louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06667388: Effect of Backward Walking Training vs Forward Walking Training to Improve Balance and Mobility in Children With CP
Official title: Effect of Backward Walking Training Versus Forward Walking Training Program to Improve Balance and Mobility in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Children with cerebral palsy frequently experience balance issues and gait impairments; gait training is a crucial component of their rehabilitation because it greatly enhances the children's socialisation and quality of life.

Detailed description: Since there is no known cure for cerebral palsy, the focus of treatment is shifting to enhancing activities like walking and self-care. Enabling the child with cerebral palsy is the ultimate goal of therapy.

Eligibility criteria: Inclusion Criteria:

* Only CP patients will be included.
* Patient will be included from Bahawalpur only.
* Patient will be included having minimum age of 10 year.

Exclusion Criteria:

* Other cities patient will not be included.
* Patient less than 10 years age.
* Patient suffering from other neurological conditions.

Primary outcomes:
measure: Pediatric Functional Independent Measure for Children (WeeFIM)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Bahāwalpur
country: Pakistan
facility: sadiq abbasi hospital bwp Contact: jangi wala road BWP
Study officials:
References:
Clinical trial NCT00975988: Regulatory TYKERB® Tablets PMS
Official title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of TYKERB® Tablets Administered in Korean Patients According to the Prescribing Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: PMS (post-marketing surveillance)
TYKERB® tablets
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-09-14
Enrollment: 750
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients administrated TYKERB® tablets at the site

Brief summary: Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information TYKERB® is a registered trademark of the GlaxoSmithKline group of companies.

Detailed description: Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information

TYKERB® tablets will be administered with capecitabine for HER2 overexpressing advanced or metastatic breast cancer treatment or with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 as described the prescribing information of TYKERB® tablets

Eligibility criteria: All subjects must satisfy the following criteria at PMS entry according to MFDS PMS regulation:

* Subjects with indication in the locally approved prescribing information
* Subjects with no contraindication according to the prescribing information

Primary outcomes:
measure: Occurrence of adverse events after TYKERB® tablets administration
timeFrame: 12 months
Secondary outcomes:
measure: Effectiveness of TYKERB® tablets and Occurrence of unexpected adverse drug reaction and serious adverse event after TYKERB® tablets administration
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05800288: Effect of Midazolam Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Models
Official title: Clinical Comparison Between Two Propofol TCI Models(Eleveld and Schnider) for General Anaesthesia After Premedication With Midazolam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Propofol
Anesthesia Brain Monitoring
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI, and Midazolam premedication will be recruited

Brief summary: No trials have evaluated the effect of a Midazolam bolus (routinely used for premedication before general anesthesia) on the Concnetration at the effector site of Propofol (CeP) of Eleveld and Schnider TCI models, routinely used for general anesthesia delivery.

Detailed description: During recent years Eleveld and colleagues ideated a new propofol pharmacokinetic/pharmacodynamic (PK/PD) model for total intravenous anaesthesia with target controlled infusion (TIVA-TCI) pumps that has been proposed to have slightly better predictive performance for measured propofol plasma concentrations compared with those of the Marsh and Schnider models, and suitable for children, adults, older subjects, and obese adults, being considered as a "General purpose" model.

However, no trials have compared the Eleveld to the Schnidermodel after a premedication with Midazolam bolus (0.03 mg/kg) from a clinical point of view; so, this study aimed toevaluate midazolam effect on the estimated effector site concentration of the two models (CePE and CePS, respectively) at loss of responsiveness (LoR), during anaesthesia maintenance (Bispectral Index \[BIS\] 40-60) and return of responsiveness (RoR). The study also compared the incidence of deepening or superficializing anaesthesia (defined respectively as lowering or increasing in out-of-target BIS after initial CeP detection), as well as unwanted anaesthesia events: burst suppression (BSupp, identified as a burst suppression ratio \[BSR\] \>0) and unwanted spontaneous responsiveness.

Eligibility criteria: Inclusion Criteria:

* Undergo general anaesthsia with Targted Controlld Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model)after midazolam premedication

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Obesity

Primary outcomes:
measure: Correlation between Concentration at the effector site of Propofol after Midazolam
timeFrame: We will collected data about Drugs concentration and BIS values during general anaesthesia. We will collect BIS and TCI Propofol values during all the duration of anesthesia, form the start of midazolam bolus until the emergence from anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: ULSS2
Study officials:
References:
Clinical trial NCT00345488: Fast Track Admittance of Hip Fracture Patients
Official title: Fast Track ER Admittance of Hip Fracture Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Fracture
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2006-06-28
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The study examines time spent in the emergency room on admission of patients with hip fracture in a cohort with a traditional setup compared with a prospective cohort with a fast track admission schedule including nurse initiation of treatmnet, standardized analgesia, fluid and oxygen therapy and standardized logistics for x-ray and admission procedures.


Eligibility criteria: Inclusion Criteria:

* Admission with a primary hip fracture

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hvidovre University Hospital
name: Nicolai B Foss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02327988: Cryotherapy and Laser Therapy on Muscle Damage
Official title: Cryotherapy and Laser Therapy do Not Interfere in the Response to Eccentric Exercise-induced Muscle Damage: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myalgia [C05.651.542]
Keywords: cryotherapy
laser therapy
eccentric exercise
delayed onset muscle soreness
muscle damage
dynamometry
electromyography
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 60
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study propose investigate the effect of cryotherapy and laser therapy in response to strenuous exercise-induced muscle damage on the biceps brachii muscle (muscle of the arms). All the individuals underwent to an strenuous exercise protocol (2 series of 10 contractions of non-dominant elbow flexors) and three assessments (pre, post and 48hr after the exercise), composed of pain sensation, measure of the strength and muscle activation.


Eligibility criteria: Inclusion Criteria:

* Female sex
* Aged between 18 and 28 years
* Healthy, considered active according to the International Physical Activity Questionnaire -Short Form (IPAQ)
* Engaging in physical activity involving upper limbs at least 2 times a week
* Exhibiting shoulder joint, elbow and non-dominant hand integrity
* Not having a history of osteo-myoarticular injuries in the assessed limb in the last 6 months, or neurological, visual and/or non-corrected auditory impairments.
* Furthermore they could not be allergic to ice (verified by the ice cube test) or any absolute contraindication for the use of laser (cancer and pregnancy).

Exclusion Criteria:

* Not understanding the commands given in the protocols and/or inadequate performance during assessments.

Primary outcomes:
measure: Pain sensation
timeFrame: Within the first 3 days
Secondary outcomes:
measure: Strength
timeFrame: Within the first 3 days
measure: Muscle activation
timeFrame: Within the first 3 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00312988: Topotecan Vs. Topotecan + Etoposide Vs.Topotecan + Gemcitabine in Ovarian Cancer Therapy
Official title: Topotecan-Monotherapy Vs. Topotecan + Etoposide Vs. Topotecan + Gemcitabine in Therapy in Patients With Recurrent Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: Ovarian cancer
Lead sponsor: North Eastern German Society of Gynaecological Oncology
Sponsor class: OTHER
First posted: 2006-04-11
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Determination of total survival under Topotecan Monotherapy, Topotecan + Etoposide and Topotecan + Gemcitabine in second-line therapy in patient with recurrent ovarian cancer.

Detailed description: In Germany ovarian cancer belongs to the most frequently forms of cancer in the female population. The prognosis for women with a platin refractory ovarian cancer is very bad. The median survival time amounts for less a year. Especially in this palliative situation therapies regarding efficacy as well as quality of life are needed. in Germany Topotecan is approved since 1996 for patients after previous treatment with platin, the rare non-hematological side-effects making it interesting for a palliative therapy. Since best results in a chemo-therapeutical treatment are commonly obtained with the combination of two or more cytostatic agents this study tests a Topotecan Monotherapy and two Topotecan combinations. Both combination agents show efficacy alone against solid cancer using from Topotecan different mechanism resulting in different main side effects. Total survival, remission rates, time ti progression and quality of life are the main criteria investigated.

Eligibility criteria: Inclusion Criteria:

* Patient with recurrent ovarian cancer
* Second-line chemotherapy
* \> = 18 years of age
* ECOG \< = 2

Exclusion Criteria:

* ECOG \> 2
* Patients with more than one chemotherapy in anamneses

Primary outcomes:
measure: overall survival
Secondary outcomes:
measure: time to progression
measure: determining adverse effects
measure: quality of life
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jalid Sehouli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fotopoulou C, Karavas A, Trappe R, Chekerov R, Lichtenegger W, Sehouli J. Venous thromboembolism in recurrent ovarian cancer-patients: A systematic evaluation of the North-Eastern German Society of Gynaecologic Oncology Ovarian Cancer Study Group (NOGGO). Thromb Res. 2009 Nov;124(5):531-5. doi: 10.1016/j.thromres.2009.03.013. Epub 2009 May 8.
Clinical trial NCT01134588: Assessment of Quality of Life in Disorders of the Pelvic Floor
Official title: Assessment of Quality of Life in Disorders of the Pelvic Floor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the touch-screen version of the PFDI-20, PFIQ-7, PISQ 12 and SF-36 french questionnaires to their paper versions. The investigators hypothesize that the percentage of completely filled questionnaires will be higher in the touch-screen version.


Eligibility criteria: Inclusion Criteria:

* the patient has pelvic organ prolapse
* the patient requires a surgical intervention within the next 4 to 8 weeks
* the patient understands and reads french
* the patient is affiliated with a social security system
* the patient has given consent

Exclusion Criteria:

* the patient refuses to participate
* the patient is under guardianship

Primary outcomes:
measure: Presence / absence of a completely filled out questionnaire
timeFrame: 6 months post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Vincent Letouzey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00528788: How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
Official title: Effect of Doxercalciferol on Endothelial Cell Function in End Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperparathyroidism, Secondary
Kidney Failure, Chronic
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2007-09-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with chronic kidney disease and end stage renal disease have greater cardiovascular risk than the general population. Vitamin D analogues have been shown in observational studies to have mortality benefit for these patients. This study is designed to investigate doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible mechanism to explain the mortality benefit.


Eligibility criteria: Inclusion Criteria:

* Stage 5 Chronic Kidney Disease
* Hyperparathyroidism (PTH\>300) requiring vitamin D therapy
* Age 18-80 years old
* Ability to provide informed consent

Exclusion Criteria:

* Subjects with neovascularization present, such as neoplasm, active wounds or significant retinopathy
* Subjects with contraindications or allergy to vitamin D
* Subjects currently on vitamin D therapy or a history of vitamin D therapy in the previous 60 days
* Serum phosphorus \> 6
* Serum calcium \> 10.5
* contraindications to nitroglycerin (such as being on sildenafil)

Primary outcomes:
measure: Change in Endothelial Cell Function
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center Dialysis Unit
state: North Carolina
Study officials:
affiliation: University Texas-Southwestern
name: Jula Inrig, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Lynda Szczech, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00550888: Comparison of Uterine Exteriorization Versus in Situ Repair at Cesarean Section: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cesarean Section
Keywords: uterus
abdominal delivery
suture techniques
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2007-10-30
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 44
Standard ages: CHILD
ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: There is no difference between extra-abdominal or in situ suture of the uterus in cesarean section.


Eligibility criteria: Inclusion Criteria:

* indication of cesarean section
* gestational age \> 24 weeks

Exclusion Criteria:

* two or more cesarean sections
* chorioamnionitis
* hemorrhagic complications
* unable to consent
* previous abdominal surgery

Primary outcomes:
measure: endometritis
timeFrame: within the first 30 days after surgery
Secondary outcomes:
measure: nausea and vomiting during surgery, mean operative time, estimated intraoperative blood loss, number of surgical sutures for uterine repair, pain postoperative, number of postoperative analgesic doses, surgical site infection
timeFrame: from surgery to 30 days after surgery
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: IMIP Prof. Fernando Figueira
state: Pernambuco
Study officials:
affiliation: IMIP
name: Eronildo F Silva
role: STUDY_DIRECTOR
References:
citation: Coutinho IC, Ramos de Amorim MM, Katz L, Bandeira de Ferraz AA. Uterine exteriorization compared with in situ repair at cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2008 Mar;111(3):639-47. doi: 10.1097/AOG.0b013e31816521e2.
Clinical trial NCT01545388: Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)
Official title: A Phase III, Randomized, Placebo and Active-Controlled, Double-Blind Clinical Trial to Study the Efficacy and Safety of the Addition of Metformin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Sitagliptin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-03-06
Enrollment: 337
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg q.d. is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in HbA1c at 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus (T2DM)
* Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 4 weeks, on any additional oral hypoglycemic agent (AHA) in the prior 8 weeks, and HbA1c ≥ 6.0% and ≤ 9.0%; or
* Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 10 weeks, not on any additional oral AHA in the prior 8 weeks, and HbA1c ≥ 6.5% and \< 10.0%

Exclusion Criteria:

* Type 1 diabetes mellitus,
* Secondary diabetes mellitus, or
* Gestational diabetes mellitus

Primary outcomes:
measure: Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Experienced at Least One Adverse Event
timeFrame: Up to 26 weeks
measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
Study officials:
References: