louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04919278: Ciropractic Care and Pregnant Women
Official title: The Effects of Chiropractic on Quality of Life, Sleep and Pain in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Back
Pregnancy Related
Sleep
Quality of Life
Keywords: Chiropractic
Lead sponsor: Barcelona College of Chiropractic
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The aim of this study is to investigate the effectiveness of Chiropractic care on pain, quality of life and sleep in pregnant women compared to a control group.

The study is designed as non-randomized controlled trial. Forty-two pregnant women at least on the 14th week of gestation will be included. Control group will include women receiving regular care, but no chiropractic care. Care will extend for 4 weeks.

Outcomes measures include sleep quality, pain and quality of life questionnaires.


Eligibility criteria: Inclusion Criteria:

* pregnant women over the age of 18
* of at least 14 weeks gestation,
* with a good understanding of English, Spanish or French.

Exclusion Criteria:

* women over the age of 45,
* pregnancies of more than 35 weeks gestation
* high-risk pregnancies (tobacco, alcohol or substance use, diagnosed medical conditions or high blood pressure).

Primary outcomes:
measure: SF-36 questionnaire Quality of Life
timeFrame: 4 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 weeks
measure: Numeric pain rating scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Barcelona College of Chiropractic
Study officials:
References:
Clinical trial NCT06758271: Special Drug Use-results Survey for Long-term Use（Avacopan）
Official title: Special Drug Use-results Survey for Long-term Use
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Microscopic Polyangiitis (MPA)
Granulomatosis With Polyangiitis (GPA)
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-03
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with granulomatosis with polyangiitis or microscopic polyangiitis who are treatment with avacopan

Brief summary: The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.

Detailed description: The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.

Eligibility criteria: Inclusion Criteria:

* Patients with granulomatosis with polyangiitis or microscopic polyangiitis who are treatment with avacopan

Primary outcomes:
measure: Adverse events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Research site
Study officials:
References:
Clinical trial NCT00909571: Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus
Official title: A Phase 3 Pilot Study to Describe the Pharmacokinetics of Tacrolimus in Patients Undergoing Primary Liver Donor Liver Transplantation Treated With Prograf Injection and Modified Release Tacrolimus Based Immunosuppressive Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Transplantation
Keywords: FK506E
MR4
Prograf
Tacrolimus
Living Liver Transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2009-05-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.

Detailed description: To describe the pharmacokinetics of Tacrolimus when administered as two different doses of modified release formulation FK506E(MR4) combined with Prograf injection in patients undergoing primary living donor liver transplantation based on the single center (Asan Medical Center) standard protocol regimen.

Eligibility criteria: Inclusion Criteria:

* Patients receiving a primary partial liver graft from a living donor
* Patients must receive the first dose of Tacrolimus after surgery and are expected to be maintained on Tacrolimus throughout the study

Exclusion Criteria:

* Patients receiving a multi-organ transplantation or having previously received an organ transplantation
* Patients receiving an auxiliary graft or in whom a bio-artificial liver has been used
* Patients allergic or intolerant to macrolide antibodies or Tacrolimus

Primary outcomes:
measure: Assessment of pharmacokinetic parameters
timeFrame: Day 6 and Day 14
Secondary outcomes:
measure: Incidence of acute rejection
timeFrame: within 12 weeks
measure: Time to acute rejection
timeFrame: within 12 weeks
measure: Assessment of graft survival
timeFrame: within 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Korea, Inc.
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT06486571: Strategies to Control Robotic Hand Prosthesis Via HD-sEMG and to Restore Sensory Feedback Via TENS
Official title: Development of Innovative Strategies for the Control of Robotic Hand Prostheses Based on High-density Electromyography and Restitution of Sensory Feedback Via Trans-cutaneous Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Limb Amputees
Keywords: Upper limb amputation
HD-sEMG
Pattern recognition
Sensory feedback
TENS
Lead sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Upper limb amputation still causes severe disability today; prostheses currently on the market are able to restore partially to the amputee the lost functionality. In addition to the motor capacity of the limb, prosthetic systems should also aim to restore to the sensory information from the surrounding environment during contact with objects. Therefore, it is important to develop bidirectional prostheses. It is thus apparent that the development of new techniques for decoding the efferent channel, such as high-density surface electromyography, and for encoding of the afferent channel afferent, to return multimodal somatosensory sensations of mechanoception, nociception, and thermoception using TENS, isimportant to improve the patient's use of the prosthesis.


Eligibility criteria: Inclusion Criteria:

* Upper limb amputation;
* Stable clinical condition;
* Skin integrity of the stump;
* Age between 18 and 65 years;
* High level of motivation to participate in the study and acceptance of the purpose of the study;
* Signed informed consent document.

Exclusion Criteria:

* Clinical instability;
* Dehiscence of the amputation wound;
* Failure to complete the informed consent;
* State of pregnancy;
* Implanted devices that can interfere with TENS stimulation (e.g. pacemakers);

Primary outcomes:
measure: Improve gestures decoding by means of HD-sEMG decoding algorithms
timeFrame: through study completion, an average of 2 year through study completion, an average of 2 year
measure: Elicit somatic sensations in amputees
timeFrame: through study completion, an average of 2 year through study completion, an average of 2 year
Secondary outcomes:
measure: Increase the number of hand grasps to be classfiied
timeFrame: through study completion, an average of 2 year through study completion, an average of 2 year
measure: Development of encoding strategies
timeFrame: through study completion, an average of 2 year through study completion, an average of 2 year
Other outcomes:
Locations:
city: Budrio
country: Italy
facility: Centro Protesi Inail
state: BO
Study officials:
References:
Clinical trial NCT02143271: Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
Official title: A Single-dose Phase 1 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Secondary Hyperparathyroidism
Keywords: Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Stable chronic renal disease patients receiving peritoneal dialysis for at least 16 weeks prior to the screening
* intact parathyroid hormone value ≥ 240 pg/mL at the screening
* Corrected serum calcium ≥ 8.4 mg/dL at the screening

Exclusion Criteria:

* Patients with primary hyperparathyroidism
* Patients who received cinacalcet within 2 weeks prior to the screening
* Patients who began to take or changed the dose/dosing regimen of active vitamin D/its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
* Patients who underwent parathyroidectomy and/or parathyroid intervention
* Patients with uncontrolled hypertension and/or diabetes
* Patients with severe heart disorder
* Patients with severe hepatic disease
* Patients who take investigational drug in another clinical trial within 12 weeks prior to the screening
* Patients who have been judged ineligible to participate in the study by the investigator

Primary outcomes:
measure: Number and types of adverse events
timeFrame: For 8 days
Secondary outcomes:
measure: Profiles of pharmacokinetics
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 and 168 hours post-dose
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Kyowa Hakko Kirin
Study officials:
References:
Clinical trial NCT00641771: 4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter 4-Week Study to Assess the Effect of Alendronate 70 mg and Vitamin D3 2800 IU Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 56
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis

Detailed description: Placebo will be administered over a 4 week, single-blind run-in phase. Calcium, as citrate-malate, will be administered throughout the study at an individualized dose supplementing the patient's daily dietary calcium intake to a total of approximately 1200 mg. At the end of the stabilization period, baseline calcium absorption will be determined and patients will be randomized to receive either MK0217A, or matching placebo once weekly for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* The patient is a postmenopausal osteoporotic female
* The patient is willing to limit direct sunlight exposure during the course of the study
* The patient must be ambulatory
* The patient has serum 25-hydroxyvitamin D =25 ng/mL

Exclusion Criteria:

* The patient is contraindicated to bisphosphonate therapy
* The patient has a vitamin D deficiency
* Patient will be excluded if their weight is above 85 kg
* The patient has a history of prior osteoporotic fracture
* The patient is currently or has received in the past treatment with effects on bone or calcium metabolism
* The patient has malabsorption syndrome
* The patient has active thyroid disease
* The patient has metabolic bone disease
* The patient had a myocardial infarction within 6 months of screening visit
* The patient has impaired renal function
* The patient is currently or has been a smoker in the last year

Primary outcomes:
measure: To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Shapses SA, Kendler DL, Robson R, Hansen KE, Sherrell RM, Field MP, Woolf E, Berd Y, Mantz AM, Santora AC 2nd. Effect of alendronate and vitamin D(3) on fractional calcium absorption in a double-blind, randomized, placebo-controlled trial in postmenopausal osteoporotic women. J Bone Miner Res. 2011 Aug;26(8):1836-44. doi: 10.1002/jbmr.395.
Clinical trial NCT01573871: Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula
Official title: Tolerance and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infant
Gastrointestinal Intolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 25
Sex: ALL
Maximum age (years): 180
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.


Eligibility criteria: Inclusion Criteria:

* Infant is 0 to 180 days of age
* Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate
* Infant has not consumed an extensively hydrolyzed infant formula
* Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted
* Infant is not receiving steroids.
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
* Parent(s) confirm their intention not to administer solid foods or juices to their infant through the duration of the study.
* Parent(s) confirm their intention not to administer vitamin or mineral during the study

Exclusion Criteria:

• Participation in another study

Primary outcomes:
measure: Weight maintenance
timeFrame: 14 days
Secondary outcomes:
measure: Formula volume intake
timeFrame: 14 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Northpoint Pediatrics
state: Indiana
city: Cleveland
country: United States
facility: Metro-Health Medical Center
state: Ohio
city: Huber Heights
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Marlene Borschel, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00130871: Levosimendan Pretreatment for Weaning Patients From Cardio-Pulmonary Bypass
Official title: Impact of Levosimendan Pretreatment on Weaning From Cardiopulmonary Bypass (CPB) in Patients With Diminished Left Ventricular Function Before Coronary Artery Bypass Grafting (CABG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Heart Disease
Keywords: levosimendan
weaning
cardio-pulmonary bypass
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2005-08-16
Enrollment: 60
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 study evaluates the efficacy of intravenous levosimendan treatment started during a coronary artery bypass operation to wean patients from a heart lung machine.

Detailed description: Levosimendan or placebo infusion is started at the time of induction of anesthesia.

Eligibility criteria: Inclusion Criteria:

* Three vessel coronary artery disease.
* Indication for on-pump coronary artery bypass surgery.
* Ejection fraction below 50%

Exclusion Criteria:

* Indication for any cardiac valve surgery
* Previous coronary artery bypass surgery

Primary outcomes:
measure: Proportion of successful primary weanings
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Turku
country: Finland
facility: Turku University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital, Finland
name: Markku Salmenperä, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00970671: Treatment of Surgical Scars Using the Pulsed Dye Laser
Official title: Treatment of Surgical Scars With the 595nm Pulsed Dye Laser Using Purpuric and Nonpurpuric Parameters: A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Laser Therapy
Keywords: scar
laser therapy
lasers, pulsed dye
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether treatment of fresh surgical scars with a pulsed dye laser using purpura-inducing settings will improve clinical appearance better than one using non-purpura-inducing settings or no treatment.


Eligibility criteria: Inclusion Criteria:

* Patients requiring Mohs micrographic surgery or excisions for skin cancer or atypical nevi, with an expected post-excision scar of 4.5cm in length or more.
* Willing to participate.
* Able to give informed consent

Exclusion Criteria:

* Location of excision or Mohs surgery on the genitals, hands, or feet.
* Fitzpatrick skin type V or VI.
* Prior history of known light sensitivity.

Primary outcomes:
measure: Vancouver Scar Scale score
timeFrame: 6weeks, 10weeks, and 18weeks after surgery
Secondary outcomes:
measure: Subjective rating of pain on scale of 0 to 10
timeFrame: at each treatment visit: 2weeks, 6weeks, and 10weeks after surgery
measure: Cosmetic appearance of scar
timeFrame: 6weeks, 10 weeks, and 18weeks after surgery
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Perlman Ambulatory Center - Dermatology clinic
state: California
Study officials:
affiliation: University of California, San Diego
name: Julie A Gladsjo, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: S. Brian Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05455671: Real-Time Assessment of Lung Structure and Function in Children and Young Adults With CF Using Electrical Impedance Tomography
Official title: Real-Time Assessment of Lung Structure and Function in Children and Young Adults With CF Using Electrical Impedance Tomography
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cystic Fibrosis
Healthy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 110
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and young adults between 3 and 21 years old, with or without cystic fibrosis

Brief summary: The purpose of this study is to determine the ability of electrical impedance tomography (EIT) to identify structural and functional physiological changes that occur with disease progression in cystic fibrosis patients. The investigators also aim to determine whether EIT can serve as an alternative for CT to identify regions of air trapping and consolidation, whether EIT can provide clinically useful information about response to treatment for an acute PE, and whether EIT can provide longitudinal information about structural changes in the lung.


Eligibility criteria: Inclusion Criteria:

Cohort 1:

* Age 3-21 years
* Male or female
* Healthy subjects with no known or suspected chronic or temporary lung disease

Cohort 2:

* Age 3-21 years
* Male or female
* CF as diagnosed based on sweat chloride value(\>60 mmol/L) or two known disease causing mutations

Cohort 3:

* Age 3-21 years
* Male or female
* CF as diagnosed based on sweat chloride value (\>60 mmol/L) or two known disease causing mutations
* Experiencing a protocol defined pulmonary exacerbation and being started on oral or intravenous antibiotics

Exclusion Criteria:

* Unwilling/refusal to sign consent
* Known congenital heart disease, arrhythmia, or history of heart failure
* Wearing a pacemaker or a metallic surgical implant in the chest
* History of infection with Burkholderia cepacia
* Developmental delays that could result in an inability to complete study procedures

Primary outcomes:
measure: Identification of air trapping and consolidation by EIT
timeFrame: 36 months
Secondary outcomes:
measure: Determining utility of EIT information in response to treatment for a pulmonary exacerbation
timeFrame: 36 months
measure: Determination of structural changes in the lung by EIT
timeFrame: 36 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Jordana Jordana, MD
role: PRINCIPAL_INVESTIGATOR
References: