louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02881606: Evaluation of the Clinical Effectiveness of Naso-alveolar Molding (NAM) Versus Computer Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Lip and Palate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 28
Sex: ALL
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1 presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM (CAD/NAM). The aim of the study is to compare between short term clinical effects of both interventions as regards alveolar alignment, nasal esthetics and interlabial gap.


Eligibility criteria: Inclusion Criteria:

• Bilateral cleft lip and palate

Exclusion Criteria:

Patients without cleft palate Unilateral cleft lip Patients having systemic medical problems that contraindicate NAM treatment Patients with history of previous presurgical infant orthopedics Patients with history of any surgical procedures (ex: lip adhesion)

Primary outcomes:
measure: Alveolar alignment
timeFrame: 5-6 months
Secondary outcomes:
measure: Nasal and labial esthetics
timeFrame: 5-6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine, Cairo University
Study officials:
References:
Clinical trial NCT05004506: Intra-articular Analgesia Versus Adductor Canal Block for Arthroscopic Knee Surgery
Official title: A Prospective Randomized Controlled Trial of Intra-articular Analgesia Versus Adductor Canal Block for Arthroscopic Knee Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Post-Operative Pain, Chronic
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A will be for single shot adductor canal block. Group B will receive the intra-articular injection.
Primary purpose: TREATMENT

Brief summary: This study is a randomized study that compares two commonly used post-operative pain reducing techniques by measuring the level of pain and use of pain medication after knee surgery.

Detailed description: Post-operative pain is a commonly associated with knee surgery. Treatment often includes an oral or intravenous (IV) narcotic regimen which often leads to nausea, vomiting and can cause consti-pation. These issues can contribute to the overall discomfort of the post-operative patient. Intra-operative injections and local nerve blocks have become common adjuncts to narcotics to reduce post-operative pain and the necessity for oral or IV narcotic use. The aim of this study is to com-pare analgesic use and clinical effects on post-operative pain management with intra-articular in-jection of 20ccs of 2% lidocaine with epinephrine at the start of the case plus 20ccs 0.5% mar-caine with epinephrine at the end of the case vs. adductor canal saphenous nerve blockade in pa-tients undergoing knee arthroscopy, as indicated by the need for rescue narcotics and patient pain scores. A randomized, single blinded study will be performed to evaluate post-operative pain control using VAS scores at 1, 2, 4, 8, 12, 24, 36, and 48hrs post-operatively, rescue narcotic use in the PACU, and total narcotic consumption over the same time period.

Eligibility criteria: Inclusion Criteria:

* ASA I-III patients
* Age 18 to 65 years

Exclusion Criteria:

* Allergy or intolerance to local anesthetics, NSAIDs, or opioids
* Inability to understand the consent or study process
* Any contraindication to regional anesthesia
* Known history of substance abuse
* Chronic home opioid therapy
* History of major neurologic deficit in operative limb
* Chronic pain syndromes
* Pregnancy and nursing women

Primary outcomes:
measure: Analgesic efficacy
timeFrame: 1, 2, 4, 8, 12, 24, 36, and 48 hours after surgery
measure: Rescue narcotics use
timeFrame: During post-surgical hospitalization
measure: Total narcotic consumption
timeFrame: During post-surgical hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT04242849: IDH1/2 Mutational Analysis in AML Patients: Diagnosis and Follow-up
Official title: IDH1/2 Mutational Analysis in AML Patients: Diagnosis and Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Lead sponsor: Josep Carreras Leukaemia Research Institute
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2020-01-27
Enrollment: 354
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 \>18 years old with de novo acute myeloid leukemia (AML).

Brief summary: In a spanish series of AML patients it is intended to perform, at the moment of diagnosis, pyrosequencing of IDH1 and IDH2 genes. Taking into account the incidence of AML in the area, it is planed to study 100 patients per year.

Among the cases with IDH1/2 mutations, targeted deep sequencing (TDS) of a panel covering coding regions of 40 myeloid related genes will be applied. With TDS, pyrosequencing results will be validated at the same time that prognosis value of co-mutated genes could be studied. Furthermore, with TDS, molecular architecture of IDH1 and IDH2 mutated cases might be better understood.


Eligibility criteria: Inclusion Criteria:

* Patients \>18 years old with de novo acute myeloid leukemia will be included. All patients will be treated according to clinical routine.

Exclusion Criteria:

* Patients not following the above criteria.

Primary outcomes:
measure: Presence of IDH1/2 mutation
timeFrame: 1 day
Secondary outcomes:
measure: Detection of co-mutations
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01469949: Mental Imagery Enhances Proprioception in Patients With Low Back Pain
Official title: Effect of Mental Imagery in Improvement of the Repositioning Accuracy and Proprioception in Patients With Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: Improvement of the accuracy of Lumbar repositioning
Lead sponsor: Lebanese University
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifty-five patients, with a history of common low back pain, have participated to the study. The subjects have been randomly distributed in two experimental groups and one control group. The gender, age, weight and height characteristics of the three groups (Visual Imagery Group, VIG; Kinesthetic Imagery Group, KIG; and Control Group, CG) are presented in Table 1. The patients presented no history of neurological or psychiatric disease, and gave their informed written consent.

Brief summary: Mental imagery has been used in a variety of pathological instances in support to classical therapeutic treatments. The aim of the present study was to observe the effect of internal Kinesthetic and external Visual Imagery to improve proprioceptive feedback in low back pain. Fifty-five subjects with a history of low back pain were included in two experimental groups who used mental imagery and one control group who did not. The results showed the effectiveness of the Internal Kinesthetic Imagery to improve the accuracy of repositioning of lumbo-sacral spine that may subsequently improve the quality of the proprioceptive input. The possibility to use effectively mental imagery, as a part of proprioceptive rehabilitation process, is the principal outcome of this study.


Eligibility criteria: Inclusion Criteria:

* Subjects suffering from common non-specific low back pain

Exclusion Criteria:

* Recent history of inner ear infection causing associated balance or coordination problems
* History of cerebral trauma followed by unresolved neurosensory symptoms
* Recent history of vestibular disorder and previous spinal surgery
* An involvement in specific balance or stabilization training during the 6 months prior testing. Patients taking pain medication were excluded from the study.

Primary outcomes:
measure: Accuracy of Lumbar Spine Repositioning
timeFrame: 2hours
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Center of Physical Therapy
state: Hadath
Study officials:
References:
Clinical trial NCT00410449: Oxidative Stress and Hemodialysis Access Failure
Official title: Study of the Effect of Oral Supplementation With Vitamin E on Circulating Oxidative Markers, Hemodialysis Vascular Access Occlusion, and Clinical Events in Patients With End Stage Renal Failure Treated by Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Hemodialysis
Keywords: End stage renal disease treated by hemodialysis
Hemodialysis vascular access patency
Vitamin E
oxidative markers
pentosidine
hydroxynonenal
levuglandin
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
Collaborators: name: Leonard B Rosenberg Renal Research Foundation
First posted: 2006-12-12
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Complications of hemodialysis access are the most frequent single reason for hospitalization among patients with End Stage Renal Disease (ESRD). Uremia, and particularly uremia in patients with diabetes, is a state of increased oxidative stress. The central hypothesis to be tested by this project is that oxidative stress is a major (and modifiable) trigger for vascular access complications. We hope to slow or reduce rates of stenosis, thrombosis and access complications by giving Vitamin E supplementation to patients being treated by hemodialysis.

Detailed description: Patients continued their usual treatment on hemodialysis three times per week. This was a double-blinded placebo controlled trial. Patients took either Vitamin E 400 IU bid or placebo. An initial evaluation of access patency was performed and baseline blood drawn before starting Vitamin E. Every 3 months there was a followup evaluation with blood drawn for oxidative stress markers, and with a test of vascular access patency. The study was closed to new participants, vitamin E or placebo stopped, and data analysis performed in 2003.

Eligibility criteria: Inclusion Criteria:

Adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula)

Exclusion Criteria:

Temporary catheter dialysis access, inability to be compliant with study medication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Center for Dialysis Care
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Miriam F Weiss, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwing WD, Erhard P, Newman LN, Nodge MM, Czechanski BJ, Orlin SM, Walden SM, Behm K, Cacho CP, Negrea LA, Siu DS, Kern EO, Weiss MF. Assessing 24-hour blood glucose patterns in diabetic paitents treated by peritoneal dialysis. Adv Perit Dial. 2004;20:213-6.
Clinical trial NCT00026949: Study of Etoposide in Breast Cancer Patients
Official title: Pharmacokinetics of Etoposide in Patients With Breast Cancer Receiving High-Dose Etoposide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Etoposide
Breast Cancer
Pharmacokinetics
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2001-11-15
Enrollment: 33
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study will examine how the body handles etoposide, a drug used to treat breast cancer. The knowledge gained may lead to more effective use of the drug with fewer side effects in the future.

Breast cancer patients who are receiving etoposide as part of their treatment may participate in this study. Patients will have 18 blood samples (about a teaspoon or less each) drawn over a 72-hour period during and after their infusion of etoposide. The initial blood samples cannot be taken from the same intravenous line (small tube placed in a vein) used to deliver the etoposide, so a second line may have to be placed temporarily to obtain these samples.

Detailed description: Etoposide is a topoisomerase II inhibitor that has a broad range of anticancer activity at conventional doses (100 mg/m(2) daily x 5 days) and is administered in high doses (greater than 1200 mg/m(2)) as a component of pre-transplant myeloablative chemotherapy regimens. Etoposide pharmacokinetics are linear over a 30-fold dose range, but disposition is highly variable. Etoposide is highly protein bound (95%) to albumin, but protein binding (and therefore free drug concentrations) vary widely in cancer patients. Etoposide is eliminated by metabolism and renal excretion, which may also contribute to the variability. The pharmacokinetics of etoposide will be studied in patients receiving high-dose etoposide as part of their pre-transplant preparative regimen, and pharmacokinetic parameters generated from pharmacokinetic modeling will be correlated with clinical and laboratory characteristics and toxicity in order to develop more rational dosing methods.

Eligibility criteria: INCLUSION CRITERIA

Age greater than or equal to 18 years.

Patients with breast cancer who are entered on existing Medicine Branch protocols that include high-dose etoposide.

Must be able to provide informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
References:
citation: Herzig RH. High-dose etoposide and marrow transplantation. Cancer. 1991 Jan 1;67(1 Suppl):292-8. doi: 10.1002/1097-0142(19910101)67:1+3.0.co;2-7.
citation: Hainsworth JD, Greco FA. Etoposide: twenty years later. Ann Oncol. 1995 Apr;6(4):325-41. doi: 10.1093/oxfordjournals.annonc.a059180.
citation: Pfluger KH, Hahn M, Holz JB, Schmidt L, Kohl P, Fritsch HW, Jungclas H, Havemann K. Pharmacokinetics of etoposide: correlation of pharmacokinetic parameters with clinical conditions. Cancer Chemother Pharmacol. 1993;31(5):350-6. doi: 10.1007/BF00686147.
Clinical trial NCT02486549: Supraclavicular Versus Interscalene Block for Shoulder Surgery
Official title: A Prospective Randomized Comparison of Ultrasound-guided Supraclavicular and Interscalene Block in Patients Undergoing Arthroscopic Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain
Anesthesia Recovery Period
Brachial Plexus
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the supraclavicular block to interscalene block in patients undergoing arthroscopic shoulder surgery.

Detailed description: The aim of this study is to evaluate the efficacy of the supraclavicular block in comparison with interscalene block on postoperative pain, quality of recovery and side effects in patients undergoing arthroscopic shoulder surgery under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing shoulder surgery in American Society of Anesthesiologists physical status I-II

Exclusion Criteria:

* with a known allergy to study medications,
* chronic opioid use,
* ipsilateral upper limb neurological deficits,
* severe respiratory disease,
* coagulopathy

Primary outcomes:
measure: Postoperative Pain
timeFrame: up to postoperative 24 hours
Secondary outcomes:
measure: Quality of recovery
timeFrame: in the postoperative 24 hours
measure: Motor block
timeFrame: up to postoperative 24 hours
measure: Sensory block
timeFrame: up to postoperative 24 hours
measure: Adverse events
timeFrame: up to postoperative 24 hours
measure: Analgesics requirement time
timeFrame: up to postoperative 24 hours
measure: Systolic Blood pressure changes
timeFrame: at time of surgery
measure: Heart rate changes
timeFrame: at time of surgery
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University Medical School
Study officials:
affiliation: Gaziosmanpasa University Medical School
name: Tugba Karamanaraman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00637949: Safety of Lumiracoxib in Patients With Osteoarthritis
Official title: A 6-Week Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Clinical Saftey Study to Evaluate Incidence of Predefined Gastrointestinal Adverse Events and Peripheral Edema in Subjects With Primary Osteoarthritis Treated With COX189 400 mg o-do Using Rofecoxib 25 mg o.d. as a Comparator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis
lumiracoxib
rofecoxib
Cox-2
Osteoarthritis (primary osteoarthritis hip, hand, knee or spine (cervical or lumbar)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-03-18
Enrollment: 309
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This safety study evaluated the incidence of gastrointestinal adverse events and edema in patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator


Eligibility criteria: Inclusion Criteria:

* Age \>=50 years old
* Primary osteoarthritis in hip, hand, knee or spine for at least 3 month
* Pain in the target joint of moderate intensity
* Written informed consent

Exclusion Criteria:

* Secondary osteoarthritis
* Active upper gastro intestinal tract ulceration
* Inflammatory joint disease
* Gout
* Clinically significant hepatic or renal disease

Other in and exclusion criteria may apply

Primary outcomes:
measure: Incidence of at least one of seven predefined gastrointestinal adverse events
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Stricker K, Yu S, Krammer G. A 6-week, multicentre, randomised, double-blind, double-dummy, active-controlled, clinical safety study of lumiracoxib and rofecoxib in osteoarthritis patients. BMC Musculoskelet Disord. 2008 Sep 8;9:118. doi: 10.1186/1471-2474-9-118.
Clinical trial NCT06403449: The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and Subclinical PTSD Among Adolescents : a Pilot Study
Official title: The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and Subclinical PTSD Among Chinese Adolescents: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: PTSD
adolescents
randomized controlled trial
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 53
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to examine the effectiveness of the group-delivered guided written exposure therapy (G-WET) for post-traumatic stress disorder (PTSD) and subclinical PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 40 participants, with 20 randomized to the G-WET group and 20 randomized to the waiting list (WL) group. The G-WET intervention consists of 5-8 group sessions. The primary outcome PCL-5 ( PTSD Checklist-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up assessments.


Eligibility criteria: Inclusion Criteria:

1. Adolescents aged 10-18 years.
2. Meeting full or subthreshold PTSD (up to one symptom missing) diagnostic criteria according to the Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I).
3. If taking psychotropic medication, currently stabilized on psychotropic medication for at least four weeks.
4. Capable of writing and understanding written instructions.

Exclusion Criteria:

1. Presence of severe psychopathology necessitating immediate medical attention
2. Moderate to high suicide risk (e.g., intent or plan to attempt suicide in the near future)
3. Evidence of a moderate or severe traumatic brain injury
4. Currently undergoing psychotherapy specifically for PTSD.

Primary outcomes:
measure: PTSD Checklist-5 (PCL-5)
timeFrame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
Secondary outcomes:
measure: Patient Health Questionnaire 9-item
timeFrame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
measure: Generalized Anxiety Disorder 7-item
timeFrame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
measure: The Strengths and Difficulties Questionnaire
timeFrame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
References:
Clinical trial NCT01044849: Clinical Test Report for Blood Pressure Meter CH-609
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: Blood Pressure
Lead sponsor: Citizen Systems Japan Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-01-08
Enrollment: 85
Sex: ALL
Minimum age (years): 22
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: Blood pressure meter model CH-609 was to be assessed against the standard mercury sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.


Eligibility criteria: Inclusion Criteria:

* 85 subjects with a wide range of blood pressure were selected.

Exclusion Criteria:

* Subjects could be taking antihypertensive medication, but excluded in atrial fibrillation or with any sustained arrhythmia.

Primary outcomes:
measure: Measure the accuracy of blood pressure meter model CH-609 against the standard mercury sphygmomanometer according to the protocol of ANSI/AAMI SP-10.
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: