louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03680703: Bariatric Scalable Internet Treatments
Official title: Randomized Clinical Trial Testing Two Scalable Internet-Based Weight Loss Treatments Following Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Weight Loss
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 33
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: The purpose of the study is to conduct a randomized clinical trial examining the feasibility and effectiveness of two guided self-help behavioral weight loss (gshBWL) treatments delivered via the internet for individuals struggling with weight loss one year following bariatric surgery. The two treatments will consist of 1) gshBWL delivered through the internet only (gshBWL-I) and 2) gshBWL delivered via the internet with additional complementary phone sessions (gshBWL-IP).


Eligibility criteria: Inclusion Criteria:

* gastric bypass and sleeve surgery patients from Yale's Bariatric/Gastrointestinal Surgery Program
* surgery 1-2 years prior
* \<60% excess weight loss
* able to read English proficiently enough to read the patient self-help materials and study assessments
* available for the duration of the treatment
* availability of internet and phone to participate in study interventions
* agree to the study procedures

Exclusion Criteria:

* medical status judged by the surgeon as contraindication (rare instances of need for additional surgery or medical instability)
* unable to ambulate
* current medications that influence eating/weight
* current substance dependence or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment.

Primary outcomes:
measure: Weight Change
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Department of Psychiatry
state: Connecticut
Study officials:
affiliation: Yale University
name: Valentina Ivezaj, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00602303: Bioequivalency Study of Torsemide Tablets Under Fasting Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of 20 mg Torsemide Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edema
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Torsemide or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Seven day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, Inc.
state: Missouri
Study officials:
affiliation: Bio-Kinetic Clinical Applications, Inc.
name: Dennis Morrison, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01630603: Maternal Vitamin D Status and Neonatal Bone Strength
Official title: Maternal Vitamin D Status and Neonatal Bone Strength
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Maternal Vitamin D Status
Neonatal Bone Quantitative Ultrasound Measurements
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inborn mother infants pairs

Brief summary: Objectives:

1. To determine the incidence of vitamin D deficiency among Israeli pregnant women
2. To access whether maternal vitamin D status affects infant bone strength.

Methods:

1. Vitamin D levels -in cord blood and maternal blood
2. The mother will fill a demographic and nutritional questionnaire

   The Infants:
3. Growth assessment of the infants: weight length and head circumference
4. Bone strength measurement by Quantitative Ultrasound (Sunlight Omnisense 7000/8000TM)


Eligibility criteria: Inclusion Criteria:

* mother-baby pairs,
* birth week 35-42.
* Jewish and Arab women that read and understand Hebrew.

Exclusion Criteria:

* large neonatal congenital defects.

Primary outcomes:
measure: Bone speed of sound and maternal vitamin D levels
timeFrame: first tow days of life
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Neonatal department Meir Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT06358703: Impact of Acute ITTP Therapies on Long Term Neurologic and Cognitive Outcomes in ITTP Survivors
Official title: Impact of Acute ITTP Therapies on Long Term Neurologic and Cognitive Outcomes in ITTP Survivors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Immune Thrombotic Thrombocytopenia
Keywords: TTP
iTTP
aTTP
Cognitive impairment
Lead sponsor: US Thrombotic Microangiopathy Alliance
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with iTTP

Brief summary: 1. We expect to find that the silent cerebral infarct (SCI) rate is two fold higher in patients treated without caplacizumab. We also expect to find that the rate of mild and major cognitive impairment in patients treated with caplacizumab within 3 days of starting plasma exchange will be lower than patients treated without caplacizumab.
2. We expect that the differences in cognitive impairment in cases (caplacizumab) versus controls (no caplacizumab) will persist on serial evaluation 1 year later. We also expect that there will be differences in these groups even after adjusting for time since episode and severity of presentation.
3. We expect to find that SCI and cognitive impairment is associated with worse scores on the health related quality of life instrument (SF-36)
4. Based on studies in non-TTP populations, we expect to find that the rate of incident stroke over the period of follow up is at least 2 fold higher in patients that have SCI compared with patients who do not have SCI


Eligibility criteria: Inclusion Criteria:

1. Age \>= 18 years
2. Confirmed iTTP based on ADAMS13 activity \< 10 % (or 10-20% with positive inhibitor or antibody) during an acute iTTP episode
3. Only 1 episode of iTTP that was treated with plasma exchange and caplacizumab started within 3 days of diagnosis (or if more than 1 episode, then all episodes treated with plasma exchange and caplacizumab started within 3 days of diagnosis)

Exclusion Criteria:

1. Any contraindication for MRI (metallic implants, shrapnel, MRI incompatible stents, etc)
2. Unable to speak, read or understand instructions in English (for NIH ToolBox)
3. Combination of iTTP episodes treated without caplacizumab or with caplacizumab.
4. Caplacizumab started at \>= 4 days from diagnosis or for refractory iTTP

Primary outcomes:
measure: Silent cerebral infarction
timeFrame: 12 months
measure: Cognitive impairment
timeFrame: 12 months
Secondary outcomes:
measure: Depression scores on BDI-II
timeFrame: 12 months
measure: SF-36 scores for quality of life
timeFrame: 12 months
measure: Patient reported cognitive performance
timeFrame: 12 months
Other outcomes:
Locations:
city: Groveport
country: United States
facility: USTMA
state: Ohio
Study officials:
References:
Clinical trial NCT05372003: IL-4 and Insulin Resistance for Treatment of Patients With Atopic Dermatitis
Official title: IL-4 & Insulin Resistance in Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to better understand the interactions between the innate immune system, in particular eosinophils, their secreted cytokines (interleukin-4), and metabolism in human health and disease states such as obesity and insulin resistance.

Detailed description: Patients with a body mass index (BMI) less than 30 kg/m2 and a history of atopic dermatitis on long-term (greater than 6 months) treatment with dupilumab. Researchers will compare in vivo evaluations of insulin sensitivity in subjects on dupilumab vs subjects matched for similar weight and BMI, with atopic dermatitis, but without dupilumab therapy (phototherapy).

Eligibility criteria: Inclusion Criteria:

* Ability to sign informed consent form.
* Body mass index (BMI), 22-29 kg/m\^2.
* Diagnosis of Atopic Dermatitis treated with dupilumab for longer than 6 months.
* Diagnosis of Atopic Dermatitis treated with topical steroids or phototherapy.

Exclusion Criteria:

* Any prescription for systemic glucocorticoid, immunosuppressant, antidiabetic medications in the past 6 months.
* Evidence of diabetes mellitus.
* Morning Cortisol \< 5 mg/dl (collected before 10.30 am).
* Presence of acute illness.
* Low hemoglobin or hematocrit.
* Current participation in a weight-loss regimen, with a weight loss \> 10% total body weight in the last 6 months).
* Smoking history in the last 6 months (tobacco, nicotine-containing products including e-cigarettes).
* Pregnant or breastfeeding.
* Personal history of gastric bypass surgery.
* Previous participation in a clinical trial with an investigational product in the past 30 days, or 5 half-lives, or twice the duration of the biological effect of the investigational drug (whichever is longest).
* Exposed to more than 4 new chemical entities within 12 months before study enrollment.
* Any other condition or event considered exclusionary by the PI and the study physician.

Primary outcomes:
measure: Homa IR
timeFrame: baseline
measure: Matsuda Index
timeFrame: baseline
Secondary outcomes:
measure: Adipo-IR
timeFrame: baseline
measure: Systemic inflammatory markers
timeFrame: baseline
measure: Adipokines
timeFrame: baseline
measure: Fasting Free Fatty Acid
timeFrame: baseline
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo
name: Elena Anna De Filippis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05854303: Effect of Opioid Cessation on Opioid-Induced Esophageal Dysfunction
Official title: Prospective Evaluation of the Effect of Opioid Cessation on Opioid-Induced Esophageal Dysfunction (OIED)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Opioid-Induced Esophageal Dysfunction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being seen in the Pain Rehabilitation Center for opioid cessation at Mayo Clinic Rochester.

Brief summary: The purpose of this study is to evaluate the effect of opioid cessation on opioid-induced esophageal dysfunction (OIED).


Eligibility criteria: Inclusion Criteria:

- Patients enrolled in the Pain Rehabilitation Center for opioid cessation, with or without esophageal symptoms.

Exclusion Criteria:

* Inability to provide informed consent.
* Patients with previous gastroesophageal surgery or pneumatic dilation.
* Esophageal botulinum toxin injection within the prior 12 months.
* Esophageal stricture
* Achalasia types I and II
* Allergy to Lidocaine or other local anesthetics
* Subjects on anticoagulation
* Bilateral nasal obstruction
* Pregnancy or breast feeding

Primary outcomes:
measure: Number of subjects to have opioid-induced esophageal dysfunction resolution
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of subjects with dysphagia
timeFrame: 4 weeks
measure: Number of subjects with chest pain
timeFrame: 4 weeks
measure: Number of subjects with opioid-induced esophageal dysfunction
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Diana Snyder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03397303: Quantification of Nerve Stiffness in Neuropathies
Official title: Quantification of Nerve Stiffness in Patients with Peripheral Neuropathies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
Charcot-Marie-Tooth Disease, Type IA
Anti-MAG Neuropathy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Université de Nantes
First posted: 2018-01-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls.

Detailed description: The following nerve will be studied bilaterally, in a randomised order: Median, ulnar, Radial, Sciatic and Tibial.

Participants will be asked to remain relaxed during elastography measurements.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 to 65
* Having social insurance status
* Having given informed consent
* Diagnostic of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), CMT1a or Anti-MAG (peak immunoglobulin M (IGm)\>15,000 BTU)

Exclusion Criteria:

For controls:

* Person staying in a health or social facility
* Person unable to understand the protocol and to respect the modalities
* Person deprived of liberty
* Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)
* Participation in another biomedical research in progress
* Diabetes, history of neuromuscular disease

For CIDP:

* Person staying in a health or social facility
* Person unable to understand the protocol and to respect the modalities
* Person deprived of liberty
* Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)
* Participation in another biomedical research in progress
* MRC score \< 3

For Charcot-Marie-Tooth type 1 (CMT1) and anti-MAG:

* Person staying in a health or social facility
* Person unable to understand the protocol and to respect the modalities
* Person deprived of liberty
* Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)
* Participation in another biomedical research in progress

Primary outcomes:
measure: nerve shear wave velocity
timeFrame: Day0
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Univeristy of Nantes
Study officials:
affiliation: Nantes University Hospital
name: Yann Pereon, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01355003: GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)
Official title: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) Post Marketing Surveillance Protocol
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Papillomavirus Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-05-17
Enrollment: 1080
Sex: ALL
Minimum age (years): 9
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected from physicians who prescribed GARDASIL™ and who voluntarily agree to provide information on their patients. Each physician can provide up to five reports corresponding to five patients.

Brief summary: This study will collect safety information on the use of GARDASIL™ in the Philippines.


Eligibility criteria: Inclusion Criteria:

* Received GARDASIL™

Primary outcomes:
measure: Number of participants with adverse events following any dose of vaccine
timeFrame: At least 30 days following any vaccine dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00406003: Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects
Official title: A Randomized, Open, Three-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Dosing of Each Enteric-coated Geomatrix Control Release Tablet Strength (12.5, 25, 37.5mg) in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder
Keywords: BRL029060/Paroxetine CR
pharmacokinetics
safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 6
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study was designed to describe the relationship between dose and pharmacokinetic parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR tablet (12.5 to 37.5 mg) as well as safety profile


Eligibility criteria: Inclusion criteria:

* 19-45 years healthy Chinese
* Body weight \> 50 kg
* BMI between 19-25
* serological negative for HIV, syphilis and hepatitis B and C
* no abnormalities in ECG
* Female with negative pregnancy and male has no plan to have a child during and 3 months after the study.

Exclusion criteria:

* History of chronic physical/mental disease, current disease and concomitant medication

Primary outcomes:
measure: To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects
timeFrame: Up to 32 days
Secondary outcomes:
measure: To describe Safety profile of healthy subjects when dosed with paroxetine controlled release
timeFrame: Up to 32 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06864390: Genicular Nerve Phenol Neurolysis Versus Radiofrequency Ablation for Pain Relief in Grade 4 Knee Osteoarthritis
Official title: Genicular Nerve Phenol Neurolysis Versus Radiofrequency Ablation for Pain Relief in Grade 4 Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Joint Pain
Keywords: phenol neurolysis
radiofrequency
Knee osteoarthritis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 114
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the efficiency and efficacy of genicular nerves blockade by chemical phenol neurolysis versus radiofrequency ablation in managing pain in patients suffering from grade IV KOA in term of NRS pain score.

The participants will be evaluated by numeric rating scale and oxford knee score for assessment of pain relief up to 16 weeks.


Eligibility criteria: Inclusion Criteria:

* Grade 4 knee osteoarthritis according to Kellgren-Lawrence radiological classification.
* Failure to manage pain with conservative methods.

Exclusion Criteria:

* Prior knee replacement
* Patients with cardiac pacemakers or implantable cardiac defibrillators.
* Septic knee or systemic sepsis.
* Allergy to any of the drugs used in the study.
* Coagulopathy or patients on anticoagulants.
* Patients with psychiatric illness.

Primary outcomes:
measure: Numeric rating scale
timeFrame: baseline, 2, 4, 8,12 and 16 weeks after the procedure
Secondary outcomes:
measure: oxford knee score
timeFrame: baseline, 4, 8, 12, 16 weeks after the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Ahmed Boeith, MD
role: PRINCIPAL_INVESTIGATOR
References: