louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00429624: Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain
Official title: Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck Pain
Chiropractic manipulation
Randomized controlled trial
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Foundation for Chiropractic Education and Research (FCER)
First posted: 2007-02-01
Enrollment: 70
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 this study is to determine whether chiropractic manipulation or medical therapy is effective in the treatment of chronic neck pain.

Detailed description: Neck pain is a common complaint, approximately 10% of the population have neck pain. Many modalities are used to treat neck pain, but no therapy has been found to be clearly superior. We conducted a randomized controlled study of chiropractic manipulation versus medical therapy for chronic neck pain.

Subjects (n=70) with neck pain for more than 3 months but with no evidence of radiculopathy or myelopathy were randomized. Both groups were instructed to do neck exercises and use heat daily. The chiropractic group received 12 standardized manipulations over 6 weeks. Nurses saw the medical group on the same visit schedule and received acetaminophen 1,000 milligrams four times a day as needed. Blinded observer performed all measurements. The primary outcome measure was the Neck Disability Index (NDI). Secondary measures were pain via a visual analogue scale, global via Medical Outcome Study Short Form and range of motion via Cybex electronic inclinometer.

Eligibility criteria: Inclusion Criteria:

* Neck pain for more than 3 months

Exclusion Criteria:

* Cervical radiculopathy or myelopathy
* Contraindications to cervical manipulation: metastatic cancer, coagulation disorder, cervical spine abnormalities, neuromuscular disease
* Medical contraindications: uncontrolled hypertension, active coronary artery disease, history of cerebral vascular disease, alcohol or drug dependency, acetaminophen allergy
* Active litigation involving neck pain
* Medical or Chiropractic treatment within the past 3 months

Primary outcomes:
measure: Neck Disability Index scale 0-30, clinically significant difference is a change greater than or equal to 5
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: David J Tanaka, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06335524: Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants
Official title: Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Development
Infant Development
Infant, Premature, Diseases
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 188
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.


Eligibility criteria: Inclusion Criteria:

* inborn at UAB, delivered at less than 34 weeks' gestation, 32-39 weeks' PMA, off sedatives, and off invasive respiratory support.

Exclusion Criteria:

* a major malformation, a known syndrome, enrolled in a competing trial targeting neurodevelopmental outcomes as a primary outcome.

Primary outcomes:
measure: ASQ-3 scores
timeFrame: 12 months corrected age
Secondary outcomes:
measure: ASQ-3 scores
timeFrame: 24 months corrected age
measure: ASQ scores below -2SD
timeFrame: 12 months corrected age
measure: ASQ scores below -2SD
timeFrame: 24 months corrected age
measure: ASQ scores below -1SD
timeFrame: 12 months corrected age
measure: ASQ scores below -1SD
timeFrame: 24 months corrected age
measure: ASQ-SE2 scores
timeFrame: 12 months corrected age
measure: ASQ-SE2 scores
timeFrame: 24 months corrected age
measure: Severe neurodevelopmental impairment
timeFrame: 24 months corrected age
measure: Moderate or severe neurodevelopmental impairment
timeFrame: 24 months corrected age
measure: Cognitive Composite Score on BSID-IV
timeFrame: 24 months corrected age
measure: Language Composite Score on BSID-IV
timeFrame: 24 months corrected age
measure: Motor Composite Score on BSID-IV
timeFrame: 24 months corrected age
measure: Edinburgh Postnatal Depression Scale
timeFrame: 6 months
measure: MCHAT score
timeFrame: 24 months corrected age
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Colm P Travers
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06231524: Development and Validation of a PSN-AI Prediction Model
Official title: Development and Validation of a AI Prognostic Model Based on DNA Ploidy, Stroma, and Nucleotyping for Synchronous Peritoneal Metastasis From Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Peritoneal Metastases
Keywords: Colorectal Cancer
Synchronous peritoneal metastasis
DNA ploidy
Stroma-tumor fraction
Nucleotyping
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent cytoreduction surgery for synchronous peritoneal metastasis from colorectal cancer.

Brief summary: Heterogeneity concerning survival in synchronous peritoneal metastasis from patients with colorectal cancer exists, thereby further classification is urgently required. This study aimed to validate a PSN-AI model based on DNA ploidy, stroma-tumor fraction, and nucleotyping (PSN) for the prediction of survival of synchronous peritoneal metastasis from colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Histological proof of synchronous peritoneal metastases of a nonappendiceal colorectal adenocarcinoma.
* Resectable disease determined by computed tomography (CT) and a peritoneal cancer index (PCI) of ≤20 at diagnostic laparoscopy or laparotomy;
* No evidence of systemic (e.g. liver, lung) colorectal metastases within three months prior to enrolment;
* Undergoing cytoreduction surgery for synchronous peritoneal metastasis from colorectal cancer.

Exclusion Criteria:

* Combined with other types of malignant tumors.

Primary outcomes:
measure: Overall survival
timeFrame: At least 1-year follow up
Secondary outcomes:
measure: Progression-free survival
timeFrame: At least 1-year follow up
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05425524: Leptospirosis Care Bundle Study
Official title: Leptospirosis Care Bundle Study: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leptospirosis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 300
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: So in management of Leptospirosis patients There really is no another approach to treatment. The importance of the problem was acknowledged by the researchers. As a result, this study was performed in order to The Leptospirosis Care Bundle has been used, and has been proved that its use can reduce the risk of acute renal failure.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* Suspicious Leptospirosis including body temperature \> 38 celcius, Severe myalgia, and exposure to reservoir hospital of flood water.
* Calf muscle tenderness
* Conjunctival suffusion
* Anuria or oliguria and/or proteinuria
* Jaundice
* Hemorrhagic manifestations (pulmonary and intestine)
* Meningeal irritation
* Nausea, vomiting, abdominal pain, diarrhea.
* Admitted in hospital

Exclusion Criteria:

* other infectious disease
* pregnancy

Primary outcomes:
measure: Number of Participants with Reduce AKI in 72 hours
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn university
Study officials:
References:
Clinical trial NCT00234624: Hepatic Hemodynamic Changes and Simulation in Living-Related Liver Transplantation
Official title: Hepatic Hemodynamic Changes and Simulation Before /After Living-Related Liver Transplantation in Donors/Recipients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Right Hepatectomy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-10-07
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This 1-year project is intended to study the hemodynamic changes of poratal and hepatic artery during living related liver transplantation. We hypothesize that after right hepatectomy for living related liver transplatation, portal vein overflow will change the remnant liver contour and result in liver hyperplasia.

Detailed description: We use CT as tools to reconstruct 3D images of portal vein and hepatic artery before and one month after operation. The images are transferred to CAD and computer simulation is performed.

Eligibility criteria: Inclusion Criteria: - Informed adult-to adult living donor underwent right lobectomy

Exclusion Criteria:

* no written informed contents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
affiliation: NTUH
name: Po-Huang Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04662424: Effect of Music in Labor in Women Who Underwent Induction of Labor
Official title: Effect of Music in Labor in Women Who Underwent Induction of Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Pain
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Women's experience of pain during labor varies greatly, and pain control is a major concern for obstetricians. Several methods have been studied for pain management for women in labor, including drug and non-drug interventions Most methods of non-pharmacological pain management are non-invasive and appear to be safe for mother and baby, including immersion in water, relaxation, acupuncture, and massage. However, their efficacy is unclear, and based mostly on non-randomized studies. On the other hand, there are strong data to support the efficacy of pharmacological methods, including epidural analgesia, which improves pain relief but increase the incidence of operative vaginal delivery Recently a clinical trial showed that music in labor was associated with maternal benefits in women who underwent spontaneous vaginal delivery. However, the effect of music in labor in women undergoing induction of labor is still a subject of debate.


Eligibility criteria: Inclusion Criteria:

* Nulliparous women
* Singleton gestation
* Vertex presentation
* Induction of labor, i.e. cervical ripening with prostaglandins
* Gestational age between 37 and 42 weeks

Exclusion Criteria:

* Multiparous womne
* Multiple gestations
* Preterm labor
* Preterm premature rupture of membranes
* Induction of labor with oxytocin and without prostaglandins
* Induction of labor with balloon
* High risk pregnancies, including hypertensive disorders of pregnancies, diabetes, intrauterine growth restriction, fetal abnormalities.

Primary outcomes:
measure: mean pain level during the active phase of labor
timeFrame: at the time of the active phase of labor
Secondary outcomes:
measure: Mean anxiety level during the active phase of labor, second stage, and at post-partum
timeFrame: at the time of the active phase of labor
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Gabriele Saccone
Study officials:
affiliation: Federico II University
name: Gabriele Saccone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000324: Tryptophan and Behavior Therapy for Cocaine Abuse - 1
Official title: Tryptophan and Behavior Therapy for Cocaine Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Johns Hopkins University
First posted: 1999-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of tryptophan vs. placebo, and voucher payments vs. a control condition, in the treatment of cocaine dependence.

Detailed description: This clinical trial uses a 2 by 2 design to compare tryptophan to placebo, and voucher incentives vs. a control condition, in the outpatient treatment of cocaine dependence- using a relapse prevention model of treatment intervention.

Eligibility criteria: Inclusion Criteria:

* Cocaine dependent

Exclusion Criteria:

* Physically dependent on drugs of abuse other than cocaine
* Significant medical or psychiatric illness (besides substance abuse disorder)
* Pregnant

Primary outcomes:
measure: Side effects
measure: Retention
measure: Cocaine use
measure: Cocaine craving
measure: Other drug use
measure: Psychosocial functioning
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric C Strain, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones H.E., Johnson, R.E., Bigelow G.E., Strain E.C. Differences at treatment entry between opioid-dependent and cocaine-dependent males and females. Addictive Disorders and Their Treatment 3:110-121, 2004.
citation: Jones HE, Johnson RE, Bigelow GE, Silverman K, Mudric T, Strain EC. Safety and efficacy of L-tryptophan and behavioral incentives for treatment of cocaine dependence: a randomized clinical trial. Am J Addict. 2004 Oct-Dec;13(5):421-37. doi: 10.1080/10550490490512753.
Clinical trial NCT02872324: Evaluation of the Impact of the Level of Mindfulness on the Management of Patients With Recurrent Depressive Disorders by the Mindfulness Based Cognitive Therapy ( MBCT ): an Exploratory Study
Official title: Evaluation of the Impact of the Level of Mindfulness on the Management of Patients With Recurrent Depressive Disorders by the Mindfulness Based Cognitive Therapy ( MBCT ): an Exploratory Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Recurrent Depressive Disorders
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Mindfulness is both a natural resource of individuals present in all individuals in varying degrees characteristic ability of attention to the experience that unfolds moment by moment without judgment and a practice based on meditation, mindfulness exercises, which aims to enhance two central skills of mindfulness that are the presence and acceptanc. In the context of recurrent depression, the practice of mindfulness meditation in the frame of MBCT is recognized as effective in psychological suffering and relapse. The mechanisms implied in MBCT efficacy are emotional but especially cognitive. Among the cognitive mechanisms, reduction of rumination is a major factor in the action of MBCT, especially for patients with less than three depressive relapses.

This exploratory research focuses on the impact of mindfulness functioning (mindfulness resource level at baseline) on the benefits of MBCT for patients with recurrent depressive disorder.

The objective is to assess whether the level of mindfulness resource of patients with recurrent depression is a factor contributing to the positive effect of a MBCT applied in add-on to conventional care.

This objective will be measured by comparing the clinical improvement of patients secondary to MBCT according to the initial categorization of the mindfulness resource.

Clinical improvement will be more important for patients characterized by a lower initial level of mindfulness resource.


Eligibility criteria: Inclusion Criteria:

Major patient Patient with recurrent depression Patient have read, understood and signed the non-opposition form.

Exclusion Criteria:

Inability to understand or read English or French. Individuals unable to personally express their opposition not under whose major legal or private protection of liberty by judicial or administrative decision, or hospital emergency

Primary outcomes:
measure: Decrease in depression score (Beck Scale)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assitance Publique Hôpitaux de Marseille
name: Catherine GEINDRE, Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02218424: Magnesium vs Placebo for Tonsillectomy
Official title: Systemic Magnesium to Improve Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blinded, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a double-blind randomized controlled trial using intravenous magnesium versus placebo to determine if systemic magnesium can decrease postoperative pain in pediatric patients undergoing tonsillectomy.

Participants will be in one of two arms. Those in Arm 1 will receive magnesium (30 mg/kg bolus followed by a 10mg/kg/hr infusion) while those in Arm 2 will receive an equal volume of normal saline bolus followed by infusion (placebo).

The primary objective is to determine if systemic magnesium will decrease postoperative pain in patients undergoing tonsillectomy. The secondary objectives will determine if systemic magnesium administration is associated with a decrease in opioid-related side effects, decrease the incidence of emergence delirium, and improve postoperative functional recovery.

The study hypothesis is that the use of intravenous magnesium will decrease postoperative pain, decrease opioid-related side effects, decrease the incidence of emergence delirium, and improve functional recovery in patients undergoing tonsillectomy.


Eligibility criteria: Inclusion Criteria:

* Patients aged 4-10 years old undergoing tonsillectomy by a single surgeon and under the care of that participating surgeon
* American Society of Anesthesiology (ASA) patient classification of I-III

Exclusion Criteria:

* Physical or developmental delay
* Psychiatric illness
* Current use of sedative or anticonvulsant medication
* Pre-existing renal disease
* Pre-existing cardiovascular disease
* Regular use of analgesic medication
* Having other procedures in addition to tonsillectomy (however, patients undergoing adenoidectomy with their tonsillectomy will be included in the study)

Primary outcomes:
measure: Postoperative Pain
timeFrame: 90 minutes
Secondary outcomes:
measure: Postoperative Pain Medication
timeFrame: 90 minutes
measure: Postoperative Pain at Home
timeFrame: 7 days
measure: Emergence Delirium
timeFrame: 5 minutes after awakening in the recovery room
measure: Number of Patients With Postoperative Vomiting
timeFrame: 90 minutes
measure: Respiratory Depression
timeFrame: 90 minutes
measure: Time to PACU Discharge
timeFrame: Approximately 90 minutes
measure: Parent Satisfaction
timeFrame: 7 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Hubert A Benzon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: