louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03023150: Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert
Official title: Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Rehabilitation
Ischemic Preconditioning
Physical and Rehabilitation Medicine
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Marquette University
First posted: 2017-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be the first study to use ischemic preconditioning (IPC) as an intervention to improve stroke rehabilitation. IPC is a well studied, well tolerated intervention which has been shown to improve regional blood flow, motor neuron excitability and muscle function in multiple patient groups and in young, healthy subjects. Because IPC targets three physiological systems which are all affected by stroke, we hypothesize that repeated bouts of IPC during the first days to months following stroke (when the majority of recovery occurs) will make traditional rehabilitation strategies more effective.


Eligibility criteria: Inclusion Criteria:

1. be between the ages of 40-80
2. able to give informed consent.
3. be \< 6 months post diagnosis of unilateral cortical stroke and
4. have residual leg paresis.

Exclusion Criteria:

1. chronic low back or hip pain
2. substance abuse
3. head trauma with loss of conciousness in last 6 months
4. neurodegenerative disorder
5. participant taking any medication or supplement that adversely interacts with nitroglycerin (exclusion from nitro administration only, applies to outpatients only)
6. participant has a known allergy to nitroglycerin (exclusion from nitro administration only, applies to outpatients only)
7. resting systolic blood pressure \< 90mmHg (exclusion from nitro administration only, applies to outpatients only)
8. any condition where knee extension contractions are contraindicated
9. people who are unable to follow multi step commands.
10. pregnancy (DXA scan exclusion only)
11. history of major psychiatric disorder
12. participant has had a myocardial infarction in the last year
13. participant has stage II hypertension (BP\>160/100)
14. participant is unable to contract knee muscles
15. participant is unable to sit upright for 2 hours
16. participant has a resting heart rate \>100 beats per minute
17. history of multiple strokes

Primary outcomes:
measure: Change in Knee Extensor Strength
timeFrame: Admission into study and within 3 days of Discharge from Froedtert Hospital
Secondary outcomes:
measure: Change in Walking Speed
timeFrame: Admission into study and within 3 days of Discharge from Froedtert Hospital
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT04031950: Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
Official title: Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea
Lead sponsor: Acurable Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sheffield Children's NHS Foundation Trust
name: University Hospital Southampton NHS Foundation Trust
First posted: 2019-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all children who have been referred for a sleep test.

Brief summary: The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.

The Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.

Detailed description: The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.

The Study will involve patients who will have been referred for diagnosis of sleep apnoea, and the ultimate aim will be to compare the output of a novel apnoea detection system against in -clinic polysomnography.

Patients who are referred to the clinic will spend one night's sleep in the clinic. They will wear a polysomnography system (current goldstandard) and the novel device.

At the end of the trial, we will compare the diagnosis results from both systems.

Eligibility criteria: Inclusion Criteria:

* Children older than one year old
* Children who have been referred to a sleep clinic due to suspicion of sleep apnoea.

Exclusion Criteria:

* Patients whose parents/legal guardians/carers are not fluent in English, or who have special communication needs.
* Known allergy to the adhesive dressing.
* Patients with physical or mental impairments who would be too distressed with additional sensors on themselves.
* Patients with not enough space on the neck area to fit the sensor.
* Clinical problem in the area in which the device will be attached, eg skin condition

Primary outcomes:
measure: Specificity and sensitivity of novel device
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Children Hospital
city: Southampton
country: United Kingdom
facility: Southampton Children's Hospital
Study officials:
affiliation: Sheffield Children's NHS Foundation Trust
name: Ruth Kingshott, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00079950: Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Sarcoma, Soft Tissue
Keywords: soft
sarcoma
metastatic
Lead sponsor: Enzon Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2004-03-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Pegamotecan (Peg-Camptothecin) in patients with Advanced or Metastatic Soft Tissue sarcoma.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of soft tissue sarcoma with measurable disease.
* Target tumors outside prior radiation field(s).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count.
* Adequate renal function
* Adequate liver function
* No history of hemorrhagic cystitis or evidence of microscopic hematuria
* Capable of understanding the protocol requirements and risks and providing written informed consent.
* Either 0 or 1 prior chemotherapy regimens

Exclusion Criteria:

* Subject has a diagnosis of gastrointestinal stromal tumors.
* Concurrent serious medical illness unrelated to tumor within the past 6 months.
* Known chronic infectious disease, such as AIDS or hepatitis.
* Positive screening pregnancy test or is breast-feeding.
* A female or male subject of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this study.
* Receiving concurrent chemotherapy, radiotherapy, or surgery, or has received wide field radiation within the previous 4 weeks.
* History of another active malignancy (except non-melanoma skin cancer and carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for the last 2 years.
* Known or clinically suspected brain metastases.
* Received more than one prior treatment regimen (excluding adjuvant or neoadjuvant therapy) for soft tissue sarcoma.
* Received any investigational drug within the last 30 days.
* Not fully recovered from any prior surgery (at least 4 weeks recovery period for major surgery), and from any reversible side effects related to the administration of cytotoxic chemotherapy or radiation therapy.
* Received a prior camptothecin analog (e.g., topotecan, irinotecan).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Century City Hospital
state: California
city: Philadelphia
country: United States
facility: Pennsylvania Oncology Hematology Association
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: San Antonio
country: United States
facility: Institute for Drug Development Cancer Therapy and Research Center
state: Texas
Study officials:
References:
Clinical trial NCT01659450: Low Energy Dense, Weight Maintenance, Risk of Cardiovascular Disease
Official title: Low Energy Density Diet and Weight Loss Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Body Weight Decreased
Keywords: overweight
obesity
low energy dense
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Investigators presumed that low energy density (LED) diet consumers will have lower risk of cardiovascular disease and are able to maintain their weight longer .

Detailed description: Previous studies introduced different dietary interventions for weight loss maintenance. Besides the debate on low fat or low carbohydrate diets, focusing on some food groups including fruits, vegetables and low fat dairies in the diet may be helpful for weight maintenance. However, energy intake is the key factor of weight maintenance. Energy intake will decrease by reducing energy density (ED) of a diet without producing short-term calorie restriction or feeling hunger. There are several studies which showed the beneficial effects of low energy density diets on weight reduction. However, few studies discuses regarding the effects of such diets on weight maintenance.

Eligibility criteria: Inclusion Criteria:

* who were on weight loss diet for the last one year and additionally, they did not want to lose more weight.
* Non-pregnant, non-lactaries and non-smokers aged 40-70 years included in the present study

Exclusion Criteria:

* dietary poor compliance

Primary outcomes:
measure: better weight maintenance by LED
timeFrame: 7 months
Secondary outcomes:
measure: better CVD risks status by LED
timeFrame: 7 months
Other outcomes:
measure: better weight control
timeFrame: 7 months
Locations:
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Leila Azadbakht, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
Clinical trial NCT05974150: Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring
Official title: Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia (AML) Using Remote Symptom Monitoring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lung Cancer
Multiple Myeloma
Ovarian Cancer
Acute Myelogenous Leukemia
Lead sponsor: Carevive Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients receiving cancer treatment for breast, lung, GI or multiple myeloma

Brief summary: The goal of this study is to create a data set to add to Carevive's registry from real world clinical and patient reported data collected using an electronic care planning system (CPS) with remote symptom monitoring that is used in routine care for cancer patients on active treatment.

Patients will complete a baseline survey in person using a secured device or remotely using their own electronic device in a location of their choice. Weekly electronic patient reported outcome (PRO) surveys are collected from the patients using the Carevive platform for a minimum of 12 weeks. Patients may continue weekly surveys as long as they are receiving treatment.


Eligibility criteria: Inclusion Criteria:

* All participants must be 18 years of age or older.
* Subjects may be any stage and anywhere in the treatment continuum.
* Subject participants must have a diagnosis of a breast, lung, AML, ovarian cancer or multiple myeloma.
* Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.
* All participants must be able to understand English.

Exclusion Criteria:

* Any patient who cannot understand written or spoken English.
* Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.
* Any patient on a treatment clinical trial.
* Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).

Primary outcomes:
measure: Create Data Set
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Evanston
country: United States
facility: Northshore University Health System
state: Illinois
city: Chapel Hill
country: United States
facility: Univeristy of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke
state: North Carolina
city: Canton
country: United States
facility: Cleveland Clinic Mercy Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center
state: Ohio
city: Massillon
country: United States
facility: Tri-County Hematology & Oncology Associates, Inc.
state: Ohio
Study officials:
References:
Clinical trial NCT01925950: Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate) Administered as Monotherapy in the Treatment of Upper Gastrointestinal (GI) Symptoms Caused by GVHD in Patients With Chronic GI GVHD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Gastrointestinal Graft vs Host Disease
Keywords: BDP
orBec
GVHD
beclomethasone dipropionate
bone marrow transplant
hematopoietic cell transplant
HCT
stem cell transplant
marrow transplant
SCT
beclomethasone 17,21-dipropionate
Lead sponsor: Soligenix
Sponsor class: INDUSTRY
First posted: 2013-08-20
Enrollment: 2
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: Use of an oral topically-active glucocorticoid with limited side effects may control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.


Eligibility criteria: Inclusion Criteria:

* Receipt of allogeneic hematopoietic cell transplant \>100 days prior to consent
* Documented cGVHD as defined by the NIH consensus criteria in at least one organ system other than the GI tract (for example, cGVHD of the oral cavity would qualify as a criterion)
* Endoscopic findings consistent with GI GVHD
* Must be able to swallow tablets
* Must be able to read and understand informed consent
* Adequate birth control methods for the duration of the study

Exclusion Criteria:

* \>500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study drug
* GI infection
* Multi-organ failure or other condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
* HIV seropositivity
* Pregnant or nursing female
* Use of any investigational drug to treat chronic GVHD within 28 days of the first dose of study drug
* Evidence of recurrent or progressing malignant disorder that was the indication for HCT

Primary outcomes:
measure: Gastrointestinal (GI) Graft-vs-Host Disease (GVHD) Symptoms
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
References:
Clinical trial NCT05970250: Effect Of Whole Body Vibration Versus Weight Bearing Exercises On Osteoporosis In Breast Cancer Patients After Chemotherapy
Official title: Effect Of Whole Body Vibration Versus Weight Bearing Exercises On Osteoporosis In Breast Cancer Patients After Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Breast Cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 45
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chemotherapy can damage bone marrow and therefore impair the production of white blood cells, platelets and red blood cells with the resulting anemia and osteoporosis.

Detailed description: Purposes of this study were:

1. To determine the therapeutic efficacy of the whole-body vibration (WBV) in improving osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.
2. To determine the therapeutic efficacy of the weight bearing exercise in improving osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.
3. To gain knowledge about the whole-body vibration (WBV) and the weight bearing exercise in improving osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.
4. To share in designing an ideal protocol for the treatment of the osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.

Eligibility criteria: Inclusion Criteria:

* Breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis.
* Their age ranges from 35-55 years old.
* All patients will have the same medical and nursing care.
* All the patients will receive a good explanation of treatment and measurement device.
* They are neurologically free.

Exclusion Criteria:

Patients will be excluded from this study for any of the following causes:

* Uncooperative patients.
* Instability of patient's medical condition.
* Association of another medical problem.
* Patients who have diabetes.
* Patients who have history of medical chronic relevant diseases.
* Patients who have acute or chronic hepatitis.
* Patients who have pacemaker.
* Patients who have genitourinary infections.

Primary outcomes:
measure: Assessing the change in bone mineral density
timeFrame: at baseline and after 2 months of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic faculty of physical therapy cairo university
Study officials:
affiliation: Cairo University
name: Eman Elgendy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06197750: Effect of Vestibular Stimulation on Motor Proficiency and Balance Among Children With Down Syndrome
Official title: Effect of Vestibular Stimulation on Motor Proficiency and Balance Among Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular System Disorder
Keywords: Vestibular stimulation (VeS)
Hypotonic cerebral palsy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This was a randomized controlled trial study where there the total participants were 22and these participants were randomly selected and then distributed in to two groups all participants were selected according to the inclusion exclusion criteria of the study and then they were randomly distributed in two groups named as group A and group B both of the contain equal number of participants which are randomly distributed in groups each group contain 11 participants .Group A received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and group B will receive general strengthening exercises of whole body for same time period. Data will be then analyzed by using SPSS windows version 25

Detailed description: This was a randomized controlled trial study where there the total participants were 22and these participants were randomly selected and then distributed in to two groups all participants were selected according to the inclusion exclusion criteria of the study and then they were randomly distributed in two groups named as group A and group B both of the contain equal number of participants which are randomly distributed in groups each group contain 11 participants .Group A received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and group B will receive general strengthening exercises of whole body for same time period.

Eligibility criteria: Inclusion Criteria:• Down syndrome

* Age 6 to 11 years
* Having no other medical history (6)

Exclusion Criteria:

* • Visual impairment

  * Patient with hearing impairment
  * Patient with poor cognition (6, 8)

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 16 WEEKS
measure: motor proficiency
timeFrame: 16 WEEKS
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Rabia Razzaq
state: Punjab
Study officials:
affiliation: Riphah International University
name: Fareeha Kausar, PP-DPT
role: PRINCIPAL_INVESTIGATOR
References: