louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01345994: Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Martinos Center for Biomedical Imaging
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2011-05-02
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This study will characterize brain plasticity in Carpal Tunnel Syndrome and will determine how this central fMRI biomarker is modulated by acupuncture. This study will also investigate the behavioral consequences of maladaptive cortical plasticity in this disease population.


Eligibility criteria: Inclusion Criteria:

1. Male and female adults aged 20-60.
2. History

   * Pain and/or paresthesia in median nerve distribution (i.e., numbness in some combination of digit 1, 2, 3, and the radial part of digit 4)
   * Nocturnal pain and/or paresthesia in median nerve distribution
   * Symptoms (a and b) greater than 3 months in duration
3. Physical Exam with two of the following three findings:

   * Phalen's and Durkin's sign (positive with paresthesia in at least 1 of 3 radial digits)
   * Abnormal grip strength (greater than 2 S.D. compared to uninvolved side using an isometric hand grip device)
4. Nerve conduction findings consistent with mild to severe CTS:

Mild CTS: Delayed distal latency of the sensory nerve conductions across the wrist (\> 3.7milliseconds and/or \> than 0.5 milliseconds compared to the ulnar sensory conduction) with normal motor conductions

Moderate CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with delayed distal latency of the motor conductions across the wrist (\> 4.2 milliseconds).

Severe CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with greater than 50% loss of motor amplitudes (relative to unaffected side and/or normative range).

Exclusion Criteria:

1. Contraindications to MRI examination (pregnancy, pacemaker, etc. according to guidelines set by MGH NMR-Center)
2. History of diabetes mellitus or other major cardiovascular, respiratory, or neurological illnesses.
3. History of rheumatoid arthritis.
4. History of wrist fracture with direct trauma to median nerve.
5. Current usage of prescriptive opioid pain medication.
6. Severe thenar atrophy.
7. Nerve entrapment other than median nerve.
8. Cervical radiculopathy or myelopathy.
9. Generalized peripheral neuropathy.
10. A blood dyscrasia or coagulopathy or current use of anticoagulation therapy

Primary outcomes:
measure: Functional MRI brain response
timeFrame: Baseline vs. Post-Acupuncture (average 9 weeks later)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT02409394: Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects
Official title: Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Subjects
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-04-06
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy.
* Weight≥50 kg，19≤BMI≤28 kg/m2.
* Platelet count is within normal range

Exclusion Criteria:

* History of clinically significant illness.
* History of alcohol or drug abuse.

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of hetrombopag
timeFrame: 0h-120h
measure: The area under the plasma concentration-time curve (AUC) of hetrombopag
timeFrame: 0h-120h
measure: The accumulative excretion rate of hetrombopag and its metabolites in urine and feces
timeFrame: 0h-120h
Secondary outcomes:
measure: The change of platelet count
timeFrame: On day 2, 4, 6, 8,12, 14 and 16
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to Day 16
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West Hospital, Sichuan University
state: Sichuan
Study officials:
References:
citation: Wang Z, Chen X, Li A, Chen L, Wang Y, Zheng L. Effect of Food on the Pharmacokinetic and Pharmacodynamic Profiles of Hetrombopag in Healthy Volunteers. Clin Ther. 2020 Dec;42(12):2280-2288. doi: 10.1016/j.clinthera.2020.10.002. Epub 2020 Oct 24.
Clinical trial NCT03393260: Epidemiological Characteristics and Prognosis Factors of Cancer Patients Admitted at French Emergency Departments
Official title: Epidemiological Characteristics and Prognosis Factors of Cancer Patients Admitted at French Emergency Departments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Patients
Emergencies
Keywords: cancer
emergency departments (ED)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 1380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of 18 years or more with active malignancy or in remission for less than 5 years and being attended in one of the 400 French emergency centers participating in the study during 3 consecutive days will be enrolled

Brief summary: Patients with cancer or hematological malignancy are susceptible to present acute complications linked to their disease or to their specific treatments (dyspnea, sepsis, coma, hemorrhagic syndrome). Emergency physicians are in first line when these complications arise and have to face with some complex situations in which informations about patient malignancy or prognosis may be lacking. Nowadays, there is very few epidemiological data published concerning how cancer patient use Emergency Departments (EDs) and cancer patient care delivery in the EDs.

Thus, an observational multicenter prospective cross-sectional study is conducted to study the prevalence of cancer patients admitted to French EDs, and to describe the different reasons for cancer patients to seek care in EDs with their prevalence and underscore those linked to cancer or treatment complication


Eligibility criteria: Inclusion Criteria:

* adult patients (age \>=18 years)
* with active malignancy or a history of cancer in remission within the last 5 years
* being attended in one of the 400 French emergency centers participating in the study during the 3-day study period

Exclusion Criteria:

* opposition to participate

Primary outcomes:
measure: Reasons for cancer patients to seek care in EDs
timeFrame: 1 day
Secondary outcomes:
measure: cancer location
timeFrame: 1 day
measure: hospitalisation rate
timeFrame: 1 day
measure: intensive care unit (ICU) admission
timeFrame: 7 days
measure: ICU mortality
timeFrame: 7 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint Louis
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier Peyrony, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peyrony O, Fontaine JP, Trabattoni E, Nakad L, Charreyre S, Picaud A, Bosc J, Viglino D, Jacquin L, Laribi S, Pereira L, Thiriez S, Paquet AL, Tanneau A, Azoulay E, Chevret S, Initiatives de Recherche Aux Urgences Iru-Sfmu Research Group. Cancer Patients' Prehospital Emergency Care: Post Hoc Analysis from the French Prospective Multicenter Study EPICANCER. J Clin Med. 2021 Mar 9;10(5):1145. doi: 10.3390/jcm10051145.
Clinical trial NCT04608760: Prevention of Acute Pancreatitis After Endoscopic Interventions
Official title: Prevention of Acute Pancreatitis After Endoscopic Interventions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cholangiolitis
Acute Pancreatitis
Keywords: Cholangiolithiasis, endoscopic, acute pancreatitis, cholangiography
Lead sponsor: Vitebsk State Medical University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to develop a method for the prevention of acute pancreatitis after minimally invasive interventions of the bile ducts using a drug regimen.

Detailed description: A prospective, randomized, single-center study is planned to identify the most effective drug regimen in order to prevent the development of acute pancreatitis after transpapillary interventions of the bile ducts.

Eligibility criteria: Inclusion Criteria:

1. Patients with cholangiolithiasis.
2. Patients with benign formations of the bile ducts.
3. Patients with malignant formations of the bile ducts.
4. Patients with extrahepatic bile duct cysts.
5. Patients with biliary hypertension of unknown etiology.
6. Patients with cholangitis.
7. Patients with extrahepatic bile duct strictures.
8. Patients suffering from oncopathology of the head of the pancreas, complicated by obstructive jaundice.
9. Patients with malignant pathology of the pancreas.
10. Patients with benign pancreatic pathology.

Exclusion Criteria:

1. ASA scale\> III (severe concomitant cardiovascular pathology)
2. Severe pathology of the respiratory system.
3. Acute period of myocardial infarction.
4. Acute period of cerebral infarction.

Primary outcomes:
measure: Change in the level of inflammation and pain, assessment of severity according to the Ranson scale and Krasnogorov at 1 week
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Vitebsk
country: Belarus
facility: VSMU
Study officials:
affiliation: Vitebsk State Medical University
name: Yury Arlouski, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00177060: Topical Hydromorphone for Wound Healing
Official title: Topical Hydromorphone for Wound Healing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Wound Healing
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The hypothesis is that topical opioids will hasten wound healing in humans.

Detailed description: This is based on our published data that morphine is a powerful stimulant of angiogenesis and our preclinical study of wounds in rats which demonstrate that topical opioids (morphine, hydromorphone and fentanyl) hasten healing of punch biopsy wounds. This study will focus on hydromorphone which was more powerful than morphine as a wound-healer in the rat study.

Eligibility criteria: Inclusion Criteria:

* Self-identified as normal, healthy volunteers age 18-65.

Exclusion Criteria:

* Known bleeding disorder.

Primary outcomes:
measure: Healing rates and microvessel density will be compared statistically for the control-ointment versus hydromorphone-ointment subjects.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Maria Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Robert Hebbel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02156960: Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoporosis
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: It has not been well known about the changes of bone metabolic markers, bone mineral density and other bone-related markers after teriparatide and/or denosumab treatment in Japanese osteoporotic patients.


Eligibility criteria: Inclusion Criteria:

* Osteoporotic patients

Exclusion Criteria:

* none

Primary outcomes:
measure: Changes of bone mineral density
timeFrame: every 4-6 months
Secondary outcomes:
measure: Changes of bone turnover markers
timeFrame: every 3-6 months
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Yukio Nakamura
state: Nagano
Study officials:
References:
citation: Nakamura Y, Kamimura M, Ikegami S, Mukaiyama K, Uchiyama S, Taguchi A, Kato H. Changes in serum vitamin D and PTH values using denosumab with or without bisphosphonate pre-treatment in osteoporotic patients: a short-term study. BMC Endocr Disord. 2015 Dec 15;15:81. doi: 10.1186/s12902-015-0077-3.
Clinical trial NCT04914260: Injured - Sport Health Armed Forces (Blessé - Sport Santé Armées): Reconstruction Through Sport in the Armed Forces
Official title: Injured - Sport Health Armed Forces (Blessé - Sport Santé Armées): Reconstruction Through Sport in the Armed Forces
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Injury
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of French soldiers who have been physically injured and have been registered by a casualty assistance cell.

Brief summary: Since 2014, the armed forces have been offering injured military personnel the opportunity to rebuild their lives through sport. Sport, considered as the "DNA" of the military, thus becomes a vector of socio-professional reintegration for physically and psychologically injured soldiers.

In its 2019-2024 national Sport-Health strategy and in the Ministry of the Armed Forces' "Sport 2025" plan, rebuilding injured military personnel through sport is becoming a major focus of the new sports policy for the armed forces.

In addition to the well identified physiological benefits, sports are recognized as a way to encourage social relationships, fight stress and isolation, and promote solidarity. Sport thus contributes to the physical and mental reconstruction of the injured, promoting the phenomenon of resilience well described in the Anglo-Saxon world.

The implementation of the Reconstruction through Sport Program ("PRS") is based on the coordinated actions of the assistance units for the wounded, the French Armed Forces Health Service and the National Center for Defense Sports (CNSD), which have set up a complete sports program (discovery, leisure, competitions), adapted and evolving, regardless of the physical and/or psychological after-effects and the disability secondary to the injury.

In France, there are an increasing number of PRS-labeled sports events, such as the Military Injury and Sports Meetings, the Ad Victoriam Challenge, and internationally, the Invictus Games and the Military World Games. It should also be noted that this pathway leads some injured people to high-level competition.

No study has yet evaluated the path of reconstruction through sport for French injured military personnel initiated in 2014.


Eligibility criteria: Inclusion Criteria:

* French military
* Physically injured since January 1st, 2008
* Registered by a casualty assistance cell
* On duty or on long term sick leave

Exclusion Criteria:

* No physical injury
* Individuals who do not speak, understand or read French

Primary outcomes:
measure: Level of knowledge of the rehabilitation through sport program
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
Study officials:
References:
Clinical trial NCT02541760: Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Official title: Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Media With Effiusion
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 143
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. The aim of this study was to compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.


Eligibility criteria: Inclusion Criteria:

* • Children who were between 2 to 6 years old

  * Definite diagnosis of OME with symptoms and examination

Exclusion Criteria:

* • Currently were using corticosteroids or prophylactic monteleukast

  * Chronic pulmonary or cardiac diseases or immune deficiency
  * Allergic rhinitis
  * Hypersensitivity to monteleukast or corticosteroids
  * Avoidance of parents to fill the written informed consent

Primary outcomes:
measure: Treatment response
timeFrame: 1 months
Secondary outcomes:
measure: Drug side effects
timeFrame: 1 month
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Hormozgan University of Medical Sciences
state: Hormozgan
Study officials:
affiliation: Hormozgan University of Medical Sciences
name: Hamidreza Mahboobi, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahmati MB, Safdarian F, Shiroui B, Zare S, Sadeghi N. Montelukast versus inhaled mometasone for treatment of otitis media with effusion in children: A randomized controlled trial. Electron Physician. 2017 Jul 25;9(7):4890-4894. doi: 10.19082/4890. eCollection 2017 Jul.
Clinical trial NCT02319460: An Observational Cohort Study to Investigate the Risk of Thromboembolic Events in Patients Receiving Kcentra® or Plasma to Reverse Vitamin K Antagonist (VKA) Therapy in the Setting of Acute Major Bleeding
Official title: An Observational Cohort Study of the Risk of Thromboembolic Events Among Adult Patients Treated With KCENTRA® Compared With Plasma for Urgent Reversal of Vitamin K Antagonist Therapy in the Setting of Acute Major Bleeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Keywords: Vitamin K Reversal Antagonist Therapy of Acute Major Bleeding
Warfarin Reversal
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
First posted: 2014-12-18
Enrollment: 2238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult members of the Kaiser Permanente Northern and Southern California health care delivery systems, receiving chronic warfarin therapy and meeting study eligibility criteria.

Brief summary: This observational cohort study is designed to obtain product safety information from the routine clinical setting within large, diverse, community-based populations. In the setting of acute major bleeding in which patients are treated for Vitamin K antagonist reversal, the risk of thromboembolic events (TEE) in patients treated with Kcentra® and in patients treated with plasma will be assessed.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years and older at admission for VKA-associated major bleeding
* A minimum of 365 days of continuous health plan enrollment before the index hospitalization involving acute VKA reversal treatment
* A minimum of 365 days of continuous pharmacy benefit before the index hospitalization involving acute VKA reversal treatment

Exclusion Criteria:

Patients will be excluded from the primary analyses if they:

* Require urgent reversal of VKA therapy in the setting of bleeding due to major trauma (eg, motor vehicle accident)
* Requiring urgent reversal of VKA therapy for a surgical procedure unrelated to major bleeding (eg, appendicitis)

Primary outcomes:
measure: Risk of thromboembolic events (TEE) for patients without a recent history of TEE
timeFrame: Within 45 days after the index date
Secondary outcomes:
measure: Risk of thromboembolic events
timeFrame: Within 45 days after the index date
measure: Risk of death from any cause
timeFrame: Within 45 days after the index date
measure: Rates of use of VKA therapy after the index date
timeFrame: Within 90 days after the index date
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Study Site
state: California
Study officials:
affiliation: CSL Behring
name: Clinical Epidemiologist
role: STUDY_DIRECTOR
affiliation: Kaiser Permanente
name: Alan S. Go, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Kristi Reynolds, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00320060: Effect of Pyridorin in Patients With Diabetic Nephropathy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study to Evaluate the Safety and Tolerability of Pyridorin (Pyridoxamine Dihydrochloride) in Patients With Diabetic Nephropathy Associated With Type 1 or Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathy
Keywords: Diabetic nephropathy
Advanced Glycation Endproduct Inhibitor
Pyridorin
Pyridoxamine
Lead sponsor: BioStratum
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the safety and tolerability of Pyridorin (pyridoxamine dihydrochloride) 50 mg given orally twice daily in patients with diabetic kidney disease.


Eligibility criteria: Inclusion Criteria:

* Males and Females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes
* Sitting blood pressure of \<=170/100 mm Hg at weeks -2 and -1
* Hemoglobin A1C \<=12% at week -2
* Patients with diagnosis of diabetic nephropathy as defined by

  1. Serum Creatinine \<=2.0 mg/dL at weeks -2 and -1
  2. Urinary albumin excretion \>=300 mg/24 hours at week -2
  3. Diagnosis of diabetic retinopathy
* Creatinine clearance \>=40 mL/min at weeks -2 and -1
* Voluntary written consent to participate in this study

Exclusion Criteria:

* History of allergic or adverse response to any B vitamin
* History of major cardiovascular or cerebrovascular events
* History of cancer except adequately treated basal or squamous cell carcinoma of the skin
* History of diabetic ketoacidosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: BioStratum, Inc.
name: Thorsten P Degenhardt, Ph.D.
role: STUDY_DIRECTOR
References: