louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05739903: Phamacokinetics and Safety Profiles of DA-1229_01 5/1000mg in Healthy Subjects at Fasting State
Official title: An Open Label, Randomized, Single Dose, Cross-over ,Two-group Study to Evaluate the Pharmacokinetics and Safety of DA-1229_01 5/1000mg in Healthy Subjects at Fasting State
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-22
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 (5/1000 mg x1 tablets) at fasting state.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* BMI between 18 and 30 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History

Primary outcomes:
measure: AUCt
timeFrame: pre-dose~96 hours post-dose
measure: Cmax
timeFrame: pre-dose~96 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Metro Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00186303: Transplantation for Patients With Chronic Lymphocytic Leukemia
Official title: Autologous and Allogeneic Peripheral Blood Progenitor (PBPC) Transplantation for Patients With Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia, Lymphocytic, Chronic
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the role of high dose therapy and autologous or allogeneic hematopoietic cell transplantation for the treatment of chronic lymphocytic leukemia.

Detailed description: To determine effectiveness of allogeneic transplantation in eradicating chronic lymphocytic leukemia.

Eligibility criteria: Inclusion Criteria:- adequate organ function

* normal bone marrow cytogenetics Exclusion Criteria:- active CNS disease
* For autologous patients more than 30% bone marrow involvement

Primary outcomes:
measure: Efficacy
Secondary outcomes:
measure: Feasibility
measure: Toxicity
measure: olymerase Chain Reaction (PCR) for minimal residual disease
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Robert S Negrin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00630903: PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides
Official title: Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
Lead sponsor: Madrilenian Group of Cutaneous Lymphomas
Sponsor class: OTHER
First posted: 2008-03-07
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if combination of PUVA with interferon alpha is better than PUVA alone to treat mycosis fungoides stage Ia Ib or IIa.


Eligibility criteria: Inclusion Criteria:

* Mycosis fungoides Stage Ia Ib IIa
* Written informed consent
* 18-70 y.o., both sex
* No concomitant systemic disease

Exclusion Criteria:

* Pregnant or lactating women
* Fertile women not accepting contraception
* Medical history of melanoma or non melanoma skin cancer
* Concomitant infections
* Immunodeficiency states
* Previous Heart disease
* Respiratory insufficiency
* Chronic RRenal insufficiency
* Chronic hepatopathy
* Epilepsy
* Depression
* Leucocytes \<3000 or neutrophiles \<1000 or thrombocytes \<100000 or hemoglobin \<12 gr/dL or ANA \<1/80
* Treatment with systemic steroids
* Altered thyroid hormones
* Previous resistance to PUVA and/or IFN
* Hypersensitivity to IFN
* Patients under treatment with teophiline and/or dicumarol
* Previous total skin electron beam
* Wash up period less than 3 month for IFN and /or PUVA
* Wash up period less than 1 month for topical treatments

Primary outcomes:
measure: Efficacy of PUVA vs PUVA + IFN
timeFrame: Weeks 4, 8, 12, 16 and 24
Secondary outcomes:
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Hospital Príncipe de Asturias.
state: Madrid
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Madrid
country: Spain
facility: Hospital de la Princess
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Gómez Ulla
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
affiliation: Hospital 12 de Octubre
name: Francisco Vanaclocha Sebastián, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Jesús Fernández Herrera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
Clinical trial NCT04369703: Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery
Official title: Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sellar and Suprasellar Masses
Pituitary Tumor
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sellar and suprasellar masses.

Brief summary: 1. Access the optimal cut point value of copeptin which predicts development of central diabetes insipidus postoperatively with highest accuracy.
2. Access the optimal cut point value of copeptin which predicts the lack of central diabetes insipidus postoperatively with highest accuracy
3. Access the relative change in copeptin values between baseline and post-surgery as a predictor for diabetes insipidus development.

Detailed description: Patient serum levels of copeptin would be measured after phlebotomy of 3 ml of blood in EDTA tube twice a) within 1-4 hours of extubation and b) within 4-24 hours of extubation (the morning following surgery).

Eligibility criteria: Inclusion Criteria:

\* Patients with sellar and suprasellar masses who undergo neurosurgical procedure at Mayo Clinic Rochester.

Exclusion Criteria:

\* Patients with preexisting CDI.

Primary outcomes:
measure: Predict central diabetes insipidus development
timeFrame: 2 years
measure: Predict lack of central diabetes insipidus development
timeFrame: 2 years
measure: Assess relative change
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dana Erickson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01326403: Tranexamic Acid in Hip Fracture Patients
Official title: Tranexamic Acid in Hip Fracture Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Closed Fracture of Hip
Keywords: proximal
hip
fractures
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel-Aviv Sourasky Medical Center
First posted: 2011-03-30
Enrollment: 60
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: This is a randomized controlled trial comparing the use of tranexamic acid to placebo in patients admitted to hospital with a hip fracture.

Detailed description: 1. transfusion of allogeneic RBC's is not free of adverse events and has been associated with an increased risk of postoperative infection
2. Tranexamic acid in trauma patients has been shown to reduce 30-day mortality. Hospital trauma protocol includes tranexamic acid in patients with major bleeding.
3. Tranexamic acid in orthopedic elective joint reconstruction surgery has been shown to substantially decrease bleeding in knee and hip arthroplasty.
4. in hip fracture surgery, transexamic acid reduces erythrocyte transfusion rate but may promote a hypercoagulable state.
5. Tranexamic acid is an antifibrinolytic drug that inhibits plasminogen from turning into plasmin thereby inhibiting clot breakdown.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the emergency room with proximal hip fractures (31A-31B according to the Muller AO classification of fractures - long bones).
* Patients mentally capable of giving informed consent.

Exclusion Criteria:

1. Vascular events within the last 2 months such as CVA, TIA, ACS, MI, DVT or arterial thrombosis.
2. Patients receiving anticoagulation therapy with Coumadin or Plavix.
3. Pregnancy and breastfeeding females.
4. Previous arterial or venous thrombosis
5. History of seizures.
6. Creatinine \>2.
7. Oestroprogestive therapy.
8. Multiple fractures.

Primary outcomes:
measure: Total amount of blood loss per patient from admission to day 5 post-op
timeFrame: 5 DAYS
Secondary outcomes:
measure: Number of packed cell transfusion per patient.
timeFrame: 5 DAYS
measure: Initial functional outcome and feeling of well-being.
timeFrame: 5 days
measure: thromboembolic events
timeFrame: 5 days
measure: post-operative bacterial infection
timeFrame: 5 days
measure: 30 day mortality rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: ELI SHTEINBERG, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00333203: Next Generation Ophthalmic Irrigating Solution Posterior Segment Study
Official title: Clinical Evaluation of the Safety of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Surgery for Removal of Epimacular Membrane and Vitrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eye Diseases
Keywords: epimacular membrane
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 369
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 evaluate the safety of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular membrane and vitrectomy.


Eligibility criteria: Inclusion Criteria:

* Patients of any race and sex, with an epimacular membrane who would benefit from vitrectomy and membrane removal.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 18 years of age.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Best-corrected logMAR visual acuity
Secondary outcomes:
measure: Intraocular pressure (IOP)
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: United States
state: Texas
Study officials:
References:
Clinical trial NCT05427903: Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis
Official title: Evaluation of Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomized Parallel Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Procedural
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is designed as a randomized parallel controlled trial with three groups. Participants aged above 18 years with the first permanent molars with symptomatic signs of irreversible pulpitis will be randomly assigned into 3 groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block) will be anesthetized using 4% articaine 1:100.000 plus cryotherapy application, and the second group (experimental group) will be anaesthetised with IANB plus buccal infiltration. For the third group (control group), the mandibular molars will be anaesthetized using epinephrine using the inferior alveolar nerve block.


Eligibility criteria: Inclusion Criteria:

* Patients aged above 18 years
* Presence of at least one mandibular first permanent molar, with signs and symptoms of irreversible pulpititis

Exclusion Criteria:

* Participants with a history of taking medications that could interfere with the action of the anaesthetic solutions
* Presence of paresthesia
* Presence of psychological problems
* Taking analgesics or other medications that would alter the inflammatory response of the pulp or provide analgesia 12 h pre-operatively

Primary outcomes:
measure: Pain assessment
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
References:
Clinical trial NCT06148103: A Comparison Between Dexmedetomidine and Propofol-fentanyl Infusions for Sedation for Colonoscopy Procedures
Official title: Sedation for Colonoscopy Procedures Using Dexmedetomidine Versus Propofol-Fentanyl Infusions: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety and Fear
Lead sponsor: Zulekha Hospitals
Sponsor class: OTHER
Collaborators: name: Al-Azhar University
First posted: 2023-11-28
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for painless sedation or monitored anesthesia care. The aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.

Detailed description: Background: Different intravenous sedative drugs have been utilized for colonoscopy, with many anesthetists for conscious sedation or monitored anesthesia care. Aim of this study was the quality of colonoscopy and the incidence of adverse events such as respiratory depression, hemodynamic instability, and failure to provide adequate sedation.

Patients and methods: Sixty patients of both sexes and 21-60 years old with ASA physical status I-II, were randomly assigned to receive either dexmedetomidine (D group) or propofol-fentanyl (PF group) infusions in equal numbers. Minimal infusion rates of dexmedetomidine (0.1-0.4 μg/kg/h) in the D group and fentanyl (0.01-0.05 μg/kg/min) in the PF group were continued during colonoscopy, which lasted approximately 30 minutes.

Eligibility criteria: * Inclusion Criteria:

  1. both sexes
  2. 21-60 years old, with
  3. ASA physical status -
* Exclusion Criteria:

  * severe cardiovascular or respiratory disease
  * (ASA grade ≥III)
  * pregnancy
  * allergies to the drugs being used
  * known alcohol or substance abuse
  * expected communication difficulties with the patient.

Primary outcomes:
measure: The quality of painless sedation during colonoscopy.
timeFrame: From start of procedure to 120 minutes after end of colonoscopy
Secondary outcomes:
measure: incidence of adverse events, Prevalence of adverse effects
timeFrame: from start of procedure to 120 minutes after end of colonoscopy
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar faculty of medicine
Study officials:
affiliation: Assistant professor, Anesthesiology, Intensive care and pain management
name: sameh H Seyam, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05114603: A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation
Official title: An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Advanced Melanoma With BRAF V600 Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Melanoma
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2021-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation


Eligibility criteria: Inclusion Criteria:

* Age\>=18Y
* Good Organ Function
* Expected survival time ≥ 3 months
* advanced melanoma with BRAF V600 mutation that have been diagnosed
* ECOG score 0-1;

Exclusion Criteria:

* Previous treatment with BRAF inhibitors or MEK inhibitors
* Symptomatic brain or meningeal metastases (unless the patient has beenon \> treatment for 3 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinicalsymptoms are stable).
* Severe active infections requiring systemic anti-infective therapy
* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.

Primary outcomes:
measure: ORR
timeFrame: from first dose to the last patient was followed up for 6 month
Secondary outcomes:
measure: PFS
timeFrame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 1 years
measure: DOR
timeFrame: from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first) assessed up to 1 years
measure: OS
timeFrame: from the first dose to the time of death due to any cause，assessed up to 2 years
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Cancer Hospita
state: Beijing
city: Changsha
country: China
facility: Hunan cancer hospital
city: Chendu
country: China
facility: West China Hospital of Sichuan University
city: Fujian
country: China
facility: Fujian cancer hospital
city: Taiyuan
country: China
facility: Shangxi Bethune Hospita
city: Wuhan
country: China
facility: union Hospital Tongji Medical College, Huazhong University of Science and Technology
city: Zhengzhou
country: China
facility: Henan cancer hospital
Study officials:
References:
Clinical trial NCT05682703: A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Nasopharyngeal Carcinoma.
Official title: A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites During the Occurrence and Development of Nasopharyngeal Carcinoma in Southern China.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasopharyngeal Carcinoma
EBV Infection
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who met the diagnosis and criteria and were admitted to Nanfang Hospital of Southern Medical University.

Brief summary: The transformation process of nasopharyngeal carcinoma is complex, so it is particularly important to explore the relationship between various disease states on its clinical pathway. Therefore, we carried out this study to explore the changes of plasma and urine metabolites at different stages during the occurrence and development of nasopharyngeal carcinoma.


Eligibility criteria: Inclusion Criteria:

* EBV virus infector: QPCR/EBV antibody, diagnosed as EBV infection patient with previous infection;
* Nasopharyngeal carcinoma patients:Patients diagnosed as nasopharyngeal carcinoma by pathological diagnosis (2018 WHO standard);
* Healthy people: Healthy people who have no history of nasopharynx related diseases or other known diseases that may affect blood lipid/protein metabolism and have been hospitalized in the Physical Examination Center of Southern Hospital.

Exclusion Criteria:

1. People who have a history of non research related liver diseases or other diseases known to affect blood metabolism (except for controlled type II diabetes);
2. Have a history of other malignant tumors, except for fully treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ;
3. Diseases requiring long-term use of immunosuppressive drugs (including steroids), including but not limited to congenital or acquired immunodeficiency diseases or active central nervous system metastatic cancer, active infection or uncontrolled heart disease;
4. Suffer from other uncontrolled serious diseases at the same time, such as unstable heart disease requiring treatment, diabetes with unsatisfactory control (fasting blood glucose\>1.5 × Upper limit of normal value), mental illness and severe allergic history.
5. BMI is less than 18 or more than 25. -

Primary outcomes:
measure: Achieve the expected number of enrolled cases
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern medical university
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: jian guan, MD
role: PRINCIPAL_INVESTIGATOR
References: