louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02315170: Assessment of Novel Intraocular Injection Guide
Official title: Assessment of Novel Intraocular Injection Guide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Disease
Keywords: diabetic retinopathy
age-related macular edema
Lead sponsor: Maturi, Raj K., M.D., P.C.
Sponsor class: INDIV
First posted: 2014-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine if a novel intraocular injection guide (IIG) reduces patient discomfort during and after intravitreal injections.

Detailed description: This study is being conducted to assess the potential for an intraocular injection guide to increase comfort levels both during and after such injections. The hypothesis is that patients will feel increased comfort from a device which eliminates the need for a speculum while still keeping the eyelids apart, allowing a physician to deliver treatment. The results of this study will allow physicians to select the optimal device for patient comfort and well-being during intravitreal injections

Eligibility criteria: Inclusion Criteria:

* Subjects must be receiving bilateral injections of the same dose of vascular endothelial growth factor (VEGF) inhibitor
* Injections in both eyes must be given on the same day
* Male or female age 18 years or older

Exclusion Criteria:

-Any condition or reason that precludes the subject's ability to comply with the study -

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: one time for about 30 sec or less
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Raj K Maturi MD PC
state: Indiana
Study officials:
affiliation: Raj K. Maturi, MD, PC
name: Raj K Maturi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06230770: Impact of Progestin-only Contraception on Bleeding Patterns in Individuals Initiating GATT
Official title: The Impact of Progestin-only Contraception on Bleeding Patterns in Individuals Initiating Testosterone Therapy for Gender Affirmation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gender
Contraception
Keywords: progestin
testosterone
gender-affirming
bleeding
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll 160 participants who are English-speaking, at least 18 years old, currently have a uterus and ovaries, desire to initiate GATT, and potentially desire to initiate a progestin (within 14 days of GATT initiation). To ensure generalizability of results, participants with baseline irregular bleeding will not be excluded.

Participants who have recently initiated a progestin may be eligible for inclusion. Participants who have had gender-affirming surgery to remove their uterus and/or ovaries will not be eligible for inclusion.

We will recruit participants from clinics in San Diego that prescribe GATT, including the UCSD OBGYN clinic, two UCSD Gender Health program affiliated clinics, and UCSD Student Health Services.

Brief summary: Gender diverse individuals who use gender-affirming testosterone therapy (GATT) to reduce gender dysphoria may also use progestins for contraception and to manage or suppress uterine bleeding. Research is limited, however, regarding expected bleeding patterns for individuals who choose to initiate GATT concurrently with a progestin. Clinicians who prescribe GATT do not have sufficient data to adequately counsel patients on side effects of concurrent progestin use and therefore extrapolate from studies conducted in cisgender women. This study is a prospective cohort study evaluating bleeding patterns and satisfaction among patients initiating GATT with or without concurrent initiation of a progestin contraceptive. The results from this study will enable clinicians to more accurately counsel patients using GATT on how the use of a progestin might affect their bleeding and whether this differs by progestin method.


Eligibility criteria: Inclusion Criteria:

* English-speaking currently have a uterus and ovaries
* desire to initiate GATT
* potential desire to initiate a progestin (within 14 days of GATT initiation)

Exclusion Criteria:

* previous gender-affirming surgery to remove their uterus and/or ovaries

Primary outcomes:
measure: Mean days bleeding or spotting
timeFrame: Start of GATT to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: UC San Diego
name: Kelsey Loeliger, MD. PhD
role: STUDY_DIRECTOR
affiliation: UC San Diego
name: Sarah Averbach, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06165770: Cornual Pregnancy: Results of a Single-center Retrospective Experience and Systematic Review on Reproductive Outcomes
Official title: Cornual Pregnancy: Results of a Single-center Retrospective Experience and Systematic Review on Reproductive Outcomes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ectopic Pregnancy
Keywords: cornual pregnancy
ectopic pregnancy
laparoscopy
methotrexate
fertility
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Cornual pregnancy aged ≥ 18.

Brief summary: To present our experience in the diagnosis and management of cornual pregnancy. A systematic review was also conducted to investigate reproductive outcomes after treatment.


Eligibility criteria: Inclusion Criteria:

* age ≥18 years;
* patients with a diagnosis of cornual pregnancies.

Exclusion Criteria:

* All patients whose medical records did not contain the data deemed necessary for study analysis or who did not consent to the publication and use of their data;
* Other type of ectopic pregnancies.

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 2 years
measure: ongoing pregnancy rate
timeFrame: 2 years
measure: miscarriage rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02932670: Minimum Effective Volume of Lidocaine Costoclavicular Brachial Plexus Block
Official title: Minimum Effective Volume of Lidocaine for Ultrasound-Guided Costoclavicular Infraclavicular Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Extremity Surgery
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the minimum effective volume of lidocaine in 90% of patients (ED90) required for single-injection US-guided costoclavicular infraclavicular.

Detailed description: The aim of this study is to determine the minimum effective volume of lidocaine in 90% of patients (ED90) required for single-injection US-guided costoclavicular ICB. Determination of the minimum effective volume of LA is important because it prevents the administration of an unnecessarily large (and potentially toxic) dose. Furthermore, when multiple blocks need to be performed at the same time in the same patient, knowledge of the minimum effective volume allows to the operator to preserve efficacy without sacrificing safety for each block.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 70 years
* American Society of Anesthesiologists classification 1-3
* body mass index between 20 and 30

Exclusion Criteria:

* adults who are unable to give their own consent
* pre-existing neuropathy (assessed by history and physical examination)
* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine≥ 100)
* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases≥ 100)
* allergy to local anesthetics
* pregnancy
* prior surgery in the infraclavicular region
* chronic pain syndromes requiring opioid intake at home

Primary outcomes:
measure: success rate
timeFrame: 0-30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: De QH Tran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sotthisopha T, Elgueta MF, Samerchua A, Leurcharusmee P, Tiyaprasertkul W, Gordon A, Finlayson RJ, Tran DQ. Minimum Effective Volume of Lidocaine for Ultrasound-Guided Costoclavicular Block. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):571-574. doi: 10.1097/AAP.0000000000000629.
Clinical trial NCT06612970: A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants
Official title: A Phase 1a, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0056 in Adult Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Keywords: HB0056
Lead sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.

Detailed description: This is a single-dose escalation study of HB0056 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0056.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects age ≥ 18 and ≤ 55 years.
* Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m².
* Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion Criteria:

* History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
* Current or history of malignancy. • Family history of premature Coronary Heart Disease (CHD)
* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
* Pregnant or Breasting feeding subject. Women with a positive pregnancy test .
* Further exclusions criteria applied.

Primary outcomes:
measure: Percentage of subjects with drug related adverse events (AEs)
timeFrame: Up to 2700 hours
Secondary outcomes:
measure: Cmax
timeFrame: Up to 2700 hours
measure: AUC0-infinity
timeFrame: Up to 2700 hours
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: New Zealand Clinical Research
Study officials:
affiliation: New Zealand Clinical Research
name: Cory Sellwood
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02390570: Incorporating Patient Capacity Into the Clinical Landscape
Official title: Incorporating Patient Capacity Into the Clinical Landscape
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Patient Capacity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is designed to answer why "patient capacity" (i.e. patient available abilities and resources to enact self-care and access healthcare) is not regularly documented in the Electronic Medical Record (EMR) in a way that is useful for clinicians.

Through the implementation of communication tools designed for patient capacity assessment and engagement of stakeholders in a process of user-centered design, the study team hypothesizes that the study can help clinicians elicit this information in conversation and regularly document it in the medical record for future healthcare discussions.


Eligibility criteria: Inclusion Criteria:

* Patients who have one or more chronic condition and do not have any barriers to consent (such as major cognitive disabilities) will be eligible for enrollment.

Primary outcomes:
measure: Number of resource limitations measured by medical record review
timeFrame: Baseline up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kasey Boehmer, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boehmer KR, Dobler CC, Thota A, Branda M, Giblon R, Behnken E, Organick P, Allen SV, Shaw K, Montori VM. Changing conversations in primary care for patients living with chronic conditions: pilot and feasibility study of the ICAN Discussion Aid. BMJ Open. 2019 Sep 3;9(9):e029105. doi: 10.1136/bmjopen-2019-029105.
Clinical trial NCT03628170: Soft Tissue Profile Following Socket Preservation With Platelet Rich Fibrin Versus Free Gingival Graft
Official title: Evaluation of the Soft Tissue Profile Following Socket Preservation With Platelet Rich Fibrin Versus Free Gingival Graft: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Soft Tissue Mass
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing socket preservation with Platelet -Rich Fibrin versus Free gingival graft.

Detailed description: Extraction of the non restorable tooth, then socket preservation is applied in experimental group using platelet rich fibrin, while in comparative group free gingival graft is applied with socket preservation.

Eligibility criteria: Inclusion Criteria:

* Age range 25-50 years.
* Non- restorable teeth indicated for extraction.
* Good oral hygiene.
* Intact facial and lingual plates of bone, without infection or pathosis.
* Adequate apiacl bone for primaru stability

Exclusion Criteria:

* Presence of uncontrolled Systemic disease eg: diabetes, bone disease or the use of medicines that interfere with bone metabolism, history of head and neck radiotherapy.
* Presence of periodontal and/or periapical infection.
* Smokers.
* Non-compliant patients.
* Pregnancy or lactation in females.
* History of head and neck radiotherapy.

Primary outcomes:
measure: Soft tissue profile change
timeFrame: 6 months
Secondary outcomes:
measure: Crestal bone level change
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and dental medicine, Cairo University
Study officials:
References:
Clinical trial NCT01917370: VEGF Signaling Promotes Cell Growth and Metastasis in Intrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway
Official title: VEGF Signaling Promotes Cell Growth and Metastasis in Intrahepatic Cholangiocarcinoma in a VEGF
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: intrahepatic cholangiocarcinoma
icc
vegf signal pathway
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Guangdong Province, Department of Science and Technology
First posted: 2013-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: intrahepatic cholangiocarcinoma patients underwent surgical therapy

Brief summary: The investigators study the VEGF signaling in ICC cell lines／human tissues and its mechanism in HCC growth, proliferation and apoptosis.

Detailed description: Several studies have documented the elevated expression of VEGF and its receptors in ICC cell lines and tumor tissues. Another study observed that the elevation of VEGF promotes the growth. Clinical analyses have discovered the high expression of VEGF is correlated with tumor progression, vascular invasion, distal metastasis and poor prognosis. However, few studies have been conducted to investigate the VEGF signaling in ICC cells and its possible mechanism in regulating ICC growth.Therefore,we try to clarify the mechanism of VEGF signal in ICC growth,proliferation and apoptosis.

Eligibility criteria: Inclusion Criteria:

1. hepatocellular patients diagnosed through biopsy;or either dynamic imagine with a diagnosis of intrahepatic cholangiocarcinoma and CA199\>100U/L；or two or more dynamic imagine with a diagnosis of intrahepatic cholangiocarcinoma
2. Child-Pugh A or B
3. well preserved renal and hematopoietic Function
4. receive complete surgical therapy
5. achieve complete section accessed by contrast-enhanced CT

Exclusion Criteria:

1. incomplete section
2. Child-Pugh C
3. combination with other hepatobiliary disease
4. suffer from other tumors concurrently or in last five years

Primary outcomes:
measure: the variation of the quantity of VEGF signal pathway genes in normal liver tissue,peri tumor,tumor and metastasis.
timeFrame: the day when conducting surgery (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Ming Kuang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01507870: Randomized Controlled Prospective Multicenter Study Primary Onlay- Mesh After Elective Median Laparotomy in Patients With BMI ≥ 27
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Incisional Hernia
Obesity
Keywords: body mass index
Lead sponsor: Austrian Hernia Study Group
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Incisional hernia is one ot the most frequently seen long term complications in abdominal surgery. Despite studies on the optimal suturing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. One major risk factor for incisional hernia after a median laparotomy is obesity.

The closure technique of midline incisions has remained unchanged since many decades and primarily consists of suturing the linea alba. Interest in prevention of incisional hernias with the aid of synthetic mesh is growing and only one large randomized trial is active recruiting patients in Germany, Netherlands and Belgium (Prima Trial).

Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after midline incision with an incidence of 22% after 12 months. This high risk group of patients may benefit from prevention.

Some small studies have been performed to evaluate the usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk for incisional hernias and a low infection rate, even when used in contaminated wounds such as colostomy surgery.

The goal of this study is to evaluate the effectiveness of incisional hernia prevention after elective median laparotomy in patients with a BMI of more than 27. A randomized controlled trial will be performed comparing the commonly used technique of running suture to close with the aid of a prosthetic onlay mesh. The primary outcome measure will be incisional hernia occurrence. Secondary outcome measures will be complications, surgical site infections, post-operative pain and quality of life.


Eligibility criteria: Inclusion Criteria:

* Every elective midline laparotomy for patients with a BMI of more than 27. Signed informed consent

Exclusion Criteria:

* Age \< 18 years
* Emergency procedure
* Inclusion in other trials
* Previous midline incision
* Life expectancy less than 24 months
* Pregnant women
* Immune suppression therapy within 2 weeks before surgery

Primary outcomes:
measure: incisional hernia occurrence
timeFrame: 3 years
Secondary outcomes:
measure: complications
timeFrame: 3 years
measure: postoperative pain
timeFrame: 14 days postoperative
measure: life quality
timeFrame: 14 days postoperative
Other outcomes:
Locations:
city: Wiener Neustadt
country: Austria
state: Lower Austria
Study officials:
References: