louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05803837: Thoracotomy Effects on Pulmonary Function Test and Chest Expansion
Official title: Effects of Concave Thoracoplasty on Chest Circumference and Ventilatory Function in Adolescence With Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Idiopathic Scoliosis
Keywords: lung functions and thoracotomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: thirty patients Participants have received a good explanation of the treatment and measurement device. aged between 12 and 18 years with AIS; the patients were admitted to hospital

Brief summary: The purpose of the present study was to investigate the effect that corrective surgery for scoliosis would have on pulmonary function as well as the circumference of the chest. As a result, the current investigation was carried out on thirty individuals who had idiopathic scoliosis and had been admitted to the hospital. Before the surgery, after it had been completed (on the fifth day), and again three months later, the pulmonary function was tested.

Detailed description: The purpose of this study was to see how corrective scoliosis surgery affected pulmonary function and chest circumference. As a result, the current investigation was carried out on 30 individuals brought to the hospital with idiopathic scoliosis. The pulmonary function was assessed before surgery, on the fifth day following surgery, and three months thereafter.

Eligibility criteria: Inclusion Criteria:

• Adolescent idiopathic scoliosis

Exclusion Criteria:

* smoking.
* Associated comorbidity that affects PFT.
* Any contraindication interfering with performing spirometry.

Primary outcomes:
measure: chest expansion
timeFrame: 10 months
measure: PFT
timeFrame: 10 months for each parameter
Secondary outcomes:
measure: cobb angle
timeFrame: 10 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: nisreen moh elnahass, Prof
role: STUDY_DIRECTOR
References:
citation: Rao KE, Krodel D, Toaz EE, Fanelli J, Hajduk J, Kato K, Rychlik K, King E, Sarwark J, Grayhack J, Burjek NE. Introduction of an enhanced recovery pathway results in decreased length of stay in patients with adolescent idiopathic scoliosis undergoing posterior spinal fusion: A description of implementation strategies and retrospective before-and-after study of outcomes. J Clin Anesth. 2021 Dec;75:110493. doi: 10.1016/j.jclinane.2021.110493. Epub 2021 Sep 2.
Clinical trial NCT01776437: Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers
Official title: A Phase 1 Food Effect Study of BMN 673 Administered to Healthy Adult Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-01-28
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a randomized, 2-period, 2-sequence crossover study to evaluate the effect of food on the relative bioavailability of BMN 673 during fasting and fed conditions in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Male, between the ages of 18 and 55.
* Non-smoking for at least 1 year before Screening.
* Willing and able to provide informed consent.
* Have a BMI between 18 to 30kg/m2.
* Willing and able to comply all study procedures.
* Have adequate organ function
* Sexually active patients must be willing to use an acceptable method of contraception.

Exclusion Criteria:

* History of any illness that might confound the results of the study or pose an additional risk in administering study medication to the subject.
* Current use of prescription medication or regular treatment with over-the-counter medications.
* Consumption of herbal medications or dietary supplements.
* Consumption of more that than 3 units of alcoholic beverages per day.
* Consumption of more than five 240-mL servings of coffee or other caffeinated beverage.
* History of alcohol or drug abuse or addiction within 6 months of study entry.
* Participation in a clinical Study involving administration of an investigational drug within 1 month or 5 half lives (whichever is longer).
* Donation of any blood or having had a significant loss of blood with 56 days.

Primary outcomes:
measure: The primary outcome of this study is to evaluate the effect of food on the relative bioavailability of BMN 673. The Pharmacokinetic analyses of plasma BMN 673 concentration-time will be measured using non-compartmental methods.
timeFrame: 4 months
Secondary outcomes:
measure: Assess the safety and tolerability of BMN 673 during fasting and fed conditions with the following safety assessments: adverse events, physical examination, vital signs, concomitant medications, clinical laboratory tests and ECG.
timeFrame: 4 months
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Covance Clinical Research Unit Inc.
state: Indiana
Study officials:
References:
Clinical trial NCT04720937: Knowledge, Perception, Attitude and Responsibility of Dentists Regarding to Physical Child Abuse in Some Governorates of Upper Egypt
Official title: Knowledge, Perception, Attitude and Responsibility of Dentists Regarding Child Physical Abuse in Some Governorates of Upper Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Abuse
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 420
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dentists

Brief summary: Child abuse and neglect (CAN), child maltreatment, and child victimization are interchangeable terms that refer to a major public health problem confronting children and families. . This study Investigated dentists' level of knowledge, perception, attitude \& responsibility regarding child physical abuse in some of Upper Egypt governorates


Eligibility criteria: Inclusion Criteria:

* Dentists who working in Egyptian Ministry of health \&/ or private dental clinics \&/ or centres in three governorates of Upper Egypt (Minia, Assuit \& Sohag).
* Dentists with all dental academic degrees (Bachelor, diploma, master, doctoral \& other post graduate degree).

Exclusion Criteria:

* Dentists who are working in any other governorates except (minia, Assuit \& Sohag).
* Under graduated dental students

Primary outcomes:
measure: knowledge
timeFrame: 1 year
measure: perception
timeFrame: 1 year
measure: attitude
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Reham
Study officials:
References:
Clinical trial NCT04849637: Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients
Official title: Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid19
Keywords: virgin coconut oil
COVID19
Lead sponsor: University of the Philippines
Sponsor class: OTHER
Collaborators: name: Philippine Coconut Authority
name: Philippine Council for Health Research & Development
First posted: 2021-04-19
Enrollment: 74
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 is a research that will investigate the safety and efficacy of virgin coconut oil (VCO) as an adjunctive therapy for Coronavirus Disease 2019 (COVID-19)

Detailed description: This study will be a randomized controlled trial among hospitalized COVID-19 patients, aged 18 years old and above, admitted at the Philippine General hospital. Patients will be grouped into the following:

1. Group receiving standard of care
2. Group receiving standard of care plus virgin coconut oil (15ml, 3x/day for 2 weeks) as adjunctive therapy.

Patients will be observed as regards to primary outcomes such as recovery/resolution of symptoms and duration of hospital stay

Eligibility criteria: Inclusion Criteria:

* symptomatic and asymptomatic COVID-19 hospitalized patients
* has laboratory-confirmed illness during the time of recruitment
* able to take food and medicines enterally

Exclusion Criteria:

* uncontrolled or newly diagnosed diabetes mellitus
* with chronic heart disease
* having elevated lipid profile at baseline (admission)

Primary outcomes:
measure: Duration of hospital stay
timeFrame: Two weeks
measure: Time to recovery/resolution of symptoms
timeFrame: Two weeks
Secondary outcomes:
measure: Time to first receipt of ventilation and admission to intensive care unit
timeFrame: Two weeks
measure: IL-6 levels (pg/mL)
timeFrame: Two weeks
measure: Ferritin levels (ng/mL)
timeFrame: Two weeks
measure: CRP levels (mg/dL)
timeFrame: Two weeks
measure: LDH levels (mg/dL0
timeFrame: Two weeks
measure: TNF-Alpha levels (pg/mL)
timeFrame: Two weeks
measure: Interferon-gamma levels (pg/mL)
timeFrame: Two weeks
measure: Monocyte chemoattractant protein levels (pg/mL)
timeFrame: Two weeks
measure: Immunoglobulin levels (mg/L)
timeFrame: Two weeks
measure: CD4+ counts (cells/L)
timeFrame: Two weeks
Other outcomes:
measure: Negative test result for COVID by RT-PCR
timeFrame: Two weeks
Locations:
city: Manila
country: Philippines
facility: Philippine General Hospital
state: Metro Manila
Study officials:
affiliation: UP Manila
name: Marissa M Alejandria, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UP Manila
name: Leslie Michelle M Dalmacio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004437: Phase II Study of the Multichannel Auditory Brain Stem Implant for Deafness Following Surgery for Neurofibromatosis 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neurofibromatosis 2
Keywords: acoustic neuroma
genetic diseases and dysmorphic syndromes
hearing loss
neurofibromatosis
neurologic and psychiatric disorders
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: Cochlear
First posted: 1999-10-19
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Define the tonotopocity of multichannel brain stem stimulation and use this information to better program the auditory brain stem implant for an individual.

II. Optimize device fitting by combining monopolar and bipolar stimulation, and individual psychoacoustic channels for each patient, to increase the number of usable information channels for each patient and reduce or eliminate undesirable side effects.

III. Evaluate performance and learning effects using optimized fitting procedures.

Detailed description: PROTOCOL OUTLINE: Patients undergo surgery to remove the first side or second side tumor, during which the multichannel auditory brain stem implant is implanted. Initial stimulation is conducted 4-6 weeks after surgery.

Patients are followed every 3 months for the first year, then annually thereafter.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Confirmed diagnosis of neurofibromatosis type 2 Scheduled to undergo first side or second side tumor removal First side implantation performed only on patients with onset of symptoms prior to age 40 --Prior/Concurrent Therapy-- If a nonfunctional auditory brain stem implant (ABI) is present (implanted during the removal of a first side tumor), a multichannel ABI may be implanted during the removal of a second side tumor --Patient Characteristics-- English is the primary language

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cochlear
name: Steven J. Staller
role: STUDY_CHAIR
References:
Clinical trial NCT00520637: A Phase I, Study to Evaluate the Safety and Tolerability of Intravenous EZN-2208 in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-01)
Official title: A Phase I, Multicenter, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of Intravenous EZN-2208 (PEG-SN38) Administered Every 3 Weeks in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lymphoma
Lead sponsor: Enzon Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-08-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to patients with advanced cancer or lymphoma. The safety of the study drug and its effect on the disease will also be studied.

Enzon will also perform pharmacokinetic (PK) testing of EZN-2208. PK testing measures the amount of a drug in the body at different time points.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma that is refractory to standard therapy
* Measurable or evaluable disease
* Score of 0 to 2 on the ECOG performance scale

Exclusion Criteria:

* Concurrent serious medical illness
* Known, clinically suspected, or history of central nervous system (CNS) tumor involvement
* Active diarrhea
* Known history of coagulation disorder
* Patients requiring cytochrome P450 3A4 (CYP3A4) enzyme inducing medications
* Requirement for ketoconazole or other strong inhibitor of CYP3A4 enzymes
* Prior chemotherapy, immunotherapy, investigational agent, or other therapy used to treat the cancer within 4 weeks (6 weeks for prior treatment with mitomycin C or nitrosoureas) prior to the scheduled administration of EZN-2208

Primary outcomes:
measure: Determine the MTD of i.v. EZN-2208 administered q3wk and recommended Phase 2 dose of i.v. EZN-2208
Secondary outcomes:
measure: Evaluate the safety and tolerability of EZN-2208, assess the pharmacokinetic PK profile of EZN-2208, SN38, and SN38G as well as detect preliminary evidence of tumor response activity of EZN-2208
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology
state: Illinois
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Razelle Kurzrock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University Feinberg School of Medicine
name: Mary Frances Mulcahy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06741137: A Pilot Study of the Effect of the Combination of Inhaled Nitric Oxide and Prone Position Under EIT Monitoring on Efficacy in Patients with ARDS
Official title: A Pilot Study of the Effect of the Combination of Inhaled Nitric Oxide and Prone Position Under EIT Monitoring on Efficacy in Patients with ARDS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ARDS
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigating the Impact of Combined Inhaled Nitric Oxide and Prone Positioning on the Efficacy in ARDS Patients


Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years;
2. Patients with moderate to severe ARDS on mechanical ventilation

Exclusion Criteria:

1. Patients with severe asthma or acute exacerbation of chronic obstructive pulmonary disease (COPD), lung tumors, post-lung resection, and post-lung transplantation.
2. Patients with hemodynamic instability requiring vasopressor support: dopamine or dobutamine \>15 µg/kg/min, norepinephrine \>0.3 µg/kg/min.
3. Cardiogenic pulmonary edema.
4. Patients with severe facial deformities, facial trauma, or severe thoracoabdominal trauma that precludes prone positioning ventilation.
5. Mid to late pregnancy.
6. Patients with a history of malignancy or other irreversible diseases/conditions, including those in the terminal stage.
7. Patients expected to be discharged soon or requiring invasive mechanical ventilation for less than 24 hours.
8. Patients currently participating in other studies.

Primary outcomes:
measure: Intratidal gas distribution
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT03446937: Effect of Antenatal Corticosteroids on Neonatal Morbidity.
Official title: Effect of Antenatal Corticosteroids on Neonatal Morbidity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Respiratory Distress Syndrome
Keywords: Antenal corticosteroids
Late preterm delivery
Neonatal morbidity
Lead sponsor: Ahmadu Bello University Teaching Hospital
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: PREVENTION

Brief summary: It will be a randomized controlled trial. There will be two study groups. Study group 1 will be given dexamethasone while study group 2 will be given betamethasone. The control group will be given placebo.

Detailed description: The study will be a double blind randomised controlled trial. There will be two study groups and one control group.

The first study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular dexamethasone sodium phosphate.

The second study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular betamethasone sodium phosphate.

The control group will be pregnant women at risk of late preterm birth that will be given intramuscular water for injection.

Eligibility criteria: Inclusion Criteria:

* Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation and a probability of delivery in the late preterm period irrespective of diagnosis who give consent.
* Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation scheduled for elective/emergency delivery in the late preterm period irrespective of indication and route of delivery who give consent.

Exclusion Criteria:

* Evidence of Chrioamnionitis.
* Evidence of foetal distress.
* History of use of antenatal corticosteroids in index pregnancy.
* Women who do not give consent.

Primary outcomes:
measure: Neonatal Respiratory distress syndrome
timeFrame: Within the first 72 hours of life
Secondary outcomes:
measure: Transient tachypnoea of the newborn:
timeFrame: Within the first 72 hours after delivery/birth
measure: Admission into neonatal intensive care unit.
timeFrame: Within the first 72 hours after delivery/birth
measure: 2. Admission into neonatal intensive care unit. Apnoea.
timeFrame: Within the first 72 hours after delivery/birth
Other outcomes:
Locations:
city: Zaria
country: Nigeria
facility: Ahmadu Bello University Teaching Hospital Shika-Zaria
state: Kaduna
Study officials:
affiliation: Ahmadu Bello University
name: Anisah Yahya, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04746937: Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis
Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of Nitazoxanide in Secondary Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Double-Blind Placebo-Controlled study
Primary purpose: PREVENTION

Brief summary: the study is to evaluate the possible efficacy and safety of nitazoxanide as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.

Detailed description: due to high recurrence rate of spontaneous bacterial peritonitis , we will study and evaluate the possible efficacy and safety of NTZ as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.

Eligibility criteria: Inclusion Criteria:

* Patients aged 21 - 65 years old with cirrhosis and ascites who had at least one previous confirmed episode of spontaneous bacterial peritonitis.

Exclusion Criteria:

* Exclusion criteria included active gastrointestinal bleeding Hepatic encephalopathy (\>grade 2) Hepatocellular carcinoma (HCC) or other malignancies Allergy to used medications.

Primary outcomes:
measure: Prevention of Secondary Spontaneous Bacterial Peritonitis
timeFrame: 3 months
Secondary outcomes:
measure: Change in Biological Biomarkers
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Supervisor for my master degree
name: Sahar M. Elhagar, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06611137: SBRT Followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Larynx Preservation in Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx
Official title: SBRT Followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Larynx Preservation in Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Laryngeal Cancer
Hypopharynx Cancer
Keywords: SBRT
immunotherapy
larynx preservation
laryngeal cancer
hypopharynx cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 35
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: This trial aims to evaluate the safety and efficiency of SBRT followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx


Eligibility criteria: Inclusion Criteria:

* Laryngeal (T3-4N0-3M0 ) and hypopharyngeal ( T2-4N0-3M0) cancers staged by AJCC8th
* age 18-70
* PS score 0-1
* normal functions to tolerate chemotherapy, immunotherapy and radiotherapy

Exclusion Criteria:

* Patients with a combination of other malignant tumours
* Individuals with contraindications to immunotherapy

Primary outcomes:
measure: objective response rate
timeFrame: two weeks after the last course of neoadjuvant chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: