louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01975792: Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes
Official title: Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcome in Women at High Risk for Preterm Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Women Admitted to Labor and Delivery for the Management of Preterm Labor and/or Preterm Premature Rupture of Membranes (PPROM)
Keywords: PPROM
Pregnant
Preterm
Premature, labor
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients with singleton pregnancies admitted to labor and delivery at the Hospital of the University of Pennsylvania between 28-36 weeks gestation for the management of spontaneous preterm labor (defined as uterine contractions and documented cervical change) and/or preterm premature rupture of membranes.

Brief summary: The thymus gland is a specialized organ in the chest that plays a central role in the adaptive immune system throughout development until puberty. In response to stress, the fetal thymus gland may shrink, or involute. The investigators propose a prospective cohort study that will enroll pregnant women admitted to labor and delivery for the management of preterm labor and/or preterm premature rupture of membranes from 28-36 weeks gestation. Based on sonographic thymus measurements, the investigators will develop a clinical prediction tool to identify babies who are at increased risk for adverse neonatal outcomes. A reliable non-invasive predictor of adverse neonatal outcome using thymic ultrasound measurements has the potential to affect clinical management, improve outcomes for premature babies, and direct further research efforts.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy between 28-36 weeks gestation
* Active spontaneous preterm labor symptoms (contractions, cervical dilatation and/or PPROM)

Exclusion Criteria:

* Non-singleton pregnancies
* Gestational hypertension/preeclampsia
* Major fetal anomalies
* Known fetal aneuploidy
* Intrauterine Fetal Demise

Primary outcomes:
measure: Respiratory Distress
timeFrame: Date of delivery up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Nadav Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02741492: Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair
Official title: Continuous Transversus Abdominus Plane Block for Open Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Operative Pain
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate pain control of continuous transversus abdominis plane (TAP) blocks placed for open inguinal hernia repair. The investigators hypothesize that there will be improved pain control when compared with sham blocks.

Detailed description: This study is a randomized, controlled trial designed to determine whether continuous transversus abdominis plane (TAP) block versus sham block has a substantial impact on pain following open inguinal hernia repair. Our primary outcome is to determine whether there will be a difference in opioid consumption within the first two days following surgery. Secondary outcomes will include: pain scores and activity assessment score.

Eligibility criteria: Inclusion Criteria:

* Unilateral open inguinal hernia repair
* ASA physical status I-III
* \>18 years old
* Consent to participate in the study

Exclusion Criteria:

* Refusal to participate in the study
* \<18 years old
* Chronic opioid use
* Localized infection
* Pregnancy or lactating
* Pre-existing coagulopathy or active anticoagulant use
* Allergy to ultrasound gel or local anesthetics

Primary outcomes:
measure: Opioid Consumption (Intravenous Morphine Equivalents)
timeFrame: 48 Hours
Secondary outcomes:
measure: Pain (Numeric Rating)
timeFrame: 30 Days
measure: Activity Assessment Score
timeFrame: 30 Days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: Neil A Hanson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flaherty JM, Auyong DB, Yuan SC, Lin SE, Meier AW, Biehl TR, Helton WS, Slee A, Hanson NA. Continuous Transversus Abdominis Plane Block for Primary Open Inguinal Hernia Repair: A Randomized, Double-Blind, Placebo-Controlled Trial. Pain Med. 2020 Feb 1;21(2):e201-e207. doi: 10.1093/pm/pnz275.
Clinical trial NCT03223792: Acceptance Of A Partially-Hydrolyzed Infant Formula
Official title: Acceptance Of A Partially-Hydrolyzed Infant Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stool
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 100
Sex: ALL
Minimum age (years): 28
Maximum age (years): 300
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.


Eligibility criteria: Inclusion Criteria:

* Singleton 28-300 days of age at randomization
* Gestational age less than or equal to 35 weeks
* Receiving minimum 18oz infant formula in the 24hrs prior to randomization
* History of hard stools or stooling difficulty
* Signed informed consent and protected health information

Exclusion Criteria:

* Current diagnosis of cow's milk protein allergy or intolerance
* Use of extensively hydrolyzed or amino acid formula at randomization
* Any abdominal or gastrointestinal surgery prior to randomization
* History of underlying metabolic or chronic disease or congenital malformation
* Organic causes of constipation

Primary outcomes:
measure: Stool consistency measured by MJN stool consistency scale
timeFrame: 14 days
Secondary outcomes:
measure: Stool frequency
timeFrame: 14 days
measure: Formula acceptance measured by intake diary
timeFrame: 14 days
measure: Formula gastrointestinal tolerance measured by diary
timeFrame: 14 days
measure: Bowel movement characteristics by diary
timeFrame: 14 days
measure: Medically confirmed adverse events throughout the study period
timeFrame: 14 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatric Clinic
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, P.A.
state: Arkansas
city: Evansville
country: United States
facility: Deaconess Clinical Research
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Clinic
state: Indiana
city: Bardstown
country: United States
facility: Kentucky Pediatrics/Adult Research
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Pediatrics
state: Kentucky
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
Study officials:
affiliation: Mead Johnson Nutrition
name: Steven Wu
role: STUDY_DIRECTOR
References:
Clinical trial NCT06083792: ICP Threshold After Decompressive Craniectomy
Official title: ICP Threshold of Severe Traunatic Brain Injury After Decompressive Craniectomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Traumatic Brain Injury
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 240 patients

Brief summary: Severe traumatic brain injury (sTBI) is a critical disease of public health importance. Increased intracranial play a significant role in the secondary injury of TBI. Reducing the ICP is helpful in reducing the mortality of sTBI. The threshold of ICP for sTBI has been suggested. The threshold of ICP for sTBI after decompressive craniectomy is not clear.

Detailed description: 240 sTBI patients who meet the inclusion criteria will be enrolled in the present study.

All sTBI patients will be screened. If meeting the including criteria, the investigators will contact the family, explain the study, and send a consent form for review.

After obtaining written consent from the family, the ICP and blood pressure will be monitored continuously until retraction of ICP sensor. A mean ICP of each patient will be calculated. The neurological outcome will be assessed at 180 days after injury. A threshold for ICP after decompressive craniectomy will be derived by analyzing the association between mean ICP and neurological outcome.

Eligibility criteria: Inclusion Criteria:

* history of traumatic brain injury age: 18-80 years admission GCS score≤8 admitting to hospital with 24 hours after injury received decompressive craniectomy received invasive ICP monitoring

Exclusion Criteria:

* refuse follow-up received operation before admitting to hospital received cardio-pulmonary resuscitation after injury disturbance of consciousness caused by non-traumatic reasons prior history of traumatic brain injury or stroke expected lifetime less than 180 days admitting to other ongoing study systemic disease: uremia, liver cirrhosis, malignant tumor, mental disease, drug or alcohol dependence

Primary outcomes:
measure: Modified Glasgow Outcome score
timeFrame: 180 days after injury
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tang-Du Hospital
name: Yan Qu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06974292: The Mass Balance and Biotransformation Study of [14C] VC005 in Chinese Healthy Adult Male Volunteers
Official title: The Mass Balance and Biotransformation Study of [14C]VC005 in Chinese Healthy Adult Male Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: Jiangsu vcare pharmaceutical technology co., LTD
Sponsor class: INDUSTRY
First posted: 2025-05-15
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the mass balance and biotransformation after single-dose of \[14C\]VC005 orally in Chinese healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* A healthy male adult.
* Age is between 18 and 45, inclusive.
* Weight ≥ 50 kg and Body mass index is between 19 and 26, inclusive.
* Voluntarily to provide informed consent form.
* Willing and able to communicate with investigators and complete the trial according to clinical trial protocol.

Exclusion Criteria:

* Any abnormal and clinical significant findings to physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine+occult blood, thyroid function), 12 lead electrocardiogram, chest X-ray (upright position), abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidney), anal directorial rectum examination, and so on.
* Tested positive for any one of the following: HBsAg/HBeAg, Anti-HCV IgG, HIV-Ag/Ab or treponema pallidum antibody (Syphilis) .
* Volunteers who have to work in radioactive conditions in long time, participated in radio-labeled drug clinical trial or had significant radioactive exposure within one year before the trial, more than 2 times of chest/abdominal CT, or more than 3 times of different types of X-ray exam.
* Volunteers are not suitable for this clinical trial, in the opinions of investigators.

Primary outcomes:
measure: Cumulative excretion rate of radioactivity in urine
timeFrame: from 0 hour to 216 hours after administration
measure: Cumulative excretion rate of radioactivity in feces
timeFrame: from 0 hour to 216 hours after administration
measure: Total radioactivity
timeFrame: from 0 hour to 216 hours after administration
Secondary outcomes:
measure: Adverse events
timeFrame: From signing the ICF until 10 days after the dosing
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Suzhou University
state: Jiangsu
Study officials:
affiliation: First Affiliated Hospital of Suzhou Medical College
name: Liyan Miao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00579592: Campath, Rituximab, and Myfortic With Short-Course Calcineurin Inhibitor Therapy in Renal Transplanation
Official title: A Pilot Study of Campath-1H Induction Therapy Combined With Rituximab®, Myfortic™ and a Short Course of Calcineurin Inhibitor Therapy to Allow for a Long Term Calcineurin Inhibitor Free Regimen After Renal Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Rejection
Renal Transplantation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 11
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 hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation. Most successful strategies to date have relied on the use of either tacrolimus or cyclosporine for an indefinite period of time. However, the advantage of a long term, calcineurin inhibitor free regimen may include improved renal allograft function, a lower incidence of hypertension, diabetes, and less drug related side effects. This is a non-randomized open-label pilot trial in 30 adult renal transplant patients. Subjects will receive 2 doses of Campath-1H (30mg given on Day 0 and Day 1) and a single dose of Rituximab (375mg/m2) on Day 0, given intra-operative. Subjects will take maintenance doses of prednisone and enteric coated mycophenolate sodium (Myfortic™). Subject will also be given cyclosporine (Neoral®) therapy for approximately 2 weeks (10-20 days).


Eligibility criteria: Inclusion Criteria:

* Recipient of cadaver or non HLA identical living donor transplantation (tx), Re-tx recipient (second tx) allowed, but no organ other than a kidney (ie no prev k/p)
* Females of CBP must have neg preg test at the time of study enrollment (SOC) \& agree to practice birth control for duration of the study, or for 6 weeks after the last dose of Myfortic

Exclusion Criteria:

* Subjects who are pregnant or nursing.
* Current malignancy or a malignancy in the past 5 years, except for excised skin CA (BCC or SC)
* Multi-organ tx, ABO incompatible and + CM
* Subjects with a current PRA \>50% within the past 30 days pre tx
* Subjects with active current infection requiring continued use of antibiotics, or the presence of chronic active hepatitis B (surface antigen +) or +HCV.
* Exclude for subjects who have received an investigational drug within 4 weeks of study entry

Primary outcomes:
measure: renal function
timeFrame: 2 years
Secondary outcomes:
measure: hypertension
timeFrame: 2 years
measure: drug side effects
timeFrame: 2 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Hans Sollinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03464292: Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
Official title: Spinal and Supra-Spinal Pain Mechanisms in Patients With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents living in or near Gainesville, FL

Brief summary: Fibromyalgia (FM) patients have increased windup (WU). However, WU of FM patients is only quantitatively but not qualitatively different from healthy controls (HC). Thus WU abnormalities of FM patients could be the result of supra-spinal and not the result of spinal pain mechanisms. The study team will test this hypothesis by sensitizing FM patients with topical capsaicin.

Detailed description: The study team hypothesizes that at baseline the slopes of sensitivity adjusted WU of FM patients are not statistically different from HC. However, after capsaicin application, the slopes of sensitivity adjusted WU will be significantly different from baseline and greater than those of HC, suggesting central sensitization. This would imply that FM patients are sensitive to heat pain but not sensitized.

Eligibility criteria: Inclusion Criteria:

* individuals diagnosed with fibromyalgia will have pain of duration \> 6 months and meeting the 1990 Research Diagnostic Criteria for FM (ACR).
* healthy, pain-free age matched controls without chronic pain

Exclusion Criteria:

* Allergy to red chili peppers;
* Pregnant;
* Significant hearing loss;
* Presence of chronic disease (e.g. cancer, cardiovascular disease, liver disease, kidney disease, diabetes, etc.).
* FM patients must be willing to discontinue or hold their FM related medications for at least 5 half-lives.

Primary outcomes:
measure: Progression of Temporal Summation of Second Pain
timeFrame: 2 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Roland Staud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03440892: Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients
Official title: Longitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of Survivin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: survivin
biomarker of pharmacological response
antirheumatic treatment
methotrexate
sulfasalazin
abatacept
tocilizumab
tofacitinib/baricitinib
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2018-02-22
Enrollment: 2500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis patients

Brief summary: To validate the utility of survivin as a biomarker of pharmacological response to therapeutic intervention in rheumatoid arthritis patients.

Detailed description: In a prospective observational study the investigators aim to study the ability of modern antirheumatic treatments to suppress levels of survivin in sera. Rheumatoid arthritis patients scheduled to start new pharmacological treatment will be followed for a period of 6 months. No intervention or influence on choice of treatment will be performed, the decision of new/other medication is entirely made by the patient and their rheumatologist. The study entails addition of survivin analyse (1 vial of sera) before and after start of new treatment. Data concerning survivin levels, disease activity and other clinical parameters before and after start of new treatment will also be analysed. The patients will leave sera for survivin analyse at baseline and 3 and 6 months after start of new treatment.

Eligibility criteria: Inclusion Criteria:

* Patients fulfilling the RA classification criteria according to the ACR/EULAR

Exclusion Criteria:

* Patients at stable/unchanged anti-rheumatic treatment
* Other serious physical or mental illness
* Lack of knowledge in Swedish making answering the questionnaires impossible

Primary outcomes:
measure: Survivin status
timeFrame: 6 months
Secondary outcomes:
measure: Disease activity (DAS28)
timeFrame: 6 months
measure: Response to treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept of Rheumatology and Inflammation research
Study officials:
References: