louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03248648: Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery
Official title: Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Ghada Mohammed AboelFadl
name: Abualauon Elbiblawy
First posted: 2017-08-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of intra-articular administration of neostigmine versus ketamine as adjuvant analgesics after knee arthroscopy.

Detailed description: Arthroscopic knee surgery is commonly performed as an outpatient procedure and is often associated with postoperative pain. Intraarticular (IA) local anesthetics (LA) are often used for prevention of pain after arthroscopic knee surgery; however, the degree of postoperative pain varies. In an effort to find the ideal regime for sufficient, long-lasting postoperative analgesia, many different drugs, including opioids, nonsteroidal anti-inflammatory drugs, ketamine, clonidine, and neostigmine, have been added to the IA LAs The investigators designed this study to compare the efficacy of intra-articular administration of neostigmine versus ketamine as adjuvant analgesics after knee arthroscopy.

Eligibility criteria: Inclusion Criteria:

* One hundred patients aged above 18-50 years (ASA I or II) scheduled for elective arthroscopic knee surgery under intrathecal anaesthesia will be enrolled in our study.

Exclusion Criteria:

* Absolute or relative contraindications for intrathecal anaesthesia,
* Allergy for the studied drugs.
* Patients having history of cardiovascular, cerebrovascular, and respiratory diseases,
* Patients receiving chronic pain treatment or hypertension treated with α methyldopa, clonidine or β adrenergic blockers were excluded from the study.

Primary outcomes:
measure: postoperative analgesic consumption
timeFrame: 36 hours postoperative the total consumption of analgesics in the first 36h postoperative
Secondary outcomes:
measure: Postoperative visual analogue pain scale (VAS)
timeFrame: 36 hours postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
state: Assiut Governorate
Study officials:
affiliation: Assiut University
name: Abualauon Elbiplaoy, lectural of anesthesia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00776048: Validation of an Obstacle Course Used in Patients With Muscle Tightness
Official title: The Validation of a New Method to Evaluate the Effects of Chemoneurolytic Intervention on Balance and Community Ambulation in Spastic Hemiplegic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Traumatic Brain Injury
Multiple Sclerosis
Spasticity
Healthy Controls
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2008-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects ages \> 18 years of age for this study. A total of up to 10 age matched controls and 30 clinical patients with lower extremity spasticity will be enrolled. Of the 30 clinical patients, 20 clinical patients will have received BOTOX ® injections from their clinical physician after their first visit.

Brief summary: This study is being conducted to compare healthy patients versus patients with muscle tightness in their leg(s) after an acquired brain injury using walking trials time, a balance test, and foot pressure data. This data is obtained using foot pressure sensors, timers, and distance walked.

Detailed description: This study is being conducted to demonstrate the objective utility of the use of pedobarography as a tool to differentiate normal controls from people with spastic gait as well as having utility in objectification of treatment effect on level surfaces and on a ADA based obstacle course.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age
* Must wear shoe size 5½ - 11 US womens or size 6 - 13 US mens
* For treatment group be a clinical patient being treated for lower extremity spasticity

Exclusion Criteria:

* Age matched controls must have no significant neurological or orthopedic disease that would effect their gait
* Clinical patients who are unable to walk for 1 minute

Primary outcomes:
measure: To demonstrate the objective utility of the use of pedobarography to differentiate normal controls from people with spastic gait as well as having utility in objectification of treatment effect on level surfaces and on a ADA based obstacle course.
timeFrame: 4 months post acquired brain injury
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: KesslerMRREC
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Elie P Elovic, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03356548: Transferrin Saturation and Asthenia in Hemochromatosis
Official title: Study of the Association Between Transferrin Saturation and Asthenia in Hemochromatosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemochromatoses, Genetic
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with genetic hemochromatosis HFE

Brief summary: Observational study.

Detailed description: The linked HFE genetic hemochromatosis (C282Y mutation in the homozygous state) is the most common form of genetic iron overload.

Its treatment is based on bloodletting, and takes place in 2 phases, according to the recommendations of the High Authority of Health (HAS). The first phase, called induction, aims to achieve ferritinemia \<50 by performing weekly bleeds.

The second phase, called maintenance, aims to maintain this ferritinemia \<50 by performing bleeding every 1 to 6 months depending on the case.

The treatment is therefore according to the current recommendations only adapted according to ferritinemia, and not according to the effectiveness on the functional symptoms. However, some patients report persistent asthenia during maintenance treatment, despite ferritin levels \<50. This could reflect an incomplete control of their disease, and leads us to raise two points:

* It is known that in some subjects, the Transferrin Saturation Coefficient remains high, despite ferritinemia \<50; it is also known that this elevation of the Transferrin Saturation Coefficient may be accompanied by a rise in circulating free iron, which is toxic for the organism1.
* The asthenia observed in some patients in the maintenance phase could be linked to a high rate of Transferrin Saturation Coefficient.

Our objective is to evaluate, in patients homozygous C282Y in maintenance phase, the association between quality of life and Transferrin Saturation Coefficient .

Eligibility criteria: * Inclusion criteria:

  * homozygous C282Y ;
  * in the maintenance phase for at least 6 months ;
  * follow-up at Rennes University Hospital ;
  * patient who has not expressed his opposition to participate in the study.
* Exclusion criteria:

  * Permanent: any cause of modification of the CST unrelated to hemochromatosis (chronic inflammatory disease, excessive consumption of alcohol ...) ;
  * Temporary: infectious syndrome within 7 days before bleeding.

Primary outcomes:
measure: Quality of life questionnaire SF 36
timeFrame: Through study completion, an average of 3 months
measure: Biological markers : Transferrin Saturation Coefficient
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Britain
Study officials:
affiliation: Rennes University Hospital
name: Fabrice LAINE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01376648: Thyroid Hormones Effect on Brown Adipose Tissue
Official title: Study on the Relationship Between the Thyroid Hormones and the Activity of Brown Adipose Tissue in Human
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperthyroidism
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty Graves' disease-caused hyperthyroid patients who were newly diagnosed and untreated were included. All hyperthyroid patients were treated with Methimazole and had been followed up until their symptoms disappeared and the thyroid hormone levels went back to normal range.

Brief summary: Brown adipose tissue (BAT) is important in energy expenditure through thermogenesis although the regulatory factors are not well known in humans. There is evidence suggesting that the thyroid hormones affect BAT functions in lower mammals, but the effects of the thyroid hormones on BAT activity in humans are still unclear. The objective of this study was to investigate the effects of thyroid hormones on glucose metabolism of BAT and other organs in humans.

Detailed description: Twenty consecutive patients with Graves'-caused hyperthyroidism who are newly diagnosed and untreated will be studied at the Endocrine Department of Huashan Hospital, Fudan University. All subjects are screened and examined by two senior investigators. Putative BAT activity is determined by the integrated 18F-fluorodeoxyglucose (18F-FDG) PET-CT. After the first PET scan, hyperthyroid patients will be treated with Methimazole following clinical guidelines. None of them uses beta adrenergic blockade. The initial dose of methimazole employed is 10mg thrice a day. During follow-up, the thyroid hormone levels (free triiodothyronine and free thyroxine) will be measured every twenty days. The PET-CT scans and assessments will be repeated when the symptoms have disappeared and the thyroid hormone levels return to normal range. Then the dose of methimazole will be adjusted accordingly.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed and untreated hyperthyroid patients
* Informed consent was obtained

Exclusion Criteria:

* History of other endocrine diseases
* Useing beta adrenergic blockade
* Pregnant women
* Pacemaker implantation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital
name: Yiming Li, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT02762448: Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas
Official title: Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hepatitis c
Lead sponsor: Tainan Municipal Hospital
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is an open label pilot without control group or other intervention. Participants will be recruited to a known intervention. Assessments will be conducted in an unblinded fashion. In terms of genotypes, 1b and 2a were suggested to be risk factors for the developing lymphoma in most HCV patients. In HCV-infected patients with splenic marginal zone or indolent B-cell NHL, many studies reported that combined treatment with interferon-alpha and ribavirin may lead to HCV clearance and concomitant regression of lymphomas

Brief summary: Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study

Detailed description: Prospectively collect cases with NHL (n=10), having HCV genotype 1b related NHL, who will be treated with ASV (200 mg twice daily) + DCV(60 mg once daily) for 24 weeks The patients will be observed and followed to determine whether there is regression of NHL after antiviral treatment. Conventional chemotherapy should be initiated shortly in cases without regression.

Eligibility criteria: Inclusion Criteria:

1. Men and women
2. 18 to 70 years of age
3. Who had chronic HCV genotype 1b infection
4. An HCV RNA level of 105 IU per milliliter or higher
5. Being diagnosed to be low grade B cell non-Hodgkin lymphoma

Exclusion Criteria:

1. Patients with hepatitis B virus infection,
2. Other liver diseases
3. HIV infection,
4. Pre-existing HCV variants in the NS5A domain included Q30R, L31 M/V, and Y93C/N
5. Evidence of cirrhosis, as documented by means of either liver biopsy or assessment of imaging results.

Primary outcomes:
measure: HCV clearance and complete regression of NHL by ASV+ DCV
timeFrame: 2years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00479648: A Phase 2 Study of Immunogenicity, Safety and Tolerability of CSL412 in Elderly Participants
Official title: A Phase II, Double-Blind, Randomised, Controlled, Multi-Centre Study to Evaluate the Immunogenicity, Safety and Tolerability of Three Formulations of CSL412 in Adults (≥ 18 to ≤ 45 Years) and Older Adults (≥ 60 Years)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Current influenza vaccines have a reduced efficacy in the elderly. This study will investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in elderly participants.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 to ≤ 45 OR ≥ 60
* Ability to provide pre-vaccination venous blood sample

Exclusion Criteria:

* History of clinically significant medical conditions
* Immunomodulative therapy
* Acute infection

Primary outcomes:
measure: seroprotection rate, HI titre & seroconversion/ significant increase
measure: grade 3 or higher, vaccine associated fever or vaccine associated site ulceration, abscess or necrosis
Secondary outcomes:
Other outcomes:
Locations:
city: Slough
country: United Kingdom
facility: Chiltern International
Study officials:
affiliation: Chiltern International
name: Elizabeth Hancox, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01923948: Preoperative Pain Control in Liver Surgery Patients
Official title: A Randomized Placebo-Controlled Study of Whether Pre-operative Pregabalin 150 mg Will Improve Pain Control in Patients With Hepatocellular Carcinoma Undergoing Partial Hepatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Hepatectomy
randomized controlled trials(RCTs)
Postoperative Pain
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 40
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: TREATMENT

Brief summary: Pregabalin 150mg or placebo are administered 1 hour preoperatively in patients undergoing partial hepatectomy. Postoperatively, patients receive morphine as rescue analgesic. Morphine consumption in the first 48 hours is documented. Postoperative pain is measured by the visual analogue scale (VAS) score.

Detailed description: Methods: In this Randomized Controlled Trial, patients undergoing partial hepatectomy will be administered a single pre-operative dose of Pregabalin or a placebo. Primary endpoints are as follows:

* Post-operative analgesic requirements
* Post-operative VAS scale (rated 0-10)
* Complications
* Post-operative antiemetic requirement
* Length of stay

Eligibility criteria: Inclusion Criteria:

* patients undergoing partial hepatectomy

Exclusion Criteria:

* contraindication against pregabalin
* creatinine \> 2.0 mg/dl
* GGT \>165, AST \>105, ALT \>135
* peptic Ulcus
* haemorrhagic diathesis
* angina pectoris, myocardial infarction
* stroke
* bronchial asthma
* opioid abuse

Primary outcomes:
measure: Postoperative Opioid Consumption
timeFrame: 48 hours
Secondary outcomes:
measure: Postoperative Pain Scores on the Visual Analog Scale
timeFrame: 24 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
name: li ai jun, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04491448: Acceptability of Social Risk Screening
Official title: Acceptability of Social Risk Screening in Adult Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Health Care
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for a routine physicals or new patient visits

Brief summary: Social risk screening asks patients to provide information on health-related social needs that are non-medical but affect health. These include housing stability, food security, reliable medical transportation, consistent utilities service (heat, light, water), and interpersonal safety. This research will determine the acceptability of such screening in adult patients who attend a primary care clinic in-person or via a telemedicine visit, the level of social need in patients, and how to flag such information for care, planning, and follow up.

Detailed description: This study will evaluate the acceptability of social risk screening among adult patients seen in the General Internal Medicine Offices (GIMO) at Montefiore Hospital. The research will enroll patients using the resident clinic, which provides medical care to lower-income patients as well as other patients. The study will be limited to new patients or patients receiving routine follow-up care.

Acceptability will be assessed by (i) the proportion of patients completing the screen among those approached; (ii) the proportion of screening questions completed; and (iii) the proportion of patients willing to complete the screening over the phone (a) by interviewer or (b) on via website using Qualtrics.

The representativeness of the sample will be assessed by comparing the participant sample to aggregate clinic demographic characteristics and deidentified Epic EHR indicators using an honest broker.

The survey instrument is the CMS Accountable Care Communities instrument. It includes patient indicators (demography) and appraisals of care (e.g., trust) that will allow assessment of correlates of social need and acceptability of screening in the clinical setting.

Eligibility criteria: Inclusion Criteria:

1. Aged 18+
2. New patient or routine physical exam, GIMO clinic, Montefiore Hospital

Exclusion Criteria:

1. Unable to provide verbal informed consent
2. Unable to complete questionnaire

Primary outcomes:
measure: Acceptability of social needs screening in medical encounter
timeFrame: One-time interview, 20-25 minutes
Secondary outcomes:
measure: Effects of reported social needs on medical utilization and patient behavior
timeFrame: One-time interview, 20-25 minutes
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Steven M Albert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00727948: The Effect of Aspirin on Angiogenesis Proteins in Women on Tamoxifen Therapy
Official title: The Impact of the Anti-Platelet Agent Aspirin on Angiogenesis Proteins in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Angiogenesis
Keywords: Breast cancer
Angiogenesis
Aspirin
Tamoxifen
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2008-08-04
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Changes in major angiogenic proteins have been seen following initiation of tamoxifen and aromatase inhibitor therapy in women with breast cancer. One source of these proteins is the circulating platelet pool. The investigators hypothesize that in addition to their anti-platelet properties, agents such as aspirin can be used as targeted anti-angiogenesis therapy. The investigators will determine the influence of aspirin on the release of angiogenic proteins from platelets in 35 patients with breast cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven breast cancer
* Pre or post-menopausal
* Age \>18
* Completed adjuvant non-hormonal therapy \>30 days prior to initiation of study (surgery and/or chemotherapy and/or radiation therapy)
* Platelet count and hemoglobin within normal ranges for local lab within 30 days of initiation of study therapy
* Receiving tamoxifen therapy for at least 90 days prior to initiation of study therapy, and is expected to continue that therapy for the duration of the study (75 days)

Exclusion Criteria:

* Chemotherapy, radiation therapy or surgery within 30 days of study therapy
* Current use of aspirin, anti-platelet or anti-coagulation agents on a continuous basis
* Prior history of gastrointestinal or central nervous system bleeding, or documented or self-reported blood in stools or bright red blood per rectum

Primary outcomes:
measure: Changes in pro-angiogenic and anti-angiogenic protein levels.
timeFrame: 75 days
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Chris E Holmes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: