louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03791463: Effect of Food on Pharmacokinetics of Salvianolic Acid A in Healthy Subjects
Official title: A Phase I, Single Centre, Randomized, Open-Label, Three-Period Crossover Study to Investigate the Effect of Food on Pharmacokinetics of Salvianolic Acid A in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2019-01-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is an open-label, randomized, cross-over design with two single-dose treatment periods and a washout of at least 3\~5 days in between each treatment visit. The study period consists of 3 visits to the study centre: Visit 1 (enrolment), Visit 2 (first single-dose treatment), Visit 3 (second single-dose treatment).

Target subject population is healthy subjects aged 18-45 years. Following an overnight fast of at least 10 hours, a single dose of 90mg salvianolic acid A will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.


Eligibility criteria: Inclusion Criteria:

1. healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19.0 and ≤25.0 kg/m2 at screening
2. The subject is able to communicate well with the investigator and is able to complete the trial in accordance with the protocol.

Exclusion Criteria:

1. Planned for pregnancy or pregnant within 6 months after enrollment throughout the trial.
2. Subject has any clinically significant abnormal finding on the physical exam at screening or admission.
3. Subject has a positive screening test for alcohol or drugs of abuse at screening or admission.
4. Allergic to the body.
5. Participated in any clinical trial within 3 months prior to the trial.

Primary outcomes:
measure: The Effect of Food Timing (Fasting and After Meal) on Pharmacokinetics of salvianolic acid A in Healthy Subject
timeFrame: Hour 24
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiaocong Pang
Study officials:
References:
Clinical trial NCT04570163: Berlin Registry of Right Heart Interventions
Official title: Berlin Registry of Right Heart Interventions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tricuspid Regurgitation
Pulmonary Regurgitation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after interventional therapy of valvular diseases of the right heart (such as "cardioband" and "edge-to-edge" techniques of the tricuspid valve) performed in Berlin/ Brandenburg (primarily at the Charité, Universitätsmedizin Berlin).

Brief summary: The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo. The aim is to assess the different interventional therapies and their impact on patient's outcome.

Detailed description: The subject of the study is to register interventional therapies of right heart diseases (such as "cardioband" and "edge-to-edge" techniques of the tricuspid valve) performed in Berlin/ Brandenburg (primarily at the Charité, Universitätsmedizin Berlin). Based on the development and the increasing use of interventional therapies in tricuspid and pulmonary valve diseases, the impact on the patients' symptoms and life expectancy after interventions will be investigated. The aim is to identify patient subgroups that benefit the most.

Primary endpoints: Total mortality, cardiovascular mortality, heart failure hospitalization.

Secondary endpoints: NYHA class, NTproBNP, liver and kidney function (laboratory measurements), valve function, cardiac function, and cardiac morphology.

Eligibility criteria: Inclusion Criteria:

* Patients with planned or recent valve interventions of the right heart (tricuspid regurgitation/ stenosis, pulmonary regurgitation/ stenosis)
* \>18 years
* Written, documented consent

Exclusion Criteria:

* Patients in care or unable to consent
* Patients who are unable to comply with follow-up examinations
* Patients who are detained in an institution

Primary outcomes:
measure: Overall mortality
timeFrame: 2 months after intervention
measure: Cardiovascular mortality
timeFrame: 2 months after intervention
measure: Unscheduled hospitalization for heart failure progression
timeFrame: 2 months after intervention
Secondary outcomes:
measure: NYHA class
timeFrame: 2 months after intervention
measure: NTproBNP
timeFrame: 2 months after intervention
measure: valve function
timeFrame: 2 months after intervention
measure: liver function
timeFrame: 2 months after intervention
measure: kidney function
timeFrame: 2 months after intervention
measure: cardiac function
timeFrame: 2 months after intervention
measure: cardiac morphology
timeFrame: 2 months after intervention
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
References:
Clinical trial NCT00684463: Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)
Official title: Study to Evaluate the Efficacy and Safety of Single IV Doses of Onicit® (Palonosetron) 0.25 mg in the Prevention of Acute and Delayed Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neoplasms
Nausea
Vomiting
Keywords: Antiemetic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy and safety of single IV doses of Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years of age or older.
* Histological or cytological confirmation of malignant disease.
* Karnofsky index \>= 50%
* Naïve to chemotherapy (First Cycle of chemotherapy IV with moderate or high emetic risk administered during Day 1 of the study, according to modification of the classification of Paul Hesketh's schema published on Annals of Oncology 17: 20-28, 2006 (Appendix 3).
* Patients that voluntarily sign the consent form.

Exclusion Criteria:

* Pregnancy or suspected.
* Patients during breast feeding.
* Inability to understand or cooperate with the study procedures.
* Received any investigational drugs within 30 days before study entry.
* Received any drug with potential anti-emetic efficacy within 24 hours prior to the beginning of the treatment
* Seizure disorders requiring anticonvulsant medication.
* Persistent vomiting due to any organic etiology.
* Experienced any vomiting, nausea or retching, in the 24 hours prior to chemotherapy.
* Any systemic disease different to base disease
* Known current or history of drug or alcohol abuse
* Gastric outlet or intestinal obstruction

Primary outcomes:
measure: Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.
timeFrame: During 24 hours after administration of chemotherapy.
Secondary outcomes:
measure: Proportion of patients who achieved a CR and of those who achieved complete control
timeFrame: Days 1 to 5 at different time intervals for each secondary outcome.
measure: Number of emetic episodes
timeFrame: Days 1 to 5 at different time intervals for each secondary outcome.
measure: Time to first emetic episode; time to administration and need for rescue therapy; and to treatment failure time to first emetic episode or administration of rescue medication
timeFrame: Days 1 to 5 at different time intervals for each secondary outcome.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01280786: Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official title: A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: AML
leukemia
relapsed or refractory AML
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2011-01-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.

Detailed description: This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when administered to patients with advanced myeloid leukemia.

Eligibility criteria: Inclusion Criteria:

* Adults with cytologically confirmed Acute Myeloid Leukemia (AML) that has relapsed after the completion of induction and/or consolidation therapy or has failed to respond to standard induction therapy
* ECOG performance status of 0-2
* Acceptable organ and marrow function during the screening period as defined by the protocol
* Reliable venous access suitable for study drug infusions

Exclusion Criteria:

* Significant cardiovascular disease
* Candidates for hematopoietic stem cell transplant
* Women who are pregnant or breast-feeding
* Prior treatment with chronic immunosuppressants
* Other clinically significant uncontrolled conditions

Primary outcomes:
measure: Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability.
timeFrame: 1 year
measure: Measurement of study drug concentrations to characterize pharmacokinetics.
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of Dose Limiting Toxicities and Response based on Peripheral Blood Counts and Bone Marrow
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT00005386: Biobehavioral Determinants of Obesity in Black Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Obesity
Telangiectasis
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To examine the biobehavioral determinants of obesity in Black as compared with white women.

Detailed description: BACKGROUND:

Behavioral medicine surveys consistently find that obesity is a treatment-resistant disease that continues to be a significant health problem and that the incidence of obesity is much higher in Blacks relative to whites in general, and even higher in Black women relative to white women. In fact, an NIH Program Announcement (PA-91-99), stated that "Obesity in adults has not declined in the past three decades" and "Obesity is particularly prevalent in minority populations, especially among minority women." Obesity is an independent risk factor for cardiovascular disease, stroke, and hypertension. Obesity is a complex phenomenon involving behavioral, lifestyle, and complex biobehavioral mechanisms. In 1995, there were no prospective studies that simultaneously evaluated a systematic set of psychosocial variables with energy balance (dietary intake, physical activity, resting metabolic rate) determinants that may account for the increased risk for obesity in African-American versus Euro-American women.

DESIGN NARRATIVE:

After subjects were recruited, psychosocial and energy balance (dietary intake, physical activity, metabolic rate) baseline measures were related to levels of body fat as measured by DEXA (dual electron X-ray absorptiometry). The role of these variables were evaluated prospectively to adiposity changes in both white and Black women over a 24-month period.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Memphis
name: Robert Klesges
References:
citation: Scarinci IC, Slawson DL, Watson JM, Klesges RC, Murray DM. Socioeconomic status, ethnicity, and health care access among young and healthy women. Ethn Dis. 2001 Winter;11(1):60-71.
citation: Scarinci IC, Watson JM, Slawson DL, Klesges RC, Murray DM, Eck-Clemens LH. Socioeconomic status, ethnicity, and environmental tobacco exposure among non-smoking females. Nicotine Tob Res. 2000 Nov;2(4):355-61. doi: 10.1080/713688150.
Clinical trial NCT01776086: Neuropsychological Testing Using Mobile Devices
Official title: Neuropsychological Testing Using Mobile Devices
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Inpatients With Normal Neurological Function
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this studying is to develop and characterize neuropsychological testing software for evaluating the prefrontal and temporal function of patients. As no software has been used for this purpose, this study will gather pilot data on the baseline performance of patients in a hospital setting that lack any neurological impairment. After creating this baseline, later experiments can be proposed to compare the performance in normal subjects with those who have neurologic injury or disease.


Eligibility criteria: Inclusion Criteria:

* Inpatients \> = 18 years of age
* Patient must be able to provide informed consent

Exclusion Criteria:

* Patients with score of \< 26 on Folstein Mini-Mental Status Exam
* Patients with known brain lesions
* Patients with history of stroke, neurologic disease or dementia
* Patients with acute illness or who are in imminent distress

Primary outcomes:
measure: Determination of "normal performance" curve
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
Study officials:
affiliation: Englewood Hospital and Medical Center
name: James Young, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004786: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Sclerosis
Raynaud Disease
Keywords: Raynaud's syndrome
arthritis & connective tissue diseases
cardiovascular and respiratory diseases
rare disease
systemic sclerosis
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Pittsburgh
First posted: 2000-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Evaluate the safety and efficacy of oral iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon secondary to systemic sclerosis.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and digital cutaneous ulcers.

Patients receive oral iloprost or placebo twice daily for 6 weeks. Thrombolytic drugs, oral anticoagulants, and heparin are prohibited on study. Concurrent therapy with angiotensin-converting enzyme inhibitors for Raynaud's is prohibited; calcium channel blockers for severe digital ischemia are allowed as needed.

Patients are followed at 2 and 6 weeks.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Raynaud's phenomenon secondary to systemic sclerosis (SS) SS meets American College of Rheumatology diagnostic criteria
* At least 6 Raynaud's attacks per week

--Prior/Concurrent Therapy--

* No prior participation in oral iloprost study
* At least 4 weeks since participation in other investigational drug studies
* At least 2 months since prostanoid therapy
* At least 12 months since sympathectomy of upper limb
* Ongoing therapy for systemic sclerosis may continue on study Raynaud's therapy discontinued at entry

--Patient Characteristics--

Hematopoietic: No platelet disorder

Hepatic: No bleeding diathesis

Renal: Creatinine clearance (estimated) at least 30 mL/min

Cardiovascular:

No unstable angina pectoris

None of the following within 3 months:

* Stroke
* Transient ischemic attack
* Myocardial infarction

Other:

* No active cancer or other uncontrolled disease
* No current history of alcohol or drug abuse
* No mental disorder precluding compliance
* No pregnant or nursing women
* Negative pregnancy test required of fertile women
* Adequate contraception required of fertile women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Thomas A. Medsger, Jr.
role: STUDY_CHAIR
References:
Clinical trial NCT03494686: LLETZ Under General Versus Local Anesthesia
Official title: Large Loop Excision of the Transformatione Zone Under General Versus Local Anesthesia: a Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Dysplasia
Keywords: conization
LLETZ
randomized controlled trial
loop excision
general anaesthesia
local anaesthesia
Lead sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 229
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conduct a prospective, randomized trial to assess the benefits of performing large loop excision of the transformatione zone (LLETZ) under local anesthesia and compare it to LLETZ under general anesthesia. The primary endpoint of this study is women´s satisfaction.


Eligibility criteria: Inclusion Criteria:

* colposcopy Prior to conization
* informed consent
* histologically proven high grade cervical dysplasia
* Transformation zone typ 1 or 2

Exclusion Criteria:

* significant language barrier
* a personal history of conization
* pregnancy
* the use of blood thinner
* unwillingness to participate
* oncological disease
* inpatient treatment
* women who are not fasting
* risk of aspiration
* columnar-squamous epithelium border not fully visible

Primary outcomes:
measure: Womens satisfaction
timeFrame: 2 hours
Secondary outcomes:
measure: Postoperative pain
timeFrame: 2 hours
measure: the resected cone mass
timeFrame: 10 minutes
measure: Operation time
timeFrame: 20 minutes
measure: Operative complications
timeFrame: 14 days
measure: Time to complete intraoperative hemostasis
timeFrame: 120 seconds
measure: Surgeons satisfaction
timeFrame: 20 minutes
measure: number of fragments of the surgical specimen
timeFrame: 20 minutes
measure: the dimensions of the surgical specimens
timeFrame: 20 minutes
measure: Intraoperative blood loss
timeFrame: 5 hours
measure: Margin status
timeFrame: 2 days after conization
Other outcomes:
Locations:
city: Herne
country: Germany
facility: Department of Obstetrics and Gynecology of the Ruhr University Bochum
state: NRW
Study officials:
affiliation: Zydolab - Institute of Cytology and Immune Cytochemistry
name: Ziad Hilal, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rezniczek GA, Hecken JM, Rehman S, Dogan A, Tempfer CB, Hilal Z. Syringe or mask? Loop electrosurgical excision procedure under local or general anesthesia: a randomized trial. Am J Obstet Gynecol. 2020 Dec;223(6):888.e1-888.e9. doi: 10.1016/j.ajog.2020.06.041. Epub 2020 Jul 24.
Clinical trial NCT02874586: Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis
Official title: Plasma Exchange Combination of Immunosuppressive Regimens for the Remission of Auto-immune Hepatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis, Autoimmune
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with auto-immune hepatitis based on liver biopsy results, with the indications of immunosuppressive therapy;
* High levels of total bilirubin (TB) (≥10 X ULN);
* High levels of immunoglobulin G(IgG) (≥1.5 X ULN);
* Agreed to participate in the trial, and assigned informed consent;

Exclusion Criteria:

* The presence of hepatitis A, B, C, D, or E virus infection;

  * Patients with presence of liver cirrhosis or portal hypertension;
  * Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy;
  * Pregnant and breeding women;
  * Patients with severe anemia (hemoglobin \< 8 g/dL), leukopenia (WBC \< 2500/mm3), or thrombocytopenia (platelet count \< 50,000/mm3);
  * Severe disorders of other vital organs, such as severe heart failure, cancer;
  * Parenteral administration of blood or blood products within 6 months before screening;
  * Recent treatment with drugs having known liver toxicity;
  * Taken part in other clinic trials within 6 months before screening.

Primary outcomes:
measure: Percent of patients that achieve biochemical remission of AIH
timeFrame: Month 6 after the treatment initiated
Secondary outcomes:
measure: Alanine transaminase (ALT)
timeFrame: Day 1, and Week 1, 2, 4, 12, 24
measure: Aspartate transaminase(AST)
timeFrame: Day 1, and Week 1, 2, 4, 12, 24
measure: Globin(GLB)
timeFrame: Day 1, and Week 1, 2, 4, 12, 24
measure: Immunoglobulin G(IgG)
timeFrame: Day 1, and Week 1, 2, 4, 12, 24
measure: Total bilirubin(TB)
timeFrame: Day 1, and Week 1, 2, 4, 12, 24
measure: Direct bilirubin(DB)
timeFrame: Day 1, and Week 1, 2, 4, 12, 24
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital,Chengdu, Sichuan, China
name: Li Yang, MD
role: STUDY_CHAIR
References: