louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01576562: Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation
Official title: Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Implantable Cardioverter Defibrillator
Ventricular Assist Device
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2012-04-12
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with wireless ICDs undergoing VAD implantation (study group) or other cardiothoracic surgery (control group) will be included.

Brief summary: The purpose of this research study is to test the function of a subjects implantable cardioverter defibrillator (ICD) function throughout the duration of their heart surgery. ICD function can be altered during some types of heart surgery such as those when a pump (ventricular assist device - VAD) is implanted. The investigators would like to study the mechanism of device and ICD malfunction.

Detailed description: ICD function is typically measured prior to and after surgery. For the study, the investigators will measure ICD lead function multiple times throughout the surgery as well, to determine if and when device malfunction occurs. ICD lead function is measured noninvasively through a specialized computer the same way it is checked in the clinic. In addition, the investigators will test ICD function as they usually do following surgery.

Eligibility criteria: Inclusion Criteria:

* Patients ages 18 and older
* Have a wireless implantable cardioverter defibrillator (ICD) and are undergoing VAD implantation or other cardiothoracic surgery.

Exclusion Criteria:

* Patients who are pacemaker dependent
* children, human fetuses, neonates
* prisoners will not be included
* Pregnant women will not be included

Primary outcomes:
measure: observational study to assess potential changes that may occur in the RV ICD lead function during LVAD implantation and what mechanism may cause those changes in RV ICD lead function
timeFrame: RV ICD lead function will be measured throughout LVAD placement , at 1 week post LVAD placement, and 3 months post LVAD placement Description:
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jordana Kron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hu YL, Kasirajan V, Tang DG, Shah KB, Koneru JN, Grizzard JD, Ellenbogen KA, Kron J. Prospective Evaluation of Implantable Cardioverter-Defibrillator Lead Function During and After Left Ventricular Assist Device Implantation. JACC Clin Electrophysiol. 2016 Jun;2(3):343-354. doi: 10.1016/j.jacep.2016.01.008. Epub 2016 Mar 23.
Clinical trial NCT02760862: Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache
Official title: Comparative Study Between Hydrocortisone and Mannitol in Treatment of Postdural Puncture Headache: a Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Headache
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 50
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: Fifty patients of both sex, aged 18-50 years and ASA I and II undergoing elective lower abdominal and pelvic surgery under spinal anesthesia were included in this randomized double-blind study. Patients were randomly divided into 2 groups 25 each; group (I) received intravenous hydrocortisone 100mg every 8 hours for 48 hours and group (II) received intravenous infusion of mannitol 20% 100ml over 30 minutes followed by 100ml every 12hours. Mean (+/- SD) of headache intensity at 0, 6, 12, 24 and 48 hours after beginning of treatment was assessed using visual analog scale.


Eligibility criteria: Inclusion Criteria:

* aged 18-50 years old.
* both sex.
* ASA physical status I and II.
* 70-90 kg body weight.
* height 160-180 cm.
* Elective lower abdominal and pelvic surgery e.g. repair of inguinal hernia, repair of incisional hernia, varicocele and hydrocele.

Exclusion Criteria:

* Patients with impaired kidney or liver functions.
* history of cardiac or central nervous system disease.
* uncontrolled medical disease (diabetes mellitus and hypertension)
* history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery
* allergy to the used medications
* patient's refusal
* duration of surgery more than 120 minutes.

Primary outcomes:
measure: Number of Patients (in Digits) Got Earlier Relief of PDPH (in Hours) After Use of Hydrocortisone or Mannitol.
timeFrame: within 48 hours after starting of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04960462: Case Report of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canal Plasty for the Treatment of Sacral Canal
Official title: Case Report of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canal Plasty for the Treatment of Sacral Canal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tarlov Cysts
Keywords: tarlov cysts surgery
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinical data (symptoms, signs, imaging findings) of patients with sacral cysts treated with sacral cyst reconstruction using nerve root sleeve reinforcement

Brief summary: A retrospective study of the changes in the VAS scores and imaging examinations after the reconstruction and reinforcement of nerve root sleeves and caudal angioplasty for the treatment of sacral cysts from August 2017 to January 2018 was used to evaluate the efficacy of the surgical prescription.

Detailed description: Objective: To clarify the curative effect of nerve root sleeve reconstruction and reinforcement and caudal plasty in the treatment of sacral cysts Design: A retrospective study of the changes in the VAS score and imaging examinations after the reconstruction and reinforcement of nerve root sleeves and sacral canoplasty for the treatment of sacral cysts from August 2017 to January 2018 to evaluate the efficacy of the surgical prescription.

Eligibility criteria: Inclusion Criteria:a) Symptomatic nerve root cyst diagnosed by MRI b) The capsule of the cyst is intact and the sacral lamina is not defective c) No other diseases of the nervous system, pelvic floor and important organs d) Reconstruction of patients with artificial dural nerve root sleeve reinforcement -

Exclusion Criteria:a) Non-radiotomy cyst or asymptomatic cyst b) The cyst causes severe bone erosion to lamina absorption c) Combined with other diseases of the nervous system, pelvic floor and important organs d) Those who have not used artificial dura mater for nerve root sleeve reinforcement and reconstruction

-

Primary outcomes:
measure: Symptomatic nerve root cyst diagnosed by MRI
timeFrame: 2017/08-2018/01
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: bin liu
role: STUDY_CHAIR
References:
Clinical trial NCT02304562: Umbilical Cord Blood-derived Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair
Official title: Umbilical Cord Blood-derived Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Sweat Gland Diseases
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with skin injury treated with Umbilical Cord Blood-derived Mesenchymal Stem Cells,such as deep burn damaged sweat glands,Effectiveness of Umbilical Cord Blood-derived Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair is determined.


Eligibility criteria: Inclusion Criteria:

* Burn area:10-20％TBSA

Exclusion Criteria:

* Have influence on the speed of wound healing of patients with chronic diseases

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Active and inactive lesion count
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: xiaobing FU
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fu X, Qu Z, Sheng Z. Potentiality of mesenchymal stem cells in regeneration of sweat glands. J Surg Res. 2006 Dec;136(2):204-8. doi: 10.1016/j.jss.2005.03.024. Epub 2006 Oct 20.
Clinical trial NCT06256562: A Study of GZR18 Injection in Obese/Overweight Patients
Official title: A Multicenter, Randomized, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Obese/Overweight Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Overweight
Lead sponsor: Gan and Lee Pharmaceuticals, USA
Sponsor class: INDUSTRY
First posted: 2024-02-13
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, randomized, placebo-controlled phase II clinical study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of GZR18 injection in Chinese adult obese/overweight subjects.


Eligibility criteria: * Inclusion Criteria:

  1. Male or female aged 18-65 years (inclusive).
  2. Obese subjects (BMI≥28 kg/m2), Or overweight subjects (24 kg/m2≤BMI\<28 kg/m2) with at least one comorbidity.
  3. Able to understand the procedures and methods in this study; willing and able to maintain a stable diet and exercise lifestyle during the research period, and willing to sign the ICF voluntarily.
* Exclusion Criteria:

  1. Limb deformities or defects affecting height and body weight measurement.
  2. Pregnant or lactating women, men or women of reproductive potential unwilling to use contraception throughout the study and for 6 months after the last dose of investigational drug.
  3. History of drug abuse within 1 year before screening, or positive results in drug abuse screening during screening or before randomization.
  4. Alcohol abuse history within 6 months prior to screening.
  5. Subjects who are known or suspected to be allergic to GLP-1 drugs or excipients.
  6. Subjects with an absolute weight change greater than 5.0% due to any reason within the 3 months prior to screening.

Primary outcomes:
measure: Percent (%) change from baseline in body weight at the end of the study (W30)
timeFrame: 30 weeks
Secondary outcomes:
measure: Proportion of subjects who achieved (yes/no) body weight reduction ≥5%, 10%, 15%, 20% from baseline.
timeFrame: 30 weeks
measure: The number of adverse events (AEs)that occurred during the study.
timeFrame: 33 weeks
measure: steady-state trough plasma concentration (Css_min)
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Gan & Lee Pharmaceuticals Co., Ltd
Study officials:
affiliation: Gan & Lee Pharmaceuticals.
name: Liyuan Zhao, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00842062: Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation
Official title: Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Facial Rhytides
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2009-02-12
Enrollment: 380
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, non-randomized study to evaluate the performance of the MyoScience Tissue Remodeling Device for the treatment of glabellar lines (frown lines), lateral orbital lines (crow's feet), and frontalis lines (horizontal forehead lines).


Eligibility criteria: Inclusion Criteria:

* The subject must be a female 30 to 70 years of age.
* The subject must have a clinical examination prior to treatment including assessment of hyperdynamic line severity.
* The subject must have a wrinkle rating of at least "1" at rest in one or more of the following treatment areas (glabellar, lateral orbital, or frontalis).
* The subject must have signed an informed consent form.
* The subject should not have undergone any other facial cosmetic procedures at or above the level of the cheekbones within the past 6 months.
* The subject should not be participating in any other facial cosmetic research study.

Exclusion Criteria:

* The subject is on a regular regimen of prescribed or over-the-counter anticoagulants.
* The subject has an infection or skin problem at the injection site.
* The subject has a history of facial nerve palsy.
* The subject has marked facial asymmetry.
* The subject has ptosis.
* The subject has excessive dermatochalasis.
* The subject has deep dermal scarring.
* The subject has thick sebaceous skin.
* The investigator is unable to substantially lessen facial lines by physical separation.
* The subject has a history of neuromuscular disorder.
* The subject has undergone prior surgery that alters the subcutaneous anatomy of the areas being treated.
* Subjects with laxity of the canthal tendon and/or with lower lid retraction, and subjects who recruit their zygomaticus major muscle to animate their crow's feet.
* The subject has any physical or psychiatric condition that in the investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study.

Primary outcomes:
measure: Investigators' and subjects'rating of line severity in the target areas at rest and in animation at each follow-up interval.
timeFrame: Up to 6 months
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: The Aesthetics Research Center
state: California
Study officials:
References:
Clinical trial NCT04847362: The Effect of Tele-Health Education Provided in the Postpartum Period in the Covid 19 Pandemic
Official title: Investigation of the Effect of Tele-Health Education Provided in the Postpartum Period in the Covid 19 Pandemic on the Depression, Attachment and Anxiety Levels of Women: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Depression
Anxiety State
Keywords: postpartum depression
mother-baby attachment
anxiety
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
Primary purpose: PREVENTION

Brief summary: In the planned study, it was aimed to examine the effect of tele-education offered in the postpartum period in the covid 19 pandemic on the levels of depression, attachment and anxiety of women.

Detailed description: In the planned study, it was aimed to examine the effect of tele-education offered in the postpartum period in the covid 19 pandemic on the levels of depression, attachment and anxiety of women.

Eligibility criteria: inclusion Criteria

* literate
* Giving birth at term (between 38-42 weeks of gestation)
* Being on the 7th Postpartum Day,
* Participation in the study is voluntary,
* Absence of any psychiatric illness,
* Women who have characteristics such as not using any psychiatric medication.
* Baby with normal birth weight and APGAR score of 8 and above
* Those who have not developed postpartum complications
* Speaks and understands Turkish

Exclusion Criteria:

women who do not meet the sample selection criteria

-

Primary outcomes:
measure: postpartum depression
timeFrame: postpartum 6 weeks
measure: postpartum depression
timeFrame: postpartum 3 months
measure: postpartum mother-baby attachment
timeFrame: postpartum 6 weeks a
measure: postpartum mother-baby attachment
timeFrame: postpartum 3 months
measure: anxiety state
timeFrame: postpartum 6 weeks
measure: anxiety state
timeFrame: postpartum 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
city: Istanbul
country: Turkey
facility: Saglık Bilimleri Universitesi
Study officials:
References:
Clinical trial NCT05701462: Role of B Mode and Color Doppler Sonography in Differentiation Between Pleural Neoplasm and Inflammatory Pleural Thickening in Correlation With CT Findings
Official title: Role of B Mode and Color Doppler Sonography in Differentiation Between Pleural Neoplasm and Inflammatory Pleural Thickening in Correlation With CT Findings
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pleural Thickening
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: pleura is a serous membrane, it consist of parietal pleura and visceral pleura. pleural thickening is any form of thickening involving the pleura more than 3 mm.

there is malignant thickening : methoselioma, metastasis and non malignant thickening.

trans thoracic USn is a reliable , safe and gold standard for studying pleura.


Eligibility criteria: Inclusion Criteria:

* Adult patients diagnosed as having pleural thickening with or without pleural effusion.

Exclusion Criteria:

* Emphysema or contraindication to pleural biopsy

Primary outcomes:
measure: sensitivity of sonography in pleural thickening in comparison to CT and histopathology
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Porcel JM. Pleural ultrasound for clinicians. Rev Clin Esp (Barc). 2016 Nov;216(8):427-435. doi: 10.1016/j.rce.2016.05.009. Epub 2016 Jun 6. English, Spanish.
citation: Hallifax RJ, Haris M, Corcoran JP, Leyakathalikhan S, Brown E, Srikantharaja D, Manuel A, Gleeson FV, Munavvar M, Rahman NM. Role of CT in assessing pleural malignancy prior to thoracoscopy. Thorax. 2015 Feb;70(2):192-3. doi: 10.1136/thoraxjnl-2014-206054. Epub 2014 Jul 30.
citation: Sureka B, Thukral BB, Mittal MK, Mittal A, Sinha M. Radiological review of pleural tumors. Indian J Radiol Imaging. 2013 Oct;23(4):313-20. doi: 10.4103/0971-3026.125577.
citation: Pairon JC, Laurent F, Rinaldo M, Clin B, Andujar P, Ameille J, Brochard P, Chammings S, Ferretti G, Galateau-Salle F, Gislard A, Letourneux M, Luc A, Schorle E, Paris C. Pleural plaques and the risk of pleural mesothelioma. J Natl Cancer Inst. 2013 Feb 20;105(4):293-301. doi: 10.1093/jnci/djs513. Epub 2013 Jan 25.
Clinical trial NCT02451462: Pilot Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients
Official title: Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hematopoietic Stem Cell Transplant
Bone Marrow Transplant
Keywords: hematopoietic stem cell transplant
bone marrow transplant
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2015-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients who undergo bone marrow transplant for different types of cancer are exposed to many treatments such as steroids and whole body radiation. These treatments make the transplant possible but also make their bones weaker and more prone to fractures which can be a source of significant disability and decreased quality of life for cancer survivors. Our trial will investigate whether giving one dose of Zoledronic acid (a commonly used drug given to preserve bone mass in osteoporosis) before bone marrow transplant can protect from the bone loss caused by the transplant procedures. The investigators are also interested in studying the complex interactions of bone, muscle and fat which are greatly affected after bone marrow transplant.

Detailed description: Primary Objective:

To determine whether a single dose of zoledronic acid pre-transplant will prevent HSCT-related bone loss without impeding engraftment, compared with placebo.

Secondary Objectives:

To identify bone and muscle deficits and alterations in fat distribution prior to HSCT, compared with healthy controls.

Eligibility criteria: Inclusion Criteria:

* First allogeneic HSCT
* Age \> 18 years
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Current or prior use of bone active medication (bisphosphonates, teriparatide, selective estrogen receptor modulators, or Denosumab)
* Hypo- (Ca \< 8.5 mg/dL) or hyper-calcemia (Ca \> 10.5 mg/dL)
* Hyperthyroidism (TSH \< 0.4 mIU/L and free T4 \> 1.6 ng/dL)
* Hyperparathyroidism (PTH \> 80 pg/mL)
* Estimated GFR \< 35 ml/min/1.73 m2
* Other chronic disease unrelated to HSCT that may impact bone metabolism
* Osteoporosis: patients with a history of fragility fracture, or a Hip or Spine T score of \<-2.5 (these patients will be treated with Zoledronic Acid and followed, but excluded from randomization)

Primary outcomes:
measure: % change in Bone Mineral Density at the Femoral Neck
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Joy Wu
role: PRINCIPAL_INVESTIGATOR
References: