louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00058851: Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms
Official title: Massage Therapy for Breast Cancer-Related Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphedema
Keywords: Manual lymph drainage
Combined physiotherapy
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-04-15
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the short-term and long-term efficacy of massage therapy alone compared to massage therapy plus compression bandaging in the treatment of breast cancer treatment-related swelling of the arms and legs.

Detailed description: Massage therapy (in the form of manual lymph drainage \[MLD\]) and compression bandaging (CB) are integral components of combined physical therapy (CPT), the recommended treatment for peripheral lymphedema (LE). According to the World Health Organization, LE afflicts hundreds of millions worldwide and probably millions in the United States. Effects of various forms of massage on lymph circulation have been postulated for more than a century, but the efficacy of MLD alone without CB has not been demonstrated. New data suggest that MLD alone reduces established LE volume as effectively as CB in combination with CPT and minimizes LE development.

Patients will be randomly assigned to either treatment with MLD alone or a combination of MLD and CB. Patients will be treated in 10 one-hour sessions over 2 weeks. They will also undergo lymphangioscintigraphy (a nuclear medicine test) to depict the function of their lymphatic system. Patients will continue self treatment at home and will be followed for 6 months.

Eligibility criteria: Inclusion Criteria:

* Lymphedema (5% to 20% increase in volume) after breast cancer treatment

Exclusion Criteria:

* Physically unable to perform massage or bandaging during home program

Primary outcomes:
measure: volume change
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Michael J Bernas, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04409951: Pharmacy Education During Covid-19 Outbreak
Official title: Impact of Covid-19 on Pharmacist Student Education in Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Event, Life Change
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All grades pharmacy students in Faculty of pharmacy

Brief summary: Coronavirus disease 2019 (COVID-19) outbreak is considered one of the most important public health crisis all over the world. General recommendations and rules around the world have been legislated to avoid or delay transmission of covid-19. Education process and learning plan are changed to focus on online Learning instead of traditional educational model. Pharmacy is one of the important practical medical science which affected by Covid-19 outbreak.

Detailed description: Detailed Description:

The survey will enroll as many individuals of the Egyptian pharmacy students as possible in the survey portion of the study - The number of participates have no limitations, at least 100 participants.

The survey will be enrolled in online google form, face to face interview(this will be reduced to encourage social isolation) \& semi-structured telephone interviews if possible.

The research procedures:

An online survey link will include questions regarding the effect of COVID 19 pandemic on the educational process in Egypt,and how the online learning process are affecting pharmacy students it will measure the impact on the psychological health of the students as well as their level of understanding of information.and their overall satisfaction from the e learning method of education used during the COVID 19 pandemic Face to face and semi-structured interviews if possible: For those Egyptian citizens who state that they would like to participate in an interview, a random sample will be contacted.

Inclusion Criteria:

pharmacy students

Exclusion Criteria:

non pharmacy students

Eligibility criteria: Inclusion Criteria:

* pharmacy students

Exclusion Criteria:

* non pharmacy students

Primary outcomes:
measure: Impact of Covid-19 on pharmacy Education study in Egypt
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beheira
country: Egypt
facility: Damanhour university
state: Damanhour
Study officials:
References:
Clinical trial NCT04935151: HoLEP vs BPRP in the Management of a Large Volume (> 80 gm) Symptomatic BPH
Official title: Holmium Laser Enucleation Versus Bipolar Resection in the Management of a Large Volume (> 80 gm) Symptomatic BPH: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPH With Urinary Obstruction
Male
Keywords: BPH
enucleation
Large Prostate
LUTS
IPSS
quality of life
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Theodor Bilharz Research Institute
First posted: 2021-06-22
Enrollment: 112
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (\> 80 gm)

Detailed description: To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of symptomatic large BPH (\> 80 gm)

Eligibility criteria: Inclusion Criteria:

* Patients suffering from LUTS secondary to infravesical obstruction from BPH with failed medical treatment
* International Prostate Symptom Score (IPSS) \> 13
* a peak urinary flow rate (Qmax) \< 15 ml/sec
* a prostate size ≥ 80 gm

Exclusion Criteria:

* presence of a urethral stricture
* neurological disorder
* bladder cancer
* prostate cancer
* previous history of bladder neck surgery or TURP

Primary outcomes:
measure: hemoglobin drop postoperatively (gm/dL)
timeFrame: within two hours after surgery
Secondary outcomes:
measure: operative duration in minutes
timeFrame: Time lapsed during surgery
measure: Hospital stay
timeFrame: From time of randomisation up to last day of admission in hospital (in days) up to 30 days
measure: blood transfusion
timeFrame: during surgery and hospitalisation up to 10 days
Other outcomes:
measure: complications (percent)
timeFrame: Three years
measure: International prostate symptom score (IPSS)
timeFrame: Three years
measure: Quality of life (QoL)
timeFrame: Three years
measure: flowmetry
timeFrame: Three years
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
city: Giza
country: Egypt
facility: Theodor Bilharz research institute
Study officials:
affiliation: Theodor Bilharz research institue
name: Mamdouh A Roshdy, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06826651: Use of Bipolar Diathermy VS Clips in Laparoscopic Appendectomy
Official title: Thermal Sealing by Bipolar Diathermy Versus Clips Closure of Mesoappendix in Laparoscopic Appendectomy ..A Comparative Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Laparoscopic Appendectomy
Bipolar Diathermy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 100
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: Acute Appendicitis is the most frequent acute pathological abdominal illness needing immediate surgery. The laparoscopic appendectomy (LA) has become more popular and is advised as the first course of treatment, particularly for female, obese, and elderly patients.LA can also give surgeons a greater field view and identification of other abdominal organs that can have different pathologies that could mimic the symptoms of acute appendicitis.The most crucial step in preventing major complications such postoperative bleeding, peritonitis, sepsis is sealing the mesoappendix. Due to this circumstance, surgeons are looking for alternative treatments for LA. The best technique for sealing mesoappendix should be affordable, practical, safe, and easy to apply technically. Extracorporeal sliding knots, intracorporeal ligations, endo-loops, nonabsorbable polymer clips (Hem-o-lock clips), hand-made loops, and Ligasure usage, and bipolar cautery division are some of the techniques utilized at LA to seal mesoappendix. According to studies, each of these techniques is secure and practicable.5 In this study, there is a comparative study between using Bipolar diathermy as a source of sealing and other mechanical closure techniques for mesoappendix To assess effect of energy source sealing of mesoappendix by using Bipolar diathermy in comparison to mechanical closure by clips as regard outcome and complications.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to AUH with uncomplicated acute appendicitis or chronic appendicitis
* Age group (18-70)

Exclusion Criteria:

* patients with complex appendicitis (appendicular mass, abscess, etc).
* patients who had the following conditions: cirrhosis with ascites, abdominal distention, and coagulation disorders, cardiac patients; shock upon arrival, a large ventral hernia, and inflammatory bowel disease

Primary outcomes:
measure: intraoperative blood loss
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06371651: Creatine and GAA for Brain Oxygenation
Official title: Enhancing Brain Oxygenation: Effects of Short-Term Co-Administration of Creatine and Guanidinoacetic Acid at Rest and During Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Deficiency
Keywords: creatine
guanidinoacetic acid
oxygen saturation
brain
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of this randomized controlled trial is to evaluate cerebral blood oxygenation after 7-day administration of a creatine-guanidinoacetic acid (GAA) mixture in healthy adults before, during, and after a series of cognitive tests.


Eligibility criteria: Inclusion Criteria:

* Age 18-30 years
* Absence of metabolic disorders or other health complications
* Provision of signed informed consent

Exclusion Criteria:

* History of dietary supplement use within the preceding 4 weeks
* Lack of consent to randomization
* Concurrent participation in other studies

Primary outcomes:
measure: Brain oxygen saturation
timeFrame: Change from baseline brain oxygen saturation at 2 weeks
Secondary outcomes:
measure: Hemoglobin index
timeFrame: Change from baseline hemoglobin index at 2 weeks
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Applied Bioenergetics Lab at Faculty of Sport and PE
state: Vojvodina
Study officials:
affiliation: University of Novi Sad
name: Sergej Ostojic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Watanabe A, Kato N, Kato T. Effects of creatine on mental fatigue and cerebral hemoglobin oxygenation. Neurosci Res. 2002 Apr;42(4):279-85. doi: 10.1016/s0168-0102(02)00007-x.
citation: Hammett ST, Wall MB, Edwards TC, Smith AT. Dietary supplementation of creatine monohydrate reduces the human fMRI BOLD signal. Neurosci Lett. 2010 Aug 2;479(3):201-5. doi: 10.1016/j.neulet.2010.05.054. Epub 2010 May 24.
Clinical trial NCT02110251: Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease
Official title: Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease With Critical Limb Ischemia or Tissue Loss. A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with peripheral arterial disease with symptoms of critical ischemia or reduced tissue loss have a very high mortality and morbidity rate. So far, treatment strategies focused on the preservation of life and limb by an open surgical or endovascular revascularization, together with cardiovascular risk management and pain relief. Important modifiable factors related to mortality and morbidity are not covered in the current national and international guidelines. This study investigates the effects on mobility, mortality and quality of life with supplementation of the standard treatment of critical limb ischemia with supervised exercise therapy. Also a reduction of cardiovascular risk by intensive risk factor management and lifestyle coaching will be taken in to account. The supervised exercise therapy will take place under the supervision of a trained physiotherapist.


Eligibility criteria: Inclusion Criteria:

* Patients with peripheral arterial disease Rutherford stage 4 and 5, where it is possible to improve the vascularization of the affected leg with the help of an endovascular and / or open surgical vascular intervention.
* Patients with both legs are affected, but the most severe leg does not exceed stage 5.

Exclusion Criteria:

* Severe cardiopulmonary comorbidity (NYHA 4) and previous amputations of lower leg or thigh.
* Patients with limited amputation of the toes can participate.
* Insufficient understanding of the Dutch language.
* No physiotherapy insurance.

Primary outcomes:
measure: Mobility
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-Brabant
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Joep Teijink, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02795351: Induction of Migraine Aura With Sildenafil
Official title: The Effect of the Selective PDE5 Inhibitor, Sildenafil, on Aura and Migraine Headache Induction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Migraine With Aura
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In a double blind placebo-controlled cross-over study the effect of Sildenafil on aura and migraine headache induction is tested in patient with migraine with aura.


Eligibility criteria: Inclusion Criteria:

* Migraine with aura
* Minimum of 2 attacks/year

Exclusion Criteria:

* Any other type of headache, except tension-type headache \< 4 days per month
* History of cardio- or cerebrovascular diseases
* Hypertension or hypotension
* Any daily intake of medication, including prophylactic migraine treatment, except oral contraceptives
* Pregnancy and lactation

Primary outcomes:
measure: Aura and migraine like headache
timeFrame: 14 hours
Secondary outcomes:
measure: Markers of endothelial function in blood
timeFrame: 2 hours
measure: Migraine without aura
timeFrame: 14 hours
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Neurology, Herlev-Gentofte Hospital
Study officials:
affiliation: Department of Neurology, Herlev-Gentofte Hospital
name: Christina Kruuse, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butt JH, S Eddelien H, Kruuse C. The headache and aura-inducing effects of sildenafil in patients with migraine with aura. Cephalalgia. 2022 Sep;42(10):984-992. doi: 10.1177/03331024221088998. Epub 2022 Mar 25.
Clinical trial NCT00526851: Oral Cancer Screening Among Nursing Home Dentists in Ohio
Official title: Oral Cancer Screening: Practices, Knowledge and Opinions of Ohio Nursing Home Dentists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: lip and oral cavity cancer
oropharyngeal cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-09-10
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nursing Home Dentists in Ohio

Brief summary: RATIONALE: Learning about oral cancer screening practices, knowledge, and opinions of Ohio nursing home dentists may help the study of oral cancer in the future.

PURPOSE: This clinical trial is studying oral cancer screening among nursing home dentists in Ohio.

Detailed description: OBJECTIVES:

* To develop a comprehensive sample of nursing home dentists in Ohio.
* To document knowledge of oral cancer detection among these dentists.
* To describe opinions of these dentists about oral cancer screening competency.
* To describe the current oral cancer screening practices of these dentists.

OUTLINE: Participants are stratified according to geographical location (urban vs rural).

A comprehensive sample of nursing home dentists practicing in Ohio are contacted through a recruitment letter and are asked to respond to questions regarding oral cancer screening practices, knowledge of oral cancer detection, and opinions about oral cancer screening using a newly developed survey, which is based on parts of an existing, pre-tested instrument (Oral Cancer Prevention and Early Detection Survey).

Eligibility criteria: DISEASE CHARACTERISTICS:

* Dentist practicing either full-time or part-time in a nursing home setting in the state of Ohio

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Knowledge of oral cancer detection among nursing home dentists in Ohio
timeFrame: Cross-Sectional
measure: Opinions of these dentists about oral cancer screening competency
timeFrame: Cross-Sectional
measure: Current oral cancer screening practices of nursing home dentists in Ohio
timeFrame: Cross-Sectional
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Suparna A. Mahalaha, DDS, MPH
role: STUDY_CHAIR
References:
Clinical trial NCT05860751: The Effect of Dry Needling With Electrical Stimulation on Individuals With Restless Legs Syndrome
Official title: The Effect of Dry Needling With Electrical Stimulation on Individuals With Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neck Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of dry needling with electrical stimulation (DNES) on sleep quality, symptom severity, and function in individuals with restless legs syndrome.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* Clinical diagnosis of restless legs syndrome

Exclusion Criteria:

* Active cancer diagnoses
* Neuropathic pain (e.g., lumbosacral radiculopathy and/or diabetic neuropathy),
* Pregnancy
* Immunocompromised disease (e.g., HIV, AIDS, lupus)
* Insufficient English-language skills to complete all questionnaires
* Inability to maintain treatment positions
* Contraindications to dry needling:35,36

  * Presence of needle phobia
  * History of abnormal reaction to needling or injection
  * History of bleeding disorder

Primary outcomes:
measure: Change in sleep quality
timeFrame: Baseline, 4 weeks and 8 weeks post-intervention
measure: Change in periodic limb movement
timeFrame: Baseline, weekly for 3 weeks
measure: Change in Restless Legs Syndrome symptom severity
timeFrame: Baseline, 4 weeks and 8 weeks post-intervention
Secondary outcomes:
measure: Change in pain level
timeFrame: Baseline, 4 weeks and 8 weeks post-intervention
measure: Change in quality of life
timeFrame: Baseline, 4 weeks and 8 weeks post-intervention
measure: Acute change in Restless Legs Syndrome symptoms
timeFrame: Baseline, Immediately post-intervention
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ray Lunasin, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00101751: INITIATE Plus (INITiation of Insulin to Reach A1c TargEt) Study
Official title: Efficacy and Safety of a Standard Titration Algorithm Coupled With a Conventional Dietary Intervention or Intensive Dietary Intervention Versus a Standard Titration Algorithm, Alone, in Patients With Type 2 Diabetes Initiating NovoLog® Mix 70/30 Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-01-13
Enrollment: 4877
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: This trial is conducted in the United States of America (USA). The purpose of this study is to compare the effectiveness and safety of a biphasic insulin aspart standard titration regimen when coupled with dietary intervention to standard titration without dietary intervention.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes

Primary outcomes:
measure: HbA1c and Incidence of hypoglycemia
timeFrame: After 24 weeks of treatment
Secondary outcomes:
measure: Postprandial glucose from 8-point SMBG spontaneously reported adverse events; any changes from baseline
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Trippe BS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu PL, Oyer DS. Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATEplus trial). Curr Med Res Opin. 2012 Jul;28(7):1203-11. doi: 10.1185/03007995.2012.686444. Epub 2012 Jun 25.
citation: Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Deluzio AJ, Chu PL, Trippe BS; Initiateplus Study Group. Efficacy and tolerability of self-titrated biphasic insulin aspart 70/30 in patients aged >65 years with type 2 diabetes: an exploratory post hoc subanalysis of the INITIATEplus trial. Clin Ther. 2011 Jul;33(7):874-83. doi: 10.1016/j.clinthera.2011.05.093. Epub 2011 Jul 8.