louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00248898: Quality of Life After Open Heart Surgery in Older Patients
Official title: Quality of Life After Open Heart Surgery in Older Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Heart Surgery Patients
Keywords: nonagenarians
quality of life
cardiothoracic surgery
long term survival
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2005-11-04
Enrollment: 49
Sex: ALL
Minimum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A (consecutive) series of 49 patients age 90 years or older underwent cardiac operations between May 1995 and October 2004 at New York Presbyterian Hospital-Weill Medical College of Cornell University.

Brief summary: Long term follow-up of nonagenarians who have undergone open heart procedures.

Detailed description: Based on population studies, life expectancy at age 80 is 8.5 years, and at the age of 85 years, it is 6.3 years (US Bureau of Census 2000). There are currently 1.6 million nonagenarians and roughly 72,000 centenarians living in the United States. With this increasing elderly population, knowledge of the special management issues and long-term sequela are imperative. Bacchetta and coworkers from our institution presented a 10-year outcomes experience in nonagenarians undergoing cardiac surgery. In 42 consecutive patients, in-hospital mortality was 7%, and 30-day mortality 5%. Postoperative morbidity was documented in 67% with arrhythmias accounting for 31% of the cases, followed by respiratory complications, infections, and strokes. While this is mostly in-hospital data, long-term follow-ups have not been performed.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent open heart procedures and who were 90 years or greater between 1995 and 2004 at The New York Presbyterian Hospital

Exclusion Criteria:

* Patients who refuse follow-up

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Presbyterian Hospital - Weill Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Karl H Krieger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ullery BW, Peterson JC, Milla F, Wells MT, Briggs W, Girardi LN, Ko W, Tortolani AJ, Isom OW, Krieger KH. Cardiac surgery in select nonagenarians: should we or shouldn't we? Ann Thorac Surg. 2008 Mar;85(3):854-60. doi: 10.1016/j.athoracsur.2007.10.074.
Clinical trial NCT04378998: Is Acupuncture Able to Reduce Nausea and Vomiting in the Terminal Ill Patient
Official title: Is Acupuncture Able to Reduce Nausea and Vomiting in the Terminal Ill Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Terminal Illness
Keywords: Acupuncture
Nausea
Vomiting
Palliative care
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparative effectiveness research design was used. The sample size was calculated to 136 patients, who were randomized to an intervention group and a control group respectively. The patients were terminal ill patients enrolled to three in-bed hospices in Denmark and nausea and vomiting were measured using EORTC QlQ-c15-PAL (European Organisation for Research and Treatment of Cancer, Quality of Life Questionaire, core 15, Palliation)

Detailed description: The terminal ill patient is suffering from many different symptoms. In total 70% are suffering from nausea and vomiting due to the wide spread of cancer or due to side effects of treatment. Often the antiemetic's are not able to reduce symptoms to a level that enable the patient to experience quality in life in the last days of his life. The investigators had some experience with acupuncture as a complementary therapy but the investigators wanted more systematically to investigate if acupuncture is able to reduce the terminal ill patient´s nausea and vomiting. Literature show that acupuncture is able to reduce nausea and vomiting in patients receiving chemotherapy, but there is no literature that support the ability of acupuncture to reduce nausea and vomiting in the terminal ill patient.

The purpose of this study was to generate evidence based knowledge close to practice regarding the effect of acupuncture in reducing nausea and vomiting in the terminal ill patient.

Participants:

Terminal ill patients suffering from nausea and/or vomiting

Interventions:

The intervention group received usual care plus acupuncture for three days. The acupuncture spots: Pericardium-6, Stomach-36, Liver-3 and Yin Tang were used. The control group received usual care.

Eligibility criteria: Inclusion Criteria:

* Able to participate due to cognitive ability
* Nausea
* Admitted to in-bed hospice

Exclusion Criteria:

* Not able to participate due to cognitive impairment
* Lymphedema in the area of acupuncture site

Primary outcomes:
measure: Change in nausea score
timeFrame: Change in nausea score from before intervention to three day after the intervention
measure: Change in vomiting
timeFrame: Change in vomiting from before intervention to four day after the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02287298: Triple Combination Therapy of Choroidal Neovascularization in AMD, a Cost Effect and Efficient Therapeutic Treatment
Official title: Triple Combination Therapy of Choroidal Neovascularization in Exudative Age-related Macular Degeneration - a Cost Effect and Efficient Therapeutic Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exudative Macular Degeneration
Lead sponsor: The Retina Center of St. Louis County, PC
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PATIENTS MUST HAVE A DIAGNOSIS CODE OF AGE RELATED MACULAR DEGENERATION AND MUST BE 50 YEARS OR OLDER AND HAVE EXUDATIVE AMD IN ATLEAST ONE EYE

Brief summary: We propose to undertake a retrospective review of approximately 200 patients with a diagnosis of exudative macular degeneration treated with triple combination therapy (Bevacizumab, Dexamethasone and Photo-dynamic therapy) during the years of 2006 to 2010 at The Retina Center and compare those results with an additional group of approximately 200 patients also treated with triple combination therapy and 20 mg of daily oral zeaxanthin.

Detailed description: Study parameters will include best corrected visual acuity, number of combination treatments, reduction of central foveal thickness by OCT measurement and development of exudative macular degeneration in the fellow eye. Follow up will include all patients with a minimum of two years. Retrospective review of patient charts in the office of The Retina Center.

Eligibility criteria: Inclusion Criteria:

- MUST HAVE AGE RELATED MACULAR DEGENERATION

Exclusion Criteria:

-

Primary outcomes:
measure: BEST CORRECTED VISUAL ACUITY
timeFrame: REVIEW OF EXAMINATION SHEETS
Secondary outcomes:
measure: NUMBER OF COMBINATION TREATMENTS
timeFrame: REVIEW OF CHART
measure: REDUCTION OF CENTRAL FOVEAL THICKNESS BY OCT MEASUREMENT
timeFrame: REVIEW OF CHART
measure: DEVELOPMENT OF EXUDATIVE MACULAR DEGENERATION IN THE FELLOW EYE
timeFrame: REVIEW OF CHART
Other outcomes:
Locations:
city: St Louis
country: United States
facility: The Retina Center
state: Missouri
Study officials:
affiliation: THE RETINA CENTER
name: ROBERT J OLK, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00814398: Single Embryo Transfer Versus Double Embryo Transfer
Official title: Single Embryo Transfer Versus Double Embryo Transfer in Day 3 or Blastocyst Stage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: Infertility
IVF
SET
DET
Blastocyst
Lead sponsor: Vida Recoletas Sevilla
Sponsor class: OTHER
First posted: 2008-12-24
Enrollment: 199
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this project is to study the best number (1 or 2)and day (3 vs 5)of embryo transfer in good prognosis patient.


Eligibility criteria: Inclusion Criteria:G

* Good prognosis IVF patients

Exclusion Criteria:

* Bad prognosis IVF patients

Primary outcomes:
measure: Live-birth delivery rate
timeFrame: End of pregnancy (nine months after last transfer)
Secondary outcomes:
measure: Multiple live-birth rate
timeFrame: End of pregnancy (nine months after last transfer)
measure: Acceptance of assigned randomised group
timeFrame: Day of randomisation
Other outcomes:
Locations:
city: Seville
country: Spain
facility: IVI-Sevilla
Study officials:
affiliation: Vida Recoletas Sevilla
name: Manuel Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04492098: Mucosal-Associated Invariant T Cells in Cases of Miscarriage
Official title: Analysis of Mucosal-Associated Invariant T (MAIT) Cells in Cases of Spontaneous and Recurrent Miscarriage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Miscarriage
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All pregnant women presented with spontaneous miscarriage

Brief summary: Miscarriage is the most frequently encountered complication of pregnancy ranging from 10% to 30%. The etiology of recurrent spontaneous miscarriage (RSM) in 40%-50% of cases cannot be identified. Immunological disturbances have been suggested to play an important role.

Previous studies have focused that women with miscarriage have elevated NK cell numbers and activity both in the periphery and in the endometrium. Also, NK cells in women with RSM displayed an imbalance of Killer cell Ig-like receptors (KIRs) in favor of activating KIR leading to an unbalanced activation of dNK cytotoxicity and higher risk of miscarriage.


Eligibility criteria: Inclusion Criteria:

* Regular marital life with the same partner.
* Regularly menstruating before current pregnancy.
* Spontaneous conception.

Exclusion Criteria:

* Women with Polycystic ovarian syndrome or any endocrinal abnormalities like DM, thyroid disorders.
* History of abnormal uterine cavity proved by sonohysterography or hysteroscopy before pregnancy.
* Women with positive consanguinity.

Primary outcomes:
measure: The percentages of MAIT cells and MAIT cells expressing CD56 and CD16 in comparison with NK cells and NKT cells in both blood and decidua
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT00669045: An Observational Study of TNKase in Patients Enrolled in the National Registry of Myocardial Infarction 4 and 5 (POST)
Official title: A Phase IV, Prospective, Observational Study of TNKase in Patients Enrolled in the National Registry of Myocardial Infarction 4 and 5 (POST)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: TNKase
AMI
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 253668
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: The POST study comprised patients whose data were entered into the NRMI 4 and 5 databases. NRMI is a prospective, observational study of patients presenting with AMI in the United States. NRMI was launched in 1990 and to date has enrolled more than 2.5 million AMI patients. More than 1,700 hospitals have participated in NRMI during the last 16 years. The NRMI 4 and 5 substudies were sponsored by Genentech and collected data on approximately 160,000 AMI patients (both ST elevation and non-ST-elevation MI) hospitalized in the United States each year. This corresponds to approximately 18% of the AMI patients in the United States.


Eligibility criteria: Inclusion Criteria:

* Presence of LBBB or ST-segment elevation (new or of unknown duration)
* ICD-9-CM discharge code of 410.X1
* Treatment with one of the following regimens: TNKase; Other thrombolytic regimens; No initial reperfusion

Exclusion Criteria:

* Patients who were transferred out of the facility
* Patients with pending data clarification forms on fields related to study variables

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01000545: The Efficacy and Safety Study of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease
Official title: The Efficacy and Safety of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Kidney Disease
Keywords: Diabetes Mellitus
Chronic Kidney Disease
Glycosaminoglycans
Sulodexide
Macroalbuminuria
Safety and Efficacy
Lead sponsor: Corbridge Group Philippines, Inc.
Sponsor class: OTHER
Collaborators: name: Alfasigma S.p.A.
First posted: 2009-10-23
Enrollment: 1508
Sex: ALL
Minimum age (years): 19
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 the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD).


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* positive 2 of 3 ACR \> 300 mg/g or 24h urine protein or albumin collection \> 300 mg/d in the absence of urinary tract infection
* serum creatinine 1.3 - 3 mg/dl in women and 1.5 - 3 mg/dl in men

Exclusion Criteria:

* age of onset of DM \\\< 18 years
* + renal disease like non-DM renal disease
* + CV diseases such as UA, MI, CABG
* + CVA or TIA within last 6 months
* untreated UTI

Primary outcomes:
measure: macroalbuminuria and serum creatinine
timeFrame: 52 weeks
Secondary outcomes:
measure: adverse events
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Lipa City
country: Philippines
facility: Mary Mediatrix Medical Center
state: Batangas
city: Metro Manila
country: Philippines
facility: Rizal Private Clinics
state: Rizal
city: Dumaguete City
country: Philippines
facility: Holy Child Hospital
city: Mandaluyong City
country: Philippines
facility: Victoriano R. Potenciano Medical Center
city: Manila
country: Philippines
facility: Metropolitan Medical Center
city: Pasay City
country: Philippines
facility: Manila Adventist Medical Center
city: Pasig City
country: Philippines
facility: The Medical City
Study officials:
References:
Clinical trial NCT01965145: Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis (EYEGUARD™-B)
Official title: A Randomized, Double-masked, Placebo-controlled Study of the Efficacy of Gevokizumab in the Treatment of Patients With Behçet's Disease Uveitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Behcet's Uveitis
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2013-10-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet's disease uveitis exacerbations

Detailed description: A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis

Eligibility criteria: Inclusion Criteria:

* Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria.
* History of Behçet's disease uveitis with ocular involvement of the posterior segment.
* Patients with a stable background treatment of oral corticosteroid and at least one immunosuppressive drug.
* Male or female, age ≥18 (or legal age of majority in the country) at selection
* For subjects with reproductive potential, a willingness to use highly effective contraceptive measures

Exclusion Criteria:

* Infectious uveitis, uveitis due to causes other than Behçet's disease.
* Monocular vision
* Presence of severe cataract or severe posterior capsular opacification.
* Contraindication to mydriasis or presence of posterior synechiae.
* Active TB disease.
* History of severe allergic or anaphylactic reactions to monoclonal antibodies
* History of malignancy within 5 years prior to Selection.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Time to first acute ocular exacerbation
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: London
country: United Kingdom
facility: St Thomas' Hospital
Study officials:
affiliation: Severance Hospital
name: Sung Chul LEE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tugal-Tutkun I, Pavesio C, De Cordoue A, Bernard-Poenaru O, Gul A. Use of Gevokizumab in Patients with Behcet's Disease Uveitis: An International, Randomized, Double-Masked, Placebo-Controlled Study and Open-Label Extension Study. Ocul Immunol Inflamm. 2018;26(7):1023-1033. doi: 10.1080/09273948.2017.1421233. Epub 2018 Jan 25.
Clinical trial NCT00840645: A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients
Official title: Long-term Study of YM178: Long Term Study of YM178 in Subjects With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder, Overactive
Keywords: YM178
Urinary Bladder, Overactive
Mirabegron
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-02-10
Enrollment: 204
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is intended to test the safety, tolerability, and efficacy of long-term treatment with YM178 in patients with overactive bladder symptoms.


Eligibility criteria: Inclusion Criteria:

* Subject has symptoms of overactive bladder for \>= 24 wks
* Subject experiences frequency of micturition at average \>= 8 times per 24 hrs confirmed by the 3-day patient diary

Exclusion Criteria:

* Subject is breastfeeding, pregnant, or intends to become pregnant during the study
* Subject obviously has stress incontinence
* Subject has an indwelling catheter or practices intermittent self catheterization
* Subject has evidence of symptomatic urinary tract infection, interstitial cystitis, bladder stone, etc
* Subject has an average total daily urine volume \> 3000 mL confirmed by patient diary
* Subject has uncontrollable hypertension (SBP \>= 180 mmHg or DBP \>= 110 mmHg)

Primary outcomes:
measure: Vital signs, AEs, lab tests, ECG, post-void residual volume
timeFrame: 52 weeks
Secondary outcomes:
measure: Changes from baseline in the mean number of micturitions/24hrs
timeFrame: 52 weeks
measure: Changes from baseline in the mean number of urinary urgencies/24 hrs
timeFrame: 52 weeks
measure: Changes from baseline in the mean number of incontinence episodes/24 hrs
timeFrame: 52 weeks
measure: Changes from baseline in the mean number of urge incontinence episodes/24 hrs
timeFrame: 52 weeks
measure: Changes from baseline in the mean number of nocturnal urinations
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Kansai
country: Japan
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT05586945: Anemia and Pneumonia
Official title: Association of Anemia With Pneumonia in Children up to Two Years Attending Assiut University Children 's Hospital .
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumonia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 156
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 2 month S up to two years

Brief summary: Assess prevalence of anemia among pneumonic children aged two months up to two years.

Detailed description: Pneumonia is an infection via one or both lungs . bacteria and viruses are the most common causes. pneumonia can be medical emergency especially among high risk group like children less than five years Iron deficiency anemia is one of the major health problem in young children. It may be associated with increased risk of pneumonia (1).

A study conducted by Bhaskaram reported high frequency of anemia 83 % in children with pneumonia (2). Iron functions in the immune system are essential, among which are included: the maintenance of the activity of phagocyte oxidase, an iron excess can be used by bacteria to improve its growth (3). Anemia was found to be independently associated with fatal outcome in pneumonic children (4). The risk of development of pneumonia in children with anemia increases approximately by four times in comparison with children who have no anemic syndrome (5).

Breast-feeding protects against lower respiratory tract infection because of breast milk's unique antiinfective properties (6). Infants who were not being breast fed were 17 times more likely than those being breast fed without formula milk to be admitted to hospital for pneumonia (7). one of the factors that affects severe malnutrition is wrong parenting as parents can play an important role in their children's growth through proper, adequate feeding (8). There's no available studies that examine the association between anemia and pneumonia in our locality.

Eligibility criteria: Inclusion Criteria:

1. Inclusion criteria: Children aged two months up to two years who attend to Assiut University Hospital with pneumonia in the outpatient pediatric clinic, emergency unit and from inpatient .

Exclusion Criteria:

* . Exclusion criteria: All patients with other comorbidities will be excluded from our study as: severe sepsis \& localized infection e.g endocarditis, empyema, autoimmune diseases,renal diseases and congenital anomaly

Primary outcomes:
measure: Determine association between anemia and pneumonia in children aged two months up to two years Secondary (subsidiary): Study other associated factors as nutrition and sociodemographic factors
timeFrame: 6 months duration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: