louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06354374: Soft Tissue Volume, Dimensions and Tomographic Alveolar Ridge Classification System for Dental Implant Treatment.
Official title: Relationship Between Soft Tissue Volume, Dimensions and Tomographic Alveolar Ridge Classification System for Dental Implant Treatment.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Soft Tissue Volume
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: British University In Egypt
First posted: 2024-04-09
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This cross sectional observational clinical study will include 350 patients that will be recruited from the outpatient clinic of the department of Oral Medicine, Periodontology, and Diagnosis, Faculty of Dentistry, The British University in Egypt.

Demographic data of all patients will be collected. Patients will be clearly instructed about the purpose of this study and will give their consent by signing an informed consent.

The study will be started after being accepted by the faculty of Dentistry, The British University in Egypt Research Ethics Committee. The study tracks the guidelines of the research ethical committee in line with the Helsinki Declaration of 1975.

Brief summary: Despite the importance of soft tissue dimensions for periodontal, restorative, implant, and orthodontic treatment, the current classifications of tomographic alveolar ridge topography lack the soft tissue component(Tolstunov, 2014). Therefore, the present study will be to evaluate the relationship between soft tissue volume and the dimensions \& tomographic alveolar ridge classes as well as to incorporate the soft tissue volumetric evaluation in the classification system.


Eligibility criteria: Inclusion Criteria:

1. Adult patients in a healthy systemic condition who required comprehensive dental treatment.
2. Both genders with age group \> 18 years old.
3. Patients should have at least a single missing tooth that requires dental implant placement.
4. Healing period of 3 months after extraction prior to surgical procedures.
5. CBCT scans will be obtained as a part of the comprehensive dental treatment.
6. Patients should approve to deliver a signature to a written consent after studying nature explanation.

Exclusion Criteria:

1. Patients with severe smoking habits \>10 cig \\ day.
2. Pregnant females, decisional impaired individuals, Prisoners, and handicapped patients.
3. Patients having poor oral hygiene or not wanting to carry out oral hygiene measures.
4. Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin)
5. Patients with infections either periodontally or periapically

Primary outcomes:
measure: the relationship between soft tissue volume & tomographic alveolar ridge classes
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Al Shorouk City
country: Egypt
facility: Ahmed Hamdy
state: Cairo
Study officials:
References:
Clinical trial NCT06190574: Diagnostic Efficacy and Prognostic Value of 18F-FDG PET/CT (MR) in Pediatric Solid Blastoma
Official title: Diagnostic Efficacy and Prognostic Value of 18F-FDG PET/CT (MR) in Pediatric Solid Blastoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 18F-FDG
Neuroblastoma
Hepatoblastoma
Wilms Tumor
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We reviewed the electronic medical record and imaging data of 47 children who underwent 18F- FDG PET/CT or PET/MR for the diagnosis of suspected NB, HB or WT from Jan 1, 2013, to Aug 30, 2021.

Brief summary: the primary histologic origin of extracranial solid tumors in children is malignant embryonic cells, including Neuroblastoma (NB) , Hepatoblastoma(HB), and kidney, wilms' tumor(WT). Their main clinical symptoms are large abdominal masses, the most common lymph node metastasis . NB accounts for 15% of childhood cancer deaths, but some low-risk NB can disappear on its own. The International Neuroblastoma Risk Group Staging System (INRGSS) was used to determine Risk before NB treatment, whereas the INRGSS was entirely based on the Neuroblastoma diagnosis, illustrating the importance of imaging in the assessment of NB.18F-FDG is the most commonly used agent in PET imaging of tumor. It can reflect the glucose metabolism of tumor and is widely used in the diagnosis, staging, evaluation of curative effect and prognosis prediction of tumor In this study, the investigators retrospectively analyzed 18F-FDG PET/CT or PET/MRI images from patients with NB, HB, and WT. The investigators sought to assess whether these images provide useful information for diagnosis and prognosis.


Eligibility criteria: Inclusion Criteria:

1. age \< 18 years,
2. have pathological results or definite clinical diagnosis as the gold standard.

Exclusion Criteria：

1. had surgery or chemotherapy before imaging,
2. accompanying other tumors,
3. diabetic patients or patients with fasting blood glucose ≥ 200 mg/dL.

Primary outcomes:
measure: Region of Interest (ROI)
timeFrame: up to 2 years
measure: Sensitivity and specificity of diagnosis and staging
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: China, Hubei Province
state: Hubei
Study officials:
affiliation: Study Principal Investigator Wuhan Union Hospital, China
name: Xiaoli Lan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03121274: Early Versus Delayed Pushing in the Second Stage of Labor
Official title: Early Versus Delayed Pushing in the Second Stage of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Delivery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 184
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Nulliparous women in spontaneous or induced labour with term singleton pregnancy are randomized into two groups first group (early pushing) in this group patients were allowed to push within one hour after full cervical dilatation whether the vertex was visible or not. Second group (delayed pushing) patients here were asked not to push for maximum of 3 hours or start pushing when the vertex was visible.

Detailed description: Nulliparous women in spontaneous or induced labour with term singleton pregnancy are randomized into two groups first group (early pushing) in this group patients were allowed to push within one hour after full cervical dilatation whether the vertex was visible or not. Second group (delayed pushing) patients here were asked not to push for maximum of 3 hours or start pushing when the vertex was visible.

Oxytocin was allowed in both group and fetus was monitored with CTG.

Eligibility criteria: Inclusion Criteria:

* Healthy women
* Gestational age 36 to 40 weeks
* singleton pregnancy

Exclusion Criteria:

* women indicated for cesarean section
* Medical complications of pregnancy as hypertensive disorders or Diabetes Mellitus
* Fetal distress
* Epidural anaesthesia

Primary outcomes:
measure: successful vaginal delivery
timeFrame: within 3 hours from full cervical dilatation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
References:
Clinical trial NCT06674174: Effect of Lower Limb Resistance Versus Endurance Training in Smokers
Official title: Effects of Lower Limb Resistance Versus Endurance Training on Pulmonary Function in Smokers With Shortness of Breath
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients was selected based on inclusion and exclusion criteria. Experimental group was treated with Resistance training while control group received endurance training. Data was collected by spirometry and International Physical activity questionnaire readings was recorded in every session for baseline, 3rd week and 6thweeks.

Detailed description: Experimental group will receive lower limb strength training and control group will receive endurance training. Both groups will receive treatment for three days a week and each session will be given according to FITT formula. Measurement will be recorder pre-treatment and post treatment of both groups at baseline, third , and 6 th week.

Eligibility criteria: Inclusion Criteria:

* Young cigarette smokers (10 cigarette/day for at least 10 years)
* Male
* Age 25-45 years
* Sedentary lifestyle
* Body mass: less than 80kg
* BMI:22-30

Exclusion Criteria:

* Heart or pulmonary disease
* MSK disorder
* incapable of realizing the protocol of exercises,
* Recent surgery
* Recent Trauma.
* Any infective respiratory illness.

Primary outcomes:
measure: Spirometry
timeFrame: 6 weeks
measure: International Physical Activity Questionnaire
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dera Ismāīl Khān
country: Pakistan
facility: Samina International Hospital
Study officials:
affiliation: Riphah International University
name: Maria Razzaq, MsCPPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03764774: A Study of LY3463251 in Healthy Participants
Official title: A Randomized, Placebo-Controlled, Subject- and Investigator-Blind, Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetics Study of LY3463251 in Healthy and Overweight Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-12-05
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen.

This is a two-part study. Participants will enroll in only one part. For each participant, Part A will last about 10 weeks and Part B will last about 23 weeks, including screening.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females

Exclusion Criteria:

* Diagnosed with Type 1 or Type 2 diabetes
* Women who are of childbearing potential or who are breastfeeding
* Donated blood of more than 500 millilitres (mL) within the previous 3 months of study screening
* Have used any tobacco product within 3 months of Day -1, or are unwilling to refrain from the use of tobacco during the study

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251
timeFrame: Baseline to Day 29 (Part A); Baseline to Day 107 (Part B)
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3463251
timeFrame: Baseline to Day 29 (Part A); Baseline to Day 107(Part B)
measure: Pharmacodynamics (PD): AUC of glucose
timeFrame: Baseline to Day 85 (Part B)
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Day 85 (Part B)
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Inc
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00790374: BN83495 in Prostate Cancer
Official title: A Phase I Dose Escalating Study Evaluating the Pharmacodynamic Profile and Safety of BN83495 in Patients With Prostate Cancer With Evidence of Disease Progression While on Androgen Ablative Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Pharmacodynamic profile and safety of BN83495
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 17
Sex: MALE
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: The purpose of the study is to evaluate the pharmacodynamic profile and safety of BN83495 in patients with prostate cancer with disease progression while on androgen ablative therapy

Detailed description: Evaluate the PD profile of BN83495 after 28 days of daily oral administration in patients with locally advanced or metastatic prostate cancer on androgen ablative therapy and with rising prostatic specific antigen

Eligibility criteria: Inclusion Criteria:

* Confirmed and locally advanced or metastatic prostate cancer with rising prostate-specific antigen (PSA), while on androgen ablative therapy.
* Over age 18.
* Demonstrated PSA "biochemical failure".
* Adequate bone marrow and hepatic function

Exclusion Criteria:

* Luteinizing Hormone-Releasing Hormone analogue treatment and treated with more than one additional second line of endocrine therapy
* Prior treatment with ketoconazole
* Prior chemotherapy for hormone refractory prostate cancer
* Pre-existing cardiac failure and/or clinically significant abnormal ECG or Echo

Primary outcomes:
measure: Absolute and percentage change in levels of hormones from baseline to D28/29 at 6 timepoints
timeFrame: 28 days
Secondary outcomes:
measure: Tolerance (Physical Exam, ECOG Performance Status, Electrocardiogram, biochemistry/haematology, Urinalysis, Adverse Events, Concomitant Medications, disease progression)
timeFrame: Each visit through day 28/29
measure: Pharmacokinetic assessments/Pharmacodynamic assessments
timeFrame: Pre-determined timepoints from baseline to day 28/29
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University Medical Center
state: Maryland
city: Durham
country: United States
facility: Duke University Medical Center United States
state: North Carolina
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02755974: The London COPD Exacerbation Cohort
Official title: Relationship Between Patient Phenotypes and Exacerbations in Chronic Obstructive Pulmonary Disease.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with COPD who are generally seen in outpatient clinic.

Brief summary: The London COPD exacerbation (EXCEL) cohort builds on an established cohort started in 1995 and designed to study COPD exacerbations and their impact on health-status and disease progression.

Detailed description: Our intentions are to phenotype Chronic Obstructive Pulmonary Disease (COPD) patients on the basis of factors that a related to (a) exacerbation frequency which will include (b) lung function to assess disease severity, (c) baseline therapy, (d) airway and systemic inflammatory markers, (e) health status, (f) gene expression, (g) airway bacterial and viral load and (h) co-morbidity including cardiovascular disease, diabetes and psychological disease, (i) psychological factors,(j) mortality, (k) nasal susceptibility to rhinovirus infection, (l) heart rate variability (m) exhaled hydrogen sulphide.

Eligibility criteria: Inclusion Criteria:

* Forced Expiratory Volume in 1 sec (FEV1)/Forced Vital Capacity (FVC) ratio of \<0.70
* Able and willing to give informed and written consent

Exclusion Criteria:

* Patients with a history of asthma, bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease were excluded.
* Patients on Immunosuppressive medications or with active cancer
* Long term steroid therapy
* Age \<40 years at recruitment

Primary outcomes:
measure: Annual exacerbation rate (number of exacerbations over a 12 month period)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: National Heart and Lung Institute, Imperial College
Study officials:
affiliation: Imperial College London
name: Jadwiga Wedzicha
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01741974: Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
Official title: Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopausal Syndrome
Atherosclerosis
Keywords: perimenopause
phytoestrogen
atherosclerosis
intima-media thickness
Lead sponsor: Institute for Atherosclerosis Research, Russia
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 340
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the anti-atherosclerotic and anti-climacteric action of natural drug Karinat based on phytoestrogen-rich botanicals in perimenopausal women.


Eligibility criteria: Inclusion Criteria:

* Perimenopausal women aged 45 to 60 years with intact womb and ovaries
* The absence of menstruations between 6 to 24 months
* Last menstruation after the age of 40 years
* Follicle-stimulating hormone (FSH) blood level ≥ 35 ng/ml
* Mammography without nodal form of mastopathy or breast cancer signs
* Absence of hypolipidemic therapy or HRT (hormone replacement therapy) during 6 months before the inclusion

Exclusion Criteria:

* Administration of lipid-lowering drugs, and/or HRT, and/or phytoestrogens during 6 month before inclusion
* Personal history or diagnostic of following diseases:

nodal form of mastopathy or breast cancer any cancer except non-melanoma skin cancer stroke or myocardial infarction chronic renal failure II-III chronic hepatic failure II-III liver cirrhosis chronic heart failure IIa-III exacerbation of chronic stomach or duodenal ulcer obesity (BMI \>30 kg/m2) alcohol abuse uncontrolled arterial hypertension (systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 90 mmHg) current cigarette smoking (\>10 cigarettes a day) diabetes mellitus deep vein thrombosis or pulmonary embolism

* Individual intolerance of Karinat or major side effects

Primary outcomes:
measure: B-mode ultrasound of carotid arteries
timeFrame: up to 3 years
Secondary outcomes:
measure: Measure of serum atherogenicity
timeFrame: up to 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03114774: Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography
Official title: Evaluation of Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography Received Sedoanalgesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sedoanalgesia
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients in ASA 1-2 category scheduled for sedation and ERCP

Brief summary: The bispectral index (BIS) monitoring is an EEG-based method that uses electroencephalogram analysis and a complex algorithm to generate a numerical scoring 0-100 (0 flat line EEG, 100, wide awake) BIS monitoring allows noninvasive, objective measurement of level of consciousness of a sedated patient. A limited number of studies have used measurements of BIS monitoring to assist endoscopic sedation.There are studies using BIS monitoring to make sedation easy for ERCP procedures. However, the studies evaluating use of BIS for gastrointestinal endoscopy show inconsistent results.

The objective of this study is to evaluate effects of sedation on the dosage of propofol by monitoring with BIS values, hemodynamics, recovery parameters, respiratory functions and endoscopist satisfaction based on the hypothesis that the investigators would reduce the risk for respiratory depression using minimal doses of propofol in order to achieve the desired level of sedation with BIS monitoring.


Eligibility criteria: Inclusion Criteria:

1. 20-75 years old
2. ASA 1-2

Exclusion Criteria:

1. Emergency Operation
2. Those who had symptoms of neurological disease (TİA, syncope, dementia, etc.)
3. Patients that are allergic to drugs considered to use

Primary outcomes:
measure: Total dosage of propofol
timeFrame: 1-3 hours
measure: The heart rate (HR)(n/dk)
timeFrame: 1-3 hours
measure: mean systolic-diastolic blood pressure(mmHg)
timeFrame: 1-3 hours
measure: peripheral oxygen saturation (%)
timeFrame: 1-3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01414374: Hibiscus Sabdariffa and Centella Asiatica in the Treatment of Anemia by Iron Deficiency
Official title: Prevalence of Genetic Polymorphisms of DMT1 and Ferroportin Enzymes in Adults With Anemia by Iron Deficiency, and Its Influence on the Efficacy of Conventional and Herbal Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency Anemia
Keywords: iron
anemia
herbal medicine
phytotherapy
Centella asiatica
Hibiscus sabdariffa
Lead sponsor: Casa Espirita Terra de Ismael
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2011-08-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to investigate the prevalence of genetic polymorphisms in adults with iron deficiency and anemia, and the responses to two different treatments: iron sulphate and a composite herbal medicine (Hibiscus sabdariffa plus Centella asiatica). The main outcome will be hemoglobin, measured before and after 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 y and \< 50 y
* A diagnostic of iron deficient anemia

Exclusion Criteria:

* Severe anemia
* Treatment interruption for more than 25% of the 6 weeks
* New onset severe adverse symptoms or events
* Patient's request

Primary outcomes:
measure: Hemoglobin
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Monte Santo de Minas
country: Brazil
facility: Laboratorio M. F. Teixeira
state: Minas Gerais
Study officials:
References: