louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06670495: HPV Genotype Attribution and Disease Burden of Anal Cancer in China
Official title: Understanding the Human Papillomavirus Genotype Attribution and Disease Burden of Anal Cancer in China: a Multicenter Hospital-based Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anal Cancer
Keywords: HPV prevalence
HPV genotype
Anal cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients with anal canal cancer: patients with anal canal cancer originating from the superior border of the functional anal canal (separated from the rectum) and defined as the palpable upper border of the anal sphincter and puborectalis muscles of the anorectal ring. It is approximately 3 to 5 cm in length, and its inferior border starts at the anal verge, the lowermost edge of the sphincter muscles, corresponding to the introitus of the anal orifice.
2. Patients with perianal cancer: The perianal region starts at the anal verge and includes the perianal skin over a 5-cm radius from the squamous mucocutaneous junction

Brief summary: To demonstrate HPV prevalence and its genotype distributions in anal cancer in China and to describe demographic and clinical features of HPV-related anal cancer in China; To describe the epidemiological characteristics ,trends and of disease burden of anal cancer in China


Eligibility criteria: Inclusion Criteria:

* (1) Patients diagnosed with anal cancers, (2) Patients without radiation or chemotherapy prior to specimen collection;

Exclusion Criteria:

* (1) Patients with HIV infection, (2) Patients with immunosuppression after solid organ transplantation, (3) Those who do not agree to specimen collection and testing, (4) For retrospective study cases, those who without specimen.

Primary outcomes:
measure: Prevalence and types of distribution of HPV
timeFrame: From enrollment to pre-treatment
measure: Incidence of anal-cancers-associated complications
timeFrame: From enrollment to pre-treatment
measure: Routine laboratory testing results
timeFrame: From enrollment to pre-treatment
Secondary outcomes:
measure: Incidence rates of anal cancer in China
timeFrame: From enrollment to pre-treatment
measure: Mortality rate of anal cancer in China
timeFrame: From enrollment to pre-treatment
measure: Annual percentage changes (APCs) and average APCs (AAPCs)
timeFrame: From enrollment to pre-treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05900895: Estradiol Plus Olaparib for Breast Cancer (PHOEBE)
Official title: Phase 1b Study of Olaparib and Estradiol in Advanced ER+ Breast Cancer (PHOEBE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Keywords: metastatic
locally advanced
estradiol therapy
olaparib
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth-Hitchcock Medical Center
First posted: 2023-06-13
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Single-arm, 3+3 design with a dose-expansion cohort.
Primary purpose: TREATMENT

Brief summary: Determine the safety and recommended Phase II dose of olaparib in combination with 17b-estradiol in post-menopausal patients with advanced ER+/HER2- breast cancer.

Detailed description: Patients with endocrine-resistant ER+/HER2- breast cancer are eligible. Patients will be treated with the combination of 17b-estradiol and olaparib for 2 cycles, and then treated with single-agent 17b-estradiol until disease progression. Clinical benefit, progression-free survival, objective response, tumor metabolic response, and toxicity will be determined.

Eligibility criteria: Inclusion Criteria:

* Post-menopausal women with ER+/HER2- breast cancer.
* Metastatic or locoregional recurrence not amenable to treatment with curative intent.
* Received ≥1 prior line of endocrine-based therapy in the advanced/metastatic setting.

Exclusion Criteria:

* During study treatment, no concurrent anti-cancer therapies are allowed with the following exceptions:

  o Anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) permitted.
* Any investigational cancer therapy or systemic chemotherapy in the last 3 weeks.
* Any radiation therapy in the last 2 weeks.
* Known CNS disease, unless clinically stable for ≥ 3 months.
* Concomitant use of known strong or moderate CYP3A inhibitors.
* Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy.
* History of any of the following:

  * Deep venous thrombosis
  * Pulmonary embolism
  * Stroke
  * Acute myocardial infarction
  * Congestive heart failure
  * Previous malignancy not treated with curative intent, or with an estimated recurrence risk ≥30%
  * Severe renal impairment (creatinine clearance ≤ 30 mL/min).

Primary outcomes:
measure: Determine the Phase II dose of olaparib in combination with 17b-estradiol
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical benefit rate
timeFrame: 6 months
measure: Objective response rate
timeFrame: 6 months
measure: Progression-free survival
timeFrame: 12 months
measure: Plasma Olaparib concentration
timeFrame: 6 hours
measure: Plasma 17b-Estradiol/Estrone concentration
timeFrame: 6 hours
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Cancer Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Mary Chamberlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07013695: Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery
Official title: Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthopedic Procedure
Anesthesia
Sedation
Lead sponsor: Centre Hospitalier Eure-Seine
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel-group study with two arms (virtual reality group vs. control group) comparing the effect of virtual reality on sedation use during regional anesthesia.
Primary purpose: OTHER

Brief summary: The VIRTUALR study evaluates the effect of virtual reality combined with hypnosis on anxiety in patients undergoing orthopedic surgery under regional anesthesia. Patients are randomly assigned to two groups: one group receiving virtual reality and a control group without the device. Anxiety and satisfaction questionnaires are used to compare the two groups.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Patient affiliated with or benefiting from a social security system
* Patient aged 18 years or older
* Patient requiring regional anesthesia for scheduled orthopedic surgery of the upper or lower limb

Exclusion Criteria:

* Patient refusal to participate in the study
* Device interfering with the surgical or anesthetic procedure
* Premedication before arrival in the operating room
* Psychiatric or cognitive disorders, communication disorders
* Patient unable to understand the study (language barrier, psychological issues)
* Emergency surgery

Primary outcomes:
measure: Comparison of sedation use rates between the experimental group and the control group (level 0 versus ≥1).
timeFrame: Intraoperative period (from arrival in the operating room to the end of surgery)
Secondary outcomes:
measure: Mean age of patients
timeFrame: Baseline (before anesthesia consultation or at inclusion)
measure: Sex distribution
timeFrame: Baseline (before anesthesia consultation or at inclusion)
measure: type of surgery
timeFrame: Baseline (before anesthesia consultation or at inclusion)
measure: ASA score distribution
timeFrame: Baseline (before anesthesia consultation or at inclusion)
Other outcomes:
Locations:
city: Evreux
country: France
facility: Centre Hospitalier Eure-Seine
Study officials:
affiliation: Centre Hospitalier Eure-Seine
name: Jean-Baptiste HARDY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03753295: The Effect of BMI on Hand Grip Force in Healthy Adults
Official title: The Effect of BMI on Hand Grip Force in Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Motor Activity
Overweight and Obesity
Hand Injuries
Keywords: BMI, Hand Grip, Healthy Adults
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
Collaborators: name: Cairo University
First posted: 2018-11-26
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 90 healthy male and female students with age 19 to 25 years old, and right dominant hand, will be recruited from the College of Applied Medical Sciences, Jazan University.

Brief summary: This study will be conducted to investigate the effect of BMI on hand grip force in healthy subjects. The participants in this study will be 90 healthy subjects with right dominant lower limb (49 females and 49 males) they will be recruited from College of Applied Medical Sciences, Jazan University.

Detailed description: Subjects will be categorized according to BMI into three groups:

Group I (normal subjects): 30 individuals (15 male, and 15 female students) with (BMI\<25 kg/m2) Group II (overweight subjects): 30 individuals (15 male, and 15 female students) with (BMI, 25-30 kg/m2).

Group III (obese subjects): 30 individuals (15 male, and 15 female students) (BMI\>30 kg/m2).

Baseline hydraulic hand dynamometer: (Fabrication Enterprises Incorporated, White Plains,New York, USA) will be used to measure the hand grip strength and pinch strength

Eligibility criteria: Inclusion Criteria:

1. Subjects would not have any diseases of the central nervous system.
2. Subjects would not have any orthopedic disorders either of the trunk or the lower limbs in the previous year.
3. None of the subjects has history of balance training ( Erkmen et al., 2010, Li Li, 2012) .

Exclusion Criteria:

1. Sign of foot pain, reduced tactile and thermal foot sensibility.
2. Peripheral neuropathy.
3. A history of previous back or abdominal surgery/injury
4. A history of patellofemoral pain syndrome, plantar fasciitis, and back pain .
5. Limb-length discrepancy, and anterior or posterior tibialis dysfunction.
6. Evidence of a systemic or musculoskeletal disease within the past six months (AlAbdulwahab \& Kachanathu, 2016).

Primary outcomes:
measure: Hand Grip Force of the Right Dominant Hand in The Three Groups
timeFrame: 10 minutes
measure: Comparison of Hand Grip Force between Both Arms in three Groups
timeFrame: 20 minutes
Secondary outcomes:
measure: the effect of gender on the hand grip
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Jazan University
state: Jazan
Study officials:
References:
Clinical trial NCT01630395: The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery
Official title: The Effect of Recruitment Maneuver With Protective Ventilation on the Pulmonary and Systemic Inflammatory Response to One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Thoracic Surgery
Inflammation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if a recruitment maneuver combined with protective ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to one-lung ventilation during thoracic surgery.


Eligibility criteria: Inclusion Criteria:

* 20 Years and older
* Patients undergoing thoracic surgery

Exclusion Criteria:

* Emergency surgery
* Heart failure
* Pulmonary hypertension
* Forced vital capacity or forced expiratory volume in 1 sec \< 50% of the predicted values
* Coagulation disorder
* Pulmonary or extrapulmonary infections
* History of treatment with steroid in 3 months before surgery
* History of recurrent pneumothorax
* History of lung resection surgery

Primary outcomes:
measure: Levels of IL-8, TNFa in the bronchoalveolar lavage
timeFrame: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
Secondary outcomes:
measure: Levels of IL-1, IL-6, IL-10 in the bronchoalveolar lavage
timeFrame: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
measure: plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa
timeFrame: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
measure: oxygenation
timeFrame: 1 hour after extubation
measure: Chest-X ray
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03763695: Effectiveness of a VAP Prevention Bundle in the PICU
Official title: Effectiveness of a Bundle of Ventilator Associated Pneumonia (VAP) Prevention in the Pediatric Intensive Care Unit (PICU): an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator Associated Pneumonia
Keywords: Pediatric intensive care unit
Oral Hygiene Care
Chlorhexidine
Broncho-alveolar lavage
Pharyngeal swab
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Ilaria Vitali
name: Antonio Maria Dell Anna
name: Leonardo Dassatti
name: Giuseppe Bello
name: Giorgio Conti
name: Antonio D Addona
First posted: 2018-12-04
Enrollment: 242
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients admitted to our ICU requiring mechanical ventilation for more than 48 hours

Brief summary: This observational monocentric prospective study aims to evaluate the efficacy of new measures for ventilator associated pneumonia (VAP) management in the pediatric population in the pediatric intensive care unit (PICU) of Fondazione Policlinico Agostino Gemelli of 8 beds. The investigators will compare the incidence of VAP in the group of patients in which this protocol has been implemented to a retrospective control group of patients before the new protocol implementation. VAP bundle includes oral care hygiene measures (i.e chlorhexidine swab), to keep clean and dry ventilator circuits and head positioning at 45 degrees.


Eligibility criteria: Inclusion Criteria:

* age \< 18 years
* patients receiving mechanical ventilation for more than 48 hours

Exclusion Criteria:

* no informed consent
* pregnancy
* previous endotracheal antibiotic therapy

Primary outcomes:
measure: VAP incidence
timeFrame: From 48 hours after intubation to 48 hours after extubation
Secondary outcomes:
measure: Prevalence of orotracheal bacterial colonization in ventilated patients
timeFrame: From 48 hours after intubation to 48 hours after extubation
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
state: RM
Study officials:
affiliation: Università Cattolica del Sacro Cuore; Fondazione Policlinico Universitario Agostino Gemelli; IRCCS
name: Giorgio Conti, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05755295: Horse Therapy for Children, Adolescents and Young Adults in Remission From Medulloblastoma
Official title: Pilot Study Evaluating Feasibility and Acceptability of Horse Therapy for Children, Adolescents and Young Adults in Remission From Medulloblastoma and Describing the Evolution of Their Physical and Psychological Characteristics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuroblastoma
Keywords: hippotherapy
equitherapy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: On average, each year in the former region, 60 new patients under the age of 18 are treated for a brain tumor, with an active post-treatment follow-up file of 350 patients. Because of the significant sequelae induced by the disease or the treatments, these patients will very often require rehabilitative care.

The interest of involving the horse in the population of patients cured of a medulloblastoma but with important physical and psychological after-effects is to be able to combine a therapy using animal mediation (equitherapy) and a rehabilitation therapy based on the three-dimensional movement of the horse (hippotherapy).


Eligibility criteria: Inclusion Criteria:

* complete remission of medulloblastoma and after 5 years of the end of treatment
* living within 30 km away the riding center and/or less than 1 hour of transport
* informed consent

Exclusion Criteria:

* Landsky score below 50% for minors until 16 years old and Karnofsky score below 50% for patients over 16 years
* major under juridical protection

Primary outcomes:
measure: number of sessions performed
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Anne-Isabelle BERTOZZI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00552695: Lidocaine Patches Prior to Intravenous Insertion
Official title: Phase II Study of Lidoderm Patches Prior to Intravenous Catheter Insertion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Need for Intravenous Catheter
Keywords: intravenous catheter
emergency department
pain
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2007-11-02
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine whether application of a patch containing a topical anesthetic (numbing medicine) named lidocaine can reduce the pain of subsequent insertion of an intravenous catheter in Emergency Department patients.

Detailed description: Patients will be randomly assigned to an active lidocaine patch or a patch that conatins a placebo or inactive agent. Neither the patient nor the practitioner will know which patch is used since they will appear identical.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 3,
* Need for non-emergent intravenous catheter

Exclusion Criteria:

* Unstable patients,
* Allergy to lidocaine or tetracaine

Primary outcomes:
measure: Pain on Visual Analog Scale (VAS)
timeFrame: 0 MINUTES
Secondary outcomes:
measure: Success of Intravenous (IV) Insertion
timeFrame: After first attempt of catheter insertion
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook University
name: Adam J Singer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01892995: Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial
Official title: Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide
Keywords: suicide
ketamine
low-dose ketamine
suicidal ideations
emergency department
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2013-07-08
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will enroll patients presenting to the emergency department with acute suicidal ideation meeting inclusion and exclusion criteria. Patients will be randomized to one of three arms: ketamine (intervention) or diphenhydramine (control) or placebo (control). Serial measurements will be made in the ED and at follow-up intervals.


Eligibility criteria: Inclusion Criteria:

* Patients age 18 to less than 75 who present to the SAMMC ED with either overt or incidental suicidal ideations with a SADPERSONS score 5 or greater that the treating provider feels warrant formal evaluation.

Exclusion Criteria:

* -Poor vital sign stability hypoxia: O2 \< 95%, hypotension: SBP\< 90 hypertension: SBP\>180 Heart rate: \< 50 or \>120 Respiratory Rate: \<10 or \>30
* Altered mental status or intoxication
* Patient is unwilling to participate or provide informed consent
* Any allergy to ketamine or diphenhydramine
* Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis
* Pregnancy or breast feeding
* Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis
* Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias
* Presence of intracranial mass or vascular lesion.
* Presence of a history of psychosis or hallucinations (as assessed by electronic chart review)
* Weight greater than 115 kg or less than 45kg
* History of increased intracranial pressure/hypertensive hydrocephalus
* Non-English speaking patients
* Patient is acutely psychotic
* Provider feels that patient currently or likely will require chemical and/or physical restraints
* History of prolonged QT-interval

Primary outcomes:
measure: Change in Beck Scale for Suicidal Ideation
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
References: