfish or opioids.
* History of seizures.
* Clinically significant structural or functional abnormalities of the nose and upper airway, obstruction of the nasal passages, or mucosal lesions of the nostrils.
* Smoked or used tobacco or nicotine products in the past six months or expects to during the study.
* Positive for hepatitis B or hepatitis C or HIV antibodies.

Primary outcomes:
measure: To characterize the repeat dosing plasma profile, extent of accumulation and repeat dose pharmacokinetics of morphine, morphine-3-glucuronide, and morphine-6-glucuronide during administration of MNS075.
timeFrame: Multiple
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Corporation
state: Texas
Study officials:
affiliation: Javelin Pharmaceuticals
name: Javelin Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03264599: Measurement of the Fetal Occiput-spine Angle During the First Stage of Labor as Predictor of the Outcome of Labor
Official title: Measurement of the Fetal Occiput-spine Angle During the First Stage of Labor as Predictor of the Maternal and Fetal Outcome of Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Delivery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a total of 400 women with gestational age 37 weeks or more and history of one vaginal delivery at least

Brief summary: 2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will be performed to quantify the degree of fetal head flexion in respect to the trunk

Detailed description: 2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will be performed to quantify the degree of fetal head flexion in respect to the trunk.

The sonographer was not involved in the patient's care and the managing obstetrician was blinded to the ultrasound findings and the occiput-spine angle. For each patient of the study group, the progress of labor using a partogram ( cervical dilation ,effacement ,consistency, position and station ) and the mode of delivery were assessed retrospectively.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 \& 35 years old.
2. BMI is less than 30
3. The gestational age between 37- 42 weeks. (calculated by LMP or 1st trimesteric U/S)
4. Singleton pregnancy.
5. History of one vaginal delivery.
6. Occiputo anterior position.
7. Active phase of first stage of labor.

Exclusion Criteria:

1. Age (below18 or above 35).
2. Primigravida.
3. Occiputo posterior position.
4. Indications of cesarean section like malpresentations , macrosomia , placenta previa, previous cesarean section .
5. Multiple gestation.
6. Medical disorders like hypertension, DM, liver or renal diseases

Primary outcomes:
measure: vaginal delivery
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: kasr Alainy medical school
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04881149: Rollover Study to Evaluate Histological Results of Radiofrequency Device Treatments on the Flanks
Official title: Rollover Study to Evaluate Histological Results of Radiofrequency Device Treatments on the Flanks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate histological results of the treatments with the TempSure Firm handpiece on the flanks performed in the CYN20-FIRM-LIPO study.

Detailed description: Up to 10 subjects will be enrolled at up to 3 study centers. Subjects will receive 2 biopsies, 1 biopsy in the treatment area (the flanks) and 1 biopsy outside of the treatment area to serve as a control.

Eligibility criteria: Inclusion Criteria:

• Subject has completed their participation in the CYN20-FIRM-LIPO study.

Exclusion Criteria:

* The subject has not had any other treatment in the treatment area after their involvement in the CYN20-FIRM-LIPO study.
* The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Primary outcomes:
measure: Number of Treatment Samples With Different Levels of Elastin When Compared to Baseline Samples From the Same Patient
timeFrame: 1 Week (7-10 days) Post Baseline
measure: Number of Treatment Samples With Different Levels of Dermis Collagen When Compared to Baseline Samples Taken From the Same Patient
timeFrame: 1 Week (7-10 days) Post Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: JUVA Skin & Laser Center
state: New York
Study officials:
affiliation: Cynosure, Inc.
name: Jennifer Civiok
role: STUDY_DIRECTOR
References:
citation: Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
Clinical trial NCT02854449: Tumor Response in Hypofractionated Radiotherapy
Official title: Biomarkers of Tumor Response in Hypofractionated Radiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoplasms
Keywords: Immune Marker
Immunologic Marker
Radiotherapy
Dose Hypofractionation
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tongren Hospital
First posted: 2016-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receive local hypofractionated radiotherapy

Brief summary: This study will follow-up different immune cell populations in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of Local Hypofractionated Radiotherapy and a rationale for adjuvant immunotherapy.

Detailed description: * Patient information and collection of a signed informed consent form
* Clinical data collection
* Blood samples of 5 mL:

  1. after registration, prior to the first fraction of radiotherapy
  2. during radiotherapy sessions
  3. one month, 3 months after the last radiotherapy session
* Storage of the blood samples at ambient temperature
* Transportation of the samples to the Institute of Biology of Lille (IBL) - CNRS UMR8161 for analysis
* Destruction of the samples at the end of the analysis

Eligibility criteria: Inclusion Criteria:

* Patient requiring a hypofractionated irradiation;
* pathologically confirmed Unspecified Adult Solid Tumor
* Age ≥ 18 years old
* KPS≥70
* Signed written informed consent.

Exclusion Criteria:

* Patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling,
* Pregnant or breastfeeding woman,
* Patient under guardianship or tutorship.

Primary outcomes:
measure: Percentage of immune cells
timeFrame: prior to the first fraction of radiotherapy;14(±2) days from the begining of RT; the day (±2) of the last radiotherapy sessions ;one month, 3 months after the last radiotherapy session
Secondary outcomes:
measure: Local control
timeFrame: 3 months
measure: Acute and Late toxicities
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Gao Xianshu, Master
role: STUDY_CHAIR
References:
Clinical trial NCT00002049: Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
Official title: Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Semen
Thymopentin
Leukocytes, Mononuclear
HIV Seropositivity
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Examine the ability of Timunox (thymopentin) to reduce the amount and/or frequency of virus isolation. Examine the ability of thymopentin to stimulate the immune system and alter the clinical findings of patients infected with HIV who do not yet have AIDS.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Aerosolized pentamidine.

Patients must have the following:

- Seropositive for HIV-1 (ELISA assay) confirmed by Western blot. HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patients' peripheral blood monocytes (PBMC) on two separate occasions. Voluntarily sign consent.

Patients with HIV "wasting syndrome" are included.

Prior Medication:

Allowed:

* Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
* Significant hepatic disease.
* Thrombocytopenia.
* Hypersensitivity to thymopentin.
* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
* Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.

Patients with the following are excluded:

* AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
* Significant hepatic disease.
* Thrombocytopenia.
* Hypersensitivity to thymopentin.
* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
* Abnormal chest x-ray (indicative of active disease (opportunistic infection)) within 30 days prior to study entry.

Prior Medication:

Excluded within 30 days of study entry:

* Immunomodulatory or experimental therapy.
* Excluded within 90 days of study entry:
* Zidovudine (AZT).

Intravenous drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Annandale
country: United States
facility: Immunobiology Research Institute
state: New Jersey
Study officials:
References:
Clinical trial NCT03283449: Tau PET Imaging in Atypical Dementias
Official title: Tau PET Imaging in Atypical Dementias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary Progressive Aphasia With Suspected Alzheimer's Disease
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-09-14
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to demonstrate the feasibility of mapping tau pathology in subjects with Primary Progressive Aphasia, using PET protocol with F-AV-1451 (trade name AV-1451) and to systematically document the extent and location of tau pathology in PPA patients in vivo using the same techniques.


Eligibility criteria: Inclusion Criteria:

* Must have primary progressive aphasia

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Receiving radiation clinically

Primary outcomes:
measure: Tau levels in PPA participants
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago - American School Building
state: Illinois
Study officials:
affiliation: University of Chicago
name: Emily Rogalski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05848349: Vitamin D Status Among Infertile Women in Sweden
Official title: Vitamin D Status, Its Determinants and IVF Outcomes Among Infertile Women in South-Western Sweden.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Vitamin D Deficiency
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2023-05-08
Enrollment: 265
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18-38 who will go through in vitro fertilization during 2020-2021 (one year) for infertility at the Department of Obstetrics and Gynecology, Sahlgrenska University Hospital in Gothenburg, Sweden.

Brief summary: The goal of this prospective cohort study is to learn about the overall and seasonal prevalence of vitamin D insufficiency and its determinants in a population of women with infertility who will go through in vitro fertilization in Sweden. The main questions it aims to answer are:

* What is the prevalence of vitamin D insufficiency?
* What are the determinants of this insufficiency? Participants will be asked to complete a questionnaire validated for dietary assessment of vitamin D intake and sun exposure habits and they will leave a blood sample for measurement of 25(OH)D concentration.

Researchers will compare the in vitro fertilization outcomes between women with vitamin D insufficiency and sufficiency to see if there is any difference.


Eligibility criteria: Inclusion Criteria:

* women aged 18-38 years, who will go through in vitro fertilization for infertility.

Exclusion Criteria:

* women who will go through pre-implantation genetic testing
* women who will go through sperm- or oocyte donation treatment
* Fertility preservation cycles

Primary outcomes:
measure: Prevalence of vitamin D insufficiency
timeFrame: September 2020 - August 2021
measure: Determinants of vitamin D insufficiency
timeFrame: September 2020 - August 2021
Secondary outcomes:
measure: In vitro fertilization outcomes
timeFrame: September 2020 - August 2021
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Obstetrics and Gynecology, Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT02259049: The Effects of L-Tyrosine on 24 Hour Blood Pressure and Heart Rate in Parkinson's Disease
Official title: The Effects of L-Tyrosine on Non-invasive Ambulatory Blood Pressure and Heart Rate Monitoring in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Blood Pressure
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2014-10-08
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators are observing the effects 2,000 mg of L-tyrosine will have on 24 hour blood pressure fluctuations in individuals with Parkinson's disease.

Detailed description: We will be monitoring 24 hour ambulatory BP and HR in subjects with PD on 3 separate visits. The first visit will be without an intervention to establish a baseline of 24 hour BP fluctuations. One week later the subject will be given either L-tyrosine (2,000 mg) with B6 (10 mg) or a sugar pill. We will monitor 24 hour BP and HR after supplementation. One week later the subject will repeat the same procedures with either supplement or placebo.

This is a total of 3 visits with 24 hour ambulatory BP and HR monitoring.

Eligibility criteria: Inclusion Criteria:

1. All subjects must have a diagnosis of PD by a licensed neurologist according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (UKPDBB).(Goetz, 2010) The UKPDBB is a 3 step diagnostic tool which defines inclusion and exclusion criteria for diagnosing PD
2. between 35 and 79 years of age
3. mentally able to participate in the study

Exclusion Criteria:

1. Pregnancy
2. any person who is currently taking amino acid supplements.
3. Any history of myocardial infarction, stent, or CABG
4. Phenylketonurics
5. Untreated hypertension

Primary outcomes:
measure: Blood Pressure
timeFrame: 24 hours
Secondary outcomes:
measure: Heart Rate
timeFrame: 24 hours
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: New York Institute of Technology
state: New York
Study officials:
affiliation: New York Institute of Technology
name: Joanne Donoghue, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00663949: Assessment of the Effect of Captopril Versus Combination of Captopril and Pentoxifylline on Reducing Proteinuria in Type 2 Diabetic Nephropathy
Official title: Phase 2 Trial of Effect of Combine Pentoxifylline and Captopril on Proteinuria in Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Nephropathy
Keywords: diabetes
proteinuria
pentoxifylline
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-04-22
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic patients they can not hinder the progression of renal disease completely. Pentoxifylline as a TNFa blocker may hinder progression of diabetic nephropathy in combination of captopril.

Detailed description: Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic patients they can not hinder the progression of renal disease completely. TNFa is a cytokine that is a target for medical therapy in diabetic nephropathy. In this study the effect of captopril on overt diabetic nephropathy compared to effect of combination of captopril and an antiTNFa drug ( pentoxifylline).

Eligibility criteria: Inclusion Criteria:

1. Absence of kidney or urinary tract disease
2. Absence of high blood pressure OR Controlled blood pressure (≤140/90) with medication other than ACE inhibitors and/or non dihydropyridine calcium channel blockers
3. A well controlled blood sugar level (HbA1c≤7.5%)
4. Adhering to the diet protocol for patients with renal disease

Exclusion Criteria:

1. NYHA functional class III, IV
2. Valvular heart disease
3. Unstable angina, myocardial infarction, cerebrovascular accidents
4. Psychiatric disease
5. Prior allograft kidney transplant
6. Acute illness
7. Infectious disease including urinary tract infection
8. Leukocytosis or any febrile illness at enrollment
9. Prior history or development of any form of malignancy
10. History of alcohol or drug abuse or smoking
11. Pregnancy
12. Need for surgery during the study
13. Allergy to derivatives of methyl xanthines
14. Current Pentoxyphilline use

Primary outcomes:
measure: decreasing urinary protein
timeFrame: 2 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences ,Nemazee and Faghihi Hospital
state: Fars
Study officials:
affiliation: sums
name: Jamshid Roozbeh, MD
role: STUDY_CHAIR
affiliation: SUMS
name: mohammad ghezloo, MD
role: STUDY_DIRECTOR
affiliation: SUMS
name: mohammad mahdi sagheb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SUMS
name: Amin Banihashemi
role: PRINCIPAL_INVESTIGATOR
References: