louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02170480: Pin Size Influence the Incidence of Knee Pain
Official title: Does Pin Size Influence the Incidence of Knee Pain in Patients Undergoing Temporary Skeletal Traction?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 9
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: Patients admitted to the University of Utah Trauma and/or Orthopaedic Trauma services indicated for skeletal traction pin placement based on the presence of a femoral diaphyseal fracture and/or certain pelvic and acetabular fractures.

Brief summary: It has been the investigators observation that large diameter traction pins cause more postoperative knee pain than smaller traction pins. To the investigators knowledge, no study to date has identified knee pain as a consequence of traction pin placement. Furthermore, no study has identified whether pin size has an effect on the incidence of postoperative knee pain. The goal of the present study is to establish whether use of temporary skeletal traction is associated with subsequent knee pain and to determine whether traction pin size influences the incidence and/or magnitude of knee pain.

Objective #1:

Determine whether pin size influences the incidence and/or severity of postoperative knee pain in patients who undergo temporary skeletal traction.

Hypothesis:

Larger traction pins are associated with an increase in both the incidence and severity of postoperative knee pain.

Objective#2:

Determine whether pin size affects musculoskeletal function in the postoperative period.

Hypothesis:

There is no difference between small and large traction pins in postoperative musculoskeletal function.


Eligibility criteria: Inclusion Criteria:

* Male and female adults
* At least 18 years old
* Injury (Pelvic, acetabular, or femoral fracture) requiring temporary skeletal traction.

Exclusion Criteria:

* Neurovascular compromise.
* Ipsilateral fractures presenting contraindication to skeletal traction
* Patients who are non-ambulatory.
* Patients less than 18 years of age.
* Patients who do not speak English.
* Ipsilateral ligamentous knee injury

Primary outcomes:
measure: 2000 IKDC Subjective Knee Evaluation form, and pin site Visual Analog Pain Scale (VAS)
timeFrame: Post-operative follow-up visits up to 1 year
Secondary outcomes:
measure: Short Musculoskeletal Function Questionnaire (SMFA)
timeFrame: Post-operative follow-up visits up to 1 year
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Erik Kubiak, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00083980: Kava Kava for the Treatment of Generalized Anxiety Disorder (GAD)
Official title: KAVA KAVA in Generalized Anxiety: A Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anxiety Disorders
Keywords: Kava
Complementary Therapies
Medicine, Herbal
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-06-07
Enrollment: 16
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 evaluate the safety and effectiveness of the herbal medicine kava kava for the treatment of generalized anxiety disorder (GAD).

Detailed description: Kava kava (KAV) is a plant-derived treatment widely used in Europe to treat anxiety disorders. Several studies suggest that KAV may be effective in reducing anxiety symptoms; however, trial data are limited. This study will compare KAV, the drug venlafaxine-XR (VEN), and placebo for the treatment of GAD.

This study will last 10 weeks. Participants will be randomly assigned to receive KAV, VEN, or placebo for 8 weeks. Participants will then undergo a 1-week tapering of their medication followed by an additional week of observation. Self-report scales and questionnaires will be used to assess the anxiety, depression, and functional impairment of participants. Side effects, vital signs, and laboratory measures will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of generalized anxiety disorder (GAD)

Primary outcomes:
measure: Hamilton Anxiety Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Jonathan Davidson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04757480: Thoracolumbar Interfascial Plane Block Versus Bilateral Erector Spinae Plane Block In Lumbar Laminectomy
Official title: Ultrasound Guided Thoracolumbar Interfascial Plane Block Versus Bilateral Ultrasound Guided Erector Spinae Plane Block for Post-Operative Pain Management In Lumbar Laminectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lumbar Laminectomy
Thoracolumbar Interfascial Plane Block
Erector Spinae Plane Block
Ultrasound
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective randomized trial is to compare the efficacy ultrasound guided thoracolumbar interfascial plane block versus bilateral ultrasound guided erector spinae plane block for post-operative pain management after lumbar laminectomy


Eligibility criteria: Inclusion Criteria:

* Seventy cases with herniated lumbar disc scheduled for lumbar single-level or multiple-level lumbar discectomy with American Society of Anesthesiologists physical status (ASA) I or II aged between 21 and 60 years of both genders.

Exclusion Criteria:

1. Body mass index \>32
2. History of relevant allergy to any of the drugs used in the procedure
3. Previous lumbar spine surgery or back surgery with planed spinal fixation

Primary outcomes:
measure: Degree of pain by visual Analog Scale (VAS) score at rest
timeFrame: First 24 hours postoperative
Secondary outcomes:
measure: Degree of pain by visual Analog Scale (VAS) score at movement
timeFrame: First 24 hours postoperative
measure: Total rescue analgesics consumption
timeFrame: First 24 hours postoperative
measure: The time to first analgesic
timeFrame: First 24 hours postoperative
measure: 24-h morphine consumption
timeFrame: First 24 hours postoperative
measure: Side effects associated with morphine
timeFrame: First 24 hours postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: ElGharbiaa
Study officials:
References:
Clinical trial NCT04497480: The Extremities Rehabilitation Training System for Sarcopenic Hospitalized Aged 80+ Years
Official title: Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation System for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 60
Sex: ALL
Minimum age (years): 80
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most previous clinical trials that addressed the rehabilitation training system for sarcopenic elderly subjects focused on community-dwelling older adults who were relatively healthy. There is a notable paucity of high-quality research investigating the effects and feasibility of the device for hospitalized or institutionalized older people, who are generally frailer and more severe in functional impairment than those living in the community. Moreover, most reported the system were of long-term duration, which typically lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term the device training would be effective for treating sarcopenia. Therefore, the investigators aimed to assess the effectiveness of Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System for treating sarcopenia in hospitalized older patients aged 80 years and over.


Eligibility criteria: Inclusion Criteria:

* Sarcopenia defined by the Asia Working Group of Sarcopenia (AWGS)
* Agree to participant this study and sign the informed consent
* Aged 80 years or over

Exclusion Criteria:

* Patients who could not follow the training plan due to cognitive impairment, emotional problems or any other reasons;
* Severe heart and lung diseases;
* Renal insufficiency;
* Any type of tumor;
* Bedridden patients

Primary outcomes:
measure: The change of activities of daily living
timeFrame: 3 Months
Secondary outcomes:
measure: The change of handgrip strength
timeFrame: 3 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital，Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT04112680: Contagious Misinformation Trial
Official title: The Contagious Misinformation Trial: Debunking Prevalent Misinformation About an Infectious Disease Through Audio Dramas in Freetown, Sierra Leone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Misinformation
Keywords: Misinformation
Communication
Infectious diseases
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional study, with 3 arms (2 intervention groups, 1 control group) to test communication elements of audio dramas aiming to counter prevalent belief in misinformation about an infectious disease in Freetown, Sierra Leone
Primary purpose: OTHER

Brief summary: In the Contagious Misinformation Trial the investigators aim to debunk prevalent misinformation about an infectious disease using two evidence-based methods of debunking. The two debunking methods are packaged in two audio dramas of 4 episodes each, which will be sent to the WhatsApp of participants who are randomised to intervention group 1 or 2. The control group will receive audio messages about a different topic. The primary outcome is the reduction in belief in two misinformation statements about the infectious diseases.


Eligibility criteria: Inclusion Criteria:

* Adults
* Living in Freetown
* In possession of a mobile phone that has WhatsApp
* Fluent in Krio

Exclusion Criteria:

* Deafness

Primary outcomes:
measure: Change in the belief in misinformation
timeFrame: Up to 2 months
Secondary outcomes:
measure: Inadvertent promotion of misinformation: the backfire effect
timeFrame: Up to 2 months
measure: As treated analysis of primary outcomes
timeFrame: Up to 2 months
measure: Knowledge about preventive methods
timeFrame: Up to 2 months
measure: Health-related discussions among family/friend
timeFrame: Up to 2 months
measure: Method of administration
timeFrame: Up to 2 months
measure: Differences in self-efficacy
timeFrame: Up to 2 months
measure: Risk perception & preventive methods
timeFrame: Up to 2 months
measure: Objective versus subjective learning
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Freetown
country: Sierra Leone
facility: Focus1000
state: Western Area
Study officials:
affiliation: Karolinska Institutet
name: Helena Nordenstedt, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winters M, Oppenheim B, Sengeh P, Jalloh MB, Webber N, Pratt SA, Leigh B, Molsted-Alvesson H, Zeebari Z, Sundberg CJ, Jalloh MF, Nordenstedt H. Debunking highly prevalent health misinformation using audio dramas delivered by WhatsApp: evidence from a randomised controlled trial in Sierra Leone. BMJ Glob Health. 2021 Nov;6(11):e006954. doi: 10.1136/bmjgh-2021-006954.
Clinical trial NCT00035880: Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host Disease
Official title: A Phase II/III, Multicenter, Open Label, Randomized Clinical Trial Evaluating ABX-CBL When Compared to Atgam as Second Line Therapy in Patients With Steroid Resistant Acute Graft Versus Host Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Graft Vs Host Disease
Keywords: Acute graft versus host disease
Stem Cell Transplantation
Lead sponsor: Abgenix
Sponsor class: INDUSTRY
Collaborators: name: Sangstat Medical Corporation
First posted: 2002-05-07
Enrollment: 95
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trial evaluating the improvement in survival at 180 days of two therapies (Atgam versus ABX-CBL, a monoclonal antibody) in patients with acute graft versus host disease that does not respond to steroid therapy.


Eligibility criteria: Inclusion Criteria:

* Recipient of single allogeneic stem cell transplant from any donor type
* Time post transplant less than 100 days
* Received no treatment for GVHD other than steroids

Exclusion Criteria:

* Recipient of second allogeneic stem cell transplant or subsequent lymphocyte product from the donor post transplant
* IBMTR index less than A
* Received any murine product in the past
* Diagnosed with chronic GVHD
* Received Atgam later than day 10 post transplant
* Change to prophylactic regimen for acute GVHD within 72 hours of randomization

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Abgenix, Inc
state: California
Study officials:
References:
Clinical trial NCT00681980: Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM)
Official title: Study Of Valproic Acid To Treat TSP/HAM Patients In Sao Paulo, Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Paraparesis Spastic Tropical
Keywords: TSP/HAM, HTLV-1, treatment
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Is the valproic acid efficacy to treat TSP/HAM


Eligibility criteria: Inclusion Criteria:

* HTLV-1; TSP/HAM fulfill criteria

Exclusion Criteria:

* Age \<18 years

Primary outcomes:
measure: Neurological sacles
timeFrame: 24 months
Secondary outcomes:
measure: Quality of life
timeFrame: 2009
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Institute of Tropical Medicine at Sao Paulo University
state: SP
Study officials:
References:
Clinical trial NCT04225962: Intimacy of Women With Cystic Fibrosis
Official title: Intimacy of Women With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucoviscidosis
Keywords: Cystic fibrosis
Women
Private life
Sexual disorders
Quality of sex life
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 211
Sex: FEMALE
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: Adult patients with cystic fibrosis

Brief summary: The intimate life of patients with cystic fibrosis has not been the subject of specific research, it is even left behind in favor of respiratory, digestive or endocrinological dysfunctions endangering these patients. After 16 years of practice, it is significant that this subject is problematic, painful but difficult to tackle; No doubt just as much on the side of caregivers: this question has never found its way into team exchanges, it seems to be evaded doubtless difficult or too intimate to welcome. These disorders arise from the effects of the disease on the health of the mucous epithelial tissues also located in the genital area. These difficulties are more closely approached by the difficulties of procreation; PMA allows them to get around them, nevertheless making it possible to be a parent, with the residual frustration of a satisfactory sex life: a deaf "addition", adding to many care constraints.

It is therefore in terms of sexual health and quality of sexual life that it is desirable to shed light on this aspect of cystic fibrosis in women.

Bibliographic research confirms this approach: this subject is not explored, the rare publications concern the vulnerability of the cervix or the difficulty on both sides of tackling this subject.


Eligibility criteria: Inclusion Criteria:

* Major women with cystic fibrosis
* Tracked in the various CRCMs in France,
* Having or having had sexual intercourse,
* Having previously been informed of the aims and confidentiality of this research and not having opposed their participation.

Exclusion Criteria:

* Major women with cystic fibrosis whose state of health (acute episode of their disease or worsening phase) does not lend itself to such a collection
* Adult women with cystic fibrosis who are unable to receive the information and make a non-objection

Primary outcomes:
measure: Assessment of specific intimate disorders of patients with cystic fibrosis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud - CRCM adultes, médecine interne
Study officials:
affiliation: Hospices Civils de Lyon
name: Françoise SIMONNET-BISSON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00514462: Carpal Tunnel Syndrome Treated With 830nm Diode Laser
Official title: Instiutional Review Board of Chung Shan Medical University Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: National Taiwan University
First posted: 2007-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine that 830nm diode laser directly above the transverse carpal ligament (between the pisiform and navicular bone) on subjects' wrists, and test this therapeutic effect.

Detailed description: The low level laser instrument (Painless Light PL-830, Advanced Chips \& Products Crop., USA) emitted two light beams with a distance of 2.5cm between them by two laser diodes.

Eligibility criteria: Inclusion Criteria:

* no operation of the wrist
* first onset of CTS more than 1 year ago with repeated episodes
* never having laser treatment before.

Exclusion Criteria:

* patients with any rheumatoid arthritis
* history of metabolic disease or paralyzed limbs caused by stroke
* taking any anti-inflammatory drug
* with other treatments, such as acupuncture, physical therapy and wearing orthosis

Primary outcomes:
measure: treatment effect
timeFrame: two weeks
Secondary outcomes:
measure: EMG, Jamar dynamometer, Carpal tunnel function disability form
timeFrame: two weeks
Other outcomes:
Locations:
city: Chinese Taipei
country: China
facility: Chung Shan Medical University Hospital
state: Taiwan
Study officials:
affiliation: Chung Shan Medical University
name: Chin-Ping Han, MD/PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03270462: CNS Study of Patients Switching From Tacrolimus to Envarsus
Official title: A Pilot Study of Stable Kidney Transplant Recipients Taking Tacrolimus With CNS Symptoms Switched to Envarsus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplant Patients
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study documenting the neurotoxic side effects including tremors in patients with a stable graft who are receiving Tacrolimus following kidney transplantation. A standardized questionnaire will be used to document these symptoms.

Detailed description: Immunosuppressive therapies have burdensome side effects which may lead to sub-therapeutic dosing and non-compliance.

This study provides renal transplant patients the opportunity for an alternative treatment using tacrolimus, with possible less Central Nervous Symptom (CNS) side effects. CNS side effects are one of the main reasons that patients complain about after having a kidney transplant while on tacrolimus (Prograf). The side effects can be debilitating and can affect the patient's overall well-being. In severe cases it may lead to non-compliance. The advantage of the study of using Envarsus is the ability to avoid these debilitating CNS side effects and afford better compliance with the patients taking the medicine.

Eligibility criteria: Inclusion Criteria:

* Kidney transplant recipients with stable graft function.
* More than 1 months post-transplant.
* 18+ years of age with some CNS problems secondary to Prograf (tacrolimus).

Exclusion Criteria:

* Multi-organ patients (kidney/pancreas, kidney/liver).
* Evidence of graft rejection or treatment of acute rejection within 14 days prior to baseline visit.
* Inability to self-administer the QOL questionnaires.

Primary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, 1 Month, 6 Months
Secondary outcomes:
measure: Therapeutic Tacrolimus Drug Levels
timeFrame: Baseline, 1 Month, 6 Months
measure: Kidney Function: Serum Creatinine Levels
timeFrame: Baseline, 1 Month, 6 Months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Lisa Kornfeld
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Laurence Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: