louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01705717: A Retrospective Study of Real World Treatment Outcomes of Patients With Chronic Hepatitis C
Official title: Treatment Outcomes in the Management of Patients With Chronic Hepatitis C: A Case Study of Faculty of Medicine Vajira Hospital, University of Bangkok Metropolis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-12
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective survey of medical records of patients with chronic hepatitis C

Brief summary: This retrospective, observational study will assess the real world treatment out comes in the management of patients with chronic hepatitis C. No prospective ass essment or procedure with patients during this study will be conducted. Data wil l be collected from patient medical records of the year 2000-2011.


Eligibility criteria: Inclusion Criteria:

* Patients newly diagnosed with chronic hepatitis C during the year 2000 to 2010
* Availability of data for at least 6 months following the diagnosis date

Exclusion Criteria:

* Patients who participated in an investigational clinical trial
* Co-infection with hepatitis A, hepatitis B, hepatitis D, and/or human immunodeficiency virus (HIV)
* Patients with known severe medical conditions that are contraindicated to HCV treatment

Primary outcomes:
measure: Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Participants Who Were HCV Seronegative at the End of Treatment
timeFrame: End of Study, up to 36 months after diagnosis.
measure: Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion
timeFrame: End of Study, up to 36 months after diagnosis.
measure: Percentage of Participants Who Progressed From CHC to Cirrhosis
timeFrame: Diagnosis and End of Study, up to 36 months after diagnosis.
measure: Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)
timeFrame: Diagnosis and End of Study, up to 36 months after diagnosis.
measure: Percentage of Participants Who Died
timeFrame: Diagnosis and End of Study, up to 36 months after diagnosis
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Vajira Hospital; Division of Gastroenterology and Hepatology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02874417: Computerized Psychoeducation for Anxiety Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Sensitivity
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This investigation examines the efficacy of a 35 minute computerized psychoeducation protocol in the reduction of elevated anxiety sensitivity cognitive concerns, a risk factor for the development and maintenance of various forms of psychopathology.


Eligibility criteria: Inclusion Criteria:

* Elevated Anxiety Sensitivity Cognitive Concerns and indicated by the anxiety sensitivity index-3

Exclusion Criteria:

* History of epilepsy or seizures

Primary outcomes:
measure: Anxiety Sensitivity Index-3
timeFrame: 10 minutes post intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01473017: Improving Mental Health in Diabetes: A Guided Self-Help Study
Official title: Improving Mental Health in Diabetes: A Guided Self-Help Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 2 Diabetes
Anxiety
Depression
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study employs a Randomised Controlled Trial design to investigate whether a CBT-based guided self-help intervention can improve anxiety, depression, psychological well-being, quality of life, Diabetic self-care and adherence; as compared to controls. The study aims to recruit 42 individuals with Diabetes and mild to moderate anxiety or depression. Anxiety and depression are common in patients with Type 2 Diabetes, and has been shown to affect Diabetes control. Literature suggests that CBT can benefit individuals with Diabetes and comorbid mental ill-health, however little research has been done to date on the effect of guided self-help in this population. It is expected that this intervention will improve patient's mental health, as well as extend the limited knowledge-base on guided self-help in chronic illness.


Eligibility criteria: Inclusion Criteria:

* Individuals with a diagnosis of Type 2 Diabetes with mild-moderate anxiety and/or depression (scoring 8 to 15 on the HADS scale) will be recruited, provided they do not meet any one of the exclusion criteria listed below. Patients will be able to provide written informed consent.

Exclusion Criteria:

* Individuals with a history of clinically diagnosed psychotic symptoms, schizophrenia or bipolar disorder.
* Participants with a known Learning Disability or severe visual impairment.
* Participants who cannot read or write
* Participants under 18 years of age or over age 75
* Long-term hospital inpatients
* Individuals with a diagnosis of Diabetes secondary to a major physical condition (consultation will be sought from medical professionals where appropriate on an individual basis)

Primary outcomes:
measure: Anxiety and/or depression in Type 2 Diabetes
timeFrame: 18 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
state: Highlands
Study officials:
References:
Clinical trial NCT05224817: NECROtizing Soft Tissue Infections and Their Scoring System
Official title: Prospective, Multicenter Derivation and Validation of a NECROtizing Soft Tissue Infections (NECROSIS) Score
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Necrosis
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 1010
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center.

Brief summary: Primary Objective:

The primary objective of this study is to develop and validate a clinical risk index score for identifying NSTIs in emergency general surgery patients being evaluated for a severe skin and soft tissue infection.

Secondary Objectives:

To describe the contemporary microbiology of NSTIs and explore the effects on outcomes and to identify predictors of amputation and mortality.

Detailed description: This study is designed as a multicenter, prospective, observational study. There will be no direct interaction with subjects and involves no interventions; study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center. We plan to complete the data collection and analysis by 12/30/2021.

Eligibility criteria: Inclusion Criteria:

* All adult patients (age ≥18 years old and ≤89 years old) with suspected or confirmed NSTI

Exclusion Criteria:

* Age \<18 years old and age \> 89 years
* Pregnancy
* Prisoners
* Below ankle diabetic foot infections complicated by peripheral vascular disease
* Burn wounds

Primary outcomes:
measure: Change in the presence of necrosis
timeFrame: up to 30 days
measure: Change in the presence of necrosis
timeFrame: up to 30 days
measure: mortality length of time in hospital
timeFrame: 30-90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Michael Truitt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03585517: Safety and Efficacy Evaluation of IM23 CAR-T Cells (IM23CAR-T)
Official title: Safety and Efficacy Evaluation of IM23 CAR-T Cells On CD123+ AML Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: AML
Lead sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-07-13
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML

Detailed description: Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML and determine the best dosage.

Eligibility criteria: Inclusion Criteria:

* Patients with CD123+ Refractory or Relapsed AML
* To be aged 3 to 80 years
* Expression of CD123 in Blast ≥90%
* ECOG score ≤2
* Voluntary participation in the clinical trials and sign the informed consent.

Exclusion Criteria:

* Intracranial hypertension or unconsciousness
* Respiratory failure
* CD19 negative
* Disseminated intravascular coagulation
* ALT /AST\>3 x normal value; Creatinine\> 1.5 x normal value; Bilirubin \>2.0 x -normal value
* Hematosepsis or Uncontrolled active infection
* Uncontrolled diabetes
* Abalienation;
* Patients in pregnancy or breast-feeding period
* Previously treatment with any gene therapy products
* Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial

Primary outcomes:
measure: Occurrence of study related adverse events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xian Lu
Study officials:
References:
Clinical trial NCT01349517: Health-related Quality of Life of Patients With Esophageal Cancer After Surgery
Official title: Health-related Quality of Life of Patients With Esophageal Cancer After Surgery in China: A Prospective Cohort Study From Multi-center
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: health-related quality of life(HRQL)
Esophageal Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: The First Hospital of Jilin University
name: Fujian Medical University Union Hospital
name: Shanxi Province Cancer Hospital
name: Wuxi People's Hospital
name: Linyi People's Hospital
First posted: 2011-05-06
Enrollment: 400
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this multi-center prospective cohort study is to study the health-related quality of life (HRQL) together with other outcomes of patients with esophageal cancer after surgery in China.

Detailed description: * To study the influence of health-related quality of life of patients with esophageal cancer before and after surgery.
* To compare the impact of different procedures on the the health-related quality of life of patients with esophageal cancer.
* To compare morbidities and oncological results(3,5- year survival) from different procedures.

Eligibility criteria: Inclusion Criteria:

* Clinical stage I/II esophageal cancer
* Normal blood test of basic metabolism panel
* Pulmonary function: FEV1 \> 1.2L, FEV1% \> 50%, DLCO \> 50%
* Heart function: NY grade I and grade II

Exclusion Criteria:

* Mental disorders
* Combination with other cancers
* With a previous history of thoracic or ventral surgery

Primary outcomes:
measure: Health related quality of life
timeFrame: postoperative 2 year
Secondary outcomes:
measure: Morbidity Mortality Survival rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhong Shan Hospital, Fu Dan University
state: Shanghai
Study officials:
affiliation: Zhongshan Hospital, Fudan University, China
name: Lijie Tan, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00785317: Effects of Estradiol on Menopausal Breast
Official title: Effects of Oral 1 mg Oestradiol (E2)/ 2 mg of Drospirenone (DRSP) Compared to Oral 1 mg of Oestradiol (E2)/ 0.5 mg Noresthisterone Acetate (NETA)on the Postmenopausal Breast; a Double Blind Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hormone Replacement Therapy
Keywords: Postmenopausal Hormone Replacement Therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2008-11-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects on breast in postmenopausal women randomized to either oestradiol in combination with DRSP or E2 in combination with NETA during six months.


Eligibility criteria: Inclusion Criteria:

* Naturally postmenopausal, symptomatic, apparently healthy women, with the need for hormone therapy aged 50 - 70 years with a BMI \>18 and ≤30 kg/m2 and without any previous history of breast disease will be recruited for the study.
* They should be amenorrheic for at least 12 months or less than 12 months with S- FSH values \>40 IU/L.
* They should be free of any sex hormone treatment for at least three months before inclusion.

Exclusion Criteria:

* General contraindications for HT according to Swedish product label. Age \>60 years. BMI ≤18 or ≥30 kg/m2.
* Any previous history of cancer.
* Any previous history of breast disease or abnormal mammogram.
* In addition: hypertension (systolic BP \>160 mm Hg or diastolic \>100 mm Hg), hyperlipidemia (total cholesterol \>8.0 mmol/L or triglycerides \>3.0 mmol/L), diabetes mellitus, history of thromboembolic disease, heart failure, liver disease or porphyria, undiagnosed vaginal bleeding. No sex hormone treatment for at least three months before inclusion.
* No concomitant treatment known to influence hormone metabolism (warfarin, rifampicin, carbamazepine, griseofulvin, hydantoins, primidone, barbiturates, broad spectrum antibiotics) is to be accepted.

Primary outcomes:
measure: Mammographic breast density - classified according to digitized data-based quantification of breast density.
timeFrame: 6 months
Secondary outcomes:
measure: Effects on serum levels of Oestradiol etc.
timeFrame: 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT05813717: A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986325 in Healthy Japanese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants


Eligibility criteria: Inclusion Criteria:

* Participants must be ethnically Japanese (both biological parents are ethnically Japanese).
* Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations.
* Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at screening.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study.
* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status (eg, history of splenectomy).

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: Up to day 92
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to day 64
measure: Number of participants with vital sign abnormalities
timeFrame: Up to day 64
measure: Number of participants with ECG abnormalities
timeFrame: Up to day 64
measure: Number of participants with physical examination abnormalities
timeFrame: Up to day 64
Secondary outcomes:
measure: Serum concentrations of BMS-986325
timeFrame: Up to day 64
measure: Maximum observed serum concentration (Cmax)
timeFrame: Up to day 64
measure: Time of maximum observed serum concentration (Tmax)
timeFrame: Up to day 64
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
timeFrame: Up to day 64
measure: Pharmacokinetics/pharmacodynamic (receptor occupancy) (PK/PD (RO)) correlation
timeFrame: Up to day 64
measure: Absolute Bioavailability (F) of BMS-986325
timeFrame: Up to day 64
measure: Number of Participants With Anti-Drug Antibody Response
timeFrame: Up to day 64
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Local Institution - 0001
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00867217: Vitamin D3 for Aromatase Inhibitor Induced Arthralgias
Official title: A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
name: BTR Group
First posted: 2009-03-23
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.

Detailed description: The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D) and various quality of life measures in women being treated with letrozole as standard care for early stage breast cancer. All subjects received letrozole and a standard dose of vitamin D3 (600 IU daily). Randomization was between high dose vitamin D3 (30,000 IU once per week) vs. a blinded, matched placebo,

Eligibility criteria: Inclusion Criteria:

* Post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor
* Serum 25OHD levels \< 40 ng/ml

Exclusion Criteria:

* Severe or debilitating musculoskeletal pain
* Known metastatic disease
* History of renal stones
* History of hypercalcemia or hyperthyroidism
* Currently receiving adjuvant or neoadjuvant chemotherapy
* Currently receiving other investigational agents

Primary outcomes:
measure: Number of Participants With Worsening of Musculoskeletal Symptoms (MS)
timeFrame: Change from Baseline to 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Westwood
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Wichita
country: United States
facility: Cancer Centers of Kansas, P.A.
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Qamar J Khan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02940717: Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers
Official title: Clinical Evaluation of the Fracture Resistance for E-max Cad and Vita Suprinity Laminate Veneers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Discoloration
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients need laminate veneer for their teeth usually use Emax CAD as an etchable ceramic. Yet fracture may occur so a stronger material is needed. Vita Suprinity is a recent material with glass ceramic enriched with zirconia (approx. 10% by weight) that offer practices and laboratories a high-strength, zirconia-reinforced lithium silicate ceramic (ZLS) and can be used to fabricate laminate veneers but the investigators have to know clinically it is fracture resistance, so the investigators are going to have Parallel groups in a randomized clinical trial.


Eligibility criteria: Inclusion Criteria:

All subjects are required to be:

* From 18-60 years old, and able to read and sign the informed consent document.
* Physically and psychologically able to tolerate conventional restorative procedures
* Have no active periodontal or pulpal diseases, have teeth with good restorations
* Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ....)
* Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

* Patients in the growth stage with partially erupted teeth
* Patient with fractured teeth of more than 50% enamel loss
* Patients with poor oral hygiene and motivation
* Pregnant women
* Psychiatric problems or unrealistic expectations
* Lack of opposite occluding dentition in the area intended for restoration

Primary outcomes:
measure: Fracture resistance assessed by clinical evaluation using dental mirror and probe according to the modified united states public health criteria
timeFrame: 1 Year
Secondary outcomes:
measure: Patient satisfaction assessed using a Questionnaire
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
References:
citation: Elsaka SE, Elnaghy AM. Mechanical properties of zirconia reinforced lithium silicate glass-ceramic. Dent Mater. 2016 Jul;32(7):908-14. doi: 10.1016/j.dental.2016.03.013. Epub 2016 Apr 14.
citation: Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.
citation: Weyhrauch M, Igiel C, Scheller H, Weibrich G, Lehmann KM. Fracture Strength of Monolithic All-Ceramic Crowns on Titanium Implant Abutments. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):304-9. doi: 10.11607/jomi.4601.