louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04283110: Impact of Adding Midzolam to Bupavicaine 0.5% in Regional Spinal Anaesthesia on Maternal Middle Cerebral Artery Velocimetry in Parturients With Severer Preeclampsia
Official title: Impact of Adding Midzolam to Bupavicaine 0.5% in Regional Spinal Anaesthesia on Maternal Middle Cerebral Artery Velocimetry in Parturients With Severer Preeclampsia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Midazolam in Preeclamptic Patients
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trial to use GABA mimetic action of midazolam to ameliorate the severe preeclampsia induced neuronal excitotoxicity using middle cerebral artery transcranial doppler resisitive vasculer indices to evaluate . Secondery goal is to study end organ injury


Eligibility criteria: Inclusion Criteria:

* All parturients with severe preeclampsia for urgent C.S

Exclusion Criteria:

* Ladies refusal to participate. Refusal to have spinal anesthsia

Primary outcomes:
measure: Measuring Pulsatality index and resistive index of maternal middle cerebral artery
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Elminia university
Study officials:
References:
Clinical trial NCT01553110: An Observational Study to Evaluate The Relationship of Nasal Mucus Properties and Symptoms
Official title: An Observational Study to Evaluate The Relationship of Nasal Mucus Properties and Symptoms in Acute Rhinosinusitis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Rhinosinusitis
Allergic Rhinitis
Keywords: Cold
Acute Rhinosinusitis
Allergic Rhinitis
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinics and Community

Brief summary: This is a study to learn more about the common cold from studying the nasal secretions produced during a cold or episode of allergic rhinitis.

Detailed description: This study involves collecting and analyzing nasal mucus to see if there are changes in mucus properties during the course of a cold or episode of allergic rhinitis. Outcome measures include SNOT20 questionnaire, nasal secretion collection, acoustic rhinometry on the fifth and fourteenth day of symptoms. The investigators will also collect SNOT20 questionnaires on the tenth and twenty-eighth day.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects 12 years of age and older with acute nasal discharge fewer than 7 days or a history suggesting nasal allergic symptoms for at least 1 year. Internet access required during the course of the study. Patients must be symptomatic at screening.

Exclusion Criteria:

* Symptoms suggesting bacterial rhinosinusitis such as fever ≥ 101ºF/38.3ºC, facial swelling, and serve tooth pain. History of CRS or sinus/nasal surgery for this condition within 6 months before screening. History of respiratory signs and symptoms due to allergic rhinitis. Therapy with bronchodilators, nasal steroids, oral corticosteroids in the past 30 days. Therapy with antihistamines, nasal (Neti) washings, or decongestants in the past 24 hours. Use of any OTC cold or allergy medication 24 hours before study visits requires a 24 hour washout phase

Primary outcomes:
measure: Nasal Secretion Collection
timeFrame: 10 minutes
Secondary outcomes:
measure: Subjective nasal scoring
timeFrame: 10 Minutes
measure: Nasal Volume
timeFrame: 15 Minutes
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University School of Medicine
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University School of Medicine
name: Bruce K Rubin, MEngr, MD, MBA, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University School of Medicine
name: Melissa A Yopp, M.S.H.A
role: STUDY_DIRECTOR
References:
Clinical trial NCT00857610: Retinol-induced Dermatitis in Aged Skin
Official title: Molecular Analyses of Retinoid-induced Dermatitis in Aged/Photoaged Human Skin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aged Skin
Photoaged Skin
Keywords: Aged skin
Photoaged skin
Retinol
Topical retinoids
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2009-03-06
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be between the ages of 21-60 years of age, with moderate clinical photodamage, and either gender.

Brief summary: Topical therapy with retinoids is the only proven medical therapy for aged/photoaged human skin. However, topical therapy with retinoids often result in unwanted cutaneous dermatitis, including erythema and scaling. The reseachers intend to investigate the dose, frequency of use, and time dependence of topical retinol-induced dermatitis. The researchers intend to evaluate retinoid-induced dermatitis biochemically, including retinol regulation of retinoid responsive genes that control retinoid metabolism and serve as markers for retinoid bioactivity. The researchers will also investigate the role of EGF receptor pathway in retinoid-induced dermatitis.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Subject is at least 21 years of age
* Good general health
* No disease states, physical conditions or medications that would impair evaluation of the test sites
* Willingness and ability to follow protocol
* Signed written and witnessed informed consent form
* No use of oral retnoids in the past year
* No use of topical steroids to the treatment area in the past 2 weeks

Exclusion Criteria:

* Has received an experimental drug or used and experimental device in the 14 days prior to admission to the study
* History of keloids
* History of hypersensitivity to lidocaine or epinephrine
* Pregnant or nursing women
* Disease states or physical condition that would impair evaluation of the test sites or compliance with the protocol
* History of chemical peels or laser treatments to the sites evaluated

Primary outcomes:
measure: Retinoid-induced dermatitis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
Study officials:
affiliation: University of Michigan Professor of Dermatology
name: Dana Sachs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01996410: The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients
Official title: The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer Stages I Through III
Keywords: Breast Cancer
Acupuncture
Taxol
Cytoxan
Adriamycin
Taxotere
Carboplatin
Perjeta
Chemotherapy
Chemotherapy-induced nausea, vomiting
Chemotherapy-induced peripheral neuropathy
Adriamycin (60 mg/m2), Cytoxan (600 mg/m2), Taxol (175 mg/m2)
Adriamycin (60 mg/m2), Cytoxan (600 mg/m2), Taxol (80 g/m2)
Taxotere (75mg/m2), Cytoxan (600 mg/m2)
Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose)
Lead sponsor: OhioHealth
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine if acupuncture improves multiple symptoms associated with chemotherapy on the MD Anderson Symptom Inventory (MDASI): nausea, vomiting, fatigue, anxiety, anorexia, pain, disturbed sleep, shortness of breath, dry mouth, depression, and peripheral neuropathy (see statistical section). The investigators hypothesis is that acupuncture will result in lower MDASI scores over the course of chemotherapy for the acupuncture group vs. control group.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* English speaking/reading/writing
* Breast cancer stages I through III
* Any performance status suitable for chemotherapy as determined by the physician
* Primary or secondary chemotherapy, but enrolling patients prior to a chemotherapy regimen regardless of previous radiation therapy exposure and/or previous mastectomy.
* Scheduled to receive either of the following two regimens:
* Adriamycin (60 mg/m2), Cytoxan (600 mg/m2), Taxol (175 mg/m2)
* Adriamycin (60 mg/m2), Cytoxan (600 mg/m2), Taxol (80 g/m2)
* Taxotere (75mg/m2), Cytoxan (600 mg/m2)
* Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose)

Exclusion Criteria:

* History of narcolepsy
* Sleep apnea requiring continuous positive airway pressure (CPAP)
* Other acupuncture treatment within one month of enrollment
* Acupuncture treatment for chemotherapy in the past
* Current participation in any other research studies

Primary outcomes:
measure: MDASI Score of Chemotherapy-associated Symptoms With Acupuncture Treatment
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Columbus Oncology and Hematology Associates
state: Ohio
Study officials:
affiliation: OhioHealth
name: Jeffery Bell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05373810: Registration Study Sarcoma
Official title: Registration Study on Bone and Soft Tissue Sarcoma - An Observational Cohort Study -
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoma
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Radiotherapiegroep
First posted: 2022-05-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with bone or soft tissue sarcoma who are recently diagnosed, currently under treatment or have been treated will be asked to participate in this cohort study.

Brief summary: The prospective and retrospective data collection on bone and soft tissue sarcoma is an observational cohort study aimed to collect clinical data and patient reported outcomes of all patients who have been diagnosed with bone or soft tissue sarcoma in the Netherlands. All patients diagnosed with bone or soft tissue sarcoma who are treated, planned for treatment or currently being treated, will be asked to participate in this project.

Detailed description: The main objectives of this project are:

* To improve the knowledge and therefore the treatment care, in patients with bone or soft tissue sarcoma in the Netherlands
* To start an observational cohort study of bone and soft tissue sarcoma patients from their primary diagnosis until death
* To prospectively and retrospectively collect data on medical history, co-morbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, functional outcome, cosmetic outcome, hospital stays and interventions.
* To collect data on health related quality of life and work ability, to collect data on patient reported outcomes measures.
* To create a continuous basis for a large variety of research purposes including:

  * Prognostic and predictive research
  * Health care policies and cost-effectiveness studies

Eligibility criteria: Inclusion Criteria:

* Histologically proven bone or soft tissue sarcoma, excluding Gastrointestinal Stromal Tumours

Exclusion Criteria:

* Altered mental status that would prohibit the understanding of and giving of informed consent

Primary outcomes:
measure: Progression free survival
timeFrame: up to 10 years
Secondary outcomes:
measure: Health related quality of life
timeFrame: up to 5 years
measure: grade 3/4 serious adverse events
timeFrame: up to 5 years
measure: Disease free survival
timeFrame: up to 10 years
measure: Overall survival
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Radiotherapiegroep
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
References:
Clinical trial NCT01433510: Tolerability of Grazax in Patients With Hayfever in Real Life Settings
Official title: Observational National Clinical Trial of Safety and Tolerance in Patients Suffering of an Allergic Grass Pollen Rhinitis and Treated by Grazax in Real Life Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinoconjunctivitis
Keywords: Allergic
Rhinoconjunctivitis
Immunotherapy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2011-09-14
Enrollment: 628
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: The purpose of this study is to assess the safety profile of specific immunotherapy with Grazax for three consecutive grass pollen seasons.

Detailed description: To assess the safety profile with Grazax according to the presence or not of polysensitization and/or asthma at enrollment

Eligibility criteria: Inclusion Criteria:

* History of grass pollen allergy
* Positive skin prick-test and/or positive specific IgE to grass

Exclusion Criteria:

* Severe, unstable or uncontrolled asthma (FEV1\<70% of predicted value)

Primary outcomes:
measure: Adverse Events related to Grazax
timeFrame: From November 2007 to October 2010 (3 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: Centre Hospitalier Universitaire F-44000 Nantes
name: François FW Wessel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wessel F, Chartier A, Meunier JP, Magnan A. Safety and tolerability of an SQ-standardized GRAss ALlergy immunotherapy tablet (GRAZAX(R)) in a real-life setting for three consecutive seasons - the GRAAL trial. Clin Drug Investig. 2012 Jul 1;32(7):451-63. doi: 10.2165/11634270-000000000-00000.
Clinical trial NCT02664610: Community Study to Reduce High Blood Pressure Through Text Messaging (REACH OUT)
Official title: REACH OUT: to Reduce High Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Stroke
Keywords: hypertension treatment
stroke prevention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: One of the most powerful predictors of stroke is hypertension, with estimates of approximately 33% of adults in the United States experiencing this condition. Hypertension is significantly more prevalent in African Americans compared to European Americans. Importantly, hypertension is a modifiable stroke risk factor.

This proposal will use a community-based participatory research approach to perform a randomized trial of a mobile phone text-messaging intervention to reduce high blood pressure in an urban African American community in Flint, Michigan.

Detailed description: This is a randomized controlled trial of text messaging and blood pressure self-monitoring to reduce blood pressure.

Eligibility criteria: Inclusion Criteria:

* Adult (\>18 y/o) participants with BP ≥140/90 who have mobile phones with text-messaging capability.

Exclusion Criteria:

* Adult who is illiterate, non-English speaking, pregnant, incarcerated/ institutionalized resident, or has a pre-existing condition that makes follow-up for 6 months unlikely.

Primary outcomes:
measure: Mean Change in Systolic Blood Pressure
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Mean Change in Diastolic Blood Pressure
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Lesli Skolarus
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02252510: Reliability for the Detection of Sperm DNA Damage by a Sperm Chromatin Dispersion Test (Halosperm)
Official title: Evaluation of the Reliability for the Measurement of Sperm DNA Damage by a Sperm Chromatin Dispersion Test (Halosperm)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertile Men
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infertile men

Brief summary: It is proposed to measure sperm DNA damage by sperm chromatin dispersion test. This measurement helps to better diagnose male infertility and seems easy to apply in routine. However, the reliability of this method needs to be evaluated before applying for clinical practice in andrology laboratory.

Detailed description: The aim of this study is to measure the inter and intra-observer reliability for the measurements of sperm DNA damage by sperm chromatin dispersion test (halosperm). The gold standard to measure sperm DNA damage is TUNEL (Terminal desoxynucleotidyl end labelling) method. However, this method is not easy to apply in routine. Therefore we investigate to analyse the inter-method reliability between sperm chromatin dispersion test and TUNEL.

Eligibility criteria: Inclusion Criteria:

* infertile men
* \<50 years
* with at least 5.106spermatozoa/ml in the ejacu

Exclusion Criteria:

* azoospermia

Primary outcomes:
measure: - Percentage of spermatozoa with DNA damage (Sperm chromatin dispersion test)
timeFrame: at day 1
Secondary outcomes:
measure: Percentage of sperm DNA damage measured by TUNEL method
timeFrame: at day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00250510: Reimbursement Effects on Enrollment in Obesity Treatment
Official title: A Prospective Study to Determine the Effects of a Reimbursement Incentive on Enrollment and Outcomes in a Community Weight Control Program.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity treatment
Insurance reimbursement
Health care utilization
Health care costs
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2005-11-08
Enrollment: 401
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to simulate what would occur if insurance reimbursement became available for obesity treatment but required that the individual meet defined performance milestones.

Detailed description: This is a prospective study to determine whether a reimbursement incentive (the prospect of reimbursement of half of the out-of-pocket fee for participation in the UAB EatRight Weight Management Program, when it is contingent upon consistent Program participation and loss of 6% of initial body weight) is associated with (1) a higher rate of Program enrollment and (2) greater percent weight loss, greater reductions in medication dosages and costs, and fewer visits to health care providers after 12 weeks and 9 months.

Eligibility criteria: Inclusion Criteria:

* Adults with obesity (BMI at least 30 kg/m2)
* Commitment of the full EatRight Weight Management Program fee

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of inquirers who enroll in obesity treatment
timeFrame: 16 months
Secondary outcomes:
measure: Class attendance
timeFrame: 12 weeks
measure: Percent weight loss
timeFrame: 12 weeks and 9 months
measure: Changes in medication dosages and costs
timeFrame: 12 weeks and 9 months
measure: Visits to health care providers
timeFrame: 12 weeks and 9 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Douglas C Heimburger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hubbert KA, Bussey BF, Allison DB, Beasley TM, Henson CS, Heimburger DC. Effects of outcome-driven insurance reimbursement on short-term weight control. Int J Obes Relat Metab Disord. 2003 Nov;27(11):1423-9. doi: 10.1038/sj.ijo.0802403.
Clinical trial NCT05456412: JAK Inhibition in Ulcerative Colitis
Official title: Influence of JAK Inhibitors on the Disease-associated Network of Intestinal Immune Cells in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colitis, Ulcerative
Keywords: Janus Kinase Inhibitors
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Galapagos NV
First posted: 2022-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Clinical practice protocol is followed. Additional biopsies and blood samples are taken.
Primary purpose: BASIC_SCIENCE

Brief summary: The treatment for Ulcerative Colitis (UC) aims to achieve and maintain remission and is usually lifelong and expensive. Current available medications are unable to break the cycle of chronic inflammation, and still a significant proportion of patients will fail to respond (primary non-response) or lose response over time (secondary non-response). There is now growing evidence that there is substantial interpatient variation in the composition of the inflammation associated network of immune cells. A deeper knowledge of the patient's alterations in the mucosal immune response would help identify key drivers of inflammation and select the appropriate therapy. By analyzing the changes in the composition of immune cells induced by Janus Kinase (JAK) inhibition, we aim to obtain a better insight into the mechanistic effects of JAK inhibition and the downstream effects. These mechanistic insights are needed to identifying potential responders and non-responders in the future.


Eligibility criteria: Age Ulcerative colitis active disease

Primary outcomes:
measure: Multi-omics analyses of changes observed after JAK inhibition
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid Holland
Study officials:
affiliation: Leiden University Medical Center
name: Andrea van der Meulen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: