louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06207955: I-PRF After Arthrocentesis Plus Botox Injection to Lateral Pterygoid Muscle in Treatment of Anterior Disc Displacement
Official title: Does Intra-articular Injection of Platelet-Rich Fibrin After Arthrocentesis Followed by Lateral Pterygoid Muscle Injection With Botulinum Toxin Type A Improve Clinical Outcomes for Anterior Disc Displacement?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: TMJ Disc Disorder
TMJ Pain
Keywords: Anterior Disc Displacement
TMJ Clicking
I-PRF
Lateral Pterygoid Muscle
Arthrocentesis
Botulinum Toxin Type A
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 39
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of Study : To evaluate the efficacy of TMJ arhtrocentesis followed by injection of liquid platelet rich fibrin (I-PRF ) in addition to intramuscular injection of lateral pterygoid muscle with botulinum toxin on clinical outcomes of painful TMJ , maximum mouth opening , joint sounds and range of lateral movement in patients with TMJ anterior disc displacement with reduction

Hypothesis : Intramuscular injection of lateral pterygoid muscle with botulinum toxin plus TMJ intra-articular injection of liquid platelet rich fibrin after arthrocentesis are more effective than TMJ arthrocentesis followed by intra-articular injection of ( I-PRF ) or TMJ arthrocentesis only .


Eligibility criteria: Inclusion Criteria:

* Patients with painful tmj during jaw movements
* Patients with joint sounds ( clicking ) during jaw opening and mastication
* Patients age range from 16 years old to 45 years old
* Patients with Class I maxillo-mandibular relationship
* Patients with reduced mouth opening
* All patients diagnosed clinically and radiographically by MRI as TMJ anterior disc displacement with reduction

Exclusion Criteria:

* Patient with history of recent trauma
* Patients with malocclusion
* Patients with systematic condition that affect bone and joints such as osteoarthritis , systemic lupus and epilepsy .
* Patients allergic to botox injection
* Pregnant or lactating females
* Patients with non-reducible disc on MRI
* Patients contraindicated to exposure to MRI
* Patients with previous tmj arthrocentesis , arthroscopy or TMJ surgery
* Significant mechanical obstruction that prevents mouth opening, acute capsulitis, benign or malignant temporomandibular joint lesions.
* Patients with blood diseases, and coagulation disorders

Primary outcomes:
measure: Maximum Mouth Opening
timeFrame: 6 months
Secondary outcomes:
measure: Clicking
timeFrame: 6 months
measure: Lateral movement
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05249855: Balneotherapy and Anxiety During SARS-CoV-2 Pandemic
Official title: Balneotherapy and Anxiety During SARS-CoV-2 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: D001452
Keywords: balneology
anxiety
fear of SARS-CoV-2
resilience
general trust
Lead sponsor: University of Bucharest
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: General Trust mediates the relation between the level of anxiety at the beginning of the treatment and the end of the treament.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Investigators will measure the level of anxiety and fear of Covid during the balneological treatment in patients. They are interested in the effect of general trust and resilience on the level of anxiety state.

Detailed description: Investigators will measure the level of anxiety and fear of SARS-CoV-2 virus during the balneological treatment in patients. They are interested in the effect of general trust and resilience on the level of anxiety state.

A number of between 300 and 800 inpatients are expected to get involved in the study. They suffer from cardiovascular disease, osteoarthritis, respiratory diseases and many others.

Eligibility criteria: Inclusion Criteria:

* enrolled in balneological treatment

Exclusion Criteria:

* not enrolled in the balneological treatment

Primary outcomes:
measure: Level of Anxiety
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00971555: Thyroid Function in Late Preterm Infants
Official title: Thyroid Function in Late Preterm Infants in Relation to Severity of Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transient Hypothyroxinemia
Keywords: Transient Hypothyroxinemia
Late Preterm Infants
Total T4
TSH
Illness severity
NICU
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2009-09-03
Enrollment: 150
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Late preterm infants

Brief summary: Transient hypothyroxinemia (TH) is a condition characterized by low levels of serum thyroxine (T4) and normal levels of thyroid stimulating hormone (TSH). TH in premature infants has been found to be related to severity of illness. T4 levels in very low birth weight infants born prematurely has been found to be inversely correlated to severity of illness. In very low birth weight infants, TH has been associated with poor outcomes. Little is known about thyroid function in late preterm infants.

Hypotheses:

1. Ill late preterm infants will have lower total T4 levels than healthy late preterm infants.
2. Total T4 and possibly TSH levels will be inversely correlated with short-term outcomes.
3. Late Preterm infants born by cesarean section will have lower T4 levels compared to those born by vaginal birth.


Eligibility criteria: Inclusion Criteria:

* any infant born between 34 0/7 weeks and 36 6/7 weeks gestation born at Christiana Hospital

Exclusion Criteria:

* outborn infants
* infants with major congenital anomalies

Primary outcomes:
measure: Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery.
timeFrame: First week of life
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
Study officials:
affiliation: Christiana Hospital
name: Renee M Behme, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Hospital
name: David A Paul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Behme RM, Mackley AB, Bartoshesky L, Paul DA. Thyroid function in late preterm infants in relation to mode of delivery and respiratory support. J Pediatr Endocrinol Metab. 2014 May;27(5-6):425-30. doi: 10.1515/jpem-2013-0243.
Clinical trial NCT02180555: Diabetes Mellitus After Intensive Care Admission
Official title: Incidence and Predisposing Factors for the Development of Glucose Metabolism Disturbances and Diabetes Mellitus After Intensive Care Admission
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress Hyperglycemia
Diabetes Mellitus
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 400
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: ICU patients

Brief summary: Stress hyperglycaemia is commonly observed during hospitalization in the intensive care unit (ICU) and has been shown to adversely influence outcome. It has been hypothesized that, when it occurs in previously non-diabetic patients, it reflects a latent disturbance of the glucose metabolism. Assessing the incidence of this phenomenon and identifying its risk factors could support prevention, detection and early treatment of impending diabetes mellitus type 2. We will perform a glucose tolerance test approximately 6-9 months post-ICU admission to screen for disorders of glucose metabolism. Furthermore, we examined characteristics that could have predicted the post-discharge disturbances: patient characteristics, parameters of disease severity and of glucose metabolism, as well as the FINDRISC (Finnish Diabetes Risc Score). We plan to enroll 400 patients.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old)
* admitted for 36 hours or longer to the ICU
* still alive 6 months after ICU discharge

Exclusion Criteria:

* known Diabetes Mellitus or any other glucose tolerance disturbance
* an estimated short life expectancy
* pregnancy
* a history of transplantation or acute pancreatic disease
* language barrier preventing a clear understanding of the informed consent

Primary outcomes:
measure: Glucose metabolism disturbance
timeFrame: 6-9 months after ICU discharge
Secondary outcomes:
measure: Patient characteristics predicting adverse outcome
timeFrame: 6-9 months after ICU discharge
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerpen
Study officials:
References:
citation: Gornik I, Vujaklija-Brajkovic A, Renar IP, Gasparovic V. A prospective observational study of the relationship of critical illness associated hyperglycaemia in medical ICU patients and subsequent development of type 2 diabetes. Crit Care. 2010;14(4):R130. doi: 10.1186/cc9101. Epub 2010 Jul 8.
citation: Van Ackerbroeck S, Schepens T, Janssens K, Jorens PG, Verbrugghe W, Collet S, Van Hoof V, Van Gaal L, De Block C. Incidence and predisposing factors for the development of disturbed glucose metabolism and DIabetes mellitus AFter Intensive Care admission: the DIAFIC study. Crit Care. 2015 Oct 2;19:355. doi: 10.1186/s13054-015-1064-9.
Clinical trial NCT00835055: Expression of Molecular Markers Before and After Neo-adjuvant Chemoradiotherapy in Rectal Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rectal Cancer
Keywords: rectal cancer with neoadjuvant treatment
standardized clinical tests
tumor markers on tumor tissue
Lead sponsor: St. Claraspital AG
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: group is selected from a single institution ( community hospital)

Brief summary: The purpose of this study is to determine whether markers on tumor tissue may be an indicator for good response to neoadjuvant chemoradiotherapy in patients with rectal cancer.


Eligibility criteria: Inclusion Criteria:

* locally advanced rectal cancer uT3 or uT4
* no distant metastasis
* neoadjuvant radiochemotherapy required

Exclusion Criteria:

* rejection of radiochemotherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St. Claraspital, Chirurgische Klinik
Study officials:
References:
Clinical trial NCT05320055: Pain and Readmission After Lap IPOM vs. Robotic Ventral Hernia Repair
Official title: Less Postoperative Pain and Length of Stay After Robotic-assisted Laparoscopic Transabdominal Repair With Retro Rectus Mesh Placement (rTARUP) Compared With Laparoscopic Intraperitoneal Onlay Mesh Repair (IPOM) for Small and Medium-sized Ventral Hernias
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Ventral
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population is all patients referred from primary sector and eligible for laparoscopic primary ventral or incisional hernia repair

Brief summary: Comparison of results after rTARUP and lap IPOM in patients with small- and medium-sized ventral hernia. Retrospective cohort study of consecutive patients undergoing rTARUP or IPOM repair for small or medium-sized primary ventral and incisional hernias. The primary outcome was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter, secondary outcomes were 30-day complications, and length of stay. All patients underwent elective surgery and were followed for 30 days postoperatively.

Detailed description: Single-center retrospective cohort study of consecutive patients undergoing rTARUP or IPOM repair for small or medium-sized primary ventral and incisional hernias. The primary outcome was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter, secondary outcomes were 30-day complications, and length of stay. All patients underwent elective surgery and were followed for 30 days postoperatively.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing elective minimally invasive repair for small or medium-sized primary ventral or incisional hernia repairs at one academic hernia center with an unrestricted patient referral.

Consecutive patients undergoing IPOM (December 1st, 2017 - December 1st, 2018) and rTARUPrRetrorectus (March 1st, 2021 - June 1st, 2021).

Exclusion Criteria:

* open repairs

Primary outcomes:
measure: epidural blockade or TAP block
timeFrame: 0-1 postoperative day
Secondary outcomes:
measure: readmissison
timeFrame: 30 days
measure: complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: University of Copenhagen, Bispebjerg Hospital
name: Mette Willaume, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christoffersen MW, Jorgensen LN, Jensen KK. Less postoperative pain and shorter length of stay after robot-assisted retrorectus hernia repair (rRetrorectus) compared with laparoscopic intraperitoneal onlay mesh repair (IPOM) for small or medium-sized ventral hernias. Surg Endosc. 2023 Feb;37(2):1053-1059. doi: 10.1007/s00464-022-09608-w. Epub 2022 Sep 15.
Clinical trial NCT03125655: Regulation of Inflammatory Genes in Psoriasis
Official title: Regulation of Inflammatory Genes in Psoriasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis
Inflammation
Keywords: cytokines
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 13
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects 19 and older will be recruited from the Dermatology clinics at UAB

Brief summary: Psoriasis is a chronic and recurrent skin disorder characterized by marked inflammatory changes in the skin. An extensive cytokine network including generated by activated dendritic cells and T cells mediates the formation of psoriatic lesions. These immune-response parameters can be used as markers in the severity and management of the disease after further in-depth studies.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of psoriasis
* Must be age 19 or older.
* Must be Fitzpatrick skin type I, II, III, IV, V, VI.

Exclusion Criteria:

* Subjects who do not have photosensitive disease and are not on photosensitizing medications.
* Subjects with a history of keloids (who are more likely to develop hypertrophic scars following skin biopsy).
* Subjects who have an allergy to local anesthetics, antibiotics and/or anticoagulants.
* Subjects who are pregnant.

Primary outcomes:
measure: Inflammatory genes
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Kirklin Clinic
state: Alabama
Study officials:
References:
Clinical trial NCT03722355: Hyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma
Official title: A Phase III Comparison of Hyperfractionated Radiation Therapy (RT) With BCNU and Conventional RT With BCNU for Supratentorial Malignant Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glioma
Glioblastoma Multiforme
Astrocytoma
Keywords: Glioma
Glioblastoma
Glioblastoma multiforme
Astrocytoma
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
First posted: 2018-10-26
Enrollment: 712
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: Hyperfractionated radiation therapy (RT) to 72.0 Gy with BCNU will be compared to conventional radiation therapy to 60.0 Gy with BCNU to determine if hyperfractionated RT can improve the median survival time of adults with supratentorial malignant gliomas.


Eligibility criteria: Inclusion Criteria:

* Histopathologically confirmed glioblastoma multiforme (with areas of necrosis), malignant astrocytoma and astrocytoma with foci of anaplasia
* Karnofsky Performance Score ≥ 60
* Absolute Neutrophil count ≥ 1,500
* Platelets ≥ 100,000
* BUN ≤ 25
* Creatinine ≤ 1.5
* Bilirubin ≤ 2.0
* Hemoglobin ≥ 10 gm
* SGOT \< 2 x upper limit of normal
* SGPT \< 2 x upper limit of normal

Exclusion Criteria:

* No prior radiation to the head or neck area, chemotherapy or radiosensitizer
* No malignancy with the past five years except non-melanomatous skin cancer or carcinoma in-situ of the cervix

Primary outcomes:
measure: Overall Survival
timeFrame: From randomization to the date of death or last follow up, assessed up to 131 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Radiation Therapy Oncology Group
name: Walter J Curran, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00240955: Extension Study of Enteric-coated Mycophenolate Sodium With Short-term or no Steroid Use Compared With Enteric-coated Mycophenolate Sodium With Standard Steroid Therapy in de Novo Kidney Recipients
Official title: Efficacy and Safety of Two Immunosuppressive Regimens Mycophenolate Sodium (EC-MPS) With Short-term Steroid Use or Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Keywords: Renal/Kidney, Transplantation, steroids, EC-MPS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the long-term safety and tolerability of EC-MPS on the patients who completed the core study and wish to continue treatment on EC-MPS.


Eligibility criteria: Inclusion Criteria/ Exclusion Criteria

* All patients who completed the core study and who are still receiving the EC-MPS and wish continue treatment with EC-MPS and from whom written informed consent has been obtained

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Safety and tolerability of enteric-coated mycophenolate sodium based on adverse event (AE) reporting.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT04038255: Mindfulness Based Smoking Cessation Among Cancer Survivors
Official title: Smartphone Application Versus Group Mindfulness-based Smoking Cessation Intervention for Cancer Patients and Survivors: Reach Versus Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Smoking
Keywords: cancer
nicotine replacement therapy
mindfulness
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 18
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 study will examine the effect of a mindfulness-based smoking cessation program among cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Be 18 years and older
* Cancer survivors (based on the NCI definition - "a person is considered to be a survivor from the time of diagnosis until the end of life" National Cancer Institute Dictionary of Cancer Terms, 2014)
* Cancer patients currently in active treatment
* Have smoked ≥ 5 cigarettes/day in the past year
* Be interested in making a quit attempt in the next 30 days
* Own a smartphone (apple/android)
* Read/speak English
* Able to consent
* Have no plans to move in the next 3 months
* Are not pregnant or planning to be pregnant in the following 3 months

Exclusion Criteria:

* Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
* Have cognitive/mental health impairment that inhibits mindfulness treatment
* Are currently being treated for smoking cessation, alcoholism, or illicit drug use
* Are adults unable to consent
* Are individuals who are not yet adults
* Are pregnant women
* Are prisoners

Primary outcomes:
measure: Number of participants with confirmed smoking abstinence
timeFrame: 3 months
Secondary outcomes:
measure: Change in number of cigarettes smoked per day
timeFrame: Baseline, 3 months
measure: Number of participants with reported relapse
timeFrame: 3 months
measure: Usability of the Craving-to-Quit app as assessed by the number of times participant logged in the app
timeFrame: 3 months
measure: Usability of the Craving-to-Quit app as assessed by the number of days of completed app use
timeFrame: 3 months
measure: Usability of the Craving-to-Quit app as assessed by the comfortability with the app
timeFrame: 3 months
measure: Acceptability
timeFrame: 3 months
measure: Feasibility of recruitment as assessed via enrollment rate
timeFrame: Baseline
measure: Attrition
timeFrame: 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: University of Miami
name: Taghrid Asfar, MD
role: PRINCIPAL_INVESTIGATOR
References: