louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02115360: Epidural Calcitonin in Lower Limb Amputation
Official title: The Pre-emptive Value of Epidural Calcitonin in Patients With Lower Limb Amputation. A Double Blinded Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation Stumps
Keywords: epidural calcitonin
amputation
postoperative pain
Later Complication
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A prospective randomized double-blind clinical trial design will be used in a cohort of sixty patients of both genders, physical status American Society of Anaesthesiologist (ASA) I and II who will undergo lower limb amputation, will be enrolled into the present study. Patients will divided randomly into two equal groups: Epidural Bupivacain-Calcitonin and fentanyl (BC) Group and Bupivacain- fentanyl (BF) Group, comprising of 30 patients each.

Detailed description: a cohort of sixty patients of both genders, physical status American Society of Anaesthesiologist (ASA) I and II who will undergo lower limb amputation, will be enrolled into the present study. Patients will divided randomly into two equal groups: Epidural Bupivacain-Calcitonin and fentanyl (BC) Group and Bupivacain- fentanyl (BF) Group, comprising of 30 patients each.

Eligibility criteria: Inclusion Criteria:

* prospective randomized double-blind clinical trial design will be used in a cohort of sixty patients of both genders
* physical status American Society of Anaesthesiologist (ASA) I and II
* will undergo lower limb amputation

Exclusion Criteria:

* history of pituitary gland dysfunction
* cardiac disease
* chronic obstructive respiratory disease
* contraindications to performing an epidural block such as:

  * coagulation abnormalities
  * spinal deformities, and
* patients allergic to local anesthetics and or calcitonin will be excluded from the study

Primary outcomes:
measure: visual analogue scale
timeFrame: 48 hours
Secondary outcomes:
measure: Analgesic consumption
timeFrame: 48 hours
Other outcomes:
measure: post amputation pain
timeFrame: 6 months
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Algharbyia
Study officials:
affiliation: Assistant Professor
name: Ayman A Yousef, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knopp-Sihota JA, Newburn-Cook CV, Homik J, Cummings GG, Voaklander D. Calcitonin for treating acute and chronic pain of recent and remote osteoporotic vertebral compression fractures: a systematic review and meta-analysis. Osteoporos Int. 2012 Jan;23(1):17-38. doi: 10.1007/s00198-011-1676-0. Epub 2011 Jun 10.
Clinical trial NCT03835260: Pivot Breath Sensor Human Factors and Usability Study
Official title: Pivot Breath Sensor Human Factors and Usability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Smoking, Tobacco
Lead sponsor: Pivot Health Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: UserWise, LLC
First posted: 2019-02-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Prospective, observational open label, single center study enrolling up to 15 subjects to evaluate human factors and usability of the Pivot Breath Sensor.

Detailed description: The objectives of this Human Factors/Usability study are to:

* Ensure that representative intended users are able to operate the Pivot Breath Sensor independently
* Validate appropriate mitigations of use related hazards identified in risk management documentation
* Uncover previously unforeseen use errors

This human factors and usability testing is conducted to demonstrate that the Pivot Breath Sensor can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions.

Eligibility criteria: Inclusion Criteria:

* 18-80 years of age
* English speaking
* Owns and uses a smartphone
* Willing to sign the Informed Consent Form

Exclusion Criteria:

* Prior experience with a study sponsored by Carrot Inc
* Pregnancy

Primary outcomes:
measure: Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings
timeFrame: Each study session was completed on a single day, for up to 60 minutes. Device set up was assessed at about 5 minutes in. Device use was assessed at about 10 minutes in. Interpretation of results was assessed at about 15 and 20 minutes in.
measure: Human Factors - User Documentation Assessment With Observer Ratings
timeFrame: Each study session was completed on a single day, for up to 60 minutes. The user documentation assessment occurred at approximately 30 minutes into the study session.
measure: Human Factors - Subjective Feedback Questionnaire
timeFrame: Each study session was completed on a single day, for up to 60 minutes. The subjective feedback questionnaire was administered at approximately 40 minutes into the study session.
measure: Human Factors - Participant Feedback Using Rating Scale
timeFrame: Each study session was completed on a single day, for up to 60 minutes. Participant feedback using a rating scale was provided at approximately 50 minutes into the study session.
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Carrot Inc.
state: California
Study officials:
affiliation: Pivot Health Technologies Inc.
name: Jennifer Marler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03576560: Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis
Official title: Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chorioamnionitis
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 768
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients born at Women's Hospital/Cone Health in Greensboro, NC, from July, 2012 (when EMR was implemented), to present.

Brief summary: Retrospective Chart Review to determine the selective use of antibiotics in neonates born to mothers with suspected chorioamnionitis

Detailed description: To determine the incidence and types of adverse outcomes in infants born to mothers with signs of chorioamnionitis when these infants are asymptomatic and are not treated with antibiotics empirically.

Eligibility criteria: Inclusion Criteria:

• Mother/baby dyads in which the mother was diagnosed with chorioamnionitis and/or had intrapartum fever (as diagnosed by obstetrician)

Exclusion Criteria: None

Primary outcomes:
measure: Infants born to mother with chorioamnionitis/intrapartum fever as assessed by chart review.
timeFrame: Infants born from July, 2012 to December 31, 2018.
Secondary outcomes:
Other outcomes:
Locations:
city: Greensboro
country: United States
facility: Women's Hospital of Greensboro
state: North Carolina
Study officials:
affiliation: MEDNAX Employee
name: John Wimmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02296060: Evaluation of Exercise Tolerance During Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the exercise tolerance during pregnancy and after thanks the 6MWT


Eligibility criteria: Inclusion Criteria:

* 18-50 years old
* healthy women

Exclusion Criteria:

* BMI (before pregnancy) \> 25
* complication with their pregnancy

Primary outcomes:
measure: 6 minutes walking test
timeFrame: after 6 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
state: Woluwé-Saint-Lambert
Study officials:
References:
Clinical trial NCT00156260: Feasibility Study of Evaluating Breast Cancer Patients With Ductal Lavage
Official title: UMCC 2-48 Feasibility Study of Evaluating Breast Cancer Patients With Ductal Lavage
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The primary purpose of this research is to analyze the cells present in the fluid obtained via ductal lavage from the nipple of a woman with a known diagnosis of breast cancer. A portion of the lavage fluid may be used in future breast cancer biomarkers. Remaining lavage fluid will be used to analyze its biochemical composition, for investigational purposes only.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age
2. biopsy-proven unilateral invasive breast cancer of any histology or ductal carcinoma in situ
3. patient desires or requires treatment with mastectomy
4. any patient who has undergone prior excisional biopsy of their primary breast tumor must have had margins positive for disease, or must have either mammographic or ultrasonographic evidence of probable residual disease in the breast.
5. patients receiving induction chemotherapy remain eligible for participation in the study regardless of tumor response; those with a clinical complete response remain eligible.
6. voluntarily signed informed consent. -

Exclusion Criteria:

1. male gender
2. lobular carcinoma in situ as the only cancerous histology
3. prior margin-negative excisional biopsy of primary breast tumor, with no evidence of residual disease
4. patient being treated with breast conservation therapy inability to understand the nature of the procedure pregnancy and/or active lactation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Lisa Newman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01594060: Basal Bolus vs. Sliding Scale for Treatment of Diabetic Patients in Medical Wards
Official title: A Randomized, Comparative Study of Basal-bolus Insulin Versus Conventional Sliding-scale Regular Insulin Therapy in Management of Non-critically Ill Patients Hospitalized in the Medical Ward.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus Type 2
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison of two treatment approaches for hyperglycemia in diabetic patients hospitalized in the medical department. The first approach is called basal-bolus in which 4 insulin shots are given daily ( 3 short acting before meals and one long acting before bed time). The second approach is called sliding scale in which short acting insulin alone is given before meals and before bed time according to the patient's glucose values. The aim is to keep fasting glucose between 140-180 mg/dl.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to internal medicine ward with blood glucose (BG) between 140-400 mg/dl.
* Known history (\>6months) of diabetes.
* Aged 18-80 years old.
* Previous therapy including either diet alone or any combination of oral hypoglycemia agents, glucagon-like peptide 1 (GLP-1) analogs and long acting insulin analogs or Neutral Protamine Hagedorn (NPH).

Exclusion Criteria:

* Pregnancy
* Patients with ketoacidosis
* Patients with unknown history of diabetes
* Patients with type 1 diabetes mellitus
* Patients with clinically relevant hepatic disease or renal impairment ( serum creatinine≥2.5 mg/dl)
* Use of corticosteroid therapy
* Patient with any mental disorder preventing him to cooperate and give informed consent.
* Patients on multiple daily doses of insulin regimen.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03350360: Attention Control Training for PTSD Related to Combat or Interpersonal Violence
Official title: Randomized Clinical Trials of Attention Control Training for PTSD Related to Combat or Interpersonal Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 73
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants will complete a pre and post training psychological assessment. Participants will be assigned to attention control training or the comparison stimuli computer task in a double-blind randomized control trial design. Both computerized dot probe tasks display two stimuli on a computer screen, one above the other, followed by a small right or left arrow appearing in the location vacated by one of the stimuli. Participants are required to respond as quickly as they can by pressing the indicated right or left arrow on their computer keyboard without compromising accuracy. Participants complete 6 training sessions.


Eligibility criteria: Inclusion Criteria:

* military veteran or woman exposed to interpersonal violence (e.g. domestic or sexual violence).
* significant symptoms of PTSD

Exclusion Criteria:

* bipolar disorder, schizophrenia, OCD, unable to attend sessions sober.

Primary outcomes:
measure: Change in posttraumatic stress disorder (PTSD) symptoms from pre to post test
timeFrame: 30 minute long administration at both pre and post training to measure change. (repeat assessments are conducted 1 month apart)
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
References:
citation: Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.
Clinical trial NCT01480960: Effects of a Whole Body Vibration Training in Patients After Lung Transplantation
Official title: Effects of a Whole Body Vibration Training on the Exercise Performance in Patients After Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Following Lung Transplantation (Single and Double)
Keywords: lung transplantation
whole body vibration
exercise training
pulmonary rehabilitation
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients following lung transplantation. Exercise training has been shown to be a cornerstone of an inpatient rehabilitation program to reduce muscle dysfunction and improve exercise performance. In our study we will investigate the benefit of a whole body vibration training in addition to a standard pulmonary rehabilitation program that includes endurance and strength training. We will include a total of 140 patients (70 patients \< 1 year after lung Transplantation and 70 patients \> 1 year after lung Transplantation). Our hypothesis is that an addtitional whole body vibration training produces a greater benefit to exercise capacity in lung transplantat patients (LTx).


Eligibility criteria: Inclusion Criteria:

* participation in an inpatient rehabilitation program
* double or single lung transplantation due to chronic obstructive pulmonary disease, Alpha-1-antitrypsine deficiency, interstitial lung disease

Exclusion Criteria:

* severe exacerbation in the last 4 weeks with the necessity of delivering antibiotics/ corticosteroids
* non-compliance

Primary outcomes:
measure: change in 6-minute walking distance
timeFrame: change from baseline to day 21
Secondary outcomes:
measure: change in Wmax
timeFrame: change from baseline to day 21
measure: change in Fmax
timeFrame: change from baseline to day 21
measure: change in fibre cross sectional area
timeFrame: change from baseline to day 21
measure: change in chair rise time
timeFrame: change from baseline to day 21
measure: change in quality of life
timeFrame: change from baseline to day 21
measure: change in body cell mass
timeFrame: change from baseline to day 21
measure: change in IGF-1
timeFrame: change from baseline to day 21
Other outcomes:
Locations:
city: Schönau am Königssee
country: Germany
facility: Schön Klinik Berchtesgadener Land
Study officials:
References:
citation: Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.
Clinical trial NCT06249360: Lymphatic System Reflux After Lymphatic Operation
Official title: Influence of Lymphatic System Reflux After Operation in Patients With Lymphatic Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 79
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients (age \>20 years) receiving LVA for lower limb lymphedema at a tertiary medical center were retrospectively reviewed from October 2015 to December 2022.

Brief summary: This study aimed to determine the impact on outcomes when recipient veins with reflux were used for LVA for the treatment of unilateral lower limb lymphedema.

Detailed description: The use of recipient veins with reflux for lymphaticovenous anastomosis (LVA) is discouraged because of the common belief that it may lead to venous-lymphatic reflux (VLR), a phenomenon in which venous blood is refluxed into the lymphatic lumen after anastomosis, which can lower the long-term patency rate. However, this concept has yet to be validated.

Eligibility criteria: Inclusion Criteria:

* This study including patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from October 1, 2015, to December 31, 2022.
* Patients who underwent LVA for unilateral lower-limb lymphedema.

Exclusion Criteria:

* Patients under the age of 20.
* Patients lost to follow-up or with incomplete data.

Primary outcomes:
measure: Volume change after LVA.
timeFrame: 6/12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT02444260: A Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation for Hernioplasty
Official title: Improving Patient Outcomes With Inguinal Hernioplasty - a Randomized Controlled Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Inguinal Hernia
Anesthesia, Local
Conscious Sedation
Keywords: Inguinal Hernia,
Local Anesthesia
Randomized Clinical trial
HERNIOPLASTY
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this RCT is to compare patient outcomes of inguinal hernioplasty under Local Anaesthesia alone versus Local Anaesthesia and Conscious Sedation

Specific study objectives are to determine the effect of conscious sedation on:

(i) patient satisfaction (ii) postoperative pain (iii) time to discharge (iv) intraoperative complications (v) postoperative functional status (vi) short-term postoperative complications (vii) long-term postoperative complications


Eligibility criteria: Inclusion Criteria:

* Reducible inguinal hernia

Exclusion Criteria:

* Renal, hepatic, respiratory, cardiovascular, neurologic or psychiatric disease
* Body mass index \< 18.5 kg/m2 or \> 30 kg/m2
* Recurrent inguinal hernias
* Bilateral inguinal hernias
* Large inguinoscrotal hernias
* Incarcerated hernia
* Allergies to local anaesthetic and sedative agents
* Pregnancy
* Lactation
* Chronic pain syndromes
* Anxiety disorders
* Marijuana use
* Long term use of opioid or sedative agents

Primary outcomes:
measure: patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale
timeFrame: 1 year
Secondary outcomes:
measure: Operative time
timeFrame: 2 weeks
measure: Frequency (total count) of postoperative complications using a questionaire
timeFrame: 1 year
measure: Post-operative assessment of physical activity using Activities Assessment Scale
timeFrame: 1 year
measure: Time to discharge
timeFrame: 2 weeks
measure: change in postoperative pain score from baseline assessed with visual analog scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Kingston
country: Jamaica
facility: University of the West Indies, mona
state: Please Select
Study officials:
References:
citation: Leake PA, Toppin PJ, Reid M, Plummer JM, Roberts PO, Harding-Goldson H, McFarlane ME. Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2017 Feb 7;6(2):e20. doi: 10.2196/resprot.6754.