louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02416167: Study of FYU-981 in Hyperuricemia With or Without Gout
Official title: Confirmatory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIb) Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperuricemia
Lead sponsor: Fuji Yakuhin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-04-14
Enrollment: 200
Sex: ALL
Minimum age (years): 20
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 confirmatory investigation of safety and efficacy (dose response and optimal dose according to the percent reduction from baseline in serum urate level at the final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout for 12 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 8 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.


Eligibility criteria: Inclusion Criteria:

* Hyperuricemic or gout patients
* Serum urate level:

\>= 7.0mg/dL in patients with history of gout, or \>= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dL

Exclusion Criteria:

* Gouty arthritis within two weeks before start of study treatment
* Secondary hyperuricemia
* HbA1c: \>= 8.4%
* Uric acid-overproduction type in the classification of hyperuricemia
* History of, clinically significant cardiac, hematologic and hepatic disease
* Kidney calculi or clinically significant urinary calculi
* eGFR: \< 30mL/min/1.73m\^2
* Systolic blood pressure: \>= 180 mmHg
* Diastolic blood pressure: \>= 110 mmHg

Primary outcomes:
measure: Percent reduction from baseline in serum urate level at the final visit
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo and Other Japanese City
country: Japan
facility: Japan
Study officials:
References:
citation: Hosoya T, Sano T, Sasaki T, Fushimi M, Ohashi T. Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: randomized, multicenter, double-blind, placebo-controlled, parallel-group, confirmatory phase 2 study. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):53-61. doi: 10.1007/s10157-019-01818-2. Epub 2019 Dec 3.
Clinical trial NCT01181167: A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
Official title: A Phase 3, Randomized, Double-Blind, Double-Dummy Efficacy and Safety Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-5 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention
Venous Thromboembolism
Keywords: Anticoagulants
Venous thromboembolism
Thromboembolism
Thrombosis
enoxaparin sodium
Embolism
Deep vein thrombosis
DU-176b
edoxaban
factor Xa
total hip arthroplasty
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 610
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing unilateral total hip arthroplasty

Exclusion Criteria:

* Subjects with risks of hemorrhage
* Subjects with thromboembolic risks
* Subjects who weigh less than 40 kg
* Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

Primary outcomes:
measure: Incidence of Subjects With Venous Thromboembolism Events
timeFrame: 2 weeks
Secondary outcomes:
measure: Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Osaka Koseinenkin Hospital
name: Takeshi Fuji
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kawai Y, Fuji T, Fujita S, Kimura T, Ibusuki K, Abe K, Tachibana S. Edoxaban versus enoxaparin for the prevention of venous thromboembolism after total knee or hip arthroplasty: pooled analysis of coagulation biomarkers and primary efficacy and safety endpoints from two phase 3 trials. Thromb J. 2016 Dec 1;14:48. doi: 10.1186/s12959-016-0121-1. eCollection 2016.
Clinical trial NCT03903367: Thoracic Paravertebral Block Versus IV Fentanyl Infusion
Official title: Bilateral Continous Thoracic Paravertebral Block Versus IV Fentanyl Infusion For Perioperative Analgesia in Patients Undergoing Cardiac Surgery Through Median Sternotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Postoperative Pain
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: High-quality analgesia during and following cardiac surgery is infrequently obtained, Sternotomy and thoracotomy is associated with significant pain that resulte in hypoventilation, atelectasis, and hypoxemia,Pain management is rarley a priority in the immediate postoperative care of these patients, who frequently require mechanical ventilation in an intensive care environment

Detailed description: Paravertebral nerve blocks (PVBs) can provide excellent intraoperative anaesthetic and postoperative analgesic conditions with less side effects and fewer contraindications than central neural blocks,Bilateral PVB has been successfully used in the thoracic, abdominal, and pelvic regions(12). Paravertebral analgesia is produced by placing local anaesthetic (LA) alongside the vertebral column, close to the exit of the spinal nerves(13)..

Traditionally, profound intraoperative analgesia has been provided by using high doses of opioids to suppress hormonal and metabolic stress responses to surgical stimuli. This regimen resulted in improved morbidity and mortality after cardiac surgery(14).

Eligibility criteria: Inclusion Criteria:

* males and females patients scheduled for elective open heart surgery

Exclusion Criteria:

* Patients with chest trauma, injuries to peripheries, unstable hemodynamics, sensitivity to local anesthetic drugs, infection at the operation site, renal or hepatic dysfunction, left ventricular dysfunction, coagulation abnormalities and patients on opioids

Primary outcomes:
measure: Critical-Care Pain Observation Tool
timeFrame: Critical-Care Pain Observation Tool (CPOT) will be assessed 1 hour after admitting the patient to the ICU, as base line reacord then every 4 hoursfor 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef University Hospital
Study officials:
affiliation: Assisstant proffesor of anesthesia
name: Samaa ak Rashwan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01937767: Remimazolam Phase II Cardiac Anesthesia Study
Official title: A Randomized, Single-blind Phase II Study Evaluating the Efficacy, Safety and Pharmacokinetics of Remimazolam in General Anesthesia in Adult Patients Undergoing Cardiac Surgery, Including Follow-up Sedation in the PACU/ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: General Anesthesia
Lead sponsor: Paion UK Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Aptiv Solutions
First posted: 2013-09-10
Enrollment: 90
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: This phase II study in patients undergoing elective cardiac surgery will evaluate the efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and sevoflurane, during the induction and maintenance of general anesthesia.


Eligibility criteria: Inclusion Criteria:

* scheduled for major elective cardiac surgery.
* scheduled for mechanical ventilation via tracheal intubation.

Exclusion Criteria:

* thoraco-abdominal replacement of the aorta or other procedure expected to be accompanied by a massive hemorrhage (at least 15% of the circulating blood volume).

Primary outcomes:
measure: Proportion of patients with successful anesthesia
timeFrame: Between the start of study medication and the end of the surgical procedure (up to approx 12 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Stefan Probst, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01591967: Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate
Official title: A Randomized Controlled Trial to Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: Chiropractic
Blood pressure
Pulse Rate
Thoracic
Lead sponsor: Spinal Missions, Inc., LLC
Sponsor class: OTHER
First posted: 2012-05-04
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled trial (RCT) is to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both normotensive and hypertensive humans.

Detailed description: OBJECTIVE: Previous studies on the effects of chiropractic treatment on blood pressure (BP) and pulse rate (PR) have reported decreases in both systolic and diastolic BP, as well as PR. However, many of those studies have been criticized for various study flaws, and accused of drawing erroneous conclusions, due to small sample size and various methodological concerns. The purpose of this randomized controlled trial (RCT) is to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both normotensive and hypertensive humans.

Eligibility criteria: Inclusion Criteria:

* Subjects were invited to participate in accordance with the Guidelines for Chiropractic Quality Assurance and Practice Parameters: proceedings of the Mercy Center Consensus Conference, Gaithersburg, MD, 1993, Aspen Publishers Inc.

Additionally and specifically for this RCT:

1. Both male and female subjects age 18 years and older were invited to participate
2. Subjects must not be pregnant
3. Subjects must not have any recent or current fractures of the arms or legs
4. Subjects must not have any visceral or abdominal condition such that being in the prone position would be detrimental to their health
5. Subjects must not have any known primary cancers of the spine or spinal column, nor any secondary metastatic process of the spine or spinal column
6. Subjects must not be under the influence of drugs or alcohol
7. Subjects must not have vertigo or any other imbalance condition
8. Subjects must not have any arm or leg prosthetic device
9. Subjects must be able to understand spoken and/or written Spanish and/or English

Exclusion Criteria:

Primary outcomes:
measure: The purpose of this randomized controlled trial (RCT) was to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both normotensive and hypertensive humans.
timeFrame: Baseline, pre-adjustment, post-adjustment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Spinal Missions, Inc., LLC
name: Steven D. Roffers, DC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05244967: Epidemiology of Sexually Transmitted Infections and Its iMpAcT on fEmale Infertility
Official title: Epidemiology of Sexually Transmitted Infections and Its iMpAcT on fEmale Infertility
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sexually Transmitted Infection
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 533
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young women aged 18-22 years.

Brief summary: A longitudinal study to investigate the prevalence of sexually transmitted infections among young women and determine the role of the female genital tract microbiome in fertility


Eligibility criteria: Inclusion Criteria:

* 18-22 years
* informed consent

Exclusion Criteria:

* pregnancy
* sterilization
* not capable of giving informed consent

Primary outcomes:
measure: number of young women with STIs
timeFrame: at enrollment
measure: monitoring of STIs and their impact on infertility
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Klinik für Infektiologie und Mikrobiologie
Study officials:
References:
Clinical trial NCT04432467: Fertility Restoration Using Autologous Mesenchymal Stem Cells
Official title: Fertility Restoration Using Autologous Adipose Tissue Derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Endometritis
Uterus; Scar
Uterine Synechiae
Fallopian Tube Obstruction
Keywords: Fertility restoration
Mesenchymal stem cells
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian Medical Academy of Post-Graduate Education
First posted: 2020-06-16
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of the patients with scarring and adhesions in the uterus resulting from caesarean section or chronic inflammation in the mucosa of the uterus and fallopian tubes and preventing the occurrence of these effects in the future

Detailed description: The aim of the project is to develop a biomedical cell product based on autologous adipose tissue derived mesenchymal stem cells and a biodegradable carrier for highly effective treatment and prevention of scarring and adhesions in the uterus acquired as a result of cesarean section or chronic inflammatory processes in the uterine mucosa and fallopian tubes; to conduct the clinical trials of the biomedical cell product in the treatment of uterus scarring and infertility in women.

Eligibility criteria: Inclusion Criteria:

* chronic endometritis
* postoperative uterus scars
* uterine synechia
* fallopian tube obstruction
* absence of acute inflammation in the uterus

Exclusion Criteria:

* Patients with genetic diseases of muscle and connective tissue;
* Patients with malformations of the uterus;
* Acute and chronic infectious diseases: HIV, mycoplasma infection, hepatitis B and C, syphilis; autoimmune diseases; oncological diseases; continuous hormonal therapy with cytostatics corticosteroids; acute noncommunicable diseases;
* mental disorders;
* Drug or alcohol addiction;
* Benign tumors of uterus and appendages;
* Hypersensitivity to any component of the studied biomedical cell product.

Primary outcomes:
measure: Number of cured patients
timeFrame: 6 months
measure: Number of patients with treatment-related adverse events
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: Head of the Lab of Institute of Biophysics and Cell Engineering
name: Igor D Volotovski, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01619267: Role of New Diagnostic Tool in Device (ICD / PM) Associated Infections
Official title: Device Associated Infections - Role of New Diagnostic Tools
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biomarkers in Device Associated Infections
Keywords: pacemaker defibrillator infection
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: University Hospital Dubrava
First posted: 2012-06-14
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients presenting with device associated infections

Brief summary: Infections related to implantable pacemakers or cardioverters defibrillators are sometimes difficult to be diagnosed. Diificulties in the diagnosis include a low sensitivity of standard markers of inflammation such as C-reactive protein or white blood cell count and the diagnosis is mainly based on the clinical presentation. The observational DIRT-study evaluates if new biomarkers may be more suitable to support a diagnosis of device associated infections than the currently available ones.


Eligibility criteria: Inclusion Criteria:

* device associated infections

Exclusion Criteria:

* malignancy
* cytostatic or immunomodulating therapy

Primary outcomes:
measure: procalcitonine
timeFrame: no follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
city: Landshut
country: Germany
facility: Krankenhaus Landshut-Achdorf
city: München
country: Germany
facility: Deutsches Herzzentrum
city: Rome
country: Italy
facility: Ospedale San Pietro FBF
Study officials:
References:
citation: Lennerz C, Vrazic H, Haller B, Braun S, Petzold T, Ott I, Lennerz A, Michel J, Blazek P, Deisenhofer I, Whittaker P, Kolb C. Biomarker-based diagnosis of pacemaker and implantable cardioverter defibrillator pocket infections: A prospective, multicentre, case-control evaluation. PLoS One. 2017 Mar 6;12(3):e0172384. doi: 10.1371/journal.pone.0172384. eCollection 2017.
Clinical trial NCT03304067: Asthma Control Study
Official title: Digital Health Tool for Parental Management of Childhood Asthma -- Impact on Asthma Control Test Scores
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Asthma
Lead sponsor: Evidation Health
Sponsor class: INDUSTRY
Collaborators: name: Tueo Health
First posted: 2017-10-06
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The "Digital Health Tool for Parental Management of Childhood Asthma -- Impact on Asthma Control Test Scores" Study is a 16 week, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the Tueo Health program on asthma control as indicated by change in baseline and study end (week 16) score on the Childhood Asthma Control Test score (ages 6- under 12 years) and the Asthma Control Test (ages 12-17 years) in children with uncontrolled asthma as the primary study objective.


Eligibility criteria: Inclusion Criteria:

* Parent has a child who is \> 6 and \< 17.5 years old
* Parent reports child has a diagnosis of asthma
* Child takes daily asthma controller medication
* Child has used rescue inhaler (e.g.albuterol, ProAir, etc) or nebulizer at least 2 times per week in the past 4 weeks
* Child sleeps on a toddler, single, or double bed by themselves
* Child will live in the same home for the majority of the next 16 weeks
* Parent is \> 18 years old

Exclusion Criteria:

* Child's asthma has been controlled over the past 4 weeks
* Child has any of the following conditions: sleep apnea, congenital heart disease, cardiac arrhythmias, or any other heart abnormalities, neurologic conditions including seizures, cerebral palsy, muscular dystrophy, genetic conditions or developmental disorders, autism, other major medical condition
* Child is currently pregnant
* Child was born premature (earlier than 36 weeks)
* Parent is not fluent in English
* No in-home WiFi
* Parent does not use an Android phone as their primary phone
* In a household with an existing enrolled participant in the study, even for a different child (e.g. only one child in a household may have questions reported back to the researchers by their parent)
* Lives in Hawaii or Alaska

Primary outcomes:
measure: Change in ACT/C-ACT scores
timeFrame: Baseline and Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Evidation Health
state: California
Study officials:
References:
Clinical trial NCT01902667: Preoperative Imaging in Retroperitoneal Sarcoma
Official title: Preoperative Imaging in Retroperitoneal Sarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Retroperitoneal Sarcoma
Magnetic Resonance Imaging
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: Royal Marsden NHS Foundation Trust
name: Cancer Research UK
First posted: 2013-07-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with retroperitoneal sarcoma randomised for preoperative radiotherapy plus surgery versus surgery alone.

Brief summary: This is a prospective observational study in which patients with untreated retroperitoneal sarcoma will have Magnetic Resonance Imaging (MRI) prior to surgery. In addition, patients who will be undergoing pre-operative radiotherapy will have an additional MRI scan at two weeks post radiotherapy. For both groups, the magnetic resonance images will be correlated with tumour pathology.

The study hypothesis is that Magnetic Resonance Imaging will provide a more accurate assessment of tumour volume and local staging than CT and will identify areas of altered oxygenation, cellularity and perfusion which change in response to radiotherapy before tumour shrinkage occurs.


Eligibility criteria: Inclusion Criteria:

* Patients with retroperitoneal sarcomas planned for surgical resection +/- preoperative radiotherapy.

Exclusion Criteria:

* MRI incompatible metal implants
* claustrophobia

Primary outcomes:
measure: Prediction, by MRI, of early response to radiotherapy prior to tumour shrinkage
timeFrame: 2-4 weeks
Secondary outcomes:
measure: To determine the reproducibility of multi-parametric MRI measurements within tumour regions of interest in patients with retroperitoneal sarcoma.
timeFrame: 1-7 days
Other outcomes:
measure: Correlation of imaging features with histopathological assessment of tumour size, local staging, cellularity, necrosis and viable tumour.
timeFrame: 2 months
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
References:
citation: Winfield JM, Miah AB, Strauss D, Thway K, Collins DJ, deSouza NM, Leach MO, Morgan VA, Giles SL, Moskovic E, Hayes A, Smith M, Zaidi SH, Henderson D, Messiou C. Utility of Multi-Parametric Quantitative Magnetic Resonance Imaging for Characterization and Radiotherapy Response Assessment in Soft-Tissue Sarcomas and Correlation With Histopathology. Front Oncol. 2019 Apr 25;9:280. doi: 10.3389/fonc.2019.00280. eCollection 2019.