louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00330941: Intravenous Lidocaine and Acute Rehabilitation
Official title: Intravenous Lidocaine Infusion Improves Outcome After Laparoscopic Colectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Opioid Consumption, Postoperative
Postoperative Fatigue
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: University of Liege
First posted: 2006-05-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Intravenous infusion of lidocaine may decrease postoperative pain and speed return of bowel function. The investigators therefore tested the hypothesis that including perioperative lidocaine infusion improves recovery from laparoscopic colectomy and shortens the duration of hospitalization.

Methods: Forty patients scheduled for laparoscopic colectomy were randomly allocated to receive intravenous lidocaine (bolus injection of 1.5 mg.kg-1 lidocaine at induction of anesthesia, then a continuous infusion of 2 mg.kg-1.h-1 intraoperatively and 1.33 mg.kg-1.h-1 for 24 h postoperatively) or an equal volume of saline. All patients received similar intensive postoperative rehabilitation. Postoperative pain scores, opioid consumption, and fatigue scores were measured. Times to first flatus, defecation, and hospital discharge were recorded. Postoperative endocrine (cortisol and catecholamines) and metabolic (leucocytes, C-reactive protein, and glucose) responses were measured for 48 h. Data (median \[25%-75% interquartile range\] Saline vs Lidocaine groups) were analyzed using Mann-Whitney tests. P\<0.05 was considered statistically significant.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* non-malignant disease

Exclusion Criteria:

* greater than 70 years
* history of gastro-duodenal peptic ulcer or renal failure (contraindications to the use of nonsteroidal anti-inflammatory drug)
* hepatic insufficiency
* psychiatric disorder
* steroid treatment
* chronic treatment with opioid

Primary outcomes:
measure: Sevoflurane consumption
measure: Pain scores
measure: abdominal comfort
measure: fatigue scores
Secondary outcomes:
measure: bowel function
measure: hospital stay
measure: endocrine and metabolic responses
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: CHU de Liège, University of Liège
Study officials:
affiliation: Department of Anesthesia and Intensive Care Medicine, CHU de Liège, University of Liège, Belgium
name: Jean Joris, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02914041: Kyphotic Measure Using Distance From the Wall
Official title: Kyphotic Measure Using Distance From the Wall: Reliability, Validity and Distance From the Wall to Indicate Risk for Spinal Fracture
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kyphosis
Keywords: Kyphosis
Kyphosis wall distance
elderly
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 96
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly who live community-dwelling with different degrees of kyphosis, aged at least 60 years with a body mass index between 18.5-29.9 kg/m2 and OWD \>0 cm. (Wongsa et al., 2012). However, elderly are excluded if they present signs and symptoms that may affect participation in the study, i.e. unstable medical condition, pain or inflammation in the joints of the lower extremity (pain scale \> 5), having sequelae of neurological deficits, and unable to understand and follow a simple command used in the study.

Brief summary: Are the KypDisT and conventional C7WD are practical, valid, reliable, and effectiveness of the tools to discriminate the functional ability impairments relating to kyphosis when compare with gold standard (Cobb's method), and compare among physical therapy, VHS and caregiver?

Detailed description: 1. To further develop an innovation to measure kyphosis using distance from the wall, a Kyphosis wall distance tool (KypDisT).
2. investigate validity of the measurements in terms of 2.1 Concurrent validity of conventional C7WD and KypDisT as compared to a gold standard (Cobb's method).

   2.2 Discriminative ability of conventional C7WD and KypDisT on functional abilities in elderly with different severity of kyphosis.
3. To investigate the reliability of the measurements in terms of 3.1 Test-retest reliability of conventional C7WD and KypDisT. 3.2 Reliability of conventional C7WD and KypDisT comparing among physical therapy, VHS and caregiver.
4. To explore the distance to indicate risk of spinal fracture to indicate a risk of spinal fracture.

Eligibility criteria: Inclusion Criteria:

* Community-dwelling elderly with different degrees of kyphosis,
* Aged at least 60 years
* Body mass index between 18.5-29.9 kg/m2
* OWD \>0 cm.

Exclusion Criteria:

* Present signs and symptoms that may affect participation in the study, i.e. unstable medical condition, pain or inflammation in the joints of the lower extremity (pain scale \> 5), having sequelae of neurological deficits
* Unable to understand and follow a simple command used in the study.

Primary outcomes:
measure: KMD
timeFrame: 7 days
Secondary outcomes:
measure: 10MWT
timeFrame: 1 day
measure: FTSST
timeFrame: 1 day
measure: TUGT
timeFrame: 1 day
measure: 6MinWT
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand
name: Sugalya Amatachaya, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03571841: Sexual Health and Rehabilitation After Ovarian Suppression Treatment
Official title: Sexual Health and Rehabilitation After Ovarian Suppression Treatment (SHARE-OS): An Educational Intervention for Young Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivors
Sexual Function Disturbances
Ovarian Suppression Treatment
Keywords: Breast Cancer Survivors
Sexual Function Disturbances
Ovarian Suppression Treatment
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Howard Cox Fund for Women Assistant Professors
First posted: 2018-06-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is evaluating an educational intervention for breast cancer survivors who have experienced changes in sexual function after ovarian suppression treatment to reduce the risk of breast cancer recurrence.

Detailed description: The purpose of this research is to study the effectiveness of an educational intervention for breast cancer survivors who have experienced changes in sexual function after ovarian suppression treatment to reduce the risk of cancer recurrence. The aim is to develop an effective intervention to help women manage these changes and restore sexual health and functioning.

- This study consists of attending a group educational session followed by a one-on-one telephone coaching session.

* The group educational session will last about 4 hours, and will include information on resources, self-help strategies, and relaxation techniques.
* The telephone coaching session will take place four weeks after the group session, and will last about 15 minutes

Eligibility criteria: Inclusion Criteria:

* Women with a history of breast cancer who are currently on chemical ovarian suppression
* Current age ≤ 50
* No active cancer therapy in the past 6 months and no future therapy planned
* Endorsement of at least one sexual symptom (see Appendix A for eligibility screening)
* English-speaking

Exclusion Criteria:

* History of pelvic radiation
* Prior participation in one of Dr. Bober's sexual health workshops

Primary outcomes:
measure: Change in Sexual Function (FSFI)
timeFrame: Paired t-test (Wilcoxon signed-rank test) Baseline to 2 Month Follow-up
Secondary outcomes:
measure: Change in participants psychological distress on Brief Symptom Inventory
timeFrame: Baseline to 2 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Sharon Bober, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03119441: Effect of Dental Waterjet on Oral Hygiene for Patients With Braces
Official title: The Efficacy of Dental Water Jet in Plaque Removal During Orthodontic Treatment With Fixed Appliances: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Hygiene
Lead sponsor: Riyadh Colleges of Dentistry and Pharmacy
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the efficacy of dental water jet in plaque removal and gingival health during orthodontic treatment with fixed appliances.

Detailed description: Subjects will be randomized into two groups. The first group will receive a dental water jet and the second group will receive dental floss. Plaque accumulation using plaque index and gingival health using gingival index will be measured at baseline and after four weeks for each group and then, results will be compared.

Eligibility criteria: Inclusion Criteria:

* Subjects having orthodontic fixed appliance.
* Subjects aged 12 years old and above who own mobile phones and no mental or physical disabilities.
* Subjects willing to comply with given oral hygiene instructions.

Primary outcomes:
measure: Change in plaque index
timeFrame: At baseline and after 4 weeks.
measure: Change in gingival index
timeFrame: At baseline and after 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Riyadh Colleges of Dentistry and Pharmacy
state: ArRiyadh
Study officials:
affiliation: Riyadh Colleges of Dentistry and Pharmacy
name: Omar AlKadhi, BDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01524341: Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
Official title: A Proof-of-concept, Open Label, 3-day Repeated Dose Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malaria
Keywords: Acute malaria
KAE609
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAE609 at 30 mg/day


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 20 to 60 years
* Presence of mono-infection of P. falciparum or P. vivax
* Weight between 40 kg to 90 kg

Exclusion Criteria:

* Patients with signs and symptoms of severe/complicated malaria
* Mixed Plasmodium infection
* Presence of other serious or chronic clinical condition requiring hospitalization.
* Severe malnutrition
* Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Parasite clearance time
timeFrame: From baseline to the time point when the blood parasite count is zero(up to a maximum of 5 days)
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: vital signs: Days 1 through 6; ECG: Days1, 2, 3; Labs: Days 2, 3, 5, study completion
measure: Area under the curve (AUC)0-24h on Day 1 and Day 3
timeFrame: Day 1 and Day 3
measure: The accumulation ratio (Racc) (=AUC0-24h, day3/AUC0-24h, day1)
timeFrame: Day 1 and Day 3
measure: Maximum concentration (Cmax) on Day 1 and Day 3
timeFrame: Day 1 and Day 3
measure: Time to maximum concentration (Tmax) on Day 1 and Day 3
timeFrame: Day 1 and Day 3
measure: Half-life (T1/2)
timeFrame: Day 3
measure: Clearance (CL/F )
timeFrame: Day 3
measure: The apparent volume of distribution during the terminal elimination phase following extravascular administration (Vz/F)
timeFrame: Day 3
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Tak Province
country: Thailand
facility: Novartis Investigative Site
city: Tak
country: Thailand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: White NJ, Pukrittayakamee S, Phyo AP, Rueangweerayut R, Nosten F, Jittamala P, Jeeyapant A, Jain JP, Lefevre G, Li R, Magnusson B, Diagana TT, Leong FJ. Spiroindolone KAE609 for falciparum and vivax malaria. N Engl J Med. 2014 Jul 31;371(5):403-10. doi: 10.1056/NEJMoa1315860.
Clinical trial NCT02271841: How Are Changing the Practices After the Introduction of the Pleth Variability Index? A Before/After Survey.
Official title: How Are Changing the Practices After the Introduction of the Pleth Variability Index? A Before/After Survey.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Management
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Universitair Ziekenhuis Brussel
name: Vrije Universiteit Brussel
First posted: 2014-10-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The plan will seek to recruit a minimum of 3 centers in Belgium and/or France who have little to no prior PVI experience, each institution requiring about a minimum of 10 participating anesthesiologists for that institution. As it may be difficult to locate a center without Masimo technology, the goal is to locate a center not actively in use with PVI technology for managing fluid responsiveness, and the clinicians are not actively consulting with Masimo

Brief summary: This study evaluated the practice before and after the introduction of a particular model pulsoxymeter giving, in addition, information on the state of fluid responsiveness of the patient.

Detailed description: This study aims to qualify the capability of general anesthesiologist to adopt Pleth Variability Index (PVI) into their practice. It also seeks to establish whether the introduction of the PVI in the clinical practice is associated with a modification of the practice. In this scope, the intent is to see the impact of introduction of PVI monitoring on anesthesiologist practices, and to do this by comparing their survey response both before and after use of PVI in their surgeries, and to see how clinical practices for GDT and outcomes may have changed. To that end, the intent is to conduct this at sites with no current experience in use of PVI parameter, so that one can closely follow the change in clinician practice as PVI is adopted.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* ASA 1 to 3

Exclusion Criteria:

* ASA 4

Primary outcomes:
measure: Practice concerning fluid management
timeFrame: One day
Secondary outcomes:
measure: Fluid management by center
timeFrame: One day
measure: Mortality after the introduction of Pleth Variability Index
timeFrame: 30 days after surgery
Other outcomes:
measure: Fluid management in the elderly person in belgium
timeFrame: One day
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT01178541: Simultaneous Measurement of Both Fetal's Lateral Ventricles of the Brain
Official title: Simultaneous Measurement of Both Fetal's Lateral Ventricles of the Brain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: ventricles
fetal
brain
asymmetry
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: low risk pregnant women

Brief summary: Study designed to measure simultaneously the width of both lateral ventricles of the fetal brain. Thus, will enable to evaluate the normal asymmetry that may exist between the right and the left ventricles during the pregnancy.

Detailed description: Study will enable to evaluate the normal asymmetry that may exist between the right and the left ventricles during the pregnancy.

Eligibility criteria: Inclusion Criteria:

* low risk pregnant women

Exclusion Criteria:

* high risk pregnant women

Primary outcomes:
measure: width of lateral ventricles along the pregnancy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rotshild Women Health Center
Study officials:
affiliation: Clalit Health Services
name: David Vardimon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005341: Blood Donation--Immune Sequelae and Recruitment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Blood Disease
Blood Donors
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine if there were immune sequelae related to the long-term donation of blood or blood products.

Detailed description: DESIGN NARRATIVE:

The study had two objectives. The first objective was to investigate changes in immune function which may have occurred as a result of blood, plasma, or platelet donations. Preliminary studies had shown evidence of alterations in immune parameters in normal apheresis donors with the most marked changes occurring in long-term plasmapheresis donors. To ascertain whether donation of blood or blood products altered specific immune parameters, studies were conducted on white blood cell (WBC) receptors known to be involved in normal host defense mechanisms, lymphocyte subpopulations, plasma proteins, and complement activation products from 30 individuals in each of four separate donor groups: whole blood donors, bulk plasma donors, plasma donors stimulated with incompatible RBC, and platelet donors. Donor immune data were compared with results in nondonor controls and were also correlated with demographic data, donation history, laboratory data, and clinical findings. The second objective of the study was to determine if changes in an individual donor's immune status occurred over time. A longitudinal study of 15 new donors in each donation group was performed to evaluate alterations in immune function that may have occurred in committed donors of blood products and whether there was any clinical significance to the findings. New donors were enrolled in donation groups and followed longitudinally for a period of up to two years.

The study was extended through January, 1997 on FY 1995 funds.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kutvirt SG, Armon ME, Simon TL, Lewis SL. Lymphocyte phenotypes and infection incidence in transfused preterm neonates. Transfus Med. 1996 Dec;6(4):329-36. doi: 10.1111/j.1365-3148.1996.tb00092.x.
Clinical trial NCT05420441: Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis
Official title: Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Knee Arthritis
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be conducted to answer the following questions:

* Is there an effect of phonophoresis using glucosamine on pain level , function and range of motion in knee osteoarthritis patients ?
* Is there an effect of phonophoresis using chitosan on pain level , function and range of motion in knee osteoarthritis patients ?
* Is there a difference between the effect of phonophoresis using glucosamine and phonophoresis using chitosan on pain level , function and range of motion in knee osteoarthritis patients ?


Eligibility criteria: Inclusion Criteria:

* unilateral or bilateral grade II knee osteoarthritis (clinical and imaging diagnosis X-ray).
* knee pain intensity ≥ 5 on the Visual Analogue Scale (VAS)

Exclusion Criteria:

* Anterior Cruciate Ligament (ACL) and meniscus injury
* use of oral or injected corticosteroids in the last 3 months
* history of knee surgery or fracture
* acute infectious synovitis or arthritis conditions
* presence of malignancy
* individuals with, topical lesions, contact dermatitis and history of cutaneous hypersensitivity

Primary outcomes:
measure: Change in Visual Analog Scale
timeFrame: Baseline and Change from baseline pain scores at four weeks
measure: Change in WOMAC INDEX
timeFrame: Baseline and Change from baseline scores at four weeks
measure: Range of Motion at knee joint both in extension and flexion
timeFrame: Baseline and Change from baseline scores at four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Al Manyal
country: Egypt
facility: El-Kasr El-Ainy hospital
state: Cairo
Study officials:
affiliation: Cairo University
name: Mohamed H ElGendy, Ph.D
role: STUDY_CHAIR
References: