louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01199393: Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer
Official title: Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasm
Drug Therapy
Polymorphism,Single Nucleotide
Keywords: breast neoplasm
drug therapy
polymorphism
gene
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female patients with metastatic breast cancer

Brief summary: The investigators want to research whether genetic polymorphisms of drug-metabolizing enzymes can be used to predict chemotherapeutic outcomes in patients with metastatic breast cancer.

Detailed description: 1. Patients evaluation On all patients a complete clinical history and physical examination is performed, including routine hematology and biochemistry analyses. Hematology and biochemistry analyses are repeated at the end of each cycle. Toxicity is classified according to WHO criteria at each cycle for each patient. Response is assessed after two cycles of chemotherapy and every two cycles thereafter, using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
2. Sample collection and SNP genotyping Venous blood (4 ml) is collected from each subject and placed into tubes containing EDTA. Genomic DNA is isolated with a DNA Blood isolation kit.Genotypes are performed by PCR-RFLP, PCR-DHPLC and PCR-direct sequencing, etc.
3. Statistical Analysis x2 test is used to summarize the association of response and adverse events to chemotherapy with genetic polymorphisms.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic breast cancer
* Female
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* At least one measurable lesion
* Normal cardiac, hepatic, renal and bone marrow functions
* Life expectancy ≥3 months
* Discontinuity of previous chemotherapy for a minimum of 4 weeks

Exclusion Criteria:

* Central nervous system metastases
* Serious or uncontrolled concurrent medical illness
* History of other malignancies

Primary outcomes:
measure: Response to chemotherapy
timeFrame: 6 months
Secondary outcomes:
measure: Time to disease progression
timeFrame: 1 year
measure: Overall survival
timeFrame: 5 years
measure: Toxicity
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Ningning Dong, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: Jun Jia, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02981693: Evaluation of iRoot SP as Root Canal Sealer: A Clinical Study
Official title: 1-year Evaluation of iRoot SP as a Root Canal Sealer Compare to AH Plus Sealer: A Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irreversible Pulpitis
Apical Periodontitis
Lead sponsor: The Dental Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 283
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus arm randomly. After root canal shaping and cleaning, the teeth were obturated according to their arms. Assessment of postoperative pain was done 1 week after root canal obturation using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were carried out. Statistical analysis at P \< 0.05 was conducted to measure difference between the arms.


Eligibility criteria: Inclusion Criteria:

Subjects were required to:

1. have a mature tooth with closed apices;
2. have one single or multi-rooted tooth with irreversible pulpitis, pulp necrosis or apical periodontitis;
3. be prepared to appear for follow-up and
4. sign informed consent form.

Exclusion Criteria:

Subjects with:

1. moderate or severe marginal periodontitis;
2. internal or external root resorption in periapical radiograph;
3. active systemic disease;
4. physical or mental disability,
5. pregnant or lactating

Primary outcomes:
measure: Radiographical assessments
timeFrame: 1 year after root canal therapy
Secondary outcomes:
measure: Clinical assessments
timeFrame: 1 year after root canal therapy
measure: Postoperative Pain Evaluation
timeFrame: 1 week after root canal therapy
Other outcomes:
Locations:
Study officials:
affiliation: Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University
name: Hui Chen
role: STUDY_CHAIR
References:
Clinical trial NCT00155493: Age-Related Changes in Proliferation and Differentiation Capacity of Human Preadipocytes From Periorbital Fat.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Aging
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: Periorbital rejuvenation has been an issue of great interest in plastic surgery. Adipose tissue plays an important role in the periorbital anatomy, and has a great impact on the aging process of the region. We believe age-related atrophy of the facial adipose tissue may be related to the decreased proliferation and differentiation capability of the preadipocytes (adipose precursor cells).

Detailed description: Understanding the age-related changes in periorbital adipose tissue is crucial for improving current rejuvenation techniques, or developing new ones. However, no such study has been reported in the literature.

Hundreds of people came to our hospital requesting upper blepharoplasty every year. Taking advantage of the discarded soft tissue in the blepharoplasty surgery, samples of bilateral pretarsal fat can be easily obtained from patients of various ages. This study is designed to objectively evaluate the age-related changes of the preadipocytes in human periorbital adipose tissue regarding their proliferation and differentiation capability.

The adipose samples taken during the surgery are sent to the lab immediately to separate the preadipocytes from the specimens. Their number is estimated under the microscope, and then the cells are cultured in vitro to evaluate their proliferation and differentiation capability. Proliferation is assessed by counting the number of preadipocyte everyday for 7 days, and differentiation is assessed by Glycerol-3-phosphate dehydrogenase (GPDH) assay.

A linear regression analysis is used to analyze correlations of the parameters with age. Moreover, by dividing the subjects who had their periorbital fat sampled during upper blepharoplasty operation into three age groups, the parameters are compared with ANOVA test. Therefore, the age-related changes of the proliferation and differentiation capability of the preadipocytes in human periorbital adipose tissue can be concluded.

Eligibility criteria: Inclusion Criteria:

* patients receiving lower blepharoplasty

Exclusion Criteria:

* patients who do not require fat removal

Primary outcomes:
measure: preadipocyte proportion in aged versus young group
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Yueh-Bih Tang, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06580093: Nutritional Status in Patients With Chronic Kidney Disease
Official title: Nutritional Status and Nutritional Problems in Patients With Chronic Kidney Disease Treated With Hemodialysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malnutrition
Keywords: Malnutrition
Muscle mass
GLIM
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2024-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Chronic Kidney Disease (CKD) treated with hemodialysis at one university hospital in Sweden.

Brief summary: The goal of this observational study is to investigate how the GLIM criteria\* for the diagnosis of malnutrition should be operationalized in patients with chronic kidney disease (CKD) treated with hemodialysis. The main questions it aims to answer are:

* How can malnutrition be defined when applying different combinations and operationalization strategies of the GLIM criteria?
* How can information from other nutrition assessment tools be used in the operationalization of GLIM?
* Which combinations and operationalization strategies of the GLIM criteria can best predict deterioration in quality of life, muscle strength, and increased mortality? An observational study on patients with CKD in hemodialysis will be performed. Variables will be extracted from the Swedish renal registry, SNR and medical records at two hemodialysis units at one university hospital in Sweden. With start in the fall of 2024, data will be collected during two timepoints (baseline and follow-up) when wanted variables for this study are routinely measured at the units.

  * The Global Leadership Initiative on Malnutrition (GLIM) criteria to diagnose malnutrition in adults


Eligibility criteria: Inclusion Criteria:

* age ≥18 years
* dialysis duration \&amp;gt;3 months prior to recruitment

Exclusion Criteria:

* patients who only have a dialysis frequency of once a week
* patients treated with a combination of peritoneal dialysis and hemodialysis or treated at home
* patients were written consent cannot be obtained due to medical or mental illness or weakened state of health

Primary outcomes:
measure: Malnutrition diagnosis
timeFrame: From Aug/Sept 2024 to May 2025
Secondary outcomes:
measure: Overall survival
timeFrame: From Aug/Sept 2024 to Dec 28
measure: Muscle strength
timeFrame: From Aug/Sept 2024 to May 2025
measure: Health related quality of life
timeFrame: Aug/Sept 2024 (baseline)
measure: Muscle mass
timeFrame: From Aug/Sept 2024 to May 2025
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University hospital
Study officials:
affiliation: Umeå University
name: Sandra Einarsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06320093: Training Social and Health Care prOfessionals in mUsic-based Therapeutic iNterventions to Support Older People With Dementia
Official title: Training Social and Health Care prOfessionals in mUsic-based Therapeutic iNterventions to Support Older People With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Older People
Keywords: dementia
older people
music
caregiver
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2024-03-20
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study will investigate the effects of an inovative intervention based on the use of music on 45 professionals in the field of dementia, 45 elderly people with dementia.

Detailed description: The study aims to develop an innovative therapeutic intervention (SOUND intervention) based on the use of music to improve behavior, mood, well-being, and maintain cognitive function in older people with dementia.

The study will investigate the effects of the SOUND intervention on 45 professionals in the field of dementia, 45 elderly people with dementia, and 5 family caregivers by monitoring quantitative outcome variables that will be measured through psychometric and qualitative scales interpreted through open-ended questions and observations.

Eligibility criteria: Inclusion Criteria:

* mild to moderate dementia
* no severe hearing and visual impairment or motor problems

Exclusion Criteria:

* no formal caregiver
* no informal caregiver

Primary outcomes:
measure: Change in mental wellbeing of patients with dementia
timeFrame: baseline, 12 and 14 weeks later
measure: Change in cognitive status of patients with dementia
timeFrame: baseline, 12 and 14 weeks later
measure: Change in stress of health care providers
timeFrame: baseline, 12 and 14 weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: INRCA Hospital
city: Trofa
country: Portugal
facility: Sons do Estamine Associacao
city: Bucarest
country: Romania
facility: Associatia Habilitas
Study officials:
References:
Clinical trial NCT01039493: Living With Cervical Cancer: Assessing Utilities Associated With Common Treatment Complications
Official title: Living With Cervical Cancer: Assessing Utilities Associated With Common Treatment Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2009-12-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patient Population: Patients ≥18 and \<61 years old who were diagnosed with early cervical cancer (stages I and II) at least 3 years prior to the interview. We cannot limit our population to stage IB2 patients and meet our accrual goals due to the rarity of the disease. Patients with stages I and II cervical cancer are included because they have the potential to be exposed to the same treatment complications as patients with stage IB2 disease. Patients of all health statuses will be accepted.

Provider Population: Providers who care for patients with cervical cancer at the University of Wisconsin, including: gynecologic oncologists, radiation oncologists, physician's assistants and nurses. Providers must be ≥18 and \<61 years old in any health status.

Brief summary: The objective of this study is to establish patient preferences in regards to common complications of cervical cancer treatments, and to compare these preferences to those of medical providers who care for cervical cancer patients. These preferences will be determined via a interview using the Standard Gamble, which is a well-recognized method for establishing utilities.


Eligibility criteria: Inclusion Criteria:

* A subject has to have been diagnosed with early cervical cancer (Stage I or II) within the last 3 years and/or take care of patients with cervical cancer and identify her or himself as one of the following: gynecologic oncologist, radiation oncologist, physician's assistant or nurse.
* Subjects must be ≥18 and \<61 years old.

Exclusion Criteria:

* Subjects who are unable to read and speak English proficiently will be excluded. Proficiency will be assessed by the investigator enrolling patients.
* Subjects who do not have capacity to consent will not be included in this study.
* Subjects may not be investigators on this study.

Primary outcomes:
measure: Utilities of complications associated with cervical cancer treatment.
timeFrame: At time of interview
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ellen M Hartenbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006493: Rosiglitazone in the Treatment of HIV-Associated Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Hyperlipidemia
Keywords: HIV-associated hyperlipidemia
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-11-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to study the effects of rosiglitazone, a drug usually taken for Type II diabetes, on HIV-associated hyperlipidemia. HIV-associated lipodystrophy is a medical condition characterized by gradual changes in the distribution of body fat. The body fat located in the extremities and face disappears while body fat around the abdomen and upper back increases. Certain biochemical changes occur in association with these changes in fat distribution. Lipid levels particularly serum triglycerides are increased. HDL, the "good cholesterol" is decreased. Higher than normal level of insulin or insulin resistance is also found in this condition. This latter condition is one of the hallmarks of Type II diabetes. The protease inhibitors, a class of HIV medications, are associated with the occurrence of HIV-associated lipodystrophy. It has been suggested that a biochemical pathway known as the peripheral peroxisomal activating receptor (PPAR) gamma system is blocked leading to the onset of this condition.

Rosiglitazone is a new drug approved by the FDA in 1999 for the treatment of type II diabetes. It lowers blood sugar by improving insulin resistance, which as mentioned before, is the hallmark of Type II diabetes. It has also been noted to improve blood lipid levels. Rosiglitazone works by stimulating the PPAR gamma system. It is hoped that this drug can turn on the PPAR system and reverse the HIV-associated lipodystrophy syndrome.


Eligibility criteria: Inclusion Criteria:

* HIV-positive with CD4 count \> 500 and undetectable viral load
* Treated with protease inhibitors for more than three months
* Serum triglycerides \> 400mg/dl
* Clinical diagnosis of HIV-associated lipodystrophy
* No history of type II diabetes
* Fasting blood sugar \< 126 mg/dl
* No history of liver disease
* Negative Hepatitis B antigen and Hepatitis C antibody
* Not on the following medications: warfarin, digoxin, nifedipine, erythromycin, cyclosporine or HMG coA-reductase inhibitors
* Hemoglobin \> 11g/dl
* Women of childbearing age must consent to barrier contraception

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Division of Endocrinology
state: New York
Study officials:
References:
Clinical trial NCT05852093: Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy
Official title: Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Rotator Cuff Tears
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The perspective, randomized controlled trial is to investigate and evaluate the effect of Tizanidine on the function and pain of patients with rotator cuff tear after shoulder arthroscopy;


Eligibility criteria: Inclusion Criteria:

1 Patients who were diagnosed as supraspinatus tendon and infraspinatus tendon tear and underwent shoulder arthroscopic surgery in the Second Affiliated Hospital of Zhejiang University; 2 Age 20\~70 years old; 3 Those with a long medical history, and symptoms such as shoulder joint pain and weakness in a short period of time are obviously aggravated; 4. After 3 months of medication and physical therapy, the symptoms and functions have not improved significantly; 5 Volunteer to participate in this study, and the person and his/her family members have given informed consent to the content of this study and signed the consent form

Exclusion Criteria:

1. Patients with simple frozen shoulder;
2. Patients with shoulder joint tuberculosis, gout, tumor, rheumatoid disease or infectious disease; 3. There are other joint pain factors before operation;

4 Patients with subscapularis tendon tear, long head tendinopathy requiring surgical treatment, and severe shoulder synovitis were found during the operation; 5 Patients with upper limb nerve injury, shoulder fracture, bone defect or severe osteoporosis; 6. Patients with serious organ or hematopoietic system and other primary diseases; 7. Those who are allergic to the drugs used in this study; 8 Women who are breast-feeding, pregnant or preparing to become pregnant; 9 Patients with language and communication disorders, mental history, cognitive dysfunction, etc. who cannot cooperate with the completion of nursing intervention and research, and cannot complete the questionnaire required for this study.

Primary outcomes:
measure: Pittsburgh sleep quality index；PSQI
timeFrame: From Week 0 (baseline) to Week24
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons Score; ASES
timeFrame: From Week 0 (baseline) to Week24
measure: UCLA score; UCLA
timeFrame: From Week 0 (baseline) to Week24
measure: Visual Analogu Scale; VAS
timeFrame: From Week 0 (baseline) to Week24
measure: Oxford Shoulder Score; OSS
timeFrame: From Week 0 (baseline) to Week24
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03539393: Fremanezumab Compassionate Use Program for Pediatric Patients
Official title: Fremanezumab (TEV-48125) Compassionate Use Program for Pediatric Patients (6 to 17 Years) With Chronic or Episodic Migraine
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Migraine
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-29
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD

Brief summary: This is a Compassionate Use Program (CUP) based on a licensed physician's unsolicited request. Specifically, this CUP is for male and female pediatric patients 6 to 17 years with a diagnosis of either episodic or chronic migraine who have successfully completed the Teva sponsored study TV48125-CNS-30084 (SPACE study).

Detailed description: Patients must have successfully completed the clinical trial according to the 30084 protocol, without any major protocol violations or tolerability issues, or who are anticipated to complete this trial within the next 2months, and whose Requesting/Treating Physician is requesting continued supply of the investigational medicinal product (IMP) known as TEV-48125 (fremanezumab) on behalf of the patient.

Eligibility criteria: Inclusion Criteria:

* Eligible patients may enter this CUP after successfully completing TV48125-CNS-30084 and all End of Study procedures
* In the opinion of your physician/investigator are able to continue IMP (fremanezumab) in a safe and compliant way.

Exclusion Criteria:

* Additional criteria may apply, please contact your physician/investigator for more information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: