louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05737862: Effect of Moringa Oleifera Leaf on Hemoglobin Levels in Anemia
Official title: Effect of Moringa Oleifera Leaf Capsul on Hemoglobin Levels in Anemia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia of Pregnancy
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 group receives capsules of powdered Moringa leaves (active comparator), and the other group receives IFA tablets as part of routine clinical care.
Primary purpose: TREATMENT

Brief summary: The main objective of this study was to compare the results of hemoglobin levels between pregnant women in the treatment group and the control group. Participants will be subjected to anthropometric measurements, recall of food intake for 1 x 24 hours, check hemoglobin before and after being given the intervention and participants in the treatment group are given moringa leaf capsules and iron tablets while participants in the control group are only given iron tablets. Researchers will compare the final results of hemoglobin levels between the treatment group and the control group


Eligibility criteria: Inclusion Criteria:

* Pregnant women with 2nd and 3rd trimester of pregnancy
* Pregnant women with mild to moderate anemia At day 90 after treatment

Exclusion Criteria :

* Hypotensive pregnant women
* Pregnant women with Gemelli
* Pregnant women with chronic diseases (hepatitis and HIV)

Primary outcomes:
measure: Changes in Haemoglobin (Hb) level
timeFrame: Day 0 and day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: University Padjajaran
state: West Java
Study officials:
References:
Clinical trial NCT01836562: A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism
Official title: A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism. It is Self Funded (Patients' Own Funding) Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Autism
Keywords: Autism stem cell MNCs
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial is a single Arm, single centre to check the safety and efficacy of bone marrow derived autologous mono nuclear cells (MNC) (100 million per dose). Trial to be conducted for 36 months.

Detailed description: Autism is a developmental disorder that appears in the first 3 years of life, and affects the brain's normal development of social and communication skills. Autism is a physical condition linked to abnormal biology and chemistry in the brain. The exact causes of these abnormalities remain unknown,Symptoms-Children with autism typically have difficulties in: Pretend play, Social interactions, Verbal and non-verbal communication. Some children with autism appear normal before age 1 or 2 and then suddenly "regress" and lose language or social skills they had previously gained. This is called the regressive type of autism. People with autism may: Be overly sensitive in sight, hearing, touch, smell, or taste.

Eligibility criteria: Inclusion Criteria:

* Patient should suffer from Autism.
* willingness to undergo bone marrow derived autologous cell therapy.
* patient those provide fully Informed consent form for the study.
* Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

Exclusion Criteria:

* Patients with pre - existing or Current systemic disease such as lung , liver ( exception; History of uncomplicated Hepatitis A),gastrointestinal, Cardiac , Immunodeficiency,(including HIV) Or laboratory Investigation that could cause a neurological defect.History of Life threatening Allergic or immune- mediated reaction.

Primary outcomes:
measure: Improvement in childhood autism rating scale
timeFrame: 6 month
Secondary outcomes:
measure: Improvement in perfusion of brain with PET scan report
timeFrame: 6 MONTH
Other outcomes:
Locations:
city: Pune
country: India
facility: Chaitanya Hospital
state: Maharashtra
Study officials:
affiliation: CHAITANYA HOSPITAL
name: ANANT E BAGUL, M.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00238862: Treatment of PED With AMT and Autologous Serum
Official title: Efficacy of Amniotic Membrane Transplantation and Autologous Serum in Treatment of Persistent Epithelial Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Epithelial Defect
Keywords: Diabetes
Corneal transplant
Neurotrophic keratitis
Post-bacterial keratitis
Metaherpetic keratitis
Lead sponsor: King Khaled Eye Specialist Hospital
Sponsor class: OTHER_GOV
First posted: 2005-10-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with persistent corneal epithelial defects who have not responded to conventional therapy will be randomized to treatment with either amniotic membrane transplantation or autologous serum 20%. Outcome measures will be (1) presence or absence of complete re-epithelialization within 28 days and (2) retention of intact epithelium for at least 90 days.


Eligibility criteria: Inclusion Criteria:

* Corneal epithelial defect of more than 14 days that has not responded to conventional therapy

Exclusion Criteria:

* Under age 18
* Pregnant/lactating females
* Patients with hemoglobin levels \< 12 mg/ml
* Patients with limbal stem cell deficiency

Primary outcomes:
measure: Corneal re-epithelialization (= initial success)
measure: Persistent corneal re-epithelialization (= lasting success)
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Khaled Eye Specialist Hospital
Study officials:
affiliation: King Khaled Eye Specialist Hospital
name: Michael D Wagoner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03716362: Neonatal Hearing Screening at Neonatal Intensive Care Unit
Official title: Neonatal Hearing Screening at Neonatal Intensive Care Unit of Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hearing Loss
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will conduct on neonates who will be admitted at intensive care unit

Brief summary: Hearing loss is one of the most common congenital anomalies . It has been shown to be greater than that of most other diseases and syndromes (eg, phenylketonuria, sickle cell disease) screened at birth. Data from the newborn hearing-screening programs in Rhode Island, Colorado, and Texas showed that 2-4 of every 1000 neonates have hearing loss.

Early Intervention at or before 6 months of age allows a child with impaired hearing to develop normal speech and language, alongside his or her hearing peers and can prevent severe psychosocial, educational, and language impairment.

One of the most high risk population are neonates who spend time in the newborn intensive care unit , exposed to high frequency ventilation, hyperbilirubinemia, low birth-weight, and exposed to ototoxic medications.

Auditory brainstem response , otoacoustic emissions , and automated Auditory brainstem response testing have all been used in newborn hearing-screening programs. otoacoustic emissions are fast objective, efficient, and frequency-specific measurements of peripheral auditory sensitivity are used to assess response of the outer hair cells to acoustic stimuli. To measure otoacoustic emissions, a probe assembly is placed in the ear canal, tonal or click stimuli are delivered, and the otoacoustic emissions generated by the cochlea is measured with a microphone .


Eligibility criteria: Inclusion Criteria:

* Neonates of both sexes.
* Neonates with In utero infection such as cytomegalovirus, rubella, toxoplasmosis, or herpes.
* Neonatal indicators, specifically hyperbilirubinemia at a serum level requiring exchange transfusion.

Exclusion Criteria:

* neonates whose parent refuse to participate in the study.

Primary outcomes:
measure: Prevalence of hearing loss in all neonates in Neonatal Intensive Care Unit
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT03817762: Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events
Official title: Respiratory Polygraphy in Children : Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea Hypopnea Syndrome
Keywords: pediatric obstructive sleep apnea hypopnea syndrome
pediatric respiratory polygraphy
device acceptance
signal quality
automatic detection of respiratory events
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 54
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with clinical obstructive sleep apnea hypopnea syndrome in University Health Center

Brief summary: The use of respiratory polygraphy (RP) in children for the diagnosis of obstructive sleep apnea hypopnea syndrome (OSAHS) can be challenging: device acceptance, sensors displacement. The automatic analysis of respiratory events has never been evaluated in a pediatric population. The primary objective of this study was to determine the feasibility of pediatric RP in an ENT department routine practice. The second objective was to evaluate the reliability of the automatic signal analysis in children.

Detailed description: Retrospective single center study of 50 children (32 boys and 18 girls, mean age 5.5 ± 2.3 years) who benefited from an overnight RP in an ENT hospitalization department between January and August 2016 for OSAS suspicion. Manual detection of respiratory events was performed by the same ENT specialist, and compared to the automatic analysis.

Eligibility criteria: Inclusion criteria:

* Age between 2 and 12 years
* child having performed a ventilatory polygraph for suspicion of obstructive hypopnoea apnea syndrome

Exclusion criteria:

- over 12 years old

Primary outcomes:
measure: Overall signal quality of the respiratory polygraph
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Mohamed AKKARI, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04292262: Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit
Official title: A Prospective Observational Study on the Incidence of Acute Kidney Injury in Polytrauma Patients in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AKI (Acute Kidney Injury) Due to Trauma
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: a prospective observational cohort study.

Brief summary: Acute Kidney Injury (AKI) is a common complication of severe trauma patients and is associated with increased morbidity and mortality.Trauma patients have many risk factors for AKI such as hypovolemic shock, rhabdomyolysis, massive transfusion, major surgeries and abdominal compartment syndrome.The primary outcome of the study is to correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS .The secondary outcomes are ;the length of ICU and hospital stay and 28 days mortality in AKI patients.

Detailed description: • Study Population: 60 cases of polytrauma patients who have ISS\>15.

* Inclusion Criteria:

  * Age from 18 to 70 years old males or females
  * Injury Sensitivity Score (ISS \>15 )
* Exclusion Criteria:

Patients have end stage liver disease, end stage kidney disease, disseminated malignancy or decompensated heart failure.

Sample size :the calculated sample size is 60 cases of trauma patients.

• All patients' data will be recorded on admission and daily for 7 days:

* Vital signs (blood pressure, heart rate, respiratory rate, body temperature).
* Lab investigations: complete blood count, international normalized ratio, prothrombin time, arterial blood gases, kidney function tests, liver function tests, creatine kinase, creatine kinase-muscle band, creatinine clearance, serum sodium, serum potassium and serum phosphorus will be requested for all patients at admission then daily follow up by creatine kinase, creatine kinase-muscle band, kidney function tests, serum sodium, serum potassium and serum phosphorus for 7 days. Glasgow Coma Scale (GCS), Injury Severity Score (ISS),Urine output (ml/kg/h),RIFLE criteria.,Length of ICU and hospital stay,28 days mortality.

Eligibility criteria: Inclusion Criteria:

* • Age from 18 to 70 years old males or females

  * Injury Sensitivity Score (ISS \>15 )

Exclusion Criteria:

* Patients have end stage liver disease, end stage kidney disease, disseminated malignancy or decompensated heart failure.

Primary outcomes:
measure: Correlate between the AKI by using RIFLE criteria and the trauma severity by using ISS
timeFrame: 7 days
Secondary outcomes:
measure: the length of ICU and hospital stay and 28 days mortality in AKI patients.
timeFrame: 28 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hanaa El Gendy
state: Ain Shams University Specialized Hospital
Study officials:
References:
Clinical trial NCT02766062: Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome
Official title: Effects of Propofol and Sevoflurane on Early Postoperative Cognitive Dysfunction in Elderly Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Keywords: Postoperative cognitive dysfunction
metabolic syndrome
propofol
sevoflurane
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2016-05-09
Enrollment: 94
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.

Detailed description: By now, a series risk factors of cardiovascular diseases, which are also related to the development of postoperative cognitive dysfunction (POCD), are becoming more common.The investigators don't know whether propofol based anesthesia has a more severe impact on early postoperative cognitive function than sevoflurane in elderly patients with metabolic syndrome. In this study, the investigators want to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.

Eligibility criteria: Inclusion Criteria:

* aged ≥60 years;
* ASAⅡor Ⅲ
* noncardiac surgery and nonneural surgery

Exclusion Criteria:

* Mini Mental State Examination \[MMSE\] score too low
* chronic alcoho and drug abuse
* disturbed renal and liver function
* history of a cerebrovascular accident
* permanent ventricular pacing
* preoperative cognitive deficits
* lack of cooperation

Primary outcomes:
measure: Number of participants with Postoperative cognitive dysfunction (POCD) as assessed by Mini-Mental State Examination (MMSE) score in propofol group and sevoflurane group
timeFrame: up to 7days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02942862: Evaluation of New Histoprognostic Criteria in a Retrospective Study of Colon Cancers Operated at Amiens University Hospital
Official title: Evaluation of New Histoprognostic Criteria in a Retrospective Study of Colon Cancers Operated at Amiens University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Neoplasms
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients operated on for colon adenocarcinoma between 2004 and 2009 at the University Hospital of Amiens

Brief summary: Colon cancer is a very common cancer. Prognosis and adjuvant treatment depend on the pathological results. Histoprognostic new factors have recently been published by several authors, but their validity is still debated.


Eligibility criteria: Inclusion Criteria:

* All patients operated on for colon adenocarcinoma between 2004 and 2009 at the University Hospital of Amiens

Exclusion Criteria:

* Non-operated patients
* Patients operated on before 2004 or after 2009
* Patients operated in another center
* The other histological types
* Vicinity of tumors invading the colon by contiguity
* Colic metastasis
* Patients whose blocks or blades were not found in the archives.

Primary outcomes:
measure: survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Denis CHATELAIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01503762: Mirror Therapy and Hand Rehabilitation
Official title: Mirror Therapy in Patients With Hand Orthopedic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Fractures
Keywords: Hand Flexor tendon Injuries
hand Extensor Tendon Injuries
Hand Joint Dislocations and subluxation
Lead sponsor: Ahvaz Jundishapur University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-01-04
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The purpose of this study is to determine effects of mirror therapy in restoring hand function in patients with flexor lag following orthopedic injuries.

Methods: In a prospective randomized controlled trial, 22 patients with Flexor Lag will be measured. Intervention group will receive mirror therapy, 30-minute a day, 5 days a week for 3-week, as well, half an hour conventional rehabilitation after each mirror therapy session. Patients in the control group will receive the same treatment program, but instead of mirror, they will directly observe the affected hand. Outcome measures including Total Active Motion (TAM), and Disabilities of Arm, Shoulder and Hand (DASH) questionnaire will be administered before and after the treatment period and 3 weeks after the final treatment session.


Eligibility criteria: Inclusion Criteria:

* hand orthopedic Injuries
* more active range of motion than passive range of motion

Exclusion Criteria:

* crush injuries
* hand deformities
* not treated fractures and tendon ruptures
* complex regional pain syndrome
* psychiatric problems

Primary outcomes:
measure: Total Active Motion
timeFrame: 6 Weeks
Secondary outcomes:
measure: Disabilities of the Shoulder, Arm, hand
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Ahvaz
country: Iran, Islamic Republic of
facility: Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur university of medical sciences
state: Khouzestan
Study officials:
affiliation: Ahvaz Jundishapur University of Medical Sciences
name: Hamid Reza Rostami
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rostami HR, Arefi A, Tabatabaei S. Effect of mirror therapy on hand function in patients with hand orthopaedic injuries: a randomized controlled trial. Disabil Rehabil. 2013 Sep;35(19):1647-51. doi: 10.3109/09638288.2012.751132. Epub 2013 Jan 22.
Clinical trial NCT03660462: Iron Bioavailability of High Surface Area Ferric Phosphate
Official title: Iron Bioavailability of High Surface Area Ferric Phosphate in Thai Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Mahidol University
First posted: 2018-09-06
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare iron absorption of high surface area ferric phosphate with that of ferrous sulfate and bulk ferric phosphate in a rice-based meal in non-pregnant women.


Eligibility criteria: Inclusion Criteria:

* Women of reproductive age (18 to 49 years) in Thailand
* BMI \< 23 kg/m2
* Body weight \< 65 kg
* Mildly anaemic to normocythemic (Hb 80-110 g/L)
* Ferritin \< 25 µg/L
* Not pregnant (confirmed by pregnancy test stripe) or lactating
* No inflammation (CRP \< 5 mg/L)
* Having provided written informed consent

Exclusion Criteria:

* Haemoglobinopathies (except heterozygosity for haemoglobin E and alpha-thalassemia 1)
* Coeliac disease or other chronic diseases of malabsorption that could influence iron absorption or metabolism
* Blood donation or significant blood loss due to surgery or accident \< 4 months before start of the study
* Consumption of vitamin or mineral supplements 2 weeks before start of the study
* Regular use of medication (except oral contraceptives), that influences iron absorption
* Chronic inflammatory disease
* Smoking

Primary outcomes:
measure: Fractional iron absorption
timeFrame: Measured 14 days after consumption of the 4 different types of iron vehicles (Days 16 and 31)
Secondary outcomes:
Other outcomes:
Locations:
city: Salaya
country: Thailand
facility: Mahidol University
state: Nakhon Pathom
Study officials:
References: