louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06757088: Combined Effects of Transcranial Direct Current Stimulation on Postural Control in Elderly
Official title: Effects of Combined Transcranial Direct Current Stimulation for Cerebral Cortex and Cerebellum on Postural Control in Elderly Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural; Defect
Keywords: Posture
Old age
transcranial direct current
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study aims to determine the effects of combination stimulation (M1 Cortex+ Cerebellum) along with balance training (X-box with Kinect) on postural control in elderly population and to compare the combined stimulation (M1+CbS) with individual motor cortex, cerebellar or sham stimulation.

Detailed description: The current study has been designed to investigate the potential effects of short term transcranial direct current stimulation on motor cortex and cerebellum both simultaneously and to document any additional benefits over each individual stimulations (M1 cortex stimulation, cerebellar stimulation or sham stimulation). Patients will be receiving the transcranial direct current stimulation combined with non-immersive virtual reality using Xbox 360 with Kinect in each group.

Eligibility criteria: Inclusion Criteria:

* Both genders
* Healthy elderly patients
* Age group of ≥ 60 years
* Fluent in reading and speaking Urdu language

Exclusion Criteria:

* Patients who have any congenital/Acquired walking or standing difficulty due to certain circumstances won't be included in the healthy adults group.
* Patients with Osteo-Arthritis (OA)
* Patients with cerebellar issues or issues such as vertigo with standing and walking etc.
* Individuals who had significant dysarthria or aphasia that might impair understanding of speech or verbal instruction
* Cognitive/communication impairment

Primary outcomes:
measure: Berg balance scale (BBS)
timeFrame: 3 weeks
measure: Timed Up and Go test (TUG)
timeFrame: 3 weeks
measure: Bestest Balance Evaluation-Systems Test (Bestest)
timeFrame: 3 weeks
measure: Twenty-five feet walk test (25FWT)
timeFrame: 3 weeks
measure: Six-minute walk test (6MWT)
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Arshad Nawaz Malik
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06719388: Exercise Therapy and Jaw-Mobilizing Device for Trismus in Head and Neck Cancer Patients
Official title: Exercise Therapy Combined with a Jaw-Mobilizing Device for Improving Maximal Mouth Opening and Trismus in Patients with Head and Neck Cancer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancers
Trismus
Radiotherapy Side Effects
Keywords: Head and Neck Cancer
Trismus
Radiotherapy-Induced Mouth Opening Limitation
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two parallel groups: the experimental group, which receives exercise therapy combined with a jaw-mobilizing device, or the control group, which receives exercise therapy only. Both groups are followed concurrently throughout the study period.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the effects of exercise therapy combined with a jaw-mobilizing device on enhancing quality of life in head and neck cancer patients undergoing radiotherapy.

Detailed description: This study investigates the efficacy of exercise therapy combined with a jaw-mobilizing device (ET-JMD) in improving maximal mouth opening (MMO), preventing trismus, enhancing quality of life (QoL), and alleviating trismus-related symptoms in head and neck cancer (HNC) patients undergoing radiotherapy.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 20 years.
* Ability to communicate in Mandarin or Taiwanese, without significant reading, hearing, or writing impairments, and capable of completing questionnaires independently or with researcher assistance.
* Diagnosed with head and neck cancer and scheduled for initial radiotherapy to the head and neck region.
* Clear consciousness without severe cognitive or psychiatric disorders.
* Presence of intact central incisors (#11, #41) on the right side or (#21, #31) on the left side of both the upper and lower jaws.
* Baseline maximal mouth opening (MMO) ≥ 25 mm.
* Willingness to participate in the study with signed informed consent.

Exclusion Criteria:

* Known temporomandibular joint disorders.
* Postoperative wound healing complications diagnosed by a physician that prevent participation in mouth-opening rehabilitation exercises.

Primary outcomes:
measure: Maximal Mouth Opening
timeFrame: Baseline to Week 36
Secondary outcomes:
measure: Quality of Life Scores
timeFrame: Baseline to Week 36
measure: Trismus-Related Symptom Distress Scores
timeFrame: Baseline to Week 36
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: tri-Service Gereral Hospital
Study officials:
References:
Clinical trial NCT02716688: S-1 and Radiotherapy for Elderly Esophageal Cancer Patients
Official title: A Phase Ⅱ Study of S-1 With Concurrent Radiotherapy in Elderly Esophageal Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Esophageal Cancer
S-1
Radiotherapy
Keywords: Esophageal cancer
Radiotherapy
elder
S-1
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older patients with esophageal cancer.

Detailed description: Older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including concurrent chemoradiotherapy. In this phase II trial, the efficacy and toxicity of S-1 with concurrent radiotherapy will be investigated in this setting.

Eligibility criteria: Inclusion Criteria:

1. Cytologically or histologically confirmed esophageal carcinoma;
2. ECOG performance status: 0-1;
3. No treatments prior to enrollment;
4. At least one measurable lesion on CT, MRI or esophageal barium exam;
5. Normal functions of heart, lung, liver, kidney and bone marrow;
6. Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL;
7. Informed consent signed.

Exclusion Criteria:

1. Prior treatments of chemotherapy or irradiation;
2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
4. Participating in other clinical trials;
5. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
6. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.

Primary outcomes:
measure: response rate
timeFrame: week 4
Secondary outcomes:
measure: Progression-free survival
timeFrame: year 0 - year 2
measure: Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)
timeFrame: year 0 - year 1
measure: Overall survival
timeFrame: year 0 - year 2
Other outcomes:
measure: Dysphagia score
timeFrame: month 0 - month 6
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT00548288: Effect of Local Pamidronate in Preventing Bone Loss After Total Hip Arthroplasty
Official title: Phase 1 Study of the Effect of Local Pamidronate Application in Preventing Periprosthetic Bone Loss After Total Cemented Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Arthroplasty
Mineral Density
Lead sponsor: General and Teaching Hospital Celje
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of the study are to determine whether pamidronate applied locally causes diminished periprosthetic bone loss and decreased rate of bone turnover compared to patients receiving placebo after cemented total hip arthroplasty (THA). The study design will be prospective, randomized, and blind. Periprosthetic bone mineral density (BMD) will be measured with dual energy X-ray absorptiometry (DXA) at the total periprosthetic area as well as at seven Gruen zones or regions of interest. DXA scans will be performed at one week (baseline), three months, and six months postoperatively. Mean values of biochemical markers of bone turnover, BMD, and baseline-normalized BMD values will be compared between the bisphosphonate and placebo groups at each time point. For all temporal measurements including bone markers, BMD and normalized BMD, mean values will be compared across each time point within a given group.


Eligibility criteria: Inclusion Criteria:

* patients with hip arthritis scheduled for total cemented hip arthroplasty

Exclusion Criteria:

* pregnancy
* endoprosthesis on contralateral hip

Primary outcomes:
measure: Periprosthetic bone mineral density
timeFrame: 6 months
Secondary outcomes:
measure: Biochemical markers of bone turnover
timeFrame: 6 months
Other outcomes:
Locations:
city: Celje
country: Slovenia
facility: Department for Orthopaedic Surgery and Sports Trauma, Celje Teaching Hospital
Study officials:
affiliation: General and Teaching Hospital Celje
name: Samo K Fokter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06186388: Glaucoma Screening
Official title: TEMPO (iMOvifa) Glaucoma Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Cape Fear Eye Institute
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: * The primary objective of this study is to evaluate the diagnostic accuracy of the TEMPO (iMOvifa) visual field perimeter screening test by measuring the sensitivity in a population of eyes with glaucoma and the specificity in a population of normal eyes and to measure repeatability of the screening test.
* The secondary objective of this study is to gather and analyze ancillary data to confirm the diagnosis or absence of glaucoma.


Eligibility criteria: Inclusion Criteria (All subjects):

* Subjects 40 years of age or older on the date of informed consent.
* Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
* BCVA 20/40 or better in both eyes.

Inclusion Criteria- Normal Population

* IOP ≤ 21 mmHg
* Healthy anterior and posterior segment evaluation on clinical examination.

Inclusion Criteria - Pathology Population

• Diagnosis of glaucoma on clinical examination.

Exclusion Criteria (All subjects):

* Unable to tolerate ophthalmic imaging and/or diagnostic testing.
* History of intraocular surgery (uncomplicated surgeries are accepted).
* Ocular diseases including uveitis, non-glaucomatous optic neuropathy, severe or proliferative diabetic/ hypertensive retinopathy (controlled diabetes and hypertension participants with no or mild to moderate retinopathy \[not involving the macula\] can be included), unresolved trauma.
* Any neurodegenerative diseases including Alzheimer, Parkinson, or dementia, or history of stroke.
* Unreliable VF testing and/or poor-quality OCT scans.
* Poor fixation.

Primary outcomes:
measure: Sensitivity and specificity
timeFrame: 1 day
Secondary outcomes:
measure: RNFL and GCL thickness
timeFrame: 1 day
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Cape Fear Eye Institute
state: North Carolina
Study officials:
affiliation: Clinical Research Coordinator
name: Christina Jones
role: STUDY_DIRECTOR
References:
Clinical trial NCT00957788: Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus
Official title: Safety and Feasibility Study of NST - 001 in Inner Ear Using Neuroject Injection Set for the Treatment of Tinnitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Tinnitus
Keywords: tinnitus
acouphenes
ear
ringing
buzzing
roaring
hissing
clicking
Lead sponsor: NeuroSystec Corporation
Sponsor class: INDUSTRY
First posted: 2009-08-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study involves an experimental drug (NST_001) and a delivery system. The main purpose of this research study is to investigate the safety of NST-001, delivered directly to the inner ear for the treatment of tinnitus.


Eligibility criteria: Inclusion Criteria:

* Patients able to provide voluntary consent.
* Severe tinnitus in one ear that began no more than ten years ago.
* Ear to be treated must be deaf or have profound hearing loss.
* Subjects with cardiac disease or hypertension, must have stable disease for at least 6 months.
* Subject must have intact cochlear nerve on the ear to be treated.
* Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods as recommended by the study physician.

Exclusion Criteria:

* Current diagnosis of bilateral tinnitus.
* Current diagnosis or history of pancreatitis.
* Females that are pregnant or lactating.
* Use of investigational drugs within the previous 30 days.
* History of drug dependency or other substance abuse.

Primary outcomes:
measure: Subjects will be followed for identification and frequency of drug or procedure-related adverse events.
timeFrame: At each follow-up visit.
Secondary outcomes:
measure: Observe any effect on tinnitus as determined by the visual analog scale, subject tinnitus diary, and investigator interview.
timeFrame: At each follow-up visit.
Other outcomes:
Locations:
city: Mont-Godinne
country: Belgium
facility: Cliniques Universitaries U.C.L.
city: Bobigny
country: France
facility: Hôpital Avicenne
state: Cedex
Study officials:
affiliation: Hôpital Avicenne
name: Bruno Frachet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques Universitaries U.C.L.
name: Pierre Garin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02818088: Cognitive Training in Obsessive Compulsive Disorder
Official title: Cognitive Training in Patients With Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: University of Stellenbosch
Sponsor class: OTHER
Collaborators: name: University of Cape Town
First posted: 2016-06-29
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This unique study will allow us to observe the neural correlates associated with working memory in an obsessive compulsive disorder (OCD) paradigm. We believe that developing working memory in participants suffering with OCD will reduce the severity of their symptomology. This will allow a greater understanding into the functioning of these participants which in turn presents with treatment possibilities.

Detailed description: It is currently unclear whether cognitive training using a working memory task, is effective in reducing obsessive-compulsive symptoms and neuropsychological deficits in patients with OCD. Two groups (OCD and control) will be recruited. Both groups will undergo an intervention consisting of 8 weeks of cognitive training. Working memory, neuropsychological functioning and OCD symptomatology will be assessed pre and post-treatment, in both groups. Furthermore neuroimaging using functional magnetic resonance imaging (fMRI) will be conducted at baseline as well as at the end of the 8 week period in both groups. The scan will serve to show any structural or functional changes in the frontostriatal area involved with working memory. To our knowledge, this is one of the first studies to date to examine whether cognitive training improves symptoms in OCD.

Eligibility criteria: Inclusion Criteria:

* A primary diagnosis of OCD, with a score \> 16 on the Yale-Brown Obsessive Compulsive Scale (YBOCS) (Goodman et al, 1989b, 1006-1011).
* Participants must be aged older than 18 and younger than 65 years.
* Right handed.
* If taking SSRI's the participant needs to be on a stable dose for at least 2 months.

Exclusion Criteria:

* Significant physical or neurological illnesses. An exception will be made for patients taking SSRI's (and not using any other drugs).
* Any significant current DSM disorder (in addition to OCD).
* Past history of significant substance or alcohol abuse.
* Pregnancy.
* Any metal pins/ prostheses or cardiac pacemakers.
* Sufferers of claustrophobia.
* Head injury

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Immediately after intervention
measure: Cambridge neuropsychological test automated battery (CANTAB)
timeFrame: Immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Stellenbosch University
state: Western Cape
Study officials:
References:
Clinical trial NCT01362088: Microcirculation in Continuous Venovenous Hemofiltration Patients on the Intensive Care Unit
Official title: Evaluation of Sublingual Microcirculation by Means of SDF Imaging by Stepwise Ultrafiltration in CVVH Patients on the ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Continuous Venovenous Hemofiltration
Keywords: microcirculation
intensive care
ultrafiltration
CVVH
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2011-05-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive Care patients treated with CVVH

Brief summary: In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance. From there, the ultrafiltration steps are performed, after increasing the ultrafiltration rate, the sublingual microcirculation is assessed by sidestream dark field (SDF). The images are subsequently randomly analyzed, and the sublingual microcirculation is expressed as a number, the microvascular flow index (MFI).

Detailed description: Before deciding to threat a patient actively with CVVH, a target balance will be agreed for the next 12 hours. Then the ultrafiltration rate for the zero balance is calculated. From there, the ultrafiltration rate progressively increased to 50 ml per hour, up to a maximum ultrafiltration rate of 300 ml per hour.

After each increase of the ultrafiltration rate, the sublingual microcirculation is assessed by SDF.

After obtaining the desired ultrafiltration rate, the microcirculation will again be assessed before and after the patient is temporarily placed in Trendelenburg position. This could possibly show that underfill has the greatest influence on the microcirculation, and not other factors like a rising hematocrit.

Eligibility criteria: Inclusion Criteria:

* age \> 18 jaar
* informed consent

Exclusion Criteria:

* age \< 18 jaar
* oral surgery

Primary outcomes:
measure: Difference in MFI between zero balance and maximal ultrafiltrationrate (300 ml/hr)
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Centre Leeuwarden
Study officials:
affiliation: Frisius Medisch Centrum
name: Christiaan Boerma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bemelmans RH, Boerma EC, Barendregt J, Ince C, Rommes JH, Spronk PE. Changes in the volume status of haemodialysis patients are reflected in sublingual microvascular perfusion. Nephrol Dial Transplant. 2009 Nov;24(11):3487-92. doi: 10.1093/ndt/gfp267. Epub 2009 Jun 10.
Clinical trial NCT00913588: To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fed and Fasted Conditions
Official title: Comparative, Randomized, Single-Dose, 3-way Crossover Bioavailability Study of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Health Adult Males Under Fed and Fasted Conditions Following Administration of a 40 mg Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fed and fasted conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 141 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Research Center (Cincinnati)
name: Roderick Malone, M.D.
role: PRINCIPAL_INVESTIGATOR
References: