louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03680547: Nephropathy in Patients With Sickle Cell Disease
Official title: Pattern of Sickle Cell Nephropathy in Patients With Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sickle Cell Nephropathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: to assess degree of renal affection in patients with sickle cell disease attending Assuit university Children hospital by estimating some predictors of glomerular and tubular dysfunction.detailed history taking and thorough clinical examination and laboratory investigations

Brief summary: There are some diseases that give rise to diverse renal manifestations as does sickle cell disease

Detailed description: Such involvement adversely affects virtually all major physiological processes in the kidney, and leads to complications that are common and chronic on the one hand (such as impaired urinary concentrating ability), and those that are rare and uniformly fatal on the other (such as renal medullary carcinoma) This steady adverse renal sequelae shortens the average lifespan of patients with SCD.

Proteinuria and a reduced glomerular filtration rate are risk factors associated with increased mortality among those patients with approximately 16-18% of overall mortality in this patient group is due to kidney disease.

Once end stage renal disease is reached, the mortality of patients who are on haemodialysis and have SCD is increased severalfold relative to the mortality of patients who are on haemodialysis but do not have SCD.

Thus,although the average lifespan of patients with SCD has increased during recent decades owing to improved management of complications outside the kidney,kidney disease contributes substantially to the still increased mortality in SCD.

Eligibility criteria: Inclusion Criteria:

* All patients with sickle cell anemia attending the unit will be included in the study.

Exclusion Criteria:

* patient with any underlaying systemic diseases other than sickle cell anaemia

Primary outcomes:
measure: sickle cell nephropathy in patient with sickle cell disease
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: assiut
name: omnia talat hasan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01665547: Adding L-carnitine in Clomiphene Resistant Polycystic Ovary Improves the Quality of Ovulation and the Pregnancy Outcome
Official title: Adding L-carnitine in Clomiphene Resistant Pco Improves the Quality of Ovulation and the Pregnancy Outcome,a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Treatment Resistant Disorders
Keywords: clomiphene resistant
pcos
induction of ovulation
l-carnitine
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 157
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Adding L-carnitine is more successful than clomiphene as a first line therapy for ovulation induction in women with clomiphene resistant PCOS

Detailed description: Patients younger than 35 years, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with PCO according to Rotterdam's criteria who had received five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included.

Eligibility criteria: Inclusion Criteria:

* Patients younger than 35 years, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with PCO according to Rotterdam's criteria who had received five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included. The diagnosis was based on a complete history taking, physical examination and a paper documented complete infertility work-up within the previous 6 months, either conducted within the setting of the hospital or at a licensed infertility management clinic.

Exclusion Criteria:

* age more than 40 years,
* tubal,uterine or male factor infertility

Primary outcomes:
measure: ovulation induction
timeFrame: 0ne year
Secondary outcomes:
measure: pregnancy
timeFrame: 0ne year
Other outcomes:
Locations:
Study officials:
affiliation: Women's Health Hospital
name: Alaa M Ismail, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04321447: Clinical Practice Guideline for Neonatal Extravasation Injury
Official title: Clinical Practice Guideline on the Prevention and Management of Neonatal Extravasation Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extravasation Injury
Keywords: Intravenous nursing
Newborn infant
Neonatal intensive care units
Evidence-based professional practice
Lead sponsor: United Christian Hospital
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 213
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is aimed to evaluate the effectiveness of an evidence-based clinical practice guideline in the prevention and management of neonatal extravasation injury, and to examine the change in nurses' knowledge of and adherence to the guideline.

Detailed description: A study with controlled before-and-after design was conducted. The clinical practice guideline was developed and a multifaceted educational program was delivered for nurses. Neonatal outcomes were collected at baseline and after completion of the intervention. The changes in nurses' level of knowledge and adherence to the guideline were also measured.

Eligibility criteria: Inclusion Criteria:

* Neonates who were admitted for intravenous medication or infusion therapy, and
* Neonates whose parents were equal to or over 18 years old and able to communicate in Chinese or English.

Exclusion Criteria:

* Neonates who were born with congenital dermatological problems such as ichthyosis and epidermolysis bullosa.

Primary outcomes:
measure: Change in rate of peripheral intravenous extravasation
timeFrame: Change from Baseline rate at one month
measure: Change in rate of extravasation from a central line
timeFrame: Change from Baseline rate at one month
Secondary outcomes:
measure: Change in nurses' level of knowledge
timeFrame: Change from Baseline Knowledge level at six months
measure: Change in nurses' adherence to clinical practice guidelines
timeFrame: Change from Baseline Adherence level at six months
Other outcomes:
Locations:
Study officials:
affiliation: United Christian Hospital
name: Kam Ming Chan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan KM, Chau JPC, Choi KC, Fung GPG, Lui WW, Chan MSY, Lo SHS. Clinical practice guideline on the prevention and management of neonatal extravasation injury: a before-and-after study design. BMC Pediatr. 2020 Sep 23;20(1):445. doi: 10.1186/s12887-020-02346-9.
Clinical trial NCT03554447: Role of Pentoxifylline as an Adjuvant Therapy for Adult Patients With Major Depressive Disorder
Official title: Pentoxifylline as a New Adjuvant in Adult Patients With Major Depressive Disorder: Randomized, Double Blind, Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Pentoxifylline
Anti-inflammatory
MDD
phosphodiastrase inhibitors
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 80
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: This study aimed to evaluate the therapeutic benefits of pentoxifylline (PTX) in treatment of adult patients with MDD as it has anti-inflammatory and phosphodiastrase inhibition activities.

Detailed description: In this study, the investigators evaluated the potential antidepressant effect of PTX in adult patients with MDD. the investigators hypothesized that MDD patients taking add-on PTX would present greater amelioration of their depressive symptoms than patients taking add-on placebo. Furthermore, the investigators assessed the relationship between HAM-D score and several peripheral biomarkers as well as their role in diagnosis and therapeutic targets of MDD.

Eligibility criteria: Inclusion Criteria:

* Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
* Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.

Exclusion Criteria:

* Patients with bipolar I or bipolar II disorder
* Patients with personality disorders
* Patients with eating disorders
* Patients with substance dependence or abuse
* Patients with concurrent active medical condition
* Patients with history of seizures
* Patients with history of receiving Electroconvulsive therapy (ECT)
* Patients with inflammatory disorders
* Patients with allergy or contraindications to the used medications
* Patients with finally pregnant or lactating females

Primary outcomes:
measure: Effect on Hamilton Depression rating scale score (HAM-D score)
timeFrame: 12 week
Secondary outcomes:
measure: Effect on biological markers
timeFrame: 12 week
Other outcomes:
Locations:
Study officials:
affiliation: Tanta University
name: Sahar El-Haggar, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00331747: Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate
Official title: Three Dimensional Gait Evaluation in Relapsing Remitting Multiple Sclerosis Patients Treated With Glatiramer Acetate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis: Treatment with Glatiramer acetate prevents deterioration of gait in multiple sclerosis (MS) patients.

During the study patients will undergo a 3 dimensional gait analysis before starting treatment with glatiramer acetate and after 1 year of treatment.

Detailed description: Patients with a definite diagnosis of relapsing remitting multiple sclerosis (MS) will undergo a 3 dimensional gait analysis before initiation of treatment with glatiramer acetate. The gait analysis will include kinematic evaluation using a Charnwood Dynamics CODA CX-1 system, 4 AMTI force plates and a Noraxon telemetric EMG system. Patients will be videotaped and will also undergo a detailed physical examination by a physical therapist.

Treatment with Glatiramer acetate will be initiated after the gait analysis. Therapy will be observed and controlled by a neurologist fromn the staff of the Multiple Sclerosis Center.

Repeat gait analysis will be performed after one year of treatment.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of multiple sclerosis
* EDSS less than 5.5
* No cognitive disability

Exclusion Criteria:

* EDSS over 5.5
* Inability to cooperate with gait analysis

Primary outcomes:
measure: Computerized gait analysis: at the beginning of treatment and after 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Multiple Sclerosis Center, Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center; Tel Aviv University
name: Uri Givon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center; Tel Aviv University
name: Anat Achiron, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04126447: Platelet Indices in Decompensated Post Hepatitic Liver Cirrhosis
Official title: Platelet Indices ( Platelet Count - Mean Platelet Volume - Platelet Distribution Width ) in Decompensated Post Hepatitic Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MPV
PDW
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aim of the present work is to study platelet indices as noninvasive predictors in decompensated post hepatitic liver cirrhosis .

Brief summary: The aim of the present work is to study platelet indices ( platelet count - mean platelet volume - platelet distribution width ) as noninvasive predictors in decompensated post hepatitic liver cirrhosis .

Detailed description: Cirrhosis is an advanced liver disease characterized by fibrosis and alteration in hepatic architecture with the development of structurally anomalous nodules . Ascites is a condition in which pathological collection of fluid occurs within the peritoneal cavity mainly because of portal hypertension. It is a major complication of liver cirrhosis, The appearance of ascites in cirrhotic patients indicates a poor prognosis , Spontaneous bacterial peritonitis is a severe infection, commonly occurring in cirrhotic ascitic patients.

Platelets are attributed to preserve hemostasis. Yet, recently, there has been growing recognition that they also play an essential role in inflammatory and immune response. Platelets release prothrombotic and proinflammatory agents and participate in the induction and advancement of vascular and inflammatory disorders . Larger-sized platelets contain many granules, and are therefore more efficient in their hemostatic and proinflammatory actions . This is why the mean platelet volume (MPV) and platelet distribution width (PDW) are worth considering as potential tests for platelet function and activation .

The MPV and PWD can be calculated using almost all automated hematology analyzers. The MPV indicates the average platelet size in femtoliters. The PDW, reflecting homogeneity of platelet size, is calculated from the MPV by the equation (SD of platelet volume divided by MPV×100) or the distribution width at 20% frequency .

Eligibility criteria: Inclusion Criteria:

* post hepatitic liver cirrhotic patients

Exclusion Criteria:

* renal failure patients
* pregnents
* diabetic patients
* patients with bone marrow disorders specially platelet disorders
* patient with other cause of liver cirrhosis

Primary outcomes:
measure: platelet indices ( platelet count - mean platelet volume - platelet distribution width ) in decompensated post hepatitic liver cirrhosis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01673347: Allograft Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe
Official title: Allograft Knee Meniscal Transplantation in the Treatment of Osteoarthritis of the Metatarsophalangeal (MTP) Joint of the Great Toe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: allograft
great toe
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Musculoskeletal Transplant Foundation
First posted: 2012-08-28
Enrollment: 24
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: Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe.

Detailed description: A variety of surgical procedures have been developed for the treatment of MTP joint osteoarthritis of the great toe. Using the concept of an implant acting as a spacer and stabilizer, the proposed study will evaluate the use of allograft knee meniscus in the treatment of MTP joint osteoarthritis of the great toe. Patients will be evaluated for pain and range of motion at 3-months, 6-months, 1-year, 2-years, 3-years, 4-years, and 5-years postoperatively or until allograft failure. Stability of the allograft will be evaluated by the surgeon at these time points per radiographic imaging.

Eligibility criteria: Inclusion Criteria:

* symptomatic of stage 3 osteoarthritis of the great toe
* symptoms recalcitrant to nonoperative management as determined clinically by the principal investigator

Exclusion Criteria:

* diabetes mellitus
* kidney insufficiency
* oa in the adjacent joints
* malignancy with in the past 10 yrs
* minors (\< 18 yrs of age)
* pregnant women and fetus
* mentally disabled or cognitively impaired individuals

Primary outcomes:
measure: Allograft Stability
timeFrame: 5-years postoperative
Secondary outcomes:
measure: Pain
timeFrame: 3-months postoperative
measure: Range of Motion Plantarflexion
timeFrame: 3-months postoperative
measure: Range of Motion Dorsiflexion
timeFrame: 3-months postoperative
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: WILLIAM BEAUMONT HOSPITAL ROYAL OAK
name: PAUL FORTIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: COLE BJ, CARTER TR, RODEO SA,
Clinical trial NCT04316247: Demographic , Clinicopathological Characteristics and Survival of Breast Cancer
Official title: Demographic, Clinicopathological Characteristics and Survival of Breast Cancer Patients in Assiut University Hospital (2015-2019).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Carcinoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective study on breast cancer patients : A single institution study

Brief summary: The investigators will retrospectively study the demographic , clinicopathological characteristics and survival of breast cancer patients admitted to Assiut University hospital from the year 2015 to 2019

Detailed description: Breast cancer is one of the most common malignancies in females, which is the second leading cause of cancer death throughout the world after lung cancer . The incidence of breast cancer has been increasing over the past decades , especially in young women (≤ 35 years old). There is approximately 182,000 women with breast neoplasm annually in the United States, accounting for about 26% of all incident cancers among women.

In Asia, the morbidity rate is as high as 9.5%-12% . Even worse in China, the average onset age of breast cancer might be 8-10 years younger than that in Western countries which account for upto 4% in total breast cancer patients .

In Egypt, breast cancer is the commonest type of female malignancy represented about 38.8% among common cancer sites in females.Although The unclear etiology of the majority of breast cancer, but there are numerous risk factors for the disease. Screening and early detection when combined with adequate, efficient treatment is considered the hope for a reduction of mortality in breast cancer as postulated by World Health organization (WHO).

Eligibility criteria: Inclusion Criteria:

* All histologically confirmed and documented patients with invasive ductal or lobular carcinoma of the breast attending at Assiut University hospital from year 2015 to 2019.

Exclusion Criteria:

* • Patients who previously received treatment outside Assiut University hospital.

  * A serious un controlled concomitant disease that would contraindicate with use of systemic treatment. .

Primary outcomes:
measure: The survival rate of breast cancer in assiut university hospital
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Samir E Shehata, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen S, Chen H, Yi Y, Jiang X, Lei H, Luo X, Chen Y, Liu S, Yuan D, Jia X, Li J. Comparative study of breast cancer with or without concomitant Paget disease: An analysis of the SEER database. Cancer Med. 2019 Jul;8(8):4043-4054. doi: 10.1002/cam4.2242. Epub 2019 May 28.
Clinical trial NCT01053247: Study of 0416 Ointment in the Treatment of Atopic Dermatitis
Official title: Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0416 Ointment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Lead sponsor: Fougera Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-21
Enrollment: 793
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 aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis.

Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 2 weeks.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Atopic Dermatitis
* Good health with the exception of Atopic Dermatitis
* Percent Body Surface Area minimum requirements

Exclusion Criteria:

* Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
* Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis

Primary outcomes:
measure: Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA).
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Melville
country: United States
facility: Fougera Pharmaceuticals Inc.
state: New York
Study officials:
affiliation: Fougera Pharmaceuticals Inc.
name: Angela C Kaplan
role: STUDY_DIRECTOR
References: