louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00249418: Training Therapists to Administer Contingency Management-Patient Phase - 3
Official title: Training Therapists to Administer Contingency Management-Patient Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Keywords: Contingency Management
Substance Abuse Treatment
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-11-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to train therapists to administer contingency management (CM). This project will train up to 42 community-based treatment providers about the rationale for and the specifics of administering CM. Initial training will occur in 2-day workshops, followed by weekly supervision in delivery of CM with test cases. We expect that the majority of therapists will achieve high levels of competence and adherence in administering CM treatment within 3-5 test cases, as measured by ratings of audiotapes. To examine the efficacy of CM, each therapist who achieves adherence and competence in delivering CM will administer standard treatment alone or standard treatment plus CM to substance-abusing outpatients. In the CM condition, patients will have the opportunity to win prizes for submission of negative samples, and the treatment will be in effect for 12 weeks. In total, up to 200 patients will be randomly assigned to one of the two conditions. A research evaluator will conduct follow-up assessments, scheduled for 3, 6 and 9 months after treatment initiation.


Eligibility criteria: Inclusion criteria:

* age 18 years or older
* meets DSM-IV criteria for cocaine abuse or dependence
* English speaking (est. \>90% of patients)

For those in drug-free programs, they must have initiated treatment within the past week. For methadone patients, they must be stabilized on a dose of methadone, defined as being on the same dose for at least 30 days and not currently requesting or being considered for a dose modification. Methadone patients must also have submitted at least 30% cocaine positive urine samples in the past 3 months.

Exclusion criteria:

* acute uncontrolled psychiatric disorder (psychosis, suicidality) as determined by the SCID
* dementia (\<23 on the Mini Mental State Exam; Folstein \& Folstein, 1975)
* in recovery for pathological gambling

Primary outcomes:
measure: Drug use
timeFrame: baseline and each follow-up
measure: Retention
timeFrame: each follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Nancy Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04553718: Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women During Pregnancy
Official title: Construct and Evaluate the Effectiveness of a Theory-based mHealth for Overweight and Obese Women --Develop Applications With Wearable Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Weight Gain
Physical Activity
Keywords: overweight
obese
pregnant women
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 82
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was to construct and develop an application (APP) based on social-cognitive theory for overweight and obese women during pregnancy.

Detailed description: Our program used and evaluated the mHealth program, which has pregnant women using APP and wearable devices to help prevent excessive gestational weight gain, and it continued to promote physical activity for overweight and obese pregnant women.

Eligibility criteria: Inclusion Criteria:

pregnant women--who have had, for 8-12 weeks, a pre-pregnancy body mass index of more than 25 kg/m2

Exclusion Criteria:

high risk pregnancy, such as pre-clampsia, pregnancy induced hypertension, preterm contraction

Primary outcomes:
measure: Manage gestational weight gain
timeFrame: 4-6 week
Secondary outcomes:
measure: Increase physical activity level
timeFrame: 4-6 week
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of Nursing
Study officials:
affiliation: Mackay Medical College
name: Ching Fang Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06265818: The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder
Official title: A Randomized Controlled Trial to Explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Rhythm Disorder
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

Detailed description: A growing body of literature indicates the existence of a highly stable, coordinative relation between respiration and oropharyngeal swallowing in healthy adults. The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

Eligibility criteria: Inclusion Criteria:

* diagnosed with Respiratory Rhythm Disorder
* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.

Primary outcomes:
measure: The Penetration-Aspiration Scale
timeFrame: day 1 and day 15
Secondary outcomes:
measure: The Functional Oral Intake Scale
timeFrame: day 1 and day 15
measure: Yale Pharyngeal Residue Severity Rating Scale
timeFrame: day 1 and day 15
measure: Fiberoptic Endoscopic Dysphagia Severity Scale
timeFrame: day 1 and day 15
measure: Murray Secretion Scale
timeFrame: day 1 and day 15
measure: Swallowing Quality of Life
timeFrame: day 1 and day 15
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Center Rehabilitation Hospital
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01769118: The Influences of Caffeine on Heart Rate Variability of Preterm Infants
Official title: The Influences of Caffeine on HRV of Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autonomic Nervous System
Keywords: Autonomic nervous system
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-01-16
Enrollment: 25
Sex: ALL
Minimum age (years): 25
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 preterm infants

Brief summary: Caffeine has a stimulatory effect on the ANS. This has not yet been investigated in preterm infant who get caffeine before stopping ventilation. The investigators hypothesis is that this stimulatory effect may be characterized by HRV analysis methods.


Eligibility criteria: Inclusion Criteria:

* infants born before 34 weeks gestation

Exclusion Criteria:

* sepsis
* congenital malformations

Primary outcomes:
measure: Heart rate variability
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: RMC
Study officials:
References:
Clinical trial NCT03366818: New Stent Retriever, VERSI System for AIS
Official title: Efficacy and Safety of VERSI System for Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: Kobe City General Hospital
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: To confirm efficacy and safety of VERSI system for acute ischemic stroke

Detailed description: Efficacy; TICI 2a or more recanalization upto 3 pass of study device Safety; symptomatic intracranial hemorrhage within 24 hours of procedure

Eligibility criteria: Inclusion Criteria:

* onset to treat within 8 hours
* NIHSS 8 or more
* ASPECTS 5 or more
* Target vessel is ICA, MCA, VA, BA, PCA
* non-eligible or failed IV rt-PA

Exclusion Criteria:

* known hemorrhagic tendency
* arterial dissection, vasculitis
* allergy for contrast media
* other inappropriate condition

Primary outcomes:
measure: incidence of treatment-related severe adverse event
timeFrame: within 24 hours after procedure
Secondary outcomes:
measure: recovery to independent life {modified Rankin score of 2 or less]
timeFrame: 90days after procedure
measure: all intracralnial hemorrhage
timeFrame: within 24 hours after procedure
measure: acceptable clinical outcome
timeFrame: 90days after procedure
measure: Severe adverse event related to device
timeFrame: within 24 hours after procedure
measure: recanalization ability of device
timeFrame: immediatry after procedure
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe City General Hospital
state: Hyogo
Study officials:
affiliation: Kobe City Medical Center General Hospital, Kobe, Japan
name: Nobuyuki Sakai, MD DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sakai N, Imamura H, Adachi H, Tani S, Tokunaga S, Funatsu T, Suzuki K, Adachi H, Sasaki N, Kawabata S, Akiyama R, Horiuchi K, Ohara N, Kono T, Fujiwara S, Kaneko N, Tateshima S. First-in-man experience of the Versi Retriever in acute ischemic stroke. J Neurointerv Surg. 2019 Mar;11(3):296-299. doi: 10.1136/neurintsurg-2018-014040. Epub 2018 Sep 27.
Clinical trial NCT03880318: Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot
Official title: Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Flat Foot; Rigid
Flat Foot; Spastic
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 22
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the investigators want to obtain a functional and radiological outcome of peroneus brevis, tertius and extensor digitorum longus muscles lengthening together with calcaneal osteotomies in the treatment of the spasmodic flat- foot.

Detailed description: One of the most common foot complaints is the "flatfoot" deformity. Clinical evaluation of flatfeet primarily focuses on differentiation between the two main types: flexible and rigid. The rigid flatfoot deformity is an uncommon diagnosis (occurring one-third as often as the flexible type) but often is symptomatic and requires treatment". Multiple causes of rigid flatfeet have been identified such as rheumatoid arthritis, tarsal coalitions (being the most common cause) that are excluded from that research. Triple arthrodesis is used for treatment of rigid flat foot but the patient satisfaction is not good as there is some stiffness in the foot .but here the investigators want to know what is the effect of extensor digitorum longus, peroneus brevis and tertius lengthening together with osteotomies in alignment of spasmodic flat- foot. In patient with rigid flat- foot or spasmodic flat- foot will often have the hind-foot alignment to the outside. Alignment of the heel influences how weight-bearing stress is applied to the foot, ankle, knee and hip. So, these patients may benefit from the calcaneal osteotomies and extensor digitorum longus, peroneus brevis and tertius lengthening to improve that alignment.

Eligibility criteria: Inclusion Criteria:

* Painful, incorrectable pes Plano valgus after failure of conservative treatment
* Age: patients with skeletally mature foot as proved by x-ray

Exclusion Criteria:

* coalition bar
* Ankle subtalar joint arthritis.
* Previous foot fractures.
* Severe trophic skin disorders
* Standard contraindications to any surgery such as poor circulation, concurrent infection, other co-morbidity".

Primary outcomes:
measure: assess the foot deformity
timeFrame: Baseline
measure: assess the pain: Visual Analog Score
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06312618: Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation
Official title: Efficacy of Propofol Versus Dexmedetomidine to Prevent Emergence Agitation After Sevoflurane Anesthesia in Children Undergoing Squint Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Emergence Agitation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare Propofol versus Dexmedetomidine in children undergoing squint surgery. The main question it aims to answer is:

• Which drug is more effective in preventing the appearance of Emergence Agitation in children after sevoflurane anesthesia in squint surgery, propofol or dexmedetomidine?

Emergence agitation (EA) is a period of restlessness, agitation, inconsolable crying, disorientation, delusions, and hallucinations with impaired cognition and memory that commonly occurs in children undergoing ophthalmic surgery especially after Short acting volatile agents such as sevoflurane.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients from 3 to 7 years.
* American Society of Anesthesiologists (ASA) Physical Status Class-I and II.
* Patients undergo squint surgery.

Exclusion Criteria:

* Declining to give written informed consent by patient legal guardian.
* Age younger than 3 years or older than 7 years.
* ASA classification ≥ III.
* History of allergy to the medications used in the study or egg products.
* Psychiatric disorder
* Other co-morbidities or congenital anomalies or neurological.

Primary outcomes:
measure: the overall incidence of postoperative Emergence Agitation
timeFrame: EA incidence and severity will be determined using (PAED) scale at extubation (E0), upon arrival to the Post Anesthesia Care Unit (PACU) E1 and after 15 minute (E2), then after 30 minute in the PACU (E3).
Secondary outcomes:
measure: heart rate changes
timeFrame: 30 minutes in the PACU
measure: mean arterial pressure (MAP) changes
timeFrame: 30 minutes in the PACU
measure: peripheral oxygen saturation (SpO2) changes
timeFrame: 30 minutes in the PACU
measure: Proportion of patients with adverse events in the PACU
timeFrame: assessed up to 30 minutes after arrival of patient to PACU.
measure: Proportion of patients with Post Operative Nausea and Vomiting (PONV)
timeFrame: assessed up to 30 minutes after arrival of patient to PACU.
measure: Time to discharge from the PACU.
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT00818818: Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients
Official title: Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients Infected With Leishmania (Viannia) Braziliensis in Bahia State, Brazil. An Open Uncontrolled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Localized Cutaneous Leishmaniasis
Keywords: Leishmaniasis
Cutaneous leishmaniasis
Leishmania braziliensis
Pentavalent antimonial
Glucantime
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2009-01-08
Enrollment: 13
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. The hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.


Eligibility criteria: Inclusion Criteria:

* Age \> 65 years
* Permanent residence in the endemic area
* Availability of a caregiver for dependent patients

Exclusion Criteria:

* Mucosal disease caused by leishmaniasis
* Disseminated cutaneous disease
* Severe cardiac, renal or hepatic disorders
* Active cancer
* Active tuberculosis
* Leprosy
* HIV positive
* Total bilirubin \> 1.5mg/dL
* Urea and creatinin \> 1.5 times the upper normal level
* Alkaline phosphatase and aminotransferases \> 2.5 times the upper normal level
* Lipase and amylase \> 1.5 the upper normal level
* Hemoglobin \< 5 g/dL of

Primary outcomes:
measure: Clinical cure
timeFrame: Three months after treatment
Secondary outcomes:
measure: Adverse events rate - day 7
timeFrame: 7th day
measure: Adverse events rate - day 14
timeFrame: 14th day
measure: Total Adverse events rate
timeFrame: 20th day
Other outcomes:
Locations:
city: Corte de Pedra, Presidente Tancredo Neves
country: Brazil
facility: Health Center Unit of Corte de Pedra
state: Bahia State
Study officials:
affiliation: Faculty of Medicine, University of Brasilia
name: Julia S Ampuero-Vela, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, University of Brasilia
name: Gustavo Adolfo S Romero, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01281618: Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
Official title: Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus
Keywords: Barrett's esophagus
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2011-01-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those diagnosed with barrett's esophagus confirmed by pathology with no dysplasia or low grade dysplasia

Brief summary: The purpose of this study is to determine the association between acid reflux and cell changes in Barrett's esophagus.

Specific aim 1: To test the hypothesis that controlled acid reflux is associated with lesser degree of stromal activation.

Specific aim 2: To test the hypothesis that stromal fibroblast derived growth factors drive BE epithelial proliferation.


Eligibility criteria: Inclusion Criteria:

1. Prior histological demonstration of Barrett's esophagus that is endoscopically visible; length of visible segment \>/= 1 cm
2. Absence of dysplasia or LGD on biopsies within the past 5 years
3. Ability to provide informed consent
4. Age between 18 years and 90 years at study entry.

Exclusion criteria:

1. Eastern Cooperative Oncology Group performance status 3 or 4
2. Inability to tolerate endoscopic procedures
3. Pregnancy: Females of child-bearing age will be screened with pregnancy test.
4. Prior esophageal surgery, or cancer

Primary outcomes:
measure: activated myofibroblasts
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT05641818: Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 3 (VITAD/3)
Official title: Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 3: Screening Tool for Identification of Subjects at Risk for Suboptimal Vitamin D Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitamin D Serum Levels
Lead sponsor: Nutrition Institute, Slovenia
Sponsor class: OTHER
Collaborators: name: National Institute of Public Health, Slovenia
name: VIST - Faculty of Applied Sciences
name: Slovenian Research Agency
First posted: 2022-12-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult users and non-users of vitamin D drugs and food supplements living in Slovenia. Participants invited from the database at Nutrition Institute.

Brief summary: Validation of a screening tool for identification of subjects at risk for suboptimal vitamin D status. Developed questionnaire-based screening tool will be used on subjects with various risks for vitamin D deficiency, and compared with 25-OH-vitamin D levels.


Eligibility criteria: Inclusion Criteria:

* Signed Informed consent form (ICF),
* Age between 18 and 65 years at the time of the signature of Informed consent form (ICF),
* Did not change use of vitamin D conatining drugs/supplements for last 6 weeks
* Willingness to follow all study procedures

Exclusion Criteria:

* Pregnancy or breastfeeding,
* Change in use of food supplements containing Vitamin D in last 6 weeks
* Acute ilness
* Mental incapacity that precludes adequate understanding or cooperation.

Primary outcomes:
measure: Difference between vitamin D status (deficiency) assessed by two different methods
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Nutrition Institute, Ljubljana
Study officials:
affiliation: Institut za nutricionistiko
name: Igor Pravst, PhD
role: STUDY_CHAIR
affiliation: VIST - Faculty of Applied Sciences
name: Katja Žmitek, PhD
role: PRINCIPAL_INVESTIGATOR
References: