louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00815906: Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis
Official title: An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthritis, Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Emergent Product Development Seattle LLC
First posted: 2008-12-31
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
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 tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Must meet American College of Rheumatology criteria for rheumatoid arthritis with functional class I to III.
* Rheumatoid arthritis disease onset at \>16 years of age and duration of disease at least 6 months.
* Men or women of nonchildbearing potential (WONCBP), aged 20 to 70 years, inclusive at the screening visit.

Exclusion Criteria:

* Any significant health problems other than rheumatoid arthritis.
* Treatment of greater than 10 mg of prednisone per day.
* Therapy with immunosuppressants within 6 months before study day 1

Primary outcomes:
measure: Safety and tolerability as determined by the number and severity of adverse events at the different dose levels
timeFrame: 12 months
Secondary outcomes:
measure: To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA
timeFrame: 12 months
measure: To evaluate the effect of a pretreatment regimen on the occurrence of systemic reactions following SC administration of 100 mg or 200 mg SBI-087
timeFrame: 12 month
measure: To investigate if changes in biomarkers (eg, complement activation markers, B-cells, CRP, IgE and tryptase levels) are related to the occurrence of systemic reactions on the day of infusion or injection of SBI-087
timeFrame: 12 month
Other outcomes:
Locations:
city: Ehime
country: Japan
facility: Pfizer Investigational Site
city: Fukui
country: Japan
facility: Pfizer Investigational Site
city: Kanagawa
country: Japan
facility: Pfizer Investigational Site
city: Miyagi
country: Japan
facility: Pfizer Investigational Site
city: Oita
country: Japan
facility: Pfizer Investigational Site
city: Shizuoka
country: Japan
facility: Pfizer Investigational Site
city: Tokyo
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02711306: Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome
Official title: Office of Human Research, Taipei Medical University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Metabolic syndrome (MS) is a complex disease with a cluster of risk factors and clinical features, which includes central or abdominal obesity, atherogenic dyslipidemia, impaired glucose regulation, hyperinsulinemia, high blood pressure, and concomitance of pro-inflammatory cytokine and insulin resistance. Glucomannan (GM) is a water-soluble dietary fiber derived from the root of Amorphophallus konjac that can improve blood sugar, blood fat concentration, and weight management, and has other health benefits.The purposes of this study are going to investigate the effects of KGM noodle (KGN) as stable food to MS and diabetic patients.

Detailed description: The KGN diet was composed of well-cooked noodle with 2 g of KGM in a dosage of 200 g/piece twice daily to substitute the daily carbohydrate for 4 weeks, with a 2-week washout period between alternative diets. All 33 subjects received two servings of either GMNs or PNs (400 g) per day, which replaced the main carbohydrate in two daily meals for 4 weeks. After a 2-week washout period, the subjects received the other type of noodle for 4 weeks. The body weight, BMI, waist circumference, fasting blood glucose and lipid profile, as well as serum vitamin A, E, β-carotene and high sensitivity C-reactive protein (hs-CPR) were measured by HPCL.

Eligibility criteria: Inclusion Criteria: Adults with metabolic syndrome

Subjects were considered to have metabolic syndrome if subjects had 3 of the following 5 characteristics:

1. Abdominal obesity (waist circumference \>= 90 cm in men and \>= 80 cm in women)
2. Impaired fasting glucose ( \>= 5.6 mmol/L)
3. Hypertriglyceridemia ( \>= 1.7 mmol/L)
4. Low HDL-C (\< 1.0 mmol/L in men and \< 1.3 mmol/L in women)
5. Increased blood pressure (SBP \>= 130 mmHg and DBP \>= 85 mmHg).

Exclusion Criteria:

1. Liver and renal diseases
2. Undergoing statin therapy
3. Pregnancy women
4. Taking antioxidant vitamins supplements

Primary outcomes:
measure: Body Weight
timeFrame: 4 weeks
Secondary outcomes:
measure: Waist Circumference
timeFrame: 4 weeks
measure: Glycemic Index
timeFrame: 4 weeks
measure: Lipid Index
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Office of Human Research, Taipei Medical University
name: Chih-Han Lin, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sood N, Baker WL, Coleman CI. Effect of glucomannan on plasma lipid and glucose concentrations, body weight, and blood pressure: systematic review and meta-analysis. Am J Clin Nutr. 2008 Oct;88(4):1167-75. doi: 10.1093/ajcn/88.4.1167.
Clinical trial NCT03802006: Ultrasound Assessment of Gastric Contents in Fasted Surgical Patients With Previous Subtotal Gastrectomy
Official title: Ultrasound Assessment of Gastric Contents in Fasted Surgical Patients With Previous Subtotal Gastrectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroparesis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will conduct a study targeting the patients with previous subtotal gastectomy among the patients fasted for an operation under general, spinal or MAC anesthesia, except people with other anatomical abnormality or mass of stomach except gastrectomy

Brief summary: Investigators assess the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy.

Detailed description: Investigators evaluate the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy, quantitatively and qualitatively. The frequency of visualization fully will be also analyzed.

Eligibility criteria: Inclusion Criteria:

* The preoperative fasted patients with previous subtotal gastrectomy

Exclusion Criteria:

* Other anatomical abnormality or mass of stomach except gastrectomy

Primary outcomes:
measure: Incidence of full cross section image
timeFrame: Before the induction of anesthesia
Secondary outcomes:
measure: Type of gastric content assessed by gastric ultrasound
timeFrame: Before the induction of anesthesia
measure: Cross section area of stomach body assessed by gastric ultrasound
timeFrame: Before the induction of anesthesia
measure: Incidence of full stomach
timeFrame: Before the induction of anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Tea Kyong Kim, M.D.,Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04745806: Post Marketing Trial for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard To Heal Wounds
Official title: A Prospective, Single Arm, Post Marketing Study for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard to Heal Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wounds
Keywords: Chronic
Ulcer
Lower extremity
DFU
VLU
Lead sponsor: RedDress Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-09
Enrollment: 6
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 study is a prospective, single arm, post- marketing study. The subjects enrolled to the study will receive weekly applications of ActiGraft until complete healing or until investigator's decision that patient can no longer benefit from the study treatment.


Eligibility criteria: Inclusion Criteria:

1. Subject is ≥18 years of age
2. Patient with a chronic lower extremity ulcer (i.e DFU, VLU, ...)
3. Ulcer duration \>30 days.
4. Ulcer size decreased in less than 30% in the 14 days prior to enrollment, while treated with standard of care (or advanced treatment)
5. Subject must be willing to comply with the protocol including having blood drawn to create the ActiGraft
6. Subject can read and understand the Informed Consent form

Exclusion Criteria:

1. Presence of active underlying osteomyelitis.
2. Known malignancy in the reference wound bed or margins of the wound
3. Cannot withdraw blood in the required amount technically.
4. Subject is receiving (i.e., within the past 30 days) systemic steroids (more than 10mg per day)
5. Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (within the past 30 days).
6. Subject has been treated with hyperbaric oxygen, wound VAC or Ozone gas(O3) within the past 5 days or is scheduled to receive during the study

Primary outcomes:
measure: Percent of Reduction in Wound Size Over 12 Weeks
timeFrame: 4, 8, and 12 weeks
Secondary outcomes:
measure: Number of Participants Achieving a Complete Wound Closure at 12 Weeks
timeFrame: 12 weeks
measure: Number of Participants Achieving a Complete re-epithelialization at 18 and 24 Weeks
timeFrame: 18 and 24 weeks
measure: Percent of Reduction in Wound Size Over 18 and 24 Weeks.
timeFrame: 18 and 24 weeks
measure: The change in wound pain by 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
Study officials:
affiliation: RedDress Ltd.
name: Sharon Sirota
role: STUDY_DIRECTOR
References:
Clinical trial NCT00007306: Treatment of Psoriasis With Parathyroid Hormone
Official title: Evaluation of the Therapeutic Efficacy & Safety of Topical Administration of Parathyroid Hormone (PTH) in Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Plaque Psoriasis
Keywords: Parathyroid hormone
Psoriasis
Lesions
Topical medications
Ointment
Calcium metabolism
Skin biopsy
Lead sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sponsor class: NIH
First posted: 2000-12-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a clinical study in two phases. The first phase compares the effect of an ointment containing parathyroid hormone (PTH) with the effect of a placebo ointment (inactive ointment without PTH) on psoriasis lesions. Neither the study participants nor the researchers will know who is receiving PTH ointment and who is receiving placebo until the end of this first study phase. The second phase is a study of the PTH ointment on large areas of psoriasis to find out how long the effects last.

Detailed description: Patients with active plaque psoriasis will be withdrawn from systemic and topical medications. After washout, we will select active psoriatic lesions of at least 25 square cm in size to receive either placebo ointment or a proprietary ointment containing PTH for 8 weeks. We will see the patients every 2 weeks. We will evaluate the lesions by examination and digital photography at each visit and measure parameters of calcium metabolism periodically during the 8 weeks.

At the conclusion of the 8 weeks, we will obtain punch biopsies from the treated lesions and from one lesion without treatment. If the patients elect, we will transition them into an open label trial with the PTH ointment including up to 1000 square cm of psoriatic lesions and monitor them for duration of effect and changes in parameters of calcium metabolism.

Eligibility criteria: Inclusion Criteria:

* Active plaque psoriasis at least 10 percent BSA (body surface area)
* Age 18-70

Exclusion Criteria:

* Abnormalities of calcium metabolism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
name: Michael Holick, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holick MF, Chimeh FN, Ray S. Topical PTH (1-34) is a novel, safe and effective treatment for psoriasis: a randomized self-controlled trial and an open trial. Br J Dermatol. 2003 Aug;149(2):370-6. doi: 10.1046/j.1365-2133.2003.05437.x.
Clinical trial NCT01533506: Stiripentol in Dravet Syndrome
Official title: Compassionate Use of Stiripentol in Intractable Epilepsy Due to Dravet Syndrome
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Dravet Syndrome
Keywords: treatment with stiripentol
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-02-15
Sex: FEMALE
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The patient has failed all other available agents and has intractable epilepsy due to Dravet Syndrome. Stiripentol is highly efficacious in Dravet Syndrome. The overall goals of therapy with Stiripentol are primarily to significantly reduce the frequency and severity of seizures.


Eligibility criteria: Inclusion Criteria:

* Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Elaine Wirrell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03279406: REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion
Official title: REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion for Patients With Atrial Fibrillation in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Stroke
Thrombus
Left atrial appendage
Bleeding
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with percutaneous Left Atrial Appendage Occlusion among those referred to one of the French centers involved in this database

Brief summary: The objective of this observational non-randomized multicenter study is to compile real-world clinical characteristics and outcomes data for patients treated with LAA (left atrial appendage) closure systems in a daily clinical setting.


Eligibility criteria: Inclusion Criteria:

* Patients who are eligible for a LAA occlusion device and treated with a commercially available device according to international and local guidelines and per physician discretion.

Exclusion Criteria:

* None

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: From date of inclusion until the date of first documented event, whichever came first, assessed up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Tours
name: Laurent Fauchier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fauchier L, Cinaud A, Brigadeau F, Lepillier A, Pierre B, Abbey S, Fatemi M, Franceschi F, Guedeney P, Jacon P, Paziaud O, Venier S, Deharo JC, Gras D, Klug D, Mansourati J, Montalescot G, Piot O, Defaye P. Device-Related Thrombosis After Percutaneous Left Atrial Appendage Occlusion for Atrial Fibrillation. J Am Coll Cardiol. 2018 Apr 10;71(14):1528-1536. doi: 10.1016/j.jacc.2018.01.076.
Clinical trial NCT05118906: Pilot Study on BP1.4979 Effect on Binge Eating Disorders
Official title: A Double-blind, Placebo-controlled Pilot Trial of BP1.4979 for the Treatment of Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Binge-Eating Disorder
Lead sponsor: Bioprojet
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study is to assess the efficacy and safety of BP1.4979 15 mg BID in female patients with moderate to severe binge eating disorder (BED), as defined according to DSM-5 guidelines.

Detailed description: First clinical study to assess the effect of the BP1.4979 on BED in female patients over an 8 week-tretament period.

Eligibility criteria: Inclusion Criteria:

* Patient must voluntarily express a willingness to participate in this study, sign and date an informed consent prior to beginning any protocol required procedures.
* Female aged between 18 and 65 years, inclusive.
* Diagnosis of BED according to DSM-5 criteria
* BMI \< 50 kg/m2.

Exclusion Criteria:

* Current diagnosis of bulimia nervosa or anorexia nervosa.
* History of bariatric surgery.
* Patient who is pregnant, lactating, or of childbearing potential who is not using adequate contraceptive measures. The following are considered adequate methods of birth control: 1. intrauterine device (IUD); 2. barrier protection; 3. contraceptive implantation system; 4. oral contraceptive pills; 5. surgically sterile patient; and 6. abstinence. All participants should have a negative pregnancy test prior to randomization
* Ongoing alcohol or tobacco addiction treatment (except Nicotine Replacement Therapy \[NRT\] with at least one-month stable dose prior to screening visit).

Primary outcomes:
measure: Binge Eating episodes per week
timeFrame: 8 weeks
Secondary outcomes:
measure: Binge Eating days per week
timeFrame: 8 weeks
measure: Quality of Life improvement (CGI-I)
timeFrame: 8 weeks
Other outcomes:
measure: Safety assessed by AEs collection
timeFrame: 8 weeks
Locations:
city: Paris
country: France
facility: Nutrition Department, La Pitié Salpêtrière Hospital
Study officials:
affiliation: Nutrition Department, La Pitié Salpêtrière Hospital, Paris
name: Karine Clément, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00318006: Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms
Official title: A Randomized Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Rhinosinusitis
Keywords: chronic
nasal
sinus
symptoms
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: NeilMed Pharmaceuticals
First posted: 2006-04-25
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will compare nasal saline irrigation with nasal saline spray for the treatment of chronic nasal and sinus symptoms. Participants will complete a questionnaire regarding their nasal and sinus symptoms and will be randomly assigned to one of the treatment groups. Each participant will be instructed on how to perform daily nasal treatment.The subjects will complete follow-up surveys at regular intervals to assess any change in their nasal symptoms after starting nasal saline treatment. Participants may take their usual medications for sinus symptoms during their participation in the study.

Detailed description: See publication: Arch OtolaryngolHeadNeckSurg. 2007;133(11):1115-1120

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Presence of any one of the following symptoms for \> 4 days/week and \> 15 days in the past 1 month:

  * Nasal stuffiness
  * Nasal congestion
  * Nasal dryness or crusting
  * Abnormal nasal discharge
  * Thick nasal discharge

Exclusion Criteria:

* Functional endoscopic sinus surgery (FESS) in the last 3 months
* Epistaxis in the last 3 months that required treatment
* Acute illness like otitis media, laryngitis, pharyngitis, or rhinitis in the last 2 weeks
* Acute attack of asthma or bronchitis in the last 2 weeks
* Inability to speak or read English
* Current use of any of the study medications regularly for more than a week in the last 1 month
* Any history of intolerance to saline treatment (if used)

Primary outcomes:
measure: Change in the mean score of the sinonasal outcome test-20
measure: Change in medication usage for nasal and sinus symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Melissa A Pynnonen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pynnonen MA, Mukerji SS, Kim HM, Adams ME, Terrell JE. Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. Arch Otolaryngol Head Neck Surg. 2007 Nov;133(11):1115-20. doi: 10.1001/archotol.133.11.1115.