louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04473196: The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
Official title: Prospective, Randomized Trial to Evaluate the Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hallux Valgus
Hallux Rigidus
Keywords: MTP Hallux rigidus Osteoarthritis
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions

Detailed description: The objective of this prospective, randomized controlled trial is to determine if there are any adverse outcomes associated with immediate weight bearing as compared to non-weight bearing following first MTP joint fusion. The primary outcome measures will look at patient reported outcomes of pain and function. The secondary outcome measures will be the difference in the incidence of non-union, as well as adverse events/complications (malunion, wound complications, hardware complications, infection, stress fracture).

Eligibility criteria: Inclusion Criteria:

* Age 18 years or great
* Medically fit for surgery
* Patients diagnosed with condition for which a 1st MTP joint fusion is a surgical management option based on clinical examination and radiographs
* Failed non-operative management (orthotics, bracing, Tylenol, NSAIDs, shoe-wear modification)
* Surgery is for an isolated 1st MTP fusion
* Able and willing to comply with follow up schedule and requirements
* Capable of providing informed consent

Exclusion Criteria:

* Age \<18 years old
* Surgical booking is for more than just 1st MTP fusion
* Unable to comply with follow up schedule and requirements
* Unable to provide informed consent

Primary outcomes:
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: pre op
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: 6 months
measure: Visual analogue scale(VAS)
timeFrame: pre op
measure: Visual analogue scale(VAS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Radiographic healing
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
affiliation: NSHA\ Dalhousie UNiversity
name: Mark Glazebrook, MD FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rammelt S, Panzner I, Mittlmeier T. Metatarsophalangeal Joint Fusion: Why and How? Foot Ankle Clin. 2015 Sep;20(3):465-77. doi: 10.1016/j.fcl.2015.04.008. Epub 2015 Jun 10.
citation: Wood EV, Walker CR, Hennessy MS. First metatarsophalangeal arthrodesis for hallux valgus. Foot Ankle Clin. 2014 Jun;19(2):245-58. doi: 10.1016/j.fcl.2014.02.006. Epub 2014 Mar 21.
citation: Little JB. First metatarsophalangeal joint arthrodesis in the treatment of hallux valgus. Clin Podiatr Med Surg. 2014 Apr;31(2):281-9. doi: 10.1016/j.cpm.2013.12.009. Epub 2014 Feb 26.
Clinical trial NCT01731496: The Efficacy of Reminders to Complete HPV Series
Official title: Improving Communication and Health for Adolescents With Technology - Implementation of Immunization Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Completion of Three Dose Series of HPV
Improvement in Vaccine Intervals Between HPV Doses
Keywords: Human Papillomavirus
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2012-11-21
Enrollment: 749
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The human papillomavirus (HPV) vaccine is routinely recommended for both adolescent girls and boys starting at age 11, although it can be offered as young as 9 years of age. This is a 3-dose series and many adolescents do not complete it after getting the first dose. This study will study how effective it will be to send reminders to parents to schedule an appointment when their child is due for the next dose of HPV. Parents can chose whether they would like a phone call or text message reminder. This study will determine if the reminders work, and if one method is better than another (phone message vs. text message).


Eligibility criteria: Inclusion Criteria:

* Parents of adolescents aged 10 - 17 who have had at least 1 dose of HPV
* Patients aged 18 - 21 who have had at least 1 dose of HPV

Exclusion Criteria:

Primary outcomes:
measure: HPV completion rate
timeFrame: One Year
Secondary outcomes:
measure: HPV Dosing Intervals
timeFrame: One Year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Culver Medical Group
state: New York
city: Rochester
country: United States
facility: Highland Family Medicine
state: New York
city: Rochester
country: United States
facility: Strong Pediatric Practice
state: New York
Study officials:
affiliation: University of Rochester
name: Cynthia Rand, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rand CM, Vincelli P, Goldstein NPN, Blumkin A, Szilagyi PG. Effects of Phone and Text Message Reminders on Completion of the Human Papillomavirus Vaccine Series. J Adolesc Health. 2017 Jan;60(1):113-119. doi: 10.1016/j.jadohealth.2016.09.011. Epub 2016 Nov 8.
Clinical trial NCT02893696: Extra Sitting Time After Spinal Anesthesia for Cesarean Section and Fetal Well-being
Official title: The Effect of Sitting After Spinal Injection of Hyperbaric Local Anesthetic on Fetal Acid-base Balance After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Complications; Cesarean Section
Hypotension
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After injection of the spinal anesthetic drug, women will be allowed to lie down immediately (0-30 sec) or after three minutes (180 sec) of sitting. The incidence of maternal hypotension and fetal umbilical cord blood pH will be recorded.


Eligibility criteria: Inclusion Criteria:

* Women with elective cesarean delivery at 39-42 wks gestation.

Exclusion Criteria:

* Women who shorter than 5'0" in height, those with primary or pregnancy-induced hypertension, macrosomia, multiple gestation will be excluded.
* Women with known risks of bleeding or potential hysterectomy such as those with placenta previa or accrete will also be excluded.
* If the epidural catheter cannot be placed within the specific time frame after the spinal injection, the case will be excluded.

Primary outcomes:
measure: Incidence of fetal umbilical artery pH below 7.20
timeFrame: At fetal delivery
Secondary outcomes:
measure: Incidence of maternal hypotension
timeFrame: During cesarean surgery
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Weike Tao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04240496: Clinical and Genetic Influencing Factors on Clozapine Pharmacokinetics
Official title: Clinical and Genetic Influencing Factors on Clozapine Pharmacokinetics in Schizophrenic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CYP1A2 Polymorphism
CYP2C19 Polymorphism
Clozapine
Schizophrenia
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 51
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: SUPPORTIVE_CARE

Brief summary: Clozapine (Clz), an atypical antipsychotic, is the reference medication for patients with treatment-resistant schizophrenia. Due to the high inter-individual variability of its pharmacokinetics and its narrow therapeutic index, a close therapeutic drug monitoring (TDM) of Clz is highly recommended.

Several factors can cause a variation in the pharmacokinetics as age, smoking habits, coffee consumption and drug interaction. Genetic factors related to hepatic expression levels of the cytochrome P450 (CYP), regulate the hepatic clearance of Clz, thereby determine its bioavailability.

The CYP1A2 and CYP2C19 isoenzymes are mainly responsible for the metabolism of several drugs including Clz. It has been demonstrated that there is an interethnic variation in the expression and function of these two isoenzymes. This variation is caused by single nucleotide polymorphisms (SNPs) of genes encoding these proteins.

While the Influence of the different polymorphisms related to CYP1A2 and CYP2C19 have been established especially in Asian and Caucasian populations, no study has examined the impact of these SNPs in the southern Mediterranean populations. Moreover, the impact of these SNPs is very controversial. The present study aims to investigate in Tunisian schizophrenic patients, the influence of genetic (CYP1A2 and CYP2C19 polymorphisms) and non-genetic factors on Clz pharmacokinetics.


Eligibility criteria: Inclusion Criteria:

* Schizophrenic patients receiving clozapine
* Good adherence to the treatment (clozapine)

Exclusion Criteria:

* Patients who were co-prescribed drugs that affected the pharmacokinetics of Clozapine.
* Patients who presented gastrointestinal disorders disturbing absorption of clozapine.

Primary outcomes:
measure: Determination of trough plasma concentration of clozapine (C0)
timeFrame: One and a half months
Secondary outcomes:
measure: Determination of the correlation between the presence of CYP1A2*1F (rs762551;-163C> A), CYP1A2*1C (rs2069514;-3860 G> A) and CYP 2C19*2 (rs4244285; 681G>A) and the variability of C0/Daily dose.
timeFrame: One and a half months
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Faculty of Medecine of Monastir
Study officials:
References:
Clinical trial NCT06528496: N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
Official title: N10: Reduced Therapy for High-Risk Neuroblastoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: High-risk Neuroblastoma
Neuroblastoma
Childhood Neuroblastoma
Keywords: High-risk neuroblastoma
neuroblastoma
childhood neuroblastoma
N10
Memorial Sloan Kettering Cancer Center
24-144
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of NB as defined by histopathology, BM metastases plus high urine catecholamine levels, or positivity in MIBG scan.
* HR-NB, defined as MYCN-amplified stage L2/M/MS at any age and stage M in patients \>18 months old.
* No more than one prior cycle of HR-NB chemotherapy
* Age \<19 years.
* Signed informed consent indicating awareness of the investigational nature of this treatment.

Exclusion Criteria:

* Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity \> grade 2
* Inability to comply with protocol requirements
* Pregnancy

Primary outcomes:
measure: Evaluate participant response
timeFrame: After 2 cycles of mAb-based therapy (each cycle is 21 days)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Brian Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03509896: Study of Chinese Newly Diagnosed Participants With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
Official title: Treatment Pattern, Clinical Outcome and Healthcare Resource Utilization Associated With Chinese Newly Diagnosed Patients With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP): A Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Myeloid Leukemia
Philadelphia Chromosome
Chronic Myeloid Leukemia in Chronic Phase
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-04-26
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Multi-center, observational, medical record review of approximately 1000 newly diagnosed CML-CP patients in China

Brief summary: Observational medical record review of newly diagnosed CML-CP participants in China


Eligibility criteria: Inclusion Criteria:

* Ph+ CML-CP patients who were diagnosed between August 1, 2014 to August 1, 2016
* 18 years or older at time of diagnosis

Exclusion Criteria:

* Participants once enrolled in any interventional clinical trial for CML
* Participants whose records are not available

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of participants receiving each first-line treatment option
timeFrame: 2 years
measure: Number of participants with complete cytogenetic response
timeFrame: 2 years
measure: Number of participants with major molecular response (MMR)
timeFrame: 2 years
measure: Number of participants of each initial dose schema
timeFrame: 2 years
measure: Starting dose of each first-line agent
timeFrame: 2 years
Secondary outcomes:
measure: Distribution of demographic characteristics
timeFrame: 2 years
measure: Distribution of clinical characteristics
timeFrame: 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Local Institution
state: Tianjin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04610996: The Valid of GFR in Chronic Kidney Disease Patients
Official title: The Validation of Calculated Equations of GFR in Thai Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Kidney Disease
Keywords: GFR CKD
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2020-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population in Dindang Destric, central Bangkok regoin was select in this cohort.

Brief summary: Study was cancel due to principle investigator had been resigned

Detailed description: Study was cancel due to principle investigator had been resigned

Eligibility criteria: Inclusion Criteria:

* Age more than 16

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01169896: Impact of Ventricular Pacing in Unselected ICD/CRT-D Patients
Official title: Impact of Ventricular Pacing in Unselected ICD/CRT-D Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Keywords: Impact of ventricular pacing on the incidence of VT/VF episodes for each models
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2010-07-26
Enrollment: 616
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: unselected ICD/CRT-D implanted patients

Brief summary: Observational study is evaluating Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) thérapies as a function of ventricular pacing

Detailed description: This protocol consists in a non-interventional multi-centre, prospective study. The observational study will also answer the question of the impact of ventricular pacing on the outcome of patients implanted with ICD \& CRT-D devices and how the ICD \& CRT-D devices are used in clinical practice through two years follow-up.

Eligibility criteria: Main inclusion Criteria:

•Patient implanted (primo implantation or replacement) with an ICD (OVATIO VR 6250, DR 6550, CRT 6750 models, or any similar or higher range device, that includes specific diagnostic and therapeutic functionalities, mandatory to make homogeneous the collection of data)

Main exclusion Criteria:

* Presence of a contra-indication to the ICD therapy.
* Life expectancy less than 12 months.

Primary outcomes:
measure: VT/VF episodes according to ventricular pacing (> and <50%)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: St Denis
country: France
facility: CCN
Study officials:
affiliation: CCN St Denis
name: Olivier Piot, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06586996: The Construction of Bidirectional Column Study of Acute Osteoporotic Vertebral Compression Fractures
Official title: The Construction of Bidirectional Column Study and Prognosis Prediction of Acute Osteoporotic Vertebral Compression Fractures Based on Imaging and Clinical Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis Fracture
Keywords: osteoporosis fracture
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the acute osteoporosis vertebral compression fracture patients who search for treatments in our hospital

Brief summary: Our research group plans to establish a disease specific bidirectional cohort study on prognosis prediction of acute osteoporotic vertebral compression fracture based on imaging and clinical data, and to establish a comprehensive bioinformation database on OVCFs, including patient status, clinical data, laboratory examination, and imaging examination database


Eligibility criteria: Inclusion Criteria: all patients who suffer a acute osteoporosis vertebral compression fractures -

Exclusion Criteria: those who have endocrine disease which have impacts on the bone density

-

Primary outcomes:
measure: VAS value
timeFrame: 2 weeks, 1 month, 2 months, 3months, 6 months and 12 months
measure: vertebrae height
timeFrame: 2 weeks, 1 month, 2 months, 3months, 6 months and 12 months
measure: T value
timeFrame: 6months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospita
Study officials:
References:
Clinical trial NCT01064596: Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery
Official title: Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Obesity
Surgery
Keywords: obesity
fondaparinux
surgery
anti-Xa activity
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2010-02-08
Enrollment: 40
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: obesity patients who need a bariatric surgery

Brief summary: After bariatric surgery , thromboembolics complications are major cause of mortality. However, in obese patients, thromboprophylaxia is a controversy. Fondaparinux' efficacy is superior to HBPM, and is a good treatment for this population. Pharmacokinetics information with Fondaparinux in this population are rare.

Detailed description: We proposed a bicentric study cohort of obese patients (BMI \> 40 kg/m2) treated by 1 day injection of Fondaparinux 2.5 mg after bypass surgery. Anti-Xa activity of Fondaparinux will be measured 4 times during hospitalisation for each patient to realise a pharmacokinetic modelisation of Fondaparinux. Haemorrhage and thromboembolics events will be collected.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* requiring a bariatric surgery
* requiring an antithrombotics prophylaxis
* having a morbid obesity based on a BMI \>40 kg/m2
* having signed the inform consent form

Exclusion Criteria:

* contra-indication to fondaparinux
* history of heparin induced thrombopenia (HIT)
* platelets \< 100 G/l
* requiring an effective antithrombotic treatment

Primary outcomes:
measure: To evaluate pharmacodynamics parameters of fondaparinux based on anti-Xa activity estimated by a non linear model at mixed effect of obese morbid patients following a bariatric surgery
timeFrame: 5 days
Secondary outcomes:
measure: To evaluate the incidence of symptomatic venous thromboembolics events (DVT and PE) between D5 and D10 and at 1month ± 10 days
timeFrame: D5
measure: the incidence of major and clinically significative bleeding between D5 and D10 and at 1 month ± 10 days
timeFrame: 5 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris
city: Saint-etienne
country: France
facility: Clinique de la Mutualiste
city: Saint-etienne
country: France
facility: Chu de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Patrick MISMETTI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: