louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01572688: Safety and Efficacy Study of High Dose Melphalan to Treat Multiple Myeloma
Official title: A Multicenter, Single Arm, Open Label Study of Autologous Stem Cell Transplantation With High Dose Melphalan in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2012-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and effectiveness of melphalan for injection for autologous stem cell transplant in multiple myeloma


Eligibility criteria: Inclusion Criteria:

* Patients with greater or equal to 18 years, with a upper age limit of 65 years are eligible.
* Multiple myeloma patients, symptoms conform to diagnosis of multiple myeloma of IMWG2003/WHO2008 criteria.
* Patients with responsive disease after induction therapy not more than 6 courses of treatment
* A complete response
* A very good partial response
* A partial response
* At least 4 weeks long from last cytotoxic treatment(exclude Bortezomib, thalidomide, dexamethasone);
* Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 Patient has an absolute neutrophil count of ≥1.5×109/L and platelet count≥80×109/L;
* Calculated creatinine clearance \>50ml/min by Cockcroft-Gault formula or collect urine within 24 hours.
* Patient with a total bilirubin ≤1.5 times of normal upper limit, AST,ALT≤2.5times of normal upper limit;
* Cardio-pulmonary function is adequate to conduct autologous stem cell transplant.
* Ratio of body weight and ideal body weight \<175%;
* All patients should have a life expectancy of more than 12 weeks
* Signed informed consent form voluntarily

Exclusion Criteria:

* CD34 positive hematopoietic stem cell collected \<2.0×106/kg
* Patients have a psychiatric history
* Female subject is pregnant or breast-feeding
* Patients are hypersensitive to this trial product or other alkylating agents
* Participate of other clinical trials within the past 4 weeks Active CNS lesions
* Concomitant of active infection or positive of HIV antibody
* Concomitant of other un-healed malignancy
* Left ventricular ejection fraction≤50%
* Patients with serious thrombosis
* Any severe concomitant disease that will expose study subjects to unacceptable risks.
* Patients not suitable to enroll by investigators considerations.

Primary outcomes:
measure: 1 year Progression Free Survival
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Hematologic Hospital of Chinese Academy of Medical Sciences
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Lugui Qiu, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00640588: Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine
Official title: Prospective Exploratory Study to Describe in CHB naïve and Non-naïve Patients, Hepatitis B Virus (HBV) Kinetics During the First 24 Weeks of Treatment With Telbivudine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B, Chronic
Keywords: Hepatitis B, chronic
Viral kinetics
Telbivudine
Adefovir
Compliance
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine


Eligibility criteria: Inclusion Criteria:

* Male or female, at least 18 years of age.
* Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.

Exclusion Criteria:

* Co-infection with HCV, HDV, or HIV.
* Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir.
* History of hepatic decompensation
* History of malignancy
* Patient has one or more additional known primary or secondary causes of liver disease

Primary outcomes:
measure: HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
timeFrame: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
Secondary outcomes:
measure: Liver function assessed at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks HBV genotype measured at baseline
timeFrame: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT06339788: Pharmacokinetics of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers
Official title: A Randomized, Open-label, Crossover, Phase 1 Study to Evaluate Pharmacokinetics and Safety of HD-P023 in Comparison With Co-administration of Teneligliptin and Empagliflozin High in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics and safety of HD-P023 and coadministration of Teneligliptin and Empagliflozin in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

* Patients who are 19 years or older on screening
* Signed informed consent
* Healthy Volunteer
* Other inclusion applies

Exclusion Criteria:

* Clinically relevant/significant findings as evaluated by the investigator
* Other exclusion applied

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUCt) of Teneligliptin and Empagliflozin
timeFrame: 72 hours
measure: Peak Plasma Concentration (Cmax) of Teneligliptin and Empagliflozin
timeFrame: 72 hours
Secondary outcomes:
measure: Area under the plasma concentration versus time curve zero to time infinity (AUC∞) of Teneligliptin and Empagliflozin
timeFrame: 72 hours
measure: Ratio of AUCt and AUC∞ (AUCt/AUC∞) of Teneligliptin and Empagliflozin
timeFrame: 72 hours
measure: Time to peak drug concentration (Tmax) of Teneligliptin and Empagliflozin
timeFrame: 72 hours
measure: Volume of distribution (VZ/F) of Teneligliptin and Empagliflozin
timeFrame: 72 hours
measure: Clearance (CL/F) of Teneligliptin and Empagliflozin
timeFrame: 72 hours
Other outcomes:
Locations:
city: Siheung-si
country: Korea, Republic of
facility: Central Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT01538888: Effects Whole Body Vibration in Ergospirometrics Parameters and Quality of Life
Official title: Effects Whole Body Vibration in Ergospirometrics Parameters, Strength And Quality of Life: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: WHOLE BODY VIBRATION
AGED
VO2
muscle strength
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 35
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study makes sure that the training of whole body vibration induces changes in ergospirometric parameters, in strength and influence in quality of life in healthy elderly. A case that is run like a vibration training combined, increasing strength and VO2.

Detailed description: The search use the spirometric values after whole body vibration training and resistance training

Eligibility criteria: Inclusion Criteria:

* aged 60 to 74 years
* sedentary or irregularly active according to the IPAQ short form with no known diseases

Exclusion Criteria:

* smoking
* acute hernia
* thrombosis
* labyrinthitis
* diabetes
* hemodynamic instability
* obesity
* osteoporosis
* neuromuscular diseases
* pulmonary comorbidities
* heart disease
* electrocardiographic changes during exercise
* taking medications that affected bone metabolism or muscle and don't adapt to any of the protocols

Primary outcomes:
measure: VO2
timeFrame: 03 MONTHS IN INTERVENTION
Secondary outcomes:
measure: quality of life
timeFrame: 03 month
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Maíra F Pessoa, MS
role: STUDY_DIRECTOR
affiliation: Universidade Federal de Pernambuco
name: Rafaela B Sá, MS
role: STUDY_CHAIR
References:
Clinical trial NCT03614988: Evaluation of Evening Versus Morning Levothyroxine Intake in Elderly
Official title: Comparative Evaluation of Evening Versus Morning Levothyroxine Administration in Treatment of Hypothyroidism in Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Primary Hypothyroidism
Interaction Drug Food
Keywords: Polypharmacy
Elderly
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2018-08-03
Enrollment: 208
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study designed to compare evening versus morning levothyroxine intake in the elderly.

Detailed description: This is a randomized crossover trial of two dosing strategies for pharmacological treatment of hypothyroidism in a sample of individuals aged 60 years or older, performed at an outpatient healthcare in a tertiary center.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 60 years or older who consult at the Geriatrics, Endocrinology and Internal Medicine Clinic at Hospital Clinicas de Porto Alegre
* Patients diagnosed with Primary Hypothyroidism
* Patients on levothyroxine for at least 6 months
* Patients with the same dose of levothyroxine for at least 3 months

Exclusion Criteria:

* Severe Dementia
* Severe Congestive Heart Failure (NYHA IV or / and three or more hospitalizations for heart failure within 1-year interval)
* Diagnosis of Advanced Stage Neoplasia
* Diagnosis of Thyroid Cancer

Primary outcomes:
measure: Variation in TSH (Thyroid-Stimulating Hormone) levels.
timeFrame: 24 weeks.
Secondary outcomes:
measure: Prevalence of drugs with potential drug interaction with levothyroxine.
timeFrame: 24 weeks
measure: Level of TSH (Thyroid-Stimulating Hormone) control in each group.
timeFrame: 24 weeks
measure: TSH (Thyroid-Stimulating Hormone) levels of the patients at baseline
timeFrame: Baseline (0 weeks)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Professor of the Post Graduate Program in Endocrinology at the Hospital de Clinicas de Porto Alegre
name: Renato Gorga Bandeira de Mello
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giassi K, Piccoli V, da Costa Rodrigues T, Gorga Bandeira de Mello R. Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE). Trials. 2019 Dec 17;20(1):742. doi: 10.1186/s13063-019-3816-3.
Clinical trial NCT00004488: Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gaucher's Disease
Osteopenia
Keywords: Gaucher's disease
inborn errors of metabolism
rare disease
sphingolipidoses
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with Gaucher's disease.

Detailed description: PROTOCOL OUTLINE:

This is a randomized, double blind, placebo controlled study.

All patients receive oral calcium carbonate and cholecalciferol daily. Patients are randomized to receive oral alendronate sodium or placebo daily for 24 months.

Patients are followed every 6 months for 2 years.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of type 1 Gaucher's disease enzymatically proven to have acid beta glucosidase deficiency

Must have been on stable dose (8-60 U/kg/every 2 weeks) of alglucerase enzyme therapy (Cerezyme or Ceredase) for at least 24 months

Lumbar spine bone density below the mean for age, sex, and race

--Prior/Concurrent Therapy--

At least 6 months since prior medications that directly affect skeletal metabolism including, but not limited to, bisphosphonates, calcitonin, parathyroid hormone, or estrogen

--Patient Characteristics--

Renal: No chronic renal failure; No recurrent renal stones

Esophageal: No history of dysphagia; No frequent heartburn; No esophagitis requiring treatment

Other: No untreated hyperthyroidism or hypothyroidism; No concurrent hyperparathyroidism; No concurrent malignancy; No history of alcohol or drug abuse; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center - Cincinnati
state: Ohio
city: Dayton
country: United States
facility: Wright State University School of Medicine
state: Ohio
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Richard J. Wenstrup
role: STUDY_CHAIR
References:
Clinical trial NCT04049188: Access to Single-Fraction Palliative Radiation Therapy in Cancer Patients Enrolled in Hospice
Official title: Impact of Access to Single-Fraction Palliative Radiation Therapy in Cancer Patients Enrolled in Hospice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Metastatic
Keywords: Cancer Patients Hospice Care
Palliative Radiation Therapy
Lead sponsor: Care Partners
Sponsor class: OTHER
Collaborators: name: OHSU Knight Cancer Institute
name: Oregon Health and Science University
First posted: 2019-08-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Feasibility study to report on the impact of ACCESS of single-fraction radiation therapy on cancer patients with bone metastases enrolled in hospice care.

Detailed description: Hospice care for terminally ill patients with metastatic cancer improves quality of life, pain control, and potentially also survival when patients are enrolled early.1-3 However, hospice programs are often seen by patients and their caregivers as the last resort after exhaustion of all effective treatment options. The need to revoke active treatment (for all hospice patients with cancer outside of the VA system) discourages hospice enrollment.

This study aims to understand and analyze barriers to access specifically for short course palliative radiation therapy in cancer patients enrolled in hospice.

Eligibility criteria: Inclusion Criteria:

* Solid Tumor Malignancies and Multiple Myeloma with Bone Metastases and Associated Bone Pain Enrolled in Hospice

Exclusion Criteria:

* Decisionally-Impaired Subjects, Pregnant Women

Primary outcomes:
measure: Change in Opioid Use for Pain Management
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Improved Quality of Life Measures
timeFrame: During study completion
measure: Improved Activities of Daily Living
timeFrame: During study completion
Other outcomes:
Locations:
city: Hillsboro
country: United States
facility: CarePartners
state: Oregon
Study officials:
References:
Clinical trial NCT01516788: Photoprovocation Testing in Subjects With Cutaneous Lupus
Official title: Photoprovocation Testing in Subjects With Cutaneous Lupus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lupus Erythematosus
Photosensitivity Conditions
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Photosensitivity is well documented among lupus patients and is one of the diagnostic criteria for systemic lupus erythematosus (SLE). Photosensitivity is highly prevalent in lupus and has a wide range of clinical presentations. However, photosensitivity is a poorly defined in lupus and its pathogenesis is not well understood. The purpose of this study is to characterize the early clinical and histopathological changes in lupus skin that occur as a response to ultraviolet light.


Eligibility criteria: Inclusion Criteria:

* Participants who have a diagnosis of CLE based on either the Gilliam classification of DLE and SCLE, or SLE based on the American College of Rheumatology criteria.

Exclusion Criteria:

1. Participants who do not meet criteria for either CLE or SLE.
2. Participants with a diagnosis of Erythropoietic Protoporphyria and Solar Urticaria, or another photodermatoses other than Polymorphous light eruption.
3. Participants who are not yet 18 years old or who are not capable of giving written informed consent prior to enrolling in the study.
4. Participants who have undergone any recent phototesting, or phototherapy exposure, or those who are suspected of having a drug-induced photosensitivity.
5. Female participants who are pregnant or breastfeeding will be excluded from the study. This will be determined by patient self-reporting.

Primary outcomes:
measure: The change from baseline of the neutrophil and inflammasome response to ultraviolet radiation at 24 hours.
timeFrame: 24 hours and 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05389488: OsciPulse D-dimer Efficacy Trial
Official title: A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Venous Thromboses
Ischemic Stroke
Lead sponsor: OsciFlex LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Pennsylvania
First posted: 2022-05-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety and efficacy of the OsciPulse System in reducing serum d-dimer levels in hospitalized ischemic stroke patients.

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Eligible and enrolled patients who have been admitted to the hospital for an ischemic stroke will be randomized in a non-blinded study to receive compression therapy from either standard-of-care intermittent compression garments, or the OsciPulse System. During the duration of the subject's hospital stay serum d-dimer levels will be monitored serially.

Eligibility criteria: Inclusion Criteria:

1. Adult aged ≥ 18 years old
2. Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke
3. Last known normal \< 24 hours.
4. NIH stroke score ≥5
5. Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores, items 6A and 6B)
6. Prescribed mechanical therapy for DVT prophylaxis.

Exclusion Criteria:

1. Inability or contraindication to applying IPC to both legs such as:

   * Evidence of bone fracture in lower extremities
   * Burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis,

     * ischemic limb in the legs at the site of IPC placement
   * Acute ischemia in the lower extremities
   * Severe peripheral vascular disease
   * Amputated foot or leg on one or two sides
   * Compartment syndrome
   * Severe lower extremity edema
   * Acute deep vein thrombosis
2. Subjects who received tPA therapy for their stroke
3. Pregnancy or within 6 weeks of postpartum period
4. Limitation of life support, life expectancy \< 7 days, or in hospice care
5. A head-unit is unavailable for the first 24 hours or more
6. At the discretion of the attending physician and / or clinical team, the subject's participation in the study is believed not to be in the best interest of the subject.

Primary outcomes:
measure: Relative change in serum d-dimer levels
timeFrame: 7 days
Secondary outcomes:
measure: Device tolerability
timeFrame: 7 days
Other outcomes:
measure: Device Safety event rate
timeFrame: 7 days
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: