louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00503178: Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)
Official title: Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bone Metastases
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2007-07-18
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Highly selective irradiation requires accurate target definition by high-resolution three-dimensional imaging. Co-registration of FDG-PET and high-resolution CT might be the imaging modality of choice. This choice might target radiation therapy precisely to the intra-osseous volume that is responsible for pain and to spare selectively healthy bone in the vicinity of the metastasis. This strategy could result in equal anti-pain efficacy as conventional large volume radiotherapy, but could allow bone remodeling and preservation of bone structural strength in the vicinity and could lead to reduced toxicity to neighboring organs.


Eligibility criteria: Inclusion Criteria:

* Painful bone metastasis of solid tumors
* A maximum number of bone metastases less or equal to 3
* Life expectancy \> 6 months
* Minimum age 21 years
* Signed informed consent

Exclusion Criteria:

* Previous radiotherapy to the painful site
* Bone metastasis from malignant melanoma or renal cell carcinoma
* Associated fracture or extra-osseous component

Primary outcomes:
measure: Pain assessment
timeFrame: t0
Secondary outcomes:
measure: Acute toxicity
timeFrame: t0
measure: Bone remodeling
timeFrame: t0
measure: Resulting volumes of the targets and functional active areas
timeFrame: t0
measure: Mismatch and/or overlap areas
timeFrame: t0
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Wilfried De Neve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05532371: The Effect of Exercise on Cognitive Status in Older Adults
Official title: Is Aerobic and Dual-task Training Combination the Most Effective Exercise Combination to Improve the Cognitive Status and Physical Function in Older Adults With Mild Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older People
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate the effectiveness of the different combinations of exercises on the cognitive status of older adults with cognitive decline.

Detailed description: This study is planned to examine the effects of combined exercise on cognitive status, lower extremity muscle strength, mobility, physical performance, mood and quality of life in older adults with Mild Cognitive Impairment. Aerobic exercise training and lower limb (extremity) strengthening exercises were applied to the first group, dual-task training and lower limb strengthening exercises were applied to the second group, and aerobic exercise training, dual-task training and lower limb strengthening exercises were applied to the third group.

Eligibility criteria: Inclusion Criteria:

* Not had a fall in the last six months.
* Older adults with an mini mental state examination score between18-23.
* Age ≥ 65years.

Exclusion Criteria:

* having central nervous system pathology that will affect balance
* diagnosed with vestibular pathology,
* having deformities in the waist, hip, and knee joints,
* having lower extremity amputation,
* with lower extremity operation history,
* malignancy affecting the lower extremity,
* having moderate and severe congenital heart disease, coronary heart disease and cerebrovascular disease,
* participants who cannot cooperate,
* participants who use an assistive walking device,
* participants having vision problems.

Primary outcomes:
measure: Mini-Mental State Examination
timeFrame: 12 weeks
measure: Commander Power Track 2 Manual Tester
timeFrame: 12 weeks
measure: Timed Up and Go Test
timeFrame: 12 weeks
measure: Single Leg Stance Test
timeFrame: 12 weeks
measure: Activities-specific Balance Confidence Scale
timeFrame: 12 weeks
measure: Six-Minute Walk Test
timeFrame: 12 weeks
measure: Short Physical Performance Battery
timeFrame: 12 weeks
measure: Hamilton Depression Rating Scale
timeFrame: 12 weeks
measure: World Health Organization Quality of Life-Old module
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: İsmail Uysal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01235871: A Single and Multiple-Dose Study of SB1578
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SB1578 When Administered Orally to Healthy Adult Subjects With One Single-Dose Group Crossing Over to Assess Food Effect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Safety
Tolerability
SB1578
Lead sponsor: S*BIO
Sponsor class: INDUSTRY
First posted: 2010-11-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of SB1578 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males and/or females of non-childbearing potential, 18 to 55 years of age (inclusive).
* Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55 and 100 kg (inclusive).
* Medically healthy with clinically insignificant screening results.

Exclusion Criteria:

* History or presence of significant disease.

Primary outcomes:
measure: Assess number of participants with adverse events as a measure of safety and tolerability
timeFrame: 312 hours postdose
Secondary outcomes:
measure: Assess pharmacokinetics to determine study drug half-life, maximum concentration time, elimination time, and area under the curve
timeFrame: Predose to 312 hours postdose
measure: Assess pharmacodynamics to determine study drug levels to signal pJAK2, pSTAT3, and pSTAT5
timeFrame: Predose, 6 and 24 hours postdose
measure: Assess food effects on pharmacokinetics
timeFrame: Predose to 312 hours postdose
measure: Determine recommended dose
timeFrame: March 2011
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Celerion
name: Mark J Allison, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00832871: Compassionate Use of Mifepristone in Brain/Nervous System and Other Cancers
Official title: INST 0817: Compassionate Use of Mifepristone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Keywords: Mifepristone
RU-486
Compassionate Use
Antiprogesterone
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
Collaborators: name: The Feminist Majority Foundation
First posted: 2009-01-30
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if mifepristone prevents worsening of your cancer. Mifepristone is an antiprogesterone agent, a drug which blocks female hormones, that is commonly used for the termination of pregnancies. It has not been approved by the Food and Drug Administration for use in the treatment of cancer. It is unlicensed in the United States for your condition. However, previous work has indicated that mifepristone may be useful due to how it works. It is being made available for use in the United States for compassionate use through the Feminist Majority Foundation.

Detailed description: This is a compassionate use of mifepristone treatment for patients with conditions that could respond to an antiprogesterone agent, including:

* Meningioma.
* Breast cancer
* Colon Cancer
* Endometrial Stromal Sarcoma
* Bilateral Chronic Central Serous Retinopathy
* Cushing's Syndrome
* Metastatic Adrenocortical Cancer
* Ovarian Cancer
* Other conditions as determined by the attending physicians

Eligibility criteria: Inclusion Criteria:

* All patients 18 years of age or older.
* Patients must sign an informed consent.
* Patients should be in such a health condition in the opinion of the attending physician that with the administration of mifepristone benefits may outweigh risks.

Exclusion Criteria:

* Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.

Primary outcomes:
measure: Duration of Response
timeFrame: 5 years
Secondary outcomes:
measure: Toxicity Associated With Adrenal Insufficiency
timeFrame: Up to 8 weeks after the end of study treatment or until any adverse events are resolved (whichever is longest)
Other outcomes:
measure: Overall Survival
timeFrame: 5 years
Locations:
city: Albuquerque
country: United States
facility: Universtiy of New Mexico - Cancer Center
state: New Mexico
Study officials:
affiliation: University of New Mexico Cancer Center
name: Fa-Chyi Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00398671: PreCoCa - "Prehospital Cooling With Cool-Caps"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Arrest
Keywords: primary successful cardio-pulmonary resuscitation
pre-hospital setting
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2006-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study shall investigate the feasibility of the use of cool-caps in the preclinical setting in patients with successful primary cardio-pulmonary resuscitation Hypothesis: cool-caps are efficient and feasible to use in the preclinical setting in patients after successful CPR.


Eligibility criteria: Inclusion Criteria:

* All patients with primary successful CPR

Exclusion Criteria:

* Age \< 18
* Pregnancy
* Severe bleeding or severe trauma
* Body core temperature \< 34 degrees celsius

Primary outcomes:
measure: Body core temperature at hospital/ ICU admission
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Hospital
Study officials:
affiliation: Charite University Medicine
name: Dietrich Hasper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Storm C, Schefold JC, Kerner T, Schmidbauer W, Gloza J, Krueger A, Jorres A, Hasper D. Prehospital cooling with hypothermia caps (PreCoCa): a feasibility study. Clin Res Cardiol. 2008 Oct;97(10):768-72. doi: 10.1007/s00392-008-0678-1. Epub 2008 May 29.
Clinical trial NCT01083771: Med Diet Prevention Metabolic Syndrome Men Undergoing Androgen Deprivation Therapy Prostate Cancer
Official title: Eight Week Plant-based Mediterranean Diet as Prevention of Metabolic Syndrome in Men Undergoing Androgen Deprivation Therapy for Prostate Cancer: A BrUOG Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
First posted: 2010-03-10
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess for changes in a patient's overall energy level and well-being (quality of life) after 8 weeks of dietary intervention.

Detailed description: Primary Objective: To assess for changes in the following measurements after 8 weeks of following a Mediterranean diet-- LDL, HDL, TG, FBS, creatinine, serum testosterone, triglycerides, serum insulin, CRP, 1bs, Waist circumference, blood pressure, body weight

Eligibility criteria: Inclusion Criteria:

* Histologically documented carcinoma of the prostate
* On treatment with androgen deprivation therapy for at least 3 months
* Required laboratory values:
* Serum creatinine less than 2.5
* Triglycerides \<300
* Fasting glucose \< 126
* Testosterone level \<50

Exclusion Criteria:

* No diabetes mellitus (Type 1 or 2)
* No renal failure (Serum creatinine \> 2.5)
* No active cardiac disease -no history of myocardial infarction/stroke within the last 12 months, no recurrent unstable angina, uncontrolled/unstable arrhythmias, uncontrolled hypertension (systolic blood pressure \>160, diastolic blood pressure \>100)
* No severe peripheral vascular disease
* No commencement of lipid lowering agent within 8 weeks of enrollment the study or change in dose throughout the study

Primary outcomes:
measure: Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet
timeFrame: eight weeks
Secondary outcomes:
measure: To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Anthony Mega, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02479971: Effect of Peritoneal Lavage With Clindamycin-gentamicin on Laparoscopic Sleeve Gastrectomy
Official title: Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Pain and Analytic Acute Phase Reactants Following Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A prospective, randomized study will be performed in patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups: those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2). Postoperative pain and C reactive protein will be investigated 24 hours after surgery.

Detailed description: A prospective, randomized study will be performedin patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups: those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2). Postoperative pain and C reactive protein will be investigated 24 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity
* Patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure.

Exclusion Criteria:

* Gastroesophageal reflux
* Preoperative diagnosis of chronic renal failure
* Uncontrolled psychiatric disorders
* Active infections
* Malignancies
* Any other concomitant pathology considered as a contraindication for bariatric surgery.

Primary outcomes:
measure: Postoperative pain
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: C reactive protein
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Hospital general Elche
name: Antonio Arroyo, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06389071: Laser Treatment for Lichen Sclerosus
Official title: Safety and Efficacy of Ablative Fractional 2940 nm Laser Treatment for Lichen Sclerosus Lesion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lichen Sclerosus Lesion
Lead sponsor: Sciton
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fractional ablative laser treatment for Lichen Sclerosus lesion


Eligibility criteria: Inclusion Criteria:

* Female aged 18 years or older
* Biopsy-proven vulvar lichen sclerosus lesion
* Experiencing one or more of the following symptoms of LS:

  1. Dryness
  2. Itching
  3. Burning
  4. Bleeding
  5. Blistering
  6. Soreness
  7. Easily bruises
  8. Easily tears
  9. Ulcerated lesions
  10. Painful intercourse
* Negative urine pregnancy test if subject is of childbearing potential before enrollment
* Absence of vulvovaginal infection i.e. fungi, bacterial vaginosis, and STI
* Ability to understand and sign informed consent, questionnaires, and all investigation requirements
* Willing to consent to clinical photographs of the treatment area
* Willing to consent to ultrasound images of the treatment area
* Willing and able to logistically follow schedule of treatments and follow-up visits

Exclusion Criteria:

* Pregnancy, less than 3 months postpartum, or planning to become pregnant during the investigation to protect integrity of the data
* Is a nursing mother
* History of uncontrolled malignant disease
* Active urogenital infection or chronic infection (i.e., candida, herpes, herpes simplex, bacterial vaginosis, trichomoniasis, or other infection)
* Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich syndrome)
* Subjects with genital skin disease, psoriasis due to risk of koeberizing
* Subjects on immunosuppressants: mycophenolate, retinoids, azathioprine, cyclosporin
* Known allergy or intolerance to local anesthesia
* Known history of connective tissue disease
* Known propensity for keloid formations
* Known medical condition that may affect wound healing
* Any reason that the investigator deems prohibits participation in the investigation

Primary outcomes:
measure: Histological clearance
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Val-d'Or
country: Canada
facility: Clinique Medicale Uro-Gyneco de l'Abitibi
state: Quebec
Study officials:
affiliation: Clinique Medicale Uro-Gyneco de l'Abitibi
name: Josee Parent, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04496271: Quality Control of CE-Certified Phonak Hearing Aids - 2020_06
Official title: Quality Control of CE-Certified Phonak Hearing Aids - 2020_06
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2020-08-03
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Detailed description: This study will investigate the combination of the features to determine if the audiological performance and quality of the new successor of the Marvel family shows an improved benefit over Phonak Audéo Marvel before going into the System Validation. Therefore this study will be a comparative study. The study will determine if hearing impaired users wearing the successor hearing aids, have better initial acceptance with the new precalculation, better sound quality and speech intelligibility, more clarity and loudness comfort in soft and loud environments compared to Phonak Marvel RIC (Receiver in channel) hearing aids. Another objective of the study is to compare the listening effort with the two different study devices.

Eligibility criteria: Inclusion Criteria:

* Self-reported confidence to using Bluetooth smartphone
* Hearing Loss range: moderate and moderate/ severe
* experienced hearing aid user
* willingness and interest in testing new features
* willingness to wear behind the ear hearing aids
* Informed Consent as documented by signature

Exclusion Criteria:

* the audiogram is not in the fitting range of the intended hearing aid
* limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* participant is not able to describe experiences and hearing impressions
* participant has finger movement disorders

Primary outcomes:
measure: Rating of the sound quality for the new and the comparative Hearing aid
timeFrame: 5 weeks
Secondary outcomes:
measure: Rating sound quality of own voice
timeFrame: 5 weeks
measure: Evaluating listening effort
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
Study officials:
References: