louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00396708: Wearable Robotic Functional Assistance for Stroke Rehabilitation
Official title: Wearable Robotic Functional Assistance for Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CVA (Cerebrovascular Accident)
Keywords: Robotics
Rehabilitation
Arm
Stroke
Weakness
Outpatient
Chronic
Lead sponsor: Myomo
Sponsor class: INDUSTRY
First posted: 2006-11-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of using the myomo e100 wearable robotic rehabilitation system for increasing functional independence and long term rehabilitation of chronic stroke victims with a hemiparetic upper extremity.

Detailed description: This is a case controlled study for evaluation of the effectiveness of using the myomo e100 wearable robotic rehabilitation for upper arm therapy following stroke.

The intervention for the study will be for the control group- 6-8 weeks of therapeutic exercise and functional training for a total of 18 hours of intervention, or the case group- 6-8 weeks of therapeutic exercise and functional training with the use of the AJB for a total of 18 hours of intervention. Each session will be one hour in length. The length of the study and length of each session is per standard rehabilitation protocol that has been well documented in previous studies as well as the pilot study regarding the AJB. A pre and post test with a 3 month follow up of all measures will be included in the study.

Study procedures will focus on performing functional tasks using the e100.

Eligibility criteria: Inclusion Criteria:

* Medically Stable
* Cognitive Awareness
* Weakness in upper arm
* Over 1 year post CVA
* not engaged in any other upper arm therapies

Exclusion Criteria:

* Rashes, open wounds or skin sensitivity on arm
* Very high elbow tone (arm rigid in flexion or extension)

Primary outcomes:
measure: Motor Activity Log
measure: Fugl-Meyer Upper Arm Function
measure: Wolf Motor Function
measure: SF-36 QOL Survey
measure: Range of Motion
measure: Muscle Strength Test
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: myomo Inc.
state: Massachusetts
Study officials:
affiliation: Inventor
name: Kailas N Narendran, BS, MEng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00563108: Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
Official title: A Double-blind Randomized Single-center Trial of Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Graft vs Host Disease
Hematopoietic Stem Cell Transplantation
Keywords: Acute graft-versus-host disease post allogeneic stem cell transplantation
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: Novartis Pharmaceuticals
name: The Hong Kong Blood Cancer Foundation
First posted: 2007-11-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Graft-versus-host disease (GVHD) contributes substantially to transplant-related morbidity and mortality. Steroids remains first line therapy for acute GVHD but there is currently no consensus on second line therapy for those in whom steroids have been ineffective. Basiliximab has been shown to be a safe and effective immunosuppresant in the prevention and treatment of rejection after renal transplantation and its role in acute GVHD prophylaxis and treatment has been described favourably. This is a randomized control trial to investigate its efficacy and safety in the management of acute GVHD post allogeneic stem cell transplantation (SCT).


Eligibility criteria: Inclusion Criteria:

* Grade II to IV acute GVHD after SCT

Exclusion Criteria:

* Known allergy to basilixmab

Primary outcomes:
measure: Resolution of GVHD by Day 12
timeFrame: 12 days
Secondary outcomes:
measure: Duration and grading of acute GVHD
timeFrame: 100 days
measure: Total dose of steroid and immunosuppresant
timeFrame: 100 days
measure: Mortality, GVHD-related and all cause
timeFrame: 100 days
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: Department of Medicine/ Haematology and Oncology, Queen Mary Hospital
name: Lawrence SY Ma, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01595308: A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers
Official title: A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Male Infertility
Keywords: Male infertility
Lead sponsor: POM Wonderful LLC
Sponsor class: INDUSTRY
First posted: 2012-05-10
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: How daily consumption of pomegranate juice affects the concentration, morphology or motility of sperm in healthy men.

Detailed description: To determine, in this pilot study, whether daily consumption of pomegranate juice (POM) affects the concentration, morphology or motility of sperm in healthy men. The purpose of the present pilot study is to examine the hypothesis that POM may improve semen parameters in men.

Eligibility criteria: Inclusion Criteria:

* 12 healthy men aged 18-40
* normal sperm counts

Exclusion Criteria:

* History of undescended testes or surgery to the scrotal contents,
* History of marijuana or alcohol abuse, hot tub usage at least 3 months prior to entry into the study
* No alpha adrenergic medications within two weeks of entry into the study,
* No anabolic steroid use,
* No anticholinergic or antimuscarinic drugs, use of colchicine, cimetidine, sulfasalazine, antipsychotics, antidepressants, immunosuppressive drugs prior use of any chemotherapeutic drugs, or UTI on screening visit.

Primary outcomes:
measure: change in sperm counts
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in Sperm count
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical Trials Program at University of California
state: California
Study officials:
affiliation: Institute of Urologic Oncology at UCLA
name: Jacob Rajfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03676608: Use of Bee Wax Mammary Areolae to Improve Breastfeeding
Official title: Study of Health Education to Improve Adherence to Breastfeeding in Primiparous Women Through the Use of Bee Wax Mammary Areolae
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breastfeeding
Lead sponsor: University of Alicante
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A comparative randomized intervention study is presented between a mixed strategy of use of bee wax mammary areolae. Together with the health education program for the promotion of breastfeeding by the WHO and another educational program with the aim of improving the adherence of breastfeeding to primiparous women. The use of both interventions can contribute to the adherence to exclusive maternity in 20% in the first 6 months of life, than only with the educational program.

The study provides evidence of nursing practice, thus contributing to the improvement of nursing mothers in the prevention of lesions in the nipple and care in them if they occur. Consequently, improve the rates of successful breastfeeding, as well as the quality of life of breastfeeding mothers. The study will be carried out with several groups of midwives in Health Centers, in Spain, Colombia and Mexico. The sample was calculated in 240 women who attend the midwife's controls between week 29 and 40.


Eligibility criteria: Inclusion Criteria:

* Primiparous women regardless of age.
* Attended in the consultation of midwives of health centers selected for the study.
* Signature of informed consent.

Exclusion Criteria:

* Atopias and dermatological problems.
* No willingness to continue breastfeeding.
* Mental diseases.
* Allergy to the products of the bee.
* No informed consent.

Primary outcomes:
measure: Percentage of women with exclusive breastfeeding for 6 months.
timeFrame: 6 months
measure: Exclusive breastfeeding time in days.
timeFrame: 6 months
Secondary outcomes:
measure: Mammary congestion
timeFrame: 6 months
measure: Mastitis
timeFrame: 6 months
measure: Cracks
timeFrame: 6 months
measure: Irritation
timeFrame: 6 months
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Universidad Simón Bolívar
city: San Nicolás De Los Garza
country: Mexico
facility: Universidad Autónoma de Nuevo León
state: Nuevo León
city: San Vicente Del Raspeig
country: Spain
facility: University of Alicante
state: Alicante
Study officials:
References:
citation: Vieira F, Bachion MM, Mota DD, Munari DB. A systematic review of the interventions for nipple trauma in breastfeeding mothers. J Nurs Scholarsh. 2013 Jun;45(2):116-25. doi: 10.1111/jnu.12010. Epub 2013 Mar 1.
citation: Britton C, McCormick FM, Renfrew MJ, Wade A, King SE. Support for breastfeeding mothers. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD001141. doi: 10.1002/14651858.CD001141.pub3.
Clinical trial NCT06002308: Influence of Injury to the Kaplan Fibers in Adult and Pediatric Patients With ACL Injury
Official title: Influence of Injury to the Kaplan Fibers and Anterolateral Ligament on Anterolateral Rotatory Knee Laxity in Adult and Pediatric Patients With Anterior Cruciate Ligament Injury: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACL-injury
Keywords: Rotatory instability
Kaplan fiber injury
Anterolateral ligament
Meniscal injury
Magnetic resonance imaging
Anterior cruciate ligament
Lead sponsor: Sichuan Province Orthopetic Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 540
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1994 patients were identified from medical records between Jan. 2019 and Dec. 2021. After reviewing the inclusion and exclusion criteria, 540 patients were included in the present study (71 pediatric patients and 469 adults).

Brief summary: The goal of this \[type of study: observational study\] is to \[detect concomitant KF and ALL injury in knees with ACL injury using MRI in both adult and pediatric patients and compare the effect of KF injury and multiple risk factors (concomitant injury to the ALL, medial collateral ligament \[MCL\], or anterior, central, or posterior part of the medial or lateral meniscus) on anterolateral rotatory laxity as measured by the pivot-shift test in a clinical setting.\].

The main question \[s\] it aims to answer are:

\[Does the main risk factor for a high-grade pivot shift after acute ACL injury differ between pediatric patients and adults?\] \[Does Concomitant KF injury significantly affect the pivot-shift phenomenon in pediatric patients with acute ACL injury?\] Researchers will compare \[71 pediatric patients and 469 adults\] to see if \[main risk factor for a high-grade pivot shift after acute ACL injury differs between pediatric patients and adults?\].


Eligibility criteria: Inclusion Criteria:

* unilateral acute primary ACL tear, considered when the patient reported knee injury occurring less than 2 weeks before the examination;
* bone bruising on the femoral condyles and tibial plateau identiﬁed on MRI.

Exclusion Criteria:

* concomitant ligament (posterior cruciate ligament and/or posterolateral complex) procedures or realignment procedures; contralateral knee injury;
* previous injury or surgery affecting the ipsilateral knee;
* insufficient data from the electronic medical record system;
* lack of KF visualization on MRI.

Primary outcomes:
measure: KF injury
timeFrame: 3 years
measure: ALL injury
timeFrame: 3 years
measure: MCL injury
timeFrame: 3 years
measure: Medial meniscus injury
timeFrame: 3 years
measure: Lateral meniscus
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial Orthopedic Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT06635408: Cystatin c: a Biomarker of AKI in Aneurysmal Subarachnoid Haemorrhage Patients
Official title: Cystatin c as a Predictive Biomarker of Acute Kidney Injury and Neurological Outcomes in Aneurysmal Subarachnoid Haemorrhage Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: Acute kidney injury
Delayed cerebral ischemia
Angiographic vasospasm
Aneurysmal subarachnoid hemorrhage
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Aneurysmal subarachnoid hemorrhage patients

Brief summary: The goal of this observational study is to assess cystatin c as a predictive biomarker of early acute kidney injury in aneurysmal subarachnoid hemorrhage patients. The main question it aims to answer is:

- Does cystatin c biomarker can predict early acute kidney injury in aneurysmal subarachnoid hemorrhage patients?

Participants will be grouped into Aki and Non-Aki groups based on RIFLE criteria and Cystatin c biomarker will be tested to answer the study question.


Eligibility criteria: Inclusion Criteria:

* Patient admission to hospital within 48 hours of subarachnoid haemorrhage onset.
* Subarachnoid haemorrhage caused by intracranial aneurysm rupture and is confirmed via computed tomography angiography (CTA).
* Medical treatment, microsurgical clipping, or interventional endovascular treatment of aneurysm is performed within 48 hours of subarachnoid haemorrhage onset.

Exclusion Criteria:

* Prior onset of subarachnoid haemorrhage or other neurological diseases such as ischemic stroke, hemorrhagic stroke, or severe head trauma.
* Systemic diseases, such as chronic liver diseases, chronic lung diseases, chronic heart failure, thyroid diseases and cancer.
* Renal impairment at time of admission (creatinine-based eGFR less than 60 ml/min per 1.73 m2 body surface area).
* Patients who are hemodynamically unstable at time of admission.
* Mortality within 10 days after admission (duration of study).

Primary outcomes:
measure: Acute kidney injury
timeFrame: 6 days
Secondary outcomes:
measure: Adverse neurological outcomes
timeFrame: 10 days all except mortality within 28 days
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of medicine, Alexandria University
Study officials:
affiliation: Alexandria University
name: Mohamed A El Erian, Professor
role: STUDY_CHAIR
affiliation: Alexandria University
name: Ashraf A Abdelhalim, Professor
role: STUDY_CHAIR
affiliation: Alexandria University
name: Sherif M El Hadi, Professor
role: STUDY_CHAIR
References:
citation: Wang RR, He M, Gui X, Kang Y. A nomogram based on serum cystatin C for predicting acute kidney injury in patients with traumatic brain injury. Ren Fail. 2021 Dec;43(1):206-215. doi: 10.1080/0886022X.2021.1871919.
Clinical trial NCT06072508: Prognostic Interest of Vasorin in Septic Shock
Official title: Prognostic Interest of Vasorin in Septic Shock
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Acute Kidney Injury
Keywords: vasorin
Sepsis
angiotensin II
Acute Kidney Injury
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Abbeville
First posted: 2023-10-10
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: OTHER

Brief summary: In septic shock, the intensity and duration of low blood pressure can lead to a critical reduction in renal tissue perfusion and lead to the onset of more or less severe Acute Kidney Injury (AKI). Vasorin (Vasn) is a protein strongly expressed in large vessels and kidneys, whose functions are still poorly known. Previous experimental studies show that Vasn is associated with decreased Angiotensin II concentrations, a vessel contractility defect and early mortality.

The investigators hypothesize that Vasn (the potential direct regulator of blood pressure) would be an early biomarker predicting the severity of AKI post septic shock, which may be associated with mortality from septic shock or lead to longer-term Chronic Renal Failure (CKD).


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old.
* Hospitalized in intensive care or medical resuscitation units.
* With a septic shock state defined by 2 mmol/l lactate sepsis, requiring vasopressors to maintain mean blood pressure 65 mmHg (despite adequate vascular filling).
* Whether or not they have developed AKI.
* Patient/family information and collection of non opposition

Exclusion Criteria:

* Patients with chronic respiratory failure.
* Pregnant women.
* Patients in palliative care.
* Information for the patient/someone close and collection of his opposition

Primary outcomes:
measure: correlation between vasorin concentration at day 0 and mortality rate
timeFrame: day 0
measure: correlation between vasorin concentration at day 3 and mortality rate
timeFrame: day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References:
Clinical trial NCT01903538: Interference With Cognitive Control by Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Insufficient cognitive control over emotional distracters is characteristic for major depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is associated with this deficit. In this study the investigators assess the effect of a decrease of dlPFC activity in healthy subjects by cathodal transcranial direct current stimulation (tDCS) on cognitive control.

In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators determine the effect of a single-session of cathodal tDCS to the left dlPFC on cognitive control in healthy subjects. To assess the cognitive control the investigators use a delayed response working memory task (DWM)and an arithmetic inhibition task (AIT) with pictures of varying valence.


Eligibility criteria: Inclusion Criteria:

informed consent

Exclusion Criteria:

psychiatric or neurological disorders seizures cardiac pacemakers

Primary outcomes:
measure: Correctness and reaction time of response
timeFrame: Within 30 min starting 5 min after the initiation of stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Tübingen
Study officials:
References:
Clinical trial NCT05826938: Can Virtual Reality Technology Improve the Patient Experience in Oocyte Retrieval?
Official title: Can Virtual Reality Technology Improve the Patient Experience in Oocyte Retrieval?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Female
Keywords: Infertility
Virtual reality
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A non-pharmacological, non-blinded, randomized cohort study that will investigate the effect of Virtual Reality technology on the patient experience during oocyte retrieval.

The primary objective of the trial is to investigate the impact of Virtual Reality technology on the patient experience


Eligibility criteria: Inclusion Criteria:

* Women undergoing oocyte retrieval
* Understanding and speaking Danish

Exclusion Criteria:

* Previous participation in the trial
* Acupuncture as pain relief during oocyte retrieval

Primary outcomes:
measure: Questionnaires regarding impact on patient experience
timeFrame: 30-60 minutes
Secondary outcomes:
measure: Questionnaires reagarding the impact on the consumption of analgesic medication
timeFrame: 30-60 minutes
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: Fertility Clinic Skive, Skive Regional Hospital
Study officials:
References: