louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02313090: Study of Welltang- a Cell Phone-based Diabetes Management Application's Effect on Blood Glucose Control
Official title: Study of Welltang- a Cell Phone-based Diabetes Management Application's Effect on Blood Glucose Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 100
Sex: ALL
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 aim was to assess the impact of a cell phone-based diabetes management application (Welltang) on HbA1c, blood glucose, lipids, physical activity, weight, and blood pressure during 3 months. And hypoglycemic events, the satisfaction of the patients with Boyibang, their diabetes knowledge and self-care behaviors were also evaluated.

Detailed description: At baseline, all patients completed the Diabetes Self- Care Behavior Questionnaire and a Diabetes Knowledge Survey. Health, medical and demographic history, height and weight, waist and hip circumferences, and blood pressure were recorded. HbA1c and low-density lipoprotein cholesterol (LDL-C) level were tested. All of these data were measured 3 months later at the conclusion of the study intervention.

Eligibility criteria: Inclusion Criteria:

* All diabetes, aged more than 18 years old. No limit for HbA1c was defined

Exclusion Criteria:

* patients have any severe complications such as end phase of diabetic nephropathy or proliferative retinopathy. patients who cannot use smart phone.

Primary outcomes:
measure: HbA1c
timeFrame: 3 months
Secondary outcomes:
measure: blood pressure
timeFrame: 3 months
measure: low density lipoprotein cholesterol
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: the First Affiliated Hospital to Zhejiang University School of Medicine
name: Weibin Zhou, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02739490: Effect of the Pelvic Loin Musculature Training on the Dynamic Hip Stabilization
Official title: Effect of the Pelvic Loin Musculature Training on the Dynamic Hip Stabilization: Random Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Addiction
Keywords: physiotherapeutic techniques
pelvis
Muscle strength
Lead sponsor: Universidade Estadual do Centro-Oeste
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Introduction: The stability of the pelvis is of great importance in body balance as a whole, can be improved by training the pelvic muscles fillet (MLP), which is characterized by low intensity isometric synchronous and the deep muscles of the trunk. This study aims to determine the effect of a stability program target, with the training of the MLP region on pelvic stability.

Detailed description: This study aims to determine the effect of a stability program target, with the training of the MLP region on pelvic stability. Materials and Methods: We recruited 20 volunteers of both sexes were randomly divided into control group (CG) and training group (TG). The evaluations were performed before and after training the MLP. The training was held four isometrics series with a time of 30 seconds with 30 seconds rest in between reps during 10 sessions distributed twice weekly.

Eligibility criteria: Inclusion Criteria:

* considered individuals of both sexes, aged 18 and 35
* absence of low back pain
* lack of musculoskeletal dysfunction in the lower limbs
* have never participated in any stabilization training program of the MLP region
* agree to the Terms Informed consent form (ICF) and the sign voluntarily.

Exclusion Criteria:

* the study of abandonment by a participant
* the disagreement with the terms of IC and its not signing
* the volunteer does not understand the implementation of dynamic hip stabilization test
* present cramps or pain during the test and / or training
* historical column in injury, knee and / or ankle.

Primary outcomes:
measure: Values of pelvic tilts , left and right expressed in degrees ( ° ) , the control group (CG ) and training group (TG ) .
timeFrame: 5 weeks
measure: Values of unilateral pelvic tilts between the control group (CG) and training group (TG ) after training.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Estadual do Centro-Oeste
name: Camila Gallina
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00346190: The Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.
Official title: A Six Month Double-Blind, Placebo-Controlled Trial Followed by Six Month Open-Label Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Merck Frosst Canada Ltd.
First posted: 2006-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine whether administration of Alendronate early is more effective than late in the prevention of osteoporosis following a hip fracture


Eligibility criteria: Inclusion Criteria:

Male and Female aged \> 55 Low trauma hip fracture up to 90 days Be willing to submit to periodic bone mineral density radiographic studies of the spine \& 24 hr urine collection Written informed consent

-

Exclusion Criteria:

* Disorders known to affect bone metabolism Not taking bisphosphonates within last 6 months Drugs known to interfere with calcium metabolism within the lats 6 months prior to hip fracture serum calcium\> 2.65 mmol/L Treatment with any investigational drug within the last 30 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Mcgill University Health center
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Richard Kremer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03164590: Effects of Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Cytokines
Official title: Effects of Local Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Inflammatory Cytokines Response After Total Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometrial Adenocarcinoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 60
Sex: FEMALE
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: This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on inflammatory cytokine response after total abdominal hysterectomy.


Eligibility criteria: Inclusion Criteria:

* ASA I-II patients
* age range (18-60) years,
* weight (50- 90) kg

Exclusion Criteria:

* allergy to study drugs
* significant cardiac disease
* respiratory disease
* renal disease
* hepatic disease

Primary outcomes:
measure: severity of pain at rest and on coughing
timeFrame: 24 hours
Secondary outcomes:
measure: sedation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer instIitute
Study officials:
affiliation: South Egypt Cancer Institute
name: fatma el sherif, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05842590: Clinical Evaluation of Direct Composite Veneer Restorations
Official title: Clinical Evaluation of Direct Composite Veneer Restorations Performed in Permanent Incisors Affected by Molar-Incisor Hypomineralization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Molar Incisor Hypomineralization
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this research was to evaluate the clinical success of direct composite veneer restorations performed in permanent incisors affected by molar-incisor hypomineralization.


Eligibility criteria: Inclusion Criteria:

* Cooperative children diagnosed with MIH according to European Academy of Paediatric Dentistry (EAPD) criteria
* Maxillary anterior teeth with MIH-caused coloring and opacity areas
* Fully erupted anterior teeth

Exclusion Criteria:

* Patients and parents of patients who accept to participate.
* Patients who are not in cooperation with the procedure.

Primary outcomes:
measure: 1.Change from baseline to 12 months regarding "Anatomic form"
timeFrame: baseline, 3-month, 6-month,12-month
measure: 2.Change from baseline to 12 months regarding "Marginal adaptation"
timeFrame: baseline, 3-month, 6-month,12-month
measure: 3.Change from baseline to 12 months regarding "Surface roughness"
timeFrame: baseline, 3-month, 6-month,12-month
measure: 4.Change from baseline to 12 months regarding "Marginal staining"
timeFrame: baseline, 3-month, 6-month,12-month
measure: 5.Change from baseline to 12 months regarding "Retention"
timeFrame: baseline, 3-month, 6-month,12-month
measure: 6.Change from baseline to 12 months regarding "Incisal wear"
timeFrame: baseline, 3-month, 6-month,12-month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT06708364: Virtual Reality Training for Heart Rate Variability and Recovery Heart Rate
Official title: Effects of Virtual Reality Training on Heart Rate Variability and Recovery Heart Rate in Sedentary Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Keywords: Heart rate variability
Recovery Heart rate
Virtual Reality Training
Sedentary life style
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine effects of VR training on Heart Rate Variability (HRV), Recovery Heart rate (RHR), Rate Pressure Product (RPP) and Rate of Perceived Exertion (RPE) in sedentary Individuals. Sedentary behavior is a significant public health concern associated with various chronic diseases and reduced quality of life. By elucidating the potential of virtual reality training as an innovative approach to promote physical activity and improve cardiovascular health, this research contributes to addressing the growing burden of sedentary lifestyle-related health conditions.

Detailed description: Virtual reality (VR) training in cardiopulmonary rehabilitation (CR) offers an innovative approach to traditional exercise programs by incorporating enjoyable activities. Utilizing VR enhances cardiopulmonary endurance training and promotes the beneficial effects of CR by engaging patients in fun and challenging activities. This approach aims to increase motivation and adherence to CR over an extended period, resulting in improved mental and physical outcomes compared to conventional CR programs

Eligibility criteria: Inclusion Criteria:

* Sedentary Individuals (IPAQ-short version) \< 3.3 METS daily
* Daily sitting time≤7 hours

Exclusion Criteria:

* Decline Consent
* Known cases of systemic or Cardiovascular Diseases.
* Obese (Asian BMI) \> 29.9
* Any contra-indication to exercise/ Pregnancy

Primary outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: 2 weeks, 4 weeks, 6 weeks
measure: Recovery Heart Rate
timeFrame: 2 weeks, 4 weeks, 6 weeks
measure: Rate Pressure Product
timeFrame: 2 weeks, 4 weeks, 6 weeks
measure: Rating of Perceived Exertion (RPE)
timeFrame: 2 weeks, 4 weeks, 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mehwish Waseem, MSPT-CPPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00651690: Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Muscle Spasticity
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 62
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: This study evaluates the responsiveness of 7 functional tasks to botulinum toxin Type A treatment in poststroke patients with spasticity of the upper-limb flexors


Eligibility criteria: Inclusion Criteria:

* Medically stable poststroke with focal unilateral upper-limb spasticity

Exclusion Criteria:

* Stroke within 6 months of the study enrollment visit
* Previous or current botulinum toxin therapy of any type in the study limb

Primary outcomes:
measure: Seven functional tasks (nail filing, hand cleaning, holding a water bottle, brushing teeth, holding a small fruit, holding a medium fruit, and holding a large fruit)
timeFrame: Week 6
Secondary outcomes:
measure: Spasticity of the upper-limb flexors as measured by the Ashworth Scale
timeFrame: Week 6
Other outcomes:
Locations:
city: Indianapolis
country: United States
state: Indiana
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Turkel CC, Bowen B, Liu J, Brin MF. Pooled analysis of the safety of botulinum toxin type A in the treatment of poststroke spasticity. Arch Phys Med Rehabil. 2006 Jun;87(6):786-92. doi: 10.1016/j.apmr.2006.02.015.
citation: Turkel C, Bowen B, Liu J, Brin M. A pooled analysis of the safety of BoNTA (BOTOX(R)) in the treatment of poststroke spasticity. Neurorehabil Neural Repair 2006;20(1):200 ABS-P3-081
Clinical trial NCT01774890: ST2, a Novel Biomarker for Cardiac Remodeling in Adults With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults born with congenital heart disease in stable clinical condition

Brief summary: The remarkable improvement in survival of children with congenital disease has led to a continuously growing number of adults with congenital heart disease in the developed world. Many of these patients had had cardiac surgery at early age, the may live for many years with pressure overload, volume overload, systolic or diastolic dysfunction, cyanosis or any combination of the above. These past and ongoing cardiac insults often result in significant cardiac remodeling. A biomarker for fibrosis and remodeling may have enormous clinical and prognostic value for these patients.

Serum biomarkers are now integrated in many fields in medicine. In cardiology, a number of biomarkers are used. In the last decade, our group has focused on the natriuretic peptides as markers for heart disease in infants and children. This resulted in many studies and more than 25 publications in the medical literature. We believe that the newly discovered cardiac marker, ST2, will emerge as an important addition to cardiac evaluation in the coming years.The aim of this study is to measure ST2 levels in patients with congenital right heart disease and correlate ST2 levels to clinical status, imaging and prognosis.


Eligibility criteria: Inclusion Criteria:

* Adults (age\>18 y)
* congenital heart disease

Exclusion Criteria:

* Additional lung diseases, renal disease or inflammatory disease.
* Patients who underwent therapeutic intervention between the MRI and the ST2 - measurements.
* Pregnant women

Primary outcomes:
measure: NYHA classification and/or 6 minute walk distance
timeFrame: six months
Secondary outcomes:
measure: Hemoglobin level
timeFrame: six months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organizrtion
Study officials:
References:
Clinical trial NCT02900690: Health Economics Evaluation of the Management of Severe Postpartum Hemorrhage: Comparison of Recombinant Activated Factor VII Strategy to the Reference Strategy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Health Care Cost
Post Partum Haemorrhage
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this study is the population described in "rhuFVIIa in Post-partum Hemorrhage " NCT00370877

Brief summary: The main objective of this project is to assess the average cost of the treatment of bleeding postpartum with recombinant activated factor VII (NovoSeven®) and compare it to the reference strategy. Costs related to medicine NovoSeven® can generate surplus, but it also avoids in some cases very costly invasive procedures. It will be interesting to compare the average cost of the complete strategies supported.


Eligibility criteria: Inclusion Criteria:

* Severe haemorrhage is defined by the following criteria: blood loss greater than 1500 ml graduated measured in the bag and / or hemodynamically unstable and / or requiring transfusion of packed red blood cells (3);
* Sulprostone (Nalador®) ineffective;
* Age over 18 years;
* The term is more than 27 SA (child's viability);
* Without anthropomorphic limit;
* The outcome of the pregnancy is normal or pathological;
* Informed consent "emergency procedure" is signed by the husband or family.

Exclusion Criteria:

* minors, majors in guardianship, with a personal history of venous or arterial thrombosis may cons-indicate treatment with rFVIIa or refuses to sign the consent

Primary outcomes:
measure: direct medical cost
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05473390: Effect of FES of Back Muscles on Spinal Posture and Gait in Hemiplegia
Official title: Effect of FES of Back Muscles on Spinal Posture and Gait in Hemiplegia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hemiplegic patient have unbalanced posture because paralysis leads to muscle atrophy, which then causes an unbalanced alignment in the structure of spinal joints. Evaluation and therapy of postural alignment are important as early predictable factors in the overall daily function of stroke patients

Detailed description: To evaluate whether the application of FES of the back muscles in hemiplegic affect spinal posture and/or gait

Eligibility criteria: Inclusion Criteria:

* 20 children with c.p. hemiplegia
* moving and performing daily activities independently
* no problems in terms of verbal communication
* no physical and cognitive restrictions.

Exclusion Criteria:

* Having cognitive impairment as tested by the Mini-Mental State Examination (with scores \< 24)
* Uncontrolled hypertension (systolic blood pressure \> 160 mmHg)
* Joint replacement
* Incontinence

Primary outcomes:
measure: spinal posture
timeFrame: "up to 8 weeks"
measure: Balance assessment
timeFrame: "up to 8 weeks"
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National institute for Gerontology
Study officials:
affiliation: National institute for Gerontology
name: mohammed s Saif, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03873090: SBRT in 4 Fractions for Prostate Cancer
Official title: Phase I-II Study of High Dose SBRT in 4 Fractions for Intermediate Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be \[ 4 x 9.5 Gy = 38 Gy \] delivered in 5 alternative days.


Eligibility criteria: Inclusion Criteria:

* Age ≤ 85years.
* WHO performance status ≤ 2.
* PSA\>10 and ≤ 20 ng/ml or Gleason Score 7 or T2a-T2c.
* Histologically proven prostate adenocarcinoma
* No pathologic lymph nodes on CT/ MRI scan.
* No distant metastases.
* No previous prostate surgery other than TURP (at least 6 weeks interval before initiation of RT).
* No malignant tumours in the previous 5 years.
* IPSS 0-7.
* Combined HT according to risk factors.
* Informed consent.

Exclusion Criteria:

* Prostate size greater than 60cc.
* Previous TURP less than 6 weeks before radiotherapy.
* Previous prostate surgery other than TURP.
* Diabetes \*.
* Use of anticoagulants drugs \*.
* Chronic inflammatory bowel disease \*.
* Previous pelvic irradiation.
* Inability to obtain written informed consent.

Primary outcomes:
measure: Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients.
timeFrame: up to 5 years
measure: Tumour response to local radiation therapy by assessing freedom from biochemical failure.
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: