louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02675491: Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors
Official title: Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors Harboring Either a ROS1 or NTRK Fusion Gene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Malignant Tumors
Keywords: Advanced solid tumor
DS-6051b
ROS1
NTRK
refractory to standard therapy
no standard therapy
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-02-05
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene.

Detailed description: This study is single arm study with DS-6051b in approximately 9 subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene. Safety and tolerability, pharmacokinetics (PK), maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) and preliminary efficacy of DS-6051b will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Advanced solid malignant tumors that are refractory to standard therapy or for which no standard therapy is available.
* An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

Exclusion Criteria:

* Previously had or currently has any of the following diseases:

Cardiac failure (NYHA Functional Classification ≥ Class III), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary/peripheral artery disease, pulmonary thrombosis, uncontrolled deep vein thrombosis, clinically severe thromboembolic event, or autoimmune disease requiring treatment.

* Previously had or currently has clinically severe pulmonary disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, radiation pneumonia).
* Severe or uncontrolled concomitant disease.
* Clinically active brain metastases or central nervous system tumor requiring steroid or anticonvulsant treatment.

Primary outcomes:
measure: number and severity of adverse events
timeFrame: Day 1 through 28 days after last dose
Secondary outcomes:
measure: Cmax of DS-6051a
timeFrame: Days 1 and 15 of Cycle 1
measure: Tmax of DS-6051a
timeFrame: Days 1 and 15 of Cycle 1
measure: AUC of DS-6051a
timeFrame: Days 1 and 15 of Cycle 1
measure: clearance (CL/F) of DS-6051a
timeFrame: Days 1 and 15 of Cycle 1
measure: Number of participants with dose-limiting toxicities
timeFrame: 21 days following the first dose of treatment
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Osaka
country: Japan
facility: Kinki University Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT03828591: Endometriosis and Psychological Support
Official title: The Impact of Psychological Support During the Hospitalization in Women With Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Keywords: Endometriosis
Psychological support
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Endometriosis is a common disease, causing significant pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically reducing patients' quality of life.

Endometriosis surgery is often a stressful event for the patient. For that reason, psychological support can improve patients' general health state.

Detailed description: Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study.

Psychological support is offered to all women one month before and one month after surgery. A group of patients will receive intensive psychological support during hospitalization.

Patients are divided into 2 groups:

Group A: patients receiving intensive psychological support during hospitalization

Group B: patients not receiving intensive psychological support during hospitalization

After surgery, patients will be included in the post-operative follow-up, as usual in the investigator's clinical practice.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery for endometriosis
* Patients that have signed an informed consent

Exclusion Criteria:

* Patients with active or history of psychological/psychiatric diseases
* Patients that refuse psychological support

Primary outcomes:
measure: General health state
timeFrame: From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery
Secondary outcomes:
measure: Postoperative pain: Numeric Rating Scale
timeFrame: Postoperative: at the hospitalization discharge (assessed up to 7 days after surgery) and one month after surgery
measure: Anxiety and Depression
timeFrame: From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery
measure: Stress
timeFrame: From one month before surgery until the hospitalization discharge; assessed up to 7 days after surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria Sant'Orsola Malpighi
state: BO
Study officials:
References:
Clinical trial NCT01319591: Comparison of Creatinine Clearance Calculation for Estimation of GFR in Patients Receiving HD Methotrexate
Official title: Comparison of Creatinine Clearance Calculation Methods for Estimation of Glomerular Filtration Rate in Patients Receiving High-Dose Methotrexate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CNS Lymphoma
CNS Involvement of Systemic Lymphoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2011-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving high-dose methotrexate therapy at Dana-Farber Cancer Institute/Brigham and Women's Hospital

Brief summary: The purpose of this study is to compare different estimates of calculating creatinine clearance by mathematical formula and compare them to creatinine clearance based on a timed urine collection in patients who received high-dose methotrexate for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma.

Detailed description: We intend to perform a retrospective chart review to identify a serum creatinine-based equation that gives the best estimate of CrCl as compared with an equation derived from a 24-hour urine collection.

Study subjects will be identified using the Brigham and Women's Hospital and Dana-Farber Cancer Institute's Adult Pharmacy systems to identify patients who received high-dose methotrexate. Data will be collected starting with December 31, 2010 and proceeding chronologically backwards until the target enrollment of 40 patients is reached.

Eligibility criteria: Inclusion Criteria:

* Age \>/= 18 years
* Received high-dose methotrexate therapy at Dana-Farber Cancer Institute/Brigham and Women's Hospital for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma
* Available timed urine collection within 1 week of HDMTX

Exclusion Criteria:

* Receiving high-dose methotrexate for indications other than primary CNS lymphoma or CNS involvement of systemic lymphoma
* Documented viral hepatitis

Primary outcomes:
measure: To identify a serum creatinine-based equation that gives the best estimate of CrCl as compared to a measured creatinine clearance formula.
timeFrame: 1 year
Secondary outcomes:
measure: To further compare each formula in a different subset of patients.
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Audrea H Szabatura, PharmD, BCOP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01303991: Hexvix Photodynamic Therapy in Patients With Bladder Cancer
Official title: A Phase I Feasibility Study of Hexvix Photodynamic Therapy in Patients With Intermediate or High-risk Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intermediate or High-risk Bladder Cancer
Lead sponsor: Photocure
Sponsor class: INDUSTRY
Collaborators: name: Karl Storz
First posted: 2011-02-25
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the safety and feasibility of Hexaminolevulinate based photodynamic therapy in patients with intermediate or high-risk transitional cell carcinoma of the bladder.

Detailed description: Non-muscle invasive bladder cancer is currently treated by transurethral resection (TURB) and/or fulguration. However, recurrence and progression rates following endoscopic treatment of visible lesions are significant. To prevent recurrent and progressive disease, adjuvant intravesical chemotherapy and immunotherapy are applied. There is also increasing interest in new therapeutic strategies such as photodynamic therapy.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 years or above who have given written informed consent.
* Patients with intermediate or high-risk superficial bladder cancer, defined as low-grade early recurrence within 6 months after local chemotherapy or BCG, primary or recurrent high-grade disease (TaG3, TaG3 with CIS or CIS alone) or patients with primary T1G3 who are tumour free at second resection.

Exclusion Criteria:

* Patients with muscle invasive tumour
* Patients with bladder shrinkage
* Patients who have received prior PDT for bladder cancer
* History of T1G3 disease or other indications for cystectomy
* Patient with porphyria
* Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with PDT)
* Patients who have received BCG or chemotherapy within three months prior to Hexvix instillation, except for a single dose of chemotherapy for prevention of seeding after resection
* Known allergy to hexaminolevulinate or a similar compound
* Participation in other clinical studies either concurrently or within the last 30 days
* Women of child-bearing potential.
* Conditions associated with a risk of poor protocol compliance

Primary outcomes:
measure: Number of patients with adverse events
Secondary outcomes:
measure: The number of tumour-free patients after 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Urology Department, Medizinische Fakultät der LMU Muenchen
name: Dirk Zaak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01570491: A Real-Time Ultrasound Guided Approach For Spinal Anesthesia
Official title: Cardiothoracic Anesthesia and Critical Care Patient Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Aged 55 or Older
BMI More Than 40 kg/m2
Scoliosis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 38
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our goal was to compare the number of attempts to perform spinal anesthesia using real-time ultrasound guidance versus landmark technique in patients meeting predefined criteria for difficult spinal anesthesia.

Detailed description: Patients who consent to receive spinal anesthesia (as opposed to some other anesthetic technique) and who meet the inclusion/exclusion criteria for the study (given below) will be randomized on day of surgery after obtaining informed consent to either ultrasound-guided or standard spinal anesthesia technique.

A block randomization scheme with random block sizes ranging from 2-8 patients will be used. The outcomes will be recorded by a third party observer in the block room/operating room who might be a nurse or resident or clinical research fellow not directly involved with performing the block. The post procedure outcomes will also be recorded by a clinical research fellow or resident who was not directly involved with performing the block.

No sample size estimation methodology currently exists for the right-censored count data models. We expect less number of attempts in the ultrasound group a 20 % difference between the two groups which we feel is a minimum of a clinically-relevant effect. At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group,therefore we plan to recruit 40 patients in total.

The analysis will be conducted by a statistician who will be blinded.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 55 or older
2. BMI more than 40
3. Scoliosis

Exclusion criterion:

1 Patients who have undergone previous Spine Surgery

Primary outcomes:
measure: Number of Attempts
timeFrame: 10-15 minutes before the surgery
Secondary outcomes:
measure: Difficulty of Block Insertion
timeFrame: 10-15 minutes before the surgery
measure: Patient Satisfaction
timeFrame: after insert the block but before the surgery
measure: Time to Perform Block (Second)
timeFrame: as measured in seconds after needle insertion, surgical date
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Hesham Elsharkawy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004091: Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results
Official title: Development of Antibody-Based Diagnostic Markers for Abnormal Cervical Cells
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: cervical cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-03-01
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients must have a diagnosis of an abnormal Pap test, performed as part of standard of care screening in the clinic. The patient's informed consent will be obtained during their initial interview with the clinic physician.

Brief summary: RATIONALE: Examining biomarkers in abnormal cervical cells may improve the ability to detect these cells and plan effective treatment.

PURPOSE: Diagnostic trial to detect specific biomarkers in abnormal cervical cells in women who have abnormal Pap test results.

Detailed description: OBJECTIVES: I. Compare the detection of transferrin receptor, epidermal growth factor receptor, and the MaTu-MN protein in exfoliated cervical epithelial cells from women with abnormal Pap test using fluorescent labeled antibody probe vs histology.

OUTLINE: Patients undergo a Pap test and a colposcopy. Cervical epithelial cells are collected from the most abnormal appearing lesion. Cells are examined for molecular markers using a fluorescent antibody test. The presence or absence of these markers is compared to results of the Pap test and the histology of the cells.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 6 months.

Eligibility criteria: DISEASE CHARACTERISTICS: Diagnosis of abnormal Pap test, as indicated by one of the following: Atypical squamous cells of undetermined significance (ASCUS) Low grade squamous intraepithelial lesion (LGSIL) High grade squamous intraepithelial lesion (HGSIL) Visible lesion on cervix by colposcopy

PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-4 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Pregnant or nursing women allowed

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior pelvic irradiation Surgery: No prior total hysterectomy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center, Northwestern University
state: Illinois
Study officials:
affiliation: Florida Gynecologic Oncology - Fort Myers
name: Phillip Y. Roland, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00380991: Topic Compatibility Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene
Official title: Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensitivity) of Dermacyd Delicata (New Fragrance)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-09-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the absence of potential irritation (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Delicata (new fragrance of Dermacyd)


Eligibility criteria: Inclusion Criteria:

* Phototype Skin I,II, III and IV
* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs
* Personal history of atopy;
* History of sensibilization or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs or cosmetics during the study

Primary outcomes:
measure: score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG)
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT00661791: Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants
Official title: Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Keywords: preterm infants
massage
physical activity
weight gain
length of hospital stay
NICU
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2008-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine whether massage with or without physical exercise impacted weight gain or length of hospital stay for premature infants.

Detailed description: Premature infants are often cared for in a fashion that minimizes physical activity in order to reduce stress and stress-related complications. Previous studies have indicated that massage therapy may increase weight gain and enabled earlier discharge of premature infants.

In this study, premature infants were randomly assigned to one of three groups:

A: Control Group

B: Massage Group, 15 minutes twice a day;

C: Massage and physical exercise group 15 minutes each, twice a day.

Eligibility criteria: Inclusion Criteria:

* low birth weight, less than 1500 grams
* weight of at least 1000 grams at time of entry into study
* must be at least one week of age
* must have relative medical stability
* gestational age between 28-32 weeks

Exclusion Criteria:

* infants with major congenital anomaly
* those that require mechanical ventilatory support
* those that are restricted in their movement or ability to undergo the intervention

Primary outcomes:
measure: Average daily weight gain. Length of hospital stay
timeFrame: From birth until time of hospital discharge
Secondary outcomes:
measure: Effect on heart rate and respirations
timeFrame: Birth until time of hospital discharge
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Hany Z Aly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04288791: Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations
Official title: Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is conducted to evaluate the clinical performance of class I reinforced glass ionomer restorations (Zirconomer Improved and Equia Forte Fil)


Eligibility criteria: Inclusion Criteria:

* Normal occlusal relation with normal dentition.
* Absence of pain from the tooth to be restored.
* Absence of any active periodontal and pulpal diseases from the tooth to be restored.
* Medium-sized (buccolingually and mesio-distally) occlusal carious lesions extending into dentin.

Exclusion Criteria:

* Patients with a history of tooth sensitivity.
* Patients with bruxism.
* Defective restorations adjacent or opposing to the tooth.
* Abutment teeth used for fixed or removable prosthesis.
* Patients who refused to sign the consent form.
* Inability to return to recall appointments

Primary outcomes:
measure: Clinical Performance of the restoration
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University, Faculty of Dentistry For Girls
Study officials:
References: