louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04963465: The Accuracy of Amniotic Fluid Ferning in the Second Trimester in the Diagnosis of Preterm Prelabor Rupture of Membranes
Official title: Assessing the Accuracy of Amniotic Fluid Ferning in the Second Trimester in the Diagnosis of Preterm Prelabor Rupture of Membranes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Premature Rupture of Membrane
Amniotic Fluid Leakage
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 100
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: Prospective observational study including pregnant women 18 years or older who present for pregnancy termination, between 15 and 24 weeks gestation. Women with a singleton or multi-fetal gestation, who have previously established dating based on a first trimester ultrasound or ultrasound prior to 22 weeks gestation, will be included. Exclusion criterion are women who are less than 18 years of age, non-English speaking, and rupture of membranes or anhydramnios (no measurable amniotic fluid on ultrasound) at the time of data collection in the operating room.

Brief summary: Although much investigation has been done on the use of ferning in the second and third trimesters, particularly with the development of rapid protein clinical assays, there appears to be lower ferning rates in clinical practice with traditional techniques compared to previous published research on the subject. Much of the older study designs are lacking in detail and lack a large enough sample sizes at each gestational age to appropriately interpret the significance of ferning results by gestational age. Additionally, a large premise for the current tests used to diagnose rupture of membranes is based on these older studies. Given this, we propose collecting amniotic fluid vaginally to evaluate for the presence of ferning in the second trimester to determine if there is a difference in ferning based on gestational age as well as the time interval after rupture of membranes in which ferning can observed on microscope examination.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* English speaking
* singleton or multi fetal gestation
* between 15 and 24 weeks gestation
* undergoing elective pregnancy termination

Exclusion Criteria:

* known rupture of membranes or anhydramnios

Primary outcomes:
measure: Ferning
timeFrame: 1 minute
measure: Ferning
timeFrame: 5 minutes
measure: Ferning
timeFrame: 10 minutes
measure: Ferning
timeFrame: 15 minutes
measure: Ferning
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Albany Medical College
name: OBGYN Research Director
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04911465: Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients
Official title: Continuous Assessment of Hemodynamic Compensation in Pediatric Trauma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trauma
Keywords: Pediatric
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's National Research Institute
First posted: 2021-06-03
Enrollment: 300
Sex: ALL
Minimum age (years): 31
Maximum age (years): 26
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Traumatically injured pediatric patients who present to Children's Hospital Colorado or Children's National Hospital

Brief summary: This is an observation study using the Flashback CRI T1 tablet to collect data on compensatory reserve index in pediatric trauma patients. Highest trauma activations at the institution will be enrolled in the study and data will be collected for 12-24 hours based on the patient's hemodynamic status. The device collects data via a pulse oximeter probe. No treatment decisions will be made based on the values of the on the CRI tablet. Data will be retrospectively reviewed to determine if any trends exist that correlate with blood loss, need for operation or blood transfusion.


Eligibility criteria: Inclusion Criteria:

• Children 31 days through 26 years (inclusive) of age who undergo Trauma Red (highest level) activation or Trauma Level 1 (mid-level) activation at Children's Hospital Colorado or Children's National Medical Center.

Exclusion Criteria:

* Pregnant patients
* Incarcerated patients
* Patients who object to study participation at any time
* Limited access to or compromised monitoring sites for non-invasive finger sensors
* Brain death (GCS 3 with fixed, dilated pupils)

Primary outcomes:
measure: Number of participants with abnormal CRI values
timeFrame: 12-24 hours
measure: Number of participants who require blood products
timeFrame: 12-24 hours
measure: Number of participants who require operation or angiographic intervention
timeFrame: 12-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: Children's Hospital Colorado
name: Steven L Moulton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06715865: Clinical Study on Thymus-Kidney Transplantation From Neonatal Donors for the Induction of Immune Tolerance
Official title: Clinical Study on Thymus-Kidney Transplantation From Neonatal Donors for the Induction of Immune Tolerance
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Transplant
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Thymus transplantation for the induction of immune tolerance in kidney transplantation: This study aims to understand how thymus transplantation can induce immune tolerance in recipients of allogeneic kidney transplants to achieve the discontinuation of immunosuppressive therapy. It will evaluate the safety of thymus transplantation, explore the functional output of thymus tissue, investigate the optimal timing for withdrawal of immunosuppressants, and identify key indicators for the reconstruction of immune suppression capacity.


Eligibility criteria: Inclusion Criteria:

1. Recipients of both thymus and kidney transplants from the same donor.
2. Age between 18 and 65 years.
3. Non-solid organ combination transplant recipients (including heart-kidney or liver-kidney transplants, except thymus).
4. ABO blood type compatibility with the donor.
5. Negative donor-specific antibody (DSA).
6. Negative lymphocyte crossmatch (CDC).
7. Normal cardiac function (confirmed through ECG and echocardiograms).
8. Normal liver function.
9. Bodyweight between 40-100 kg (inclusive).
10. Evidence of prior epstein-barr virus (EBV) infection with positive EBV-specific immunoglobulin G (IgG) and negative immunoglobulin M (IgM).
11. Signed informed consent form.
12. Ability to adhere to regular follow-ups.
13. Normal hematopoietic function.

Exclusion Criteria:

1. Clinically significant genital or urinary tract dysfunction.
2. Underlying kidney diseases with a high risk of recurrence in the transplanted kidney, including:

   * a. Focal segmental glomerulosclerosis (FSGS).
   * b. Type I or II membranoproliferative glomerulonephritis.
   * c. Hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP).
3. Any genetic mutation-associated diseases.
4. Presence of infectious diseases:
5. Strongly positive panel reactive antibodies (PRA).
6. History of receiving blood transfusion therapy.
7. Any other conditions that, in the investigator's opinion, are incompatible with participation in the trial.

Primary outcomes:
measure: Duration of immunosuppressive therapy after surgery
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT03814265: Effect of Laughter Yoga on Mental Symptoms Frequency and Level of Saliva Cortisol
Official title: Effect of Laughter Yoga on Mental Symptoms Frequency and Level of Saliva Cortisol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Keywords: Cortisol
Laughter Yoga
Mental Symptom
Nursing
Student
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency and salivary cortisol level among the 1st Year Nursing Students.

This is a randomized controlled study using pre-post-test design with control group. The population of our research; Ankara University Faculty of Health Sciences Nursing Department consisting of 202 students studying at the First Year.

Detailed description: The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency and salivary cortisol level among the 1st Year Nursing Students.

This is a randomized controlled study using pre-post-test design with control group. The population of our research; Ankara University Faculty of Health Sciences Nursing Department consisting of 202 students studying at the First Year. A descriptive question form will apply to the entire population of the research.191 students fulfilling the criteria of this study will be included. Eleven students who have not fullfilled this criteria the inclusion criteria will be excluded from the study. Power analysis has been performed and the required sample volume for each group has been calculated as 34 with 0,90 power and 0.05 margin of error. Sample of the study consistsof 75 students considering the possibility of students leaving the research. This 75 students will be divided into two groups as intervention group (n=38) and control group (n=37). Intervention and control group have been randomly selected among Ankara University Faculty of Health Sciences Nursing Department.

Eligibility criteria: Inclusion Criteria:

* Ankara University Faculty of Health Sciences Department of Nursing to be a 1st year student.

Exclusion Criteria:

* Diabetes mellitus
* Hypertension
* Hypothyroidism
* Hyperaldosteronism
* Pregnancy
* Malignancy
* Congestive heart failure
* Psychotic disorder
* Chronic hepatic failure
* Nephrotic syndrome
* Chronic renal failure diagnosis
* Using medical drug

Primary outcomes:
measure: Measurement of mental symptoms
timeFrame: Four weeks
Secondary outcomes:
measure: Measurement of saliva cortisol
timeFrame: Each session for four weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
state: Altindag
Study officials:
affiliation: Ankara Uviversity
name: Ayfer Tezel, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002065: Depot Disulfiram for AIDS and ARC
Official title: Depot Disulfiram for AIDS and ARC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Delayed-Action Preparations
Disulfiram
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To assess the safety and efficacy of depot disulfiram as a new treatment for AIDS and AIDS related complex.


Eligibility criteria: Inclusion Criteria

Patients must have a positive diagnosis of AIDS or AIDS related complex (ARC) according to the CDC criteria.

* Also patient must be:
* Able to understand the study.
* Strongly motivated to participate in the study, and willing to comply with all the conditions specified in the informed consent forms.
* Ambulatory and able to maintain an independent life outside the hospital.
* Free of clinically significant organic disease affecting neurologic, hepatic, renal, and clinical status.

Patients must be free of clinically significant organic disease affecting neurologic, hepatic, renal, and clinical status.

Patients must be free of clinically significant organic disease affecting neurologic, hepatic, renal, and clinical status.

History of alcohol abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Saint Vincent's Med Ctr
state: New York
Study officials:
References:
Clinical trial NCT03976765: Interest of an Early Rehabilitation Program in Liver Transplant Surgery
Official title: Early Rehabilitation Program in Liver Transplant Surgery: Hospital Discharge at Day 7 in a Targeted Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Liver transplant patients

Brief summary: Monocentric, prospective study to evaluate 10 liver transplanted patients

Detailed description: The improvement of perioperative technics and the prevention of complications with immunosuppression allowed for the development with success of liver transplant. 1322 liver transplants occurred in 2016 in France to 806 in 2000. Centre Hospitalier Universitaire (CHU) of Rennes became a reference with 122 liver transplants in 2016 being the second liver transplant center in France.

Early rehabilitation concept is a multidisciplinary approach (surgical, anesthetic...) that aims to reduce the length of hospital stay and peri operative morbidity/mortality. These programs have first been developed in colorectal surgery before extending to complicated surgery like cephalic duodeno-pancreatectomy or hepatectomy. There are poor data in the literature on early rehabilitation program in liver transplant.

Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years old
* First liver transplant
* Liver transplant alone
* MELD (Model for End stage Liver Disease) score ≤ 15
* CHILD-PUGH score ≤ 8 if cirrhosis
* Body Mass Index \< 30 kg/m2
* No history of transplant nor immunosuppression
* Absence of ascites nor hydrothorax drain
* Absence of treatment for diabetes
* Absence of renal insufficiency (glomerular filtration flow \> 60 mL/min)
* Family help at home

Exclusion Criteria:

* Cold ischemia time \> 8 hours
* Grafts from type III Maastricht
* Super urgent liver transplantation
* Perioperative blood transfusion \> 4 packed red blood cells and/or 3 fresh frozen plasma
* Arterial anastomosis in splenic artery, in aorta or in coeliac artery
* Bilio-digestive anastomosis
* Persons deprived of liberty
* Pregnant or breastfeeding women

Primary outcomes:
measure: Number of patients with an hospital discharge at day 7
timeFrame: Day 7
Secondary outcomes:
measure: Number of patients readmission in the first month
timeFrame: Month 1
measure: Number of days of hospitalization during the first month (post-surgery and prehospitalization)
timeFrame: Month 1
measure: Number of death in the first month
timeFrame: Month 1
measure: Satisfaction of the patient in the first month
timeFrame: Month 1
measure: Number of surgery complications according to Dindo and Clavien classification during the first month
timeFrame: Month 1
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT01058265: Integrative Medicine Consultation for Patients With Pain or Fatigue
Official title: Effect of an Integrative Medicine Consultation on Outcome for Patients With Pain or Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Fatigue
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-01-28
Enrollment: 47
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: Patients with a diagnosis of chronic fatigue or pain benefit minimally from a conventional medical evaluation yet consume a large amount of medical resources and time. The question is to see if patients with a diagnosis of chronic pain or fatigue benefit from an Integrative Medicine medical evaluation conducted by physician who has additional training in Integrative Medicine. Patients who call for a general medical examination with a complaint of chronic fatigue or pain will be set up with the integrative medical specialist or standard general medical evaluation.


Eligibility criteria: * Patients seeking a medical evaluation for a primary complaint of pain or fatigue.

Primary outcomes:
measure: Short Form 36 (SF-36) Physical Component Summary (PCS)
timeFrame: 3 months
measure: Short Form 36 (SF-36) Mental Component Summary (MCS)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Larry Bergstrom, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00711165: Mometasone and Markers of Airway Inflammation
Official title: The Effects of Mometasone on Markers of Airway Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Nitric Oxide
Exhaled Breath Condensate
Methacholine Challenge
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2008-07-08
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A post-marketing study to look at the effects of Asmanex on markers of airway inflammation.

Detailed description: Patients with asthma and not treated with anti-inflammatory medications were studied. This was a parallel, randomized, placebo-controlled study to investigate the effects of Asmanex on markers of airway inflammation including exhaled nitric oxide, airway reactivity, FEV1 and nitrates/nitrites and pH in exhaled breath condensate.

Eligibility criteria: Inclusion Criteria:

* Asthma
* non-smoker
* FEV1 of at least 60% predicted

Exclusion Criteria:

* Pregnancy or lactation
* Corticosteroid use in past 30 days

Primary outcomes:
measure: Exhaled Nitric Oxide
timeFrame: 8 weeks
Secondary outcomes:
measure: Airway Reactivity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
Study officials:
affiliation: Creighton University
name: Thomas B Casale, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehta V, Stokes JR, Berro A, Romero FA, Casale TB. Time-dependent effects of inhaled corticosteroids on lung function, bronchial hyperresponsiveness, and airway inflammation in asthma. Ann Allergy Asthma Immunol. 2009 Jul;103(1):31-7. doi: 10.1016/S1081-1206(10)60140-8.
Clinical trial NCT06710665: Tumor Regression Grade As Predictor of Adjuvant Therapy
Official title: Tumor Regression Grade As Predictor of Adjuvant Therapy Benefits in Patients with Esophageal Squamous Cell Carcinoma After Neoadjuvant Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Squamous Cell Carcinoma (ESCC)
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Xiamen University
name: Quanzhou First Hospital
First posted: 2024-11-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes patients who underwent R0 esophagectomy for thoracic ESCC after neoadjuvant therapy.

Brief summary: Neoadjuvant therapy followed by surgery is preferred for locally advanced esophageal squamous cell carcinoma, but the necessity of adjuvant therapy remains controversial. Tumor regression grade reflects the response to neoadjuvant therapy and may predict patient prognosis, yet its role in guiding adjuvant therapy remains unexplored.

Detailed description: We aim to explore the role of TRG and other clinical characteristics in predicting the efficacy of postoperative adjuvant therapy in ESCC patients receiving neoadjuvant therapy. This study Includes patients who underwent R0 esophagectomy for thoracic ESCC after neoadjuvant therapy. Patients will be assessed by TRG and divided into good responders (TRG 0-1) and poor responders (TRG 2-3). The main variable of interest is adjuvant therapy, and the primary outcome is OS, defined as time from diagnosis until death. Cox proportional hazards regression models will be used to calculate hazard ratios and 95% confidence intervals to assess the impact of various variables on survival time.

Eligibility criteria: Inclusion Criteria:

(I) underwent R0 resection with either two-field or three-field lymphadenectomy (II) received neoadjuvant therapy such as preoperative radiotherapy, chemoradiotherapy, or combined immunotherapy (III) had esophageal squamous cell carcinoma pathology.

Exclusion Criteria:

(I) Patients with incomplete clinical data or follow-up information (II) Diagnosed with multiple primary malignancies

Primary outcomes:
measure: Overall survival
timeFrame: for patients surviving at least 90 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu
name: Bin Zheng
role: STUDY_DIRECTOR
References: