louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05783284: HS2 US Liver Reader Study
Official title: HS2 US Liver Reader Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reader Study
Keywords: Holographic visualization
Lead sponsor: HoloCare AS
Sponsor class: INDUSTRY
First posted: 2023-03-24
Enrollment: 22
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: US patients whose liver CT images will be used to create HVs.

Brief summary: The purpose of this study is to to assess the ability of 5 Gastro-Intestinal (GI) surgeons, within liver surgery, the readers, to identify pre-defined anatomical landmarks in liver images processed by HS2, and assessment of landmark distance between CT and Holographic visualization (HV).

Detailed description: This is a retrospective investigation of Computer Topographies (CTs)/ Holographic visualization based on CTs retrieved from patients with metastases in the liver from colorectal cancer.

The study consists of:

* Preparations at Day 0. The reader is not involved in the preparation
* Using of HS2 and evaluation at Day 1-2
* Calculation at Day 3.

The study will enroll eligible subject's images.

Eligibility criteria: Inclusion Criteria:

1. Livers with colorectal cancer liver metastasis
2. CTs from individuals 22 years or older
3. CTs retrieved from US hospitals
4. CTs from patients treated in the US
5. At least 1 visible liver lesion to complete detection of L1

Exclusion Criteria:

No exclusion criteria

Primary outcomes:
measure: Identification of all pre-defined landmarks.
timeFrame: 3 days
Secondary outcomes:
measure: Comparison between CT and HV distance.
timeFrame: 3 days
measure: Comparison of image quality between CT and HV.
timeFrame: 3 days
measure: Evaluate ease of use.
timeFrame: 3 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
References:
Clinical trial NCT00687284: Observational Study of Glycaemic Control in Patients Uncontrolled on Oral Antidiabetic Agents and Starting With 1 (Once) Daily Levemir® (Insulin Detemir) as the Treatment of Type 2 Diabetes Mellitus
Official title: Observational Study on Evaluation of Glycaemic Control in Patients Using Levemir® (Insulin Detemir) as Initiation Insulin Therapy by Levemir® (Insulin Detemir) Administered Once Daily as the Treatment for Type 2 Diabetes Mellitus.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 2188
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetes mellitus type 2

Brief summary: This study is conducted in Europe. An observational study evaluating glycaemic control in patients using Levemir® as initiation insulin therapy as the treatment of type 2 diabetes in Slovakia.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes
* Patients inadequately controlled by OAD
* Patients willing to sign informed consent
* Selection of study participants at the discretion of the physician
* Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit;
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
* Women who are pregnant, breastfeeding or have the intention of becoming pregnant within next 6 months

Primary outcomes:
measure: Change in glycaemic control as measured by HbA1c.
timeFrame: For the duration of the study
Secondary outcomes:
measure: Percentage of subjects to reach HbA1c below 7.0% and below or equal 6.5%
timeFrame: After 12 weeks and 24 weeks
measure: The effect on glycaemic control as measured by FPG
timeFrame: After 12 weeks and 24 weeks
measure: Change in body weight
timeFrame: After 12 weeks and 24 weeks
measure: Change in waist and hip perimeter
timeFrame: After 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Kosice
country: Slovakia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00722384: Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5
Official title: An Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5 by Single Intravitreal Injection in Patients With Wet Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Macular Degeneration
Keywords: AMD
Macular Degeneration
Opko Health
Acuity Pharmaceuticals
bevasiranib
Cand5
Age-Related
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-25
Enrollment: 15
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To establish the tolerability and preliminary efficacy of Cand5 by a single intravitreal injection in patients with wet age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

* Patients with subfoveal predominantly classic, minimally classic and purely occult lesions, secondary to age related macular degeneration, with a total lesion size (including blood, atrophy/scar and neovascularization) of \< 12 total disc areas, of which at least 50% are active CNV.
* Patients must have visual acuity 20/50 to 20/320 in the study eye.
* Patients must have better visual acuity in the fellow eye than the study eye.
* Subretinal hemorrhage (if any) must comprise no more than 50% of total lesion size.

Exclusion Criteria:

* Patients with concomitant eye disease, including glaucoma, uveitis, diabetic retinopathy, presence of pigment epithelial tears or rips, acute ocular or periocular infection in the study eye.
* Patients with \> 3 prior PDT treatments with Visudyne in the study eye.
* Patients who received PDT in the study eye within eight weeks prior to the baseline angiography/photography.

Primary outcomes:
measure: Complications, including those related to the intravitreal injection, and adverse events, and loss of lines of best-corrected visual acuity, slit lamp findings, lens opacification, intraocular pressure, fundus findings, and laboratory findings.
Secondary outcomes:
measure: Stabilization of visual acuity (prevention of loss of three or more lines on the ETDRS chart), stabilization of lesion size, lack of leakage of lesion, or decrease in subretinal fluid
Other outcomes:
Locations:
city: Morristown
country: United States
facility: OPKO site
state: New Jersey
Study officials:
References:
Clinical trial NCT06420284: Immunological Parameters Between MRONJ Stages
Official title: Characterization of Immunological Parameters in Different Clinical Stages of Medication-Related Osteonecrosis of the Jaw
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Medication-Related Osteonecrosis of Jaw
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for this research comprises adults aged 18 and older, both male and female, who present with medication-related osteonecrosis of the jaw (MRONJ) at the Oral and Maxillofacial Surgery Clinic of Marmara University Faculty of Dentistry. All participants must have provided written informed consent either personally or through a legal representative to be included in the study.

Brief summary: This study aims to conduct a detailed analysis of the immunological response profiles that emerge at different clinical stages of medication-related osteonecrosis of the jaw (MRONJ). The research seeks to understand how these responses influence the pathogenesis, staging, and treatment of MRONJ. Throughout the study, cytokine levels, inflammation markers, and other immunological parameters observed at various stages will be comprehensively assessed. The results of these analyses are expected to provide insights into how stage-specific immunological variables could play a role in the diagnosis and treatment of MRONJ.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 18 and over
* Both male and female participants
* Individuals who apply to the Oral and Maxillofacial Surgery Clinic at Marmara University Faculty of Dentistry due to medication-related osteonecrosis of the jaw during the study period
* Individuals or their legal representatives who have provided written consent to participate in the study

Exclusion Criteria:

* Non-drug-related osteonecrosis/osteomyelitis
* Osteoradionecrosis
* Metastasis to the oral region
* Individuals who have not given written consent to participate in the study

Primary outcomes:
measure: Lymphocyte Proliferation Analysis
timeFrame: Baseline
measure: Apoptosis Analysis in Lymphocytes
timeFrame: Baseline
measure: Cytokine Profile Analysis
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
affiliation: Marmara University Faculty of Dentistry
name: Ferit Bayram, PhD
role: STUDY_CHAIR
References:
citation: Ruggiero SL, Dodson TB, Aghaloo T, Carlson ER, Ward BB, Kademani D. American Association of Oral and Maxillofacial Surgeons' Position Paper on Medication-Related Osteonecrosis of the Jaws-2022 Update. J Oral Maxillofac Surg. 2022 May;80(5):920-943. doi: 10.1016/j.joms.2022.02.008. Epub 2022 Feb 21.
Clinical trial NCT00253084: Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease
Official title: A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: Impax Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with Parkinson's disease.

Detailed description: IPX054 contains two different drugs called levodopa and carbidopa in one tablet.

* levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
* carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with idiopathic Parkinson's disease based on CAPIT (Core Assessment Program for Intracerebral Transplantations) criteria.
* Currently being treated with immediate-release carbidopa-levodopa with a stable dosing regimen over the past 4 weeks.

Exclusion Criteria:

* Diagnosed with atypical parkinsonism.
* Allergic or non-responsive to previous carbidopa-levodopa therapy.
* Active or history of narrow-angle or wide-angle glaucoma.
* History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizure.
* Requires concomitant therapy with tricyclic antidepressants, MAO-B inhibitors, COMT inhibitors or anticholinergics.
* Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 6 months.
* Treatment with any dopaminergic blocking agent within the previous 6 months.

Primary outcomes:
measure: "ON" time without disabling dyskinesias
timeFrame: 2 weeks
Secondary outcomes:
measure: UPDRS analysis
timeFrame: 2 weeks
measure: Mean time to "ON"
timeFrame: 2 weeks
measure: Mean time to "wearing OFF"
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Site 1
state: Illinois
city: Charleston
country: United States
facility: Site 2
state: South Carolina
Study officials:
affiliation: Impax Laboratories, LLC
name: Impax Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06239584: Generation of Lung Tumor Organoids From Patients Undergoing Diagnostic Bronchoscopy
Official title: Generation of Lung Tumor Organoids From Patients Undergoing Diagnostic Bronchoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Generation of Lung Cancer Organoids
Keywords: Organoids.
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First posted: 2024-02-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Interventional (low intervention level), non-pharmacological, prospective, feasibility pilot study of the preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice.

Detailed description: Interventional, non-pharmacological, prospective, feasibility pilot study of the preparation of organoids starting from lung tumor tissue collected during biopsies performed via diagnostic bronchoscopy according to standard clinical practice. This protocol is classified as "interventional" (low intervention level) since that, if possible, an additional quantity of lung tumor tissue will be collected compared to that normally obtained as standard clinical practice, during bronchoscopy, al in order to increase the probability of successful generation of organoids. Involves the prospective recruitment of patients undergoing diagnostic bronchoscopies for suspected lung cancer.

Eligibility criteria: Inclusion Criteria:

* patients with suspected diagnosis of centrally located and accessible lung cancer endoscopically;
* patients for whom it is indicated to undergo in-depth diagnostic testing through bronchoscopy for the purpose of determining the histotype of the lung neoplasm, according to clinical practice standard;
* aged over 18;
* patients who express informed consent to the study.

Exclusion Criteria:

* medical contraindication to taking biopsy samples;
* medical contraindication to carrying out endoscopic investigations;
* patients with suspected lung cancer not accessible endoscopically;
* patients with lung neoformation already subjected to diagnostic sampling;
* contraindications to taking an additional quantity of tissue.

Primary outcomes:
measure: Preparation of at least 10 tumor organoid cultures lung
timeFrame: 12 months
Secondary outcomes:
measure: Correspondence between the generated organoids and the tissue tumor of origin
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
affiliation: IRCCS "Regina Elena" National Cancer Institute
name: Giovanni Blandino, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01189084: Observational Study to Monitor Long-term Immunogenicity and Efficacy of UB 311 Vaccine in Subjects With Alzheimer's Disease
Official title: An Observational Study to the Patients With Alzheimer's Disease Who Previously Received UB311-Treatment in the V118-AD Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
amyloid beta
vaccine
Lead sponsor: United Biomedical
Sponsor class: INDUSTRY
Collaborators: name: Taipei Veterans General Hospital, Taiwan
name: National Taiwan University Hospital
First posted: 2010-08-26
Enrollment: 14
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrolled subjects who received UB 311-treatment in the initial UBI Protocol V118 (Protocol V118-AD) Phase I trial are eligible for continued follow-up to week 48

Brief summary: The purpose of this observational study is to determine whether the vaccine (UB 311), targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's disease (AD) who previously received UB 311-treatment. Amyloid beta was selected as the target antigen based on supporting evidence of the hypothesis that places the accumulation of amyloid beta at the initiating step of AD.


Eligibility criteria: Inclusion Criteria:

* Individuals with mild to moderate Alzheimer's disease who received three (3) injections of UB 311 in the initial Phase I V118-AD trial

Exclusion Criteria:

* Individuals with Alzheimer's disease who are currently on prohibited medications, have severe or uncontrolled systemic disease, or are unable or unwilling to comply with study protocol requirements.

Primary outcomes:
measure: Immunogenicity
timeFrame: 24 weeks
Secondary outcomes:
measure: Efficacy
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital (NTUH)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital (TVGH)
name: Pei-Ning Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital (NTUH)
name: Ming-Jang Chiu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang CY, Finstad CL, Walfield AM, Sia C, Sokoll KK, Chang TY, Fang XD, Hung CH, Hutter-Paier B, Windisch M. Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. Vaccine. 2007 Apr 20;25(16):3041-52. doi: 10.1016/j.vaccine.2007.01.031. Epub 2007 Jan 19.
Clinical trial NCT03824184: Endometrial Assessment of Women With Uterine Infection
Official title: Endometrial Assessment Women With Infertility Who Will do IUI and ICSI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility .

Detailed description: Implantation is the main rate limiting step in IVF outcome. Implantation is described at the cellular and the molecular levels by adhesion or fixation of a good quality embryo to receptive endometrium within a critical period of time, which is called the window of implantation

Eligibility criteria: Inclusion Criteria:

* Women with infertility age from 20-40 years

Exclusion Criteria:

* Any factor of infertility

Primary outcomes:
measure: the number of women who will get pregnant after IUI
timeFrame: within 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03772184: Modified Cervical Inversion During CS in Placenta Previa
Official title: Alalfy Modofied Cervical Inversion During CS in Placenta Previa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Previa
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Suez Canal University
First posted: 2018-12-11
Enrollment: 240
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Using cervical inversion during cesarean section
Primary purpose: PREVENTION

Brief summary: There is an increasing rates of placenta previa nowadays

Detailed description: several techniques were described to control bleeding .

Eligibility criteria: Inclusion Criteria:

* pregnant women 38 weeks or more with placenta previa

Exclusion Criteria:

* pregnant ladies with normally implanted placenta or placenta accreat , increta or percreta

Primary outcomes:
measure: The number of women whose placental bed bleeding will be controlled by cervical inversion cervical inversion
timeFrame: within an hour
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and helwan university
Study officials:
affiliation: National research centre , Aljazeerah hospital
name: Mahmoud Alalfy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02533284: Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy
Official title: Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study the effect of adding Magnesium sulfate to TAP block in analgesia after laparoscopic cholecystectomy.

Detailed description: After approval of local ethical committee, consent will be obtained from 90 patients scheduled for laparoscopic cholecystectomy in GEC center, Mansoura University, Egypt. Patients will be of either ASA I and II, with Age ranging from 18-40 years, and BMI less than 35. Patients will be randomized into 3 groups (using closed envelope technique in blocks of 18); Controlled group (C group), Bupivacaine group (B group), Bupivacaine Magnesium group (M group).

Anesthesia induction will be the same in the three groups (Propofol 1-1.5mglkg, Fentanyl 1 mic/kg, Atracrium 0.5 mg/kg) then Sevoflorane inhalational anesthesia for maintainace in 0.4 oxygen/air mixtures.

In both M group and B group, preemptive US guided Subcostal TAP block (Toshiba Xario, Japan) was performed on both sides using 20 ml volume (0.25 Bupivacaine in B group or 0.25 Bupivacaine plus 0.5 gm MgSo4 in M group). Surgical sterilization will be started 5 minutes after the block and surgery started5 minutes later. Hemodynamic data (HR, MAP) will be collected immediately after induction, at start of surgery, and each 10 minutes later.

At the end of surgery, and after closure of surgical ports, anesthesia was terminated and extubation done when patients fulfilled the required criteria. Postoperative hemodynamic data (HR, MAP), VAS, and PONV will berecorded at 0, 1, 2, 6, 12, 24 hours after surgery, Ramsay sedation was recorded at 0, 1, 2, 6 hours postoperatively. Boluses of Morphine (0.02 mg/kg) will be given whenever VAS ≥4.

Eligibility criteria: Inclusion Criteria:

* ASA I, II for lap cholecystectomy

Exclusion Criteria:

* ASA III, IV

Primary outcomes:
measure: analgesia after laparoscopic cholecystectomy
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dkahleya
Study officials:
References: