louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00719628: Depth of Anaesthesia and Cognitive Dysfunction
Official title: Depth of Anaesthesia and Presence of Postoperative Cognitive Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Dysfunction
Keywords: Postoperative
Cognitive
Dysfunction
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2008-07-22
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients above 60 years eligible for surgery

Brief summary: The purpose of this study is to investigate if there is an association between the depth of anaesthesia and the presence of cognitive deterioration after surgery.


Eligibility criteria: Inclusion Criteria:

* Age above 60
* Surgery in general anesthesia
* surgery \> 1 hour
* ASA: 1-3

Exclusion Criteria:

* Dementia
* Excessive Use of alcohol or anxiolytics
* Unable to understand danish
* MMSE score \< 24

Primary outcomes:
measure: mean Cerebral state index in relation to postoperative cognitive dysfunction
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep Anaesthesia, HOC, Rigshospitalet
Study officials:
affiliation: Dep anaesthesia, HOC, Rigshospitalet
name: Lars S Rasmussen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05166928: Effect of Upper Third Molar Extraction on Distalization Carriere Motion Appliance :A Prospective Clinical Study
Official title: Effect of Upper Third Molar Extraction on Distalization Using Carriere Motion Appliance :A Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class II Malocclusion
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 16
Sex: ALL
Minimum age (years): 14
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study will be directed to compare the effect of presence or absence of third molar on distalization of the upper posterior segment by using carriere motion appliance


Eligibility criteria: Inclusion Criteria:

1. Angle´s Class II canine relationship, at least half-unit.
2. Skeletal Class I or mild Class II relationship.
3. Upper second molars were fully erupted before starting distalization.
4. Normal or horizontal growth pattern.
5. Good oral hygiene.
6. Absence of any systemic diseases

Exclusion Criteria:

Previous orthodontic treatment. 2. Patients who required surgery to correct skeletal discrepancies (sever skeletal class11).

3. Patients with hyperdontia, hypodontia, or syndromic diseases. 4. Extraction or badly destructed teeth in upper arch

-

Primary outcomes:
measure: change in upper first molar position
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: al-Azhar university
state: Naser Ciry
Study officials:
References:
Clinical trial NCT03948828: Clinical Study of NK Cells in the Treatment of Severe Endometriosis
Official title: Clinical Study on the Treatment of Endometriosis by Combining With the Pathogenesis of Endometriosis and the Application Characteristics of NK Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: NK Cell Mediated Immunity
Endometriosis
Keywords: Endometriosis
NK cell therapy
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dysfunction of natural koller cells (NK cells) is an important factor in the development of endometriosis. NK cell therapy was applied to treat severe endometriosis, which is an exploration of the pathogenesis of this refractory disease.

Detailed description: Endometriosis (EMs) is one of the common and frequently occurring diseases in women of childbearing age, which seriously affects the health and quality of life of the vast majority of women. The pathogenesis of endometriosis is unknown until now, and the recurrence rate of existing treatment methods is high. It is more and more necessary to introduce new therapeutic methods and strategies in view of the mechanism associated with the reduction of natural killer cell (NK) cytotoxicity. In this study, routine therapy combined with NK cell therapy was used in the treatment of severe endometriosis. The clinical data were collected to confirm the efficacy and safety of NK cell therapy. It is expected to provide a new way of thinking and method for the clinical treatment of EMs.

Eligibility criteria: Inclusion Criteria:

1. Diagonsed as endometriosis stage III\~IV
2. Age ≥18 years ≤ 45 years at the time of informed consent
3. With indications for conservative endometriosis surgery
4. With complete clinical data

Exclusion Criteria:

1. Severe allergy to drugs
2. Patients with abnormal immune status (Autoimmune disease or long-term use of immunosuppressive agents)
3. With serious cardiac, cerebrovascular diseases and liver, kidney disorders
4. With a history of severe mental illness

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety]
timeFrame: 3 months after treatment
measure: Purity and Function of NK cells
timeFrame: once per three months
Secondary outcomes:
measure: Endocrine hormone levels
timeFrame: every three months, up to 36 months
measure: Pain score
timeFrame: every three months, up to 36 months
measure: The percent of pregnancy
timeFrame: 36 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
Study officials:
affiliation: Shen Zhen People's Hospital
name: Hui Qi, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06491628: Liver Function Abnormalities in Patients With Acute Heart Failure
Official title: Liver Function Abnormalities in Patients With Acute Heart Failure in Sohag University Hospitals
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Heart Failure
Keywords: LFTs, AHF
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients aged 18 yrs or older presenting with AHF

Brief summary: The aim of this study is to evaluate liver function test abnormalities and to identify associated cardiac and non cardiac factors mediating hepatic impairment in acute heart failure patients

Detailed description: Cardiac failure has a negative impact on the function of all parenchymatous organs, based both on the low organ perfusion in the left-sided failure and on the venous congestion in the right-sided failure.

The pathophysiology of acute heart failure (AHF) is complex and not fully understood. It has been hypothesized that an episode of acute decompensation affects not only the cardiovascular system itself, but may also deteriorate the function of other organs, c ausing serious clinical consequences. Liver involvement has been mostly described and investigated in patients with chronic HF.

Liver enzyme alterations are usually classified as relating predominantly to liver cell necrosis (signified by transaminase elevations) or predominantly to cholestasis (signified by elevated alkaline phosphatase (AP) level).

Eligibility criteria: Inclusion Criteria:

* patients aged 18 yrs or older presenting with AHF

Exclusion Criteria:

* Congenital heart disease
* acute and chronic liver diseases

Primary outcomes:
measure: Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals
timeFrame: baseline
Secondary outcomes:
measure: Liver function abnormalities in patients with acute heart failure in Sohag University Hospitals
timeFrame: 1 year
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
affiliation: Sohag University
name: Hamdy Saad
role: STUDY_CHAIR
affiliation: Sohag University
name: Haitham Mohammad
role: STUDY_CHAIR
References:
Clinical trial NCT01068028: Safety and Pharmacokinetic Study With Multiple Ascending Doses of ORM-12741
Official title: Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of ORM-12741
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer study
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2010-02-12
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of ORM-12741.

Detailed description: The purpose is to evaluate the safety, tolerability and pharmacokinetics of escalating multiple doses of ORM-12741 in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Good general health ascertained by detailed medical history and physical examinations.
* Males between 18 and 45 years (inclusive).
* Body mass index (BMI) between 18-30 kg/m2 inclusive (BMI = weight/height2).
* Weight 55-100 kg (inclusive).

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator.
* Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant medication during the study.
* Susceptibility to severe allergic reactions.
* Regular consumption of more than 14 units of alcohol per week (1 unit = 4 cl spirits, about 13 g of alcohol).
* Current use of nicotine-containing products more than 5 cigarettes or equivalent/day.
* Inability to refrain from using nicotine-containing products during the stay at the study centre.
* Inability to refrain from consuming caffeine-containing beverages during the stay at the study centre e.g. propensity in getting headache when refraining from caffeine-containing beverages.
* Blood donation or loss of significant amount of blood within 3 months prior to the screening visit.
* Abnormal finding in ECG, vital signs, laboratory tests or physical examination.
* Intake of an investigational compound within 3 months prior to the start of this study or earlier participation in a clinical study with ORM-12741

Primary outcomes:
measure: Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values
timeFrame: 12 days
Secondary outcomes:
measure: Pharmacokinetic profile (Cmax, tmax, t1/2, AUC, PTF) of ORM-12741 and its metabolites
timeFrame: PK samples will be collected for 12 days
Other outcomes:
Locations:
city: Rouffach
country: France
facility: Forenap Pharma
Study officials:
affiliation: Forenap Pharma
name: Déborah Metzger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01229228: Study of Naproxen Capsules to Treat Dental Pain
Official title: A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Naproxen [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Pain
Lead sponsor: Iroko Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2010-10-27
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.


Eligibility criteria: Inclusion Criteria:

* Patient is male or female between 18 and 50 years of age
* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
* Patient requires extraction of 2 or more third molars
* Patient must be willing to stay at the study site overnight

Exclusion Criteria:

* Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
* Patient has a current disease or history of a disease that will impact the study or the patient's well-being
* Patient has used or intends to use any of the medications that are prohibited by the protocol
* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
* Patient has taken another investigational drug within 30 days prior to screening

Primary outcomes:
measure: Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0
timeFrame: Over 0 to 12 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Premier Research Group Limited
state: Texas
Study officials:
References:
citation: Young CL, Strand V, Altman R, Daniels S. A phase 2 study of naproxen submicron particle capsules in patients with post-surgical dental pain. Adv Ther. 2013 Oct;30(10):885-96. doi: 10.1007/s12325-013-0057-9. Epub 2013 Oct 15.
Clinical trial NCT00316628: Safety and Immunogenicity of an Adjuvanted Influenza Vaccine in Subjects Aged 65 Years and Over.
Official title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, (Adjuvanted With MF59C.1) Influenza Vaccine, Formulation 2005-2006, When Administered to Elderly Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: influenza
elderly
vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2006-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of an adjuvanted influenza vaccine in elderly subjects.


Eligibility criteria: Inclusion Criteria:

* 65 years of age or older and in good health

Exclusion Criteria:

* Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure.
* any acute disease or infections requiring systemic antibiotic or antiviral therapy
* hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
* history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days

Primary outcomes:
measure: CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
Secondary outcomes:
measure: Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
measure: Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
measure: Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: G. D'Annunzio University
city: Lanciano
country: Italy
facility: Office of Hygiene and Public Health, ASL Lanciano
Study officials:
affiliation: Novartis
name: Novartis Vaccines - Drug Information Services
role: STUDY_DIRECTOR
References:
Clinical trial NCT06414928: Prognostic Model Heart Failure
Official title: In-hospital & 30-day Prognostication of Acute Heart Failure Patients by Comparing 4 Validated Scores in Patients Presenting to the Emergency Department of Cardiac Tertiary Care Hospital, Karachi- Pakistan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure Acute
Lead sponsor: National Institute of Cardiovascular Diseases, Pakistan
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presented at the Emergency Department with signs and symptoms of Acute Heart Failure who are fulfilling the eligibility criteria will be enrolled.

Brief summary: This study aims to determine the prognosis of heart failure in our population by using multiple validated risk scores and to evaluate the strengths of these scores in assessing prognosis with better discrimination.

Detailed description: After fulfilling the eligibility criteria, informed consent will be obtained from all the patients regarding using data for research while maintaining anonymity. All the included patients will be interviewed by the assigned physician to complete the detailed questionnaire, including patient demographics, risk factors, and validated questionnaires including the Acute Decompensated Heart Failure National Registry (ADHERE), The Get With The Guideline-Heart Failure (GWTG-HF) Risk Score, the Ottawa Heart Failure Risk Scale (OHFRS), and EHMRG30-ST score. All the patients will be followed after 30 days, and survival status will be obtained. The AUC of the GWTG-HF risk score for all-cause death was 0.687 (95% CI, 0.649-0.725) \[18\], at 95% confidence interval, ±3% margin of error, the sample size was calculated to be n=626 patients. The calculated sample size was inflated by a factor of 1.5 for the design effect; hence, the sample size for the study will be N=939.

For data verification, 10% of the data will be cross-checked with the source document (Patient file).

Eligibility criteria: Inclusion Criteria:

* Patients of age \> 18 years or more
* Either gender
* Patients visited the emergency department at NICVD, Karachi
* Newly/Already diagnosed with Heart Failure
* Giving informed consent
* Who can be followed in 30 days via Telephone or in OPD

Exclusion Criteria:

* Patients of age \<18 years
* Patients who do not give consent
* Patients who are mentally handicapped due to any neurological or psychiatric illness (excluding depression/anxiety)

Primary outcomes:
measure: In-Hospital Prognosis
timeFrame: From admission till discharge/death
measure: 30-day Prognosis
timeFrame: From day of admission of last visit till 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: National Institute of Cardiovascular Diseases
state: Sindh
Study officials:
affiliation: National Institute of Cardiovascular Diseases
name: Madiha Fatima, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01837628: Reducing Urethral Pain During Urodynamic Test - Comparison Between Lidocaine Gel and Paraffin Oil
Official title: Reducing Urethral Pain During Urodynamic Test - Comparison Between Lidocaine Gel and Paraffin Oil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Urodynamic
Paraffin oil
Lidocaine gel
Pain
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-04-23
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our purpose is to compare between intraurethral lidocaine gel and paraffin oil in reducing urethral pain during urodynamic test.

Detailed description: Patients will be randomized into two groups: 1) Lidocaine Gel 2) Paraffin Oil. They will fill out 1 visual analogue scale (0-10) for urethral pain during the test.

Eligibility criteria: Inclusion Criteria:

* All men who will be referred for urodynamic test

Exclusion Criteria:

* Active infection
* Permanent Catheter

Primary outcomes:
measure: Visual Analogue scale (0-10) for pain
timeFrame: up to 1 hour after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Assaf Harofe MC
name: Kobi Stav, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03473028: Transvaginal Ultrasonography Guided Embryo Transfer
Official title: Could Transvaginal Ultrasonography Guided Embryo Transfer Improves Pregnancy Outcome in Obese Patients Undergoing Intracytoplasmic Sperm Inoculation? Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Keywords: obesity
embryo transfer
invitro fertilization
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 800
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: to evaluate the value of using transvaginal ultrasound guided embryo transfer in obese patients undergoing in vitro fertilization.

Detailed description: The 800 participants with body mass index more than 30kg/m2 were randomly allocated to two groups of equal size using an automated web-based randomization system. The first group 400 patient undergoing the transabdominal-guided embryo transfer, the second group 400 patient undergoing transvaginal-guided embryo transfer.

Eligibility criteria: Inclusion Criteria:

* BMI more than 35, good ovarian reserve, unexplained infertility more than 3 years.

Exclusion Criteria:

* severe male factor of infertility,uterine factor of infertility excluded by ultrasonography and hysteroscopy ,ovarian endometrioma or patients with poly cystic ovary syndrome, obesity caused by abnormal endocrine function (thyroid or adrenal disorder)

Primary outcomes:
measure: clinical pregnancy rate'
timeFrame: 4 weeks following embryo transfer
Secondary outcomes:
measure: live birth rate
timeFrame: immediately following delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainiy Hospital
Study officials:
References:
citation: Mohamed Hassan S, Ramadan W, Elsharkawy M, Ali Bayoumi Y. The Role of Transvaginal Ultrasound Guided Embryo Transfer to Improve Pregnancy Rate in Obese Patients Undergoing Intracytoplasmic Sperm Injection. Int J Womens Health. 2021 Sep 21;13:861-867. doi: 10.2147/IJWH.S325557. eCollection 2021.