louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06847256: Genetic Risk Factor for Heat Stroke
Official title: Exploring a Common Genetic Risk Factor for Heat Stroke and Dehydration
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Carrier State
Heat Stroke
Dehydration
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have previously been genotyped as CF Carriers or Controls.

Brief summary: The goal of this observational study is to examine the effect of the Cystic Fibrosis (CF) Carrier state on the risk for dehydration and other CF-specific fluid-and-electrolyte disorders in male and female adults.

The primary aim of the study is to estimate the risk of electrolyte disorders attributable to the CF carrier state in a genotyped cohort.

This will be accomplished with two smaller projects- Aim 1 and Aim 2.

Aim 1 will consist of 100 CF Carriers and 100 age- and sex-matched controls. Participants in this aim will be asked to complete a Participant Info and Temperature Survey consisting of questions about race, ethnicity, medical history, and how they experience heat.

Aim 2 will consist of a subset of 25 CF Carriers and 25 age- and sex-matched controls from Aim 1. Participants in this aim will be scheduled for a visit to complete a heat challenge. At this visit, they will also complete the Participant Info and Temperature Survey. They will also sit in a sauna at 62 - 63 degrees Celsius for 45 minutes.


Eligibility criteria: Inclusion Criteria:

* Previously genotyped as a CF carrier or control
* Comfortable speaking/reading English

Exclusion Criteria:

* Previously genotyped as a CF patient
* Diagnosis of Type 1 or Type 2 diabetes
* History of heart attack, stroke, heart failure, or atherosclerosis
* Currently pregnant
* Currently taking beta blockers or diuretics
* Prisoner status
* Unable to provide own written informed consent

Primary outcomes:
measure: Participant Scores for Temperature Sensitivity and Regulation Survey
timeFrame: Baseline
measure: Change in Weight
timeFrame: Up to 45 minutes
measure: Change in Sodium Concentration
timeFrame: Up to 45 minutes
measure: Change in Potassium Concentration
timeFrame: Up to 45 minutes
measure: Concentration of Sweat Chloride
timeFrame: Up to 45 minutes
measure: Final Score on Comfort Scale
timeFrame: Up to 45 minutes
measure: Final Score on Thermosensation Scale
timeFrame: Up to 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Aaron Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03633656: Iron Dosing Pilot Study Using Model Predictive Control
Official title: Iron Dosing Pilot Study Using Model Predictive Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Insufficiency, Chronic
Anemia, Iron Deficiency
Anemia of Chronic Kidney Disease
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a pilot study to test the utility of an integrated approach in the management of the anemia of chronic kidney disease through the administration of both an erythropoietic stimulating agent and iron. Subjects will be studied for 6 months during which all iron dosing will be recommended using a computer based tool using model predictive control. Comparisons will be made to the 6 months prior to enrollment in to the study.


Eligibility criteria: Inclusion Criteria:

* chronic kidney disease
* anemia
* receiving intravenous iron

Exclusion Criteria:

* none

Primary outcomes:
measure: Percentage of tsat values within range
timeFrame: Monthly for 6 months
Secondary outcomes:
measure: Iron dose over ride by physician
timeFrame: Monthly for 6 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Alfred Jacobs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02016456: TMS Treatment for Depression in the National Health Service
Official title: An Evaluation of Transcranial Magnetic Stimulation in the National Health Service
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Transcranial Magnetic Stimulation
Neuronavigation
Magnetic Resonance Imaging
Lead sponsor: Institute of Mental Health Nottingham
Sponsor class: OTHER
Collaborators: name: Nottinghamshire Healthcare NHS Trust
First posted: 2013-12-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research programme purports to test the effectiveness of two Transcranial Magnetic Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI) scans to improve the localization of TMS targets.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of depressive disorder (DSM-IV)
* Diagnosis of treatment resistance (at least stage 1 as defined by Thase \& Rush, 1997 for depression)
* Female or male between 18 and 70 years

Exclusion Criteria:

* History of Bipolar disorder
* Clinically relevant neurological comorbidity such as brain neoplasm, cerebral vascular events, epilepsy, neurodegenerative disorders, prior brain surgery
* Metal objects in and around body that cannot be removed
* Pregnancy
* Cardiac pacemaker or implanted medication pump
* Major unstable medical illness
* Change in prescribed medication in the 2 weeks preceding the start of TMS trial
* Current alcohol/stimulant dependence with propensity for toxic/withdrawal seizures

Primary outcomes:
measure: Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score
timeFrame: 4 weeks
Secondary outcomes:
measure: Mean change in Beck Depression Inventory scores
timeFrame: 4 weeks
Other outcomes:
measure: Change in processing speed (using modified digit-symbol test) scores
timeFrame: 4 weeks and 3 months
measure: Change in Clinical Global Impression scores
timeFrame: 4 weeks and 3 months
measure: Change in Social and Occupational Functioning Assessment scores
timeFrame: 4 weeks and 3 months
Locations:
city: Nottingham
country: United Kingdom
facility: Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust
state: England
Study officials:
affiliation: Nottinghamshire Healthcare NHS Trust
name: Sudheer Lankappa, MRCPsych
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04147156: Efficacy of a New Type of Mechanical Rotational Chair in Treating BPPV
Official title: Efficacy of a New Type of Mechanical Rotational Chair (ROTUNDUM) in Treating BPPV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPPV
Keywords: Benign Paroxysmal Positional Vertigo
Vertigo
Dizziness
Vestibular diseases
Epley Maneuver
Semont Maneuver
Repositioning chair
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to establish the efficacy of a new type of mechanical rotational chair in treating BPPV. In addition, comparison of three types of treatment maneuvers using the mechanical rotational chair.

Detailed description: Open-label, randomized controlled trial comparing three different treatment maneuvers in a mechanical rotational chair (ROTUNDUM-chair) in treating BPPV. Patients diagnosed with BPPV will be randomized to one of three maneuvers in the ROTUNDUM-chair:

1. Epley's maneuver
2. Semont maneuver
3. 360 degree vertical rotation

Eligibility criteria: Inclusion Criteria:

* Characteristic (for BPPV) positional nystagmus
* Positive Dix-Hallpike Test
* Medical history compatible with BPPV

Exclusion Criteria:

* Treatment in a mechanical rotational chair within the last 6 months
* Exclusion of BPPV diagnosis
* Lack of treatment cooperation
* Known cerebral aneurism or cerebral hemorrhage
* Treated for BPPV within the past month

Primary outcomes:
measure: Number of treatments
timeFrame: 2 years
measure: Treatment success after first treatment
timeFrame: 2 years
Secondary outcomes:
measure: Dizziness Handicap Inventory (DHI) questionnaire
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
measure: Value of liberatory nystagmus
timeFrame: 2 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Otolaryngology, Head & Neck Surgery and Audiology
state: North Denmark Region
Study officials:
affiliation: Aalborg University Hospital
name: Dan D Hougaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05638256: 68Ga-labeled NY104 PET Imaging in Patients
Official title: 68Ga-labeled NY104 PET Imaging in Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Renal Cell Carcinoma
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY104 PET Imaging in patients with Renal Cell Carcinoma


Eligibility criteria: Inclusion Criteria:

1. Patients voluntarily signed informed consent;
2. Age 18-75, male or female;
3. Patients diagnosed with renal cell carcinoma confirmed by histopathology or cytology;
4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
5. ECOG score 0\~3; Life expectancy of at least 3 months;

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
4. Patients with autoimmune diseases, including rheumatoid arthritis;
5. Inadequate control of arrhythmias, including atrial fibrillation;
6. Uncontrolled hypertension;
7. Patients with allergies or allergies to any component of the imaging agent or antibody;
8. Patients who cannot undergo PET/CT imaging scan;
9. Syphilis, HBV, HCV, or HIV positive subjects;
10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
11. Pregnant or lactating women;
12. Patients with a history of mental illness or related conditions;
13. Other subjects considered unsuitable by researchers.

Primary outcomes:
measure: Evaluation of tissue distribution of 68Ga-NY104
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
Study officials:
References:
Clinical trial NCT02960256: The Impact of Infectious Disease on QT Segment
Official title: The Impact of Infectious Disease on QT Segment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Pneumonia
Cardiomyopathy, Secondary
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients admitted to an internal medicine department due to an infectious disease.

Brief summary: Sepsis related to the development of cardiac complications. However, the investigators understanding regarding this condition remains incomplete. Possible explanations raised include coronary perfusion decrease, activation of the coagulation system and release of inflammatory mediators, including endotoxins, cytokines and others.

In this study the investigators wanted to examine the impact of any infectious disease, (not necessarily Pneumonia), on the QT interval in patients hospitalized for acute infectious disease.


Eligibility criteria: Inclusion Criteria:

* Internal ward hospitalized patient, due to illness which its etiology is bacterial, fungal or viral

Exclusion Criteria:

* Can not technically perform reliably ECG (amputated legs, lack of cooperation, etc.)
* Subject with permanent pacemaker

Primary outcomes:
measure: Prolongation of the QT
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
References:
Clinical trial NCT03111056: Web-Based Treatment of Heavy Drinking Among Women With a History of Sexual Trauma
Official title: Web-Based Treatment of Heavy Drinking Among Women With a History of Sexual Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Assault
Heavy Drinking
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 200
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 empirically evaluate a web-based intervention to reduce heavy drinking among college women with a history of sexual assault who display elevated levels of psychological distress. College women with a history of sexual assault often report more heavy drinking and psychological distress than women without a history of assault. Moreover, women with assault histories often have difficulty regulating their emotions and tolerating distress which can lead to a pattern of drinking to cope distress. Trauma exposure, negative mood, and poor coping strategies have been associated with poor treatment outcomes and relapse following alcohol treatment. Incorporating distress tolerance and emotion regulation skills with an alcohol intervention may enhance treatment effects among women with a history of sexual assault by decreasing their motivation to drink to cope with depression or anxiety and by building adaptive coping strategies. Therefore, the web-based intervention will include cognitive behavioral skills for reducing alcohol consumption and incorporate emotion regulation and distress tolerance skills from Dialectical Behavior Therapy.

Detailed description: For the small randomized controlled trial, heavy drinking college women with a history of sexual assault will be recruited and randomized to receive the intervention or an assessment only control. Online surveys will be administered at baseline, and post-treatment as well as 1-month and 6-months post-treatment.

Eligibility criteria: Inclusion Criteria:

* Enrollment at the University of Washington,
* female,
* 18 or older,
* lifetime history of sexual assault (defined as unwanted attempted or completed oral, vaginal, or anal penetration but excluding unwanted sexual contact only),
* at least 2 instances of heavy episodic drinking (defined as 4 or more drinks in 2 hours) in the past 30 days,
* average consumption equal or greater than 7 drinks per week in the past 30 days.

Exclusion Criteria:

* None

Primary outcomes:
measure: Changes in Daily Drinking Questionnaire
timeFrame: Baseline, Immediately upon completion of the intervention, 1-month and 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Cynthia Stappenbeck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03555656: Repeated Educational Intervention for the Prevention of Diabetic Foot Ulcers in High-risk Patients
Official title: Patient Education for the Prevention of Lower Limb Ulcers in Patients With Type 2 Diabetes: Validation of an Educational Intervention Repeated Every Three Months for 2 Years.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Following a prior observation that a brief structured group educational intervention is effective for the prevention of diabetic foot ulcers in high-risk patients, but that the efficacy decreases over the time, this study is designed to verify the effect of a repetition of the educational intervention.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Either diabetic neuropathy or previous foot ulcer

Exclusion Criteria:

* Arteriopathy of lower limbs, with ABI\<0.8 or needing revascularization

Primary outcomes:
measure: Incidence of foot ulcers
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of foot ulcers
timeFrame: 6 months
measure: incidence of foot ulcers
timeFrame: 12 months
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Diabetologia AOU Careggi
Study officials:
References:
Clinical trial NCT02476656: Placental Inflammation in Prenatal Care
Official title: Placental Inflammation in Prenatal Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: preganant women who present for delivery at term at Greenville Health System with the Obstetrics Teaching Service

Brief summary: Objective of study is to explore expression of stress-related genes and inflammation in placentas and umbilical cord blood for women participating in group prenatal care compared with women receiving individual prenatal care.

Detailed description: This study aims to evaluate levels of inflammatory markers and genetic indicators of stress an inflammation in the placentas and umbilical cord blood in pregnancies that undergo group prenatal care as compared to traditional prenatal care. The investigators know that women receiving group prenatal care have fewer spontaneous preterm deliveries. What is not known is the mechanism behind this difference. By collecting umbilical cord blood samples and placentas of 40 women at the time of delivery, the investigators hope to study expression of stress-related genes and levels of inflammatory markers at the maternal-fetal interface.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Singleton pregnancy

Exclusion Criteria:

* Presence of known fetal congenital anomalies (lethal anomaly or anomalies that may lead to early delivery or increased risk of neonatal death).
* Presence of known chromosomal abnormalities
* Progesterone treatment during the current pregnancy after 14 weeks
* Chronic corticosteroid (i.e. Prednisone or other steroids) treatment during the current pregnancy (not including inhalers or topical)

Primary outcomes:
measure: Inflammatory markers (CRP, IL-6) of cord blood
timeFrame: drawn from the umbilical cord within 15 minutes of delivery
Secondary outcomes:
measure: Genome wide expression profiling of cord blood
timeFrame: drawn from the umbilical cord within 15 minutes of delivery
Other outcomes:
Locations:
Study officials:
affiliation: Prisma Health-Upstate
name: Amy Picklesimer, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02797756: Impact of Gastroesophageal Reflux and Aspiration on Airway Inflammation and Microbiome in Children With Chronic Cough
Official title: Impact of Gastroesophageal Reflux and Aspiration on Airway Inflammation and Microbiome in Children With Chronic Cough
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Cough (CC)
Gastroesophageal Reflux (GER)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 35
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children (Age 0 - 24 years) referred to the NYU Pediatric AeroDigestive Center to evaluate for CC (\>4weeks).

Brief summary: Using an active cohort of children in whom Airway and gastrointestinal endoscopy will be performed, investigators will conduct a chart review to obtain relevant clinical data and the investigators will use an aliquot of airway sample obtained during the clinically indicated bronchoscopy for microbiome analysis. A case-control study design will be used to study whether subjects with CC with GER have a distinct lung microbiome and increased inflammation as compared with subjects with CC without GER and to determine whether the microbiome and degree of inflammation is related to the type of GER (acidic versus nonacidic).


Eligibility criteria: Inclusion Criteria:

* Children (Age 0 - 24 years) referred to the NYU Pediatric AeroDigestive Center to evaluate for CC (\>4weeks).

Exclusion Criteria:

* Antibiotic or steroids (inhaled or systemic) use within the prior one-week. Rationale: Antibacterial drugs and immune-modulators are confounders that may impact the microbiome and inflammation. While longer period free of Antibacterial drugs and immune-modulators would be desired, it would be unethical and it is not the usual standard of care to withdraw treatment for longer periods of time.
* Interstitial Lung Disease or pneumonia on X-ray
* Cystic fibrosis
* Primary ciliary dyskinesia
* Immunodeficiency syndromes
* Major airway abnormalities
* Proton pump inhibitor/H2-receptor antagonist therapy within the prior 2 weeks

Primary outcomes:
measure: Comparison of Reflux Finding Score (RFS) in CC/GER- group and CC/GER+ group
timeFrame: 2 Years
measure: Comparison of bronchoscopic secretions scoring system (BSSS) in CC/GER- group and CC/GER+ group
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Mikhail N Kazachkov, MD
role: PRINCIPAL_INVESTIGATOR
References: