louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01424033: A Clinical Trial for CTD-ILD Treatment
Official title: Clinical Trial of Oral Medication for CTD-ILD Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Interstitial Lung Disease
Connective Tissue Disease
Keywords: Interstitial lung disease
Connective tissue disease
Scleroderma
Rheumatoid arthritis
Sjogren's syndrome
Mixed connective tissue disease
Dermatomyositis
Polymyositis
Systemic lupus erythematosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 5
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 first objective of this protocol is to assess the tolerability and safety of N-acetylcysteine (NAC) in patients with connective tissue disease related interstitial lung disease (CTD-ILD).

Detailed description: The investigators will assess tolerability and safety at scheduled intervals via standard of care physical exam findings, monitoring complete blood count, serum chemistry, and pulmonary function tests, along with patient reports of medication intolerance and change in symptoms of dyspnea.

Eligibility criteria: Inclusion:

1. Subject gives voluntary written informed consent to participate in the study.
2. Subject has been diagnosed with a connective tissue disease and associated interstitial lung disease confirmed by computed tomography of the lungs along with symptoms of cough and/or shortness of breath.
3. Males and females age greater than 18 years at time of screening.
4. Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception and have a negative pregnancy test confirmed at baseline before starting NAC as per standard of care. Women who are surgically sterile or have been post-menopausal for at least two years are not considered to be of child-bearing potential.

Exclusion:

1. History of severe chronic kidney disease defined as a glomerular filtration rate of less than 30.
2. Hemoglobin concentration less than 70% of the lower limit of the normal range at time of screening.
3. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.

Primary outcomes:
measure: Pulmonary Function Tests
timeFrame: Every 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT02126033: Telomeres Parameters in Celiac Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Celiac Disease
Keywords: celiac
telomere
telomerase
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Celiac disease is an autoimmune process that causes destructive changes in the epithel of the small bowel and it is also a pre-malignant state (e.g lymphoma). The aim of the study is to examine telomere length and other parameters of genetic instability from peripheral blood lymphocytes of patients with celiac disease compared with healthy controls.


Eligibility criteria: Inclusion Criteria:

* patients with celiac disease

Exclusion Criteria:

* known malignancy
* cannot sign informed consent
* under age 18

Primary outcomes:
measure: telomere length
timeFrame: at entry, after 6 months of gluten-free diet
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05699733: Mechanical Traction Force and Knee Joint Space
Official title: Influences of Mechanical Traction Using Different Forces on Knee Joint Space, Range of Motion, and Hamstring Flexibility in Asymptomatic Subjects: Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthritis
Lead sponsor: University of Hail
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 11
Sex: ALL
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: the recruited sample will be subjected to 3 treatment conditions according to the traction force used. pre-post comparisons and between conditions comparisons will be conducted
Primary purpose: TREATMENT

Brief summary: the purposes of this crossover study are to Purpose

1. To determine the most effective traction force for knee joint that can be used in the treatment of patients with KOA.
2. To determine the influence of knee joint traction on ROM ok knee joint flexion and extension
3. To determine the influence of knee joint traction on the flexibility of hamstring muscles

Detailed description: this study is a pilot study design aiming to determine the most effective mechanical traction force used for knee joint treatment. this effectiveness was assessed in favor of the separation of the joint surfaces in cm in addition to the hamstring flexibility measured in cm and active knee flexion range of motion.

according to previous literature, there is no consensus regarding the most appropriate traction force that can produce statistical and clinically meaningful differences so we started this pilot study.

the results of this study will be used to conduct a larger-scale study using the most appropriate traction force on patients having knee osteoarthritis.

Eligibility criteria: Inclusion Criteria:

1. Healthy subject
2. males or females
3. No previous surgery in lower limbs

Exclusion Criteria:

1. Diseased knee joint
2. Knee osteoarthritis
3. Any musculoskeletal problem in the lower extremities
4. Varicose veins
5. Pregnancy

Primary outcomes:
measure: knee joint space
timeFrame: immediate (after first session)
measure: knee joint space
timeFrame: short term (30 minutes after the first session)
Secondary outcomes:
measure: hamstrings flexibility
timeFrame: immediate (after first session)
measure: hamstrings flexibility
timeFrame: short term (30 minutes after the first session)
measure: knee active range of motion
timeFrame: immediate (after first session)
measure: knee active range of motion
timeFrame: short term (30 minutes after the first session)
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: University of Hail
Study officials:
References:
Clinical trial NCT00588133: A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery
Official title: A Preliminary Study of a New Tranexamic Acid Dosing Schedule for Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Surgery
Keywords: antifibrinolytic, bleeding, heart
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 20
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: Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac surgery and cardiopulmonary bypass. We have developed an assay for tranexamic acid. We have developed an alternative dosing schedule for tranexamic acid. The objective of this preliminary study is to determine if this new dosing schedule can achieve the desired plasma concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic acid plasma concentrations relative to the current dosing schedule.

Detailed description: Tranexamic acid is administered intravenously to prevent bleeding associated with cardiac surgery and cardiopulmonary bypass. The current dosing regimen for tranexamic acid was empirically derived based upon pharmacokinetics in normal patients receiving the drug. We have developed an assay for tranexamic acid and found that the plasma concentration of tranexamic acid varies greatly between patients and also over time within each patient, especially in patients with renal insufficiency. We have developed an alternative dosing schedule for tranexamic acid that incorporates the effects of renal function on tranexamic acid concentrations. The objective of this preliminary study is to determine if this new dosing schedule can achieve the desired plasma concentration of tranexamic acid and reduce intra and inter patient variability in tranexamic acid plasma concentrations relative to the current dosing schedule. The results of this study will be used in a larger subsequent study of what level of plasma tranexamic acid concentration is needed to prevent bleeding and transfusion of blood products in patients undergoing cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* Age 18 years old or greater having cardiac surgery.

Exclusion Criteria:

* Age less than 18 years old.
* Since tranexamic acid is not approved for pregnant patients, those extremely rare patients that are pregnant and having cardiac surgery will be excluded from the study

Primary outcomes:
measure: Plasma tranexamic acid levels
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic College of Medicine
name: Gregory A. Nuttall, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01517633: Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
Official title: Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Amniotic Fluid Leakage
Keywords: Amniotic fluid leakage
Urinary incontinence
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the reliability and validity of a new device with standard methods for diagnosing between amniotic fluid leakage due to premature rupture of the membranes (PROM) and urine.

Detailed description: Pregnant women sensing wetness and arriving to the delivery room with suspect PROM will use a self-testing device to test whether the wetness is caused by amniotic fluid leakage or urinary incontinence. Clinical evaluation will be performed to all pregnant women using standard clinical tests. The results of the standard clinical tests will be compared to the women's reading of the self-testing device results. Sensitivity and specificity of the device evaluation will be calculated.

Eligibility criteria: Inclusion Criteria:

1. Pregnant women age 18 years and older attending delivery room.
2. Stage of gestation: pregnancy between 16 and 42 weeks of gestation.
3. Able and willing to read and sign an informed consent document.

Exclusion Criteria:

Subjects will be excluded from the study if any of the following will be present:

1. Prior use of any amniotic fluid detection test.
2. Use of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours.
3. Vaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours.
4. Sexual intercourse within the past 24 hours.
5. Confirmed diagnosis of any vaginal infection within the past 7 days.
6. Use of vaginal products or antibiotic treatments that reduce bacterial population or use of medications such as tamoxifen that reduce estrogen levels or antihistamines that dry mucous membranes within the past 7 days..
7. Patients unable or unwilling to participate.
8. Patients in active labor (or with regular contractions).

Primary outcomes:
measure: Presence / absence of stains comparing to a known color index printed on the product
timeFrame: 12 hours
Secondary outcomes:
measure: Presence / absence of stains comparing to a known color index printed on the product
timeFrame: 12 hours
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
citation: El-Messidi A, Cameron A. Diagnosis of premature rupture of membranes: inspiration from the past and insights for the future. J Obstet Gynaecol Can. 2010 Jun;32(6):561-569. doi: 10.1016/S1701-2163(16)34525-X.
Clinical trial NCT00550433: Study Evaluating Bazedoxifene/CE in Postmenopausal Women
Official title: An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Clinical and Commercial Formulations of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopause
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-29
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to study the blood levels of a drug (conjugated estrogens) in the body from one dosage form compared to another. The four formulations of the study drug that eligible participants will receive will contain the same amounts of the same medications. In addition, information will also be obtained regarding the safety and tolerability of the formulations given to healthy postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women aged 35 to 70 years.
* Spontaneous or surgical amenorrhea for at least 6 months.
* Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg.

Exclusion Criteria:

* Hypertension or elevated supine blood pressure (\>139 mm Hg systolic or \>89 mm Hg diastolic).
* History of any clinically important drug allergy.
* Use of any prescription or investigational drug within 30 days before test article administration.

Primary outcomes:
measure: The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02477033: Impact of Butyricicoccus Pullicaecorum in Healthy Subjects
Official title: A Placebo-controlled Cross-over Randomized Study to Investigate the Impact of Butyricicoccus Pullicaecorum in Healthy Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2015-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: During this project the safety, tolerability and effect on gut microbiota of oral administration of Butyricicoccus pullicaecorum was investigated in healthy human volunteers by a placebo-controlled cross-over randomized study.

Detailed description: Intervention periods were 4 weeks, with daily intake of 1 capsule. Wash-out periods were 3 weeks.

Eligibility criteria: Inclusion Criteria:

* BMI between 18 and 28 kg/m²
* Good general health
* Regular eating pattern (3 meals/day on at least 5 days/week)

Exclusion Criteria:

* Chronic gastrointestinal disease (Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic constipation or chronic diarrhea)
* Surgery of the gastrointestinal tract (except for an appendectomy)
* Use of antibiotics during the month preceding the study
* Use of medication or dietary supplements influencing gut transit or intestinal microbiota during the month preceding the study. Examples of such medication/dietary supplements are antispasmodics (e.g. buscopan), antidiarrheal medication (e.g. imodium), probiotic medication (e.g. lacteol, enterol)
* Intake of pre- or probiotics during the study or during the month preceding the study
* Being on a weight-loss diet during the study or during the month preceding the study
* Extreme dietary habits (e.g. vegan, Atkins diet, Montignac diet)
* Females who are pregnant, lactating or planning to become pregnant during the study period

Primary outcomes:
measure: Safety profile of Butyricicoccus pullicaecorum intake (composite outcome measure), measured by abdominal complaints surveys, standard blood tests and fecal calprotectin measurements
timeFrame: 1 year
Secondary outcomes:
measure: The effect of Butyricicoccus pullicaecorum intake on gut microbiota composition, measured by 16S rDNA Illumina profiling of the bacterial communities
timeFrame: 1 year
measure: The effect of Butyricicoccus pullicaecorum intake on gut microbiota activity, measured by GC-MS analysis of the fecal volatile organic compounds
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KULeuven
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT03530033: Lidocaine Reduces Muscle Tremor is Beneficial for Intraoperative Recurrent Laryngeal Nerve Monitoring
Official title: Lidocaine Reduces Muscle Tremor Caused by Electric Energy Devices, Which is Beneficial for Intraoperative Recurrent Laryngeal Nerve Monitoring During Endoscopic Thyroid Lateral Neck Dissection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Cancer
Neck Cancer
Recurrent Laryngeal Nerve Injuries
Accessory Nerve Injuries
EMG: Repetitive Nerve Stimulation Abnormality
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 40
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: In recent years, the application of intraoperative recurrent laryngeal nerve monitoring in thyroid surgery has greatly reduced the complications of recurrent laryngeal nerve injury. The use of intraoperative neurological monitoring requires the reduction of the dose of neuromuscular blockade, which often leads to muscle tremors during the application of electrical energy, which affects the fine separation around the muscles. This study explored the effect of local application of lidocaine on reducing muscle tremor during surgery and its optimal dose.

Detailed description: According to the random number method, eligible patients were randomly divided into 2 groups. Group A was the conventional surgery group, and Group B was the lidocaine group. The operative time for the separation of the sternocleidomastoid muscle from the two groups of patients was analyzed, as well as the length of time for the search for the accessory nerve and the effect of intraoperative nerve monitoring on the EMG signal.

Eligibility criteria: Inclusion Criteria:

* Thyroid papillary carcinoma
* Lateral cervical lymph node metastasis
* The diameter of the metastatic lymph nodes is less than 3cm
* Without internal jugular vein invasion

Exclusion Criteria:

* Lidocaine allergy sufferers

Primary outcomes:
measure: dose of muscle relaxant drugs
timeFrame: At the end of surgery
measure: dose of lidocaine
timeFrame: At the end of surgery
measure: Number of nerve signal loss cases
timeFrame: At the end of surgery
measure: Anatomical time of accessory nerve
timeFrame: At the end of surgery
measure: The satisfaction of sternocleidomastoid muscle separation
timeFrame: At the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: FuZhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT03335033: New Technologies to Determine Carotid Plaque Vulnerability in Patients With Significant Carotid Plaques
Official title: New Technologies to Determine Carotid Plaque Vulnerability: A Pilot Study to Assess Contrast-Enhanced Ultrasound (CEUS) and Shear Wave Elastography (SWE) in Patients With Significant Carotid Plaques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carotid Artery Plaque
Keywords: Carotid Plaque
Contrast Enhanced Ultrasound
Shear Wave Elastography
Endarterectomy
Stenosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The researchers are trying to determine if the characterization of "vulnerable" carotid artery plaques can be accomplished with ultrasound-based methods that look for vessels in the plaque and measure the plaque stiffness.

Detailed description: All participants will receive a one time Carotid contrast-enhanced Ultrasound (CEUS) examination that may take 30-60 minutes. Follow up calls will be made to the Participants at 6, 12 ,24 and 36 months to ask about occurrence of major adverse cardiovascular events.

Eligibility criteria: Inclusion Criteria:

* Subject has carotid plaque with \> 50% stenosis
* Subject is able to understand the study procedure and provide informed consent

Exclusion Criteria:

* Subject is pregnant or breast feeding
* Subject is unable to provide informed consent
* Subject has contraindication to the use of the Lumason contrast agent.

Primary outcomes:
measure: Number of Subjects Who Completed All of the Ultrasound Examinations
timeFrame: 1 year after recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew W Urban
role: PRINCIPAL_INVESTIGATOR
References: