louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03788200: Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly
Official title: Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Odontoid Fracture
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective study addresses one of the most controversial topics in the treatment of cervical spine trauma: the management of type II odontoid process fractures in the elderly. It is the hypothesis that surgical treatment will result in improved functional outcome measures, neck pain and mortality rates as compared with nonsurgical management. Furthermore, it is hypothesized that surgical treatment of odontoid process fractures will limit hospital re-admissions and development of medical complications secondary to prolonged immobilization in a cervical orthosis and delayed surgery related to late fracture displacement, which are often associated with non-operative care. Additionally, data from this study will be useful in identifying patient-specific predictors of improved outcome which can be used to optimize treatment algorithms and more effectively counsel patients who sustain these injuries.


Eligibility criteria: Inclusion Criteria:

Patients to be considered for trial enrollment will include those:

1. ages 65 and older;
2. presenting with type II odontoid fracture confirmed by CT scan to one of the study centers;
3. deemed appropriate by the attending surgeon involved for C1-2 posterior cervical fusion procedure if surgical management were to be indicated
4. able to independently cooperate in the completion of all study consents, forms and documents.
5. able to speak, read and write English at an elementary school level

Exclusion Criteria:

Patients to be excluded from trial enrolment include:

1. those with previously documented type II odontoid fracture;
2. those with odontoid fracture related to malignancy or infection;
3. those with associated spinal cord injury
4. those with other cervical, thoracic or lumbar injuries requiring surgical intervention
5. those with aberrant/anomalous local anatomy which precludes posterior placement of C1/2 instrumentation

Primary outcomes:
measure: neck disability
timeFrame: 6 months post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04933500: Regional Anesthesia
Official title: Comparative Study Between Dural Puncture Epidural Technique and Conventional Epidural Technique During Elective Gynecological Vaginal Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthetic Regional Techniques for Vaginal Surgeries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 88
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult female Egyptian patients

Brief summary: Both techniques are efficacious for sacral anesthesia during vaginal surgeries. Dural puncture epidural technique allows partial confirmation of epidural catheter placement.


Eligibility criteria: Inclusion Criteria:

* ASA I-II

  --Age(25-55)years
* Height(150-170cm)

Exclusion Criteria:

* patient refusal
* severe mitral or aortic stenosis

Primary outcomes:
measure: Onset of bilateral sacral sensory loss
timeFrame: 4months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Abdelrahman
Study officials:
References:
Clinical trial NCT06172400: Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet
Official title: Wide Awake Open Carpal Tunnel Release With or Without a Tourniquet: a Randomized Single-blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 120
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 goal of this clinical trial is to compare open carpal tunnel release using local anesthesia with or without a tourniquet. The main questions it aims to answer are:

1. Do the tourniquet cause more procedural pain?
2. Does the use of tourniquet affect the outcome after the procedure? Participants will be randomized to either local anesthesia with a tourniquet or local anesthesia with adrenaline, and undrgo standard open carpal tunnel release.


Eligibility criteria: Inclusion Criteria:

* Primary idiopathic CTS
* Age 18 or older
* Symptoms of classic or probable carpal tunnel syndrome according to Katz hand diagram
* No previous wide awake hand surgical procedures under local anesthesia
* No planned concomitant procedures

Exclusion Criteria:

* Recurrent carpal tunnel syndrome
* Vibration induced neuropathy
* Polyneuropathy
* Cognitive impairment
* Anxiety disorder
* Swedish language insufficiency
* Active substance abuse
* Allergy to local anesthesia or adrenaline
* Patient refusal to participate

Primary outcomes:
measure: Procedural pain
timeFrame: Day 1
Secondary outcomes:
measure: Injection pain
timeFrame: Day 1
measure: Procedure satisfaction
timeFrame: Day 1
measure: Surgery time
timeFrame: Day 1
measure: Use of diathermy/need to inflate or deflate tourniquet
timeFrame: Day 1
measure: Adverse events
timeFrame: 2 weeks
measure: 11-item disabilities of arm, shoulder and hand questionnaire (QuickDASH)
timeFrame: 3 months, 1 year
measure: Atroshi-Lyrén scale
timeFrame: 3 months, 1 year
measure: Palmar pain scale
timeFrame: 3 months, 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02865200: The Effectiveness of Dry Needling and Classic Physiotherapy Programs in The Patients Suffering From Chronic Low Back Pain Caused by Lumbar Disc Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Physical Activity
Quality of Life
Keywords: Nutrition
Public Health
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 34
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: This study was planned for comparing physical activity levels, nutrition quality and quality of life of the individuals that are diagnosed with and without metabolic syndrome (MetS) and that live in the Turkish Republic of Northern Cyprus (TRNC).

Method: 1200 individuals in total, in which (n: 660) individuals diagnosed with MetS and (n:660) individuals not diagnosed with MetS, participated in this study. Socio-demographic characteristics of the individuals that participated the study were registered with a survey form. The long form of the International Physical Activity Questionnaire was used for determining physical activity levels of the individuals; whereas total numbers of daily steps were carried out with pedometer. The 14-item Mediterranean Diet Adherence Screener (MEDAS) was used for the assessment of dietary habits, Nottingham Health Profile (NHP) was used for the assessment of health-related qualities of life of individuals and Beck Depression Inventory (BDI) was used for the assessment of depression. In addition, biochemical analysis and anthropometric measurements of individuals were also taken.


Eligibility criteria: Inclusion Criteria:

* Patients among the ages of 35-70,
* Suffering from LBP for at least 3 months,
* Diagnosed with LDH having at least 1 active trigger point that can be cooperated .

Exclusion Criteria:

* Those with LDH that show neurological symptom,
* Having any orthopaedic problem at lower extremity and lower back region,
* Having sacroiliac joint problem, diagnosed with lumbar spondylolisthesis,
* Having any neurologic, rheumatic, oncologic problem,
* Who received any physiotherapy program at least 6 months before, patients having any corticosteroid treatment or oral medication
* Those having needle phobia were not included in the trial.

Primary outcomes:
measure: Pain assessed using the Short Form of McGill Pain Questionnaire-Visual Analogue Scale
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01523600: Whole Body Vibration Training Among Older People Using Sheltered Housing
Official title: Effect of Whole Body Vibration Training on Physical Functioning and Risk of Falling in Older People Using Sheltered Housing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Falls
Physical Performance
Fear of Falling
Keywords: whole body vibration
physical functioning
falls
older people
prevention
Lead sponsor: UKK Institute
Sponsor class: OTHER
Collaborators: name: Ministry of Education and Culture, Finland
name: Pirkanmaa Hospital District
First posted: 2012-02-01
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomised (double-blind) controlled exercise intervention trial is to determine whether the whole body vibration (WBV) training can effectively improve physical functioning of older people living in or regularly using services of sheltered housing, reduce their fear of falling, and prevent falling. The study comprises a 10-week training period and a 10-month follow-up period.


Eligibility criteria: Inclusion Criteria:

* lives in sheltered housing or uses regularly services provided by sheltered housing
* ambulatory, able to walk independently with or without a walking aid
* Mini Mental State Examination (MSSE) points 16 or more

Exclusion Criteria:

* knee or hip prosthesis
* osteosynthetic material in lower limbs
* stiffening operation of the spinal column
* cardiac pacemaker
* recent fracture (\< 1 yr for lower limb or spinal fractures, \< ½ yr for upper limb fractures)
* recent major surgical operation
* acute thrombosis or its high risk
* acute musculoskeletal inflammation
* gall or bladder stones
* problematic hernia
* unstable cardiovascular or other systematic disease
* tumor
* diabetic neuropathy
* strong vertigo

Primary outcomes:
measure: Number of falls
timeFrame: One year
Secondary outcomes:
measure: Physical functioning
timeFrame: 10 weeks and one year
measure: Fear of falling
timeFrame: 10 weeks and one year
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Kaukaharjun Seniorikeskus
city: Tampere
country: Finland
facility: Kuuselan Seniorikeskus
city: Tampere
country: Finland
facility: Tammenlehvä-keskus
city: Tampere
country: Finland
facility: Viola-koti
Study officials:
affiliation: The UKK Institute
name: Harri Sievanen, ScD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06635200: Pain Phenotype in Patients With Carpal Tunnel Syndrome
Official title: Determination of Dominant Pain Phenotype in Patients With Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Voluntary participants between the ages of 18-65 who have been diagnosed with Carpal Tunnel Syndrome will be included in the study

Brief summary: The aim of this study was to determine the dominant pain phenotype in a group of patients with Carpal Tunnel Syndrome by applying the International Association for the Study of Pain (IASP) criteria.

Detailed description: Voluntary participants between the ages of 18-65 who have been diagnosed with CTS will be included in the study.The 7 steps in the Clinical Criteria/Rating System determined by the International Association for the Study of Pain (IASP) for Nosiplastic Pain and Carpal Tunnel Syndrome will be applied to people with CTS. Thermal pain threshold, mechanical pain sensitivity and static/dynamic allodynia will be evaluated to determine pain hypersensitivity (Step 5). Specific questions will be asked to confirm the history of hypersensitivity in patients (Step 6). Finally, comorbidities, if any, will be determined (Step 7). As a result, the pain phenotype of patients with CTS will be determined (Nociceptive, Neuropathic or Nosiplastic). Shapiro-Wilk test will be performed to determine the distribution of the data. One-way ANOVA (continuous) or Kruskal-Wallis (categorical) will be used to examine whether the dependent variables differ between groups. For significant F-test, an additional investigation of differences between groups will be performed with Gabriel's post hoc procedure.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with CTS
* Being between the ages of 18-65
* Volunteering to participate in the study

Exclusion Criteria:

* Having systemic inflammatory disease
* Having a disease that may cause polyneuropathy such as diabetes mellitus
* Having a pacemaker
* Having a disease affecting the central nervous system
* Having cervical radiculopathy
* History of previous operation or local steroid injection due to CTS
* Hypersensitivity to heat and cold

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: 1 minute
Secondary outcomes:
measure: Cold Pain Threshold
timeFrame: 2 minutes
measure: Hot Pain Threshold
timeFrame: 2 minutes
measure: Mechanical Pain Threshold
timeFrame: 3 minutes
measure: Static mechanical allodynia
timeFrame: 3 minutes
measure: Dynamic Mechanical Allodynia
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
affiliation: Kutahya Health Science University
name: Emrah Afsar, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01868100: Financial Distress in Patients With Advanced Cancer
Official title: Preliminary Study of Financial Distress and Quality of Life in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Quality of Life
Keywords: Cancer
quality of life
palliative care
supportive care
Financial distress
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Advanced cancer has an adverse effect in virtually all dimensions of patients' lives (physical, psychosocial, spiritual, familial, role function). One of the less frequently explored effects of cancer is its impact on personal finances and the contribution of financial-related distress to overall suffering and quality of life. Financial issues have been recently found to be the second most frequent source of distress identified by cancer patients in a community cancer center context (22%).

In the context of continuous increased health care costs, it is likely that the frequency of health care related financial problems will keep rising. The relative contribution of these adverse financial events in advanced cancer patients to overall patient distress is not well assessed and this is particularly true in France. The main objective of this work is to determine the association between financial distress and quality of life of patients with advanced cancer in a Public General Hospital and in a Comprehensive Cancer Center. A secondary objective is to characterize the frequency and intensity of financial distress reported by French cancer patients and their impact on their quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients must be at least 18 years old and have a diagnosis of advanced cancer which is defined as one of the following: recurrent disease, received \>2 lines of chemotherapy, locally-advanced disease, metastatic disease, or refractory disease.
* Patients must have a cancer diagnosis of: breast, colon, lung or prostate.
* Patients must be able to understand, read, write, and speak French.

Exclusion Criteria:

* Clinical evidence of cognitive impairment, as determined by the palliative care physician.

Primary outcomes:
measure: Financial distress and quality of life
timeFrame: Cross sectional (one day)
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Unité de soins palliatifs Groupement Hospitalier Sud
state: Pierre Bénite
Study officials:
References:
citation: Barbaret C, Brosse C, Rhondali W, Ruer M, Monsarrat L, Michaud P, Schott AM, Delgado-Guay M, Bruera E, Sanchez S, Filbet M. Financial distress in patients with advanced cancer. PLoS One. 2017 May 18;12(5):e0176470. doi: 10.1371/journal.pone.0176470. eCollection 2017.
Clinical trial NCT03983200: Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy
Official title: Effect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the eﬀect of Rotating Magnetic Therapy on Diabetic Peripheral Neuropathy using Nerve conduction velocity examination.


Eligibility criteria: Inclusion Criteria:

- 1. Volunteer to participate and sign informed consent prior to the study 2. Patients with type 2 diabetes, who met WHO1999 diagnostic criteria, had diabetes distal symmetrical multiple neuropathy (1) clear history of diabetes; (2) neuropathy at or after diagnosis of diabetes;(3) clinical manifestations and signs are consistent with DPN;(4) have clinical symptoms (pain, numbness, paresthesia, etc.), 5 examination (ankle reflex, acupuncture pain sense, vibration sense, pressure sense, temperature sense) any 1 abnormal;If there were no clinical symptoms, 2 of the 5 examinations were abnormal.(5) exclude other causes of neuropathy).

3. HbA1c\<7.5%, the hypoglycemic regimen was stable for 3 months 4. No acute complications, such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.

Exclusion Criteria:

* 1. Patients with foreign metal bodies or pacemakers 2. Patients with a history of surgery at magnetic therapy sites within one year 3. Patients with obvious discomfort to magnetic therapy 4. Patients with bleeding or bleeding tendency 5. Patients with acute complications such as diabetic ketoacidosis 6. Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal 7. History of drug abuse and alcohol dependence in the past 5 years 8. Systemic hormone therapy was used in the last three months 9. Patients with infection and stress within 4 weeks 10. Patients who are pregnant, breast-feeding, or intending to become pregnant. 11. Any other obvious conditions or co-existing diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors, other pancreatic diseases, patients with a history of mental illness, or severe wasting diseases

Primary outcomes:
measure: Nerve conduction velocity examination
timeFrame: 1 month
Secondary outcomes:
measure: MNSI
timeFrame: 1 month
measure: Glycosylated serum albumin
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06526000: Study to Assess Changes in Immunoglobulins in Patients With Relapsing Multiple Sclerosis Treated With Anti-CD20 Therapies
Official title: Retrospective EMR Study to Assess Changes in Immunoglobulins in Patients With Relapsing Forms of Multiple Sclerosis Treated With Anti-CD20 Monoclonal Antibodies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Multiple Sclerosis
Clinically Isolated Syndrome
Relapsing-remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-07-29
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief summary: This was an observational retrospective cohort study using electronic medical records (EMRs) to study immunoglobulin levels over time among patients with relapsing forms of multiple sclerosis (MS) newly initiating anti-CD20 monoclonal antibody treatment in clinical practice.

The index date was defined as the date of anti-CD20 drug initiation during the study period. The baseline period was defined as 12 months prior to the index date.


Eligibility criteria: Inclusion criteria:

* Patients aged 18 years or older at index.
* Patients with RMS, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and secondary progressive multiple sclerosis (SPMS) at the time of initiating anti-CD20 treatment.
* Newly initiated anti-CD20 treatment after March 2017 (no history of anti-CD20 therapy at any time in medical record before this date) to the latest data cutoff (November 2022).
* Patients with at least one documented IgG lab value pre- and post-anti-CD20 drug initiation.

Exclusion criteria:

* Patients with diagnosis of primary progressive multiple sclerosis (PPMS) prior to anti-CD20 treatment.
* Participated in an anti-CD20 drug clinical trial during the study period.

Primary outcomes:
measure: Percentage Change per Year in Immunoglobulin G (IgG) Levels in Patients Receiving Ocrelizumab
timeFrame: Up to 5 years
Secondary outcomes:
measure: Percentage of Patients Newly Treated with Ocrelizumab With Low Immunoglobulin Values
timeFrame: Up to 5 years
measure: Percentage Change per Year in Immunoglobulin M (IgM) Levels in Patients Receiving Ocrelizumab
timeFrame: Up to 5 years
measure: Percentage Change per Year in IgG Levels Associated With Risk Factors in Patients Treated With Ocrelizumab
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: