louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00510016: Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome
Official title: Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neonatal Abstinence Syndrome
Keywords: infants
opioid withdrawal
abstinence syndrome
methadone
heroin
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Johns Hopkins University
First posted: 2007-08-01
Enrollment: 80
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.


Eligibility criteria: * neonates born at gestational age of 35 weeks or greater
* neonates aged 0 to 14 days
* prenatally exposed to opioids
* severe NAS defined as 2 consecutive modified Finnegan Scores (MFS) \> or = 9

Exclusion Criteria:

* \< 35 weeks gestational age
* Intrauterine growth retardation defined as \<5%tile of gestational age
* postnatal treatment with barbiturates or benzodiazepines,
* major congenital anomalies
* major concomitant medical illness requiring oxygen therapy, intravenous fluids or medications.
* breastfed infants

Primary outcomes:
measure: Length of treatment for neonatal abstinence syndrome
timeFrame: duration of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Estelle B Gauda, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoder EL, Leckman JF, Poulsen J, Caruso KA, Ehrenkranz RA, Kleber HD, Cohen DJ. Clonidine treatment of neonatal narcotic abstinence syndrome. Psychiatry Res. 1984 Nov;13(3):243-51. doi: 10.1016/0165-1781(84)90039-8.
citation: Gold MS, Pottash AL, Extein I, Kleber HD. Clonidine and opiate withdrawal. Lancet. 1980 Nov 15;2(8203):1078-9. doi: 10.1016/s0140-6736(80)92295-3. No abstract available.
citation: Agthe AG, Kim GR, Mathias KB, Hendrix CW, Chavez-Valdez R, Jansson L, Lewis TR, Yaster M, Gauda EB. Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trial. Pediatrics. 2009 May;123(5):e849-56. doi: 10.1542/peds.2008-0978. Epub 2009 Apr 27.
Clinical trial NCT02873416: Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer
Official title: Clinical Study Using Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Precision Cell Immunotherapy
Chemotherapy
Advanced Lung Cancer
Keywords: Precision Cell Immunotherapy
Chemotherapy
Advanced Lung Cancer
Lead sponsor: Ningbo Cancer Hospital
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy to treat Advanced Lung Cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Lung Cancer.

Detailed description: A total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility criteria: Inclusion Criteria:

1. Age 18\~65 years old, male or female;
2. Life expectancy≥6 months;
3. ECOG score: 0-3;
4. Advanced Malignancies (lung cancer) were diagnosed by pathological or clinical physicians;
5. Enough venous channel, no other contraindications to the separation and collection of white blood cells;
6. Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥60 x10\*/L,hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level；
7. Signed informed consent；
8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

1. Expected Overall survival \< 6 months;
2. Patients with uncontrolled hypertension (\>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months.
3. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
4. Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month.
5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Progress-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo No.5 Hospital (Ningbo Cancer Hospital)
state: Zhejiang
Study officials:
affiliation: Ningbo No.5 Hospital (Ningbo Cancer Hospital)
name: Jiangtao Wang
role: STUDY_DIRECTOR
affiliation: Shanghai Cell Therapy Research Institute
name: Huajun Jin
role: STUDY_CHAIR
affiliation: Shanghai Cell Therapy Research Institute
name: Qijun Qian
role: STUDY_CHAIR
References:
Clinical trial NCT06219616: Prediction of BK Virus Reactivation in Kidney Transplant Recipient
Official title: Prediction of BK Virus Infection by Flow Cytometric Analysis of BK Virus-specific T Cell Responses in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Transplant Infection
BK Virus Infection
BK Virus Nephropathy
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Every kidney transplant recipient will be tested for BKV-specific immune response after transplantation to identify the potential immune predicting tool for developing BKV reactivation.
Primary purpose: SCREENING

Brief summary: There has been no effective predicting tool to accurately predict BKV reactivation after kidney transplantation. The aim is to elucidate the use of flow cytometric analysis for both intracellular cytokines and surface activation markers for BKV-specific T cell response in kidney transplant recipients.


Eligibility criteria: Inclusion criteria:

1. New kidney transplantation cases (either living donor or deceased donor transplantation)
2. Age ≥ 18 years old
3. Agree to give a permission to blood sampling post-transplantation, and at the time of BK viremia.

Exclusion criteria:

1. Pregnant
2. Primary non-function of kidney allograft (i.e. kidney allograft never function).

Primary outcomes:
measure: BKV-specific immune response
timeFrame: Day 30, Day 90 after transplantation before BK viremia
Secondary outcomes:
measure: Dynamic change of BKV-specific immune response
timeFrame: Day 30, Day 90 after transplantation, irrespective ly to BK viremia
measure: BKV-specific immune response and immunosuppression regimen
timeFrame: Day 30, Day 90 after transplantation, in correlation to immunosuppressive medications
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
References:
Clinical trial NCT05331716: Modification of the Local Abnormal Ventricular Activity Only
Official title: Substrate Based Modification in Ventricular Tachycardia: Ablation of the Local Abnormal Ventricular Activity Only
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Keywords: local abnormal ventricular activity
substrate modification
electrophysiology
LAVA
decremental
Lead sponsor: University of Kiel
Sponsor class: OTHER
Collaborators: name: Krankenhaus Landshut Achdorf
First posted: 2022-04-18
Enrollment: 22
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: all consecutive patients undergone LAVA modification alone for treatment of therapy refractory ventricular arrhythmia

Brief summary: Local abnormal ventricular activity (LAVA) is composed of high-frequency, mainly low voltage signals that represent near-field signals from slow-conducting tissue and thus potential VT isthmuses. The identification of LAVA potentials and their modification have usually been a complimentary component of the substrate-based modification of scar related ventricular arrhtyhmias. With better identification through technical solutions and improved algorithms, LAVA modification may be feasible for treatment in therapy refractory VT.

Detailed description: As of 2019 we started LAVA modification only in a subset of patients with therapy refractory ventricular tachycardia. The cohort icludes 55% patient with ischemic cardiomyopathy and 45% with dilated cardiomyopathy. 80% are ICD recipients. These patients were now retrospectively analysed in depth. The endpoint is time to relapse of ventricular tachycardia or ICD shock or death due to malignant arrhythmia. We evaluated all patients we treated accordingly from March 2019 through October 2020. No patient was excluded.

Eligibility criteria: Inclusion Criteria:

therapy refractory ventricular arrhythmia

Exclusion Criteria:

none

Primary outcomes:
measure: VT
timeFrame: 12 months
measure: appropriate therapy delivered by defibrillator (ICD)
timeFrame: 12 months
measure: death
timeFrame: 12 months
Secondary outcomes:
measure: death any cause
timeFrame: 36 months
Other outcomes:
Locations:
city: Landshut
country: Germany
facility: Krankenhaus Landshut Achdorf
state: Bavaria
Study officials:
affiliation: University of Kiel - Medical Faculty
name: Hendrik Bonnemeier, PhD
role: STUDY_DIRECTOR
affiliation: University of Kiel - Medical Faculty
name: Stefan Borov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03545516: Wound Infiltration as Part of an Opioid Free Pain Management Pathway Following Cesarean Delivery
Official title: Randomized Control Trial for an Opioid Free Analgesic Pathway Post Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain, Postoperative
Anesthesia, Local
Opioid Use
Keywords: Wound infiltration
Post Cesarean
Pain management
bupivacaine
dexmedetomidine
postoperative pain
Lead sponsor: Richmond University Medical Center
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 540
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect of three types of wound infiltration on post Cesarean opioid analgesia consumption when used in conjunction with an opioid free postoperative analgesia pathway.

Detailed description: The subjects that meet the inclusion criteria of the study will be randomized preoperatively into three arms following a 1:1:1 ratio. During the intraoperative course one of three combinations of wound infiltration will be administered to subjects prior to the closure of the surgical incision. Subjects in Group I will receive a placebo of normal saline. Subjects in Group II will receive bupivacaine alone. Subjects in Group III will receive both bupivacaine and dexmedetomidine.

Eligibility criteria: Inclusion Criteria:

* All scheduled Cesarean deliveries with intrathecal or epidural anesthesia

Exclusion Criteria:

* Emergency Cesarean deliveries
* Multifetal gestation
* Subjects \<18 years old
* Subjects belonging to a vulnerable population (including subjects with a known opioid addiction, subjects with a history of mental illness and prisoners)
* Cesarean delivery with general anesthesia
* Known allergy or hypersensitivity to any of the study medications
* Subjects that can't comprehend the visual analog scale for quantitative pain assessment

Primary outcomes:
measure: Total number of opioid free Cesarean deliveries
timeFrame: 1 year
Secondary outcomes:
measure: Time to first rescue analgesia
timeFrame: 0 hour post-cesarean to time rescue analgeisa is administered]
measure: Total opioid consumption
timeFrame: 0-14 days
measure: Side effects/Adverse reactions
timeFrame: 0-14 days
measure: Postoperative hospital stay
timeFrame: 0-14days
measure: Complications from procedures
timeFrame: 0-14 days
measure: Breast feeding capacity
timeFrame: 0-14 days
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
Study officials:
affiliation: Richmond University Medical Center
name: Nisha Lakhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01195116: Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis
Official title: Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Interstitial Cystitis
Keywords: Post-operative pain management
Pain Management
Painful bladder syndrome
frequency and urgency
Dexmedetomidine
hydrodistension
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2010-09-03
Enrollment: 41
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: The purpose of this study is to assess the effects of dexmedetomidine while patients undergo treatment for Interstitial Cystitis (IC). The investigators goal is to demonstrate in patients with IC undergoing bladder hydrodistension that the use of dexmedetomidine as a supplemental anesthetic agent will result in better postoperative pain management.

Detailed description: Inclusion Criteria: Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.

Data collected will include:

I. Postoperative Outcomes i. Pain Reported (Visual Analogue Scale) ii. Post-operative opiate use iii. Time in PACU iv. Time until discharge v. Adverse Events (i.e. nausea/vomiting, nursing intervention) II. Intermediate-term Outcomes (4-6 weeks) i. Interstitial Cystitis Symptom \& Problem Index ii. Revised McGill Pain Score

Eligibility criteria: Inclusion Criteria:

* Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.
* 2. Gender of Patients: Male \& female,Age of Patients: 18 and older

Exclusion Criteria:

* Conduction disturbance (second degree AV block or greater), or previous reaction to medications used in this study. Patients receiving spinal anesthesia will not be included.

Primary outcomes:
measure: Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU
timeFrame: Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester Department of Affiliation
name: Suzanne Karan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester Department of Urology
name: Robert Mayer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester Department of Anesthesiology
name: Denham Ward, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03626116: Patient Satisfaction After Silicone Metacarpophalangeal Arthroplasty
Official title: What Determines Satisfaction of Patients With Rheumatoid Arthritis After Hand Reconstruction Using Silicone Metacarpophalangeal Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis - Hand Joint
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with RA / Psoriasisarthritis / Lupus erythomatodes who had a SMPA

Brief summary: The primary objective of this study is to identify determinants of long-term patient satisfaction after hand reconstruction using silicone metacarpophalangeal arthroplasty (SMPA). The investigators hypothesize that appearance of the hand, ulnar drift, range of motion, pain, hand function and intake of the newer antirheumatic drugs (i.e. biologicals) influence patient satisfaction.

Detailed description: This is an ambidirectional, monocenter research project consisting of a retrospective chart review and a prospective cohort project.

Participants fulfilling all of the following inclusion criteria are eligible for the project:

* Patients with rheumatoid Arthritis (RA) / Psoriasisarthritis / Lupus erythomatodes who had a SMPA between Jan 2007 and one year before the project examination
* Informed Consent as documented by signature

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

* Major surgery at another joint at the hand (e.g. proximal interphalangeal (PIP) joint arthroplasty, thumb trapeziectomy) less than 6 months ago
* Legal incompetence
* German language barrier to complete the questionnaires

Eligibility criteria: Inclusion Criteria:

* Patients with RA / Psoriasisarthritis / Lupus erythomatodes who had a SMPA between Jan 2007 and one year before the project examination
* Informed Consent as documented by signature

Exclusion Criteria:

* Major surgery at another joint at the hand (e.g. PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
* Legal incompetence
* German language barrier to complete the questionnaires

Primary outcomes:
measure: Satisfaction with the treatment result assessed on a 5-point Likert Scale
timeFrame: at least one year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Schulthess Klinik
Study officials:
affiliation: Schulthess Klinik
name: Stephan Schindele, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00468416: Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection
Official title: Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Rabin Medical Center
name: Kaplan Medical Center
First posted: 2007-05-02
Enrollment: 60
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: The purpose of this study is to evaluate the safety and effectiveness of the NiTi CAR device in the creation of colorectal anastomosis


Eligibility criteria: Inclusion Criteria:

* Patient age over 18 years
* Patient scheduled for colorectal cancer surgery
* Patient is able to comprehend and sign the Informed Consent Form

Exclusion Criteria:

* Patient has known allergy to nickel
* Patient with bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection
* Patients who are participating in another trial
* Patient on regular steroid medication
* Patients who are undergoing a stoma
* Patients with contraindications to general anesthesia
* Patient with preexisting sphincter problems or evidence of extensive local disease in the pelvis
* Patients after radiation
* Patients who refuse consent

Primary outcomes:
measure: Functioning anastomosis and no occurrence of adverse events related to device use
timeFrame: During hospitalization and one month post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Hagit Tulchinsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06386016: Detection of Valvular Heart Disease Using Artificial Intelligence-based Stethoscope
Official title: Detection of Valvular Heart Disease Using Artificial Intelligence-based Stethoscope
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Valvular Heart Disease
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with and without valvular heart disease assessed by echocardiography

Brief summary: The aim of this study is to develop a deep learning-based application of heart sounds in the diagnosis of valvular heart disease, which can be used to screen patients with valvular heart disease and promote earlier clinical monitoring and intervention.


Eligibility criteria: Inclusion Criteria:

1. age\>18 years
2. In the past 1 month, echocardiography was performed to diagnose valvular heart disease (positive group) and echocardiography to exclude valvular heart disease (negative group).
3. Consent to study and be able to sign informed consent

Exclusion Criteria:

1. After prosthetic valve replacement
2. Congenital heart disease (except bilobal aortic valve)
3. Hypertrophic Cardiomyopathy（HCM）
4. Pregnant, lactating women

Primary outcomes:
measure: valvular heart disease
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References: