louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02291159: Effects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke
Official title: Effectiveness of Dry Needling (DNHS Technique) in the Treatment of Upper Limb Spasticity and Function in Stroke Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spasticity
Keywords: stroke
spasticity
dry needling
upper motor neuron syndrome
motor function
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Stroke is a neurological deficit caused by a decrease in cerebral blood flow. The DNHS ® (Dry Needling for hypertonia and Spasticity) technique is a dry needling technique to reduce spasticity and hypertonia and improve function in patients with CNS injury. The main objective of this trial is to analyze the therapeutic effect of DNHS® technique in motor function in patients between 45 and 80 in a chronic state after a stroke. Methods: Double-blinded randomized clinical trial. There will be an intervention group (DNHS® technique) and a sham control group. The intervention will be 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei. The Fugl Meyer Assessment Scale, Modified Ashworth Scale and Stroke Impact Scale will be used as outcome measures. The data will be expressed as mean ± (Standard Deviation). The standardized difference or effect size (ES, 90% confidence limit) in the selected variables will be calculated.


Eligibility criteria: Inclusion Criteria:

* people aged 40-85 years with hemiplegia resulting from stroke of more than 6 months evolution (chronic stroke)
* ability to follow instructions and reply to assessment questonnaires

Exclusion Criteria:

* recurrent stroke episodes
* other concomitant neurodegenerative conditions
* fear to needles
* participation in a parallel study
* any absolute contraindication for deep dry needling

Primary outcomes:
measure: Fugl Meyer Assessment Scale (Motor Function)
timeFrame: Two weeks
Secondary outcomes:
measure: Modified Ashworth Scale (Hypertonia/Spasticity)
timeFrame: Two weeks
measure: Impact Stroke Scale (Quality of Life)
timeFrame: Two weeks
Other outcomes:
Locations:
city: Villanueva de Gallego
country: Spain
facility: San Jorge University
state: Zaragoza
Study officials:
affiliation: San Jorge University
name: Herrero Pablo, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05048459: Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated Head and Neck Cancer and Show No Signs of Disease
Official title: Randomized Clinical Trial of Tele-Surveillance and Remote Symptom Monitoring Compared to Standard Surveillance for HPV-Associated Oropharynx Cancer With No Evidence of Disease on Post-Treatment Imaging
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Squamous Cell Carcinoma
Keywords: Tele-Surveillance
Remote Symptom Monitoring
21-347
HPV-associated Head and Neck Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is a 1:1 randomized clinical trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare standard surveillance with telemedicine surveillance (tele-surveillance) and find out which surveillance approach is best for people with HPV-associated head and neck cancer who have no evidence of disease after treatment. The researches will look at how the two approaches affect participants' quality of life, health outcomes, and expenses (for example, costs of routine visits and procedures). They will also determine doctors' and patients' satisfaction with tele-surveillance.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* ECOG 0-3
* Pathologically (histologically or cytologically) diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls)
* No evidence of disease on post-treatment PET/CT within 9 months of completing radiation therapy. No evidence of disease is a consensus determination by the patient's radiation, medical, and surgical oncologist. If the first PET/CT is equivocal, then a second PET/CT can be obtained within 9 months of completing radiation therapy.
* Post-treatment diagnostic imaging with either CT or MRI (recommended but not required)
* Able to speak and read English fluently
* Able to provide informed consent

Exclusion Criteria:

* Patients on clinical trials related to head and neck cancer that have protocol defined follow up activities
* Incomplete response or recurrent disease on post-treatment PET/CT
* Completion of radiation and chemotherapy more than 9 months ago

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 2 years
Secondary outcomes:
measure: Locoregional recurrence (LRR)
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nancy Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06682559: Comparison Between Two Different Healing Abutments in Single Posterior Implants
Official title: Comparison of Two Different Healing Abutments in Single Posterior Implants: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implants
Dental Implants, Single-tooth
Keywords: Dental implants
single missing posterior teeth
peri-implant soft tissues
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 24
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 aim of this randomized clinical trial is to evaluate the volumetric analysis of peri-implant soft tissues after 3 months of the use of a prefabricated healing abutment with scan peg in comparison to customized healing abutment.

Detailed description: Volumetric analysis of peri-implant soft tissues after 3 months of the use of a prefabricated healing abutment with scan peg with convex emergence profile in comparison to customized healing abutment with concave emergence profile.

Eligibility criteria: Inclusion Criteria:

* Adult patients who are classified as ASA I or II physical status and require mandibular single implants (single missing mandibular posterior teeth) with:

  1. Proper bone height and width.
  2. Adequate zone of keratinized tissue (at least 2 mm)

Exclusion Criteria:

* Any systematic disease as uncontrolled diabetes mellitus or metabolic bone diseases
* Pregnancy and Lactation
* A history of head and neck radiation treatment.
* Chronic periodontal diseases.
* Poor oral hygiene (Silness-Löe plaque index score 2 and 3)
* Parafunctional habits.

Primary outcomes:
measure: Measurement of peri-implant soft tissues volume
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University, Egypt
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University, Egypt
Study officials:
affiliation: Alexandria University
name: Mervat E Abdellah
role: STUDY_DIRECTOR
References:
Clinical trial NCT07024459: CARESCAPE Monitoring Systems ME Study
Official title: CARESCAPE Monitoring Systems ME Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Surgery, Intensive Care
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Improving the reliability and accuracy of the current parameter measurement technologies is always based on measurement data to develop a newer generation. Different parameters from different age groups will be studied under this study protocol.

Detailed description: Improving the reliability and accuracy of the current parameter measurement technologies is always based on measurement data to develop a newer generation.

In this study it is essential to gain data from different age groups; children, adults, and elderly people since they are targeted population to use the devices in the future. In different age groups, there is e.g., a different physiological factures that may affect the product under development.

Different parameters will be studied under this study protocol. To get real picture of these parameters investigated, it is essential to also collect data from other parameters, e.g., electrocardiogram (ECG), oxygen saturation (SpO2) and carbon dioxide (CO2, including CO2 derived respiration rate (RR)).

The results of this study are intended to be used in product development purposes and as an additional data to support conformity to the general safety and performance requirements of the Medical Device Regulation within device's Clinical Evaluation process. The study described herein is being conducted to collect feedback from the parameters studied, and to collect the parameter raw data from the patients in the hospital units using the investigational devices.

Eligibility criteria: Inclusion Criteria:

1. Able to provide written informed consent or have a Legally Designated Representative (LDR) to provide written informed consent;
2. Are being cared for in a hospital unit and are expected to remain in the unit for the duration of the study procedure; AND
3. Parameter(s) in scope of the study can be collected

Exclusion Criteria:

1. Are known to be pregnant;
2. Are breastfeeding;
3. Are suffering from infection(s) or immunocompromised patients that require isolation.
4. Have an implantable pacemaker if investigational parameters NMT and/or respiration rate are under evaluation
5. PI or designee decision due to subject's health condition

Primary outcomes:
measure: Clinical evaluation of the performance and usability
timeFrame: From admission to discharge, maximum of 24 hours
Secondary outcomes:
measure: Collection of data
timeFrame: From admission to discharge, maximum of 24 hours
Other outcomes:
measure: Collection of safety information
timeFrame: From admission to discharge, maximum of 24 hours
Locations:
city: Espoo
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
Study officials:
References:
Clinical trial NCT02189759: Kangaroo Mother Care to Prevent Hypothermia in Term Infants
Official title: A Randomized Trial of Kangaroo Mother Care to Prent Neonatal Hypothermia - Trials 2A & 2 B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Newborn
Keywords: Hypothermia
Hyperthermia
Kangaroo Mother Care
Newborn
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 375
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing WHO thermoregulation care will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (\<32.0 degrees C) in term infants (greater than or equal to 37 weeks of gestational age) when compared with routine WHO thermoregulation alone.

Detailed description: The overall hypothesis is that better adherence to Kangaroo Mother Care (KMC) in combination with existing World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, KMC whenever possible, early and exclusive breastfeeding, postponement of bathing and weighing, appropriate bundling, and use of air incubator, radiant warmer, or heat mattress if the neonate develops hypothermia) will reduce the incidence of moderate hypothermia (32-36 degrees C) or severe hypothermia (\<32.0 degrees C) in term infants (greater than or equal to weeks of gestational age) when compared with routine WHO thermoregulation alone.

Eligibility criteria: Inclusion Criteria:

* Estimated gestational age greater than or equal to 37 weeks
* Delivery in the hospital

Exclusion Criteria:

* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder

Primary outcomes:
measure: Number of Infants With Axillary Temperature <36.0 Degrees Celsius
timeFrame: Time of birth to 1 hour
measure: Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge
timeFrame: At discharge or 24 hours after birth (whichever is first)
Secondary outcomes:
measure: Number Infants Admitted to the Neonatal Intensive Care Unit
timeFrame: Duration of hospitalization-an average of 2 weeks
measure: Duration of Kangaroo Mother Care
timeFrame: Duration of hospitalization-an average of 2 weeks
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: University of Alabama at Birmingham
name: Waldemar A Carlo, MD
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Manimaran Ramani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramani M, Choe EA, Major M, Newton R, Mwenechanya M, Travers CP, Chomba E, Ambalavanan N, Carlo WA. Kangaroo mother care for the prevention of neonatal hypothermia: a randomised controlled trial in term neonates. Arch Dis Child. 2018 May;103(5):492-497. doi: 10.1136/archdischild-2017-313744. Epub 2018 Feb 22.
Clinical trial NCT00425659: Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea
Official title: Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea in High Risk Population in Hong Kong
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Keywords: Health utility
Home sleep study
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2007-01-23
Enrollment: 150
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: HEALTH_SERVICES_RESEARCH

Brief summary: Newer home sleep study device and algorithm provides an alternative for inpatient sleep study and improve the service provides to patients

Detailed description: Purpose: Assess different potential algorithms to improve the service and cost utility for diagnosis and treatment of obstructive sleep apnea syndrome (OSAS) in patients with high pretest probability in Hong Kong.

Hypothesis: Newer home sleep study device and algorithm provides an alternative for inpatient sleep study Design: Prospective randomized study Subject: High pretest probability of OSAS patients referred to a tertiary centre.

Study instruments: a portable sleep study device, AutoCPAP and inpatient sleep monitoring system.

Interventions: comparison between 3 different algorithms of health service for OSA patients would be made: conventional in-patient sleep study, empirical treatment and home sleep study.

Main outcome measures: The primary outcome is the validity of the home sleep study device compare to inpatient sleep study. The secondary outcomes are the relative efficacy of different algorithms and the numbers of failed procedures in each algorithm.

Eligibility criteria: Inclusion Criteria:

* Adult patients with high pretest probability of OSAS, i.e. ESS \> 10 or symptomatic patients, with BMI \> 23 and/or cranial facial features associated with OSA, as assessed by the attending respiratory physician in the respiratory clinic.
* Patients aged between 18-65 years who agree to participate in the study.

Exclusion Criteria:

* Pregnant women
* Patients who refuse signing consent of the study
* Do not have high pretest probability of OSAS
* Refuse to have home sleep study
* Refuse any treatment offered; or
* Could not comply with the set up of home study.

Primary outcomes:
measure: Validity of the new home sleep study device compare with conventional inpatient sleep study
timeFrame: 1 year
Secondary outcomes:
measure: The relative efficacy between different algorithm
timeFrame: 1 year
measure: Failure rates in different algorithms which need to switch to the conventional algorithm
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Kin W To, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615159: Maintenance of Recommended Sodium Intake
Official title: Maintenance of Recommended Sodium Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maintenance of Recommended Sodium Intake
Keywords: Sodium
Diet
Urinary sodium excretion
Feeding study
Diet maintenance
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: McCormick Science Institute
First posted: 2012-06-08
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall objective of this study is to assist the general public in achieving and maintaining the currently recommended sodium intake of 1500 mg/day through a reduced sodium intervention that emphasizes spices and herbs. The investigators hypothesize that after four weeks of eating a controlled diet, individuals will acclimate and adhere to a reduced sodium intake of 1500 mg/day and their taste preferences will change. The investigators also hypothesize that individuals in a low sodium behavioral intervention will maintain greater adherence to a dietary sodium intake of ≤ 1500 mg/day than individuals in a self-directed control group.


Eligibility criteria: Inclusion Criteria:

* Adults to whom the U.S. Dietary Guideline of \< 1500 mg/day of sodium applies

Exclusion Criteria:

* Individuals with chronic kidney disease,
* Chronic poor health state,
* Pregnancy,
* Inability to complete feeding study,
* Investigator discretion

Primary outcomes:
measure: Change from baseline in urinary sodium excretion
timeFrame: Weeks 4, 24
Secondary outcomes:
measure: Change from baseline in preferences for level of sodium in food products
timeFrame: Weeks 4, 24
measure: Percentage of people below 2300 mg/day sodium intake
timeFrame: Weeks 4, 24
measure: Percentage of people below 1500 mg/day sodium intake
timeFrame: weeks 4, 24
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Cheryl A Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson CA, Cobb LK, Miller ER 3rd, Woodward M, Hottenstein A, Chang AR, Mongraw-Chaffin M, White K, Charleston J, Tanaka T, Thomas L, Appel LJ. Effects of a behavioral intervention that emphasizes spices and herbs on adherence to recommended sodium intake: results of the SPICE randomized clinical trial. Am J Clin Nutr. 2015 Sep;102(3):671-9. doi: 10.3945/ajcn.114.100750. Epub 2015 Aug 12.
Clinical trial NCT00913159: A Trial Comparing Efficacy of HM3 Versus F2 Lithotripters for Stone Fragmentation
Official title: A Randomized Controlled Trial Comparing Efficacy of HM3 vs F2 Lithotripters for Stone Fragmentation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urolithiasis
Keywords: Renal stones
lithotripsy
stone free rate
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-06-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The older lithotripter, HM3, has over 90% stone-free rate in most studies. However, it's less transportable than the new model, F2. There are no prospective trials performed to make a valid comparison between these 2 lithotripters in terms of efficacy of stone fragmentation and clinical outcomes.

Detailed description: Shock wave kidney stone treatment was introduced in the 1980's. It is the least invasive method to treat kidney stone disease. The unmodified Dornier HM3 has over 90% stone free rate in most studies. The MH3 requires immersion in a full bath, necessitating dedicated operative space. The new generation model F2 uses water cushion as a coupling medium and is easily transported. The generators used in both machines are also different. The newer model has the advantage of being more convenient due to portability and ease of use of the coupling medium, but there have been no prospective studies to compare these 2 machines in terms of efficacy of stone fragmentation and clinical outcomes. We seek to compare the HM3 with the F2 models in terms of stone free rates, complications and clinical outcomes to determine which machine is the most effective and will limit the need for additional stone procedures.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with urolithiasis and choose to have ESWL treatment
2. Age 18-90 years old
3. Able to understand the informed consent

Exclusion Criteria:

1. Minors
2. Cognitively impaired

Primary outcomes:
measure: Stone free rate, complications and need for ancillary procedures
timeFrame: 3-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Division of Urology, Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Alana Desai, MD
role: PRINCIPAL_INVESTIGATOR
References: