louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02177201: Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting
Official title: Effect of Intravenous Crystalloid Volume on Postoperative Nausea and Vomiting After Tonsillectomy and/or Adenoidectomy: a Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Vomiting
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2014-06-27
Enrollment: 160
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Postoperative nausea and vomiting is very common in children undergone tonsillectomy and/or adenoidectomy. The purpose of this clinical trial is to evaluate the antiemetic effect of super-hydration with 0.9% saline in children undergoing specifically elective otorhinolaryngological surgery. Fluid intake reduces vomiting as seen following extended period of fasting that interrupts the perfusion in gut. Based on this knowledge, we hypothesized that administration of supplemental fluid would reduce the incidence of postoperative vomiting.

Detailed description: At the initiation of the study, 160 patients we enrolled consecutively . Six of the patients were excluded according to the inclusion/exclusion criteria. Remaining one hundred fifty four were American Society of Anesthesia (ASA) I-II classified children , aged 2-15 yr, undergoing elective tonsillectomy, with or without adenoidectomy, under general anesthesia . Induction and maintenance of anesthesia were standardized with fentanyl, lidocaine, rocuronium and sevoflurane in nitrous oxide (N(2)O). Subjects were assigned to two groups administered with saline solution (%0.9 saline) at different rates; either 10 ml/kg/h or 20ml/kg/h delivery arms.

Eligibility criteria: Inclusion Criteria:ASA physical status I or II

* Age 2-15 yr
* Scheduled for elective tonsillectomy and/or adenotonsillectomy

Exclusion Criteria:

* History of diabetes
* History of mental retardation
* Obesity (BMI = \> 95th percentile for age and sex)
* Intake of antiemetic or psychoactive medication within 24 hours before surgery
* Known gastroesophageal reflux

Primary outcomes:
measure: Postoperative Vomiting
timeFrame: First 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University Training and Research Hospital
city: Aydın
country: Turkey
facility: Adnan Menders University
Study officials:
affiliation: Adnan Menderes University,Faculty of Medicine, Department of Anesthesia
name: SİNAN YILMAZ, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00443001: Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias
Official title: Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Non-Invasive Blood Pressure
Sinus Rhythm
Oscillometric
Invasive Blood Pressure
AAMI/ANSI SP10 Standard
Compliance with ANSI/AAMI SP10 2002 standard
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2007-03-05
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This protocol focuses on the evaluation of the GE noninvasive blood pressure parameter in subjects with dysrhythmias and normal sinus rhythm. The study follows the recommendations of the ANSI/AAMI SP10 Standard.


Eligibility criteria: Inclusion Criteria:

* signed informed consent
* a patient who is undergoing a specialized procedure such as a surgical procedure or cardiac catheterization, or during critical care monitoring in which a central arterial catheter is in place to determine systolic, diastolic, and/or mean arterial blood pressure values.
* ability to monitor ECG, NIBP and/or pulse oximetry
* presence of atrial fibrillation, atrial flutter, or normal sinus rhythm

Exclusion Criteria:

* any subject deemed too unstable, at the clinician's discretion, to participate in the study
* any subject with a cardiac or vascular malformation that results in an abnormal waveform inappropriate to be considered a reference standard
* any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery.
* presence of peripheral vascular disease in arms
* inability to perform a minimum of 4 fast flushes (two at the study beginning and two at the study end) on an arterial catheter or line in order to determine a frequency response. The volume of fluid will not exceed a total pre-specified by the Principal Investigator or designee.
* if the baseline arm to arm mean difference is \> 10 mmHg, then the differences will be recorded and evaluated by the Principal Investigator for possible subject exclusion from the data analysis.
* subjects who, at the clinician's discretion, could not tolerate approximately 5 to 12, but possibly up to 25 repeated blood pressures on each arm

Primary outcomes:
measure: Comparison of early systolic, systolic, and diastolic blood pressure, MAP and pulse rate as collected by an investigational non-invasive blood pressure device versus reference standards
timeFrame: 1-4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: GE Healthcare
state: Wisconsin
Study officials:
affiliation: Cardiac Catheterization Laboratory Division of Cardiology
name: Russel Hirsch, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04709601: Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in Women With Recurring Urinary Tract Infections.
Official title: Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in the Management of Recurrent Urinary Tract Infections in Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Urinary Tract Infections
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 14
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure the concentration of formaldehyde in the urine of women with recurrent urinary tract infections on Hiprex; and then, assuming its urinary presence is confirmed at the proper acid urinary pH, evaluate if such a therapy has favorable effects in decreasing the rate of recurrent urinary tract infections over time.


Eligibility criteria: Inclusion Criteria:

1. Female
2. Age 50 - 85
3. Have RUTIs (at least 2 UTIs within the past 6 months or 3 within the past year) -

Exclusion Criteria:

1. Being on antibiotics at baseline (i.e. suppressive therapy or antibiotic therapy for urinary or non-urinary infections)
2. Neurogenic bladder condition
3. Using urinary catheters (including Foley catheter, intermittent catheterization, and suprapubic catheter)
4. Uncontrolled diabetes (HbA1c \> 9)
5. Chronic renal failure defined as serum creatinine \> 1.5 mg/dL
6. History of liver disease
7. Patients from out of town, in whom follow-up will not be possible
8. Pregnancy
9. Allergy to Hiprex
10. Inability to take Hiprex reliably at home, such as having psychosis, dementia, or swallowing disorders
11. Non-English speakers -

Primary outcomes:
measure: Number of Urinary Tract Infections
timeFrame: 1 year
Secondary outcomes:
measure: Number of oral anti-biotic usage
timeFrame: 1 year
measure: Number of hospital re-admissions
timeFrame: 1 year
measure: Number of adverse events related to Hiprex
timeFrame: 1 year
measure: Urine acidity levels
timeFrame: 1 year
measure: Number of urinary tract infection episodes
timeFrame: up to 2 years
measure: Severity of UTI symptoms as measured by the UTI Symptom Assessment questionnaire
timeFrame: 1 year
measure: Duration of intervals between UTI episodes
timeFrame: 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT-Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Philippe Zimmern, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02368301: Expanded Access Treatment Protocol CA204-143
Official title: An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-02-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at U.S. sites where licensed physicians determine clinical need.


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

Inclusion Criteria

* Men and women 18 years and older.
* Active, relapsed or refractory multiple myeloma by IMWG (International myeloma Working Group) criteria as assessed by the treating physician and have received one prior line of multiple myeloma therapy.
* Prior lenalidomide exposure is permitted only if they fulfill all of the following:.

  i) Were not refractory to prior lenalidomide defined as no progression while receiving lenalidomide (induction dose) or within 60 days of last dose of lenalidomide. Patients progressing on lenalidomide maintenance dose are eligible for enrolment.

A. Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE.

Exclusion Criteria

* Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 109/L).
* All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade ≤ 2.
* Significant cardiac disease as determined by the treating physician including cardiac amyloidosis.
* HIV infection or active hepatitis A, B, or C.
* History of participation in elotuzumab studies CA204-004, CA204-006 or CA204-009.
* Inadequate recovery from prior surgery or prior myeloma therapy. If prior allogeneic stem cell transplant, history of moderate to severe chronic graft versus host disease (GvHD).
* Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient.
* Certain abnormal physical or laboratory findings.
* Hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab formulation, or recombinant protein.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01477801: Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels
Official title: Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels. A Phase 2 Randomized Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Vitamin D Deficiency
Lead sponsor: Azienda Unita' Sanitaria Locale Di Modena
Sponsor class: OTHER
Collaborators: name: Abiogen Pharma
First posted: 2011-11-23
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether cholecalciferol supplementation in patients with chronic heart failure and low vitamin D levels improves:

1. performance at six minutes walking test
2. echocardiographic parameters
3. neurohormonal imbalance


Eligibility criteria: Inclusion Criteria:

* Heart failure diagnosis according to European Society of Cardiology Guideline criteria
* Age \> 60 years old
* 25(OH) Vitamin D level \< 30 ng/ml
* Clinical and therapeutic stability for one month (NYHA class II or III)

Exclusion Criteria:

* Chronic use of anticonvulsants or barbiturates, steroids, thiazides, aluminium or magnesium, colestipol or cholestyramine
* Glomerular filtration rate lower than 30 ml/min/1.73 m2 according to MDRD equation
* Nephrolitiasis, Sarcoidosis or hypercalcemia
* Recent (three months) acute coronary syndrome or stroke or major vascular surgery
* Reduced life expectancy due to other diseases (active neoplasms, liver cirrhosis...)

Primary outcomes:
measure: SIX MINUTE WALKING TEST DISTANCE
timeFrame: six months
Secondary outcomes:
measure: ECHOCARDIOGRAPHIC PARAMETERS
timeFrame: six months
measure: NEUROHORMONAL CHANGES
timeFrame: six months
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Medicina Cardiovascolare - NOCSAE - Azienda USL
state: (mo)
Study officials:
affiliation: Azienda USL di Modena
name: Fabrizio Turrini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda USL di Modena
name: Marco Bondi, MD
role: STUDY_DIRECTOR
affiliation: Università di Modena
name: Paola Loria, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00990301: A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide in Healthy Adult Volunteers Under Fasting Conditions
Official title: A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide 15mg/25mg Tablets (Paddock Laboratories, Inc) and Uniretic® 15mg/25mg Tablets (Schwarz Pharma)(Moexipril HCl/Hydrochlorothiazide) in Healthy Adult Volunteers Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
Bioequivalence
Lead sponsor: Paddock Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-06
Enrollment: 48
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: The purpose of this study was to evaluate the relative bioavailability of Paddock Laboratories, Inc.'s test formulation of Moexipril/ Hydrochlorothiazide 15mg/25mg tablets with a reference formulation Uniretic®(Moexipril/ Hydrochlorothiazide) 15mg/25mg tablets, under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening

Exclusion Criteria:

* Positive test results for HIV or Hepatitis B or C
* History of allergy or sensitivity to Moexipril, Hydrochlorothiazide or related drugs

Primary outcomes:
measure: Bioequivalence specified outcomes
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburg
country: United States
facility: Novum Pharmaceutical Research Services
state: Pennsylvania
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Kennedy, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03135301: Letrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome
Official title: Efficacy of Combined Letrozole-metformin in Comparison With Letrozole Only in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Infertility, Female
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome accounts for the vast majority of anovulatory symptoms and hyperandrogenism in women. The diagnosis of Polycystic ovary syndrome has life-long implications, with increased risk for infertility, metabolic syndrome, and type 2 diabetes mellitus, and possibly for cardiovascular disease and endometrial carcinoma. Polycystic ovary syndrome is diagnosed in adolescents with otherwise unexplained, persistent hyperandrogenic anovulatory symptoms that are inappropriate for age and stage of adolescence. It should be considered in any adolescent girl with a chief complaint of hirsutism, treatment-resistant acne, menstrual irregularity, acanthosis nigricans, and/or obesity


Eligibility criteria: Inclusion Criteria:

* polycystic ovaries patients who had failed to become pregnant after 3 courses of 150 mg of clomiphene citrate (considered as clomiphene resistant),whereas the value of the above mentioned investigation are normal.

Exclusion Criteria:

1. women with other causes of infertility as male factor,tubal factor,those with endocrine disorders as thyroid dysfunction and hyperprolactinemia.
2. women who received hormonal treatment or ovulation induction drugs in the last 3 months before the study.
3. women with history of liver,kidney or cardiovascular disease.

Primary outcomes:
measure: The ovulation rate
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
citation: Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.
Clinical trial NCT01256801: Gene Expression Profiling of Breast Cancer Cells Predict the Response of Malignant Pleural Effusion
Official title: Gene Expression Profiling of Breast Cancer Cells in Pleural Effusion Prodict the Response of Malignant Pleural Effusion to Immunotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Neoplasm Metastasis
Gene Expression Profiling
Immunotherapy
Keywords: Metastatic Breast Neoplasms
Gene Expression Profiling
immunotherapy
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2010-12-09
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The breast cancer patiets present with pleural effusion and can receive chemotherapy.

Brief summary: The investigators want to develop a gene expression profile for the prediction of immunotherapy response of patients with metastatic breast cancer presenting malignant pleural effusion.

Detailed description: 1. The patiets with malignant pleural effusion are randomizned to be treated with cytokins(inteleukin 2) or dendritic cells(DC) plus cytokine induced killer cells(CIK) locally.
2. Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy.
3. The enriched cancer cells are flash frozen and stored at -80℃ until processing.
4. The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups .
5. Statistical analysis is performed using unsupervised hierarchical cluster.

Eligibility criteria: Inclusion Criteria:

* Patients should be histologically confirmed with metastatic breast cancer and malignant pleural effusion
* 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.
* Not receive chemotherapy in pleural cavity

Exclusion Criteria:

* previous history of other malignancies;
* previous surgery history on the needle biopsy organ;
* Serious or uncontrolled concurrent medical illness.

Primary outcomes:
measure: immunotherapy response
timeFrame: 1 month
Secondary outcomes:
measure: immunological status
timeFrame: 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: JUN REN, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04879901: Changes in Shoulder Muscle Activation According to the Methods of Carrying Backpacks
Official title: Changes in Muscle Activation of Serratus Anterior, Deltoid (Anterior) and Trapezius (Upper and Lower) According to the Methods of Carrying Backpacks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Muscle Activation
Surface Emg
Keywords: backpack
shoulder muscle activation
surface emgsurface emg
deltoid, serratus anterior, trapezius deltoid, serratus anterior, trapezius
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To investigate change of shoulder muscles by measuring muscle activity according to the position of the backpack.

Detailed description: Most of modern people, including students and office workers, wear backpacks for a considerable amount of time. There have been prior studies on the change in muscle activity around the spine and shoulders muscles according to the weight of the backpack, but studies on the change in muscle activity according to the direction of the bag are insufficient. So this study is to evaluate the effect on the musculoskeletal system by comparing the activity of the muscles around the shoulder according to the anterior or posterior wearing of the backpack.

Muscles around the shoulder are composed of: Serratus anterior, trapezius(upper and lower) which control scapular movement and deltoid muscles which activate shoulder abduction directly. We would like to focus change of these muscles's activities when carrying a backpack according to the anterior or posterior direction and bilateral or unilateral.

To measure muscle activity, eight-channel electromyography (EMG) Using Nicolet EDX (Natus Medical Inc., San Carolos, CA, USA), surface EMG (sEMG) signal were used.

Eligibility criteria: Inclusion Criteria:

* Healthy adults from 20s to 50s

Exclusion Criteria:

* Restriction of joint motion range of shoulder and elbow
* Hisory of upper limb surgery in the past 6 months
* If there is an external wire such as a temporary external pacemaker or central line guide wire

Primary outcomes:
measure: Root mean square of each muscle activation
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Bundang CHA Medical Center
state: Gyeonggi-do
Study officials:
affiliation: Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
name: Kyunghoon Min, MD, PhD
role: STUDY_DIRECTOR
References: