louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00274807: Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Official title: Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Keywords: untreated adult acute myeloid leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute myeloid leukemia.

Detailed description: OBJECTIVES:

* Determine the complete remission rate in patients with acute myelogenous leukemia treated with induction chemotherapy comprising mitoxantrone hydrochloride, cytarabine, and etoposide.
* Determine the feasibility and toxicity of this regimen when given to patients with newly diagnosed acute myelogenous leukemia.

OUTLINE: Patients receive induction chemotherapy comprising mitoxantrone hydrochloride IV on days 1-3, cytarabine IV continuously over 72 hours on days 1-3 and 8-10, and etoposide IV continuously over 72 hours on days 8-10. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 4 and continuing until blood counts recover.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia

  * Previously untreated disease

    * Previous hydroxyurea and/or corticosteroids are acceptable
* No preexisting history of a hematologic disorder

  * Myelodysplastic features allowed
* No acute leukemia secondary to previous therapy
* No leukemic meningitis

PATIENT CHARACTERISTICS:

* Bilirubin \< 2.0 mg/dL (unless felt to be increased because of hepatic infiltration with leukemia)
* Creatinine \< 2.0 mg/dL
* Pregnant or lactating patients are ineligible
* Fertile patients must use effective contraception
* No history of or active congestive heart failure

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Matt E. Kalaycio, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01782807: Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy
Official title: Ovarian Function After Hysterectomy With or Without Fimbriectomy or Salpingectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Function Insufficiency
Keywords: Ovarian function
Hysterectomy
Salpingectomy
Anti mullerian hormone
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The impact of Hysterectomy with preservation of the ovaries on ovarian function has long been controversial. studies have shown conflicting data regarding ovarian function after simple Hysterectomy.

In recent years, there is a growing evidence that Salpingectomy or Fimbriectomy may have preventive value reducing Ovarian and Primary Peritoneal carcinoma, but the safety and the consequences regarding ovarian function have yet to be established.

The aim of this study is to evaluate ovarian function after Hysterectomy alone Vs. Hysterectomy combined with salpingectomy or fimbriectomy


Eligibility criteria: Inclusion Criteria:

* Women undergoing Hysterectomy for Benign In dication (eg. Uterus Myomatous) before menopause

Exclusion Criteria:

* Menopause
* known or suspected malignancy

Primary outcomes:
measure: Ovarian function
timeFrame: 60 days post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Kaplan Medical Center
Study officials:
References:
citation: Maseela T, Scheele R. [Hysterosalpingectomy. A contribution to the prevention of primary tubal neoplasms]. Fortschr Med. 1980 Jun 5;98(21):818-22. German.
citation: Zalel Y, Lurie S, Beyth Y, Goldberger S, Tepper R. Is it necessary to perform a prophylactic oophorectomy during hysterectomy? Eur J Obstet Gynecol Reprod Biol. 1997 May;73(1):67-70. doi: 10.1016/s0301-2115(97)02702-4.
citation: Morse AN, Hammer RA, Walter AJ, Baker S, Magtibay PM. Does hysterectomy without adnexectomy in patients with prior tubal interruption increase the risk of subsequent hydrosalpinx? Am J Obstet Gynecol. 2002 Dec;187(6):1483-5; discussion 1485-6. doi: 10.1067/mob.2002.130212.
citation: Farquhar CM, Sadler L, Harvey SA, Stewart AW. The association of hysterectomy and menopause: a prospective cohort study. BJOG. 2005 Jul;112(7):956-62. doi: 10.1111/j.1471-0528.2005.00696.x.
citation: Riedel HH, Lehmann-Willenbrock E, Semm K. Ovarian failure phenomena after hysterectomy. J Reprod Med. 1986 Jul;31(7):597-600.
citation: Bulent Tiras M, Noyan V, Ozdemir H, Guner H, Yildiz A, Yildirim M. The changes in ovarian hormone levels and ovarian artery blood flow rate after laparoscopic tubal sterilization. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 1;99(2):219-21. doi: 10.1016/s0301-2115(01)00410-9.
Clinical trial NCT06651307: The Effect of Neoprene Elbow Sleeves on Bench Press and Shoulder Press Performance
Official title: The Effect of Neoprene Elbow Sleeves on Bench Press and Shoulder Press Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healhty
Keywords: bench press
maximal strength
elbow sleeves
shoulder press
as many repetitions as possible
Lead sponsor: Nord University
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All subjects performed testing with and without elbow sleeves. The sequence of conditions was allocated by a randomized and counterbalanced crossover approach.
Primary purpose: OTHER

Brief summary: We examined the effect of neoprene elbow sleeves on bench press and shoulder press perforamance in a group of healhty students.

Detailed description: 20 healhty volunteers performed one repetition maximum tests in bench press and shoulder press, with and without elbow sleeves. We also tested how many repetitions the subjects were able to lift at 85% of one repetition maximum, with and without elbow sleeves.

Eligibility criteria: Inclusion Criteria:

* Healthy young volunteers that participated regularly in strength training

Exclusion Criteria:

* any injuries or ailments in the upper body that restricted their ability to perform heavy bench press or shoulder press lifting

Primary outcomes:
measure: One repetition maximum in bench press and shoulder press
timeFrame: Within 2 weeks after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Nord University
state: Nordland
Study officials:
References:
Clinical trial NCT02414607: Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
Official title: Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mild Cognitive Impairment
Keywords: Elderberry juice
Alzheimer's
Inflammation
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2015-04-13
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Elderberries (Sambuci fructus) have been shown in a number of studies to have significant anti-inflammatory and antioxidant effects. Multiple human and animal studies have supported the anti-inflammatory and antioxidant effects of elderberry preparations and it has been used in natural medicine for hundreds of years. Studies examining factors that may decrease the risk of Alzheimer's disease have revealed that drinking juices with similar properties to elderberries is one of the most reliable way to decrease risk. As such the investigators wish to determine the effects of elderberry juice on cognitive decline in a group of subjects at high risk for Alzheimer's disease, those with mild cognitive impairment. Elderberry juice is a commercially available nutritional supplement and easily available to this population.


Eligibility criteria: Inclusion Criteria:

* CDR score of 0.5
* MMSE of at least 24
* Age 50 or older

Exclusion Criteria:

* Known history of sensitivity to elderberry products.
* Diabetes.
* Bleeding disorder.
* Current Pregnancy.
* Known allergy to honeysuckle.
* Currently making changes to other drugs that might affect cognitive performance (subjects showing the greatest cognitive decline and other signs of Alzheimer's disease may be prescribed cholinesterase inhibitors as this is a standard of care for Alzheimer's disease but not MCI).
* Presence of any condition the health professional believes will impair ability to complete study procedures (ex. terminal illness, comorbid major psychiatric disorders such as schizophrenia, or drug abuse).
* Potentially confounding neurodegenerative diseases (e.g. MS).

Primary outcomes:
measure: Visuospatial Problem Solving Battery (VSP)
timeFrame: 12 wks, 6 mos
Secondary outcomes:
measure: Clinical Dementia Rating (CDR) Scale
timeFrame: 12 wks, 6 mos
measure: Mini-Mental State Examination (MMSE)
timeFrame: 12 wks, 6 mos
measure: Hopkins Verbal Learning Test (HVLT)
timeFrame: 12 wks, 6 mos
measure: Boston Naming Test (BNT)
timeFrame: 12 wks, 6 mos
measure: Rey Complex Figure Task (Rey)
timeFrame: 12 wks, 6 mos
measure: Anagrams
timeFrame: 12 wks, 6 mos
measure: Instrumental Activities of Daily Living Scale (IADLS)
timeFrame: 12 wks, 6 mos
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Hospital
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: David Q Beversdorf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05677607: Feedback Loop Between Intracranial Atherosclerosis and Cerebral Small Vessel Disease
Official title: Feedback Loop Between Intracranial Atherosclerosis and Cerebral Small Vessel Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ICAS - Intracranial Atherosclerosis
Cerebral Small Vessel Diseases
Keywords: Intracranial atherosclerosis
Cerebral small vessel disease
Feedback mechanism
Multimodal MRI
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with at least on intracranial artery ≥ 50% atherosclerotic stenosis.

Brief summary: The present study aims at verifying the mutual effects between intracranial large artery atherosclerosis and cerebral small vessel disease on disease progression and prognosis by magnetic resonance imaging, and providing biomarkers for the early prevention and treatment of cerebrovascular disease.

Detailed description: Cerebrovascular disease is the most common cause of death worldwide. There is a close link in structure and function between the intracranial large arteries and cerebral small vessels. Moreover, growing evidences have demonstrated that large artery atherosclerosis often coexists with small vessel disease, which may deteriorate the clinical outcomes of stroke and dementia. The mutual feedback mechanism between them is not fully understood. The present study focuses on the mechanism of mutual feedback between large artery atherosclerosis and cerebral small vessel disease by using magnetic resonance imaging. The study may provide biomarkers for the early prevention and treatment of cerebrovascular disease.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* At least one intracranial artery ≥ 50% atherosclerotic stenosis
* Modified Rankin Scale \< 2
* Mini-mental State Examination \> 24

Exclusion Criteria:

* Concurrent ipsilateral extracranial artery ≥ 50% stenosis
* Pregnant women
* Contraindications to magnetic resonance examination (patients with pacemakers, nerve stimulators, artificial metal heart valves and other metal foreign bodies)

Primary outcomes:
measure: Progression in total cerebral small vessel disease burden
timeFrame: 1-3 YEARS
measure: Frequency of stroke recurrence
timeFrame: 1-3 YEARS
Secondary outcomes:
measure: Frequency of stroke of asymptomatic participants
timeFrame: 1-3 YEARS
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Jinhao Lyu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02211807: Suicidality and Suicide Attempt Among HIV Patients on Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens
Official title: The Risk of Suicidality and Suicide Attempt Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Truven Health Analytics
First posted: 2014-08-08
Enrollment: 11400
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in a commercial insurance database and a Medicaid database

Brief summary: The purpose of this study was to compare the frequency of suicidality and suicide attempt among HIV patients starting treatment with Efavirenz and with patients starting treatment with other HIV medications.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* At least 6 months of enrollment before first prescription
* Antiretroviral naive

Exclusion Criteria:

* No diagnosis of HIV on patient record
* Age \< 12 years

Primary outcomes:
measure: Number of cases of Suicidality, defined as suicidal ideation and suicide attempt
timeFrame: Patients will be followed from date of index fill of efavirenz or comparator antiretrovirals until earliest of date of suicidality claim,30th day after the last day of the days supply of the index medication,last day of enrollment or end of study period
Secondary outcomes:
measure: Number of suicide attempt cases, defined as an inpatient or emergency room claim with at least one ICD-9-CM code for suicide attempt
timeFrame: Patients will be followed from date of index fill of efavirenz or comparator antiretrovirals until earliest of date of suicidality claim,30th day after the last day of the days supply of the index medication,last day of enrollment or end of study period
measure: Number of suicide attempt cases
timeFrame: Patients will be followed from date of index fill of efavirenz or comparator antiretrovirals until earliest of date of suicidality claim,30th day after the last day of the days supply of the index medication,last day of enrollment or end of study period
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05441007: The Effect of Hypercapnia on Physiological Parameters During Short-term Breathing
Official title: The Effect of Hypercapnia and Hypoxia on Physiological Parameters During Short-term Breathing Experiment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxia
Hypercapnia
Cardiac Output, High
Keywords: Cardiac Output
Perfusion index
Pulse oximetry
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Interventional single blinded randomized crossover prospective study. All participants go through all study arms, in random order.
Primary purpose: OTHER

Brief summary: The aim of the project is to evaluate the effect of hypercapnia on physiological parameters in a healthy person during short-term hypoxia and hypercapnia.

Detailed description: Hypercapnia causes changes in physiological parameters at various levels throughout the body. The study aims to evaluate the effect of hypercapnia on physiological parameters in a healthy person during short-term hypoxia and hypercapnia. It is an intervention prospective study that will be conducted at the Faculty of Biomedical Engineering on healthy volunteers. All the volunteers undergo three different phases in random order. The individual phases differ in the breathed mixture of oxygen, nitrogen and carbon dioxide gases. Non-invasive measurements of physiological parameters, especially blood oxygen saturation, perfusion index and cardiac output, will be performed continuously during the experiment.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* pregnancy
* severe cardiovascular conditions
* severe asthma or other severe respiratory conditions
* injury to the upper limbs or hands that could affect the peripheral perfusion
* diabetes
* hypotension or hypertension

Primary outcomes:
measure: Changes in Cardiac output due to the induced hypoxia and hypercapnia
timeFrame: 1 hour
measure: Changes in Perfusion index due to the induced hypoxia and hypercapnia
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Czech Technical University in Prague
Study officials:
References:
Clinical trial NCT00538707: Effect of Mental Stress on Platelet Function
Official title: Effect of Mental Stress on Platelet Function in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Stress
Keywords: mental stress
platelet adhesion
platelet function
catecholamines
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-10-03
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the project is to study the acute and chronic effect of mental stress on platelet adhesion and aggregation in two population composed of normal subjects at different ages

Detailed description: Psychological stress is an important cardiovascular risk factor. Activation of platelets plays an important role in atherosclerosis development and it could be one of the mechanisms linking psychological stress and cardiovascular diseases.

We plan to include 32 healthy subjects. (16 in every group). One group with subjects at age 20 - 49 and the other group with subjects at age 50 - 70 years.

The aim of the study will be to assess the acute and chronic effect of a standard short mental stress (2-minute Bondet Test) on platelet function and of the level of endothelin-1, catecholamines and cortisol. We plan to evaluate if age may play a role in the effect of psychological stress on platelet function.

Eligibility criteria: Inclusion Criteria:

* healthy subjects between 20 - 70 years of age
* written informed consent
* no evidence of diseases

Exclusion Criteria:

* pregnancy
* oral contraceptives
* smoking
* use of aspirin or NSAIDs within the last week
* use of benzodiazepines within the last week
* Alcohol or drug abuse
* participation in another study within the last month

Primary outcomes:
measure: Evaluation of platelet function (shear stress dependent platelet adhesion and aggregation) before and after mental stress
timeFrame: 60 minutes
Secondary outcomes:
measure: Evaluation of the plasma level of endothelin, catecholamines and salivary cortisol level before and after mental stress
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: University of Zurich
name: Georg Noll, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00611507: A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer
Official title: A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-02-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in advanced colorectal cancer


Eligibility criteria: Inclusion Criteria:

* Histologically proven gastric or gastroesophagic junction adenocarcinoma
* Measurable disease at least in a unidimensional manner. If a unique metastasis constitutes the only disease symptom, histological confirmation will be required
* Metastatic or locally non-surgical primary gastric cancer
* Recurrent gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant chemotherapy period or a neo-adjuvant chemo-radiotherapy of at least 6 months
* Serum bilirubin\< 2 mg/dl
* Serum creatinine \< or =to 2 times normal superior limit
* Absolute neutrophil count \> or =to 2000/dl
* Platelet count \> or =to 100000/dl
* Hemoglobin \> or =to 10 g/dl
* AST/ALT \< or =to 2.5 times normal superior institutional limit
* Alkaline phosphatase \< or =to 5 times the normal superior institutional limit
* Age \> 18 years
* Performance Status ECOG 0-2
* Written informed consent signed and dated

Exclusion Criteria:

* Symptomatic sensory peripheral neuropathy
* Uncontrolled concomitant disease.(e.g. severe diabetes mellitus, arterial hypertension)
* Any other malignancy diagnosed within 5 years previous to the gastric cancer, with the exception of " in situ " cervix carcinoma or non-melanoma skin cancer
* Concomitant anti-tumoral treatment
* Cerebral metastases
* Unstable heart disease, even though under treatment
* Myocardial infarction within the last 6 months
* Pregnancy or nursing (or women in reproductive life without adequate contraception)
* Significant neurological or psychiatric disorders

Primary outcomes:
measure: Response rate - RECIST criteria (unidimensional)
timeFrame: During the study conduct
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: During the study conduct
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Juan Carlos Gomez
role: STUDY_DIRECTOR
References: