louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06729190: Effect of Biofeedback and Functional Electrical Stimulation in Children
Official title: Combined Effect of Biofeedback and Functional Electrical Stimulation on Upper Limb Functions in Children With Hemiplegia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 40 children with hemiplegia cerebral palsy from both sex will be recruited from outpatient clinic of abo resh hospital ,their age ranged from 5-10 years

Detailed description: 40 children with hemiplegia cerebral palsy from both sex will be recruited ,their age ranged from 5-10 years, treatment includes functional electrical nerve stimulation and biofeedback to assess their combined effect on upper limb function

Eligibility criteria: Inclusion Criteria:

* Their age will range from 5 to 10 years.
* Spasticity grade range from 1+ to 2, according to Modified Ashworth Scale (MAS) (Bohannon and Smith, 2011).
* Their UL ability function will be at level II according to Manual Ability Classification System (MACS) (Penta et al., 2001).
* They will be able to follow instructions.

Exclusion Criteria:

* Loss of sensation
* The presence of visual or auditory impairments.
* Musculoskeletal problems or fixed deformities in the upper extremities.
* Seizures.
* Surgical interference in upper limbs.
* Botulinum toxin injections in the last 6 months.

Primary outcomes:
measure: hand function in children with CP
timeFrame: pre intervention and re assessed after 3 months of treatment
Secondary outcomes:
measure: Range of motion
timeFrame: pre intervention and re assessed after 3 months of treatment
measure: muscle grip strength
timeFrame: pre intervention and re assessed after 3 months of treatment
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: professor of physical therapy
name: Khaled A Mamdouh, PHD
role: STUDY_DIRECTOR
affiliation: Professor of physical therapy
name: Eman I Alhadedy, PHD
role: STUDY_DIRECTOR
affiliation: Lecturer of physical therapy
name: Amira I Fathi
role: STUDY_DIRECTOR
References:
Clinical trial NCT01599390: Influenza Burden Assessment in the United States, July1997 - up to April 2009
Official title: Burden of Influenza in the United States, July 1997 up to April 2009
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: United States
Burden of Disease
Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Sage Analytica
First posted: 2012-05-16
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All records of people in the US in the Nationwide Inpatient Sample (NIS) hospitalization data or in the US mortality data will be included in this study.

Brief summary: The study will assess the burden of severe influenza outcomes by age, risk status, and influenza subtype, in order to create a profile of the burden of influenza-related morbidity and mortality in United States from July 1997 to April 2009.

Detailed description: This epidemiological study is a modelling of time series retrospectively extracted from multiple databases. Data will be extracted from existing electronic healthcare databases.

Eligibility criteria: Inclusion Criteria:

* Recorded in the US NIS hospitalization data or the US National Vital Statistics System (NVSS) mortality data with a pre-specified diagnostic code.

Exclusion Criteria:

* Missing data in the following fields: age, primary discharge diagnosis, admission month (NIS) /month of death (NVSS), and status at discharge (alive / dead).

Primary outcomes:
measure: Occurrences of potentially influenza-attributable hospitalization or death by age, risk status, region and season.
timeFrame: From July 1997 to April 2009 (i.e., up to almost 12 years)
measure: Amount of circulating influenza A and B, and RSV strains determined for each season.
timeFrame: From July 1997 to April 2009 (i.e., up to almost 12 years)
Secondary outcomes:
measure: Influenza vaccine content and effectiveness by season.
timeFrame: From July 1997 to April 2009 (i.e., up to almost 12 years)
measure: Influenza vaccine coverage by season.
timeFrame: From July 1997 to April 2009 (i.e., up to almost 12 years)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Matias G, Taylor R, Haguinet F, Schuck-Paim C, Lustig R, Shinde V. Estimates of hospitalization attributable to influenza and RSV in the US during 1997-2009, by age and risk status. BMC Public Health. 2017 Mar 21;17(1):271. doi: 10.1186/s12889-017-4177-z.
Clinical trial NCT05010590: Anabolic Therapy in Postmenopausal Osteoporosis
Official title: Anabolic Therapy in Postmenopausal Osteoporosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women at high risk of fracture

Exclusion Criteria:

* Prior therapy exclusions

  1. current use or use in the past 12 months of oral bisphosphonates or denosumab
  2. current use or use within the past 3 months of estrogens, SERMs, or calcitonin.
  3. use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
  4. any current or previous use of romosozumab or strontium
  5. current use or use within the past 3 years of teriparatide, abaloparatide, or any parenteral bisphosphonate.

Other exclusions

1. Confirmed serum alkaline greater than 2 times the upper normal limit.
2. Stage 4 or 5 chronic kidney disease (GFR less than 30)
3. Hypercalcemia (Ca greater than 10.5 mg/dL)
4. Hypocalcemia (Ca less than 8.8 mg/dL)
5. Elevated blood PTH (intact PTH greater than 77 pg/mL)
6. Serum 25-OH vitamin D less than 20 ng/mL
7. HCT less than 32%.
8. History of malignancy (except basal cell carcinoma).
9. Significant pulmonary disease
10. History of myocardial infarction or stroke within the preceding year.
11. History of unstable angina or transient ischemic attack in the past year.
12. Current atrial fibrillation.
13. Any health condition that, in the opinion of the study physician, significantly increases the risk of cardiovascular events.
14. Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
15. Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
16. Uncontrolled eczema
17. Congenital or acquired bone disease other than osteoporosis.
18. Known sensitivity to denosumab or any of its excipients.
19. Known sensitivity to romosozumab or any of its excipients.
20. History of osteonecrosis of the jaw, extensive dental work involving extraction or dental implants in the past 3 months, or extensive dental work planned in the upcoming 12 months.

Primary outcomes:
measure: Total hip areal bone mineral density
timeFrame: Month 0 to 12
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Mass. General Hospital
name: Benjamin Leder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03538990: Effect of DASH Eating Pattern on Heart Failure Outcomes
Official title: Effect of Dietary Approaches to Stop Hypertension Eating Pattern on Cardiometabolic Markers in Advanced Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure NYHA Class III
Keywords: Nutrition
Dietary Approaches to Stop Hypertension
Cardiometabolic Outcomes
Pulmonary Artery Pressure
CardioMEMS
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2018-05-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to examine the effect of nutritional intake on cardiometabolic, inflammation, and physical function markers in advanced heart failure patients using a one-group pre-post test design feeding trial. Effects on hemodynamic markers will be assessed in a subsample of patients with implanted hemodynamic monitoring devices (CardioMEMS). The pre-test condition is represented by participants' self-selected diet, and the post-test condition is represented by a prescribed Dietary Approaches to Stop Hypertension (DASH) diet.


Eligibility criteria: Inclusion Criteria:

1. 18+ years of age
2. English language literacy
3. Diagnosis of HF ≥ 3 months
4. Diagnosis of NYHA Class III HF (historical assessment)
5. Subjects must be stable on HF medication regimen for one month prior to study entry
6. At least 1 HF hospitalization within 24 months of enrollment
7. BNP \>200 pg/ml

Exclusion Criteria:

1. Subjects who have had an unplanned HF-related hospitalization within 2 months of enrollment
2. Subjects with a Glomerular Filtration Rate (GFR) \<25 ml/min who are nonresponsive to diuretic therapy or who are on chronic renal dialysis
3. Subjects likely to undergo heart transplantation within 2 months of enrollment
4. Subjects with severe conditions limiting 6-month survival
5. Unavailability during scheduled data collection points
6. Cognitive impairment

Primary outcomes:
measure: Change in Cardiometabolic Marker Levels between Calibration and DASH Diet Intervention Phase
timeFrame: Baseline, week 3, week 6
Secondary outcomes:
measure: Change in Functional Exercise Capacity between Calibration and DASH Diet Intervention Phase
timeFrame: Baseline, week 3, week 6
Other outcomes:
measure: Change in Inflammation Marker Levels between Calibration and DASH Diet Intervention Phase
timeFrame: Baseline, week 3, week 6
measure: Change in Hemodynamic Marker Levels between Calibration and DASH Diet Intervention Phase
timeFrame: week 1-3, week 3-6
Locations:
city: Athens
country: United States
facility: University of Georgia Clinical and Translational Research Unit
state: Georgia
Study officials:
affiliation: University of Georgia
name: Elisabeth L Sattler, PhD, BSPharm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02994264: A Study to Compare Adjuvant Concurrent Chemoradiation (CCRT) to Adjuvant Radiation Therapy (RT) in Grade 2 and 3 Extremity Soft Tissue Sarcomas
Official title: A Retrospective Cohort Study to Assess Adjuvant Concurrent Chemoradiation (CCRT) Compared to Adjuvant Radiation Therapy (RT) in the Treatment of Grade 2 and 3 Extremity Soft Tissue Sarcomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma,Soft Tissue
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients records would be extracted from the electronic health record system of Institut de Cancérologie de Lorraine

Brief summary: The aim of the study is to retrospectively evaluate the outcome of adjuvant concurrent chemoradiation delivered to patients with high grade non-metastatic soft tissue sarcomas of the extremities at the investigators institution paired with patients treated by adjuvant radiation therapy


Eligibility criteria: Inclusion Criteria:

* All patients consecutive enrolled from 1990 to 2004 with soft tissue sarcomas located either in the limbs or girdles, superficial or deep, grade 2 or 3 (FNCLCC), who were first treated with radical conservative surgery and adjuvant RT atto a minimum biologically equivalent dose of 45 Gy, with or without concurrent adjuvant chemotherapy.

Exclusion Criteria:

* A patient record captured outside the time frame from 1990 to 2004 with trunk, retro-peritoneum, and head and neck localisations, grade 1 histology and, PS≥3, were excluded as well as and those plus patients who had received neoadjuvant treatment. Differentiated liposarcomas, dermatofibrosarcomas protuberans, extraskeletal Ewing's sarcomas, primitive neuroectodermal tumors and osteosarcomas were also excluded due to specific treatment strategies.

Primary outcomes:
measure: overall survival
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05976464: Efficacy of Magnesium Sulfate as an Adjuvant in Erector Spinae Plane Block as an Anesthetic Post Operative After Modified Radical Mastectomy
Official title: Efficacy of Magnesium Sulfate as an Adjuvant to Local Anesthetic in Erector Spinae Plane Block for Post-operative Analgesia After Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: ESPB, Mg Sulfate,Post Mastectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: efficacy of magnesium sulfate as an adjuvant in erector spinae plane block as an anesthetic post-operative after modified radical mastectomy


Eligibility criteria: Inclusion Criteria:

* 1. ASA I-II. 2. Female patients aged 18-65 years. 3. Scheduled for a modified radical mastectomy with axillary dissection for breast cancer.

Exclusion Criteria:

1. ASA \< II.
2. more than 65 years old
3. Patients with known allergies to the study drugs
4. Skin infection at the site of needle puncture.
5. Coagulopathy

5. Drug or as that would interfere with perception and assessment of pain. 6. Uncooperative patients.

Primary outcomes:
measure: - The primary outcome measure in this study will be the total dose of morphine consumption during the 24 hour Postoperatively.
timeFrame: Up to 24 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05621564: Pre-operative Therapy in Breast Cancer
Official title: The Effect of Pre-operative Therapy on Response and Survival in Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 488
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be selected from the hospital where they are treated

Brief summary: This is a prospective and retrospective study to evaluate the effect of pre-operative therapy on response and survival, and compare the difference in response and survival by pre-operative regimen or by patient's clinicopathological characteristic in early or advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

* Female, Aged ≥18 years
* Histologically confirmed primary breast cancer
* Plan to receive pre-operative therapy
* Adequate organ function

Exclusion Criteria:

* History of neurological or psychological disease, including epilepsy or dementia
* Not suitable to participate in this study judged by investigators

Primary outcomes:
measure: Pathologic Complete Response
timeFrame: at surgery
Secondary outcomes:
measure: Objective response rate
timeFrame: from the start of pre-operative treatment until the completion of surgery up to 6 months
measure: Disease-free Survival
timeFrame: From surgery until time of event up to 8 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
Study officials:
References:
Clinical trial NCT03876964: J-Valve Compassionate Use
Official title: J-Valve Compassionate Use Cases
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Aortic Valve Disease
Aortic Valve Insufficiency
Aortic Valve Stenosis
Lead sponsor: JC Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA

Detailed description: The J-Valve is designed to treat patients with aortic valve disease requiring replacement. There are certain patient subsets that the J-Valve TF is uniquely able to treat and where there are no good alternative treatments for patients at high surgical risk. Physicians have applied for individual approval to treat patients with the J-Valve in certain clinical conditions.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01126164: Parent Intervention to Reduce Binge Drinking
Official title: Parent Intervention to Reduce Binge Drinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Keywords: parents
peer
basics
college student drinking
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Parent and peer interventions to reduce student drinking

Detailed description: Parent and peer interventions to reduce student drinking:

Efficacy;

Mediation:

Moderation

Eligibility criteria: Inclusion Criteria:

* varsity athlete in high school

Exclusion Criteria:

* not a varsity athlete in high school

Primary outcomes:
measure: heavy episodic drinking
timeFrame: 6 months post baseline
measure: heavy episodic drinking
timeFrame: 9 months post baseline
measure: heavy episodic peak drinking
timeFrame: 6 months post baseline
measure: heavy episodic peak drinking
timeFrame: 9 months post baseline
Secondary outcomes:
measure: drinking consequences
timeFrame: 9 months post baseline
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Robert Turrisi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turrisi R, Larimer ME, Mallett KA, Kilmer JR, Ray AE, Mastroleo NR, Geisner IM, Grossbard J, Tollison S, Lostutter TW, Montoya H. A randomized clinical trial evaluating a combined alcohol intervention for high-risk college students. J Stud Alcohol Drugs. 2009 Jul;70(4):555-67. doi: 10.15288/jsad.2009.70.555.
Clinical trial NCT01768364: Antibiotic Prophylaxis When Removing Ureteric Stent After Stone Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ureteric Stent After Stone Surgery
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Is there anything to gain in giving antibiotics as prophylaxis when removing ureteric stents cystoscopically after stone surgery?

Detailed description: Many patients undergoing stone surgery receive a ureteric stent that should be removed after 14 days. This stent is removed cystoscopically and today this is done without giving antibiotics. Some patients get urinary tract infections subject to this. However the investigators do not know how many of these patients get UTI as most are followed by their primary care doctor. With this study the investigators would like to find out whether it is possible to avoid such infections and also find out how many actually do get infected.

Eligibility criteria: Inclusion Criteria:

* stone surgery patients with ureteric stent that should be removed after 14 days

Exclusion Criteria:

* ongoing antibiotic treatment, allergy to trimetoprim-sulfa

Primary outcomes:
measure: 14 days infection rate w/wo antibiotics
timeFrame: 14 days
Secondary outcomes:
measure: infection rate with ureter stent wo antibiotics
timeFrame: 14 days
Other outcomes:
Locations:
city: Lorenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: University Hospital, Akershus
name: Tor Erik Sand, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04160364: Gender Dysphoria in Children and Adolescents : Parents' Perspectives
Official title: Gender Dysphoria in Children and Adolescents : Parents' Perspectives
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gender Dysphoria
Keywords: children
adolescents
parents
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be proposed to parents of transgender children \<18 years of age followed in the endocrinology, diabetology and nutrition department of the University Hospital of Nancy on the occasion of the regular follow-up visit at the outpatient clinic ( consecutive recruitment).

Brief summary: Gender dysphoria is defined as a persistent incongruence between an experienced gender and the assigned sex at birth Transgender and gender nonconforming persons desire to modify their appearance to be consistent with their self-identified gender identities. In non-binary people, contrary to binary transgender persons, self-identified gender identities do not fit the classical pattern male/female.

During the last decennium, an increase in the number of young subjects, especially children and adolescents, referred to gender identity centres has been observed. A new nosological entity "rapid-onset gender dysphoria in adolescents and young adults" has recently been described in the literature, whose etiology has not been well understood.

This growing demand of adolescents and young adults observed in the recent years is not well understood.


Eligibility criteria: Inclusion Criteria:

* be a parent of a child \<18 years followed in the endocrinology department of the University Hospital of Nancy for gender dysphoria
* be in stable couple
* both parents agree to participate
* capacity to communicate in French
* Person who has received complete information on the organization of the research and who agreed to the exploitation of the data

Exclusion Criteria:

* Refusal to participate
* Inability to be physically, psychologically or linguistically involved in the study

Primary outcomes:
measure: thematic analysis
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: University Hospital of Nancy
Study officials:
affiliation: University Hospital of Nancy, France
name: Eva Feigerlova, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: