louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06993870: Phase I Study of HBT-708 for Patients With Advanced Solid Tumors
Official title: A Phase I Study to Evaluate the Safety, Tolerability, and Initial Efficacy of HBT-708 Monotherapy for Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: solid tumors
Lead sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2025-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be to evaluate the safety, tolerability, and inital efficacy of HBT-708 in subjects with advanced solid tumors.

Detailed description: This study is a study of HBT-708 monotherapy in advanced solid tumors. This study includes dose-escalation and dose-expansion cohort, with the accelerated titration combined 3+3 dose escalation method. The administration frequencies of HBT-708 is Q3W i.v. All cohorts will assess the efficacy and safety of the preset several dose levels of HBT-708 in advanced solid tumors.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects, age 18 years or older.
2. Histologically and/or cytologically documented advanced or measurable solid tumors.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Life expectancey \> = 3 months.
5. Willingness to provide written informed consent for the study.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Subjects must have recovered (≤ Grade 1 or pretherapy baseline) from AEs due to previously administered therapies. (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to HBT-708 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Number of participants with any treatment-emergent adverse event (TEAE) and dose-limiting toxicities
timeFrame: up to 24 months (every cycle visit, each cycle is 21 days)
measure: Determine the maximum tolerated dose (MTD) and the maximum administration dose
timeFrame: up to 24 months (every cycle visit, each cycle is 21 days)
Secondary outcomes:
measure: the plasma concentration of HBT-708
timeFrame: Cycle1Day1, Cycle1Day2, Cycle1Day4, Cycle1Day8, Cycle1Day15; Cycle2 Day1; Cycle3 Day1, Cycle3Day2, Cycle3Day4, Cycle3Day8, Cycle3Day15; then Day 1 of every 2 cycles ( each cycle is 21 days)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01770470: Chitosan Chewing Gum Study in Dialysis Patients
Official title: A Pilot Study of Dietary Chitosan Chewing Gum in Dialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Keywords: serum phosphate
chitosan
kidney disease
salivary phosphate
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient hemodialysis facility

Brief summary: The purpose of the pilot study is to determine the impact of short-term administration of chitosan-containing chewing gum on phosphate levels in patients with elevated serum phosphate levels.

Detailed description: The impact of using salivary phosphate binders in ESRD patients is not fully known. The purpose of the pilot study is to determine the impact of short-term administration of chitosan-containing chewing gum on phosphate levels in patients with elevated serum phosphate levels.

Eligibility criteria: Inclusion Criteria:

* Age 18-64 years old
* ESRD receiving hemodialysis
* serum phosphate \> 6.0 mg/dL

Exclusion Criteria:

* Unable to sign consent

Primary outcomes:
measure: Serum phosphate
timeFrame: 6 weeks
Secondary outcomes:
measure: Salivary phosphate levels
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Thomas Dowling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01718470: Proseal Laryngeal Mask Airway or Endotracheal Tube for Emergence From Neuroanesthesia
Official title: Proseal Laryngeal Mask Airway Attenuates Systemic and Cerebral Hemodynamic Response During Awakening of Neurosurgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension on Emergence
Keywords: Systolic blood pressure
Heart rate
Laryngeal mask
Endotracheal tube
craniotomy
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
Collaborators: name: Fundacion Clinic per a la Recerca Biomédica
First posted: 2012-10-31
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Extubation and emergence from anesthesia lead to systemic and cerebral hemodynamic changes that can cause cerebral edema and hemorrhage. The hemodynamic profile on emergence is more favorable if a laryngeal mask airway (LMA) is inserted before neurosurgical patients emerge from anesthesia. We aimed to compare the impact of awakening neurosurgery patients after insertion of a ProSeal LMA to replace the endotracheal tube (ETT).

Detailed description: At the end of surgery, the anesthesiologist opened a sealed envelope labeled with software-generated randomized numbers to learn the patient's assignment to one of two groups to emerge from anesthesia with the ETT still in place or after it had been replaced by an LMA.

Hemodynamic variables were recorded at 8 moments: baseline, in the operating room one minute before anesthetic induction; 5 minutes after the end of surgery before awakening (ETT group) or before tube replacement (LMA group); and 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).

Eligibility criteria: Inclusion Criteria:

* Elective craniotomy

Exclusion Criteria:

* Difficult airway
* Uncontrolled hypertension before surgery
* gastroesophageal reflux

Primary outcomes:
measure: systolic blood pressure change
timeFrame: 1 minute before anesthesia induction, 5 minutes before extubation, and minute 1, 5, 10, 15, 30 and 60 after extubation
Secondary outcomes:
measure: heart rate change
timeFrame: 1 minute before anesthesia induction, 5 minutes before extubation, and minutes 1,5,10,15,30 and 60 after extubation
Other outcomes:
measure: Norepinephrine plasma concentration change
timeFrame: 1 minute before anesthesia induction, 1 minute and 30 minutes after extubation,
Locations:
city: Barcelona
country: Spain
facility: Anesthesia department, Hospital Clínic de Barcelona
Study officials:
affiliation: Anesthesia Specialist, Anesthesia department, Hospital Clínic de Barcelona
name: Perelló Laura, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruder N, Stordeur JM, Ravussin P, Valli M, Dufour H, Bruguerolle B, Francois G. Metabolic and hemodynamic changes during recovery and tracheal extubation in neurosurgical patients: immediate versus delayed recovery. Anesth Analg. 1999 Sep;89(3):674-8. doi: 10.1097/00000539-199909000-00027.
Clinical trial NCT06735170: Tuberoplasty Versus Balloon Spacer
Official title: Tuberoplasty Versus Balloon Spacer in Treatment of Rotator Cuff Tears
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Rotator Cuff Tears
Keywords: rotator cuff tear
shoulder surgery
tuberoplasty
subacromial balloon spacer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two armed study with each arm receiving one of two interventions: biologic tuberoplasty procedure or subacromial balloon spacer
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine bone-to-bone contact between the tuberosity as compared to a subacromial balloon spacer procedure. Using biplanar fluoroscopy to determine the three-dimensional (3D) motion of the shoulder compared pre-procedure to post-procedure, the investigators will be able to assess 1) the bone-to-bone contact of the tuberosity and acromion in the setting of a massive posterior superior rotator cuff tear 2) if the placement of a dermal allograft over the tuberosity does indeed decrease bone contact and 3) if the placement of a subacromial balloon spacer decreases bone-to-bone contact. Doing so will allow assessment of the relative contribution of the implant for arm elevation versus potential compensatory motion of increased scapulothoracic motion. The investigators will also be able to correlate this to patient-reported outcomes of pain and shoulder function.


Eligibility criteria: Inclusion Criteria:

* Massive irreparable rotator cuff tear involving the supraspinatus and infraspinatus.
* No involvement of the subscapularis.
* Centered humeral head on X-ray examination.
* Primary complaint of pain.
* History of prior surgery, including failed rotator cuff repair.

Exclusion Criteria:

* Involvement of the subscapularis.
* Acromiohumeral distance less than 7 mm on upright anterior-posterior (AP) radiograph.
* Rotator cuff deemed repairable at the time of surgery.
* Patients younger than 65 years due to FDA clearance of the subacromial balloon spacer only for patients over 65

Primary outcomes:
measure: change in bone-to-bone contact between tuberosity and acromion
timeFrame: presurgery, 6 months postop, 12 months postop
measure: shoulder range of motion
timeFrame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
measure: single assessment numerical evaluation (SANE) of the shoulder
timeFrame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
measure: American shoulder and elbow surgeons (ASES) score
timeFrame: presurgery, 1 week, 6 weeks, 3 months, 6 months, and 12 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Allison Rao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03690570: Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015
Official title: Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Keywords: Glioma
Children
Chemotherapy
treatment toxicitT
Survival
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 5 years old with high grade glioma (WHO status III or IV)

Brief summary: High grade glioma is a rare disorder affecting children at all ages with a high mortality rate. Overall survival is estimated at 40%, depending on the type of treatment administered. Major late sequelaes are experienced with the irradiation in this population under 5 years. Therefore, the current recommendations by The French Society for Childhood Cancers are based on a treatment including surgery followed by chemotherapy and avoiding radiotherapy as long as patients present no sign of treatment failure. The results published in 2006, underlying the fact that some patients treated exclusively with surgical resection and chemotherapy can achieve long term survival, are showing evidence of an acceptable long-term strategy. Few studies concerning evaluation of treatment toxicity and long term outcomes are available. Therefore, it is important to collect retrospective data concerning those small patients with high grade glioma in order to understand the reasons of treatment success or failure and treatment toxicities. This retrospective study will evaluate long term survivals comparatively to clinical, radiological and histological features at diagnosis and the treatment toxicities including neurological, endocrine and hearing impairment to go further and propose new potential guidelines and chemotherapy schedules


Eligibility criteria: Inclusion Criteria:

* Children under 5 years old
* High grade glioma (WHO status III or IV)
* No previous treatment with chemotherapy or radiotherapy
* No contraindication to chemotherapy
* Consent of legal representative for participation in the study

Exclusion Criteria:

* Low grade glioma
* Any other histological pattern
* Parent's denial to access data concerning their child in the frame of medical research

Primary outcomes:
measure: Assessment of patient survival associated with relapse rate after surgery
timeFrame: 10 years
measure: Assessment of patient survival associated with relapse rate after chemotherapy
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pédiatrie 3
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Natacha ENTZ-WERLE, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01293370: Important Factors in Integration of Vocational Rehabilitation in Mental Health
Official title: Important Factors in Integration of Vocational Rehabilitation in Mental Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Patients Experiences of Vocational Rehabilitation During Admittance in Hospital
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted or discharged hospital patient, who also receives vocational rehabilitation

Brief summary: The purpose of this study is to explore, through a qualitative approach, how a group of people with serious mental illness experienced the integration of a vocational rehabilitation intervention during their admittance in hospital.

Detailed description: People with serious mental illness admitted to hospital face significant barriers to gain both education and employment. Norway is a high-income welfare society with low unemployment rates, but the employment rates are very high in the population with psychosis and schizophrenia. Norway have a strategy for work and mental health, and through this strategy, the government has supported some pilot projects which focus on new ways of supporting people with serious mental illness in gaining employment. This study focuses on a representative sample participating in a pilot study. The sample consists of admitted patients who have received vocational rehabilitation under admittance. The study design is qualitative in nature with open- ended questions to allow the sample to express their opinions, attitudes and thoughts about the assistance they have had during their rehabilitation stay in hospital.

Eligibility criteria: Inclusion Criteria:

* Formerly and present admitted patients in the Rehabilitation ward who participated in a project with vocational rehabilitation.

Exclusion Criteria:

* Mental retardation

Primary outcomes:
measure: Increase the understanding of the issues faced by people with serious mental illness who want to gain or maintain employment through vocational rehabilitation
timeFrame: From February 2011 - April 2011
Secondary outcomes:
measure: Identify the obstacles that people with serious mental illness face within the service delivery system on their pathway to gain employment
timeFrame: February 2011 - April 2011
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Nordland Hospital trust
state: Nordland County
Study officials:
affiliation: University of Northern Norway
name: Knut Sørgård, Dr.philos
role: STUDY_DIRECTOR
References:
Clinical trial NCT06992570: Risk Assessment of Mild Traumatic Brain Injury in Military Training
Official title: Identification and Risk Assessment of Mild Traumatic Brain Injury (mTBI) in Czech Armed Forces Soldiers During Specific Training Activities
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma, Brain
Keywords: mTBI
Biomechanics
Military Training
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Military University Hospital, Prague
First posted: 2025-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The SNIPER-TBI study aims to identify and quantify the risk of mild traumatic brain injury (mTBI) in soldiers of the Czech Armed Forces during specific high-risk training activities, including parachute jumps, high-caliber firearms shooting, artillery blasts, and Close Quarters Battle (CQB) exercises. The study will utilize both diagnostic biomarker analysis and experimental biomechanical measurements to assess the physiological impact of these activities on brain health. The ultimate goal is to reduce mTBI incidence, improve operational readiness, and extend the active service duration of soldiers through targeted preventive measures.

Detailed description: The SNIPER-TBI study aims to quantify the risk of mild traumatic brain injury (mTBI) in Czech Armed Forces soldiers during high-risk training activities, including parachute jumps, high-caliber firearms shooting, artillery blasts, and Close Quarters Battle (CQB) exercises. The study combines diagnostic biomarker analysis (GFAP, UCH-L1) and experimental biomechanical measurements using wearable sensors and high-speed cameras. These data will provide critical insights into the forces exerted on the brain during training and help establish exposure limits to minimize long-term neurological impairment. The results will guide the development of protective strategies and enhance soldier readiness.

Eligibility criteria: Inclusion Criteria:

* Age 18-50 years
* Active-duty military personnel
* Participating in designated high-risk training activities

Exclusion Criteria:

* History of significant brain injury
* Current neurological disorders
* Use of anticoagulant medications

Primary outcomes:
measure: Quantification of mTBI Risk 1
timeFrame: Up to 24 hours post-exposure
measure: Quantification of mTBI Risk 2
timeFrame: Up to 24 hours post-exposure
measure: Biomechanical Analysis of Head Impact Forces 1
timeFrame: Baseline
measure: Biomechanical Analysis of Head Impact Forces 2
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Military University Hospital Prague
state: Czech Republic
Study officials:
affiliation: Military University Hospital, Prague
name: Michal Soták, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00705770: A Multi-Dose Study With a Treatment for Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Open-Angle Glaucoma
Keywords: Open-Angle Glaucoma
Intraocular Pressure
Anecortave Acetate
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 0
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: The purpose of this study is to determine whether Anecortave Acetate is effective for lowering intraocular pressure caused by open-angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years old with a clinical diagnosis of Open-Angle Glaucoma for at least 6 months and currently treated with a monotherapy hypotensive medication

Exclusion Criteria:

* Prior angle surgery in the study eye, severe visual field loss in either eye, and any other form of glaucoma besides open-angle glaucoma

Primary outcomes:
measure: Mean Intraocular Pressure
timeFrame: 6 months
Secondary outcomes:
measure: Percent of patients with therapeutic benefit, number and percent of treatment failure and time to treatment failure
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06109870: Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening
Official title: Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HPV
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cervical cancer is a disease that is preventable through vaccination against the virus that causes it, human papillomavirus (HPV), and through screening and treatment of cervical disease before it becomes cancet.

Detailed description: Primary Objectives:

The overall purpose of this protocol is to evaluate the feasibility and acceptability of CHW-delivered selfsample HPV testing (CHW-SS) to increase cervical cancer screening among women in RGV and other low- resource communities in Texas.

The specific aims of this protocol are to:

Specific Aim 1: Determine the feasibility of CHW-SS in the RGV and other low-resource communities in Texas (i.e., reach, screening uptake, notification of test results).

Specific Aim 2: Assess the acceptability and experiences of CHW-SS among under screened persons in rural, persistent poverty communities in the RGV and other low-resource communities in Texas.

Secondary Objectives:

Exploratory Aim 3: Assess attendance for clinical follow-up among individuals who participate in CHW-SS and test positive for HR-HPV.

Exploratory Aim 4: Evaluate contextual fit of the intervention.

Eligibility criteria: Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following criteria:

* Provision of signed and dated informed consent form
* Currently resident in RGV or other low-resource community in Texas
* Stated willingness to comply with all study procedures
* Females; Age ≥25 years
* Have no history of hysterectomy with removal of the cervix
* Have no history of cervical cancer or high-grade dysplasia
* Have not had a Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Unable to communicate in English or Spanish
* Lack valid telephone contact information
* Report being currently pregnant.

Primary outcomes:
measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
timeFrame: through study completion; an average 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jane Montealegre, M D
role: PRINCIPAL_INVESTIGATOR
References: