louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00162292: Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background
Official title: Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 33
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 clinical research study is to learn if it is safe for rheumatoid arthritis patients to take BMS-582949 along with methotrexate.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years
* Diagnosis of RA for ≥6 months
* Swollen or tender joint or ESR \>ULN. Subject must be on stable doses of MTX
* Women of Childbearing Potential

Exclusion Criteria:

* Serum transaminase levels \>ULN
* CK\>ULN
* Cannot have taken Orencia or Remicade within 8 weeks of baseline, Humira or Enbrel within 4 weeks of baseline
* Use of H2 blockers or Proton Pump inhibitors while on study

Primary outcomes:
measure: To evaluate safety and tolerability of BMS-582949 in subjects with active rheumatoid arthritis receiving concomitant MTX at steady state
timeFrame: during 28 doses of treatment
Secondary outcomes:
measure: To evaluate the PK of BMS-582949 in clinically stable RA subjects on stable doses of MTX and concomitant BMS-582949
measure: To explore DAS28, ESR, RF and CRP of clinically stable doses of MTX and concomitant BMS-582949 compared to MTX alone
timeFrame: during 28 days of treatment
measure: To evaluate PK of MTX in stable RA subjects in the absence and presence of BMS-582949 for subjects enrolled prior to approval of amendment 2
Other outcomes:
Locations:
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Upland
country: United States
facility: Boling Clinical Trials
state: California
city: Delray Beach
country: United States
facility: Delray Research Associates
state: Florida
city: Ocala
country: United States
facility: Ocala Rheumatology Research Center
state: Florida
city: Fall River
country: United States
facility: Phase Iii Clinical Research
state: Massachusetts
city: Dallas
country: United States
facility: Covance Clinical Research Unit Inc.
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio Northeast
state: Texas
city: San Antonio
country: United States
facility: Healthcare Discoveries, Inc
state: Texas
city: Metepec
country: Mexico
facility: Local Institution
state: Estado De Mexico
city: Leon
country: Mexico
facility: Local Institution
state: Guanajuato
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00145392: Body Composition, Glucose Metabolism, Insulin Resistance and Gene Expression in Muscle Cells in Healthy Overweight Women
Official title: Body Composition, Glucose Metabolism, Insulin Resistance and Gene Expression in Muscle Cells in Healthy Overweight Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Type 2 Diabetes
Polycystic Ovary Syndrome
Keywords: Polycystic ovary syndrome
growth hormone
insulin resistance
overweight
glucose metabolism
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: In this study, we will clarify the degree of insulin resistance and characterise muscle glucose metabolism and gene expression in a group of overweight healthy women. The study will clarify how overweight influences body glucose metabolism and thereby in the long-run increases the risk for developing type 2 diabetes. Moreover, the study may clarify why some overweight women develop hormone disorders and diabetes while others remain healthy.

The study is essential as many patients suffer from diseases aggravated by overweight. In addition, a genetic disposition for diabetes or polycystic ovary syndrome may give rise to the disease if the patient gains weight. It is therefore important that weight-matched control subjects are included in projects with overweight patients.

This clinical trial includes 10 overweight women with regular hormones and normal level of male sex hormone. The patients included must be healthy, take no medications influencing the study results. The subjects must take no contraceptive pills or receive any other hormone treatment.

In connection with the investigation, the following will be carried out on all patients: clinical examination, blood tests, hyperinsulinaemic euglycaemic clamp, muscle biopsies, bone scan.

The purpose of the study is to gain more knowledge of how overweight influences women's risk of developing hormone diseases and diabetes.


Eligibility criteria: Inclusion Criteria:

* Regular menses, i.e. cyclus length 25-34 days
* Premenopausal
* Ferrimann-Gallway score \< 2
* BMI \> 27 kg/m2
* normal total testosterone value \< 3.5 nmol/l

Exclusion Criteria:

* Age \<18 years
* Contraceptive pills within the past 3 months
* Postmenopausal (increased FSH)
* Diabetes mellitus
* Endocrine or other disease requiring treatment
* Eating disorder or other psychiatric history
* Drug use known to influence parameters investigated in this trial
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Endocrinology, Odense University Hospital
state: Funen
Study officials:
affiliation: Odense University Hospital
name: Dorte Glintborg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05739292: Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old
Official title: A Single Center, Randomized, Observer-blinded, Active Comparator Phase I Study to Assess the Safety and Immunogenicity of Meningococcal (Groups A, C, W-135, X and Y) Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection, Meningococcal
Lead sponsor: EuBiologics Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2023-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, X, and Y)-CRM197 Conjugate vaccine


Eligibility criteria: Inclusion Criteria:

* Subjects 19 to 55 years of age
* Written informed consent
* Available for all visits and telephone calls scheduled for the study

Exclusion Criteria:

* Previous or suspected disease caused by N. meningitides
* Household and/or intimate exposure to an individual with culture-proven N. meningitides infection within 60 days prior to screening
* Serious acute, chronic or progressive disease as determined by investigator
* History of alcohol or substance abuse

Primary outcomes:
measure: Occurrence of solicited adverse events
timeFrame: within 7 days post vaccination
measure: Occurrence of unsolicited adverse events
timeFrame: within 28 days post vaccination
measure: Occurrence of serious adverse events
timeFrame: within 180 days post vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: EuBiologics Co.,Ltd
name: YJ Choi
role: STUDY_DIRECTOR
References:
Clinical trial NCT00467792: Natural History of Urticaria Pigmentosa in Children
Official title: Natural History of Urticaria Pigmentosa in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urticaria Pigmentosa
Keywords: urticaria pigmentosa
mastocytosis
mastocytomas
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Society for Pediatric Dermatology
First posted: 2007-05-01
Enrollment: 47
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study involves children, of age 0-18 years old who are diagnosed with urticaria pigmentosa during their visit at the Pediatric Dermatology Clinic.

Brief summary: The purpose of this study is to determine how long the skin lesions usually last and what kind of symptoms and signs children with urticaria pigmentosa may develop over the years. This information will allow physicians to better care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding what to expect for the future of their child. This research is being done because many unanswered questions remain regarding children with urticaria pigmentosa and its course.

Detailed description: This study involves children, of age 0-18 years old who are diagnosed with urticaria pigmentosa during their visit at the Pediatric Dermatology Clinic. Parents and child will be interviewed to gain medical and family history, in addition, the doctor will perform a physical exam and take a photograph. Children older than 4 years of age will complete the "Children Dermatology Life Quality Index." Children less than 4 years of age with an active disease will have laboratory tests requiring a sample of blood (1 teaspoon).

Patients will receive $50 for their first office visit as financial reimbursement for participating in the study.

Eligibility criteria: Inclusion Criteria:

* Age 0-18 years old at diagnosis of UP
* 3 or more mastocytomas (diagnosis can be based on clinical exam; biopsy only necessary if diagnosis is in question)
* patients recruited from Children's Hospital of Wisconsin Dermatology Clinic

Exclusion Criteria:

* Less than 3 mastocytomas
* Diffuse mastocytosis
* TMEP
* residence is out of Wisconsin/Illinois area or the United States

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Sheila Galbraith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06836492: A Prospective Clinical Cohort Study on Stratified Treatment of Rhabdomyosarcoma Based on Risk Factors.
Official title: A Prospective Clinical Cohort Study on Stratified Treatment of Rhabdomyosarcoma Based on Risk Factors: a Single Arm Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rhabdomyosarcoma
Pediatric Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose is to explore the efficacy and safety of the SYSUCC-RMS regimen for pediatric RMS patients and to explore the impact of concurrent radiotherapy and chemotherapy on the survival rate of low-risk, medium risk, high-risk, and extremely high-risk patients in children.


Eligibility criteria: Inclusion Criteria:

1. 0 years \< age \< 18 years old, regardless of gender;
2. Tumor patients diagnosed by histopathology or bone marrow cytology;
3. Patients are treated for the first time;
4. ECoG score ≤ 2;
5. The expected survival time is more than 8 months;
6. Patient's parent or guardian signs informed consent.

Exclusion Criteria:

1. Combined with immunodeficiency disease
2. Second tumor

Primary outcomes:
measure: The objective response rate (ORR)
timeFrame: Up to 1 year
measure: disease control rate (DCR)
timeFrame: Up to 1 year
measure: progression-free survival (PFS)
timeFrame: Up to 10 years
measure: overall survival (OS)
timeFrame: Up to 10 years
Secondary outcomes:
measure: The safety of the SYSUCC-RMS regimen for pediatric RMS patients.
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Suying Lu
state: Guangdong
Study officials:
References:
Clinical trial NCT01051492: Development of Predictive Biomarkers and Novel Approached to Therapy in Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2010-01-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any individual who has been diagnosed with breast cancer

Brief summary: Breast cancer is a common malignancy world-wide, and is the commonest female malignancy in Singapore, with rising trends in incidence over the last 2 decades. While there have been improvements in treatment, mortality from breast cancer remains significant. Development of biomarkers to predict treatment response and toxicity to anti-cancer agents can rationalize the choice of therapy for the individual patients to optimize treatment outcome and to reduce unnecessary toxicities. Development of novel therapies or novel approaches to therapy is also critical to improve the treatment armamentarium in breast cancer. These research strategies will have an significant impact on breast cancer treatment both in Singapore as well as globally.


Eligibility criteria: Inclusion Criteria:

This program will recruit mainly cancer patients, predominantly breast cancer patients. The exact inclusion criteria will vary between each individual study. Each individual component study will be submitted to DSRB for separate approval, along with the study protocol and patient informed consent sheet.

Exclusion Criteria:

The exact exclusion criteria will vary between each individual study. Each individual component study will be submitted to DSRB for separate approval, along with the study protocol and patient informed consent sheet.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital Singapore
Study officials:
References:
citation: Tan SH, Lee SC, Goh BC, Wong J. Pharmacogenetics in breast cancer therapy. Clin Cancer Res. 2008 Dec 15;14(24):8027-41. doi: 10.1158/1078-0432.CCR-08-0993.
citation: Goetz MP, Rae JM, Suman VJ, Safgren SL, Ames MM, Visscher DW, Reynolds C, Couch FJ, Lingle WL, Flockhart DA, Desta Z, Perez EA, Ingle JN. Pharmacogenetics of tamoxifen biotransformation is associated with clinical outcomes of efficacy and hot flashes. J Clin Oncol. 2005 Dec 20;23(36):9312-8. doi: 10.1200/JCO.2005.03.3266.
Clinical trial NCT00762892: Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients
Official title: A Pilot Study--randomized, Prospective, Single Site Trial Evaluating Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: Raltegravir
Integrase inhibitor
Protease inhibitor
Naive patients
HIV disease
Lipids
Treatment Naïve
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-09-30
Enrollment: 33
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: This is a pilot that will evaluate two regimens for treating HIV infected patients that haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial infarction and antiretroviral therapy used may contribute to this. We will evaluate virological, immunological and cardiovascular effects of two HIV treatment regimens.

Detailed description: We will check blood studies used to evaluate HIV patients response to therapy including CD4 count and HIV viral load test. We will check routine safety labs done on HIV patients and also check homocysteine levels and creatine kinase level. We will evaluate homocysteine and IL6 levels at baseline, week 48, and week 96.

Eligibility criteria: Inclusion Criteria:

* Patients must be HIV-1 positive and naïve to HIV therapy.
* Patients must plan to participate and be available for the trial for the 96-week study period.
* Patients followed at Thomas Street Clinic.
* Patients must be over 18 years old.

Exclusion Criteria:

* Patients must not be pregnant or plan to become pregnant over the 96-week study period.
* Patients cannot be on a proton pump inhibitor.
* Patients cannot be undergoing treatment for active tuberculosis.
* Renal Insufficiency with a creatinine clearance \< 50 ml/min/1.73 m2 by the MDRD GFR calculation.

Primary outcomes:
measure: Change From Baseline in CD4 Count at 48 Weeks
timeFrame: Baseline and 48 weeks
measure: Change From Baseline in Log HIV Viral Load at 48 Weeks
timeFrame: Baseline and 48 weeks
Secondary outcomes:
measure: Change From Baseline in Lipids at 48 Weeks
timeFrame: Baseline and 48 weeks
measure: Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks
timeFrame: Baseline and 48 weeks
measure: Change From Baseline in Homocysteine at 6 Months
timeFrame: Baseline and 48 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Thomas Street Clinic
state: Texas
Study officials:
affiliation: UT-Houston
name: Tanvir K Bell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03768492: Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
Official title: A Phase 1, Randomized, Double Blinded, Placebo Controlled Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Carcinoma Breast
Keywords: Masectomy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 60
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 the study is to evaluate whether a caffeine-based cream can reduce the rates of reconstructive complications in patients with tissue expander based reconstruction requiring post-mastectomy radiation therapy when compared to a placebo cream.


Eligibility criteria: Inclusion Criteria:

* Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted)
* Patient has undergone mastectomy with tissue expander-based reconstruction and require post-mastectomy radiation therapy (PMRT) per the - Stage DCIS (0) -III breast cancer, excluding any patients with inflammatory breast cancer at presentation.
* Patient will receive irradiation of the chest wall. Additional fields to treat the regional nodes including the supraclavicular / axillary and/or internal mammary chains is allowed but not required. If a patient requires a boost field to the chest wall, scar and/or nodal region this is allowed.

Exclusion Criteria:

* Patient with skin changes or inflammatory carcinoma at presentation Patient has (cT4b-d)
* unhealed wound in the radiation field
* Patient has allergy to Caffeine
* Patient has systemic lupus erythematosus or scleroderma that increases the risk of radiation dermatitis development
* Patient will receive concurrent chemotherapy with radiation. (Patient is allowed to take concurrent hormonal therapy or Trastuzumab)
* Planned accelerated or hypofractionated fractionation.
* Previous radiation to the ipsilateral breast or chest wall or thoracic region.
* Anyone who will require bolus use during radiation (per physician discretion) as this will increase rates of acute toxicity interfering with measurement of the primary study endpoint.
* All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy. Pregnant women will be excluded from the study.

Primary outcomes:
measure: Standard Toxicity Scoring
timeFrame: 4 Years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Medical Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Naamit Kurshan Gerber
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02204592: Level of Burn Out of Surgical Residents Working in Government Hospitals of Lahore
Official title: Burn Out Among Surgical Residents Working at Government Institutes in Lahore: An Area of Grave Concerns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burn Out Syndrome
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2014-07-30
Enrollment: 133
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General surgical residents of All the government Hospitals Of Lahore

Brief summary: The term burnout was coined by psychologist Herbert Freudenberger in 1974 in an article entitled "Staff Burnout" in which he discussed job dissatisfaction precipitated by work-related stress. A broadly applicable description defines burnout as a state of mental and physical exhaustion related to work or care giving activities. A long-standing conceptual and operational definition characterized burnout as a triad of emotional exhaustion (emotional over extension and exhaustion), depersonalization (negative, callous, and detached responses to others), and reduced personal accomplishment (feelings of competence and achievement in one's work) In the World Health Organization International Classification of Diseases, 10th revision, burnout is defined as a "state of vital exhaustion." Although no specific diagnosis of burnout is mentioned in the Diagnostic and Statistical Manual of Mental Disorders, burnout is a clear syndrome with significant consequences.

Burnout in health care professionals has gained significant attention over the last several years. Given the intense emotional demands of the work environment, clinicians are particularly susceptible to developing burnout above and beyond usual workplace stress. Residency training, in particular, can cause a significant degree of burnout, leading to interference with individuals' ability to establish rapport, sort through diagnostic dilemmas, and work though complex treatment decision making. Overall, burnout is associated with a variety of negative consequences including depression, risk of medical errors, and negative effects on patient safety. The goal of this review is to provide medical educators and leaders with an overview of the existing factors that contribute to burnout, the impact of burnout, inter specialty variation, and suggestions for interventions to decrease burnout.


Eligibility criteria: Inclusion Criteria:

* General Surgical resident

Exclusion Criteria:

* Residents of all other specialties
* All the General surgical consultants

Primary outcomes:
measure: average working hours of residents
timeFrame: upto 3 months
Secondary outcomes:
measure: emotional exhaustion
timeFrame: 3 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Hospitals
state: Punjab
Study officials:
affiliation: SIMS/SHL
name: Sami Ullah, MBBS
role: PRINCIPAL_INVESTIGATOR
References: