louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02017405: Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults
Official title: A Randomized, Crossover Clinical Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate (SBI) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Digestibility
Healthy volunteers
serum-derived bovine immunoglobulin protein isolate
bovine IgG
adults
Lead sponsor: Entera Health, Inc
Sponsor class: INDUSTRY
First posted: 2013-12-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the digestibility of serum-derived bovine immunoglobulin protein isolate in healthy adults. The information generated may help elucidate SBI's mechanism of action.

Detailed description: This study is evaluating the safety and absorption of serum-derived bovine immunoglobulin protein isolate (SBI) in healthy adults using 5, 10, and 20 g doses of SBI and placebo equivalents in a double blind crossover study and SBI affects over 14 days. Additionally, plasma amino acid response and IgG concentrations in both stool and plasma will be investigated.

Eligibility criteria: Inclusion Criteria:

* Body mass index of 18-32
* Medically normal with no significant abnormal findings at screening

Exclusion Criteria:

* Allergy or intolerance to beef
* Participated in another investigational study within 30 days
* Seropostive for HIV, hepatitis B surface antigen, hepatitis C virus

Primary outcomes:
measure: Concentration of Total Plasma Amino Acids
timeFrame: 0, 180 minutes following administration of the investigational product in crossover phase.
Secondary outcomes:
measure: Number of Participants With Quantifiable Bovine IgG Plasma Concentration
timeFrame: 0 and 90 minutes following investigational product dosing during crossover phase; and after 14 days of open label dosing
measure: Bovine IgG Concentration in Stool
timeFrame: 14 days after starting the open label phase
Other outcomes:
Locations:
city: Cary
country: United States
facility: PMG Research of Cary
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
Study officials:
affiliation: Entera Health
name: Eric Weaver, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01762605: Treatment of Distal Radius Buckle Fractures
Official title: Supportive Care Versus Casting for Distal Forearm Buckle Fractures in Children; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fracture Treatment
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 11
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study determines if patients with buckle fractures of the distal radius and/or ulna treated with supportive care only demonstrate non-inferior outcomes in regard to pain control during healing, functional outcome at the wrist joint, and parental satisfaction, when compared with patients treated with the standard treatment regimen of 3-4 weeks in a short arm cast.


Eligibility criteria: Inclusion Criteria:

Children age 1-17 with buckle fractures of the distal radius and/or ulna. -

Exclusion Criteria:

* Patients are excluded if there is any other injury to the upper limb or serious bodily trauma that might complicate pain scores. Children with suspected or proven metabolic bone disease, or pathologic fractures are excluded due to resultant abnormal bone healing.

Primary outcomes:
measure: Pain
timeFrame: 4-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Atrium Health Wake Forest Baptist
name: John Frino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01016405: Prospective Health Assessment of Cataract Patients' Ocular Surface
Official title: Cataract and Dry Eye The PHACO Study (Prospective Health Assessment of Cataract Patients' Ocular Surface)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Keywords: Dry eye
incidence and severity
cataract surgery
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2009-11-19
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic.

Brief summary: This study will determine the incidence and severity of dry eye in patients undergoing cataract surgery as determined by grade on the International Task Force (ITF) scale.


Eligibility criteria: Inclusion Criteria:

* Patients should be at least 55 years old.
* Patients must be scheduled to undergo cataract surgery.

Exclusion Criteria:

* No previous intraocular surgery in the previous 3 months in either eye.
* No previous Corneal laser vision correction in either eye within the last one year.
* No previous lid surgery within the past 3 months.
* Patients may not have used topical antibiotics, topical NSAIDs or topical steroid in either eye in the past month.
* Patients are not eligible if they have recently been started on Restasis solely as a perioperative treatment regimen.
* Patients presently using Restasis in either eye will not undergo any of the study testing but a questionnaire should be completed for these patients regarding use of these medications.

Primary outcomes:
measure: Incidence of dry eye as evaluated by grade on ITF (International Task Force) level.
timeFrame: One study visit
Secondary outcomes:
measure: TBUT (tear break-up time), OSDI (Ocular surface disease index), corneal staining with fluorescein, conjunctival staining with lissamine, Schirmer's, and a patient questionnaire. These are all standard operations of care.
timeFrame: One study visit
Other outcomes:
Locations:
city: Miami
country: United States
facility: The Center for Excellence in Eye Care
state: Florida
Study officials:
affiliation: The Center for Excellence in Eye Care
name: William Trattler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00544505: Pre-operative Chemotherapy in Operable Breast Cancer, Phase III Study Comparing a Short Intensive Pre-operative Chemotherapy With the Same Therapy Initiated Shortly After Surgery(Peri-operatively)(POCOB)EORTC 10902)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-10-16
Enrollment: 10
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pre-operative chemotherapy in operable breast cancer, phase III study comparing a short intensive pre-operative chemotherapy with the same therapy initiated shortly after surgery (peri-operatively) (POCOB) (EORTC 10902)


Eligibility criteria: Inclusion Criteria:

Disease Characteristics:

* Palpable, operable breast cancer that has been diagnosed by core needle biopsy (mandatory for T1c tumors) or fine needle aspiration within 21 days prior to entry
* Stage T1c-4b, N0-1, M0

Hormone receptor status:

* Not specified
* No bilateral breast cancer

Prior/Concurrent Therapy:

* No previous treatment for breast cancer

Biologic therapy:

* Not specified

Chemotherapy:

* No previous chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Core needle biopsy or fine needle aspiration within 21 days prior to entry
* Repeated core needle biopsy permitted

Patient Characteristics:

Age:

* 16 to 70

Sex:

* Women only

Menopausal status:

* Not specified

Performance status:

* WHO 0-2

Hematopoietic:

* WBC at least 4,000
* Platelets at least 100,000

Hepatic:

* Bilirubin no greater than 2.8 mg/dL (50 micromoles/L)

Renal:

* Creatinine no greater than 1.3 mg/dL (120 micromoles/L)

Cardiovascular:

* No congestive heart failure
* No significant arrhythmia
* No bilateral bundle branch block
* No recent myocardial infarction
* No uncontrolled hypertension (diastolic pressure greater than 110 mm Hg)

Other:

* No male breast cancer
* No pregnant or nursing women
* No second malignancy except adequately treated:

  * Nonmelanomatous skin cancer
  * Cervical cancer

Primary outcomes:
measure: Efficacy
timeFrame: overall
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia
name: Adnan Ezzat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03261505: Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain
Official title: Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Knee Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: fMRI
acupuncture
osteoarthritis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 125
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate brain response and connectivity changes evoked by video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in knee osteoarthritis patients to elucidate the underlying brain mechanisms of mind-body interaction, imagery, and acupuncture.


Eligibility criteria: Inclusion Criteria:

* Right-handed
* Knee osteoarthritis patients
* Ages 40 to 70 years old

Exclusion Criteria:

* Any contraindications to MRI scanning (claustrophobia, metal implants)
* Current or past history of major medical, neurological, or psychiatric illness other than knee osteoarthritis (including high blood pressure, heart disorders, impaired elimination, stomach problems, major kidney or liver problems, bleeding problems, severe dehydration, history of diabetes, history of asthma or other respiratory condition)
* Pregnancy
* Non fluent English speaker

Primary outcomes:
measure: fMRI signal increases
timeFrame: 4 days; Sessions 2-5
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Athinoula A. Martinos Center for Biomedical Imaging
state: Massachusetts
Study officials:
References:
Clinical trial NCT04231305: Antithrombotics and Complications in Skin Grafts
Official title: Complications in Skin Grafts When Continuing Antithrombotic Therapy Prior to Cutaneous Surgery Requiring Skin Grafting: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Graft Complications
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 172 patients (92 males and 80 females) having 187 skin grafts were included. Avarage size of the skin grafts were 1278 mm2 ranging from 52mm2 to 14283mm2. Skin grafts where the patients received no or paused antithrombotic treatment were 90 while 97 skin grafts belonged to patients in antithrombotic treatment

Brief summary: Patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked

Detailed description: Use of anticoagulants is common and practice regarding continuation or discontinuation of the medication peri-operatively for cutaneous surgery lacks evidence-based consensus. Therefore, patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked

Eligibility criteria: Inclusion Criteria:

Patients referred to cutanous surgery with full thickness or split skin grafting. The excision should be performed on the levels of subcutis or perichondrium -

Exclusion Criteria:

Patients having a pacemaker, needed skin graft on bare bone and patients with an INR above 3.5

-

Primary outcomes:
measure: Postoperative bleeding
timeFrame: 5-7 postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Lene Birk-Sørensen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02858505: Impact of One Versus Two Amino Acid Chelated Iron Capsules on Prevention of Iron Deficiency Anemia in Non-anemic Women With Twin Gestations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anaemia is the most worldwide health problem affecting pregnant women in both developed and developing countries. During pregnancy there is an inconsistent increase in plasma volume and haemoglobin mass.

Iron deficiency anemia is the commonest type of anemia during pregnancy. The pregnant woman needs about 1000 mg of iron during pregnancy.

Diet alone cannot give pregnant woman the daily required amount of the iron (about 27 mg/day) so the Centers for Disease Control and Prevention recommend that pregnant women take a daily supplement of 30 mg of elemental iron as a preventive dose. As most women begin their pregnancy with low iron stores, particularly in the second and third trimesters, so prevention should start as soon as possible even before pregnancy to prevent depletion of iron store and further Iron deficiency anemia.

Oral iron is a cheap, effective and relatively safe line to prevent Iron deficiency anemia during pregnancy. The common available ferrous salts include ferrous fumarate, ferrous sulphate and ferrous gluconate. Unfortunately; these iron forms are associated usually with constipation, darkened stools, diarrhea, loss of appetite, nausea, stomach cramps, and vomiting.

Iron amino acid chelates have been emerged to be used as agents for prevention and treatment of Iron deficiency anemia. These agents provide maximum bioavailability and maximum efficacy with minimal unpleasant side effects.

Twin pregnancies have a significant role in perinatal morbidity due to increased risks of low birth weight and preterm birth. The iron requirement for twin pregnancy is probable double fold that of a singleton pregnancy and maternal hemoglobin in twin gestations is usually lower than in singleton pregnancy resulting in higher rate of Iron deficiency anemia.


Eligibility criteria: Inclusion Criteria:

* twin gestations
* ±12 weeks)
* normal hemoglobin level (Hb ≥ 120 g/L).
* women were living in nearby area to make up follow up quit possible
* willing to participate in our study

Exclusion Criteria:

* a recent blood transfusion
* threatened miscarriage
* pathological blood loss
* vegetarian diet
* intolerant to oral iron form
* history of haematologic disorder
* chronic diseases
* unwillingness to co-operate.

Primary outcomes:
measure: Hemoglobin level
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT00262405: Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis
Official title: Phase II Trial of Zileuton Compared to Azathioprine/Prednisone for the Treatment of Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-12-06
Enrollment: 44
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open label trial of zileuton compared to azathioprine/prednisone for patients with idiopathic pulmonary fibrosis. Study subjects will undergo a detailed clinical, radiographic, and physiologic assessment at baseline. Subjects will be monitored off treatment for three months for changes in symptoms and physiology. Subjects will then be randomized to six months of treatment with zileuton or azathioprine/prednisone. The primary endpoint of this trial is change in LTB4 levels in bronchoalveolar lavage fluid following six months of treatment. Secondary endpoints are progression free survival, change in dyspnea, change in quality of life, and change in physiology.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic pulmonary fibrosis
* Taking \< 15 mg prednisone for at least 30 days prior to screening
* Age 35-80, inclusive
* Able to understand a written informed consent and comply with the study protocol

Exclusion Criteria:

* Significant environmental exposure
* Diagnosis of collagen vascular disease
* Evidence of active infection
* Clinically significant cardiac disease Myocardial infarction, coronary artery bypass or angioplasty within 6mo Unstable angina pectoris Congestive heart failure requiring hospitalization within 6 months Uncontrolled arrhythmia
* Poorly controlled or severe diabetes mellitus
* Pregnancy or lactation
* Women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm, Norplant)
* Current enrollment in another experimental protocol

Physiologic Criteria:

* FEV1/FVC \< 0.60

Laboratory Criteria:

* Total bilirubin \> 1.5 X upper limit normal
* AST or ALT \> 3X upper limit normal
* Alkaline phosphatase \> 3X upper limit normal
* White blood cell count \< 2,500/mm3
* Hematocrit \< 30%
* Platelets \< 100,000/mm3
* Prothrombin time INR \> 1.5

Primary outcomes:
measure: LTB4 level in BAL
timeFrame: 6 months
Secondary outcomes:
measure: CRP score
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Galen B Toews, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01546805: Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm
Official title: The Effect of Zinc Supplementation on the Efficacy and Duration of Botulinum Toxin for the Treatment of Oculofacial Spasm Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blepharospasm
Hemifacial Spasm
Keywords: Blepharospasm
Hemifacial spasm
Botox
Zinc
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 40
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: The purpose of this study is to determine whether zinc supplements are effective in enhancing the treatment of oculofacial spasm disorders with botulinum toxin.

Detailed description: Botulinum Toxin (Botox) has been used for many years in the treatment of oculofacial dystonias such as blepharospasm and hemifacial spasm. It has also gained widespread use for cosmetic purposes. The efficacy and duration of its effect is not constant amongst all patients. Some patient respond very well, while others have no clinical benefit or the clinical benefit does not last as long as expected. Zinc is known to be an important co-factor in the molecular effects of Botox. The investigators hypothesize that one of the many factors that may contribute to the variability in the response to Botox may be the level of Zinc available within the neuromuscular junction of those patients. The investigators plan to to test whether or not giving patients supplemental Zinc with their Botox injections would help improve the magnitude and duration of the intended clinical effect.

Eligibility criteria: Inclusion Criteria:

* greater than the age 18 years old
* patient with hemifacial spasm
* patient with benign essential blepharospasm.

Exclusion Criteria:

* patients who have received Botox within 3 months time,
* patients prone to malabsorption (i.e. those with Celiac disease, inflammatory bowel disease, liver disease, laxative use)
* patients who cannot tolerate zinc supplementation due to kidney disease, gastrointestinal disease, or any other medical condition.

Primary outcomes:
measure: Jankovic Rating Scale
timeFrame: 3 months post Botox injection
Secondary outcomes:
measure: Treatment Duration Cycle
timeFrame: The time frame will vary with each patient. The time frame is in fact the outcome measure being measured. On average the Botox treatment cycles last 3 months, however this average may be affected by zinc supplements.
measure: Blepharospasm Disability Index (BDI)
timeFrame: 3 months post Botox injection
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St Joseph's Hospital Hamilton
state: Ontario
city: Mississauga
country: Canada
facility: Carrot Eye Centre
state: Ontario
Study officials:
affiliation: St Joseph's Hospital Hamilton
name: John Harvey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Yasser Khan, MD
role: PRINCIPAL_INVESTIGATOR
References: