louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01976442: Use of Saline-Washed Platelet and Red Cell Transfusions in Adult Acute Leukemia
Official title: Impact of Washed Transfusions in Adult Patients With Acute Myeloid or Lymphoid Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Myeloid, Acute
Leukemia, Lymphoblastic, Acute
Keywords: Leukemia
Transfusion
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 100
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is comprised of 98 men and women who were both diagnosed and treated for Acute Myeloid Leukemia or Acute Lymphoid Leukemia at Strong Memorial Hospital, a tertiary medical center located in Rochester, NY, USA. All of these patients received washed red cell and platelet transfusions as part of the hospital's standard protocol for patients with acute leukemia.

Brief summary: The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature.

Detailed description: The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature. Key outcomes will be treatment related mortality (deaths at 30, 60 and 100 days) and three year survival.

Eligibility criteria: Inclusion Criteria:

* previously untreated patients with a diagnosis of acute leukemia between the ages of 0 and 50 (AML) and 18 and 50 (ALL)

Exclusion Criteria:

* all other patients

Primary outcomes:
measure: Survial Rate at 30 Days
timeFrame: 30 days
measure: Survial Rate at 60 Days
timeFrame: 60 days
measure: Survial Rate at 100 Days
timeFrame: 100 days
measure: Survial Rate at 5 Years
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Strong Memorial Hospital (University of Rochester Medical Center)
state: New York
Study officials:
affiliation: University of Rochester Medical Center, School of Medicine and Dentistry
name: Neil Blumberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blumberg N, Heal JM, Rowe JM. A randomized trial of washed red blood cell and platelet transfusions in adult acute leukemia [ISRCTN76536440]. BMC Blood Disord. 2004 Dec 10;4(1):6. doi: 10.1186/1471-2326-4-6.
Clinical trial NCT01942642: Evaluation of Dry Eye and Meibomian Gland Dysfunction After Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meibomian Gland Dysfunction
Keywords: cataract surgery, meibomian gland dysfunction, meibum expressibility, meibography
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 48
Sex: ALL
Minimum age (years): 45
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for cataract surgery

Brief summary: Meibomian gland dysfunction (MGD) is a common and important disease has been investigated the pathophysiology, diagnosis, treatment modalities of MGD, however, the changes of MGD after the cataract surgery, the most popular surgery to ophthalmologist, had not been evaluated. The investigators evaluated parameters related with MGD including lid margin abnormalities, meibomian gland expressibility and meibography before and after surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for cataract surgery

Exclusion Criteria:

1. other comorbid ocular diseases such as ocular allergies.
2. continuous use of topical ocular medications before surgery
3. histories of ocular surgery, or ocular injury
4. Already had severe obstructive MGD before surgery, abnormal findings on lid margin (\> 3 positive findings), reduced meibum expression (\> grade 2), and obstructed gland dropout (meibography score \> 3)

Primary outcomes:
measure: Ocular parameters
timeFrame: change of Ocular parameters from 1 to 3 months after cataract surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00732342: Contingency Management Treatment Duration
Official title: Contingency Management Treatment Duration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Keywords: Alcohol Abuse
Contingency Management
Treatment Duration
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2008-08-12
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 310 alcohol abusing or dependent patients beginning intensive outpatient day treatment at community-based clinics will be randomly assigned to one of four conditions: (a) standard treatment as usual (ST) at the clinic without contingency management (CM); (b) standard treatment with contingency management for 12 weeks with a 0.5 probability of winning prizes for each negative sample submitted; (c) standard treatment with contingency management for 24 weeks with a 0.34 probability of winning prizes for each negative sample submitted; or (d) standard treatment with contingency management for 24 weeks with a 0.5 probability of winning prizes for each negative sample submitted. We expect that contingency management will decrease alcohol use to a greater extent than non-contingency management treatment, and that availability of contingency management for 24 weeks may result in longer term benefits than 12 week exposure to contingency management. This study will be the first to evaluate the effects of probability of winning prizes on response to contingency management.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* current DSM-IV diagnosis of alcohol abuse or dependence
* willing to sign informed consent and able to pass an informed consent quiz

Exclusion Criteria:

* serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) on the basis of history or medical examination
* current DSM-IV diagnosis of opioid dependence
* in recovery from pathological gambling

Primary outcomes:
measure: longest duration of negative breath samples submitted
timeFrame: active phase and throughout follow-up phase
Secondary outcomes:
measure: subjective reports of alcohol use
timeFrame: baseline and each follow-up
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Prospect House
state: Connecticut
city: Hartford
country: United States
facility: Alcohol and Drug Recovery Centers, Inc.
state: Connecticut
city: New Britain
country: United States
facility: The Hospital of Central Connecticut at New Britain General
state: Connecticut
city: Waterbury
country: United States
facility: Morris Foundation
state: Connecticut
city: Springfield
country: United States
facility: Carlson Recovery Center
state: Massachusetts
Study officials:
affiliation: UConn Health
name: Nancy M Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06020742: Automitochondrial Transplantation Improves Live Birth in Elderly Patients With Low Prognosis After Repeated IVF Failure
Official title: Automitochondrial Transplantation Improves Live Birth in Elderly Patients With Low Prognosis After Repeated IVF Failure
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Infertility, Female
Mitochondrial
Elderly
Assisted Reproductive Technique
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal to this clinical trial is to study the effectiveness and safety of automitochondrial transplantation of urine derived stem cells(USCs) in in elderly patients with low prognosis after repeated IVF failure. The main questions it aims to answer are:

(1）test the effectiveness and safety of automitochondrial transplantation of urine derived stem cells (2) establish intracytoplasmic sperm injection(ICSI) mitochondrial transplantation platform Participants will be asked to:1)urine collections to further culture of autologous USCs 2)ovarian stimulation、trigger eggs、ICSI with autologous mitochondria 3）embryo transfer 4)accept pregnancy follow-up at given point


Eligibility criteria: Inclusion Criteria:

1. 1) At least 35 years old
2. 2) Repeated IVF failure: more than or equal to 2 egg retrieval with poor embryo quality, no transplanted embryos or failed embryo transfer (more than or equal to 4 embryos)
3. 3) Egg number ≤9
4. 4) Participate voluntarily and sign informed consent.

Exclusion Criteria:

1: Infertility caused by severe oligospermia, severe intrauterine adhesions, genital tract malformations, thyroid dysfunction and other endocrine, immune system, tumor and genetic diseases

Primary outcomes:
measure: live birth rate
timeFrame: 1year after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University People's hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02265042: Effect of Electrostimulation on Denervated Muscles in Individuals with Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2014-10-15
Enrollment: 10
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: The aim of the study is to investigate whether there is an effect of electrical stimulation on the denervated gluteus muscle (buttocks) in individuals with chronic spinal cord injury. The expected outcome is an increase in muscle volume and a better pressure distribution during sitting. The stimulation of the gluteus muscle is performed daily for 35 minutes over a period of six months. The muscle volume and the pressure distribution are measured before stimulation, three months after having started stimulation and after six months.


Eligibility criteria: Inclusion Criteria:

* chronic spinal cord injury (min. 2 years after injury)
* lesion height from T10-L5
* ASIA (American Spinal Cord Injury Association) Impairment Scale A

Exclusion Criteria:

* acute pressure sore in stimulated area (M. gluteus)
* arteriosclerosis
* skin irritation or infection in stimulated area (M. gluteus)
* \< 3 months after plastic surgery in stimulated area (M. gluteus)

Primary outcomes:
measure: change in muscle volume
timeFrame: day 0 to 3 months
Secondary outcomes:
measure: change in muscle volume
timeFrame: 3 months to 6 months
measure: change in sitting pressure
timeFrame: day 0 to 3 months
measure: change in sitting pressure
timeFrame: 3 months to 6 months
measure: change in quality of life
timeFrame: day 0 to 3months
measure: change in quality of life
timeFrame: 3 months to 6 months
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
References:
Clinical trial NCT05108142: Resistant Starch Type-3, Glucose Metabolism and Appetite
Official title: Impact of Resistant Starch Type-3 on Glucose Metabolism and Appetite in Healthy Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistant Starch
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Resistant starch (RS) is considered to have many of the same health benefits as dietary fiber. The aim of this study was to examine the effects of RS3 on postprandial glycemic and insulinemic responses and appetite.

Healthy males (aged 18-35 years) participated in this study. Subjects were provided meals in the laboratory after overnight fasting on two separate occasions, at least 1 week apart. On each laboratory visit, subjects were given either a control meal (COM) or an RS3 meal (RSM). Both meals during the two visits consisted of vegetarian pasta and were matched for energy intake, composition, ingredients, and amount, but were prepared in different ways. The COM was hot, freshly cooked pasta, while the RSM was re-heated pasta that had been cooked the previous day and chilled overnight. Blood samples and subjective appetite ratings were collected at fasting and for a period of 3 h after meal consumption (i.e., 15-min intervals for glucose and 30-min intervals for insulin, ghrelin, and subjective appetite).


Eligibility criteria: Inclusion Criteria:

* Healthy males
* Aged between 18 and 40 years
* Normal weight (BMI 18.5-24.9 kg/m2)
* No history of serious disease or currently taking any medications
* Not dieting or seeking to lose weight.

Exclusion Criteria:

* Smokers
* Allergy to gluten-containing products, lactose intolerance, or dairy allergy
* Particular dislike to any of the foods provided during the study.

Primary outcomes:
measure: Changes in fasting and postprandial blood glucose concentrations (n=8)
timeFrame: 3 hours
Secondary outcomes:
measure: Changes in of fasting and postprandial serum insulin concentrations (n=8)
timeFrame: 3 hours
measure: Changes in subjective appetite ratings (Visual Analogue Scale) (n=8)
timeFrame: 3 hours
measure: Changes in fasting and postprandial plasma ghrelin concentrations (n=8)
timeFrame: 3 hours
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Maha Alhussain
Study officials:
References:
Clinical trial NCT01351142: Cytokines and Cognitive Decline in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2011-05-10
Enrollment: 133
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Amyloid plaques and neurofibrillary tangles are the 2 well-known etiopathological hallmarks of Alzheimer's disease (AD). Beside these 2 lesions, inflammation response is described in the brain of patients with AD.

The main objective of our study is to analyse the correlation between the value of plasma cytokines (interleukin 1, 6, TNFα and chemochine Rantes) and the rapidity of the cognitive decline in AD over a 2-year follow-up.

Secondary objectives include:

* the predictive value of the cytokines on the cognitive decline after 6 months and one year of follow-up., of the patients include 150 patients with AD (MMSE: 16-25)
* correlation between plasma cytokines levels and expression of the protein kinase PKR (involved in death cell) in blood mononuclear cells.


Eligibility criteria: Inclusion Criteria:

* Alzheimer's disease (AD)patients
* MMSE score: 16-25
* Written informed consent

Exclusion Criteria:

* AD patients with specific treatment for AD before inclusion MMSE score under 16 or over 25 at inclusion
* patients with anti-inflammatory drugs (non steroids or corticosteroids) or immunosuppressive agents
* Patients with acute disease (infectious disease, rheumatologic disease) or chronic disease (malignancy, infectious, rheumatologic disease) that could interact with plasma cytokines level
* Patients with a life threatening disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers - service Gérontologie clinique
city: Limoges
country: France
facility: Hôpital Dupuytren - CHU de Limoges
city: Nantes
country: France
facility: CHU de NANTES - service Gériatrie
city: Nantes
country: France
facility: CHU DE NANTES - Centre ambulatoire de Gérontologie clinique
city: Paris
country: France
facility: Hôpital Broca - service de Gériatrie
city: Paris
country: France
facility: Hôpital Pitié Salpétrière
city: Poitiers
country: France
facility: Chu de Poitiers -
city: Strasbourg
country: France
facility: Chu Strasbourg
city: Tours
country: France
facility: CHU de TOURS - service de Gériatrie
city: Villeurbanne
country: France
facility: Hôpital gériatrique des Charpennes
Study officials:
References:
Clinical trial NCT01435642: A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Children With Type 1 Diabetes
Official title: Diabcare Paediatric - A Survey-study on Diabetes Management, Complications and Psychosocial Aspects of Type 1 Childhood Diabetics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-09-16
Enrollment: 349
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with type 1 diabetes mellitus being treated at diabetes clinics will be selected according to the inclusion and exclusion criteria.

Brief summary: This study is conducted in Africa. The aim of this non-interventional study is to evaluate the current status of diabetes management, complications and psychosocial aspects for children with type 1 diabetes in Algeria.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained from the patient and his legal representative before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
* Type 1 diabetes
* Time since diabetes diagnosed at least 5 years
* Followed for diabetes at consultation for at least 12 months

Exclusion Criteria:

* Patient previously included in this study
* Secondary diabetes
* Pregnant patient
* Patient consulting for an emergency

Primary outcomes:
measure: Mean HbA1c (glycosylated haemoglobin)
timeFrame: At the first visit (only one study visit) after 12 month of follow up
Secondary outcomes:
measure: Percentage of patients on insulin therapy
timeFrame: At the first visit (only one study visit) after 12 month of follow up
measure: Mean duration of insulin therapy
timeFrame: At the first visit (only one study visit) after 12 month of follow up
measure: Mean number of insulin injections/day
timeFrame: At the first visit (only one study visit) after 12 month of follow up
measure: Mean insulin units per day
timeFrame: At the first visit (only one study visit) after 12 month of follow up
measure: Percentage of patients on OAD or other treatments
timeFrame: At the first visit (only one study visit) after 12 month of follow up
measure: Percentage of patients having complications (ophthalmological, peripheral, renal and others)
timeFrame: At the first visit (only one study visit) after 12 month of follow up
measure: To quantify quality of life
timeFrame: At the first visit (only one study visit) after 12 month of follow up
Other outcomes:
Locations:
city: Blida
country: Algeria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: La prise en charge du diabéte de type 1 chez l'enfant en Algérie (DiabCare Pédiatrique); Bensenouci A, Achir M et al.; Médecine des Maladies Métaboliques 2015; Doi: 10.1016/S1957-2557(14)70902-2
Clinical trial NCT02432742: Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate and Severe Nasolabial Folds
Official title: A Randomised, Multi-center, Evaluator-blinded Study in China to Evaluate the Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Folds in Chinese Population
Keywords: hyaluronic acid, comparative study, NLF
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2015-05-04
Enrollment: 100
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 purpose of this study is to determine the safety and efficacy of using Restylane Perlane compared to Restylane for correction of moderate to severe nasolabial folds (NLF) in a Chinese population.


Eligibility criteria: Inclusion Criteria:

* Chinese origin
* Subjects intent to undergo correction of both NLFs with a Wrinkle Severity Rating Scale (WSRS) of 3 on both side or 4 on both side.
* Subjects willing to abstain from other facial plastic surgical or cosmetic procedures during the study period.
* Singed Informed Consent

Exclusion Criteria:

* Subjects with traumatic scars or ongoing active skin disease in the area to be treated
* Permanent inplant or filler, including fat injection placed in the area to be treated
* Previous tissue augmentation therapy in the NLFs with non-permanent filler within 12 months prior to inclusion
* Any medical condition in the opinion of the treating investigator who will make the subject unsuitable for inclusion

Primary outcomes:
measure: Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
city: Wuhan
country: China
city: Zhejiang
country: China
Study officials:
affiliation: Galderma R&D
name: Q-Med AB
role: STUDY_DIRECTOR
References: